Stent graft with integrated valve device and method

• US 6,676,699 B2
• Filed: 04/26/2002
• Issued: 01/13/2004
• Est. Priority Date: 04/26/2002
• Status: Active Grant

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Inventors: Shiu, Brian
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): SWEET, THOMAS
• Application Number:
  US10/132,934
• Publication Number:
  US 20030204243A1
• Time in Patent Office: 627 Days
• Field of Search: 623/1.24, 623/1.26, 623/1.35, 623/23.68, 623/1.16
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

A bifurcated endoluminal prosthesis is provided that includes a valve or gate in one of the bifurcated branches. The valve or gate prevents flow of blood through the branch when it is closed and permits the flow of blood when it is open. In one variation, the valve comprises a spring member attached to a graft material substantially impermeable to the flow of blood. The spring member holds the graft material over the opening that forms a lumen in the bifurcated portion. The spring member may be flipped from a closed position in which it is initially deployed, to an open position whereby the graft material forms an opening continuous with lumen in the bifurcated portion permitting the flow of blood therethrough. The invention may be used in bifurcated or branched tubular grafts for endoluminal placement within a body lumen, including blood vessels, and for the treatment of abdominal and other aneurysms.

Claims

1. An endoluminal prosthesis comprising:

a tubular graft configured to sealingly engage an inner wall of a body lumen and comprising;

a proximal portion comprising a trunk portion having a proximal opening, and a distal portion branched into a first branch portion and a second branch portion, each of the first and second branch portions having a distal opening, the trunk portion and the first and second branch portions forming a lumen for the flow of body fluids from the proximal opening through the distal openings of the first and second branch portions; and

a valve located at least in part within the first branch portion, said valve comprising a first support member, a second support member and a section of graft material coupled to the first and second support members,

wherein the first support member is coupled to the first branch portion within the first branch portion so that the first support member provides an opening in the first branch portion through which body fluids from the trunk portion may flow, and

wherein the second support member has a first, closed position and a second, open position wherein in the first closed position a portion of the section of the graft material comprises a cover configured to prevent the flow of body fluids through the opening in the first branch portion, wherein the second support member is configured to hold the portion of the section of graft material in a position in which it is forms the cover, and wherein in the second, open position, the second support member is configured to hold the graft material in a position that permits the flow of body fluids through the opening in the first branch portion.

2. The endoluminal prosthesis of claim 1 wherein the first support member comprises an annular spring.

3. The endoluminal prosthesis of claim 2 wherein the graft material coupled to the annular spring forms a tube around the annular spring.

4. The endoluminal prosthesis of claim 1 wherein the second support member comprises a semicircular spring member.

5. The endoluminal prosthesis of claim 4 wherein the graft material forms a generally semicircular shape where it is coupled to the second support member.

6. The endoluminal prosthesis of claim 1 wherein the second support member comprises a spring member.

7. The endoluminal prosthesis of claim 1 wherein the first branch portion comprises an inner circumferential wall wherein in the closed position the second support member engages the inner circumferential wall.

8. The endoluminal prosthesis of claim 1 wherein the prosthesis is an aneurysm exclusion device.

9. The endoluminal prosthesis of claim 1 wherein the second support member comprises an annular member configured to fold into a semicircular member in the first, closed position and to open to a ring configuration in the second, open position.

10. An endoluminal prosthesis comprising:

a tubular graft, configured to sealingly engage an inner wall of a body lumen and comprising;

a proximal portion comprising a trunk portion having a proximal opening, and a distal portion branched into a first branch portion and a second branch portion, each of the first and second branch portions having a distal opening, the trunk portion and each of the first and second branch portions forming lumens for the flow of body fluids from the proximal opening through the distal openings of the at least two branch portions; and

a valve located at least in part within the first branch portion, said valve comprising a support member comprising a portion of a ring and a section of graft material coupled to the support member, wherein the support member has a first, closed position and a second, open position wherein in the first closed position, the support member holds the graft material in a position that prevents flow of body fluids through the opening in the first branch portion, and wherein in the second, open position, the support member is engaged with the first branch portion so that the support member provides an opening in the first branch portion through which body fluids may flow from the tank portion through the distal opening in the first branch portion.

11. The endoluminal prosthesis of claim 10 wherein the first branch portion comprises an inner wall forming a branch lumen and wherein a portion the graft material of the support member is secured to the inner wall of the first branch portion.

12. The endoluminal prosthesis of claim 11

wherein in the first, closed position, the support member is located within the branch lumen on the inner wall of the first branch portion at an opposite side of the branch lumen from the portion of the graft material secured to the inner wall of the first branch portion, and

wherein in the second, open position, the support member is located adjacent the portion of the graft material secured to the inner wall of the first branch portion.

13. An endoluminal prosthesis comprising:

a tubular graft configured to sealingly engage an inner wall of a body lumen and comprising;

a proximal portion comprising a trunk portion having a proximal opening, and a distal portion branched into a first branch portion and a second branch portion, each of the first and second branch portions having a distal opening, the trunk portion and the first and second branch portions forming a lumen for the flow of body fluids from the proximal opening through the distal openings of the first and second branch portions; and

a valve located at least in part within the first branch portion, said valve comprising;

a section of graft material in the shape of a partial cylinder;

a first support member comprising an annular member coupled to the section of graft material to form a lumen through the first support member and the section of graft material; and

a second support member comprising a portion of an annular spring and coupled to the section of graft material,

wherein the first support member is coupled to the first branch portion within the first branch portion so that the first support member provides said lumen through which body fluids from the trunk portion may flow, and

wherein the second support member has a first, closed position within the tubular graft and a second, open position within the tubular graft wherein in the first, closed position a portion of the section of the graft material comprises a cover configured to prevent the flow of body fluids through the opening in the first branch portion, wherein the second support member is configured in a semi circular shape adjacent a first portion of the inner circumference of the tubular graft to hold the portion of the section of graft material in a position in which it is forms the cover, and wherein in the second, open position, the second support member is adjacent a second portion of the inner circumference of the tubular graft and is configured to hold the graft material in a position against the second portion of the inner circumference of the tubular graft to permit the flow of body fluids through the lumen.

14. An endoluminal prosthesis comprising:

a tubular graft means for sealingly engaging the inner wall of a body lumen and for excluding a portion of a body vessel, the tubular graft means including;

a proximal portion comprising a trunk portion having a proximal opening, and a distal portion branched into at least two branch portions, each of the at least two branch portions having a distal opening, the trunk portion and the branch portions forming a lumen means for the flow of body fluids from the proximal opening through the distal openings of the at least two branch portions; and

a valve means located at least in part within a first of the branch portions having a branch lumen means therethrough, said valve means comprising a graft means for providing a barrier to the flow of blood; and

a first support means for opening and closing the valve means by covering or uncovering the branch lumen means to prevent or permit the flow of blood respectively from the trunk portion through the first of the branch portions.

15. The endoluminal prosthesis of claim 14 further comprising a second support means for providing an opening through the graft means in the first of the branch portions through which body fluids from the trunk portion may flow, wherein the first support means comprises means for opening and closing the opening provided by the second support means.

16. A method of deploying an endoluminal prosthesis comprising the steps of:

providing an endoluminal prosthesis comprising;

a tubular graft configured to sealingly engage an inner wall of a body lumen and comprising;

a proximal portion comprising a trunk portion having a proximal opening, and a distal portion branched into a first branch portion and a second branch portion, each of the first and second branch portions having a distal opening, the trunk portion and the first and second branch portions forming a lumen for the flow of body fluids from the proximal opening through the distal openings of the first and second branch portions; and

a valve located at least in part within the first branch portion, said valve a comprising a first support member, a second support member and a graft material coupled to the first and second support members,

wherein the first support member is engaged with the first branch portion within the first branch portion so that the first support member provides an opening in the first branch portion through which body fluids from the trunk portion may flow, and

wherein the second support member has a first, closed position and a second, open position wherein in the first closed position, the second support member holds the graft material in a position that prevents flow of body fluids through the opening in the first branch portion, and wherein in the second, open position, the second support member holds the graft material in a position that permits the flow of body fluids through the opening in the first branch portion;

locating a delivery catheter containing the endoluminal prosthesis at a site for deployment;

deploying the prosthesis at the site so that the prosthesis engages the inner wall of the body lumen wherein the valve is in a first closed position; and

opening the valve.

17. The method of claim 16 wherein the step of opening the valve comprises:

providing an extension prosthesis loaded in a catheter;

locating the catheter in the first branch portion by positioning the distal end of the catheter through the valve to open the valve; and

releasing the extension member so that a proximal portion of the extension member is located within the first branch portion and the distal end of the extension member is located within a branch artery.

18. The method of claim 17

wherein the first branch portion comprises an inner circumferential wall wherein in the closed position the second support member engages a first portion of the inner circumferential wall;

and

wherein the step of positioning the distal end of the catheter through the valve to open the valve comprises positioning the distal end of the catheter between the second support member and the first portion of the inner circumferential wall and moving the second support member away from its position against the first portion of the inner circumferential wall to a position against a second portion of the inner circumferential wall.

19. A method of deploying an endoluminal prosthesis comprising the steps of:

providing an endoluminal prosthesis comprising;

a tubular graft, configured to sealingly engage an inner wall of a body lumen and comprising a proximal portion comprising a trunk portion having a proximal opening, and a distal portion branched into a first branch portion and a second branch portion, each of the first and second branch portions having a distal opening, the trunk portion and each of the first and second branch portions forming lumens for the flow of body fluids from the proximal opening through the distal openings of the at least two branch portions; and

a valve located at least in part within the first branch portion, said valve comprising a support member comprising a portion of a ring and a graft material coupled to the support member, wherein the support member has a first, closed position and a second, open position wherein in the first closed position, the support member holds the graft material in a position that prevents flow of body fluids through the opening in the first branch portion, and wherein in the second, open position, the support member is engaged with the first branch portion so that the support member provides an opening in the first branch portion through which body fluids may flow from the trunk portion through the distal opening in the first branch portion;

locating a delivery catheter containing the endoluminal prosthesis at a site for deployment;

deploying the prosthesis at the site so that the prosthesis engages the inner wall of the body lumen wherein the valve is in a first closed position; and

opening the valve.

20. The method of claim 19 wherein the step of opening the valve comprises:

providing an extension prosthesis loaded in a catheter;

locating the catheter in the first branch portion by positioning the distal end of the catheter through the valve to open the valve; and

releasing the extension member so that a proximal portion of the extension member is located within the first branch portion and the distal end of the extension member is located within a branch artery.

21. The method of claim 20

wherein the first branch portion comprises an inner circumferential wall wherein in the closed position the support member engages a first portion of the inner circumferential wall;

and

wherein the step of positioning the distal end of the catheter through the valve to open the valve comprises positioning the distal end of the catheter between the support member and the first portion of the inner circumferential wall and moving the support member away from its position against the first portion of the inner circumferential wall to a position against a second portion of the inner circumferential wall.