Flexible tubular device for use in medical applications

• US 5,741,429 A
• Filed: 05/31/1995
• Issued: 04/21/1998
• Est. Priority Date: 09/05/1991
• Status: Expired due to Term

• Current Assignee: Ev3 Peripheral Inc. (Medtronic Plc)
• Original Assignee: Cardia Catheter Company
• Inventors: Schwartz, Robert S., Berry, David, Holmes, David R., Donadio, James V. III
• Primary Examiner(s): ALANKO, ANITA KAREN
• Assistant Examiner(s): Adjodha, Michael E.
• Application Number:
  US08/455,331
• Time in Patent Office: 1,056 Days
• Field of Search: 216/8, 216/10, 216/56, 216/100, 216/48
• US Class Current: 216/8
• CPC Class Codes: A61M 2025/09066 having a coil without a core possibly combined with a sheath
• CPC Class Codes: A61M 2025/091 having a lumen for drug delivery or suction
• CPC Class Codes: A61M 2025/09191 made of twisted wires
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: B29C 41/20 incorporating preformed parts or layers, e.g. moulding inserts or for coating articles
• CPC Class Codes: B29L 2023/001 Tubular films, sleeves
• CPC Class Codes: B29L 2031/7542 Catheters
• CPC Class Codes: C23F 1/02 Local etching

Abstract

Manufacturing processes for apparatus, including slotted hypotube, for use as a catheter, a guidewire, a catheter sheath for use with catheter introducers or a drug infusion catheter/guidewire are disclosed. The manufacturing process includes creating a pattern of slots or apertures in a flexible metallic tubular member, by processes including but not limited to, electrostatic discharge machining (EDM), chemical milling, ablation and laser cutting. These slots or apertures may be cut completely or partially through the wall of the flexible metallic tubular member. These manufacturing processes may include the additional step of encasing the flexible metallic member such that a fluid tight seal is formed around the periphery of the tubular member.

Claims

1. A method for producing a flexible tubular device comprising:

a. providing a tubular element including an outer surface, the tubular element being sized for intravascular insertion within a human body;

b. providing a light source; and

c. creating a desired pattern on the tubular element by;

1) applying a photoresistive material to at least a portion of the outer surface of the tubular element;

2) providing a mask intermediate the tubular element and the light source, at least a portion of the mask including a mask pattern having locations translucent to light from the light source;

3) activating the light source to selectively expose the photoresistive material on the outer surface of the tubular element, such that exposed and unexposed locations are created on the photoresistive material;

4) developing the photoresistive material on the tubular element; and

5) removing segments of the tubular element corresponding to either the exposed or unexposed locations of the photoresistive material such that the tubular element is provided with the desired pattern, the desired pattern including a plurality of apertures that extend completely through the tubular element between an inner and outer diameter of the tubular element, the plurality of apertures being arranged and configured for providing the tubular element with in a desired flexibility suitable for intravascular operations.

2. The method of claim 1, wherein some of the apertures extend partially through the tubular element.

3. The method of claim 1, wherein the apertures are rectangular.

4. The method of claim 1, wherein the apertures are round.

5. The method of claim 1, wherein the tubular element is metal.

6. The method of claim 5, wherein the tubular element is stainless steel or nitinol.

7. The method of claim 1, wherein the mask includes a patterned tube for concentric placement around the tubular element.

8. The method of claim 1, wherein the mask includes a patterned film having a length approximately equal to the circumference of the tubular element.

9. The method of claim 1, wherein the light source is a laser.

10. The method of claim 1, wherein the flexible tubular device is a catheter.

11. The method of claim 1, wherein the flexible tubular device is a catheter sheath.

12. The method of claim 1, wherein the flexible tubular device is a drug infusion catheter.

13. The method of claim 1 additionally comprising removing the remaining photoresistive material.

14. The method of claim 13 additionally comprising laminating the tubular element with a coating.

15. The method of claim 14, wherein the laminated coating is a polymeric material.

16. The method of claim 1, wherein the step of developing the photoresistive material includes developing the photoresistive material positively or negatively.

17. The method of claim 1, wherein the step of removing the segments of the tubular element includes chemical etching.

26. The method of claim 3, wherein the pattern mask comprises a patterned film.

18. A method for producing a flexible tubular medical device comprising:

providing a tubular element sized for intravascular insertion in a human body, the tubular element including an outer surface;

providing a light source;

applying a photoresist to at least a portion of the outer surface of the tubular element;

providing a pattern mask intermediate the tubular element and the light source;

exposing the photoresist by directing light from the light source through the mask;

rotating the tubular element about its longitudinal axis;

translating the mask across the tubular element;

coordinating the operation of the light source with the movement of the tubular element and the mask such that an exposed pattern and an unexposed pattern are generated on the outer surface of the tubular element;

developing the photoresist to remove first regions of the photoresist that correspond to one of the exposed and unexposed patterns; and

removing first portions of the tubular element that correspond to the first regions of the photoresist such that the tubular element is provided with a desired pattern, the desired pattern including a plurality of apertures that extend completely through the tubular element between an inner and outer diameter of the tubular element, the plurality of apertures being arranged and configured for providing the tubular element with a desired flexibility suitable for intravascular operations.

19. The method of claim 18, wherein the pattern mask is substantially flat.

20. The method of claim 19, wherein the pattern mask is translated substantially along a planar path.

21. The method of claim 19, wherein the pattern mask has a patterned region having a length at least substantially equal to an outer circumference of the tubular element.

22. The method of claim 19, wherein the pattern mask comprises a patterned film.

23. The method of claim 18, wherein the pattern mask is substantially curved.

24. The method of claim 23, wherein the pattern mask is translated substantially along a curved path.

25. The method of claim 23, wherein the pattern mask has a patterned region having a length at least substantially equal to an outer circumference of the tubular element.