CN103489360B - physical heart simulator - Google Patents

Abstract

The present invention provides an apparatus comprising a mock-up cavity simulating a real body cavity of a human subject, wherein the walls defining the mock-up cavity comprise tissue equivalent material (TEM). An array of electrodes is embedded in the wall. The device also includes a programmable signal generator connected to the electrodes and configured to apply varying electrical potentials to the electrode array to simulate electrophysiological potentials occurring in the real body cavity on the surface of the wall .

Description

Physical Heart Simulator

technical field

The present invention relates generally to invasive medical procedures, and in particular to the simulation of invasive electrophysiological procedures.

Background technique

There is generally a learning curve associated with any medical procedure, and depending on the procedure, this learning curve can be relatively "steep" in some cases. Even where the learning curve is not steep, it often takes a significant amount of time to learn and perfect the procedure. This time can be shortened if the surgery can be simulated.

Contents of the invention

An embodiment of the present invention provides a device, the device includes:

a mock-up cavity simulating a real body cavity of a human subject, wherein the walls defining the mock-up cavity comprise tissue equivalent material (TEM);

an array of electrodes embedded in the wall; and

A programmable signal generator connected to the electrodes and configured to apply a varying electrical potential to the electrode array to simulate electrophysiological potentials occurring in the actual body cavity on the surface of the wall.

Typically, a mock-up cavity is included in a mock-up human heart, and the simulated electrophysiological potentials replicate sinus potentials that occur in a human heart.

Alternatively, the simulated electrophysiological potentials replicate the arrhythmic potentials that occur in the human heart.

In a disclosed embodiment, the apparatus includes a heartbeat generator configured to cause the mock-up human heart to beat.

In a further disclosed embodiment, the apparatus includes a system probe configured to be inserted into said mock-up human heart and measure a characteristic of human heart activity. The system probe may include a probe electrode configured to sense the electrophysiological potential simulated on the surface of the wall. The system probe may include a force sensor configured to sense a force exerted on the sensor by a surface of the mock-up human heart. The system probe may include a sensor configured to sense a temperature of a surface of the mock-up human heart.

In an alternative embodiment, a mock-up human heart is located within a mock-up human patient. The mock-up human patient may include surface electrodes configured to sense surface potentials responsive to the simulated electrophysiological potentials. Typically, the surface potential mimics an electrocardiogram (ECG) signal on the skin of a human patient. The alternative embodiment may include a breath generator configured to simulate breathing in the mock-up human patient.

According to an embodiment of the present invention, a method is also provided, the method comprising:

simulating an actual body cavity of a human subject with a mockup cavity, wherein walls defining the mockup cavity comprise tissue equivalent material (TEM);

embedding an array of electrodes into said wall;

connecting a programmable signal generator to the electrodes; and

A programmable signal generator is configured to apply varying electrical potentials to the electrode array to simulate electrophysiological potentials occurring in the real body cavity on the surface of the wall.

Through the detailed description of the following embodiments in conjunction with the accompanying drawings, the present invention will be more fully understood:

Description of drawings

1 is a schematic diagram of a simulation system shown according to an embodiment of the present invention;

2 is a schematic cross-sectional view of a mock-up heart and elements coupled to the mock-up heart according to an embodiment of the present invention;

3 is a flowchart of steps performed during a simulated invasive medical procedure according to an embodiment of the invention; and

4 is a flowchart of steps performed during a simulated invasive medical procedure according to an alternative embodiment of the present invention.

detailed description

review

Embodiments of the present invention provide apparatus and methods that allow an operator, typically a medical professional, to use a mock-up cavity to simulate invasive medical procedures performed on a body cavity of a human subject. A mock-up cavity has walls formed from a tissue equivalent material (TEM) and is typically part of a mock-up of a human heart or other internal organ in which a simulated procedure will be performed.

An array of electrodes is embedded in the walls of the cavity of the mockup, and a programmable signal generator is connected to the electrodes. The generator is configured to apply a varying electrical potential to the electrodes to simulate electrophysiological (EP) potentials occurring in the real body cavity on the surface of the wall.

In the case of a mock-up heart, the EP potentials can be configured to replicate the normal sinus conditions (sinus spatiotemporal patterns) of heart beating. Alternatively, the EP potentials may be configured to replicate potentials from one of a plurality of spatiotemporal patterns of arrhythmia. Typically, the data used by the generator to generate the different potentials is stored in the device's memory and is provided to the generator once the operator has selected a condition to be simulated, such as a normal sinus condition.

The mock-up cavity is typically installed in the mock-up patient, and the operator inserts the EP system probe, which includes elements such as sensing devices at its distal end, through the mock-up patient and into the mock-up cavity. electrodes and position sensors. When the sensing electrodes are in contact with the walls of the cavity, the sensing electrodes detect the electrical potential generated on the walls and provide electrical potential and position signals to the processing unit of the device. The processing unit may typically be included in a catheter tracking system, such as the CARTO system offered by Biosense Webster Inc. (Diamond Bar, CA). Typically, the operator moves the sensing electrode into contact with a number of different locations on the wall, recording the electrical potential at each location. The processing unit may use the recorded potentials to prepare a simulated electrophysiological map of the cavity.

In some embodiments, typically those in which a mockup patient includes a mockup heart, the heartbeat generator and/or the breath generator may be configured to beat the mockup heart and/or cause the mockup patient to breathe.

detailed description

Referring now to FIG. 1 , there is shown a schematic diagram of a simulation system 20 according to an embodiment of the present invention. System 20 allows a system operator 22, typically a medical professional such as a physician, to perform a simulation of an invasive medical procedure. In a real medical procedure, an operator inserts a catheter stylet into a lumen of a patient, usually an organ such as the heart, and guides the distal end of the stylet by manipulating a controller located at the stylet's proximal end.

In the simulation system 20, an electrophysiological (EP) system probe 24 is inserted into a mock-up patient 26, which takes the place of a real patient in an actual procedure. The EP system probe 24 is substantially similar in construction and operation to probes used in real surgery, referred to herein as surgical probes. However, unlike surgical probes, EP system probes 24 are not required to meet the same stringent safety standards as surgical probes, and are generally reusable. Thus, the EP system probe 24 typically includes at least some of the same functional elements as a surgical probe, such as functional distal tracking elements and functional potentiometric electrodes located at the distal end.

In alternative embodiments, the EP system probe 24 may be configured with other functional elements that may be present in a surgical probe, such as a functional force sensor 55 and a functional temperature sensor 58 . In a further alternative embodiment, system 20 may be configured to simulate the effects of elements present in a surgical probe. Such elements may include, but are not limited to, ablation electrodes, ie, electrodes configured to deliver radio frequency energy. The simulation required for these elements is typically implemented using corresponding software components described in more detail below.

It is assumed herein by way of example that the mockup patient 26 has a box shape. However, the mockup patient may have any convenient shape, including a more human-like shape. The system 20 is typically used to teach the use of surgical probes before the operator 22 has to perform the actual surgery. Alternatively or in addition, the system 20 may be used by an operator to review the results of real surgery, as well as for research and development purposes.

In the embodiments described below, it is assumed that the system probe 24 is used to simulate insertion of a surgical probe into one or more chambers of a real patient's heart. In a real surgery, the signal is sensed by a surgical probe. System 20 simulates the signals that would occur on real chamber walls due to the electrophysiological action of a real heart, and these simulated signals are sensed by the system probes. Alternatively, system 20 may be used mutatis mutandis to simulate other therapeutic and/or diagnostic procedures in the heart or in other body organs.

During real surgery, operator 22 typically uses more than one surgical probe, each of these different surgical probes having a different configuration, such as a unique shape or a different number or type of electrodes. The operator may also use more than one type of system probe 24 in the simulations described herein. For clarity, when necessary and when more than one system probe is used, the different system probes can be distinguished by adding a letter after the identifier 24, so that when simulating a procedure using two system probes, the operating The staff can use system probe 24A and system probe 24B.

In some embodiments, a procedure involving more than one surgical probe is simulated by using one system probe 24, ie, the physical system probe, and one or more simulated or virtual probes. Unlike the physical system probe, the mock probe has no physical components that are inserted into the mock-up patient 26 . Examples of using two physical system probes 24A, 24B, or one physical system probe 24 and one simulation probe are described below.

The operation of the system 20 is controlled by a system controller 28 which includes a processing unit 30 in communication with a memory 32 for storing software required for the system 20 to operate. Controller 28 is typically an industry standard personal computer including a general purpose computer processor. However, in some embodiments, the controller, and the modules included in the controller (hereinafter described) at least some of the features. Communication between the system controller 28 and the elements of the system 20, including signals between the controller and the elements, may be accomplished through physical cables such as conductive or fiber optic cables and/or by wireless means. For clarity, the communication-related physical elements of system 20 are not shown in FIG. 1 .

The software in memory 32 may be downloaded electronically to the controller, eg over a network. Alternatively or in addition, the software may be provided on non-transitory tangible media such as optical, magnetic or electronic storage media.

Controller 28 includes various modules of operating system 20 . Each module can be implemented by hardware, software stored in the memory 32, or a combination of hardware and software, as described above, the modules in the controller 28 are:

• A programmable signal generator 31 that provides signals to the array of electrodes 33 in the mock-up heart 48 . Signal generator 31 , electrodes 33 and mockup heart 48 , along with other elements associated with system 20 , are described in more detail below with reference to FIG. 2 .

• A heartbeat generator 37 that generates a signal or provides a physical output to a mechanical vibrator 56 in the mockup patient through a mechanical linkage such as a hydraulic or mechanical connection, thereby causing the mockup heart 48 to beat.

• A breath generator 39 that generates a signal or provides a physical output through a mechanical linkage to cause the mock-up lungs 41 in the mock-up patient to breathe.

• A force module 57 coupled to the force sensor 55 to determine the force value measured by the sensor.

• A temperature module 59, which is used by the processing unit 30 to estimate the temperature during the simulation. The estimated temperatures correspond to those temperatures that would be sensed by the temperature sensors in the surgical probe.

System 20 also includes an electrophysiological (EP) control system 29 for receiving signals from system probes 24 and mockup patient 26 and providing other functions that may be implemented in system 20 . The EP system 29 can be implemented and operated by the CARTO system offered by Biosense Webster Inc. (Diamond Bar, CA), which can be modified if necessary. Alternatively, the EP control system 29 may be operated by the system controller 28 . For simplicity, it is assumed in the description herein that EP system 29 is operated by system controller 28 .

The EP control system 29 includes a number of modules that may be implemented by hardware, software, or a combination of hardware and software. The modules in System 29 are:

• An intracardiac electrogram (ECG) signal receiver 43 that receives signals from one or more electrodes 45 located at the distal end 38 of the system probe 24 .

• A body surface ECG signal receiver 49 that receives signals from one or more "skin" electrodes 51 on the surface of the mockup patient 26 . As described in more detail below, the signal on electrode 51 is derived from an electrical current transmitted through mockup torso 54 of mockup patient 26 , which is generated in response to an electrical potential on electrode 33 . The mock-up torso 54 is constructed of TEM and implemented to have electrical properties similar to a real human torso.

• An ablation module 53 that allows the operator 22 to input simulation parameters related to the simulated ablation into the system 20 and to generate a simulated output of the simulated ablation. Analog input parameters that can be set by the operator include, for example, radio frequency power level and time of application of radio frequency power. Analog outputs that may be generated by the module include, for example, the temperature of tissue that has been subjected to simulated ablation. Other functions of the ablation module 53 are described below in conjunction with FIG. 4 .

• The remote tracking module 52C, described below in connection with other elements of the system 20, allows the operator 22 to track the position and orientation of the distal end 38.

System controller 28 operates a graphical user interface (GUI) 34 that presents system-generated results to operator 22 on display 44 . The GUI 34 also enables the operator to select from various options when setting up the simulation scene. Typically, the operator interacts with the controller 28 and GUI 34 using a pointing device 36 , such as a touchpad or mouse.

Within the mockup patient 26, the operator 22 is able to manipulate the distal end 38 of the system probe 24 by grasping and manipulating the proximal end 40 of the system probe. Typically, an elastic tube 42 supported by a material such as fiberglass or polystyrene pellets is placed within mock-up patient 26 to simulate a real patient's veins or arteries. Tube 42 serves as a support and guide for the system probe without unduly obstructing the forward or rearward movement of the probe. Typically, the operator uses the handle 44 to hold the system probe, just as he would normally hold a surgical probe during a real medical procedure. Operator manipulation often also includes other movements, such as lateral and rotational movements of the proximal end to correspondingly manipulate the distal end.

Manipulation of the proximal end includes insertion of a system probe into a mock-up heart 48 in the distal region of the mock-up patient via a hole 46 in the mock-up patient connected to tube 42 . (Manipulation also includes removal of the system probe via the same hole.)

To implement the simulation, system controller 28 uses tracking signals from object tracking system 52 to track the location of distal end 38 . Tracking is performed at least within the mock-up heart 48, and often also partially outside the heart. During a real surgery, the distal end of the surgical probe is tracked, for example, by a magnetic tracking system such as implemented in the CARTO system mentioned above. Although embodiments of the present invention may use such a tracking system mutatis mutandis, it is not necessary to track distal end 38 with systems typically used in invasive procedures. Those of ordinary skill in the art will be familiar with other systems for tracking the distal end 38, such as ultrasound systems, and all such systems and their associated tracking devices are assumed to be within the scope of the present invention.

By way of example herein, it is assumed that the position of distal end 38 is tracked relative to a set of orthogonal xyz axes defined by the edges of mockup patient 26 . Also by way of example, assume that tracking system 52 includes a coil 52A mounted in distal end 38, a magnetic transmitter 52B interacting with the coil, and a remote tracking module 52C that operates the transmitter and Signals are received from the coil to determine the position and orientation of the distal end.

2 is a schematic cross-sectional view of a mock-up heart 48 and components coupled to the mock-up heart, according to an embodiment of the present invention. Mock-up heart 48 generally comprises a full-scale flexible model of a normal heart constructed of cardiac tissue equivalent material (TEM) 80 . Thus, the model formed by TEM 80 includes, for example, a mockup right atrium 82, a mockup right ventricle 84, a mockup left atrium 86, and a mockup left ventricle 88, and these mockup cavities have corresponding surfaces 92, 94, 96, and 98. For clarity, only some portions of TEM 80 including mock-up right atrium, mock-up right ventricle, mock-up left atrium, mock-up left ventricle, and mock-up diaphragm with surface 99 are shaded in FIG. 97 sections of the wall. TEM 80 is supported by electrical insulator 81 as required.

Material 80 is selected to have substantially similar electrical conductivity and thermal properties to the endocardium, but the electrical functionality of material 80 is modified as described below. The modification is carried out such that the signal transmitted from the programmable signal generator 31 forms an electrical potential on the surface of the mock-up heart corresponding to the electrophysiological (EP) potential present on the corresponding surface of a real heart. For simplicity, the description herein refers to the surface on which the EP potential is formed as surface 100 , and includes, but is not limited to, surfaces 92 , 94 , 96 , 98 , and 99 . Those of ordinary skill in the art will adapt the description to surface 100 in addition to surfaces 92 , 94 , 96 , 98 , and 99 .

To simulate the electrophysiological potential of a real heart, sections of TEM 80 have an array of electrodes 33 embedded in the material. Typically, the electrodes are embedded such that they do not protrude from the surface 100, terminating below the surface. However, in some embodiments, the electrodes may terminate flush with the surface, and in some embodiments, the electrodes may protrude slightly from the surface. The electrodes 33 pass through and are held in place by an insulator 81 which insulates the electrodes from each other.

In some embodiments, one or more force sensors 83 and/or one or more temperature sensors 85 are embedded in TEM 80 . The controller 28 may use the sensors to provide force and temperature measurements of the sensor embedding area. Such measurements may be used by the controller to compare to force and temperature measurements provided by force sensor 55 and temperature sensor 58 located in distal end 38 .

The electrodes 33 receive signals from the programmable signal generator 31 via respective wires 102 connecting the generator to each electrode, corresponding to the potentials to be generated on the cavity surface of the mockup. For clarity, in FIG. 2 each electrode 33 is shown as a straight line with a solid circle at one end, which corresponds to the point at which a particular wire 102 and a particular electrode 33 are connected.

Typically, at least some of the mock-up cavities of mock-up heart 48 are at least partially filled with a conductive liquid, such as conventional saline solution. Conductive liquids are useful for simulating the EP potential on the surface 100 . To simulate the EP potential as accurately as possible, an initial calibration procedure can be performed whereby the signal generated by the generator 31 is varied and the resulting potential on the surface 100 is measured until the desired EP potential is achieved.

In some embodiments, heartbeat generator 37 is implemented to cause mock-up heart 48 to beat. By way of example, generator 37 reversibly delivers fluid 104 , liquid or gas, to elastic balloon 102 and the generator uses the fluid to inflate or deflate the balloon. Inflation and deflation of the balloon compresses the mock-up heart or allows it to expand. The balloon 102, along with the fluid 104, serves as the mechanical vibrator 56 of the mock-up heart. Alternatively, the generator may reversibly deliver fluid 104 to one or more chambers of mock-up heart 48, thereby causing the mock-up heart to beat. In this case, the cavity and fluid 104 comprise the mechanical vibrator. In some embodiments, fluid 104 includes the above-mentioned conductive liquids that facilitate modeling EP potentials. Alternatively, the generator 37 may use electromechanical, hydraulic, or other suitable actuation systems to beat the mock-up heart for generating repetitive beating motions, as will be apparent to those skilled in the art of.

In some embodiments, the breath generator 39 is implemented to activate the mock-up lungs 41 to breathe, thus causing the mock-up heart 48 to move in a circular breathing path. Mock-up lung 41 may be implemented as an elastic balloon substantially similar to balloon 102, and the balloon may be deflated and inflated using a fluid as described above. Alternatively, the generator 39 may be implemented to breathe mock-up lungs using the systems mentioned above for generating repetitive motion.

During the simulation, and once the operator 22 has inserted the distal end 38 into the mock-up heart 48 , the electrodes 45 sense the electrical potential on the surface 100 and transmit the sensed electrical potential to the catheter signal receiver 43 . The receiver 43 processes the surface potential together with the PU 30 and can present the processing result on the display 44 . Results are usually presented in pictures and/or in text format. For example, a graph of sensed potential versus time may be presented on display 44 .

Also during the simulation, electrodes 51 (only one electrode 51 is shown in FIG. 2 for clarity) sensed a "skin" potential developed in response to the EP potential developed on surface 100 . The skin potential is transmitted to the ECG receiver 49 and may typically be presented on the display 44 after processing in a format similar to the potential from the surface 100 .

FIG. 3 is a flowchart 150 of steps performed during a simulated invasive medical procedure in accordance with an embodiment of the present invention. It is assumed that the simulated procedure is used to prepare an electrophysiological map of the heart. In a preprogramming step 152 , sets of data corresponding to the electrodes to be applied to the electrodes 33 are stored in the memory 32 . Typically, said sets of data are generated during the above-mentioned calibration process.

Typically, each set of stored data corresponds to an electrophysiological potential of a known cardiac condition. For each condition, a set of correspondences of potential versus time is stored for each electrode 33, typically for a time period of at least one complete heartbeat. Thus, the "sinus set" of data corresponds to the electrical potentials and application times of the electrical potentials applied to electrodes 33 during sinus rhythm of the heart. The "Atrioventricular Nodal Reentry Tachycardia (AVNRT) group" of data corresponds to the potentials applied to electrodes 33 during an AVNRT arrhythmia of the heart. Other cardiac arrhythmias for which potential versus time relationships can be stored include, but are not limited to, atrial tachycardia, atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular flutter, ventricular fibrillation, atrioventricular reentrant tachycardia (AVRT), and Wolf-Parkinson-White (WPW) syndrome.

Additionally, one or more sets of data corresponding to potentials that have been previously recorded for a particular patient may be stored in memory 32 .

In a simulation build step 154 , operator 22 selects a cardiac condition to be simulated by system 20 . Additionally, the operator typically selects the heart rate and respiration rate that will be applied during the simulation. The selection is typically performed by a display 44 showing the operator possible heart conditions corresponding to the sets of data stored in step 152 . The operator can use the pointing device 36 to select the conditions to be simulated, as well as the heartbeat and breathing rates.

The processor 30 provides the data from the selected conditions to the programmable signal generator 31 which uses the data along with the selected heart rate to generate a periodically varying potential for the set of electrodes 33 . In addition, the processor 30 activates the heartbeat generator 37 and the breath generator 39 such that the mechanical vibrator 56 activates the mock-up heart 48 to beat and the mock-up lungs 41 to breathe.

In some embodiments, processor 30 may add a or multiple noise figures. The added noise figure for the EP potentials causes the value of each potential on electrode 33 to vary within a predetermined range from cycle to cycle. The processor can apply a similar noise figure to vary the amplitude and frequency of heartbeat and respiration within corresponding preset ranges.

The potential developed on electrode 33 forms the ECG potential on skin electrode 51 . Receiver 49 processes the ECG potentials from electrodes 51 and presents the results, typically a graph on display 44, to operator 22, indicating to the operator that mock-up patient 26 is "alive".

In an insert probe step 156 , the operator inserts the EP system probe 24 through the hole 46 and into the mockup patient 26 . During the time the system probe is within the mock-up patient, the potentials sensed on the electrodes 45 are processed by the catheter signal receiver 43 and the results of the processing are typically presented numerically and/or graphically on the display 44 . In addition, the tracking device 52 tracks the distal end of the system probe and presents the location of the distal end on the display.

In an investigation step 158, the operator continues to insert the system probe until it makes contact with a region of the surface 100 of the heart wall. The operator can verify the contact by the position of the distal end and the EP potential measured by the electrodes 45 , both shown on the display 44 . Once a particular region of the surface 100 has been contacted, the processor, at the direction of the operator, samples the value of the EP potential generated by that region versus time. The processor records the sampled value of the EP potential.

The operator moves the distal end of the probe to make contact with different regions of the surface 100, and the processor samples and records the EP potential of that region. The operator continues this process of moving the distal end to different regions of the surface 100, and recording the EP potential for that region, until a sufficient number of different regions have been measured to enable the processor to generate a solid model heart at the termination point of the simulation. Electrophysiological diagram.

Flowchart 150 describes the steps used by system 20 to simulate the preparation of a cardiac electrophysiological map. System 20 may be used to simulate other invasive procedures, and a simulation of one such procedure is described below in conjunction with FIG. 4 .

FIG. 4 is a flowchart 200 of steps performed during a simulated invasive medical procedure according to an alternative embodiment of the present invention. In this case, it is assumed that the simulated procedure involves ablation of cardiac tissue to correct the heart with AVNRT. Surgical probes used in such real procedures typically include force sensors, temperature sensors, and one or more electrodes with which radiofrequency energy can be applied to endocardial tissue to ablate the tissue. For the simulations described herein, the ablation was simulated, not actually performed on the TEM80. One of ordinary skill in the art will adapt the description mutatis mutandis to the case where the TEM 80 is actually ablated.

In the simulations described herein, it is assumed that system probe 24 includes force sensor 55 and may include temperature sensor 58 . Furthermore, it is assumed that the system 20 using the processing unit 30 and the ablation module 53 simulates the presence of a temperature sensor in the system probe through the temperature module 59 and also simulates the ablation effect through the ablation module 53 . (In the case of real ablation by the system 20, it is assumed that the system probe 24 includes a temperature sensor 58, allowing the processing unit to measure the real temperature of the distal end 38.)

The first step 202 is substantially the same as the preprogramming step 152 , in that sets of data corresponding to the potentials to be applied to the electrodes 33 are stored in the memory 32 . It is assumed that each set of data includes a set corresponding to sinus rhythm, a set corresponding to AVNRT arrhythmia, and a set corresponding to different stages during AVNRT arrhythmia ablation.

Simulation step 204 is substantially similar to simulation step 154 . In step 204, it is assumed that the operator selects AVNRT arrhythmia.

In a probe positioning step 206 , the operator inserts the system probe 24 into the mockup patient 26 . Using the position of the distal end of the system probe as determined by the tracking device 52 , the operator positions the distal end relative to a desired area of the surface 100 . The operator can use the output from the tracking device and the EP potential measured by the electrodes 45 to confirm the correct positioning of the distal end. In addition, the operator reads the force applied by the distally located force sensor from the display 44 and adjusts the force to a desired value. If the sensor 59 is located in the system probe, the operator can use the sensor 59 to estimate the temperature of the surface 100 .

In an ablation simulation step 208, the operator simulates performing an ablation. The operator uses the ablation module 53 to set ablation parameters, such as the simulated power level to be used. The operator operates the probe 24 to simulate application of ablation to the tissue, and the processor 30 measures the time for applying the simulated ablation. Using the time the ablation was applied, the force applied during the ablation, and the programmable parameters that have been stored in the memory 32, the processor uses the temperature module 59 to estimate the temperature of the tissue that is undergoing the simulated ablation. The operator can view the temperature on the display 44 and use the temperature to assess the progress of the simulated ablation.

Real ablation procedures typically include multiple ablations performed sequentially in stages. After each stage, the generated EP potential on the real surface of the heart generally changes. As explained above for step 202 , the sets of EP potentials for different phases are stored in memory 32 .

In step 208, the processor monitors the simulated ablation that has been performed. Depending on the ablation stage reached, the processor 30 selects an appropriate set of EP potentials to be used by the programmable signal generator 31 to generate periodically varying potentials on the electrodes 33 .

In an optional monitoring step 210, the operator may decide to check that up to any specified stage of the simulated ablation performed was successful. In such a case, the operator may temporarily suspend the overall simulated ablation procedure and manipulate the distal end of the system probe so that electrode 45 is in contact with one or more desired regions of surface 100 . In step 208 , the EP potential that occurs after each ablation phase is visible to the operator on display 44 as processor 30 implements a periodically varying potential on electrode 33 after each ablation phase.

During a real ablation procedure, it is often desirable to draw a surgical conclusion as quickly as possible, so that monitoring the EP potential after different stages of a real ablation procedure may be difficult or impossible. However, in a simulated ablation procedure, there is no need for such rapid surgical conclusions, and the ability to monitor EP potentials after different stages of the simulated procedure increases the usefulness of the system 20 .

In a conditional step 212 the processor 30 checks whether in step 208 all ablation phases required to correct the AVNRT condition have been performed. Step 212 may be initiated automatically by the processor. Optional step 212 may be initiated by an operator using pointing device 36 to indicate completion of the simulation.

If the condition step provides a positive return, then in a sinus step 214 the processor provides a sinus data set to the generator 31 such that the electrodes 33 produce a sinus state of potential on the surface 100 . In step 214, the operator may manipulate the electrodes 45 to check that the mock-up heart 48 is in sinus rhythm.

If the conditional step provides a negative return, then in an error step 216 the processor may present an error notification on the display 44 . Error notifications typically indicate that one or more ablation phases have been performed incorrectly or have been missed. Typically, in step 216, the processor provides the generator 31 with a non-sinus data set (typically corresponding to the last ablation phase performed) so that the electrodes 33 generate an arrhythmic state of the potential on the surface 100, which the operator can use Electrode 45 observes this. Typically, the operator may return to step 208 in order to correct the error.

The flowcharts described above have assumed the use of one system probe 24 . Invasive medical procedures can often use more than one real probe, and embodiments of the invention can also use more than one system probe, or one system probe with one or more simulated probes. Some examples of using more than one probe are described below.

In the procedure shown by flowchart 150 (FIG. 3), in step 156, the operator may insert first system needle 24A into heart 48 and position the first system probe for use as a reference probe. The operator may then insert the second system probe 24B and may then execute the instructions of steps 156 and 158 to map the mock-up heart 48 .

In the procedure shown by flowchart 200 (FIG. 4), the condition selected in step 204 may require different types of probes, for example two types of lasso probes. First system stylet 24C and second system stylet 24D may be in the form of actual lasso stylets that an operator may insert into heart 48 and then The instructions in step 206 and subsequent steps may be executed.

In some embodiments, instead of using two or more physical system probes, the operator may use the physical system probe, system probe 24, and a dummy probe that has no physical parts inserted into the mockup patient. . Instead, the motion of the simulated probe is simulated by the processing unit 30 .

For example, in the procedure shown in flowchart 150, in step 156, the operator may simulate using pointing device 30 and display 44 to insert a reference probe into heart 48 so that the cursor representing the simulated probe is correctly positioned. On the image of the mock-up heart 48. The operator may then insert the physical system probe 24 and may then execute the instructions of steps 156 and 158 to map the mock-up heart 48 . Furthermore, during the simulation, the outputs displayed by the processing unit 30 on the display 44 correspond to those from the simulated reference probe.

It should be understood that the above embodiments are cited by way of example only, and the present invention is not limited to what has been specifically shown and described above. Rather, the scope of the present invention includes combinations and sub-combinations of the various features described above, and variations and modifications thereof, which would occur to those skilled in the art upon reading the foregoing description, and which variations and modifications are not disclosed in the prior art.

Claims (26)

1. a kind of equipment for being used for the simulation to intrusive mood electro physiologies operations, including：

Mockup cavity, the true body cavity of the mockup cavity simulation human subject, wherein limiting the mockup cavity Wall include tissueequivalentmaterial (TEM)；

The electrod-array of the embedded wall；And

Programmable signal generator, the programmable signal generator are connected to the electrode and are configured to the electrode array Row apply the potential of change, to simulate the electro physiology potential occurred in the true body cavity on the surface of the wall.

2. equipment according to claim 1, wherein the mockup cavity is included in physical model human heart.

3. equipment according to claim 2, wherein the electro physiology potential simulated replicates the sinus occurred in human heart Property potential.

4. equipment according to claim 2, wherein the electro physiology potential simulated replicates the heart occurred in human heart Restrain not normal potential.

5. equipment according to claim 2, and including heartbeat generator, the heartbeat generator is configured to make described Physical model human heart is beated.

6. equipment according to claim 2, and including system probe, the system probe is configured to insert the reality In body Model human heart and measure human heart activity feature.

7. equipment according to claim 6, wherein the system probe includes probe electrode, the probe electrode is configured The electro physiology potential simulated into sensing on the surface of the wall.

8. equipment according to claim 6, wherein the system probe includes force snesor, the force snesor is configured The power being applied into sensing by the surface of the physical model human heart on the sensor.

9. equipment according to claim 6, wherein the system probe includes sensor, the sensor is configured to feel Survey the temperature on the surface of the physical model human heart.

10. equipment according to claim 2, wherein the physical model human heart is located at physical model human patientses It is interior.

11. equipment according to claim 10, wherein the physical model human patientses include surface electrode, the surface Electrode is configured to sensing in response to the surface potential for the electro physiology potential simulated.

12. equipment according to claim 11, wherein the electrocardiogram on the skin of surface potential simulation human patientses (ECG) signal.

13. equipment according to claim 10, and including breathing generator, the breathing generator is configured to simulate Breathing in the physical model human patientses.

14. a kind of method for being used for the simulation to intrusive mood electro physiologies operations, including：

The true body cavity of human subject is simulated with mockup cavity, wherein limiting the wall of the mockup cavity includes tissue Equivalent material (TEM)；

Electrod-array is embedded in the wall；

Programmable signal generator is connected to the electrode；And

The programmable signal generator is configured to apply to the electrod-array to the potential of change, so as in the table of the wall The electro physiology potential occurred in the true body cavity is simulated on face.

15. according to the method for claim 14, wherein the mockup cavity is included in physical model human heart.

16. according to the method for claim 15, wherein the electro physiology potential simulated replicates generation in human heart Sinus property potential.

17. according to the method for claim 15, wherein the electro physiology potential simulated replicates generation in human heart Arrhythmia cordis potential.

18. according to the method for claim 15, and including making the physical model human heart beat.

19. according to the method for claim 18, and including system probe is inserted in the physical model human heart, The system probe is configured to measure the feature of human heart activity.

20. according to the method for claim 19, wherein the system probe includes probe electrode, the probe electrode by with It is set to the electro physiology potential that sensing is simulated on the surface of the wall.

21. according to the method for claim 19, wherein the system probe includes force snesor, the force snesor by with It is set to the power that sensing is applied to by the surface of the physical model human heart on the sensor.

22. according to the method for claim 19, wherein the system probe includes sensor, the sensor is configured to Sense the temperature on the surface of the physical model human heart.

23. according to the method for claim 15, wherein the physical model human heart is located at physical model human patientses It is interior.

24. according to the method for claim 23, wherein the physical model human patientses include surface electrode, the surface Electrode is configured to sensing in response to the surface potential for the electro physiology potential simulated.

25. according to the method for claim 24, wherein the surface potential simulates the electrocardiogram on the skin of human patientses (ECG) signal.

26. according to the method for claim 25, and methods described includes simulating in the physical model human patientses Breathing.