Multi-filar coil medical stent

• US 6,019,779 A
• Filed: 10/09/1998
• Issued: 02/01/2000
• Est. Priority Date: 10/09/1998
• Status: Expired due to Term

• Current Assignee: Ev3 Peripheral Inc. (Medtronic Plc)
• Original Assignee: Intratherapeutics Incorporated (Sulzer Medica)
• Inventors: Gunderson, Richard C., Thorud, Michael S.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US09/169,246
• Time in Patent Office: 480 Days
• Field of Search: 606/1, 606/108, 606/194, 606/198, 606/200, 623/1, 623/12
• US Class Current: 606/198
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires

Abstract

Multi-filar, open and closed coil, tubular medical stents that are introduced to a site in a body lumen and released to expand at the site to provide a passageway through the stent lumen are disclosed. Each stent filar is a coil wound in substantially the same pitch through the majority of its length between the ends thereof. The coils are attached together at least at one coil end to form an end of the stent and wound in an interleaved manner such that the adjacent coils are substantially evenly spaced apart or in close contact in the released state and do not cross over one another. In one open coil stent embodiment, both ends of each coil are attached in respective first and second common attachment junctions, and the resulting coils have relatively even predetermined spacing between adjacent coil turns through the majority of the length of the stent between the first and last coil turns when the stent is released. Preferably, the first and second stent ends are formed by attaching the coil ends in common, and the stent ends are squared by decreasing the pitch of the first coil turn extending from the stent end such that the spacing of the stent end from the adjacent coil is reduced from the predetermined spacing. Additionally, multi-filar closed coil stent embodiments are disclosed having only one end of each coil attached in common and adjacent coil turns in substantial mutual and overlying contact in the restrained state during implantation and non-overlying contact in the released state. Preferably each common attachment junction of attached coil ends and each free coil end is formed into an enlarged stent end in at least one dimension for ease of attachment to and release from a stent delivery catheter. The common attachment junction can be snared or grasped by a stent retrieval system and retracted from the body lumen.

Claims

1. An implantable multi-filar coil stent having a substantially tubular shape and an expanded stent length and expanded stent diameter in an expanded state adapted to be introduced, while reduced to a reduced stent diameter and stent length, to a site in a body lumen and implanted at the site at an expanded stent diameter and stent length in contact with the wall of the body lumen comprising:

a plurality of coils each having a pre-determined coil cross-section and extending for a predetermined length between a first coil end and a second coil end and each wound in a common winding direction and having a common winding pitch through an intermediate portion of the coil length intermediate the first and second coil ends with opposing turns of said coils being substantially parallel spaced-apart in said intermediate portion and with said coils being non-overlapping in said intermediate portion; and

said first coil ends coupled together at a first stent end for cooperatively maintaining said plurality of coils in a multi-filar winding relationship providing the substantially tubular stent shape and maintaining substantially parallel spacing between adjacent turns of the plurality of coils through said intermediate portion and, at said first stent end, said winding pitch of said plurality coils respectively varied for said first ends of said coils to be angled toward one another in helical paths to a cuspless, first common junction point in side-by-side alignment.

2. The multi-filar coil stent of claim 1 further comprising a first enlarged tip at said first common junction point and having a cross-section exceeding, in at least one direction, the combined cross-section of the plurality of coils attached together at said first common junction point.

3. The multi-filar coil stent of any of claim 1, wherein said plurality of coils of said coil stent are formed with a rectangular cross-section.

4. The multi-filar coil stent of any of claim 1, wherein said coils of said coil stent have an elasticity allowing said coils to be wound under applied force to a restrained diameter on stent deployment means to allow for introduction of said coil stent to the site of implantation while reduced in diameter and to unwind from said restrained diameter and to resume substantially said expanded stent diameter when implanted at the site.

5. The multi-filar coil stent of any of claim 1, wherein said coils of said coil stent are formed of a superelastic metal alloy and have an elasticity allowing said coils to be wound under applied force to a restrained diameter of about 10% to 90% of the expanded stent diameter on stent deployment means to allow for introduction of said coil stent to the site of implantation while reduced in diameter and to unwind from said restrained diameter and to resume substantially said expanded stent diameter when implanted at the site.

6. The multi-filar coil stent of any of claim 1, wherein said coils of said coil stent have an elasticity allowing said coils to be wound under applied force to a restrained diameter and a restrained pitch on stent deployment means to allow for introduction of said coil stent to the site of implantation while reduced in diameter and having a reduced state stent length that is substantially the same as the expanded stent length and to unwind from said restrained diameter and to resume substantially said expanded stent diameter, pitch and stent length when implanted at the site.

7. The multi-filar coil stent of any of claim 1, wherein said plurality of coils have a common cross-section and said plurality of coils comprise two coils.

8. The multi-filar coil stent of any of claim 1, wherein said plurality of coils have a common cross-section and said plurality of coils comprise three coils.

9. The multi-filar coil stent of any of claim 1, wherein said coils of said coil stent are formed of a superelastic metal alloy and have an elasticity allowing said coils to be wound under applied force to a restrained diameter and a restrained pitch on stent deployment means to allow for introduction of said coil stent to the site of implantation while reduced in diameter and having a reduced state stent length that is substantially the same as the expanded stent length and to unwind from said restrained diameter and to resume substantially said expanded stent diameter, pitch and stent length when implanted at the site.

10. The multi-filar coil stent of any of claim 1, further comprising a tubular sheath of fluid pervious or impervious material fitted over said plurality of coils.

11. The multi-filar stent according to claim 1 wherein said second coil ends are coupled together at a second stent end with said winding pitch of said plurality coils respectively varied at said second coil ends for said second ends of said coils to be angled toward one another to a second cuspless, common junction point.

12. The multi-filar coil stent according to claim 11 further comprising a first enlarged tip at said first common junction point and having a cross-section exceeding, in at least one direction, the combined cross-section of the plurality of coils attached together at said first common junction point.

18. The system of any of claims 13-15, wherein multi-filar coil stent of any of claims 1-8, wherein said coils of said coil stent are formed of a superelastic metal alloy and have an elasticity allowing said coils to be wound under applied force to a restrained diameter of about 10% to 90% of the expanded stent diameter on stent deployment means to allow for introduction of said coil stent to the site of implantation while reduced in diameter and to unwind from said restrained diameter and to resume substantially said expanded stent diameter when implanted at the site.

13. A system for implanting a tubular stent at a site in a body lumen at an expanded stent diameter and stent length in contact with the wall of the body lumen comprising:

a stent having a substantially tubular shape and an expanded stent length and expanded stent diameter in an expanded state formed of a plurality of coils each having a pre-determined coil cross-section and extending for a predetermined length between a first coil end and a second coil end and each wound in a common winding direction and having a common winding pitch through a substantial portion of the coil length intermediate the first and second coil ends, and with first end coupling means for coupling the plurality of first coil ends together at a first stent end and with second end coupling means for coupling the plurality of second coil ends together at a second stent end for cooperatively maintaining said plurality of coils in is an interleaved, multi-filar winding relationship providing the substantially tubular stent shape and maintaining substantially equal coil spacing between adjacent turns of the plurality of coils through a substantial portion of the lengths of the plurality of coils, said first end coupling means comprising a first enlarged tip attached to each of the first coil ends having a cross-section exceeding, in at least one direction, the combined cross-section of the plurality of coils attached together at the first stent end, and said second end coupling means comprising a second enlarged tip attached to each of the second coil ends, whereby the first coil ends are commonly coupled together and the second coil ends are commonly coupled together; and

a

a stent implantation catheter extending between proximal and distal ends and having a stent mounting and release mechanism for restraining said tubular stent wound around a distal end segment thereof and reduced to a reduced state stent diameter and stent length, said stent mounting and release mechanism further comprising;

first means for attaching the stent implantation catheter release mechanism around the first coil end and against the first enlarged tip;

second means for attaching the stent implantation catheter release mechanism around each second coil end and against the second enlarged tip; and

means for releasing the first and second attaching means from said first and second coil ends thereby allowing the tubular stent to expand from the restrained stent diameter to the expanded stent diameter to contact the wall of the body lumen.

16. The system of any of claims 13-14, wherein said plurality of coils of said coil stent are formed with a rectangular cross-section.

17. The system of any of claims 13-14, wherein said coils of said coil stent have an elasticity allowing said coils to be wound under applied force to a restrained diameter on stent deployment means to allow for introduction of said coil stent to the site of implantation while reduced in diameter and to unwind from said restrained diameter and to resume substantially said expanded stent diameter when implanted at the site.

19. The system of any of claims 13-15, wherein said coils of said coil stent have an elasticity allowing said coils to be wound under applied force to a restrained diameter and a restrained pitch on stent deployment means to allow for introduction of said coil stent to the site of implantation while reduced in diameter and having a reduced state stent length that is substantially the same as the expanded stent length and to unwind from said restrained diameter and to resume substantially said expanded stent diameter, pitch and stent length when implanted at the site.

20. The system of any of claims 13-15, wherein said plurality of coils have a common cross-section and said plurality of coils comprise two coils.

21. The system of any of claims 13-15, wherein, wherein said plurality of coils have a common cross-section and said plurality of coils comprise three coils.

22. The system of any of claims 13-15, wherein said coils of said coil stent are formed of a superelastic metal alloy and have an elasticity allowing said coils to be wound under applied force to a restrained diameter and a restrained pitch on stent deployment means to allow for introduction of said coil stent to the site of implantation while reduced in diameter and having a reduced state stent length that is substantially the same as the expanded stent length and to unwind from said restrained diameter and to resume substantially said expanded stent diameter, pitch and stent length when implanted at the site.

23. The system of any of claims 13-15, further comprising:

a tubular sheath of fluid pervious or impervious material fitted over said plurality of coils.

14. A system for implanting a tubular stent at a site in a body lumen at an expanded stent diameter and stent length in contact with the wall of the body lumen comprising:

a stent having a substantially tubular shape and an expanded stent length and expanded stent diameter in an expanded state formed of a plurality of coils each having a pre-determined coil cross-section and extending for a predetermined length between a first coil end and a second coil end and each wound in a common winding direction and having a common winding pitch through a substantial portion of the coil length intermediate the first and second coil ends, and with first end coupling means for coupling the plurality of first coil ends together at a first stent end for cooperatively maintaining said plurality of coils in an interleaved, multi-filar winding relationship providing the substantially tubular stent shape and maintaining substantially equal coil spacing between adjacent turns of the plurality of coils through a substantial portion of the lengths of the plurality of coils, said first end coupling means comprising a first enlarged tip coupled to said common junction having a cross-section exceeding, in at least one direction, the combined cross-section of the plurality of coils attached together at the first stent end, and a second enlarged tip attached to each of the second coil ends, whereby the first coil ends are commonly coupled together and the second coil ends are separated from one another; and

a stent implantation catheter extending between proximal and distal ends and having a stent mounting and release mechanism for restraining said tubular stent wound around a distal end segment thereof and reduced to a reduced state stent diameter and stent length, said stent mounting and release mechanism further comprising;

first means for attaching the stent implantation catheter release mechanism around the first coil end and against the first enlarged tip;

second means for attaching the stent implantation catheter release mechanism around the second coil ends and against each second enlarged tip; and

means for releasing said first and second attaching means from said first and second coil ends thereby allowing the tubular stent to expand from the restrained stent diameter to the expanded stent diameter to contact the wall of the body lumen.

15. The system of claim 14, wherein said plurality of coils of said coil stent are formed with a rectangular cross-section, and said stent mounting and release mechanism for restraining said tubular stent wound around a distal end segment thereof and reduced to a reduced state stent diameter and stent length further comprises:

means for restraining each coil turn of said plurality of coils wound over the adjacent coil along the length of said catheter distal end segment to stack said plurality of coils over one another and to shorten the restrained stent length to approximately the expanded stent length.

24. A method of implanting a tubular stent at a site in a body lumen at an expanded stent diameter and stent length in contact with the wall of the body lumen comprising the steps of:

providing a stent having a substantially tubular shape and an expanded stent length and expanded stent diameter in an expanded state formed of a plurality of coils each having a pre-determined coil cross-section and extending for a predetermined length between a first coil end and a second coil end and each wound in a common winding direction and having a common winding pitch through a substantial portion of the coil length intermediate the first and second coil ends, and with first end coupling means for coupling the plurality of first coil ends together at a first stent end and with second end coupling means for coupling the plurality of second coil ends together at a second stent end for cooperatively maintaining said plurality of coils in an interleaved, multi-filar winding relationship providing the substantially tubular stent shape and maintaining substantially equal coil spacing between adjacent turns of the plurality of coils through a substantial portion of the lengths of the plurality of coils, said first end coupling means comprising a first enlarged tip attached to each of the first coil ends having a cross-section exceeding, in at least one direction, the combined cross-section of the plurality of coils attached together at the first stent end, and said second end coupling means comprising a second enlarged tip attached to each of the second coil ends, whereby the first coil ends are commonly coupled together and the second coil ends are commonly coupled together;

providing a stent implantation catheter extending between proximal and distal ends and having a stent mounting and release mechanism for restraining said tubular stent reduced to a reduced state stent diameter and stent length along a distal end segment thereof;

attaching the stent implantation catheter release mechanism around each first coil end and against the first enlarged tip;

winding the adjacent turns of the plurality of coils around the distal end segment at the restrained stent diameter to mount the stent in a restrained state having a restrained stent length to the catheter distal end segment;

attaching the stent implantation catheter release mechanism around each second coil end and against the second enlarged tip;

introducing the stent wound onto the catheter distal end segment in the restrained state to the implantation site; and

operating the stent implantation catheter release mechanism to release the first and second coil ends thereby allowing the tubular stent to expand from the restrained stent diameter to the expanded stent diameter to contact the wall of the body lumen.

25. The method of claim 24, wherein said winding step further comprises the step of:

winding each coil turn of said plurality of coils along the length of said catheter distal end segment so that the restrained stent length is approximately equal to the expanded stent length.

26. A method of implanting a tubular stent at a site in a body lumen at an expanded stent diameter and stent length in contact with the wall of the body lumen comprising the steps of:

providing a stent having a substantially tubular shape and an expanded stent length and expanded stent diameter in an expanded state formed of a plurality of coils each having a pre-determined coil cross-section and extending for a predetermined length between a first coil end and a second coil end and each wound in a common winding direction and having a common winding pitch through a substantial portion of the coil length intermediate the first and second coil ends, and with first end coupling means for coupling the plurality of first coil ends together at a first stent end for cooperatively maintaining said plurality of coils in an interleaved, multi-filar winding relationship providing the substantially tubular stent shape and maintaining substantially equal coil spacing between adjacent turns of the plurality of coils through a substantial portion of the lengths of the plurality of coils, said first end coupling means comprising a first enlarged tip coupled to said common junction having a cross-section exceeding, in at least one direction, the combined cross-section of the plurality of coils attached together at the first stent end, and a second enlarged tip attached to each of the second coil ends, whereby the first coil ends are commonly coupled together and the second coil ends are separated from one another;

providing a stent implantation catheter extending between proximal and distal ends and having a stent mounting and release mechanism for restraining said tubular stent reduced to a reduced state stent diameter and stent length along a distal end segment thereof;

attaching the stent implantation catheter release mechanism around the first coil end and against the first enlarged tip;

winding the adjacent turns of the plurality of coils around the distal end segment at the restrained stent diameter to mount the stent in a restrained state to the catheter distal end segment;

attaching the stent implantation catheter release mechanism around the second coil ends adjacent each respective second enlarged tip;

introducing the stent wound onto the catheter distal end segment in the restrained state to the implantation site; and

operating the stent implantation catheter release mechanism to release the first and second coil ends thereby allowing the tubular stent to expand from the restrained stent diameter to the expanded stent diameter to contact the wall of the body lumen.

27. The method of claim 26, wherein said plurality of coils of said coil stent are formed with a rectangular cross-section, and said winding step further comprises the step of:

winding each coil turn of said plurality of coils over the adjacent coil along the length of said catheter distal end segment to stack said plurality of coils over one another and to shorten the restrained stent length to approximately the expanded stent length.