Modular vascular prosthesis having axially variable properties and improved flexibility and methods of use

• US 8,002,818 B2
• Filed: 02/25/2005
• Issued: 08/23/2011
• Est. Priority Date: 02/25/2005
• Status: Active Grant

• Current Assignee: Abbott Laboratories Limited (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Laboratories Limited (Abbott Laboratories Incorporated)
• Inventors: Bregulla, Rainer
• Primary Examiner(s): Severson; Ryan J
• Application Number:
  US11/067,090
• Publication Number:
  US 20060195175A1
• Time in Patent Office: 2,370 Days
• Field of Search: 623/1.15, 623/1.16, 623/1.42, 623/1.13
• US Class Current: 623/1.16
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/30019 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2002/30428 made by inserting a protrusion into a slot
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

The present invention provides a vascular prosthesis featuring a plurality of modular segments interengaged by flexible, and preferably lockable, inter-engageable elements forming joints. The segments may have a number of different mechanical properties and may be assembled by the clinician to customize the prosthesis for a specific patient or application.

Claims

1. A modular vascular prosthesis having a delivery configuration and a deployed configuration, the vascular prosthesis comprising:

a radially expandable first segment having proximal and distal ends, the radially expandable first segment comprising a plurality of first struts coupled by a plurality of first bends, the plurality of first struts and the plurality of first bends having a first thickness;

a radially expandable second segment having proximal and distal ends, the radially expandable second segment comprising a plurality of second struts coupled by a plurality of second bends, the plurality of second struts and the plurality of second bends having a second thickness;

a plurality of first inter-engageable elements extending from the distal end of the first segment, the first inter-engageable elements comprising disk shaped portions having a distally extending circumferentially projecting peripheral flange extending from one first strut of the plurality of first struts about a periphery of the disk shaped portion to a second strut of the plurality of first struts, the disk shaped portions having a thickness approximately equal to the first thickness and the circumferentially projecting flange having a thickness that is less than the first thickness; and

a plurality of second inter-engageable elements extending from the proximal end of the second segment, each of the second inter-engageable elements comprising a socket element directly coupled to a pair of second struts of the plurality of second struts and configured to accept the disk shaped portions and overlie the flange of the first inter-engageable element, the socket element having a thickness that is less than the second thickness,

wherein the plurality of first inter-engageable elements are engaged in the plurality of second inter-engageable elements to permit articulation of the first segment relative to the second segment in the delivery configuration.

2. The modular vascular prosthesis of claim 1 wherein the pluralities of first and second inter-engageable elements fixedly engage each other in the deployed configuration while forming a substantially uniform transition between said radially expandable first segment and said radially expandable second segment.

3. The modular vascular prosthesis of claim 1, wherein the first and second segments comprise hoops having a generally zig-zag configuration.

4. The modular vascular prosthesis of claim 3 wherein at least one of the first and second segments comprises first and second hoops having a generally zig-zag configuration.

5. The modular vascular prosthesis of claim 4 wherein the first and second hoops are coupled by flexible spiral joints.

6. The modular vascular prosthesis of claim 1, wherein first segment has a first length and the second segment has a second length, and the first and second lengths are different.

7. The modular vascular prosthesis of claim 1, wherein first segment comprises a first material and the second segment comprises a second material, and the first material is different than the second material.

8. The modular vascular prosthesis of claim 7, wherein the first material comprises a metal alloy and the second material comprises a polymer.

9. The modular vascular prosthesis of claim 1, wherein first segment possesses a first set of mechanical properties and the second segment possesses a second set of mechanical properties, and the first set of mechanical properties is different than the second set of mechanical properties.

10. The modular prosthesis of claim 9 wherein the first segment is balloon expandable and the second segment is self-expanding.

11. The modular vascular prosthesis of claim 1, wherein first segment has a first strut configuration and the second segment has a second strut configuration, and the first strut configuration is different than the second strut configuration.

12. The modular vascular prosthesis of claim 1, wherein at least one of the first and second segments comprises a drug-eluting polymeric material.

13. The modular vascular prosthesis of claim 1, wherein at least one of the first and second segments includes a side-branch aperture.

14. The modular vascular prosthesis of claim 1, wherein at least one of the first and second segments includes a cover comprising a biocompatible graft material.

15. The modular vascular prosthesis of claim 1, further comprising:

a plurality of second inter-engageable elements extending from the distal end of the second segment.

16. The modular vascular prosthesis of claim 1, further comprising:

a plurality of first inter-engageable elements extending from the proximal end of the first segment; and

a plurality of second inter-engageable elements extending from the distal end of the second segment.

17. The modular vascular prosthesis of claim 1, further comprising:

a plurality of second inter-engageable elements extending from the distal end of the first segment, individual ones of the plurality of second inter-engageable elements interleaved with individual ones of the first inter-engageable elements extending from the distal end of the first segment; and

a plurality of first inter-engageable elements extending from the proximal end of the second segment, individual ones of the plurality of first inter-engageable elements interleaved with individual ones of the second inter-engageable elements extending from the proximal end of the second segment.

18. A modular vascular prosthesis having a delivery configuration and a deployed configuration, the modular vascular prosthesis having a longitudinal axis, the vascular prosthesis comprising:

a radially expandable first segment having proximal and distal ends;

a radially expandable second segment having proximal and distal ends;

a plurality of first inter-engageable elements extending from the distal end of the first segment; and

a plurality of second inter-engageable elements extending from the proximal end of the second segment,

wherein the plurality of first inter-engageable elements are engaged in the plurality of second inter-engageable elements to permit articulation of the first segment relative to the second segment in the delivery configuration, and

wherein each of the pluralities of first and second inter-engageable elements comprise spiral elements forming independent, distinct structures configured to selectively intertwine with one another in an arrangement of complementary intertwining spirals while in both the delivery configuration and the deployed configuration to form a substantially uniform transition between said radially expandable first segment and said radially expandable second segment and a substantially smooth exterior surface to the modular vascular prosthesis, and to selectively couple the first segment and the second segment.

19. A modular vascular prosthesis having a delivery configuration and a deployed configuration, the vascular prosthesis comprising:

a plurality of radially expandable first segments having proximal and distal ends, the plurality of radially expandable first segments having a first thickness;

a plurality of radially expandable second segments having proximal and distal ends, the plurality of radially expandable second segments having a second thickness;

a plurality of first inter-engageable elements extending from the distal ends of the first segments, the first inter-engageable elements comprising disk-shaped portions having a circumferentially projecting peripheral flange extending from a first strut of a pair of struts about a periphery of the disk shaped portion to a second strut of the pair of struts, the disk-shaped portions having a thickness approximately equal to the first thickness and the circumferentially projecting flange having a thickness that is less than the first thickness; and

a plurality of second inter-engageable elements extending from the proximal ends of the second segments, the plurality of second inter-engageable elements engaged with the plurality of first inter-engageable elements, each of the second inter-engageable elements being connected to two struts of the second plurality of struts and comprising a socket configured to accept the disk-shaped portion and overlie the flange, the socket having a thickness that is less than the second thickness,

wherein the first segments possess a first set of mechanical properties and the second segments possess a second set of mechanical properties, and the first set of mechanical properties is different than the second set of mechanical properties, and

wherein the plurality of first inter-engageable elements and the plurality of second inter-engageable elements engage to form a plurality of connections that have a thickness that is substantially equal to the first and second thicknesses while forming a substantially uniform transition between said radially expandable first segment and said radially expandable second segment.

20. The modular vascular prosthesis of claim 19 wherein the pluralities of first and second inter-engageable elements fixedly engage each other in the deployed configuration.

21. The modular vascular prosthesis of claim 19, wherein first segments comprise a first material and the second segments comprise a second material, and the first material is different than the second material.

22. The modular vascular prosthesis of claim 21, wherein the first material comprises a metal alloy and the second material comprises a polymer.

23. The modular vascular prosthesis of claim 19, wherein first segments have a first strut configuration and the second segments have a second strut configuration, and the first strut configuration is different than the second strut configuration.

24. The modular vascular prosthesis of claim 19, wherein the first segments have a first length and the second segments have a second length, and the first and second lengths are different.

25. The modular vascular prosthesis of claim 19, wherein at least a subset of plurality of first segments comprises a drug-eluting polymeric material.

26. The modular vascular prosthesis of claim 19, wherein at least one of the plurality of first segments includes a side-branch aperture.

27. The modular vascular prosthesis of claim 19, wherein at least one of the plurality of first segments includes a cover comprising a biocompatible graft material.

28. The modular vascular prosthesis of claim 19, further comprising:

a plurality of second inter-engageable elements extending from the proximal ends of the first segments; and

a plurality of first inter-engageable elements extending from the distal ends of the second segments.

29. The modular vascular prosthesis of claim 19, further comprising:

a plurality of first inter-engageable elements extending from the proximal ends of the first segments; and

a plurality of second inter-engageable elements extending from the distal ends of the second segments.

30. A modular vascular prosthesis having a delivery configuration and a deployed configuration, the vascular prosthesis comprising:

a plurality of radially expandable first segments having proximal and distal ends;

a plurality of radially expandable second segments having proximal and distal ends;

a plurality of first inter-engageable elements extending from the distal ends of the first segments; and

a plurality of second inter-engageable elements extending from the proximal ends of the second segments, the plurality of second inter-engageable elements engaged with the plurality of first inter-engageable elements,

and

wherein each of the pluralities of first and second inter-engageable elements comprise spiral elements forming independent, distinct structures configured to selectively intertwine with one another in an arrangement of complementary intertwining spirals while in both the delivery configuration and the deployed configuration to form a substantially uniform transition between said radially expandable first segment and said radially expandable second segment, a substantially smooth exterior surface to the modular vascular prosthesis, and to selectively couple the first segment and the second segment.