Medical device

• US 8,048,060 B2
• Filed: 08/16/2006
• Issued: 11/01/2011
• Est. Priority Date: 03/27/2003
• Status: Expired due to Fees

• 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): STIGELL, THEODORE J
• Application Number:
  US11/505,119
• Publication Number:
  US 20070049902A1
• Time in Patent Office: 1,903 Days
• Field of Search: 604/264, 604523-528, 604/95.04, 604/160, 604/530, 604/532
• 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 finished medical device, comprising:

an elongated metallic tubular member including a tubular wall having an inner surface, an outer surface, and a plurality of slots defined therein, the tubular member having a length;

wherein the elongated metallic tubular member has a longitudinal axis;

wherein at least some of the slots lie in a plane that is normal to the longitudinal axis;

an inner tubular member disposed along the inner surface of the tubular member, the inner tubular member having a guidewire lumen extending therethrough;

wherein the tubular member and the inner tubular member define a catheter shaft;

wherein the plurality of slots are disposed along the entire length of the tubular member, extend through the tubular member, and allow for fluid communication between the inner surface and outer surface in the finished medical device along the entire length of the tubular member; and

wherein at least a portion of the tubular member includes a linear elastic nickel-titanium alloy.

2. The medical device of claim 1, wherein the linear elastic nickel-titanium alloy demonstrates no martensite/austenite phase changes detectable by DSC and DMTA analysis over a temperature range of about −

60°

C. to about 120°

C.

3. The medical device of claim 1, wherein the linear elastic nickel-titanium alloy has stress/strain characteristics such that it does not display a superelastic plateau or a superelastic flag region in its stress/strain curve.

4. The medical device of claim 1, wherein the linear elastic nickel-titanium alloy has stress/strain characteristics such that as recoverable strain increases, stress continues to increase in a substantially linear relationship until a plastic deformation begins.

5. The medical device of claim 1, wherein the linear elastic nickel-titanium alloy demonstrates mechanical bending properties that remain linear-elastic over a temperature range of about −

60°

C. to about 120°

C.

6. The medical device of claim 1, wherein the linear elastic nickel-titanium alloy demonstrates linear elastic mechanical bending properties at both ambient or room temperature and at body temperature.

7. The medical device of claim 1, wherein the linear elastic nickel-titanium alloy comprises about 50 to about 60 wt. % nickel with the balance being substantially titanium.

8. The medical device of claim 1, wherein the linear elastic nickel-titanium alloy comprises about 54 to about 57 wt. % nickel.

9. The medical device of claim 1, wherein the tubular member includes a super elastic nickel-titanium alloy.

10. The medical device of claim 1, wherein the device comprises a catheter.

11. A tubular shaft for use in a finished medical device, the tubular shaft comprising:

a metallic tubular member including a tubular wall having a plurality of slots defined therein, the tubular member consisting essentially of a linear elastic nickel-titanium alloy, the tubular member having a length; and

an inner tubular member disposed along an inner surface of the tubular wall of the tubular member, the inner tubular member having a guidewire lumen extending therethrough;

wherein the tubular member and the inner tubular member define a catheter shaft;

wherein the plurality of slots are disposed along the entire length of the tubular member and extend through the tubular wall of the tubular member, wherein the tubular member is free of an encasing that would close the slots such that the slots remain open and allow for fluid communication therethrough in the finished medical device along the entire length of the tubular member.

12. The tubular shaft of claim 11, wherein the linear elastic nickel-titanium alloy demonstrates no martensite/austenite phase changes detectable by DSC and DMTA analysis over a temperature range of about −

60°

C. to about 120°

C.

13. The tubular shaft of claim 11, wherein the linear elastic nickel-titanium alloy has stress/strain characteristics such that it does not display a superelastic plateau or a superelastic flag region in its stress/strain curve.

14. The tubular shaft of claim 11, wherein the linear elastic nickel-titanium alloy has stress/strain characteristics such that as recoverable strain increases, stress continues to increase in a substantially linear relationship until a plastic deformation begins.

15. The tubular shaft of claim 11, wherein the linear elastic nickel-titanium alloy demonstrates mechanical bending properties that remain linear-elastic over a temperature range of about −

60°

C. to about 120°

C.

16. The tubular shaft of claim 11, wherein the linear elastic nickel-titanium alloy demonstrates linear elastic mechanical bending properties at both ambient or room temperature and at body temperature.

17. The tubular shaft of claim 11, wherein the linear elastic nickel-titanium alloy comprises about 50 to about 60 wt. % nickel with the balance being substantially titanium.

18. The tubular shaft of claim 11, wherein the linear elastic nickel-titanium alloy comprises about 54 to about 57 wt. % nickel.

19. A finished catheter shaft, comprising:

a metallic tubular member having an inner surface, an outer surface, a proximal end and a distal end, a length, and including a plurality of slots defined therein that are disposed along the entire length of the tubular member, extend through the tubular member, and allow for fluid communication between the inner surface and outer surface in the finished catheter shaft along the entire length of the tubular member, wherein at least a portion of the metallic tubular member includes a linear elastic nickel-titanium alloy;

wherein the metallic tubular member has a longitudinal axis;

wherein at least some of the slots lie in a plane that is normal to the longitudinal axis;

an inner tubular member disposed along the inner surface of the tubular member, the inner tubular member having a guidewire lumen extending therethrough;

a hub disposed adjacent the proximal end of the metallic tubular member; and

a tip disposed adjacent the distal end of the metallic tubular member.