Methods and apparatus for conformably sealing prostheses within body lumens

• US 5,769,882 A
• Filed: 09/08/1995
• Issued: 06/23/1998
• Est. Priority Date: 09/08/1995
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Lenker, Jay A., Cox, Brian J., Will, Allan R., Fogarty, Thomas J., Freislinger, Kirsten
• Primary Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/525,989
• Time in Patent Office: 1,019 Days
• Field of Search: 623/1, 623/11, 623/12, 600/36, 606/194, 606/195
• US Class Current: 128/898
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2/945 hardenable, e.g. stents formed in situ
• 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 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

A tubular prosthesis is implanted at a target location within a body lumen by transluminally placing and embedding an expansible prosthesis body within a sealing layer. The sealing layer occludes at least a circumferential band within an interface region between the prosthesis body and the inner wall of the body lumen, thus providing for blockage of body lumen flow past the prosthesis. The sealing layer may be introduced prior to or simultaneously with the prosthesis body. A tubular prosthesis may be implanted in blood vessels, particularly to protect aneurysms.

Claims

1. In a method for implanting a tubular prosthesis in a body lumen of a type wherein the tubular prosthesis is expanded in situ so that an exterior surface of the prosthesis engages an inner wall of the body lumen over an interface region, the improvement comprising expanding the tubular prosthesis, in a sealing layer disposed in at least a portion of the interface region, the interface region having varying spacing between the prosthesis and the inner wall of the body lumen, the sealing layer conforming to the varying spacing to occlude the interface region.

2. A method as in claim 1, wherein the tubular prosthesis has at least a first end, a second end, and a lumen therebetween, and wherein the sealing layer is disposed over at least one circumferential band within the interface region.

3. A method as in claim 2, wherein the sealing layer is disposed within substantially the entire interface region.

4. A method as in claim 1, wherein the tubular prosthesis has a first end and a pair of branched second ends with lumens therebetween, and wherein the sealing layer is disposed over at least a circumferential band within the interface region near the first end.

5. A method as in claim 4, wherein the sealing layer is disposed over substantially the entire interface region.

6. A method as in claim 1, wherein the sealing layer is selected from the group consisting of gels, foams, sponges, biological polymers, microporous meshes, and a self-expanding mechanical assembly.

7. A method as in claim 1, wherein the sealing layer is disposed over at least a portion of the exterior surface of the tubular prosthesis prior to in situ expansion.

8. A method as in claim 1, wherein the improvement further comprises introducing the sealing layer within the body lumen prior to in situ expansion of the tubular prosthesis.

9. In a method for implanting a tubular prosthesis in a body lumen of a type wherein the tubular prosthesis is expanded in situ so that an exterior surface of the prosthesis engages an inner wall of the body lumen over an interface region, the improvement comprising expanding the tubular prosthesis, in a sealing layer disposed in at least a portion of the interface region, wherein the sealing layer is a microporous silicone rubber mesh.

10. A method for implanting a tubular prosthesis in a body lumen, said method comprising:

introducing a sealing layer over an interface region along an interior wall of the body lumen; and

expanding a tubular prosthesis within the body lumen, the interface region having a varying spacing between the tubular prosthesis and the body lumen, the sealing layer conforming to the varying spacing so that the sealing layer provides a seal between an exterior surface of the tubular prosthesis and the interior wall of the body lumen.

11. A method as in claim 10, wherein the tubular prosthesis expanding step comprises transluminally positioning a distal end of a catheter near the sealing layer within the body lumen and releasing a radially constrained, self-expanding prosthesis within said sealing layer.

12. A method as in claim 10, wherein the tubular prosthesis expanding step comprises transluminally positioning a distal end of a catheter near the sealing layer within the body lumen and inflating a balloon on the catheter to expand an at least partially malleable prothesis within said sealing layer.

13. A method for implanting a tubular prosthesis in a body lumen, said method comprising:

introducing a sealing layer over an interface region along an interior wall of the body lumen by transluminally positioning a distal end of a catheter at the interface region within the body lumen and applying a fluid phase sealing material from the distal end of the catheter over said interface region; and

expanding a tubular prosthesis within the body lumen so that the sealing layer provides a seal between an exterior surface of the tubular prosthesis and the interior wall of the body lumen.

14. A method as in claim 13, wherein the fluid phase sealing material is selected from the group consisting of gels, foams, adhesives, and biological polymers.