Curved intra aortic balloon with non-folding inflated balloon membrane

• US 5,116,305 A
• Filed: 10/23/1991
• Issued: 05/26/1992
• Est. Priority Date: 02/01/1990
• Status: Expired due to Term

• Current Assignee: Abiomed, Inc. (Johnson & Johnson)
• Original Assignee: Abiomed, Inc. (Johnson & Johnson)
• Inventors: Rosenberg, Meir, Milder, Fredric L.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): LACYK, JOHN P
• Application Number:
  US07/780,393
• Time in Patent Office: 216 Days
• Field of Search: 600/16-18, 606/191-200, 604/96, 604/103
• US Class Current: 600/18
• CPC Class Codes: A61M 60/139 inside the aorta, e.g. intra-aortic balloon pumps
• CPC Class Codes: A61M 60/274 the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
• CPC Class Codes: A61M 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/497 for balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/843 Balloon aspects, e.g. shapes or materials
• CPC Class Codes: A61M 60/865 Devices for guiding or inserting pumps or pumping devices into the patient's body

Abstract

An intra aortic balloon pumping device comprises a pumping balloon, an attached inflation catheter, a supporting member which is disposed within and extends from the catheter into the balloon. The balloon membrane of the invention resists the formation of membrane folds in the tail section of the balloon. This characteristic of the balloon membrane is believed to result from the addition of tension to the balloon membrane. Tension may be applied to the membrane by ensuring that the portion of the support member which is disposed within the balloon is equal to the length of the outer curve of the balloon wall such that it resides on an outer curve of the wall. Alternatively, tension may be applied by extending the support member within the balloon.

Claims

1. A cardiac assist device for insertion into the aorta, comprising:

a pumping balloon having a membrane formed in a generally cylindroidal inflated shape wherein the maximum diameter in a plane transverse to the long axis of the balloon is located intermediate the ends of the balloon and wherein the balloon diameter decreases in both directions from the plane of largest diameter along said axis;

a catheter means for providing fluid to the balloon when the balloon is positioned within the aorta, said catheter means being joined at a terminal end thereof to one end of the balloon; and

a support member tensioning the inflated balloon membrane, said support member being located within and extending the length of the balloon, the support member also being in contact with an interior surface of the balloon membrane, said balloon membrane being stretched along the length of its surface contacting said support member to provide said tensioning.

2. The device of claim 1 wherein the support member is disposed within and extends from the terminal end of the catheter means.

3. The device of claim 2 wherein a bushing is mounted within the catheter means and surrounds the support member to prevent relative rotational movement of the catheter means and the support member.

4. The device of claim 2 wherein the diameter of said catheter means decreases, at the terminal end to engage outer walls of said support member to prevent relative rotational movement of the catheter means and the support means.

5. The device of claim 1 wherein the inflated balloon and the support member are curved, such that said balloon has an inner curved wall and a longer, outer curved wall and wherein said support member is in contact along substantially the entire length of the interior surface of the outer curved wall and has a length substantially equal to that of the outer curved wall.

6. The device of claim 5 wherein the inflated balloon and the support member have a curved portion with a characteristic radius of curvature in the range of approximately 2 to 5 centimeters.

7. The device of claim 5 wherein the inflated balloon and the support member have a curved portion which approximately conforms to the curvature of the aortic arch.

8. The device of claim 5 wherein the outer curve of the balloon membrane wall is thicker than the remainder of the balloon membrane wall.

9. The device of claim 8 wherein the ratio of the thickness of the outer curve of the balloon membrane to the of the remainder of the balloon membrane wall is in the range of about 1.2:

1 to 1.6;

1.

10. The device of claim 5 wherein said terminal end of the catheter means has a curvature substantially equal to that of the support member.

11. The device of claim 1 wherein said balloon is formed in a substantially flat condition.

12. The device of claim 1 wherein said support member is a hollow tube.

13. The device of claim 12 wherein said hollow tube is a pressure monitoring lumen.

14. The device of claim 1 wherein said support member is a solid member.

15. The device of claim 1 wherein the balloon is formed of a thin elastomeric material, said balloon having a volumetric compliance within the range of about 5 to 15 cc/100 mm Hg transmembrane pressure.

16. The device of claim 13 wherein the compliance is approximately 7 cc/100 mm Hg transmembrane pressure.

17. The device of claim 1 wherein the balloon is formed of a thin elastomeric material, said balloon having a diameter compliance in the range of about 2-5 mm/100 mmHg transmembrane pressure.

18. A cardiac assist device for insertion into the aorta, comprising:

a pumping balloon having a membrane formed in a generally cylindrical inflated shape wherein the maximum diameter in a plane transverse to the long axis of the balloon is located intermediate the ends of the balloon and wherein the balloon diameter decreases in both directions from the plane of maximum diameter along said axis;

a catheter means for providing fluid to the balloon when the balloon is positioned within the aorta, said catheter means being joined at a terminal end thereof to one end of the balloon; and

an extensible support means for selectively tensioning the balloon membrane, said support means located within said balloon and upon extension extending the length of the balloon to impart tension to said membrane.

19. A method of wrapping a balloon of an intra aortic balloon pumping device, comprising the steps of:

providing an intrinsically curved IAB device having a deflated balloon having a membrane including an inner curved wall and an outer curved wall with a hollow support member extending therethrough, said support member residing against an interior surface of said outer curved wall of the balloon membrane and imparting tension to the balloon membrane;

inserting a straightening member through the interior volume of the balloon to reduce the intrinsic curvature of the device;

removing the support member from contact with the outer curve of the balloon member;

evacuating the balloon to render the balloon membrane substantially flat and disposing the support member at a substantially central portion of the balloon membrane with balloon membrane segments on either side of the support member; and

simultaneously wrapping both membrane segments around the support member in the same direction.

20. The method of claim 19 wherein the insertion step involves inserting a straightening member through the hollow support member.

21. The method of claim 19 wherein the insertion step involves inserting a straightening member which encompasses at least a portion of the hollow support member.

22. A cardiac assist device for insertion into the aorta, comprising:

a pumping balloon having a membrane formed in a generally cylindroidal inflated shape wherein the maximum diameter in a plane transverse to the long axis of the balloon is located intermediate the ends of the balloon and wherein the balloon diameter decreases in both directions from the plane of largest diameter along said axis;

a catheter means for providing fluid to the balloon when the balloon is positioned within the aorta, said catheter means being joined at a terminal end thereof to one end of the balloon;

a support means for tensioning the balloon membrane, said support means located within the balloon; and

a bushing means for preventing relative rotational movement of the catheter means and the support means, said bushing means mounted within the catheter means and extending around at least a portion of said support means.

23. A cardiac assist device for insertion into the aorta, comprising:

a pumping balloon having a membrane formed in a generally cylindroidal inflated shape wherein the maximum diameter in a plane transverse to the long axis of the balloon is located intermediate the ends of the balloon and wherein the balloon diameter decreases in both directions from the plane of largest diameter along said axis;

a catheter means for providing fluid to the balloon when the balloon is positioned within the aorta, said catheter means being joined at a terminal end thereof to one end of the balloon; and

a support means for tensioning the balloon membrane, said support means located within the balloon;

said catheter means having a diameter at said terminal end which tapers so as to engage said support means such that an inner diameter of the catheter means is substantially equal to an outer diameter of the support means.

24. The device of claim 23 further comprising a radiopaque cap element secured to the tapered diameter of the catheter means.