Balloon delivery system for deploying stents

• US 5,935,135 A
• Filed: 05/23/1997
• Issued: 08/10/1999
• Est. Priority Date: 09/29/1995
• Status: Expired due to Fees

• Current Assignee: Calmedica LLC
• Original Assignee: United States Surgical Corporation (Medtronic Plc)
• Inventors: Addis, Bruce, Bramfitt, John
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): Shai, Daphna
• Application Number:
  US08/862,422
• Time in Patent Office: 809 Days
• Field of Search: 606/191, 606/192, 606/194, 606/198, 623/1, 623/12, 604/96, 604/108
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve

Abstract

A balloon delivery system for deploying stents including a balloon catheter, and a stent fixedly positioned on the balloon portion of the balloon catheter by at least one protrusion such as annular cuff formed around the balloon. The balloon can include two or more continuous or discontinuous cuffs formed along the balloon which maintain one or more stents in position on the balloon. The protrusion can be created from excess material of the balloon which is configured in a desired fashion around the balloon to form the protrusion. The protrusion improves the fixation of the stent on the balloon catheter until the balloon is inflated to deploy the stent within a body lumen. The protrusion restrains the movement of the stent without a significant change in the overall profile of the balloon delivery system. The protrusion or protrusions can be provided as a series of circumferentially spaced-apart projections, a C-shaped annular cuff, a continuous annular cuff or two or more axially spaced-apart projections or cuffs.

Claims

1. A balloon delivery system for deploying a stent within a tubular body lumen comprising:

an expandable balloon configured to receive a stent for maintaining an inside diameter of a lumen;

a passage in a tube in fluid communication with the expandable balloon;

at least one protrusion formed on an exterior of the balloon for securing the stent on the balloon during delivery and deployment of the stent within the lumen, the at least one protrusion being formed from the same material as the balloon, the at least one protrusion being formed of a flexible plastic material, the protrusion being transformed from a protruding configuration to a non-protruding configuration upon inflation of the balloon and the protrusion retaining the non-protruding configuration upon subsequent deflation of the balloon.

2. The balloon delivery system according to claim 1, wherein the at least one protrusion is formed integral with an expandable portion of the balloon.

3. The balloon delivery system according to claim 1, wherein the at least one protrusion has an L-shape in cross section.

4. The balloon delivery system according to claim 3, wherein the at least one protrusion comprises two annular cuffs which are L-shaped in cross section and the L-shaped cuffs are oriented such that extending legs of the cuffs extend toward one another.

5. The balloon delivery system according to claim 1, wherein the at least one protrusion comprises two annular cuffs and the balloon includes a space between the cuffs adapted for a stent to be positioned on the balloon.

6. The balloon delivery system according to claim 1, wherein the at least one protrusion comprises three annular spaced-apart cuffs, at least two stents being positioned on the balloon within spaces between the cuffs.

7. The balloon delivery system according to claim 1, wherein the at least one protrusion has a T-shaped cross section.

8. The balloon delivery system according to claim 1, wherein the at least one protrusion is heat treated to set a shape of the protrusion so that the protrusion shape is retained during sterilization and protracted shelf life.

9. The balloon delivery system according to claim 1, wherein the at least one protrusion comprises at least two annularly spaced-apart projections.

10. The balloon delivery system according to claim 1, wherein the at least one protrusion comprises a C-shaped ring.

11. A balloon delivery system for deploying a stent to maintain an inside diameter of a lumen, the system comprising:

an expandable balloon;

an expandable stent positioned on the balloon;

a tube connected to the balloon for inflating the balloon;

at least one protrusion formed on an exterior of the balloon securing the stent on the balloon, the at least one protrusion being formed from the same material as the balloon, the at least one protrusion being formed of a flexible plastic material, the protrusion being transformed from a protruding configuration to a non-protruding configuration upon inflation of the balloon and the protrusion retaining the non-protruding configuration upon subsequent deflation of the balloon.

12. The balloon delivery system according to claim 11, wherein the at least one protrusion is formed from the same material as the balloon.

13. The balloon delivery system according to claim 11, wherein the at least one protrusion is formed integral with an expandable portion of the balloon.

14. The balloon delivery system according to claim 11, wherein the at least one of the protrusion is L-shaped in cross section.

15. The balloon delivery system according to claim 11, wherein the at least one protrusion comprises two spaced-apart annular cuffs which are L-shaped in cross section and the L-shaped cuffs are oriented such that extending legs of the cuffs extend toward one another.

16. The balloon delivery system according to claim 11, wherein the at least one protrusion comprises three spaced-apart annular cuffs, the balloon is provided with three cuffs and includes spaces between the cuffs, at least two stents being positioned on the balloon within spaces between the cuffs.

17. The balloon delivery system according to claim 11, wherein the at least one protrusion has a T-shaped cross section.

18. The balloon delivery system according to claim 11, wherein the at least one protrusion is heat treated to set a shape of the protrusion so that the protrusion shape is retained during sterilization and protracted shelf life.

19. The balloon delivery system according to claim 11, wherein the at least one protrusion comprises at least two annularly spaced-apart projections.

20. The balloon delivery system according to claim 11, wherein the at least one protrusion comprises a C-shaped ring.

21. The balloon delivery system according to claim 11, wherein the stent is a substantially cylindrical member which is positioned adjacent the at least one protrusion.

22. A method of deploying a stent within a body lumen with a balloon catheter, the balloon catheter including a balloon having at least one protrusion for securing the stent in place on the balloon, the method comprising the steps of:

positioning a stent adjacent said at least one protrusion on the balloon catheter;

inserting the balloon catheter and stent into a body through a tubular catheter;

positioning the stent within a body lumen;

deploying the stent by inflating the balloon;

deflating the balloon; and

removing the balloon and the catheter from the body, the at least one protrusion being formed from the same material as the balloon, and the protrusion becoming non protruding upon inflation of the balloon.

23. The method of deploying a stent of claim 22, wherein the at least one protrusion comprises two spaced-apart annular cuffs, the step of positioning the stent including positioning the stent between the two cuffs on the balloon.

24. The method of deploying a stent of claim 22, wherein the at least one protrusion comprises three spaced-apart annular cuffs, the stent being positioned between one pair of the cuffs and an additional stent being positioned between another pair of the cuffs, the stents being deployed by inflating the balloon.

25. A balloon delivery system for deploying a stent within a tubular body lumen comprising:

an expandable balloon having at least one protrusion formed on an exterior of the balloon; and

an articulated expandable stent positioned on the balloon, the stent including two substantially cylindrical portions connected by a bridge element, the bridge element cooperating with the at least one protrusion to secure the stent on the balloon, the at least one protrusion being formed from the same material as the balloon, and the protrusion becoming non-protruding upon inflation of the balloon.

26. A balloon for deploying a stent within a body lumen comprising:

an expandable balloon configured to receive a stent for maintaining an inside diameter of a lumen;

the balloon having a pre-inflated state, wherein protrusions extending from the balloon protrude radially to secure the stent to the balloon;

the balloon having an inflated state, wherein the protrusions extending from the balloon transform from a protruding configuration to a non-protruding configuration; and

the balloon having a deflated state, wherein the protrusions are in the non-protruding configuration.