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

• US 9,295,484 B2
• Filed: 06/17/2009
• Issued: 03/29/2016
• Est. Priority Date: 11/17/2003
• Status: Expired due to Fees

• Current Assignee: Syntach AG
• Original Assignee: Syntach AG
• Inventors: Solem, Jan Otto
• Primary Examiner(s): Eastwood, David C
• Application Number:
  US12/486,678
• Publication Number:
  US 20090264983A1
• Time in Patent Office: 2,477 Days
• Field of Search: 623/1.14, 623/1.18, 623/1.2, 606/167, 606/179, 606/180, 606/159
• US Class Current: 1/1
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3205 Excision instruments
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/249 Device completely embedded in the heart wall

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.

Claims

1. A kit of shape-changing devices for treatment of disorders in a 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 tubular part has expansion characteristics so as to circumferentially cut through an entire vessel wall of said vessel along an entire circumference and along a length of the tubular part into a tissue surrounding the vessel at the desired position and destroy the tissue in order to prevent the tissue from transmitting electrical signals,

wherein at least one of the shape-changing devices is adapted to be inserted to a position at an orifice of a pulmonary vein in a heart, and at least one of the shape-changing devices is adapted to be inserted to a position in a coronary sinus.

2. The kit as claimed in claim 1, wherein the shape-changing device that is adapted to be inserted to a position at the orifice of the pulmonary vein comprises an arm, which in the second state is arranged to contact the shape-changing device adapted to be inserted to the position in the coronary sinus.

3. The kit as claimed in claim 2, wherein said arm comprises a trough in an area to come in contact with the shape-changing device adapted to be inserted to the position in the coronary sinus.

4. The kit as claimed in claim 1, wherein at least one of the shape-changing devices is adapted to be inserted into an inferior vena cava.

5. The kit as claimed in claim 4, wherein at least one of the shape-changing devices is adapted to be inserted into a superior vena cava.

6. The kit as claimed in claim 5, 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.

7. The kit as claimed in claim 1, wherein the kit comprises four shape-changing devices, each being adapted to be inserted into a respective pulmonary vein.

8. The kit as claimed in claim 7, wherein at least a first of the four shape-changing devices adapted to be inserted into a respective pulmonary vein comprises an arm, which in the second state is arranged to contact at least a second of the four shape-changing devices adapted to be inserted into a respective pulmonary vein.

9. The kit as claimed in claim 1, wherein at least one of the shape-changing devices is adapted to be inserted into a left atrial appendage.

10. The kit as claimed in claim 9, 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 adapted to be inserted to the position at the orifice of the pulmonary vein.

11. The kit as claimed in claim 9, 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.

12. The kit as claimed in claim 1, wherein at least one of the shape-changing devices is adapted to be inserted into a right atrial appendage.

13. A kit for heart rhythm treatment comprising:

a plurality of heart rhythm treatment devices having a compressed configuration that is sized for advancing within a vascular system of a patient and an expanded configuration forming a tubular shape with a diameter larger than a diameter of a desired target location within a body such that said tubular shape circumferentially cuts entirely through a tissue of said target location along an entire circumference and along a length of the tubular shape;

wherein a first heart rhythm treatment device of said plurality of heart rhythm treatment devices is sized and curved to fit within a coronary sinus.

14. The kit of claim 13, wherein a second heart rhythm treatment device is shaped to fit within a left inferior pulmonary vein.

15. The kit of claim 14, wherein a third heart rhythm treatment device is shaped to fit within a right inferior pulmonary vein.

16. The kit of claim 15, wherein a fourth heart rhythm treatment device is shaped to fit within a left superior pulmonary vein.

17. The kit of claim 16, wherein a fifth heart rhythm treatment device is shaped to fit within a right superior pulmonary vein.

18. The kit of claim 17, wherein a sixth heart rhythm treatment device is shaped to fit within a left or right atrial appendage.

19. The kit of claim 18, wherein a seventh heart rhythm treatment device is shaped to fit within an inferior or a superior vena cava.

20. A kit of shape-changing devices for treatment of disorders in a heart rhythm regulation system, said kit comprising:

a first device having a compressed state for delivery within a vascular system and an expanded state sized for circumferentially cutting entirely through a left inferior pulmonary vein along an entire circumference of the left inferior pulmonary vein and pressing into a heart atrium;

a second device having a compressed state for delivery within the vascular system and an expanded state sized for circumferentially cutting entirely through a right inferior pulmonary vein along an entire circumference of the right inferior pulmonary vein and pressing into said heart atrium;

a third device having a compressed state for delivery within the vascular system and an expanded state sized for circumferentially cutting entirely through a left superior pulmonary vein along an entire circumference of the left superior pulmonary vein and pressing into said heart atrium;

a fourth device having a compressed state for delivery within the vascular system and an expanded state sized for circumferentially cutting entirely through a right superior pulmonary vein along an entire circumference of the right superior pulmonary vein and pressing into said heart atrium; and

a fifth device having a compressed state for delivery within the vascular system and an expanded state sized for circumferentially cutting entirely through a coronary vein along an entire circumference of the coronary vein;

said expanded state being further curved to conform to said coronary vein.