# US 10,369,356 B2 · Transcoronary sinus pacing system, LV summit pacing, early mitral closure pacing, and methods therefor

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- Number: US 10,369,356 B2
- Document ID: US10369356B2
- Status: Granted
- Kind: B2
- Application number: 14/996,631
- Filed: 2016-01-15
- Published: 2016-07-07
- Granted: 2019-08-06
- Earliest claimed: 2006-10-03
- Assignees: Case Western Reserve University
- Applicants: Case Western Reserve University
- Inventors: Vincent A. Gauduani
- Web page: https://patentgrep.com/patent/US10369356B2

## CPC

- A61N 1/056: {Transvascular endocardial electrode systems}
- A61B 6/481: {involving the use of contrast agents}
- A61B 6/485: {involving fluorescence X-ray imaging}
- A61B 8/5292: {using additional data, e.g. patient information, image labeling, acquisition parameters}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61M 25/0082: {Catheter tip comprising a tool}
- A61N 1/0587: {Epicardial electrode systems; Endocardial electrodes piercing the pericardium}
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61B 2090/378: {using ultrasound}
- A61M 25/0021: {characterised by the form of the tubing (A61M25/0054 takes precedence)}
- A61M 2025/0037: {characterized by lumina being arranged side-by-side}
- A61N 1/36843: {Bi-ventricular stimulation}
- 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)
- 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

A transcoronary sinus pacing system comprising a sheath having a lumen, a pacing catheter having a pacing needle, wherein the catheter can be advanced within the lumen and placed in the LV summit, and a right ventricular pacing device. A LV summit pacing device. An early mitral valve closure pacing device configured to operate with a right ventricular apex pacing device. A method for implanting a pacing device at a target coronary sinus tissue location, wherein the target can be the posterior LV summit. A method for achieving early closure of a mitral valve. A method for using visualization devices such as fluoroscopy or ultrasound and/or catheter features such as a radiopaque marker to locate a target location for LV pacing and to avoid piercing an artery or the pericardium when anchoring the LV pacing electrode.

## Claims

### Claim 1

A pacing system, comprising:
a. a guiding catheter comprising a first guidewire lumen and a second pacing catheter lumen separate from and parallel to the first guidewire lumen, wherein the first guidewire lumen is longer than the second pacing catheter lumen and configured to allow a guidewire to pass therethrough, wherein a distal end of the first guidewire lumen has a first guidewire lumen exit port that is configured to lodge within a coronary sinus of a heart distal to cardiac tissue;
b. a pacing catheter configured to pass through the second pacing catheter lumen, and having a pacing electrode wire, a pacing needle at a distal end of the pacing electrode wire with a tip capable of piercing the coronary sinus and a pacing needle anchor proximal to the pacing needle electrode configured to lodge in the cardiac tissue without breaching the cardiac tissue and shaped as a pigtail knot formed of the pacing electrode wire to anchor the pacing needle electrode in the coronary sinus, wherein the pacing needle extends at least 1 cm beyond the pacing needle anchor; and
c. a pacing device, wherein the pacing device engages the pacing electrode wire.

### Claim 2 (depends on 1)

The system of claim 1, wherein the guiding catheter is steerable by the guidewire.

### Claim 3 (depends on 1)

The system of claim 1, wherein the guiding catheter further provides a radiopaque marker.

### Claim 4 (depends on 1)

The system of claim 1, wherein the guiding catheter has a teardrop cross-section.

### Claim 5 (depends on 1)

The system of claim 1, wherein the pacing catheter optimizes early closure of the mitral valve when anatomically positioned within a heart.

### Claim 6 (depends on 1)

The system of claim 1, wherein the pacing catheter reduces a time required to activate the left ventricle when anatomically positioned within a heart.

### Claim 7 (depends on 1)

The system of claim 1, wherein placement of the pacing catheter is irrespective or an anatomical position of the veins of a coronary sinus.

### Claim 8 (depends on 1)

The system of claim 1, wherein the guiding catheter is removable.

### Claim 9 (depends on 1)

The system of claim 1, wherein the first guidewire lumen exit port is distal to a second lumen exit port.

### Claim 10 (depends on 1)

The system of claim 1, wherein the anchor of the top of the pacing catheter comprises one or more of a pigtail or an enlarged end.

### Claim 11

An early mitral valve closure pacing system, comprising:
a. a guiding catheter comprising a first guidewire lumen and a second pacing catheter lumen separate from and parallel to the first guidewire lumen, wherein the first guidewire lumen is longer than the second pacing catheter lumen and configured to allow a guidewire to pass therethrough, wherein a distal end of the first guidewire lumen has a first guidewire lumen exit port that is configured to lodge within a coronary sinus of a heart distal to cardiac tissue;
b. a pacing catheter configured to pass through the second pacing catheter lumen, and having a pacing electrode wire, a pacing needle at a distal end of the pacing electrode wire with a tip capable of piercing the coronary sinus and a pacing needle anchor proximal to the pacing needle electrode and shaped as a pigtail knot formed of the pacing electrode wire configured to lodge in the cardiac tissue without breaching the cardiac tissue to anchor the pacing needle electrode in the coronary sinus, wherein the pacing needle electrode extends at least 1 cm beyond the pacing needle anchor, the pacing catheter being configured to activate early mitral valve closure; and
c. a pacing device configured to engage the pacing electrode wire, wherein the pacing device operates in conjunction with a right ventricular apex pacing device.

### Claim 12 (depends on 11)

The system of claim 11, wherein the guiding catheter is steerable by a guidewire.

### Claim 13 (depends on 11)

The system of claim 11, wherein the guiding catheter further provides a radiopaque marker.

### Claim 14 (depends on 11)

The system of claim 11, wherein the guiding catheter has a teardrop cross-section.

### Claim 15 (depends on 11)

The system of claim 11, wherein the pacing catheter optimizes early closure of the mitral valve when anatomically positioned within a heart.

### Claim 16 (depends on 11)

The system of claim 11, wherein the pacing catheter reduces the time required to activate the left ventricle when anatomically positioned within a heart.

### Claim 17 (depends on 11)

The system of claim 11, wherein placement of the pacing catheter is irrespective or an anatomical position of the veins of a coronary sinus.

### Claim 18 (depends on 11)

The system of claim 11, wherein the guiding catheter is removable.

### Claim 19 (depends on 11)

The system of claim 11, wherein the first guidewire lumen exit port is distal to a second lumen exit port.

### Claim 20 (depends on 11)

The system of claim 11, wherein the anchor of the top of the pacing catheter comprises one or more of a pigtail or an enlarged end.