System, methods and apparatus for cerebral protection

• US 20050209579A1
• Filed: 02/08/2005
• Published: 09/22/2005
• Est. Priority Date: 03/22/2004
• Status: Active Grant

• Current Assignee: Vahe S. Yacoubian, M. D.
• Original Assignee: Vahe S. Yacoubian, M. D.
• Inventors: Shahinian, Hrayr Karnig, Yacoubian, Vahe Stephan
• Granted Patent: US 8,298,169 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• 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 2025/004 characterized by lumina being arranged circumferentially
• 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 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A device, system and method for perfusing an oxygenated medium in the cerebral vasculature includes positioning pressure cuffs on upper extremities; providing a catheter having a multi-region configuration with a balloon; inserting the catheter into a subclavian or femoral vein; advancing the catheter such that the balloon is positioned substantially in the superior vena cava junction substantially proximal to the take-off of the left inominate vein. During a perfusion mode, the cuffs and balloon are inflated causing an increase in cerebral blood flow, retrogradely; and oxygenated blood which may be cooled is pumped from a femoral artery into the catheter for a suitable period. During a non-perfusion mode the cuffs and balloon are deflated. The catheter has at least two regions, namely, guide wire and fluid delivery regions. Optionally, a separate balloon inflation region may be provided.

Claims

1. A method for perfusing an oxygenated medium in the cerebral vasculature of a patient, comprising the acts of:

(1) positioning a left pressure cuff on a left upper extremity of a patient;

(2) positioning a right pressure cuff on a right upper extremity of said patient;

(3) inserting the catheter into a subclavian vein of said patient, said catheter having an expandable member sealably attached around a portion of the catheter;

(4) advancing the catheter through the subclavian vein such that the expandable member is positioned in the superior vena cava junction proximal to the take-off of the left inominate vein of said patient;

(5) during a perfusion mode of a perfusion/non-perfusion cycle, performing the acts of;

(a) inflating said left and right pressure cuffs;

(b) expanding the member to cover a substantial portion of the cross-sectional area of the superior vena cava causing an increase in cerebral blood flow retrogradely;

(c) pumping the oxygenated medium from a femoral artery into the catheter; and

(6) during a non-perfusion mode of said perfuision/non-perfusion cycle, performing the acts of;

(a) deflating the left and right pressure cuffs; and

(b) collapsing the expanded member.

2. The method of claim 1, further comprising the act of measuring the central venous pressure in the superior vena cava during at least one of the perfusion mode and non-perfusion mode.

3. The method of claim 1, wherein said acts of inflating, expanding and pumping during said perfusion mode are performed substantially simultaneously.

4. The method of claim 1, wherein said acts of deflating and collapsing during said non-perfusion mode are performed substantially simultaneously.

5. The method of claim 1, further comprising the act of cooling the oxygenated medium while it is being pumped.

6. A method for perfusing an oxygenated medium in the cerebral vasculature of a patient, comprising the acts of:

(1) positioning a left pressure cuff on a left upper extremity of a patient;

(2) positioning a right pressure cuff on a right upper extremity of said patient;

(3) inserting a catheter into an insertion site of a subclavian vein of said patient, said catheter having a first expandable member sealably attached around a first portion of the catheter, and a second expandable member sealably attached around a second portion of the catheter;

(4) advancing the catheter through the subclavian vein such that the first expandable member is positioned in the superior vena cava junction proximal to the take-off of the left inominate vein and the second expandable member is positioned proximal to the insertion site;

(5) during a perfusion mode of a perfusion/non-perfusion cycle, performing the acts of;

(a) inflating said left and right pressure cuffs;

(b) expanding the first expandable member to cover a substantial portion of the cross-sectional area of the superior vena cava thereby causing blood pressure upstream of the member to increase resulting in an increase in cerebral blood flow retrogradely;

(c) expanding the second expandable member to cover a substantial portion of the cross-sectional area of the insertion site; and

(d) pumping the oxygenated medium from a femoral artery into the catheter;

(6) during a non-perfusion mode of said perfusion/non-perfusion cycle, performing the acts of;

(a) deflating the left and right pressure cuffs; and

(b) collapsing the first and second expandable members.

7. The method of claim 6, wherein said acts of inflating, expanding and pumping during said perfusion mode are performed substantially simultaneously.

8. The method of claim 6, wherein said acts of deflating and collapsing during said non-perfusion mode are performed substantially simultaneously.

9. The method of claim 6, further comprising the step of cooling the oxygenated medium while it is being pumped.

10. A method for perfusing an oxygenated medium in the cerebral vasculature of a patient, comprising the acts of:

(1) positioning a left pressure cuff on a left upper extremity of a patient;

(2) positioning a right pressure cuff on a right upper extremity of said patient;

(3) inserting the catheter into a femoral vein of said patient, said catheter having an expandable member sealably attached around a first portion of the catheter;

(4) advancing the catheter through the femoral vein such that the expandable member is positioned in the superior vena cava junction proximal to the take-off of the left inominate vein of said patient;

(5) during a perfusion mode of a perfusion/non-perfusion cycle, performing the acts of;

(a) inflating said left and right pressure cuffs;

(b) expanding the member to cover a substantial portion of the cross-sectional area of the superior vena cava causing an increase in cerebral blood flow retrogradely;

(c) pumping the oxygenated medium from a femoral artery into the catheter; and

(6) during a non-perfusion mode of said perfusion/non-perfusion cycle, performing the acts of;

(a) deflating the left and right pressure cuffs; and

(b) collapsing the expanded member.

11. The method of claim 10, wherein said acts of inflating, expanding and pumping during said perfusion mode are performed substantially simultaneously.

12. The method of claim 10, wherein said acts of deflating and collapsing during said non-perfusion mode are performed substantially simultaneously.

13. The method of claim 10, further comprising the step of cooling the oxygenated medium while it is being pumped.

14. The method of claim 10, wherein the catheter is advanced through the femoral vein such that a distal end of the expandable member is positioned in the superior vena cava junction proximal to the take-off of the left inominate vein of said patient and a proximal tip of the expandable member is positioned in the inferior vena cava;

and wherein expanding the expandable member further covers a substantial portion of the cross-sectional area of the inferior vena cava thereby causing blood pressure upstream of the member resulting in an increase in cerebral blood flow retrogradely.

15. A method for perfusing an oxygenated medium in the cerebral vasculature of a patient, comprising inserting and advancing a catheter through one of a subclavian vein and a femoral vein of said patient such that an expandable member attached to said catheter is positioned substantially in the superior vena cava junction proximal to the take-off of the left inominate vein of said patient;

wherein said expandable member is cyclically inflated and deflated such that,

during an inflation part of said cycle, pressure cuffs on said patient are simultaneously inflated, the expandable member is inflated and oxygenated medium is pumped from a femoral artery into said catheter, said pressure cuffs being positioned to increase said perfusion of the oxygenated medium in the cerebral vasculature while inflated; and

during a deflation part of said cycle, pressure cuffs on said patient are simultaneously deflated and the expandable member is collapsed.

16. The method of claim 15, further comprising cooling the oxygenated medium.

17. The method of claim 15, wherein said expandable member is configured to occlude the inferior vena cava during said inflation part of said cycle.

18. The method of claim 15, further comprising expanding, during said inflation part, a further expandable member to substantially occlude an insertion site of said at least one of the subclavian vein and the femoral vein.

19. A catheter configured for insertion through an insertion site of a vessel of a patient, said catheter having a catheter body divided into three regions and having a proximal end and a distal end, said catheter comprising:

a guide wire region extending through the catheter body separate from an inflation region and a fluid delivery region, the guide wire region being dimensioned to slidably receive an elongated flexible guide wire therethrough;

the inflation region, extending through the catheter body separate from the guide wire region and fluid delivery region, the inflation region having an inflation port which mates with the inflation region at an inflation proximal end of the inflation region, said inflation port communicating, via the inflation region, with a balloon affixed to the elongate catheter body near the distal end of the catheter body, the inflation region being configured to cyclically couple a fluid between the inflation port and the balloon thereby transitioning the balloon between an inflated state and a deflated state, said balloon being configured to substantially occlude superior vena cava of said patient when in said inflated state; and

the fluid delivery region extending through the catheter body separate from the guide wire region and the inflation region, the fluid delivery region having a fluid delivery port which mates with a fluid proximal end of the fluid delivery region, the fluid delivery region being configured to couple oxygenated fluid from an artery of said patient into said superior vena cava.

20. The catheter of claim 19, wherein said cyclic coupling is performed under control of an external processor firther synchronized with the heart rate of said patient.

21. The catheter of claim 19, wherein said balloon is configured to substantially occlude the superior vena cava in said inflated state in substantial synchronization with arterial blood of said patient perfusing the fluid delivery catheter.

22. The catheter of claim 19, wherein said fluid delivery region is configured to couple the oxygenated fluid from said artery into said superior vena cava under control of an external pump in substantial synchronization with said balloon being in said inflated state.

23. The catheter of claim 19, wherein the catheter body has a length approximately in the range from 10 cm to 30 cm, and outer diameter approximately in the range from 1 F to 10 F, a guide wire region diameter approximately in the range from 0.2 mm to 5 mm, an inflation region diameter approximately in the range from 0.2 mm to 5 mm, and a fluid delivery region diameter approximately in the range from 0.2 mm to 10 mm.

24. The catheter of claim 19, wherein the fluid delivery region has a coating.

25. The catheter of claim 24, wherein the coating is loaded with a compound and is adapted to release the compound for treatment over time.

26. The catheter of claim 24, wherein the coating includes the drug heparin.

27. The catheter of claim 19, further comprising a further balloon affixed to said elongate catheter body near the proximal end of the elongate catheter body so as to internally occlude the insertion site to prevent back bleeding through the vessel.

28. The catheter of claim 19, wherein said fluid includes a gaseous medium or a liquid medium.

29. The catheter of claim 19, wherein said fluid includes helium or saline.

30. A catheter for insertion through a vessel of a patient to maintain cerebral perfusion in said patient, said catheter having a catheter body divided into two regions having a proximal end and a distal end, the catheter comprising:

a guide wire region extending through the catheter body separate from a fluid delivery region, the guide wire region being dimensioned to slidably receive an elongated flexible guide wire therethrough; and

the fluid delivery region extending through the catheter body separate from the guide wire region, the fluid delivery region having a fluid delivery port which mates with the fluid delivery region at a delivery proximal end of the fluid delivery region, the fluid delivery region being in communication with a balloon near a delivery distal end of the fluid delivery region, said balloon being configured to substantially occlude a superior vena cava of said patient in an inflated state, the fluid delivery region being configured to couple said arterial blood from an artery of said patient into said patients superior vena cava.

31. The catheter of claim 30, wherein said balloon is configured to substantially occlude the superior vena cava of said patient in the inflated state in substantial synchronization with arterial blood of said patient perfusing the fluid delivery catheter.

32. The catheter of claim 30, wherein said fluid delivery region is configured to couple the oxygenated fluid from said artery into said superior vena cava under control of an external pump in substantial synchronization with said balloon being in said inflated state.

33. A catheter for insertion through an insertion vessel of a patient to maintain cerebral perfusion during cerebral ischemia comprising:

a catheter body; and

an expandable member sealably attached around a portion of said catheter body;

wherein said catheter body is divided into a plurality of regions;

wherein said plurality of regions include;

a guide wire region configured to slidably receive a guide wire for positioning said expandable member in a desired location in said patient; and

a fluid delivery region configured to receive blood from an artery of said patient and perfuse said blood approximately near said desired location.

34. The catheter of claim 33, wherein said guide wire is inserted in said guide wire region for positioning said expandable member in said desired location.

35. The catheter of claim 33, wherein said desired location is a superior vena cava of said patient.

36. The catheter of claim 33, wherein said insertion vessel is a subclavian vein or a femoral vein of said patient.

37. The catheter of claim 33, wherein said fluid delivery region is configured to perfuse said blood under control of an external pump in substantial synchronization with said expandable member being in an inflated state.

38. The catheter of claim 33, wherein said fluid delivery region is configured to perfuse said blood under control of an external pump in substantial synchronization with said expandable member being in an inflated state in order to increase cerebral blood flow retrogradely.

39. The catheter of claim 33, further comprising a second expandable member configured to occlude said insertion vessel substantially near an insertion site.

40. The catheter of claim 33, further comprising a second expandable member configured to expand and prevent back bleeding through said insertion vessel.

41. The catheter of claim 33, wherein said expandable member is configured to expand in response to said fluid delivery region providing said blood to said desired location.

42. The catheter of claim 33, further comprising an inflation region, said expandable member being in communication with said inflation region.

43. The catheter of claim 33, further comprising an inflation region, said expandable member being in communication with said inflation region, said inflation region being configured to cyclically couple a fluid for cyclically inflating and deflating said expandable member.

44. A catheter for insertion in a vessel of a patient comprising:

a catheter body; and

an expandable member sealably attached around a portion of said catheter body;

wherein said expandable member is configured to substantially occlude said vessel in an inflated state to substantially block blood flow in said vessel.

45. The catheter of claim 44, wherein said catheter body comprises a fluid delivery region having a closed end substantially near said expandable member.

46. The catheter of claim 45, wherein said catheter body further comprises an inflation region having a closed end substantially near said expandable member.

47. The catheter of claim 46, wherein said inflation region has at least one expansion hole surrounded by said expandable member and said fluid delivery region has at least one perfusion hole not surrounded by said expandable member.

48. The catheter of claim 47, wherein said catheter body comprises a guide wire region having an open end substantially near said expandable member;

said guide wire region being configured to slidably receive a guide wire that is extendable pass said open end.

49. The catheter of claim 44, wherein said expandable member is configured to expand in response to blood perfusing through said fluid delivery region.

50. The catheter of claim 44, wherein said fluid delivery region has at least one perfusion hole not surrounded by said expandable member.

51. The catheter of claim 44, wherein said fluid delivery region has at least one expansion hole surrounded by said expandable member.