Split-tip catheter including lateral distal openings

• US 8,066,660 B2
• Filed: 10/17/2008
• Issued: 11/29/2011
• Est. Priority Date: 10/26/2007
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Gregersen, Colin S., Woodley, William D., Walton, Mark E., Patterson, Ryan C., Moehle, Ryan T.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Gilbert; Andrew
• Application Number:
  US12/253,870
• Publication Number:
  US 20090112153A1
• Time in Patent Office: 1,138 Days
• Field of Search: 604/28, 604/29, 604/43, 604/94.01, 604/93.01
• US Class Current: 604/29
• 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 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2202/0021 removed from and reintroduced into the body, e.g. after treatment
• 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 25/003 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 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A split-tip catheter for placement within the vasculature of a patient and for use in hemodialysis or other suitable procedures is disclosed. In one embodiment, the split-tip catheter includes a catheter body that defines a first lumen and a second lumen. The catheter body further comprises a split distal region, including a venous segment that defines a distal portion of the first lumen and an arterial segment that defines a distal portion of the second lumen. The venous segment includes a recess extending proximally of a nose portion; and a lateral opening in fluid communication with the first lumen. The arterial segment is separate from the venous segment and is removably seatable in the recess provided by the venous segment such that it “nests” therein. The arterial segment also includes a lateral opening in fluid communication with the second lumen.

Claims

1. A split-tip catheter for providing vascular access to a vasculature of a patient, the split-tip catheter comprising:

a catheter body defining first and second lumens, the catheter body including a split distal region, the split distal region comprising;

an arterial segment defining a distal portion of the second lumen; and

a venous segment separate from the arterial segment and defining a distal portion of the first lumen, the venous segment further defining a recess into which the arterial segment is removably positioned in a nested configuration forming a continuous columnar outer surface along the length of the recess.

2. The split-tip catheter as defined in claim 1, wherein the venous segment includes a venous distal opening on a nose portion thereof, the venous distal opening being in fluid communication with the first lumen, the nose portion disposed at a distal end of the venous segment, and wherein the arterial segment includes an arterial distal opening on a distal end thereof, the arterial distal opening being in fluid communication with the second lumen.

3. The split-tip catheter as defined in claim 2, wherein the arterial segment is maintained in the nested configuration by a guidewire extending through the venous segment and the arterial segment.

4. The split-tip catheter as defined in claim 3, wherein the guidewire is passed through the venous segment via a guidewire channel defined in the nose portion of the venous segment, and wherein the guidewire passes through the arterial segment via the arterial distal opening.

5. The split-tip catheter as defined in claim 4, wherein the nose portion of the venous segment is disposed distal to the recess.

6. The split-tip catheter as defined in claim 5, wherein the nose portion is tapered.

7. The split-tip catheter as defined in claim 6, wherein the venous distal opening is defined on a tapered portion of the nose portion.

8. The split-tip catheter as defined in claim 7, wherein the guidewire channel is defined at a distal tip of the nose portion.

9. The split-tip catheter as defined in claim 2, wherein the venous segment further comprises a venous lateral opening defined proximally of the nose portion of the venous segment, and wherein the arterial segment further comprises an arterial lateral opening defined proximally of the arterial distal opening.

10. The split-tip catheter as defined in claim 9, wherein the venous and arterial lateral openings are each defined by a compound-angle cross cut so as to impart a lateral direction component to fluid outflow from either the venous or arterial lateral opening.

11. The split-tip catheter as defined in claim 9, wherein an unseating of the arterial segment from recess of the venous segment enables a separation to be achieved between the venous lateral opening and the arterial lateral opening.

12. The split-tip catheter as defined in claim 9, wherein when inserted into a vasculature of a patient:

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

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

13. The split-tip catheter as defined in claim 2, wherein a guidewire channel is defined from a distal end of the arterial segment to the first lumen defined by the venous segment so as to provide a guidewire path from the arterial segment to the venous segment and maintain the arterial segment and the venous segment in a joined configuration when the guidewire is passed through the guidewire channel.

14. The split-tip catheter as defined in claim 1, wherein the catheter body is substantially straight.

15. The split-tip catheter as defined in claim 1, wherein the catheter is a long-term dialysis catheter.

16. A split-tip catheter, comprising:

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

a venous segment defining a distal portion of the first lumen, the venous segment including;

a nose portion that defines a venous distal opening in fluid communication with the first lumen, the nose portion further defining a guidewire channel extending from a proximal end of the nose portion to a distal end thereof;

a recess extending proximally of the nose portion; and

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

an arterial segment separate from the venous segment and defining a distal portion of the second lumen, the arterial segment removably seatable in the recess provided by the venous segment, the arterial segment including;

an arterial distal opening in fluid communication with the second lumen, the arterial distal opening aligning with the guidewire channel of the nose portion when the arterial segment is removably positioned in a nested configuration forming a continuous columnar outer surface along the length of the recess of the venous segment; and

an arterial lateral opening in fluid communication with the second lumen.

17. The split-tip catheter as defined in claim 16, wherein the arterial segment is movable between a seated state in which the arterial segment is received in the recess of the venous segment and an unseated state in which the arterial segment is not received in the recess of the venous segment.

18. The split-tip catheter as defined in claim 17, wherein a spacing longitudinally extends in the recess between the nose portion and a distal end of the arterial segment.

19. The split-tip catheter as defined in claim 16, wherein a distal end of the arterial segment is rounded so as to provide a smooth contour.

20. The split-tip catheter as defined in claim 16, 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 the vasculature of the patient.

21. The split-tip catheter as defined in claim 20, wherein the venous lateral opening is sized to enable full flow from the first lumen therethrough, and wherein the arterial lateral opening is sized to enable full flow from the second lumen therethrough.

22. The split-tip catheter as defined in claim 21, wherein the venous and arterial lateral openings are defined about at least a portion of a circumference of the split distal region so as to protect against vessel wall suck-up.

23. The split-tip catheter as defined in claim 20, wherein the venous and arterial lateral openings are skived such that a longitudinal axis of each lateral opening defines an acute angle with respect to a longitudinal axis of the respective venous or arterial segment and such that a lateral flow direction is imparted to fluid outflow therefrom.

24. The split-tip catheter as defined in claim 20, wherein a guidewire can be received through the guidewire channel of the venous segment nose portion, the arterial distal opening and the second lumen so as to maintain the arterial segment in a seated configuration.

25. The split-tip catheter as defined in claim 16, wherein the venous lateral opening is on an opposing surface of the venous segment with respect to the recess.

26. The split-tip catheter as defined in claim 16, wherein the catheter body includes a pre-curved configuration.

27. The split-tip catheter as defined in claim 16, wherein the arterial segment occupies the entirety of the recess when seated therein.

28. A split-tip catheter, comprising:

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

a venous segment defining a distal portion of the first lumen, the venous segment further defining a distal nose portion of the split-tip catheter;

an arterial segment split from the venous segment and defining a distal portion of the second lumen, a distal end of the arterial segment being disposed proximal to the nose portion of the venous segment, wherein the arterial segment is positionable such that the arterial segment does not radially extend beyond a boundary defined by an outermost perimeter of the nose portion of the venous segment.

29. The split-tip catheter as defined in claim 28, further comprising:

a guidewire channel for enabling a guidewire to pass through a portion of the venous segment and the arterial segment to maintain the arterial segment in a position wherein the arterial segment does not radially extend beyond an outer diameter defined by the nose portion of the venous segment.

30. The split-tip catheter as defined in claim 28, wherein the nose portion shields the arterial segment during distal advancement of the split-tip catheter through a pathway in a body of a patient.