System for treating heart valve malfunction including mitral regurgitation

• US 9,566,443 B2
• Filed: 11/26/2013
• Issued: 02/14/2017
• Est. Priority Date: 11/26/2013
• Status: Active Grant

• Current Assignee: Corquest Medical, Inc. (Celyad Oncology SA)
• Original Assignee: Corquest Medical, Inc. (Celyad Oncology SA)
• Inventors: de Canniere, Didier
• Primary Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US14/090,383
• Publication Number:
  US 20150148590A1
• Time in Patent Office: 1,176 Days
• Field of Search: 600 16- 18, 600/37
• US Class Current: 1/1
• CPC Class Codes: A61M 60/191 mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
• CPC Class Codes: A61M 60/289 Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
• CPC Class Codes: A61M 60/468 the force acting on the actuation means being hydraulic or pneumatic
• CPC Class Codes: A61M 60/839 of devices for mechanical circulatory actuation
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/0597 Surface area electrodes, e.g. cardiac harness
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation

Abstract

A system for treating heart valve malfunction specifically including mitral regurgitation including a positioning structure operative to assume both expanded and contracted orientations and a retaining assembly positioned and structured to operatively dispose the positioning structure in moveably supporting lifting and/or positioning relation to the ventricular wall portion of the heart. The retaining assembly and the positioning structure are cooperatively disposed and structured to accomplish a shape variance of the heart upon a lifting or positioning force being exerted thereon substantially concurrent to the positioning structure being disposed in the expanded orientation. The force exerted on the heart at least partially defines a shape variance thereof to the extent of positioning of the leaflets of the mitral valve into a closed orientation which restricts mitral regurgitation.

Claims

1. A system for treating heart valve malfunction including mitral regurgitation, said system comprising;

a positioning structure operative to assume an expanded orientation and a contracted orientation,

a retaining assembly positioned and structured to dispose said positioning structure in moveably positioning relation to an exterior of a wall of a heart,

said retaining assembly and a positioning member cooperatively disposed and structured to accomplish a shape variance of the heart, substantially concurrent to said expanded orientation of said positioning assembly, and

said shape variance at least partially defining a position of a mitral valve into a predetermined orientation which restricts mitral regurgitation,

wherein said retaining assembly comprises a retaining structure dimensioned and configured for disposition in at least partially covering relation to a biventricular mass of a myocardium,

and wherein said retaining structure comprises an open mesh material including a plurality of strands disposed in at least partially spaced relation to one another, said strands collectively disposed in at least partially surrounding relation to the biventricular mass and concurrently in retaining relation to said positioning structure.

2. The system as recited in claim 1 wherein said predetermined orientation comprises a positioning of at least a portion of the mitral valve during systoly.

3. The system as recited in claim 2 wherein said predetermined orientation further comprises a dynamic positioning of portions of the mitral valve sufficient to facilitate diastolic filling.

4. The system as recited in claim 1 wherein said retaining assembly is positioned to operatively dispose said positioning structure in moveably supporting relation to the exterior of the wall of the heart, the wall of the heart comprising a ventricular wall of the heart, corresponding to a tethered papillary muscle.

5. The system as recited in claim 4 wherein said retaining assembly is configured to be disposed in engaging, retained relation with a biventricular mass of the heart.

6. The system as recited in claim 4 wherein said positioning structure comprises at least one inflatable member structured to respectively define said expanded and contracted orientation as an inflation and a deflation of said inflatable member.

7. The system as recited in claim 6 further comprising a pump assembly disposed in fluid communication with said at least one inflatable member, said pump assembly structured to regulate inflation and deflation of said one inflatable member.

8. The system as recited in claim 7 wherein said pump assembly comprises a sufficiently reduced dimension to facilitate operative placement thereof within a chest cavity.

9. The system as recited in claim 6 wherein said at least one inflatable member comprises a bladder at least partially formed of a flexible, inflatable material.

10. The system as recited in claim 1 wherein said retaining relation comprises said positioning structure disposed in a lifting relation to a ventricular wall corresponding to a capillary muscle tethered to the mitral valve, when said positioning structure is in said expanded orientation.

11. The system as recited in claim 1 wherein said positioning structure comprises at least some of said plurality of strands being inflated into said expanded orientation and deflatable into said contracted orientation.

12. The system as recited in claim 11 wherein said plurality of strands and a remainder of said retaining structure are configured to be cooperatively disposed and structured to exert a lifting force on the ventricular wall portion corresponding to a papillary muscle tethered to the mitral valve, when in, said expanded orientation;

a lifting relation at least partially defining a shape variance of the heart including a positioning of the mitral valve into said orientation which restricts mitral regurgitation.

13. The system as recited in claim 1 wherein said positioning structure is operatively disposed between an inner surface of a pericardium and an outer surface of a myocardium.

14. The system as recited in claim 13 wherein said positioning structure comprises a first surface portion structured to facilitate predetermined operative engagement with an inner pericardial surface and a second surface portion structured to facilitate predetermined operative engagement with the outer surface of the myocardium.

15. The system as recited in claim 1 further comprising an activating assembly connected to said retaining structure in an operative relation to the heart, said activating assembly structured to detect electrical activity of the heart.

16. The system as recited in claim 15 wherein said activating assembly includes sensing capabilities operative to synchronize expansion and contraction of said positioning structure with a cardiac cycle.

17. The system as recited in claim 16 wherein said activating assembly includes pacing capabilities operative to stimulate the heart into biventricular resynchronization pacing.

18. The system as recited in claim 16 wherein said activating assembly comprises a plurality of electrodes connected to said retaining structure in at least partially spaced relation to one another.

19. The system as recited in claim 16 wherein said activating assembly further comprises a processor electrically connected to said plurality of electrodes and operatively determinative of said sensing capabilities and including said synchronized expansion and contraction of said retaining structure.

20. The system as recited in claim 19 wherein said processor is electrically connected to said plurality of electrodes and operatively determinative of said pacing capabilities.

21. A system for treating heart valve malfunction including mitral regurgitation, said system comprising;

a positioning structure operative to assume an expanded orientation and a contracted orientation,

a retaining assembly positioned and structured to dispose said positioning structure in moveably positioning relation to an exterior of a wall of a heart,

said retaining assembly and said positioning structure cooperatively disposed and structured to accomplish a shape variance of the heart, substantially concurrent to said expanded orientation of said positioning structure, and

said shape variance at least partially defining a positioning of a mitral valve into a predetermined orientation which restricts mitral regurgitation;

wherein said positioning structure is operatively disposed between an inner surface of a pericardium and an outer surface of a myocardium;

wherein said positioning structure comprises a first surface portion and a second surface portion respectively structured to facilitate predetermined operative engagement with an inner pericardial surface and the outer surface of the myocardium,

wherein said first surface portion is structured to include a first coating structured to facilitate a gripping engagement with the inner pericardial surface.

22. The system as recited in claim 21 wherein said second surface portion is structured to include a second coating structured to facilitate a non-frictional engagement with the outer surface of the myocardium.

23. A system for treating mitral regurgitation comprising

a positioning structure operative to assume an expanded orientation and a contracted orientation,

a retaining structure disposed and structured to maintain said positioning structure within a pericardium in moveably positioning relation to a ventricular wall portion of a heart,

a retaining assembly comprising said retaining structure dimensioned and configured for disposition in at least partially covering relation to a biventricular mass of a myocardium concurrently in retaining relation to said positioning structure,

said positioning structure disposed in lifting relation to a ventricular wall portion corresponding to a papillary muscle tethered to a mitral valve, when said positioning structure is in said expanded orientation, and

said lifting relation at least partially defining a shape variance of the heart including a positioning of the mitral valve into an orientation which restricts mitral regurgitation,

wherein said positioning structure comprises at least one inflatable member structured to respectively define said expanded and contracted orientation as an inflation and a deflation of said one inflatable member,

and wherein said retaining structure comprises an open mesh material including a plurality of strands disposed in at least partially spaced relation to one another, said strands collectively disposed in at least partially surrounding relation to the biventricular mass and concurrently in retaining relation to said positioning structure.

24. The system as recited in claim 23 further comprising an activating assembly connected in operative relation to the heart, said activating assembly structured to detect electrical activity of the heart including sensing capabilities operative to synchronize expansion and contraction of the retaining structure with the cardiac cycle.

25. The system as recited in claim 24 wherein said activating assembly includes pacing capabilities operative to stimulate the heart into biventricular resynchronization pacing.

26. The system as recited in claim 23 wherein said positioning structure is operatively disposed between an inner surface of the pericardium and an outer surface of the myocardium.

27. A system for treating mitral regurgitation comprising

a positioning structure operative to assume an expanded orientation and a contracted orientation

a retaining structure disposed and structured to maintain said positioning structure within a pericardium in moveably positioning relation to a ventricular wall portion of a heart,

a retaining assembly comprising said retaining structure dimensioned and configured for disposition in at least partially covering relation to a biventricular mass of a myocardium concurrently in retaining relation to said positioning structure,

said positioning structure disposed in lifting relation to a ventricular wall portion corresponding to a papillary muscle tethered to a mitral valve, when said positioning structure is in said expanded orientation, and

said lifting relation at least partially defining a shape variance of the heart including a positioning of the mitral valve into an orientation which restricts mitral regurgitation;

wherein said positioning structure is operatively disposed between an inner surface of the pericardium and an outer surface of the myocardium;

wherein said positioning structure comprises first and second surface portions respectively including first and second coatings;

said first and second coatings respectively structured to facilitate a gripping engagement with an inner pericardial surface and a non-frictional engagement with an outer surface of the myocardium.