CATHETER ASSEMBLY INCLUDING TRIPLE LUMEN TIP

• US 20090118661A1
• Filed: 10/31/2008
• Published: 05/07/2009
• Est. Priority Date: 11/01/2007
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Barron, William R., Sanders, Scott W., Moehle, Ryan T.
• Granted Patent: US 8,092,415 B2
• Time in Patent Office: Days
• US Class Current: 604/6.160
• 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 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow general flow characteristics A61M2206/10
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2202/0021 removed from and reintroduced into the body, e.g. after treatment
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• 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 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026

Abstract

A catheter assembly for use in accessing a vasculature of a patient during renal replacement or other therapies is disclosed. In one embodiment, the catheter assembly includes a catheter body that defines first and second lumens. The catheter body defines a distal tip region that includes a venous lateral opening that is in fluid communication with the first lumen and includes a distal-facing portion. The distal tip region further includes an arterial lateral opening that is in fluid communication with the second lumen, includes a distal-facing portion, and is substantially un-staggered with respect to the venous lateral opening. A distal end opening is defined on the distal tip region and is sized to pass a fluid therethrough. In one embodiment, the distal end opening is in fluid communication with a third lumen of the catheter body that can withstand high fluid flow rates associated with power injection of contrast media.

Claims

1. A catheter assembly, comprising:

a catheter body defining at least a first lumen and a second lumen, the catheter body including a distal tip region, the distal tip region including;

at least one venous lateral opening in fluid communication with the first lumen, the at least one venous lateral opening including a distal-facing portion;

at least one arterial lateral opening in fluid communication with the second lumen, the at least one arterial lateral opening including a distal-facing portion, the at least one arterial lateral opening being opposingly positioned in about an un-staggered configuration with respect to the at least one venous lateral opening; and

a distal end opening sized to pass a fluid therethrough.

2. The catheter assembly as defined in claim 1, wherein the at least one venous lateral opening and the at least one arterial lateral opening are symmetrically positioned with respect to one another.

3. The catheter assembly as defined in claim 1, wherein the distal end opening is in communication with a third lumen defined by the catheter body.

4. The catheter assembly as defined in claim 1, wherein the distal end opening is in communication with the first lumen.

5. The catheter assembly as defined in claim 4, wherein a guidewire is passable from the first lumen through the distal end opening via a guidewire channel, the guidewire channel in communication with both the first lumen and the distal end opening.

6. The catheter assembly as defined in claim 1, wherein the at least one venous lateral opening and the at least one arterial lateral opening are defined by an angled cross cut through an outer perimeter of the catheter body.

7. The catheter assembly as defined in claim 1, wherein the first and second lumens define circular cross sectional shapes, wherein the distal end opening is in fluid communication with a third lumen defined by the catheter body, the third lumen defining a circular cross sectional shape, and wherein an outer perimeter of the catheter body defines an oblong cross sectional shape.

8. The catheter assembly as defined in claim 7, wherein the third lumen can withstand a flow rate therethrough of between about three and about eight milliliters per second.

9. The catheter assembly as defined in claim 1, wherein the at least one venous lateral opening and the at least one arterial lateral opening provide substantially equal recirculation rates in a forward flow direction and in a reverse flow direction.

10. The catheter assembly as defined in claim 1, wherein the distal tip region further defines a tapered nose portion, a portion of both the at least one venous lateral opening and the at least one arterial lateral opening being defined on the nose portion, the distal end opening defined at a distal end of the nose portion.

11. The catheter assembly as defined in claim 10, wherein the distal end opening is centrally defined on the nose portion.

12. The catheter assembly as defined in claim 10, wherein the nose portion includes a material having a low hardness relative to a material from which the catheter body is defined.

13. The catheter assembly as defined in claim 12, wherein the catheter body includes a material having a Shore D hardness of approximately 60, and wherein the nose portion includes a material having a Shore A hardness of approximately 85.

14. The catheter assembly as defined in claim 13, wherein the nose portion includes a polyurethane-based resin.

15. By a catheter assembly, a method of treating blood of a patient, the method comprising:

a) aspirating blood from the patient through a first opening defined in a first lumen of the catheter assembly;

b) treating the blood outside the body of the patient;

c) infusing the treated blood to the patient through a second opening defined in a second lumen of the catheter assembly;

d) infusing a fluid through a third lumen of the catheter assembly; and

e) reversing the flow of blood within the first and second lumens so as to infuse blood through the first lumen and aspirate blood through the second lumen, a recirculation rate after reversal of the flow of blood being less than or equal to about five percent.

16. The method of treating blood as defined in claim 15, wherein infusing the fluid further comprises:

infusing the fluid through the third lumen such that the fluid exits the catheter assembly via a distal end opening defined distally of the first and second openings.

17. The method of treating blood as defined in claim 15, wherein a recirculation rate of treated blood during stages a-c is less than or equal to about five percent.

18. The method of treating blood as defined in claim 15, wherein infusing the fluid further comprises:

infusing the fluid through the third lumen at a flow rate of between about three and about eight milliliters per second.

19. The method of treating blood as defined in claim 15, wherein infusing the fluid further comprises:

infusing the fluid through the third lumen at a fluid pressure of between about 50 and about 250 psi.

20. A catheter assembly, comprising:

a catheter body defining a first lumen, a second lumen, and a third lumen, the catheter body including a distal tip region, the distal tip region including;

a tapered nose portion;

a venous lateral opening in fluid communication with the first lumen and defined on a portion of the nose portion so as to define a distal-facing portion;

an arterial lateral opening in fluid communication with the second lumen and defined on a portion of the nose portion so as to define a distal-facing portion, the venous and arterial lateral openings symmetrically opposed in substantially un-staggered position with respect to one another; and

a distal end opening defined on a distal end of the nose portion, the distal end opening in fluid communication with the third lumen.

21. The catheter assembly as defined in claim 20, wherein the third lumen can withstand a flow rate therethrough of between about three and about eight milliliters per second and a fluid pressure of between about 50 and about 250 psi.

22. The catheter assembly as defined in claim 21, wherein the venous and arterial lateral openings are shaped as to impart a lateral and a distal direction to fluid flowing out therefrom.

23. The catheter assembly as defined in claim 22, wherein the nose portion is joined to a distal end of the catheter body, the nose portion including a material having a lower hardness relative to a hardness of the catheter body.

24. The catheter assembly as defined in claim 23, wherein the nose portion is joined to the distal end of the catheter body by RF fusion.

25. The catheter assembly as defined in claim 23, wherein the venous and arterial lateral openings are defined by an angled cross cut.

26. The catheter assembly as defined in claim 25, wherein the venous and arterial lateral openings are defined about at least a portion of a circumference of the catheter body so as to protect against vessel wall suck-up.

27. The catheter assembly as defined in claim 24, wherein both of the distal-facing portions of the venous and arterial lateral openings can provide a distal flow of fluid during catheter assembly operation when the distal tip region is positioned against a vessel wall.

28. The catheter assembly as defined in claim 27, wherein the venous and arterial lateral openings are defined by a perimeter defining a figure-eight shape.

29. The catheter assembly as defined in claim 28, wherein a recirculation rate of fluids infused via the venous lateral opening by the arterial lateral opening is less than or equal to about five percent.

30. The catheter assembly as defined in claim 20, further comprising:

a first pre-curved extension leg in fluid communication with the first lumen of the catheter body; and

a second pre-curved extension leg in fluid communication with the second lumen of the catheter body.

31. The catheter assembly as defined in claim 20, wherein both of the venous segment and the arterial segment can be employed for blood aspiration and blood infusion when the catheter is inserted in a vasculature of a patient.

32. The catheter assembly as defined in claim 20, wherein when inserted into a vasculature of a patient:

in a first operational configuration state blood is aspirated from the vasculature via the arterial lateral opening and blood is infused into the vasculature via the venous distal opening; and

in a second operational configuration state blood is aspirated from the vasculature via the venous lateral opening and blood is infused into the vasculature via the arterial distal opening.

33. The catheter assembly as defined in claim 20, wherein the venous and arterial lateral openings are defined such that a long axis of each lateral opening defines an acute angle with respect to a longitudinal axis of the catheter body such that a lateral and distal flow direction is imparted to fluid outflow therefrom.

34. A catheter assembly, comprising:

a catheter body defining a first lumen and a second lumen, the catheter body including a distal tip region, the distal tip region including;

a nose portion defining a distally converging outer surface;

a venous lateral opening in fluid communication with the first lumen, the venous lateral opening being at least partially defined on the distally converging outer diameter;

an arterial lateral opening in fluid communication with the second lumen, the arterial lateral opening being at least partially defined on the distally converging outer diameter, the venous and arterial lateral openings being symmetrically disposed in a substantially un-staggered position with respect to one another; and

a distal end opening in fluid communication with one of the venous and arterial lumens and sized to pass a guidewire therethrough.

35. The catheter assembly as defined in claim 34, wherein each of the venous and arterial lateral openings include a distal-facing portion.

36. The catheter assembly as defined in claim 34, wherein a guidewire channel provides the fluid communication between the distal end opening and the respective one of the first and second lumens.

37. The catheter assembly as defined in claim 36, wherein the distal end opening is in fluid communication with the first lumen and wherein the guidewire channel and the distal end opening are axially aligned with the first lumen.

38. The catheter assembly as defined in claim 34, wherein fluid is passable from the first lumen to exit via the distal end opening.

39. The catheter assembly as defined in claim 34, wherein a portion of each of the venous and arterial lateral openings is further defined on a terminal catheter portion of the distal tip region, the terminal catheter portion being proximal to the nose portion.

40. The catheter assembly as defined in claim 34, wherein the nose portion defines one of a bullet shape and a tapered shape.

41. The catheter assembly as defined in claim 34, wherein the catheter body defines an oblong cross sectional shape and wherein an outer wall of the catheter body is thickened on opposing sides thereof.