CATHETER CURVATURE BRACES AND METHODS OF USING SAME

• US 20130317410A1
• Filed: 05/23/2012
• Published: 11/28/2013
• Est. Priority Date: 05/23/2012
• Status: Active Grant

• Current Assignee: Integra LifeSciences Switzerland Sàrl
• Original Assignee: Codman & Shurtleff Incorporated (Johnson & Johnson)
• Inventors: DEXTRADEUR, ALAN
• Granted Patent: US 9,901,707 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• 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 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

A catheter curvature brace, catheter assembly and method for managing fluid in a patient, the brace being attachable to a distal portion of a shaft of a catheter and having an elongated frame with a distal end and a proximal end. The frame is formed with at least one curve in a relaxed curved configuration. At least two coupling elements are connected to the frame, each coupling element configured to engage an outer surface of the catheter. At least the frame is formed of an elastic, biocompatible material capable of being straightened by a force and then returning to the relaxed curved configuration after the force is removed, thereby bending the catheter to substantially conform to the relaxed curved configuration.

Claims

1. A first catheter curvature brace, comprising:

an elongated frame having a distal end and a proximal end, the frame being formed with at least a first curve in a first relaxed curved configuration;

at least two coupling elements connected to the frame, each coupling element configured to engage an outer surface of a catheter; and

at least the frame being formed of an elastic, biocompatible material capable of being straightened by a force and then returning to the first relaxed curved configuration after the force is removed.

2. The catheter brace of claim 1 wherein the elastic, biocompatible material is a nitinol alloy.

3. The catheter brace of claim 1 wherein at least one of the coupling elements is formed as a substantially circular ring.

4. The catheter brace of claim 1 wherein at least one of the coupling elements is formed as a C-type member.

5. The catheter brace of claim 1 wherein at least one of the coupling elements is formed as a continuation of the frame.

6. The catheter brace of claim 1 further including at least a second catheter curvature brace substantially the same as the first catheter brace except that the second catheter brace has at least a second curve in a second relaxed curved configuration, the second curve being different that the first curve.

7. A fluid management catheter assembly suitable for implantation into a ventricle in a brain of a patient, comprising:

a catheter with an elongated shaft having a distal end and a proximal end, the shaft defining at least one lumen extending substantially therethrough, the shaft further defining a plurality of fluid management openings along a distal portion of the shaft, the fluid management openings being in fluid communication with the lumen; and

a catheter curvature brace attached to the distal portion of the shaft, the brace having an elongated frame with a distal end and a proximal end, the frame being formed with at least one curve in a relaxed curved configuration, and at least two coupling elements connected to the frame, each coupling element configured to engage an outer surface of the catheter; and

at least the frame being formed of an elastic, biocompatible material capable of being straightened by a force and then returning to the relaxed curved configuration after the force is removed, thereby bending the catheter to substantially conform to the relaxed curved configuration.

8. The catheter brace of claim 7 wherein the elastic, biocompatible material is a nitinol alloy.

9. The catheter brace of claim 7 wherein at least one of the coupling elements is formed as a substantially circular ring.

10. The catheter brace of claim 7 wherein at least one of the coupling elements is formed as a continuation of the frame.

11. A fluid management kit, comprising:

a catheter with an elongated shaft having a distal end and a proximal end, the shaft defining at least one lumen extending substantially therethrough, the shaft further defining a plurality of fluid management openings along a distal portion of the shaft, the fluid management openings being in fluid communication with the lumen; and

at least first and second catheter curvature braces attachable to the distal portion of the shaft, each brace having an elongated frame with a distal end and a proximal end, the frame being formed with at least one curve in a relaxed curved configuration, at least two coupling elements connected to the frame, each coupling element configured to engage an outer surface of the catheter, and at least the frame being formed of an elastic, biocompatible material capable of being straightened by a force and then returning to the relaxed curved configuration after the force is removed, thereby bending the catheter to substantially conform to the relaxed curved configuration; and

wherein the at least one curve of the first catheter brace is different from the at least one curve of the second brace.

12. The catheter brace of claim 11 wherein the elastic, biocompatible material is a nitinol alloy.

13. The catheter brace of claim 11 wherein at least one of the coupling elements is formed as a substantially circular ring.

14. A method for managing fluid within a patient, comprising:

selecting a catheter with an elongated shaft having a distal end and a proximal end, the shaft defining at least one lumen extending substantially therethrough, the shaft further defining a plurality of fluid management openings along a distal portion of the shaft, the fluid management openings being in fluid communication with the lumen;

selecting a catheter curvature brace attachable to the distal portion of the shaft, the brace having an elongated frame with a distal end and a proximal end, the frame being formed with at least one curve in a desired relaxed curved configuration, at least two coupling elements connected to the frame, each coupling element configured to engage an outer surface of the catheter, and at least the frame being formed of an elastic, biocompatible material capable of being straightened by a force and then returning to the desired relaxed curved configuration after the force is removed;

attaching the catheter brace to the distal portion of the catheter to form a catheter assembly and bend the distal portion of the catheter to substantially conform to the desired relaxed curved configuration;

placing a stylet within the catheter lumen to apply the force to straighten the catheter assembly;

inserting the catheter assembly within the patient to implant the distal portion in a targeted location; and

removing the stylet to allow the distal portion of the catheter to substantially conform to the desired relaxed curved configuration.

15. The method of claim 14 wherein the elastic, biocompatible material is a nitinol alloy.

16. The method of claim 14 wherein at least one of the coupling elements is formed as a substantially circular ring.

17. The method of claim 14 wherein at least one of the coupling elements is formed as a continuation of the frame.

18. The method of claim 14 wherein the catheter is selected to be suitable for implantation within the brain of the patient.

19. The method of claim 18 wherein inserting the catheter within the patient includes positioning the distal portion within a ventricle of the brain of the patient as the targeted location.

20. The method of claim 19 wherein selecting the catheter brace includes determining a preferred curvature for the distal portion of the catheter after implantation and then choosing the catheter brace from among a plurality of catheter braces having different relaxed curved configurations.