Micro-catheters and methods of their manufacture

• US 6,186,986 B1
• Filed: 01/21/1998
• Issued: 02/13/2001
• Est. Priority Date: 01/21/1998
• Status: Expired due to Term

• Current Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories)
• Original Assignee: St Jude Medical Cardiovascular Group Incorporated
• Inventors: St. Germain, Jon Patrick, Berg, Todd Allen
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Sirmons, Kevin C.
• Application Number:
  US09/010,366
• Time in Patent Office: 1,119 Days
• Field of Search: 604/264, 604/523, 604/524, 604/525, 604/526, 604/527
• US Class Current: 604/264
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• 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

Abstract

A micro-catheter including an inner primary liner and a plurality of concatenated tubes is provided. The primary liner extends substantially from the proximal end to the distal end of the catheter. Each of the tubes has a respective inner surface that is fused to the outer surface of the primary liner. For each and every pair of tubes, the outer diameter of the more proximally located tube is equal to or greater than the outer diameter of the more distally located tube. Each of the tubes may have different physical properties and dimensions for making customized micro-catheter profiles.

Claims

1. A micro-catheter having a proximal end and a distal end, said micro-catheter comprising:

a tubular primary liner that substantially extends from said proximal end to said distal end, said primary liner having an inner surface and an outer surface; and

a plurality of concatenated tubes having respective inner surfaces fused to said primary liner outer surface, such each and every pair of said tubes comprises a proximal tube having an outer diameter and a distal tube having an outer diameter that does not exceed said outer diameter of said proximal tube and wherein at least one of said each and every pairs comprises a respective proximal tube and a respective distal tube such that an outer diameter of said respective distal tube is less than an outer diameter of said respective proximal tube.

2. The micro-catheter of claim 1 wherein each of said tubes comprises a polymer.

3. The micro-catheter of claim 2 wherein each of said tubes has a hardness, said distal tube hardness not exceeding said proximal tube hardness.

4. The micro-catheter of claim 3 wherein at least one of said tubes has a hardness that decreases distally.

5. The micro-catheter of claim 4 wherein said at least one of said tubes has a hardness that continuously decreases distally.

6. The micro-catheter of claim 2 wherein said polymer comprises polyetheramide having a polyether concentration and an polyamide concentration at a polyether-polyamide ratio, wherein said ratio for said proximal tube is not less than said ratio for said distal tube.

7. The micro-catheter of claim 1 wherein each of said tubes has a flexural modulus, said distal tube flexural modulus not exceeding said proximal tube flexural modulus.

8. The micro-catheter of claim 7 wherein said tubes include a tip section, said tip section being closest to said distal end of said catheter, said tip section outer diameter being less than about 0.030 inches.

9. The micro-catheter of claim 8 wherein at least one of said tubes has an outer diameter that decreases distally.

10. The micro-catheter of claim 9 wherein said at least one of said tubes has an outer diameter that continuously decreases distally.

11. The micro-catheter of claim 1 further comprising a structural tube disposed on said outer surface of said primary liner for providing torque response, kink resistance, and burst resistance to said catheter.

12. The micro-catheter of claim 11 wherein said structural tube comprises a structural material.

13. The micro-catheter of claim 12 wherein said structural material is metal.

14. The micro-catheter of claim 13 wherein said structural material is selected from a group consisting of braided, coiled, and ribboned materials.

15. The micro-catheter of claim 11 wherein a distal most tube has a distally located tip portion, said structural tube being disposed on said primary liner up to a proximal end of said tip portion so that said tip portion has a desired stiffness.

16. The micro-catheter of claim 15 wherein said tip portion has an axial length of between about 3 millimeters and about 10 millimeters.

17. The micro-catheter of claim 11 wherein said structural tube is substantially between said outer surface of said primary liner and said tubes.

18. The micro-catheter of claim 11 wherein said structural tube has a wall thickness of between about 0.001 inches and about 0.003 inches.

19. The micro-catheter of claim 1 wherein said electromagnetically opaque material is substantially opaque to electromagnetic radiation having a frequency in the x-ray portion of the electromagnetic spectrum.

20. The micro-catheter of claim 19 wherein said electromagnetically opaque material is selected from a group consisting of bismuth carbonate, tungsten, barium sulfate, and mixtures thereof.

21. The micro-catheter of claim 19 wherein said opaque material is a solid marker attached to a known position of said catheter.

22. The micro-catheter of claim 19 wherein said opaque material is a powder dispersed in at least one of said tubes.

23. The micro-catheter of claim 22 wherein said opaque material has a different concentration in each of said at least one tubes for identification purposes during use of said catheter.

24. The micro-catheter of claim 1 wherein said catheter has an integrated secondary lumen.

25. The micro-catheter of claim 24 wherein said secondary lumen is at least partially formed in one of said tubes.

26. The micro-catheter of claim 25 wherein at least two of said adjacent tubes at least partially overlap.

27. The micro-catheter of claim 1 wherein said primary liner comprises a material selected from a group consisting of polytetrafluoroethylene, polyamide, polyimide, polyetheramide, and any combination thereof.

28. The micro-catheter of claim 1 wherein said primary liner has an inner diameter of less than about 0.020 inches.

29. The micro-catheter of claim 1 wherein said primary liner has a wall thickness of between about 0.00075 inches and about 0.003 inches.

30. The micro-catheter of claim 1 wherein said primary liner outer surface is roughened.

31. The micro-catheter of claim 1 further comprising an electromagnetically opaque material for determining a position of said catheter with electromagnetic radiation during catheter use.

32. The micro-catheter of claim 1 wherein each of said tubes has a length, said distal tube length not substantially exceeding said proximal tube length.

33. The micro-catheter of claim 1 wherein at least one of said tubes has a flexural modulus that decreases distally.

34. The micro-catheter of claim 33 wherein said at least one of said tubes has a flexural modulus that continuously decreases distally.

35. The micro-catheter of claim 1 wherein at least one of said plurality of tubular tubes is curved to improve steerability.