MULTI-LEAFLET COUPLING FOR BRANCH VESSEL CONNECTION

• US 20130282102A1
• Filed: 04/18/2012
• Published: 10/24/2013
• Est. Priority Date: 04/18/2012
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: PETERSON, ASHLEY
• Granted Patent: US 9,095,421 B2
• Time in Patent Office: Days
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching

Abstract

A prosthesis includes a tubular body of a graft material, a plurality of stents coupled to the tubular body, and a coupling. The coupling has a plurality of overlapping leaflets successively coupled to the tubular body around an opening formed in the graft material. The leaflets in a non-deployed configuration lay flush with the graft material of the tubular body and partially cover the opening, and the leaflets in a deployed configuration extend radially outward from the graft material of the tubular body. Delivery and deployment of a branch vessel prosthesis through the opening causes the leaflets to transform from the non-deployed configuration to the deployed configuration, and causes a diameter or width of a passageway defined by the leaflets to increase. Leaflet material properties, as well as size, shape, and sewing patterns on adjacent leaflets may be varied in order to vary the flexibility and/or orientation of the coupling.

Claims

1. An endovascular prosthesis comprising:

a tubular body of a graft material, the tubular body defining a lumen and having an opening formed therein;

a plurality of stents coupled to the tubular body; and

a multi-leaflet coupling having a plurality of overlapping leaflets successively coupled to the tubular body around the opening, the leaflets defining a passageway that is in fluid communication with the lumen of the tubular body, wherein the leaflets in a non-deployed configuration lay flush with the graft material of the tubular body and partially cover the opening of the tubular body and wherein the leaflets in a deployed configuration extend radially outward from the graft material of the tubular body, and wherein a diameter of the passageway defined by the leaflets increases when the leaflets transform from the non-deployed configuration to the deployed configuration.

2. The endovascular prosthesis of claim 1, wherein the amount of overlap between adjacent leaflets decreases when the leaflets transform from the non-deployed configuration to the deployed configuration.

3. The endovascular prosthesis of claim 1, wherein each leaflet is a flap of material having a first edge that is coupled to the tubular graft and a second edge that is not coupled to the tubular graft, the second edge having a generally U-shaped profile with two generally straight side segments and a curved segment extending there between.

4. The endovascular prosthesis of claim 1, wherein at least two leaflets of the plurality of leaflets differ in size or shape.

5. The endovascular prosthesis of claim 1, wherein each leaflet is angled such that a longitudinal axis of the coupling in the deployed configuration is non-perpendicular with respect to an outer surface of the graft material.

6. The endovascular prosthesis of claim 1, wherein at least a portion of at least one leaflet of the plurality of leaflets is reinforced with stitches.

7. The endovascular prosthesis of claim 1, wherein the leaflets are formed from a fabric.

8. The endovascular prosthesis of claim 7, wherein at least a portion of at least one leaflet of the plurality of leaflets is coated with a polymer.

9. The endovascular prosthesis of claim 1, wherein the leaflets are formed from an elastomer.

10. The endovascular prosthesis of claim 1, wherein each leaflet is a flap of material having a first edge that is coupled to the tubular graft and a second edge that is not coupled to the tubular graft, and a ring is disposed around the second edges of the leaflets.

11. A main prosthesis and a branch vessel prosthesis assembly comprising:

a main prosthesis configured for placement in a main vessel, the main prosthesis including a tubular body of graft material, a plurality of stents coupled to the tubular body, and a multi-leaflet coupling having a plurality of overlapping leaflets successively coupled to the tubular body around an opening formed in the tubular body, wherein the leaflets lay flush with the graft material of the tubular body and partially cover the opening of the tubular body in a non-deployed configuration; and

a branch vessel prosthesis configured for placement through the opening formed in the tubular body of the main prosthesis and into a branch vessel that extends from the main vessel, wherein the leaflets in a deployed configuration extend radially outward from the graft material of the tubular body and an inside surface of the leaflets forms a seal onto an outer surface of the branch vessel prosthesis.

12. The assembly of claim 11, wherein each leaflet is a flap of material having a first edge that is coupled to the tubular graft and a second edge that is not coupled to the tubular graft, the second edge having a generally U-shaped profile with two generally straight side segments and a curved segment extending there between.

13. The assembly of claim 11, wherein at least two leaflets of the plurality of leaflets differ in size or shape or orientation with respect to an outer surface of the graft material when the coupling is deployed.

14. The assembly of claim 11, wherein each leaflet is a flap of material having a first edge that is coupled to the tubular graft and a second edge that is not coupled to the tubular graft, and a ring is disposed around the second edges of the leaflets.

15. A method for excluding an aneurysm at a target location near a junction of a main vessel and a branch vessel, comprising the steps of:

delivering a main prosthesis in a compressed configuration to the target location in the main vessel, the main prosthesis including a tubular body of graft material, a plurality of stents coupled to the tubular body, and a multi-leaflet coupling having a plurality of overlapping leaflets successively coupled to the tubular body around an opening formed in the tubular body, wherein the leaflets lay flush with the graft material of the tubular body and partially cover the opening of the tubular body;

aligning the multi-leaflet coupling with the branch vessel;

deploying the main prosthesis such that the tubular body expands from the compressed configuration to an expanded configuration, wherein the tubular body is disposed in the main vessel;

delivering a branch vessel prosthesis in a compressed configuration through the opening formed in the tubular body of the main prosthesis and into the branch vessel, wherein delivery of the branch vessel prosthesis through the opening deploys the leaflets to extend radially outward from the graft material of the tubular body and form a seal onto an outer surface of the branch vessel prosthesis.

16. The method of claim 15, further comprising the steps of:

deploying the branch vessel prosthesis such that the branch vessel prosthesis radially expands to an expanded configuration and an outside surface of a portion of the branch vessel prosthesis is in contact with an inner surface of a portion of the multi-leaflet coupling, wherein deployment of the branch vessel prosthesis causes a diameter of a passageway defined by the leaflets to increase.

17. The method of claim 15, wherein main vessel is the aortic arch.

18. The method of claim 15, wherein each leaflet is a flap of material having a first edge that is coupled to the tubular graft and a second edge that is not coupled to the tubular graft, the second edge having a generally U-shaped profile with two straight side segments and a curved segment extending there between.

19. The method of claim 15, wherein at least two leaflets of the plurality of leaflets differ in size or shape or orientation with respect to an outer surface of the graft material when the coupling is deployed.

20. The method of claim 15, wherein each leaflet is a flap of material having a first edge that is coupled to the tubular graft and a second edge that is not coupled to the tubular graft, and a ring is disposed around the second edges of the leaflets.