# US 10,945,634 B2 · Modular electrophysiology mapping system and method

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- Number: US 10,945,634 B2
- Document ID: US10945634B2
- Status: Granted
- Kind: B2
- Application number: 15/851,415
- Filed: 2017-12-21
- Published: 2018-05-17
- Granted: 2021-03-16
- Earliest claimed: 2016-09-22
- Applicants: Walter Kusumoto
- Inventors: Walter Kusumoto
- Web page: https://patentgrep.com/patent/US10945634B2

## CPC

- A61B 5/065: {Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe}
- A61B 5/062: {using magnetic field}
- A61B 5/063: {using impedance measurements}
- A61B 5/282: Holders for multiple electrodes (for introduction into the body A61B5/287)
- A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
- A61B 5/6848: {Needles}
- A61B 5/6851: {Guide wires}
- A61B 5/6852: {Catheters}
- A61B 5/7425: {Displaying combinations of multiple images regardless of image source, e.g. displaying a reference anatomical image with a live image}
- A61B 5/7445: {Display arrangements, e.g. multiple display units}
- A61B 17/3403: {Needle locating or guiding means}
- A61B 5/743: {Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots}
- A61B 2017/00053: {Mapping}
- A61B 2017/00243: {cardiac}
- A61B 2017/22001: {Angioplasty, e.g. PCTA}
- A61B 2017/22051: {with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence)}
- A61B 2017/3413: {guided by ultrasound}
- A61B 2034/2051: {Electromagnetic tracking systems}
- A61B 2090/3954: {magnetic, e.g. NMR or MRI}
- A61B 2562/0223: Magnetic field sensors
- A61B 2562/0257: Proximity sensors
- A61M 25/104: {used for angioplasty}
- 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

An electrophysiology mapping system is provided with modules which can be attached thereto, each module including an item of subcutaneous interventional equipment and information about the item of subcutaneous interventional equipment, including shape information and size information. At least one sensor is placed upon the item of subcutaneous interventional equipment at a known location thereon. This sensor allows for position, and also preferably orientation, of the item within an image presented on a display of the electrophysiology mapping system. The at least one sensor can be at least one electrode or two or more electrodes, with different known positions for the electrode, or electrodes. The at least one sensor can be one or more magnetic field sensors interacting with a magnetic field associated with the electrophysiology mapping system. Transthoracic ultrasound fitted with sensors thereon can also be utilized as a further module attachable to the electrophysiology mapping system.

## Claims

### Claim 1

A system for visualizing subcutaneous interventional equipment, comprising combination:
at least one sensor located upon an item of subcutaneous interventional equipment;
an electrophysiology mapping system including electrodes and a display, said display visualizing subcutaneous patient anatomical structures;
said at least one sensor coupled to said electrophysiology mapping system to communicate subcutaneous interventional equipment location information and allow said item of subcutaneous interventional equipment to have its position be visualized on said display accurately relative to adjacent patient anatomical structures; and
wherein said item of subcutaneous interventional equipment includes a repository of item specific information therein which is removably coupled both to the electrophysiology mapping system along with the item of subcutaneous interventional equipment, the information including shape of the item of interventional equipment, size of the item of subcutaneous interventional equipment and location of said at least one sensor upon said item of subcutaneous interventional equipment.

### Claim 2 (depends on 1)

The system of claim 1 wherein said at least one sensor on said item of subcutaneous interventional equipment includes a wire extending therefrom and coupled, at least indirectly to the electrophysiology mapping system.

### Claim 3 (depends on 1)

The system of claim 1 wherein said at least one sensor is located at a tip of said item of subcutaneous interventional equipment.

### Claim 4 (depends on 1)

The system of claim 1 wherein said at least one sensor is located a known distance from said tip of said item of subcutaneous interventional equipment.

### Claim 5 (depends on 1)

The system of claim 1 wherein said at least one sensor includes a unipolar electrode, and wherein a separate reference electrode is also associated with said item of subcutaneous interventional equipment.

### Claim 6 (depends on 1)

The system of claim 1 wherein said at least one sensor includes a plurality of sensors on said item of subcutaneous interventional equipment, said plurality of sensors including a plurality of electrodes located at known positions upon said item of subcutaneous interventional equipment.

### Claim 7 (depends on 1)

The system of claim 1 wherein said at least one sensor includes a plurality of sensors on said item of subcutaneous interventional equipment, said plurality of sensors including a plurality of magnetic field sensors located at known positions upon said item of subcutaneous interventional equipment.

### Claim 8 (depends on 1)

The system of claim 1 wherein said item of subcutaneous interventional equipment includes a percutaneous needle extending to a tip and with said at least one sensor located a known distance away from said tip.

### Claim 9 (depends on 1)

The system of claim 1 wherein said item of subcutaneous interventional equipment includes a guide wire including said at least one sensor at a known position upon said guide wire for accurate placement of said guide wire within an image visualized upon said display of said electrophysiology mapping system.

### Claim 10 (depends on 1)

The system of claim 1 wherein said item of subcutaneous interventional equipment includes a vascular catheter with said at least one sensor located at a known position upon said vascular catheter for accurate placement of said vascular catheter within an image visualized upon said display of said electrophysiology mapping system.

### Claim 11 (depends on 1)

The system of claim 1 wherein said item of subcutaneous interventional equipment includes an angioplasty balloon with said at least one sensor located a known position upon said angioplasty balloon for accurate placement of said angioplasty balloon within an image visualized upon said display of said electrophysiology mapping system.

### Claim 12

A method for visualizing an item of subcutaneous interventional equipment, including steps of:
removably connecting at least one sensor located upon the item of subcutaneous interventional equipment to an electrophysiology mapping system, the electrophysiology mapping system including electrodes and a display for visualization of patient anatomical structures in a subcutaneous space; and
said connecting step including communicating to the electrophysiology mapping system from a repository of item specific information, details of the item of subcutaneous interventional equipment including shape of the item of subcutaneous interventional equipment and location of said at least one sensor upon said subcutaneous interventional equipment, for accurate placement of said subcutaneous interventional equipment upon an image visualized on said display of said electrophysiology mapping system.

### Claim 13 (depends on 12)

The method of claim 12 wherein said connecting step includes connecting a plurality of sensors to said item of subcutaneous interventional equipment; and
wherein said connecting step includes communicating information from each of said sensors to said electrophysiology mapping system for accurate orientation of the item of subcutaneous interventional equipment within an image presented on the display of the electrophysiology mapping system.

### Claim 14

A system for visualizing subcutaneous interventional equipment, comprising combination:
at least one sensor located upon an item of subcutaneous interventional equipment;
an electrophysiology mapping system including electrodes and a display, said display visualizing subcutaneous patient anatomical structures;
said at least one sensor coupled to said electrophysiology mapping system to communicate subcutaneous interventional equipment location information and allow said item of subcutaneous interventional equipment to have its position be visualized on said display accurately relative to adjacent patient anatomical structures; and
wherein said item of subcutaneous interventional equipment includes a repository of items specific information therein which is removably coupled to the electrophysiology mapping system along with the item of subcutaneous interventional equipment, the information including at least one detail taken from a group of details including a shape of the item of interventional equipment, a size of the item of interventional equipment, and a location of said at least one sensor upon said item of subcutaneous interventional equipment.