Aortic occluder with tensioned balloons

• US 9,668,741 B2
• Filed: 08/14/2014
• Issued: 06/06/2017
• 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
• Primary Examiner(s): Severson, Ryan J
• Assistant Examiner(s): KNAUSS, CHRISTIAN D
• Application Number:
  US14/460,124
• Publication Number:
  US 20150051634A1
• Time in Patent Office: 1,027 Days
• 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 first expandable member to expand from an empty configuration to an expanded configuration, the first expandable member being disposed on the elongate member in first tension such that the first expandable member is pre-loaded with tensile stress in the empty configuration;

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

2. The catheter of claim 1, further comprising:

at least a first heat-shrink tube disposed around a first end segment of the first expandable member and at least a second heat-shrink tube being disposed around a second end segment of the first expandable member to hold the first expandable member in tension on the elongate member;

the second expandable member being mounted on the elongate member proximal the first expandable member; and

at least a third heat-shrink tube disposed around a first end segment of the second expandable member and at least a fourth heat-shrink tube being disposed around a second end segment of the second expandable member to hold the second expandable member in tension on the elongate member.

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

4. The catheter of claim 2, wherein the second expandable member is disposed in less stress on the elongate member than the first expandable member.

5. 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.

6. The catheter of claim 1, wherein the first expandable member comprises a body, a first end segment that is radially smaller than the body, and a conical segment connecting the first end segment to the body.

7. The catheter of claim 2, wherein the first heat shrink tube comprises a first end segment closely surrounding the first end segment of the first expandable member and a conical segment closely surrounding a conical segment of the first expandable 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, during use, the distal region allows the elongate member to conform to a portion of a patient'"'"'s aorta while the first expandable member is positioned in the portion of the aorta and is at least partially expanded to increase cerebral perfusion.

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

11. 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 in tension prior to expansion of the first expandable balloon under the influence of an inflation fluid; and

at least a second expandable balloon disposed on the catheter body in tension prior to expansion of the second expandable balloon under the influence of an inflation fluid, the second expandable balloon being disposed in tension on the catheter body in less stress than the first expandable balloon.

12. The medical device of claim 11, wherein at least a first heat-shrink tube is disposed around a first end segment of the first expandable balloon and at least a second heat-shrink tube is disposed around a second end segment of the first expandable balloon to hold the first expandable balloon in tension on the catheter body.

13. The medical device of claim 11 wherein, during use, the catheter body conforms to a portion of a patient'"'"'s aorta while the first expandable balloon is positioned in the portion of the aorta and is at least partially expanded to increase cerebral perfusion.

14. The medical device of claim 11, wherein the first expandable balloon comprises a body, a first end segment that is radially smaller than the body, and a conical segment connects the first end segment to the body of the first expandable balloon.

15. The medical device of claim 11, 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.

16. The medical device of claim 11, wherein the first expandable balloon comprises a body, a first end segment that is radially smaller than the body, and a conical segment connects the first end segment to the body of the first expandable balloon, at least a first heat-shrink tube being disposed around a first end segment of the first expandable balloon, wherein the first heat shrink tube comprises a first end segment closely surrounding the first end segment of the first expandable balloon and a conical segment closely surrounding the conical segment of the first expandable balloon.

17. The medical device of claim 11, wherein the first expandable balloon is a cylindrical expandable balloon having an outer surface and an enclosed chamber.

18. The medical device of claim 11, further comprising a stiffening element that is insertable into a lumen of the catheter body.

19. The medical device of claim 11, wherein a proximal region of the catheter body provides stability to prevent migration during use.