Claims for Patent: 8,696,696

Summary for Patent: 8,696,696

Title:	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.
Inventor(s):	Solem; Jan Otto (Bjarred, SE)
Assignee:	Syntach AG (Schaffhausen, CH)
Application Number:	13/764,681
Patent Claims:	1. A tissue cutting device configured to reduce undesired signal transmission in a heart tissue in order to treat arrhythmia, 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, 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 arrhythmia, the device is combined with a tubular part 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 a tissue surrounding said body vessel, in order to create said cutting action configured for cutting said heart tissue and/or a cutting action configured for cutting said tissue surrounding said body vessel, the tubular part of said device comprises a plurality of segments connected to each other in a longitudinal direction of said tubular part of said device, 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, 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. 2. The device according to claim 1, wherein the device is of an at least partly spherical shape. 3. The device according to claim 1, wherein the device is made out of at least one thread or wire. 4. The device according to claim 3, wherein the device is made from a plurality of wires, and wherein the wires are interconnected or braided to each other. 5. The 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. 6. The device according to claim 5, wherein the net-like pattern forms a spherical form encompassing a substantial part of said atrium, an ellipsoidal segment that is arranged to encompass a substantial part of said atrium, a cup-shape, or a globulus arranged and configured to be placed inside said atrium. 7. The device according to claim 1, wherein: at least a part of the device, in the further expanded shape, has a form that is the same as at least a part of the inner surface of said atrium but is larger than the atrium, the device expands from the expanded delivered shape inside said atrium, through the entire wall of said atrium, to the further expanded shape in which at least a part of the device is outside of the atrium, and expansion of the device from the expanded delivered shape to the further expanded shape cuts said atrium into islets of atrial wall tissue separated by scar tissue that is unable to conduct electrical signals. 8. The device according to claim 1, wherein the device comprises a resorbable shape memory polymer configured for achieving said change of shape from said temporary delivery shape to said expanded delivered shape. 9. The device according to claim 8, wherein a time for resorption of the polymer is determinable by means of x-ray radiation, ultrasound, electron beams, or light of a defined wavelength. 10. The device according to claim 1, wherein the second segment is configured to fit in a branch of a pulmonary vein system having a smaller diameter than the first segment. 11. The device according to claim 1, wherein the at least one cutting arm has a form comprising at least one closed loop. 12. The device according to claim 1, wherein said body vessel into which the device is structured and arranged to be inserted is the coronary sinus. 13. The device according to claim 1, wherein an outside surface of the device is provided with drugs and wherein said drugs are selected from the group consisting of a drug adapted to increase a cutting effect through tissue, a drug adapted to prohibit a thickening of a wall of the body vessel in which the device is inserted, an antiarrhythmic drug, and combinations thereof. 14. The device according to claim 1, wherein an outside surface of the device is provided with a drug selected from the group consisting of an alcohol, glutaraldehyde, formaldehyde, a proteolytic enzyme, a collagenase, cyclosporin, taxiferol, rapamycin, tacrolimus, Endothelium Growth Factor, Heparin, amiodarone, sotalol, an antiarrhythmic drug, and combinations thereof. 15. The device according to claim 1, wherein said device has a net-like shape formed of closed loops. 16. A kit of shape-changing cutting devices according to claim 1, said kit comprising: a plurality of devices according to claim 1 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, at least one of the shape-changing devices is adapted to be inserted to a desired position in the coronary sinus, and the kit is assembled from devices designed to fit to anatomical conditions of the treatment locations. 17. The kit according to claim 16, wherein one of the shape-changing devices is adapted to be inserted into the pulmonary vein and comprises an arm which, in the expanded delivered shape and/or further expanded shape, is arranged to contact another shape-changing device in the coronary sinus. 18. The kit according to claim 17, wherein said arm comprises a trough in an area to come in contact with a shape-changing device in the coronary sinus. 19. The kit according to claim 16, wherein at least one of the shape-changing devices is adapted to be inserted into the inferior vena cava or the superior vena cava. 20. The kit according to claim 16, wherein the kit comprises four shape-changing devices, each being adapted to be inserted into a respective pulmonary vein. 21. The kit according to claim 20, wherein at least one of the shape-changing devices is adapted to be inserted into a pulmonary vein comprises an arm which, in one or both of the expanded delivered shape and further expanded shape, is arranged to contact the shape-changing device in another pulmonary vein. 22. The kit according to claim 16, wherein at least one of the shape-changing devices is adapted to be inserted into the left atrial appendage or the right atrial appendage. 23. The kit according to claim 22, wherein the shape-changing device is adapted to be inserted into the left atrial appendage and wherein: said shape-changing device comprises an arm which, in one or both of the expanded delivered shape and further expanded shape, is arranged to contact the shape-changing device in a pulmonary vein and/or said shape-changing device comprises a film, which covers an end of the tubular shape of the device. 24. A kit of shape-changing cutting devices according to claim 1, said kit comprising a plurality of tissue cutting devices configured to reduce undesired signal transmission in a heart tissue in order to treat arrhythmia, wherein: each tissue cutting 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, each tissue cutting device is configured to create cutting action for cutting of said heart tissue including said atrium, and wherein each 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 arrhythmia, 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, at least one of the shape-changing devices is adapted to be inserted to a desired position in the coronary sinus, the kit is assembled from devices designed to fit to anatomical conditions of the treatment locations, and wherein the said plurality of devices are configured to produce a cutting pattern that is substantially a Maze III-pattern, said cutting pattern comprising a plurality of cuts chosen from: a first cut around the left superior pulmonary vein (LSPV) and the left inferior pulmonary vein (LIPV) and a corresponding second cut around the right superior pulmonary vein (RSPV) and the right inferior pulmonary vein (RSPV); a third cut connecting the first cut and the second cut around the pulmonary veins (PV); a fourth cut from the third cut to the coronary sinus (CS); a fifth cut from the left pulmonary veins to the left atrial appendage; a sixth cut from the inferior vena cava (IVC) to the superior vena cava (SVC); a seventh cut connecting the second cut around the right pulmonary veins and the sixth cut between the IVC and the SVC; an eighth cut from the sixth cut between the IVC and the SVC along the right lateral atrium wall; and a ninth cut isolating the right atrial appendage.

Details for Patent 8,696,696

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2025-05-17