Controlled deployment of a medical device

• US 5,545,209 A
• Filed: 06/30/1994
• Issued: 08/13/1996
• Est. Priority Date: 09/30/1993
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Texas Petrodet, Inc.
• Inventors: Chin, Yem, Chu, Michael S. H., Roberts, George T., Nott, Sepideh H., Hess, Kathleen L.
• Primary Examiner(s): Jones, Mary Beth
• Assistant Examiner(s): FOSSUM, LAURA J
• Application Number:
  US08/269,064
• Time in Patent Office: 775 Days
• Field of Search: 623/1, 623/12, 606/108, 606/191, 606/192, 606/194, 606/198, 606/96
• 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 ballon catheter extending over a length and having an inflatable balloon on its exterior, said balloon being inflatable by injection of fluid through a lumen in said catheter, and said balloon being initially partially constrained against inflation by a slidable constraint surrounding a portion of said balloon, said constraint configured such that the injection of fluid into said balloon causes said constraint to slide axially along said balloon, permitting inflation of further portions of said balloon, and

a tubular prosthesis disposed on said catheter over at least a portion of said balloon and a portion of said constraint, said tubular prosthesis having a contracted condition and an expanded condition, said tubular prosthesis being initially disposed on said catheter in said contracted condition.

2. The prosthesis delivery system of claim 1 wherein said sheath is designed to axially slide along a length of said balloon such that said balloon may be progressively incrementally inflated.

3. The prosthesis delivery system of claim 2 wherein said slidable sheath is adapted to slide axially onto a shaft of said catheter so that said sheath may be retrieved from a patient with said shaft.

4. The prosthesis delivery system of claim 1 wherein said tubular prosthesis is a stent.

5. The system of claim 4 wherein said prosthesis is folded around said balloon and constraint.

6. The prosthesis delivery system of claim 1 wherein said balloon is substantially inelastic.

7. The prosthesis delivery system of claim 6 wherein said axially slidable sheath is formed of a low coefficient of friction polymer.

8. The prosthesis delivery system of claim 7 wherein said polymer is Teflon®

.

9. The system of claim 1 wherein said balloon and said prosthesis each have a length of about 5 cm or more.

10. The system of claim 9 wherein the length of said balloon and prosthesis is in a range of about 8-12 cm.

11. The system of claim 1 wherein said prosthesis includes a clot inducing fabric.

12. The system of claim 1 wherein said catheter includes a single lumen for injection of said inflation fluid.

13. The system of claim 1 wherein said inflation lumen includes an inflation port for directing fluid into said balloon, said port located at a region corresponding to a portion of said balloon not initially constrained by said constraint.

15. The system of any one of claims 1, 2, 3 or 4-13 wherein said constraint has a short length such that it remains entirely within the body after full inflation of said balloon.

16. The system of any one of claims 1, 2, 3, or 4-13 wherein said constraint has a length that is less than the length of said balloon.

14. A prosthesis delivery package comprising

a balloon catheter having an inflatable inelastic balloon on its exterior, said balloon being inflatable by injection of fluid through a lumen in said catheter and having a length of about 8-12 cm, said balloon being initially partially radially constrained against inflation by a slidable constraint having a length less than the length of said balloon and constructed as a slidable low coefficient of friction polymeric sleeve surrounding a portion of said balloon, said constraint configured such that the injection of fluid into said balloon causes said sleeve to slide axially along said balloon, permitting progressive incremental inflation of said balloon, and

a tubular prosthesis, having a length substantially corresponding to the length of said balloon, disposed on said catheter over at least a portion of said balloon and a portion of said constraint, said tubular prosthesis having a contracted condition and an expanded condition, said tubular prosthesis being initially disposed on said catheter in said contracted condition.