Collapsible vessel sleeve implant

• US 5,151,105 A
• Filed: 10/07/1991
• Issued: 09/29/1992
• Est. Priority Date: 10/07/1991
• Status: Expired due to Fees

• Current Assignee: Clifford Kwan-Gett
• Original Assignee: Clifford Kwan-Gett
• Inventors: Kwan-Gett, Clifford
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): GUALTIERI, GINA
• Application Number:
  US07/772,067
• Time in Patent Office: 358 Days
• Field of Search: 604/93-96, 604/280-282, 604/264, 606/151, 606/153, 606/191, 606/192, 623/1, 623/10
• US Class Current: 623/1.32
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

An implantable collapsible tubular sleeve for implanting inside a live tissue fluid vessel and system, the sleeve ends each including a collapsible circular stent or annular balloon affixed thereto. A pair of linear stiffeners are each attached to opposite sleeve exterior sides, in longitudinal orientation, and the sleeve is adapted to be collapsed and maintained in that collapsed state to be fed along the patients'"'"'s femoral artery and into position within an abdominal or throacic aorta, spanning an aortic aneurysm. A capsule band is wound around to maintain the collapsed sleeve for travel to the aneurysm, and it is maneuvered through the femoral artery on a guide wire by means of a catheter. At the aneurysm the capsule band is removed and the sleeve released, forming its cylindrical configuration. The circular stents or annular balloons at the sleeve ends can be adjusted to be perpendicular to the aorta axis and are urged into the graft wall into sealing engagement with the aorta lumen. After positioning, sleeve implant may be stabilized utilizing a tacking system operated from within the graft, to drive barbed ends of tacks through the sleeve inner wall and into the artery wall. The tacking system is operated by pulling an erecting ball between flexing arms, the arms pivoting outwardly to drive barbed ended tack releasably mounted thereto through the sleeve to lodge in the aorta wall, which barbed end tacks are then released from the flexing arms.

Claims

1. An implantable collapsible tubular sleeve for implanting inside a live tissue fluid vessel, said sleeve comprising an open-ended generally cylindrical body portion being flexible and collapsible, a pair of resilient and substantially circular stiffening members positioned and integral with said sleeve at opposite annular ends of said body, a pair of longitudinal stiffening members extending parallel to a central axis of said sleeve, each member having one end attached to a body portion of the sleeve and opposite ends overlapping and loosely extending from a middle portion of said body for adjusting the length of said sleeve, and means for positioning and erecting said sleeve in said live tissue fluid vessel.

2. A collapsible vessel sleeve according to claim 1, wherein said body portion is constructed of a synthetic fabric material.

3. A collapsible vessel sleeve according to claim 1, further including a coil spring positioned inside of said sleeve for urging said body portion against the interior wall of said live tissue fluid vessel.

4. A collapsible vessel sleeve according to claim 1, wherein each of said resilient, essentially circular stiffening members comprises at least one spring coil formed of a flat spring steel material.

5. A collapsible vessel sleeve according to claim 4, wherein the flat spring steel material for forming the spring coil, is a plurality of overlapping, essentially concentric windings, arranged as a plurality of leafs.

6. A collapsible vessel sleeve according to claim 1, wherein each of said resilient, essentially circular stiffening members comprises an inflatable annular balloon.

7. A collapsible vessel sleeve according to claim 1, wherein the means for positioning and erecting includes a removable encapsulating means for encapsulating the sleeve to permit said sleeve to be inserted into and through said live tissue fluid vessel.

8. A collapsible vessel sleeve according to claim 7, further including catheter means attached to the sleeve for inserting said sleeve into and maneuvering it through said live tissue fluid vessel.

9. A collapsible vessel sleeve according to claim 8, further including a pair of positioning wires removably attached to the sleeve for precisely positioning said sleeve within said live tissue fluid vessel.

10. A system for maintaining an implantable collapsible tubular sleeve inside a live tissue fluid vessel comprising, a tacking system for mounting on an end of a catheter wherein a draw wire is fitted to slide longitudinally within said catheter;

a draw rod and connected erecting means, said erecting means having a curved surface outwardly from its connection to said draw rod mounted to an end of said draw wire;

at least a pair of flexing arm means that are individually pivotally mounted on one end of said catheter end that is positioned within an implantable collapsible tubular sleeve having means for maintaining longitudinal stiffening of said sleeve, said means extending parallel to said sleeve central longitudinal axis to receive said erecting means curved surface between which flexing arms, with each flexing arm releasably maintaining a tack means extending outwardly from its opposite end;

a tack means having a broad head on one end of a straight shaft with a pointed barbed end as the other shaft end; and

means for releasably maintaining said tack, pointed barbed end pointing outwardly from each said flexing arm means.

11. A collapsible vessel sleeve according to claim 10, wherein the erecting means is a sphere having a cylindrical collar extending from its surface, said cylinder to fit between the flexing arm ends and receives the draw rod secured thereto.

12. A collapsible vessel sleeve according to claim 10, wherein the flexing arms pivotal coupling is a flexible tab connected along one edge to said flexing arm end and to a catheter end mount along its opposite edge.

13. A collapsible vessel sleeve according to claim 10, wherein the tack shaft length is selected to provide for the tack barbed end passing through which implantable collapsible tubular sleeve and lodging in the wall of the live tissue fluid vessel to provide a snug fit of the tack head undersurface against said implantable collapsible tubular sleeve interior surface.

14. A collapsible vessel sleeve according to claim 10, wherein the means for releasably maintaining the tack to the flexing arm means is a lateral opening into said flexing arm means to freely pass the tack head end therein;

a right angle longitudinal passage in said flexing arm means to intersect said lateral opening, with spaced apart flanges above said longitudinal passage that with a longitudinal space therebetween to accommodate the tack shaft sliding therebetween.

15. A collapsible vessel sleeve according to claim 10, further including a covering sleeve means for travel with the catheter, covering the tacking system, that is arranged to be slide by an operator out of covering engagement over said tacking system positioned within the implantable collapsible tubular sleeve.

16. An implantable collapsible sleeve system comprising a sleeve, for implanting inside a live tissue fluid vessel, having an open-ended, generally cylindrical body portion being flexible and collapsible, and a pair of resilient and substantially circular stiffening members positioned and fixed to opposite annular ends of said sleeve;

a guide wire extending through said body portion;

a catheter positioned to slide on said guide wire through the interior of said cylindrical body portion a flexible wrapping having one end fixed to said catheter adjacent said one end of the body portion and an opposite end of said flexible wrapping fixed to said guide wire adjacent said opposite end of said body portion, said flexible wrapping mounted to slide over said guide wire and spirally wrapping around said body portion before being fixed to said opposite end of said body portion, and means for maintaining said sleeve at a site within a live tissue vessel.

17. A collapsible vessel sleeve according to claim 16, further including at least one longitudinal stiffening member extending substantially the length of the body portion;

and means for securing each said longitudinal stiffening member to said body portion such that said longitudinal stiffening member extends substantially parallel to the central axis of said body portion and said body portion is movable axially with respect to the longitudinal stiffening member.

18. A collapsible vessel sleeve according to claim 17, further including a pair of positioning wires each having one end releasably attached to one of the opposite ends of the body portion and extending substantially parallel to the catheter.

19. A collapsible vessel sleeve according to claim 18, wherein the ends of the positioning wires attached to the ends of the body portion are formed as spirals that are screwed into said body portion and that are removed by screwing them out of said body portion.

20. A collapsible vessel sleeve according to claim 19, wherein the annular stiffening members are constructed of spring steel.

21. A collapsible vessel according to claim 20, wherein the annular stiffening members include a plurality of annular windings.

22. A collapsible vessel sleeve according to claim 20, wherein the annular stiffening members are inflatable bands.

23. A collapsible vessel sleeve according to claim 16, wherein the flexible wrapping is made of a strong sheet material having a smooth exterior surface.

24. An implantable collapsible vessel sleeve system according to claim 16, wherein the means for maintaining the sleeve at a site within the live tissue fluid vessel is a tacking system for mounting on an end of a catheter wherein a draw wire is fitted to slide longitudinally;

a draw rod and connected erecting means, said erecting means having a curved surface outwardly from its connection to said draw rod mounted to an end of said draw wire;

at least a pair of flexing arm means that are individually pivotally mounted on one end of said catheter end that is positioned within said sleeve to receive said erecting means curved surface between which flexing arms, with each said flexing arm releasably maintaining a tack means extending outwardly from its opposite end;

a tack means that is a tack having a broad head on one end of a straight shaft with a pointed barbed end as the other shaft end; and

means for releasably maintaining said tack, pointed barbed end, pointing outwardly from each said flexing arm means.

25. An implantable collapsible vessel sleeve system according to claim 24, wherein the erecting means is a sphere having a cylindrical collar extending from its surface, said cylinder to fit between the flexing arm ends and receives the draw rod secured thereto.

26. An implantable collapsible vessel sleeve system according to claim 24, wherein the flexing arms pivotal coupling is a flexible tab connected along one edge to said flexing arm end and to a catheter end mount along its opposite edge.

27. An implantable collapsible vessel sleeve system according to claim 24, wherein the tack shaft length is selected to provide for the tack barbed end passing through which sleeve and lodging in the wall of the live tissue fluid vessel to provide a snug fit of the tack head undersurface against said sleeve interior surface.

28. An implantable collapsible vessel sleeve system according to claim 24, wherein the means for releasably maintaining the tack to the flexing arm means is a lateral opening into said flexing arm means to freely pass the tack head end therein;

a right angle longitudinal passage in said flexing arm means to intersect said lateral opening, with spaced apart flanges above said longitudinal passage and with a longitudinal space therebetween to accommodate the tack shaft sliding therebetween.

29. An implantable collapsible vessel sleeve system according to claim 24, further including a covering sleeve means for travel with the catheter, covering the tacking system, that is arranged to be slid by an operator out of covering engagement over said tacking system positioned within the sleeve.