High flow rate dialysis catheters and related methods

• US 10,105,477 B2
• Filed: 08/21/2013
• Issued: 10/23/2018
• Est. Priority Date: 02/24/1998
• Status: Expired due to Term

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Davey, Christopher T., Sansoucy, Michael R., McCarthy, Matthew N.
• Primary Examiner(s): Bosques, Edelmira
• Application Number:
  US13/971,879
• Publication Number:
  US 20130338640A1
• Time in Patent Office: 1,889 Days
• Field of Search: 604 43
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube natural lumen, e.g. vessels A61M25/04
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• 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

Abstract

High flow rate catheters, and related methods, are useful in dialysis and other procedures. A catheter according to the invention comprises a hub and a generally elongated conduit. The conduit has a substantially continuous and smooth wall. The conduit also defines at least one lumen and has a length extending from a proximal end to a distal end of the conduit. The proximal end is coupled to a hub and the distal end has an opening in communication with the lumen. The conduit has a conical shape which tapers along the length.

Claims

1. A catheter comprising:

a hub; and

a flexible conduit comprising an outer wall and an internal divider defining at least a first and second lumen, the conduit further comprising;

a cylindrical proximal section;

a frusto-conical middle section; and

a cylindrical distal section;

wherein the frusto-conical middle section includes a transition zone extending from a first point to a second point and having a first cross-sectional area at the first point and a second cross-sectional area at the second point, wherein the first point is proximal of the second point, and wherein the first cross-sectional area is larger than the second cross-sectional area;

wherein a thickness of the outer wall smoothly increases in a distal to proximal direction over the transition zone with a concomitant increase in cross-sectional area in a distal to proximal direction of each of the first and second lumens over the transition zone, and

wherein the cylindrical proximal section is in direct contact with the hub.

2. The catheter of claim 1 wherein a surface of the flexible conduit is treated to inhibit association of materials with the conduit.

3. The catheter of claim 1 wherein a surface of the flexible conduit is treated with heparin.

4. The catheter of claim 1 further comprising at least one connecting tube to the hub, whereby the at least one connecting tube is in communication with at least one of the lumens.

5. The catheter of claim 1 wherein the flexible conduit is reinforced to prevent kinking.

6. The catheter of claim 1 wherein the flexible conduit is reinforced by the change in cross-sectional area along the length of the flexible conduit, without adding a wire to the flexible conduit.

7. The catheter of claim 1 wherein the first lumen and second lumen are in constant open fluid communication with the hub.

8. The catheter of claim 7 further comprising at least two connecting tubes connected to and in fluid communication with the hub.

9. The catheter of claim 8 wherein the hub contains a void that links the first lumen and the second lumen to one of the connecting tubes.

10. The catheter of claim 1 wherein the cross-section of one end of the first lumen and the second lumen are semi-circular, circular, round, or oval.

11. The catheter of claim 10 wherein the cross-sectional diameter of the distal most end of the first lumen and the second lumen are smaller than the cross-sectional diameter of the proximal most end of the first lumen and the second lumen.

12. The catheter of claim 1 wherein the distal section further comprises cross sectional areas of similar diameter.

13. The catheter of claim 1 wherein the middle section comprises cross sectional areas of varying diameters.

14. The catheter of claim 1 wherein the proximal section comprises cross sectional areas of varying diameters.

15. The catheter of claim 1 wherein the distal section comprises cross sectional areas of varying diameters.

16. The catheter of claim 13 wherein the middle section comprises at least one taper.

17. The catheter of claim 14 wherein the proximal section comprises a taper.

18. The catheter of claim 15 wherein the distal section comprises a least one taper.

19. The catheter of claim 16 wherein the middle section further comprises cross sectional areas of a similar diameter.

20. The catheter of claim 17 wherein the proximal section further comprises cross sectional areas of a similar diameter.

21. The catheter of claim 18 wherein the distal section further comprises cross sectional areas of a similar diameter.

22. The catheter of claim 21, wherein a ratio of lumen volume is maximized such that fluid is capable of achieving a high flow rate through the conduit.

23. The catheter of claim 21, wherein the catheter is capable of achieving a flow rate of at least 300 ml/min.

24. The catheter of claim 1, wherein the first cross-sectional area is circular.

25. The catheter of claim 1, wherein the second cross-section area is circular.

26. A catheter comprising:

a hub; and

a flexible conduit comprising an outer wall and a septum defining at least a first and second lumen, the conduit further comprising;

a cylindrical proximal section;

a frusto-conical section; and

a cylindrical distal section;

wherein the frusto-conical section includes a transition zone extending from a first point to a second point and having a first cross-sectional area at the first point and a second cross-sectional area at the second point, wherein the first point is proximal of the second point, and wherein the first cross-sectional area is larger than the second cross-sectional area;

wherein a thickness of the outer wall and the septum smoothly increases in a distal to proximal direction over the transition zone with a concomitant increase in cross-sectional area in a distal to proximal direction of each of the first and second lumens over the transition zone; and

at least one connecting tube to the hub, whereby the at least one connecting tube is in communication with at least one of the lumens; and

wherein the proximate end of the cylindrical proximal section is adjoined directly to the hub.

27. The catheter of claim 26, wherein the flexible conduit comprises varying cross-sectional diameters.

28. The catheter of claim 27, wherein at least one of the varying cross-sectional diameters is circular.