Split tip dialysis catheter

• US 6,758,836 B2
• Filed: 02/07/2002
• Issued: 07/06/2004
• Est. Priority Date: 02/07/2002
• Status: Expired due to Term

• 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): Casler, Brian L.
• Assistant Examiner(s): Han, Mark K
• Application Number:
  US10/072,788
• Publication Number:
  US 20030149395A1
• Time in Patent Office: 880 Days
• Field of Search: 604/6.16, 604/27, 604/29, 604/30, 604/33, 604/35, 604/39, 604/40, 604/43, 604/48, 604/93.01, 604/94.01, 604/164.01, 604/164.02, 604/164.04, 604/171, 604/173, 604/174, 604/249, 604/264, 604/275, 604/284, 604/523, 604/533, 604/534, 604/535, 604/537, 604/538, 604/539
• US Class Current: 604/284
• 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 tip portion, a body portion and a port, wherein the body portion comprises a first lumen, and wherein the tip portion comprises a second lumen in fluid communication with the first lumen; and

an inner tube disposed within the body portion of the outer tube along at least a portion of its length, comprising a third lumen, wherein the position of a distal end of the inner tube relative to the port is variable;

wherein the outer tube further comprises a releasable seal at the proximal end thereof, wherein the inner tube is secured by the releasable seal.

2. The multi-lumen catheter according to claim 1, wherein the tip portion is smaller in diameter than the body portion.

3. The multi-lumen catheter according to claim 1, wherein the tip portion further comprises at least one opening.

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

5. The multi-lumen catheter according to claim 1, wherein the distal end of the inner tube comprises at least one opening.

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

7. 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.

8. 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.

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

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

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

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

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

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

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

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

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

18. A multi-lumen catheter, comprising:

an outer tube comprising a tip portion, a body portion and a port, wherein the body portion comprises a first lumen, wherein the tip portion comprises a second lumen in fluid communication with the first lumen, and wherein the body portion further comprises a septum; and

an inner tube disposed within the body portion of the outer tube along at least a portion of its length, comprising a third lumen, wherein the position of a distal end of the inner tube relative to the port is variable.

19. A multi-lumen catheter, comprising:

an outer tube comprising a tip portion, a body portion and a port, wherein the body portion comprises a first lumen, wherein the tip portion comprises a second lumen in fluid communication with the first lumen, and wherein the tip portion further comprises a septum; and

an inner tube disposed within the body portion of the outer tube along at least a portion of its length, comprising a third lumen, wherein the position of a distal end of the inner tube relative to the port is variable.

20. A multi-lumen catheter, comprising:

an outer tube comprising a tip portion, a body portion and a port, wherein the body portion comprises a first lumen, and wherein the tip portion comprises a second lumen in fluid communication with the first lumen; and

an inner tube disposed within the body portion of the outer tube along at least a portion of its length, comprising a third lumen, wherein the position of a distal end of the inner tube relative to the port is variable, and wherein the inner tube further comprises a septum.

21. A multi-lumen catheter, comprising:

an outer tube comprising a tip portion, a body portion and a port, wherein the body portion comprises a first lumen, wherein the tip portion comprises a second lumen in fluid communication with the first lumen, and wherein the port comprises a valve mechanism to control the flow of fluid therethrough; and

an inner tube disposed within the body portion of the outer tube along at least a portion of its length, comprising a third lumen, wherein the position of a distal end of the inner tube relative to the port is variable.

22. A multi-lumen catheter, comprising:

an outer tube comprising a tip portion, a body portion and a port, wherein the body portion comprises a first lumen, and wherein the tip portion comprises a second lumen in fluid communication with the first lumen; and

an inner tube disposed within the body portion of the outer tube along at least a portion of its length, comprising a third lumen, wherein the position of a distal end of the inner tube relative to the port is variable;

wherein at least one of the tip portion of the outer tube and the inner tube further comprise a valve mechanism that controls the flow of fluid therethrough.

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

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

33. The multi-lumen catheter according to claim 26, wherein the gauging element is a series of markings disposed on an outer surface of the inner tube.

23. A multi-lumen catheter, comprising:

an outer tube comprising a tip portion, a body portion and a port, wherein the body portion comprises a first lumen, and wherein the tip portion comprises a second lumen in fluid communication with the first lumen; and

an inner tube disposed within the body portion of the outer tube along at least a portion of its length, comprising a third lumen, wherein the position of a distal end of the inner tube relative to the port is variable, wherein the inner tube further comprises a tapered portion at the distal end thereof, wherein the diameter of the inner tube proximal to the tapered portion is greater than the diameter of the port.

42. The multi-lumen catheter according to claim 23, further comprising a gauging element to ascertain the position of the inner tube with respect to the outer tube.

43. The multi-lumen catheter according to claim 42, wherein the gauging element a series of markings disposed on an outer surface of the inner tube.

24. A multi-lumen catheter, comprising:

an outer tube comprising a tip portion, a body portion and a port, wherein the body portion comprises a first lumen, and wherein the tip portion comprises a second lumen in fluid communication with the first lumen;

an inner tube disposed within the body portion of the outer tube along at least a portion of its length, comprising a third lumen, wherein the position of a distal end of the inner tube relative to the port is variable; and

a second inner tube, comprising a fourth lumen and at least one opening therein, the fourth lumen being in fluid communication with said at least one opening, wherein the position of a distal end of the second inner tube relative to the port is variable.

27. A multi-lumen catheter, comprising:

an outer tube comprising a tip portion, a body portion and a port, wherein the body portion comprises a first lumen, and wherein the tip portion comprises a second lumen in fluid communication with the first lumen, wherein the body portion further comprises a proximal portion having a first cross-sectional shape and a distal portion having a second cross-sectional shape, wherein the first and second cross-sectional shapes are different from one another; and

an inner tube disposed within the body portion of the outer tube along at least a portion of its length, comprising a third lumen, wherein the position of a distal end of the inner tube relative to the port is variable.

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

29. A multi-lumen catheter, comprising:

an outer tube comprising a tip portion, a body portion and a port, wherein the body portion comprises a first lumen, and wherein the tip portion comprises a second lumen in fluid communication with the first lumen; and

an inner tube disposed within the body portion of the outer tube along at least a portion of its length, comprising a third lumen, wherein the position of a distal end of the inner tube relative to the port is variable, wherein the inner tube further comprises a proximal portion having a first cross-sectional shape and a distal portion having a second cross-sectional shape, wherein the first and second cross-sectional shapes are different from one another.

30. The multi-lumen catheter according to claim 29, wherein the first and second cross-sectional shapes are joined together at a transition point.

31. A multi-lumen catheter, comprising:

an outer tube comprising a tip portion, a body portion and a port, wherein the body portion comprises a first lumen, and wherein the tip portion comprises a second lumen in fluid communication with the first lumen; and

an inner tube disposed within the body portion of the outer tube along at least a portion of its length, comprising a third lumen, wherein the position of a distal end of the inner tube relative to the port is variable;

wherein the inner tube further comprises a pin element and the outer tube further comprises a guide track, wherein the pin element is received within the guide track to control the movement of the inner tube with respect to the outer tube.

32. The multi-lumen catheter according to claim 31, further comprising a gauging element to ascertain the position of the inner tube with respect to the outer tube.

34. A multi-lumen catheters, comprising:

an outer tube comprising a tip portion, a body portion and a port, wherein the body portion comprises a first lumen, and wherein the tip portion comprises a second lumen in fluid communication with the first lumen;

an inner tube disposed within the body portion of the outer tube along at least a portion of its length, comprising a third lumen, wherein the position of a distal end of the inner tube relative to the port is variable; and

a bifurcation element having a first movement control element, wherein the inner tube further comprises a second movement control element, wherein the first and second movement control elements operate together to control the movement of the inner tube with respect to the outer tube.

35. The multi-lumen catheter according to claim 34 wherein the first movement control element is a plate having an opening therein and the second control element is a guide track, and wherein the opening is configured to receive the guide track.

36. The multi-lumen catheter according to claim 35, wherein the opening has a pin element that engages the guide track.

37. The multi-lumen catheter according to claim 34, wherein the first movement control element is a guide track and the second control element is a pin element.

38. The multi-lumen catheter according to claim 37, wherein the guide track is disposed on an inner surface of the bifurcation element.

39. The multi-lumen catheter according to claim 37, wherein the guide track is disposed on an outer surface of the bifurcation element.

40. The multi-lumen catheter according to claim 39, wherein the guide track comprises a set of teeth, and wherein the pin element comprises a thumb slide.

41. The multi-lumen catheter according to claim 34, wherein the first movement control element is a female thread and the second control element is a male thread.

44. A multi-lumen catheter, comprising:

an aspirating tube comprising a tip portion, a body portion and a port, wherein both the tip portion and the body portion have a lumen that together define an arterial lumen; and

an infusion tube disposed within the body portion of the aspirating tube along at least a portion of its length, comprising a venous lumen, wherein the position of a distal end of the infusion tube relative to the port is variable;

wherein the aspirating tube further comprises a releasable seal at the proximal end thereof, wherein the infusion tube is secured by the releasable seal.

45. A multi-lumen catheter, comprising:

an infusion tube comprising a tip portion, a body portion and a port, wherein both the tip portion and the body portion have a lumen that together define a venous lumen; and

an aspiration tube disposed within the body portion of the infusion tube along at least a portion of its length, comprising an arterial lumen, wherein the position of a distal end of the aspiration tube relative to the port is variable;

wherein the infusion tube further comprises a releasable seal at the proximal end thereof, wherein the aspiration tube is secured by the releasable seal.

46. A catheter having at least two separate lumens, comprising:

a first tube comprising a first lumen; and

a second tube comprising a tip portion, a body portion and a port, wherein both the tip portion and the body portion have a lumen that together define a second lumen, wherein the port is positioned proximal to both the tip portion and a distal end of the first tube, and wherein the port is adapted for the passage of fluid therethrough;

wherein the second tube further comprises a releasable seal at the proximal end thereof, wherein the first tube is secured by the releasable seal.