Device And Kit For Treatment Of Disorders In The Heart Rhythm Regulation System

Abstract

A tissue cutting device is disclosed, which is structured and arranged to be inserted through the vascular system into a body vessel adjacent to the heart and/or into the heart, and to be subsequently subjected to a change of shape in order to penetrate into the heart tissue. The tissue cutting device may thus be used for treating disorders to the heart rhythm regulation system. A kit of devices provides a plurality of devices for creating a lesion pattern for treating such disorders.

1 . A tissue cutting device configured to reduce undesired signal transmission in a heart tissue in order to treat atrial fibrillation,
 wherein the device is structured and arranged to be inserted in a temporary delivery shape through the vascular system and at least partly be positioned into said atrium that is intended to be treated and to be subsequently subjected to a change of shape, from said temporary delivery shape via an expanded delivered shape to a further expanded shape, extending at least beyond an outer surface of said atrial tissue,   wherein said tissue cutting device is configured to create cutting action for cutting of said heart tissue including said atrium, and wherein said tissue cutting device is structured and arranged to penetrate a wall of said heart tissue by said cutting action, in such a manner that a cut of said tissue created by said cutting action is continuously replaced by scar tissue that does not conduct electrical signals to isolate ectopic sites of said heart tissue causing said atrial fibrillation.   
   
   
       2 . The tissue cutting device according to  claim 1 , wherein the device is adapted to be positioned in the upper or lower part of the left or right atrium. 
   
   
       3 . The tissue cutting device according to  claim 1 , wherein the device is of an at least partly spherical shape. 
   
   
       4 . The tissue cutting device according to  claim 1 , wherein the device is made out of at least one thread or wire. 
   
   
       5 . The tissue cutting device according to  claim 4 , wherein the device is made out of more than one wire, wherein the wires are interconnected or braided to each other. 
   
   
       6 . The tissue cutting device according to  claim 1 , wherein the device is formed in a net-like pattern to a shape that is arranged to encompass at least a portion of said atrium that it is intended to treat before cutting through a wall of said atrium. 
   
   
       7 . The tissue cutting device according to  claim 6 , wherein the net-like pattern forms a spherical form encompassing a substantial part of said atrium. 
   
   
       8 . The tissue cutting device according to  claim 6 , wherein the net-like pattern forms an ellipsoidal segment that is arranged to encompass a substantial part of said atrium. 
   
   
       9 . The tissue cutting device according to any of  claim 6 , wherein the net-like pattern forms a cup-shape. 
   
   
       10 . The tissue cutting device according to  claim 1 , wherein the device is formed identical to at least a part of the inner surface of said atrium, only considerably larger, allowing the device to grow through the entire wall of the heart, to come outside of the atrium and thereby cutting said atrium in pieces, wherein said cut is configured to be replaced continuously by said scar tissue that does not conduct electrical signals, such that islets of atrial wall tissue containing tissue that conduct electrical signals are isolated unable to transmit erratic current to the next islet. 
   
   
       11 . The tissue cutting device according to  claim 6 , wherein the device is in form of a globulus arranged and configured to be placed inside said atrium. 
   
   
       12 . The tissue cutting device according to  claim 1 , wherein the tissue cutting device is arranged and configured to create a cutting pattern intended for forming blocks against propagation of undesired electrical signals in the heart. 
   
   
       13 . The tissue cutting device according to  claim 1 , wherein the device comprises a shape memory material configured for achieving said change of shape from a temporary delivery shape to an expanded delivered shape in said atrium of said heart. 
   
   
       14 . The tissue cutting device according to  claim 13 , wherein said shape memory material is a resorbable shape memory polymer. 
   
   
       15 . The tissue cutting device according to  claim 14 , wherein a time for resorption of the polymer is determinable by different ingredients of polymers. 
   
   
       16 . The tissue cutting device according to  claim 14 , wherein a time for resorption of the polymer is determinable by means of external altering, such as by means of K-ray radiation, ultrasound, electron beams, or light of a defined wavelength. 
   
   
       17 . The tissue cutting device according to  claim 1 , wherein the device is biodegradable. 
   
   
       18 . The tissue cutting device according to  claim 1 , wherein the device is combined with a tubular part. 
   
   
       19 . The tissue cutting device according to  claim 18 , wherein the tubular part of the device is structured and arranged to be inserted in a temporary delivery shape through the vascular system into a body vessel adjacent to the heart, and to be subsequently subjected to a change of shape, from said temporary delivery shape via an expanded delivered shape to a further expanded shape, extending at least beyond an outer surface of said tissue, in order to create said cutting action configured for cutting said heart tissue and/or said body vessel, wherein the tubular part of said device comprises a plurality of segments connected to each other in longitudinal direction of said tubular part of said device, wherein a first segment of said plurality of segments has a dimension in a direction perpendicular to said longitudinal direction of said tubular part of said device that is larger than that dimension of a second segment thereof, at least in said expanded delivered shape. 
   
   
       20 . The tissue cutting device according to  claim 19 , wherein the second segment is configured to fit in a branch of the pulmonary vein system having a smaller diameter than the first segment. 
   
   
       21 . The tissue cutting device according to  claim 19 , wherein said device further comprises at least one cutting arm being structured and arranged to initially extend substantially perpendicular to said longitudinal direction from the tubular part of said tissue cutting device in order to be inserted into a heart atrium wall and said cutting arm being structured and arranged to change shape to extend radially from the tubular part of said tissue cutting device. 
   
   
       22 . The tissue cutting device according to  claim 21 , wherein the at least one cutting arm has a form comprising at least one closed loop. 
   
   
       23 . The tissue cutting device according to any of  claim 19 , wherein said body vessel, which the device is structured and arranged to be inserted into, is the coronary sinus. 
   
   
       24 . The tissue cutting device according to  claim 1 , wherein an outside surface of the device is provided with sharp edges. 
   
   
       25 . The tissue cutting device according to  claim 1 , wherein an outside surface of the device is provided with drugs. 
   
   
       26 . The tissue cutting device according to  claim 27 , wherein said drugs include drug adapted to increase a cutting effect through tissue. 
   
   
       27 . The tissue cutting device according to  claim 26 , wherein said drug adapted to increase a cutting effect is any one in the group of alcohol, glutaraldehyde, formaldehyde, and proteolytic enzymes. 
   
   
       28 . The tissue cutting device according to  claim 27 , wherein said proteolytic enzymes are collagenase. 
   
   
       29 . The tissue cutting device according to  claim 25 , wherein said drugs include a drug adapted to prohibit a thickening of a wall of the body vessel in which the device is inserted. 
   
   
       30 . The tissue cutting device according to  claim 29 , wherein said drug adapted to prohibit a thickening is any one in the group of ciclosporin, taxiferol, rapamycin and tacrolimus. 
   
   
       31 . The tissue cutting device according to  claim 25 , wherein said drugs include any one in the group of Endothelium Growth Factor, Heparin, and amiodarone, sotalol or any other antiarrythmic drug. 
   
   
       32 . The tissue cutting device according to  claim 1 , wherein said device has a net-like shape formed of closed loops. 
   
   
       33 . The tissue cutting device according to  claim 1 , wherein the device is at least partly bioresorbable. 
   
   
       34 . The tissue cutting device according to  claim 1 , wherein the device is made of a shape memory polymer. 
   
   
       35 . The tissue cutting device according to  claim 1 , wherein the device is connected to at least one transversally expandable tubular part. 
   
   
       36 . A kit of shape-changing cutting devices, comprising at least one tissue cutting device according to  claim 1  for treatment of disorders in the heart rhythm regulation system, said kit comprising:
 a plurality of shape-changing cutting devices, which each has a first delivery and a second delivered state, wherein each device in the first state has such dimensions as to be insertable to a desired position within the vascular system, and wherein each device is capable of changing shape to substantially the second state when located at said desired position, at least the tissue cutting device in the second state having an at least partly spherical shape, which strives to a diameter that is larger than the diameter of the heart tissue at the desired position, whereby the tissue cutting device will become embedded into the tissue surrounding the tissue cutting device at the desired position and destroy the tissue in order to prevent it from transmitting electrical signals,   wherein at least one of the shape-changing devices is adapted to be inserted to a desired position at the orifice of a pulmonary vein in the heart, and at least one of the shape-changing devices is adapted to be inserted to a desired position in the coronary sinus, wherein the complete kit is assembled from devices designed to fit to the anatomical conditions of the actual treatment locations and to create a cutting pattern of said tissue by cutting action of said devices, wherein the devices are arranged and configured to continuously replace the cuts by scar tissue that does not conduct electrical signals.   
   
   
       37 . The kit according to  claim 36 , wherein the cutting pattern is independent of specific locations of ectopic sites causing said disorders in the heart rhythm regulation system in each individual case. 
   
   
       38 . The kit according to  claim 36 , wherein the cutting pattern is substantially a Maze III-pattern, comprising a plurality of cuts chosen from:
 a first cut (B) around the left superior pulmonary vein (LSPV) and the left inferior pulmonary vein (RSPV) and the right inferior pulmonary vein (RSPV);   a third cut ( 12 ) connecting the first cut ( 8 ) and the second cut ( 10 ) around the pulmonary veins (PV);   a fourth cut ( 14 ) from the third cut ( 12 ) to the coronary sinus (CS);   a fifth cut ( 16 ) from the left pulmonary veins to the left atrial appendage;   a sixth cut ( 18 ) from the inferior vena cava (IVC) to the superior vena cava (SVC);   a seventh cut ( 20 ) connecting the second cut ( 10 ) around the right pulmonary veins and the sixth cut ( 18 ) between the IVC and the SVC;   an eighth cut ( 22 ) from the sixth cut ( 18 ) between the IVC and the SVC along the right lateral atrium wall; and   a ninth cut ( 24 ) isolating the right atrial appendage.   
   
   
       39 . The kit according to  claim 36 , wherein one of the shape-changing devices is adapted to be inserted into the pulmonary vein and comprises an arm, which in the second state is arranged to contact another shape-changing device in the coronary sinus. 
   
   
       40 . The kit according to  claim 39 , wherein said arm comprises a trough in an area to come in contact with the shape-changing device in the coronary sinus. 
   
   
       41 . The kit according to  claim 36 , wherein at least one of the shape-changing devices is adapted to be inserted into the inferior vena cava. 
   
   
       42 . The kit according to  claim 41 , wherein at least one of the shape-changing devices is adapted to be inserted into the superior vena cava. 
   
   
       43 . The kit according to  claim 42 , wherein at least one of the shape-changing device that is adapted to be inserted into the superior vena cava and the shape-changing device that is adapted to be inserted into the inferior vena cava comprises an arm, which in the second state is arranged to form a connection between these shape-changing devices. 
   
   
       44 . The kit according to  claim 36 , wherein the kit comprises four shape-changing devices, each being adapted to be inserted into a respective pulmonary vein. 
   
   
       45 . The kit according to  claim 44 , wherein at least one of the shape-changing devices is adapted to be inserted into a pulmonary vein comprises an arm, which in the second state is arranged to contact the shape-changing device in another pulmonary vein. 
   
   
       46 . The kit according to  claim 36 , wherein at least one of the shape-changing devices is adapted to be inserted into the left atrial appendage, 
   
   
       47 . The kit according to  claim 46 , wherein the shape-changing device that is adapted to be inserted into the left atrial appendage comprises an arm, which in the second state is arranged to contact the shape-changing device in a pulmonary vein. 
   
   
       48 . The kit according to  claim 46 , wherein the shape-changing device that is adapted to be inserted into the left atrial appendage comprises a film, which covers an end of the tubular shape of the device in the second state. 
   
   
       49 . The kit according to  claim 36 , wherein at least one of the shape-changing devices is adapted to be inserted into the right atrial appendage.