Catheter assembly

• US 9,610,422 B2
• Filed: 11/14/2014
• Issued: 04/04/2017
• 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: Moehle, Ryan T., Barron, William R., Sanders, Scott W.
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US14/542,495
• Publication Number:
  US 20150073336A1
• Time in Patent Office: 872 Days
• Field of Search: 604 401, 604 501, 604 616, 604507, 604508, 604523, 604611
• 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
• 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 an arterial lateral opening that is in fluid communication with the second lumen.

Claims

1. A catheter assembly, comprising:

a catheter body including;

an outer wall;

a first lumen and a second lumen separated by a septum; and

a distal tip region including;

a terminal catheter portion;

a nose portion distal of the terminal catheter portion;

a venous lateral opening in fluid communication with the first lumen; and

an arterial lateral opening in fluid communication with the second lumen, the venous and arterial lateral openings positioned un-staggered with respect to one another, each having a proximal end defined through the catheter outer wall in the terminal catheter portion, the defined proximal end openings comprising a shape that is symmetrical with respect to a plane through a central axis of the catheter body perpendicular to the septum.

2. The catheter assembly according to claim 1, wherein the venous lateral opening and the arterial lateral opening are symmetrically positioned with respect to one another.

3. The catheter assembly according to claim 1, wherein the proximal end of each of the venous and arterial lateral openings defines a partial oval perimeter in the terminal catheter portion.

4. The catheter assembly according to claim 1, further comprising a distal end opening located in the nose portion.

5. The catheter assembly according to claim 4, wherein the distal end opening is in communication with a third lumen defined by the catheter body.

6. The catheter assembly according to claim 5, wherein the distal end opening is centrally positioned with respect to the central axis of the catheter body.

7. The catheter assembly according to claim 5, wherein the third lumen has a circular cross sectional shape.

8. The catheter assembly according to 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 according to claim 1, wherein the venous lateral opening and the arterial lateral opening provide substantially equal recirculation rates in a forward flow direction and in a reverse flow direction.

10. The catheter assembly according to claim 1, wherein the nose portion includes a material having a low hardness relative to a material from which the catheter body is defined.

11. The catheter assembly according to claim 10, 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.

12. The catheter assembly according to claim 11, wherein the nose portion includes a polyurethane-based resin.

13. The catheter assembly according to claim 1, wherein the nose portion is joined to the terminal catheter portion by RF fusion.

14. The catheter assembly according to claim 1, 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.

15. The catheter assembly according to claim 1, 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.

16. The catheter assembly according to claim 1, wherein the catheter body defines an oblong cross sectional shape and wherein the catheter body outer wall is thickened on opposing sides thereof.

17. The catheter assembly according to claim 1, wherein the septum extends from the terminal catheter portion into the nose portion.

18. The catheter assembly according to claim 17, wherein the septum extends to a distal end of the nose portion.

19. The catheter assembly according to claim 17, wherein the septum tapers toward the central axis of the catheter body.

20. The catheter assembly according to claim 1, wherein the nose portion includes an outer wall extending from the catheter outer wall, the nose portion outer wall tapering toward the septum.

21. The catheter assembly according to claim 1, wherein the venous and arterial lateral openings extend to a distal end of the terminal catheter portion.

22. A catheter assembly, comprising:

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

a terminal catheter portion;

a nose portion distal of the terminal catheter portion;

a venous lateral opening in fluid communication with the first lumen; and

an arterial lateral opening in fluid communication with the second lumen, the venous and arterial lateral openings positioned un-staggered with respect to one another, each of the venous and arterial lateral openings;

having a proximal end defined through a catheter outer wall in the terminal catheter portion; and

extending into the nose portion;

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

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

23. A catheter assembly, comprising:

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

a terminal catheter portion;

a nose portion distal of the terminal catheter portion;

a venous lateral opening in fluid communication with the first lumen; and

an arterial lateral opening in fluid communication with the second lumen, the venous and arterial lateral openings positioned un-staggered with respect to one another, each of the venous and arterial lateral openings having a proximal end defined through a catheter outer wall in the terminal catheter portion;

wherein the septum extends to a distal end of the nose portion;

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.