Endovascular stent graft

• US 7,686,842 B2
• Filed: 05/04/2001
• Issued: 03/30/2010
• Est. Priority Date: 05/04/2000
• Status: Expired due to Fees

• Current Assignee: Oregon Health & Science University
• Original Assignee: Oregon Health & Science University
• Inventors: Rösch, Josef, Pavcnik, Dusan, Keller, Frederick S.
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US09/849,044
• Publication Number:
  US 20010041928A1
• Time in Patent Office: 3,252 Days
• Field of Search: 623/1.13, 623/1.25, 623/1.36, 623 142- 154, 623/1.11, 623/1.15, 623/1.35, 623/1.23, 606/198, 606/197, 606/195, 606/194
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching

Abstract

A stent graft (10) with a stent frame (12) having a plurality of stents (16) connected together with monofilament line (22). A covering (14) of collagen having an extracellular matrix (ECM), such as small intestine submucosa (SIS), is disposed through the inside and over the outside of the stent frame. The covering (14) is affixed to the stent frame (12) such as by being sutured onto the stent frame at the ends of the stent frame and also at the connections of the stent bodies, such as at eyelets (24).

Claims

1. A stent graft device suitable for placement at a vascular treatment site, the stent graft device comprising:

a proximal, inflow end of the stent graft device as a whole;

a distal, outflow end of the stent graft device as a whole;

a stent frame that includes a plurality of stents connected together with lumens of the respective stents coaligned to form a common continuous lumen extending from a proximal stent frame end to a distal stent frame end, each of said stents having a proximal end and a distal end and including a plurality of struts disposed circumferentially about the stent in a zig-zag pattern, wherein each of the struts in the zig-zag pattern has a proximal end that converges with the proximal end of an adjacent strut at an eyelet occurring at the proximal end of the stent such that the stent provides a circumferential array of proximal eyelets about its proximal end, and wherein each of the struts in the zig-zag pattern further has a distal end that converges with the distal end of an adjacent strut at an eyelet occurring at the distal end of the stent such that the stent provides a circumferential array of distal eyelets about its distal end,

the plurality of stents including a first stent and an adjacent, second stent connected together by a monofilament that extends through the proximal eyelets of the first stent and the distal eyelets of the second stent, with the proximal eyelets of the first stent and the distal eyelets of the second stent being offset from one another along the monofilament; and

a covering of collagen having an isolated extracellular matrix layer that becomes remodeled by host tissue, secured to the plurality of stents and extending therealong between the proximal and distal stent frame ends, wherein the covering is a sleeve that initially has a length about equal to twice the length of the stent frame, a first portion of the sleeve extends along and complements an inside surface of the plurality of stents, and a second portion of the sleeve extends along and complements an outside surface of the plurality of stents, wherein the first portion and the second portion of the sleeve are sutured to the distal stent frame end and the proximal stent frame end of the stent frame, wherein the first portion of the sleeve is secured to the inside surface of the plurality of stents by sutures to struts of the plurality of stents between the distal stent frame end and proximal stent frame end and also by sutures through proximal eyelets and distal eyelets of each of said plurality of stents, wherein the second portion of the sleeve is secured to the outside surface of the plurality of stents by sutures to struts of the plurality of stents between the distal stent frame end and proximal stent frame end and also by sutures through proximal eyelets and distal eyelets of each of said plurality of stents, and the covering extending therealong between the proximal and distal stent frame ends, the stent graft device placeable at the vascular treatment site such that the proximal stent frame end is located upstream of the distal stent frame end, the distal stent frame end providing said distal, outflow end of the stent graft device as a whole through which blood flowing through the stent graft device can exit the stent graft device.

2. The stent graft device of claim 1, wherein the covering is secured to the plurality of stents at locations along the stent frame using a filament of biocompatible material, the locations being adapted to secure the filament in position against movement axially with respect to the stent frame during deployment at a treatment site of a patient.

3. The stent graft device of claim 2, wherein the covering is a sleeve of material.

4. The stent graft device of claim 1, wherein the sleeve is defined by connecting together along a seam, opposite edges of the isolated extracellular matrix layer.

5. A stent graft device comprising:

a stent frame defining only a single lumen extending from a first end of said stent graft device to a second end of said stent graft device;

said stent frame having a proximal stent frame end and a distal stent frame end, said stent frame provided by a plurality of stents connected together with lumens of the respective stents coaligned to form a common continuous lumen, each of said stents having a proximal end and a distal end and including a plurality of struts disposed circumferentially about the stent in a zig-zag pattern, wherein each of the struts in the zig-zag pattern has a proximal end that converges with the proximal end of an adjacent strut at an eyelet occurring at the proximal end of the stent such that the stent provides a circumferential array of proximal eyelets about its proximal end, and wherein each of the struts in the zig-zag pattern further has a distal end that converges with the distal end of an adjacent strut at an eyelet occurring at the distal end of the stent such that the stent provides a circumferential array of distal eyelets about its distal end,

the plurality of stents including a first stent and an adjacent, second stent connected together by a monofilament that extends through the proximal eyelets of the first stent and the distal eyelets of the second stent, with the proximal eyelets of the first stent and the distal eyelets of the second stent being offset from one another along the monofilament;

the proximal stent frame end providing a proximal, inflow end of the stent graft device as a whole;

the distal stent frame end providing a distal, outflow end of the stent graft device as a whole;

a covering of collagen secured to the stent frame, said covering of collagen having an isolated extracellular matrix layer that becomes remodeled by host tissue; and

wherein the covering is a sleeve having a single lumen therethrough, the sleeve has a length about equal to twice the length of the stent frame, a first portion of the sleeve extends along and complements an inside surface of the stent frame, and a second portion of the sleeve extends along and complements an outside surface of the stent frame, wherein the first portion and the second portion of the sleeve are sutured to the distal stent frame end of the stent frame that provides the distal, outflow end of the stent graft device as a whole, wherein the first portion and the second portion of the sleeve are sutured to the proximal stent frame end of the stent frame that provides the proximal, inflow end of the stent graft device as a whole, wherein the first portion of the sleeve is secured to the inside surface of the stent frame by sutures to struts of the stent frame between the distal stent frame end and proximal stent frame end and also by sutures through proximal eyelets and distal eyelets of each of said plurality of stents, and wherein the second portion of the sleeve is secured to the outside surface of the stent frame by sutures to struts of the stent frame between the distal stent frame end and proximal stent frame end and also by sutures through proximal eyelets and distal eyelets of each of said plurality of stents.

6. The stent graft device of claim 5, wherein the stent frame has eyelets at the proximal and distal ends.

7. The stent graft of claim 6, wherein the covering is sutured to the stent frame using a filament of biocompatible material that extends through the eyelets at the proximal and distal ends of the stent frame.

8. The stent graft device of claim 5, wherein the stent graft device incorporates an absorbable suture material.

9. The stent graft device of claim 5, wherein the covering is secured to the stent frame at locations along the stent frame using a filament of bio compatible material, the locations being adapted to secure the filament in position against movement axially with respect to the stent frame during deployment at a treatment site of a patient.

10. The stent graft device of claim 5, wherein the covering is a sleeve of small intestine submucosa material.

11. The stent graft device of claim 10, wherein the sleeve is defined by connecting together along a seam, opposite edges of at least one flat tissue of the small intestine submucosa material.