Radially expanded prostheses with axial diameter control

• US 5,984,957 A
• Filed: 05/15/1998
• Issued: 11/16/1999
• Est. Priority Date: 08/12/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Laptewicz, Joseph E. Jr., Silvestrini, Thomas A.
• Primary Examiner(s): Yu, Mickey
• Assistant Examiner(s): Nguyen, Dinh X.
• Application Number:
  US09/079,806
• Time in Patent Office: 550 Days
• Field of Search: 623/1, 623/11, 623/12, 623/66, 623/900, 606/191, 606/194, 604/104, 600/36
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• 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 2/90 characterised by a net-like or mesh-like structure
• 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
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility

Abstract

A tubular, radially self-expanding stent includes a latticework of interbraided, helically wound resilient structural strands. An axial control member is secured to the tubular latticework at axially spaced apart proximal and distal coupling locations. At the proximal location, the control member is coupled slidably, to permit an adjustment of the axial distance between the coupling locations, thus to selectively adjust the radius profile of the latticework between the two locations. To set a desired radius profile, the control member either is crimped near the proximal location or fixed within a self-locking connector. The control members, preferably monofilament strands, can be elastic or substantially inextensible. Two or more control members can be used if desired. In an alternative embodiment, recovery metal control members are fixed at their opposite ends to the latticework, then plastically deformed by elongation to axially elongate and radially reduce the latticework. Following deployment, the control members are heated sufficiently to cause the control members to return to their shorter, nominal shapes, to axially shorten and radially enlarge the stent. Both versions preferably feature selvaged ends.

Claims

1. A body insertable prosthesis, including:

a body compatible prosthesis structure in the form of a braided tube having opposite open selvaged ends and comprising at least two oppositely directed sets of helically wound strands forming multiple intersections of oppositely directed pairs of strands, said braided tube further being enlargeable radially in concert with an axial shortening thereof, and alternatively reducible radially in concert with an axial elongation thereof; and

at least one elongate control member coupled to the prosthesis structure at a first coupling location and further coupled to the prosthesis structure at a second coupling location spaced apart axially from the first coupling location in a manner that allows the control member to travel axially relative to the prosthesis structure while remaining substantially axially fixed relative to the prosthesis structure at the first coupling location, whereby an axial spacing between the first and second coupling locations is adjustable toward a selected spacing amount corresponding to a selected radius profile over a region of the prosthesis structure between the coupling locations, and wherein the first and second coupling locations are located at respective first and second ones of said intersections.

2. The prosthesis of claim 1 wherein:

the control member is slideably coupled to the prosthesis structure at the second coupling location.

3. The prosthesis of claim 2 further including:

a connector fixed to the prosthesis structure and adapted to receive the control member for sliding movement therein.

4. The prosthesis of claim 3 wherein:

the connector further is adapted to secure the control member integrally relative to the prosthesis structure at the second coupling location.

5. The prosthesis of claim 1 wherein:

the control member is fixed with respect to the prosthesis at the first coupling location, and the second coupling location further is coupled to allow a fixation thereof to set the axial spacing at said selected amount.

6. The prosthesis of claim 1 wherein:

the control member comprises a linear, axially extending strand.

7. The prosthesis of claim 6 wherein:

the strand is resilient.

8. The prosthesis of claim 7 wherein:

the prosthesis structure is resilient.

9. The prosthesis of claim 1 wherein:

at least one of the first and second coupling locations is disposed along a medial region of the prosthesis structure.

10. The prosthesis of claim 9 wherein:

the second coupling location is disposed along said medial region.

11. The prosthesis of claim 1 wherein:

the control member is thermally bonded to the prosthesis structure at the first location.

12. The prosthesis of claim 1 further including:

the plurality of the connectors mounted integrally to the strands at at least one of said open ends, to selvage the at least one open end.

13. The prosthesis of claim 12 wherein:

at least one of the connectors slideably receives the at least one control member.

14. The prosthesis of claim 13 wherein:

the prosthesis structure is resilient, and the at least one connector further is adapted to fixedly secure the at least one control member in a self-locking manner.

15. The prosthesis of claim 1 wherein:

the at least one control member comprises a plurality of substantially linear, axially extending strands, each strand having a first end fixed to the structure at the first coupling location.

16. The prosthesis of claim 15 wherein:

the first coupling location extends circumferentially about the prosthesis structure, and the associated first ends of the strands are circumferentially spaced apart from one another.

17. The prosthesis of claim 16 wherein:

each of the strands further is slideably coupled to the prosthesis at the second coupling location, and the second coupling location extends circumferentially about the structure.

18. The prosthesis of claim 1 wherein:

the control member is sufficiently rigid in the axial direction to push the prosthesis structure at the first coupling location, to axially elongate and radially reduce the prosthesis structure over said region between the coupling locations.

19. A braided prosthesis structure including:

a plurality of structural strands, intermingled with one another to form a generally tubular prosthesis structure enlargeable radially in concert with an axial shortening thereof and alternatively reducible radially in concert with an axial elongation thereof, the structure having two opposite open ends;

a plurality of connectors secured integrally to the strands at at least one of the open ends, to selvage at least one open end; and

at least one elongate control strand fixed to the prosthesis structure at a fixation point and slideably received within an associated one of the connectors, whereby an axial spacing between the associated connector and the fixation point is adjustable by movement of the prosthesis structure relative to the control strand, thus to selectively adjust a radius profile of the structure over a region between the fixation point and the associated connector.

20. The prosthesis of claim 19 wherein:

the structural strands are arranged in at least two oppositely directed sets to form intersections of oppositely directed strands, and each of the connectors is joined to two oppositely directed ones of the strands.

21. The prosthesis of claim 20 wherein:

the associated connector further is adapted to secure the control strand in a fixed axial position relative to the associated connector.

22. A body insertable and controllably expandable prosthesis, including:

a body compatible, generally tubular prosthesis structure formed of a material lacking any substantial shape memory property, said prosthesis structure enlargeable radially in concert with an axial shortening thereof, and alternatively reducible radially in concert with an axial elongation thereof; and

at least one control member constructed of a recovery metal, having a nominal shape defining a nominal length between first and second opposite ends thereof, plastically deformable to an altered shape defining an altered length between the opposite ends different than the nominal length, and tending to return to the nominal shape from the altered shape responsive to a predetermined change in temperature;

wherein the at least one control member, proximate said first and second ends, is joined integrally with respective first and second axially spaced apart locations along the prosthesis structure, whereby subjecting the plastically deformed control member to said predetermined temperature change alters an axial distance between the first and second locations, thus selectively adjusting a radius profile of the prosthesis structure along a region thereof between the first and second locations.

23. The prosthesis of claim 22 wherein:

the at least one control member has a substantially sinusoidal nominal shape and a linear altered shape when plastically deformed, whereby subjecting the control member to the predetermined temperature change axially shortens the structure along said region.

24. The prosthesis of claim 23 wherein:

the temperature change comprises an increase in temperature at least to a threshold level at which at least one control member tends to assume the nominal shape.

25. The prosthesis of claim 22 wherein:

the prosthesis structure is a braided tube comprising at least two sets of oppositely directed helically wound structural strands.

26. The prosthesis of claim 25 further including:

means for selvaging opposite open ends of the braided tube.

27. The prosthesis of claim 22 wherein:

said first and second locations are proximate opposite open ends of the prosthesis structure.

28. A body insertable prosthesis, including:

a body compatible and generally tubular prosthesis structure enlargeable radially in concert with an axial shortening thereof, and alternatively reduceable radially in concert with an axial elongation thereof; and

a plurality of substantially linear, axially extending strands, each strand having a first end fixed to the prosthesis structure at a first coupling location, each strand further coupled to the prosthesis structure at a second coupling location spaced apart axially from the first coupling location in a manner that allows the strand to travel axially relative to the prosthesis structure, whereby an axial spacing between the first and second coupling locations is adjustable toward a selected amount corresponding to a selected radius profile over a region of the prosthesis structure between the coupling locations.

29. The prosthesis of claim 28, wherein:

the first coupling location extends circumferentially about the prosthesis structure, and the associated first ends of the strands are circumferentially spaced apart from one another.

30. The prosthesis of claim 29, wherein:

each of the strands further is slideably coupled to the prosthesis structure at the second coupling location, and the second coupling location extends circumferentially about the structure.

31. The prosthesis of claim 28, wherein:

the prosthesis structure is a braided tube comprising at least two oppositely directed sets of helically wound strands forming multiple intersections of oppositely directed pairs of strands, and the first and second coupling locations are located at respective the first and second ones of said intersections.

32. A body insertable prosthesis, including:

a body compatible and generally tubular prosthesis structure enlargeable radially in concert with an axial shortening thereof, and alternatively reduceable radially in concert with an axial elongation thereof;

at least one elongate control member coupled to the prosthesis structure at a first coupling location in a manner to substantially fix the elongate control member axially relative to the prosthesis structure;

wherein the elongate control member further is coupled to the prosthesis structure at a second coupling location spaced apart axially from the first coupling location, in a manner that allows movement of the control member axially relative to the prosthesis structure to selectively vary an axial spacing between the first and second coupling locations toward a selected spacing amount and thereby selectively vary a radius profile, over a region of the prosthesis structure between the coupling locations toward a selected radius profile; and

wherein the control member and the prosthesis structure further are adapted to allow a fixation of the control member axially relative to the prosthesis structure at the second location after so selectively varying the axial spacing, to set the axial spacing at said selected spacing amount and thereby prevent any substantial radial reduction of the prosthesis structure over said region.

33. The prosthesis of claim 32, further including:

a connector fixed to the prosthesis structure at the second location and adapted to receive the control member for sliding movement therein.

34. The prosthesis of claim 33, wherein:

the connector further is adapted to secure the control member integrally relative to the prosthesis structure.

35. The prosthesis of claim 34, wherein:

the connector further is adapted to secure the control member in a self-locking manner.

36. The prosthesis of claim 32, wherein:

the control member is fixed with respect to the prosthesis structure at the first coupling location.

37. The prosthesis structure of claim 36, wherein:

the prosthesis structure is resilient, and the control member, when so fixed to set the axial spacing at the selected spacing amount, counteracts an elastic restoring force in the prosthesis structure to maintain the selected radius profile.

38. The prosthesis structure of claim 32, wherein:

the prosthesis structure is a braided tube comprising at least two oppositely directed sets of helically wound strands forming multiple intersections of oppositely directed pairs of strands, and the first and second coupling locations are located at respective the first and second ones of said intersections.

39. A body insertable prosthesis, including:

a body compatible and generally tubular prosthesis structure enlargeable radially in concert with an axial shortening thereof, and alternatively reduceable radially in concert with an axial elongation thereof;

at least one elongate control member coupled to the prosthesis structure at a first coupling location in a manner to substantially fix the elongate control member axially relative to the prosthesis structure;

wherein the elongate control member further is coupled to the prosthesis structure at a second coupling location spaced apart axially from the first coupling location, in a manner that allows axial movement of the control member relative to the prosthesis structure, to selectively vary an axial spacing between the first and second coupling locations toward a selected spacing amount, thereby to selectively vary a radius profile of the prosthesis structure, at least over a region thereof between the coupling locations, toward a selected radius profile corresponding to the selected spacing amount.

40. The prosthesis of claim 39, wherein:

said at least one elongate control member extends axially along the prosthesis structure.

41. The prosthesis of claim 39, wherein:

said control member and the prosthesis structure further are adapted to allow a fixation of the control member axially relative to the prosthesis structure at the second location after the axial spacing has been so selectively varied, to set the axial spacing at the selected spacing amount and thereby prevent any substantial radial reduction of the prosthesis structure over said region.

42. The prosthesis of claim 39, wherein:

the prosthesis structure is a braided tube comprising at least two oppositely directed sets of helically wound strands forming multiple intersections of oppositely directed pairs of strands, and the first and second coupling locations are located at respective the first and second ones of said intersections.