Flexible Delivery System and Implantable Stent for Surgical Use

Abstract

The invention is a tube, which would be used to facilitate the movement of an object through the lumen of the tube or over the outside of the tube. The invention could also be used as a stent designed for indwelling in a body, where its purpose would be to assist in the drainage of liquid from one part of the body to another. The expected use of the tube would be in minimally invasive surgical procedures where greater flexibility, radial strength and pushability than that provided by prior art are desirable to improve the speed of operations and the success rate of operations; to reduce the level of trauma caused to patients and to improve patient recovery rate. It could have use in applications requiring an exceptionally flexible and highly pushable tubing such as invasive surgery in vessels that are or have become tortuous and narrow, such as veterinary procedures for small animals, paediatric ureteral conditions, angioplasty for certain conditions and certain neurovascular work.

Claims

1. A tube having a distal and proximal end comprising a wire or rod or a plurality of longitudinal wires or rods or rods in a tube and wherein said tube is reinforced radially by a series of hoops or similarly shaped objects having a lumen or incomplete hoops, or by a braid, mesh, coil or the like, wherein the ability to apply longitudinal pressure to the tube without deformation is increased by the wire or rod; further wherein the wire or rod adds structural rigidity to the tube; and further wherein said tube is capable of being inserted into a patient.

2. The tube according to claim 1, wherein said wire or rod or plurality of longitudinal wires or rod or rods in an inner tube is/are ground down at the distal end of the wire or rod or plurality of longitudinal wires or rod or rods in an inner tube; or said wire or rod or plurality of longitudinal wires or rod or rods in an inner tube further comprise a coil, mesh, braid or a series of hoops at the distal end, wherein said coil, mesh, braid or series of hoops increase the flexibility of the distal end of said wire or rod or plurality of longitudinal wires or rod or rods in an inner tube.

3. The tube according to claim 1, wherein said wire or a plurality of longitudinal wires are capable of moving in and out of the tube.

4. The tube according to claim 1, further comprising wires inserted into the wall of the tube on alternating sides, such that at a given point, said tube may have a wire on one side and no wire on the opposite side, or alternatively, with a wire on one side and no wire on the opposite side and the reverse pattern after that, or alternatively, with a wire inserted into the wall of the tube followed by a gap followed by a wire inserted after the gap, wherein said alternating wire pattern provides increased flexibility at a given point or further comprising varying patterns of wires placed longitudinally at different points in the wall of the tube to provide varying flexibility on any axis.

5. The tube according to claim 1, further comprising a series of hoops or similarly shaped objects with lumens, or a coil, mesh, braid, expandable coil, expandable braid, expandable mesh or any combination thereof, attached longitudinally to a wire or a plurality of wires, or having a wire or a plurality of wires passed longitudinally through lumens that form part of the hoops or similarly shaped objects with lumens or coil or braid or mesh such that the longitudinal wires and latitudinal hoops or similarly shaped objects or coil or braid or mesh form a tube in terms of length and breadth.

6. The tube according to claim 1, further comprising an outer jacket having a lumen wherein said wire or plurality of wires are passed longitudinally through the lumen of the outer jacket or further comprising separate parts having lumens that are connected to the hoops or coil or braid or mesh wherein said wire or plurality of wires are passed longitudinally through the lumen of the separate parts connected to the hoops or coil or braid or mesh.

7. The tube according to claim 1, further comprising an inner liner, hydrophilic coating or other coating including coating with a drug, a marker band or other means of increasing the radiopacity of the tube or parts of the tube or any other means of adding materials to the tube or wherein said tube is formed into a spiral cup shape or a loop or a series of loops or a circular disc shape or a cup shape on top of an inverted cup shape at one or both ends.

8. The tube according to claim 1, further comprising a polymer or metallic cap that can substantially close the distal end of said tube, or a wire or wires which exert force on the distal end of the tube to substantially close said distal end, wherein when said polymer or metallic cap or wire is installed in said distal end of said tube, said cap can be uninstalled by the force of a stent, guidewire, endoscope or other similar item when said stent, guidewire, endoscope or other similar item is pushed by the user from the proximal end of the tube, through the length of the tube and out through the distal end of said tube.

9. The tube according to claim 1, wherein said tube is manufactured from a wire inserted into a series of hoops or similarly-shaped objects with lumens that are attached to a series of larger hoops or similarly-shaped objects with lumens with standard additions of outer jackets, inner liners, coatings and other standard tubing parts where desirable.

10. The tube according to claim 1, wherein said tube is manufactured from a wire attached to a series of triangular objects, or similarly-shaped objects or angled parts with a similar effect, with hoops or similarly shaped objects situated between the series of triangular objects or similarly shaped objects with standard additions of outer jackets, inner liners, coatings and other standard tubing parts.

11. A tube according to claim 1, wherein said tube is manufactured from a wire or a plurality of wires inserted into the lumen of a series of hoops or similarly-shaped objects with an inner liner placed into the lumen of the series of hoops or similarly-shaped objects, such that the wire or plurality of wires is between the inner liner and the hoops, and an outer jacket placed over the series of hoops or similarly-shaped objects.

12. A tube according to claim 1, wherein said tube is manufactured from a series of hoops or similarly shaped objects with a coil or a braid or a mesh or a series of gaps between the series of hoops with standard additions of outer jackets, inner liners, coatings and other standard tubing parts where desirable or wherein said tube is manufactured of a series of hoops or cut into a series of hoops with a spiral-cut or interrupted-cut pattern between the series of hoops with standard additions of outer jackets, inner liners, coatings and other standard tubing parts where desirable.

13. A tube according to claim 1, wherein said tube is cut into a series of incomplete hoops that are connected to each other by an uncut portion of the tube with standard additions of outer jackets, inner liners, coatings and other standard tubing parts where desirable.

14. A tube according to claim 1, wherein said tube is manufactured from a coil or a braid or a mesh attached longitudinally to a wire or a plurality of wires with standard additions of outer jackets, inner liners, coatings and other standard tubing parts where desirable.

15. A stent comprising a tube according to claim 1, wherein said tube is manufactured from a tube or metallic tube or a hypotube used to treat bodily vessel obstructions, said stent being formed by a laser cutting said tube, metallic tube or hypotube into a helix.

16. A guidewire for use in minimally invasive surgery comprising of a core wire having a distal and a proximal end, a series of hoops, coils, mesh, braids or a combination thereof wherein said hoops, coils, mesh or braid have an internal lumen, wherein the distal end of the core wire is attached to the inner surface of said hoops, coils, mesh or braids; further wherein said core wire does not pass through the center of said lumen of said hoops, coils, mesh or braids and further comprising a protective external coating.

17. A method comprising use of a motor, such as a single molecule electric motor, placed in the lumen or wall of a tube or on the distal end of a guidewire or stent itself, said motor using linear or rotary force to move the tube or guidewire or stent to a defined location in the body.

18. A method of inserting or installing a stent in a patient by delivering the stent through a tube that is comprised of a proximal section having a wider inside diameter than the inside diameter of the distal section and using a stent inserter or introducer or a guidewire or gravity to move the stent from the wider inside diameter of the proximal section of the tube into a narrower section of the tube wherein a cap may be placed on the proximal end of the tube; wherein a second tube may be employed to hold the stent in the proximal section of the tube; and further wherein a connection at the proximal end of the first tube may be used to facilitate attachment of a syringe.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0056] FIG. 1 is an illustration of a cross-sectional view of one iteration of the hypotube;

[0057] FIG. 2 is an illustration of a longitudinal view of one iteration of the hypotube;

[0058] FIG. 3 is an illustration of a longitudinal view of a second iteration of the hypotube;

[0059] FIG. 4 is an illustration of a longitudinal view of a third iteration of the hypotube;

[0060] FIG. 5 is an illustration of a longitudinal view of a fourth iteration of the hypotube;

[0061] FIG. 6 is an illustration of a cross-sectional view of a fifth iteration of the hypotube;

[0062] FIG. 7 is an illustration of a longitudinal view of a fifth iteration of the hypotube;

[0063] FIG. 8 is an illustration of a cross-sectional view of a sixth iteration of the hypotube;

[0064] FIG. 9 is an illustration of a longitudinal view of a sixth iteration of the hypotube;

[0065] FIG. 10 is an illustration of a longitudinal view of a seventh iteration of the hypotube;

[0066] FIG. 11 is an illustration of a longitudinal view of an eighth iteration of the hypotube;

[0067] FIG. 12 is an illustration of a longitudinal view of a ninth iteration of the hypotube before a stricture;

[0068] FIG. 13 is an illustration of a longitudinal view of a ninth iteration of the hypotube passing a stricture;

[0069] FIG. 14 is an illustration of a longitudinal view of a tenth iteration of the hypotube;

[0070] FIG. 15 is an illustration of a longitudinal view of an eleventh iteration of the hypotube;

[0071] FIG. 16 is an illustration of a longitudinal view of a twelfth iteration of the hypotube;

[0072] FIG. 17 is an illustration of a longitudinal view of the distal end of a thirteenth iteration of the hypotube;

[0073] FIG. 18 is an illustration of a longitudinal view of the distal end of a fourteenth iteration of the hypotube;

[0074] FIG. 19 is an illustration of a longitudinal view of the distal end of a fifteenth iteration of the hypotube;

[0075] FIG. 20 is an illustration of a longitudinal view of a sixteenth iteration of the hypotube;

[0076] FIG. 21 is an illustration of a longitudinal view of a seventeenth iteration of the hypotube;

[0077] FIG. 22 is an illustration of a longitudinal view of an eighteenth version of the hypotube;

[0078] FIG. 23 is an illustration of a longitudinal view of a nineteenth version of the hypotube;

[0079] FIG. 24 is an illustration of a longitudinal view of a twentieth version of the hypotube;

[0080] FIG. 25 is an illustration of a longitudinal view of a twenty-first version of the hypotube; and

[0081] FIG. 26 is an illustration of a longitudinal view of a twenty-second version of the hypotube.

DETAILED DESCRIPTION OF THE INVENTION

[0082] There are numerous possible embodiments associated with the tube and stent designs for the invention described herein and these are detailed in the claims below. All drawings, summaries, descriptions, embodiments and objects are intended to be illustrative rather than limiting.

Embodiments

[0083] The wire attached to the hoops can consist of a metal or a plastic polymer material such as, but not restricted to PVC, polyurethane, polyethylene, silicone, FEP, PEBAX, polyamide, polyimide and PEEK. Alternatively, the wire can be a combination of a polymer tube surrounding a metal cannula or mandrel (FIG. 3A).

[0084] FIG. 1 shows a cross-sectional view of a hypotube. This hypotube would be made by laser-welding a wire 1 to a metal tube 2.

[0085] FIG. 2 shows a longitudinal view of a hypotube. The hypotube has been laser-cut into hoops 3 or as close to full hoops as is practical with cuts at 90° angle 4 across the width of the tube and wires 5, 6 attached longitudinally at opposite sides,

[0086] Designs could use cuts at a wide variety of other angles depending on the needs of the user. It may be preferable to reduce drag on the hoops and angle the laser cuts at 80° for example. FIG. 3 shows a longitudinal view of a design with a 70° cut 7. Similarly, it may be preferable to use non-uniform cuts 8. A cut could start at 0.5 mm kerf width at one side and finish at 1 mm kerf width for example, if it was desirable to have one side more flexible than the other for a portion or for the entire length of the hypotube. Alternating kerf widths could be used to move points of stress along the tube as would be used in interrupted-cut designs. The standard design for structural rigidity would be 90° uniform cuts with variances to the angle of the cut and the uniformity of the cuts to introduce additional flexibility for specific uses. Wires are attached longitudinally at 9 and 10.

[0087] FIG. 4 shows a longitudinal view of a third iteration of the hypotube design with four wires 11, 12, 13 and 14 laser-welded to the latitudinal hoops 15 for additional structural rigidity.

[0088] FIG. 5 shows a longitudinal view of a fourth iteration of the hypotube design with wires 16 and 17 laser-welded to a coil 18.

[0089] FIG. 6 shows a cross-sectional view of a tube 20 with central lumen 21 and a wire 19 inserted into the wall of the tube. The tube would typically have radial reinforcement in the form of hoops or a braid or a coil. FIG. 7 is a longitudinal view of the same tube with the wire 22 inserted into the wall 24 of the tube with a central lumen 23.

[0090] In a slightly different iteration, FIG. 8 is a cross-sectional view of a tube 31 with a central lumen 29 and wires 25, 26, 27, 28 inserted into the wall 30 of the tube. Placement of the wires can be in any part of the wall of the tube and near the inner diameter or the outer diameter 32. FIG. 9 is a longitudinal view of the same tube 39 with a central lumen 33 and wires 34, 36, 37, 38 inserted into the wall 35 of the tube. The tube would typically have radial reinforcement in the form of hoops or a braid or a coil.

[0091] FIG. 10 is a longitudinal view of a tube or stent made from a coil or mesh or braid 41 with a wire 40 attached to the wall of the coil or mesh or braid. This wire could be attached to the inner wall or outer wall of the coil or mesh or braid.

[0092] FIG. 11 is a longitudinal view of a tube 42 with part of the tube cut latitudinally 43, such that the uncut part of the tube next to the cut section becomes a series of hoops.

[0093] FIG. 12 shows a longitudinal view of a series of hoops 47 enclosed in an outer jacket 44 encountering a stricture 45 in a bodily vessel 46.

[0094] FIG. 13 shows the same series of hoops 50 enclosed in an outer jacket 49 pushing out the stricture by virtue of the radial strength of the hoops and the force pushing them with the hoops remaining closely connected on the inside of the bend and spreading outwards on the outside of the bend, such that a minimum of trauma, as a result of force or radial stress at any particular point, is caused to the walls of the vessel 48.

[0095] FIG. 14 is a longitudinal view of a tube made of hoops 52 connected by a coil or mesh or braid 51. It could be possible to make this tube from a single piece of metal by using a heavy spiral cut between the hoops if that provided sufficient flexibility for the clinical use. This tube could also have a wire attached to the outer or inner wall of the tube and could be used as a stent, as could many of these tube iterations.

[0096] FIG. 15 is a longitudinal view of a tube with metal hoops 56 inside the outer jacket 53 and an inner liner 55 inside the metal hoops. A wire or rod 54 is inserted between the metal hoops and the inner liner. This is a variation in the placement of the wire, which may be desirable for certain manufacturing or clinical needs.

[0097] FIG. 16 is a longitudinal view of a tube made up of an outer jacket 58 with triangle parts 57 attached to a wire or rod 59 and with unconnected hoops 61 between the triangular parts and an inner liner 60 passing through the hoops. The triangle design would allow for movement of the hoops through a given angle in both directions as well as maintaining the hoops in position.

[0098] FIG. 17, FIG. 18 and FIG. 19 show the distal ends of tubes. In FIG. 17, the distal end 63 of the tube 62 is closed by bringing one side down to the other side. In FIG. 18, the distal end 65 of the tube 64 is closed by bringing the edge of the tube in to a central point. In FIG. 19, the distal end 66 of the tube is formed by running one side of the tube out to a central point and back inside the other side of the tube. It may work better to form these distal ends by using a wire inside the wall of the tube as in previous iterations described here, rather than just a polymer end. The intention of these designs is to reduce bodily materials catching on the distal end of the tube or building up inside the distal end of the tube. The force needed to open the distal end of the tube should not be so great as to impact on the atraumatic passage of a stent or endoscope or guidewire through it.

[0099] FIG. 20 shows a longitudinal view of a tube 69 with a wire or rod 68 in the wall of the tube and a gap 67 in the length of the wire. The principle of this is to facilitate higher levels of flexibility where necessary. There would be significantly reduced pushability of the distal section(s) of tubing after a gap or gaps in the wire had been passed into the body.

[0100] FIG. 21 shows a side view of a hoop 72 with a smaller hoop 70 attached to it and a wire or rod 71 passing through it. The smaller hoop would allow for movement of the larger hoop along the axis of the wire and at angles to it, while leaving the entire lumen of the larger hoop free for passage of stents, guidewire or similar objects through it.

[0101] FIG. 22 is a longitudinal view of a hypotube which has a wider diameter portion 73 tapering in 74 to a narrower diameter portion 75. The purpose of this is to facilitate placement of a stent loader tube 77 into the wider portion. This allows for one person to place the stent 76 by pushing it with a stent inserter or guidewire into the narrow diameter part of the hypotube which is designed to fit in the bodily vessel. Once the stent pigtail has been pushed out the distal end of the hypotube, the hypotube can be withdrawn and the stent is placed. Other hypotube designs generally need two people to place the stent, one to push the stent loader tube tight against the hypotube and one to push the stent. This design also allows for the stent kit to be made from four parts, which makes it easier to use and easier to understand how to use it and reduces the possibility of error in the system with less working parts and no use of glue or other type of adhesive. A possible adaptation would be to form the proximal end of the hypotube into a luer lock or luer slip style connection to allow for tight contact with a syringe.

[0102] FIG. 23 is a longitudinal view of a hypotube with a wider diameter portion 78 tapering in 80 to a narrower diameter portion 79. This design could be used in larger diameter stents where there is more space available in the narrower diameter portion of the hypotube due to it being placed into wider vessels which can take a wider hypotube. The stent 81 would be pushed by a stent inserter or guidewire into the narrower diameter portion of the hypotube as in FIG. 22. The advantage of the wider diameter portion of the hypotube 78 is that it would facilitate placement of the stent into it. This type of pre-loaded design would be useful when the hypotube can be placed directly into the vessel without use of a guidewire which may be possible in pediatric usage. Use of a scope or direct vision may facilitate this method of placement which would be a very efficient method of placement, reducing the number of step in the procedure such as placement of a guidewire and the sheath or hypotube over the guidewire, removal of the guidewire and placement of the stent into the hypotube. A useful modification of this embodiment of the invention would be the incorporation of a cap at the proximal end of the hypotube to prevent the stent from falling out.

[0103] FIG. 24 is an iteration of the invention in which a tube is formed from a wire with braid or mesh extensions that can be pushed against each other to form a narrow low profile state to facilitate tracking along the vessel and that can be expanded by balloon or by removing a sheath or some similar method of expansion. The extensions form an incomplete tube in their high profile state. This iteration shows a longitudinal wire 82 attached to alternating braid extensions 83 in their high profile state.

[0104] FIG. 25 is an iteration of the invention in which a tube is formed by attaching a braid or a mesh or a coil 84 to a wire 85, said braid or mesh being expandable to be capable of being placed in a low profile state for faster and more flexible placement.

[0105] FIG. 26 is an iteration of the invention in which a tube is formed by a number of wires 86, 87, 88, 89 with braid or mesh or solid extensions 90, 91.

[0106] A further embodiment of the instant application are methods of installing or inserting a stent into a patient in need of a stent. The first method comprises using a motor, such as a single molecule electric motor, placed in the lumen or wall of a tube or on the distal end of a guidewire or stent itself. The motor could rotate a pulley-like device that when attached to the tube, guidewire or stent, draws the tube or guidewire or stent to a defined location in the body. Thereafter, a minimal force is applied to said tube, guidewire or stent to deliver said tube, guidewire or stent to the desired position in the patient wherein said minimal force causes minimal trauma to delicate vessels.

[0107] Of use to the tube in this invention is a method of inserting or installing a stent in a patient, which involves delivering the stent through a tube that is comprised of a proximal section having a wider inside diameter than the inside diameter of the distal section and using a stent inserter or introducer or a guidewire to push the stent or using gravity to move the stent from the wider inside diameter of the proximal section of the tube into a narrower section of the tube. A second tube may be optionally employed to hold the stent in the proximal section of the tube and optionally a cap may be placed on the proximal end of the tube. Further, a connection at the proximal end of the first tube, may be used to facilitate attachment of a syringe or a handle. This method, and the physical form of the tube used in it, allows very narrow medical devices, such as stents, endoscopes and guidewires, to be transitioned into a narrow distal section of a tube with ease. This is of particular value where shape memory is used in a part, an outer jacket is delicate, or there are concerns about damaging the distal end of a medical device when loading it into a narrow tube. It is not possible to flare a very narrow wall thickness in a tube to accommodate insertion of a medical device, hence the use of this method, which is to weld or attach a larger inner diameter tube to a narrower distal tube and pass the medical device into the narrow distal tube with ease.

[0108] In yet another embodiment of the invention, the invention of the instant application is directed to a guidewire, composed of a core wire having a distal and a proximal end and standard guidewire coatings, wherein the distal end of the core wire is attached to the inner surface of a series of hoops, coil or braid all of which having lumens, wherein said core wire does not pass through the center of the lumen of the hoops or coil or braid.

[0109] As a development of the means of placing a tube or a guidewire or a stent in a bodily vessel with a view to eliminating or reducing bodily trauma and maximizing surgical efficiency, which this patent application is generally concerned with, it may be worth investigating the possible benefits of a new method of placing same, whereby a surgical team would be less exposed to radiation from the use of fluoroscopy and would be less likely to suffer a health impact from same. This advancement would be to use a robotic system to place the device. The surgeon would make the initial incision and initial placement of the device in the vessel. It could then be tracked through the body using a sensitive pump or other pushing force that would advance the device smoothly and very slowly over very short distances through the vessel to an intended end point indicated by the surgeon using a GPS or other indicator on the body. The pump should have an automatic shut-off mechanism with an alerting system when there is any force transmitted back to it from the distal end of the device, due to encountering a stricture or an obstruction in the vessel or a difficult bend. Having established by imaging that pushing the device would not rupture the vessel, the surgeon would have to decide to increase the pushing force used or manually push through the obstruction using the tactile skills of a surgeon, depending on the issue encountered. It may be possible to program the machine to insert additional wiring into the tube or to change wiring in the tube to stiffen or make the tube more flexible which a surgeon would do by changing guidewires during an operation if an obstruction demanded it. It may also be possible to define the force necessary to rupture a vessel and ensure that the pump was not capable of that level of force, which could save lives. Advances in imaging and robotics may also allow for a machine to track a device using fluoroscopy, possibly from incision to final placement. This method of placing a device would reduce the time spent by surgeons in the theatre, since a number of operations could be monitored at the one time. It would reduce human error in medical device placement and it would also reduce surgical team exposure to radiation. The possibility of hardware and software error in any robotic system would obviously need to be tested very thoroughly, ideally mitigating the risk of either by ensuring the forces necessary to damage a vessel are not possible for the system.

[0110] In order to reduce the need to push a tube or guidewire through tortuous anatomy, which can cause trauma to the vessel, magnetic force, GPS or a similar system could possibly be used to attract a tube through a vessel to a given destination in the body without damaging the vessel walls. If pushing is necessary to move the tube or guidewire, a proximity sensor could be used to detect when the center of a tube or guidewire is against a wall. Technological advancement would be needed for some of these embodiments to function in a given space, but they would be welcome advancements for delicate, tortuous anatomy, such as can exist in a newborn child's diseased ureter, where breakage of a tube is not an option.

Equivalents

[0111] While specific embodiments of the subject invention have been discussed, the above specification is illustrative and not restrictive. Many variations of the invention will become apparent to those skilled in the art upon review of this specification. The full scope of the invention should be determined by reference to the claims, along with their full scope of equivalents, and the specification, along with such variations.

[0112] Unless otherwise indicated, all numbers expressing quantities of ingredients, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in this specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention.

[0113] The Abstract of the Disclosure is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, it can be seen that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separately claimed subject matter.