Stent-catheter assembly with a releasable connection for stent retention

• US 9,283,099 B2
• Filed: 08/25/2004
• Issued: 03/15/2016
• Est. Priority Date: 08/25/2004
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Gale, David C., Kleine, Klaus, Abbate, Anthony J., Atladottir, Svava Maria, Huang, Bin
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US10/927,601
• Publication Number:
  US 20060047336A1
• Time in Patent Office: 4,220 Days
• Field of Search: 623/1.11, 623/1.12
• 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30448 using adhesives
• 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 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/005 using adhesives

Abstract

Medical assemblies with a releasable connection and methods of constructing such medical assemblies are disclosed. The medical assemblies generally comprise a stent, a catheter assembly having catheter body a balloon, and a releasable connection between the stent and the catheter assembly that releases the stent from the catheter assembly in response to enlargement of the balloon or when the balloon has been enlarged to an expanded configuration.

Claims

1. A medical assembly comprising:

a stent;

a catheter assembly comprising a catheter body and a balloon having the stent positioned on the balloon, the balloon having a deflated configuration and capable of being enlarged to an expanded configuration; and

a releasable connection between the stent and the catheter body, wherein the releasable connection retains the stent on the catheter assembly when the balloon is in the deflated configuration, wherein the releasable connection is formed in a region of the catheter body axially distal or proximal to the balloon, and the releasable connection releases the stent from the catheter body in response to enlargement of the balloon or when the balloon has been enlarged to an expanded configuration, wherein the releasable connection is located between an inner surface of the stent and an outer surface of the catheter body.

2. The assembly of claim 1, wherein the stent is a biodegradable stent.

3. The assembly of claim 1, wherein the releasable connection releases off of the stent.

4. The assembly of claim 1, wherein the releasable connection releases off of the catheter.

5. The assembly of claim 1, further comprising an intermediary material between the releasable connection and the stent, the releasable connection and the catheter body, or the combination thereof.

6. The assembly of claim 5, wherein the intermediary material is a coating.

7. The assembly of claim 5, wherein the releasable connection releases off of the intermediary material.

8. A method for constructing a medical assembly comprising:

placing a stent over a balloon of a catheter assembly;

forming a releasable connection between the stent and the catheter assembly such that in response to the enlargement of the balloon or when the balloon has been enlarged to an expanded configuration, the stent is detached from the catheter assembly,

wherein the forming a releasable connection comprises;

depositing an adhesive material on an outer surface of the catheter assembly to form the releasable connection, the adhesive material being of the type that allows for the detachment of the stent from the catheter assembly in response to the enlargement of the balloon or when the balloon has been enlarged to an expanded configuration; and

applying pressure to the stent to allow the adhesive material to contact the stent and catheter assembly to form the releasable connection;

applying heat to assist the pressure to form the releasable connection formed by the adhesive material.

9. The method of claim 8, wherein the balloon is in a collapsed configuration when the releasable connection is formed between the stent and the catheter assembly.

10. The method of claim 8, wherein the stent is a biodegradable stent.

11. The method of claim 8, wherein the releasable connection disengages from the stent.

12. The method of claim 8, wherein the releasable connection disengages from the balloon.

13. The method of claim 8, wherein the releasable connection is configured to break in parts to disengage the stent from the balloon.

14. The method of claim 8, wherein the adhesive material secures the inner surface of the stent to the outer surface of the catheter.

15. The method of claim 8, wherein the stent is a biodegradable stent and the method of forming the releasable connection comprises

applying a solvent to an inner surface of the biodegradable stent and/or an outer surface of the balloon;

followed by

crimping the biodegradable stent to the balloon;

followed by

removing the solvent.

16. The method of claim 8, wherein the stent is a biodegradable stent and the method of forming the releasable connection comprises

applying a solvent to an inner surface of the biodegradable stent and/or an outer surface of the catheter assembly;

prior to

placing the biodegradable stent over the balloon wherein the diameter of the stent allows for a fitted mate between the catheter assembly and the stent such that adjusting the diameter of the stent once positioned over the balloon is not required;

followed by

removing the solvent.

17. The method of claim 8, wherein the stent includes a material on an inner surface thereof and/or the catheter assembly includes a material on the outer surface thereof, and the method of forming the releasable connection comprises

applying a solvent to the material on the stent and/or the material on the catheter assembly;

followed by

crimping the stent on the catheter assembly;

followed by

removing the solvent.

18. The method of claim 17, wherein the releasable connection disengages from the material on the stent, the material on the balloon, the material on the catheter assembly in a region outside of the balloon, or a combination thereof.

19. The method of claim 8, wherein the stent includes a material on an inner surface thereof and/or the catheter assembly includes a material on the outer surface thereof, and the method of forming the releasable connection comprises

applying a solvent to the material on the stent and/or the material on the catheter assembly;

prior to

placing the stent over the balloon wherein the diameter of the stent allows for a fitted mate between the catheter assembly and the stent such that adjusting the diameter of the stent once positioned over the balloon is not required;

followed by

removing the solvent.

20. The method of claim 19, wherein the releasable connection disengages from the material on the stent, the material on the balloon, the material on the catheter assembly in a region outside of the balloon, or a combination thereof.

21. The method of claim 8, wherein the forming the releasable connection comprises:

injecting a melted material between the catheter assembly and the stent;

applying a melted material between the catheter assembly and the stent followed by crimping the stent on the catheter assembly;

applying a melted material on an inner surface of the stent and/or on an outer surface of the catheter assembly prior to placing the stent over the balloon;

or

applying a melted material on an inner surface of the stent and/or on an outer surface of the catheter assembly prior to crimping the stent on the catheter assembly.

22. The method of claim 8, wherein the forming the releasable connection comprises:

applying ultrasonic energy to the stent and/or the catheter assembly to connect the stent to the catheter assembly;

applying vibration to the stent and/or the catheter assembly to connect the stent to the catheter assembly;

spinning the stent around the balloon, spinning the balloon within the stent, or spinning both the balloon and the stent to connect the stent to the catheter assembly;

or

applying an electromagnetic energy to the stent and/or the catheter assembly to connect the stent to the catheter assembly.

23. The method of claim 22, wherein the stent is a biodegradable stent.

24. The method of claim 22, wherein the stent includes a material deposited on an inner surface of the stent and/or the catheter assembly includes a material deposited on the outer surface of the catheter assembly for allowing the stent to be connected to the catheter assembly or for enhancing or facilitating the connection of the stent to the balloon.

25. The method of claim 22, wherein the electromagnetic energy is radio frequency energy, microwave energy, or infrared energy.

26. The method of claim 8, wherein the stent is a biodegradable stent and the method of connecting the stent to the catheter assembly includes laser welding the stent to the catheter assembly.

27. The method of claim 8, wherein forming the releasable connection comprises laser welding a material between the stent and the catheter assembly so as to cause the connection of the stent to the catheter assembly.

28. A method for constructing a medical assembly comprising:

placing a stent over a balloon of a catheter assembly; and

forming a releasable connection between the stent and the catheter assembly by applying heat using a heat source positioned between a surface of the stent and a surface of the catheter assembly such that in response to the enlargement of the balloon or when the balloon has been enlarged to an expanded configuration, the stent is detached from the catheter assembly,

wherein the stent is a biodegradable stent and the method of forming the releasable connection comprises

applying the heat to weld an inner surface of the biodegradable stent to an outer surface of the catheter assembly to form the connection between the stent and the catheter assembly.

29. The method of claim 28 additionally including applying inward radial pressure to the stent that reduces the diameter of the stent during the application of the heat and/or subsequent to the application of heat.

30. The method of claim 28, wherein the method of forming a releasable connection additionally comprises crimping the stent on the catheter assembly and wherein heat is applied

prior to crimping of the stent on the catheter assembly;

during the crimping of the stent on the catheter assembly; and

/or

subsequent to crimping of the stent on the catheter assembly.

31. The method of claim 28, wherein the heat is applied by a heating tool, or by an electric current.

32. A method for constructing a medical assembly comprising:

placing a stent over a balloon of a catheter assembly; and

forming a releasable connection between the stent and the catheter assembly such that in response to the enlargement of the balloon or when the balloon has been enlarged to an expanded configuration, the stent is detached from the catheter assembly,

wherein the forming the releasable connection comprises;

placing a heating element between the stent and the catheter assembly; and

applying heat to weld the stent to the catheter assembly.

33. The method of claim 32, wherein the stent is a biodegradable stent made completely or in-part from a polymeric material.

34. The method of claim 32, wherein the stent includes a material deposited on an inner surface thereof and/or the catheter assembly includes a material deposited on an outer surface thereof, such that application of heat to the material on the stent and/or the material on the catheter assembly allows for connection of the stent to the catheter assembly.

35. The method of claim 34, wherein the material on the stent and/or the catheter assembly has a lower melting temperature than the stent and the catheter assembly.

36. The method of claim 34, wherein the material on the stent and/or the catheter assembly has a higher melting temperature than the stent and the assembly.