JP2020529879A - Methods of cardiac mapping and model synthesis - Google Patents

Abstract

Several embodiments are methods of cardiac mapping and model synthesis, including premature ventricular contraction (PVC) activation maps of the heart, a three-dimensional (3D) cardiac model, and a PVC electrocardiogram (ECG) in the PVC of the heart. ) Generating a 3D internal surface model of the heart and 3D activation by generating based on data records and by triangulating point-by-point contact data collected during electrophysiological (EP) treatment. The map and the 3D internal surface model are combined to form a PVC activated surface model, and the heart is placed within the no longer activated region identified within the PVC activated surface model. To provide a method of pacing with and including. [Selection diagram] FIG. 12

Description

Cardiac defects in some conduction systems cause asynchronous contractions (arrhythmias) of the heart, sometimes referred to as conduction disorders. As a result, the heart does not pump enough blood, which can eventually lead to heart failure. Conduction disorders can have a variety of causes, including age, heart (muscle) damage, drug and genetic characteristics.

Premature ventricular contraction (PVC) is an abnormal or extraordinary heartbeat that begins somewhere in the ventricles, rather than in the upper atrium of the heart, similar to a normal sinus beat. PVC usually contracts before the ventricles are completely filled with blood, resulting in reduced cardiac output. PVC can also cause ventricular tachycardia (VT or V-Tach).

Ventricular tachycardia (VT or V-Tach) is another cardiac arrhythmia disorder caused by abnormal electrical signals in the ventricles. In VT, an abnormal electrical signal causes the heart to beat faster than normal, usually more than 100 times per minute, and the beat begins in the ventricles. VT generally occurs in people with underlying heart abnormalities. VT can sometimes occur in a structurally normal heart, and in such patients, the cause of abnormal electrical signals can be at multiple locations within the heart. One common location is the right ventricular outflow tract (RVOT), which is the path through which blood flows from the right ventricle to the lungs. In patients who have had a heart attack, scarring resulting from a heart attack can create an intact myocardial environment and scars that make the patient more susceptible to VT.

Other common causes of conduction disorders include defects in the rapidly activated fibers of the left and / or right ventricle, the His-Purkinje system, or scar tissue. As a result, the left and right ventricles may not be synchronized. This is called Left Bundle Branch Block (LBBB) or Right Bundle Branch Block (RBBB).

Cardiac resynchronization therapy (CRT), also called biventricular pacing or multipoint ventricular pacing, is a known method of improving cardiac function in the case of LBBB or RBBB. CRT involves simultaneous pacing of the right ventricle (RV) and left ventricle (LV) using a pacemaker. To perform CRT, in addition to the usual RV endocardial leads (with or without the right atrial (RA) lead), coronary sinus (CS) leads are placed for LV pacing. The basic purpose of CRT is to improve the mechanical function of LV by restoring LV synchrony in patients with dilated cardiomyopathy and QRS complex expansion, which are primarily the result of LBBB.

Catheter ablation is a selective treatment in patients with VT and / or symptomatological PVC. The target of ablation is the location in the heart where PVC is occurring, or where the signs of VT are occurring. To determine the appropriate ablation position, the therapist first proposes using an electrical lead to determine whether the ablation at the proposed position provides the desired electrical activation pattern stimulation of the heart. Stimulate the position.

Currently, determining the proper positioning of the lead for maximum cardiac synchrony or the desired electrical activation pattern involves some speculation on the part of the surgeon.

However, current methods do not allow the optimal location of electrical leads to be determined on a patient-by-patient basis. In addition, if the desired activation pattern is not achieved when the heart is stimulated in place, current methods provide instructional guidance for adjusting the position of the leads to provide an improved activation pattern. Not done. Therefore, there is a need for improved guidance in determining the proper position of the CRT electrical lead and in determining the cauterization position.

In some embodiments, a method of cardiac mapping and model synthesis, premature ventricular contraction (PVC) activation map of the heart, is a three-dimensional (3D) cardiac model and PVC electrocardiogram (ECG) in the PVC of the heart. Generating a 3D internal surface model of the heart by generating based on data records and triangulation of point-by-point contact data collected during premature ventricular (EP) treatment and a 3D activation map. And the 3D internal surface model are combined to form a PVC activated surface model, and an EP catheter is used to place the heart within the no longer activated region identified within the PVC activated surface model. Also provided are methods that include pacing at the first pacing position.

In some embodiments, a method of cardiac mapping involves attaching the 12 electrodes of an electrocardiogram (ECG) device to the patient's chest and using the ECG device to record electrocardiogram (ECG) data. , ECG data, a 3D chest model, and a two-dimensional (2D) image of the patient's heart to generate a cardiac activation map, wherein the PVC activation map no longer contains the activation region. And, based on the comparison between the no longer activated region and the predicted no longer activated region in the activation model, the offset between the actual position of each of the electrodes contained in the 3D chest model and the ideal position of each of the electrodes is determined. It provides methods that include doing and adjusting the activation map based on the determined offset. Some embodiments include applying a reference marker to the patient's body (eg, chest or torso) to identify the anatomical location, the marker being reflected from the reference marker contained in the image data. By detecting light, it is configured to be recognized in the image data, and by aligning the identified anatomical position with the corresponding anatomical position in the image obtained from a CT or MRI scan. , A patient-specific three-dimensional (3D) anatomical model can be generated that synthesizes image data of the patient's chest with a 3D anatomical model.

The accompanying drawings, which are incorporated herein and constitute a portion of the present specification, illustrate exemplary embodiments of the invention, with the schematic description given earlier and the detailed description given below. At the same time, it is useful to explain the features of the present invention.

It is an example of a 3D model of the heart according to some embodiments. FIG. 5 is a plan view of a 3D model of electrical activation of the heart according to some embodiments. FIG. 5 is a plan view of a 3D model of electrical activation of the heart according to some embodiments. It is a top view of the synchronism map which concerns on some embodiments. It is a top view of the synchronism map which concerns on some embodiments. It is the schematic of the cardiac imaging system which concerns on some embodiments. FIG. 5 is a plan view of a 3D model of electrical activation of the heart according to some embodiments. FIG. 5 is a plan view of a 3D model of electrical activation of the heart according to some embodiments. It is a top view of the synchronism map which concerns on some embodiments. It is a top view of the synchronism map which concerns on some embodiments. It is the schematic of the cardiac imaging system which concerns on some embodiments. It is a flowchart which shows the method which concerns on some Embodiment. FIG. 5 is a schematic diagram of LAO and PA diagrams of 3D models of electrical activation of the heart according to some embodiments. FIG. 5 is a schematic diagram of LAO and PA diagrams of synchronization maps according to some embodiments. FIG. 5 is a schematic diagram of LAO and PA diagrams of 3D models of electrical activation of the heart according to some embodiments. FIG. 5 is a schematic diagram of LAO and PA diagrams of synchronization maps according to some embodiments. It is the schematic of the surgical imaging system which concerns on some embodiments. FIG. 5 is a flow chart of a method of using the system of FIG. 9 according to some embodiments. It is a flow chart of the method using the system of FIG. 9 which concerns on some embodiments. An example of a reference heart image generated during the method of FIG. 11A is illustrated. The activation map that can be generated during the method of FIG. 11A is shown. The activation map that can be generated during the method of FIG. 11A is shown. FIG. 5 is a flow chart of a method of using the system of FIG. 9 according to some embodiments. It is a system block diagram of the cardiac imaging system which concerns on some embodiments. 3D images of electrical leads and reference markers on the patient's torso according to some embodiments. 3D images of electrical leads and reference markers on the patient's torso according to some embodiments.

Mutual reference of related applications This application is the US provisional patent application No. 62 / 539,740 entitled "METHODS OF CARDIAC MAPPING AND DIRECTIONAL COUNTIAL GUIDANCE" filed on August 1, 2017, and August 1, 2017. US provisional patent application No. 62 / 539,787 entitled "METHODS OF CARDICA MAPPING AND DIRECTIONAL GUIDANCE" filed on the same day and "METHODS OF CARDICA MAPPING AND MODEL MEG" filed on August 1, 2017. US Provisional Patent Application No. 62 / 539,802 entitled, and US Provisional Patent Application No. 62 entitled "CARDICA MAPPING SYSTEMS, METHODS, AND KITS INCLUDING FIDUCIAL MARKERS" filed on July 30, 2018. Claiming the benefit of priority to / 711,777, all of which is incorporated herein by reference for all purposes.

Some embodiments will be described in detail with reference to the accompanying drawings. Wherever possible, use the same reference numbers throughout the drawing to refer to the same or similar parts. References to specific examples and embodiments are for purposes of illustration only and are not intended to limit the scope of the invention or claims.

As used herein, an electrocardiogram (ECG) is defined as any method of correlating the actual electrical activity of the myocardium with (preferably non-invasively) what is measured or derived from the heart (electrical activity). .. In the classical electrocardiogram, the potential difference between the electrodes on the body surface correlates with the electrical activity of the heart. The derived ECG can also be obtained by other methods (for example, measurement by a so-called ICD (implantable cardioverter-defibrillator)). In order to obtain such a functional image, an estimate of the movement of electrical activity must be provided.

Cardiac dyssynchrony adversely affects cardiac function by increasing myocardial oxygen consumption while reducing the mechanical performance of the left ventricle (LV). In addition, cardiac dyssynchrony probably causes LV remodeling. Therefore, cardiac dyssynchrony accelerates the progression of chronic congestive heart failure (CHF) and reduces patient survival.

During normal conduction, activation of the heart begins in the endocardium of both the left ventricle (LV) and the right ventricle (RV). In particular, electrical impulses (ie, depolarized waves) travel substantially simultaneously through both the left and right ventricles. Bundle branch block (BBB) is a condition in which there is a delay or interruption along the path of the electrical impulse. Delays or interruptions may occur on the path that sends electrical impulses to the left or right ventricle.

The left BBB is a state in which the electrical impulse to the LV is decelerated, which is one of the main causes of cardiac desynchronization. In particular, activation begins only within the RV and proceeds through the septum before reaching the LV endocardium.

A pacemaker is a nearly pocket watch-sized electronic device that senses a unique cardiac rhythm and provides electrical stimulation when directed. Cardiac pacing is either temporary or permanent.

Permanent pacing is most commonly the endocardium (ie, right atrium or right ventricle) or epicardium (ie, coronary) of the leads connected to a pacing generator placed subcutaneously in the subclavian region. It is achieved by intravenous placement on the LV surface) via the venous sinus. However, miniaturized pacemakers have been developed for implantation on or directly into the heart.

Cardiac resynchronization therapy (CRT) is a specialized type of pacemaker therapy that provides biventricular pacing. CRT is performed with or without an implantable cardioverter defibrillator (ICD), a device used to treat and prevent patients at risk for ventricular tachycardia (VT) or ventricular fibrillation (VF). Will be done.

In the present application, regions within the heart that are electrically stimulated (eg, paced) by pacing electrodes, microcatheter, etc. may be referred to interchangeably as "pacing position" or "stimulation position".

FIG. 1 shows a three-dimensional (3D) model of heart 1 viewed from two different directions. The 3D model includes a mesh 6 representing the outer surface of the heart, here the surface of the myocardium. In this example, the model may also include a septum. The mesh 6 has a plurality of nodes 8. In this example, the mesh is a triangular mesh whose surface of the heart is approximated by adjacent triangles.

2A-2D are 3D models 4 of the heart showing the initial electrical activation of the heart 1 from various single stimulation positions 10. 2A-2C show the ventricular surface of the myocardium with the middle septum 2. In general, the 3D model 4 may include a mesh 6 representing the ventricular surface of the heart, here the lateral surface of the ventricular myocardium having a medial septum as shown in FIG. The mesh 6 has a plurality of nodes 8. In the illustrated example, the heart 1 is electrically stimulated at the stimulation position 10. Upon receiving electrical stimulation at the stimulation position 10, the electrical signal is transmitted through the heart tissue. Therefore, different parts of the heart are activated at different times. Each position on the heart has a specific delay to the initial stimulus. Each node 8 is associated with a value representing the time delay between the stimulation of the heart 1 at the stimulation position 10 and the activation of the heart at each node 8. The positions sharing the same delay time are connected by the isochrone 12 in FIGS. 2A to 2D. In this application, a tautochrone is defined as a line drawn on a 3D cardiac surface model connecting points on the model where activation occurs or arrives at the same time. The delay times of the nodes across the heart surface in this example are also displayed by varying the shade of the rendering. The vertical bar indicates the time delay associated with each color in milliseconds. The stimulation site 10 can be the location of the endogenous activation of heart 1.

FIG. 3 is a system block diagram of the system 100 for providing an explanation of the synchrony of electrical activation of heart tissue. The system 100 includes a processing unit 102 and a memory 104.

The 3D electrical activation model 4 may be acquired in the system 100 by combining the electrocardiogram data and the medical image data. This data may be stored in the memory 104. The processing unit 102 may be connected to the electrocardiogram system 106 and the medical imaging system 108 in order to retrieve the data and store the corresponding data in the memory 104. An electrocardiographic imaging (ECGI) method capable of determining cardiac activation from a 12-lead ECG may be applied by the processing unit 102 to determine a 3D model 4 of electrical activation of the heart. The ECGI method allows the ECG signal to be combined with a patient-specific 3D anatomical model of the heart, lungs, and / or torso to calculate the location of the cardiac isochron. The patient-specific 3D anatomical model may be obtained from magnetic resonance imaging (MRI) or computed tomography (CT) images received from the medical imaging system 108. Alternatively or additionally, the 3D anatomical model showing the closest fit to the patient may be selected from a database containing the plurality of 3D anatomical models and optionally modified. The selected and optionally modified 3D anatomical model may serve as a patient-specific 3D anatomical model.

The 3D model 4 may also include additional information. In the example shown in FIG. 2A, the 3D model 4 may include cardiovascular 14 and / or veins on the myocardium. This information may be added to the 3D model 4 in that the nodes are shown as related to such vessels. The blood vessel 14 is then identified and may optionally be displayed on the 3D model 4. The processing unit 102 may optionally include a first recognition unit 110 configured to automatically retrieve information representing the location of such blood vessels from a 3D anatomical model of the patient's heart. The processing unit 102 may then automatically insert this information into the 3D model 4.

The 3D model 4 may also contain information about scar tissue. The location of the scar tissue is obtained from a delayed contrast magnetic resonance imaging (MRI) image and may be added to the 3D model 4. Scar tissue can be simulated in 3D model 4 because it slows the propagation of electrical signals through it. Scar tissue can be described by making the transition from one node to another very slow or non-transition in the area within the heart wall where the scar tissue resides. The processing unit 102 optionally comprises a second recognition unit 112 configured and arranged to automatically extract information representing the location of such scar tissue from a patient-specific 3D anatomical model of the heart. It may be included. The processing unit 102 may automatically insert this information into the 3D model 4.

In some embodiments, the resulting 3D model 4 may be used to obtain further information regarding the electrical activation of the heart. For example, the time delay of activation from one node to another may be determined. It may be used to generate other diagrams resulting from initial stimuli at other nodes of the mesh 6 based on the 3D model 4. To make this possible, the processing unit 102 may include an insertion unit 114 that incorporates the 3D model 4 and defines a particular node as the stimulus position. It will be appreciated that the 3D model 4 can assume stimuli at a given node. The insertion unit 114 may exclude the stimulus at its predetermined node for calculation.

FIG. 2B shows an example of a 3D model 4 resulting from an initial stimulus at another stimulus position 10'. It will be appreciated that diagrams resulting from initial stimuli at other nodes of mesh 6 can be generated for each node of mesh 6.

A particular electrical activation sequence of the entire heart 1 resulting from stimulation at a particular node may be summarized in a single parameter, cardiac activation synchrony. Cardiac activation synchrony provides an indicator of how synchronously the entire heart is activated. In general situations, more synchronous activation of the heart is believed to be beneficial. The measure of cardiac activation synchrony in this example is the standard deviation (std) of the depolarization (dep) time of the heart. Thus, cardiac activation synchrony provides an indicator of overall cardiac activation synchrony as a result of stimulation at each node. The processing unit 102 may include a synchronization determination unit 116 configured to determine cardiac activation synchronization.

In some embodiments, cardiac activation synchrony may be determined separately for stimuli at each node. Therefore, it is possible to provide a measure of cardiac activation synchrony for each node of the mesh. The processing unit 102 may include a synchronization map generation unit 118 configured to generate a synchronization map based on the calculation of heart activation synchronization for each node by the synchronization determination unit 116. The processing unit 102 may be connected to an output unit 120 that is configured to output a synchronization map 15 and / or alternative data to the user. The output unit may be a display unit, a printer, a messaging unit, or the like.

FIG. 2C shows an example of a cardiac synchrony map 15. In the example illustrated in FIG. 2C, cardiac activation synchrony is shown for each node in map 15. In this example, the indicator can be indicated by providing pseudocolor and / or isosynchronous lines 16. The equisynchronous line 16 connects the nodes having the same cardiac activation synchrony. The cardiac synchrony map 15 shows which positions on the heart provide good cardiac activation synchrony and which positions on the heart are poor cardiac activation synchrony when the heart is stimulated in such positions. Provides a single 3D overview map showing what results. In the example illustrated in FIG. 2C, it can be seen that the original stimulation position 10 does not provide particularly good synchronization in the cardiac activation synchrony value, with a standard deviation of the depolarization time of the heart of about 45 ms. The most unfavorable stimulation position, here the position with the highest cardiac activation synchronization value, is indicated by S-. In this example, the most preferred stimulation location where the lowest cardiac activation synchrony value occurs is indicated by S +. In some cases, as shown in FIG. 2D, the most preferred stimulus position S + is best visible when the synchronization map 15 is viewed from another direction.

Another example of a measure of cardiac activation synchrony is the range of depolarization time (maximum depolarization time to minimum depolarization time). The range of depolarization time may be corrected for the cycle length. Another example of a measure of cardiac activation synchrony is the standard deviation of the left ventricular (LV) depolarization time only. Another example of a measure of cardiac activation synchrony is the delay between stimulation and septal activation. Another example of a measure of cardiac activation synchrony is AV delay. Another example of a measure of cardiac activation synchrony is VV delay. The measure of cardiac activation synchrony may be selected according to the immediate task and / or the specific symptoms or abnormalities experienced by the patient.

FIG. 4A shows a second example in which the second stimulation position 18 is defined. The 3D model 4 and the simultaneous stimulation at the first stimulation position 10 and the second stimulation position 18 are used to calculate the electrical activation of the heart. In this example, the insertion unit 114 does not exclude the stimulus at the first position 8 for calculation. FIG. 4A shows the electrical activation of heart 1 resulting from the calculation. In the example shown in FIG. 4A, the total activation time is shortened by the addition of the second stimulation position 18. In this example, the first stimulation position 10 represents the position of the intrinsic activation of the heart, or the initially selected stimulation position, or the stimulation generated by a pacemaker lead already present in the heart.

FIG. 4B shows an example of electrical activation of the heart resulting from the stimulation at the first stimulation position 10 and the initial stimulation at the second stimulation position 18'. A diagram resulting from the initial stimulus at the second node of the mesh 6 may be generated for each node of the mesh 6 at the same time as the stimulus at the first node associated with the first stimulus position 10.

In the examples shown in FIGS. 4C and 4D, specific electrical activation sequences throughout the heart are combined and shown as cardiac activation synchrony. In this example, the electrical activation sequence comprises stimulation at the first stimulation position 10 as well as stimulation at the second stimulation position 18. Cardiac activation synchrony also provides an indicator of how synchronously the entire heart is activated. In some embodiments, cardiac activation synchrony may be determined separately for the stimulus at each node at the same time as the stimulus at the first stimulus position 10 and the second stimulus position 18. This provides a measure of cardiac activation synchrony for each node acting as a third stimulation position in mesh 6.

FIG. 4C shows which position on the heart provides good cardiac activation synchrony when the heart is simultaneously stimulated at such positions by stimulation at the first stimulation position 10 and the second stimulation position 18. , An example of a cardiac synchrony map showing which position on the heart results in poor cardiac activation synchrony. In the example illustrated in FIG. 4C, when the first stimulation position 10 and the second stimulation position 18 are simultaneously stimulated, the most unfavorable third stimulation site S- is a maximum cardiac activation synchronization of about 41 ms. It had a sex value. In this example, the most preferred third stimulation position S + had the lowest cardiac activation synchronization value when the first stimulation site 10 and the second stimulation site 18 were simultaneously stimulated. In some situations, as shown in FIG. 4D, the most preferred stimulus position S + can be best seen when the synchronization map 15 is viewed from another direction.

FIG. 5 is a data flow display of the system 100 that provides a synchronization map. FIG. 6 is a diagram showing a method of determining cardiac synchrony using the system 100 shown in FIGS. 3 and 5 according to an embodiment. With reference to FIGS. 3 and 5, the system 100 includes a processing unit 102 that receives data from the hardware module. The processing unit 102 may optionally receive ECG data from the electrocardiogram system 106. The processing unit may receive patient-specific anatomical data from the medical imaging system 108.

The processing unit 102 may receive information from the positioning system 109 regarding the position of the ECG leads with respect to the patient's anatomy, such as a 3D image of the patient's chest including electrodes. The 3D image and the fuselage model may be aligned, or the positions of the electrodes in the model may be adjusted to match the positions of the electrodes in the 3D image. Knowledge of the location of the ECG electrodes, especially the Vl-V6 precordial electrodes, with respect to the heart is particularly important for the accurate calculation of the starting position of PVC.

In some embodiments, the electrode offsets from the assumed ideal position, especially the V1-V6 electrode offsets, are used to compare the detected normal heartbeat ECG signal to the ideal normal heartbeat ECG signal. It may be determined based on. For example, the offset may be determined based on how the detected ECG signal is affected by changes in the electrode position relative to the ideal electrode position. In particular, the recorded ECG data may be used to determine the stimulus start position for normal beating. Since the normal starting position at the SA node is known, the determined offset position can be compared to this known starting position and the electrode offset can be estimated based on the variation between them. Therefore, it is possible to determine the electrode offset without generating a 3D map.

From patient-specific anatomical data, the processing unit 102 may determine the synchronization map 15. The processing unit 102 may include the following units, and may generate a synchronization map by executing the operation of the method 200 shown in FIG. 6 and described later. In method 200, the processing unit 102 may use a patient-specific 3D anatomical model of the patient's chest and the size, orientation, and location of the heart within the chest. Such a model may be selected in block 201 for further use by the processing unit 102. The processor may determine in determination block 202 whether such a model is already available. If the model is not yet available (ie, decision block 202 = N), in decision block 204, search unit 103 checks to see if a suitable anatomical model for this patient exists in database 117. You may.

If a suitable patient-specific anatomical model is not available in database 117 (ie, determination block 202 = N), in block 208, search unit 103 is based on received patient-specific anatomical 3D image data. , Patient-specific anatomical models may be generated.

If a suitable patient-specific anatomical model is available in database 117 (ie, determination block 202 = Y), in block 206, search unit 103 retrieves the suitable anatomical model from database 117. Also, at block 206, the search unit 103 adapts the anatomical model from the database to the patient's 3D image in order to transform the selected anatomical model into a patient-specific (quasi) 3D anatomical model. You may. The patient-specific 3D model may also optionally include the size, orientation and / or position of other structures of the patient, such as lungs and / or other organs. The patient-specific 3D model may be a volume conductor model.

If a patient model is available (ie, decision block 202 = Y), or a patient model created in block 208 or patient-fitted in block 206, a stored model, ECG lead location, and patient. Using a unique model, at block 210, the read locator module 105 may determine the corresponding position of the ECG lead in the patient-specific 3D model to provide an enhanced patient-specific model.

For determination block 212, if patient-specific anatomical and / or enhanced patient-specific models are available, whether ECG data representing endogenous or stimulatory activation are available. Is determined. When endogenous activation data or pacing stimuli from one or more already existing pacemaker leads are available (ie, determination block 212 = Y), in block 214, activation unit 107 is associated with a patient-specific model. Based on ECG data, a 3D electrical model showing the current activation of the patient's heart may be generated.

If ECG data on intrinsic activation or stimulus activation is not available (ie, decision block 212 = N), in block 216, the virtual stimulus unit 111 is between nodes previously determined and / or assumed between nodes. Initial hypothetical stimulation may be added to the electrical model of the heart based on the rate of transition. The assumed transition speed may be, for example, 0.8 ms. The electrical model may include arteries, veins, and / or scar tissue as described above. At block 218, a 3D electrical model of the virtual activation of the patient's heart may be generated.

From a 3D electrical model of the patient's heart's intrinsic, stimulating, or virtual activation, the synchronization determination unit 116 may generate a synchronization map 15 at block 222, as described above. Based on the synchronism map, the processing unit 102 may determine in determination block 230 whether the artificial stimulus position or virtual stimulus position provided optimal activation and synchrony. If so (ie, determination block 230 = Y), the processing unit may calculate the optimal stimulation position for the patient's heart in block 234.

If it is determined in block 230 that optimal synchronization has not been achieved (ie, determination block 230 = N), method 200 proceeds to determination block 232 where additional virtual stimulus positions are needed or added. It is determined whether or not the virtual stimulus position should be moved or changed with respect to the timing parameters. This determination may be made by the clinician, by the processing unit, or by the clinician based on the information or recommendations presented on the display by the processing unit.

If it is determined that additional virtual reads are needed (ie, determination block 232 = Y), virtual pacing positions may be added in block 224 according to the determined synchronization. If no additional virtual leads are needed and it is determined that the virtual stimulus position should be moved or changed (ie, determination block 232 = N), then in block 225, the artificial or virtual stimulus position is accordingly. It may be adjusted.

At block 226, new activations may be generated. The process may then be repeated in block 222 until the synchronism is recalculated and it is determined in determination block 230 that the desired activation is achieved.

The system 100 may also virtually adapt the current artificial stimulation position, i.e. the pacemaker lead position, with respect to the current stimulation parameters to achieve optimal synchronization.

System 100 may be used to evaluate multiple stimuli. For example, the plurality of stimuli may be a combination of endogenous activation and stimulus activation (pacing). For example, the plurality of stimuli may be a plurality of stimulus activations (pacing). The user or processing unit 102 can determine 232 whether an additional stimulus position, such as an additional pacemaker lead, is desirable.

If an additional stimulation position is desired, the additional stimulation position may be inserted by the insertion unit 114. The activation for the situation with the original stimulus position and the added virtual stimulus position may then be redetermined at block 226 and the synchrony may be recalculated at block 222. Based on the synchrony map, the processing unit 102 may determine in determination block 230 whether the additional virtual stimulus position provided optimal synchronism. If optimal synchronization has not been achieved, method 200 proceeds to block 232, where whether additional virtual stimulus positions should be added, or whether virtual stimulus positions should be moved or removed with respect to timing parameters. Is judged. In such cases, the process may be repeated one or more times.

A cardiac synchronization model may be generated based on a patient-specific cardiac activation model. The synchronism model may be a 3D heart surface model including the equisynchronism lines as described above, where the equisynchronism lines represent the activation synchrony of the heart. This synchrony may be based on specific activation conditions, such as right ventricular activation at the lead position of the pacemaker.

As an example, in the following blocks, a synchrony model may be generated and activation simultaneous lines for the endogenous LBBB pattern may be determined.

1A) Patient-specific anatomical 3D models of the heart, lungs, and chest are generated based on, for example, MRI or CT images of the patient, or obtained from a database, eg, using a 3D camera, and the patient. It may be derived from a model adapted to the dimensions of. The anatomical 3D model may include a 3D surface model of the heart, a 3D surface model of the lungs, and a 3D surface model of the chest. The 3D surface model may be a close approximation of the actual surface of the heart using a plurality of polygonal meshes, such as triangles connected by their corners. The interconnected corners form the nodes of the mesh.

1B) ECG, for example 12-lead ECG, may be measured. The exact location of the electrodes of the ECG device on the chest may be recorded. The position of the electrodes in the 3D anatomical model may be used to estimate the distribution, variation, and / or movement of electrical activity through the heart tissue. The exact location of the recording lead or ECG device may be entered in the anatomical 3D display of the chest.

1C) Optionally, scar tissue may be incorporated into the anatomical 3D representation of the heart. The presence and location of scar tissue may be derived from delayed contrast MRI images.

1D) Measurements per recording read of the ECG device may be related to the geometry of the heart and torso. Intrinsic activation may be determined using the reverse procedure. The distribution, variation, and / or movement of electrical activity through the heart tissue may be based on the myocardial distance function, the fastest route algorithm, the shortest path algorithm, and / or the fast marching algorithm.

2) Once the activation coincidence for the endogenous LBBB pattern is determined, a stimulus site is added to the endogenous activation for each node on the heart, from which the desired synchronization of the heart is calculated. May be done. "Node" refers to the intersection of the triangles on which the anatomical 3D heart model is based.

The above method may also be used to determine the optimal position for implantation of the electrodes of a cardiac pacemaker. A synchronization map may be calculated to determine the optimal pacing site. The endogenous activation map may be applied to a new cardiac tautochrone positioning map in combination with the determined stimulation points.

FIG. 7A shows an example of a 3D synchronization map of the LBBB activation pattern of the heart. On the left side, FIG. 7A shows a left front oblique (LOA) diagram. The rear-front (PA) diagram is shown on the right side of FIG. 7A. FIG. 7B shows a synchronization map for the heart of FIG. 7A. The LAO diagram is shown on the left side of FIG. 7B, and the PA diagram is shown on the right side of FIG. 7B.

The synchronization map of FIG. 7B shows the standard deviation of the depolarization time of the heart as a result of combining the endogenous activation of the heart with one additional stimulation position. From FIG. 7B, it can be seen that selecting additional stimulation positions on the basal left ventricular free wall 20 most reduces the standard deviation of the depolarization time of the heart. Therefore, in this example, the area on the basal left ventricular free wall can be selected as the best location for the pacemaker electrode.

An updated 3D model of electrical activation of the heart may be generated, including intrinsic activation with simultaneous stimulation in the region on the basal left ventricular free wall. The updated 3D map may then be used to generate a new synchronization map to check the position of the leads in the RV. By doing this, the clinician may decide whether or not to stimulate the reed as well as merely sensing. The clinician may also determine if the lead should be shifted. The clinician may also decide whether to add additional stimulation leads.

The clinician may also determine if endogenous AV conduction is beneficial. Endogenous AV conduction generally conducts to the right bundle branch branch, after which the LV needs to be activated by stimulating the LV. This can be reversed, i.e., the RBBB may wait for LV activation and stimulate the RV free wall in optimal position. By repeating the procedure for both the left and right ventricles, the exact location and timing of cardiac pacing can be fine-tuned.

If the endogenous activation signal is not available due to severe heart damage, the entire procedure may be performed using only simulated (pacemaker) stimuli instead of endogenous activation. In that case, the above blocks 1B and 1D may be omitted. As a result, all treatments will be based on artificial activation.

FIG. 8A shows an example of left stimulus activation of the LBBB pattern. FIG. 8A shows the LAO diagram on the left side and the PA diagram on the right side. FIG. 8B shows an example of the cardiac synchronization map 15 shown in FIG. 8A. FIG. 8B shows a LAO diagram on the left side and a PA diagram on the right side. The synchronization map of FIG. 8B shows the standard deviation of the depolarization time of the heart as a result of one additional stimulation position combined with the left side stimulation activation of the heart. From FIG. 8B, it can be seen that selecting additional stimulation positions within the region on the basal left ventricular free wall 20 most reduces the standard deviation of the depolarization time of the heart. Therefore, in this example, the region on the basal left ventricular free wall can be selected as the best position for the pacemaker electrode. An updated 3D model of electrical activation of the heart may be generated, including intrinsic activation with simultaneous stimulation in the region on the basal left ventricular free wall.

All of the above procedures may be performed during the implantation procedure to find the most optimal pacing site.

FIG. 9 is a block diagram of a cardiac imaging system according to some embodiments. FIG. 10 is a flow diagram illustrating a method 300 of implanting electrodes using the system of FIG. 9, according to some embodiments. With reference to FIGS. 9 and 10, in block 301, a 3D activation map of the patient's heart may be generated by the processing unit 400 of the system. In particular, a 3D model of the patient's chest and / or heart may be generated by the CT or MRI device 108, the patient's ECG data may be recorded by the ECG recording device 106, and the 3D image of the patient's torso may be 3D. It may be generated by the camera 109. This data may be provided to the activation map generation unit 320 of the processing unit 400. ECG data may include extrinsic and / or intrinsic stimulus signals received from the patient.

At block 302, one or more optimal pacing prediction positions may be specified. For example, an activation map may be provided to the synchronization determination unit 322 to determine cardiac synchrony. This data may then be used by the virtual stimulus point generator 324 to identify one or more predicted pacing positions.

In CRT patients, the pacing position may be located where cardiac asynchrony occurs, whereby the stimulation is predicted to produce the maximum amount of cardiac activation and / or synchronization. The pacing position may also be based on, for example, the difference between the LV activation time and the RV activation time, the earliest and / or latest activation of the LV and / or RV, the detected depolarization wave blockade, and the like. Good.

At block 304, one or more virtual pacing positions may be displayed. For example, one or more pacing positions may be added to the activation map as virtual pacing positions. In an alternative example, an activation map and an image generated by a real-time image pickup device 328 such as a fluoroscope, a radiographic apparatus, an X-ray computed tomography (CT) apparatus may be provided to the image integration unit 326. The image integration unit 326 may compare and / or align the activation map with the real-time image. Based on comparison and / or alignment, an activation map containing stimulus points may be overlaid on the real-time image. In other embodiments, virtual stimulus points may be added to the real-time image and provided to display 330 for rendering to generate a modified real-time image.

In some embodiments, in addition to displaying the activation map, block 304 may include providing the display 330 with a reference image showing the internal structure of the heart. The additional image may be based on one of the 2D heart images, such as an MRI or CT image used to generate an activation map. Such 2D images may be modified to show additional features. For example, the 2D cardiac image may be modified to identify the structure contained in the region of the activation and / or pacing position no longer contained in the activation map. Therefore, the reference image can be referred to when positioning the electrodes using the real-time image pickup apparatus 328. The reference image will be described in detail below with reference to FIG. 11B.

In block 306, one or more pacing electrodes may be located at the identified virtual stimulation points. The physician may use the reference image and / or activation map shown on display 330 to align the pacing electrode with the virtual stimulation point. The heart may then be paced and the resulting ECG data may be collected.

At block 308, the collected ECG data may be used to generate an updated activation map to show the effect of the stimulus. In some embodiments, ECG data may be used to locate the pacing location, which may be displayed on the activation map. Since the pacing electrode is located at the pacing position, the pacing position may represent the current position of the pacing electrode. Therefore, the pacing electrode position may be displayed while navigating to the pacing position. Therefore, no additional mapping application is required to determine the position of the pacing electrodes, which may substantially reduce the cost of the pacing procedure.

In the determination block 310, it may be determined whether or not the pacing electrode is arranged at a suitable heart position. For example, in a CRT patient, it may be determined whether the stimulus has a sufficient amount of synchronization and / or has restored a desired amount of cardiac function. If so (ie, determination block 310 = yes), in block 312, the electrodes may be sutured in place. If not (ie, determination block 310 = no), a new cardiac stimulation point may be generated in block 302 based on the updated activation map generated in block 308. For example, one or more virtual stimulus points may be moved to new positions and / or additional virtual stimulus points may be added. Virtual stimulation points may then be added to the real-time cardiac image at block 304. In some embodiments, the pacing interval in which the LV and RV are stimulated may also be adjusted.

For PVC and / or VT patients, determination block 310 may include determining whether the stimulus reproduces the patient's PVC using an updated activation map. In other words, the determination block 310 may include determining whether or not the stimulation point is a suitable ablation point. If so (ie, determination block 310 = yes), in block 312, the heart may be cauterized at the stimulation point. If not (ie, determination block 310 = no), new stimulus points may be generated in block 302 based on the ECG data collected during the previous stimulus.

In some embodiments, activation maps may be used to determine if the CRT is appropriate for the patient. For example, a CRT may be determined to be unsuitable for a patient if the patient's cardiac output is not predicted to reach acceptable levels after optimal placement of a pacemaker or pacing lead.

In some embodiments, wired or wireless to a processing unit 400, a display 330, and other hardware such as CT / MRI apparatus 108, 3D camera 109, ECG recording apparatus 106, and / or real-time imaging apparatus 328. A workstation that includes a connection may be used. The workstation may also include an interface for controlling a surgical device such as a catheter implanter or other robotic surgical device.

FIG. 11A is a flow diagram illustrating a cardiac imaging method 500 using the system of FIG. 9 according to some embodiments. 11B and 11C show activation maps generated during the method of FIG. 11A.

Cauterization is an effective treatment for PVC and / or VT. However, some patients may experience transient VT and / or PVC, during the catheter insertion procedure in the hospital or during the electrophysiological examination in the electrophysiological equipment room. , The event or symptom may not occur while the patient is being tested. Even if the ECG data is recorded using a portable ECG recording device 106, such as a Holter-type device, to ensure that sufficient ECG data is obtained for patients with transient VT and / or PVC symptoms. Good.

With reference to FIGS. 9 and 11A, the processing unit 400 may generate a PVC activation map showing electrical activation in PVC in block 501. For example, the PVC activation map may identify the no longer activated region in the PVC. The PVC activation map may be based on ECG data collected during PVC, in addition to CT and / or MRI data from the patient, as described above. In particular, the data may be provided to the activation map generator 320 of the processing unit 400. In some embodiments, ECG data from a single PVC beat may be sufficient to generate a PVC activation map. The PVC activation map may identify areas of the heart where activation no longer occurs during the PVC heartbeat.

In some embodiments, the method may optionally include block 502. At block 502, processor 400 may be used to generate a reference image showing the internal structure of the heart. The activation map and reference image may be displayed on the same display or on different displays at the same time or at different times. In other words, blocks 501 and 502 may include providing the generated activation map and reference image to display 330.

The reference image may be based on a cardiac image such as one of the 2D MRI or CT images used to generate the activation map. In addition to the internal cardiac structure shown in the cardiac image, the reference image may include additional features. For example, in order to form a reference image, the cardiac image may be modified to show the structure contained in the region of the activation and / or virtual pacing position contained in the activation map.

In some embodiments, the processing unit 400 may be configured to select a cardiac image that most closely approximates the image provided by the real-time imager 328, as described in block 503. In other embodiments, the reference image may be based on a manually selected heart image. Therefore, the reference heart image can be referred to when positioning the electrodes using the real-time imaging device 328.

FIG. 11B shows an example of a reference image for a PVC / VT patient. With reference to FIG. 11B, the reference image may identify the no longer activated region 340 (eg, the cardiac structure within the 2D image contained in the no longer activated region. The reference image may also identify pacing. The position 342 may be included. The pacing position 342 may be a virtual pacing position generated by the stimulus point generator 324. In some embodiments, the pacing position 342 is the actual pacing / catheter position. For example, when the heart is paced, the processing unit 400 analyzes the resulting ECG data to identify the corresponding pacing position 342, thereby determining the current position of the pacing catheter, pacing electrode, etc. It may be specified.

In some embodiments, if the pacing position 342 does not provide the desired cardiac response, such as PVC simulation or desired cardiac synchrony, the guidance information generator 332 indicates a vector 344 indicating the direction in which the electrodes should be moved. Guidance information such as may be provided.

At block 503, the method comprises performing an electrophysiological (EP) procedure that involves inserting a catheter into the heart and analyzing electrical activity to determine where the arrhythmia is located. In PVC patients, the purpose of EP treatment may be to pace the heart in a position that results in a PVC that closely approximates the patient's symptomatic PVC. For example, EP treatment may now include pacing the heart using a catheter at some location within the activation region. ECG data may be detected internally during the EP procedure by inserting additional electrodes. For example, pacing data may be recorded by recording ECG data during pacing.

EP treatment may also include mapping internal features of the patient's heart, such as features within and around the PVC no longer activated region. In some embodiments, the EP procedure may include generating a point-by-point 3D triangulation internal surface model by contacting different points of the heart with the catheter. Suitable systems for performing EP procedures include the EnSite Precision mapping system and the Carto3 mapping system. Such a system has the ability to track the 3D position of the catheter in the body and record the internal surface position of the heart each time a contact occurs between the catheter and the heart tissue. The collection of these 3D positions is synchronized with the heartbeat and ensures that each point is collected when the heart is in the same state as the other recorded points (ie, the maximum volume opposite to contraction). .. In addition to building the model, relative ECG activation times may be recorded and mapped onto the cardiac model.

Block 503 may also include generating a real-time image of the heart using a real-time imager 328, as described above. In some embodiments, block 502 may be performed after the real-time image has been generated so that the reference image is based on a cardiac image that approximates the real-time image.

EP treatment may also include positioning the catheter in contact with a location within the activation region anymore. At block 504, a catheter may then be used to pace the heart via electrical stimulation. The purpose of pacing may be to pace the heart in a position that results in a PVC that closely approximates the patient's symptomatic PVC. Additional electrodes may also be inserted to detect ECG data internally during EP treatment. For example, pacing data may be recorded by recording ECG data during pacing.

EP treatment and pacing are shown as separate blocks in FIG. 11A, but the present disclosure is not limited to this. For example, EP treatment and pacing may both occur during a single treatment.

In some embodiments, block 504 may include using the collected ECG data to generate an updated activation map to show the effect of the stimulus. In some embodiments, ECG data may be used to locate the pacing location, which may be displayed on the activation map. Since the pacing electrode is located at the pacing position, the pacing position may represent the current position of the pacing electrode. Therefore, the pacing electrode position may be displayed while navigating to the pacing position. Therefore, no additional mapping application is required to determine the position of the pacing electrode, which substantially reduces the cost of the pacing procedure.

The determination block 506 may analyze the pacing data to determine if the pacing electrodes are located at a suitable cardiac position to achieve the desired cardiac response. For example, the pacing data may be compared to the ECG data used to generate the activation map. In PVC, pacing may be analyzed to determine if the pacing data is in good agreement with the PVC ECG data recorded during the presentation of the patient's PVC. In other words, the pacing data is analyzed to determine if the catheter has identified a position to be cauterized to relieve the patient's PVC and / or VT. In CRT patients, pacing data may be analyzed to determine if sufficient cardiac synchrony and / or activation has been achieved.

If it is determined that the desired cardiac response has been achieved (ie, determination block 506 = yes), a catheter may be used in block 510 to cauterize the heart at the percussion position of the PVC patient. In CRT patients, pacing electrodes and / or micropacemakers may be sutured in place at block 510.

If it is determined that the desired cardiac response has not been achieved (ie, determination block 506 = no), in block 508, in order to better simulate the patient's PVC, the processing unit 400 has pacing data, PVC ECG. Data and / or catheter position data may be used to determine the direction in which the catheter should be moved. For example, the pacing data and the catheter position data may be provided to the guidance information generation unit 332 of the processing unit 400. The guidance information generator 332 will compare the pacing and / or position data with the PVC ECG data to determine the direction and / or distance the catheter should be moved in order to properly simulate the patient's PVC. It may include an algorithm configured in. This information may be presented using icons and / or text. In CRT patients, pacing data may be analyzed to determine if one or more pacing electrodes should be moved to achieve the desired cardiac response.

The guidance information generation unit 332 may provide the guidance information to the activation map generation unit 320. The activation map generation unit 320 may update the activation map based on the guidance information provided by the guidance information generation unit 332, as will be described later with reference to FIGS. 11B and 11C. In another embodiment, the guidance information generation unit 332 may provide the guidance information to the image integration unit 326 for integration with the image provided by the real-time image pickup apparatus 328. In other embodiments, guidance information may be provided to the EP system and displayed on the EP map generated thereby.

After the guidance information is displayed in block 508, the method returns to block 504 and pacs the heart again. However, in some embodiments, the method may return to block 503 to perform the EP procedure. Thus, in PVC / VT patients, pacing may result in PVC that accurately reproduces the patient's PVC, and multiple locations may be stimulated until the corresponding cautery location is identified. In CRT patients, the stimulation position may be adjusted until the desired cardiac response is achieved. In addition, the physician may be provided with guidance information to help identify the stimulus point.

In some embodiments, block 503 may include externally recording ECG data during cardiac pacing using the mapping system of FIG. In addition, block 504 may also include determining the pacing position in the heart based on the recorded ECG data using a mapping system. For example, the pacing position may be determined by identifying the region of activation of the heart during pacing. In addition, block 508 may also include adding pacing positions to the PVC activation map. Thus, during pacing, the pacing electrode is located at the pacing position, so that at least the position of the pacing electrode of the catheter may be identified on the PVC activation map.

With reference to FIG. 11C, the updated activation map may include a first point 700 indicating the pacing / stimulation position corresponding to the latest pacing position and / or catheter position. The updated activation map is also a target region for ablation and may no longer include an activation region 710. In some embodiments, the activation map may now include a vector 712 that indicates direction and distance recommendations for moving the catheter to a new stimulation position within the activation region 710.

In some embodiments, as shown in FIG. 11D, the updated activation map may include one or more third points 704 indicating previous pacing positions. For example, the updated activation map has a first point 700 representing a first stimulus position, a second point 702 representing a second stimulus position, and a third (eg, current) stimulus position. A third point 704 representing and a fourth point 706 representing the suggested stimulus position may be included. In some embodiments, the activation region 710 may no longer be recalculated based on ECG data from each pacing.

Points 700-706 may be of different colors, shades, and / or shapes to provide information over time. For example, points 700-706 can be shaded to represent the order in which the points were created, thereby identifying the path of the catheter. For example, points 700-706 may be gradually brightened or darkened. In some embodiments, the fourth point 706 may be brighter than the other points. Once pacing occurs at the position represented by the fourth point 706, points 700-706 may each be darkened or otherwise modified to indicate that the points represent the previous pacing position. ..

In other embodiments, the points may be connected by line 708 to represent the path of the catheter during the EP process. In some embodiments, the vector 712 of FIG. 11B may be applied to the activation map of FIG. 11C in addition to or in place of the fourth point 706.

FIG. 12 is a block diagram showing an image integration method 800 according to some embodiments. Method 800 may be performed using the system of FIG. With reference to FIGS. 9 and 12, in block 801 as described above, the processor 400 may be used to generate a PVC activation map of the patient's heart.

In block 802, a 3D internal surface model of the heart may be generated point by point through 3D triangulation. In particular, the internal surface features of the patient's heart, such as the features of the ventricular surface, may be mapped point by point by point contact between the internal surface of the heart and the EP catheter. Suitable systems for performing EP procedures include the EnSite Precision mapping system and the Carto3 mapping system. Such a system has the ability to track the 3D position of the catheter in the body and record the position of the surface of the heart each time a catheter contacts the heart tissue. This point-by-point contact data collection is synchronized with the heartbeat and is collected when each point is in the same state as the other recorded contacts of the heart (ie, the volume of the heart is substantially the same). Guarantee that. For example, the heart may have maximum volume or maximum contraction when point contact is made.

In conventional EP systems, the internal surface model is combined with the acquired MRI or CT dataset to form a cardiac model. In particular, the synthesis may include adjusting the internal surface model data to more accurately represent the true geometry of the heart and to show additional cardiac features that were not mapped during the EP procedure. This process involves calculating which points in CT or MR represent tissue vs. blood. Adjustments may then be made to better represent the geometry of the heart.

The EP procedure may also include recording relative ECG data (eg, activation time) during point-by-point contact. In some embodiments, this ECG data may be mapped on an internal surface model. This may include mapping normal ECG signals as it allows points to be collected quickly as soon as cardiac / catheter contact occurs.

To determine the cauterization point, a PVC activation map may be generated because the PVC activation map now contains the activation region in the PVC. However, if a conventional EP system is used to generate a PVC activation map, the catheter must be in contact with the heart during PVC. Since PVC can only occur intermittently, generating a PVC activation map using conventional methods may require a considerable amount of time compared to using non-symptomatological ECG data. .. This increases patient stress and the use of surgical resources.

Therefore, in block 804, the internal surface model generated in block 802 may be combined with the PVC activation map generated in block 801 to form a PVC activated surface model. In particular, the PVC activation data included in the PCV activation map may be applied to the internal surface model. In addition, surface features included in the PVC activation map, which already include MRI or CT data, may be combined with triangulation point-by-point data included in the internal surface model. Therefore, the PVC internal surface model may be generated without performing the conventional process of synthesizing the triangulation point-by-point data with the MRI or CT data, further simplifying the process.

In block 806, the catheter may be located in the PVC no longer activated region shown on the EP PVC activation model and the heart may be paced. Pacing ECG data may be recorded during pacing.

At block 808, the pacing data may be analyzed to determine if the ablation position has been identified. In particular, the pacing data may be analyzed to determine if the pacing data is adequately matched to the ECG data recorded during the patient's signs of PVC. In other words, the pacing data may be analyzed to determine if the catheter has paced the cauterizing position to relieve the patient's PVC and / or VT.

In the determination block 810, it is determined whether or not the ablation position has been specified. If the ablation position is identified (ie, determination block 810 = Yes), in block 814, a catheter is used to ablate the heart at the identified ablation position.

If the ablation position is not specified (ie, determination block 810 = No), guidance information may be provided in block 812, as described above for the method of FIG. 11A. The method may then proceed to block 806. However, in some embodiments, block 812 may be omitted, and if the ablation position is not specified (ie, determination block 810 = No), the method may proceed directly from determination block 810 to block 806. .. Method 800 may then be repeated until the ablation position is identified and ablated in block 814.

In some embodiments, the method may include displaying the pacing position on a PVC activation map. For example, the PVC activation surface model may be aligned with the PVC activation map and the pacing position may be added to the PVC activation map. The pacing position may also represent the position of the EP catheter during pacing. In another embodiment, the processor 400 may analyze the ECG data recorded during pacing to determine the pacing and / or pacing catheter position, which may then be added to the PVC activation map.

In some embodiments, method 800 may include generating and displaying a reference image along with a PVC activation map and / or displaying guidance information, as described above with respect to FIGS. 11A-11D. ..

Some embodiments include a hardware system that includes a processing unit configured in software to receive patient-specific data, and the electrical of the heart in the form of a synchronization map of the patient's heart based on ECG imaging data. A 3D model / map of the patient's body using a recognizable marker on the body that generates and displays a 3D model of the activation and acts as a reference reference point (referred to herein as the "reference marker"). Correlate or align with. The main anatomical reference points (eg, clavicle, shoulder, ribs) indicated by markers applied to the patient by the clinician as part of the procedure for CRT procedures using an external imaging system such as a 3D camera. 3D image data of the patient's body (eg, torso or chest) may be obtained, accompanied by such as. The patient-specific 3D anatomical model obtains the identified anatomical position from a CT or MRI scan. Image data may be combined with a 3D anatomical model of the patient's chest by aligning with the corresponding anatomical position in the captured imaging.

FIG. 13 is a system block diagram of the cardiac imaging system 1000 according to some embodiments. Referring to FIG. 13, system 1000 includes an electrocardiogram system 106, an internal imaging system 1080, an external imaging system 1090, and a processing unit 102 that may be electrically connected to hardware modules such as the output unit 1200.

The processing unit 1020 receives patient-specific data from the hardware module. From patient-specific anatomical data, processing unit 1020 may generate a synchronization map of the patient's heart, which may be output to output unit 1200. The output unit 1200 may be configured to output a synchronization map and / or alternative data to the user. The output unit may be a display unit, a printer, a messaging unit, or the like.

For example, the processing unit 1020 may receive electrocardiogram (ECG) imaging data from an electrocardiogram system 1060 such as a 12-lead ECG device. The ECG data may be used by the processing unit 1020 to determine the 3D model 4 of the electrical activation of the heart. In particular, the ECG signal may be combined with a patient-specific 3D anatomical model of the heart, lungs, and / or torso to calculate the location of the cardiac isochrone.

The patient-specific 3D anatomical model may be obtained from an internal imaging system 1080 such as an MRI or CT device. Alternatively or additionally, the 3D anatomical model showing the closest fit to the patient may be selected from a database containing multiple 3D anatomical models and optionally modified. The selected and optionally modified 3D anatomical model can serve as a patient-specific 3D anatomical model.

Further, the processing unit 1020 may receive patient image data from the external imaging system 1090. For example, the external imaging system 1090 may be a 3D camera, and the processing unit 1020 may receive 3D image data of the surface of the patient's chest, as shown in FIG. 14A or FIG. 14B.

With reference to FIG. 14A, the 3D image data may include the position of the ECG lead with respect to the patient's anatomy, such as the Vl-V6 precordial electrodes shown in FIG. 14A. Knowledge of the location of the ECG electrodes, especially the Vl-V6 precordial electrodes, with respect to the heart can be particularly important for accurately calculating the starting position of PVC.

In some embodiments, the electrode offsets from the assumed ideal position, especially the V1-V6 electrode offsets, are based on a comparison of the detected normal heartbeat ECG signal with the ideal ECG normal heartbeat signal. May be determined. For example, the offset may be determined based on how the detected ECG signal is affected by changes in electrode position relative to the ideal electrode position. In particular, the recorded ECG data can be used to determine the stimulation initiation position for normal beating. Since the normal start position at the SA node is known, the determined offset position can be compared to this known start position and the electrode offset can be estimated based on the changes between them. Therefore, it may be possible to determine the electrode offset without generating a 3D map.

The processing unit 1020 may be configured to align and / or synthesize the 3D image data generated by the external imaging system 1090 with the anatomical torso and / or heart model generated by the internal imaging system 1080. Also, the position of the electrodes in the fuselage model may be adjusted to match the position of the electrodes in the 3D image data. However, if the external imaging system 1090 is not properly aligned with the torso, it can be difficult to properly align the 3D image data and anatomical models.

To facilitate alignment of the 3D image data with the anatomical torso model, the system 100 is pre-positioned (eg, glued) on the patient's torso into the 3D image data generated by the external imaging system 109. It may include a captured reference marker. Reference markers are placed on the patient at a set anatomical position identified within the torso model by the clinician to facilitate alignment of the patient's 3D image with the anatomical torso model. You may. In some embodiments, the reference marker is of shape, color and / or surface material (eg, reflective or back-reflective) that allows the marker to be automatically identified and positioned by a processor that processes 3D image data. It may be a sticker having an adhesive backing material that is configured to adhere to the skin.

For example, the first reference marker 900 may be placed on the patient's shoulder at a set anatomical position, such as the distal end of each clavicle. The second reference marker 902 may be placed at a set anatomical position between the first reference markers 902, such as a set position on the patient's sternum.

The processing unit 1020 is configured to identify reference markers 900, 902, and their corresponding anatomical positions, based on one or more identifying features contained in the 3D image data collected by the external imaging device. You may. In some embodiments, the processing unit 1020 determines the anatomical position corresponding to the reference markers 900, 902, based on the color, shape, and / or reflectance of the corresponding anatomical markers contained in the image data. It may be configured to be specific.

In some embodiments, the reference markers 900, 902 may be configured to reflect light of a particular wavelength. For example, the first reference marker 900 may have a first color and the second reference marker 902 may have a second color. In some embodiments, the markers 900, 902 may have different colors.

In some embodiments, the reference markers 900, 902 are in the form of a reflective coating and may include a reflective material. In some embodiments, the reflective material may be configured to reflect light of one or more specific wavelengths or wavelength ranges. For example, in some embodiments, the reference markers 900, 902 may be formed of a material configured to reflect visible light, infrared light, ultraviolet light, or a combination thereof. In some embodiments, the external imaging system 1090 may include a light source, and the reflective material may be configured to reflect all or part of the light emitted from the light source. For example, the reference markers 900, 902 may be configured to selectively reflect a particular wavelength or wavelength range of emitted light. The processing unit 1020 may be configured to identify reference markers 900, 902 based on the light reflected thereby.

In some embodiments, the reference markers 300, 302 may include a back-reflecting material. In particular, the back-reflecting material may be configured to reflect the incident light or a portion thereof at an angle substantially equal to the angle of incidence of the incident light (ie, straight back towards the light source of the incident light). Back-reflective materials are well known, for example, as used in safety vests and traffic signs. In such an embodiment, the processing unit 102 may be configured to detect such light as a luminance peak in the image data received from the external imaging system.

In some embodiments, the reference marker may have one or more different shapes. For example, as shown in FIG. 14B, the system 1000 may include a triangular reference marker 904, a cruciform reference marker 906, and / or a trapezoidal reference marker 908. The processing unit 1020 may be configured to identify the anatomical position corresponding to the reference marker based on the shape of the reference marker.

However, some embodiments are limited to features for identifying any particular reference marker, as long as the reference marker includes features that are detectable by the processing unit 1020 and detectable by the external imaging system 1090. Not done. Further, although three reference markers are shown in FIGS. 14A and 14B, any suitable number of reference markers may be used.

The above method description and process flow diagram are provided merely as illustrations and are not intended to require or suggest that the steps of some embodiments must be performed in the order presented. Absent. As will be appreciated by those skilled in the art, the sequence of steps in the above embodiments may be performed in any order. Words such as "after", "next", and "next" are not intended to limit the order of the steps, and these words are simply used to guide the reader through instructions on how to do this. To. Furthermore, any reference to a singular claim element, for example using the articles "a", "an" or "the", should not be construed as limiting the element to the singular.

Some exemplary logic blocks, modules, circuits, and algorithm steps described in connection with the embodiments disclosed herein may be performed as electronic hardware, computer software, or a combination of both. Good. To articulate this hardware and software compatibility, various exemplary components, blocks, modules, circuits, and steps have been generally described above with respect to their functionality. Whether such functionality is implemented as hardware or software depends on the design constraints placed on the particular application and system as a whole. One of ordinary skill in the art can implement the described functions in various ways for each particular application, but decisions of such implementation should not be construed as causing deviations from the scope of the invention. ..

The hardware used to implement some exemplary logic, logic blocks, modules, and circuits described in connection with aspects disclosed herein are general purpose processors, digital signal processors (DSPs). ), Application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs) or other programmable logic devices, discrete gates or transistor logic, separate hardware components, or to perform the functions described herein. It may be implemented or performed using any combination of these designed in. The general purpose processor may be a microprocessor, but as an alternative, the processor may be any conventional processor, controller, microcontroller, or state machine. Processors are also implemented as a combination of computing devices, such as a combination of DSP and microprocessor, multiple microprocessors, one or more microprocessors associated with a DSP core, or any other such configuration. You may. Alternatively, some steps or methods may be performed by a circuit specific to a given function.

In one or more exemplary embodiments, the functions described may be performed in hardware, software, firmware, or any combination thereof. When implemented in software, the function may be stored as one or more instructions or codes on non-transitory computer-readable media or non-temporary processor-readable media. The steps of methods or algorithms disclosed herein can be embodied in processor executable software modules and / or processor executable instructions, which are non-transient computer readable or non-transient processors. It may be on a readable storage medium. The non-temporary server-readable, computer-readable, or processor-readable storage medium may be any storage medium accessed by the computer or processor. By way of example, such non-temporary server readable, computer readable or processor readable media include RAM, ROM, EEPROM, flash memory, CD-ROM or other optical disk storage, magnetic. It may include disk storage or other magnetic storage, or any other medium used to store the desired program code in the form of instructions or data structures and accessed by a computer. The discs (disk and disc) used herein include compact discs (CDs), laser discs (registered trademarks), optical discs, digital versatile discs (DVDs), floppy disks, and Blu-ray®. Examples include discs, where discs typically reproduce data magnetically, while disks discs optically reproduce data with a laser. The above combinations are also included within the scope of non-temporary server readable, computer readable and processor readable media. In addition, the behavior of the method or algorithm may be one or any of the code and / or instructions on a non-temporary server-readable, processor-readable, and / or computer-readable medium that may be incorporated into a computer program product. It can exist as a combination or set.

The above description of the disclosed embodiments is provided to allow any person skilled in the art to manufacture or use the present invention. Various changes to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein will be applied to other embodiments without departing from the scope of the claims. May be applied. Therefore, the present invention is not intended to be limited to the embodiments presented herein, and is most consistent with the following claims and the principles and novel features disclosed herein. A wide range should be given.

Claims (15)

A method of cardiac mapping and model synthesis
Generating a premature ventricular contraction (PVC) activation map of the heart based on a three-dimensional (3D) cardiac model and PVC electrocardiogram (ECG) data recording in the PVC of the heart.
Producing a 3D internal surface model of the heart by triangulating point-by-point contact data collected during electrophysiological (EP) treatment.
To form a PVC activated surface model by synthesizing the 3D activation map and the 3D internal surface model.
A method comprising pacing the heart at a first pacing position located within the no longer activated region identified within the PVC activated surface model. The first aspect of claim 1, wherein synthesizing the 3D activation map and the 3D internal surface model to form a PVC activated surface model comprises synthesizing the activation map with the point-by-point contact data. Method. By comparing the ECG data recorded during the pacing of the first pacing position with the PVC ECG data, whether the first pacing position is a cauterizing position that can be cauterized to prevent the PVC. To judge and
In response to the determination that the first pacing position is not the ablation position, the identification of the second pacing position and
Displaying guidance information about the second pacing position on one or both of the activation map and the internal surface map.
To move the EP catheter from the first pacing position to the second pacing position based on the guidance information,
The method of claim 1, further comprising pacing the heart at the second pacing position. The method of claim 1, wherein the 3D heart model is based on a magnetic resonance (MRI) image or a computed tomography (CT) image of the heart. The method of claim 4, wherein the 3D internal surface model is not based on the magnetic resonance (MRI) image or computed tomography (CT) image of the heart. To generate a reference image by modifying one of the 2D images to identify the no longer activated region.
The method of claim 4, further comprising displaying both the PVC activation map and the reference image. The method of claim 1, wherein the PVC ECG data is recorded during one heartbeat containing PVC. The method of claim 1, wherein the point-by-point contact data is collected by repeatedly contacting the heart with an EP catheter during normal beating of the heart. The method of claim 8, wherein contact between the EP catheter and the heart occurs while the heart is of substantially the same volume. It ’s a method of heart mapping,
Attaching the 12 electrodes of the ECG device to the patient's chest and
Recording electrocardiogram (ECG) data using the ECG device and
To generate an activation map of the patient's heart based on the ECG data, a three-dimensional (3D) chest model, and a two-dimensional (2D) image of the heart, the PVC activation map is no longer available. Including the activation region and
Based on the comparison of the no longer activated region and the predicted no longer activated region in the activation model, the actual position of each of the electrodes included in the 3D chest model and the ideal position of each of the electrodes. To determine the offset with
A method comprising adjusting the activation map based on the determined offset. The 3D chest model
By applying the reference marker to the patient's body, the reference marker is configured to be recognizable using image processing.
To generate external image data of the patient's body, including imaging the reference marker and the electrodes.
By detecting the light reflected from the reference marker included in the image data, the anatomical position corresponding to the reference marker can be specified.
The image data was generated using the 2D image by aligning the identified anatomical position with the corresponding anatomical position in an image obtained from a CT or MRI scan. 10. The method of claim 10, generated by synthesizing with a 3D anatomical model of the patient's chest. By detecting the light reflected from the reference marker contained in the image data, the anatomical position corresponding to the reference marker can be identified by two different wavelengths reflected from the two different reference markers. 11. The method of claim 11, comprising detecting light. 12. The method of claim 12, wherein two of the reference markers are placed on the shoulder of the patient and one of the reference markers is placed on the sternum of the patient. Identifying the anatomical position corresponding to the reference marker by detecting the light reflected from the reference marker contained in the image data is three different of the light reflected from the three different reference markers. 11. The method of claim 11, comprising detecting a wavelength. Each reference can identify an anatomical position corresponding to the reference marker by detecting the light reflected from the reference marker contained in the image data and having a different shape. 11. The method of claim 11, comprising detecting the shape of the marker.