Multilaminate coiled film catheter construction

• US 5,217,440 A
• Filed: 10/08/1992
• Issued: 06/08/1993
• Est. Priority Date: 10/06/1989
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Frassica, James J.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US07/958,546
• Time in Patent Office: 243 Days
• Field of Search: 128/657, 128/658, 128/772, 604/264, 604/265, 604/280-282, 72/147, 72/148, 493/292, 493/299, 493/301, 493/303, 493/304, 264/319, 264/320, 264/322, 264/149, 264/150, 156/86, 156/184, 156/203, 156/215
• US Class Current: 604/524
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: B29C 53/562 spirally

Abstract

A catheter shaft and catheter are formed by spirally rolling a thin polymeric film about a mandrel into a tubular form and fixing the spirally wound film in the tubular form. Additional elements and films may be incorporated into the spirally wound tube to provide a catheter having varied characteristics and functions.

Claims

1. A catheter for insertion into the human body comprising:

an elongate tubular shaft formed from at least one film of material rolled into an elongate tube having a plurality of layers and permanently fixed in said rolled configuration;

said shaft being formed from a biocompatible material and having a proximal end and a distal end, the shaft being constructed to enable the distal end to be inserted into the body of a human patient;

a fitting attached to the proximal end of the shaft;

said catheter including means at the distal end of the shaft for treating a medical condition of the patient, the catheter being manipulable from the proximal portion thereof disposed outside of the patient'"'"'s body.

2. A catheter as defined in claim 1 further comprising at least one additional element formed from a different material and incorporated into the wall of the elongate tube.

3. A catheter as defined in claim 2 wherein the film is formed from a polymeric material.

4. A catheter as defined in claim 2 wherein the film is a polymeric film and the additional element comprises a hollow tubular member.

5. A catheter as defined in claim 2 wherein the film is polymeric and the additional element is elastomeric.

6. A catheter as defined in claim 2 wherein the first film is polymeric and the additional element is substantially radiopaque.

7. A catheter as defined in claim 2 wherein the first film is polymeric and the additional element is a low friction material.

8. A catheter as defined in claim 2 wherein the film is polymeric and the additional element comprises an electrical conductor.

9. A catheter as defined in claim 2 wherein said at least one additional element includes a film of different material disposed along a surface of said first mentioned film and defining the inner surface of the spirally rolled.

10. A catheter as defined in either of claims 2 or 9 wherein said at least one element includes a film of different material disposed along a surface of said first mentioned film and defining the outer surface of the spirally rolled material.

11. A catheter as defined in claim 1 wherein said means for treating or diagnosing a medical condition of the patient comprises a balloon carried on the catheter shaft and means for inflating and deflating the balloon while it is in the patient'"'"'s body.

12. A catheter as defined in claim 1 wherein said means for treating or diagnosing a medical condition of the patient comprises optical means for transmitting light lengthwise of the catheter.

13. A catheter as defined in claim 1 wherein said means for treating or diagnosing a medical condition of the patient comprises electrically conductive means.

14. A catheter as defined in claim 1 wherein said means for treating or diagnosing a medical condition of the patient comprises a lumen for fluid communication between the interior and exterior of the patient'"'"'s body.

15. A catheter as defined in claim 1 wherein said means for treating or diagnosing a medical condition of the patient comprises a transducer.

16. A catheter as defined in claim 1 wherein said means for treating or diagnosing a medical condition of the patient comprises electrodes.

17. A catheter as defined in claim 1 wherein said means for treating or diagnosing a medical condition of the patient comprises the distal end of the catheter having a predetermined curve formed therein adapted to facilitate a specific medical procedure.

18. A catheter as defined in claim 1 wherein said means for treating or diagnosing a medical condition of the patient comprises a fitting at the proximal end of the shaft.

19. A catheter as defined in claim 1 wherein said medical condition comprises a wound and the catheter includes means to drain the wound.

20. A catheter as defined in claim 1 wherein the catheter shaft is constructed and arranged to have sufficient torsional rigidity to enable torque to be transmitted from the proximal to the distal end thereby to facilitate navigation of the distal end of the catheter through the patient.

21. A catheter as defined in claim 1 wherein the shaft is constructed to have sufficient column strength so that it can be pushed through a lumen in the patient.

40. A catheter shaft as defined in any of claims 3-5 wherein the rolled tube is permanently fixed by fusing at least a portion of the polymeric film from which the catheter is rolled.

41. A catheter as defined in any of claims 1-39 wherein the shaft is permanently fixed by adhesive means bonding at least portions of the spirally rolled material.

42. A catheter shaft as defined in any of claims 6-31 wherein the rolled tube is permanently fixed by fusing at least a portion of the polymeric film from which the catheter is rolled.

22. A catheter for insertion into the body of a human patient comprising:

an elongate tubular shaft formed from at least one film of material rolled into an elongate tube having a plurality of layers and permanently fixed in said rolled configuration;

said shaft being constructed to be inserted partly into the body of a patient;

said catheter including means for treating a medical condition of the patient, the catheter being manipulable from the portion thereof disposed outside of the patient'"'"'s body;

at least one additional element formed from a different material and incorporated into the wall of the elongate tubular shaft, at least one of said additional elements extending over only a portion of the length of the tube.

23. A catheter as defined in claim 22 wherein the film is formed from a polymeric material.

24. A catheter as defined in claim 22 wherein the film is a polymeric material and the additional element comprises a metallic film.

25. A catheter as defined in claim 22 wherein the film is polymeric and the additional element comprises a hollow tubular member.

27. A catheter as defined in claim 22 wherein the film is polymeric and the additional element is elastomeric.

28. A catheter as defined in claim 22 wherein the first film is polymeric and the additional element is substantially radiopaque.

29. A catheter as defined in claim 22 wherein the first film is polymeric and the additional element is a low friction material.

30. A catheter as defined in claim 22 wherein the first film is polymeric and the additional element is an optical fiber.

31. A catheter as defined in claim 22 wherein the first film is polymeric and the additional element comprises an electrical conductor.

26. A catheter as defined in clam 22 wherein the film is polymeric and the additional element is fibrous.

32. A catheter for insertion into the body of a human patient comprising:

an elongate tubular shaft formed from at least one film of polymeric material rolled into an elongate tube having a plurality of layers and permanently fixed in said rolled configuration;

said shaft being constructed to be inserted partly into the body of a patient;

said catheter including means for treating a medical condition of the patient, the catheter being manipulable from the portion thereof disposed outside of the patient'"'"'s body;

at least one additional element formed from a metallic film and incorporated into the wall of the elongate tubular shaft, at least one of said additional elements extending over only a portion of the length of the tube.

33. A catheter as defined in claim 32 wherein the metallic film is formed in a predetermined pattern.

34. A catheter as defined in claim 33 wherein the pattern forms a different pattern when rolled into tubular form.

35. A catheter having a shaft comprising:

at least one film of polymeric material spirally rolled into an elongate tube and permanently fixed in said rolled configuration; and

at least one additional element formed from a metallic film in a predetermined pattern comprising a plurality of chevrons and incorporated into the wall of the elongate tube, the pattern forming a different double helical pattern when rolled into tubular form.

36. A catheter for insertion into the body of a human patient comprising:

an elongate tubular shaft formed from at least one film of polymeric material rolled into an elongate tube having a plurality of layers and permanently fixed in said rolled configuration;

said shaft being constructed to be inserted partly into the body of a patient;

said catheter including means for treating a medical condition of the patient, the catheter being manipulable from the portion thereof disposed outside of the patient'"'"'body;

at least one additional element formed from a fibrous material and incorporated into the wall of the elongate tubular shaft, at least one of said additional elements extending over only a portion of the length of the tube.

37. A catheter for insertion into the body of a human patient comprising:

an elongate tubular shaft formed from at least one film of polymeric material rolled into an elongate tube having a plurality of layers and permanently fixed in said rolled configuration;

said shaft being constructed to be inserted partly into the body of a patient;

said catheter including means for treating a medical condition of the patient, the catheter being manipulable from the portion thereof disposed outside of the patient'"'"'s body;

at least one additional element comprising an optical fiber and incorporated into the wall of the elongate tubular shaft.

38. A catheter for insertion into the body of a human patient comprising:

an elongate tubular shaft formed from at least one film of material rolled into an elongate tube having a plurality of layers and permanently fixed in said rolled configuration;

said shaft being constructed to be inserted partly into the body of a patient;

said catheter including means defining at least one lumen extending through the wall of the catheter shaft;

said catheter including means for treating a medical condition of the patient comprising a balloon at the distal end of the shaft in communication with the lumen,

the catheter being manipulable from the portion thereof disposed outside of the patient'"'"'s body.

39. A catheter as defined in claim 38 wherein the lumen comprises a hollow elongate member contained within the catheter wall.