Low profile, thermally set wrapped cover for a percutaneously deployed stent

• US 5,948,191 A
• Filed: 10/07/1997
• Issued: 09/07/1999
• Est. Priority Date: 07/15/1996
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Solovay, Kenneth S.
• Primary Examiner(s): Simmons, David A.
• Assistant Examiner(s): LORENGO, JERRY A
• Application Number:
  US08/946,519
• Time in Patent Office: 700 Days
• Field of Search: 53/429, 53/430, 53/441, 53/442, 156/86, 156/247, 623/1, 623/11, 623/12, 606/192, 606/194, 606/195
• US Class Current: 156/86
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve

Abstract

An endoprosthesis assembly for percutaneous deployment on a balloon catheter is disclosed. The assembly includes a radially expandable stent overlied by a tubular, low profile stent cover wrapped over the stent. The wrapped cover is thermally set to maintain its low profile wrapped configuration during deployment of the assembly. At the treatment site, the balloon portion of the catheter is inflated causing the stent to expand radially and the stent cover to unwrap and open to conform to the expanded configuration of the stent.

Claims

1. A method of fabricating an endoprosthesis assembly for percutaneous deployment and implantation at a treatment site within a patient'"'"'s body, the steps of the method comprising:

a) providing a cylindrically shaped stent expandable from a first configuration to a second enlarged configuration;

b) inserting the stent in its first configuration into a cylindrical stent cover having a length less than a length of the stent and having an inner diameter at least as large as an outer diameter of the stent when the stent is in its second enlarged configuration;

c) affixing the stent cover to the stent;

d) wrapping the stent cover around the stent, the stent cover in its wrapped configuration having a substantially uniform cross sectional area over an entire length of the stent cover;

e) releasably setting the stent cover in its wrapped configuration for deployment of the assembly to the treatment site; and

f) releasably affixing the assembly to an expandable portion of a delivery catheter for deployment of the assembly to the treatment site.

2. The method of fabricating an endoprosthesis assembly set forth in claim 1 wherein the step of releasably setting the stent cover in its wrapped configuration includes the substeps of:

i) inserting the stent and wrapped stent cover in a central opening of a section of heat shrink tubing;

ii) heating the stent, wrapped stent cover and heat shrink tubing to thermally set the stent cover in its wrapped configuration; and

iii) stripping the heat shrink tubing off the cover.

3. The method of fabricating an endoprosthesis assembly set forth in claim 1 wherein the step of releasably affixing the assembly to the expandable portion of the delivery catheter includes crimping the stent to the delivery catheter expandable portion.

4. A method of percutaneously deploying and implanting an endoprosthesis assembly including a stent and stent cover affixed to the stent at a treatment site within a patient'"'"'s body, the stent being cylindrically shaped and radially expandable from a first configuration to a second enlarged configuration and the stent cover being cylindrically shaped and having a length less than a length of the stent and an inner diameter at least as large as an outer diameter of the stent when the stent is in its second enlarged configuration, the steps of the method comprising:

a) wrapping the stent cover around an outer surface of the stent, the stent cover in its wrapped configuration having a substantially uniform cross sectional area over an entire length of the stent cover;

b) releasably setting the stent cover in its wrapped configuration for deployment of the assembly to the treatment site; and

c) releasably affixing the assembly to an inflatable portion of a delivery catheter for deployment of the assembly to the treatment site;

d) inserting an end of the catheter into the patient'"'"'s body through an introducer and advancing the catheter into the body until the assembly is adjacent the treatment site;

e) inflating the inflatable portion of the delivery catheter to implant the assembly, the inflation of the inflatable portion detaching the assembly from the expandable portion, radially expanding the stent to its second expanded configuration, and at least partially unwrapping the stent cover such that the cover conforms to the outer surface of the stent when the stent is in its second expanded configuration.

5. The method of percutaneously deploying and implanting an endoprosthesis assembly set forth in claim 4 wherein the step of releasably setting the stent cover in its wrapped configuration includes the substeps of:

i) inserting the stent and wrapped stent cover in a central opening of a section of heat shrink tubing;

ii) heating the stent, wrapped stent cover and heat shrink tubing to thermally set the stent cover in its wrapped configuration; and

iii) stripping the heat shrink tubing off the cover.

6. The method of fabricating an endoprosthesis assembly set forth in claim 4 wherein the step of releasably affixing the assembly to the expandable portion of the delivery catheter includes crimping the stent to the delivery catheter expandable portion.