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

• US 8,257,376 B2
• Filed: 06/17/2009
• Issued: 09/04/2012
• 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): Severson, Ryan
• Assistant Examiner(s): EASTWOOD, DAVID C
• Application Number:
  US12/486,690
• Publication Number:
  US 20090264880A1
• Time in Patent Office: 1,175 Days
• Field of Search: 623/1.14, 623/1.18, 623/1.2, 606/167, 606/179, 606/180, 606/159
• US Class Current: 606/167
• 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 method for treatment of disorders in the heart rhythm regulation system, said method comprising:

inserting a tissue lesion creating device having a tubular cutting framework through the vascular system to a desired position in a vessel, and

changing a shape of the tissue lesion creating device at said desired position by radially expanding an entirety of said tubular cutting framework of said device to cut entirely through an outer circumference of a vessel wall into heart tissue surrounding said vessel.

2. The method according to claim 1, 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 cave, in the inferior vena cava, or in the left or right atrial appendage.

3. The method according to claim 2, further comprising inserting another tissue lesion creating device to another of the desired positions.

4. The method according to claim 3, further comprising inserting a tissue lesion creating device into each of the desired positions.

5. The method according to claim 1, further comprising restraining the tissue lesion creating device in an insertion shape during the inserting of the tissue lesion creating device.

6. The method according to claim 5, wherein the restraining comprises keeping the tissue lesion creating device inside a tube.

7. The method according to claim 5, wherein the restraining comprises cooling the tissue lesion creating device.

8. The method according to claim 5, further comprising releasing a restraint 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.

9. A method for treating heart rhythm disorders comprising:

advancing a treatment device having a tubular cutting framework through a vascular system and into a beating heart;

releasing said treatment device at a treatment site within said beating heart;

allowing said tubular cutting framework of said treatment device to expand against tissue of said beating heart;

cutting said tissue of said beating heart with said tubular cutting framework of said treatment device by radially expanding an entirety of said tubular cutting framework of said treatment device to cut entirely through an outer circumference of said tissue of said beating heart; and

,

forming scar tissue at said treatment site that reduces transmission of electrical signals through said tissue of said beating heart.

10. The method of claim 9, further comprising:

advancing a second treatment device through said vascular system and into said beating heart;

releasing said second treatment device at a second treatment site within said beating heart;

allowing said second treatment device to expand against said tissue of said beating heart;

cutting said tissue of said beating heart with said second treatment device such that said second treatment device penetrates said tissue of said beating heart; and

,

forming second scar tissue at said second treatment site that reduces transmission of electrical signals through said tissue of said beating heart.

11. The method of claim 9, wherein said treatment device expands to a curved tubular shape having a first end having a first cross sectional diameter and a second end having a second cross sectional diameter;

wherein said first cross sectional diameter is larger than said second cross sectional diameter.

12. The method of claim 9, wherein said allowing said tubular cuttin framework of said treatment device to expand against tissue of said beating heart further comprises expanding said treatment device to a tubular shape having a first diameter and folding a first portion of said treatment device radially outward to a second diameter that is larger than said first diameter.

13. The method of claim 12, further comprising extending said first portion of said treatment device against tissue of a heart atrium.

14. The method of claim 9, wherein said allowing said tubular cutting framework of said treatment device to expand against tissue of said beating heart further comprises expanding said treatment device to a tubular shape and expanding an elongated cutting arm radially away from said tubular shape.

15. The method of claim 9, wherein said allowing said tubular cutting framework of said treatment device to expand against tissue of said beating heart further comprises expanding said treatment device to a tubular shape having a first diameter;

folding a first portion of said treatment device radially outward to a second diameter that is larger than said first diameter; and

expanding an elongated cutting arm radially away from said tubular shape.

16. A method for treatment of disorders in the heart rhythm regulation system, said method comprising:

inserting a tissue lesion creating device having a tubular cutting framework through a vascular system until a portion of said tissue lesion creating device is adjacent a heart;

modifying a configuration of said tissue lesion creating device by radially expanding an entirety of said tubular cutting framework of said device to press against and cut entirely through an outer circumference of tissue of said heart.

17. The method of claim 16, wherein said modifying a configuration of said tissue lesion creating device comprises expanding a funnel-shaped region of said tissue lesion creating device.

18. The method of claim 16, wherein said modifying a configuration of said tissue lesion creating device comprises expanding a plurality of overlapping arches.

19. The method of claim 17, wherein said expanding a plurality of overlapping arches further comprises forming an annular flange and contacting an atrium of a heart with said annular flange.

20. The method of claim 19, further comprising expanding a cutting arm having a plurality of dosed loops.