# US 2023/0264017 A1 · Advanced implantable endovascular, low profile intracardiac left atrial restraining devices for low energy atrial cardioversion, pacing and sensing

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- Number: US 2023/0264017 A1
- Document ID: US20230264017A1
- Status: Published application
- Kind: A1
- Application number: 18/173,015
- Filed: 2023-02-22
- Published: 2023-08-24
- Earliest claimed: 2022-02-22
- Applicants: Randall K. Wolf
- Inventors: Randall K. Wolf; Paul Spence
- Web page: https://patentgrep.com/patent/US20230264017A1

## CPC

- A61N 1/057: {Anchoring means; Means for fixing the head inside the heart}
- A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)}
- A61B 17/12013: {for use in minimally invasive surgery, e.g. endoscopic surgery}
- A61B 17/12122: {within the heart (for closing a cardiac septal defect A61B17/0057)}
- A61N 1/056: {Transvascular endocardial electrode systems}
- A61B 17/12172: {having a pre-set deployed three-dimensional shape (methods of manufacturing A61B2017/00526)}
- A61B 17/12177: {comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated}
- A61B 2017/00243: {cardiac}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/00606: {Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/00876: {magnetic}
- A61N 2001/0585: {Coronary sinus electrodes}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Disclosed are various configurations of electrodes with accompanying extensions and wires configured to be attached at or near the left atrium of a heart to allow the device to be held snug against the endocardium and out of the blood flow for low energy defibrillation of the atria in response to atrial fibrillation or other atrial arrhythmias. The portion of the lead internal to the atrium (e.g., the left atrium) is restrained against the endocardium of the left atrium by way of a restraint mechanism. In one example, the electrode is configured to attach to the atrial septum, with wires containing memory-shaped metal to keep the wires against the heart wall. In yet another example, the electrode is configured to be part of a mitral valve device.

## Claims

### Claim 1

An implantable medical device, comprising:
a cardiac lead having a distal region and a proximal end, the proximal end of the cardiac lead adapted to be coupled to an electronics enclosure, the distal region of the cardiac lead having a structure configured to hold a portion of the distal region of the lead against a person's endocardium, the structure configured to attach to opposite sides of an atrial septum;
wherein the distal region of the lead also has an electrode that extends away from the structure and an elongated portion of the electrode is configured to maintain contact with the person's endocardium.

### Claim 2 (depends on 1)

The implantable medical device of claim 1, wherein the structure comprises a septal closure device.

### Claim 3 (depends on 1)

The implantable medical device of claim 1, wherein an elongated portion of the electrode extends along the endocardium of the left atrium away from the atrial septum.

### Claim 4 (depends on 3)

The implantable medical device of claim 3, further comprising a second electrode connected to the structure and configured to extend away from and to maintain contact with the person's endocardium.

### Claim 5 (depends on 4)

The implantable medical device of claim 4, wherein the elongated portion of the electrode extends from the structure within the left atrium of the patient's heart, and wherein the second electrode connected to the structure extends away from the structure within the right atrium of the patient's heart.

### Claim 6 (depends on 1)

The implantable medical device of claim 1, wherein the structure comprises a shape memory material.

### Claim 7 (depends on 1)

The implantable medical device of claim 1, wherein the structure includes protrusions configured to mate to the endocardium.

### Claim 8 (depends on 1)

The implantable medical device of claim 1, wherein the structure includes a U-shaped dip.

### Claim 9 (depends on 8)

The implantable medical device of claim 8, wherein the electrode is on the U-shaped dip.

### Claim 10 (depends on 1)

The implantable medical device of claim 1, wherein the distal region includes a wire extension coupled to the structure and configured to be restrained against the person's endocardium.

### Claim 11 (depends on 10)

The implantable medical device of claim 10, wherein the electrode is on the wire extension.

### Claim 12 (depends on 1)

The implantable medical device of claim 1, wherein the structure comprises a lattice.

### Claim 13 (depends on 12)

The implantable medical device of claim 12, wherein the lattice is configured to restrain the distal region of the cardiac lead to the person's endocardium.

### Claim 14 (depends on 12)

The implantable medical device of claim 12, wherein the electrode is on the lattice.

### Claim 15 (depends on 12)

The implantable medical device of claim 12, further including a U-shaped dip configured to attach to a septum of the person, and wherein the lattice comprises:
a first wire coupled to the U-shaped dip and configured to be restrained against the person's endocardium;
a second wire also coupled to the U-shaped dip and configured to be restrained against the person's endocardium; and
an interconnecting wire connected to the first and second wires to space apart the first and second wires while restrained against the person's endocardium.

### Claim 16 (depends on 1)

The implantable medical device of claim 1, wherein an elongated portion of the electrode includes a plurality of electrodes that extend along the endocardium of the left atrium away from the atrial septum.

### Claim 17 (depends on 16)

The implantable medical device of claim 16, further comprising a second plurality of electrodes connected to the structure and configured to extend away from and to maintain contact with the person's endocardium.

### Claim 18 (depends on 17)

The implantable medical device of claim 17, wherein the plurality of electrodes extend from the structure within the left atrium of the patient's heart, and wherein the second electrodes connected to the structure extend away from the structure within the right atrium of the patient's heart.

### Claim 19 (depends on 1)

The implantable medical device of claim 1, further including a mitral valve device, and the electrode is part of the mitral valve device.

### Claim 20 (depends on 19)

The implantable medical device of claim 19, wherein:
the shape memory structure includes a U-shaped dip configured to be attached to the person's septum; and
the electrode is coupled to the U-shaped dip by way of a shape memory wire that is configured to be restrained against the person's endocardium between the mitral valve device and the U-shaped dip.

### Claim at position 21

21-39. (canceled)