Curved Catheter and Methods for Making Same

• US 20140200524A1
• Filed: 01/10/2014
• Published: 07/17/2014
• Est. Priority Date: 01/11/2013
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Barron, William R., Diamond, Jordan P., Wiley, Martha R., Snyder, Scott W.
• Granted Patent: US 10,252,023 B2
• Time in Patent Office: Days
• US Class Current: 604/284
• CPC Class Codes: A61M 2025/024 having a clip or clamp system
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0013 Weakening parts of a catheter tubing, e.g. by making cuts in the tube or reducing thickness of a layer at one point to adjust the flexibility
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 5/1418 Clips, separators or the like for supporting tubes or leads
• CPC Class Codes: B29C 53/083 bending longitudinally, i.e. modifying the curvature of the tube axis
• CPC Class Codes: Y10T 29/49 Method of mechanical manufacture

Abstract

A pre-curved catheter tube of a catheter assembly or other elongate medical device and methods for forming such a device using a heating procedure is disclosed. Pre-curving of the catheter tube is desirable to impart to the catheter assembly a desired positional configuration when the catheter assembly is inserted into a patient. The heating procedure may include heat sterilization procedures commonly used to sterilize medical devices prior to use. In one embodiment, therefore, a catheter assembly is disclosed, comprising an elongate catheter tube defining at least one lumen, and a tube constraint. The tube constraint is included with the catheter assembly and is configured to temporarily constrain the catheter tube in a curved configuration during a heating procedure of the catheter assembly so as to permanently form the catheter tube in the curved configuration after the heating procedure is complete and the catheter tube is released from the tube constraint.

Claims

1. A catheter assembly, comprising:

an elongate catheter tube defining at least one lumen; and

a tube constraint included with the catheter assembly that temporarily constrains the catheter tube in a curved configuration during a heating procedure of the catheter assembly to permanently maintain the catheter tube substantially in the curved configuration after the heating procedure is complete and the catheter tube is released from the tube constraint.

2. The catheter assembly as defined in claim 1, wherein the heating procedure includes a heat sterilization procedure.

3. The catheter assembly as defined in claim 2, wherein the heating procedure includes an ethylene oxide sterilization procedure.

4. The catheter assembly as defined in claim 3, wherein the ethylene oxide sterilization procedure is performed at a temperature of at least about 55 degrees Celsius.

6. The catheter assembly as defined in claim 1, wherein the curved configuration includes a looped configuration of the catheter tube.

7. The catheter assembly as defined in claim 1, wherein the tube constraint is permanently attached to the catheter assembly.

8. The catheter assembly as defined in claim 1, wherein the tube constraint is temporarily attached to the catheter assembly.

9. The catheter assembly as defined in claim 1, wherein the tube constraint prevents a portion of the catheter tube retained by the tube constraint from physically contacting another portion of the catheter tube or bifurcation.

10. The catheter assembly as defined in claim 1, wherein the tube constraint includes at least one notch disposed on at least one of a bifurcation and a suture wing of the catheter assembly.

11. The catheter assembly as defined in claim 10, wherein the tube constraint includes a first notch disposed on the suture wing and a second notch disposed on the bifurcation such that a portion of the catheter tube is interposed between the first and second notches in a sandwich configuration when the catheter tube is in the curved configuration.

12. The catheter assembly as defined in claim 11, wherein the position of the first and second notches is predetermined so as to place the catheter tube in a curved configuration that defines a predetermined radius.

13. The catheter assembly as defined in claim 1, wherein the tube constraint includes a compliant form including at least one portion for attaching to the catheter assembly and at least one hole for receiving therethrough a portion of the catheter tube for maintaining the catheter tube in the curved configuration.

14. The catheter assembly as defined in claim 13, wherein the tube constraint includes a spun-bonded olefin sheet.

15. The catheter assembly as defined in claim 1, wherein the tube constraint includes at least one clip disposed on at least one of a bifurcation and a suture wing of the catheter assembly.

16. The catheter assembly as defined in claim 1, wherein the tube constraint includes an adhesive material temporarily attached to a portion of the catheter assembly.

5. The catheter assembly as defined in claim 5, wherein the ethylene oxide sterilization procedure is performed for a time of at least about 15 minutes.

17. A catheter assembly, comprising:

an elongate catheter tube defining at least one lumen;

a bifurcation operably connecting the elongate catheter tube to at least one extension leg tube; and

a tube constraint permanently included with the catheter assembly, the tube constraint temporarily constraining the catheter tube in a curved configuration during a heating procedure of the catheter assembly, the heating procedure imparting a permanent curve to the catheter tube after the catheter tube is released from the tube constraint.

18. The catheter assembly as defined in claim 17, wherein the catheter assembly further includes a suture wing and wherein the tube constraint includes a first notch disposed on the suture wing and a second notch disposed on the bifurcation such that a portion of the catheter tube is interposed between the first and second notches in a sandwiched configuration when the catheter tube is in the curved configuration.

19. The catheter assembly as defined in claim 18, wherein the permanent curve of the catheter tube defines a loop.

20. The catheter assembly as defined in claim 18, wherein the suture wing is rotatably attached to the bifurcation and wherein the first notch is laterally defined across a base of the suture wing.

21. The catheter assembly as defined in claim 17, wherein the heating procedure includes an ethylene oxide heat sterilization procedure.

22. The catheter assembly as defined in claim 21, wherein the ethylene oxide sterilization procedure is performed in a substantial vacuum at a temperature of at least about 55 degrees Celsius for a time of at least about 15 minutes.

23. A method for permanently curving a catheter tube of a catheter assembly, the method comprising:

constraining the catheter tube into a curved configuration;

heating the curved catheter tube for a predetermined time at a predetermined temperature; and

releasing the catheter tube from the constrained curved configuration after the heating is complete such that the catheter tube permanently and substantially retains the curved configuration.

24. The method for curving as defined in claim 23, wherein constraining the catheter tube further includes temporarily affixing a portion of the catheter tube to a tube constraint, the tube constraint at least temporarily included with the catheter assembly.

25. The method for curving as defined in claim 24, wherein constraining the catheter tube further includes inserting a portion of the catheter tube in at least one notch provided on the catheter assembly.

26. The method for curving as defined in claim 23, wherein constraining the catheter tube further includes constraining the catheter tube such that the catheter tube crosses over itself in a looped configuration.

27. The method for curving as defined in claim 23, wherein heating the curved catheter tube further comprises heating the curved catheter tube via an ethylene oxide heat sterilization procedure.

28. The method for curving as defined in claim 27, wherein heating the curved catheter tube further includes heating the curved catheter tube via the ethylene oxide heat sterilization procedure in a substantial vacuum at a temperature of at least about 55 degrees Celsius for a time of at least about 15 minutes.