Bistable Device, A Kit And A Method 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 for reducing undesired signal transmission in a heart tissue by isolating ectopic sites thereof by cutting said tissue,
 wherein 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/or into the heart and to be subsequently subjected to a change of shape, extending at least beyond an outer surface of said tissue, in order to create cutting action configured for cutting said heart tissue and/or said body vessel, wherein the device is structured and arranged to penetrate a wall of said vessel or said heart tissue by said cutting action, and wherein said tissue cutting device is bistable and has a first state of minimum energy and a second state of minimum energy, whereby said change of shape, in use, is obtained as a movement between said first state of minimum energy and said second state of minimum energy to create said cutting action in said tissue located in an area of said movement, in such a manner that a cut made will be replaced continuously by scar tissue that does not conduct electrical signals.   
   
   
       2 . The tissue cutting device according to  claim 1 , wherein said tissue cutting device comprises a first part (L 1 ) and a second part (L 2 ), which are configured to move in respect of each other between said first state and said second state, whereby, in use, said cutting action is provided. 
   
   
       3 . The tissue cutting device according to  claim 1 , wherein said tissue cutting device is configured to complete said cutting action after the tissue cutting device, in use, has made said change of shape. 
   
   
       4 . The tissue cutting device according to  claim 1 , wherein the tissue cutting device is made of a resorbable shape memory polymer, such that said tissue Page of cutting devices is configured to be resorbed a time after termination of the cutting action. 
   
   
       5 . The tissue cutting device according to  claim 1 , wherein said change of shape also is obtained from said temporary delivery shape via an expanded delivery shape to a further expanded shape. 
   
   
       6 . The tissue cutting device according to  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 radially outward oriented direction thereof, to thereby cut said heart tissue and/or body vessel. 
   
   
       7 . 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. 
   
   
       8 . The tissue cutting device according to  claim 1 , wherein said body vessel, which the device is structured and arranged to be inserted into, is the coronary sinus. 
   
   
       9 . The tissue cutting device according to  claim 1 , wherein an outside surface of the device is provided with sharp edges. 
   
   
       10 . The tissue cutting device according to  claim 1 , wherein an outside surface of the device is provided with drugs. 
   
   
       11 . The tissue cutting device according to  claim 10 , wherein said drugs include drug adapted to increase a cutting effect through tissue. 
   
   
       12 . The tissue cutting device according to  claim 11 , wherein said drug adapted to increase a cutting effect is any one in the group of alcohol, glutaraldehyde, formaldehyde, and proteolytic enzymes. 
   
   
       13 . The tissue cutting device according to  claim 12 , wherein said proteolytic enzyme is collagenase. 
   
   
       14 . The tissue cutting device according to  claim 10 , wherein said drugs include drug adapted to prohibit a thickening of a wall of the body vessel in which the device is inserted. 
   
   
       15 . The tissue cutting device according to  claim 14 , wherein said drug adapted to prohibit a thickening is any one in the group of ciclosporin, taxiferol, rapamycin and tacrolimus. 
   
   
       16 . The tissue cutting device according to  claim 10 , wherein said drugs include any one in the group of Endothelium Growth Factor, Heparin, and amiodarone, sotalol or any other antiarrythmic drug. 
   
   
       17 . The tissue cutting device according to  claim 1 , wherein said device has a net-like shape formed of closed loops. 
   
   
       18 . The tissue cutting device according to  claim 1 , wherein the device is at least partly bioresorbable. 
   
   
       19 . The tissue cutting device according to  claim 1 , wherein the device is made of a shape memory polymer. 
   
   
       20 . The tissue cutting device according to  claim 1 , wherein the device is made of Nitinol. 
   
   
       21 . The tissue cutting device according to  claim 1 , wherein the device is made of stainless steel, a titanium alloy or a magnesium alloy. 
   
   
       22 . The tissue cutting device according to  claim 1 , wherein the device is connected to at least one transversally expandable tubular part.