Catheter shaft having variable thickness layers and method of making

• US 6,663,614 B1
• Filed: 11/06/2000
• Issued: 12/16/2003
• Est. Priority Date: 11/06/2000
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Carter, Mark
• Primary Examiner(s): Mendez, Manuel
• Application Number:
  US09/707,681
• Time in Patent Office: 1,135 Days
• Field of Search: 604/523, 604/524, 604/525, 604/264, 604/915, 600/139, 600/140, 600/433-435, 600/523, 600/525, 600/534
• US Class Current: 604/525
• 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

Abstract

A catheter having a shaft with at least two variable layers, in which the relative proportions of the two layers changes along at least a part of the multilayered shaft section. The catheter shaft includes a cotapered transition section having a first layer tapering to a decreased thickness, and a second layer inversely tapering to an increased thickness. In one embodiment, the shaft has one or more tapered outer and/or inner surfaces in addition to the cotapered transition. The tapered, outer or inner surface of the shaft is typically longitudinally displaced from the cotapered transition section. In a presently preferred embodiment, the shaft having a cotapered transition section is coextruded. Another aspect of the invention includes a method of making a shaft having a cotapered transition section. The shaft of the invention provides improved transitions between shaft sections, to thereby change characteristics such as the shaft stiffness along the length of the catheter.

Claims

1. An intraluminal catheter, comprising an elongated shaft having a proximal end, a distal end, at least one lumen, a first layer, a second layer, the first layer being an inner layer relative to the second layer, and having

a) a first longitudinal section with the first layer having a tapered surface, and the second layer having an inversely tapered surface;

and

b) a second longitudinal section with a tapered outer diameter, and the first layer having a tapered inner surface and a tapered outer surface in the second longitudinal section of the catheter shaft, and the second layer having a substantially constant wall thickness in the second longitudinal section of the catheter shaft.

2. The catheter of claim 1 wherein the first longitudinal section of the catheter shaft is proximal to the second longitudinal section of the catheter shaft.

3. The catheter of claim 2 wherein the catheter shaft includes a third longitudinal section distal to the second longitudinal section of the catheter shaft, with a substantially constant outer diameter less than the outer diameter of the first longitudinal section of the catheter shaft, the first layer having a tapered surface, and the second layer having an inversely tapered surface.

4. The catheter of claim 1 wherein the first and second layers are continuous layers extending from the proximal end to the distal end of the catheter shaft.

5. The catheter of claim 1 wherein the proximal end of the second layer is distal to the proximal end of the first layer, and the distal end of the first layer is proximal to the distal end of the second layer.

6. The catheter of claim 1 wherein the catheter is a balloon catheter having a balloon secured to at least a section of the catheter shaft with an interior in fluid communication with the shaft lumen.

7. The catheter of claim 6 wherein the shaft comprises an outer tubular member defining an inflation lumen in fluid communication with the balloon, and the shaft includes an inner tubular member disposed within the inflation lumen defining a guidewire lumen, and wherein the balloon has a proximal end sealingly secured to a distal section of the outer tubular member and a distal end sealingly secured to a distal section of the inner tubular member.

8. The catheter of claim 1 wherein the first longitudinal section of the shaft has a length of about 13 cm to about 76 cm.

9. An intraluminal catheter, comprising an elongated shaft having a proximal end, a distal end, at least one lumen, a first layer having an inner surface tapering distally to a smaller inner diameter, a second layer, and having

a) a first longitudinal section with the first layer having a tapered surface, and the second layer having an inversely tapered surface;

and

b) a second longitudinal section distal to and directly adjacent to the first longitudinal section of the catheter shaft, with a tapered outer diameter, and the first layer having an outer surface tapering distally to a smaller outer diameter in the second longitudinal section of the catheter shaft and the second layer having an outer surface tapering distally to a smaller outer diameter in the second longitudinal section of the catheter shaft.

10. The catheter of claim 9 wherein the first longitudinal section has a substantially constant outer diameter.

11. An intraluminal catheter, comprising an elongated shaft having a proximal end, a distal end, at least one lumen, and having at least a section having cotapered first and second layers, so that the first layer has a tapered surface and the second layer has an inversely tapered surface, the first layer being formed of a polymer having a melt flow index of about 10 to about 20 grams/minute, and the second layer being formed of a polymer having a melt flow index of about 10 to about 20 grams/minute.

12. The catheter of claim 11 wherein the melt flow index of the first layer polymer is not greater than the melt flow index of the second layer polymer, and the first layer polymer has a higher Shore durometer hardness than the second layer polymer.

13. An intraluminal catheter, comprising an elongated shaft having a proximal end, a distal end, at least one lumen, a first layer, a second layer, the first layer being an inner layer relative to the second layer, and having

a) a first longitudinal section with the first layer having a tapered surface, and the second layer having an inversely tapered surface;

b) a second longitudinal section with a tapered outer diameter, and the first layer has a substantially constant wall thickness in the second longitudinal section of the catheter shaft, and the second layer has a tapered inner surface and a tapered outer surface in the second longitudinal section of the catheter shaft; and

c) a shaft section between and directly adjacent to the first and second longitudinal sections of the catheter shaft, having a constant outer diameter and a constant interfacial diameter between the first and second layers.

14. An intraluminal catheter, comprising an elongated shaft having a proximal end, a distal end, at least one lumen, a first layer having a proximal and a distal end, a second layer having a proximal end located distal to the proximal end of the first layer and a distal end located distal to the distal end of the first layer, and having

a) a first longitudinal section with the first layer having a tapered surface, and the second layer having an inversely tapered surface;

and

b) a second longitudinal section with a tapered outer diameter, at least one of the first or second layers having a tapered inner surface and a tapered outer surface in the second longitudinal section of the catheter shaft, and at least one of the first or second layers having a substantially constant wall thickness in the second longitudinal section of the catheter shaft.

15. An intraluminal catheter, comprising an elongated shaft having a proximal end, a distal end, at least one lumen, a first layer, a second layer, the first layer being an inner layer relative to the outer layer, and having

a) a first longitudinal section with the first layer having a tapered surface, and the second layer having an inversely tapered surface;

b) a second longitudinal section with a tapered outer diameter, at least one of the first or second layers having a tapered inner surface and a tapered outer surface in the second longitudinal section of the catheter shaft, and at least one of the first or second layers having a substantially constant wall thickness in the second longitudinal section of the catheter shaft; and

c) an inner liner having a substantially constant wall thickness on an inner surface of the first layer.