Partial aortic occlusion devices and methods for cerebral perfusion augmentation

• US 20060047262A1
• Filed: 10/21/2005
• Published: 03/02/2006
• Est. Priority Date: 03/01/1999
• Status: Active Grant

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Denise R. Barbut, Peter T. Keith, Steven W. Berhow, Stgermain Jon P
• Inventors: Barbut, Denise R., Keith, Peter T., Berhow, Steven W., St.Germain, Jon P.
• Granted Patent: US 7,468,027 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• 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 medical device, comprising:

an elongate tubular member having a proximal end, a distal end, and a lumen therebetween; and

an elongate non-spherical balloon mounted on the distal end of the elongate tubular member and communicating with the lumen, the balloon having a compliance of approximately 0.3-1.25 mm per psi and configured such that it has an initial wrinkle-free diameter of approximately 10-15 mm, and thereafter expands upon inflation, and wherein the balloon is approximately 3-6 cm in length.

2. The medical device of claim 1, wherein the balloon is capable of approximately 150% increase in diameter upon inflation to 12-50 psi.

3. The medical device of claim 1, wherein the balloon is capable of expansion to approximately 25-30 mm in diameter upon inflation to approximately 12-50 psi.

4. The medical device of claim 1, wherein the balloon has an initial wrinkle-free diameter of approximately 10-15 mm at approximately 0.5-5 psi.

5. The medical device of claim 1, wherein the balloon has a tubular or sausage shape.

6. The medical device of claim 1, wherein the balloon is made of molded polyurethane.

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

providing an elongate tubular member having a proximal end, a distal end, a lumen therebetween, and an elongate non-spherical balloon approximately 3-6 cm in length mounted on the distal end of the elongate tubular member and communicating with the lumen, the balloon having a compliance of approximately 0.3-1.25 mm per psi and configured such that it has an initial wrinkle-free diameter of approximately 10-15 mm, and thereafter expands upon inflation;

inserting the elongate tubular member into the descending aorta;

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

expanding the balloon to at least partially obstruct blood flow in the aorta.

8. The method of claim 8, further comprising the step of measuring cerebral blood flow before the step of expanding the balloon to at least partially obstruct blood flow in the aorta.

9. The method of claim 8, further comprising the step of measuring cerebral blood flow after the step of expanding the balloon to at least partially obstruct blood flow in the aorta.

10. The method of claim 10, further comprising the step of adjusting the expansion of the expandable member based on measured cerebral blood flow.

11. A medical device, comprising:

an elongate tubular member having a proximal end, a distal end, and a lumen therebetween; and

an elongate non-spherical balloon mounted on the distal end of the elongate tubular member and communicating with the lumen, the balloon having an initial wrinkle-free diameter of approximately 10-15 mm, and thereafter expands upon inflation, and wherein the balloon is approximately 3-6 cm in length.

12. The medical device of claim 11, wherein the balloon is capable of approximately 150% increase in diameter upon inflation to 12-50 psi.

13. The medical device of claim 11, wherein the balloon is capable of expansion to approximately 25-30 mm in diameter upon inflation to approximately 12-50 psi.

14. The medical device of claim 11, wherein the balloon has an initial wrinkle-free diameter of approximately 10-15 mm at approximately 0.5-5 psi.

15. The medical device of claim 11, wherein the balloon has a tubular or sausage shape.

16. The medical device of claim 11, wherein the balloon is made of molded polyurethane.