Catheter and method of manufacture

• US 20100217235A1
• Filed: 02/15/2008
• Published: 08/26/2010
• Est. Priority Date: 02/15/2007
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Inventors: Savage, James D., Thorstenson, Chad A.
• Granted Patent: US 9,254,374 B2
• Time in Patent Office: Days
• US Class Current: 604/527
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• 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 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: B29C 41/20 incorporating preformed parts or layers, e.g. moulding inserts or for coating articles
• CPC Class Codes: B29L 2031/7542 Catheters
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor

Abstract

The instant invention relates generally to introducer catheters used to help deliver catheters or other medical devices to locations within the human body. In particular, the instant invention relates to large diameter introducer catheters (introducer catheters with lumens greater than about 6 French) having increased strength, flexibility, and kink resistance. Introducer catheters according to the teachings herein may also include curved distal ends and flared (that is, funnel-like) transition sections within their lumens.

Claims

1. An introducer catheter having a distal end and a proximal end, comprising:

a polymeric inner liner having a substantially cylindrical distal section, a substantially cylindrical proximal section, and a frusto-conical intermediate section between the distal section and the proximal section, wherein the inner liner defines a lumen;

a torque transfer layer surrounding at least a portion of the inner liner; and

an outer sheath of a melt-processable polymer formed over the torque transfer layer.

2. The introducer catheter according to claim 1, wherein the lumen defined by the inner liner has a diameter of at least about 12 French.

3. The introducer catheter according to claim 1, wherein the torque transfer layer comprises at least two flat wires braided into a wire mesh.

4. The introducer catheter according to claim 1, wherein the distal section of the inner liner defines a distal section of the lumen and the proximal section of the inner liner defines a proximal section of the lumen, a diameter of the distal section of the lumen being smaller than a diameter of a proximal section of the lumen.

5. The introducer catheter according to claim 4, wherein the diameter of the proximal section of the lumen is between about 0.004″

and about 0.005″

greater than the diameter of the distal section of the lumen.

6. The introducer catheter according to claim 4, wherein the diameter of the distal section of the lumen is about 12.5 French and the diameter of the proximal section of the lumen is about 14 French.

7. The introducer catheter according to claim 1, wherein the torque transfer layer has a braid density that varies along a length of the introducer catheter, and wherein the braid density is higher adjacent the intermediate section of the inner liner than elsewhere along the length of the introducer catheter.

8. The introducer catheter according to claim 1, wherein the distal end of the introducer catheter is shaped in a preset curvature.

9. The introducer catheter according to claim 1, wherein the frusto-conical intermediate section has a slope between about 4 degrees and about 6 degrees.

10. The introducer catheter according to claim 9, wherein the slope of the frusto-conical intermediate section is about 5 degrees.

11. A method of manufacturing an introducer catheter having a distal end and a proximal end, the method comprising the steps of:

forming a polymeric inner liner about a mandrel having an outer diameter that varies along a length of the mandrel, wherein the mandrel has a substantially cylindrical proximal section, a substantially cylindrical distal section, and a frusto-conical transition section between the proximal section and the distal section;

forming a torque transfer layer over at least a portion of the inner liner, the torque transfer layer including a plurality of flat wires braided into a wire mesh;

forming an outer sheath about the torque transfer layer, the outer sheath comprising a melt-processable polymer;

applying energy to the outer sheath to bond the outer sheath to the torque transfer layer and the inner liner; and

removing the mandrel, thereby creating a lumen in the introducer catheter, the lumen having a proximal section having a first diameter, a distal section having a second diameter less than the first diameter, and a frusto-conical transition section between the proximal section and the distal section.

12. The method according to claim 11, further comprising forming the distal end of the introducer catheter into a preset curvature.

13. An introducer catheter having a distal end and a proximal end, the introducer catheter comprising:

a tubular polymeric inner liner having a lumen diameter of at least about 8 French;

a torque transfer layer surrounding at least a portion of the inner liner, the torque transfer layer comprising at least two flat wires braided into a wire mesh; and

an outer sheath of a melt-processable polymer formed over the torque transfer layer,

wherein the outer sheath includes a distal segment and a proximal segment, the proximal segment having a higher durometer than the distal segment, and

wherein the distal end of the introducer catheter is formed into a preset curvature.

14. The introducer catheter according to claim 13, wherein the distal segment comprises a frusto-conical tip segment and a substantially cylindrical intermediate segment positioned between the tip segment and the proximal segment, and wherein the intermediate segment has a durometer intermediate to the tip segment and the proximal segment.

15. The introducer catheter according to claim 13, wherein an outer diameter of the outer sheath is less than about 11 French.

16. The introducer catheter according to claim 15, wherein the outer diameter of the outer sheath is less than about 10 French.

17. The introducer catheter according to claim 13, wherein a radius of the preset curvature is between about 0.8″

and about 1.2″

, and wherein an arc of the preset curvature is between about 25 degrees and about 45 degrees.

18. The introducer catheter according to claim 17, wherein the radius of the preset curvature is between about 0.9″

and about 1.1″

, and wherein the arc of the preset curvature is between about 30 degrees and about 40 degrees.

19. The introducer catheter according to claim 18, wherein the radius of the preset curvature is about 1.0″

, and wherein the arc of the preset curvature is about 35 degrees.

20. The introducer catheter according to claim 13, further comprising a flared transition section proximate the proximal end, the lumen diameter of the inner liner proximate of the flared transition section being larger than the lumen diameter of the inner liner distal of the flared transition section.

21. The introducer catheter according to claim 20, wherein the flared transition section comprises a frusto-conical shape.

22. The introducer catheter according to claim 20, wherein the lumen diameter of the inner liner proximal of the flared transition section is between about 0.004″

and about 0.005″

greater than the lumen diameter of the inner liner distal of the flared transition section.

23. A method of manufacturing an introducer catheter having a distal end and a proximal end, the method comprising:

forming a tubular polymeric inner liner about a mandrel, the mandrel having an outer diameter of at least about 8 French;

forming a torque transfer layer over at least a portion of the inner liner, the torque transfer layer including a plurality of flat wires braided into a wire mesh;

forming an outer sheath about the torque transfer layer, the outer sheath including at least a distal segment and a proximal segment, wherein each of the distal segment and the proximal segment comprises a melt-processable polymer, and wherein a hardness characteristic of the proximal segment is greater than a hardness characteristic of the distal segment;

heating the inner liner, the torque transfer layer, and the outer sheath to a temperature sufficient to bond the outer sheath to the torque transfer layer and the inner liner;

forming the distal end of the introducer catheter into a preset curvature; and

removing the mandrel.

24. The method according to claim 23, wherein the step of forming an outer sheath about the torque transfer layer comprises abutting the distal segment of the outer sheath and the proximal segment of the outer sheath such that the distal segment of the outer sheath bonds to the proximal segment of the outer sheath during the heating step.

27. The method according to claim 23, wherein the distal segment of the outer sheath includes a tip segment and an intermediate segment positioned between the tip segment and the proximal segment of the outer sheath and wherein the tip segment comprises a frusto-conical segment.

25-26. -26. (canceled)

28-30. -30. (canceled)