Methods and devices for accessing and delivering devices to a heart

• US 9,486,281 B2
• Filed: 06/19/2014
• Issued: 11/08/2016
• 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, Helmuth, Ryan Douglas
• Primary Examiner(s): Severson, Ryan J
• Application Number:
  US14/309,835
• Publication Number:
  US 20140303721A1
• Time in Patent Office: 873 Days
• US Class Current: 1/1
• 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 devices and systems for accessing and delivering devices to a heart. The left atrial appendage may be used as an access port to allow pericardial access to internal structures of the heart. Systems that may be used to provide access to the heart via the left atrial appendage may comprise a first access element with a first alignment member, a second access element with a second alignment member, a piercing element, and an exchange element. A piercing element may be advanced to pierce the wall of the left atrial appendage to form an access site therethrough. Optionally, an exchange element may be advanced to initiate a track between the inside and outside of the left atrial appendage, which may be used for device delivery. Some systems may further comprise a left atrial appendage stabilization device.

Claims

1. A method for cardiac valve treatment via a left atrial appendage, the method comprising:

advancing a first guide intravascularly to an interior of the left atrial appendage, wherein the first guide comprises a first longitudinal lumen therethrough and a first magnet;

advancing a second guide through the pericardium to an exterior of the left atrial appendage, wherein the second guide comprises a second longitudinal lumen therethrough and a second magnet;

aligning the first and second guides using the first and second magnets such that the first longitudinal lumen is aligned with the second longitudinal lumen and homeostasis is maintained between the magnets;

advancing a piercing element through the left atrial appendage through the first and second longitudinal lumens to access a cardiac valve site;

advancing a guide element through the first and second longitudinal lumens;

advancing a treatment device along the guide element into the heart through the left atrial appendage to the cardiac valve site;

repairing or replacing the cardiac valve with the treatment device;

removing the treatment device through the left atrial appendage; and

advancing a closure device to the left atrial appendage; and

closing the left atrial appendage with the closure device.

2. The method of claim 1 wherein the treatment device comprises a cardiac valve repair device.

3. The method of claim 2 wherein the valve repair device comprises an annuloplasty band or ring.

4. The method of claim 2 wherein the valve repair device comprises a chordae tendinae replacement device.

5. The method of claim 1 wherein the treatment device comprises a cardiac valve replacement device.

6. The method of claim 1, further comprising advancing a suture device into the heart through a left ventricle access site.

7. The method of claim 1 wherein the cardiac valve is a mitral valve.

8. The method of claim 1 wherein the cardiac valve is a tricuspid valve.

9. The method of claim 1 wherein the cardiac valve is a semilunar valve.

10. The method of claim 1 wherein closing the left atrial appendage comprises ligating the left atrial appendage with a suture loop.

11. The method of claim 1 wherein closing the left atrial appendage comprises occluding the left atrial appendage with an expandable member.

12. The method of claim 1 wherein the closure device comprises a closure element forming a loop and a suture loop.

13. The method of claim 12 wherein the suture loop is releasably connected to the closure element.

14. The method of claim 1 further comprising advancing a guide element intravascularly into the left ventricle to assist in cardiac valve treatment.

15. The method of claim 1 further comprising stabilizing the left atrial appendage with the closure device before the repairing step.

16. The method of claim 15 wherein the closure device comprises a closure element forming a loop and a suture loop, and wherein stabilizing the left atrial appendage with the closure device comprises closing the closure element around the left atrial appendage to help maintain homeostasis.

17. The method of claim 16 further comprising reopening the closure element to allow the treatment device to advance therethrough and reclosing the closure element around the treatment device to help maintain homeostasis.

18. The method of claim 1 wherein a clamp connects the piercing element and the guide element.

19. The method of claim 1 further comprising expanding a balloon in the left atrial appendage to assist in closing the left atrial appendage near an ostium of the left atrial appendage.

20. The method of claim 1 wherein the first and second guides are aligned linearly end-to-end.