# US 10,368,910 B2 · Apparatus and methods for placing leads using direct visualization

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,368,910 B2
- Document ID: US10368910B2
- Status: Granted
- Kind: B2
- Application number: 15/175,601
- Filed: 2016-06-07
- Published: 2016-10-06
- Granted: 2019-08-06
- Earliest claimed: 2002-05-30
- Assignees: Intuitive Surgical Operations, Inc.
- Applicants: Intuitive Surgical Operations, Inc.
- Inventors: Christian S. Eversull; Stephen A. Leeflang; Nicholas J. Mourlas
- Web page: https://patentgrep.com/patent/US10368910B2

## CPC

- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61B 1/00073: {with externally grooved shaft}
- A61B 1/00082: {Balloons}
- A61B 1/00154: {using guiding arrangements for insertion}
- A61B 1/0051: {with controlled bending of insertion part}
- A61B 1/0057: {Constructional details of force transmission elements, e.g. control wires}
- A61B 1/015: Control of fluid supply or evacuation
- A61B 1/018: for receiving instruments
- A61B 1/05: characterised by the image sensor, e.g. camera, being in the distal end portion
- A61B 1/051: {Details of CCD assembly}
- A61B 1/053: {being detachable}
- A61B 1/3137: {for examination of the interior of blood vessels}
- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61M 25/09: Guide wires
- A61N 1/056: {Transvascular endocardial electrode systems}
- A61N 1/057: {Anchoring means; Means for fixing the head inside the heart}
- A61N 1/0587: {Epicardial electrode systems; Endocardial electrodes piercing the pericardium}
- A61N 1/059: {Anchoring means}
- A61B 2017/00243: {cardiac}
- A61B 2017/00296: {mounted on an endoscope}
- A61B 2017/3488: {Fixation to inner organ or inner body tissue}
- A61B 2090/3614: {using optical fibre}
- A61M 2025/0177: {having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes}
- 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)}
- 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)

## Abstract

A system for delivering a lead comprises an imaging device comprising a proximal end and an expandable distal end having an inner balloon and an outer balloon. The outer balloon is concentric with the inner balloon. The expandable distal end includes a channel defined between the inner balloon and the outer balloon. The imaging device further comprises a lumen extending between the proximal and distal ends and an imaging assembly for imaging through the expandable distal end. The system further comprises an elongate rail comprising a proximal end and a distal end positionable through the lumen of the imaging device and the channel. The elongate rail comprises a fixation element on the distal end. The system also comprises a lead comprising a proximal end, a distal end introduced through the lumen of the imaging device guided by the elongated rail, and one or more electrodes on the distal end.

## Claims

### Claim 1

A system for delivering a lead into a body cavity of a patient, comprising:
an imaging device comprising a proximal end and an expandable distal end having an inner balloon and an outer balloon, the outer balloon being concentric with the inner balloon, the expandable distal end including a channel defined between the inner balloon and the outer balloon, the imaging device further comprising at least one lumen extending between the proximal and distal ends and an imaging assembly for imaging through the expandable distal end while the distal end is in a fully expanded configuration and manipulated relative to a tissue wall;
an elongate rail comprising a proximal end and a distal end positionable through the at least one lumen of the imaging device and the channel, the elongate rail comprising a fixation element on the distal end for securing the distal end to a delivery location on the tissue wall; and
a lead comprising a proximal end, a distal end arranged for introduction through the at least one lumen of the imaging device guided by the elongated rail, and one or more electrodes on the distal end.

### Claim 2 (depends on 1)

The system of claim 1, wherein the expandable distal end includes a transparent membrane through which the imaging assembly captures images of the tissue wall.

### Claim 3 (depends on 1)

The system of claim 1, wherein the elongate rail comprises a guidewire.

### Claim 4 (depends on 1)

The system of claim 1, wherein the lead is configured to advance over the elongate rail.

### Claim 5 (depends on 1)

The system of claim 1, wherein the fixation element comprises at least one of a helical screw, an adhesive, a hook, a pincher, and a barb.

### Claim 6 (depends on 1)

The system of claim 1, wherein the imaging device is removable after the distal end of the elongate rail is secured to the delivery location.

### Claim 7 (depends on 1)

The system of claim 1, wherein the imaging device is removable before the lead is introduced through the at least one lumen.

### Claim 8 (depends on 7)

The system of claim 7, wherein the elongate rail comprises a tubular member sized to advance over the imaging device.

### Claim 9 (depends on 8)

The system of claim 8, wherein the lead is sized to advance through the tubular member to the delivery location.

### Claim 10 (depends on 1)

The system of claim 1, wherein the imaging device further includes a steering element coupled to the expandable distal end to steer the expandable distal end in at least one degree of freedom.

### Claim 11 (depends on 1)

The system of claim 1 wherein the imaging assembly includes an optical image element.

### Claim 12 (depends on 11)

The system of claim 11 wherein the optical image element includes an optical fiber bundle extending between the proximal and distal ends of the imaging device.

### Claim 13 (depends on 11)

The system of claim 11 wherein the optical image element includes a CMOS sensor disposed at the distal end of the imaging device.

### Claim 14 (depends on 11)

The system of claim 11 wherein the optical image element includes a CCD sensor disposed at the distal end of the imaging device.

### Claim 15 (depends on 11)

The system of claim 11 wherein the imaging device includes a light source.

### Claim 16 (depends on 1)

The system of claim 1 wherein the expandable distal end includes an inflatable member.

### Claim 17 (depends on 1)

The system of claim 1 wherein the expandable distal end includes a radially expandable frame.