Device, A Kit And A Method For Heart Support

Abstract

A device, a kit and a method is presented for permanently augmenting the pump function of the left heart. The mitral valve plane is assisted in a movement along the left ventricular long axis during each heart cycle. The very close relationship between the coronary sinus and the mitral valve is used by various embodiments of a medical device providing this assisted movement. By means of catheter technique an implant is inserted into the coronary sinus, the device is augmenting the up and down movement of the mitral valve and thereby increasing the left ventricular diastolic filling when moving upwards and the piston effect of the closed mitral valve when moving downwards.

1 . A medical device for intra-cardiac blood circulation of a heart of a patient comprising:
 a first anchor unit implantable in a cardiac vessel of said heart in proximity to a mitral valve (MV),   a force generating unit in communication with said first anchor unit, said force generating unit being operative to generate a force for assisting said blood circulation according to a cardiac cycle of said heart, and   wherein said first anchor unit is configured to receive said force in such a manner so as to cause movement of said mitral valve in a mitral valve plane in a direction to and/or from an apex of said heart.   
     
     
         2 . The device of  claim 1 , wherein said movement extends substantially along a long axis of the left ventricle of said heart, and wherein said movement is provided during systole towards an apex of said heart and/or during diastole away from said apex. 
     
     
         3 . The device of  claim 2 , wherein said movement is provided during systole towards said apex of said heart and during diastole away from said apex. 
     
     
         4 . The device of  claim 1 , wherein said movement is provided along a short axis of a left ventricle, transversal to said long axis so as to thereby assist a natural inwards and outwards movement of a lateral left ventricular wall relative to an intra-ventricular septum. 
     
     
         5 . The device of  claim 1 , wherein said force generating unit is operatively connected to an external energy source to receive energy therefrom and to controllably provide said movement in synchrony with said cardiac cycle. 
     
     
         6 . The device of  claim 1 , wherein said first anchor unit has an expandable stent structure for anchoring said anchor unit in said cardiac vessel. 
     
     
         7 . The device of  claim 1 , wherein said first anchor unit has at least one tissue anchoring element. 
     
     
         8 . The device of  claim 1 , wherein said force generating unit is an actuating unit for providing said force as a mechanical force, and wherein said first anchor unit and said actuating unit are in communication via a connecting unit for transferring said force and providing said movement. 
     
     
         9 . The device of  claim 1 , said device further comprising a second anchor unit implantable in said cardiac vessel closer to an ostium of a coronary sinus than said first anchor unit. 
     
     
         10 . The device of  claim 9 , wherein said force generating unit is comprised of an electrical motor integrated into said second anchor unit and wherein said device further includes a connecting unit between said motor and said first anchor. 
     
     
         11 . The device of  claim 9 , wherein said second anchor unit has a guiding unit for guiding said connecting unit from said first anchor through said second anchor to an actuating unit. 
     
     
         12 . The device of  claim 9 , wherein said device further comprises an elongate extension unit connecting said first and second anchor units in a loop shape, wherein said extension unit extends proximally beyond said second anchor unit to a mechanical actuator unit arranged to rotate said extension unit
 in one of first and second direction, said first direction being where said loop shaped extension unit is flexed towards the left atrium and said coronary sinus (CS) and a great cardiac vein (GCV) and said mitral valve (MV) is moved towards the left atrium, and said   second direction being opposite said first direction where said loop shaped extension unit is flexed towards a left ventricular (LV) apex and said CS and GCV and said MV is moved towards the LV apex.   
     
     
         13 . The device of  claim 1 , wherein said force generating unit is a magnetic unit for providing said force as a magnetically induced force, and wherein said first anchor unit is magnetic, and wherein said first anchor unit and said actuating unit are in magnetic communication for transferring said force and providing said movement. 
     
     
         14 . The device of  claim 13 , wherein said first anchor unit and said force generating unit are electromagnets, and wherein at least one of said electromagnets is arranged to change polarity in synchrony with said cardiac cycle. 
     
     
         15 . The device of  claim 1 , wherein said force generating unit is positionable in one of said heart, inside a side branch of the vein system on a left ventricular wall of said heart, in the left ventricle, in a right ventricle, in a right atrium, in a the left atrium of said heart, on a left ventricular outer wall of said heart. 
     
     
         16 . The device of  claim 1 , wherein said first anchor unit is positionable in one of the coronary sinus (CS), the great cardiac vein (GCV), in a branch vessel thereof of said heart and said device comprises a second anchor unit that is positionable in one of said coronary sinus (CS), the great cardiac vein (GCV) and said branch vessel thereof. 
     
     
         17 . The device of  claim 1 , further comprising a remote energy source, a control unit, and a sensor for measuring physiological parameters related to the cardiac cycle and for generating a sensor signal, wherein control unit controls said force generating unit to provide said movement by energy from said remote energy source based on said sensor signal. 
     
     
         18 . The device of  claim 17 , wherein said remote energy source is comprised of a mechanical section for generating at least one of a rotational and linear motion, and an extension unit extending from said mechanical section, wherein said mechanical section is said force generating unit and wherein said motion is transferred in operation of said mechanical section to said first anchor unit for said movement of said mitral valve plane via an extension unit. 
     
     
         19 . The device of  claim 17 , wherein said remote energy source is controlled by said control unit to provide electrical energy to one of at least one of an electromagnetical anchor unit affixed in relation to said mitral valve or
 at least one force generating unit.   
     
     
         20 . The device of  claim 1 , wherein said force generating unit is a resilient unit, and said first anchor unit includes a distal anchor unit and a proximal anchor unit, wherein said resilient unit is a loop connecting said distal and proximal anchor units, such that, when implanted, said resilient unit has a relaxed position in one MV plane position spring loaded against the other MV plane position respectively, such that the cardiac muscle force of the LV brings said loop to said spring loaded position, and said resilient unit assists said cardiac muscle force of the LV in the other direction towards said relaxed position. 
     
     
         21 . The device of  claim 20 , wherein, when implanted, said resilient unit has a relaxed position in said upper MV plane position spring loaded against said MV plane down position, such that the cardiac muscle force of the LV brings said loop to said down position, and said resilient unit assists during diastole by assisting the LV diastolic filling by forcing the open MV up against the blood stream further in the direction of the LA; or
 wherein said resilient unit has a relaxed position in said lower MV plane position spring loaded against said MV plane up position, such that the cardiac relaxation force of the LV brings said loop to the up position, and said resilient unit assists during the systole by assisting the LV systolic contraction by forcing the closed MV down towards the LV apex.   
     
     
         22 . The device of  claim 20 , wherein said resilient unit is locked by an integrated bioresorbable material in such a manner that said spring loaded action is first initiated when the resorbable material has at least partly been resorbed, such that said device has a delayed activation upon implantation. 
     
     
         23 . The device of  claim 1 , wherein said device is bistable and is characterized by equilibrium states defined by a diastolic up position and a systolic down position of the MV plane. 
     
     
         24 . The device of  claim 1 , wherein said device comprises a control unit which controls said force generating unit to provide a set sequence of said assisted movements. 
     
     
         25 . The device of  claim 24 , wherein said control unit is configured to set at least one of a frequency, a speed, and a pause time duration of said movement. 
     
     
         26 . A kit for improving left ventricular pump function of a heart comprising
 an implantable heart assist device according to  claim 1 , and   a delivery system suitable for inserting said assist device into a patient including a guide wire, a guiding catheter, and an introducing catheter.   
     
     
         27 . A method of delivering a medical device to improve intra-cardiac blood circulation of a heart of a patient comprising
 providing a medical system including said medical device of  claim 1  and an energy source, and minimally invasively delivering said medical system into said patient.   
     
     
         28 . The method of  claim 27 , further comprising providing a delivery system for minimally invasively delivering said medical device in said patient, and
 minimally invasively delivering said force generating unit in said patient by means of said delivery system, delivering said energy source, and connecting said energy source to said force generating unit.   
     
     
         29 . The method of  claim 27 , 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 said first anchor unit at a distance from a mitral valve and delivering a second anchor unit at said mitral valve in one of a coronary sinus and a great cardiac vein.   
     
     
         30 . A method for improving intra-cardiac blood circulation of a heart of a patient, said method comprising
 generating a force correlating to a cardiac cycle of said heart;   applying said force to an implant arranged in a cardiac vessel in proximity to a mitral valve of said heart so as to move said mitral valve in a mitral valve plane in a direction to and/or from an apex of said heart.   
     
     
         31 . The method of  claim 30 , wherein said mitral valve is moved in said mitral valve plane substantially along a long axis of a left ventricle of said heart. 
     
     
         32 . The method of  claim 29 , wherein said mitral valve is moved in a reciprocating movement during systole towards an apex of said heart and during diastole away from said apex. 
     
     
         33 . The method of  claim 30 , further comprising wherein said generating a force includes detecting the natural action of the heart and providing energy for displacement of said mitral valve in synchrony with the natural heart cycle. 
     
     
         34 . The method of  claim 30 , further comprising inserting a first anchor unit of an implantable heart assist device into said heart and arranging a force generating unit in a position remote of said anchor unit such that reciprocal movement of the mitral valve is provided along an axis extending from the left atrium towards said left ventricular apex of said heart. 
     
     
         35 . The method of  claim 30 , wherein said implant is dimensioned to be placed in the coronary sinus of the heart adjacent the mitral valve annulus, and includes an expandable distal anchoring unit, an expandable proximal anchoring unit, a connection unit extending from said proximal anchoring unit to said distal anchoring unit, and an actuating unit arranged to controllably change a length of said connection unit after implantation, said method further comprising:
 inserting said device at least partly into the coronary sinus;   expanding and anchoring said expandable distal anchor in the coronary sinus;   expanding and anchoring said expandable proximal anchor in or outside of the coronary sinus; and   after expanding and anchoring the expandable proximal and distal anchors actuating said actuating unit causing the connection unit to change in said length to provide a controlled movement of the mitral valve along a short axis of said left ventricle, transversal to said long axis, for assisting a natural inwards and outwards movement of a lateral left ventricular wall relative to an inter-ventricular septum.   
     
     
         36 . The method of  claim 35 , wherein said change of length is made during a single cardiac cycle. 
     
     
         37 . A computer-readable medium having embodied thereon a computer program for processing by a computer, said computer program comprising code segments for controlling a medical device for improving intra-cardiac blood circulation of a heart of a patient by assisting left ventricular pump action, wherein a code segment is provided for controlling a force generating unit to generate a force in dependence of a cardiac cycle of said heart for applying said force to an implant in a cardiac vessel proximity to and in tissue connection with a mitral valve of said heart for an assisted movement of said cardiac vessel and thus said mitral valve in a mitral valve plane in a direction to and/or from an apex of said heart.