AORTIC OCCLUDER WITH TENSIONED BALLOONS

• US 20150051634A1
• Filed: 08/14/2014
• Published: 02/19/2015
• Est. Priority Date: 08/14/2013
• Status: Active Grant

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Inventors: Kravik, Richard C., Greenberg, James, Xiong, Crystal, Lee, Nao
• Granted Patent: US 9,668,741 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• 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 17/12136 Balloons
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• 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 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon

Abstract

An aortic occluder catheter with expandable balloons for increasing cerebral blood blow has one or more balloons on a catheter shaft. To assist the balloon in bearing up against arterial blood flow while positioned retrograde in the aorta, the balloon is bonded to the catheter shaft in tension.

Claims

1. A catheter, comprising:

an elongate member having proximal and distal ends and proximal and distal regions;

at least a first expandable member mounted on the distal region of the elongate member, the first expandable member being inflatable with fluid through at least one lumen in the elongate member to cause the expandable member to expand from an empty configuration to an expanded configuration, the first expandable member being disposed on the elongate member in tension such that the first expandable member is pre-loaded with tensile stress in the empty configuration; and

wherein, during use, the flexible distal region allows the elongate member to conform to a portion of the aorta while the first expandable member is positioned in the portion of the aorta and is at least partially expanded to increase cerebral perfusion.

2. The catheter of claim 1, further comprising:

at least a second expandable member mounted on the elongate member proximal the first expandable member.

3. The catheter of claim 1, further comprising a port formed in the elongate member and communicating with a pressure monitoring lumen in the elongate member for establishing fluid communication between the port and a pressure monitoring device engageable with the pressure monitoring lumen.

4. The catheter of claim 2, wherein the second expandable member is pre-loaded onto the elongate member with tensile stress.

5. The catheter of claim 2, wherein the first and second expandable members are balloons.

6. The catheter of claim 1, wherein the first expandable member is a cylindrical expandable balloon having an outer surface and an enclosed chamber.

7. The catheter of claim 1, further comprising a stiffening element that is insertable into a lumen of the elongate member.

8. The catheter of claim 1, wherein the proximal region of the elongate member provides stability to prevent migration during use.

9. The catheter of claim 1, wherein the portion of the aorta is the descending aorta.

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

a catheter body; and

at least a first expandable balloon disposed on the catheter body and pre-loaded with tensile stress prior to expansion of the balloon under the influence of an inflation fluid.

11. The medical device of claim 10, wherein the first expandable balloon is inflatable with fluid through at least one lumen in the catheter body to cause the expandable balloon to expand from an empty configuration to an expanded configuration.

12. The medical device of claim 10 wherein, during use, the catheter body conforms to a portion of the aorta while the first expandable balloon is positioned in the portion of the aorta and is at least partially expanded to increase cerebral perfusion.

13. The medical device of claim 10, further comprising:

at least a second expandable balloon mounted on the catheter body proximal the first expandable balloon.

14. The medical device of claim 10, further comprising a port formed in the catheter body and communicating with a pressure monitoring lumen in the catheter body for establishing fluid communication between the port and a pressure monitoring device engageable with the pressure monitoring lumen.

15. The medical device of claim 13, wherein the second expandable balloon is pre-loaded onto the catheter body with tensile stress.

16. The medical device of claim 10, wherein the first expandable balloon is a cylindrical expandable balloon having an outer surface and an enclosed chamber.

17. The medical device of claim 10, further comprising a stiffening element that is insertable into a lumen of the catheter body.

18. The medical device of claim 10, wherein a proximal region of the catheter body provides stability to prevent migration during use.

19. A method for making an aortic occlusion device comprising:

disposing an expandable member on a catheter shaft formed with at least one lumen through which fluid can be provided to an interior of the expandable member; and

holding the expandable member on the catheter shaft with tensile stress on the expandable member such that the expandable member is always in tension.

20. The method of claim 19, wherein the expandable member is a first expandable member and the method further comprises:

mounting a second expandable member on the catheter shaft with tensile stress on the second expandable member such that the second expandable member is always in tension.