Coupling and stabilization system for proximal end of catheter

• US 6,332,874 B1
• Filed: 08/28/1998
• Issued: 12/25/2001
• Est. Priority Date: 08/28/1998
• Status: Expired due to Term

• Current Assignee: C.R. Bard, Inc. (Becton Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton Dickinson & Co)
• Inventors: Eliasen, Kenneth A., Schlehuber, Daniel T., Powers, Kelly B.
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): Thanh, LoAn H.
• Application Number:
  US09/143,275
• Time in Patent Office: 1,215 Days
• Field of Search: 604/174, 604/177, 604/179, 604/180, 604/164, 604/165, 604/164-1-1, 604/164.04, 604/164-3-1, 604/165.03, 128/DIG.6, 128/DIG.26
• US Class Current: 604/174
• CPC Class Codes: A61M 25/0014 Connecting a tube to a hub
• CPC Class Codes: Y10S 128/06 Intravenous injection support
• CPC Class Codes: Y10S 128/26 Cannula supporters

Abstract

A conduit of relatively tough biocompatible material encloses a longitudinally extending fluid flow lumen and has a distal end configured as a catheter coupling hub. The conduit is encircled at the distal end of the catheter coupling hub and a portion of the conduit distal of and adjacent to the catheter coupling hub by a stabilization sleeve made of a contrastingly resilient, soft material suitable for skin contact applications. A pair of stabilization wings extends laterally on opposite sides from the stabilization sleeve at an attachment location separated from the portion of the stabilization sleeve in which the catheter coupling hub is received. As a result, a strain relief region is created. The stabilization sleeve is permanently attached to the conduit at the coupling hub only. The portion of the conduit distal of and adjacent to the catheter coupling hub extends slideably through the remainder of the length of the stabilization sleeve affording axial and bending strain relief to that portion of the conduit.

Claims

1. An implantable vascular access catheter comprising:

a. a conduit of relatively tough biocompatible material enclosing a longitudinally extending fluid flow lumen, said conduit having a distal end configured as an elongated flexible catheter for disposition in the vascular system of a patient and a proximal end configured as a catheter coupling hub by which to effect mechanical and fluid interaction with extracorporeal medical equipment;

b. an elastomeric sleeve suitable for skin contact applications encircling the distal end of said catheter coupling hub and a portion of said conduit distal of and adjacent to said distal end of said catheter coupling hub;

c. a pair of stabilization wings extending laterally from said sleeve distal of said distal end of said catheter coupling hub; and

d. resilient means between said distal end of said catheter coupling hub and said stabilization wings for reducing motion imparted to the skin of a patient through said stabilization wings due to motion of said catheter coupling hub, when said stabilization wings are secured to the skin of a patient.

2. A catheter as recited in claim 1, wherein said sleeve is attached to said conduit exclusively at said catheter coupling hub.

3. A catheter as recited in claim 2, wherein said portion of said conduit distal of and adjacent to said distal end of said catheter coupling hub extends slidably through said sleeve.

4. A catheter as recited in claim 1, wherein said portion of said conduit distal of and adjacent to said distal end of catheter coupling hub extends slidably through said sleeve.

5. A catheter as recited in claim 1, wherein the hardness of said catheter coupling hub is greater than the hardness of said conduit.

6. A catheter as recited in claim 1, wherein said catheter coupling hub is comprised of polyurethane.

7. A catheter as recited in claim 1, wherein said sleeve comprises silicone.

8. A catheter as recited in claim 1, wherein:

a. said stabilization wings are generally coplanar, each of said stabilization wings having an upper surface and a lower patient contact surface on the opposite side of each of said stabilization wings therefrom;

b. the exterior of said sleeve proximally of said stabilization wings is formed into a generally planar skin contact surface disposed on the same side of said sleeve as said patient contact surfaces of said stabilization wings; and

c. said sleeve at and proximal of said stabilization wings is so configured that when said patient contact surfaces of said stabilization wings and said skin contact surface of said sleeve engage the skin of a patient, the longitudinal axis of said conduit at said proximal end thereof is elevated at an angle to the skin of the patient.

9. A catheter as recited in claim 1, wherein said stabilization wings and said sleeve are integrally formed of a single material.

10. A catheter as recited in claim 1, wherein said resilient means comprises a strain relief region of said sleeve.

11. A catheter coupling and stabilization system for the extracorporeal portion of an implant able catheter, said system comprising:

a. a catheter assembly comprised of a first class of materials, said catheter assembly comprising;

i. an elongated flexible catheter having a proximal end and a distal end; and

ii. a catheter coupling hub, the distal end of said catheter coupling hub being secured to said proximal end of said catheter; and

b. a stabilization sleeve encircling said distal end of said catheter coupling hub and a portion of said proximal end of said catheter immediately adjacent thereto, said stabilization sleeve having a passageway extending longitudinally therethrough, said distal end of said catheter coupling hub being secured in the proximal end of said passageway with said portion of said proximal end of said catheter immediately adjacent thereto extending therefrom through said passageway, said stabilization sleeve being comprised of a second class of materials having selected physical properties substantially different from corresponding selected physical properties of said first class of materials, and said stabilization sleeve comprising;

i. a pair of stabilization wings extending from opposite sides of said stabilization sleeve distal of said distal end of said catheter coupling hub; and

ii. a strain relief region between said catheter coupling hub and said stabilization wings, movement of said catheter coupling hub relative to said stabilization wings being facilitated by said strain relief region when said stabilization wings are secured to the skin of a patient.

12. A system as recited in claim 11, wherein said first class of materials comprises thermoplastic materials that are durable relative to conditions to which the implanted portion of a cardiovascular access catheter is exposed in the cardiovascular system or the tissues of a patient and relative to the environment in which the extracorporeal portion of an implanted catheter is disposed and utilized.

13. A system as recited in claim 12, wherein said first class of materials comprises polyurethane materials.

14. A system as recited in claim 13, wherein:

a. said catheter is comprised of a first polyurethane material; and

b. said catheter coupling hub is comprised of a second polyurethane material, said first polyurethane material being softer than said second polyurethane material.

15. A system as recited in claim 11 wherein said second class of materials comprises soft, flexible materials suitable for skin contacting applications.

16. A system as recited in claim 15, wherein said second class of materials comprises thermoset materials.

17. A system as recited in claim 16 wherein said second class of materials comprises biocompatible silicone materials.

18. A system as recited in claim 11, wherein said stabilization sleeve further comprises:

a. an elongated tube having proximal and distal ends, said passageway of said stabilization sleeve extending longitudinally therebetween; and

b. a hub receiving socket formed from said passageway at said proximal end of said tube, said distal end of said catheter coupling hub being secured in said hub receiving socket, said stabilization wings extending laterally from opposite sides of said tube distal of said hub receiving socket.

19. A system as recited in claim 18, wherein the wall of said passageway at said hub receiving socket and the exterior of said catheter coupling hub are provided with cooperating alignment means for facilitating and stabilizing a predetermined rotational relationship between said stabilization sleeve and said catheter coupling hub, when said distal end of said catheter coupling hub is secured in said hub receiving socket.

20. A system as recited in claim 19, wherein said alignment means comprises:

a. an elongated alignment rib upstanding on the exterior of said catheter coupling hub, said alignment rib being oriented generally parallel to the longitudinal axis of said catheter assembly; and

b. an alignment rib receiving slot formed in said wall of said hub receiving socket, said receiving slot being oriented generally parallel to the longitudinal axis of said stabilization sleeve.

21. A system as recited in claim 18, wherein radially opposed finger grips are provided on the exterior of said tube at said hub receiving socket.

22. A system as recited in claim 18, further comprising a strain relief nose located distal of said attachment location.

23. A system as recited in claim 22, wherein the diameter of said passageway at said strain relief nose is greater than or equal to the outer diameter of said catheter.

24. A system as recited in claim 22, wherein the exterior of said strain relief nose is frustoconical.

25. A system as recited in claim 18, wherein each of said stabilization wings is provided with a suture recess at which the thickness of each respective of said stabilization wings is a minimum.

26. A system as recited in claim 18, wherein a strain relief region extension notch is formed in the edge of each of said stabilization wings adjacent to said strain relief region.

27. A system as recited in claim 11, wherein said catheter coupling hub comprises:

a. a catheter receiving stent encircling the outer surface of said proximal end of said catheter; and

b. a hub body encircling the outer surface of said receiving stent.

28. A system as recited in claim 27, wherein said receiving stent is attached to said proximal end of said catheter and to said catheter coupling hub with an adhesive.

29. A system as recited in claim 27, wherein said receiving stent is welded to said proximal end of said catheter and to said catheter coupling hub.

30. A system as recited in claim 11, wherein:

a said first class of materials comprises hard polyurethane materials, and

b. said second class of materials comprises soft polyurethane materials.

31. A system as recited in claim 30, wherein:

a. said catheter is comprised of a first hard polyurethane material; and

b. said catheter coupling hub is comprised of a second hard polyurethane material, said first hard polyurethane material being softer than said second hard polyurethane material.

32. A system as recited in claim 11, wherein said first class of materials comprises castable epoxy materials.

33. A system as recited in claim 11, wherein:

a. said first class of materials comprises polyurethane materials; and

b. said second class of materials comprises biocompatible silicone materials.

34. A system as recited in claim 11, wherein each of said stabilization wings comprises:

a. a trailing edge oriented toward the proximal end of said stabilization sleeve; and

b. a notch formed in said trailing edge of each of said stabilization wings adjacent said stabilization sleeve.

35. A catheter coupling and stabilization system for the extracorporeal portion of an implantable catheter, said system comprising:

a. a catheter having a proximal end and a distal end;

b. a catheter coupling hub, the distal end of said catheter coupling hub being secured to said proximal end of said catheter; and

c. a stabilization sleeve encircling said distal end of said catheter coupling hub and a portion of said proximal end of said catheter immediately adjacent thereto, said stabilization sleeve comprising;

i. an elongated tube having a proximal end, a distal end, and a passageway extending longitudinally therebetween, said distal end of said catheter coupling hub being secured in said passageway at said proximal end of said tube;

ii. attachment means for securing said tube at a predetermined position and in a predetermined orientation to the skin of a patient, said attachment means being located on the exterior of said tube distal of said catheter coupling hub; and

iii. a strain relief region between said catheter coupling hub and said attachment means, movement of said catheter coupling hub relative to said attachment means being facilitated by said strain relief region.

36. A system as recited in claim 35, wherein said attachment means comprises a pair of stabilization wings extending laterally from said tube.

37. A system as recited in claim 35, wherein said attachment means comprises a planar stabilization wing extending laterally from said tube and being disposed generally parallel to the longitudinal axis of said tube, said stabilization wing comprising:

a. a leading edge oriented toward said distal end of said tube;

b. a trailing edge oriented toward said proximal end of said tube;

c. a tip extending between said leading edge and said trailing edge remote from said tube; and

d. a notch formed through said trailing edge of said stabilization wing adjacent said tube.

38. A system as recited in claim 35, wherein said catheter is a single lumen catheter.