Catheter assembly including coiled internal bolster

• US 9,078,997 B2
• Filed: 03/29/2008
• Issued: 07/14/2015
• Est. Priority Date: 03/29/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Li, Changqing, Brown, Ken, Sundheimer, Alan, Colvin, Boyd
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): PENG, LAUREN MICHELE
• Application Number:
  US12/079,954
• Publication Number:
  US 20090024091A1
• Time in Patent Office: 2,663 Days
• Field of Search: 604/104, 604/105, 604/174, 604/175, 604/910, 604106-109
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61J 15/0023 inserted by using a sheath
• CPC Class Codes: A61J 15/0038 expandable, e.g. umbrella type
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 25/0015 Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• 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 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract
• CPC Class Codes: A61M 3/0225 Devices on which the patient can sit, e.g. mounted on a toilet bowl combined with bidets A61M3/06; Devices containing liquid pumped by the patient's weight

Abstract

A catheter assembly including a medical catheter and an internal bolster. In a preferred embodiment, the catheter is an elongated, tubular structure preferably made of a flexible, biocompatible material. The catheter is shaped to include a generally cylindrical wall terminating in a first end and in a second end, the wall coaxially surrounding and defining a longitudinal bore preferably used to convey fluids, such as food and/or medications, to a patient in need thereof. The internal bolster is an elongated, semi-tubular structure preferably made of a flexible, biocompatible material. The bolster is resiliently and reversibly transformable between a generally planar shape, when at rest, and a straightened shape, when forcibly unfurled. The bolster has an inner end and an outer end, the inner end being generally centrally located. The inner end of the bolster is insert-molded around the first end of the catheter, with the catheter and the bolster being oriented relative to one another so that the longitudinal axis of the catheter extends generally perpendicularly to the plane of the bolster in its coiled state, with the open, semi-tubular structure of the bolster facing away from the catheter.

Claims

1. A catheter assembly comprising:

(a) a catheter, the catheter having a distal end and a proximal end;

(b) an internal bolster having a proximal end, a distal end, and a semi-tubular wall forming an open side, the proximal end of the internal bolster being disposed at directly connected to the distal end of the catheter,

the internal bolster being resiliently and reversibly transformable between a first state and a second state,

wherein in the first state the internal bolster has a generally planar coiled shape, wherein the planar shape is generally perpendicular to the catheter, and the open side of the semi-tubular wall faces away from the catheter, and

wherein in the second state the internal bolster is generally uncoiled and straight; and

(c) an external bolster that engages the abdomen to prevent longitudinal movement of the catheter.

2. The catheter assembly as claimed in claim 1 wherein each of the catheter and the internal bolster comprises a silicone rubber.

3. The catheter assembly as claimed in claim 2 wherein the silicone rubber of the internal bolster has a higher durometer than the silicone rubber of the catheter.

4. The catheter assembly as claimed in claim 3 wherein the internal bolster further comprises a resilient wire embedded in the silicone rubber.

5. The catheter assembly as claimed in claim 4 wherein the resilient wire is made of a shape memory material.

6. The catheter assembly as claimed in claim 5 wherein the shape memory material comprises a metal.

7. The catheter assembly as claimed in claim 2 wherein the internal bolster further comprises a resilient wire embedded in the silicone rubber.

8. The catheter assembly as claimed in claim 5 wherein the shape memory material comprises a polymer.

9. The catheter assembly as claimed in claim 1 wherein the internal bolster includes one or more reinforcement ribs.

10. The catheter assembly as claimed in claim 1 wherein the internal bolster is insert-molded around the distal end of the catheter.

11. The catheter assembly as claimed in claim 1 wherein the catheter is a feeding tube.

12. The catheter assembly as claimed in claim 1 wherein the catheter is a gastrostomy feeding tube.

13. The catheter assembly as claimed in claim 1 wherein the internal bolster extends beyond the distal end of the catheter.

14. The catheter assembly as claimed in claim 1 wherein the distal end of the internal bolster extends beyond the distal end of the catheter in the second state.

15. The catheter assembly as claimed in claim 1 wherein the distal end of the catheter does not extend distally beyond the internal bolster.

16. The catheter assembly as claimed in claim 1 wherein the distal end of the internal bolster is open.

17. The catheter assembly as claimed in claim 1 wherein the internal bolster has a solid wall.

18. The catheter assembly as claimed in claim 1 wherein the open side faces distally.

19. The catheter assembly as claimed in claim 1 wherein the semi-tubular wall forms a semi-circle.

20. The catheter assembly as claimed in claim 1 wherein the open side is half the circumference of the tube.

21. A kit for use in implanting a catheter assembly in a patient, the kit comprising:

(a) the catheter assembly of claim 1; and

(b) a delivery device, the delivery device being a tubular member appropriately dimensioned to be inserted over the catheter assembly from the proximal end of the catheter and to uncoil the internal bolster.