Medical device

• US 7,001,369 B2
• Filed: 03/27/2003
• Issued: 02/21/2006
• Est. Priority Date: 03/27/2003
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Griffin, Stephen, Mirigian, Gregory E., Lim, Elaine
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US10/400,750
• Publication Number:
  US 20040193140A1
• Time in Patent Office: 1,062 Days
• Field of Search: 604524-525, 604/526, 604/527, 604/95.01, 604/95.04, 604/510, 604/93.01, 604/103.09, 604/264, 604/523, 604530-532
• US Class Current: 604/524
• CPC Class Codes: A61L 29/02 Inorganic materials
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2205/0227 Materials having sensing or indicating function, e.g. indicating a pressure increase
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 25/001 Forming the tip of a catheter, e.g. bevelling process, join or taper
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0051 made from fenestrated or weakened tubing layer
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers

Abstract

An medical device include a shaft having an elongated inner tubular member and an elongated tubular reinforcing member disposed over a portion of the inner tubular member. In some embodiments, the reinforcing member is disposed about a proximal portion of the inner tubular member such that a distal portion of the inner tubular member is free of the reinforcing member. In some embodiments, the at least a portion of an outer surface of the inner tubular member is spaced from an inner surface of the reinforcing member. In some embodiments, the shaft can include a tip structure disposed on the distal portion of the inner tubular member. In some such embodiments, reinforcing member has a distal end, and the tip structure is disposed on the distal portion of the inner tubular member adjacent the distal end of the reinforcing member. Additionally, in some embodiments, the reinforcing member can include a plurality of apertures defined therein, for example, to enhance the flexibility or other such characteristics of all of portions of the reinforcing member.

Claims

1. A medical device comprising:

an elongated inner tubular member including a proximal portion and a distal portion and defining an outer surface and a lumen;

an elongated tubular reinforcing member having an inner surface, the reinforcing member being disposed about the proximal portion of the inner tubular member such that the distal portion of the inner tubular member is free of the reinforcing member, and such that at least a portion of the outer surface of the inner tubular member along the proximal portion faces and is spaced apart from the inner surface of the reinforcing member;

wherein the reinforcing member comprises a wall defining a plurality of apertures; and

wherein the spacing between the outer surface of the inner tubular member and the inner surface of the reinforcing member forms a space that is unfilled by any other structure of the device.

2. The medical device of claim 1, wherein the distal portion of the inner tubular member includes a tip structure.

3. The medical device of claim 2, wherein the tip structure includes one or more layers of material disposed on the distal portion of the inner tubular member.

4. The medical device of claim 2, wherein the tip structure includes two or more layers of material disposed about distal portion of the inner tubular member.

5. The medical device of claim 2, wherein the tip structure includes a layer of material comprising a reinforcement structure.

6. The medical device of claim 5, wherein the reinforcement structure comprises a coil.

7. The medical device of claim 2, wherein the tip structure includes a layer of polymer material.

8. The medical device of claim 7, wherein the reinforcing member is made of a first material, and the polymer material is more flexible than the first material.

9. The medical device of claim 2, wherein the tip structure includes a coil disposed about the distal portion of the inner tubular member, and a layer of polymer material disposed about the coil.

10. The medical device of claim 1, wherein the medical device includes an atraumatic tip structure disposed on the distal portion of the inner tubular member, and wherein the reinforcing member is made of a first material, and the atraumatic tip structure is made of a second material different from the first material.

11. The medical device of claim 1, wherein the reinforcing member includes a distal end, and the distal portion of the inner tubular member includes a tip structure coupled to the distal portion of the inner tubular member adjacent to the distal end of the reinforcing member.

12. The medical device of claim 1, wherein the distal portion of the inner tubular member has a length in the range of about 1 cm or greater.

13. The medical device of claim 1, wherein the distal portion of the inner tubular member has a length in the range of about 2 cm or greater.

14. The medical device of claim 1, wherein the distal portion of the inner tubular member has a length in the range of about 3 cm or greater.

15. The medical device of claim 1, wherein the inner tubular member comprises polymer material.

16. The medical device of claim 1, wherein the inner tubular member includes two or more layers of polymer material.

17. The medical device of claim 1, wherein the reinforcing member comprises a metal or metal alloy.

18. The medical device of claim 1, wherein the reinforcing member comprises a nickel-titanium alloy.

19. The medical device of claim 18, wherein the reinforcing member comprises a superelastic nickel-titanium alloy.

20. The medical device of claim 1, wherein the reinforcing member includes a distal region and a proximal region, and wherein the distal region includes the plurality of apertures therein, wherein the apertures are enclosed by the wall;

wherein the proximal region is free of a plurality of apertures defined therein.

21. The medical device of claim 1, wherein the reinforcing member is disposed over the entire proximal portion of the inner tubular member.

22. The medical device of claim 1, wherein the medical device is a catheter.

23. The medical device of claim 22, wherein the catheter is a microcatheter having an outer diameter in the range of about 1 to about 4 French.

24. The medical device of claim 1, wherein the reinforcing member has a total length, and wherein the spacing between the outer surface of the inner tubular member and the inner surface of the reinforcing member forms a space that extends along the reinforcing member in the range of 75% or greater of the total length of the reinforcing member.

25. The medical device of claim 1, wherein the space between the outer surface of the inner tubular member and the inner surface of the reinforcing member is in the range of range of about 0.0002 to about 0.004 inch in size.

26. A medical device comprising:

an elongated inner tubular member including a proximal portion and a distal portion and defining an outer surface and a lumen; and

an elongated tubular reinforcing member having an outer surface and an inner surface, and including a plurality of apertures defined in the outer surface thereof, the reinforcing member being disposed about the entire length of the proximal portion of the inner tubular member such that the distal portion of the inner tubular member is free of the reinforcing member, and wherein at least a portion of the outer surface of the inner tubular member along the proximal portion is spaced from the inner surface of the reinforcing member such that a space is formed that is unfilled by any other structure of the device; and

wherein the tubular reinforcing member is a monolithic structure having a wall defining and enclosing the apertures.

27. A catheter comprising:

an elongated inner tubular member including a proximal portion and a distal portion and defining an outer surface and a lumen;

a elongated tubular reinforcing member having a proximal end and a distal end, and defining an outer surface and an inner surface, wherein the reinforcing member has a wall defining and enclosing a plurality of apertures defined in the outer surface, the reinforcing member being disposed about the proximal portion of the inner tubular member such that the distal portion of the inner tubular member is free of the reinforcing member and such that a space is formed between the outer surface of the inner tubular member and the inner surface of the reinforcing member along the proximal portion that is unfilled by any other structure of the catheter; and

a tip structure coupled to the distal portion of the inner tubular member adjacent the distal end of the reinforcing member.

28. The catheter of claim 27, wherein the tip structure includes one or more layers of material disposed on the distal portion of the inner tubular member.

29. The catheter of claim 27, wherein the tip structure includes a layer of material comprising a reinforcement structure comprising a coil.

30. The catheter of claim 27, wherein the tip structure includes a layer of polymer material.

31. The catheter of claim 27, wherein the tip structure includes a coil disposed about the distal portion of the inner tubular member, and a layer of polymer material disposed about the coil.

32. The catheter of claim 27, wherein the distal portion of the inner tubular member has a length in the range of about 1 cm or greater.

33. The catheter of claim 27, wherein the distal portion of the inner tubular member has a length in the range of about 2 cm or greater.

34. The catheter of claim 27, wherein the reinforcing member includes a distal region and a proximal region, and wherein the distal region includes a plurality of apertures therein, while the proximal region is free of a plurality of apertures defined therein.

35. The catheter of claim 27, wherein the reinforcing member is disposed over the entire proximal portion of the inner tubular member.

36. A method of manufacturing an elongate shaft of a medical device, the method comprising:

providing a first elongated tubular member including a proximal portion and a distal portion and defining an outer surface and a lumen;

coupling an elongated tubular reinforcing member about the proximal portion of the inner tubular member such that the distal portion of the inner tubular member is free of the reinforcing member, the elongated tubular reinforcing member having an inner surface, and the elongated tubular reinforcing member being coupled to the first elongated tubular member and such that at least a portion of the outer surface of the inner tubular member along the proximal portion is spaced from the inner surface of the reinforcing member;

wherein the tubular reinforcing member includes a wall defining and enclosing a plurality of apertures; and

wherein the spacing between the outer surface of the inner tubular member and the inner surface of the reinforcing member forms a space that is unfilled by any other structure of the device.

37. The method of claim 36, wherein the reinforcing member includes a distal end, and further including coupling a tip structure to the distal portion of the inner tubular member adjacent the distal end of the reinforcing member.

38. The method of claim 37, wherein the tip structure includes one or more layers of material disposed on the distal portion of the inner tubular member.

39. The method of claim 37, wherein the tip structure includes a layer of material comprising a reinforcement structure comprising a coil.

40. The method of claim 37, wherein the tip structure includes a layer of polymer material.

41. The method of claim 37, wherein the tip structure includes a coil disposed about the distal portion of the inner tubular member, and a layer of polymer material disposed about the coil.

42. The method of claim 36, wherein the distal portion of the inner tubular member has a length in the range of about 1 cm or greater.

43. The method of claim 36, wherein the distal portion of the inner tubular member has a length in the range of about 2 cm or greater.

44. The method of claim 36, wherein the reinforcing member includes a distal region and a proximal region, and wherein the distal region includes a plurality of apertures therein, while the proximal region is free of a plurality of apertures defined therein.

45. The method of claim 36, wherein the reinforcing member is disposed over the entire proximal portion of the inner tubular member.

46. A catheter comprising:

a first elongated tubular member including a proximal portion and a distal portion and defining an outer surface and a lumen,

a means for reinforcing the proximal portion of the inner tubular member such that the distal portion of the inner tubular member is free of the reinforcing means and such that at least a portion of the reinforcing means is spaced from the proximal portion of the inner tubular member, the means for reinforcing including a wall defining and enclosing a plurality of apertures;

an atraumatic tip on the distal portion of the inner tubular member; and

wherein the spacing between the outer surface of the inner tubular member and the inner surface of the reinforcing member forms a space that is unfilled by any other structure of the catheter.