# US 2019/0172372 A1 · Realistic electro-anatomical model of the mammalian his/purkinje system

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- Number: US 2019/0172372 A1
- Document ID: US20190172372A1
- Status: Published application
- Kind: A1
- Application number: 16/208,348
- Filed: 2018-12-03
- Published: 2019-06-06
- Earliest claimed: 2017-12-04
- Assignees: St. Jude Medical, Cardiology Division, Inc.
- Inventors: Scott A. Kramer; Paul A. Belk; Juan Carlos Tantalean, II; Gavin P. Seeker; Patrick P. Senarith; Erich W. Stoermer; David J. Broman
- Web page: https://patentgrep.com/patent/US20190172372A1

## CPC

- G09B 23/30: Anatomical models {(G09B23/281 - G09B23/288 take precedence)}
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61N 1/365: controlled by a physiological parameter, e.g. heart potential {(evoked response A61N1/371)}
- A61B 2017/00053: {Mapping}
- A61B 2017/00707: {Dummies, phantoms; Devices simulating patient or parts of patient}
- A61B 2018/00351: {Heart}
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- A61N 1/056: {Transvascular endocardial electrode systems}
- G09B: EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS (devices for psychotechnics or for testing reaction times A61B5/16; games, sports, amusements A63; projectors, projector screens G03B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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

An electro-anatomical model of the mammalian His/Purkinje system includes a shell simulating the anatomy of at least a portion of a mammalian heart. The shell has a hollow interior and a first port providing an aperture to the interior of the shell. A plug is inserted in the first port so that a surface of the plug is exposed to the interior of the shell. An electrical circuit provides signals to electrodes in the plug which simulate the electrical signals generated by the bundle of His/Purkinje system in vivo. A second port provides access to the interior of the shell for an introducer catheter to locate the simulated bundle of His and to insert a pacing lead therein. The model is useful for developing tools for His pacing and for training users in techniques for implanting His pacing leads.

## Claims

### Claim 1

An electro-anatomical model of the mammalian His/Purkinje system, the model comprising:
a base;
a shell mounted to the base and simulating the anatomy of at least a portion of a mammalian heart, the shell having a hollow interior;
a first port providing an aperture to the interior of the shell;
a plug inserted in the first port, the plug having a surface exposed to the interior of the shell; and
a circuit providing electrical signals to the plug to simulate electrical signals generated by the bundle of His/Purkinje system in vivo.

### Claim 2 (depends on 1)

The electro-anatomical model as claimed in claim 1, wherein the portion of the mammalian heart includes the right atrium and the right ventricle of the heart.

### Claim 3 (depends on 2)

The electro-anatomical model as claimed in claim 2, wherein the portion of the mammalian heart further includes a portion of the superior vena cava.

### Claim 4 (depends on 1)

The electro-anatomical model as claimed in claim 1, wherein the shell is coated with a waterproofing composition.

### Claim 5 (depends on 4)

The electro-anatomical model as claimed in claim 4, wherein the waterproofing composition is coated on an exterior surface of the shell and on an interior surface of the shell.

### Claim 6 (depends on 1)

The electro-anatomical model as claimed in claim 1, wherein the shell includes a second port providing access for a tool to enter the interior of the shell.

### Claim 7 (depends on 6)

The electro-anatomical model as claimed in claim 6, wherein the second port includes a hemostasis valve.

### Claim 8 (depends on 1)

The electro-anatomical model as claimed in claim 1, wherein the exposed surface of the plug includes a material insert simulating tissue of the mammalian heart.

### Claim 9 (depends on 8)

The electro-anatomical model as claimed in claim 8, wherein the material insert in use is electrically conductive.

### Claim 10 (depends on 9)

The electro-anatomical model as claimed in claim 9, wherein the material insert has a structure including open porosity.

### Claim 11 (depends on 8)

The electro-anatomical model as claimed in claim 8, wherein the material insert comprises a polyurethane foam.

### Claim 12 (depends on 8)

The electro-anatomical model as claimed in claim 8, wherein the material insert comprises a conductive gel.

### Claim 13 (depends on 1)

The electro-anatomical model as claimed in claim 1, wherein the plug includes a first electrode connected to the circuit and a second electrode connected to ground, the first electrode being separated from the second electrode.

### Claim 14 (depends on 13)

The electro-anatomical model as claimed in claim 13, wherein the plug includes a physical barrier disposed between the first electrode and the second electrode.

### Claim 15 (depends on 14)

The electro-anatomical model as claimed in claim 14, wherein the exposed surface of the plug includes a material insert simulating tissue of the mammalian heart, the material insert providing a conductive path between the first electrode and the second electrode.

### Claim 16 (depends on 13)

The electro-anatomical model as claimed in claim 13, wherein the interior of the shell includes a conductive fluid, the conductive fluid conducting electrical signals from the first electrode to the second electrode.

### Claim 17 (depends on 1)

The electro-anatomical model as claimed in claim 1, further comprising a first video camera for capturing images at the exposed surface of the plug.

### Claim 18 (depends on 17)

The electro-anatomical model as claimed in claim 17, wherein the shell is mounted to the base by a plurality of stanchions, the first video camera being mounted in one of the stanchions in alignment with the exposed surface of the plug.

### Claim 19 (depends on 17)

The electro-anatomical model as claimed in claim 17, further comprising a second video camera mounted in the base and adapted to capture images in the vicinity of the exposed surface of the plug.

### Claim 20

A method for simulating the delivery of a pacing lead to the His bundle of a patient's heart, the method comprising:
providing an electro-anatomical model simulating the anatomy of at least a portion of a mammalian heart, the model including a shell with a hollow interior, first and second ports providing apertures to the interior of the shell, and a plug inserted in the first port, the plug having a face exposed to the interior of the shell;
transmitting electrical signals to the plug to simulate electrical signals generated by the bundle of His/Purkinje system in vivo;
providing an introducer catheter having a sheath with an axial lumen, a distal end, an electrode at the distal end, and a pacing lead disposed in the axial lumen;
inserting the introducer catheter through the second port to the interior of the shell until the distal end of the sheath confronts the exposed face of the plug;
moving the distal end of the sheath relative to the exposed face of the plug until the electrode at the distal end of the sheath receives at least a portion of the electrical signals transmitted to the plug; and
deploying the pacing lead from the axial lumen of the sheath and implanting the pacing lead in the exposed face of the plug.
