Controlled deployment of a medical device

• US 6,296,660 B1
• Filed: 03/26/1998
• Issued: 10/02/2001
• Est. Priority Date: 09/30/1993
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Hess, Kathleen L., Chin, Yem, Chu, Michael S. H., Roberts, George T., Nott, Sepideh H.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US09/048,953
• Time in Patent Office: 1,286 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.23, 623/1.3
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A prosthesis delivery system having a balloon catheter with an inflatable balloon on its exterior. The balloon is inflatable by injection of fluid through a lumen in the catheter and the balloon is initially partially constrained against inflation by a constraint. A tubular prosthesis is disposed on the catheter over at least a portion of the balloon and a portion of the constraint. The tubular prosthesis has a contracted condition and an expanded condition. The tubular prosthesis is initially disposed on the catheter in the contracted condition. Further, a balloon catheter includes a constraint so that the balloon may be sequentially inflated for dilatation purposes such as in a valvuloplasty operation.

Claims

1. A prosthesis delivery system comprising:

a catheter having an inflatable balloon on its exterior, a first portion of the balloon being initially partially constrained against inflation by a unitary elastomeric element surrounding the first portion of the balloon; and

an expandable prosthesis disposed over at least the first portion of the balloon and over the elastomeric element.

2. The system of claim 1 wherein the unitary elastomeric element is constructed in a manner to provide differing resistance to inflation pressure along the length of first portion of the balloon.

3. The system of claim 2 wherein the elasticity of the unitary elastomeric element varies progressively along its length.

4. The system of claim 1 wherein the unitary elastomeric element has a uniform elasticity.

5. The system of claim 1 wherein the unitary elastomeric element surrounds a center region of the balloon.

6. The system of claim 1 wherein the balloon is substantially nondistensible.

7. The system of claim 1 wherein the balloon has a length of about 5 cm or more.

8. The system of claim 1 wherein the balloon has a length in the range of about 8-12 cm.

9. The system of claim 1 wherein the catheter includes a single lumen.

10. The system of claim 9 wherein the lumen includes an inflation port for directing fluid into the balloon, the port located at a region corresponding to a portion of the balloon other than the first portion.

11. The system of claim 1 wherein the unitary elastomeric element is not deformable at inflation pressures below 3 atm.

12. The system of claim 1 further comprising a second unitary elastomeric element disposed over a second portion of the balloon.

13. The system of claim 1 wherein the unitary elastomeric element is plastically deformable.

14. The system of claim 1 wherein the catheter is adapted to expand a distal portion of the prosthesis to the expanded condition while a proximal portion of the prosthesis is in the contracted condition.

15. The prosthesis delivery system of claim 1 wherein said prosthesis comprises clot-inducing fabric.

16. The prosthesis delivery system of claim 1 wherein said prosthesis comprises a knitted stent.

17. The prosthesis delivery system of claim 1 wherein said balloon is made of nylon.

18. The prosthesis delivery system of claim 1 wherein said balloon is made of polyethylene.

19. The prosthesis delivery system of claim 1 wherein said balloon is made of PET.

20. The prosthesis delivery system of claim 1 wherein said balloon is made of a co-polymer of PET and Selar®

.

21. The prosthesis delivery system of claim 1 wherein the elastomeric element is made of latex.

22. The prosthesis delivery system of claim 1 wherein the elastomeric element is made of silicone.

23. The prosthesis delivery system of claim 1 wherein the elastomeric element is axially coextensive with the balloon.

24. The prosthesis delivery system of claim 12 wherein said first elastomeric element and said second elastomeric element differ in elasticity.

25. A method of expanding a prosthesis with a balloon catheter, comprising:

providing a catheter having an inflatable balloon on its exterior, a first portion of the balloon being initially partially constrained against inflation by a unitary elastomeric element surrounding the first portion of the balloon, a second portion of the balloon not being constrained by the unitary elastomeric element; and

an expandable prosthesis disposed over the first portion of the balloon, the elastomeric element and a second portion of the balloon which is not constrained by the unitary elastic element;

inflating the balloon such that an unconstrained portion of the balloon first and causes a portion of the prosthesis disposed over the second portion of the balloon to expand, and progressively inflating the balloon causing a portion of the prosthesis disposed over the first portion of the balloon to be progressively incrementally expanded.