Support for treating vascular bifurcations

• US 10,500,077 B2
• Filed: 03/11/2013
• Issued: 12/10/2019
• Est. Priority Date: 04/26/2012
• Status: Active Grant

• Current Assignee: Poseidon Medical Inc.
• Original Assignee: Poseidon Medical Inc.
• Inventors: Davis, H. Richard, Kaplan, Aaron
• Primary Examiner(s): Woznicki, Jacqueline
• Application Number:
  US14/396,688
• Publication Number:
  US 20150119972A1
• Time in Patent Office: 2,465 Days
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude 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 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2250/003 differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0035 differing in release or diffusion time
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

A prosthesis is disclosed for placement across an ostium opening from a main body lumen to a branch body lumen. The prosthesis has a radially expansible support and a bifurcation traversing portion. The radially expansible support is configured to be deployed in at least a portion of the branch body lumen. The bifurcation traversing portion has a biostable portion having a first end and a second end. The first end is located adjacent to the radially expansible support. The bifurcation traversing portion also has a biodegradable portion having a first end coupled with the second end of the biostable portion. The biodegradable portion has a second end disposed at an end of the prosthesis opposite the radially expansible support. When deployed, the bifurcation traversing portion extends from the radially expansible support across a bifurcation and into a main body lumen such that the carina is supported thereby.

Claims

1. A prosthesis for placement at an ostium opening from a main body lumen to a branch body lumen, the prosthesis comprising:

a radially expansible support configured to be deployed in at least a portion of the branch body lumen; and

a bifurcation traversing portion having a biostable portion having a first end and a second end, the first end being located adjacent to the radially expansible support and a biodegradable portion having a first end coupled with the second end of the biostable portion and a second end disposed at an end of the prosthesis opposite the radially expansible support, the bifurcation traversing portion comprising an interlock device configured to mechanically couple the biodegradable and biostable portions, the interlock device comprising a biodegradable section adjacent the biodegradable portion and a biostable section adjacent the biostable portion, the interlock device having a protrusion and a jaw member, the jaw member comprising first and second spaced apart portions configured to be moved toward each other to engage with the protrusion at least in the unexpanded state;

wherein when deployed, the bifurcation traversing portion extends from the radially expansible support across a bifurcation and into a main body lumen such that the ostium opening is supported thereby.

2. The prosthesis of claim 1, wherein the jaw member is mechanically coupled with the protrusion.

3. The prosthesis of claim 1, wherein the bifurcation traversing portion comprises a plurality of longitudinal members, each longitudinal member comprising an axially extending part of the biostable portion, an axially extending part of the biodegradable portion, the jaw member disposed on the axially extending part of the biostable portion and the protrusion disposed on the axially extending part of the biodegradable portion, the jaw member and protrusion being configured to mechanically couple the axially extending parts of the biostable and biodegradable portions.

4. The prosthesis of claim 1, wherein the biostable portion comprises a transition zone disposed adjacent to the support and being adapted to expand to cover the ostium and wherein the bifurcation traversing portion comprises a plurality of longitudinal members extending from the second end of the biodegradable portion toward the first end of the biostable portion.

5. The prosthesis of claim 4, further comprising a circumferential member extending between at least two of the longitudinal members to stabilize or position the longitudinal members within the main body lumen during a deployment procedure.

6. The prosthesis of claim 5, wherein at least one of the longitudinal members comprises a frond.

7. The prosthesis of claim 6 wherein the frond comprises a transition portion having a first end coupled with the support and a plurality of second ends spaced apart from each other and from the support.

8. The prosthesis of claim 1, wherein a portion of the bifurcation traversing portion comprises an axially oriented pattern of undulating filaments and wherein the first and second spaced apart portions of the jaw member of the interlock device comprise two filaments at a junction of the biostable and biodegradable portions.

9. The prosthesis of claim 1, wherein the support has a first wall comprising a first wall pattern, and the bifurcation traversing portion has a second wall comprising a second wall pattern different from the first wall pattern.

10. The prosthesis of claim 9, wherein the second wall has a circumferential surface area that is lower toward a proximal end thereof than adjacent to the radially expansible support.

11. The prosthesis of claim 1, wherein at least one of the biostable and the biodegradable portions comprises a serpentine or sinusoidal member.

12. The prosthesis of claim 11, wherein the biodegradable portion comprises a dual serpentine member.

13. The prosthesis of claim 1, wherein the first and second spaced apart portions include a narrow opening and a wider zone, and wherein the protrusion comprises a narrow neck and wider head such that the protrusion is configured to be inserted into the jaw member.

14. The prosthesis of claim 1, wherein the bifurcation traversing portion comprises a plurality of elongate members each comprising a first zone having two side-by-side filaments and a second zone comprising a single filament, and wherein a junction of the biostable and biodegradable portions is disposed in the first zone.

15. The prosthesis of claim 1, wherein the bifurcation traversing portion comprises a plurality of longitudinal members, each longitudinal member comprising an axially extending part of the biostable portion, an axially extending part of the biodegradable portion, the interlock device configured to mechanically couple the axially extending parts of the biostable and biodegradable portions.

16. The prosthesis of claim 15, wherein the axially extending parts of the biostable and biodegradable portions each comprises one or more undulating filaments.

17. The prosthesis of claim 16, wherein the one or more undulating filaments comprise two parallel undulating filaments.

18. The prosthesis of claim 1, wherein the biodegradable portion comprises a plurality of longitudinal members each comprising a first zone having two side-by-side axially oriented undulating filaments and a second zone comprising a single axially oriented undulating filament, and wherein the biodegradable portion further comprises a circumferential member.

19. A prosthesis for placement at an ostium opening from a main body lumen to a branch body lumen, the prosthesis comprising:

a radially expansible support configured to be deployed in at least a portion of the branch body lumen; and

a bifurcation traversing portion having a biostable portion having a first end and a second end, the first end being located adjacent to the radially expansible support and a biodegradable portion having a first end coupled with the second end of the biostable portion and a second end disposed at an end of the prosthesis opposite the radially expansible support, the bifurcation traversing portion comprising an interlock device located between the biodegradable and biostable portions configured to mechanically couple the biodegradable and biostable portions, the interlock device having a protrusion and a jaw member, the jaw member comprising first and second spaced apart portions configured to be moved toward each other to engage with the protrusion at least in the unexpanded state;

wherein when deployed, the bifurcation traversing portion extends from the radially expansible support across a bifurcation and into a main body lumen such that the ostium opening is supported thereby.

20. The prosthesis of claim 19, wherein the interlock device is located only between the biodegradable and biostable portions.

21. The prosthesis of claim 19, wherein the bifurcation traversing portion comprises a plurality of longitudinal members, each longitudinal member comprising an axially extending part of the biostable portion, an axially extending part of the biodegradable portion, the interlock device configured to mechanically couple the axially extending parts of the biostable and biodegradable portions.

22. The prosthesis of claim 19, wherein the biostable portion comprises a transition zone disposed adjacent to the support and being adapted to expand to cover the ostium and wherein the bifurcation traversing portion comprises a plurality of longitudinal members extending from the second end of the biodegradable portion toward the first end of the biostable portion.

23. The prosthesis of claim 22, further comprising a circumferential member extending between at least two of the longitudinal members to stabilize or position the longitudinal members within the main body lumen during a deployment procedure.

24. The prosthesis of claim 23, wherein at least one of the longitudinal members comprises a frond.

25. The prosthesis of claim 19, wherein the first and second spaced apart portions include a narrow opening and a wider zone, and wherein the protrusion comprises a narrow neck and wider head such that the protrusion is configured to be inserted into the jaw member.

26. A prosthesis for placement at an ostium opening from a main body lumen to a branch body lumen, the prosthesis comprising:

a radially expansible support configured to be deployed in at least a portion of the branch body lumen, the support comprising a first plurality of connectors of a first configuration; and

a bifurcation traversing portion having a biostable portion having a first end and a second end, the first end being located adjacent to the radially expansible support and a biodegradable portion having a first end coupled with the second end of the biostable portion and a second end disposed at an end of the prosthesis opposite the radially expansible support, the bifurcation traversing portion comprising a second plurality of connectors of a second configuration different from the first configuration, the second plurality of connectors comprising an interlock device located between the biodegradable and biostable portions, the interlock device having a protrusion and a jaw member, the jaw member comprising first and second spaced apart portions configured to be moved toward each other to engage with the protrusion at least in the unexpanded state;

wherein when deployed, the bifurcation traversing portion extends from the radially expansible support across a bifurcation and into a main body lumen such that the ostium opening is supported thereby.

27. The prosthesis of claim 26, wherein the interlock device is located only between the biodegradable and biostable portions.

28. The prosthesis of claim 26, wherein the first plurality of connectors are disposed at a plurality of locations within the support and configured to couple adjacent rings of the support.

29. The prosthesis of claim 26, wherein the first plurality of connectors are disposed at one or more apexes.

30. The prosthesis of claim 26, wherein the first plurality of connectors comprise axially extending struts.

31. The prosthesis of claim 26, wherein the bifurcation traversing portion comprises a plurality of longitudinal members, each longitudinal member comprising an axially extending part of the biostable portion, an axially extending part of the biodegradable portion, the interlock device configured to mechanically couple the axially extending parts of the biostable and biodegradable portions.

32. The prosthesis of claim 26, wherein the biostable portion comprises a transition zone disposed adjacent to the support and being adapted to expand to cover the ostium and wherein the bifurcation traversing portion comprises a plurality of longitudinal members extending from the second end of the biodegradable portion toward the first end of the biostable portion.

33. The prosthesis of claim 32, further comprising a circumferential member extending between at least two of the longitudinal members to stabilize or position the longitudinal members within the main body lumen during a deployment procedure.

34. The prosthesis of claim 33, wherein at least one of the longitudinal members comprises a frond.

35. The prosthesis of claim 26, wherein the first and second spaced apart portions include a narrow opening and a wider zone, and wherein the protrusion comprises a narrow neck and wider head such that the protrusion is configured to be inserted into the jaw member.

36. A prosthesis for placement at an ostium opening from a main body lumen to a branch body lumen, the prosthesis comprising:

a radially expansible support configured to be deployed in at least a portion of the branch body lumen; and

a bifurcation traversing portion having a biostable portion having a first end and a second end, the first end being located adjacent to the radially expansible support and a biodegradable portion having a first end coupled with the second end of the biostable portion and a second end disposed at an end of the prosthesis opposite the radially expansible support, the bifurcation traversing portion comprising an interlock device having a protrusion and a jaw member, the jaw member comprising first and second spaced apart portions configured to be moved toward each other to engage with the protrusion at least in the unexpanded state;

wherein when deployed, the bifurcation traversing portion extends from the radially expansible support across a bifurcation and into a main body lumen such that the ostium opening is supported thereby,

wherein the biodegradable portion comprises a plurality of longitudinal members each comprising a first zone having two side-by-side axially oriented undulating filaments and a second zone comprising a single axially oriented undulating filament such that the filaments reduce in number from the first zone to the second zone,

wherein the biodegradable portion further comprises a circumferential member, and

wherein the biostable portion comprises a plurality of longitudinal members, each longitudinal member of the biostable and biodegradable portions comprising an axially extending part, the interlock device configured to mechanically couple the axially extending parts of the biostable and biodegradable portions.

37. The prosthesis of claim 36, wherein the biostable portion comprises a transition zone disposed adjacent to the support and being adapted to expand to cover the ostium.

38. The prosthesis of claim 37, further comprising a circumferential member extending between at least two of the longitudinal members of the biodegradable portion to stabilize or position the longitudinal members within the main body lumen during a deployment procedure.

39. The prosthesis of claim 38, wherein at least one of the longitudinal members comprises a frond.

40. The prosthesis of claim 36, wherein the first and second spaced apart portions include a narrow opening and a wider zone, and wherein the protrusion comprises a narrow neck and wider head such that the protrusion is configured to be inserted into the jaw member.