COLLAPSE-RESISTANT SWELLABLE CATHETER

• US 20130317476A1
• Filed: 05/23/2012
• Published: 11/28/2013
• Est. Priority Date: 05/23/2012
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Searle, Gary, Hwang, Charles G.
• Granted Patent: US 10,220,186 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• 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; and

an outer sleeve covering an outer wall of the inner element;

wherein the inner element comprises a swellable material; and

wherein the outer sleeve comprises a non-swellable material.

2. The catheter as claimed in claim 1, wherein the inner element absorbs liquid that is administered via the catheter and swells in volume.

3. The catheter as claimed in claim 2, wherein outward swelling of the inner element is restrained by the non-swellable outer sleeve.

4. The catheter as claimed in claim 2, wherein the swelling of the inner element is directed inward toward its centerline.

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

6. The catheter, as claimed in claim 1, wherein the swellable material of the inner element comprises a swellable polymer.

7. The catheter, as claimed in claim 6, wherein swelling of the inner element is controlled by the polymer composition.

8. The catheter as claimed in claim 6, wherein the swellable polymer comprises Vialon™

biomaterial.

9. The catheter as claimed in claim 8, wherein swelling of the inner element is controlled by the Vialon™

biomaterial composition.

10. The catheter as claimed in claim 1, wherein the non-swellable material of the outer sleeve comprises a non-swellable polymer.

11. The catheter as claimed in claim 10, wherein the non-swellable polymer comprises Teflon®

polymer.

12. The catheter as claimed in claim 1, wherein the inner element comprises an inner tube having one or more thick segments and one or more thin segments.

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

14. The catheter as claimed in claim 12, wherein each of the one or more thin segments is configured to collapse toward the centerline of the catheter, as liquid is absorbed.

15. The catheter as claimed in claim 14, wherein each of the collapsed thin segments forms a support leg.

16. The catheter as claimed in claim 1, wherein the inner element comprises one or more swellable segments attached to an inner surface of the outer sleeve.

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

18. A method of administering insulin via a catheter, comprising the steps of:

providing a catheter comprising a swellable inner element and a non-swellable outer sleeve covering an outer wall of the inner element;

inserting the catheter into a patient;

administering infusate to the patient via the catheter;

absorbing liquid from the infusate by the inner element to cause swelling of the inner element; and

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

19. A method of making a catheter, comprising the steps of:

forming an inner element by extruding a swellable material;

forming an outer sleeve by extruding a non-swellable material;

inserting the inner element into the outer sleeve; and

shrinking the outer sleeve over the inner element to form the catheter.

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

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

22. An infusion system comprising:

a base;

a hub detachably attached to the base;

a pump;

a fluid tubing set that connects the pump and the base; and

a catheter comprising;

a swellable inner element; and

a non-swellable outer sleeve covering the outer wall of the tubing;

wherein the swellable inner element is attached to an inner surface of the non-swellable outer sleeve.

23. A patch pump comprising:

a base;

a hub detachably attached to the base;

a pump;

a fluid tubing set that connects the pump and the base; and

a catheter comprising;

a swellable inner element; and

a non-swellable outer sleeve covering the outer wall of the tubing;

wherein the swellable inner element is attached to an inner surface of the non-swellable outer sleeve.