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Title:
METHODS FOR MANUFACTURING A CATHETER USING AN ALUMINUM NITRIDE BONDING APPARATUS
Document Type and Number:
WIPO Patent Application WO/2014/138684
Kind Code:
A4
Abstract:
Apparatuses and methods for joining one or more tubing sections together to form a tubular catheter device, for shaping one or more tubular sections (402,404) of a catheter device, and/or for fusing elements (e.g., a radiopaque marker) onto a portion of the catheter. Each section of the catheter is typically fabricated independently from the other sections. Subsequently, the separate sections are fused together to form the catheter. The methods described herein allow the various sections of the catheter to be fitted together for fabrication without the use of heat-shrink tubing. The fitted parts are clamped in a die or mold (410) at a temperature at or near room temperature; the die (410) is then rapidly heated to fuse the parts, rapidly cooled back down to a temperature at or about room temperature, and removed from the die.

Inventors:
WROLSTAD DAVID K (US)
MANN JUSTIN K (US)
Application Number:
PCT/US2014/022098
Publication Date:
November 27, 2014
Filing Date:
March 07, 2014
Export Citation:
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Assignee:
ABBOTT CARDIOVASCULAR SYSTEMS (US)
International Classes:
B29C65/18; B29C57/00; B29C65/00; B29C67/00
Attorney, Agent or Firm:
TAYLOR, Paul et al. (60 East South Temple Suite 100, Salt Lake City Utah, US)
Download PDF:
Claims:
AMENDED CLAIMS

received by the International Bureau on29 August 2014 (29.08.2014)

1. A method, comprising:

positioning at least one section of a tubular catheter in a heater apparatus, wherein the heater apparatus has a thermal conductivity of between 140 W/m-K and 210 W/m-K;

clamping the at least one section of the tubular catheter in the heater apparatus at a temperature at or near room- temperature;

heating the heater apparatus with the at least one section of the tubular catheter clamped therein to a selected temperature sufficient to at least partially melt or reform at least a portion of the at least one section of the tubular catheter in less than 2 seconds;

cooling the heater apparatus with the at least one section of the tubular catheter clamped therein to a temperature at or near room-temperature in less than 4 seconds; and

unclamping the at least one section of the tubular catheter from the heater apparatus and removing the at least one section of the tubular catheter therefrom.

2. The method of claim 1, wherein the heater apparatus includes an aluminum nitride heating element.

3. The method of claim 2, wherein the heater apparatus includes a jaw- like clamping element coupled to the aluminum nitride heating element that is configured to separate the aluminum nitride heating element into a first section and a second section and wherein the aluminum nitride heating element further includes a heat sink linked to a first face of each section the aluminum nitride heating element and first and second effector elements linked to each second, opposite face of first and second sections the aluminum nitride heating element.

4. The method of claim 3, wherein the effector elements are configured to apply a clamping force to the article and to transmit heat from the aluminum nitride heating element to fuse and/or reshape the at least one section of the tubular catheter.

5. The method of claim 3, wherein the effector element is configured to apply a clamping force to the at least one section of the tubular catheter and for transmitting heat from the aluminum nitride heating element to bond a first portion of the tubular catheter to a second portion of the tubular catheter. 6. The method of claim 1, wherein the selected temperature is in a range from 100° C to 300° C.

7. The method of claim 1, wherein the selected temperature is in a range from 105° C to 175° C.

8. The method of claim 1, wherein the selected temperature is in a range from 110° C to 120° C.

9. The method of claim 1, wherein the heating apparatus is configured for heating from the temperature at or near room-temperature to the selected temperature in less than 1.5 seconds and the heating apparatus is configured for cooling from the selected temperature to at or near room temperature in less than 3 seconds. 10. The method of claim 1, wherein the at least one section of the tubular catheter comprises a thermoplastic material.

11. The method of claim 1 , wherein the tubular catheter comprises at least one of a tubular catheter having a tungsten marker, a tubular catheter having an inflatable balloon section, or a tubular catheter having a shaped section. 12. The method of claim 1, further comprising reshaping at least a portion of the at least one section of the tubular catheter.

13. The method of claim 12, wherein the reshaping includes one or more of forming a ring section, a spiral section, a necked section, or a prefold section on at least a portion of the at least one section of the tubular catheter. 14. The method of claim 12, wherein the reshaping includes one or more of necking a proximal end portion, a distal end portion, or a portion between the proximal end portion and the distal end portion.

15. The method of claim 14, wherein the necked portion has altered flexibility as compared to adjacent sections of the tubular catheter.

16. The method of claim 1, further comprising welding a first tubular catheter section to a second tubular catheter section to form a unitary tubular catheter section.

17. The method of claim 16, wherein the unitary tubular catheter section comprises at least a portion of the tubular catheter.

18. The method of claim 16, wherein the first tubular catheter section is an elongate member and the second tubular catheter section is a tungsten marker.

19. The method of claim 16, wherein the first tubular catheter section is an elongate member and the second tubular catheter section is an inflatable balloon member.

20. The method of claim 1, further comprising:

positioning first and second tubular catheter sections of the tubular catheter on a mandrel;

assembling the first and second tubular catheter sections of the tubular catheter by overlapping a first end of the first tubular catheter section with a first end of the second tubular catheter section;

clamping the assembled first and second tubular catheter sections in the heater apparatus at a temperature at or near room- temperature;

heating the heater apparatus to the selected temperature to weld the first and second tubular catheter sections together;

the heater apparatus to a temperature at or near room- temperature; unclamping the heater apparatus and removing the welded first and second tubular catheter sections therefrom.

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21. The method of claim 20, further comprising:

positioning the assembled first and second tubular catheter sections in an aluminum nitride heater apparatus, wherein the aluminum nitride heater apparatus is arranged with a separable jaw-like clamping element coupled to an aluminum nitride heating element to permit the first and second tubular catheter portions to be positioned therein;

closing the separable jaw-like clamping element to clamp the assembled first and second tubular catheter sections in the aluminum nitride heater apparatus at a temperature at or near room- temperature;

heating the aluminum nitride heater apparatus with the assembled first and second tubular catheter sections clamped therein to the selected temperature to couple the first and second tubular catheter portions together; cooling the heater apparatus to a temperature at or near room- temperature;

opening the separable jaw-like clamping element of the heater apparatus to unclamp the fused the first and second tubular catheter portions; and

removing the coupled first and second catheter portions from the aluminum nitride heater apparatus. 22. The method of claim 21, wherein the heater apparatus includes a jawlike clamping element coupled to the aluminum nitride heating element that is configured to separate the aluminum nitride heating element into a first section and a second section and wherein the aluminum nitride heating element further includes a heat sink linked to a first face of each section of the aluminum nitride heating element and first and second effector elements linked to each second, opposite face of first and second sections the aluminum nitride heating element.

23. The method of claim 22, wherein the effector elements are configured to apply a clamping force to the article and to transmit heat from the aluminum nitride heating element to fuse and/or reshape the at least one section of the tubular catheter.

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