Dialysis catheter

• US 7,077,829 B2
• Filed: 10/24/2002
• Issued: 07/18/2006
• Est. Priority Date: 01/09/2001
• Status: Active Grant

• Current Assignee: Argon Medical Devices
• Original Assignee: REX Medical LP
• Inventors: McGuckin, James F. Jr., Hinchliffe, Peter W. J., Paris, Michael W., Tashjian, Paul
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/279,468
• Publication Number:
  US 20030093029A1
• Time in Patent Office: 1,363 Days
• Field of Search: 600/585, 604/27, 604/43, 604/44, 604/164.01, 604/164.09, 604/164.13, 604/264, 604/272
• US Class Current: 604/264
• CPC Class Codes: A61M 1/285 Catheters therefor
• 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 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0078 for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 25/0028 characterized by features relating to at least one lumen located at the proximal part of the catheter, e.g. alterations in lumen shape or valves catheter hubs A61M25/0097
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• 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
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires

Abstract

A dialysis catheter comprising a first portion having a first diameter, an elongated distal portion having a second diameter smaller than the first diameter, and a transition region between the first portion and distal portion. A first longitudinally extending central lumen configured to deliver blood terminates in an opening in the distal portion. At least two independent longitudinally extending lumens are positioned radially of the first lumen, configured to withdraw blood from a patient, and terminate in a longitudinally directed opening in the transition portion.

Claims

1. A dialysis catheter comprising a first portion having a first diameter, an elongated distal portion having a second diameter smaller than the first diameter, and a transition region between the first portion and distal portion, a first longitudinally extending central lumen having an outer wall forming its periphery and configured to deliver blood and terminating in an opening in the distal portion, and at least two independent longitudinally extending lumens positioned radially of the first lumen, the at least two lumens positioned between the central lumen outer wall and an inner wall of the catheter such that the central lumen outer wall is spaced radially inwardly from the inner wall of the catheter, the at least two lumens configured to withdraw blood from a patient and each terminating in a longitudinally directed opening in the transition region.

2. The catheter of claim 1, wherein the transition region tapers toward the distal portion.

3. The catheter of claim 1, wherein at least a portion of the wall thickness of the catheter in the distal portion tapers toward a distalmost end, the central lumen cross-sectional area remaining substantially constant throughout its length in the distal portion.

4. The catheter of claim 2, wherein at least a portion of the wall thickness of the catheter in the distal portion tapers toward a distalmost end, the central lumen cross-sectional area remaining substantially constant throughout its length in the distal portion.

5. The dialysis catheter of claim 1, wherein the first lumen is substantially rectangular in cross-section with curved edges and each of the at least two longitudinally extending lumens is substantially oval-like in cross-section with a substantially planar edge.

6. The dialysis catheter of claim 1, wherein the cross-sectional configuration of the first lumen transitions to a circular shape at a distal portion.

7. The dialysis catheter of claim 1, wherein the catheter has proximal flared portion and the at least two longitudinally extending lumens each transitions to a substantially circular cross-section at the flared portion.

8. The dialysis catheter of claim 1, wherein the distal portion of the catheter includes a stiffening insert embedded in a wall of the catheter at the distal portion.

9. The apparatus of claim 1, wherein the central lumen is circular in cross-section and the at least two lumens for blood withdrawal are arc-shaped in cross section.

10. A dialysis catheter comprising a first portion having a first diameter, an elongated distal portion having a second diameter smaller than the first diameter, and a transition region between the first portion and distal portion, a first longitudinally extending central lumen configured to deliver blood terminating in an opening in the distal portion, and at least two independent longitudinally extending lumens positioned radially of the first lumen, the at least two lumens configured to withdraw blood from a patient and each terminating in a longitudinally directed opening in the transition region and a stiffening member removably mountable within one of the catheter lumens.

11. The dialysis catheter of claim 10, wherein a proximal portion of the stiffening member has a series of threads for removably mounting the stiffening member to the catheter.

12. The dialysis catheter of claim 10, wherein the stiffening member is removably positionable over a guidewire to temporarily increase stiffhess of the catheter to facilitate insertion.

13. The dialysis catheter of claim 12, wherein the stiffening member has a distal region having an enlarged diameter.

14. The apparatus of claim 10, wherein the central lumen is circular in cross-section and the at least two lumens for blood withdrawal are arc-shaped in cross section.

15. The catheter of claim 10, wherein the stiffening member extends distally of a distalmost tip of the catheter body.

16. A catheter for delivering and withdrawing blood from a patient'"'"'s body, the catheter comprising:

a catheter body having an outer wall, an elongated distal tip portion of reduced diameter, a transition region proximal of the distal tip portion, a first return lumen extending from a proximal portion of the catheter body through the distal tip portion and dimensioned so a guidewire can extend therethrough, and first and second longitudinally extending intake lumens independent of the first lumen and each terminating in an opening in the transition region; and

a stiffening insert positioned in the distal tip portion, the stiffening insert having a first stiffness greater than a second stiffness of the distal tip portion, the stiffening insert having a lumen therethrough communicating with the first return lumen.

17. The catheter of claim 16, wherein the distal tip portion includes multiple tapered regions of differing degrees.

18. The catheter of claim 17, further comprising a stiffening member removably positionable within the catheter to temporarily increase stiffhess of the catheter to facilitate insertion.

19. An apparatus for creating a subcutaneous tissue tunnel to enable subsequent insertion of a dialysis catheter through the tunnel, the apparatus comprising a handle and an elongated body extending from the handle and having a distal portion and a proximal portion, the distal portion having a distal tip configured to dilate tissue, the proximal portion having a connection structure removably connectable to the handle and further subsequently removably connectable to the dialysis catheter after detachment from the handle and removal of the handle, wherein after separation of the elongated body from the handle after insertion of the apparatus through the tissue tunnel, the connection structure is then attached to the dialysis catheter for passage of the dialysis catheter through the tissue tunnel.

20. The apparatus of claim 19, wherein the connection structure comprises a barbed fitting.

21. The apparatus of claim 19, further comprising a releasable latch to release the connection structure from the handle.

22. The apparatus of claim 19, wherein the handle comprises a bore having an internal thread and the connection structure is threaded onto the handle.

23. An apparatus for creating a subcutaneous tissue tunnel to enable subsequent insertion of a dialysis catheter through the tunnel, the apparatus comprising a handle and an elongated body extending from the handle and having a distal portion and a proximal portion, the distal portion having a distal tip configured to dilate tissue, the proximal portion having a first type of connection structure removably connectable to the handle and a second different type of connection structure removably connectable to the dialysis catheter after detachment and removal of the handle, wherein after separation of the first connection structure from the handle to separate the elongated body from the handle and removal of the handle after insertion of the apparatus through the tissue tunnel, the second connection structure is attached to the dialysis catheter for passage of the dialysis catheter through the tissue tunnel.

24. The apparatus of claim 23, wherein the first connection structure comprises a barbed fitting.

25. The apparatus of claim 23, wherein the second connection structure comprises a releasable latch.

26. The apparatus of claim 23, wherein the handle comprises a bore having an internal thread and the second connection structure is threaded onto the handle.