Partial aortic occlusion devices and methods for cerebral perfusion augmentation

• US 20030023200A1
• Filed: 04/24/2001
• Published: 01/30/2003
• Est. Priority Date: 03/01/1999
• Status: Active Grant

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Coaxis Incorporated (Trimble Inc.)
• Inventors: Barbut, Denise R., Keith, Peter T., St. Germain, Jon P., Berhow, Steven W.
• Granted Patent: US 6,743,196 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/1204 temporary 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 17/12136 Balloons
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 6/481 involving the use of contrast agents
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• 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 general flow characteristics A61M2206/10
• CPC Class Codes: A61M 2025/0081 Soft tip
• 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 2230/005 : Parameter used as control input for the apparatus
• 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 25/003 : 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 25/0032 : characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• 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 25/0069 : Tip not integral with tube
• CPC Class Codes: A61M 25/0074 : Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/008 : Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0082 : Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters

Abstract

Methods are provided for partial aortic obstruction for cerebral perfusion augmentation in patients suffering from global or focal cerebral ischemia. Alternatively, the methods can be used to partially obstruct aortic blood flow to condition the spinal cord to secrete neuroprotective agents prior to abdominal aortic aneurysm repair. Partial obstruction of a vessel can be accomplished by a device comprising an elongate catheter and a distally mounted expandable member. The expandable member may comprise one or two balloons. Other medical devices, such as an angioplasty, stent, or atherectomy catheter, can be inserted distal the expandable member to provide therapeutic intervention.

Claims

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

inserting 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 brachiocephalic artery;

expanding the expandable member to at least partially obstruct blood flow in the aorta;

measuring cerebral blood flow; and

adjusting the expansion of the expandable member based on measured cerebral blood flow.

2. The method of claim 1, further comprising the step of advancing a medical instrument through a lumen of the catheter, beyond a distal port of the catheter, and into an artery that branches from the aorta.

3. The method of claim 1, further comprising the step of measuring blood pressure in the proximal aorta and/or the distal aorta.

4. The method of claim 1, wherein blood pressure in the proximal aorta increases and blood pressure in the distal aorta decreases.

5. The method of claim 1, wherein the expandable member comprises a balloon.

6. The method of claim 1, wherein the expanded member includes an aperture through which blood flows during use.

7. The method of claim 1, wherein the expanded member allows blood flow through an area between the lumen of the aorta and outer dimensions of the expandable member.

8. The method of claim 1, wherein the step of expanding the expandable member includes maintaining the expanded member during systole.

38. The method of claim 1, wherein the first expandable member is located upstream from the takeoff of the renal arteries and superior mesenteric artery.

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

inserting a catheter into the descending aorta, the catheter having a proximal region, a distal region, a first expandable member mounted on the distal region, and a second expandable member mounted on the distal region proximal the first expandable member;

locating the first expandable member upstream from the takeoff of the renal arteries;

locating the second expandable member downstream from the takeoff of the renal arteries; and

expanding the second expandable member to partially occlude blood flow in the aorta.

10. The method of claim 9, further comprising the step of expanding the first constrictor to partially occlude blood flow in the aorta.

11. The method of claim 10, further comprising the step of partially reducing the expansion of the second constrictor.

12. The method of claim 9, further comprising the step of measuring cerebral blood flow.

13. The method of claim 10, further comprising the step of adjusting the expansion of the second constrictor based on measured cerebral blood flow.

14. The method of claim 9, further comprising the step of advancing a medical instrument through a lumen of the catheter, beyond a distal port of the catheter, and into an artery that branches from the aorta.

15. The method of claim 9, further comprising the step of measuring blood pressure in at least one of the proximal aorta, the distal aorta, and between the first and second expandable members.

16. The method of claim 9, wherein blood pressure in the proximal aorta increases and blood pressure in the distal aorta decreases.

17. The method of claim 9, wherein the first and second constrictors are balloons.

18. The method of claim 9, wherein the first and second constrictors, when expanded, allow blood flow through an area between the lumen of the aorta and outer dimensions of the constrictors.

19. The method of claim 9, wherein the first expandable member is located upstream from the takeoff of the superior mesenteric artery.

20. The method of claim 9, wherein the catheter includes pressure measuring capabilities disposed between the first and second expandable members, and wherein the method further comprises the step of measuring blood pressure between the first and second expandable members.

21. The method of claim 9, wherein the catheter further comprises a stiffening element, and wherein the method further comprises the step of inserting the stiffening element into a lumen of the catheter.

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

inserting a catheter into the descending aorta, the catheter having a proximal end, a distal end, a first expandable member mounted on the distal end, and a second expandable member mounted on the distal end proximal the first expandable member;

locating the first expandable member upstream from the takeoff of the renal arteries;

locating the second expandable member downstream from the takeoff of the renal arteries; and

expanding the first expandable member to partially occlude blood flow in the aorta.

23. The method of claim 22, wherein the first expandable member is located upstream from the takeoff of the superior mesenteric artery.

24. The method of claim 22, wherein the catheter includes pressure measuring capabilities disposed between the first and second expandable members, and wherein the method further comprises the step of measuring blood pressure between the first and second expandable members.

25. The method of claim 22, wherein the catheter further comprises a stiffening element, and wherein the method further comprises the step of inserting the stiffening element into a lumen of the catheter.

26. The method of claim 22, further comprising the step of expanding the second constrictor to partially occlude blood flow in the aorta.

27. The method of claim 26, further comprising the step of partially reducing the expansion of the first constrictor.

28. The method of claim 22, further comprising the step of measuring cerebral blood flow.

29. A medical device for partial aortic occlusion for cerebral perfusion augmentation, comprising:

an elongate member having proximal and distal ends;

a first expandable member mounted at the distal end of the elongate member

a second expandable member mounted at the distal end of the elongate member proximal the first expandable member; and

a pressure measuring device operable to measure blood pressure in the aorta upstream the second expandable member.

30. The device of claim 29, further comprising a first centering mechanism disposed about the first expandable member for centering the first expandable member within the aorta when deployed.

31. The device of claim 29, further comprising a second centering mechanism disposed about the second expandable member for centering the second expandable member within the aorta when deployed.

32. The device of claim 29, wherein the pressure measuring device is a pressure tube carried by the catheter and proximally connected to a pressure monitor.

33. The device of claim 29, wherein the pressure measuring device is a manometer mounted at the distal end of the catheter.

34. The device of claim 29, wherein the first and second expandable members are balloons.

35. The device of claim 29, wherein the first and second expandable members are cylindrical expandable balloons, each having an outer surface, a lumen, and an enclosed chamber.

36. The device of claim 29, wherein the pressure measuring device is disposed between the first and second expandable members.

37. The device of claim 29, further comprising a stiffening element that is insertable into a lumen of the elongate member.