# US 8,771,297 B2 · Devices, systems, and methods for closing the left atrial appendage

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- Number: US 8,771,297 B2
- Document ID: US8771297B2
- Status: Granted
- Kind: B2
- Application number: 12/055,213
- Filed: 2008-03-25
- Published: 2008-10-02
- Granted: 2014-07-08
- Earliest claimed: 2007-03-30
- Assignees: SentreHEART, Inc.
- Applicants: Gary H. Miller; Russell A. Seiber; Gregory W. Fung
- Inventors: Gary H. Miller; Russell A. Seiber; Gregory W. Fung
- Web page: https://patentgrep.com/patent/US8771297B2

## CPC

- A61B 17/12013: {for use in minimally invasive surgery, e.g. endoscopic surgery}
- A61B 17/0467: {Instruments for cutting sutures (surgical cutting instruments A61B17/32)}
- A61B 17/0469: {Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery}
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61B 17/12009: {Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot}
- A61B 2017/00243: {cardiac}
- A61B 2017/00575: {for closure at remote site, e.g. closing atrial septum defects}
- A61B 2017/00623: {Introducing or retrieving devices therefor}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/00876: {magnetic}
- A61B 2017/0475: {using sutures having a slip knot}
- A61B 2017/0477: {with pre-tied sutures}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

Described here are devices, systems and methods for closing the left atrial appendage. Some of the methods described here utilize one or more guide members having alignment members to aid in positioning of a closure device. In general, these methods include advancing a first guide having a first alignment member into the left atrial appendage, advancing a second guide, having a second alignment member, into the pericardial space, aligning the first and second alignment members, advancing a left atrial appendage closure device into the pericardial space and adjacent to the left atrial appendage, and closing the left atrial appendage with the closure device. In these variations, the closure device typically has an elongate body having a proximal end and a distal end, and a closure element at least partially housed within the elongate body. The closure element comprises a loop defining a continuous aperture.

## Claims

### Claim 1

A device for closing the left atrial appendage comprising:
an elongate body having a proximal end and a distal end;
a closure element comprising a loop defining a continuous aperture therethrough, the closure element at least partially housed within the elongate body and comprising a first end fixed relative to the elongate body and a second end moveable relative to the elongate body to change the size of the aperture;
a suture loop, the suture loop at least partially housed within the elongate body; and
a retention member, wherein the retention member is configured to releasably couple the closure element and the suture loop, wherein the retention member comprises first and second coextensive lumens, wherein the closure element is housed within the first lumen and the suture loop is housed within the second lumen.

### Claim 2 (depends on 1)

The device of claim 1, wherein the closure element is made from a shape-memory material.

### Claim 3 (depends on 2)

The device of claim 2, wherein the closure element is made from a nickel titanium alloy.

### Claim 4 (depends on 1)

The device of claim 1, wherein the suture loop is bioabsorbable.

### Claim 5 (depends on 1)

The device of claim 1, wherein the suture loop is non-bioabsorbable.

### Claim 6 (depends on 1)

The device of claim 1, wherein the second lumen has a weakened region configured to release the suture with the application of a force.

### Claim 7 (depends on 1)

The device of claim 1, wherein the second lumen has a perforated region configured to release the suture with the application of a force.

### Claim 8 (depends on 1)

The device of claim 1, wherein the second lumen has a slit extending along at least a portion of the retention member.

### Claim 9 (depends on 1)

The device of claim 1, wherein the elongate body has one or more curves along its length.

### Claim 10 (depends on 1)

The device of claim 1, wherein the elongate body is steerable.

### Claim 11 (depends on 1)

The device of claim 1, wherein the elongate body is a catheter.

### Claim 12 (depends on 1)

The device of claim 1, wherein the closure element, suture loop, or both comprise a radiopaque or echogenic material.

### Claim 13 (depends on 1)

The device of claim 1, wherein the closure element and the suture loop are separately actuatable.

### Claim 14 (depends on 1)

The device of claim 1, further comprising a cutting element.

### Claim 15

A system for closing a left atrial appendage comprising:
a first guide having a size and length adapted for accessing the left atrial appendage through the vasculature, wherein the first guide comprises a first alignment member;
a second guide having a size and length adapted for accessing the pericardial space from a subthoracic region, wherein the second guide comprises a second alignment member; and
a closure device comprising an elongate body having a proximal end and a distal end, a closure element housed at least partially therein, wherein the closure element comprises a loop defining a continuous aperture therethrough, a first end fixed relative to the elongate body and a second end moveable relative to the elongate body to change the size of the aperture, a suture loop at least partially housed in the elongate body, and a retention member configured to releasably couple the suture loop and the closure element, wherein the retention member comprises first and second coextensive lumens, wherein the closure element is housed within the first lumen and the suture loop is housed within the second lumen.

### Claim 16 (depends on 15)

The system of claim 15, further comprising an expandable member.

### Claim 17 (depends on 16)

The system of claim 16, wherein the expandable member has one or more apertures therein.

### Claim 18 (depends on 16)

The system of claim 16, wherein the expandable member is couplable to the first guide.

### Claim 19 (depends on 16)

The system of claim 16, wherein the expandable member is a balloon.

### Claim 20 (depends on 15)

The system of claim 15, further comprising a device for severing a suture from the suture loop.

### Claim 21 (depends on 15)

The system of claim 15, wherein the closure device is couplable to the second guide.

### Claim 22 (depends on 15)

The system of claim 15, wherein the first and second alignment members are magnets.

### Claim 23 (depends on 22)

The system of claim 22, wherein the magnets are located at distal ends of the first and second guides.

### Claim 24 (depends on 15)

The system of claim 15, wherein the first and second alignment members comprise radiopaque or echogenic markers.

### Claim 25 (depends on 15)

The system of claim 15, wherein the first and second alignment members comprise interconnecting members.

### Claim 26 (depends on 15)

The system of claim 15, wherein one of the first or second alignment members comprises a vacuum member.

### Claim 27 (depends on 15)

The system of claim 15, further comprising instructions for using the first guide, second guide, closure device, or combination thereof.

### Claim 28 (depends on 15)

The system of claim 15, wherein the elongate body of the closure device has one or more curves along its length.

### Claim 29 (depends on 28)

The system of claim 28, further comprising a straightening tube, configured to temporarily straighten the one or more curves.

### Claim 30 (depends on 15)

The system of claim 15, wherein the closure element is made from a shape-memory material.

### Claim 31 (depends on 30)

The system of claim 30, wherein the closure element is made from a nickel titanium alloy.

### Claim 32 (depends on 15)

The system of claim 15, wherein the suture loop is bioabsorbable.

### Claim 33 (depends on 15)

The system of claim 15, wherein the suture loop is non-bioabsorbable.

### Claim 34 (depends on 15)

The system of claim 15, wherein the second lumen has a weakened region configured to release the suture with the application of a force.

### Claim 35 (depends on 15)

The system of claim 15, wherein the second lumen has a perforated region configured to release the suture with the application of a force.

### Claim 36 (depends on 15)

The system of claim 15, wherein the second lumen has a slit extending along at least a portion of the retention member.

### Claim 37 (depends on 15)

The system of claim 15, wherein the elongate body has one or more curves along its length.

### Claim 38 (depends on 15)

The system of claim 15, wherein the elongate body is steerable.

### Claim 39 (depends on 15)

The system of claim 15, wherein the elongate body is a catheter.

### Claim 40 (depends on 15)

The system of claim 15, wherein the closure element, suture loop, or both comprise a radiopaque or echogenic material.

### Claim 41 (depends on 15)

The system of claim 15, wherein the closure element and the suture loop are separately actuatable.
