Partial aortic occlusion devices and methods for cerebral perfusion augmentation

• US 6,635,046 B1
• Filed: 03/20/2000
• Issued: 10/21/2003
• Est. Priority Date: 03/01/1999
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Coaxis Incorporated (Trimble Inc.)
• Inventors: Barbut, Denise
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Thompson, Michael M
• Application Number:
  US09/531,443
• Time in Patent Office: 1,310 Days
• Field of Search: 604/48, 604/96.01, 604/98.01, 604/532, 604/101-1-1, 604/500, 604/509, 604/505-507, 604/103, 604/103.03, 604/104, 604/164.1, 604/164.01, 604/164.03, 604/236, 604/264, 604/158, 604/915, 604/919, 606/159, 606/194, 606/198, 606/200, 606/192, 600/470, 600/465, 600/17, 600/18, 128/898
• US Class Current: 604/507
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: A61B 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence
• 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 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/127 Aorta
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

Methods are provided for partial aortic occlusion for cerebral perfusion augmentation in patients suffering from global or focal cerebral ischemia. Alternatively, the methods can be used to partially occlude aortic blood flow to condition the spinal cord to secrete neuroprotective agents prior to abdominal aortic aneurysm repair. The methods can also be used to partially occlude the renal arteries to reduce renin secretion in hypertensive patients. Partial occlusion of a vessel can be accomplished by a device comprising an elongate catheter, a distally mounted expandable occluder, a variable flow mechanism, and a manometer. The occluder may comprise two conical shells or an inflatable ring-shaped balloon disposed about a cylindrical sleeve. Other medical devices, such as an atherectomy catheter, can be inserted distal the occluder to provide therapeutic intervention.

Claims

1. A method for increasing cerebral blood flow, comprising the steps of:

advancing a catheter into the descending aorta, the catheter having a proximal region, a distal region, and an expandable member mounted on the distal region;

locating the expandable member downstream from the takeoff of the bracbiocephalic artery;

expanding the expandable member to at least partially obstruct blood flow in the aorta during systole and diastole;

measuring a physiologic parameter; and

adjusting the expansion of the expandable member based on the measured physiologic parameter.

2. The method of claim 1, wherein the physiologic parameter is blood pressure.

3. The method of claim 1, wherein the physiologic parameter is cerebral blood flow.

4. The method of claim 1, wherein the expandable member is a balloon.

5. The method of claim 1, wherein the step of expanding the expandable member includes maintaining the expandable member in an expanded condition during systole and diastole.

6. The method of claim 1, wherein blood flow to the cerebral vasculature increases by at least 20%.

7. The method of claim 1, wherein the catheter is first inserted into a peripheral artery, and then advanced into the descending aorta.

8. A method for increasing blood flow to a patient'"'"'s cerebral vasculature, comprising the steps of:

providing a catheter having a proximal end, a distal end, and an expandable constrictor mounted on the distal end, and a lumen extending from the proximal end and communicating with a port distal the constrictor;

advancing the distal end of the catheter into the descending aorta;

locating the constrictor downstream from the takeoff of the brachiocephalic artery;

expanding the constrictor to at least partially occlude blood flow in the aorta during systole and diastole, wherein blood pressure in the proximal aorta increases and blood pressure in the distal aorta decreases; and

advancing a medical instrument through the lumen, beyond the distal port, and into an artery which branches from the aorta.

9. The method of claim 8, wherein the step of expanding the constrictor includes maintaining the expanded constrictor during systole.

10. The method of claim 8, wherein the medical instrument is selected from the group consisting of a guiding catheter, an infusion catheter, an angioplasty catheter, a laser catheter, an angiography catheter, a therapeutic ultrasound catheter, a hypothermia catheter, a stent catheter, an imaging catheter, a perfusion catheter, an atherectomy catheter, an occlusion catheter, an EP catheter, and an aspiration catheter.

11. The method of claim 8, wherein the medical instrument is an interventional instrument.

12. The method of claim 11, wherein the interventional instrument is selected from the group consisting of an infusion catheter, an angioplasty catheter, a laser catheter, an angiography catheter, a therapeutic ultrasound catheter, a hypothermia catheter, a stent catheter, an imaging catheter, a perfusion catheter, an atherectomy catheter, an occlusion catheter, an EP catheter, and an aspiration catheter.

13. A method for increasing blood flow to a patient'"'"'s cerebral vasculature, comprising the steps of:

providing a catheter having a proximal end, a distal end, and an expandable constrictor mounted on the distal end;

inserting the distal end of the catheter into the descending aorta;

locating the constrictor downstream from the takeoff of the brachiocephalic artery; and

expanding the constrictor to partially occlude blood flow in the aorta and maintaining the expanded constrictor during systole, wherein blood pressure in the proximal aorta increases and blood pressure in the distal aorta decreases, and wherein blood flow to the cerebral vasculature increases and exaggerates the pulse wave to enhance the pulsatile wave form.

14. The method of claim 13, further comprising the steps of:

measuring a first blood pressure at a location distal the constrictor; and

adjusting the constrictor based on the first measured blood pressure.

15. The method of claim 14, further comprising the step of measuring a second blood pressure at a location proximal the constrictor, and wherein the constrictor is adjusted based on a comparison of the first and second measured blood pressures.

16. The method of claim 13, wherein the constrictor comprises a balloon having proximal and distal ends separated by a length of no more than 20 cm.

17. A method for increasing blood flow to a patient'"'"'s cerebral vasculature, comprising the steps of:

providing a catheter having a proximal end, a distal end, and an expandable constrictor mounted on the distal end;

advancing the distal end of the catheter into the descending aorta;

locating the constrictor downstream from the takeoff of the brachiocepliac artery;

expanding the constrictor to at least partially occlude blood flow in the aorta during systole and diastole, wherein blood pressure in the proximal aorta increases and blood pressure in the distal aorta decreases;

measuring a first blood pressure at a location proximal the constrictor and measuring a second blood pressure at a location distal the constrictor; and

adjusting the constrictor based on a comparison of the first and second measured blood pressures.

18. The method of claim 17, wherein the step of expanding the constrictor includes maintaining the expanded constrictor during systole.

19. A method for increasing blood flow to a patient'"'"'s cerebral vasculature, comprising the steps of:

providing a catheter having a proximal end, a distal end, and an expandable constrictor mounted on the distal end;

inserting the distal end of the catheter into the descending aorta;

locating the constrictor downstream from the takeoff of the brachiocephalic artery; and

expanding the constrictor to partially occlude blood flow in the aorta and maintaining the expanded constrictor during systole, wherein blood pressure in the proximal aorta increases and blood pressure in the distal aorta decreases, and wherein blood flow to the cerebral vasculature increases.

20. The method of claim 19, wherein the partial occlusion of aortic blood flow is continuous.

21. The method of claim 19, wherein aortic blood flow is partially occluded downstream from the takeoff of the left subclavian artery or the brachiocephalic artery.

22. The method of claim 19, wherein aortic blood flow is partially occluded upstream from the takeoff of the left subclavian artery.

23. The method of claim 19, wherein the patient suffers from global cerebral ischemia and blood flow to the cerebral vasculature is increased.

24. The method of claim 19, wherein the patient suffers from focal cerebral ischemia or asymptomatic vasospasm and blood flow to the cerebral vasculature is increased.

25. The method of claim 19, further comprising the step of inserting the distal end of the catheter through an incision on a peripheral artery.

26. The method of claim 25, wherein the peripheral artery is the femoral artery.

27. The method of claim 25, wherein the peripheral artery is the subclavian artery.

28. The method of claim 19, wherein blood flow through the partial occlusion is varied.

29. The method of claim 19, wherein at least one of the blood pressure upstream and downstream from the partial occlusion is measured, and wherein blood flow at the partial occlusion is varied based on the blood pressure measurement.

30. The method of claim 19, further comprising the step of removing a thromboembolic material from the carotid artery.

31. The method of claim 19, further comprising the step of localizing the constrictor with transesophageal echocardiography.

32. The method of claim 19, further comprising the step of localizing the constrictor with angiogram.

33. The method of claim 19, wherein the distal end of the catheter is inserted into the descending aorta in a antegrade direction.

34. The method of claim 19, wherein the constrictor is located in the aorta upstream from the renal arteries.

35. The method of claim 19, wherein blood flow to the cerebral vasculature increases by at least 20% and exaggerates the pulse wave to enhance the pulsatile wave form.