TECHNICAL FIELD

The present disclosure relates to medical devices and methods for simulating an anatomical structure of the body. More specifically, the disclosure relates to devices and methods for providing a simulation environment for use with an electroanatomical mapping system.

BACKGROUND

In electrophysiology, mapping is often used to identify the earliest site of atrial or ventricular activation or evidence of a slow zone of conduction. To test, or demonstrate, an electroanatomical mapping system, an animal generally is sacrificed. An anatomical model system may facilitate minimizing the harm to animals and enhancing convenience in testing and demonstrating mapping systems.

SUMMARY

Embodiments include an anatomical model assembly configured to provide a simulated environment for a mapping system. In embodiments, the anatomical model assembly utilizes electrodes that generate the simulated physiological electrical signals. The electrodes may be designed to achieve relative capacitances that facilitate detection of the electrical signals by the mapping system.

In an Example 1, an electrode assembly for use in an anatomical model assembly, the electrode assembly comprising: an electrode configured to be at least partially disposed within an aperture defined in an anatomical model shell, the electrode comprising a capacitive material, the capacitive material comprising a mixture of carbon black and silver epoxy; and a header coupled to the electrode.

In an Example 2, the electrode assembly of Example 1, the mixture comprising approximately 50% carbon black and approximately 50% silver epoxy.

In an Example 3, the electrode assembly of either of Examples 1 or 2, the header configured to receive an end of a wire, wherein the end of the wire is coupled to the electrode.

In an Example 4, the electrode assembly of any of Examples 1-3, wherein the electrode has an approximately cylindrical shape.

In an Example 5, the electrode assembly of Example 4, wherein the electrode comprises a diameter of approximately two millimeters.

In an Example 6, an anatomical model simulator system, comprising: an anatomical model assembly, comprising: an anatomical model shell having a plurality of apertures defined therein; and a plurality of electrodes, wherein each electrode of the plurality of electrodes is disposed within one of the plurality of apertures, and wherein each electrode comprises at least one of carbon black and silver epoxy; and a model control system, comprising: a power supply configured to deliver electrical energy to the plurality of electrodes; and a controller configured to control the delivery of the electrical energy to the plurality of electrodes.

In an Example 7, the anatomical model simulator system of Example 6, the anatomical shell comprising an inside surface, wherein an end surface of each electrode of the plurality of electrodes is recessed with respect to the inside surface of the anatomical shell.

In an Example 8, the anatomical model stimulator system of either of Examples 6 or 7, wherein the anatomical shell is formed from a three-dimensionally printed polymer.

In an Example 9, the anatomical model stimulator system of any of Examples 6-8, the plurality of electrodes comprising a plurality of pairs of electrodes, each of the plurality of pairs of electrodes comprising a positive electrode and a negative electrode.

In an Example 10, the anatomical model stimulator system of Example 9, wherein each of the plurality of pairs of electrodes is configured to generate an electric field having a magnitude that can be sensed by a mapping probe.

In an Example 11, the anatomical model stimulator system of Example 10, wherein the electrode is configured to be driven with approximately 0.1 volts.

In an Example 12, the anatomical model stimulator system of any of Examples 6-11, the controller comprising: a switch circuit configured to selectively activate each of the plurality of electrodes; a memory comprising a program component, the program component comprising computer-executable instructions; and a processor configured to access the program component via the memory and to executed the computer-executable instructions, wherein the computer-executable instructions are configured to cause the processor to control the power supply.

In an Example 13, the anatomical model stimulator system of Example 12, wherein the controller is configured to cause the power supply to deliver the electrical energy according to an arrhythmia pattern to cause the plurality of electrodes to simulate a propagating cardiac electrical signal corresponding to an arrhythmia.

In an Example 14, the anatomical model stimulator system of Example 12, wherein the controller is configured to prevent electrical energy from being delivered to one or more pairs of electrodes to simulate scar tissue.

In an Example 15, a method of producing an anatomical model simulator system, the method comprising: forming a first anatomical model shell piece, the first anatomical model shell piece comprising a first plurality of apertures defined therein; forming a second anatomical model shell piece, the second anatomical model shell piece comprising a second plurality of apertures defined therein; creating a mixture of carbon black and silver epoxy; positioning an end of a wire within an aperture of the first plurality of apertures; securing the end of the wire in position using an epoxy; filling the aperture with the mixture of carbon black and silver epoxy; and coupling the first and second anatomical model shell pieces to form an anatomical model shell.

In an Example 16, an electrode assembly for use in an anatomical model assembly, the electrode assembly comprising: an electrode configured to be at least partially disposed within an aperture defined in an anatomical model shell, the electrode comprising a capacitive material, the capacitive material comprising a mixture of carbon black and silver epoxy; and a header coupled to the electrode.

In an Example 17, the electrode assembly of Example 16, the mixture comprising approximately 50% carbon black and approximately 50% silver epoxy.

In an Example 18, the electrode assembly of Example 16, the header configured to receive an end of a wire, wherein the end of the wire is coupled to the electrode.

In an Example 19, the electrode assembly of Example 16, wherein the electrode has an approximately cylindrical shape.

In an Example 20, the electrode assembly of Example 19, wherein the electrode comprises a diameter of approximately two millimeters.

In an Example 21, an anatomical model simulator system, comprising: an anatomical model assembly, comprising: an anatomical model shell having a plurality of apertures defined therein; and a plurality of electrodes, wherein each electrode of the plurality of electrodes is disposed within one of the plurality of apertures, and wherein each electrode comprises at least one of carbon black and silver epoxy; and a model control system, comprising: a power supply configured to deliver electrical energy to the plurality of electrodes; and a controller configured to control the delivery of the electrical energy to the plurality of electrodes.

In an Example 22, the anatomical model simulator system of Example 21, the anatomical shell comprising an inside surface, wherein an end surface of each electrode of the plurality of electrodes is recessed with respect to the inside surface of the anatomical shell.

In an Example 23, the anatomical model stimulator system of Example 21, wherein the anatomical shell is formed from a three-dimensionally printed polymer.

In an Example 24, the anatomical model stimulator system of Example 21, the plurality of electrodes comprising a plurality of pairs of electrodes, each of the plurality of pairs of electrodes comprising a positive electrode and a negative electrode.

In an Example 25, the anatomical model stimulator system of Example 24, wherein each of the plurality of pairs of electrodes is configured to generate an electric field having a magnitude that can be sensed by a mapping probe.

In an Example 26, the anatomical model stimulator system of Example 25, wherein the electrode is configured to be driven with approximately 0.1 volts.

In an Example 27, the anatomical model stimulator system of Example 21, the controller comprising: a switch circuit configured to selectively activate each of the plurality of electrodes; a memory comprising a program component, the program component comprising computer-executable instructions; and a processor configured to access the program component via the memory and to executed the computer-executable instructions, wherein the computer-executable instructions are configured to cause the processor to control the power supply.

In an Example 28, the anatomical model stimulator system of Example 27, wherein the controller is configured to cause the power supply to deliver the electrical energy according to an arrhythmia pattern to cause the plurality of electrodes to simulate a propagating cardiac electrical signal corresponding to an arrhythmia.

In an Example 29, the anatomical model stimulator system of Example 28, wherein the controller is configured to prevent electrical energy from being delivered to one or more pairs of electrodes to simulate scar tissue.

In an Example 30, the anatomical model stimulator system of Example 21, each of the plurality of electrodes comprising a mixture comprising approximately 50% carbon black and approximately 50% silver epoxy.

In an Example 31, the anatomical model stimulator system of Example 30, each of the plurality of electrodes having an approximately cylindrical shape.

In an Example 32, the anatomical model stimulator system of Example 30, wherein each of the plurality of electrodes comprises a diameter of approximately two millimeters.

In an Example 33, a method of producing an anatomical model simulator system, the method comprising: forming a first anatomical model shell piece, the first anatomical model shell piece comprising a first plurality of apertures defined therein; forming a second anatomical model shell piece, the second anatomical model shell piece comprising a second plurality of apertures defined therein; creating a mixture of carbon black and silver epoxy; positioning an end of a wire within an aperture of the first plurality of apertures securing the end of the wire in position using an epoxy; filling the aperture with the mixture of carbon black and silver epoxy; and coupling the first and second anatomical model shell pieces to form an anatomical model shell.

In an Example 34, the method of Example 33, the mixture comprising approximately 50% carbon black and approximately 50% silver epoxy.

In an Example 35, the method of Example 32, wherein the steps of forming the first and second anatomical model shell pieces comprise three-dimensionally printing the first and second anatomical model shell pieces.

While multiple embodiments are disclosed, still other embodiments of the presently disclosed subject matter will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the disclosed subject matter. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

