US-12622747-B2 - Devices and methods for left atrial appendage closure

Abstract

Described here are devices, systems, and methods for closing the left atrial appendage. The methods described here utilize a closure device for closing the left atrial appendage and guides or expandable elements with ablation or abrading elements to ablate or abrade the left atrial appendage. In general, these methods include positioning a balloon at least partially within the atrial appendage, positioning a closure assembly of a closure device around an exterior of the atrial appendage, inflating the balloon, partially closing the closure assembly, ablating the interior tissue of the atrial appendage with the inflated balloon, removing the balloon from the atrial appendage, and closing the atrial appendage with the closure assembly.

Inventors

• Gregory W. Fung
• Randall J. Lee
• Russell PONG
• Robert L. Clark, III
• Arnold M. Escano

Assignees

• ATRICURE, INC.

Dates

Publication Date

20260512

Application Date

20231120

Claims (20)

1. 1 . A method of closing an atrial appendage comprising: positioning a balloon at least partially within an interior of the atrial appendage; positioning a closure assembly of a closure device around an exterior of the atrial appendage, wherein the closure assembly comprises a loop; inflating the balloon at least partially within the interior of the atrial appendage; partially closing the loop to close the atrial appendage around the inflated balloon; ablating the interior tissue of the atrial appendage with the inflated balloon; removing the balloon from the atrial appendage through the closure assembly; and closing the atrial appendage with the closure assembly.
2. 2 . The method of claim 1 , further comprising positioning a distal end of a first guide element in the interior of the atrial appendage and positioning a distal end of a second guide element in a pericardial space externally of the atrial appendage.
3. 3 . The method of claim 2 , wherein the first guide element and the second guide element each comprise a magnet, and further comprising aligning the first guide element and the second guide element across tissue of the atrial appendage.
4. 4 . The method of claim 2 , wherein positioning a closure device comprises advancing the closure device along the second guide element.
5. 5 . The method of claim 2 , wherein the balloon is part of the first guide element.
6. 6 . The method of claim 2 , wherein the balloon is part of a balloon catheter and wherein positioning the balloon comprises advancing the balloon catheter along the first guide element.
7. 7 . The method of claim 1 , wherein the balloon comprises an electrode positioned on an exterior surface of the balloon, and wherein ablating the interior tissue of the atrial appendage comprises ablating the interior tissue of the atrial appendage with the electrode.
8. 8 . The method of claim 7 , wherein the balloon comprises at least two electrodes, the method further comprising monitoring a tissue parameter with at least one of the electrodes during ablation of the interior tissue.
9. 9 . The method of claim 1 , wherein ablating the interior tissue of the atrial appendage comprises cryoablating the interior tissue of the atrial appendage.
10. 10 . The method of claim 1 , wherein ablating the interior tissue of the atrial appendage comprises ablating the interior tissue of the atrial appendage using heated fluid contained in the balloon.
11. 11 . The method of claim 1 , further comprising releasing the loop from the closure assembly to hold the atrial appendage closed.
12. 12 . The method of claim 1 , wherein the closure assembly comprises an electrode, and further comprising ablating an exterior of the atrial appendage with the electrode.
13. 13 . The method of claim 1 , further comprising cryoablating an exterior surface of the atrial appendage with the closure assembly.
14. 14 . A method of closing an atrial appendage comprising: positioning a distal end of a first guide element in the interior of the atrial appendage; advancing a balloon catheter along the first guide element, wherein the balloon catheter comprises a balloon; positioning a distal end of a second guide element in a pericardial space externally of the atrial appendage, wherein the first guide element is aligned across the second guide element on opposite sides of the heart; advancing a closure assembly of a closure device around an exterior of the atrial appendage along the second guide; inflating the balloon within the atrial appendage; withdrawing the first guide element from the interior of the atrial appendage; closing the atrial appendage with the closure assembly; advancing a portion of the first guide element into contact with tissue around an ostium of the closed atrial appendage; and ablating the contacted tissue with the first guide member.
15. 15 . The method of claim 14 , wherein the first guide element and the second guide element each comprise a magnet, and further comprising aligning the first guide element and the second guide element across tissue of the atrial appendage.
16. 16 . The method of claim 14 , wherein the first guide element comprises an electrode positioned at the distal end of the first guide element.
17. 17 . The method of claim 14 , further comprising advancing a wire from a distal end of the first guide element, wherein advancing a portion of the first guide member into contact with tissue around the ostium of the closed atrial appendage comprises advancing the wire into contact with the tissue around the ostium of the closed atrial appendage.
18. 18 . The method of claim 17 , further comprising cryoablating the tissue around the ostium with the wire.
19. 19 . The method of claim 14 , wherein the closure assembly comprises an electrode, the method further comprising ablating an exterior of the atrial appendage with the electrode.
20. 20 . The method of claim 14 , further comprising cryoablating an exterior surface of the atrial appendage with the closure assembly.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation application of U.S. patent application Ser. No. 17/062,406, filed on Oct. 2, 2020, which is a continuation application of U.S. patent application Ser. No. 16/289,365, filed on Feb. 28, 2019, now U.S. Pat. No. 10,799,288, issued Oct. 13, 2020, which is a continuation application of U.S. patent application Ser. No. 14/530,575, filed on Oct. 31, 2014, now U.S. Pat. No. 10,258,408, issued Apr. 16, 2019, which claims priority to U.S. Provisional patent application Ser. No. 61/898,382, filed on Oct. 31, 2013, each of which is incorporated by reference herein in its-entirety. FIELD This invention relates generally to systems and methods for closing tissue such as the left atrial appendage. BACKGROUND Atrial fibrillation is a common problem that afflicts millions of patients. Atrial fibrillation often results in the formation of a thrombus, or clot, in the appendage of the left atrium. This presents a problem, inasmuch as the thrombus can dislodge and embolize to distant organs, which may result in adverse events such as a stroke. For this reason, most patients with atrial fibrillation are treated with one or more blood thinners to help prevent the formation of a thrombus. Blood thinners, however, can present health risks of their own, especially in the elderly. These risks, such as bleeding, often require a user to make significant lifestyle changes. Several methods have been developed to address the potential problem of thrombus formation in the left atrial appendage. One such method includes suturing the left atrial appendage along the base or ostial neck where it joins the atrial chamber. In this way, blood flow into the atrial appendage is cut off, eliminating the risk of thrombus formation therein. This is typically done through open-heart surgery, which limits the availability of the procedure to those who are at a particularly high risk, or who are otherwise undergoing an open-heart procedure. In addition, open-heart surgery requires general anesthesia and has a number of well-known risks, making it less desirable. Other methods have also been investigated. These methods include methods of stapling the base of the appendage and methods of filling the appendage with a space occupying or occluding member. Stapling is not preferred given the fragility of the appendage and its tendency to rupture, while occlusion devices may not effectively prevent all blood flow into the appendage. Additional devices and methods for closing the left atrial appendage or other suitable tissues would therefore be desirable. In particular, devices and methods for closing the left atrial appendage using minimally invasive, intravascular, or a combination of these techniques, would be desirable in order to avoid the need for opening the chest. Of course, additional devices for use in open surgical procedures are desirable as well, especially when those devices offer additional advantages over standard devices. BRIEF SUMMARY Described here are devices, systems, and methods for closing an atrial appendage such as the left atrial appendage. In some instances, the methods described here may comprise positioning a balloon at least partially within an interior of the atrial appendage and positioning a closure assembly of a closure device around an exterior of the atrial appendage. The methods may further comprise inflating the balloon at least partially within the interior of the atrial appendage, and partially closing the closure assembly to pull interior tissue of the atrial appendage into contact with the inflated balloon. In some of these variations, the methods may further comprise ablating the interior tissue of the atrial appendage with the inflated balloon, removing the balloon from the atrial appendage, and closing the atrial appendage with the closure assembly. In some variations, the method may further comprise positioning a distal end of a first guide element in the interior of the atrial appendage and positioning a distal end of a second guide element in a pericardial space externally of the atrial appendage. In some instances, the first guide element and the second guide element may each comprise a magnet, and the method may further comprise aligning the first guide element and the second guide element across tissue of the atrial appendage. In some variations, positioning the closure device may include advancing the closure device along the second guide element. The balloon may be part of the first guide element, or may be part of a balloon catheter. In instances where the balloon is part of the balloon catheter, positioning the balloon may comprise advancing the balloon catheter along the first guide element. In some variations the balloon may comprise an electrode positioned on an exterior surface of the balloon, and ablating the interior tissue of the atrial appendage may comprise ablating the interior tissue of the atrial appendage with the electr