Methods and apparatus for transpericardial left atrial appendage closure

• US 7,226,458 B2
• Filed: 11/05/2001
• Issued: 06/05/2007
• Est. Priority Date: 05/20/1999
• Status: Expired due to Term

• Current Assignee: SentreHEART Incorporated (Atricure, Inc.)
• Original Assignee: Aaron V. Kaplan
• Inventors: Kaplan, Aaron V., Bajor, Jordan T.
• Primary Examiner(s): Woo; Julian W.
• Application Number:
  US10/007,364
• Publication Number:
  US 20020049457A1
• Time in Patent Office: 2,038 Days
• Field of Search: 606/153, 606/213, 606/205, 606/139, 606/140, 606/141, 606/142, 606/144, 606/148, 606/191, 606/198, 606192-194, 606/108, 606/113, 606/127, 604/22, 604/500, 604/95.04, 604/523, 600/104, 600/128, 600/207, 227/175.1, 623/1.11, 623/1.12
• US Class Current: 606/139
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/320048 Balloon dissectors

Abstract

Methods and apparatus for closing a left atrial appendage are described. The methods rely on introducing a closure tool from a location beneath the rib cage, over an epicardial surface, and to the exterior of the left atrial appendage. The closure device may then be used to close the left atrial appendage, preferably at its base, by any one of a variety of techniques. A specific technique using graspers and a closing loop is illustrated.

Claims

1. A device for closing a left atrial appendage of a heart, said device comprising:

a shaft having a proximal end and a distal end, wherein the distal end is percutaneously adapted to enter a pericardial space, advance over an epicardial surface, and approach the exterior of the left atrial appendage;

at least one closing element carried by the shaft adapted to close the left atrial appendage when the distal end of the shaft is positioned adjacent the left atrial appendage; and

the device further comprises an expander for separating the pericardium in the region of the left atrial appendage;

wherein the shaft is curved over its length and has a crescent-shaped cross-section.

2. A device for closing a left atrial appendage of a heart, said device comprising:

a shaft having a proximal end and a distal end, wherein the distal end is percutaneously adapted to enter a pericardial space, advance over an epicardial surface, and approach the exterior of the left atrial appendage;

at least one closing element carried by the shaft adapted to close the left atrial appendage when the distal end of the shaft is positioned adjacent the left atrial appendage;

wherein the distal end is configured to lie within an atrioventricular valve groove of the heart;

wherein the shaft has at least one lumen which extends from the proximal end to an exit port spaced inwardly from the distal end by a distance in the range from 0.5 cm to 5 cm;

wherein the closing element extends through the at least one lumen;

wherein the closing element comprises a grasping tool which extends through one of the lumens, said grasping tool being adapted to temporarily grasp the left atrial appendage; and

wherein the grasping tool comprises a first closing element, and the device further comprises a second closing element which is adapted to permanently close the left atrial appendage while the left atrial appendage is being temporarily closed with the grasping tool.

3. A device for closing a left atrial appendage of a heart, said device comprising:

a shaft having a proximal end and a distal end, wherein the distal end is percutaneously adapted to enter a pericardial space, advance over an epicardial surface, and approach the exterior of the left atrial appendage;

at least one closing element carried by the shaft configured to engage the left atrial appendage in a manner to close the left atrial appendage;

wherein the shaft is curved over its length from the distal end to the proximal end;

wherein the shaft has a longitudinal axis extending from the proximal end to the distal end, a width dimension measured perpendicular to the longitudinal axis, and a thickness dimension measured perpendicular to the longitudinal axis and perpendicular to the width dimension, and wherein over at least the majority of the length of the shaft the width dimension is greater than the thickness dimension; and

wherein the shaft has at least two lumens, each lumen extends from the proximal end to an exit port spaced from the distal end, wherein the shaft includes a generally thinned region adjacent the distal end, the thinned region defining a surface that forms a portion of an exterior surface of the shaft, and the exit ports for the lumens are defined in the surface.

4. A device for closing a left atrial appendage of a heart, said device comprising:

a shaft having a proximal end and a distal end, wherein the distal end is percutaneously adapted to enter a pericardial space, advance over an epicardial surface, and approach the exterior of the left atrial appendage;

at least one closing element carried by the shaft adapted to close the left atrial appendage when the distal end of the shaft is positioned adjacent the left atrial appendage; and

the device further comprises an expander for separating the pericardium in the region of the left atrial appendage;

wherein the closing element includes a clip to permanently close the left atrial appendage and wherein the expander and the closing element are introducable through lumens in the shaft.

5. A device for closing a left atrial appendage of a heart, said device comprising:

a shaft having a proximal end and a distal end, wherein the distal end is percutaneously adapted to enter a pericardial space, advance over an epicardial surface, and approach the exterior of the left atrial appendage;

at least one closing element carried by the shaft adapted to close the left atrial appendage when the distal end of the shaft is positioned adjacent the left atrial appendage;

wherein the distal end is configured to lie within an atrioventricular valve groove of the heart;

wherein the shaft has at least one lumen which extends from the proximal end to an exit port spaced inwardly from the distal end by a distance in the range from 0.5 cm to 5 cm; and

wherein the shaft has a longitudinal axis extending from the proximal end to the distal end, a width dimension measured perpendicular to the longitudinal axis, and a thickness dimension measured perpendicular to the longitudinal axis and perpendicular to the width dimension, and wherein over at least the majority of the length of the shaft the width dimension is greater than the thickness dimension.

6. A device for closing a left atrial appendage of a heart, said device comprising:

a shaft having an elongated longitudinal body including a proximal end and a distal end, wherein the distal end is configured to percutaneously enter a pericardial space, advance over an epicardial surface, and approach the exterior of the left atrial appendage;

a plurality of lumens extending through the shaft along the longitudinal body and between the proximal end and the distal end;

an expander configured to be extended through one of the lumens, the expander is configured to expand the pericardial space by separating a parietal pericardium from the epicardial surface;

a grasping tool configured to be extended through one of the lumens, the grasping tool is configured to temporarily grasp the left atrial appendage; and

a closure tool configured to be extended through one of the lumens, the closure tool is configured to close the left atrial appendage.

7. The device according to claim 6, wherein the shaft is configured to percutaneously access the left atrial appendage by approaching beneath a patient'"'"'s rib cage, between a xiphoid and adjacent costal cartilage.

8. The device according to claim 6, wherein the curvature of the shaft is adjustable.

9. The device according to claim 6, wherein the distal end is configured to lie within an atrioventricular valve groove of the heart, and the distal end of the shaft is configured to be positioned adjacent the left atrial appendage.

10. The device according to claim 6, wherein the elongated longitudinal body being of sufficient length for insertion of at least the distal end portion through a transcutaneous access to the pericardial space.

11. The device according to claim 6, wherein the lumens are constructed as separate discreet channels extending through the shaft.

12. The device according to claim 6, wherein the expander comprises an inflatable balloon, inflatable balloon is configured to create a working space between the parietal pericardium and epicardial surface.

13. The device according to claim 6, wherein the closing element comprises a loop to close the left atrial appendage.

14. The device according to claim 6, wherein the closing element is configured to simultaneously engage opposite side surfaces of the left atrial appendage.

15. The device according to claim 6, wherein the closure tool is configured to permanently close the left atrial appendage.

16. The device according to claim 6, wherein the closure tool is configured to close the left atrial appendage, such that the distal end of the shaft is positioned adjacent the left atrial appendage, while the left atrial appendage is being temporarily grasped with the grasping tool.

17. The device according to claim 6, Further comprising a handle attached to the proximal end of the shaft, the handle including at least one guide configured to manipulate the grasping tool and closure tool.

18. The device according to claim 6, wherein one of the lumens is for irrigating the pericardial space.

19. The device according to claim 6, further comprising a viewing scope positionable through one of the lumens in the shaft.

20. The device according to claim 6, further comprising an access sheath configured to be introduced into the pericardial space.

21. A device for closing a left atrial appendage of a heart, said device comprising:

a shaft having an elongated longitudinal body including a proximal end and a distal end, wherein the distal end is configured to percutaneously enter a pericardial space, advance over an epicardial surface, and approach the exterior of the left atrial appendage;

a plurality of lumens extending through the shaft along the longitudinal body and between the proximal end and the distal end;

a balloon expander configured to be extended through one of the lumens, the balloon expander configured to expand the pericardial space by separating a parietal pericardium from the epicardial surface, the balloon expander is an inflatable balloon comprising a major portion that is configured to expand toward the parietal pericardium and a minor portion that is configured to expand away from the parietal pericardium, such that the balloon expander is an asymmetrical balloon;

a grasping tool configured to be extended through one of the lumens, the grasping tool is configured to temporarily grasp the left atrial appendage; and

a closure tool configured to be extended through one of the lumens, the closure tool is configured to close the left atrial appendage.

22. The device of claim 21, wherein the major portion is extendable above a central longitudinal axis defined in the elongated longitudinal body and extendable toward the parietal pericardium, when the balloon is inflated.