Medical devices, systems, and related methods for stimulation or ablation

Abstract

A medical system for performing a pulsed field ablation medical procedure is provided. The medical system includes an ablation device configured to generate an electric field that causes electroporation of tissue of a subject; a sensor array in electrical communication with the ablation device; and a control unit in electrical communication with the ablation device and the sensor array. The ablation device includes at least one set of electrodes. The sensor array includes at least one surface electromyography (sEMG) sensor and at least one inertial measurement unit (IMU) sensor. The control unit is configured to generate a pulse waveform; transmitting the pulse waveform to the ablation device; determining a muscle contraction level based on signal data from the ablation device and sensor data from the sensor array; and determining an sEMG threshold based on the sensor data and the muscle contraction level.

Description

Technical Field

[0001] The present invention generally relates to medical devices, systems, and related methods. Specifically, embodiments of the present invention relate to medical devices, systems, and methods for, for example, the stimulation or ablation of tissues. Background Technology

[0002] Applying high-voltage electrical pulses to tissue can generate an electric field within the tissue and create localized areas of ablated tissue through irreversible electroporation. Assessing the overall performance of pulsed field ablation techniques can be challenging, for example, due to muscle contractions induced by pulsed field ablation. Muscle contractions induced by pulsed field ablation can lead to adverse events during the procedure, including electrode displacement, partial tissue ablation, or accidental damage to adjacent tissues. Improving medical devices, systems, and related methods for ablation procedures will be beneficial. Summary of the Invention

[0003] Examples of the present invention relate to medical devices, systems, and related methods for pulsed electric field ablation of tissues.

[0004] According to one example, a medical system may include an ablation device comprising a set of electrodes configured to generate an electric field. The electric field can cause electroperforation of tissue in a subject in contact with the ablation device. The medical system may include a sensor array in electrical communication with the set of electrodes of the ablation device, wherein the sensor array may include at least one surface electromyography (sEMG) sensor and at least one inertial measurement unit (IMU) sensor. The medical system may include a control unit in electrical communication with the ablation device and the sensor array. The control unit may be configured to generate a pulse waveform; transmit the pulse waveform to the set of electrodes of the ablation device; determine a muscle contraction level based on signal data from the ablation device and sensor data from the sensor array; and determine an sEMG threshold based on the sensor data from the sensor array and the muscle contraction level.

[0005] Any medical device or system described herein may include any of the following features: An ablation device may include a catheter having an insertion portion, wherein a set of electrodes may be positioned distal to the insertion portion. The catheter may include at least one of a balloon, coil, needle, or basket. The tissue of the subject in contact with the catheter may include cardiac tissue. At least one sEMG sensor in the sensor array may include multiple sEMG sensors, and at least one IMU sensor in the sensor array may include multiple IMU sensors. The sensor array may include a housing configured to attach each sensor to the epithelial tissue of the subject. The medical system may include a pad, and the pad may be configured to attach to the epithelial tissue of the subject. The medical system may include at least one wire, and the at least one wire may be configured to provide wired electrical communication between at least one sensor in the sensor array and a control unit. The medical system may include at least one controller configured to provide radio communication between at least one sensor in the sensor array and the control unit.

[0006] The control unit can be configured to modulate at least one parameter of a pulse waveform based on at least one of sensor data from a sensor array and signal data from an ablation device. The control unit can be configured to modulate the duty cycle of the pulse waveform. The control unit can be configured to receive at least one assessment score corresponding to a user evaluation of a subject's muscle contraction in response to the pulse waveform, and is configured to modulate the pulse waveform based on at least one assessment score. The control unit can be configured to determine at least one sEMG threshold based on the level of muscle contraction. The control unit can be configured to generate a report based on the level of muscle contraction and the sEMG threshold. The control unit can be configured to shut off energy transmission to the ablation device based on the sEMG threshold and at least one measurement from at least one sEMG sensor in the sensor array. The control unit can be configured to perform a machine learning model on historical signal data and determine the level of muscle contraction based on the output from the machine learning model.

[0007] According to another example, a method for performing a medical procedure may include generating a pulse waveform with a control unit; transmitting the pulse waveform from the control unit to a set of electrodes of an ablation device in electrical communication with the control unit; determining a muscle contraction level based on signal data from the ablation device and sensor data from a sensor array in electrical communication with the control unit; or determining an sEMG threshold based on sensor data from the sensor array and the muscle contraction level.

[0008] Any method described herein may include any of the following features: The method may include inserting an ablation device into a body cavity of a subject and positioning the ablation device in contact with or adjacent to the subject's tissue. The method may include measuring electrical signals from the set of electrodes of the ablation device. The method may include attaching a sensor array to the epithelial tissue of the subject. The method may include measuring electrical signals via a sensor array, wherein the sensor array includes at least one sEMG sensor and at least one IMU sensor. The method may include modulating at least one parameter of a pulse waveform based on at least one of sensor data from the sensor array and signal data from the ablation device. The at least one parameter of the modulated pulse waveform may include the duty cycle of the modulated pulse waveform.

[0009] The method may include receiving at least one assessment score via a control unit, and the at least one assessment score may correspond to a user evaluation of a subject's muscle contraction in response to a pulse waveform. The method may include modulating at least one parameter of the pulse waveform based on the at least one assessment score. The method may include generating a report based on the muscle contraction level and an sEMG threshold. The method may include shutting off energy transmission to the ablation device based on the sEMG threshold and at least one measurement from at least one sEMG sensor in a sensor array. The method may include performing a machine learning model on sensor signal data and determining the muscle contraction level based on the output from the machine learning model. The method may include training the machine learning model on historical sensor signals and muscle contraction levels.

[0010] According to yet another example, a medical system for performing a medical procedure may include an ablation device, a sensor array, and a control unit, the control unit being in electrical communication with the ablation device and the sensor array. The control unit may include at least one processor and at least one memory, the at least one memory being used to store program instructions executed by the at least one processor to perform steps for performing the medical procedure. The steps may include generating a pulse waveform using the control unit; transmitting the pulse waveform from the control unit to at least one set of electrodes of the ablation device; determining a muscle contraction level based on signal data from the ablation device and sensor data from the sensor array; and determining an sEMG threshold based on the sensor data from the sensor array and the muscle contraction level. The method may also include modulating the pulse waveform using the control unit based on the signal data from the ablation device and the sensor data from the sensor array.

[0011] Any of the examples described herein may have any of these features in any combination. Attached Figure Description

[0012] The accompanying drawings, which are incorporated in and constitute a part of this invention, illustrate exemplary aspects of the invention and, together with the description, serve to explain the principles of the invention.

[0013] Figure 1 A medical system according to various aspects of the present invention is described.

[0014] Figure 2 Another medical system according to various aspects of the present invention is described.

[0015] Figure 3 and Figure 4 Methods according to various aspects of the present invention are described.

[0016] Figure 5 An example computing device according to various aspects of the present invention is described. Detailed Implementation

[0017] Examples of the present invention include devices, systems, and related methods for stimulating or ablating, for example, tissue of a subject, by selectively and rapidly applying electrical pulse waveforms, thereby causing irreversible electroporation in the tissue of the subject.

[0018] The terms “proximal” and “distal” are used herein to refer to the relative locations of components of an exemplary medical device. When used herein, “proximal” means a location relatively closer to the exterior of a subject’s body or closer to a user, such as a medical professional, who holds or otherwise uses the medical device. Conversely, “distal” means a location relatively further away from a medical professional or another user who holds or otherwise uses the medical device, or closer to the interior of a subject’s body. As used herein, the terms “comprising,” “including,” “having,” “including,” or other variations thereof are intended to cover non-exclusive contents such that an apparatus or method comprising a list of elements includes not only those elements but may include other elements not expressly listed or not inherent to the apparatus or method. Unless otherwise stated, the term “exemplary” is used in the sense of “example” rather than “model.” As used herein, the terms “about,” “substantially,” and “approximately” indicate a numerical range within + / - 10% of the stated value. As used herein, the phrase “based on” should be understood as equivalent to the phrase “at least based on,” unless otherwise stated. The term "or" is used separately, so "at least one of A or B" includes (A), (B), (A and A), (A and B), (B and B), etc.

[0019] Reference will now be made in detail to the examples of the invention described above and shown in the accompanying drawings. Wherever possible, the same reference numerals will be used in all the drawings to refer to the same or similar parts.

[0020] Figure 1An exemplary medical system 100 according to various aspects of the present invention is depicted. The medical system 100 may include an ablation device 102, a sensor array 110, and a control unit 120. As discussed herein, the medical system 100 may be configured to monitor a patient's cardiac activity (e.g., ectopic cardiac activity) in relation to tissue ablation, or to monitor electrical signals from muscle responses to the pulse waveforms, via selective or rapid application of electrical pulse waveforms to a target treatment site. In the illustrated example, the ablation device 102 may be coupled to the control unit 120, and the ablation device 102 may be configured to ablate cardiac tissue via pulse waveforms generated by the control unit 120, which is in electrical communication with the ablation device 102. Additionally, the sensor array 110 may be attached to epithelial tissue to measure electrical signals corresponding to the patient's muscle responses. The control unit 120 may be configured to analyze sensor signal data (e.g., received from the sensor array 110), for example, to modulate subsequent pulse waveforms or to stop the delivery of ablation energy to the ablation device 102.

[0021] In some aspects, the ablation device 102 can be delivered to the target site via various insertion devices or delivery systems. For example, although not shown, the ablation device 102 can be delivered to the target site through the working channel or other cavity of an endoscope, duodenoscope, gastroscope, colonoscope, ureteroscope, bronchoscope, or various other insertion devices or delivery systems. The medical system 100 may include a handle (not shown) having one or more ports configured to receive or control one or more medical devices or one or more actuators therein. For example, the handle of the medical system 100 may be configured to insert the ablation device 102 into a patient's body cavity, for example, to ablate cardiac tissue at a target site.

[0022] The ablation device 102 may include a catheter or shaft having one or more end effectors at a distal or distal portion. For example, the ablation device 102 may include at least one of a balloon, coil, needle, basket, etc., at a distal or distal portion. The ablation device 102 may include an insertion portion having a distal portion configured to be inserted and navigated through the patient's body cavity to the target site during the medical procedure, such that the ablation device 102 is positioned immediately adjacent to the target site. In some examples, the ablation device 102 may be introduced into the endocardial space. For example, the ablation device 102 may be introduced into the endocardial space of the left atrium via atrial septal puncture. The ablation device 102 may be a single-use device that is discarded or disposed of upon disconnection from the control unit 120 (e.g., at the end of the medical procedure). Alternatively, one or more portions of the medical system 100 may be reusable, for example, in more than one medical procedure. As discussed herein, the ablation device 102 can be inserted into a patient so that the distal portion contacts tissue at the target site (e.g., heart tissue 108) to perform one or more diagnostic or non-invasive medical procedures.

[0023] The ablation device 102 may include one or more electrodes configured to deliver pulsed electric field energy (e.g., a pulsed waveform). The ablation device 102 may include a set of electrodes 104 configured to generate an electric field that can cause irreversible electroperforation of adjacent tissue (e.g., a patient's cardiac tissue 108). For example, the set of electrodes 104 may include independently energized electrodes, such as electrodes 106A and 106B positioned at the distal tip of the insertion portion of the ablation device 102. Electrodes 106A and 106B may include insulated conductors configured to maintain a potential difference across the thickness without dielectric breakdown (e.g., from about 2,000 V to about 5,000 V). In some examples, the set of electrodes 104 may be grouped into one or more anode-cathode subgroups, such as a subgroup including one anode and one cathode, a subgroup including two anodes and one cathode, a subgroup including two cathodes and one anode, etc. Figure 1 In the example shown, the group of electrodes 104 includes electrodes 106A and 106B. However, it should be understood that the ablation device 102 may include any suitable number of electrodes or groups of electrodes. For example, the ablation device 102 may include multiple electrodes grouped into two, three, four, five, six, seven, eight, or more groups, which together or independently deliver ablation pulse waveforms to tissue immediately adjacent to the ablation device 102. In some examples, one or more outer pads attached to the patient's skin may serve as cathode electrodes, which can help improve ablation efficiency, for example, by working in conjunction with an anodic electrode inserted into a body cavity.

[0024] According to some aspects, the medical system 100 may be configured to collect or measure electrical signals corresponding to tissue activity (e.g., activity of cardiac tissue 108) in response to the application of a pulse waveform from the control unit 120 to the ablation device 102. For example, the ablation device 102 may be configured to transmit electrical signals from the set of electrodes 104 to, for example, the control unit 120 or various other external computing devices discussed herein. The medical system 100 may include a sensor array 110 having one or more sensors. The sensor array 110 may be configured to measure one or more muscle responses or electrical activity of a patient (e.g., in real time or at specified intervals during a medical procedure). The sensor array 110 may include one or more surface electromyography (sEMG) sensors 112 or one or more inertial measurement unit (IMU) sensors 114. Thus, the sensor array 110 may measure one or more muscle responses, for example, in response to electrical stimulation of cardiac tissue 108 via the ablation device 102.

[0025] The medical system 100 may include electrical components that support or otherwise provide electrical communication between the control unit 120 and the sensor array 110. For example, one or more wires configured to provide wired electrical communication directly or indirectly may extend between the control unit 120 and at least one of the sEMG sensors 112 or IMU sensors 114 in the sensor array 110. This electrical communication can support the transmission of sensor signal data from the sensor array 110 to the control unit 120. For example, each sEMG sensor 112 or each IMU sensor 114 may be directly connected to the control unit 120 via a corresponding wire, allowing the control unit 120 to process or analyze data received from the individual sensors of the sensor array 110.

[0026] In some aspects, the sensor array 110 may include a housing attached to one or more sEMG sensors 112 or IMU sensors 114. The housing may be configured to attach or otherwise bind the sEMG sensors 112 or IMU sensors 114 to the patient's epithelial tissue 116 during a medical procedure. In some examples, the housing may include one or more garment articles attached to the sEMG sensors 112 or IMU sensors 114. For example, the housing may include a belt, wristband, vest, shirt, trousers, or various other garment articles attached to the sEMG sensors 112 or IMU sensors 114. The housing may include one or more resilient materials for compressing the sensor array 110 or otherwise abutting or pushing the sensor array 110 against or toward the epithelial tissue 116, for example, to help maintain contact between the patient and the sensor array 110 while measuring one or more muscle responses to an applied pulse waveform.

[0027] In an alternative embodiment, the housing may include one or more input ports that support electrical communication between the sensor array 110 and the control unit 120. For example, the control unit 120 may be in electrical communication with one or more ports of the housing, such that each of the sEMG sensor 112 and IMU sensor 114 is indirectly coupled to the control unit 120 via a port of the housing in which the sensor array 110 is housed. The housing may include wires or circuitry that support the addition or removal of one or more other sensors to the sensor array 110.

[0028] In some aspects, although not shown, the medical system 100 may optionally include a pad attached to or otherwise coupled to the epithelial tissue 116, which may facilitate the measurement of sensor signal data via the sensor array 110 during medical procedures. For example, the pad of the medical system 100 may be used to abrade the epithelial tissue 116 (e.g., to remove dead skin cells from the patient) to help improve the electrical connection between the sensor array 110 and the epithelial tissue 116.

[0029] The control unit 120 may be a computing system, controller, computing device, or other similar independent processing unit separate from and selectively connected to the ablation device 102. The control unit 120 may include a memory 122 and one or more processors 124. The memory 122 may store instructions to be executed by the processors 124 to cause the control unit 120 to perform corresponding operations. The memory 122 may include a computer-readable storage medium for storing data, such as electrical signal data from the ablation device 102 or sensor data from the sensor array 110. The processor 124 may be or include a central processing unit (CPU), graphics processing unit (GPU), tensor processing unit (TPU), field-programmable gate array (FPGA), etc.

[0030] Control unit 120 can communicate with one or more devices in or via network 118 via input / output (I / O) interface 128. I / O interface 128 can support electrical communication with ablation device 102 or sensor array 110. In some examples, medical system 100 may include an umbilical cord configured to connect to I / O interface 128. The umbilical cord can provide power transmission to or from ablation device 102, such as electrical signal data from electrode 104 corresponding to the patient's ectopic cardiac activity. In other embodiments, data transmission may include auxiliary data from one or more auxiliary sensors, such as pressure sensors or optical sensors.

[0031] Control unit 120 may include pulse generator 126 configured to generate ablation pulse waveforms for delivery to ablation device 102. For example, pulse generator 126 may include an electrical pulse waveform generator to generate and deliver pulse waveforms to electrode 104, thereby treating tissue adjacent to ablation device 102. For example, the pulse waveform delivered to electrode 104 may cause irreversible electroporation of tissue adjacent to ablation device 102 (e.g., cardiac tissue). Pulse generator 126 may generate and deliver various types of signals, including but not limited to monophasic and biphasic electrical pulses. Control unit 120 may be configured to modulate one or more parameters (e.g., amplitude, duty cycle, width, timing, etc.) of the pulse waveform output from pulse generator 126. Medical system 100 may include electrical components that support or otherwise provide electrical communication between control unit 120 and the set of electrodes 104. For example, one or more wires configured to provide wired electrical communication directly or indirectly may extend from control unit 120 to the set of electrodes 104.

[0032] According to some aspects, control unit 120 can be configured to modulate pulse waveform parameters based on analysis of electrical signal data received from ablation device 102 or sensor signal data received from sensor array 110. Control unit 120 can be configured to iteratively modulate the pulse waveform parameters. In some examples, control unit 120 can use pulse width modulation (PWM) to iteratively adjust the duty cycle or use pulse amplitude modulation (PAM) to iteratively adjust the amplitude. Control unit 120 can be configured to record or store data associated with the pulse waveform, for example, recording waveform transmission data to a database stored in memory 122 during one or more time periods of pulse waveform transmission between pulse generator 126 and ablation device 102.

[0033] In some aspects, the medical system 100 may include one or more external devices 130 coupled to the control unit 120 (e.g., via I / O interface 128). In some examples, the external device 130 may be used to manipulate one or more user interfaces generated by the control unit 120, such as a graphical user interface (GUI) displayed on a display device 132 of the medical system 100. It should be understood that the external device 130 may be separate from the display device 132. The control unit 120 may be configured to process or display (or transmit for display) data associated with the ablation device 102, the sensor array 110, or the control unit 120, for example, via the display device 132. For example, during a medical procedure, the display device 132 may display electrical signal data received from the ablation device 102, or it may display sensor signal data received from the sensor array 110. In some examples, the control unit 120 may be configured to display (e.g., via the display device 132) parameters associated with the pulse waveform transmitted to the electrodes 104 of the ablation device 102 (e.g., over a period of time). Similarly, control unit 120 may be configured to display (e.g., via display device 132) sensor signal data associated with muscle responses measured by sensor array 110 (e.g., in response to pulse waveforms to ablation device 102 over a period of time). In some examples, a user may manipulate an interface or otherwise input one or more selections to select, display, or otherwise interact with data or other information provided via display device 132 (e.g., during a medical procedure).

[0034] According to some aspects, the control unit 120 may be configured to receive one or more evaluation scores corresponding to a medical professional's assessment of muscle contraction in response to the application of an electrical pulse waveform (e.g., applied to the patient's cardiac tissue via the ablation device 102). For example, the evaluation score may correspond to a medical professional's assessment of the set of electrodes 104 adjacent to the patient's cardiac tissue in response to the delivery of a pulse waveform from the pulse generator 126, including visual confirmation of muscle contraction or absence of muscle contraction. The control unit 120 may be configured to prompt a medical professional to evaluate inputs during the period when the pulse waveform is delivered to the patient via the ablation device 102, as displayed on the display device 132.

[0035] As discussed herein, control unit 120 may be configured to modulate a pulse waveform based on sEMG data received from sensor array 110, for example, to adjust (e.g., iteratively adjust) at least one parameter of the pulse waveform output from pulse generator 126 based on analysis of evaluation scores. For example, control unit 120 may be configured to adjust (e.g., iteratively adjust) the duty cycle of the pulse waveform based on sEMG data and deliver a pulse waveform with the adjusted duty cycle to electrode 104 of ablation device 102. Pulse waveform modulation may continue to iteratively adjust pulse waveform parameters, for example, until specified criteria are met or energy delivery from control unit 120 and to ablation device 102 is otherwise indicated. For example, control unit 120 may adjust (e.g., increase) one or more pulse waveform parameters until an upper limit for the parameters is met or until muscle contraction caused by ablation energy delivery interferes with the medical procedure. In one example, if the assessment score associated with the sEMG data indicates that the patient has no muscle contraction or that the level of muscle contraction is safe, the control unit 120 may continue to increase the ablation energy delivery until a subsequent assessment score associated with the sEMG data is received, indicating that the level of muscle contraction has reached a risk threshold at the corresponding pulse waveform parameters.

[0036] Control unit 120 can be configured to report muscle contraction levels based on an input dataset, including but not limited to parameters of a pulse waveform transmitted by control unit 120, electrical signal data measured by ablation device 102, sensor signal data measured by sensor array 110, or historical signal datasets. Control unit 120 can be configured to execute instructions to access the input dataset (e.g., stored in memory 122 via network 118 or an external database) and analyze the dataset (e.g., via processor 124) to determine the muscle contraction level at a corresponding pulsed field ablation (PFA) dose. The “PFA dose” includes a pulse waveform transmitted by control unit 120 having specified parameters over a specified time period. Medical device 100 can define a lower boundary (e.g., minimum PFA dose) or an upper boundary (e.g., maximum PFA dose) for the pulse waveform parameters.

[0037] According to some aspects, the control unit 120 can be configured to determine an sEMG threshold based on sEMG data acquired by the sensor array 110 and muscle contraction assessments provided by a medical professional. The sEMG threshold can be determined based on a muscle contraction threshold corresponding to the subject's safest level of muscle contraction and the lowest PFA dose. The muscle contraction threshold can be determined by a medical professional's observation of body movement (e.g., the patient's body in response to a PFA dose) and an assessment by a medical professional of the level of risk during the medical procedure (e.g., the risk of body movement interfering with the ablation device 102, the sensor array 110, or other risks of harm to the subject).

[0038] Before initiating the medical procedure, sEMG sensor 112 and IMU sensor 114 can be attached to the patient, such as to the upper limb, lower limb, trunk, etc. Control unit 120 can begin pulse waveform delivery from the lower boundary of the PFA dose (e.g., the lowest PFA amplitude, the narrowest pulse width, and the minimum number of pulses) while collecting sensor signal data (e.g., in response to the PFA dose) via sEMG sensor 112 and IMU sensor 114. Medical professionals evaluate and record the effects of muscle contraction on body movement at the PFA dose, for example, which can be input to control unit 120 for analysis of the medical professional's evaluation. Pulse waveform parameters can be iteratively adjusted along with corresponding documented records of the medical professional's evaluation at the adjusted PFA dose with adjusted waveform parameters. This iterative process can continue, for example, (1) until patient body movement caused by ablation-induced muscle contraction interferes with the medical procedure, (2) the medical professional stops testing, or (3) the upper boundary of the parameters is reached.

[0039] In some examples, a first evaluation score corresponding to sEMG data at a first time point can be considered as a first sEMG threshold (T1), a second evaluation score corresponding to sEMG data at a second time point can be considered as a second sEMG threshold (T1), and so on, until the nth evaluation score corresponding to sEMG data at the nth time point can be considered as the nth sEMG threshold (Tn). For example, the final sEMG threshold can be determined by averaging each sEMG threshold (e.g., T, T2, Tn, etc.).

[0040] In some examples, control unit 120 is configured to execute a machine learning model (“ML model”) trained on a historical dataset and determine / refine a muscle contraction threshold based on the output from the ML model. The historical dataset may include historical data on one or more of the following: sEMG sensor signals, IMU sensor signals, PFA dose, cardiac tissue signal data, sEMG threshold and muscle contraction scores associated with the sEMG threshold, patient body mass index, etc. The ML model may include a neural network trained via the historical signal data, and the neural network may be configured to output a prediction of the muscle contraction level. During the medical procedure, the ML model may be configured to receive sensor data from sensor array 110 as input and determine the muscle contraction level based on the sensor data and PFA dose, and output the sEMG threshold prediction. In some examples, the ML model may be a semi-supervised learning model that receives at least one evaluation from the user during the medical procedure, for example, to predict and output the muscle contraction level. In some examples, the ML model may be a reinforcement learning model that optimizes one or more parameters for the PFA dose based on the historical dataset. In some examples, the medical system 100 is configured to continue training the ML model to improve performance based on additional data, such as improving the accuracy of predicting muscle contraction levels at various PFA doses.

[0041] In some respects, control unit 120 can compare measurements from sEMG sensors 112 of sensor array 110 with sEMG thresholds. Control unit 120 can be configured to perform one or more operations based on this comparison. For example, control unit 120 can turn off, stop, reduce, or otherwise adjust the energy output to ablation device 102 based on the sEMG threshold and the measurements received from sEMG sensors 112. For example, if the measurement exceeds the sEMG threshold, control unit 120 can be configured to stop the energy output to ablation device 102. If the measurement does not exceed the sEMG threshold, control unit 120 can continue to deliver energy to ablation device 102 and continue to receive sensor signals via sensor array 110 (e.g., until the sensor measurement reaches or exceeds the sEMG threshold). Typically, sEMG sensor signals precede patient movement in the range of approximately 30 milliseconds to approximately 150 milliseconds. Therefore, the control unit 120 can help to perform operations safely based on comparison (e.g., shutting off energy delivery to the ablation device 102) without damaging tissue or otherwise harming the patient during the medical procedure (e.g., due to high-pressure energy delivery).

[0042] Depending on some aspects, control unit 120 can be configured to generate a report based on acquired sEMG data. In some examples, the report may include measurements from sensor array 110 or ablation device 102. In some examples, the report may include information about muscle contraction level assessment scores. Control unit 120 can provide the report to one or more designated users, for example, by executing program instructions to electronically transmit the generated report to the designated users via email or the like. Control unit 120 can also be configured to store the generated report on a local storage medium, a remote storage medium, or a combination thereof.

[0043] although Figure 1 Only one control unit 120 is shown, but in some examples, the medical system 100 may include more than one control unit 120 that is similar to or the same as control unit 120. In these respects, the ablation device 102 (or another medical device) may also be connected to each of the control units 120. For illustrative purposes, within a medical facility, multiple procedure suites may each include a control unit 120 located within that suite, and the ablation device 102 may be selectively coupled to or separate from the control unit 120 in that particular suite.

[0044] Figure 2 Another exemplary medical system 200 is shown, which includes an ablation device 202, a sensor array 210, and a control unit 220. As discussed above, the control unit 220 is in electrical communication with the ablation device 202 and the sensor array 210. Unless otherwise stated, medical system 200 may include medical system 100 ( Figure 1 (One or more aspects of) have been omitted for the sake of brevity.

[0045] As shown in the figure, the ablation device 202 includes a set of electrodes (electrode group) 204, which has at least electrode 206A and electrode 206B. The ablation device 202 can deliver ablation pulse waveform energy to patient tissue 208 adjacent to the electrode group 204, such as cardiac tissue. It should be understood that tissue 208 is not limited to cardiac tissue, so that the ablation device 202 can deliver ablation pulse waveform energy to other types of tissue, such as, but not limited to, liver tissue, prostate tissue, and lung tissue. Sensor array 210 includes one or more sEMG sensors 212 and one or more IMU sensors 214. Sensor array 210 can collect or measure sensor signal data when attached to patient epithelial tissue 216. Control unit 220 includes memory 222, one or more processors 224, pulse generator 226 configured to generate ablation pulse waveforms, and I / O interface 228. Control unit 220 can electrically communicate with external device 230 or display device 232. The control unit 220 can be directly connected to the ablation device 202 (e.g., via the umbilicus). The control unit 220 can be configured to communicate with one or more external devices 234 via network 218.

[0046] As shown and discussed herein, medical system 200 may include one or more wireless controllers configured to provide radio communication between one or more sensors of sensor array 210 and control unit 220. For example, medical system 200 may include controller 236 in electrical communication with sensor array 210 and control unit 220. Controller 236 may be configured to receive sensor signals from one or more sensors in sensor array 210 and to wirelessly transmit sensor signal data from sensor array 210 to control unit 220. For example, controller 236 may wirelessly transmit sensor signal data corresponding to measurements from sEMG sensor 212 or IMU sensor 214. Controller 236 may be directly or indirectly coupled to sEMG sensor 212 or IMU sensor 214, for example, via electrical components supporting electrical communication between controller 236 and sensor array 210. In some examples, multiple wires may be collectively configured to support or provide electrical communication between controller 236 and each IMU sensor 212 or each sEMG sensor 214. In other examples, sEMG sensor 212 or IMU sensor 214 may include a transmitter that is electrically in communication with controller 236, for example, to support wireless communication for transmitting sensor signal data from sEMG sensor 212 or IMU sensor 214 to controller 236. Controller 236 may wirelessly transmit sensor signal data directly or indirectly to control unit 220, for example, via a local area network (LAN) or wide area network (WAN), such as network 218, that is electrically in communication with controller 236. Although not shown, controller 236 may include one or more components or auxiliary devices configured to perform computational operations, such as memory, processor, I / O interface, etc.

[0047] In some embodiments, controller 236 may execute program instructions to process raw sensor signals received from sensor array 210, for example, to filter noise from the raw sensor signals to improve the signal-to-noise ratio of the resulting sensor signal data (e.g., before transmitting the sensor signal data). In some embodiments, controller 236 may execute program instructions to transmit sensor signal data via network 218 to one or more external devices 234, such as an external database for recording sensor signal data over one or more time periods.

[0048] Figure 3 A method 300 for ablating tissue during medical procedures according to various aspects of the present invention is shown. Step 302 of method 300 includes inserting an ablation device into a body cavity. For example, medical system 100 ( Figure 1Inserting the ablation device 102 into a patient's body cavity may include inserting the medical device into the body cavity, and inserting the ablation device 102 through a cavity or channel of the medical device. Step 304 of method 300 includes positioning the ablation device in contact with or adjacent to tissue at the target site. For example, step 304 may include inserting the distal portion of the ablation device 102 having a set of electrodes 104 that are in contact with or adjacent to cardiac tissue at the target site in the patient's body during the medical procedure. Figure 1 Step 306 of method 300 includes generating a pulse waveform. For example, step 306 may include using control unit 120 ( Figure 1 The pulse generator 126 of the control unit 120 generates an ablation pulse waveform. Step 308 of method 300 includes transmitting the pulse waveform to the ablation device. For example, transmitting the ablation pulse waveform may include transmitting the ablation pulse waveform from the pulse generator 126 of the control unit 120 to the electrode 104 of the ablation device 102. Figure 1 ).

[0049] Step 310 of method 300 includes measuring electrical signals of tissue at the target site via an ablation device. For example, step 310 may include measuring ectopic cardiac activity in cardiac tissue at the target site via the set of electrodes 104 in response to an applied pulse waveform. Step 310 may also include transmitting electrical signal data from the ablation device and to the control unit, for example via the umbilicus supporting electrical communication between the ablation device 102 and the control unit 120. Figure 1 Step 312 of method 300 includes measuring sensor signals corresponding to a muscle response to a pulse waveform via a sensor array. For example, step 312 may include measuring sensor signals, including measuring sEMG signals via sEMG sensor 112 or IMU signals via IMU sensor 114. Step 312 may also include transmitting sensor signal data from the sensor array to the control unit, for example via a connection between the control unit 120 and the sensor array 110. Figure 1 Electrical communication is conducted via wires between ( ) or via controller 236 ( Figure 2 The sensor signal data is wirelessly transmitted to the control unit 220.

[0050] Step 314 of method 300 includes inputting an assessment score. For example, step 314 may include a medical professional submitting an assessment score corresponding to an observation of the muscle response in the patient to the delivery of the ablation pulse waveform. Step 316 of method 300 includes determining a muscle contraction threshold based on the assessment score. For example, step 316 may include determining the muscle contraction threshold based on an assessment score from a medical professional, electrical signal data from the ablation device 102, or the patient's BMI.

[0051] Step 318 of method 300 includes determining an sEMG threshold based on the determined muscle contraction threshold and sEMG data. For example, step 318 may include analyzing the muscle contraction threshold, sensor signal data received from sEMG sensor 112, assessment scores from a medical professional, or historical data including historical sensor signal data to determine the sEMG threshold.

[0052] Figure 4 A flowchart of a method 400 for ablating tissue during medical procedures according to various aspects of the present invention is shown.

[0053] Step 402 of method 400 includes acquiring sensor data from the sensor array. For example, step 402 may include acquiring sensor signal data, which may include data from sensor array 110 when attached to or otherwise coupled to the patient's epithelial tissue during medical procedures. Figure 1 The sEMG measurements are taken from the sEMG sensor 112. The sensor signal data may include sEMG measurements at various points over a period of time. Step 404 of method 400 includes analyzing the sensor signal data. For example, step 404 may include analyzing data from the sEMG sensor 112 (…). Figure 1 The sensor signal data from the sEMG sensor 112 is used to determine at least one sEMG measurement for at least one instance during that time period during the medical procedure. In some examples, step 404 may include processing the sensor signal data from the sEMG sensor 112, for example, to improve the signal-to-noise ratio and facilitate the analysis of the sensor signal data.

[0054] Step 406 of method 400 includes comparing an sEMG threshold with an sEMG measurement determined in step 404. If the sEMG threshold is reached or exceeded, method 400 proceeds to step 408, which includes stopping the high-voltage output to the ablation device. In some aspects, step 408 includes displaying a latest muscle contraction fraction or an error notification. For example, control unit 120 may be configured to stop or otherwise change the ablation energy output to ablation device 102 in response to determining that a measurement from sEMG sensor 112 exceeds the sEMG threshold. In some examples, step 408 may include generating or displaying an error notification during the medical procedure. For example, control unit 120 may be configured to generate an error notification and display, show, or otherwise indicate the error notification on display device 132 based on analysis of sensor signal data from sEMG sensor 112, the error notification indicating that the sEMG threshold has been reached or exceeded.

[0055] Returning to step 406, if the sEMG threshold is not reached or exceeded, method 400 continues to step 410, which includes displaying the muscle contraction level. For example, sensor signal data is processed via control unit 120 and the determined muscle contraction level is displayed to a medical professional via a display device. Figure 1 ).

[0056] Method 400 proceeds to step 412, which includes determining whether to continue energy delivery. For example, a medical professional can make this decision based on a display device 132. Figure 1 The displayed level of muscle contraction determines whether energy delivery from control unit 120 to ablation device 102 should continue. In some examples, medical system 100 may be configured to prompt the user to determine whether control unit 120 should continue energy delivery (e.g., to the set of electrodes 104). If the user selects to continue energy delivery, method 400 may return, for example, to continue energy delivery to ablation device 102, and then continue acquiring sensor signal data at step 402 (e.g., via sensor array 110). This looping or repetition of the various steps of method 400 may continue indefinitely until an sEMG threshold is exceeded at step 406, or until the user selects to interrupt energy delivery (or otherwise stop the medical procedure) at step 412. If the user selects to interrupt energy delivery at step 412, method 400 proceeds to step 414 of method 400, which includes reporting the final score. For example, control unit 120 can be configured to report a summary of the medical procedure during the procedure, including electrical signal data from ablation device 102, sensor signal data from sensor array 110, and modulation of pulse waveforms from control unit 120. Step 414 may include generating a report via control unit 120 and transmitting the generated report to one or more designated users (e.g., via email).

[0057] Figure 5 An example of a computer 500 is depicted. Figure 5 This is a simplified functional block diagram of computer 500, which can be configured to perform operations in... Figures 1 to 4The processes, steps, or operations described herein or related to them and in accordance with exemplary embodiments of the invention. For example, according to exemplary embodiments of the invention, computer 500 may be configured as one or more of medical system 100, control unit 120, or another external device 134 or component. In various embodiments, any of the systems described herein may be or include computer 500, which includes, for example, a data communication interface 520 for packet data communication. Computer 500 may communicate with one or more other computers, for example, using electronic network 256 (e.g., via data communication interface 520). Electronic network 526 may include wired or wireless networks, for example, similar to Figure 1 The optional network 118 is depicted in the text.

[0058] Computer 500 may also include a central processing unit (“CPU”) in the form of one or more processors 502 for executing program instructions 524. In some examples, processor 502 may be or include one or more field-programmable gate arrays (FPGAs), graphics processing units (“GPUs”), tensor processing units (“TPUs”), application-specific integrated circuits (“ASICs”), or any combination thereof. Program instructions 524 may include at least instructions for performing usage monitoring (e.g., if computer 500 is or is included in medical system 100). Program instructions 524 for performing operations of the present invention may include source code or object code written in one or more programming languages, such as object-oriented programming languages ​​(e.g., Python, C++, etc.) or procedural programming languages ​​(e.g., C).

[0059] Computer 500 may include an internal communication bus 508. Computer 500 may also include a drive unit 506 (such as read-only memory (ROM), hard disk drive (HDD), solid-state drive (SDD), etc.) that can store data on a computer-readable medium 522 (e.g., a non-transitory computer-readable medium); however, computer 500 may also receive programming and data via network communication. Computer 500 may also have memory 504 (such as random access memory (RAM)) that stores instructions 524 for performing the techniques illustrated herein. However, it should be noted that in some aspects, instructions 524 may be temporarily or permanently stored within other modules of computer 500 (e.g., processor 502 or computer-readable medium 522). Computer 500 may also include input and output devices 512 or a display 510 for connection to input or output devices such as a keyboard, mouse, touchscreen, monitor, display, etc. Various system functions can be implemented in a distributed manner on multiple similar platforms to distribute the processing load. Alternatively, the system can be implemented through appropriate programming of a single computer hardware platform.

[0060] The programmatic aspect of this technology can be considered a "product" or "manufactured item," typically taking the form of executable code or associated data carried on a type of machine-readable medium. "Storage" media include computers, processors, and their associated modules, such as various semiconductor memories, tape drives, disk drives, etc. (which can provide non-transitory storage for software programming at any time). Sometimes, all or part of the software can communicate via the Internet or various other telecommunications networks. For example, such communication allows software to be loaded from one computer or processor into another. Therefore, another type of medium that can carry software elements includes light waves, radio waves, and electromagnetic waves, such as physical interfaces between local devices, wired and fiber optic networks, and various air links. Physical elements carrying such waves, such as wired or wireless links, optical links, etc., can also be considered as media carrying software. As used herein, unless limited to non-transitory, tangible "storage" media, the term "computer or machine-readable medium" refers to any medium involved in providing instructions to a processor for execution.

[0061] While the principles of the invention have been described with reference to illustrative examples for specific applications, it should be understood that the invention is not limited thereto. Those skilled in the art and who access the teachings provided herein will recognize that additional modifications, applications, and substitutions of equivalents fall within the scope of the examples described herein. Therefore, the invention should not be considered limited to the foregoing description.

Claims

1. A medical system comprising: An ablation device, the ablation device including a set of electrodes, the ablation device being configured to generate an electric field that causes electroporation of tissue in a subject in contact with the ablation device; A sensor array in electrical communication with the set of electrodes of the ablation device, wherein the sensor array includes at least one surface electromyography (sEMG) sensor and at least one inertial measurement unit (IMU) sensor; and A control unit that is in electrical communication with the ablation device and the sensor array, wherein the control unit is configured to: Generate pulse waveforms; The pulse waveform is transmitted to the set of electrodes of the ablation device; The level of muscle contraction is determined based on signal data from the ablation device and sensor data from the sensor array; as well as The sEMG threshold is determined based on sensor data from the sensor array and muscle contraction levels.

2. The medical system of claim 1, wherein the ablation device comprises a catheter having an insertion portion, and wherein the set of electrodes is positioned distal to the insertion portion.

3. The medical system of claim 2, wherein the catheter comprises at least one of a balloon, a coil, a needle, or a basket, and wherein the tissue of the subject in contact with the catheter comprises cardiac tissue.

4. The medical system according to any one of the preceding claims, wherein at least one sEMG sensor in the sensor array comprises a plurality of sEMG sensors, and wherein at least one IMU sensor in the sensor array comprises a plurality of IMU sensors.

5. The medical system according to any one of the preceding claims, wherein the sensor array includes a housing configured to attach each sensor to the epithelial tissue of the subject.

6. The medical system according to any one of the preceding claims, further comprising at least one wire configured to provide wired electrical communication between at least one sensor in the sensor array and the control unit.

7. The medical system according to any one of the preceding claims, further comprising at least one controller configured to provide radio communication between at least one sensor in the sensor array and the control unit.

8. The medical system according to any one of the preceding claims, wherein the control unit is configured to modulate at least one parameter of the pulse waveform based on at least one of sensor data from the sensor array and signal data from the ablation device.

9. The medical system of claim 8, wherein the control unit is configured to modulate the duty cycle of the pulse waveform.

10. The medical system of claim 9, wherein the control unit is configured to receive at least one assessment score corresponding to a user evaluation of the subject’s muscle contraction in response to the pulse waveform, and is configured to modulate the pulse waveform based on the at least one assessment score.

11. The medical system according to any one of the preceding claims, wherein the control unit is configured to generate a report based on the muscle contraction level and the sEMG threshold.

12. The medical system according to any one of the preceding claims, wherein the control unit is configured to shut off energy transmission to the ablation device based on the sEMG threshold and at least one measurement from the at least one sEMG sensor in the sensor array.

13. The medical system according to any one of the preceding claims, wherein the control unit is configured to perform a machine learning model on historical signal data and determine the muscle contraction level based on the output from the machine learning model.

14. The medical system of claim 13, wherein the control unit is configured to execute the machine learning model on at least one evaluation score corresponding to a user evaluation of the subject’s muscle contraction in response to the pulse waveform.

15. The medical system according to any one of the preceding claims, further comprising a pad configured to attach to the epithelial tissue of the subject.

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