Aortic catheter with flow divider and methods for preventing cerebral embolization

• US 6,371,935 B1
• Filed: 08/20/1999
• Issued: 04/16/2002
• Est. Priority Date: 01/22/1999
• Status: Expired due to Term

• Current Assignee: Surgerx Medical, LLC
• Original Assignee: Cardeon Corporation
• Inventors: Macoviak, John A., Samson, Wilfred J.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/378,676
• Time in Patent Office: 970 Days
• Field of Search: 604/264, 604/96.01, 604/101-1-1, 604/102-1-1, 606/192-194
• US Class Current: 604/43
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/1205 Introduction devices
• 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 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/0067 characterised by the distal end, e.g. tips A61M25/0054, A61M25/04 take precedence; balloon catheters A61M25/10
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

The invention is a catheter with a fluid flow divider positioned near the distal end of the catheter for dividing a first lumen into two channels at a point where a second lumen branches from the first lumen, and for selectively perfusing the branch lumen. The invention is particularly suited for use in the aortic arch. The fluid flow divider may comprise one or more inflatable chambers or one or more deployable shrouds comprising a plurality of arms with a webbing extending between adjacent arms. The inflatable chambers may be relatively noncompliant or they may be compliant, exhibiting elastic behavior after initial inflation, to closely fit the aortic lumen size and curvature. The catheter may further include one or more additional or auxiliary flow control members located upstream or downstream from the fluid flop divider to further segment the patient'"'"'s circulatory system for selective perfusion to different organ systems within the body or to assist in anchoring the catheter in a desired position.

Claims

1. A fluid flow divider for dividing fluid flow within a body lumen of a patient into at least two channels, the fluid flow divider comprising a first end and a second end, a top surface and a bottom surface, and the flow divider having an undeployed state wherein the flow divider is collapsed to a small diameter and a deployed state wherein the flow divider is expanded to divide fluid flow through the body lumen into a first flow channel and at second flow channel, wherein the expanded flow divider is impermeable to blood and to emboli.

2. The fluid flow divider of claim 1, wherein the first flow channel is defined by a portion of the circumference of the walls of an aortic lumen and the top surface of the flow divider, and the second flow channel is defined by a portion of the circumference of the walls of the aortic lumen and the bottom surface of the flow divider.

3. The fluid flow divider of claim 2, wherein each flow channel has an upstream end and a downstream end.

4. The fluid flow divider of claim 3, wherein the upstream end of the first flow channel is substantially closed to fluid flow originating from upstream of the fluid flow divider.

5. The fluid flow divider of claim 1, further comprising a means for perfusing at least one of the channels with a fluid.

6. The fluid flow divider of claim 1, wherein fluid flow in each flow channel is substantially isolated from the fluid flow of the other flow channel by the fluid flow divider.

7. The fluid flow divider of claim 1, wherein the fluid flow divider comprises at least one inflatable chamber.

8. The fluid flow divider of claim 7, wherein the at least one inflatable chamber is configured to have a plurality of lateral support members when inflated.

9. The fluid flow divider of claim 7, wherein the at least one inflatable chamber is configured to have a peripheral support tube and a plurality of lateral support members when inflated.

10. The fluid flow divider of claim 1, further comprising a catheter having a catheter shaft with a distal end.

11. The fluid flow divider of claim 1, further comprising a catheter having a catheter shaft with a distal end.

12. The fluid flow divider of claim 11, wherein the catheter shaft extends along the top side of the flow divider.

13. The fluid flow divider of claim 10, wherein the catheter shaft extends from the top side of the flow divider, through the flow divider at a point proximate the first end of the flow divider to the bottom side of the flow divider.

14. The fluid flow divider of claim 11, wherein the catheter shaft extends from the top side of the flow divider, through the flow divider at a point proximate the first end of the flow divider to the bottom side of the flow divider.

15. The fluid flow divider of claim 11, wherein the distal end of the catheter shaft extends beyond the first end of the flow divider.

16. The fluid flow divider of claim 1, further comprising a catheter shaft having a first perfusion lumen for perfusing the first fluid flow channel with a fluid.

17. The fluid flow divider of claim 1, further comprising a catheter shaft having a first perfusion lumen for perfusing the first fluid flow channel with a fluid.

18. The fluid flow divider of claim 1, further comprising a catheter shaft having a first perfusion lumen for perfusing the first fluid flow channel with a fluid and a second perfusion lumen for perfusing the second fluid flow channel with a fluid.

19. The fluid flow divider of claim 17, wherein the flow divider is formed in a concave configuration.

20. The fluid flow divider of claim 11, further comprising a flow control member coupled to the catheter shaft between the distal end of the catheter shaft and the first end of the flow divider.

21. The fluid flow divider of claim 20, wherein the flow control member comprises at least one inflatable balloon.

22. The fluid flow divider of claim 20, wherein the flow control member comprises at least one deployable valve.

23. The fluid flow divider of claim 22, wherein the plurality of arms are mechanically deployable.

24. The fluid flow divider of claim 22, wherein the plurality of arms are flexible.

25. The fluid flow divider of claim 22, wherein the plurality of arms are inflatable.

26. The fluid flow divider of claim 22, wherein the flow divider is deployable from within a catheter shaft.

27. The fluid flow divider of claim 1, wherein the fluid flow divider is configured to generate low turbulence fluid flow between a first fluid flow stream in the first fluid flow channel and a second fluid flow stream the second fluid flow channel.

28. The fluid flow divider of claim 1, wherein the fluid flow divider is configured to generate low turbulence fluid flow between a first fluid flow stream in the first fluid flow channel and a second fluid flow stream in the second fluid flow channel.

29. The fluid flow divider of claim 1, wherein the fluid flow divider is configured to generate laminar fluid flow between a first fluid flow stream in the first fluid flow channel and a second fluid flow stream in the second fluid flow channel.

30. The fluid flow divider of claim 29, wherein the fluid flow divider further comprises a peripheral tube.

31. The fluid flow divider of claim 29, wherein the fluid flow divider further comprises a chamber formed between an upper film of the flow divider and a lower film of the flow divider.

32. The fluid flow divider of claim 31, and wherein an interior of the peripheral tube is in fluid communication with the chamber of the fluid flow divider.

33. The fluid flow divider of claim 31, wherein at least one portion of the upper film is coupled to at least one portion of the lower films.

34. The fluid flow divider of claim 1, wherein the flow divider is deployed by extending at least one deployment wire into the flow divider.

35. The fluid flow divider of claim 34, wherein the flow divider further comprises a peripheral tube to receive the at least one deployment wire.

36. The fluid flow divider of claim 34, wherein the fluid flow divider further comprises a catheter having a catheter shaft, and wherein a distal end of the at least one deployment wire is coupled to an exterior surface of the catheter shaft.

37. The fluid flow divider of claim 10, wherein the fluid flow divider is deployed from a distal opening of a lumen within the catheter shaft.

38. The fluid flow divider of claim 37, wherein the fluid flow divider further comprises a flexible spine.

39. The fluid flow divider of claim 38, wherein the fluid flow divider further comprises lateral stiffeners.

40. The fluid flow divider of claim 1, wherein the fluid flow divider further comprises lateral stiffeners.

41. The fluid flow divider of claim 37, wherein the fluid flow divider is deployed using a deployment wire.

42. The fluid flow divider of claim 41, wherein the fluid flow divider further comprises a retraction wire.

43. The fluid flow divider of claim 1, wherein the fluid flow divider is impermeable to embolic material.

44. The fluid flow divider of claim 1, wherein the fluid flow divider is impermeable to blood and embolic material.

45. Apparatus for dividing blood flow within a patient'"'"'s aortic arch to isolate the patient'"'"'s aortic arch vessels from a main flow channel within the patient'"'"'s aortic lumen, comprising:

an elongated catheter shaft; and

a fluid flow divider mounted on the elongated catheter shaft, the fluid flow divider having a first end and a second end, a top surface and a bottom surface, the flow divider having a deployed state and an undeployed state, wherein, when in the undeployed state, the fluid flow divider is collapsed to a small diameter, and when in the deployed state, the flow divider is expanded to divide blood flow within the patient'"'"'s aortic arch thereby isolating the patient'"'"'s aortic arch vessels from the main flow channel within the patient'"'"'s aortic lumen, wherein the expanded fluid flow divider is impermeable to blood and to emboli.

46. The apparatus of claim 45, wherein the elongated catheter shaft comprises a first perfusion lumen for perfusing the patient'"'"'s aortic arch vessels with a fluid.

47. The apparatus of claim 46, wherein the elongated catheter shaft comprises a second perfusion lumen for perfusing the main flow channel within the patient'"'"'s aortic lumen with a fluid.

48. The apparatus of claim 45, further comprising an inflatable balloon mounted on the elongated catheter shaft having an inflated state and a deflated state, wherein, when in the inflated state, the inflatable balloon is sized and configured to substantially occlude blood flow within the patient'"'"'s aortic lumen.

49. The apparatus of claim 45, wherein the fluid flow divider is configured to prevent embolic material within the main flow channel of the patient'"'"'s aortic lumen from entering the patient'"'"'s aortic arch vessels.

50. The apparatus of claim 45, herein the elongated catheter shaft is configured for retrograde introduction of the fluid flow divider into the patient'"'"'s aortic arch from an arterial access point in the patient'"'"'s femoral artery.