Split tip dialysis catheter

• US 8,021,321 B2
• Filed: 05/10/2004
• Issued: 09/20/2011
• Est. Priority Date: 02/07/2002
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Zawacki, John A.
• Primary Examiner(s): Stigell; Theodore
• Assistant Examiner(s): GILBERT, ANDREW M
• Application Number:
  US10/842,586
• Publication Number:
  US 20040210187A1
• Time in Patent Office: 2,689 Days
• Field of Search: 604/6.16, 604 29- 30, 604/35, 604/39, 604/40, 604/43, 604/94.01, 604/164.01, 604/164.02, 604/173, 604/264, 604/284, 604/523, 604533-539
• US Class Current: 604/29
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts

Abstract

A split tip dialysis catheter having an outer tube and an inner tube, the two tubes which can be arranged over at least a portion of their length in a coaxial configuration. The inner tube may be connected to the outer tube at a proximal bifurcation, secured at a distal end of the outer tube or both, but generally the inner tube will remain free to move relative to the outer tube to optimize functionality. In addition, the inner tube can be arranged to be removable from the catheter for replacement thereof.

Claims

1. A multi-lumen catheter, comprising:

an outer tube comprising a body portion having a first lumen adapted for fluid flow therethrough, a tip portion having a second lumen adapted for fluid flow therethrough in fluid communication with said first lumen, and a port positioned proximal said tip portion, wherein a cross-sectional area of said tip portion is smaller than a cross-sectional area of said body portion, and wherein a cross-sectional area of said second lumen is smaller than a cross-sectional area of at least a distal end portion of said first lumen; and

an inner tube having a third lumen adapted for fluid flow therethrough, said inner tube being positioned within said outer tube and having a distal end that is configured to pass through said port generally parallel to said outer tube and that is adapted to be variably distanced from said port.

2. The multi-lumen catheter according to claim 1, wherein said tip portion further comprises a plurality of side holes spaced around the circumference thereof.

3. The multi-lumen catheter according to claim 1, wherein said distal end of said inner tube comprises a plurality of side holes spaced around the circumference thereof.

4. The multi-lumen catheter according to claim 1, wherein said outer tube is comprised of a material selected from the group consisting of polyurethane, silicone, polytetrafluoroethylene and expanded polytetrafluoroethylene.

5. The multi-lumen catheter according to claim 1, wherein said inner tube is comprised of a material selected from the group consisting of polyurethane, silicone, polytetrafluoroethylene and expanded polytetrafluoroethylene.

6. The multi-lumen catheter according to claim 1, wherein said outer and inner tubes are comprised of the same material.

7. The multi-lumen catheter according to claim 1, wherein said outer and inner tubes are comprised of a different material.

8. The multi-lumen catheter according to claim 1, wherein the cross-sectional shape of said body portion is selected from the group consisting of circular, oval, trapezoidal, D-shaped and wedge-shaped.

9. The multi-lumen catheter according to claim 1, wherein the cross-sectional shape of said tip portion is selected from the group consisting of circular, oval, trapezoidal, D-shaped and wedge-shaped.

10. The multi-lumen catheter according to claim 1, wherein the cross-sectional shape of said inner tube is selected from the group consisting of circular, oval, trapezoidal, D-shaped and wedge-shaped.

11. The multi-lumen catheter according to claim 1, wherein said body portion further comprises a septum.

12. The multi-lumen catheter according to claim 1, wherein said tip portion further comprises a septum.

13. The multi-lumen catheter according to claim 1, wherein said inner tube further comprises a septum.

14. The multi-lumen catheter according to claim 1, further comprising a radiopaque portion.

15. The multi-lumen catheter according to claim 1, wherein said body portion further comprises a reinforcing element.

16. The multi-lumen catheter according to claim 1, wherein said inner tube further comprises a reinforcing element.

17. The multi-lumen catheter according to claim 1, wherein said port further comprises a valve mechanism to control the flow of fluid therethrough.

18. The multi-lumen catheter according to claim 1, wherein at least one of said tip portion and said inner tube further comprise a valve mechanism that controls the flow of fluid therethrough.

19. The multi-lumen catheter according to claim 1, wherein said outer tube further comprises a releasable seal at the proximal end thereof, wherein said inner tube is secured by the releasable seal.

20. The multi-lumen catheter according to claim 1, wherein said distal end of said inner tube further comprises a tapered portion, wherein the diameter of said inner tube proximal to the tapered portion is greater than the diameter of said port.

21. The multi-lumen catheter according to claim 1, wherein said inner tube is fused to said outer tube at a proximal end thereof.

22. The multi-lumen catheter according to claim 1, further comprising a second inner tube comprising a fourth lumen adapted for fluid flow therethrough, said second inner tube being positioned within said outer tube and having a distal end configured to pass through said port and adapted to be variably distanced from said port.

23. The multi-lumen catheter according to claim 22, wherein the cross-sectional shape of said inner tube and said second inner tube are substantially similar.

24. The multi-lumen catheter according to claim 22, wherein the cross-sectional shape of at least one of said inner tube and said second inner tube is selected from the group consisting of circular, oval, trapezoidal, D-shaped and wedge-shaped.

25. A multi-lumen catheter according to claim 1, comprising:

an outer tube comprising a body portion having a first lumen adapted for fluid flow therethrough, a tip portion having a second lumen adapted for fluid flow therethrough in fluid communication with said first lumen, and a port positioned proximal said tip portion, wherein a cross-sectional area of said tip portion is smaller than a cross-sectional area of said body portion, and wherein a cross-sectional area of said second lumen is smaller than a cross-sectional area of at least a distal end portion of said first lumen, wherein said body portion further comprises a proximal portion having a first cross-sectional shape and a distal portion having a second cross-sectional shape, wherein said first and second cross-sectional shapes are different from one another; and

an inner tube having a third lumen adapted for fluid flow therethrough, said inner tube being positioned within said outer tube and having a distal end that is configured to pass through said port and that is adapted to be variably distanced from said port.

26. The multi-lumen catheter according to claim 25, wherein said first and second cross-sectional shapes are joined together at a transition point.

27. The multi-lumen catheter according to claim 1, wherein said inner tube further comprises a proximal portion having a first cross-sectional shape and a distal portion having a second cross-sectional shape, wherein said first and second cross-sectional shapes are different from one another.

28. The multi-lumen catheter according to claim 27, wherein said first and second cross-sectional shapes are joined together at a transition point.

29. The multi-lumen catheter according to claim 1, wherein said inner tube further comprises a pin element and said outer tube further comprises a guide track, wherein said pin element is received within said guide track to control the movement of said inner tube with respect to said outer tube.

30. The multi-lumen catheter according to claim 1, further comprising a bifurcation element having a first movement control element, wherein said inner tube further comprises a second movement control element, wherein said first and second movement control elements operate together to control the movement of said inner tube with respect to said outer tube.

31. The multi-lumen catheter according to claim 30, wherein said first movement control element is a plate having an opening therein and said second control element is a guide track, and wherein said opening is configured to receive said guide track.

32. The multi-lumen catheter according to claim 31, wherein said opening comprises a pin element that engages said guide track.

33. The multi-lumen catheter according to claim 30, wherein said first movement control element is a guide track and said second control element is a pin element.

34. The multi-lumen catheter according to claim 33, wherein said guide track is disposed on an inner surface of said bifurcation element.

35. The multi-lumen catheter according to claim 33, wherein said guide track is disposed on an outer surface of said bifurcation element.

36. The multi-lumen catheter according to claim 35, wherein said guide track comprises a set of teeth, and wherein said pin element comprises a thumb slide.

37. The multi-lumen catheter according to claim 30, wherein said first movement control element is a female thread and said second control element is a male thread.

38. The multi-lumen catheter according to claim 29, further comprising a gauging element to ascertain the position of said inner tube with respect to said outer tube.

39. The multi-lumen catheter according to claim 38, wherein said gauging element is a series of markings disposed on an outer surface of said inner tube.

40. The multi-lumen catheter according to claim 30, further comprising a gauging element to ascertain the position of said inner tube with respect to said outer tube.

41. The multi-lumen catheter according to claim 40, wherein said gauging element is a series of markings disposed on an outer surface of the inner tube.