Medical device

• US 7,540,865 B2
• Filed: 07/13/2005
• Issued: 06/02/2009
• Est. Priority Date: 03/27/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Griffin, Stephen, Mirigian, Gregory E., Lim, Elaine
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Stigell; Theodore J
• Application Number:
  US11/180,187
• Publication Number:
  US 20050267444A1
• Time in Patent Office: 1,420 Days
• Field of Search: 604524-527, 604/510, 604/93.01, 604/65.04, 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

A medical device including a shaft having an elongated inner member and an elongated tubular reinforcing member disposed over at least a portion of the inner member. In some embodiments, at least a portion of the outer surface of the inner member is spaced from the inner surface of the reinforcing member, defining a space substantially free of any other structures of the device. In some embodiments, the shaft can include a tip structure disposed on a distal portion of the inner member. In some such embodiments, the reinforcing member has a distal end, and the tip structure is disposed on the distal portion of the inner 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 or portions of the reinforcing member.

Claims

1. A medical device comprising:

an elongated inner member having a lumen formed therein, an outer surface, and a distal end; and

an elongated tubular reinforcing member having a distal end, an inner surface, an outer surface and a wall therebetween, the wall defining a plurality of apertures;

wherein the distal end of the inner member is disposed distally of the distal end of the reinforcing member;

wherein the tubular reinforcing member is disposed about and spaced away from at least a portion of the inner member such that a space is defined between the outer surface of the inner member and the inner surface of the tubular reinforcing member;

wherein the space is substantially free of any other structures of the device; and

a coil disposed about a distal portion of the inner member, wherein the coil is disposed distal of the distal end of the tubular reinforcing member.

2. The medical device of claim 1, wherein the tubular reinforcing member is coupled to the inner member at a plurality of discrete coupling points.

3. The medical device of claim 1, wherein the tubular reinforcing member has a proximal end and a length defined between the proximal end and the distal end, wherein the space extends along at least 50% of the length.

4. The medical device of claim 3, wherein the space extends along at least 75% of the length.

5. The medical device of claim 3, wherein the space extends along at least 90% of the length.

6. The medical device of claim 3, wherein the space extends along at least 95% of the length.

7. The medical device of claim 1, wherein the space is an annular space.

8. The medical device of claim 1, wherein the tubular reinforcing member is a monolithic structure comprising a plurality of spines or beams.

9. A medical device comprising:

an elongated inner member having a lumen formed therein, an outer surface, and a distal end;

an elongated tubular reinforcing member having an inner surface, an outer surface and a wall therebetween, the wall defining a plurality of apertures;

wherein the reinforcing member has a distal end and wherein the distal end of the inner member is disposed distally of the distal end of the reinforcing member;

wherein the tubular reinforcing member is disposed about and spaced away from at least a portion of the inner member such that a space is defined between the outer surface of the inner member and the inner surface of the tubular reinforcing member;

wherein the space is substantially free of any other structures of the device;

further comprising a coil disposed about a distal portion of the inner member; and

wherein at least a portion of the coil is disposed between the outer surface of the inner member and the inner surface of the tubular reinforcing member.

10. A medical device comprising:

an elongated multi-layer inner tubular member having a proximal end, a distal end, and a lumen extending therethrough; and

an elongated tubular reinforcing member disposed about at least a portion of the inner tubular member, the reinforcing member having an inner surface, an outer surface and a wall therebetween, the wall defining a plurality of apertures;

wherein the reinforcing member has a distal end and wherein the distal end of the multi-layer inner tubular member is disposed distally of the distal end of the reinforcing member;

wherein the tubular reinforcing member is disposed about and spaced away from at least a portion of the inner tubular member such that a space is defined between the outer surface of the inner tubular member and the inner surface of the tubular reinforcing member;

wherein the space is substantially free of any other structures of the device; and

a coil disposed about the inner tubular member, wherein the coil is disposed distal of the distal end of the tubular reinforcing member.

11. The medical device of claim 10, wherein the multi-layer inner tubular member comprises a first layer and a second layer.

12. The medical device of claim 11, wherein the multi-layer inner tubular member further comprises a third layer.

13. The medical device of claim 10, wherein the distal end of the multi-layer inner tubular member includes a tip structure.

14. The medical device of claim 10, wherein the tubular reinforcing member is a monolithic structure comprising a plurality of spines or beams.

15. The medical device of claim 10, wherein the tubular reinforcing member is coupled to the multi-layer inner tubular member at a plurality of discrete coupling points.

16. The medical device of claim 10, wherein the plurality of apertures are unobstructed.

17. The medical device of claim 10, wherein the plurality of apertures are in fluid communication with the space defined between the outer surface of the multi-layer inner tubular member and the inner surface of the tubular reinforcing member.

18. The medical device of claim 10, wherein the tubular reinforcing member comprises a metallic material.

19. The medical device of claim 10, wherein the tubular reinforcing member comprises a polymeric material.

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

providing a first elongated member having a lumen formed therein, a distal end, an outer surface;

providing an elongated tubular reinforcing member having an inner surface, an outer surface and a wall therebetween, the wall defining a plurality of apertures;

disposing the elongated tubular reinforcing member about and spaced away from at least a portion of the first elongated member such that a space is defined between the outer surface of the inner member and the inner surface of the tubular reinforcing member, wherein the space is substantially free of any other structures of the device, wherein the reinforcing member has a distal end and wherein the distal end of the first elongated member is disposed distally of the distal end of the reinforcing member; and

disposing a coil about the first elongated member, wherein the coil is disposed distal of the distal end of the tubular reinforcing member.

21. The method of claim 20, wherein the first elongated member is a multi-layer tubular member.

22. The method of claim 20, further comprising coupling the tubular reinforcing member to the first elongated member at a plurality of discrete coupling points.

23. The method of claim 20, wherein the tubular reinforcing member has a proximal end and a length defined between the proximal end and the distal end, wherein the space extends along at least 50% of the length.

24. The method of claim 23, wherein the space extends along at least 75% of the length.

25. The method of claim 23, wherein the space extends along at least 90% of the length.

26. The method of claim 23, wherein the space extends along at least 95% of the length.

27. The method of claim 20, wherein the tubular reinforcing member is a monolithic structure comprising a plurality of spines or beams.