Devices and methods for assisting heart function

• US 8,303,481 B2
• Filed: 03/12/2010
• Issued: 11/06/2012
• Est. Priority Date: 06/30/2006
• Status: Active Grant

• Current Assignee: CVDEVICES, LLC
• Original Assignee: CVDEVICES, LLC
• Inventors: Kassab, Ghassan S., Navia, Jose A. Sr.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): PORTER, JR, GARY A
• Application Number:
  US12/723,278
• Publication Number:
  US 20100185044A1
• Time in Patent Office: 970 Days
• Field of Search: 600 16- 18
• US Class Current: 600/16
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61N 1/0592 Introducing the lead through the pericardium with a needle

Abstract

Devices and methods for assisting heart function. In at least one embodiment of a device for assisting heart function, the device comprises at least two electromagnetic plates having an inner surface, a cardiac processor electrically coupled to at least one of the at least two electromagnetic plates, a bladder having an inner chamber, the bladder attached to an inner surface of at least one of the at least two electromagnetic plates, a source of gas in communication with the inner chamber of the bladder, and at least one catheter having a proximal end and a distal end and having a lumen therethrough, the at least one catheter defining at least one aperture positioned therethrough at or near the distal end of the at least one catheter and comprising a pericardial balloon coupled to the at least one catheter at or near the distal end of the at least one catheter, the proximal end of the at least one catheter in communication with the inner chamber of the bladder.

Claims

1. A device for assisting heart function, comprising:

at least two electromagnetic plates, the at least two electromagnetic plates having an inner surface;

a cardiac processor electrically coupled to at least one of the at least two electromagnetic plates;

a bladder having an inner chamber, the bladder attached to the inner surfaces of each of the at least two electromagnetic plates and disposed between the at least two electromagnetic plates;

a source of gas in communication with the inner chamber of the bladder; and

at least one catheter having a proximal end and a distal end and having a lumen therethrough, the at least one catheter defining at least one aperture positioned therethrough at or near the distal end of the at least one catheter and comprising a first pericardial balloon coupled to the at least one catheter at or near the distal end of the at least one catheter, the proximal end of the at least one catheter in communication with the inner chamber of the bladder.

2. The device of claim 1, wherein when the distal end of the at least one catheter is positioned within a pericardial space, the device operates to inject gas into and/or remove gas from the first pericardial balloon.

3. The device of claim 1, wherein the at least two electromagnetic plates are operable to compress the bladder, wherein the compression of the bladder injects gas into the first pericardial balloon to inflate the pericardial balloon.

4. The device of claim 1, wherein the at least two electromagnetic plates are operable to expand the bladder, wherein the expansion of the bladder removes gas from the first pericardial balloon to deflate the pericardial balloon.

5. The device of claim 1, wherein gas enters the first pericardial balloon from the bladder, through the lumen of the at least one catheter, and out from the at least one aperture defined within the at least one catheter.

6. The device of claim 1, wherein gas is removed from the first pericardial balloon through the at least one aperture defined within the at least one catheter, through the lumen of the at least one catheter, and into the bladder.

7. The device of claim 2, wherein the distal end of the at least one catheter is adapted to be positioned within the pericardial space at or near a heart chamber and is configured to exert pressure on an epicardial wall when inflated and is further configured to relieve pressure on the epicardial wall when deflated in order to facilitate heart function.

8. The device of claim 7, wherein the distal end of the at least one catheter is adapted to be positioned within the pericardial space at or near a heart ventricle.

9. The device of claim 1, wherein the at least one catheter comprises a first catheter and a second catheter.

10. The device of claim 9, wherein the distal end of the first catheter is adapted to be positioned within a pericardial space at or near a first heart chamber and the distal end of the second catheter having a second pericardial balloon coupled thereto is adapted to be positioned within the pericardial space at or near a second heart chamber, and wherein the first and second catheters are configured to exert pressure on an epicardial wall when inflated and are further configured to relieve pressure on the epicardial wall when deflated in order to facilitate heart function.

11. The device of claim 10, wherein inflation and deflation of the first pericardial balloon occurs during the times of inflation and deflation, respectively, of the second pericardial balloon.

12. The device of claim 11, wherein the inflation and deflation of the first and second pericardial balloons create a counterpulsation.

13. The device of claim 10, wherein inflation and deflation of the first pericardial balloon occurs at a different times than the times of inflation and deflation, respectively, of the second pericardial balloon.

14. The device of claim 10, wherein the distal end of the first catheter is adapted to be positioned within the pericardial space at or near a left ventricle, and wherein the distal end of the second catheter is adapted to be positioned within the pericardial space at or near a right ventricle.

15. The device of claim 1, wherein the at least one catheter comprises three or more catheters.

16. The device of claim 1, wherein the first pericardial balloon is made of polyurethane.

17. The device of claim 1, wherein the first pericardial balloon has an inflation volume between 30 and 40 cubic centimeters.

18. A device for assisting heart function, comprising:

at least two electromagnetic plates, the at least two electromagnetic plates having an inner surface;

a cardiac processor electrically coupled to at least one of the at least two electromagnetic plates;

a bladder having an inner chamber, the bladder attached to the inner surfaces of each of the at least two electromagnetic plates and disposed between the at least two electromagnetic plates;

a source of gas in communication with the inner chamber of the bladder; and

at least one catheter having a proximal end and a distal end and having a lumen therethrough, the at least one catheter defining at least one aperture positioned therethrough at or near the distal end of the at least one catheter and comprising a pericardial balloon coupled to the at least one catheter at or near the distal end of the at least one catheter, the proximal end of the at least one catheter in communication with the inner chamber of the bladder;

wherein the at least two electromagnetic plates are operable to compress the bladder to inject gas into the pericardial balloon to inflate the pericardial balloon; and

wherein the at least two electromagnetic plates are further operable to expand the bladder to remove gas from the pericardial balloon to deflate the pericardial balloon.

19. A method of assisting heart function, the method comprising the steps of:

introducing at least part of a device for assisting heart function into a mammalian body, the device comprising;

at least two electromagnetic plates, the at least two electromagnetic plates having an inner surface,

a cardiac processor electrically coupled to at least one of the at least two electromagnetic plates,

a bladder having an inner chamber, the bladder attached to the inner surfaces of each of the at least two electromagnetic plates and disposed between the at least two electromagnetic plates,

a source of gas in communication with the inner chamber of the bladder, and

at least one catheter having a proximal end and a distal end and having a lumen therethrough, the at least one catheter defining at least one aperture positioned therethrough at or near the distal end of the at least one catheter and comprising a first pericardial balloon coupled to the at least one catheter at or near the distal end of the at least one catheter, the proximal end of the at least one catheter in communication with the inner chamber of the bladder,

wherein the distal end of the at least one catheter is positioned within a pericardial space of the mammalian body; and

operating the device to inject gas into and/or remove gas from the first pericardial balloon to assist heart function.

20. The method of claim 19, wherein the at least two electromagnetic plates are operable to compress the bladder, wherein the compression of the bladder injects gas into the first pericardial balloon to inflate the first pericardial balloon.

21. The method of claim 19, wherein the at least two electromagnetic plates are operable to expand the bladder, wherein the expansion of the bladder removes gas from the first pericardial balloon to deflate the first pericardial balloon.

22. The method of claim 19, wherein gas enters the first pericardial balloon from the bladder, through the lumen of the at least one catheter, and out from the at least one aperture defined within the at least one catheter.

23. The method of claim 19, wherein gas is removed from the first pericardial balloon through the at least one aperture defined within the at least one catheter, through the lumen of the at least one catheter, and into the bladder.

24. The method of claim 19, wherein when the distal end of the at least one catheter is positioned within the pericardial space at or near a heart chamber, inflation of the first pericardial balloon exerts pressure on an epicardial wall surrounding the heart chamber, and deflation of the pericardial balloon relieves pressure on the epicardial wall, the inflation and deflation of the pericardial balloon operable to facilitate heart function.

25. The method of claim 24, wherein the heart chamber is a heart ventricle.

26. The method of claim 19, wherein the at least one catheter comprises a first catheter and a second catheter.

27. The method of claim 26, wherein when the distal end of the first catheter is positioned within the pericardial space at or near a first heart chamber, and wherein when the distal end of the second catheter having a second pericardial balloon coupled thereto is positioned within the pericardial space at or near a second heart chamber, inflation of the first and second pericardial balloons exerts pressure on an epicardial wall surrounding the first heart chamber and the second heart chamber, and deflation of the first and second pericardial balloons relieves pressure on the epicardial wall, the inflation and deflation of the first and second pericardial balloons operable to facilitate heart function.

28. The method of claim 27, wherein inflation and deflation of the first pericardial balloon occurs during the times of inflation and deflation, respectively, of the second pericardial balloon.

29. The method of claim 28, wherein the inflation and deflation of the first and second pericardial balloons create a counterpulsation.

30. The method of claim 27, wherein inflation and deflation of the first pericardial balloon occurs at a different times than the times of inflation and deflation, respectively, of the second pericardial balloon.

31. The method of claim 27, wherein the first heart chamber is a left ventricle, and wherein the second heart chamber is a right ventricle.