Coextruded catheter and method of forming

• US 5,348,536 A
• Filed: 08/02/1993
• Issued: 09/20/1994
• Est. Priority Date: 08/02/1993
• Status: Expired due to Term

• Current Assignee: Covidien AG (Medtronic Plc)
• Original Assignee: Quinton Instrument Co. (Cardica Incorporated)
• Inventors: Abrahamson, Timothy A., Young, Pauline R., Sommercorn, Richard K.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/101,517
• Time in Patent Office: 414 Days
• Field of Search: 604/43-45, 604/52-54, 604/158-163, 604/264-266, 604/280-283, 128/656-658, 128/692, 128/742, 128/748
• US Class Current: 604/43
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08

Abstract

An elongated catheter formed of coextruded materials such that the inner surface of the extension members or body portion of the catheter have a higher durometer than the outer surface of the extension members or body portion of the catheter to reduce septum deflection during normal use, and the likelihood of tearing or sticking of the extension members is reduced.

Claims

1. A multiple lumen catheter comprising:

an elongated cylindrical body portion having distal and proximal end portions with one or more internal septums therein to form a plurality of lumens therebetween, and said body portion being formed of a plurality of materials having different durometers to form at least first, second and third layers thereon wherein said first layer has a lower durometer than said third layer.

2. The catheter of claim 1 wherein said first layer is an outer layer of said body portion.

3. The catheter of claim 1 wherein said septum is an integral inner layer of said body portion and forms at least part of said third layer.

4. The catheter of claim 1 wherein said second layer has a durometer between the durometers of said first and third layers.

5. The catheter of claim 1 wherein said second layer is formed by a combination of the materials of said first and third layers.

6. The catheter of claim 1 wherein said first layer is an integral outer layer of material on said body portion and said third layer is an integral inner layer of material on said body portion.

7. The catheter of claim 6 wherein said second layer forms an integral intermediate layer between said first and third layers.

8. The catheter of claim 1 wherein said septum includes at least first and second ends integrally connected to an interior surface of said tube member, and said third layer forms said septum and said interior surface of said body portion.

9. The catheter of claim 1 wherein said lumens are encircled by said third layer, and said first layer is an outer layer of said body portion.

10. The catheter of claim 1 wherein said septum includes at least first and second ends integrally connected to an interior surface of said body portion, and said septum forms said third layer, and said first and second ends are integral with said second layer.

11. The catheter of claim 1 wherein said second layer is formed of said materials of said first and third layers.

12. The catheter of claim 1 further including at least one extension member connected in fluid communication with at least one of said lumens along said proximal end portion of said body portion.

13. The catheter of claim 12 wherein said extension member is formed of a plurality of materials having different durometers to form inner and outer layers thereon, and said inner and outer layers have different durometers.

14. The catheter of claim 13 wherein said extension member further includes an intermediate layer integrally formed between said inner and outer layers.

15. The catheter of claim 14 wherein said intermediate layer has a durometer between said durometers of said inner and outer layers.

16. A multiple lumen catheter comprising an elongated cylindrical body portion having distal and proximal end portions with an internal septum therein to form a plurality of lumens therebetween;

at least one elongated extension member operatively connected to said proximal end portion of said body portion in flow communication with at least one of said lumens; and

at least one of said body portion or said extension member being formed of a plurality of materials having different durometers such that inner and outer layers are formed thereon having different durometers, and an intermediate layer is integrally formed therebetween.

17. The catheter of claim 16 wherein said outer layer has a lower durometer than the durometer of said inner layer.

18. The catheter of claim 16 wherein said outer layer has a durometer in the range of approximately 50A to about 93A.

19. The catheter of claim 16 wherein said outer layer has a durometer in the range of approximately 80A to 55D.

20. The catheter of claim 16 wherein said inner layer has a durometer in the range of approximately 90A to 75D.

21. The catheter of claim 16 wherein said extension member includes said inner and outer layers thereon.

22. The catheter of claim 21 wherein said body portion further includes inner and outer layers thereon having different durometers.

23. The catheter of claim 16 wherein said body portion includes inner and outer layers thereon having different durometers and said septum forms at least a portion of said inner layer.

24. The catheter of claim 23 wherein said body portion includes sidewalls having inner and outer surfaces thereon, and said inner surface thereof forms at least a portion of said inner layer.

25. A catheter comprising:

an elongated and generally cylindrical body portion with distal and proximal end portions and at least one lumen extending therebetween;

an inner layer on said body portion having a durometer in the range of approximately 72A to 85A; and

an outer layer on said body portion having a durometer in the range of approximately 90A to 75D.

26. The catheter of claim 25 further including an intermediate layer integrally formed between said inner and outer layers.

27. The catheter of claim 25 further including at least one extension member operatively connected to said proximal end portion of said body portion;

said extension member having an inner layer with a durometer in the range of approximately 90A to 75D and an outer layer with a durometer in the range of approximately 50A to 55D.

28. A catheter comprising:

an elongated cylindrical body portion having distal and proximal end portions with one or more lumens therebetween;

at least one elongated extension member operatively connected to said proximal end portion of said body portion in flow communication with at least one of said lumens; and

at least one of said body portion or said extension member being formed of a plurality of materials having different durometers such that inner and outer layers are formed thereon having different durometers, and an intermediate layer is integrally formed therebetween.

29. The catheter of claim 28 wherein said outer layer has a lower durometer than the durometer of said inner layer.

30. The catheter of claim 28 wherein said outer layer has a durometer in the range of approximately 72A to 85A.

31. The catheter of claim 28 wherein said outer layer has a durometer in the range of approximately 50A to 55D.

32. The catheter of claim 28 wherein said inner layer has a durometer in the range of approximately 90A to 75D.

33. The catheter of claim 28 wherein said body portion includes a septum extending therethrough and said septum is formed of a material having a durometer higher than said durometer of said outer layer.

34. An elongated catheter comprising:

an elongated cylindrical body portion having distal and proximal end portions;

an elongate extension member in flow communication with said proximal end portion of said body portion, said extension member being formed of a plurality of materials having different durometers to form at least first and second layers wherein said first layer has a lower durometer than said second layer; and

a connection member operatively connecting said body portion to said extension member.

35. The catheter of claim 34 wherein said extension member is further formed of a third layer wherein said third layer is integral with said first and second layers and is formed by a combination of said first and second layers.

36. The catheter of claim 34 wherein said body portion is formed of a plurality of materials having different durometers to form at least first and second layers.

37. The catheter of claim 36 wherein said first layer has a lower durometer than said second layer.

38. A method of forming a catheter having an elongated cylindrical body portion having distal and proximal end portions with one or more internal septums therein to form a plurality of lumens therebetween, the method comprising:

coextruding a plurality of materials having different durometers to form the septum and body portion of the catheter simultaneously such that the body portion of the catheter is formed to include at least first, second and third layers wherein the first layer has a lower durometer than the third layer.

39. The method as set forth in claim 38 wherein the second layer of the catheter is formed as a combination of the materials of the first and third layer such that the durometer of the second layer is intermediate to that of the first and third layers.

40. A method of forming extension members for use on a catheter, the method comprising:

coextruding a plurality of materials having different durometers to simultaneously form at least inner and outer layers on the extension members wherein the inner layer is harder than the outer layer.