Tubing

• US 5,533,985 A
• Filed: 04/20/1994
• Issued: 07/09/1996
• Est. Priority Date: 04/20/1994
• Status: Expired due to Term

• Current Assignee: James C. Wang
• Original Assignee: James C. Wang
• Inventors: Wang, James C.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/230,333
• Time in Patent Office: 811 Days
• Field of Search: 604/282, 604/280, 604/281, 604/96, 604/264, 128/656-658, 128/786
• US Class Current: 604/264
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: B29C 2948/926 Flow or feed rate
• CPC Class Codes: B29C 2948/92828 Raw material handling or dosing, e.g. active hopper or feeding device
• CPC Class Codes: B29C 48/09 Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 48/10 flexible, e.g. blown foils
• CPC Class Codes: B29C 48/11 comprising two or more partially or fully enclosed cavities, e.g. honeycomb-shaped
• CPC Class Codes: B29C 48/12 Articles with an irregular circumference when viewed in cross-section, e.g. window profiles
• CPC Class Codes: B29C 48/153 Coating both inner and outer surfaces
• CPC Class Codes: B29C 48/18 the components being layers
• CPC Class Codes: B29C 48/21 the layers being joined at their surfaces
• CPC Class Codes: B29C 48/335 Multiple annular extrusion nozzles in coaxial arrangement, e.g. for making multi-layered tubular articles
• CPC Class Codes: B29C 48/337 the components merging at a common location
• CPC Class Codes: B29C 48/34 Cross-head annular extrusion nozzles, i.e. for simultaneously receiving moulding material and the preform to be coated
• CPC Class Codes: B29C 48/92 Measuring, controlling or regulating
• CPC Class Codes: B29L 2031/7542 Catheters

Abstract

Differential stiffness tubing for medical products, such as catheters, and a method and apparatus for making the tubing. The tubing has a stiff section and a flexible section joined by a relatively short transition section in which the materials of the stiff and flexible sections are wedged into each other in a smooth gradual manner to produce an inseparable bond between the materials without abrupt joints. The tubing is made using a resin modulating system and a unique co-extrusion head that minimize the length of the transition section by minimizing the volumes in all flow channels of the head.

Claims

1. An elongated tube having an annular wall with an outer surface and an inner surface which inner surface defines a central passageway of a uniform size, said tube comprising a first section comprised of a first material, a second section comprised of a second material, the first and second materials being of different stiffness, and an intermediate section joining the first section and the second section, the intermediate section being a transition section in which the wall of the tube gradually changes from the first material of the first section to the second material of the second section to form a continuous unbroken tube of differential stiffness without abrupt joints, the materials of the first section and the second section naturally adhering to each other and being gradually combined in the transition section to form a wedge structure in which the first material extends into the second material within the transition section so that the second material surrounds the wedge structure of the first material and is between the wedge structure and both the inner surface and the outer surface of the wall.

2. The elongated tube of claim 1 wherein the average length of said transition section is about 0.25-20 inches.

3. The elongated tube of claim 1 wherein at least one additional material of a stiffness intermediate to the stiffness of said first and said second materials is gradually combined with and between said first and said second materials in the transition section to form a wedge structure in which said additional material extends into said first material and said second material extends into said additional material.

4. The elongated tube of claim 1 in which the wedge structure comprises a plurality of longitudinally extending spear points of the first material extending into the second material in the wall of the transition section, wherein the spear points have downstream ends circumferentially spaced apart in the wall of the transition section and gradually increase in size in the upstream direction until they join to form an annular wedge structure.

5. The elongated tube of claim 1 in which the wedge structure is formed by a plurality of elements of the first material which elements are circumferentially spaced apart in the wall of the transition section of the tube.

6. The elongated tube of claim 5 in which the ends of the elements of the first material that forms the wedge structure are spaced from both the inner surface and the outer surface of the wall of the tube.

7. A tubular strain relief insert for preventing kinking at or near a joint between a flexible tubing and a rigid fitting, said strain relief insert comprising the elongated tube of claim 1.

8. A non-kinking joint assembly for tubing, said joint assembly comprising a rigid fitting;

a flexible tubing coaxial with said fitting and extending distally therefrom; and

a tubular strain relief insert comprising the elongated tube of claim 1 jacketing said flexible tubing, wherein a portion of the first section of said elongated tube is disposed between said flexible tubing and said fitting and the transition and second sections of said elongated tube extend distally about said flexible tubing from said first section, providing graduated flexibility to said joint.

9. An elongated tube suitable for insertion into a quick-connect fitting comprising the elongated tube of claim 1 having a plurality of first sections, each pair of first sections having a second section therebetween joined to each of said first sections by a transition section to form a continuous unbroken tube of differential stiffness without abrupt joints.

10. A medical catheter having a shaft comprising the elongated tube of claim 1.

11. A multi-lumen catheter comprising the catheter of claim 10 wherein said tube wall defines at least one additional passageway.

12. The catheter of claim 10 further comprising a circumferential layer of braided metal mesh embedded in said wall in at least a portion of said catheter.

13. The catheter of claim 10 further comprising a helically wound metal coil embedded in said wall in at least a portion of said catheter.

14. A soft-tip guiding catheter comprising the catheter of claim 10 wherein said transition section is curved in its relaxed state and said first section is sufficiently soft to provide a low-trauma distal tip for said guiding catheter.

15. An angiographic catheter comprising the catheter of claim 10 wherein the axis of said first section is curved in its relaxed state.

16. The angiographic catheter of claim 15 wherein said tube wall is perforated in said transition section to provide medication dispensing apertures.

17. A coated guidewire for use with a medical catheter, said coated guidewire comprising a guidewire having a proximal end of uniform stiffness throughout its length and a distal end tapered to decrease its stiffness in the distal direction;

said coated guidewire further comprising a jacket about said guidewire comprising the elongated tube of claim 1, said jacket providing further differential stiffness along the length of said coated guidewire.

18. A coated guidewire of claim 17 wherein said jacket further provides a substantially uniform outer diameter along the length of said coated guidewire.

19. A coated cable comprising a cable of uniform stiffness throughout its length and a jacket about said cable comprising the elongated tube of claim 1, said jacket providing differential stiffness along the length of said coated cable.

20. A unit of bump tubing having a bell end and an insert end, said bump tubing unit comprising the elongated tube of claim 1, wherein said insert end is provided by said stiffer second section of said tube and said bell end is provided by said first section, said first material of said first section being sufficiently soft to grip an insert end of another unit of said bump tubing.

21. The elongated tube of claim 1 in which the second material surrounds the wedge structure of the first material and forms both the inner surface and the outer surface of the tube wall within the transition section.

22. The elongated tube of claim 21 in which the wedge structure is formed by a plurality of elements of the first material which elements are circumferentially spaced apart in the wall of the tube.

23. The elongated tube of claim 22 in which the ends of the elements of the first material forming the wedge structure are spaced from both the inner surface and the outer surface of the wall of the tube.

24. The elongated tube of claim 1 in which the first section is comprised primarily of the first material with the first material forming the inner surface of the wall of the first section but the second material forms the outer wall of the first section, and the second section is comprised primarily of the second material with the second material forming the outer surface of the wall of the second section but the first material forms the inner wall of the second section.

25. An elongated tube having an annular wall with an outer surface and an inner surface which inner surface defines a central passageway of a uniform size, said tube comprising a first section comprised primarily of a first material that forms the inner surface of the wall, a second section comprised primarily of a second material that forms the outer surface of the wall, the first and second materials being of different stiffness, and an intermediate section joining the first section and the second section, the intermediate section being a transition section in which the wall of the tube gradually changes from the primary material of the first section to the primary material of the second section to form a continuous unbroken tube of differential stiffness without abrupt joints, the materials of the first section and the second section naturally adhering to each other and being gradually combined in the transition section to form a structure in which the first material continues to form the inner surface of the wall of the tube within the transition section and the second material continues to form the outer surface of the wall of the tube within the transition section.

26. The elongated tube of claim 25 in which the first material continues into the second section and continues to form the inner surface of the wall in the second section and the second material continues into the first section and continues to form the outer surface of the wall in the first section.