Methods for improving stent retention on a balloon catheter

• US 9,579,225 B2
• Filed: 11/24/2014
• Issued: 02/28/2017
• Est. Priority Date: 06/19/2006
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Huang, Bin, Gale, David C., Castro, Daniel
• Primary Examiner(s): Besler, Christopher
• Assistant Examiner(s): Travers, Matthew P
• Application Number:
  US14/552,066
• Publication Number:
  US 20150074975A1
• Time in Patent Office: 827 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2002/9586 the means being inside the balloon
• CPC Class Codes: B23P 11/005 by expanding or crimping
• CPC Class Codes: Y10T 29/49863 with prestressing of part
• CPC Class Codes: Y10T 29/49913 by constricting outer annulus
• CPC Class Codes: Y10T 29/49925 Inward deformation of aperture or hollow body wall
• CPC Class Codes: Y10T 29/49927 Hollow body is axially joined cup or tube
• CPC Class Codes: Y10T 29/53065 with means to fasten by deformation
• CPC Class Codes: Y10T 29/53987 Tube, sleeve or ferrule

Abstract

A method of crimping a stent on a balloon of a catheter assembly is provided. A polymeric stent is disposed over a balloon in an inflated configuration. The stent is crimped over the inflated balloon to a reduced crimped configuration so that the stent is secured onto the balloon. The balloon wall membrane is wedged or pinched between the strut elements of the stent for increasing the retention of the stent on the balloon.

Claims

1. A method of crimping a stent onto a balloon of a catheter assembly, comprising:

positioning a stent over a balloon of a catheter assembly, the balloon having a rated burst pressure;

placing the stent and the balloon of the catheter assembly in a crimping device;

inflating the balloon with an inflation fluid to a selected pressure greater than the rated burst pressure;

crimping the stent to the balloon while the balloon is inflated to the selected pressure; and

releasing at least a portion of the inflation fluid from the balloon.

2. The method of claim 1, wherein the wall or membrane of the balloon is pinched between stent struts across the length of the stent upon crimping of the stent to the balloon.

3. The method of claim 1, wherein the wall or membrane of the balloon is pinched between stent struts in a segmented manner across an entire length of the stent upon crimping of the stent to the balloon.

4. The method of claim 1, wherein crimping the stent comprises applying a radially compressive Force to the stent in an intermittent fashion.

5. The method of claim 1, wherein crimping the stent comprises crimping the stent to a first reduced diameter.

6. The method of claim 5, further comprising crimping the stent from the first reduced diameter to a second reduced diameter.

7. The method of claim 5, further comprising:

deflating and re-inflating the balloon after crimping the stent to the first reduced diameter; and

crimping the stent to a second reduced diameter after deflating and re-inflating the balloon.

8. The method of claim 1, wherein inflating the balloon to the selected pressure is performed before placing the stent and the balloon of the catheter assembly in the crimping device.

9. The method of claim 1, wherein inflating the balloon to the selected pressure is performed after placing the stent and the balloon of the catheter assembly in the crimping device.

10. The method of claim 1, wherein inflating the balloon to the selected pressure is performed before crimping the stent to the balloon.

11. The method of claim 1, wherein the inflation fluid is released from the balloon while crimping the stent to the balloon.

12. The method of claim 11, wherein the inflation fluid is released from the balloon controllably by a valve.

13. The method of claim 1, wherein a wall or membrane of the balloon protrudes between stent struts upon inflating the balloon to the selected pressure.

14. The method of claim 1, wherein crimping the stent to the balloon comprises applying a radially compressive force to the stent.

15. The method of claim 1, further comprising, after crimping the stent to the balloon, simultaneously applying pressure and heat to the stent and balloon.

16. The method of claim 15, wherein an outer sleeve restrains the crimped stent while simultaneously applying pressure and heat to an exterior of the stent and balloon.

17. The method of claim 1, wherein the stent is a polymeric stent.

18. The method of claim 1, wherein the stent is a biodegradable polymeric stent.

19. The method of claim 1, wherein the stent is a biodegradable polymeric stent with a biodegradable metallic component.

20. The method of claim 1, wherein the stent includes a drug coating.

21. The method of claim 1, further comprising applying a solvent to the balloon.

22. The method of claim 21, wherein the solvent is acetone.

23. The method of claim 1, further comprising applying a balloon softening fluid to the balloon.

24. The method of claim 1, wherein the balloon is inflated by a heated fluid.

25. The method of claim 1, wherein the balloon is inflated by a heated fluid having a temperature not greater than 200°

C.

26. The method of claim 1, wherein the balloon is inflated by a heated fluid having a temperature not greater than 150°

C.

27. The method of claim 19, wherein the balloon is inflated by a heated fluid having a temperature not greater than 100°

C.

28. The method of claim 1, wherein the balloon is inflated by a heated fluid having a temperature not greater than 75°

C.