Method of manufacture of a cannula for a medical device

• US 5,863,366 A
• Filed: 11/15/1996
• Issued: 01/26/1999
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Snow, David W.
• Primary Examiner(s): AFTERGUT, JEFFRY H
• Application Number:
  US08/749,683
• Time in Patent Office: 802 Days
• Field of Search: 156/195, 156/143, 156/173, 156/175, 156/169, 156/192, 156/189, 156/244.13, 156/244.26
• US Class Current: 156/143
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/127 Aorta
• 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 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0133 : Tip steering devices
• CPC Class Codes: A61M 25/0155 : with hydraulic or pneumatic means, e.g. balloons or inflatable compartments
• CPC Class Codes: A61M 25/02 : Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1006 : Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/1036 : Making parts for balloon catheter systems, e.g. shafts or distal ends A61M25/1029 takes precedence

Abstract

An elongate member is coated with a coating, preferably by coextrusion, and the coated elongate member is wound in a helical manner around a mandrel. The coated elongate member preferably has a square cross-sectional shape so that adjacent portions of the coated elongate member engage one another when the coated elongate member is wound around the mandrel. The coated elongate member is then heated so that the coating on adjacent portions of the coated elongate member fuse together to form an integral strcucture. Another layer of material may be provided on the radially inner or outer wall of the coated elongate member.

Claims

1. A method comprising the steps of:

coating an elongate member with a material thereby forming a coated elongate member, the coated elongate member having opposing sides;

winding the coated elongate member so that the opposing sides are facing one another;

melting the material on the coated elongate member after the winding step so that the opposing sides fuse together to form a reinforced tube having a finite length;

forming a medical device with the reinforced tube, the medical device having a wall thickness equal to or less than 0.018 inch;

inserting at least a portion of the reinforced tube into a patient; and

performing a medical procedure on the patient with the medical device after the inserting step.

2. The method of claim 1, further comprising the steps of:

compressing the coated elongate member with a shrink tube after the winding step and before the melting step; and

removing the shrink tube after the melting step.

3. The method of claim 1, wherein:

the coating step is carried out by coextruding the material over the elongate member.

4. The method of claim 1, wherein:

the coating step is carried out with the material being a substance selected from the group consisting of thermoplastics.

5. The method of claim 1, wherein:

the coating step is carried out with the material being a material selected from the group consisting of polyurethane, polyether block amide and PVC.

6. The method of claim 1, further comprising the step of:

dipping the coated elongate member in a solution after the winding step.

7. The method of claim 1, wherein:

the coating step is carried out so that the coated elongate member has a polygonal-shaped cross-section.

8. The method of claim 7, wherein:

the coextruding step is carried out so that the polygonal-shaped cross-section is a quadrangle.

9. The method of claim 1, wherein:

the winding step is carried out so that the coated elongate member forms a structure having a circular cross-sectional shape.

10. The method of claim 1, wherein:

the coating step is carried out with the elongate member being a metal wire.

11. The method of claim 1, wherein:

the melting step is carried out by heating the coated elongate member.

12. The method of claim 1, further comprising the step of:

positioning a layer on at least one of a radially inner and a radially outer side of the coated elongate member.

13. The method of claim 1, further comprising the step of:

positioning a tube of material on a radially inner or a radially outer side of the coated elongate member before the melting step;

the melting step being carried out so that the opposing sides fuse together and the material and the tube fuse together to form the reinforced tube.

14. The method of claim 1, wherein:

the forming step is carried out with the medical device having a thickness of 0.014 to 0.017 inch.

15. The method of claim 1, wherein:

the forming step is carried out with the medical device having a lumen having an inner diameter of at least 0.180 inch.

16. The method of claim 1, wherein:

the forming step is carried out with the lumen having an inner diameter of at least 0.236 inch.

17. The method of claim 1, wherein:

the winding step is carried out with adjacent portions of the coated elongate member having a centerline spacing of less than 0.022 inch.

18. A method comprising the steps of:

coating an elongate member with a material thereby forming a coated elongate member, the coated elongate member having opposing sides;

winding the coated elongate member so that the opposing sides are facing one another;

melting the material on the coated elongate member after the winding step so that the opposing sides fuse together to form a reinforced tube having a finite length;

forming a medical device with the reinforced tube;

inserting at least a portion of the reinforced tube into a patient; and

performing a medical procedure on the patient with the medical device after the inserting step;

the winding step being carried out with the coated elongate member forming a structure having a circular cross-sectional shape having a radius which varies along the longitudinal axis.

19. The method of claim 18, wherein:

the forming step is carried out with the medical device having a wall thickness of between 0.014 to 0.017 inch.

20. The method of claim 18, wherein:

the forming step is carried out with the medical device having a wall thickness equal to or less than 0.018 inch.

21. The method of claim 20, wherein:

the forming step is carried out with the medical device having a lumen with an inner diameter of at least 0.180 inch.

22. A method comprising the steps of:

coating an elongate member with a material thereby forming a coated elongate member, the coated elongate member having opposing sides;

winding the coated elongate member so that the opposing sides are facing one another;

positioning a tube on at least one of a radially inner and a radially outer side of the coated elongate member, the layer being a tube having a thickness equal to or less than 0.007 inch;

melting the material and the tube so that the opposing sides fuse together and the material and the tube fuse together to form a reinforced tube having a finite length; and

forming a medical device with the reinforced tube;

inserting at least a portion of the reinforced tube into a patient; and

performing a medical procedure on the patient with the medical device after the inserting step.

23. The method of claim 22, wherein:

the positioning step is carried out with the thickness of the tube being between 0.001 and 0.003 inch.

24. The method of claim 22, wherein:

the forming step is carried out with the medical device having a wall thickness equal to or less than 0.018 inch.

25. The method of claim 24, wherein:

the forming step is carried out with the medical device having a lumen having an inner diameter of at least 0.180 inch.

26. A method comprising the steps of:

coating an elongate member with a material thereby forming a coated elongate member, the coated elongate member having opposing sides;

winding the coated elongate member so that the opposing sides are facing one another;

positioning a shrink tube over the coated elongate member after the winding step, the shrink tube applying a compressive force to the coated elongate member;

melting the coated elongate member after the winding step so that the opposing sides fuse together and form a matrix around the elongate member to form a reinforced tube having a finite length;

removing the shrink tube after the melting step;

forming a medical device with the reinforced tube, the medical device having a wall thickness of between 0.014 and 0.017 inch;

inserting at least a portion of the reinforced tube into a patient; and

performing a medical procedure on the patient with the medical device after the inserting step.

27. The method of claim 26, further comprising the step of:

positioning a layer on at least one of a radially inner and a radially outer side of the coated elongate member.

28. The method of claim 26, wherein:

the winding step is carried out with adjacent portions of the coated elongate member having a centerline spacing equal to or less than 0.022 inch.

29. The method of claim 26, wherein:

the forming step is carried out with the medical device having a lumen having an inner diameter of at least 0.180 inch.