Catheter Having an Ultra Soft Tip and Methods for Making the Same

• US 20110035927A1
• Filed: 10/18/2010
• Published: 02/17/2011
• Est. Priority Date: 12/10/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Chan, Huey Quoc, Griffin, Stephen, Lim, Elaine, Tassoni, Anthony F. JR., Jansen, Lex P.
• Granted Patent: US 8,973,239 B2
• Time in Patent Office: Days
• US Class Current: 29/428
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• 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: Y10T 29/49826 Assembling or joining

Abstract

An intravascular balloon catheter having an ultra soft tip. The catheter includes a braided reinforcement member extending substantially the length of the elongate shaft. A balloon is disposed at the distal end of the elongate shaft. An ultra soft tip is formed from a distal portion of balloon material extending distal of the distal end of the elongate shaft.

Claims

1. A method of forming a catheter, the method comprising:

providing an elongate shaft including a braided reinforcement member having a proximal end, a distal end and a lumen extending therethrough,

disposing an outer layer about at least a portion of the braided reinforcement member, the outer layer having a proximal end and a distal end,

disposing a sleeve having a proximal end and a distal end about a portion of the braided reinforcement member distal of the distal end of the outer layer, the sleeve extending distal of the distal end of the braided reinforcement member,

disposing an inflatable balloon having a proximal waist segment and a distal waist segment about a distal portion of the elongate shaft, wherein the distal waist segment is disposed about the sleeve and a portion of the distal waist segment extends distal of the distal end of the sleeve, and

forming a distal tip with the portion of the distal waist segment extending distal of the distal end of the sleeve.

2. The method of claim 1, further comprising:

disposing an inner layer within at least a portion of the lumen of the braided reinforcement member, the inner layer having a distal end disposed proximal of the distal end of the sleeve.

3. The method of claim 1, wherein the distal tip is an ultra soft tip.

4. The method of claim 3, wherein the ultra soft tip has a durometer hardness of between about 5 A and about 40 A.

5. The method of claim 1, wherein the outer layer includes a thermoplastic polyester elastomer.

6. The method of claim 5, wherein the thermoplastic polyester elastomer is HYTREL.

7. The method of claim 1, wherein the sleeve includes a low-density polyethylene (LDPE).

8. The method of forming a catheter according to claim 1, wherein the inflatable balloon includes a thermoplastic rubber elastomer.

9. The method of forming a catheter according to claim 8, wherein the thermoplastic rubber elastomer is CHRONOPRENE.

10. A method of making a catheter, the method comprising:

providing an elongate shaft including a reinforcement member having a proximal end and a distal end;

disposing an outer layer about at least a portion of the reinforcement member, the outer layer having a proximal end and a distal end, the distal end of the outer layer terminating proximal of the distal end of the reinforcement member;

disposing a distal extension about a distal portion of the reinforcement member, the distal extension having a proximal end and a distal end, the proximal end of the distal extension disposed distal of the distal end of the outer layer; and

disposing an inflatable member about the elongate shaft, the inflatable member including a proximal waist section and a distal waist section, the distal waist section secured to the distal extension, wherein a portion of the distal waist section extends distal of the distal end of the distal extension.

11. The method of claim 10, wherein the distal extension comprises a first polymer material and the outer layer comprises a second polymer material different from the first polymer material, and wherein a material bonding strength between the inflatable member and the first polymer material is greater than a material bonding strength between the inflatable member and the second polymer material.

12. The method of claim 10, wherein the proximal end of the distal extension is adjacent the distal end of the reinforcement member.

13. The method of claim 10, wherein the portion of the distal waist section extending distal of the distal end of the distal extension forms a distal tip.

14. The method of claim 13, wherein the distal tip has a durometer hardness of between about 5 A to about 40 A.

15. The method of claim 10, further comprising disposing an inner layer within at least a portion of the reinforcement member.

16. The method of claim 10, wherein the outer layer includes a thermoplastic polyester elastomer.

17. The method of claim 10, wherein the distal extension includes a low-density polyethylene (LDPE).

18. The method of claim 10, wherein the inflatable member includes a thermoplastic rubber elastomer.

19. A method of making a catheter, the method comprising:

providing an elongate shaft including a proximal portion and a distal extension extending distally from the proximal portion, wherein the distal extension comprises a first polymer material and the proximal portion comprises a second polymer material different from the first polymer material;

disposing an inflatable member about the elongate shaft, the inflatable member including a proximal waist section and a distal waist section, the distal waist section secured to the distal extension and a portion of the distal waist section extends distal of the distal end of the distal extension.

20. The method of claim 19, wherein the first polymer material of the distal extension provides a strong bonding substrate for a material of the balloon, whereas the material of the balloon is not as readily bondable to the second polymer material of the proximal portion.