Implantable medical device

• US 10,195,015 B2
• Filed: 05/10/2016
• Issued: 02/05/2019
• Est. Priority Date: 08/11/2009
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Rasmussen, Erik, Oehlenschlaeger, Bent, Jensen, Kim Moegelvang, Petersen, Jesper Schade
• Primary Examiner(s): Pellegrino, Brian
• Application Number:
  US15/150,987
• Publication Number:
  US 20160256257A1
• Time in Patent Office: 1,001 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• 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 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

A stent graft includes a tubular graft element to which there are attached a plurality of stent rings. The stent rings are formed of a plurality of stent struts arranged in a zig-zag arrangement with alternating peaks and valleys. The end-most stent is located at the proximal end of the graft tube. Between adjacent peaks of the end most stent, there is provided a series of bridging elements. These are preferably formed of Nitinol wire and to be substantially more flexible than the stent struts. The bridging elements extend in the region of graft material between adjacent stent peaks and are attached to the graft material, for example by suturing. The bridging elements are substantially more flexible than the stent ring and therefore impart little opening force on the graft material in comparison to the force produced by the stent ring. However, the bridging elements impart enough force on the flaps of graft material between the peaks of the stent ring keep these flaps open, that is against the vessel wall. The bridging elements can provide integral barbs.

Claims

1. A stent graft comprising:

a tubular graft having a first end opening, a second end opening, a first end opening edge, a lumen between the first end opening and the second end opening, and an intermediate region between the first end opening and the second end opening;

an end-most zig zag stent disposed on tubular graft adjacent the first end opening, the zig zag stent comprising;

a plurality of first apices extending circumferentially about the tubular graft and abutting the first end opening edge and defining a region of graft material between adjacent first apices that is unsupported by the end most zig zag stent,

a plurality of second apices extending circumferentially about the tubular graft and extending away from the first apices toward the intermediate region of the tubular graft,

a plurality of struts, with each strut extending between one of the first apices and one of the second apices;

and

a plurality of discrete wire-like bridges, each of the plurality of wire-like bridges having;

a first end engaging a first strut of the plurality of struts,

a second end engaging a second strut of the plurality of struts directly circumferentially adjacent the first strut, and

an intermediate section between the first and second ends,

wherein the intermediate section comprises a curve extending proximally between directly adjacent first apices to span the unsupported region of graft material of the tubular graft between the directly adjacent first apices,

wherein the proximally extending curve of each of the plurality of wire-like bridges aligns with and abuts the first end opening edge of the tubular graft between the directly adjacent first apices to support the unsupported region of graft material between directly adjacent apices at the first end opening edge,

wherein none of the wire-like bridges is directly connected to another of the wire-like bridges, and

wherein each of the wire-like bridges is more flexible than the zig-zag stent wire-like bridges are located entirely between the first end opening and the second end opening of the tubular graft, such that the wire-like bridges do not extend beyond the first end opening edge of the tubular graft and has less of an expansion force than the zig-zag stent.

2. The stent graft of claim 1, wherein the expansion force produced by the wire-like bridges is between 10% to 75% of the expansion force produced by the end-most zig zag stent.

3. The stent graft of to claim 1, wherein the expansion force produced by the wire-like bridges is in the region of 50% of the expansion force of the end-most zig-zag stent.

4. The stent graft of claim 1, wherein the wire-like bridges have a transverse cross-sectional area of 10% to 75% of a cross-sectional area of the struts of the end-most zig-zag stent.

5. The stent graft of claim 1, wherein the wire-like bridges have a transverse cross-sectional area of around 10%-75% of a thickness of the struts of the end-most zig-zag stent.

6. The stent graft of claim 1, wherein the wire-like bridges is a length of metal wire.

7. The stent graft of claim 1, wherein the first and second ends of each of the wire-like bridges is a free end and wherein the free ends are coils disposed around the stent struts.

8. The stent graft of claim 1, wherein the wire-like bridges are provided with at least one barb element.

9. The stent graft of claim 8, where each wire-like bridge includes two barb structures.

10. The stent graft of claim 1, wherein the wire-like bridges are disposed entirely inside the lumen of the tubular graft.

11. The stent graft of claim 1, wherein no portion of the wire-like bridges extends beyond the first end opening edge of the tubular graft.

12. A stent graft comprising:

a tubular graft having a first end opening, a second end opening, a first end opening edge, a lumen between the first end opening and the second end opening, and an intermediate region between the first end opening and the second end opening;

an end-most zig zag stent disposed on tubular graft adjacent the first end opening and configured to lie upstream in a patient'"'"'s vessel, the end-most zig zag stent comprising;

a plurality of first apices extending circumferentially about the tubular graft and abutting the first end opening edge and defining an unsupported region of graft material between adjacent first apices,

a plurality of second apices extending circumferentially about the tubular graft and extending away from the first apices toward the intermediate region of the tubular graft,

a plurality of struts, with each strut extending between one of the first apices and one of the second apices;

and

a plurality of discrete wire-like bridges, each of the plurality of wire-like bridges having;

a first end engaging a first strut,

a second end engaging a second strut directly circumferentially adjacent the first strut, and

an intermediate section between the first and second ends,

wherein the intermediate section comprises a curve extending proximally between directly adjacent first apices to span the unsupported region of graft material of the tubular graft between the directly adjacent first apices,

wherein the proximally extending curve of each of the plurality of wire bridges aligns with and abuts the first end opening edge of the tubular graft between the directly adjacent first apices to support the unsupported region of graft material between directly adjacent apices at the first end opening edge,

wherein no portion of the wire bridges extends beyond the first end opening edge of the tubular graft,

wherein none of the wire-like bridges is directly connected to another of the wire-like bridges,

and

wherein each of the wire bridges is more flexible than the end-most zig-zag stent and has less of an expansion force than the end-most zig-zag stent.