Device And A Method For Augmenting Heart Function

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 said heart in systole and/or away from said apex in diastole.

1 . A medical device for assisting left ventricular pump action in a human heart, said device comprising:
 a displacement unit;   said displacement unit adapted to assist movement of a mitral valve in a mitral valve plane substantially along a long axis of a left ventricle of said heart,   said displacement unit being an implant in said heart for contact with said mitral valve;   said displacement unit being operable to move said mitral valve in a reciprocating manner along said long axis towards an apex of said heart during systole and along said axis away from said apex during diastole.   
     
     
         2 . The device of  claim 1 , wherein said displacement unit includes a mechanical unit applying a mechanical supporting force to the mitral valve during at least one of systole and diastole. 
     
     
         3 . The device of  claim 2 , wherein said mechanical unit has a proximal end portion attachable to the mitral valve and a distal end portion that is in communication with an energy converter unit, said energy converter unit operable to transfer energy from a remote energy source into a force providing said mechanical supporting force. 
     
     
         4 . The device of  claim 3 , wherein said proximal end portion is configured for attachment to a mitral valve annulus. 
     
     
         5 . The device of  claim 4 , wherein said proximal end portion includes a fixation unit, said fixation unit being partly loop-shaped for fixation to the mitral valve annulus; said fixation unit having an extension unit protruding from said fixation unit towards a coaptation line of said mitral valve, and wherein said mechanical unit is configured for attachment to said fixation unit at said extension unit at said coaptation line. 
     
     
         6 . The device of  claim 4 , wherein said proximal end portion includes a fixation unit, said fixation unit being partly loop-shaped for fixation to the mitral valve annulus, and wherein said mechanical unit is configured for attachment 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 at least behind the posterior leaflet of the mitral valve. 
     
     
         7 . The device of  claim 1 , wherein said displacement unit comprises a magnetic unit applying a magnetic supporting force to the mitral valve during at least one of systole and diastole. 
     
     
         8 . The device of  claim 7 , wherein said magnetic unit comprises a plurality of magnetic anchors, including a first, proximal magnetic anchor and a second, distal magnetic anchor said first and second magnetic anchors being selectively magnetic relative each other, wherein said first anchor is configured for placement at the mitral valve, and the second anchor is configured for placement remote from the first anchor. 
     
     
         9 . The device of  claim 8 , wherein one of said magnetic anchors is an electromagnet that controllably changes polarity synchronized with the heart cycle. 
     
     
         10 . The device of  claim 8 , wherein one of said magnetic anchors is a loop shaped annuloplasty implant. 
     
     
         11 . The device of  claim 8 , wherein another of said magnetic anchors is implantable in a heart septum and configured for occluding an opening in said septum. 
     
     
         12 . The device of  claim 8 , wherein another of said magnetic anchors implantable in the left atrial appendage (LAA) and is configured to occlude said LAA. 
     
     
         13 . The device of  claim 1 , further comprising an energy source positioned remotely from said displacement unit and in communication with said displacement unit so as to provide energy causing movement of said displacement unit and thereby movement of said mitral valve in said mitral valve plane along said long axis. 
     
     
         14 . The device of  claim 13 , further comprising an extended connecting unit transferring mechanical movement energy to said displacement unit using energy from said remote energy source. 
     
     
         15 . The device of  claim 13 , wherein said displacement unit comprises an actuator connected to said remote energy source with a wire that communicates electrical energy from said remote energy source to said actuator. 
     
     
         16 . The device of  claim 1 , wherein said displacement unit is an implant for fixation to a native mitral valve. 
     
     
         17 . The device of  claim 1 , wherein said displacement unit is an implant for fixation to a replacement valve. 
     
     
         18 . The device of  claim 17 , wherein said replacement valve comprises a hollow frame having a longitudinal extension, wherein said frame is configured to be oriented in said heart perpendicular to said mitral valve plane and configured to be affixed to the mitral valve annulus, and wherein said frame is housing a plurality of valve leaflets, and wherein said frame is connected to said displacement unit for said movement. 
     
     
         19 . The device of  claim 17 , wherein said displacement unit comprises a housing in which said replacement valve is movably received, said housing having a longitudinal extension configured to be oriented in said heart perpendicular to a mitral valve plane and configured to be affixed to the mitral valve annulus at a mitral valve annulus attachment. 
     
     
         20 . The device of  claim 1 , further comprising an anchor unit having a foldable mitral valve annulus anchor unit affixable to said mitral valve annulus. 
     
     
         21 . The device of  claim 1 , wherein said displacement unit is bistable between a diastolic up position and a systolic down position relative to said mitral valve plane and is movable therebetween according to an external energy source controllably provided to said displacement unit. 
     
     
         22 . The device of  claim 1 , wherein said device further comprises;
 a remote energy source;   a control unit and   a sensor operatively connected to said control unit;   said sensor configured for measuring physiological parameters related to a cardiac cycle activity so as to provide a sensor signal to said control unit such that said control unit is adapted to control movement of said displacement unit using energy from said remote energy source based on said sensor signal.   
     
     
         23 . The device of  claim 22 , wherein said remote energy source includes a mechanical section and an extension unit, said extension unit positioned between said mechanical section and said displacement unit, said mechanical section operable to generate mechanical motion that is transferable to said displacement unit for said movement via said extension unit. 
     
     
         24 . The device of  claim 22 , wherein said remote energy source is controlled by said control unit to provide electrical energy to one of at least one electromagnetical anchor units affixed in relation to said mitral valve and one of at least one actuator arranged in the heart so as to provide said movement of said mitral valve plane. 
     
     
         25 . The device of  claim 22 , wherein said remote energy source is implantable in the fatty tissue under the skin adjacent to a vessel. 
     
     
         26 . The device of  claim 1 , wherein said device further comprises a control unit which operatively controls said displacement unit to provide a set sequence of said reciprocating movements. 
     
     
         27 . The device of  claim 26 , wherein said control unit is configured to set at least one of a frequency, a speed, and a pause time duration of said reciprocating movements in said set sequence. 
     
     
         28 . A kit comprising a 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 . A method of delivering a medical device adapted to enhance intra-cardiac blood circulation of a heart of a patient, said device having a displacement unit adapted to controllably move a mitral valve in a mitral valve plane substantially along a long axis of a left ventricle of said heart, said displacement unit being an implant in said heart for contact with said mitral valve; said displacement unit being operable to move said mitral valve in a reciprocating manner along said long axis towards an apex of said heart during systole and along said axis away from said apex during diastole, said method comprising
 providing a medical system including said medical device and an energy source, and surgically delivering said medical system in said patient.   
     
     
         30 . The method of  claim 29 , wherein said method comprises providing a delivery system, such as said kit according to  claim 28 , 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.   
     
     
         31 . The method of  claim 30 , 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.   
     
     
         32 . The method of  claim 30 , 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 delivery site, such as the left ventricle wall, and allowing anchor elements of the anchor unit, such as hooks or blades, to dig into the tissue at said delivery site.   
     
     
         33 . The method of  claim 32 , 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 the mitral valve annulus.   
     
     
         34 . The method of  claim 29 , comprising providing access to the 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 the right atrium ( 4 ), obtaining access to the left atrium by penetrating through an open foramen ovale or through the inter-atrial wall and thereafter advancing the guiding catheter into the left atrium, and advancing said guide catheter and the guide wire into the left ventricle through the mitral valve to the delivery site at the left ventricular wall,
 advancing a delivery system for an anchor unit inside the guide catheter or over a guide wire until its catheter opening has contact with the inner surface of the left ventricular wall, advancing the pushing catheter and pushing said anchor unit out of the catheter opening to dig into the muscular tissue and pull the anchor unit inside said muscular tissue, and thereby creating a secure anchoring of a pulling and pushing unit, and retracting the delivery catheter and pushing unit.   
     
     
         35 . The method of  claim 34 , comprising advancing a delivery system for a mitral valve annulus anchor over the pulling and pushing unit until the anchor and its arms are adjacent to the mitral valve annulus, and when in position, retracting the catheter over the catheter until outside of the patient, allowing arms and their attachments hooks to attach to the mitral valve annulus and dig into the tissue. 
     
     
         36 . The method of  claim 35 , adjusting the pushing and pulling unit and the catheter in length and attaching these to the remote energy source. 
     
     
         37 . The method of  claim 35 , comprising positioning said remote energy source in fatty tissue under the skin, adjacent to a vessel, and optionally attaching the energy source to a bony structure. 
     
     
         38 . The method of  claim 29 , wherein said method comprises providing surgical access to the mitral valve, the mitral valve annulus and the left ventricle including surgically opening the chest of a human being and establishing extra corporeal circulation (ECC) or manipulating the heart manually from the outside, while still pumping. 
     
     
         39 . The method of  claim 29 , comprising
 attaching a first anchor unit in the musculature in the area of the left ventricular apex,   attaching a second anchor unit to the mitral valve annulus, and   connecting said two anchors to each other by means of a connecting unit that may shorten and increase the 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 mitral annulus anchor.   
     
     
         40 . A method for enhancing ventricular pump function of a heart of a patient comprising:
 controllably assisting movement of a mitral valve according to synchronization with a cardiac cycle of said heart.   
     
     
         41 . The method of  claim 40 , said method wherein said controllably assisting movement comprises
 moving a mitral valve in said heart in an assisted reciprocating movement during systole towards an apex of said heart and during diastole away from said apex for assisting said pump action of said heart.   
     
     
         42 . The method of  claim 41 , further comprising detecting the natural action of the heart and providing energy for displacement of said mitral valve plane in synchrony with the natural heart cycle. 
     
     
         43 . The method of  claim 42 , further comprising providing a mitral valve replacement valve. 
     
     
         44 . The method of  claim 43 , wherein said replacement valve is mounted in a housing, and moving said heart valve up and down in said housing relative to a mitral valve annulus attachment. 
     
     
         45 . The method of  claim 41  further comprising providing a medical device according to  claim 1 . 
     
     
         46 . A system for permanently enhancing left ventricular pump function of a heart of a patient, said system comprising a displacement unit for controlled assisted 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 unit being configured to be arranged in said heart of said patient and being in contact with said mitral valve to push and/or pull said mitral valve such that said mitral valve moves in a by said displacement unit assisted reciprocating movement during systole towards an apex of said heart and/or during diastole away from said apex for assisting pump action of said heart. 
     
     
         47 . A computer-readable medium having embodied thereon a computer program for processing by a computer for permanently enhancing left ventricular pump function of a heart of a patient, said computer program comprising a code segment for synchronizing assisted mitral valve movement with a cardiac cycle of said heart.