Collapse-resistant swellable catheter

• US 10,220,186 B2
• Filed: 05/23/2012
• Issued: 03/05/2019
• Est. Priority Date: 05/23/2012
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Searle, Gary, Hwang, Charles
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Engel, Matthew A
• Application Number:
  US13/479,114
• Publication Number:
  US 20130317476A1
• Time in Patent Office: 2,477 Days
• Field of Search: 604151, 60416401, 604264-265, 604506
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61M 2025/0059 having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
• CPC Class Codes: A61M 2025/0065 which become stiffer or softer when becoming wet or humid, e.g. immersed within a liquid
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14248 of the skin patch type

Abstract

A catheter and method of making it are disclosed. The catheter includes a swellable inner element and a non-swellable outer sleeve covering an outer wall of the inner element. The inner element absorbs liquid from infusate administered through the catheter and swells in size. Outward swelling of the inner element is restrained by the non-swellable outer sleeve. The inventive catheter can be substituted for a conventional catheter that is used in an insulin infusion system.

Claims

1. A collapse-resistant catheter comprising:

an inner element including one or more indents; and

a flexible outer sleeve covering an outer wall of the inner element up to a distal end of the inner element, the flexible outer sleeve being non-slidable on the outer wall of the inner element;

wherein the inner element comprises a swellable material;

wherein the flexible outer sleeve comprises a non-swellable material; and

wherein after the collapse-resistant catheter is inserted at an infusion site and a liquid is administered via the collapse-resistant catheter, the inner element absorbs a portion of the liquid, the inner element swells in volume within the flexible outer sleeve, and the one or more indents control a direction of the swelling by causing the inner element to fold inwardly.

2. The collapse-resistant catheter as claimed in claim 1, wherein outward swelling of the inner element is externally restrained by the flexible outer sleeve.

3. The collapse-resistant catheter as claimed in claim 1, wherein the swelling of the inner element is directed inward toward its centerline.

4. The collapse-resistant catheter as claimed in claim 1, wherein an orifice of the collapse-resistant catheter is sized to receive an introducer needle.

5. The collapse-resistant catheter as claimed in claim 1, wherein the swellable material of the inner element comprises a swellable polymer.

6. The collapse-resistant catheter as claimed in claim 5, wherein swelling of the inner element is controlled by a composition of the swellable polymer.

7. The collapse-resistant catheter as claimed in claim 5, wherein the swellable polymer comprises a biomaterial including polyurethane.

8. The collapse-resistant catheter as claimed in claim 7, wherein swelling of the inner element is controlled by a composition of the biomaterial.

9. The collapse-resistant catheter as claimed in claim 8, wherein the non-swellable material of the flexible outer sleeve comprises a non-swellable polymer.

10. The collapse-resistant catheter as claimed in claim 9, wherein the non-swellable polymer comprises a fluorinated polymer material.

11. The collapse-resistant catheter as claimed in claim 8, wherein the inner element comprises an inner tube having one or more thick segments and one or more thin segments.

12. The collapse-resistant catheter as claimed in claim 11, wherein the one or more thick segments and the one or more thin segments are alternately connected.

13. The collapse-resistant catheter as claimed in claim 11, wherein each of the one or more thin segments is configured to collapse toward the centerline of the collapse-resistant catheter, as liquid is absorbed.

14. The collapse-resistant catheter as claimed in claim 13, wherein the one or more collapsed thin segments forms a support leg.

15. The collapse-resistant catheter as claimed in claim 8, wherein the inner element comprises one or more swellable segments attached to an inner surface of the flexible outer sleeve.

16. The collapse-resistant catheter as claimed in claim 15, wherein the flexible outer sleeve comprises one or more retention tabs on which the one or more swellable segments are attached.

17. A method of transferring liquid via a collapse-resistant catheter, comprising the steps of:

providing a collapse-resistant catheter comprising a swellable inner element including one or more indents and a non-swellable outer sleeve externally covering an outer wall of the swellable inner element up to a distal end of the swellable inner element;

inserting the collapse-resistant catheter into a patient using an introducer needle;

removing the introducer needle from the collapse-resistant catheter;

transferring liquid via the collapse-resistant catheter;

absorbing liquid by the swellable inner element to cause swelling of the swellable inner element whereby the one or more indents control a direction of the swelling by causing the swellable inner element to fold inwardly; and

restraining outward expansion of the swellable inner element by the externally covering non-swellable outer sleeve.

18. A method of making a collapse-resistant catheter, comprising the steps of:

forming an inner element including one or more indents by extruding a swellable material;

forming a flexible outer sleeve by extruding a non-swellable polymeric material, the flexible outer sleeve being non-slidable on the inner element;

inserting the inner element into the flexible outer sleeve; and

shrinking the flexible outer sleeve over the inner element up to a distal end of the inner element to form the collapse-resistant catheter, wherein when the inner element absorbs liquid, the inner element swells and the one or more indents control a direction of the swelling by causing the inner element to fold inwardly.

19. The method as claimed in claim 18, further comprising a step of bonding the flexible outer sleeve to the inner element.

20. The method as claimed in claim 19, wherein the bonding step comprises RF tipping.