PROSTHETIC DISORDER RESPONSE SYSTEMS
20220184311 · 2022-06-16
Inventors
Cpc classification
G16H20/30
PHYSICS
A61M5/1723
HUMAN NECESSITIES
A61M39/0208
HUMAN NECESSITIES
Y02A90/10
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
International classification
A61M5/14
HUMAN NECESSITIES
G16H20/30
PHYSICS
Abstract
A fully implanted automatic disorder response system acts as a backup “immune” system, immediately detecting and dispensing an enzyme deficient or lacking due to an inborn error of metabolism, for example, in accordance with its prescription-program. In response to a disease, the remedial action is usually medicinal and/or electrostimulatory. By directly pipeline-targeting agents through pipelines from implanted reservoirs to leak-free and durable tissue connectors at the focal points of chronic disease, the system avoids the dispersion of drugs throughout the circulation and the side effects this causes, fundamentally liberalizing while optimizing the use of drugs. Electrostimulatory and other end-effectors available, each morbidity or site thereof in comorbid disease is assigned to an arm or channel of an hierarchical control system. Symptom sensors pass data up through successively higher-level microcontroller nodes to generate the cross-channel, cross-morbidity view the control microprocessor uses to command the remedial action that will optimize overall homeostasis.
Claims
1. A fluid drug and electrical stimulation delivery system comprising ductus connectors that outflow into the blood supply of any specific solid organ or gland, and extravascular tissue connectors that outflow to any depth into any specific volume of tissue, said connectors constructed to remain in place indefinitely, and configured for use as components in a fully implanted automatic control system.
2. A fluid drug delivery system comprising an indexing mechanism which rotates each of a number of fluid drug containers into position to release a fluid drug into a fluid drug delivery pipeline, said fluid drug delivery pipelines configured to empty through a stationary leak-free connector into the blood supply of a specific targeted organ or gland, or into a volume of tissue affected by a disease process; wherewith said stationary leak-free connector blocks out all other tissue from the path and the target of fluid drug delivery.
3. An automatic diagnostic and therapeutic prescription control system to serve as an automatic prosthetic disorder response comprising a fluid drug selection mechanism such as a turret to introduce one of a number of fluid drugs into a fluid drug delivery pipeline wherein said fluid drug delivery pipeline comprises a terminus comprising a stationary leak-free connector; wherein said connector is configured to be connected to the blood supply of a specific organ or gland or volume of tissue of the site of a disease, wherein said diagnostic system comprises sensors positioned at the primary and secondary sites of symptoms associated with the disease; wherein said diagnostic system is programmed to indicate on the basis of physiological response negative feedback from said sensors, the data stored in the memory of the controller, and the fluid drugs provided to the system, the drug and dose thereof which are most efficacious in treating the disease, and using said drug selection mechanism to treat said disease in accordance with said most efficacious drug in the most efficacious dose.
4. The implanted automatic disorder response system of claim 3 of which only components too large or numerous to be implanted are relegated to a paracorporeal body pack.
5. The automatic diagnostic and therapeutic prescription control system of claim 3, wherein said fluid drug delivery pipeline is closed off to all parts of the body except the blood supply or parenchyma of a site of disease.
6. The automatic diagnostic and therapeutic prescription control system of claim 3 wherein said fluid drug delivery pipeline empties into or admits the fraction of the general circulation supplying said organ, gland, or volume of tissue of the site of a disease so that the ascertainment of maximum efficacy of the targeted drug or drugs must take into account the interactions among all the drugs targeted and in the general circulation in the doses of each present.
7. The automatic diagnostic and therapeutic prescription control system of claim 3 configured to record and retain the fluid drug selection device address and dose of the fluid drugs which had been most efficacious in treating a site of disease for later application.
8. The automatic diagnostic and therapeutic prescription control system of claim 3 wherein said system is organized hierarchically, so that an implanted master control microprocessor programmed to respond to the diagnostic and therapeutic information necessary to treat each of a number of symptoms appurtenant of a plurality of comorbidities can at a first level of diagnostic and therapeutic microcontroller node input in a hierarchical tree of such microcontroller nodes, evaluate each symptom-assigned sensor input data, pass this initial-level evaluation up to a next higher level of microcontroller nodes which then generate a therapeutic evaluation inclusive of the morbidities passed up to these to optimize the treatment for both each and the set of morbidities passed up to that level in the hierarchical tree, this data passed up through the tree to yet more inclusive node evaluators to a master control microprocessor for execution of its prescription-program by translating the sum of data needed to the optimal net therapy across the combination of morbidities to most closely reinstate normal homeostasis.
9. For a patient with plural comorbidities requiring treatment with multiple drugs and/or electrostimulation, a hierarchical control program for execution by an implanted microprocessor which uses inputs from implanted symptom-sensors which pass diagnostic and therapeutic data up through a decision tree of microcontroller node chips to generate more comorbidity symptom-inclusive data as the next higher level of these rises, to diagnose and optimize therapy to achieve optimal homeostasis across the entire set of said comorbidities for the medication made available to it.
10. An automatic diagnostic and therapeutic prescription control system which fully implanted, allows fluid drugs injected through a subcutaneously implanted port with multiple openings to be stored in subcutaneously implanted fluid drug reservoirs for release through fluid drug delivery pipelines each respective of a fluid drug reservoir, wherein said port is entered through a self-puncture resealing entry diaphragm, and the outlet of each fluid drug reservoir is connected to an outlet pump, wherein said outlet pump empties into the fluid drug pipeline respective of that fluid drug reservoir, wherein said fluid drug delivery pipelines each terminate at a different site of disease or into the general circulation through a stationary leak-free connector, wherein said reservoir outlet pumps are actuated by the system master control microprocessor executing its prescription-program.
11. The subcutaneously implanted port according to claim 10 comprising a self-resealing puncture entry diaphragm and openings leading directly or through drug reservoirs into different fluid drug delivery lines, the lumina thereof configured to pass through miniature diagnostic and therapeutic cabled devices such as scopes, lasers, intravascular ultrasound probes, and thrombectomizers to a site of disease or its blood supply, said line when connected to a large vein also capable of serving to make possible intravenous delivery of total parenteral nutrition, chemotherapy, antibiotics and other drugs, as well as to allow the withdrawal of blood and tissue biopsy samples.
12. The subcutaneously implanted port according to claim 10, further comprising one or more electrical sockets connected to conductors for energizing electrically powered therapeutic devices each such device controlled by the same controller as controls the release and doses of drugs to treat symptoms of the same disease process on the basis of disease analyte sensor feedback, wherein the output of said sensors is passed to a prescription-programmed microelectronic controller; wherein the microelectronic controller actuates said electrically powered therapeutic devices at each such site apart from or in coordination with concurrent drug delivery as necessary.
13. A combination of fluid drug delivery pipelines for direct delivery of fluid drugs from subcutaneously implanted fluid drug reservoirs; wherein said fluid drug delivery pipelines are replenished through a body surface port having openings respective of each of said drug reservoirs for delivery of said drugs into diseased tissue or the blood supply thereof; wherein said drug delivery lines are otherwise closed off from the circulatory system, further comprising a microelectronic controller and sensors; said microelectronic controller executing a pharmaceutical prescription-program responsive to sensor inputs upon which basis said implanted controller sets the doses for release to each site of disease by controlling the outlet pump of each said fluid drug reservoir.
14. A controlled fluid drug and electrical stimulation therapy delivery system comprising i) a closed system of fluid pipelines for direct delivery of medicinal fluids, ii) fluid drug reservoirs accessed by said fluid pipelines through a body surface port, iii) secure end-connectors; wherein said medicinal fluid is delivered into diseased tissue or its blood supply through secure end-connectors; iv) electrical conductors for energizing electrically powered therapeutic devices, v) analyte sensors configured to detect the need for medicinal, electrostimulatory, and thermal therapy, and vi) a prescription-programmed microelectronic control system controller; wherein each device is directed toward the same site of disease as the disease analyte sensor or sensors respective of each; wherein the data collected by said sensors is transmitted to its respective prescription-programmed microelectronic control system controller in a rising hierarchical tree; which coordinates the inputs from the different symptom sensors to include additional symptoms as the tree is ascended to that of a master control microprocessor to direct the release of medication to and actuate said therapeutic devices at each site to achieve the optimal result across the combination of symptoms.
15. The controlled fluid drug and electrical stimulation therapy delivery system according to claim 14 wherein said control system is organized in the form of a hierarchical tree of microcontroller nodes of increasing purview moving up said tree, so that an implanted master control microprocessor programmed with the diagnostic and therapeutic information necessary to treat any symptoms in a number of comorbidities can, at a first level of diagnostic and therapeutic nodes in the hierarchy, evaluate sensory data pertaining to each symptom of each morbidity, pass the evaluated sensory data up to a second level of nodes wherein the combination of therapeutic measures is optimized to cover both morbidities, wherein this pattern of more inclusive data processing is continued up said tree to include all of the symptoms to be treated, whereupon summary data is generated and is passed to the master control microprocessor to translate the sum of data in accordance with its prescription-program into the net therapy that most closely approximates normal homeostasis across the combination of morbidities.
16. The controlled fluid drug and electrical stimulation therapy delivery system according to claim 14 or claim 15, further comprising a plurality of ductus side-entry jackets and nonjacketing side-entry connectors wherewith at least one pump supplying fluid drugs to these and/or an electrical discharge therapeutic device is controlled by a microprocessor according to a prescription-program; wherein a plurality of disease associated physiological indicia acting as symptom sensors implanted at different locations in the body send outputs which the microcontroller nodes at the lowest level report up through the tree as negative feedback to signal out of the normal range conditions to the next higher level microcontroller nodes in the hierarchical tree conformed control system; wherein the microcontroller nodes pass their information up to microcontroller nodes at the next higher level in the tree until at the highest level, a master control microprocessor responds according to its prescription-program by returning a response signal back down through the chain of successive nodes to cause said pumps to index to and release the drugs prescribed for the symptoms in the doses commanded and to effect the discharge of electrical current as necessary to return said physiological indicia back to within the normal range thus minimizing if not eliminating said symptoms.
17. The hierarchically controlled fluid drug and electrical stimulation therapy delivery system according to claim 14 or claim 15, wherein the hierarchical process applied to coordinate the diagnosis and treatment of multiple symptoms in comorbid disease effectuates responsive action which achieves the optimal response for each symptom so that the sum thereof manifests normal homeostasis or as close thereto as the means made available to the system will allow.
18. The hierarchically controlled fluid drug and electrical stimulation therapy delivery system according to claim 14 or claim 15, wherein the hierarchical process applied to coordinate the treatment of multiple symptoms in comorbid disease if prevented from attaining a better resolution of a symptom due to a less than adequate drug it has been provided resorts to a subroutine with drug reference memory to identify a replacement drug best suited to correct the condition.
19. An automatic disorder response system comprising a plurality of implanted sensors, sensor data responsive microcontrollers at different levels of sensor data coordination, and means for the direct pipeline targeting of fluid drugs and electrostimulation to the sites of disease, wherein each sensor is directed to a symptom in a number of symptoms due to concurrent disease processes of which those sensors directed to the symptoms attributable to any one disease process transmit their data to higher level microcontrollers dedicated to each disease process to determine the fluid drug, drugs, and/or electrostimulators most efficacious for the treatment thereof and this data is passed up to higher level microcontrollers that coordinate the data of subordinate microcontrollers to include that pertinent to progressively more symptoms and disease processes, which pass their data to a master control microprocessor that integrates the sum of data provided to it and uses said data as the basis for commanding specific corrective measures it commands to ameliorate the combination of disease processes individually and together.
20. The automatic disorder response system of claim 19 wherein the assessment of overall drug and electrostimulatory efficacy is determined by the highest level controller on the basis of negative feedback at the microcontrollers at each of the levels of increasing inclusivity subordinate to it and therefor at its own summary level of the effect of each drug and/or electrostimulatory for its respective symptom and the combination thereof for the sum of symptoms which most closely approximates the overall effect desired.
21. The system of claim 19 where said implanted automatic disorder response system is organized in the form of a pyramidal tree comprising microcontroller nodes that deliver more inclusive information at each higher level in said tree, wherein at the highest level, a master control node—in comorbid disease, a microprocessor—accepts the sensory data coordinated and accumulated by the microcontroller nodes subordinate to it and returns motor commands that proceed in the opposite direction down said tree to control the system end-effectors, to include miniature peristaltic pumps or electrical stopcocks at the outlet of implanted drug reservoirs as well as electrostimulatory end-effectors as appropriate, said sensors continuously monitoring and reporting the responsive action up through the tree of microcontroller nodes to the master controller as it occurs so that said tree finds the optimal doses of drugs by negative feedback as a whole.
22. The automatic disorder response system of claim 19 wherein the effect of each drug on its respective symptom is considered independently by an initial level sensor or sensors and microcontroller node assigned to said symptom, the effect of said drug made evident as negative feedback in symptom alleviation responsive to the application of said drug, this information used to minimize the dose of said drug, and this ascertainment of amelioration passed up to a next higher level microcontroller node, which receiving this data and that negative feedback data from another drug directed to another symptom, generates an assessment of efficacy of these drugs when used together, this pattern of increasing inclusivity continued by being passed up to a number of higher level microcontroller nodes of which the number of levels is determined by the number of drugs used, this pattern culminating in input for integration and the identification of any adverse interactions among the drugs with the other drug on the basis of drug interaction data stored in the read only memory of the master control microprocessor, which then returns that combination of drug release and electrostimulation signals back down this control tree to the drug outlet release motors and electrostimulators associated with each symptom to dispense the optimized therapy for the combination of symptoms to be treated.
23. An automatic disorder response system according to claim 19 or claim 22 wherein the release of fluid drugs is exclusively through catheteric pipelines which isolate as said pipelines convey more than a single drug targeted to the same organ, gland, or volume of tissue directly into the blood supply or parenchyma of said organ, gland, or volume of tissue, the catheteric isolation of drugs from one another thus minimizing side effects provoked than were said fluid drugs dispersed throughout the circulatory system so that nontargeted tissue would be adversely exposed to said fluid drug, where the effect and doses of said drugs is continuously monitored by sensors dedicated to said organ, gland, or volume of tissue which transmit their data to organ symptom-dedicated microcontrollers and a master microprocessor to optimize the dose of each drug.
24. An automatic disorder response system according to claim 19 or claim 22 wherein the release of fluid drugs includes both direct release into the circulation and release through catheteric pipelines which isolate as said these convey more than a single drug targeted to the same organ, gland, or volume of tissue directly into the blood supply or parenchyma of said organ, gland, or volume of tissue, said control system configured to optimize the relative concentrations in the drugs piped and those not to obtain the best outcome for the combination of drugs used.
25. A fully implanted automatic disorder response system that coordinates the data provided by a plurality of implanted sensors, each sensor assigned to one or more symptoms of one or more disease processes, each such sensor continuously transmitting its data pertaining to the change in symptom status responsive to the release of a drug, this information passed up to a ground level microcontroller node in a rising hierarchical decision tree, said ground level microcontroller node and another adjacent to it aimed at another symptom of the same or another disease process to which another drug was directed in turn passing their data up to a next higher, cross-level microcontroller node to evaluate the efficacy of the two drugs working together, this pattern continued up to the next level microcontroller node of which each level represents the addition of another drug to one and same or different disease processes in order to provide a master control microprocessor at the head of the tree with the information necessary to determine which fluid drugs in the fewest number and smallest dose and which nondrug effectors such as electrostimulatory and thermal, acting together should optimally affect the combination of symptoms and the combined efficacy of the drugs when released together to elicit the optimal effect over the combination of disease processes and thus most closely reinstate normal homeostasis, said master control microprocessor using this information as a continuous input of negative feedback at every node in the tree to command the actuation of the motors controlling the outlets of implanted fluid drug reservoirs to release the drugs and implanted electrostimulation devices to discharge current thereby to attain the optimal therapeutic effect.
26. An implanted automatic disorder response system comprising sensors aimed at the symptoms of a disease process, wherein said sensors continuously input data indicating the instantaneous status of said symptoms to a dedicated microcontroller chip, wherein other such sensor-microcontroller chip pairs are assigned to other symptoms of disease processes, wherein both such sensor-microcontroller chip pairs input their data for coordination to a higher level microcontroller chip for determining the best combination of drugs isolated from one another by direct pipeline-targeting into the blood supply or parenchyma of each such disease site to treat the sum of said disease processes.
27. An implanted automatic disorder response system comprising sensors aimed at the symptoms of a disease process, wherein said sensors continuously input data indicating the instantaneous status of said symptoms to a dedicated microcontroller chip, wherein other such sensor-microcontroller chip pairs are assigned to other symptoms of disease processes, wherein both such sensor-microcontroller chip pairs input their data for coordination to a higher level microcontroller chip for determining the best combination of drugs isolated from one another by release into the general circulation to treat the sum of said disease processes.
28. An implanted automatic disorder response system comprising sensors aimed at the symptoms of a disease process, wherein said sensors continuously input data indicating the instantaneous status of said symptoms to a dedicated microcontroller chip, wherein other such sensor-microcontroller chip pairs are assigned to other symptoms of disease processes, wherein both such sensor-microcontroller chip pairs input their data for coordination to a higher level microcontroller chip for determining the best combination of drugs isolated from one another by direct pipeline-targeting and drugs released into the blood supply or parenchyma of each such disease site to treat the sum of said disease processes.
29. A prosthetic disorder response system which includes an epicutaneous body surface port incorporating a data transmission socket such as a universal serial bus or standard telephone port to allow a prescription-programmer to plug in a code transmission device such as a computer or universal serial bus flash drive in order to enter updates to the prescription-program during and in response to the diagnostic findings obtained during an office visit.
30. A prosthetic disorder response system incorporating a totally implanted digital drug release and electrostimulation remediation command-issuing controller, in comorbid disease, a microprocessor, capable of Internet-implemented data transmission and reception with virtual private network capability for security, said digital controller programmed to transmit out-of-range physiological patient sensor data for which it had not been provided the means of reversal and remediation to the clinic and receive responsive adjustments to the prescription-program from a remote prescription-programmer to change the onboard prescription-program in response to the emergency condition even before the patient becomes conscious of the condition.
Description
BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0577]
[0578]
[0579]
[0580]
[0581]
[0582]
DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION
[0583]
[0584] For system simplicity and economy, the release of drugs and/or other therapy such as electrostimulatory for which the need is signaled by the implanted sensors is relegated to the automatic system, whereas scheduled oral medication prescribed for a competent patient is omitted. Automatic response functions include any that demand response to sensor inputs indicating the emergence of an abnormality which had been diagnosed on the basis of a genetic evaluation and the system prepositioned to counteract the condition before the patient becomes aware of it.
[0585] For a prescription adherent patient, the functions supplied by the system may be supplemented with an oral or self-injected prescription.
[0586] As used here, the control system is the focus, end-connectors, end-effectors, and details concerning component materials and mechanical function omitted as duplicative of information having been set forth earlier in related applications identified in the section above entitled Background of the Invention. The implementation of these components in combination with an automatic ambulatory disorder response system has application to many disorders and disease processes affecting every bodily system, application to the lower urinary tract purely exemplary.
[0587] In
[0588] Body surface ports—even when positioned subcutaneously with a self-sealing cover membrane as provided in subcutaneously positioned portacaths, or mediports, allow the insertion of not just infusion lines but miniature cabled devices for passage through a side-entry jacket for entry into its substrate ductus or side-entry for entry into the substrate parenchyma. Such cabled devices include those both diagnostic and therapeutic, such as lasers, endoscopes, and intravascular ultrasound probes, which allow the application of therapy as well as the withdrawal of biopsy samples.
[0589] Depicted in
[0590] Here in
[0591] In
[0592] Exceptionally, the arrangement shown in
[0593] Significantly, the drainage system shown in
[0594] More specifically,
[0595] Bypass thus allows medication to remain without being washed away and the diseased urothelium to heal without the insult of urine flowing over it. When a drug or drugs for release into the bladder are to coat the interior while the urothelium remains dry, the valves used are not manual but rather solenoid or servo driven, and the microcontroller—or in comorbid disease where the urinary tract is one of multiple affected systems, the master control microprocessor—then automatically times the actuation of the valves to bypass the inflow of urine into a collection bag at an interval preceding the release of the drug or drugs to allow the interior to dry.
[0596] The timely administration of drugs, especially when numerous and for release at different related intervals of which some are dependent upon others will be too difficult for many patients who may already be impaired, and a requirement to additionally coordinate this timing with the need to make preparatory adjustments in the delivery mechanism is likely to meet with failure unless such adjustments are automatically coordinated with the release of the various drugs by a controller that governs both. Much the same need for coordination thus applies to the use of other drug-combined means such as electrostimulation, warming, or cooling devices to be actuated in timed relation to the release of drugs or drugs used in combination.
[0597] This is significant for facilitating healing following a surgical procedure inside the bladder, for example. The addition of a rudimentary automated system comprising an implanted microcontroller chip and an service or accessory channel on either side would allow the automatically dispensed targeting of a crystal solvent through the valve and into the tract. A more elaborate system would include sensors to detect signs of inflammation, infection, or metaplastic degeneration, for example, and initiate the dispensing of medication while the patient remained ambulatory and unconscious of this action. Copending application Ser. No. 16/873,914, entitled Vascular Valves and Servovalves—and Prosthetic Disorder Response Systems, specifies sensors capable identifying virtually any condition of disease that would affect the urinary tract.
[0598]
[0599] An oximetric sensor in this example or with respect to any artery that blocked would lead to a cerebral or myocardial infarction, for example, will instantly detect incipient hypoxia, other sensors capable of detecting the integral stress response and/or ‘cyclokine storm’ associated with the inception of a vasospasm in angina (angina pectoris) or any condition such as the rupture of a vulnerable plaque or thromboembolism associated with an imminent occlusion. As enumerated in copending application Ser. No. 16/873,914, entitled Vascular Valves and Servovalves—and Prosthetic Disorder Response Systems, the state of development in sensors now allows a host of adverse conditions to be detected.
[0600] Upon the detection of such an acute incident, a fully implanted disorder response system can immediately pipeline target a concentrated dose of a thrombolytic such as tissue plasminogen activator, uroknase, or streptokinase, to the affected coronary, carotid, or internal carotid artery in an ambulatory patient, and in so doing, interdict the onset of a potentially fatal condition before it has the chance to evolve and before the patient even becomes aware of the condition. Chronic conditions such as stable or unstable angina and cardiac syndrome X are immediately responded to with the direct pipe-targeting into the artery of a vasodilator such as nitroglycerin.
[0601] A regular maintenance sensor to detect a chronic condition of atherogenic dyslipidemia rather than an imminent vascular accident monitors the timely dispensing and the effect of maintenance medication such as a statin, low-dose aspirin, clopidogrel, beta blocker, calcium channel blocker, and/or short term acting nitroglycerin. That the onset and duration of action of these drugs is variable and several may be prescribed for timely application means that automatic dispensing will preclude failure to adhere to the prescription despite its complexity or the forgetfulness or the disorientation of an elderly patient, for example.
[0602] To conserve energy, where appropriate to the application, sensors are activated intermittently. For system simplicity and reduced expense, newer drugs which are administered by injection in any event, such as proprotein convertase subtilisin/kexin tye 9 (PCSK9) inhibitors to suppress the production of low density lipoprotein currently every two to four weeks with currently experimental variants to be taken as infrequently as twice a year should still be administered through manual injection by a clinician. That is, the automatic system would be capable of administering a drug semiannually, but the increased cost and complexity of the system to incorporate such an infrequently taken drug is best avoided.
[0603] The sensor and automatic response remain in place following an angioplasty and stenting to prevent the angina, for example. Copending application Ser. No. 16/873,914, entitled Vascular Valves and Servovalves—and Prosthetic Disorder Response Systems, shows inline coupling jackets which under the control of the automatic disorder response system can replace a segment along a ductus without interfering with the flow therethrough of blood. If vulnerable plaque is situated along a segment of the artery, this segment can be replaced. Otherwise, severe angina is best alleviated by a coronary artery bypass graft.
[0604] For immediate response to an emergency signaled to the clinic by implanted sensors that requires a change in the prescription-program, changes are transmitted over the Internet to the unique name of the microprocessor supported by an accompanying mobile hot spot with security provided by a virtual private network, for example. The section above entitled Updating the Prescription-Program deals with remote access to the patient microprocessor by various methods to include remote desktop protocol, or remote computer access with the aid of a virtual private network to protect the privacy of the patient. Intended to represent one in a number of comorbidities, the same arrangement would apply were the condition monomorbid with the system managed by a microcontroller rather than a master control microprocessor in comorbid disease.
[0605] For pictorial clarity, the drug, pump, and drugline mechanism in
[0606] Such becomes necessary only once the number of components becomes excessive due to the compresence of numerous disorders. Such a condition is not limited to the elderly but may be seen, for example, in the multiply severe comorbid disorders due to congenital, to include pleiotropic origin, in young patients with trisomy mutations. In monomorbid disease with the disorder response system fully implanted, the drug selection mechanism is controlled by a microcontrol chip. In comorbid disease, control is by a microprocessor.
[0607] In
[0608] In the arrangement depicted in
[0609]
[0610] Pump 56 is continuously adjustable in speed and reversible, allowing outflow to and inflow from either jacket over the range of drug volumetric flow rates without the need to switch to lines of different caliber. Pump 56 is usually one of a pair, one pump usually connected to the sideline, that is, the service or accessory channel which allows access to the jacket or connector for the directly targeted delivery of medication or a miniature cabled device such as a laser scope, or intravascular ultrasound probe. When more than one pump-pair is present, the connection of these to either jacket is through lines connected to the turret respective of each jacket.
[0611] Reciprocally, jackets not shown in
[0612] As shown, the left-hand turret lacks a vial and reservoir hose plug in table seen at 58 on the right, indicating that in this application, only the right-hand turret loads drug vials or receives medicated hydrogel or other therapeutic substance reservoir lines or hoses. Were, however, drugs to be supplied from the turret to the left or a tacky medicinal hydrogel, for example, to be recirculated through the closed pump circuit with pump 56 when rotated clockwise, then the turret on the left would be of the same kind as that on the right. If to fill the line then stop or recirculate the gel, a reservoir hose would supply the gel necessary to fill the line. Segments along a line of medicinal or nonmedicinal gel or water can be interposed between segments of the primary medicinal as a way to deliver the primary medicinal in an intermittent manner.
[0613] Control of this rotating turret mechanism is one means by which the master controller can position drugs for release to specific targets, alternative embodiments such as miniaturized functionally equivalent. To conserve space, drugs are moved through narrow gauge druglines, often conventional catheters. If the distance to the target makes it necessary, the drug can be diluted or positioned at the head of a column of gel or water. This application concerned with control of a totally implanted disorder response system, the review is necessarily cursory, a more thorough description of drug delivery mechanisms provided in copending application Ser. No. 15/998,002.
[0614]
[0615] In
[0616] Also not shown are service or accessory channels to deliver an anticoagulant such as a heparin or thrombolytic drip to prevent the accumulation of a residue along the inner wall of the druglines, or of clot when the fluid moved is blood. In
[0617] Part number 5 is a the outer sealing grommet cap of an eccentric bushing that allows the razor sharp circle cutter, or trepan, at the end of the bushing facing into the jacket, hidden in this view but clearly shown in copending application Ser. No. 15/998,002, entitled Ductus Side-entry Jackets and Prosthetic Disorder Response Systems filed on 25 Aug. 2014, to be rotated and reciprocated to expedite removal from the side of the ductus of a plug of tissue to serve as the ostium of sideline 13 exiting side connector, side-stem, or mainline 6, ordinarily fed by a subsidiary sideline shown here as part number 10.
[0618] Jacket side-stem, or side-connector 6 shown here ensheaths mainline 13 here used as a drugline leading to the turret aligned drug reservoir vial 58; part number 10 is a side-stem subsidiary takeoff, or sidestem, that ordinarily conveys a drugline or service or accessory channel; 11 used to empty into service or accessory channel; 13, the jacket mainline having emerged through side-stem, or side-connector 6, used here as the drugline connecting the jacket to the turret aligned drug reservoir vial 58.
[0619] Part number 14 is a spring-hinge which urges the jacket shut but not with a restorative force so great as to prohibit growth in a young child; 15 indicates the position of the joint separating the spring-loaded semicylindrical halves of the jacket opposite to the jacket spring-hinges; 16 schematically represents the subcutaneously implanted body surface port through drugs and therapeutic solutions are replenished regardless of the number or size of the components needed as too numerous or large for the system to be fully implanted so that the internally unaccommodable components had to be relegated to a body pack. Part number 18 schematically represents the body surface integument, comprising the skin, subcutaneous fascia, and fat.
[0620] Part number 19 points to side-entry jacket and lining through and through slits to allow open exposure of a sufficient area of the vascular adventitia of the encircled artery as essential to preclude the complete enclosure of its nervelets and tiny vessels as would induce atherosclerotic degeneration; 56 is the right hand of two drug delivery pumps, shown here as peristaltic, or of the roller type, for propelling drugs from the drug reservoir 58 and through sideline, or service or accessory channel 11.
[0621] Part number 57 is the drug pump outflow indexing turret plate; 58 is the drug turret drug reservoir or vial storage tray that rotates to index the required drug vial into alignment with line 65 leading to drug pump 56 as the drug pump intake line; 59 is the pump intake drug vial hold-down plate, which along with drug storage vial sectional tray 58, comprises the drug pump intake turret; 60 is the drug inlet turret motor of the right-hand pump shown.
[0622] Part number 61 is the drug outlet turret motor for the right-hand pump shown; 62 is the right hand drug turret stile or mounting shaft; 63 is the drug vial hold-down plate retainer cap; 64 is the drug pump outlet line that leads into the sideline or service or accessory channel 11; 65 is the pump drug intake line from drug storage vial 58; and 69 are fluid line cleanouts. An additional service or accessory channel feeding into the druglines to drip in an anticoagulant or thrombolytic to prevent the formation of clot is not integral to the mechanism is not shown.
[0623] Whereas bedridden patients need drugs to be pumped to the target, in an ambulatory patient able to maintain an upright posture, drug reservoirs can allow the drug to flow down to the target due to gravity. Generally, it is simpler and less costly to move expensive drugs through druglines in the form of a diluted continuous column rather than to arrange for a much smaller concentrated amount of the drug to be driven down the drugline ahead of a column of water by the reservoir pump. That is, the degree of control, precision calibration of the componentry, expense, and susceptibility to malfunction to provide such head of water column drug-water reservoir switching and apportioning are greater than is the use of narrow gauge druglines and diluted drugs of like dose as were these highly concentrated and positioned ahead of a column of water.
[0624] Moreover, that the continuous input of sensor feedback as medication is added is the basis for determining whether the optimal dose has been delivered means that the gradual rate of drug delivery is easier to determine than would be the sudden delivery of the drug. Nevertheless, if excessive water or dilution are problematic, the alternative of delivery at the head of a column of water which upon delivery is stopped leaving almost all of the water in the line is to be preferred. Depending upon the connections made between pumps and jackets, a pump or pump-pair can support one or more side-entry jackets, and more than one pump-pair can support a single jacket. In
[0625] When too small to provide the volume of medication required, the standardized drug vial shown in FIGS. 33 thru 36 of copending application Ser. No. 15/998,002 for insertion into a turret drug vial receptacle, represented here as part number 58, serves as the connector attached to the end of a drug delivery line from the drug reservoir for engagement in the turret. The vial also provides the initial dose of the drug or another drug preparatory to delivery of the primary drug. A more usual and versatile arrangement is shown here in
[0626] The two jackets represented in
[0627] Whereas lines supporting side-entry connection jackets placed along the vascular tree or the urogenital tract are small enough in caliber that placement should seldom encroach upon neighboring tissue as to cause pain by compression of a nerve or vessel, larger jackets positioned along the gastrointestinal tract or airway might do so. Where anatomical or operative considerations discourage the placement of multiple lines to access a given jacket, the input line to each jacket is provided with a conventional miniature piggyback port with valve. Encroachment upon neighboring tissue is to be avoided. All jackets have their edges and corners rounded, If necessary, a polymeric gas-permeable cushion not subject to enzymatic or hydrolytic breakdown can be glued to the jacket to serve as a cushion between it and the neighboring anatomy.
[0628]
[0629] A paracorporeal such as a waist-worn body pack affords considerably more space and can hold numerous drugs, other therapeutic agents, and equipment maintenance solutions in relatively large volumes. While depicted with full-sized components as relegated to a body pack, the control hierarchy is always microminiaturized and therefore implantable with the impediment of a pack eliminated.
[0630] Accordingly,
[0631] The number of symptom or disease process axes (channels, arms) of nodes at the ground level, usually incorporated into their respective end-connectors, and the number of levels rising up from the ground level progressively more inclusive and integrative of the data passed up to them, hence, the number of levels in the tree are determined by the number of comorbidities or symptoms to be treated. Unlike
[0632] More specifically,
[0633] In
[0634] When implanted, the contents labeled body pack at the lower left in
[0635]
[0636] Fluid and electrical connections between the implanted and pack-relegated components are conventional, numerous like situations—ventricular assist devices, artificial hearts—having set the precedent. In
[0637] In
[0638] Further for visual clarity, where the electrical and fluid lines between nodes and jackets are actually separate and distinct, those between nodes and jackets are shown as consolidated until finally led to each jacket, and remote sensors and auxiliary drug supply reservoirs have been omitted. Electrical connectors, more remote sensors, drug supply reservoirs and outlet pumps controlled by the master node have been omitted. If provided with the requisite switching and valving, the fluid and electrical lines shown as shared could support each jacket independently but not simultaneously, the utility thereof contingent upon the condition or conditions to be treated; simultaneous capability is accomplished by furnishing the components necessary.
[0639] While the ultimate object here is to provide a completely implanted disorder and disease or comorbid disease response system which functions autonomously and silently in a fully ambulatory patient oblivious to its operation where the occasional need for a supplementary body pack is unavoidable, nothing said here should be misconstrued as discounting an embodiment comprising an extracorporeal console inclusive of the control, power, and drug storage and selection components where only the end-connectors, end-effectors, and connecting lines have been implanted for connection to the console through a body surface multiconductor receptacle. Whether configured to respond to conditions of disease, disorder, and/or use to administer an organ transplant, for example, such consoles can be portable or kept in the clinic.