Branch Vessel Prosthesis With a Roll-Up Sealing Assembly

• US 20100241218A1
• Filed: 03/23/2009
• Published: 09/23/2010
• Est. Priority Date: 03/23/2009
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Bruszewski, Walter, Mafi, Masoumeh, Shamlou, Shahram
• Granted Patent: US 8,052,741 B2
• Time in Patent Office: Days
• US Class Current: 623/1.280
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2002/061 provided with means for allowing access to secondary lumens
• 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
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: D04C 1/06 Braid or lace serving particular purposes
• CPC Class Codes: D10B 2509/06 Vascular grafts; stents

Abstract

A branch prosthesis configured for placement in a branch vessel includes an expandable tubular body portion, an expandable annular flange attached to a proximal end of the body portion, and a sealing sleeve proximally extending from the annular flange. The sealing sleeve is adapted to deform to a generally straight cylindrical hollow shape during implantation. When deployed, the sealing sleeve rolls up to a tightly-wound coil that bears against the annular flange. When used in conjunction with a main prosthesis having a side opening and deployed within in a main vessel, the annular flange of the branch prosthesis engages an outer surface of the main prosthesis around a perimeter of the side opening and the sealing sleeve engages an inner surface of the main prosthesis around the perimeter of the side opening to form a fluid-tight seal between the main prosthesis and the branch prosthesis.

Claims

1. An intraluminal prosthesis for placement in a side branch vessel, comprising:

an tubular body portion having a radially compressed first configuration and a radially expanded second configuration, the body portion having a first outer diameter in the second configuration, the body portion having a proximal end and a distal end;

an expandable flange coupled to the proximal end of the body portion, the flange having a radially compressed first configuration and a radially expanded second configuration, the flange having a second outer diameter in the second configuration that is greater than the first diameter of the body portion in the second configuration; and

a sealing sleeve extending proximally from the expandable flange, the sealing sleeve adapted to deform to a first configuration and to deploy to a second configuration, wherein the sealing sleeve is a generally straight cylindrical hollow shape in the first configuration and the sealing sleeve is a rolled-up coil with a proximal end having at least a 270 degree turn towards the flange in the second configuration, wherein the coil bears against the annular flange in the second configuration.

2. The prosthesis of claim 1, wherein the body portion is an expandable single wire nitinol (NiTi) braid.

3. The prosthesis of claim 2, wherein the body portion is impermeable by elastomer impregnation, lamination of elastomer film, or lamination of ePTFE film.

6. The prosthesis of claim 1, wherein the flange and sealing sleeve are formed as one-piece and subsequently attached to the body portion.

7. The prosthesis of claim 1, wherein the body portion, flange, and sealing sleeve are formed from an expandable single wire nitinol (NiTi) braid, the braid being impermeable by elastomer impregnation, lamination of elastomer film, or lamination of ePTFE film.

8. The prosthesis of claim 1, wherein the flange and sealing sleeve are formed from nitinol (NiTi).

9. The prosthesis of claim 1, wherein the body portion has a length between 40 mm and 60 mm.

10. The prosthesis of claim 1, wherein the sealing sleeve has a length between 1 cm and 3 cm when in the first configuration.

11. The prosthesis of claim 1, wherein the first outer diameter of the body portion is between 5 mm and 8 mm.

12. The prosthesis of claim 1, wherein the first outer diameter of the body portion is between 8 mm and 14 mm.

13. The prosthesis of claim 1, wherein the flange has a triangular cross-section.

14. The prosthesis of claim 1, wherein the body portion includes a graft material.

15. The prosthesis of claim 14, wherein the graft material is selected from the group consisting of woven polyester, expanded polytetrafluoroethylene, Dacron, polyurethane, and silicone.

4. The prosthesis of claim, wherein the body portion and flange are an integral expandable single wire nitinol braid.

5. The prosthesis of claim 4, wherein the single wire extends from the flange to the sealing sleeve and includes straight members having loops at proximal ends thereof.

16. A main prosthesis and a branch prosthesis assembly comprising:

a main prosthesis configured for placement in a main vessel, the main prosthesis including an outer surface, an inner surface, and a side opening having a perimeter; and

a branch prosthesis configured for placement in a branch vessel that extends from the main vessel, the branch prosthesis having a radially compressed first configuration and a radially expanded second configuration, the branch prosthesis including;

an expandable tubular body portion with a first outer diameter in the second configuration, the body portion having a proximal end and a distal end;

an expandable annular flange coupled to the proximal end of the body portion, the flange having a second outer diameter in the second configuration that is greater than the first outer diameter; and

a sealing sleeve extending proximally from the expandable flange, wherein the sealing sleeve is a generally straight cylindrical hollow shape in the first configuration and the sealing sleeve is a rolled-up coil with a proximal end having at least a 270 degree turn towards the flange in the second configuration,

wherein in the second configuration, the annular flange engages the outer surface of the main prosthesis around the perimeter of the side opening and the sealing sleeve engages the inner surface of the main prosthesis around the perimeter of the side opening to form a seal between the main prosthesis and the branch prosthesis.

17. A method for forming a seal between a main prosthesis and a branch prosthesis, comprising the steps of:

deploying the main prosthesis in a main vessel, wherein a side opening of the main prosthesis is substantially aligned with a branch vessel;

delivering the branch prosthesis in a radially compressed first configuration to the branch vessel through the side opening of the main prosthesis, wherein the branch prosthesis includes;

a tubular body portion having a proximal end and a distal end;

an annular flange coupled to the proximal end of the body portion; and

a sealing sleeve extending proximally from the expandable flange, wherein the sealing sleeve is a generally straight cylindrical hollow shape in the first configuration,

positioning the annular flange adjacent an outer surface of the main prosthesis and the sealing sleeve adjacent an inner surface of the main prosthesis; and

deploying the branch prosthesis from the first configuration to a radially expanded second configuration wherein the tubular portion expands to a first outer diameter, the annular flange expands to a second outer diameter larger than the first outer diameter and engages the outer surface of the main prosthesis around a perimeter of the side opening, and the sealing sleeve rolls up to a coil such that a proximal end of the sealing sleeve turns at least a 270 degrees towards the flange and engages the inner surface of the main prosthesis around the perimeter of the side opening to form a seal between the main prosthesis and the branch prosthesis.

18. The method of claim 17, wherein the side opening of the main prosthesis is formed in situ subsequent to deploying the main prosthesis in the main vessel.

19. The method of claim 17, wherein the side opening of the main prosthesis is pre-formed prior to deploying the main prosthesis in the main vessel.

20. The method of claim 18, wherein main vessel is the aortic arch.