SPLIT-TIP CATHETER INCLUDING LATERAL DISTAL OPENINGS

• US 20090112153A1
• Filed: 10/17/2008
• Published: 04/30/2009
• 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., Patterson, Ryan C., Moehle, Ryan T., Woodley, William D., Walton, Mark E.
• Granted Patent: US 8,066,660 B2
• Time in Patent Office: Days
• US Class Current: 604/43
• 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 separate from the venous segment and defining a distal portion of the second lumen; and

a venous segment defining a distal portion of the first lumen, the venous segment further defining a recess into which the arterial segment is removably seated.

2. The split-tip catheter as defined in claim 1, wherein the recess of the venous segment and the arterial segment are correspondingly shaped so as to provide a columnar outer surface of the distal split-tip region for insertion into the vasculature.

3. The split-tip catheter as defined in claim 2, 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.

4. The split-tip catheter as defined in claim 3, wherein the arterial segment is maintained in a seated state in the venous segment recess by a guidewire extending through the venous segment and the arterial segment.

5. The split-tip catheter as defined in claim 4, 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

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

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

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

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

10. The split-tip catheter as defined in claim 3, 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 define proximally of the arterial distal opening.

11. The split-tip catheter as defined in claim 10, 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.

12. The split-tip catheter as defined in claim 10, 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.

13. The split-tip catheter as defined in claim 10, 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.

14. The split-tip catheter as defined in claim 3, 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.

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

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

17. 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;

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 seated in the recess of the venous segment; and

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

18. The split-tip catheter as defined in claim 17, 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.

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

20. The split-tip catheter as defined in claim 17, wherein a distal end of the arterial segment is rounded so as to provide a smooth contour.

21. The split-tip catheter as defined in claim 17, 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.

22. The split-tip catheter as defined in claim 21, 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.

23. The split-tip catheter as defined in claim 22, 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.

24. The split-tip catheter as defined in claim 21, 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.

25. The split-tip catheter as defined in claim 21, 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.

26. The split-tip catheter as defined in claim 17, wherein the venous lateral opening is on an opposing surface of the venous segment with respect to the recess.

27. The split-tip catheter as defined in claim 17, wherein the catheter body includes a pre-curved configuration.

28. The split-tip catheter as defined in claim 17, wherein the arterial segment occupies the entirety of the recess when seated therein.

29. A method for advancing a split-tip catheter over a guidewire, the guidewire extending from the body of a patient the split-tip catheter defining a first lumen and a second lumen and including a split distal region, the split distal region including a venous segment defining a distal portion of the first lumen and an arterial segment defining a distal portion of the second lumen, the method comprising:

passing the guidewire through a guidewire channel proximally extending from a distal end of the venous segment; and

passing the guidewire from the guidewire channel through an opening defined in the arterial segment such that the guidewire extends proximally through the second lumen.

30. The method for advancing as defined in claim 29, wherein passing the guidewire from the guidewire channel further comprises:

passing the guidewire from the guidewire channel through an opening defined in the arterial segment such that the guidewire extends proximally through the second lumen and such that the venous segment and arterial segments remain in substantial contact with one another.

31. The method for advancing as defined in claim 29, further comprising:

advancing the split-tip catheter over the guidewire into the body of the patient.

32. The method for advancing as defined in claim 29, wherein the guidewire channel is defined in a nose portion of the venous segment, wherein the venous segment defines a recess, the arterial segment being removably seatable in the recess, and wherein passing the guidewire from the guidewire channel further comprises:

passing the guidewire from the guidewire channel through an opening defined in a distal end of the arterial segment such that the guidewire extends proximally through the second lumen.

33. The method for advancing as defined in claim 29, wherein passing the guidewire from the guidewire channel further comprises:

passing the guidewire from the guidewire channel through an opening defined in a lateral surface of the arterial segment such that the guidewire extends proximally through the second lumen.

34. A tunneler device, comprising:

a proximal tunneler shaft;

a catheter connector including at least one barbed extension feature configured to engage a distal portion of a lumen of a catheter, the catheter including a distal split-tip, the at least one barbed extension feature being disposed in an axially offset configuration with respect to the tunneler shaft; and

a sheath configured to removably cover both the catheter connector and its engagement with the distal portion of the catheter lumen.

35. The tunneler device as defined in claim 34, wherein the sheath includes an inner bore into which the catheter connector and distal potion of the catheter are received, the inner bore being sized as to compress a portion of the catheter receive therein so as to prevent separation of the catheter connector from the distal portion of the catheter.

36. The tunneler device as defined in claim 35, further comprising a shoulder defined in the inner bore of the sheath, the shoulder engaging a portion of the catheter connector so as to seat the sheath with respect to the catheter connector.

37. A tunneler device for connecting with a split-tip catheter, comprising:

a tunneler shaft;

a catheter connector attached to an end of the tunneler shaft and including a barbed extension feature for insertion into a distal opening defined by the split-tip catheter;

a sheath slidably attached to the tunneler shaft, the sheath including a stepped inner surface, wherein sliding the sheath over the catheter connector after the barbed extension feature is inserted into the distal opening of the split-tip catheter compresses a wall of the split-tip catheter between the sheath and the catheter connector, wherein further advancement of the sheath is prevented by engagement of the stepped inner surface with a stepped end of the catheter connector.

38. The tunneler device as defined in claim 37, wherein the tunneler shaft includes a bend that limits movement of the sheath with respect to an end of the tunneler shaft.

39. The tunneler device as defined in claim 37, wherein the barbed extension feature includes at least a first barb and a second barb.

40. The tunneler device as defined in claim 37, wherein a barb of the barbed extension feature causes deformation of a portion of a distal end of the split-tip catheter proximate the distal opening so as to prevent disengagement of the split-tip catheter from the catheter connector.

41. The tunneler device as defined in claim 37, wherein the catheter connector includes a gripping portion for grasping by a clinician.

42. A method of subcutaneously tunneling a catheter, the tunneler device including a shaft, a catheter connector attached to the shaft, and a sheath slidably engaged with the shaft, the method comprising:

inserting a barbed extension feature of the catheter connector into a distal opening of the catheter;

sliding the sheath over the catheter connector so as to cover engagement of the catheter connector with the distal opening of the catheter; and

defining a subcutaneous tunnel with the shaft so as to advance the catheter into the tunnel.

43. The method of subcutaneously tunneling as defined in claim 42, wherein inserting the barbed extension feature further comprises:

inserting the barbed extension feature of the catheter connector into a distal opening of a split-tip catheter, the at least one barbed extension feature being disposed in an axially offset configuration with respect to shaft to enable axial engagement of the distal opening of the split-tip catheter.

44. The method of subcutaneously tunneling as defined in claim 42, wherein sliding the sheath further comprises:

sliding the sheath over the catheter connector so as to cover engagement of the catheter connector with the distal opening of the catheter, the sheath being sized so as to compress an outer surface of the catheter.

45. The method of subcutaneously tunneling as defined in claim 42, wherein sliding the sheath further comprises:

sliding the sheath over the catheter connector until a shoulder defined by the sheath engages a stepped feature of the catheter connector.

46. The method of subcutaneously tunneling as defined in claim 42, further comprising:

after advancing the catheter into the tunnel, sliding the sheath back so as to expose engagement of the catheter connector with the distal opening of the catheter; and

removing the barbed extension feature from the distal opening of the catheter.

47. 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 at least one venous lateral opening in fluid communication with the first lumen;

an arterial segment separate from the venous segment and defining a distal portion of the second lumen, the arterial segment including at least one arterial lateral opening in fluid communication with the second lumen, a distal portion of the venous segment and a distal portion of the arterial segment together defining a nose portion of the split-tip catheter.

a guidewire channel for enabling a guidewire to pass through a portion of the venous segment and the arterial segment; and

at least one distal opening defined by one of the venous segment and the arterial segment, the at least one distal opening in fluid communication with a respective one of the first lumen and the second lumen.

48. The split-tip catheter as defined in claim 47, wherein the nose portion defines a tapered profile.

49. The split-tip catheter as defined in claim 48, wherein the venous segment includes a plurality of lateral openings, and wherein the arterial segment includes a plurality of lateral openings.

50. The split-tip catheter as defined in claim 47, wherein the nose portion defines a rounded profile.

51. The split-tip catheter as defined in claim 47, wherein the venous segment defines a first distal opening and the arterial segment defines a second distal opening.

52. The split-tip catheter as defined in claim 47, wherein the guidewire channel is included with the at least one distal opening.

53. The split-tip catheter as defined in claim 47, above wherein the venous segment includes a first lateral opening coincident with a distal end of the venous segment, and wherein the arterial segment includes a second lateral opening coincident with a distal end of the arterial segment.

54. The split-tip catheter as defined in claim 53, wherein the first and second lateral openings extend proximally at an angle from the respective distal ends of the venous segment and arterial segment.

55. The split-tip catheter as defined in claim 47, wherein the at least one lateral opening of the venous segment and the at least one lateral opening of the arterial segment each define a semicircular shape.

56. The split-tip catheter as defined in claim 47, wherein the at least lateral opening of the venous segment and the at least one lateral opening of the arterial segment each define a triangular shape.

57. 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 an outer diameter defined by the nose portion of the venous segment.

58. The split-tip catheter as defined in claim 57, 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

59. The split-tip catheter as defined in claim 57, 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.