Device, a kit and a method for treatment of disorders in the heart rhythm regulation system

Abstract

A tissue lesion creating device is structured and arranged to be inserted through the vascular system into a body vessel adjacent the heart and to be subsequently subjected to a change of shape in order to penetrate into the heart tissue. The tissue lesion creating 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 lesion creating device for reducing undesired signal transmission in the heart tissue, 
 characterized in that the device is structured and arranged to be inserted through the vascular system into a body vessel adjacent the heart and to be subsequently subjected to a change of shape in order to penetrate into said heart tissue.    
   
   
       2 . The tissue lesion creating device as claimed in  claim 1 , wherein the device is structured and arranged to penetrate through a wall of said vessel into said heart tissue.  
   
   
       3 . The tissue lesion creating device as claimed in  claim 1 , wherein the device has an initial elongate shape and wherein the device is structured and arranged to change shape to expand its dimensions in a direction transversally to its elongate direction.  
   
   
       4 . The tissue lesion creating device as claimed in  claim 1 , wherein the device comprises a shape memory material.  
   
   
       5 . The tissue lesion creating device as claimed in  claim 1 , wherein the device comprises a transversely expandable tubular part.  
   
   
       6 . The tissue lesion creating device as claimed in  claim 5 , wherein said tubular part of the device is funnel-shaped.  
   
   
       7 . The tissue lesion creating device as claimed in  claim 5 , wherein said tubular part comprises at least two axially separated tubular portions, which are interconnected by a connecting member.  
   
   
       8 . The tissue lesion creating device as claimed in  claim 7 , wherein said tubular portions are transversely expandable to different degrees.  
   
   
       9 . The tissue lesion creating device as claimed in  claim 5 , wherein an end of the tubular part forms an atrial end, said atrial end being structured and arranged to change shape to extend radially from the tubular part.  
   
   
       10 . The tissue lesion creating device as claimed in  claim 9 , wherein said atrial end comprises a plurality of arches overlapping each other.  
   
   
       11 . The tissue lesion creating device as claimed in  claim 9 , wherein said atrial end when extending radially from the tubular part forms an annular flange.  
   
   
       12 . The tissue lesion creating device as claimed in  claim 5 , wherein said device further comprises a cutting arm being structured and arranged to initially extend axially from the tubular part in order to be inserted into a heart atrium and said cutting arm being structured and arranged to change shape to extend radially from the tubular part.  
   
   
       13 . The tissue lesion creating device as claimed in  claim 12 , wherein the cutting arm has a form comprising at least one closed loop.  
   
   
       14 . The tissue lesion creating device as claimed in  claim 13 , wherein the cutting arm has a form comprising a plurality of closed loops arranged subsequently to each other in a longitudinal direction of the cutting arm.  
   
   
       15 . The tissue lesion creating device as claimed in  claim 12 , wherein the device comprises at least two cutting arms, which are structured and arranged to change shape to extend in different radial directions from the tubular part.  
   
   
       16 . The tissue lesion creating device as claimed in  claim 5 , wherein said body vessel, which the tubular part is structured and arranged to be inserted into, is the coronary sinus.  
   
   
       17 . The tissue lesion creating device as claimed in  claim 16 , wherein the tubular part, in a first state of the device before the device is subjected to a change of shape, strives towards a shape that is curved along its longitudinal direction to fit into the coronary sinus.  
   
   
       18 . The tissue lesion creating device as claimed in  claim 16 , wherein the tubular part has a length corresponding to at least the distance between the two lower pulmonary veins.  
   
   
       19 . The tissue lesion creating device as claimed in  claim 16 , wherein the cross-section of the tubular part is at least partly elliptic.  
   
   
       20 . The tissue lesion creating device as claimed in  claim 16 , wherein said device further comprises a cutting arm being structured and arranged to initially extend in an axial direction of the tubular part in order to be inserted into the coronary sinus and said cutting arm being structured and arranged to change shape to extend radially from the tubular part.  
   
   
       21 . The tissue lesion creating device as claimed in  claim 1 , wherein an outside surface of the device is provided with sharp edges.  
   
   
       22 . The tissue lesion creating device as claimed in  claim 1 , wherein an outside surface of the device is provided with drugs.  
   
   
       23 . The tissue lesion creating device as claimed in  claim 22 , wherein said drugs include drug adapted to increase a cutting effect through tissue.  
   
   
       24 . The tissue lesion creating device as claimed in  claim 23 , wherein said drug adapted to increase a cutting effect is any one in the group of alcohol, glutaraldehyde, formaldehyde, and proteolytic enzymes like collagenase.  
   
   
       25 . The tissue lesion creating device as claimed in  claim 22 , wherein said drugs include drug adapted to prohibit a thickening of a wall of the body vessel in which the device is inserted.  
   
   
       26 . The tissue lesion creating device as claimed in  claim 25 , wherein said drug adapted to prohibit a thickening is any one in the group of ciclosporin, taxiferol, rapamycin and tacrolimus.  
   
   
       27 . The tissue lesion creating device as claimed in  claim 22 , wherein said drugs include any one in the group of Endothelium Growth Factor, Heparin, and amiodarone, sotalol or any other antiarrythmic drug.  
   
   
       28 . The tissue lesion creating device as claimed in  claim 1 , wherein said device has a net-like shape formed of closed loops.  
   
   
       29 . The tissue lesion creating device as claimed in  claim 1 , wherein the device is at least partly bioresorbable.  
   
   
       30 . The tissue lesion creating device as claimed in  claim 1 , wherein the device is made of a shape memory polymer.  
   
   
       31 . The tissue lesion creating device as claimed in  claim 1 , wherein the device is made of Nitinol.  
   
   
       32 . The tissue lesion creating device as claimed in  claim 1 , wherein the device is made of stainless steel, a titanium alloy or a magnesium alloy.  
   
   
       33 . A kit of shape-changing devices for treatment of disorders in the heart rhythm regulation system, said kit comprising: 
 shape-changing devices, which each has a first and a second state, wherein the device in the first state has such dimensions as to be insertable to a desired position within the vascular system, and wherein the device is capable of changing shape to the second state when located at said desired position, the device in the second state having a tubular part, which strives to a diameter that is larger than the diameter of the vessel at the desired position, whereby the device will become embedded into the tissue surrounding the vessel 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.    
   
   
       34 . The kit as claimed in  claim 33 , wherein the shape-changing device that is adapted to be inserted into the pulmonary vein comprises an arm, which in the second state is arranged to contact the shape-changing device in the coronary sinus.  
   
   
       35 . The kit as claimed in  claim 34 , wherein said arm comprises a trough in an area to come in contact with the shape-changing device in the coronary sinus.  
   
   
       36 . The kit as claimed in  claim 33 , wherein at least one of the shape-changing devices is adapted to be inserted into the inferior vena cava.  
   
   
       37 . The kit as claimed in  claim 36 , wherein at least one of the shape-changing devices is adapted to be inserted into the superior vena cava.  
   
   
       38 . The kit as claimed in  claim 37 , 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.  
   
   
       39 . The kit as claimed in  claim 33 , wherein the kit comprises four shape-changing devices, each being adapted to be inserted into a respective pulmonary vein.  
   
   
       40 . The kit as claimed in  claim 39 , wherein at least one of the shape-changing devices being 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.  
   
   
       41 . The kit as claimed in  claim 33 , wherein at least one of the shape-changing devices is adapted to be inserted into the left atrial appendage.  
   
   
       42 . The kit as claimed in  claim 41 , 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.  
   
   
       43 . The kit as claimed in  claim 41 , 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.  
   
   
       44 . The kit as claimed in  claim 33 , wherein at least one of the shape-changing devices is adapted to be inserted into the right atrial appendage.  
   
   
       45 . A method for treatment of disorders in the heart rhythm regulation system, said method comprising: 
 inserting a tissue lesion creating device through the vascular system to a desired position in a body vessel, and    providing a change of shape of the tissue lesion creating device at said desired position to penetrate heart tissue adjacent said body vessel.    
   
   
       46 . The method according to  claim 45 , wherein said tissue lesion creating device is inserted into a desired position in the coronary sinus, in any of the pulmonary veins, in the superior vena cava, in the inferior vena cava, or in the left or right atrial appendage.  
   
   
       47 . The method according to  claim 46 , further comprising inserting another tissue lesion creating device to another of the desired positions.  
   
   
       48 . The method according to  claim 47 , further comprising inserting a tissue lesion creating device into each of the desired positions.  
   
   
       49 . The method according to  claim 45 , further comprising restraining the tissue lesion creating device in an insertion shape during the inserting of the tissue lesion creating device.  
   
   
       50 . The method according to  claim 49 , wherein the restraining comprises keeping the tissue lesion creating device inside a tube.  
   
   
       51 . The method according to  claim 49 , wherein the restraining comprises cooling the tissue lesion creating device.  
   
   
       52 . The method according to  claim 49 , further comprising releasing a restrain on the tissue lesion creating device when it has been inserted into the desired position for allowing said change of the shape of the tissue lesion creating device.  
   
   
       53 . A medical device which is structured and arranged to be inserted into a body vessel and subsequently change shape therein, characterized in that the device is structured and arranged to change shape to extend at least partly outside the perimeter or orifice of an outer wall of said vessel.