Catheter having a high tensile strength braid wire constraint and method of manufacture

• US 20030083623A1
• Filed: 12/04/2002
• Published: 05/01/2003
• Est. Priority Date: 08/18/1993
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Galdonik, Jason A., Scovil, Brian, Berg, Todd A., Pepin, Henry
• Granted Patent: US 7,297,302 B2
• Time in Patent Office: Days
• US Class Current: 604/164.13
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0015 Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: Y10T 428/2935 Discontinuous or tubular or cellular core
• CPC Class Codes: Y10T 428/294 including metal or compound thereof [excluding glass, ceramic and asbestos]

Abstract

A tubing assembly for manufacture for a catheter of the type having an inner tubular member defining a lumen, an outer tubular member surrounding said inner member, and a support member mounted between the tubular members to provide rigidity to the flexible catheter. The support member comprises a high tensile strength wire braid, and in the preferred embodiment comprises a stainless steel wire braid which has been tempered or hardened. This higher tensile strength affords significantly greater kink resistance to the flexible catheter. One wire braid has a tensile strength in the range of 300 to 425 kpsi and a braid density of approximately 40 pic. The high tensile strength wire braid has the disadvantage of tending to flare out at its free ends. Therefore, means are provided for preventing the flaring of the wire braid during manufacture of the tubing assembly. One means includes adhesive applied over the free ends. Another means includes a restraining sleeve applied over the free ends.

Claims

1. A tubular assembly for use in catheter construction comprising:

a. a tubular member having a proximal end, a distal region, and an outer surface;

b. a braid member overlying said tubular member conforming to said outer surface, said braid member including a plurality of terminal ends in the distal region of said tubular member, said braid member formed of high tensile strength wire; and

c. means for restraining said plurality of terminal ends of said braid member to maintain conformance to said outer surface.

2. The tubular assembly of claim 1, wherein said wire comprises metallic wire.

3. The tubular assembly of claim 2, wherein said metallic braided wire comprise high tensile strength stainless steel.

4. The tubular assembly of claim 2, wherein said wire has a tensile strength of at least 200 kpsi.

5. The tubular assembly of claim 2 wherein said wire comprises a tempered metal.

6. The tubular assembly of claim 5 wherein said wire has a tensile strength of at least 200 kpsi.

7. The tubular assembly of claim 5 wherein said wire comprises stainless steel.

8. The tubular assembly of claim 6 wherein said wire has a tensile strength greater than 200 kpsi.

9. The tubular assembly of claim 5 wherein said wire has a tensile strength in the range of 300 to 475 kpsi.

10. The tubular assembly of claim 5 wherein said wire has a braid density of approximately 40 pic.

11. The tubular assembly of claim 5 wherein said wire has a braid density of at least 10 pic.

12. The tubular assembly of claim 5 wherein said wire has a diameter in the range of 0.00075 inches to 0.0035 inches.

13. A tubular assembly for use in catheter construction comprising:

a. a tubular member having a proximal end, a distal end and an outer surface;

b. a braid member overlying said tubular member conforming to said outer surface, said braid member including a plurality of terminal ends proximate the distal end of said tubular member, said braid member comprising high tensile strength metal; and

c. a sufficient quantity of adhesive means restraining said plurality of terminal ends of said braid member to maintain conformance to said outer surface.

14. The tubular assembly of claim 13 wherein said metal comprises tempered stainless steel.

15. The tubular assembly of claim 13 wherein said metal has a tensile strength of at least 200 kpsi.

16. The tubular assembly of claim 13 wherein said metal has a tensile strength in the range of 300 to 475 kpsi.

17. The tubular assembly of claim 13, wherein said adhesive means is an ultraviolet light curable adhesive.

18. The tubular assembly of claim 13, wherein said ultraviolet light curable adhesive is selected from the group consisting of:

polyurethanes, epoxies, acrylics and mixtures thereof.

19. The tubular assembly of claim 13, wherein the adhesive means is an adhesive selected from the group consisting of:

cyanoacrylates, epoxies, hot melt adhesives, acrylics, silicones and mixtures thereof.

20. A tubular assembly for use in catheter construction comprising:

a. a tubular member having a proximal end, a distal end and an outer surface;

b. a braid member overlying said tubular member conforming to said outer surface, said braid member including a plurality of terminal ends proximate the distal end of said tubular member, said braid member comprising high tensile strength metal; and

c. a restraining sleeve mounted over said tubular distal end outer surface such that said plurality of terminal ends of said braid member are restrained to maintain conformance to said outer surface.

21. The tubular assembly of claim 20 in which said restraining sleeve comprises a heat shrink polyester.

22. The tubular assembly of claim 21 wherein said braid member comprises tempered stainless steel.

23. The tubular assembly of claim 21 wherein said braid member has a tensile strength of at least 200 kpsi.

24. The tubular assembly of claim 21 wherein said braid member has a tensile strength in the range of 300 to 475 kpsi.