Vascular valves and servovalves - and prosthetic disorder response systems

Abstract

Set forth are the structure, function, placement, and applications of vascular valves and servovalves. In the vascular tree, the diversion, shunting, and bypass of flow these provide allow solid organ transplantation which eliminates anoxia and graft organ degradation following harvesting and storage, likely including late term cardiac allograft vasculopathy. Along the lower urinary tract, the diversion of urine from damaged ureters to the native or an artificial bladder or collection bag alleviates problems of intractable urinary incontinence, nocturia, overactive bladder, and frequent urination. Where the lower tract is missing, the synthetics in a valve-based prosthesis preclude infection and degenerative metaplastic transition which can result in malignancy when gut is used to construct a neobladder and/or high maintenance stoma. Accessory channels in side-entry valves and servovalves allow the direct pipe-targeting of medication to sites of disease, anastomoses, or any other trouble spots.

Claims

1. A device selectively positionable about a tubular anatomical structure, said structure itself the product of nature and not claimed, for delivering drugs, passing cabled devices into, and extracting luminal contents and biopsy tissue samples from within the lumen of said tubular anatomical structure comprising: an outer shell of semicylindrical halves joined together along a common edge where these meet by spring loaded hinges, so that said semicylindrical halves when opened and placed to encircle said tubular anatomical structure, the halves grip about said tubular anatomical structure as a stationary collar wherein; a cushioning layer to protect the small nerves and vessels that enter and depart from the outer surface of said tubular anatomical structure lines the internal surface of each said shell half; perforations which pass entirely through said outer shell and said internal cushion lining are placed to give access to the internal environment of said tubular anatomical structure; an opening in the side of said collar into which a side tube with trepan front edge can be inserted, said side tube rotatable around and reciprocable along its longitudinal axis, allowing a plug of tissue to be excised from the wall of said tubular anatomical structure so that the lumen of said side tube will be continuous with the lumen of said tubular anatomical structure; said side tube fixable in rotational angle and depth of penetration into the side of said tubular anatomical structure; a self-locking screw down cap with internal expansion bushing that fits onto an external thread at the base of said side tube allows said side tube to be fixed in rotational angle and depth of insertion into said side opening. a projectable and retractable tongue-shaped diversion chute with upturned distal end mounted within said side tube with trepan front edge wherewith to slide reciprocally to selectively positional depths into said tubular anatomical structure so that the column of bodily fluid antegrade to it is diverted out through said side hole and said trepan tube for continued flow through a synthetic tube, said combination of elements comprising a vascular valve.

2. A valve according to claim 1 where said tongue is driven by a solenoid.

3. A valve according to claim 1 where said tongue is driven by a servomotor.

4. A valve according to claim 1 which incorporates a permanent magnet layer along the internal surface of said outer shell, said magnet layer interposed between said outer shell and said cushion layer and interrupted to accommodate the opening and closing of said collar and the passing through of said perforations, said magnet layer magnetized to exert a tractive force centrally toward and perpendicular to the longitudinal axis of said collar, making possible the detention and extraction of magnetically susceptible luminal contents.

5. A valve according to claim 1 which incorporates a plurality of electromagnets between said outer shell and said cushion layer and interrupted to accommodate the opening and closing of said collar and the passing through of said perforations, said plurality of electromagnets selectively energizable to exert tractive force eccentrically and collectively energizable to exert tractive force centrally toward and perpendicular to the longitudinal axis of said collar, making possible the detention and extraction of magnetically susceptible luminal contents.

6. A valve according to claim 1 which omits said perforations and incorporates a layer of radiation shielding material in concentric relation to said long axis of said collar, said radiation shield layer situated along the internal surface of said outer shell to surround said magnet layer when present, and interposed between said outer shell and said cushion layer when said magnet layer is absent, said radiation shield layer interrupted to accommodate the opening and closing of said collar, said radiation shield layer serving to allow the passage through said collar and the line leading to it of low to moderate radiation dose rate radionuclides and radioactive isotopes without causing radiation injury to surrounding tissue.

7. A valve according to claim 1 wherein said side tube is in turn entered by a catheteric side tube subsidiary to said side tube, said subsidiary side tube allowing the directly targeted delivery into said side tube, collar, and native lumen, hence, treatment site, of fluid drugs, medicinal solutions, and tubing maintenance solutions, such as ureterolith and nephrolith solvents when said collar is applied along the urinary tract and antithrombotic medication when said collar is applied along the vascular tree.

8. A plurality of vascular valves according to claim 1 wherewith at least one pump supplying fluid medicinals to said diversion jackets is controlled according to a prescription program by a microcontroller such that: a plurality of physiological parameter sensors implanted at different locations in the body send outputs as subordinate negative feedback loop nodes in a hierarchical control system to said microcontroller as master node; these outputs represent feedback where each signals to the microcontroller an out of range condition which necessitates the prescribed medication; the microcontroller responds by causing said pump to index to and release the medication prescribed for that subordinate node in the dose proportional to the out of range feedback signal received; as master node, the microcontroller governs the discharge of the prescription program to include dispensing the medication through each subsidiary control loop as a subordinate node in a coordinated manner as governed by the prescription program so that dosing among the nodes is interrelated to attain the highest possible overall homeostasis; such a system overall thus able to treat comorbid conditions affecting different organ systems in a coordinated manner as an automatic homeostasis stabilizer and ambulatory prosthetic disorder response system.

9. The method of solid organ transplantation from a brain-dead organ donor placed on life support prior to and continued following death to an organ recipient through the seamless transfer of the organ blood supply and drainage from the recipient to the donor, the donor organ then harvested and placed in the recipient.

10. The method according to claim 9 whereby different organs are transplanted into an organ recipient through the seamless transfer of the organ blood supplies and drainages from the recipient to the donor.

11. The method according to claim 9 whereby different organs are transplanted into different recipients through the seamless transfer of the organ blood supplies and drainages from the recipients to the donor.

12. The method of transplanting one of a paired solid organ from a living organ donor to an organ recipient through the seamless transfer of the organ blood supply and drainage from the recipient to the donor.

13. The method of transplanting one of a paired solid organ from each of two living organ donors to an organ recipient through the seamless transfer of the organ blood supply and drainage from the recipient to the donor.

14. The method according to claims 9 thru 13 where this procedure is carried out under regional anesthesia without the need for cardiopulmonary bypass.

15. The method according to claims 9 thru 13 whereby said transfer of circulation is administered by an automatic control system comprising connectors to ductus and tissue surfaces, said connectors incorporating access channels for the direct delivery of drugs, synthetic fluid lines that deliver the drugs into the access channels, drug reservoirs to store the drugs,

Description

5. DESCRIPTION OF THE DRAWING FIGURES

[0872] FIG. 1 shows a nonadjustable flow-diverting basic side-entry jacket as described in copending application Ser. No. 15/998,002, entitled Ductus Side-entry Jackets and Prosthetic Disorder Response Systems, positioned along the substrate ductus prior to insertion of the trepan tube through the wall of the lumen.

[0873] FIG. 2 shows a simple urinary flow diversion jacket adjustable by the operator during placement but not afterwards by the patient, such a diversion-irreversible, or nominally fixed embodiment serving as the ureteral takeoff in a prosthesis such as that shown in FIG. 28 for a patient without a functioning lower urinary tract.

[0874] FIG. 3 is a cross section through side-stem 19 taken along line A-A′ of the diversion jacket shown in FIG. 2A. shows

[0875] FIG. 4 shows a forked vessel segment-straddling spring-return double clamp, or straddle-clamp, for briefly stopping flow through a small segment along a blood vessel shown clamped to stop the flow of blood with the segment to be jacketed trapped with blood, thereby facilitating placement of a side-entry jacket, choke valve, or vascular valve thus averting the difficulty of extracting the tissue plug for insertion of the trepan tube when, for example, obstructed due to the presence of a diversion chute in the trepan tube

[0876] FIG. 5 shows a urinary diversion valve, manually adjusted by turning a control knob on a small body surface port, where the control knob is connected to a push\pull control cable positioned to drive the diversion chute forward or backward.

[0877] FIG. 6 provides a cross sectional view along line B-B′ through the diversion valve shown in FIG. 5.

[0878] FIG. 7 is a longitudinal midline sectional view through a flow diversion jacket only capable of fully retracted or extended deployment of the diversion chute, for use along the vascular tree, where a plunger solenoid makes it possible for the operator to deploy multiple diversion chutes simultaneously as is required, for example, in a sudden switch heart transplant, shown with the solenoid positioned to have pushed the flow diversion chute to full extension for full flow diversion.

[0879] FIG. 8 shows a flow diversion jacket of the kind shown in FIG. 7, except that the solenoid is reversed in positioned to pull, rather than push, the diversion valve, this configuration placing the plunger solenoid beneath rather than in line with the accessory channel line used to advance the diversion chute, allowing the jacket to be made shorter, shown with flow diversion chute fully extended for full flow diversion.

[0880] FIG. 9 shows a pulse tubular linear servomotor suitable for miniaturization for positioning in a vascular servovalve.

[0881] FIG. 10A provides a longitudinal midsection through a vascular servovalve driven by a pulse tubular linear servomotor of the kind shown in FIG. 9 with the addition of a direct manual fine adjustment feature which allows the operator to apply minor adjustments in retraction or extension of the diversion chute with ostium obturator into the substrate native lumen. FIGS. 10B and 10C illustrate how the one control knob allows separate control over engagement of the direct manual fine adjustment device as required in a carotid endarterectomy bypass device, FIGS. 10A and 25A and 25B showing such a vascular servovalve with divided outlet, FIG. 10D providing a more detailed cross sectional view of the mechanism shown in FIGS. 10B and 10C, and FIG. 10E providing a more detailed view of the miniature endoscopic-type grasper used to stabilize the piece used to connect the detachable manual fine control device to the servomotor housing before and after the servovalve is placed along the substrate vessel.

[0882] FIG. 11 shown the use of diversion valves to exchange (switch, ‘swap’) the continuation of flow between two vessels as in an extracardiac transposition of the great arteries within one patient or between corresponding vessels in two patients.

[0883] FIG. 12 shows the use of bidirectional side-entry diversion servovalves to take the place of separate valves where, as in neonates and infants, space is at a premium.

[0884] FIGS. 13A and 13B show paired bidirectional diversion jackets without duplication along the same ductus at a nearby level in FIG. 13A and with duplication in FIG. 13B to allow flow to periodically be switched between the upper and lower pairs when, for example, permanent placement along the forcefully pulsatant great arteries to correct a transposition where an extracardiac repair is practicable but a levering movement of the valve, even though stabilized through use of the suture loops, could cause irritation.

[0885] FIG. 14 provides a longitudinal section through a vascular choke servovalve, or servochoke.

[0886] FIG. 15 is a simplified schematic representation of a metered switch transplantation, where the positions of the diversion chutes are set at the midway point of extension in either a metered switch orthotopic or heterotopic heart transplant, which in a metered switch heterotopic double heart transplant represents the setpoint when the heart of the donor matches that of the recipient in absolute stroke volume, or ejection fraction.

[0887] FIG. 16 elaborates upon the simpler schematic provided in FIG. 15 in showing that in a heterotopic switch, or double heart, transplant as exemplary for a heterotopic switch transplant, flow through the graft organ is channeled normally through all the organ arteries and veins, eliminating disuse atrophy as occurs when the graft is connected to the abdominal aorta and inferior vena cava as is commonly done in immunological laboratory testing, for example.

[0888] FIG. 17 shows the positions of the hearts in a completed double heart heterotopic bypass, or switch transplant, the added heart placed to the right hand side of that native as preferred and showed in FIGS. 15 and 16, for visual clarity, flow between only the native and added aortae, lower venae cavae, and lower right pulmonary veins shown.

[0889] FIGS. 18A and 18B show the action of the arterial blood flow diversion chutes in a sudden switch organ transplantation wherein each solenoid driver moves its flow diversion chute from the fully retracted position shown in FIG. 18A to the fully extended position shown in FIG. 18B whereby flow is bypassed from the native heart on the right and through the donor organ on the left.

[0890] FIGS. 19A and 19B show the action of the venous blood flow diversion chutes in a sudden switch organ transplantation wherein each solenoid driver moves its flow diversion chute between the fully retracted position shown in FIG. 19A whereby flow is through the native organ to the fully extended position shown in FIG. 19B whereby flow is bypassed from the native and through the donor organ.

[0891] FIGS. 20A and 20B show the action of the arterial blood flow diversion chutes in a metered switch organ transplantation wherein each servomotor driver moves its respective flow diversion chute between the fully retracted position in FIG. 20A, through the intermediate position in FIG. 20B, to the fully extended position in FIG. 20C under sensor feedback indicative of an adverse immune response to the controller, programmed to halt or slow down the process until spontaneously or medicinally resolved.

[0892] FIGS. 21A, 21B, and 21C show the action of the venous blood flow diversion chutes in a metered switch organ transplantation wherein each servomotor driver moves its flow diversion chute between the fully retracted position shown in FIG. 21A, through the intermediate position shown in FIG. 21B, to the fully extended position shown in FIG. 21C under sensor feedback indicative of an adverse immune response to the controller, programmed to halt or slow down the process until spontaneously or medicinally resolved.

[0893] FIGS. 22A and 22B show the disposition of the jackets and bloodlines before the exemplary left lung as graft organ has been harvested from the donor in FIG. 22A and after it has been placed in the recipient in FIG. 22B.

[0894] FIGS. 23A, 23B, 23C, 23D, and 23E provide a perspectival overall view in FIG. 23A, an overall side view in FIG. 23B, a closer side-view in FIG. 23C to show the near side of a surgical chestdome with surrounding cast iron weight and foam base hid behind the arm of the patient in FIG. 23A, an upper, superior or topside, view in FIG. 23D, and a bottom or foot-ward (inferior, caudad) view in FIG. 23E, of a surgical chestdome to be placed over the chest of the patient prior to entry into the chest for eliminating a surgical pneumothorax without general anesthesia and little if any mechanical ventilatory support.

[0895] FIG. 24 shows an anterior, or frontal view of a heart cage to protect a metered switch heterotopically transplanted second heart with inflow and outflow vessels from compression and the heart from tamponade when positioned outside the ribcage or otherwise left not sufficiently shielded by bone.

[0896] FIG. 25A shows a double, and FIG. 25B a single bypass, intended primarily to implement a carotid endarterectomy, which—depending upon the state of degenerative disease or surgical or accidental trauma—can be used as a permanent prosthesis, or an alternative pathway switched to during healing, for example, or as a periprocedural bypass, to accomplish the endarterectomy without ischemia, fluctuations in blood pressure, and reduced incidence of cardiovascular accidents to include those due to a release of debris that could result in an intra- or postoperative stroke, or a cerebral or even a myocardial infarction, positioning of the valves drawn side-on to the plane of section for clarity, even though the valves are actually rotated to least encroach upon neighboring structures.

[0897] FIGS. 26A, 26B, and 26C show a vertical sectional side view of an entirely below-skin (subcutaneous, subdermal) surface port 146 not requiring an outflow opening as does a urological port, with multiple openings for the injection of drugs into their respective implanted drug reservoirs for automatic release, or when the reservoir and pump are omitted as in line K to a kidney, for blood to be withdrawn for diagnosis, and in FIG. 26B a rear view of the subcutaneous multiport shown in FIG. 26A, while FIG. 26C shows a port 147 which includes both a subcutaneous drug inlet and central above-skin scope inlet and urine outlet openings.

[0898] FIG. 27A shows a front view of a manually operated four head hypodermic syringe injector and FIG. 27B the equivalent multiple jet injector (needle-free injector, pneumatic injector) for allowing the simultaneous replenishment of drug reservoirs through a surface port of the type shown from outside the body in FIGS. 17 and 27C, wherein the openings are positioned complementary to the injection points of either type multiple injector with minimal discomfort for the patient and the risk of human error considerably reduced if not eliminated. FIG. 27C shows the external tattooed markings placed to assure precise alignment of the hypodermic needle or jet injector nozzles with the injection openings in the subcutaneous port. Multiple nozzle jet injectors of which the nozzles are designed or adjustable to release drugs of different viscosities are omitted from the drawings as familiar to medical personnel.

[0899] FIG. 28 provides a schematic anterior view of a bilateral automatic urine collection and voiding prosthesis using one-time manually set valves such as those shown in FIGS. 2 and 3 or solenoid-driven valves such as shown in FIGS. 7 and 8 for permanent placement in a patient with a missing or defective lower urinary tract and therefore missing urge sensation, to divert the effluent into a synthetic or surgically constructed neobladder, thence or directly into a paracorporeal collection bag.

[0900] FIG. 29 shows a more detailed view of a neoureter confluence chamber, or synthetic neobladder, such as that shown in FIG. 28 for catching urine for automatic expulsion into a paracorporeal collection bag when filled.

[0901] FIG. 30 provides a schematic anterior view of a bilateral automatic urine collection and voiding system for a patient having urge sensation with nocturia or frequent urination, for example, whose sleep is interrupted by frequent urination intractable to conventional treatment, or for a public performer who must defer voiding until a proper receptacle can be used or drainage diverted to a collection bag voluntarily, where voiding is controlled manually by the user who rotates knobs mounted to a side of the mons pubis or mons veneris which advance and retract push/pull, or Bowden cables used to adjust valves of the type shown in FIGS. 5 and 6 or servovalves such as shown in FIG. 10A but without the fine adjustment device.

[0902] FIGS. 31A and 31B show a nonadjustable ductus flow diversion coupling for insertion into a vessel other than a carotid, jugular, or coronary or into a ureter for diverting flow into a synthetic shunt or bypass, FIG. 31A providing a front view, and FIG. 31B a perspectival view looking down at an angle toward the diverter showing the outflow pattern of a drug delivered into the space between the inner and outer tubes through the opening beneath each upwardly convex prong.

6. DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION

Valves—FIGS. 1 Thru 3, 5 Thru 8, and 10 Thru 14

[0903] To allow the internal structures to be shown clearly, valves have been drawn disproportionately large, prompting an impression of excessive size and weight. Each type valve has also been shown with every element necessary to deal with any potential application. In reality, not all of these features are likely to be needed for a specific application, so that the cost for specific valves will be less than the drawings suggest. To prevent backfilling with blood and the possibility of obstruction by clot, accessory channels along blood flow passageways are filled with water and/or provided with an anticoagulant drip. The implanted controller adjusting the diversion chutes, water fill and the release of an anticoagulant are coordinated automatically.

[0904] In FIG. 1 showing a basic side-entry jacket, number 1 is the lumen of the substrate ductus to be jacketed, and 2 the wall surrounding the lumen, both products of nature and not part of the invention. Number 3 is the outer shell of the basic side-entry jacket, usually made of polyether ether ketone, 4 a viscoelastic polyurethane foam layer lining shell 3 containing perforations along its length to avert atheromatous degeneration of the encircled ductus. The adventitia-protective open cell viscoelastic polyurethane foam lining the valve jackets shown in FIGS. 1, 2, 3, 5, 7, 8, and 10A are thoroughly wetted with an anti-inflammatory, immunosuppressive, and/or antimicrobial upon placement which is periodically replenished through accessory channel 8′.

[0905] Represented entering perpendicularly into the foam for visual clarity, entry is equally effective when the proximal end of accessory channel 8′ is inserted along ‘breathing hole’ perforation 40 running about the circumference of sidestem 19, shell 3 necessarily interrupted by solid segments for structural integrity. Part number 5 is the trepan tube with razor sharp leading front edge 6, which in a basic side-entry jacket, unlike a diversion valve jacket, requires no stationary surrounding tube to house and align driving means such as a miniature solenoid or linear servomotor, so that it alone comprises jacket side-stem 19. Features common to all valves are that to eliminate abrasive and poking of neighboring tissue, all corners and edges are rounded.

[0906] Little heat is generated or conducted through the motor enclosure to surrounding tissue. If necessary, the entire valve is further enclosed within a sock made of a soft biocompatible thermally insulating material to provide both increased freedom from abrasive encroachment on neighboring tissue as well as reduce any heat which the servomotor might generate. The basic ductus side-entry jacket shown In FIG. 1 lacks a magnetic envelope to draw superparamagnetic micro- or nanoparticle carrier-bound drugs from the passing luminal contents and/or a radiation shielding envelope sufficient to protect surrounding tissue against moderate dose-rate radionuclides, for example.

[0907] Valves of which the function would best allow direct observation by the operator of their internal function are made of a clear transparent plastic which provides thermal insulation as well. Suitable polymers include those biocompatible based upon poly(aryl-etherethereketone) or PEEK, polyethylene, and polyethylene terephthalate, for example. To facilitate endoscopic examination should the need arise, valves are best made with a polymer of high optical clarity. Vascular servovalves used to create a compound bypass to transfer a solid organ from the donor to the recipient are shown in FIGS. 10A, 25A, and 25B, FIGS. 10A thru 10E, 25A, and 25B also showing the addition of a direct manual fine control device that allows the operator to make small shifts in chute position to assure complete obturation of the ostium by the ostium obturator as necessary.

[0908] For example, when the diversion chute is passed through the ostium created in the side of the substrate ductus, the obturator (ostium obturator, stopper) is likely to fully open a tiny distance from the proximal wall of the ductus through which it was inserted. Enclosed within clear transparent plastic, the direct manual fine control adjustment device allows the operator to retract the ostium obturator that tiny distance so that the ostium obturator rests flush against the ostium, thus preventing blood from exiting through the ostium and into the protective foam or the trepan tube.

[0909] Unless an open surgical field is necessary for unrelated reasons, vascular valves are placed endoscopically. Part number 6 is the razor sharp leading edge of the surgical circle cutter, or trepan itself, of trepan tube 5. Lacking the ductus side-entry opening, or ostium, obturator, of a valve jacket, a basic side-entry jacket minimizes bleeding when the tissue plug is extracted by directing a circular jet of water over the ostium through water jacket 7 fed through water jacket inlet 7′ sideline, and accessory channel, 8.

[0910] In any instance where the valve or servovalve jacket accessory channel or channels incorporated into the jacket such as those shown in FIGS. 2, 5, 7, 8, and 10 numbered 8 or 8′ are insufficient to deliver the volume or number of drugs sought to be directly pipe-targeted to the treatment site, a separate basic ductus side-entry jacket is positioned upstream to make up the difference. Immediately after the jacket has been placed in position, accessory channel 8 becomes available for delivering drugs, for example.

[0911] The ostium is cut by a suction pump connected to trepan tube 5, the suction passing through the luminal continuum comprising an attached catheteric line, or mainline 9 connected to trepan tube 5 in the sidestem 19. Trepan tube 5 is encircled and travels within side-stem 19. absent an accessory channel, part number 8 is a small handle to advance diversion chute 18; when an accessory channel is present, 18 is its conduit.

[0912] The application of suction against ductus wall 2 through trepan tube 5 draws ureteral wall 2 past trepan 6, excising a tissue plug from the side of ureteral wall 2. The suction pump has a limit switch that instantly stops the pump when the resistance to suction suddenly drops off and the water jet minimizes bleeding while continued suction and if necessary, a guidewire with hooked distal end is used to extract the plug. If for any reason—such as an hydroxyapatite plaque cap is encountered—plug excision is resisted, the operator can loosen locking nut 10 to rotate and reciprocate trepan tube 5.

[0913] Once trepan 6 is aligned to the inner surface of ductus wall 2, locking nut 10 is tightened to lock trepan tube 5 in position. Vascular diversion jackets, valves, and servovalves are unique in shape factor and in perforative, flow diversionary, and accessory channel features but not in terms of driving means, which are miniaturized versions of solenoids and tiny servomotors, mechanisms well known to mechanical and electrical technicians and engineers. Nonadjustable and limited to use as static flow diversion means, manually applied diversion jackets have no driving means. In the vascular tree, these are positioned at the inlets into bypasses and shunts that require no adjustments in flow rate.

[0914] Manually operated urinary valves such as used in a ureter-to-collection bag diversion prosthesis usually employ simple mechanical controls for adjustment such as push\pull, or Bowden cables, but can just as well use a remotely controlled solenoid, for example, especially if to route the Bowden cables creates the potential for strangulating intervening tissue. In order from most to least simple, vascular jackets include fixed flow diversion jackets, manually controlled bistable flow nondiverted-flow diverted valves, such valves and chokevalves when solenoid driven, and continuously variable servovalves under automatic control by an implanted sensor-fed microcontroller or microprocessor.

TABLE-US-00003 TABLE 1 Servo diversion and choke valve-jackets. Diversion valve Choke valve controllable controllable all or nothing fraction fraction Chute yes yes yes—must be manually or servo-driven Dome no yes, but not yes zero flow Cone no Yes, but not zero yes flow Driver manual if no manual or linear manual or linear more than three servomotor servomotor solenoid if more

[0915] A sphincteric valve such as that shown in FIG. 11 of copending application Ser. No. 15/998,002 entitled Ductus Side-entry Jackets and Prosthetic Disorder Response Systems externally cinches about to constrict the substrate ductus from without and is structurally and functionally distinct from other vascular jackets, valves, and servovalves. Nonadjustable, the ureteral takeoff diversion jacket show in FIG. 2 is not a valve, which connotes adjustability, but rather a static prosthesis for placement in a patient with a missing or irreparable urinary tract. The diversion jacket is shown fully extended with vacuum hose having been disconnected from the rear end of trepan tube 5, after the side-entry tissue plug has been extracted and the diversion chute 18 extended into the ureteral lumen.

[0916] Nonadjustable, it requires a diversion chute, but since urine passing down the ureter should always flow freely out through the trepan tube and into the catheteric mainline, here referred to and further explained below, as a neoureter, and not accumulate, an ostium obturator, for preventing outflow into the diversion jacket is omitted. In contrast, in a urinary diversion valve which to allow the user to switch from normal urination during waking hours to diversion with no urge sensation as would awaken the wearer during the night, a ostium obturator is necessary.

[0917] In FIG. 2, part number 1 is the lumen, usually ureteral, 2 the luminal wall, 3 the outer shell of the diversion jacket, 4 viscoelastic polyurethane foam, 5 the trepan tube, and 6 the sharpened trepan leading edge of trepan tube 5. A water jacket is omitted as not required for placement, and an accessory channel not prescribed, diversion chute handle 8 connects to the rear end of flow diversion chute 18. When direct drug targeting is prescribed, accessory channel 8, a hollow capillary tube seen in drawing figures to follow, continues forward where diversion chute handle 8 is connected. Numerous apertures 40 entirely through outer shell 3 and foam lining 4, most outside the plane of the drawings, assure that the adventitia is not completely enclosed as would quickly induce atherosclerotic degeneration in the intima of the substrate ductus.

[0918] Accessory channel 8 would then move along the midline underside of diversion chute 18 and terminate in an aperture on the underside distal tip, or nose, of diversion chute 18, positioned to release a crystal solvent or drugs into ureteral lumen 1 to wet down urothelial lining 13 and 14 and then enter the bladder. Diversion chute 18 fully extended as shown, positive detent element 16 is engaged within receiving element 17. A mainline—in this case, an outflow catheter or neoureter, connected to the back end of trepan tube 5—is not attached. Diversion chute 18 is made of a material resistant to the adhesion of crystal, so that for many applications, an accessory channel will not be necessary.

[0919] Accordingly, when it is desired to target medication directly into the substrate ureter for passage down into a diseased urinary bladder, fixed as well as valvular ureteral takeoff jackets incorporate an accessory channel 8 rather than a diversion chute handle 8, that in the diversion jacket fixed in position once placed. However, where the bladder with the aid of medication is expected to recover, adjustable rather than nonadjustable diversion jackets should be used. Flow into the bladder rather than into a neobladder or collection bag is through nonjacketing side-entry connectors as described and illustrated in copending application Ser. No. 14/998,495, entitled Nonjacketing Side-entry Connectors and Prosthetic Disorder Response Systems,

[0920] Valves for placement along a ureter such as that shown in FIG. 2 are connected when the ureter is passing little if any urine and therefore pose no problem comparable to that encountered with diversion jackets and valves meant for placement along a vessel, where unless prevented, blood would run out. In basic ductus side-entry jackets such as that shown in FIG. 1, a water jacket 8 is used to restrain blood from outflow by directing a jet of water under sufficient pressure to prevent bleeding over the opening or ostium cut in the side of the ductus, typically, an artery where the blood pressure and pulse would pump blood out through the opening.

[0921] Once the jacket has been placed, accessory channel 8 makes possible the direct pipe-targeting of drugs into the jacket and the native lumen it encircles. In a urinary diversion jacket, where placement follows voiding so that no outflow occurs, or where some negligible extravasation from the substrate vessel is readily aspirated and unproblematic, a water jacket is omitted. However, when placed in conjunction with an implanted automatic disorder response system able to directly pipe-target drugs to the jacket automatically according to the prescription-program of the implanted microcontroller, one or more incorporated accessory channels is always present.

[0922] To cut the side-entry opening, or ostium, into the ureter, the trepan is moved forward with the chute retracted. As distal terminus of the mainline, the trepan is manipulated by loosening lock nut 10, freeing the trepan to be moved reciprocally or rotated. Once the opening has been cut, trepan 6 is retracted into alignment with the proximal urothelial surface, lock nut 10 used to fix it in position, and chute 18 deployed. To prevent jamming or sticking of diversion chute 18 when deployed after the jacket has been positioned, the segment at the distal end of the mainline with trepan distal edge is made of low friction fluoropolymeric tubing, such as polytetrafluoroethylene.

[0923] The accessory channel or sideline catheter is made of a polymer such as polytetrafluoroethylene in a thickness as will bend only so much as to allow the operator to advance the diversion chute into the ureteric lumen. If urging by edge of the entry hole to the side removed from the ureter at the bottom of the jacket is insufficient to guide the accessory channel tube forward, a small curved quarter round guide is bonded to that edge to assure smooth and properly aligned movement of the service channel tube through the entry hole. Sideways bendability of this material is, however, sufficient as not to interfere with any slight rotation or reciprocation of the trepan the operator may need to create the opening into the ureter.

[0924] If necessary despite the use of a suction pump as described above under Background to the Invention, mainline 9 with trepan 6 at its distal terminus can therefore be rotated from side to side to facilitate cutting the opening into the native lumen, then locked in position. Accessory channel 8 is otherwise made of a conventional catheter synthetic. Chute 18 is attached to the distal extremity of accessory channel 8 and moved forward into ureteral lumen 1 by pushing accessory channel 8 forward.

[0925] Visualization is unnecessary, full deployment signaled to the operator by an audible click when detent eminence 16 enters detent depression 17 posing resistance of the chute to further advancement. Sliding of accessory channel 8 with chute 18 is facilitated by collar 12 made of a hard and slippery gear grade nylon. The ostium cut and plug removed, diversion chute 18 is advanced to fully close off native lumen 1 and divert the flow of urine through mainline 9, here a neoureter as shown in FIG. 28. Passage continues through the components of the prosthesis required by the condition of the patient, and eventually into collection bag 149.

[0926] Fully extended (deployed, advanced), the typical 2.0 to 4.0 millimeters to span ureteral lumen 1, flow diversion chute 18 is slightly larger than the luminal diameter; so that made of a soft rubbery material and progressively thinned, or feathered, moving toward its periphery, and placed in apposition or abutment against a native surface itself compliant, chute 18 fully seals off the ureteral lumen beneath, or antegrade to it, from that retrograde above.

[0927] Such a fixed urinary and blood flow diversion jacket, shown in FIG. 2B, is suitable for use in a prosthesis where the need for adjustment after placement is not an issue. With the embodiment shown in FIG. 2, an upstream basic side entry jacket can be placed to periodically target medication to the downstream intima as an automatic drip controlled by the implanted microcontroller or microprocessor as might any accessory channel, while water jacket unrelated, or incorporated, accessory channel 8′ allows the diffusion through open cell viscoelastic polyurethane foam 4 of medication to target the downstream adventitia.

[0928] Mainline 9, temporarily connected to a vacuum pump to retract the plug of tissue cut from the side of the ductus thereafter serves as the permanent conduit conducting blood or urine out of, or in a shunt or bypass, into the ductus. Devised for application along a ureter rather than a vessel, incorporated accessory channel 8 with exit pore 31 beneath diversion chute 18 as well as an ostium obturator, or stopper to first prevent extravasation and once introduced into substrate native lumen 1, apportion blood between that tapped off and that to continue along the vessel is optional.

[0929] A separate line, smaller in gauge than mainline 9, the sideline 8, is connected to the outlet of a small flat drug reservoir implanted in the pectoral region to serve as the drugline or sideline 8 feeding into the accessory channel, also 8 to make it clear that both the line and accessory channel through the jacket or valve represent the same continuous passageway. Instead of a water jacket, valves for placement along vessels such as those shown in FIGS. 5, 7, and 8 incorporate an ostium obturator 30 which blocks blood from escaping while trepan 6 cuts the plug of tissue to create the side-entry opening, or ostium and once the ostium obturator is brought flush against the near endothelial surface 13 of lumen 1.

[0930] In a sudden switch organ transplant driven by plunger solenoids such as those shown in FIGS. 7 and 8, the ostium obturators are abruptly moved through ostium to rest flush against the endothelial lining on the far side 14 of the substrate vessel. In a vascular servovalve, the ostium obturator is initially positioned flush against the near wall 13 of lumen 1 by the operator through the use of a direct manual fine control mechanism such as that shown in FIGS. 10A thru 10C before electrical control is initiated, whereupon the microcontroller or control microprocessor registers this positional reference datum. Once this position is entered, the balance of the transplantation procedure and attendant administration of drugs as necessary is entrusted to the implanted microcontroller or microprocessor for execution under automatic control.

[0931] Adjustable, or controllable, diverters allow switching from nondiverted flow, that is, normal ureteral through-flow into the bladder or diverted flow into a bag, for example. This allows switching between the periodic release of medication into the bladder and wetting down the walls of the neoureters with an antimicrobial or crystal solvent, for example. Both nonadjustable and adjustable diversion jackets requiring the diversion chute to be slid at least forward, the sliding base plate at the bottom of the diversion chute and the sliding track or rail along which it rides, seen in the cross sections that follow are included in all diversion jackets.

[0932] Once the bladder has healed, the neoureters are endoscopically removed and the diversion chutes left in place to allow the continued release of medication directly into the ureters. Then the diversion jackets should be bilateral. Part number 10 is a lock nut to fix trepan tube 5 in position, 11 are spring hinges that urge the jacket into a closed position to stably cinch about the substrate ureter 12 is the accessory channel stabilizer, 13 is the urothelial lining of the operator-proximal luminal wall, 14 the urothelial lining of the operator-distal luminal wall, 15 suture loop to pass through suture if the ureter with jacket should be held away from neighboring tissue, 16 the sliding positive (male, eminent) detent, and 17 the receiving, or female, detent to retain diversion chute 18 in position unless the operator exerts sufficient force to move it.

[0933] Detents are unsuitable for use in servovalves such as shown in FIG. 10A, which are continuously adjustable and were it necessary, can be programmed to hold fast. Only non-servovalves, that is, bistable valves, which are manually set in shunt or bypass prostheses in the urinary tract such as shown in FIG. 2 and solenoid-driven valves such as shown in FIGS. 7 an 8, also suitable for nominally one-time setting of prostheses as irreversible, of which the use may be unavoidable for an emergency sudden bypass, or switch, organ transplant requiring the simultaneous energization of numerous such valves incorporate detents.

[0934] If necessary, such detents can be overridden through the application of somewhat greater than usual force. The reason servovalves are preferred for transplantation is the mid- and postprocedural versatility of these vis a vis nominally one-time solenoid driven valves. Servovalves, however, require a prescription-program for the implanted controlling microprocessor adapted for the specific patient, which requires lead-time that an emergency precludes. A solenoid-driven transplant can respond to a prescription-program limited to the direct pipe-targeting of drugs but not valve adjustments responsive to physiological indicia.

[0935] Where the use of solenoid-driven valves is unavoidable, greater vigilance of the patient and the manual administration of drugs, for example, is necessary. Restriction to the clinic rather than the automatic release of drugs in an ambulatory patient is in itself a deterrent. Except in a patient considered too frail to undergo revision, solenoid-driven valves should eventually be replaced with servovalves operating under a personalized prescription-program. Awareness of this eventuality is justified only when the need for immediate action does not allow adequate time for preparation.

[0936] Indicated by the absence of an ostium obturator, the diversion jacket shown in FIG. 2 is a ureteral or vascular takeoff jacket for placement at the inlet to a shunt or bypass, here a neoureter, where it will remain permanently as an nonadjustable full flow diversion prosthesis. Remote controlled adjustability of a takeoff jacket by means of push/pull, or Bowden cable or an electromechanical actuator renders it a valve, which not limited to full flow diversion, must incorporate an ostium obturator to prevent diversion, or outflow when the diversion chute is fully retracted, and assists the diversion chute in splitting the flow when partially extended.

[0937] The operator pushes accessory channel stabilization collar 12 forward until an audible click indicates the engagement of positive sliding detent or eminence 16 in stationary receiving detent or depression 17. The detent is not so resistant to disengagement that the operator is unable to retract it should the need arise. When placed endoscopically, this action is expedited through the use of a Bowden cable of the same kind as shown below in another embodiment whereby the wearer can adjust the diversion chute by turning a small dial on a small body surface port with urine outflow opening hole at the center. When used to aid placement, the cable is disconnected before closing.

[0938] FIG. 3 is a cross-section taken along line A-A′ in FIG. 2 through side-stem 19 of the diversion jacket shown in FIG. 2 to provide greater clarity as to the structure of the accessory channel 8 at the bottom center of diversion flow chute 18, and that of sliding baseplate 20 which rides over slideway, or raceway, track, or rail 21.

[0939] Accordingly, as shown in FIGS. 3 and 6, the chute 18 with accessory channel 8 travel along a raceway or slideway comprised of horizontal extensions or wings 21 which to assure smooth and properly aligned movement ride within guide restraints. Over the segment of the proximal groove past the tubular accessory channel and extending toward the ureteral lumen, or distally, to the level half way into the ureteral lumen with the chute deployed, the groove is lined with thin inverted V stock stainless steel with a horizontal side wing to either side impressed by bending the V stock longitudinally along its length with a press brake or draw press.

[0940] The wings ride along the bottom of the terminal segment of the mainline with trepan leading edge beneath guides made of slippery gear-grade implantable nylon or polyvinyl chloride comprising an alignment track (raceway, slideway). In addition to smooth and properly aligned advancement of the chute into the ureteral lumen, the stainless steel (inox) liner supports the chute to prevent downward prolapse into the ureter and imparts the stiff relation to assure positive engagement with an audible click of the detents that signals full deployment. Both trepan and chute can be moved back and forth.

[0941] FIG. 4 shows a side-entry jacket or valve jacket placement clamp (straddle-clamp, forked vessel segment-straddling spring-loaded double clamp, forked double clamp). Most ductus can be clamped briefly, exceptions being the coronary and carotid arteries, which are never to be clamped however briefly. Unlike the basic side-entry jacket shown in FIG. 1 wherein the path through the lumen of trepan tube is clear of any obstruction that might pose interference to the extraction of the side-entry tissue plug into which trepan tube 5 must be inserted, a valve jacket which incorporates a diversion chute with ostium obturator at its distal tip, or nose, inside trepan tube 5, thus obstructing the trepan tube lumen as the passageway through which the plug must be extracted, necessitates an alternative method for removing the plug to clear the way for insertion of the trepan tube.

[0942] An advantage of the straddle-clamp or separate small clamps where that downstream is place first is that this facilitates use of a trepan tube. Elimination of the trepan tube necessitates the use of an ostium obturator greater in pliancy and resiliency than needed in a valve with a trepan tube. A straddle-clamp, that is, a forked ductus segment-straddling spring double clamp or side-entry or valve jacket placement clamp, provides a simplified means for plug extraction past diversion chute 18. The straddle-clamp shown in FIG. 4 is one of a set including clamps permanently positioned at different distances from one another.

[0943] Alternatively, a double clamp can be provided such that one handle controls two clamps which can be adjusted in separation and/or the rotational angle of each. Where the segment is small so that little blood would be lost, two separate clamps can be used, allowing placement of the first downstream to increase the pressure in the segment, and that upstream placed immediately afterwards, thus slightly dilating the segment (as well as the upstream artery), making insertion of the trepan tube easier.

[0944] A ureteral takeoff jacket or valve can be placed with the aid of a clamp briefly placed upstream to interrupt continued kidney outflow, but never during a ureteral jet; extravasation analogous to that possible with a vessel is not applicable (Baker, S. M. and Middleton, W. D. 1992. “Color Doppler Sonography of Ureteral Jets in Normal Volunteers: Importance of the Relative Specific Gravity of Urine in the Ureter and Bladder,” American Journal of Roentgenology 159(4):773-775; Jequier, S., Paltiel, H., and Lafortune, M. 1990. “Ureterovesical Jets in Infants and Children: Duplex and Color Doppler US [ultrasound] Studies,” Radiology 175(2):349-353.

[0945] The forked double clamp is intended to suddenly stop the flow of blood through a segment of a vessel for valve placement. When clamped, the blood in the segment between the clamp arms is trapped, maintaining the segment at its noncollapsed diameter, so that when the valve trepan with suction pump attached to the trepan tube is used to extract the plug, only the small amount of blood that had been trapped runs out (bleeds, extravasates). With the aid of the clamp, to insert the trepan into the side-entry opening, or ostium created, and lock the jacket in place onto the vessel or ureter is accomplished in seconds. The same procedure can be used in placing any basic side-entry jacket where the extraction of the tissue plug might prove problematic. The momentary interruption in blood flow is innocuous.

[0946] Blood in the trepan tube is readily washed out with heparin. Such a clamp can be used to expedite the placement of any type jacket about any type ductus. At least one sideline leading to what serves as the water jacket during placement of a basic ductus side-entry jacket and thereafter used as an accessory channel for the delivery of drugs is attached to the side-entry jacket before placement. Differing only in functional distinction at different steps during placement as clarified by the context and structurally continuous, a water jacket, sideline, and accessory channel are all designated by part number 8. A forked double clamp is structurally little different in structure than an office paper pinch clamps; however, the differences are important.

[0947] The differences are that the return force must be no greater than is essential to stop flow through the substrate vessel, the contact surfaces on the vascular adventitia must be cushioned using biocompatible materials, and rather than continuous from side to side, such clamps have a central portion removed to create two arms spaced apart by the length of the segment to be bounded. For such use, the clamp is either coated or made of spring stainless steel. Discouraged is a clamp with adjustable spring return force to allow the use of a single clamp with vessels of different diameters; too little compression will prevent neither partial flow nor continuous extravasation, and too great a force can result in intimal injury.

[0948] Instead, the clamps are made in different sizes with different spring return forces, thus precluding complications due to human errors in adjusting the return force as might result in intimal injury. Instead, each size clamp exerts a nonadjustable return or clamping force determined by the inherent and worked factors of the spring steel, spring stainless steel, titanium, or polymer used. FIG. 3 shows the simplest of many possible embodiments incorporating torsion, tension, or compression springs and made of metal or plastic.

[0949] In FIG. 4, 22 are the clamping arms to either side of straddle-clamp, 23 the space separating clamp arms 22, which defines the segment between clamp arms 22 for the entrapment of blood inside the segment to facilitate the removal of a side-entry tissue plug from the wall of the vessel to be jacketed and placement of the diversion valve. Parts numbered 24 are the adventitial contact area cushions, 25 the extension spring-backed hinge that provides the clamp spring return force, and 26 the thumb and index finger pads the operator presses together to place, or set, and remove, or release, the clamp. Provided it is coated The suction pump hose as temporary mainline 9 can be used to pull through the plug, and if successful, can then be detached for replacement with a catheteric mainline through which blood will outflow and exit or drugs enter and inflow.

[0950] Otherwise, the suction hose removed, the straddle-clamp is left in place just long enough to allow the use of a small dental pick or similar hand tool to extract the plug. The permanent catheteric mainline through which blood will flow out or a drug flow through can then be attached and the clamp removed. A stopper affixed to the nose of the diversion chute, or ostium obturator, which serves to prevent outflow through the trepan tube when diversion is not in use, appears in the diversion valves and servovalves to be described.

[0951] The ostium obturator then prevents outflow long enough for the opposite end of the mainline to be attached. The absence of an ostium obturator indicates that outflow during placement and thereafter is not a problem. The same use of straddle-clamps can be applied to the placement of any basic side-entry jacket where the extraction of the tissue plug might encounter interference, the brief interruption in blood flow innocuous.

[0952] FIG. 5 shows a manually operated urinary flow diversion valve wherein flow diversion chute 18 is driven by a push/pull control cable between the fully closed chute extended full flow diversion and fully open chute retracted normal flow through positions. The fully extended position is suitable for use during the night to avoid being awakened by the need to void, whereas the fully retracted position is suitable for use during the day to void normally. Other applications include preventing an interruption during a public performance to the extent that urge sensation is never felt.

[0953] With the embodiment shown in FIG. 5, an upstream basic side entry jacket can be placed to supplement incorporated accessory channel 8 and 8′ in periodically targeting medication to the downstream intima as an automatic drip controlled by the implanted microcontroller or microprocessor. Incorporated accessory channel 8′ allows the diffusion through open cell viscoelastic polyurethane foam 4 of medication to target the adventitia. Incorporated accessory channel 8 is available to drip medication downstream of diversion chute 18.

[0954] When accessory channel 8′ outlets in front of collapsed diversion chute 18, diversion chute 18 sweeps the medication over the small ostial trepan wound and delivers medication into substrate native lumen 1 when ostium obturator is not set flush against the proximal intima 13. When accessory channel 8′ outlets into the open cell polyurethane protective foam 4, medication continues to diffuse through foam 4 to medicate the adventitia, the extent to which the medication reaches circumferentially determined by the frequency and volume of the drip.

[0955] In any adjustable embodiment such as this, an ostium obturator 30, shown here fully extended for full diversion, is essential to prevent outflow through trepan tube 5 when diversion chute 18 is retracted to allow normal ureter-to-bladder drainage. In FIGS. 5, 7, and 8, the ostium obturator, effectively a tiny version of an especially elastic and compliant rubbery polymeric tub drain stopper, is shown both fully extended and ‘ghosted’ to show it prior to deployment when it is retracted in the side-stem outside lumen wall 2. Accessory channel 8 for the delivery of drugs into the substrate ureter to flow thence into the bladder outlets at diversion chute 18 nose underside just within the ostium obturator 30 through opening 31.

[0956] A jacket of this type can be provided with a diversion chute detent-fixed in position with or without an accessory channel as shown in FIG. 1 or can be switched between chute 18 fully open or fully closed positions. When switchable thus, the diversion jacket is a valve capable of continuously adjustable control but degrees of extension between fully open and closed are not pertinent for the wearer who usually wishes full diversion during the night and when performing before an audience. However, this does not preclude the use of a mid-way position to delay voiding either normal or through the neobladder shown below. Accordingly, such a manually controlled valve is unsuited for use along the vascular tree where an implanted micro master controller can continuously apply fine adjustment to the valve in response to sensor data continuously fed to the controller.

[0957] FIG. 6 shows a cross-sectional view of the diversion jacket shown in FIG. 5 along line B-B′ to show diversion chute 18 handle or accessory channel 8 and diversion chute 18 reciprocal adjustment clearance slot 27 through which diversion chute 18 passes when driven by push/pull cable 28, cable 28 connected to stabilization collar 12 by coupling block 29. The rail device upon which chute 18 rides when advanced into or retracted from the substrate native lumen 1 is the same as that shown in FIG. 3 with the difference, however, that section line A-A′ indicated in FIG. 2 is not through the part of the valve where slot 27 must be cut out for passage of the accessory channel 8 as is the case along section line B-B′ in FIG. 6

[0958] To eliminate the need for direct manual contact of the operator with stabilization collar 12 and thus expedite endoscopic placement of a nonadjustable urine flow diversion jacket with optional but usually preferred accessory channel 8 for the direct delivery of drugs into the ureter 1 and bladder, cable 28 can be adjusted by means of a mechanical foot pedal control similar to that on a lawn tractor, then—retraction of chute 18 in this static prosthesis thereafter unnecessary—removed.

[0959] FIG. 7 shows a diversion jacket with flow diversion chute 18 deployed by a highly damped nonsparking miniature plunger solenoid. This allows the deployment of multiple chutes at the same instant by pressing a single switch, as is necessary in performing a sudden switch heart transplantation, for example. The device is intended to shift diversion chute 18 suddenly to the fully extended position, there to be left in place. Bistable, that is fully retracted or extended but unable to be positioned at a point intervening between these, the valve is actually less adjustable than is one cable driven, but allows remote control over multiple such devices, essential in a sudden switch solid organ transplant, for example.

[0960] With the embodiment shown in FIG. 7, as with any jacket-integral, or incorporated accessory channel, an upstream basic side entry jacket can be placed to periodically target medication to the downstream intima as an automatic drip controlled by the implanted microcontroller or microprocessor. Incorporated accessory channel 8′ allows the diffusion through open cell viscoelastic polyurethane foam 4 of medication to target the adventitia. When incorporated accessory channel 8′ outlets into the open cell polyurethane protective foam 4, medication continues to diffuse through foam 4 to medicate the adventitia, the extent to which the medication reaches circumferentially determined by the frequency of the drip.

[0961] When incorporated accessory channel 8′ outlets just ahead of ostium obturator 30 while ostium obturator 30 remains collapsed at the distal tip of diversion chute 30 prior to being deployed, ostium obturator 30 sweeps the medication, typically an anti-inflammatory, over the edges of the small ostial wound just cut. Where accessory channel 8′ with outlet into foam 4 remains effective indefinitely, positioning accessory channel 8′ to outlet just ahead of ostium obturator 30 prior to its deployment results in a reduction in its effectiveness at delivering medication into lumen 1. At all times, incorporated accessory channel 8 remains available to release medication through outlet pore 31 into the downstream flow.

[0962] Simultaneous actuation is by the operator or an assistant by direct wire connection, the wires thereafter removed and the jacket with accessory channel or channels left in place. In certain locations, the anatomy will better accommodate a valve of this configuration rather than that shorter shown in FIG. 8. If needed, Suture loops 15 at the abaxial or butt end of the valve side stem allow suture to be run through for connection to nearby connective tissue to aid in defraying the weight of the valve. Unneeded suture loops 15 are easily trimmed away with a scalpel.

[0963] Bistable control thus is distinct from control gained with a servomotor-driven diversion valve such as those shown below, wherewith continuously and valve to valve variable control is exerted by an implanted microcontroller fed pertinent data from implanted sensors and applied by the controller prescription-program. In a patient requiring the simultaneous surveillance and treatment of comorbidities, an implanted microprocessor serves as the master controller over a hierarchical control system programmed to seek out and apply that multimodal therapeutic response most likely to achieve the optimal homeostatic result across all comorbidities during and following a transplantation procedure, for example. The control of comorbidities can critically affect the sustainability of an organ transplant.

[0964] More complex control thus requires multiple command-execution channels, which unless posing a risk of strangulating tissue, are delivered along implanted wires. Otherwise, wireless such as radio remote control is used, each actuator singled out through the use of a unique carrier frequency. Part numbers in FIG. 7 are the same as in FIG. 5 with highly damped miniature nonsparking plunger solenoid plunger solenoid 32 replacing the cable drive, 33 the connector of the solenoid plunger (thrust rod, slider, shaft) to accessory channel 8, 34 the solenoid electromagnetic coil or winding, 35 the solenoid compression spring, and 36 the solenoid plunger.

[0965] Also in FIG. 7, parts numbered 40 are the ‘breathing’ apertures, which can be slits, or round holes, for example, to allow contact with the outer body cavity of the adventitia, such communication long established as necessary to prevent atherosclerotic degeneration at the intima due to compression of the nervelets, or vasa nervora, and fine blood vessels, or vasa vasora of the adventitia. Such perforations or apertures are numerous, most off the plane of section depicted in the drawings.

[0966] In FIG. 8, highly damped miniature nonsparking plunger solenoid 32 has been positioned in reverse beneath rather than in front of accessory channel feedline 8 beneath side-stem 19 to pull rather than push accessory channel feedline 8 used as the diversion chute handle. Part numbers in FIG. 8 are consistent with those in the other drawing figures. This arrangement allows the valve to be shorter expediting miniaturization for use in an infant, for example. In addition to the use of silver wire in the windings and the use of lightweight plastics, a significant reduction in size and weight for use in a small child is the use of servovalves which incorporate 2-way or bidirectional diversion chutes such as shown in FIGS. 11 and 12.

[0967] Accessory channel 8′ allows an automatically released drip to diffuse through the open cell viscoelastic polyurethane adventitia protective foam 4 to wet the adventitia. Were accessory channel 8′ continued through servovalve jacket shell 3 to outlet into the trepan tube 5 just in front of ostium obturator 30 before ostium obturator 30 is advanced into substrate ductus lumen 2, the medication released would coat the ostium about to be cut by trepan 6 at the front end of trepan tube 5 but would then become ineffective for further treatment of the intima. However, both positionings can be incorporated into the valve jacket, just as both can be incorporated into the ductus side-entry servovalves shown in FIGS. 5, 7. 9, and 10.

[0968] FIG. 9 shows one of several servomotor types suitable for use in a vascular servovalve wherein it is positioned within the valve jacket as are the plunger solenoids shown in FIGS. 7 and 8. The criteria for a linear servoactuator include precision performance, and suitability for miniaturization to achieve a size and weight least likely to cause discomfort. Unacceptable is any motor design that significantly deviates from cylindricality, such as a motor mounted to extend away from the central or long axis.

[0969] Linear actuators include those which combine a rotary motor with planetary gearing and a machine screw drive to convert rotary to linear motion and those intrinsically linear. Of the two, intrinsically linear designs are direct-drive, eliminating cogging and backlash, and better lend themselves to a tighter cylindricality at the driver end, small size, and low weight. Of the various types of linear motors—iron core, U-channel, tubular linear, miniaturized versions of linear induction machines—one that lends itself to miniaturization and a compact cylindrical shape and provides the level of precise control suitable for use in vascular valves is the pulse tubular linear shaft motor.

[0970] Such a motor is brushless, of high flux density with a conformation that affords maximum magnetic efficiency, zero cogging, highly reliable, and precise, as well as direct drive. Void of mechanical linkages, hence, backlash-free, the motor requires no maintenance, is virtually instantaneous in response, and from the standpoint of compactness, is scarcely deviant from a straight tubular conformation, making it suitable simple to adapt for use in infants. As shown for plunger solenoid diversion jackets in FIGS. 7 and 8 respectively, the linear or other form of servomotor can be positioned within the valve with connector 33 to push or pull accessory channel 8, without the limitation in performance of full displacement from one end of the stroke or the other.

[0971] In FIG. 9, adapted from illustrations published by Nippon Pulse America, Radford, Va., such a pulse linear shaft motor comprises forcer, here adapted with cylindrical housing 37, enclosing adjacent circular electromagnet coils 38 in circumferential and surrounding relation to the motor shaft 39 which incorporates successive pairs of cylindrical neodymium iron boron permanent magnets 42. The magnets are arranged along the shaft so that successive pairs consist of a forward magnet with south pole at the leading end, for example, and north pole at the trailing end, the following magnet in the pair reversing the poles so that each pair has facing north poles where the members of the pair come together and adjacent south poles where the successive pairs come together.

[0972] Shown in FIG. 10 depicting a vascular servovalve with direct manual fine control attachment and FIG. 14 of a servochoke, miniaturized versions of such a tubular linear shaft pulse servomotor are suitable for use in any side-entry valve or servochoke. At the sizes required, most tiny, the neodymium magnets should not present an absolute sum weight such that the normal alignment provided by the jacket with foam lining, and if necessary, the aid of suture run through a suture loop 15 and wound about the substrate ductus upstream will exert a levering force to compress or flex the substrate ductus. Accessory channels in the vascular servovalve shown in FIG. 10 can include any or all of those described in conjunction with the valves shown in FIGS. 2, 5, 7, and 8 bearing part number 8 or 8′.

[0973] In placing a valve along a carotid or coronary, it is important that no interruption occur in the flow of blood. Accordingly, the use, however momentary, of a clamp, one such shown in FIG. 4 is disallowed. In entering such an artery, first the suction pump applied to the mainline is used to pull the wall of the artery past the trepan to cut a plug of tissue. The pump is reversible and equipped with a limit switch, so that the instant resistance to the vacuum disappears, the pump shuts off. The plug may have adhered within the circle incised, but more likely has been extracted, but blocked by the diversion chute and the undeployed, therefore collapsed, ostium obturator, has become lodged at the front of the trepan tube. The plug must be removed with no interruption in the flow of blood as could induce a cerebral or myocardial infarction.

[0974] Now 1. The plug must be removed, and 2. Once the plug has been removed and the diversion chute passed into the substrate ostium, the ostium obturator must fit flush over the ostium to prevent blood from leaking.

[0975] Removal of the plug is by drawing the trepan tube from the ostium where the operator has wetted his glove with a heparin and positioned the thumb adjacent to the opening. The instant the trepan is removed, the operator slides a thumb over the opening, preventing blood from escaping and an assistant reverses the vacuum pump to expel one or more forceful discharges of air, driving the plug out the front of the trepan tube. If as improbable, following one or more strong puffs, or ‘blasts,’ of air the plug still adheres at the front of the trepan tube, an assistant quickly retrieves it with a tweezers or dental pick. The trepan tube is reintroduced into the opening simultaneously with the sliding away of the thumb and the valve jacket allowed to close about the artery.

[0976] Because the walls of larger arteries incorporate elastic laminae and smooth muscle, and because the ostium obturator must comprehend elasticity and resilience consistent with the need to fully deploy from a collapsed condition, despite the use of the vacuum pump or controller in an attempt to retract the obturator into a flush fit against the inside of the side-entry opening, or ostium, some rebound will usually occur which only precise manual control can overcome. Shown in FIGS. 10A thru 10E and 25 is direct manual fine control attachment device to a vascular servovalve. The attachment is used only during attachment of the valve and removed before closing. It is then sterilized by autoclave or ethylene oxide gas for use with another valve of the same type and size.

[0977] Attachment of the direct manual fine control to the servovalve is accomplished preoperatively and does not add to the duration of the operation. Adjustment of the ostium obturator 30 to fit flush against the ostium can only be accomplished by the operator mid-procedurally once the diversion chute has been moved into the lumen of the substrate native vessel. Attachment of the direct manual fine control device can serve as a precaution should a sudden vacuum force exerted on the ostium obturation by the suction pump or the automatic program itself not seat the obturator flush against the ostium. FIG. 25A illustrates the prefinal step in placement in a bypass to both the internal and external carotids, and FIG. 25B the same where only the internal carotid must be bypassed just before the attachments, each matched in size to its valve, are removed.

[0978] To minimize the weight of the servomotor, coil 38 is wound with silver wire. To this end, the longitudinal extension of the valve and consequent levering moments of force, is kept as small as possible. The pulling rather than pushing driver configuration shown in FIG. 8 is shown adapted in FIG. 10 to allow shortening the valve, reducing its moments of force, and therewith any tendency to lever under gravity, imposing a bending force on the substrate vessel.

[0979] FIG. 10A shows a puller-configured double outlet tubular pulse linear shaft motor-driven vascular side-entry diversion servovalve of the kind shown in FIG. 9 with the addition of a detachable direct manual fine control device positioned beneath servovalve side-stem 19 shown in FIGS. 10A thru 10E suitable for performing a carotid endarterectomy, for example, where one valve on the common carotid bypasses blood into the internal of the internal and external carotids. As shown in FIG. 25B, where the external carotid is unaffected, only a bypass to the internal carotid is needed. In both, the diversion chute of the valve on the common carotid must remain partially retracted to allow blood to pass through the common carotid into the facial, lingual, and superior thyroid arteries, as well as numerous arterial ‘twigs.’

[0980] Attached to the servomotor housing before use and detached after, the manual fine control, or override, device is used to manually initialize the precise horizontal position of the servomotor shaft if necessary before valve placement along the substrate vessel. The manual fine control device is housed in a separate enclosure which is attached to the motor housing during use and thereafter removed. The direct manual control device assures the correct alignment of the motor shaft for its attachment and allows the operator to apply small adjustments in the position of the servomotor shaft, hence, correct starting position of the ostium obturator to assure a flush nonleaking fit over the ostium.

[0981] The double outlet implements use of the valve a carotid endarterectomy bypass such as that shown in FIG. 25A, which can be used intraoperatively or, where the carotids are heavily diseased or must be resected to remove tumors, as a permanent prosthesis. The direct manual fine control device allows the operator to move motor shaft 39 without snap-back during a condition of no current flow. That is, the direct manual fine control device allows the operator to apply small adjustments in extension or retraction into the substrate native lumen 1 of the ostium obturator at the distal tip of diversion chute to fit flush against the ostium when the implanted control microcontroller or microprocessor has not been additionally programmed to respond to a handheld remote control to allow off-line tiny shifts of the diversion chute and the deployed diversion chute 30 is not flush against proximal intima 13 to prevent any blood from escaping.

Overall Structure or the Direct Manual Fine Control Device

[0982] Part numbers not unique to the direct manual fine control device shown in FIG. 10A are consistent with those shown in the preceding figures. The device enclosure is made of a tough clear transparent polymer such as polyethylene terephthalate, the internal parts rendered radiopaque with contrast, such as Danfoss Tantalum Technologies Danfoss Coating®, thus allowing the operator to directly observe its internal operation whether the valve is applied to the substrate native lumen with side-stem 19 directed to the left as depicted in FIG. 10A or to the right.

[0983] To fully deploy, that is, expand from its collapsed position while remaining within trepan tube 5, ostium stopper, or obturator, 30 must enter substrate native lumen 1 to a point slightly beyond a fully flush relation, possibly allowing a slight emission of blood into trepan tube 5. Trepan tube 5 blocks the blood from fouling either the protective 4 or the ‘breathing’ apertures 40. However, the actual size of the largest valves for use along the aorta is many times smaller than the valves have been shown for clarity in the drawing figures, so that unless an anticoagulant such as heparin, is released from an upstream jacket or through accessory channel 8, even a small amount of blood could prove a hindrance. However, an anticoagulant should be avoided in some patients, making an alternative approach necessary. Were blood to foul the protective foam separating the valve from the substrate vessel, the valve is supplied with replacement foam.

[0984] If used, the anticoagulant is released just before ostium obturator 30 is advanced into the native lumen 1. The advancement of ostium obturator 30 then sweeps the anticoagulant forward to wet the cut edges of the ostium. Ostium obturator thus serves three functions:

1. In advance of actuating diversion chute 18 it squeegees an anticoagulant or any other drug in fluid form through the ostium, thus immediately medicating the tiny perforating wound created.
2. While held against the proximal intima of the substrate native lumen, ostium obturator 30 prevents blood from leaking into trepan tube 5, and
3. It defines by assisting to separate into separate flow columns, hence, the relative proportion, of blood to be diverted through trepan tube 5 and that to continue antegrade past it.

[0985] When fully automated, the servomotor may be programmed to retract ostium obturator 30 immediately upon insertion of ostium obturator 30 through the ostium just enough to assure that ostium obturator 30 rests flush against the proximal internal surface of the substrate native ductus. Alternatively, the section pump can be used to generate a vacuum that pulls the obturator flush over the ostium. Normally, the process can proceed without interruption. If for any reason, however, the operator sees that a completely flush fit has not been accomplished, the direct manual fine control device, used with the power turned off, can be used to prevent even a negligible amount of blood from escaping. Precautions notwithstanding, should blood enter the foam in an amount that could significantly foul its permeability, the foam affected is quickly replaced with small pieces thereof supplied with the valve.

[0986] To allow the operator to switch between right and left hand sides for direct observation of the direct manual fine control device mechanism from either side as essential to direct the side stem 19 to the right or left, for example, the device housing is transparent, and an engagement arm consisting of arms 77 and 77′ with end receivers 78 and 78′ makes it possible to alternately engage and disengage lead nut 72 so that rather than functioning as a screw, it rotates lead nut 72 connected to a locking mechanism in the form more or less of a capital letter Y, where either arm allows such engagement each on its respective side. Engagement arm piece 88 is made in one piece of die cut stainless steel or titanium alloy sheet stock, is burnished, and projects left and right-hand arms 77 and 77′ upwards.

Internal Structure of the Direct Manual Fine Control Device

[0987] As shown in FIG. 10B. left hand arm 77 and right hand arm 77′ further diverge toward their respective sides as these rise, and at their upper ends, engagement arm piece 88 connector 76 catches 78, a triangular socket, on left arm 77 and 78′ on the right arm 77′, are poised so that much as a small socket wrench wraps about a bolt head, rotation of the engagement arm piece 88 as shown to the right causes left handed arm triangular socket, or catch, 78 to engage the left side projection of stationary engagement arm piece connector 76. To not be deflected when engaged, the engagement arm piece 88 must be inflexible, to which end it is preferably die cut from stainless steel or titanium alloy sheet stock.

[0988] To securely retain the projection of the engagement arm piece connector 76 within triangular sockets, or catches, 78 and 78′ the sides of these are wide enough to form reentrants too deep to allow engagement arm piece connector 76 to slip out when driven. Turned clockwise with moderate force to prevent accidental rotation, control knob 71 overcomes its central detent (unshown as behind knob 71) to move engagement arm piece 88 until an audible click indicates that the right-hand detent has engaged.

[0989] Turning now to FIG. 10C, to rotate engagement arm piece 88, lead nut 72 must be locked to control knob 71, while to rotate leadscrew 73 so that lead nut 72 can move along leadscrew 73, adjusting the proximal end of motor shaft 39 and therefore diversion chute 18 without at the same time rotating engagement arm piece 88 requires that lead nut 72 be unlocked from control knob 71. That is, leadscrew 73 either rotates together with lead nut 72 and engagement arm piece 88, or lead nut 72 is disengaged from the engagement arm piece, allowing engagement arm piece 88 to move along leadscrew 73 to extend diversion chute 18 into the substrate native lumen or to retract diversion chute 18.

[0990] FIG. 10C shows push/pull control cable knob 79 at the center of screw rotation control knob 71 when depressed overcomes the restorative force of small compression spring 81 to drive a Bowden cable-like flexible push-pull control wire forward so that its distal end is inserted thru leadscrew 73, then curves upwards into control wire receiver 75 locking knob 71, leadscrew 73, and lead nut 72 so as to rotate the engagement arm piece 88 as a single part.

[0991] To allow its removal once ostium obturator 30 has been correctly positioned flush against the proximal intima of the substrate vessel, thus covering over the ostium, the direct manual fine control is housed in a separate enclosure 91 attached to the bottom of enclosure 92 housing servomotor 37. Attachment of enclosure 91 to enclosure 92 is by insertion of pawl 93 into the bottom of a complementary receiving channel at the junction of left and right-hand engagement arm piece arms 77 and 77′. From FIG. 25, it will be clear that characterization of the enclosures as that upper or lower pertains when attachment to the substrate ductus is not inverted as are valves 89 and 90.

[0992] To allow the direct manual fine control device to be quickly and easily attached to and detached from the upper enclosure 92 housing servomotor 37 at a single point, engagement arm piece 88 must be positioned firmly enough to allow the insertion and withdrawal of intromitting pawl 93. To this end, the intromittent pawl receiving opening, or pawl receiver, at the bottom center of engagement arm piece 88 is tapered, or flared, wider at the bottom and curves upward to guide intromitting pawl 93 into a close enough relation to the opening that the operator need not direct undue attention or engage in an effort of precision to insert it. Shown in FIGS. 10C and 10E, the intromittent pawl receiving opening at the bottom center of engagement arm piece 88 then rises upwards into a friction fitting upper section of pawl receiver 99.

[0993] To meet these requirements, engagement arm piece 88 is suspended in its starting and ending disconnected and centered position shown in FIG. 10B by a miniaturized version of a miniature endoscopic-type grasper indicated in FIG. 10B with more detail provided in FIG. 10E and implemented as described below. The engagement arm piece must also be free to move from side to side to engage engagement arm piece connector 76 from either side as well as move with lead screw 72.

[0994] Accordingly, miniature endoscopic-type grasper 96 stably maintains engagement arm piece 88 in position, allowing the operator to insert intromittent pawl 93 into the bottom of engagement arm piece 88 and withdraw it once the adjustment in the horizontal position required has been completed, whereupon pulling down on enclosure 91 withdraws pawl 93 from the pawl receiver at the bottom center of engagement arm piece 88 for the procedure to proceed.

[0995] Grasper 96 is mounted to the side of manual control device housing 91, its shaft push/pull knob outside and shaft and grasper clamping pads, or jaws 142 inside housing 91 by a grommet-like surrounding ring, or torus, of stainless steel or titanium. The internal surface of the ring is broad enough to assure fitting about the grasper shaft as to disallow any play of grasper clamping pads 142 due to off-axis displacement at the ring when loaded and along with the shaft, is polished for nonresistant sliding to allow the clamping about and retreating of grasper clamping pads 142 from engagement arm piece 88.

[0996] Grasper shaft movement forward into manual fine control device housing 91 to stabilize engagement arm piece 88 by seizing it between grasper clamping pads 142 of grasper 96 before use so that insertion and removal of intromittent pawl 93 into the engagement arm receiver at its bottom center and will be quick and easy is limited to 5.0-7.0 millimeters by detents 94 outside enclosure, or housing 92 just in front of the grasper push/pull control knob 97 at the proximal end of grasper shaft 98, the other detent 95 along grasper shaft 98 inside housing 92. As indicated above, prior to use before engagement, arm piece connector 76 is shown in FIG. 10B ready for engagement either by engagement arm piece connector triangular socket, or catch, 78 on left arm 77 and catch 78′ on the right arm 77″before and after use in FIG. 10B.

[0997] Grasper 96 requires only one degree of freedom, that reciprocal to move its grasper clamping pads 142 to and away from engagement arm piece 88, positioned along the axis of movement at the displacement where the ostium obturator 30 will most often fit flush over the side-entry wound, or ostium, so that engagement arm piece 88 remains fixed in position for connection of the direct manual fine control device by soundly grasping engagement arm piece 88 between its grasper clamping pads 142. Requiring only reciprocal movement, grasper 96 is rigidly constrained to eliminate radial deflection.

[0998] Insertion and withdrawal of intromitting pawl 93 into the engagement arm receiver at its bottom center is manual. Thus, attaching and detaching the separably housed manual control device from engagement arm piece 88 is accomplished by the same action that connects engagement arm piece 88 for use. Grasper clamping pads 142 have miniature high coefficient of friction rubbery-lined rectangularly shaped grasper clamping pads 142 where the pad lining material can include vacuities to increase retention through the suction created when compressed and are dimensioned to interface with most of the engagement arm piece arm 77 at triangular socket, or catch, 78 or 77′ at catch 78′.

[0999] Engagement arm piece 88 is held rigidly in place while clamped by between the grasp grasper clamping pads 142 by a spring powerful for its size, the type spring, located at the junction of the linkage at grasper clamping pads 142, noncritical. To facilitate its quick location and use later by the operator or an assistant, grasper shaft push\pull control knob 97 extends out from the side of servomotor housing 92 to remain ready for later reuse when the shaft is retracted and the manual fine control device, no longer needed, is pulled off from the servomotor housing. No separate control to open and close grasper clamping pads 142 as might hinder the user are required at grasper knob 97.

[1000] Instead, a small rod inside the grasper shaft is connected to a linkage familiar to those in the art which opens grasper clamping pads 142 as the edge of engagement arm 77 is approached, and when contacted, a small spring-loaded bar at the junction of grasper clamping pads 142 is depressed to release grasper clamping pads 142 under the restorative force of the spring thus tripped. The unilateral grasper is used when attaching manual fine control deice housing 91 to motor housing 92 before use while outside the body and is easily retracted after use when inside the body by nudging up and slipping a finger the valve to retract grasper clamping pads 142. The linkage is so devised that rather than closing against the sides of engagement arm 77 in scissors fashion as would result in an uneven clamping force, grasper clamping pads 142 remain in parallel relation.

[1001] Withdrawal of the grasper by pulling out its push/pull control knob reverses this action, that is, opens grasper clamping pads 142, releasing engagement arm 88. FIG. 10C shows that in order to retract control wire 80 from lead nut 72, thus disconnecting lead nut 72 from engagement arm piece 88, freeing lead nut 72 to pass along leadscrew 73, push/pull control cable knob 79 must be pulled out as far as push/pull control cable knob 79 will allow, thereby retracting control wire 80 entirely from wire receiver 75 connecting engagement arm piece 88 to lead nut 72 as well as lead nut 72. This allows rotation control knob to rotate lead screw 73 rather than rotate lead screw 72 with engagement arm piece 88.

[1002] FIGS. 10A thru 10E show a vascular servovalve with direct manual fine control device attached and double outlet suitable for allowing a carotid endarterectomy free of complications due to ischemia, adverse fluctuations in blood pressure, as well as the risks of cerebral or myocardial infarction. In FIG. 10A, part number 82 is the male and 83 the female components of the bypass-line connector from the right common carotid to the internal carotid, and 84 and 85 respectively, those for connection of the bypass line to the external carotid. Part number 86 is the line to the internal carotid, and 87 that to the external carotid. The connections of the bypass lines from the common to the internal and external carotids is shown in FIG. 25.

[1003] To facilitate use of control knob 71 when the small button at its center must be depressed to lock lead nut 72 to engagement arm piece 88, rotation control knob 71 has projections 74 about its periphery. Accordingly, rotation of control knob 71 while depressing its central push/pull control cable knob 79 to the right as shown in FIG. 10B thus rotates engagement arm piece 88 to the right causing triangular socket, or catch, 78 to engage engagement arm piece connector 76 on the left, while rotation of engagement arm piece 88 to the left causes triangular socket, or catch, 78′ to engage the engagement arm piece connector 76 on the right side of engagement arm piece connector 76.

[1004] Rotation control knob 71 is fixed at its center position by a detent comprising a depression and complementary projection sufficiently retentive to preclude its inadvertent rotation. Accordingly, while push/pull control cable knob 79 is not depressed, rotation control knob 71 cannot rotate engagement arm piece 88 shown in FIG. 10B connected to leadscrew nut 72 in order to rotate engagement arm piece 88 with it but rather rotates leadscrew 73.

[1005] That is, when, rotation control knob 71 is rotated clockwise while small button 79 is not depressed, rotation control knob 71 rotates leadscrew 73 to drive lead nut 72 and therewith, accessory channel-feeding drugline 8 forward, hence diversion chute 18 further into lumen 1 of the substrate ductus, typically an artery. Turning knob 71 counterclockwise while push/pull control cable knob 79 is not depressed does the opposite, that is, retracts diversion chute 18.

[1006] FIG. 11 provides a schematic representation of solenoid flow diversion jackets or vascular servovalves as fully retracted, or open, on the left to allow nondiverted flow, and on the right, fully extended, or closed, to divert all flow from the substrate to the other vessel. With solenoids movement is limited to full extension or retraction to remedy a transposition of the great arteries when the defect can be addressed without cardiac entry or to accomplish a sudden switch transplant. The part numbers consistent among the drawing figures, 8 are the accessory channels, 9 and 9′ the directionally distinguished mainlines, and 18 the diversion chutes. In FIGS. 11, 12, and 13, 41 and 41′ points to directionally distinguished stream or flow lines.

[1007] To best facilitate application, jackets with the aid of a straddle clamp as shown in FIG. 4 or incorporating an ostium obturator 30 and servovalves can be positioned along their respective ductus before or after connection of the jackets or valves to their mainlines 9 and 9′. The arrows at the center denote that the action is reversible. When used for reciprocal cross-circulation during a switch transplant, this reversibility allows the immediate truncation, or ‘bailout’, of the operation by fully extending the flow diversion valves if a solenoid-driven sudden switch, or a variable retraction is a servo-driven metered switch, usually, with ensuing resumption.

[1008] Differing from plunger solenoid driven diversion jackets in allowing instantaneously continuous adjustability between full extension and retraction, the applicability of vascular servovalves extends to metered switch transplantation whereby an implanted microcontroller dynamically adjusts the valves to the achieve optimal acceptance by the recipient based upon the data provided to it by implanted physiological sensors.

[1009] Mainlines 9 should be kept as short as possible by positioning the donor and recipient to best accommodate the chirality only when the difference in distance is significant. Accordingly, whether mainlines 9 and 9′ crisscross or decussate in bias depends upon how the subjects are disposed in relation to one another. The directions of accessory channels 8 serves pictorial clarity; in fact, these are routed as least disturbs neighboring tissue.

[1010] FIG. 12 shows the use of bidirectional side-entry diversion servovalves to take the place of separate valves as shown in FIG. 11 where, in particular with neonates and infants, space to accommodate separate valves to perform a metered switch transplant is at a premium. Whereas FIG. 11 shows the separate valves switched from fully retracted from the substrate lumen, or closed on the left, thus playing no part in the normal flow of blood through the substrate lumen, and fully extended, or open for full flow diversion on the right, FIG. 12 shows the bidirectional valves at the half-way setting to allow half the flow to be exchanged between recipient and donor and half to continue the flow of blood native to the subject, the extent of mixture throughout either circulatory system contingent upon the duration of exchange.

[1011] When the defect does not reach down into the roots of the aorta and pulmonary artery, the same arrangement using solenoid-driven diversion jackets is suitable for the extracardiac correction of transposition of the great arteries in a neonate or infant. The half-way position denotes servovalve rather than solenoid control, this position exemplary for what is actually the continuous variability essential for metered switch transplantation. The use of bidirectional rather than separate servo-driven valves indicates that depicted is a moment in a metered transplant in a neonate or infant.

[1012] The valves controlled in a complementary manner, a complete shutoff or lack of outflow equates to the concurrent lack of inflow; otherwise, the volume of blood outflow equals the volume of inflow. Were the valves used in a neonate or infant to perform an extracardiac transposition of the great arteries, an adverse immune reaction would not be involved, so that to adjust and monitor the response would not be necessary. Bidirectional diversion chutes can also be incorporated into highly damped nonsparking solenoid-driven diversion jackets where the space-saving attribute facilitates the placement of duplicate jackets.

[1013] For example, shown in FIG. 13B, used to exchange flow between the great arteries when permanent placement to correct a transposition is needed, any irritation is avoided by periodically switching the exchange of flow between upper and lower pairs of jackets. If retained in fully extended or retracted position by detents, the push-pull solenoids require a momentary surge of current to overcome. Irritation and displacement are countered because:

1. The jackets are lined with a relatively thick layer of viscoelastic polyurethane foam.
2. Perforations through the jacket shells 3 and foam 4 expose sufficient surface area of the substrate ductus adventitia to the internal environment to avert the otherwise inevitable and quick atherosclerotic degeneration associated with complete enclosure.
3 In larger jackets that afford adequate clearance to allow the delivery to the adventitia of medication, accessory channels can directly release a steroid, for example.
4. The jacket spring-hinges are specified to comply with minimal resistance to the pulse of the substrate artery while applying sufficient cinching force to avert displacement, or migration, along it.
5. The suture loops at the abaxial or butt end of the valve side stem and at other points about the outer shell 3 allow connection to nearby minimally or noninnervated connective tissue to stabilize the jacket from levering with the pulse.

[1014] For these reasons, irritation, if it occurs at all, should arise only after long intervals, at which time the remedial measures are noninvasive. Lacking the versatility of servovalves, solenoid-driven diversion jackets still allow an exchange of blood within one or between two bodies to be stopped immediately. To accommodate the quick pace of growth at the outset of life, jackets are lined with somewhat thicker highly compliant viscoelastic polyurethane foam 4 and sprung hinges 11, and mainlines 9 made of highly elastic and usually accordioned or convoluted tubing. At the small diameters of the mainlines as bloodlines, the use of valves with accessory channels to directly target heparin, for example, is necessary.

[1015] FIG. 13A shows an arrangement of either bidirectional diversion jackets for the extracardiac correction of a transposition of the great arteries, or of diversion servovalves to perform a metered organ transplant, such as of the heart where space is limited. FIG. 13B shows the doubling of this arrangement at an interval along the arteries so that flow can be switched between the upper (superior, cephalad, craniad) and lower (inferior, caudad) pairs of jackets in a transposition repair or valves in a metered switch transplantation as one of several measures enumerated just above in this section to counter irritation of the substrate artery. Part numbers among the various drawings are consistent.

[1016] FIG. 14 shows a vascular servochoke. The miniature tubular pulse motor shown in FIG. 9 comprises two major outwardly evident components, shaft 42 and forcer 37. To prevent irritation to neighboring tissue, the corners and edges of the device housing (enclosure, case) are rounded. The adventitia is contacted entirely around only by felt lining 4, and rather than fully enclosed as would cause intimal degeneration, exposed to the surrounding cavity through numerous perforations 40 placed all about the jacket. As in all side-entry devices, outer shell 3 is never allowed into contact with the adventitia. Various means for providing a drugline to deliver mediation directly to the adventitia are addressed above under Background of the Invention.

[1017] In FIG. 14, part number 43 is the chokeplate (choke plate, obstruction plate, obstructor) and 10 a lock nut cap that gives access to the motor. Accessory channel 8 is shown entering with outlet into open cell viscoelastic polyurethane protective foam 4, releasing medication for diffusion to the adventitia. Accessory channel 8′ is shown entering obstruction plate 43 from below, releasing medication to flow through and out of obstruction plate 43 bottom pore 44. Dishing out, that is, creating a depression or concavity on the underside of obstruction plate 43 increases the impedance to flow, which can be used, for example, to increase uptake of the drug released through bottom pore 44, the impedance variable according to the depth and conformation of the depressions.

[1018] Flowing against gravity through a capillary tube-gauged catheter serving as accessory channel 8′ requires not only pressure equalization but increased rate and pressure of delivery by the outlet pump of the small drug reservoir implanted in the pectoral region. One function of a servochoke to increase the pressure of the oncoming flow, assuming flow is upward (cephalad, craniad) through native lumen 1, chokeplate bottom pore 44 can be used to release a nanoparticle carrier-bound drug which the choking action will pressurize for facilitated uptake in the intima. Where uptake is still inadequate, a magnetized perivascular jacket, described and illustrated in copending application Ser. No. 15/932,172, entitled Integrated System for the Infixion and Retrieval of Implants, is positioned along the segment to be penetrated, the nanoparticulate then superparamagnetic.

[1019] Radiation shielded delivery lines are described and illustrated in copending application Ser. No. 14/998,495, entitled Nonjacketing Side-entry Connectors and Prosthetic Disorder Response Systems, and Ser. No. 15/998,002, entitled Ductus Side-entry Jackets and Prosthetic Disorder Response Systems. Allowing the irradiation of ductus lining epithelia is highly exceptional and essentially limited to short segments of vessels intimately associated with malignant tissue. Such application is rarely other than endoscopic or long term. Obstruction plate 43 is introduced into the substrate native lumen 1 through a stab wound, eliminating the need for a trepan tube and thus allowing a significant reduction in size.

[1020] The action can be accomplished so quickly as to minimize if not eliminate any seepage of blood or the need for a straddle-clamp, one configuration thereof shown in FIG. 4, to define the segment for entry. Radially symmetrical, hence, neutral as to antegrade or retrograde flow, a servo chokevalve can be positioned along any vessel without regard to the direction of flow through the substrate vessel. Not requiring a well cut round entry aperture, the vascular servochoke shown in FIG. 14, chokeplate 43 is inserted through substrate lumen wall 2 through a stab wound which the operator should be able to place so quickly and with as little loss of blood as to not even require the aid of a straddle-clamp.

[1021] On the unseen backside of the servo-driven chokevalve shown in FIG. 14, a drugline enters servochoke side-stem 19 through the outer jacket 3 and foam 4 to inlet chokeplate 43. Passage through chokeplate 43 as an accessory channel is through a micromachine milled channel created when chokeplate 43 is bonded together from an upper and a lower layer as two complementary plies. The accessory channel outlet is beneath chokeplate 43 at 44.

[1022] The fluid drug and electrical lines having entered on the unseen or far side of the chokevalve, accessory channel outlet 44 drips drugs which the disruption in streamline flow backscatters for uptake into the endothelium 13 and 14. Other part numbers are consistent with those in the preceding drawings. Vascular servochokes (choke servovalves, chokevalves, choke-valves) are used primarily to raise the local blood pressure to increase the upstream uptake of drugs released into the vessel, usually a vein with lower blood pressure, a moment earlier.

[1023] A perivascular magnet jacket shown in FIGS. 2 thru 7 and described in copending application Ser. No. 15/932,172, entitled Integrated System for the Infixion and Retrieval of Implants, allows increased uptake of superparamagnetic nanoparticle-carried drugs, the more so when combined with a chokevalve. The drug may be one systemically circulated where higher uptake is wanted along the upstream segment. Release of the drug is through an accessory channel with outlet beneath the chokeplate or from an accessory channel in an upstream jacket or valve, larger volumes of an agent delivered through the its mainline. Another type of choke servovalve is the sphincteric, shown in FIGS. 11 and 12 and described in copending application Ser. No. 15/998,002 entitled Ductus Side-entry Jackets and Prosthetic Disorder Response Systems.

[1024] Chokevalves are always driven by a servomotor automatically controlled by an implant microcontroller, or in comorbid disease, a microprocessor, serving as the master controller in a hierarchical control system in accordance with physiological data fed up through the hierarchy to the master controller which executes a prescription-program devised for the specific patient. The microcontroller or microprocessor controls a small peristaltic pump at the outlet pump of a small flat drug reservoir implanted subcutaneously in the pectoral region.

Valve Applications—FIGS. 15 Thru 17 and 22 Thru 25

[1025] FIG. 15 is a simplified schematic representation of a switch transplantation, in which blood flow through the actual vessels of the native solid organ—here the heart—have been schematically summarized to make clear how flow is switched from the native to the donor organ. Depicted as applied to the heart, the same process pertains to a kidney, liver, lung, gland, or any other graft organ. Heart outflow is through the aorta and pulmonary artery (pulmonary trunk, main pulmonary artery) and inflow through the venae cavae. In an orthotopic switch transplantation, once all blood flow is through the donor organ, the native organ is removed. Alternatively, blood flow can be continued through both native and donor organs indefinitely, thus adding the donor organ as supernumerary in a heterotopic transplant.

[1026] Shown is the compound bypass transfer of blood flow from the native to the donor organ at the half-way point, 45 representing the transections at the ends of the stumps of the donor graft organ. The chutes have been depicted at an intervening point in extension instantly traversed in a sudden switch transplant but the midpoint intervening between complete retraction with the organs independently perfused and complete extension during which both organs are supplied blood by both the donor on life support and the recipient to blend the blood in order to effect a measure of immune tolerance induction.

[1027] In a metered switch transplant, this intervening point in chute extension may be temporary, the chutes partially retracted or further extended from it, or can represent the final setpoint, adjusted for a mismatch in the relative size, consistent with the absolute stroke volume, or ejection fraction if either heart. This midway point interposed between donor-recipient circulatory independence and blending is shown for arterial flow in FIG. 20B and for venous flow in FIG. 21B. The vessels involved are identified in FIG. 16. The extent to which the blood is blended is controlled by the duration the diversion chutes are positioned at such an intervening extent.

[1028] In an orthotopic transplant, excision of the donor organ is not performed until blood flow has been passed to it exclusively. That the figure represents the heart having been excised with the vascular servovalve diversion chutes at the half-way point to equally apportion flow through both indicates that this is a switch heterotopic, or double heart transplant as shown in FIGS. 16 and 17, and that while no such size matching is necessary for this procedure increasing the pool of replacement hearts, the added heart is similar in size to that native.

[1029] This continuity of circulation while the donor is kept past death on life support in the same center eliminates storage, and therewith, the endothelial degeneration and cellular breakdown products which contribute to early hyperacute rejection and late term vasculopathy. That neither native nor donor organ are incised, the recipient placed under regional, not general, anesthesia without cardiopulmonary machine support, and can remain conscious throughout the procedure likewise offer benefits over conventional transplantation. In a metered switch transplant, where the transfer of circulation from the native to the donor organ is gradual, a choice can be made at this intermediate stage as to whether the donor organ should orthotopically replace or heterotopically supplement the native organ.

[1030] Part numbers are consistent with those identified previously. If supplementation is chosen, circulation remains divided between the native and the graft organ. An hypoxic condition of either organ is detected and signaled by implanted sensors to the implanted microcontroller which then toggles the diversion chutes to alternately apportion a nearly full complement of blood to either. In contrast to metered switch transplantation, which also allows immune tolerance induction concomitant with organ transfer, a sudden switch transplant transfers circulation from the native to the donor organ abruptly and entirely without the ability to stop at an intervening point or reverse the diversion chutes, so that immune tolerance induction therapy must be pre- and postprocedural.

[1031] FIG. 16 identifies each of the nine actual vessels summarized in FIG. 15. In FIG. 16, the letter A stands for the aortae; LPA stands for the left pulmonary arteries; LPVs for the left pulmonary veins; IVC for the inferior venae cavae; SVC for the superior venae cavae; and RPVs for the right pulmonary veins. Arrowheads directed to the right denote outflow, those to the left inflow. The double heart transplant having been completed as depicted, flow through the vascular diversion servovalves have been brought to the half way retracted or withdrawn from the lumina to pass half the blood of the donor through the recipient and donor hearts.

[1032] At eighteen, the number of valves required gives emphasis to the importance of achieving the lowest weight and greatest miniaturization of each, obtained primarily through microfabrication and the use of light plastic and metal parts and electrical windings of silver. For visual clarity FIG. 16 omits flow lines through the accessory channels, or druglines, associated with each valve. All lines fluid and electrical must be routed to avoid strangulating tissue. To implement this, accessory channels can enter into the valves at a number of places such as along circumferentially running perforations 40 or transversely to sidestem 19 and intotrepan tube 5 or foam 4. If direct routing will not allow this, then fluid and electrical lines are rerouted. When clearly safer for the patient, hard wires are replaced by remote radio channels such as ‘Bluetooth.’

[1033] If valve obtrusiveness A metered switch solid organ transplant requires the use of vascular servovalve with direct manual fine control such as that shown in FIGS. 10A thru 10C so that the operator can make minor adjustments in diversion chute position during the condition of no current flow before the automated process of organ transfer is initiated. Were the hearts different in size than as shown, this valve setting would have been adjusted to either side of the half way point to accommodate the size difference in absolute stoke volume, or stoke volume, of either heart. In FIG. 16, the ‘corners’ at the connections of the mainlines, here bloodlines 9 to each of the vessels is the side-entry vascular servovalves by which the connection is made.

[1034] Since these valves not only mediate circulation postoperatively, but the transfer of circulation between the two in transferring the donor heart into the circulatory system of the recipient, only fully operational servovalves are used, disallowing the use of passive, or nonadjustable diversion jackets. This ability to apportion blood flow through either heart in accordance with the relative size or stroke volume of each heart eliminates the complications normally associated with hearts mismatched in size in heterotopic transplantation of a smaller donor heart, the use thereof making it possible to retain more of the right lung as preferred.

[1035] While the vessels can be anastomosed and bloodlines 9 removed, the jackets with druglines 8 attached and continuous with the valve accessory channels remain to deliver drugs detected as necessary by implanted sensors so that the master controller is signaled of the need for direct pipe-targeting of a medicinal or electrostimulatory therapy as necessary. FIG. 15 also represents the half-way point in an orthotopic metered switch heart transplant before the valves are adjusted to direct all blood flow through the donor heart. To perform a switch orthotopic heart transplant, the native heart is then removed and the graft organ set in its place.

[1036] Leaving the vascular diversion servovalves at the half-extended position or somewhat aside thereof to accommodate a graft organ of different size, allows the native heart to remain and the donor heart to be positioned beside it, for example, some volume of the right lung removed to accomplish this. Whether such a metered switch heterotopic for double heart transplant places the added heart in the abdominal cavity or nestled in the iliac fossa, for example, it is noteworthy that the flow of blood through all the significant vessels of both the native and donor hearts is that assigned by nature.

[1037] Downward directed arrowheads denote venous return, upward directed arrowheads ejection, and the arrowheads along the bloodlines indicate the direction of flow. The same connections apply regardless of where the donor heart is positioned in the recipient; this configuration provides a distribution of the blood-moving load proper for the chambers and the pattern of flow normal for the vessels. Preservation thus is best with the donor heart positioned as shown, but where unavoidably, placement must be lower in the body, function will still be much closer to normal than were connections made to local vessels. Direct connection to the inferior vena cava and abdominal aorta, for example, results in much flow past the offline transplant, and therewith, disuse atrophy.

[1038] The added heart functioning as an adjunct or reinforcer of the native heart, only the native heart is directly connected to the rest of the circulatory system. With the servovalves connecting the bloodlines set to favor both equally at the half way point, each heart contributes half to the overall volume of blood ejected. In fact, the valve setpoints are shifted to favor the hearts according to the competency, that is, the ejection fraction, or absolute stroke volume, of each. Thus, when the hearts are equal in this regard, the servovalves connecting the mainlines are set at about the half way point and can be intermittently shifted between an almost entirely open and closed position to allow either heart to receive the full rather than half the normal volume of blood.

[1039] Venous return is from the native to the added heart, while ejection is from the added heart to and through the native heart, so that with the hearts positioned as shown, the overall flow of blood is clockwise. The metered switch pattern of flow shown was initiated after the valve jackets and communicating lines were connected to the donor heart on the left while still in the donor on life support. This reciprocal cross-circulation was continued long enough to accomplish a measure of immune tolerance induction as integral in the process of gradually transferring the heart from the donor to the recipient.

[1040] Because unlike other organs, the heart cannot be taken from a living patient, this process can continue over a longer duration. The donor heart is then harvested, the vascular stumps sealed with suture and a fibrin sealant, and placed in the recipient without disconnecting the lines or valves. Connected thus and alternated as indicated, the ejection and venous return of two hearts add with a time lag smallest when adjacent in the chest as shown and increased as the donor heart is positioned farther down in the body.

[1041] In FIG. 17, the native or earlier orthotopically transplanted heart on the right is undisturbed in its connections to the rest of the circulatory system, the diversion servovalves extracardiac, placed on its in- and outflow vessels. The bypass, or metered switch, transplanted heart on the left in the figure communicates with the circulatory system by connection to and through the vessels of the native heart shown on the right. That flow through the graft is ‘natural’ is intended to eliminate disuse atrophy as occurs in the direct connection of a redundant heart to the inferior vena cava and abdominal aorta, for example, as has often been done in immunological research, for example.

[1042] The connection of the added to the native heart is accomplished by truncating a metered switch orthotopic heart replacement at about the half way point, then clamping, harvesting, and implanting the donor heart without disconnecting the blood diverting lines. A double heart transplant is always metered, never sudden switched. In a double heart transplant, the vascular servovalves—those of the recipient at the right end of the connecting bloodlines and those of the donor at the left end—placed while the donor on life support remains intact—mediate the compound bypass of the native organ and thereafter are not removed but rather remain to channel the blood as shown and allow the direct pipe-targeting of drugs through any valve.

[1043] For visual clarity, connecting bloodlines in the chest view of FIG. 17 were limited to three—the aortae, venae cavae, and right inferior pulmonary veins. As shown in FIG. 16, there are, however, actually nine major incurrent and excurrent major vessels, hence, nine mainlines, or bloodlines, eighteen servovalves, and 18 druglines, each routed to an accessory channel in one of the valves. In contrast to the lung transplant depicted in FIG. 22, the stumps are distant and not anastomosed, the severed ends sealed with a fibrin sealant and suture. Thus, whereas in a switch double heart transplant the 18 valves are best left in place rather than replaced with simpler side-entry jackets before closing, in an orthotopic switch heart transplant, donor and recipient stumps can be anastomosed allowing 9 of the valves to be removed.

[1044] More specifically, in a double heart transplant, retention of the valves allows maximum flexibility in automatic flow adjustments, continued maintenance and drug delivery on an indefinite basis. For these reasons, the midprocedural number of valves, rather than replaced by basic side-entry jackets, for example, are best retained after the operation has been completed. However, this separation may actually ameliorate irritation associated with direct contact, and the immediate support of directly targeted drug delivery should overcome any drawback this separation might otherwise impose.

[1045] The need for 18 valves demonstrates the importance of achieving small size, light weight, and minimal cost in valves for use in such a double heart transplant, of which the advantages, enumerated herein, are numerous, substantial, and basic With the diversion valves set at the halfway point, when both hearts beat simultaneously, the hearts divide the normal volume of blood equally. The servovalves can divide the full volume of venous return between the two hearts in any proportion, or the entire volume to either heart at a given moment, but cannot double the volume available to pass a full volume of blood to both simultaneously. To allow an almost full volume of blood to be processed by each in turn, the valves are switched to favor the one, then the other in alternation.

[1046] Cardiac hypovolemia is detected by oximeter implants in either heart and prevented by automatically initiated toggling of the servovalves to alternately favor either heart at the optimal rate the microprocessor is programmed to hunt for and set. Should a dysthythmia arise, it is detected by implant sensors using circuitry much the same as that used in an implantable cardioverter-defibrillator and the disruption electrically resynchronized, or reversed through the application of shocks initiated at a level calculated to avoid injury, which is stepped up until successful.

[1047] Thus, to prevent the inducement of a dysrhythmia that could lead to a sudden arrest, and because for the heart to beat when empty can be injurious, sufficient blood is always provided to both to avoid these eventualities. Because this arrangement allows venous return and ejection to be apportioned between the hearts, the added heart can be and is best somewhat smaller in size to allow placement with the least removal of lung tissue. Lung tissue regenerates not by increasing in mass but rather by increasing the number of alveoli per cubic centimeter, making it doubtful that the patient will experience even a temporary postoperative shortness of breath worthy of note. The graft organ should not interfere with the restoration of the ribcage to very nearly if not exactly its normal conformation before closing.

[1048] Drug delivery responsive to implanted sensor input, all of the servovalves incorporate drug-delivery, or accessory channels, through which the control system can target drugs through catheters connected to each valve from small flat reservoirs placed subdermally in the pectoral region. Drug replenishment is by injection into the reservoirs through a body surface port, of which one type is shown herein.

[1049] FIG. 17 shows the positions of the hearts following a double heart switch transplant, the added heart when possible having been placed in the chest as preferred for several reasons, to include protection by the rib cage as close to the natural position intended therefor, reducing the need to work against gravity, and for other physiological reasons. Positioning thus is overridden only due to deformity or a crushing injury to the right side of the chest where an urgent need for a heart outweighs the additional time it would take to reconstruct the damage. The vessels having already been identified in FIG. 16, to avoid clutter, only three recipient-donor connections have been shown.

[1050] Shown in FIGS. 17 and 27C, subcutaneously implanted multiple injection point port 122 of the portacath or mediport type corresponding to port 146 in FIG. 26A with on-the-skin, or cutaneous injection point indicating marks 124 allows the replenishment of implanted drug reservoirs such as shown in FIG. 26B by multiple injection means such as those shown in FIGS. 27A and 27B through tattooed injection point indicators 124. Although to be certain that the multiple injector is exactly positioned to replenish each drug through its intended injection opening only one injection point need be identified on the skin, here out of an abundance of caution, two injection points 124 are shown as preferred. The multiple injectors shown in FIGS. 27A and 27B comprise four injectors of which the injection openings 107 are shown in FIG. 26B, for which two of the injection points 124 are marked on the skin as shown in FIG. 27C.

[1051] While a port with drain 110 to the exterior such as shown in FIG. 26C for the outflow of urine would ordinarily be positioned to a side of the mons pubis where no pump is needed and the wearer has a clear view of it, where the frequent insertion of cabled diagnostic and/or therapeutic devices at a higher level is required, the same kind of port, shown as 147 in FIG. 26C, would normally be positioned in the pectoral region. Thus, depending upon the application, both ports with an opening to the exterior such as port type 147 shown in FIG. 26C and those fully subcutaneous such as port type 146 shown in FIGS. 17, 26A 26B, and 27 can be positioned at different levels.

[1052] FIG. 18 depicts the flow through one of the arteries shown in FIG. 15 in a sudden switch heart transplant. In FIG. 17A. highly damped nonsparking solenoid-driven flow diversion chutes are fully retracted, ostium obturator 30 covering over the side-entry opening along near luminal wall 13, thus blocking the outflow of blood through the ostium. When the operator or an assistant depresses a switch to send current to the solenoids at the donor and recipient ends of the mainline, or bloodline, connecting each of the vessels shown in FIG. 15, all of the blood flow diversion chutes simultaneously snap from full retraction against near luminal wall 13 to full extension, whereby all flow is diverted from the recipient to the donor graft organ, here the heart, the ostium obturator now pressed flush out of the flow path against far luminal wall 14.

[1053] In FIG. 18A, arterial flow from the donor heart before the diversion chutes are deployed is summarized, in that all arteries are depicted as one on the left, and all flow from the diseased heart of the recipient is summarized on the right. Arterial flow after the chutes have been deployed is shown in FIG. 18B, where the X strike-out indicates that with the donor organ now incorporated into the circulatory system of the recipient, the innate organ has been bypassed and removed. FIGS. 5, 7, and 8 show the structure of intravascular diversion valves and servovalves. The sizes of the jackets vary according to those of the respective substrate vessels, the rotational orientation chosen to least encroach upon neighboring tissue.

[1054] FIG. 19 depicts the same action as shown for the arterial chutes in FIG. 16 as applied to the veins. More specifically, FIG. 19A is a schematic summarization of venous flow to the donor heart on the left and the innate heart of the recipient on the right, before venous switching in FIG. 19A, and after switching in FIG. 19B. In FIG. 19B, the X strike-out indicates that circulation through the donor heart having been switched from the donor into the circulatory system of the recipient, the native heart has been removed.

[1055] FIG. 20 depicts the same starting and ending points of the blood diversion chutes at the ends of any one of the arterial bloodlines shown in FIG. 15, that is, full retraction and full extension, shown in FIGS. 18 and 19 where an intervening position at the center indicates that this is a metered rather than a sudden switch transplantation. Instead of suddenly shifting from the fully retracted to the fully extended positions, movement of the blood diversion chutes between these endpoints is gradual, implanted sensors alerting the implanted controller as to the extent of antibody release. The chute driving servomotors such as that shown in FIG. 9 can advance or retract the chutes at any rate to any point along the trajectory separating complete retraction to complete extension.

[1056] In this way, the process effectively ‘feels’ and ‘inches’ its way to full extension at which blood flow is entirely through the donor organ. Were this a metered double heart transplant, the endpoint would be closer to if not at the state depicted in FIG. 20B at which the blood of donor and recipient would eventually represent a 50/50 mix. The extent to which the process and therefore the proportion of donor blood in the mix depends when the chutes can remain at the more central endpoint with no more than manageable disturbance induced. In both sudden and metered switch transplants, the implanted disorder response system, druglines, and jacket accessory channels into which these feed remain for postoperative therapy. If donor and recipient stumps are anastomosed, the bloodlines or mainlines can be removed.

[1057] FIG. 21 shows the same three stages in a metered switch organ transplant, here the heart, for each of the veins shown in FIG. 16 as FIG. 20 shows for the arteries.

[1058] FIG. 22 shows the disposition of the bloodlines connecting the donor and the recipient organ to be replaced before the graft organ has been harvested in FIG. 22A and after it has been placed in the recipient in FIG. 22B. Transplantation of a lung requires connection of the pulmonary arteries and pulmonary veins, schematically represented here as summarized. Lungs are orthotopically, not heterotopically transplanted. The practicability much less necessity for the heterotopic transplantation of a lung are the least of any major organ.

[1059] In FIGS. 22A and 22B, part numbers are consistent with those in the other drawing figures, so that 8 is a schematically depicted arterial drugline, while 8′ is a venous drugline, all druglines passing into an accessory channel inside the valve jackets. Part number 9 represents a single bloodline as a schematic summarization of the pulmonary blood supply normally consisting of three arteries of the bronchial circulation which supply oxygenated blood and the pulmonary arteries which supply deoxygenated blood, 9′ an equivalent summarization of the venous drainage, and 41 is a flow or stream line showing the direction of flow. The condition depicted in FIG. 22B offers different options in addition to allowing the condition shown to remain so that blood flow can be switched between the native vessels and either or both arterial bypass 49 or venous bypass 49′.

[1060] Determined on the basis of clinical judgment, anastomosis of either or both stump junctions along suture lines that arterial 46 and that venous 46′ can be omitted and the bypass left in place indefinitely as a prosthesis. One consideration in this decision is that a later transluminal, or transcatheteric, procedure will have to pass through the prosthetic bypass rather than through the native structure. If the drugline or internal configuration of the diversion jacket or valve prohibits transluminal treatment, the procedure is endoscopic. Because all basic side-entry jackets, diversion jackets, and valves incorporate at least one accessory channel to directly pipe-target drugs to the treatment site, the need for a later transluminal intervention is slight.

[1061] Hypothetically then, should the donor heart in a heterotopic double heart switch transplant require the removal of obstructive plaque, for example, a coronary artery bypass graft, preferably performed endoscopically rather than a percutaneous transluminal, or transcatheteric, angioplasty is performed, the surgical procedure long established as more durable than that transluminal. When donor and recipient stumps are anastomosed as shown at 46 and 46′ respectively, either or both arterial bypass 49 and venous bypass 49′ can be removed. The valves and bloodlines will continue circulation whether donor and recipient stumps are anastomosed before closing or separately terminated with a fibrin sealant and suture.

[1062] Ordinarily, the stumps are anastomosed and only recipient arterial diversion valve 48 and donor venous diversion valve 50 left in place in order to retain their respective accessory channels upstream to anastomotic suture lines 46 for continued therapy as necessary. Periodic imaging should supplement implanted sensor feedback to the drug regulating implanted microcontroller, or more likely microprocessor, which controls the drug reservoir outlet pumps. Accordingly, every case unique, different vessels differently affected, arterial and venous bypasses would normally be treated alike, but to accommodate different conditions of disease or injury, either can deviate in any of the foregoing particulars.

[1063] Rather than to cover these over, the valves are set off at a slight distance from and positioned to directly target immunosuppressive, anti-inflammatory, and antimicrobial medication, for example, to the anastomoses. The anastomoses are therefore neither cut off from the surrounding milieu nor hidden from sight or endoscopic access. Targeting thus spares nontargeted tissue the complications that inevitably arise with immunosuppressive and chemotherapeutic drugs, for example.

[1064] While the use of permanent magnet perivascular jackets, or impasse-jackets, as described in copending application Ser. No. 15/932,172, entitled Integrated System for the Infixion and Retrieval of Implants, can achieve targeting by drawing superparamagnetic nanoparticle or microparticle carrier bound drugs into the intima, these do so at the level where they are positioned, whereas fluid drug delivery through the valve accessory channels allows the intact fluid to run down across the anastomoses. However, projecting no part into the native lumen, impasse-jackets do not pose an obstacle to transluminal passage with a cabled device or angioplasty balloon, for example, whereas valves do in situations where to retract the diversion chutes may not be practicable.

[1065] Bloodlines, or mainlines, summarized as part numbers 9 and 9′, must span the distance between the donor and the recipient over a length that may result in these being too long to position in the recipient so as not to encroach upon neighboring tissue, as well as necessitate more pressure to traverse these spans. Once the graft organ has been placed in the recipient, mainlines, here bloodlines 9 and 9′ and druglines 8 continuous with the accessory channels which course through the valves, are reduced in length to that appropriate in any of a number of ways. These include:

1. The use of highly elastic accordion-configured tubing that spontaneously shortens as this distance is reduced.
2. Additional shortening is achieved by running a bead of surgical cyanoacrylate cement adherent to the tubing plastic along the apices of the pleats of the accordion tubing to run down into the reentrants between the pleats thence to the underside of the pleat reentrants. The operator or an assistant then further shortens bloodlines 9 and 9′ and druglines 8 by pressing the tubing shorter so that successive accordion bellows-like pleats are glued together side to side. The height of the pleats sets the degree to which the tubing can be shortened. The blood passing through the tubing little diverted into the pockets posed by the entries into the pleats from the lumen, the internal diameter of the tubing is little affected, and the accumulation of clot these would normally promote is dispelled by using druglines 8 to release an intermittent low dose heparin drip.
3. Compatible with the foregoing is the use of heat shrinkable elastic accordioned tubing. In some cases the use of straight-walled, or non-accordioned, cylindrical heat shrinkable tubing will be sufficient.
4. Where the distance separating donor and recipient allows, tubing that incorporates successive thicker and thinner walled sections allows involuting (telescoping, invaginating) the thinner into the thicker sections. This reduces the internal diameter of bloodlines 9 and 9′ and druglines 8, which if necessary, is easily avoided by compensating for the reduction through the use of tubing equally larger in internal diameter at the outset. Use of this method assumes that the successive telescoped sections are sufficiently pliant as not to irritate neighboring tissue.
5. Bloodlines 9 and 9′ and druglines 8, are interposed by abridge section connected at donor and recipient ends by diversion jackets. Once the graft organ has been placed in the recipient, facing ends of bloodlines 9 and 9′ and druglines 8 are ‘anastomosed’ with strongly adherent surgical grade tape and the diversion jackets with bypass tubing removed.

[1066] While a protective lung cage and the removal of an adequate length of gut would allow positioning a lung in the abdominal cavity, air delivered to the lung through a trachea extended with synthetic tubing at the correct pressure would likely require the additional implantation of a small assist air pump, pressure sensor, and oximeter sensors. However, because the blood supply and drainage afforded by switch transplantation assure virtually normal oxygenation and removal of carbon dioxide, hypoxia in any lobe should not arise.

[1067] Such an arrangement could be made to work, but the need for it would appear rare, mostly due to chest injuries that irreversibly damaged both lungs where the use of extracorporeal membrane oxygenation, for example, would not sustain the patient for more than a short time. Lung disease and related defects often extending to the trachea and bronchi, when diseased or defective as to justify its replacement, the trachea and much of the bronchus, ordinarily not included in the transplant, is included as shown.

[1068] FIG. 23 provides in FIG. 23A an overall perspectival view of a surgical chestdome, an overall side view in FIG. 23B, a closer side view showing wraparound cast iron weight 55 and foam cushion 56 running around the bottom, in FIG. 23C, the upper, or head-facing (superior, headward or cephalad, craniad), surface thereof in FIG. 23D, and the lower, or foot-facing (inferior, caudad. footward), surface in FIG. 23E. A surgical chestdome serves to equalize the pressure surrounding the surgically breached chest with that intrapulmonary, thereby averting a surgical pneumothorax. The weak vacuum inside the chestdome will usually require the introduction of oxygen or if necessary, the use of mechanical assistance, preferably through a nasal tube, to allow spontaneous breathing.

[1069] Surgical chestdome 52 is applicable to any surgical procedure that requires entry into the chest but was devised to allow spontaneous ventilation, or normal breathing where cardiopulmonary support or extracorporeal membrane oxygenation is not used, under regional if not local anesthesia as preferable in a switch transplant. Cardiopulmonary support and/or general anesthesia often leave the patient with cognitive deficits, and a mechanical ventilator operated by anyone not expert in its use can do serious damage to the lungs.

[1070] If air enters the dome, the response of the vacuum pump with limit switch is to instantaneously equalize the pressure within to that outside the dome When the graft organ, such as a heart, is to be transplanted, the organ is harvested and placed within the dome with bloodlines and druglines attached before the chest of the patient is opened and dome 52 placed over the patient. Alternatively, a larger rectangular glove opening is provided to allow such a larger object to be passed through. In FIG. 23A surgical chestdome 52 is made of a clear transparent plastic such as polycarbonate. Glove openings 53 on each side of dome 52 give the operator and assistants easy access to the operative field. Glove openings 53 are filled by stiff bristles several layers deep 54 which brush against the sides of the gloves and any objects introduced or removed to leave virtually no space through which air might enter.

[1071] Should air enter nevertheless, the vacuum pump with limit switch will immediately reinstate the rarified condition inside dome 52. Further to assure an airtight fit of dome 52 to the surface of the operating table and/or any bedding or covering, weight 55 runs around the dome 52 just above foam cushion 56 along the bottom periphery. For rust resistance, cast iron dome surround 55 toward the bottom of the dome is galvanized with 0.001 to 0.003 inch thick inorganic zinc anti rust spray, then topcoated with a rust resistant epoxy, phenolic, acrylic, or silicone paint, for example. When the graft organ is placed beside or on the patient before dome 52 is set down, small segments of foam lining 56 if not sufficiently compliant as not to compress the bloodlines are replaced with a more compliant foam.

[1072] FIG. 24 shows a heart cage (grid, grating) for surrounding a heterotopically bypass, or switch, transplanted heart when placed in the lower abdomen, for example, where adequate protection by surrounding bone is lacking. To minimize its weight, the cage is fabricated from narrow hollow titanium or stainless steel tubing. FIG. 24 provides an anterior (frontal, face-on) view of a heart cage. The cage, fabricated by electrical resistance (‘spot,’ electrowelding), comprises two complementary sides, each conformant to the shape (profile, contour) on its respective side of the heart, always asymmetrical, to be enveloped and complementary to the periphery of the opposite half. The halves are hinged at the back by electrically welded hinges (not shown) made of the same titanium or stainless steel as the grid.

[1073] For strength and to avoid current flow, the weld metal is the same as the grid. The halves come flush together at the front, where spring-loaded upper latch-type lock fastener 64 and that lower 65, likewise attached to the grid frame and made of the same material, allow the cage to be opened should a follow-up procedure, such as examination by a transluminally passed intravascular ultrasound probe. or a coronary artery bypass graft become necessary. All of the hinges to include those along the back, or posterior, junction where the sides come flush together or seam and spring-loaded latch fastened locks similarly positioned along the front, or anterior, seam are made of the same titanium or stainless steel, each electrowelded to the grid about a third of the distance from the top and bottom.

[1074] The cage comprises gridwork 57 of hollow titanium or stainless steel tubing 3/16 inch or ½ centimeter in outer diameter, with a tubing wall thickness of 1/16 inch and grid apertures (holes, openings) 58 of 1 inch or 2½ centimeters, following the same outer shape (profile, contour) as the contained heart itself. The grid stands off at a distance of about ½ inch or 1¼ centimeters from the heart per se, affording clearance for the interposition of a protective layer of perforated viscoelastic polyurethane foam, bonded along the interior surface of the cage grid tubing and provides an opening at the top 59 to allow the superior vena cava, aortic arch, and its vessels with any perivascular fat, vasa vasora, and vasa nervora to pass through without contacting the sides of the foam-lined top opening.

[1075] The grid also has a side opening 60 at the upper right and one at the upper left 61 to allow the pulmonary arteries and veins with supportive nervelets and fine vessels pass through. Toward the bottom on the right is another opening 62 to pass through the inferior vena cava with sufficient clearance for its supportive nervelets and fine vessels to disallow encroachment by the margins of the opening. Applied after reciprocal cross-circulation through the mainlines connecting the donor and recipient to effect the metered bypass, or switch, has already been instituted, which must not be interrupted, the heart cage requires not only permanent openings 59, 60, 61, and 62 but must continue with openable flap sections respective of each, opening flap 63, spring-loaded hinged at 68, lift flap 66, spring-loaded hinged at 69, and flap 67, spring-loaded hinged at 70.

[1076] Opening flaps 63, 66, and 67 lock in the closed position are preferably kept closed as indicated by spring loaded hinges but can also use the same type spring-loaded latch engaging fasteners as those at the anterior midline to remain secure when not lifted to allow this clearance. Such an optional fastener is shown on the heart right side as part number 162 and on the heart left side as part number 163. The grid tubing must be able to withstand deformation as the result of a direct blow and at the same time, allow the operator to intentionally introduce bends as might be necessary to fit a less than ideal graft heart that had disproportionately adapted to its impairment as to present an anomalous contour. This is accomplished by heating the grid where the bends are needed with a small hand-held propane blow torch, for example, rendering the areas to be altered pliant.

[1077] Accompanied and assisted by another heart, supported by medication immediately dispensed automatically upon detection of the need therefor, and removed from the toxic condition in its host, the donor as well as the native heart should experience a significant measure of relief and recovery, even if that native had undergone heart failure. Only a significant alteration in contour after placement warrants its removal for remolding. The heart cage incorporates a sufficient number of flexible points to facilitate its removal if needed.

[1078] In use, the cage is opened, and the donor heart, having been mobilized, that is, freed of any attachments or adhesions, especially to its rear, with diversion valves, drug, and bloodlines attached to the vascular stumps, is set down on the foam lining the grid. Care is given to assure that vessel stumps rising upward clear top opening 59 without contact other than lightly against the foam lining opening 59 and pulmonary vessel stumps at the upper sides pass through side openings 60 with associated clearance flap opening 63 and opening 61 with associated clearance flap 66, and opening 62 with associated clearance flap 67 without metal contact. The cage is then closed around the heart and locked closed by means of spring-loaded latch fasteners along the front seam where right and left halves come together.

[1079] FIG. 25 shows a bypass device to allow an ischemia-free carotid endarterectomy, which in the rare circumstance that either or both the native structures have been irreparably damaged by disease or the need to resect tumors, for example, can be left in place permanently as a prosthesis, with the immediate diagnosis and treatment of erratic fluctuations in blood pressure, blood gases, and blood glucose applied by the implanted disorder response system. These mid- and postprocedural problems associated with the loss due to surgical resection or trauma of the carotid bulbs where such a prosthesis without the support of an implanted automatic disorder response system is not used are briefly reviewed above in Background of the Invention.

[1080] In FIG. 25, of the branches of the right external carotid artery included in the figure, ST is the superior thyroid artery, L the lingual artery, F the facial artery, M the maxillary artery, and SupT the superior temporal artery. Part number 88 is the servovalve attached to the common carotid, 89 that attached to the external carotid, and 90 that connected to the internal carotid. The orientation of the three valves usually required to perform a carotid endarterectomy or the two in the infrequent circumstance that the external carotid is unaffected, is that least encroaching upon neighboring tissue and minimally if at all presenting a cosmetically conspicuous bulging of the neck.

[1081] The edges and corners of the valves are rounded to eliminate abrasive or gouging contact, and the valves can be wrapped within a soft sock to eliminate any irritation. Accordingly, the three valves shown in FIG. 25 have been drawn in the plane of the figure for visual clarity and must not suggest such a disposition is prescriptive. Each servovalve is shown with a direct manual fine control assist device detachably attached beneath it in a separate enclosure which will be removed before the patient is closed. The structure of the direct manual fine control device is delineated above and shown in FIGS. 10A thru 10C. Valve 89 is positioned just above the bifurcation of the external carotid and facial arteries to minimize is not eliminate the blind pocket, or cecum, wherein clot would accumulate were it positioned at a higher level.

[1082] Valve 88 on the common carotid must remain sufficiently open, or retracted, to allow blood to pass into the facial, lingual and superior thyroid arteries. While it might appear that the internal carotid has been shown disproportionately wider than the external carotid, the illustrations provided in the popular anatomy textbooks such as Cunningham, Morris, Gray, Grant, and Sobotta, were drawn from cadaver preparations, not surgical patients in whom the blood under pressure produces distention (dilatation, dilation) such as that shorn. The common and internal carotids are large enough in caliber that in order to minimize their size and weight, the lumina of the vascular servovalves connected to these are made smaller. The rationale for this reduction without adverse sequelae is provided above under Background of the Invention.

Ports

[1083] This application concerned with vascular valves and servovalves, only a condensed summary and simplified description of body surface (on-skin), subsurface (subcutaneous subdermal), and ports which combine opening on and beneath the skin for use with an implanted automatic disorder response system can be reviewed. Suffice it to say, such ports can incorporate power button cells, which stored above-skin can be replaced, or beneath skin recharged transdermally; or transcutaneously, mechanical control knobs such as to extend or retract a push/pull, or Bowden, cable, for example, in urological applications as will be delineated below; electrical button switches to actuate tiny lamps for illumination and implanted electrostimulators when not triggered automatically by sensor feedback to the system control microprocessor; and locked system override switches which the clinician can unlock if for any reason such becomes necessary.

[1084] Subsurface (subcutaneous, subdermal) body ports for use with an implanted automatic disorder response system are portacaths, or mediports, such as those in common use, which have been modified to incorporate multiple entry openings to allow the simultaneous replenishment of subcutaneously, or subdermally, positioned small flat reservoirs storing drugs in fluid form as well as any of the manual controls listed above. As is true with a conventional single entry portacath, when drug delivery passive due to gravity and the opening is above-skin, that is, at the exterior rather than subcutaneous, the way is clear for diagnostic use, such as the drawing of blood or delivery directly to the pipe-targeted organ, gland, or nidus, for example, of fine transluminal diagnostic devices, such as an angioscope, and therapeutic devices such as an excimer laser.

[1085] In summary, such ports fall into three groups, those nonurological which are usually positioned subcutaneously in the pectoral region, those urological which are usually positioned to a side of the mons or mons veneris, and those mixed which incorporate both, wherein the medicinal openings are still subcutaneous. Both for reasons of comfort and cosmetic, in all cases, a central object is to achieve a small shape factor with minimal weight. When drug delivery is not through a passive gravity drip but rather directed by the microcontroller—or in more complex comorbid disease, a microprocessor—the reservoir and its outlet pump obstruct such passage.

[1086] For this reason, the attempt is made to always include a gravity fed line. In general, only urological ports provide an opening to the exterior for connection of a tube to pass ursine into a collection bag. Such ports will often include electrical switches to control and one or more button cell batteries to power electrical components, and control knobs mechanical Bowden cable or electrical, for example, in addition to subcutaneously positioned inlet openings for injecting drugs. Otherwise urine effluent line 110 from the bladder or neobladder is always free of obstructions.

[1087] As shown in FIG. 26B drugline K to either or both kidneys, such a drugline omits components, here the drug reservoir 102 and the drug outlet pump 103 which would block the path of the cabled device to be employed. Accordingly, nonurological ports incorporate an above-skin opening and omit the reservoir 102 and pump 103 only when diagnostic devices will be used or biopsy samples drawn, other openings for the delivery of medication located beneath the skin.

[1088] A port preferably positioned to a side of mons pubis having an above-skin central outlet pipe to pass urine into a urine collection bag tethered about the ipsilateral thigh and surrounding subcutaneous drug injection openings is shown in FIG. 26C. In a patient with retained urge and urinary tract sensation, the system used is of the type shown in FIG. 30 where a port of the kind shown in FIG. 26C provides controls for the user to switch between unilateral or bilateral partial or total automatic or voluntary evacuation, hence, the rate of collection.

[1089] The line from the bladder or neobladder can be used to pass through an endoscope to diagnose or laser to treat, for example, the interior of the surfaces in the lower urinary tract. Cabled devices best passed through a passageway that is sterile when urine effluent (outflow, emptying, egress) line 110 may become contaminated with urine containing bacteria, fungi, or other pathogen where the patient is affected by both urinary incontinence and frequent urination—the two common in infections of the lower urinary tract—are accommodated by providing an additional opening leading into an obstruction-free 8 line such as that shown as K (leading to a kidney) in FIG. 26B.

[1090] When frequent urination is not a problem, bladder effluent line 110 from the bladder or neobladder can be sanitized by releasing an antimicrobial through the accessory channel of the nonjacketing side-entry connected positioned along the bottom of the bladder or ductus side-entry jacket on the ureter and/or an antimicrobial swab run up through bladder effluent line 110 just before use. Any type port can incorporate such above-skin openings and/or components, but for better protection against infection, drug injection openings are best subcutaneous. Subcutaneous drugline entry openings also eliminate the need to remove a cap before injection, thus facilitating quick drug replenishment when all drugline openings can be accessed simultaneously with a multiple needle or needle free disposable cartridge jet injector nozzle injection head such as those depicted in FIG. 27.

[1091] That urine outlet bladder effluent pipe 110 opening and any other above-skin opening to the exterior—always covered over by a protective cap and structured to retain antimicrobials—can be used in the reverse direction to pass diagnostic tools for examining the interior of the bladder, ureters, and renal pelves on a permanent basis without the need for a ‘keyhole’ incision each time or a bandaged over, readily infected wound to allow periodic reexamination should be evident, as should the option to remove the device once a temporary condition clears.

[1092] FIG. 26A shows a vertical left side sectional view of a nonurological subcutaneous port with multiple openings for injecting drugs, FIG. 26B providing a schematized depiction of the same port in the context of an implanted automatic disorder response system. If few, the drugs are injected sequentially by hypodermic syringes or alternative means of injection 101. To minimize the duration and irritation of injection, more than two drugs are preferably injected simultaneously with a multiple needle or multiple nozzle needle free disposable cartridge jet injector head such as that depicted in FIG. 27.

[1093] Covering a 2 centimeter or so circular area of skin prepared by electrolytically removing the hair over the area, urological ports must provide an underlying surface treatment such that the interface with the skin will not result in infection or irritation such as itching. The port removable properly only by a trained clinician, the wearer can accomplished sanitizing and inflammation reversal without removing the port by using a eye dropper to drip a back pad of gauze placed before the port is attached with an antimicrobial such as an alcohol or hydrogen peroxide and/or an anti-inflammatory such as dilute prednisolone or a fluid preparation of triamcinolone provided in a vial small enough to prevent misapplication.

[1094] New materials which incorporate antimicrobials and anti-inflammatories are briefly addressed above under the section entitled Background of the Invention. Drug injection openings 107 in medicinal ports serve as the points of entry into the sidelines, thence through accessory channels 8 of the side-entry connectors, jackets, and valves at the target tissue or vessel and to prevent their disconnection are fused to the drugline 8 into which each flows. Multiple self-sealing membranes, or septa, 121 are shown as covering each port opening separately but can comprise one continuous membrane, or septum. Self-sealing membranes 121 are absorbent and wetted with an antimicrobial at the same time with a syringe introduced into injection openings 107 by inserting the Huber injection needle to just enter openings 107.

[1095] Druglines 8 are subcutaneously tunneled to the level of the target organ, gland, nidus, or tissue and then routed along the course to the target least like to strangulate intervening tissue. In FIG. 26C, the urological port is positioned to a side of the mons pubis or mons veneris so that druglines 8 must move upwards. Accordingly, in the lower position of FIG. 26C, drugline 8 would actually proceed craniad or as nearly so as would preclude kinking upon bodily movement, for example, directly upon exiting from drug injection opening 107.

[1096] As shown in FIG. 26C, were it necessary to move downward, would turn around while subcutaneous into the upward, or craniad, direction. Highly dilute (low viscosity, watery) injectants can be delivered directly to the target tissue by gravity. In FIG. 26B, where to allow direct gravity feed, the drug delivery line (drugline) 8 leading into an accessory channel of a nonjacketing side-entry connector on the organ fibrosa or into that of a side-entry perivascular jacket or servovalve on the renal artery, for example, to the kidney, denoted by the K, is continuous, that is, omits a drug storage reservoir 102 and reservoir outlet pump 103. If the line is ordinarily used for higher viscosity substances, a reservoir 101 and pump 102 are present and actuated as needed manually.

[1097] Higher viscosity drugs are injected into reservoirs such as those marked H for the heart, L for the liver, and B for the brain. The size of any component in FIG. 26B, such as the drug reservoirs 1, 2, and 3 generically identified as 102 or drug reservoir outlet pumps 103 will vary with the dose and dose release schedule of the substance injected, and the length of druglines 8 will vary based upon the distance from the port 100 to the target side-entry component. Replenishment of the flat vial storage reservoirs 102 for the independent release of each drug to a different organ, gland, or nidus to treat comorbid disease under the morbidity-distinguished hierarchical control channels or branches executed and coordinated by the system controlling microcontroller or microprocessor according to its prescription-program.

[1098] As in a conventional portacath, or mediport, migration is prevented by passing suture though small loops as shown or holes 104 or about the periphery of the port, and migration of the lines feeding into the accessory channels 8 by omitting joints with the potential to become disconnected. Shown in FIG. 26B, the pumps at the outlets of drug reservoirs 1, 2, and 3 are controlled through wires 105 by the fully implanted automatic control system microcontroller or microprocessor 106. If for any reason hard wiring should be avoided, the commands are issued by controller 106 by radio remote control, typically Bluetooth, the frequencies employed cautiously chosen to avoid extrinsic actuation by garage door openers, for example.

[1099] FIG. 26C shows a vertical cross sectional side view of a port which combines an above-skin urine outlet 110 from the bladder or neobladder and subcutaneous drug injection openings 107. In contrast to nonurological ports which are positioned subcutaneously in the pectoral region, urological ports are preferably positioned to a side of the mons pubis or mons veneris where these are easily seen and used by the patient, whether to connect a urine drain hose to or disconnect it from the urine outlet opening, adjust a ureteral valve, or make less awkward the syringe-injection of a drug into an above skin drugline opening by the patient.

[1100] Accordingly urological ports must be provided with a. Covering components to prevent microbial intrusion, and b. Situated inferior to the target tissue where passive gravity feed is not possible, a small pump, typically peristaltic. To assure freedom from infection, urine outlet, or effluent, line, or tube 110 is closed off by airtight screw-on or press-to-engage detent cap 108, and the cap filled with a small gauze wad 109 wetted with a potent antimicrobial.

[1101] Thus, should it become contaminated, the opening into urine outlet, or effluent, line 110 is routinely sterilized. The diversity of implanted components that might be controlled from such a port is considerable, and as commented upon above, includes neuromodulatory devices such as electrostimulators, control knobs the wearer uses to switch urine outflow from that normal into a proper receptacle to effluence internally through the port into a collection bag, prepositioned diagnostic viewing devices, and manual switches to release drugs by the wearer in response to predictable sources of irritation.

[1102] FIG. 27 shows the two main means for simultaneously replenishing the drug reservoirs implanted with an automatic disorder response system. The main object in simultaneous replenishment is to expedite this process with patients having multiple comorbidities who whether because of cognitive impairment due to dementia or infancy are prone to become frustrated and unruly when several injections are needed. Another advantage is that the individual syringes or needle free disposable cartridge jet injectors are prepared and confirmed as correct according to the prescription load list well before the procedure, thus effectively eliminating human error. Autoinjectors such an epinephrine pen are discounted as facilitating use by the patient, which is discouraged; replenishment should last for a period long enough that return to the clinic is not so frequent as to provoke noncompliance.

[1103] FIG. 27A shows a metal or plastic manual syringe simultaneous injector which allows multiple substantially conventional individual injection syringes 101 in FIGS. 26A and 26C collectively 111, to be used simultaneously. The drawing figures comprehend four syringes, but any number that will allow injection into such a port with multiple openings, typically 2 to 4 centimeter in diameter, and will fit into the frame can be used. Each syringe 111 will usually contain a single drug; however, drugs otherwise mixable can be combined in any one. Pending the development of switchable, such as rotatable turret mounted port openings or druglines, each opening is immutably continuous with a certain drugline, so that the destination as to organ, tissue, gland, or nidus, for example, must determine the contents of each syringe 101 in the set thereof 111.

[1104] For example, with the openings and druglines permanently associated, unless more than one drugline is led to the same destination, to inject a large volume of a drug intended for the same destination will require the use of an additional syringe to sequentially inject the same opening, and if the same drug is to be pipe-targeted to different organs, glands, tissues or nidi, these must be separated into different syringes, each aligned to the respective port opening for the destination intended. Alternatively, a confluence path between tips of adjacent syringe barrels can be used to allow two or more syringes to empty into the same reservoir. Using syringes having barrels different in diameter and loading different concentrations of the drugs are two ways to adjust the dose.

[1105] Otherwise, the set 111 of individual syringes 101 are unconventional in lacking barrel 112 or plunger 113 flanges, and in situating the hypodermic needles 114 with syringe tips (Luer, slip) as close to the periphery of each syringe as necessary so that each needle will align with its respective opening in the port. Hypodermic needles 123 can be of the Huber noncoring type with tips curved but no more than is essential to avoid coring. The barrels are conventionally calibrated with volume markings 115 in cubic centimeters or milliliters. The manual syringe simultaneous injector is comprised of outer rectangular frame 116 made of plastic or metal fabricated of channel, or U-cross section stock, through which reciprocally slidable complementary n-section internal rectangular frame 117, made of the same or a different material, can slide reciprocally as a track.

[1106] The upper member of internal frame 117 must have bonded to its upper side a floor plate 118 upon which the syringes rest covering an area that will assure the stably vertical alignment of the set 111 of individual syringes 101. As illustrated, simultaneous injection of the set of syringes 111 is accomplished by using the fingers to pull down the lower member, or crosspiece 119, of outer stationary rectangular frame 116 toward the lower reciprocally sliding member, or crosspiece 120, of internal frame 117. This drives floor 118 bonded atop the lower member 119 of outer rectangular frame 116 upward, thus forcing plungers 113 upward to eject their contents. Injection is into multiple openings 107 of subcutaneous port 146 in the sectional view of FIGS. 26A and 122 in the extracorporeal view of FIGS. 17 and 27C with backside view in FIG. 26B. Injection point indicating tattoo marks on the skin are shown as 124 in FIGS. 17 and 27C.

[1107] The markings consist of two tiny tattoo dots, which barely noticeable, can be different in color and lased away if and when the port is removed. The same markings pertain whether the device of injection is that using hypodermic needles as depicted in FIG. 27A or jet injection micronozzles as shown in FIG. 27B. Showing two of the four injection points is sufficient to align all four or more of the hypodermic needle tips or orifices of the hex nozzles of the jet injector. Front views, FIG. 27A conceals two additional hypodermic needles, and FIG. 27B two additional jet injection fill chambers to the rear. In either, provided the outlets are aligned to the injection openings in the subcutaneously implanted port, the drug fill chambers of the injectors to the rear can be of any diameter.

[1108] More specifically, the relative drug holding capacities of the syringe and fill chambers to the rear may be the same, the reverse, or different than either of those seen at the front. Nonmanual injection using ports of the Bard PowerPort® (division of Becton Dickinson-C. R. Bard, Covington, Ga.) type allow the subcutaneously implanted drug reservoirs to be replenished at the rate of 5 milliliters per/second at 300 pounds per square inch, further reducing patient annoyance. Unlike an embodiment comprising disposable cartridge jet injectors, the multiple jet injector shown in FIG. 27B is analogous to the hypodermic needle embodiment shown in FIG. 27A in applying a common driving means to the ejection plural plungers.

[1109] Means for the injection of drugs essential to support an implanted automatic disorder response system, FIG. 27B omits tiny seals, washers, valves, and screws, for example, the showing of which would be superfluous for those familiar with such devices. In FIG. 27B, 125 is the head assembly; 126 is the injection thumb actuated release button; 127 the spring release or cocking lever; 128 the main power spring, 129 the common shaft for the drug fill chambers; 130 the cocking lever spring that primes main spring 128; 131 the cocking lever hinge; 132 index and middle finger rests; 133 the injector body; 134 the upper seals of the two front fill chambers 135 and 136; 137 the lower seals of the two front fill chambers; 138 and 139 the two front fill chamber 135 and 136 ejection nozzles; and 140 and 141 the ejection outlet orifices.

[1110] FIG. 27C shows an entirely subcutaneous implanted multiport in a baby where the purpose thereof will almost always be other than to support a double heart switch, or bypass transplant as shown in FIG. 17. The entirely subcutaneous port is of the type shown in FIGS. 26A and 26B as 146 and shown as 122 in the extracorporeal view of FIG. 27C, where the on-the-skin, or cutaneous injection point indicator marks appear as 124.

[1111] FIG. 28 shows a prosthesis for the automatic elimination of urine in a patient with a missing or severely defective lower urinary tract into a synthetic neobladder for drainage into a paracorporeal collection bag usually cinched about a thigh, or directly into the collection bag. Both vascular valve implemented urinary prostheses and assist devices can be unilateral, bilateral, or switchable between the two. As a prosthesis, the system requires no voluntary controls for the wearer to turn on or off automatic collection and voiding, for example, as does a partial dependency system, or urinary assist device for a patient with intact urge and urinary tract pain sensation.

[1112] Gut not adapted to conduct urine and prone to metaplastic degeneration which can lead to malignancy, the surgical reconstruction of the urinary bladder or a stoma with harvested gut is discouraged. Because it reveals an inherent proclivity toward malignancy, this is pertinent to a lower tract missing following evisceration due to a malignancy that had metastasized to neighboring tissue. A prosthesis, the system uses nonadjustable, that is, permanently set, diversion jackets, which nonadjustable are not properly referred to as valves, such as those shown in FIGS. 2 and 3 or solenoid-driven valves such as shown in FIGS. 7 and 8.

[1113] While nonadjustable by the patient, post-implantation adjustment by a clinician can be readily accomplished by endoscopic access through a ‘keyhole’ incision. In FIG. 28, diversion jackets 143 and 143′ are of the nonadjustable nonvalve type shown in FIGS. 2, 3, 7, and 8. Nonadjustable in this regard denotes that the patient, who due to the absence or abnormality of the lower urinary tract lacks urge and pain sensation, requires full automatic control over urinary voiding. Diversion jackets 143 and 143′ tap off, divert, and pass urine, of which 41 and 41′ represent the flowlines, into synthetic prosthetic ureters, or neoureters, 144 and 144,′ which drain into synthetic neobladder, or neoureter confluence chamber 145, shown in greater detail in FIG. 29.

[1114] While the patient is erect, neobladder 145 drains into collection bag 148 under gravity. In this urinary prosthesis where urinary tract sensation and/or self-control is missing, control over voiding when the patient is recumbent must be automatic. To this end, as neoureter confluence chamber, or synthetic neobladder 145 fills, a small bar which presses down on a strain gauge (not shown) eventually imposes the threshold level of force for initiating evacuation (emptying), passing current through a small box fan-configured impeller 150 on the floor, or as shown in FIG. 29, suspended at the center of polymeric confluence chamber 145 to drive the urine out through urine effluent line, or outlet pipe 110 which exits the body through the center of combined above-skin, or cutaneous, outlet, with surrounding subcutaneous drug inlet openings such as those shown in the body surface port 147 depicted in FIG. 26C, thence through collection bag connecting hose 149 into collection bag 148.

[1115] FIG. 29 provides a more detailed view of the neobladder or neoureter confluence chamber 145 shown in FIGS. 28 and 30. In FIG. 29, small impeller 150, configured much as a box fan, is positioned at the bottom center, or as shown, suspended at the center of confluence chamber 145. Confluence chamber 145 is molded to the same shape as a native bladder and to allow the longest collection time, as large in capacity as does not encroach on neighboring tissue or present a weight when filled that induces the sensation of a foreign object. Storage in confluence chamber, or neobladder 145 causes less discomfort than loading collection bag 148 at a quicker rate.

[1116] Impeller 150 draws electrical power though wire 151 from one or more button cells positioned about the central bladder effluent pipe 110 outlet in the body surface ports as are the drug injection openings 107 shown in FIGS. 26B, 26C, and 28 and the push/pull cable control knobs shown in FIG. 30. Confluence chamber 145 is made of a light weight polymer such as polyethylene terephthalate, polypropylene, or polyether ether ketone. As shown in FIG. 28, the prosthetic lower urinary tract is not switchable to normal voiding during the daytime or when the user is before the public, for example.

[1117] Accordingly, an antiseptic delivered into the ureters through valves 143 and 143′ will be effective through the entire length of the synthetic system and passed into collection bag 148 so that native tissue is not exposed to it, making disinfection through the use of more concentrated antiseptic unobjectionable. Unless the reservoir and outlet pump or pumps are positioned within the pelvis, so that the injection openings in the surface port can be incorporated into a port positioned to a side of the mons pubis, an antiseptic, anti-inflammatory, or analgesic, for example, must be injected through a port superior to, that is, above the level of side-entry diversion valves 143 and 143′ to arrive by passive gravity without the need for intrapelvic componentry.

[1118] Ordinarily, this will be through a port positioned in the pectoral region as are conventional portacaths or mediports. The user-controllable system shown in FIG. 30 uses drugs in the same manner as the prosthesis shown in FIG. 28 only when the user switches it to urinary diversion. Switching diversion off, then, allows medication introduced through the drug openings, or injection points 107 in the surface valve treats the entire native lower urinary tract. In FIG. 29, small bar 152 positioned atop impeller 150 pushes down a small rod at the center of a strain gauge (unshown). In a standalone urinary application, the strain gauge sends its output directly to the implanted system microcontroller.

[1119] Representation of the impeller as centered within the confluence chamber and the strain gauge at the tope center thereof is exemplary. Either can be located together or separately at a number of positions. That is, while shown positioned on top of impeller 150, small bar 152 to push against rod and strain gauge can be a button of any shape and situated in any location along the interior surface of confluence chamber 145 except at the top thereof. To assure comfort and allow the confluence chamber 145 to be produced in no more than a few sizes, the controller is programmed to initiate voiding, into a collection bag 148, for example, when the signal strength received from the strain gauge is just short of that at which the user experiences discomfort.

[1120] In a system to treat comorbid disease whereof the urinary voiding subsystem constitutes but one level requiring therapeutic monitoring and coordinated response by a hierarchical control system in the treatment of multiple conditions, the strain gauge sends its output through the local or lowest level control channel, meaning that dedicated to the urinary subsystem, whence the signal rise up through and is processed by increasingly higher levels of control in the hierarchy to the multiple implant system master controller, here, a microprocessor.

[1121] FIG. 30 shows a urinary assist, or voiding control device, which allows the patient with intractable nocturia, urinary incontinence, or frequent urination, or one who must participate in an activity which does not allow for interruption, such as public appearance or performance, to switch between voidance into confluence chamber 145, with automatic emptying into collection bag 148, or into a bathroom receptacle. Following a surgical procedure on or involving the lower urinary tract, such a system is useful on a temporary basis for relieving the lower tract of constant exposure to urine by bypassing the healing tissue, thus expediting healing of the tract.

[1122] To best expedite healing, postprocedural bypass can be continuous or intermittent and automatically coordinated with the automatic pipe-targeted release of a drug, during which diversion is not used, or during prosthesis disinfection or crystal dissolution, during which diversion is not used. When administering drugs, the controller switches off the bypass feature, thus gaining access to the native tissue. When administering system maintenance substances, the controller switches on the bypass feature, thus causing the substance or substances to flow through the synthetic device. Use thus is possible whether the urinary diversion system is implanted for the procedure or was already in place.

[1123] Such use is similar to the use of a carotid prostheses such as shown in FIGS. 25A and 25B following a carotid endarterectomy, for example, where bypass to expedite healing and expose or bypass the native tissue as required can likewise be continuous or intermittent. No less pertinent for expediting healing is the capability to directly pipe-target drugs such as anti-inflammatory, antimicrobial, and/or analgesic to the treatment site, thus precluding exposure to potentially harmful substances of tissue outside the urinary tract, thus avoiding adverse side effects and the risk of complications, while at the same time allowing the use of dose levels in the treatment of the lower urinary tract not restricted due to this consideration.

[1124] If explanted, leaving in place the body surface port, controller, druglines, and accessory channels of lower urinary tract and carotid prostheses by replacing the valves with basic ductus side-entry jackets allows continued automatic targeted treatment, if necessary, to the end of life even in a younger patient. Such extended use is made possible because the system controller can schedule the periodic release of substances to maintain the system itself, such as anticoagulants, thrombolytics, and crystal dissolvents on the same basis as drugs.

[1125] Except in cases of megaureter where servomotor-driven diversion chutes controlled by potentiometers in place of mechanical control knobs 153 and 153′ positioned around urine effluent line 110 (which in turn is connected to urine effluent hose 149 for drainage into urine collection bag 148) at the center of surface port 104 positioned to a side of the mons pubis or mons veneris, the diversion chutes in valves 143 and 143′ need not advance and retract more than 5 millimeters. This small excursion allows a simple in-line direct drive mechanical embodiment providing continuous adjustability, not bistable as would a solenoid, to be produced without the expense of servomotors.

[1126] In the front schematic view of such a mechanically controllable embodiment shown in FIG. 30, push/pull cable rotating knob 153; controlling side-entry diversion valves of the kind shown in FIGS. 5 and 6 on the right hand side of the patient and valve 153′ controlling that on the left rotate proximal twisted strip segments next to be described (behind control knobs 153 and 153′ and unseen in FIG. 30) at the proximal end of push/pull control cables 28 and 28′, also shown in FIG. 5 depicting the type valve used. So that one half turn of knobs 153 and 153′ clockwise fully extends push/pull cables 28 and 28′ respectively, while one half counterclockwise rotation fully retracts each, the turns ratio of the knobs to chute displacement is best one to two; that is, so that the half way rotation of the knobs moves the diversion chutes from one end to the other, not just half way.

[1127] Requiring to control movement over a distance no more than millimetric, the push/pull control cable extension and retraction mechanism inside port 147 in FIG. 30 providing control knobs positioned as would injection openings or button cells about urine effluent line 110 as shown in FIG. 26C can be made small enough to allow the one body surface port to include subdermal injection openings and button cells as well as control knobs. The twisted strip segment of each control which is separate between the sides consists of two turns covering an overall length one millimeter greater than the equivalent excursion sought of the diversion chutes and is distinct from the proximal ends of the push/pull cables fused to the rear of the ferrules.

[1128] In the control for each side, the forward or distal of the two turns of the twisted strip is contained inside, and the near (rear, proximal) turn outside its respective ferrule. The ferrule has a rectangular opening at the front end so that rotation of the twisted strip clockwise causes the outer turn to drive the ferrule, and therewith, the push/pull cable ending at the valve continuous with it forward over the distance equivalent to the entire displacement required of the diversion chutes. The outside turn drives the cables forward and the chutes deeper into the ureter, and the inside turn pulls the cable backward, withdrawing the chutes from the ureter.

[1129] Along with the clockwise or forward detent of the control knobs, contact of the rear end of the inside turn against the rear wall of the ferrules sets the limit to movement of cables 28 and 28′ in the forward or chute deployment direction. Along with the counterclockwise or backward detent of the control knobs, the limit of backward (chute withdrawal equivalent, retractive, proximal) chute movement is set by contact of the turn in front of the ferrule with the rear of the control knob.

[1130] Accordingly, the rear ends of the ferrules fused to and continuous with the solid cables, clockwise rotation of knobs 153 and 153′ causes the respective twisted strips to drive the ferrules and thus the cables and diversion chutes continuous with these forward, or distally, deeper into the lumen of the substrate ductus, while rotation of the knobs counterclockwise draws the ferrules proximally and therewith, the cables and the chutes retracted from the lumen of the substrate ductus. The small distance for the cables to move thus allows not only the avoidance of the cost for servovalves but the need for a lever mechanism likely to catch on clothing or cause an occasional scrape.

Anastomosis Coupling or Flow Diverter

[1131] The functionality and functions of endoluminal anastomosis coupling or flow diverters in comparison with that of side-entry diversion jackets is addressed above in section 2. Background of the Invention, which briefly describes their structure. In FIG. 31A, part number 155 designates the endoluminal flow diverter in its entirety. Two accessory channels are provided, one, part number 8, delivers drugs into the intertube space, or the passageway between inner tube 156 and outer tube 157 so that under the slight to moderate pressure of the implanted drug reservoir outlet pump, these flow around and down intertube space 160 to emerge through apertures 159, one each created by the die punching outward of a pointed retention tine (barb, prong) 158.

[1132] Drugs such as anti-inflammatories delivered through accessory channel 8′ flow over the urothelium, tunica mucosa, or endothelium of the substrate ductus for absorption and uptake, not just at apertures 159, while accessory channel 8′ delivers an anticoagulant, for example, into the native lumen in vessels and a crystal solvent, for example, in the ureters. Double, or dual, lumen tubular extension 164, which protrudes radially outward from the adventitia no more than is needed to securely friction fit druglines and accessory channels 8 and 8′, opens adaxially into intertube space 160 separating inner tube 156 from outer tube 157. To avoid the need for a second puncture wound through luminal wall 2, the druglines connected to tubular extension 164 arrive through double lumen catheters, or the lines flowing into accessory channels 8 and 8′ can be separate and run in parallel from the drug sources, normally, small flat drug reservoirs implanted in the pectoral region.

[1133] Grommet 161 then encloses the single perforation. To prevent incising the tunica mucosa, urothelium, or endothelium when the endoluminal anastomosis coupling or diverter is inserted, double lumen tubular extension 164 has a smoothly burnished end 162, and along with antegrade inclined retention tines (barbs, prongs) 158, is blanketed over or with a coating of a readily absorbable substance such as a sugar or chilled butter, which can be quickly dispersed by passing water or enzymes respectively through apertures 159. Flowline 41 indicates the direction of flow through inner tube 156.

[1134] Slightly but palpably protrusive, extension 164 is easily spotted at the surface of the adventitia as a slight protuberance, showing the operator the point to remove a plug of tissue no larger than is needed to allow double lumen extension 164 to protrude out through the side of the adventitia. Grommet 161, incorporating or coated with an anti-inflammatory and antimicrobial polymer, is then placed in surrounding relation to double lumen extension 164 against the adventitia to completely enclose this junction and prevent microbial intrusion.

[1135] When inserted into the cut end of the native ductus, the tube within a tube flow diverter or adventitia coupling as shown does not allow switching flow between the diversion path and that normal. For this reason, it is functionally distinct from a side-entry diversion jacket, which is more versatile in flow control. By the same token, a straight, or nondiverter, embodiment of the device has applications of which the periductal jacket is incapable, such as transluminal placement as a stent or anastomosis coupling. Both allow the diversion of flow through a shunt or bypass, but only the diversion jacket allows the outflow to be divided.