Methods and devices for treating atrial fibrillation

• US 10,405,919 B2
• Filed: 07/14/2015
• Issued: 09/10/2019
• Est. Priority Date: 04/13/2010
• Status: Active Grant

• Current Assignee: SentreHeart, LLC (Atricure, Inc.)
• Original Assignee: SentreHEART Incorporated (Atricure, Inc.)
• Inventors: Fung, Gregory W., Seiber, Russell A., Strasser, Robert, Escano, Arnold M., Helmuth, Ryan Douglas
• Primary Examiner(s): Kim, Eun Hwa
• Application Number:
  US14/799,419
• Publication Number:
  US 20160008061A1
• Time in Patent Office: 1,519 Days
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12195 comprising a curable material
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00084 Temperature
• 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 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2018/00279 deployable
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00363 Epicardium
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/0212 : using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/1407 : Loop
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61M 25/0127 : Magnetic means; Magnetic markers
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: A61N 7/022 : intracavitary

Abstract

Described here are systems and methods for affecting tissue within a body to form a lesion. Some systems comprise tissue-affecting devices, devices that guide the advancement of the tissue-affecting elements to a target tissue region, devices that locate and secure tissue, and devices that help position the tissue-affecting devices along the target tissue. The methods described here comprise advancing a first tissue-affecting device to a first surface of a target tissue, advancing a second tissue-affecting device to a second surface of the target tissue, and positioning the first and second devices so that a lesion may be formed in the tissue between them. In some variations, the devices, systems, and methods described here are used to treat atrial fibrillation by ablating fibrillating tissue from an endocardial surface and an epicardial surface of a heart. Methods of closing, occluding, and/or removing the left atrial appendage are also described.

Claims

1. A method of affecting tissue within a body comprising:

advancing a first device comprising tissue-affecting elements to an endocardial surface of a left atrium, wherein the first device comprises a linear delivery configuration and a semi-circular deployed configuration;

advancing a second device comprising tissue-affecting elements to an epicardial surface of the left atrium, wherein the second device comprises a linear delivery configuration and a semi-circular deployed configuration, and wherein the second device is configured to align with the first device;

positioning the first device in the deployed configuration so that the tissue-affecting elements at least partially circumferentially surround a base of a pulmonary vein on the endocardial surface of the left atrium;

positioning the second device in the deployed configuration so that the tissue-affecting elements at least partially circumferentially surround a trunk of the pulmonary vein on the epicardial surface of the left atrium;

activating the first device such that the tissue-affecting elements form a lesion in the left atrium around the pulmonary vein from the endocardial surface; and

activating the second device such that the tissue-affecting elements form a lesion in the left atrium around the pulmonary vein from the epicardial surface.

2. The method of claim 1, wherein the first and second devices are activated simultaneously.

3. The method of claim 1, wherein the first and second devices are activated sequentially and the method further comprises deactivating the first device before activating the second device.

4. The method of claim 3, further comprising deactivating the second device and re-activating the first device.

5. The method of claim 1, wherein advancing the first device comprises inserting a curved sheath at a location beneath a sternum and advancing the first device through the sheath.

6. The method of claim 1, wherein the second device is configured to align with the first device using one or more magnetic components.

7. The method of claim 1, further comprising verifying that the lesion is transmural.

8. The method of claim 7, wherein the verifying step comprises assessing the lesion using electrical impedance tomography.

9. The method of claim 7, wherein the verifying step comprises assessing the lesion using thermal imaging techniques.

10. The method of claim 1, wherein advancing the first device comprises advancing a first guide wire through a puncture in a left atrial appendage into the left atrium, and advancing the first device over the first guide wire.

11. The method of claim 10, wherein advancing the second device comprises advancing a second guide wire pericardially to the epicardial surface of the left atrium, and advancing the second device over the second guide wire.

12. The method of claim 11, wherein the second guide wire comprises a magnetic component at its distal tip configured to align the second guide wire and the first device.

13. The method of claim 10, further comprising stabilizing the left atrial appendage using a looped closure assembly.

14. The method of claim 13, wherein the looped closure assembly comprises a snare loop and a suture loop.

15. The method of claim 1, wherein the tissue-affecting elements of the first and second devices deliver at least one of the following:

a cryogenic substance, high intensity focused ultrasound, heat energy, microwave energy, and radiofrequency energy.

16. The method of claim 1, wherein the first and second devices each further comprise a temperature sensor.

17. The method of claim 1, wherein the first and second devices are separate devices.

18. The method of claim 1, wherein the first device comprises a first ablation array and the second device comprises a second ablation array, wherein the first and second ablation arrays each comprise tissue-affecting elements and magnetic components.

19. The method of claim 18, wherein the first and second ablation arrays are configured to compress tissue against the ablation arrays to improve the efficacy of lesion formation.

20. The method of claim 18, wherein the first and second ablation arrays further comprise a shape-memory material.

21. The method of claim 18, wherein the ablation arrays are configured to position the tissue-affecting elements of the first device across from the tissue-affecting elements of the second device.