Device and a method for augmenting heart function

• US 8,986,376 B2
• Filed: 07/01/2013
• Issued: 03/24/2015
• Est. Priority Date: 03/25/2010
• Status: Active Grant

• Current Assignee: Syntach AG
• Original Assignee: Synergio AG
• Inventors: Solem, Jan Otto
• Primary Examiner(s): Shay, Randy
• Assistant Examiner(s): BARIA, DINAH N
• Application Number:
  US13/933,048
• Publication Number:
  US 20130289717A1
• Time in Patent Office: 631 Days
• Field of Search: 623/1.26, 623/2.36, 623/2.37, 623/3.1, 623/3.11
• US Class Current: 623/3.11
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/187 mechanically acting upon the inside of the patient's native heart, e.g. contractile structures placed inside the heart
• CPC Class Codes: A61M 60/258 Piston pumps
• 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 60/462 Electromagnetic force
• CPC Class Codes: A61M 60/495 Electromagnetic force
• CPC Class Codes: A61M 60/865 Devices for guiding or inserting pumps or pumping devices into the patient's body
• CPC Class Codes: A61M 60/871 Energy supply devices; Converters therefor
• CPC Class Codes: A61M 60/892 Active valves, i.e. actuated by an external force

Abstract

A device, a kit and a method are presented for permanently augmenting the pump function of the left heart. The basis for the presented innovation is an augmentation of the physiologically up and down movement of the mitral valve during each heart cycle. By means of catheter technique, minimal surgery, or open heart surgery implants are inserted into the left ventricle, the mitral valve annulus, the left atrium and adjacent tissue in order to augment the natural up and down movement of the mitral valve and thereby increasing the left ventricular diastolic filling and the piston effect of the closed mitral valve when moving towards the apex of the heart in systole and/or away from the apex in diastole.

Claims

1. A medical device adapted to enhance intra-cardiac blood circulation of a heart of a patient by assisting left ventricular pump action, said device having a displacement means for controllably assisting movement of a mitral valve in a mitral valve plane substantially along a long axis of a left ventricle of said heart, and said displacement means configured to be arranged in said heart of said patient in contact with said mitral valve to push and/or pull said mitral valve such that said mitral valve moves in a reciprocating movement that is assisted during systole along said long axis towards an apex of said heart and/or during diastole along said long axis away from said apex for assisting said pump action of said heart.

2. The device of claim 1, wherein said displacement unit comprises a mechanical unit devised to apply a mechanical supporting force to the mitral valve during at least a portion of systole for augmenting the natural pumping force of the heart, and/or during at least a portion of diastole for augmenting a natural filling of the left ventricle.

3. The device of claim 2, wherein said mechanical unit has a proximal end portion that is configured to be attached to a location on the mitral valve and wherein said medical device further comprises an energy converter unit attached to a distal end portion of said mechanical unit that transfers energy from a remote energy source into a linear force and/or a rotational force for providing said supporting force.

4. The device of claim 3, wherein said proximal end portion is configured to be attached to the mitral valve annulus by means of a fixation unit.

5. The device of claim 4, wherein said fixation unit is at least partly loop shaped and adapted to be affixed to the mitral valve annulus and has an extension unit protruding from said fixation unit towards a coaptation line of said mitral valve, and wherein said mechanical unit is configured to be attached to said fixation unit at said extension unit at said coaptation line.

6. The device of claim 4, wherein said fixation unit is at least partly loop shaped and adapted to be affixed to the mitral valve annulus, and wherein said mechanical unit is attached to said fixation unit at a circumference of said fixation unit, wherein said mechanical unit is adapted to penetrate said mitral valve at the mitral valve annulus, preferably behind a posterior leaflet of the mitral valve.

7. The device of claim 1, wherein said displacement unit comprises a magnetic unit devised to apply a magnetic supporting force to the mitral valve during at least a portion of systole for augmenting the natural force of the heart, and/or during at least a portion of diastole for augmenting a natural filling of the left ventricle.

8. The device of claim 7, wherein a first anchor unit of said magnetic unit is an electromagnet that is configured to controllably change polarity synchronously with the heart cycle.

9. The device of claim 1, wherein said displacement unit comprises a plurality of magnetic tissue anchors, including a first, proximal magnetic anchor and a second, distal magnetic anchor, which are controllably and selectively magnetic relative each other, wherein said first anchor is configured to be located at the mitral valve, and the second anchor is configured to be located remote from the first anchor inside or outside said heart.

10. The device of claim 9, wherein one of said magnetic anchors is a loop shaped annuloplasty implant.

11. The device of claim 9, wherein said second anchor is adapted to be located in an atrial or ventricular septum, wherein the second anchor is adapted to be inserted into and occlude an opening in said atrial or ventricular septum.

12. The device of claim 9, wherein said second anchor is adapted to be located in the left atrial appendage (LAA), wherein the second anchor is an LAA occluder.

13. The device of claim 1, further comprising an energy source, wherein said displacement unit is arranged to be driven by energy from said energy source, and wherein said energy source is adapted to provide said energy to push and/or pull said mitral valve.

14. The device of claim 13, wherein said energy is movement energy that is mechanically transferred from said energy source through an extended connecting unit to said displacement unit.

15. The device of claim 13, wherein said displacement unit comprises an actuator, and said energy is electrical energy that is electrically transferred from said energy source to said actuator.

16. The device of claim 1, wherein said mitral valve is a native mitral valve and said displacement unit is configured to be affixed in relation to said mitral valve to controllably assist movement of the mitral valve along the long axis of the left ventricle towards and/or away from the heart apex in synchrony with the cardiac cycle.

17. The device of claim 1, wherein the device comprises an artificial valve and said artificial valve comprises a hollow frame having a longitudinal extension, wherein said frame is configured to be oriented in said h art perpendicular to said mitral valve plane and to be affixed to a mitral valve annulus, and wherein said frame is connected to said displacement unit.

18. The device of claim 17, wherein said displacement unit comprises a housing in which said artificial valve is movably received, said housing having a longitudinal extension configured to be oriented in said heart perpendicular to the mitral valve plane and configured to be affixed to the mitral valve annulus at a mitral valve annulus attachment in said housing, wherein said replacement valve is arranged to move along the left ventricular long axis relative to said mitral valve annulus attachment in said housing.

19. The device of claim 1, wherein the displacement means comprises an anchor in the form of a foldable mitral valve annulus anchor unit affixable to a mitral valve annulus.

20. The device of claim 1, wherein said displacement unit is bistable between a stable diastolic up position and a stable systolic down position of the mitral valve plane, wherein said displacement unit has equilibrium states in the up and down position respectively, and wherein the displacement unit moves between the two stable positions when energy from an external energy source is controllably provided to the displacement unit in synchrony with the cardiac cycle.

21. The device of claim 1, wherein said device has a remote energy source, a control unit, and a sensor operatively connected to said control unit for measuring physiological parameters related to a cardiac cycle activity providing a sensor signal, wherein said sensor signal is provided to said control unit which controls said displacement unit to controllably assist movement of said mitral valve by energy from said remote energy source and based on said sensor signal.

22. The device of claim 21, wherein said remote energy source has a mechanical section and an extension unit devised to be arranged between said mechanical section and said displacement unit, wherein mechanical motion is generated by said mechanical section in operation thereof and transferred to said displacement unit to controllably assist movement of said mitral valve via said extension unit.

23. The device of claim 21, wherein said remote energy source is controlled by said control unit to provide electrical energy to one or more electromagnetical anchor units configured to be affixed in relation to said mitral valve, or to at least one actuator configured to be arranged at or in the heart, to contollably assist movement of said mitral valve.

24. The device of claim 21, wherein said remote energy source is adapted to be located in fatty tissue adjacent to a large vein.

25. The device of claim 1, wherein said device comprises a control unit which controls said displacement unit to controllably push and/or pull said mitral valve in a set sequence.

26. The device of claim 25, wherein said control unit is configured to set a frequency, and/or a speed, and/or a pause time duration of said set sequence.

27. A kit comprising the device of claim 1, and a delivery system for said device, including an introducer catheter with a valve, a guiding catheter, a guide wire and at least one delivery catheter.

29. The method of claim 28, wherein said method comprises providing a delivery system according to claim 27, for minimally invasively delivering said medical device in said patient, and

minimally invasively delivering said displacement unit of said medical system in said patient by means of said delivery system, delivering said energy source, and connecting said energy source and said displacement unit.

30. The method of claim 29, wherein said delivery system includes an introducer catheter with a valve, a guiding catheter and a guide wire, and wherein said method comprises introducing said introducer catheter at a puncture site into the vascular system of said patient,

inserting said guide wire into said vascular system via said introducer catheter, navigating through the vasculature and the heart to a desired site, inserting said guiding catheter over said guide wire, withdrawing said guide wire, through said guide catheter delivering a first anchor unit at a distance from a mitral valve and delivering a second anchor unit at said mitral valve.

31. The method of claim 29, wherein said delivery system includes an introducer catheter with a valve, a delivery catheter and a pushing unit, a guide wire and a guiding catheter, wherein said method comprises introducing said introducer catheter at a puncture site into the vascular system of said patient,

inserting said guide wire into said vascular system via said introducer catheter, navigating through the vasculature and the heart to a delivery site, inserting said guide catheter over said guide wire, providing an anchor unit at a distal end of said pushing unit, introducing said distal end in front of said pushing unit into said delivery catheter, and

a) wherein said delivery catheter has a smaller outer diameter than an inner diameter of the guiding catheter, and longitudinally moving the delivery catheter in said guide catheter, or

b) retracting said guide catheter, and longitudinally moving the delivery catheter over said guide wire previously placed at the delivery site by means of the guide catheter;

and

activating said anchor unit by means of pushing said pushing unit forward while the tip of the delivery catheter has contact with the surface of the delivery site and allowing anchor elements of the anchor unit to dig into tissue at said delivery site.

32. The method of claim 31, comprising

threading an extension unit through said delivery system and releasing a mitral valve annulus anchor by retracting the catheter of the delivery system from over the mitral valve annulus anchor, and attaching the mitral valve annulus anchor to a mitral valve annulus.

28. A medical method of delivering a medical device adapted to enhance intra-cardiac blood circulation of a heart of a patient by assisting left ventricular pump action, said medical device having a displacement means for controllably moving a mitral valve in a mitral valve plane substantially along a long axis of a left ventricle of said heart, and said displacement means being configured to be arranged in said heart of said patient in contact with said mitral valve to push and/or pull said mitral valve such that said mitral valve is moved in a reciprocating movement that is assisted during systole towards an apex of said heart and/or during diastole away from said apex for assisting said pump action of said heart, said method comprising

providing a medical system including said medical device and an energy source, and surgically and/or minimally invasively delivering said medical system in said patient.

33. The method of claim 28, comprising providing access to a vascular system by puncturing a large vein, placing an introducer catheter with a valve in the vein, through the introducer catheter advancing a guide wire, and over the guide wire advancing a guide catheter to a right atrium, obtaining access to a left atrium by penetrating through an open foramen ovale or through an inter-atrial wall and thereafter advancing the guide catheter into the left atrium, and advancing said guide catheter and the guide wire into the left ventricle through the mitral valve to a delivery site at a left ventricular wall;

advancing a delivery system for an anchor unit inside the guide catheter or over a guide wire until contact is made with an inner surface of the left ventricular wall, advancing a pushing catheter and pushing said anchor unit out of the guide catheter opening to dig into a muscular tissue and pull the anchor unit inside said muscular tissue, and thereby creating a secure anchoring of a pulling and/or pushing unit, and retracting the delivery catheter and pushing unit.

34. The method of claim 33, comprising advancing a delivery system for a mitral valve annulus anchor over the pulling and/or pushing unit until the anchor and its arms are adjacent to a mitral valve annulus, and when in position, retracting the quide catheter over the pushing catheter until outside of the patient, allowing arms and their attachments hooks to attach to the mitral valve annulus and dig into tissue.

35. The method of claim 34, adjusting the pulling and/or pushing unit and the catheter in length and attaching these to the energy source.

36. The method of claim 34, comprising positioning said energy source in fatty tissue, adjacent to a large vein, and attaching the energy source to a bony structure.

37. The method of claim 28, wherein said method comprises providing surgical access to the mitral valve, a mitral valve annulus and the left ventricle including surgically opening a chest of a human being and establishing extra corporeal circulation (ECC) or manipulating the heart manually while still pumping.

38. The method of claim 37, said method comprising

activating said medical device for controllably assisting movement of the mitral valve in the mitral valve plane substantially along the long axis of the left ventricle of said heart by said displacement unit, wherein said controllably moving comprises moving a mitral valve in said heart in a reciprocating movement that is assisted during systole towards an apex of said heart and/or during diastole away from said apex for assisting said pump action of said heart.

39. The method of claim 28, comprising

attaching a first anchor unit in a musculature inside a left ventricular apex, or outside on the left ventricular apex, or in adjacent tissue,

attaching a second anchor unit to a mitral valve annulus, and either

connecting said first and second anchors to each other by means of a connecting unit that may shorten and increase a length between the anchors, and attaching the connecting unit to a remote energy source or

replacing the mitral valve by an artificial valve serving as both the mitral valve and the second anchor unit.

40. A system for permanently enhancing left ventricular pump function of a heart of a patient, said system comprising a displacement means for controllably assisting mitral valve movement synchronized with a cardiac cycle of said heart substantially along a long axis of a left ventricle of said heart, said displacement means being configured to be arranged in said heart of said patient in contact with said mitral valve to push and/or pull said mitral valve such that said mitral valve moves in a reciprocating movement that is assisted during systole towards an apex of said heart and/or during diastole away from said apex for assisting pump action of said heart.