System for patient synchronous respiratory muscle stimulation

Abstract

This disclosure relates to a system for synchronized respiratory electrical muscle stimulation of a patient. The system includes: a transcutaneous electrical respiratory muscle stimulation (TERM) system comprising one or more skin electrodes configured to be placed on the respiratory muscles of a patient; at least one sensor for sensing the patient's respiratory state; and a processor configured to receive the patient's respiratory state from the at least one sensor and actuate the TERM system when the respiratory state is in the inspiratory and / or expiratory phases. The TERM system includes at least one calibrable element, and the processor (30) is further configured to actuate the TERM system (10) in a predetermined manner according to prior calibration. This disclosure also relates to methods and computer program products of the system.

Description

Technical Field

[0001] This disclosure pertains to the field of muscle therapy, and more specifically relates to electrostimulation of respiratory muscles. In particular, this disclosure relates to a system, method, and computer program product thereof for synchronous electrical stimulation of respiratory muscles in a patient. Background Technology

[0002] Patients in the intensive care unit (ICU) require continuous monitoring by medical staff to assess their vital signs. In many cases, patients require prolonged mechanical ventilation (MV) to achieve appropriate oxygen saturation levels.

[0003] Invasive MV is a common procedure in the ICU, used in approximately 33% of critically ill patients to support breathing while avoiding excessive work of the respiratory muscles. Weaning from mechanical ventilation is often problematic due to muscle weakness, which is defined as a decrease in the level of force generation at a given point in time [2].

[0004] Diaphragmatic weakness is a major cause of difficulty weaning from mechanical ventilation. A variety of factors can lead to acute or chronic diaphragmatic weakness in critically ill patients, including pre-admission injury, sepsis, medications, and multiple organ dysfunction syndrome. Other potential contributing factors include sedatives or analgesics. However, mechanical ventilation itself can cause acute diaphragmatic injury, as it may further exacerbate muscle weakness, developing into a loss of skeletal muscle strength and / or velocity, which recovers during rest and is also known as muscle fatigue. Therefore, the progressive development of diaphragmatic atrophy in the early stages of mechanical ventilation predicts an increased risk of prolonged ventilation and complications of acute respiratory failure.

[0005] Various systems and methods have been designed to improve diaphragmatic status during mechanical ventilation by electrically or mechanically stimulating muscles. These methods typically involve the use of invasive electrodes inserted into the respiratory muscles to achieve appropriate neurostimulation. However, many ICU patients are not suitable for invasive stimulation due to their medical conditions. Non-invasive solutions require the use of higher intensities to achieve the desired stimulation, but this introduces unavoidable electrical noise (as shown in Example 1), which affects and distorts measurements of biometric signals that are crucial for monitoring ICU patients.

[0006] Therefore, all these solutions involve a complex system that physically and electrically interferes with the routine operations of the ICU. For example, the need for continuous monitoring of respiratory sensors to ensure their proper functioning adds extra work for medical staff, increases the likelihood of errors, and occupies space around the patient, which may become saturated depending on the patient's condition. Furthermore, the electrical stimulation provided by the disclosed systems, due to its power and location (around the patient's chest), electrically interferes with readings from other devices, such as electrocardiograms (ECGs). The current provided by existing solutions is reflected as distortion in these monitoring signals, which either interferes with ECG signals, making the electrical stimulation incompatible with such monitoring, or requires manual monitoring because automated systems can be misled by these distortions and interpret them as harm to the patient. Thus, existing solutions either increase the resources required per patient or are incompatible with ICU monitoring systems.

[0007] Therefore, there is a need for a system for noninvasive synchronous respiratory electromyography (EMG) of patients, which can be effectively applied in the ICU under the complex requirements of space, time, personnel, and automated patient monitoring. Preferably, there is a need for a calibrable system for noninvasive synchronous respiratory EMG of patients, which can be effectively applied in the ICU under the complex requirements of space, time, personnel, and automated patient monitoring. Summary of the Invention

[0008] A first aspect of this disclosure relates to a system for synchronized respiratory electrical muscle stimulation of a patient. The system includes: a transcutaneous electrical respiratory muscle stimulation (TERM) system comprising one or more skin electrodes configured to be placed on the respiratory muscles of a patient; at least one sensor for sensing the patient's respiratory state; and a processor configured to receive the patient's respiratory state from the at least one sensor and actuate the TERM system when the respiratory state is in the inspiratory and / or expiratory phases.

[0009] In a preferred embodiment of the first aspect of this disclosure, the TERM system is configured to apply at least two electrical stimuli, the intensity of which causes one or more biometric measurements performed by one or more monitoring devices to be distorted, and the period between consecutive electrical stimuli is at least 200 milliseconds.

[0010] In another preferred embodiment of the first aspect of this disclosure, the one or more biometric measurements require a minimum measurement period to obtain the parameter of interest, and the period between consecutive electrical stimulations is extended by an additional period corresponding to the measurement period required for the one or more biometric measurements.

[0011] In another preferred embodiment of the first aspect of this disclosure, the intensity of distortion in one or more biometric measurements performed by one or more monitoring devices is at least 20 mA.

[0012] In another preferred embodiment of the first aspect of this disclosure, the intensity of distortion in one or more biometric measurements performed by one or more monitoring devices is at least 60 mA.

[0013] In another preferred embodiment of the first aspect of this disclosure, the period is at least 325 milliseconds, more preferably at least 1 second.

[0014] In another preferred embodiment of the first aspect of this disclosure, when the processor is configured to actuate the TERM system during the inspiratory phase of the respiratory state, the one or more electrodes are configured to be placed in the anterior, lateral, and / or posterior regions of the patient's torso. In a more preferred embodiment, the one or more electrodes are configured to be placed on the patient's external intercostal muscles and / or diaphragm.

[0015] In another preferred embodiment of the first aspect of this disclosure, when the processor is configured to actuate the TERM system during the expiratory phase of the respiratory state, the one or more electrodes are configured to be placed on the patient's abdominal muscles, oblique muscles, internal oblique muscles, and / or transverse muscles.

[0016] In another preferred embodiment of the first aspect of this disclosure, the system further includes at least one electromyography (EMG) sensor configured to measure the activity of one or more respiratory muscles of a patient, preferably wherein the at least one EMG sensor is a surface EMG sensor.

[0017] In another preferred embodiment of the first aspect of this disclosure, the TERM system is further configured to apply at least two electrical stimuli suitable to the patient by adjusting the amplitude, frequency, shape, and / or duration of the at least two stimuli, based on the patient's physiological, anthropometric, and / or demographic parameters. More preferably, the anthropometric parameters include one or more parameters selected from: BMI, skinfold, abdominal circumference, skin temperature, blood flow, bioimpedance measurements, base intensity, and time value.

[0018] In a more preferred embodiment, the system further includes means for determining one or more anthropometric parameters selected from: skin temperature, blood flow, bioimpedance measurement, baseline strength, and time value.

[0019] In another preferred embodiment of the first aspect of this disclosure, the at least one sensor for sensing the patient’s respiratory status is included within the mechanical ventilation system.

[0020] In another preferred embodiment of the first aspect of this disclosure, the at least two electrical stimulations are further adjusted based on mechanical ventilation-related variables, preferably, wherein the mechanical ventilation-related variables include any one of the following: airway pressure (Paw), flow rate, and volumetric pressure.

[0021] In another preferred embodiment of the first aspect of this disclosure, the biometric measurement is an electrocardiogram (ECG), and the monitoring device is an ECG monitoring device.

[0022] A second aspect of this disclosure relates to a computer-implemented method for performing synchronized electrical stimulation using a system for synchronized respiratory electromyography of a patient according to any embodiment of the first aspect of this disclosure. The method includes: a) Receive information about the patient's respiratory status from sensors connected to the mechanical ventilator; b) Determine whether the respiratory state corresponds to a selected respiratory phase of the patient based on the information, wherein the selected respiratory phase is selected from the inspiratory phase and / or expiratory phase; c) When the respiratory state corresponds to the patient's selected respiratory phase, indicate to the processor that the respiratory state corresponds to the patient's selected respiratory phase.

[0023] The third aspect of this disclosure relates to a computer program product comprising instructions configured to perform the methods described in either the second or sixth aspect of this disclosure.

[0024] A fourth aspect of this disclosure relates to a system for synchronized respiratory electrical muscle stimulation of a patient. The system includes: a transcutaneous electrical respiratory muscle stimulation (TERM) system comprising one or more skin electrodes configured to be placed on the respiratory muscles of a patient; at least one sensor for sensing the patient's respiratory state; at least one electromyography (EMG) sensor configured to measure the activity of one or more respiratory muscles of the patient; and a processor configured to receive the patient's respiratory state from the at least one sensor and actuate the TERM system when the respiratory state is in the inspiratory and / or expiratory phases.

[0025] The processor is further configured to determine the fatigue level of the patient's respiratory muscles based on the activity recorded by the at least one EMG sensor, and to actuate the RMES system based on the fatigue state of the patient's respiratory muscles.

[0026] All preferred embodiments of the first aspect of this disclosure are also preferred embodiments of the fourth aspect of this disclosure.

[0027] A fifth aspect of this disclosure relates to a system for synchronized respiratory electrical muscle stimulation of a patient. The system includes: a transcutaneous electrical respiratory muscle stimulation (TERM) system comprising one or more skin electrodes configured to be placed on the respiratory muscles of a patient; at least one sensor for sensing the patient's respiratory state; and a processor configured to receive the patient's respiratory state from the at least one sensor and actuate the TERM system when the respiratory state is in the inspiratory and / or expiratory phases.

[0028] In a fifth aspect of this disclosure, the TERM system includes at least one calibrable element, and the processor (30) is further configured to actuate the TERM system (10) in a predetermined manner according to a previous calibration.

[0029] In a preferred embodiment of the fifth aspect of this disclosure, each of the one or more skin electrodes is a multi-field electrode, the multi-field electrode including an anode and a cathode.

[0030] In this preferred embodiment of the fifth aspect of this disclosure, the processor is further configured to actuate the one or more multi-field skin electrodes under a current within a predetermined field and a predetermined current range. The minimum values ​​of the predetermined region and the predetermined current range have been predetermined according to the following steps: a. Stimulating the first cathode field of the electrode at a minimum current, wherein the minimum current is a minimum current determined by the TERM system; b. Increase the current in step (a) until detectable respiratory muscle contraction occurs; c. Associate the current in step (b) with the cathode field in step (a); d. Repeat steps (a) to (c) for at least the additional cathode field of the one or more multi-field skin electrodes; e. The cathode field that generates the minimum current required to detect respiratory muscle contraction is determined as the predetermined field, and the current required to generate detectable respiratory muscle contraction in the predetermined field is determined as the minimum value of the predetermined current range.

[0031] In a more preferred embodiment of the fifth aspect of this disclosure, the processor is configured to actuate the TERM system during the inspiratory phase of the respiratory state.

[0032] In another preferred embodiment of the fifth aspect of this disclosure, step (d) comprises: repeating steps (a) through (c) for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, or 50 additional cathode fields for the one or more multi-field skin electrodes (11a, 11b). More preferably, the additional 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, or 50 cathode fields are selected based on their proximity to the first cathode field.

[0033] In another preferred embodiment of the fifth aspect of this disclosure, step (d) includes repeating steps (a) to (c) for each cathode field of the one or more multi-field skin electrodes (11a, 11b).

[0034] In another preferred embodiment of the fifth aspect of this disclosure, at least one of the one or more skin electrodes (11a, 11b) includes a positioning mark (61) configured to guide placement on the patient's respiratory muscles. More preferably, each of the one or more skin electrodes (11a, 11b) includes a positioning mark (61) configured to guide placement on the patient's respiratory muscles.

[0035] In another preferred embodiment of the fifth aspect of this disclosure, when the processor is configured to actuate the TERM system during the inspiratory phase of the respiratory state, at least one of the one or more skin electrodes (11a, 11b), preferably each skin electrode, includes a positioning mark configured to guide placement on the patient's respiratory muscles, and a first cathode field is the field of a multi-field electrode positioned relative to the positioning mark, such that when placed on the patient's respiratory muscles, it is positioned between the 8th and 10th intercostal spaces at the level of the mid-axillary line.

[0036] In another more preferred embodiment of the fifth aspect of this disclosure, the maximum value of the predetermined current range has been predetermined according to the following steps: f. Stimulating the predetermined field determined in step (e) at the minimum value of the predetermined current range; g. Increase the current in step (f) until detectable respiratory muscle contraction no longer increases further; and h. The minimum intensity that provides the maximum detectable respiratory muscle contraction in the predetermined field is determined as the maximum value of the predetermined current range.

[0037] In another preferred embodiment of the fifth aspect of this disclosure, steps (a) to (d) for determining the minimum value of the predetermined region and the predetermined current range are performed using a minimized cathode field. The minimized cathode field is a cathode field smaller than the anode field. The step for determining the minimum value of the predetermined region and the predetermined current range further includes performing the following steps after step (d) and before step (e): d1. Select the cathode field that generates the minimum current required to detect respiratory muscle contraction as the minimized cathode field; d2. Increase the area of ​​the cathode field to be the same as the area of ​​the anode field; d3. Repeat steps (a) to (c) for each cathode field of the one or more multi-field skin electrodes that include the minimized cathode field of step (d1).

[0038] In another preferred embodiment of the fifth aspect of this disclosure, the processor is configured to actuate the TERM system during the inspiratory and expiratory phases of the respiratory state.

[0039] In another preferred embodiment of the fifth aspect of this disclosure, when the processor is configured to actuate the TERM system during the expiratory phase of the respiratory state, the predetermined current range has been predetermined according to the following steps: a. Stimulating the cathode field of the electrode at a minimum current, wherein the minimum current is a minimum current determined by the TERM system; b. Increase the current in step (a) until detectable respiratory muscle contraction no longer increases further; and c. The minimum intensity of detectable respiratory muscle contraction that no longer increases is determined as the maximum value of the predetermined current range.

[0040] In another preferred embodiment of the fifth aspect of this disclosure, the TERM system is configured to actuate the one or more multi-field skin electrodes using an anode field and a cathode field with an area between 10 and 50 cm², preferably 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 or 50 cm².

[0041] In another preferred embodiment of the fifth aspect of this disclosure, the maximum value of the predetermined current range is determined as a factor of the minimum value of the predetermined current range, wherein the factor is selected based on the patient's body mass index.

[0042] All preferred embodiments of the first aspect of this disclosure are also preferred embodiments of the fifth aspect of this disclosure.

[0043] A sixth aspect of this disclosure relates to a computer-implemented method for determining the field and current ranges of one or more multi-field skin electrodes for actuating a system for synchronized respiratory electromyography of a patient according to any embodiment of the first, fourth, or fifth aspect of this disclosure. The method includes: a. Stimulating the first cathode field of the electrode at a minimum current, wherein the minimum current is a minimum current determined by the TERM system; b. Increase the current in step (a) until detectable respiratory muscle contraction occurs; c. Associate the current in step (b) with the cathode field in step (a); d. Repeat steps (a) to (c) for at least the additional cathode field of the one or more multi-field skin electrodes; e. The cathode field that generates the minimum current required to detect respiratory muscle contraction is determined as the predetermined field, and the current required to generate detectable respiratory muscle contraction in the predetermined field is determined as the minimum value of the predetermined current range.

[0044] In a preferred embodiment of the sixth aspect of this disclosure, step 704 includes repeating steps 701 to 703 for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, or 50 additional cathode fields for the one or more multi-field skin electrodes (11a, 11b). Preferably, the additional 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, or 50 cathode fields are selected based on their proximity to the first cathode field.

[0045] In another preferred embodiment of the sixth aspect of this disclosure, step (d) includes repeating steps (a) to (c) for each cathode field of the one or more multi-field skin electrodes (11a, 11b).

[0046] In another preferred embodiment of the sixth aspect of this disclosure, the method further includes: f. Stimulating the predetermined field determined in step (e) at the minimum value of the predetermined current range; g. Increase the current in step (f) until detectable respiratory muscle contraction no longer increases further; and h. The minimum intensity that provides the maximum detectable respiratory muscle contraction in the predetermined field is determined as the maximum value of the predetermined current range.

[0047] In a preferred embodiment of the sixth aspect of this disclosure, steps (a) to (d) for determining the minimum value of the predetermined region and the predetermined current range are performed using a minimized cathode field. The minimized cathode field is a cathode field smaller than the anode field. The method further includes performing the following steps after step (d) and before step (e): d1. Select the cathode field that generates the minimum current required to detect respiratory muscle contraction as the minimized cathode field; d2. Increase the area of ​​the cathode field to be the same as the area of ​​the anode field; and d3. Repeat steps (a) to (c) for each cathode field of the one or more multi-field skin electrodes (11a, 11b) including the minimized cathode field of step (d1).

[0048] In another preferred embodiment of the sixth aspect of this disclosure, when the processor is configured to actuate the TERM system during the expiratory phase of the respiratory state, the predetermined current range has been predetermined according to the following steps: a. Stimulating the cathode field of the electrode at a minimum current, wherein the minimum current is a minimum current determined by the TERM system; b. Increase the current in step (a) until detectable respiratory muscle contraction no longer increases further; and c. The minimum intensity of detectable respiratory muscle contraction that no longer increases is determined as the maximum value of the predetermined current range. Attached Figure Description

[0049] To better understand this disclosure and to demonstrate how to implement it, it is now described by way of example only with reference to the accompanying drawings.

[0050] Figure 1 A schematic diagram of a system for synchronized respiratory electromyography of a patient according to one or more embodiments of the present disclosure is shown.

[0051] Figure 2 The locations of (a) a stimulating electrode and (b) an EMG recording electrode on a patient's body are shown according to one or more embodiments of the present disclosure.

[0052] Figure 3 A schematic diagram of a method for synchronizing diaphragmatic electrical stimulation according to one or more embodiments of the present disclosure is shown.

[0053] Figure 4 (ad) shows a schematic diagram of EMG recording samples from four different recorders according to one or more embodiments of the present disclosure being distorted and then recovered.

[0054] Figure 5A table showing the transdiaphragmatic pressure increment (delta) between records with and without TERM when applying TERM according to one or more embodiments of this disclosure, using observational analysis (a) and window analysis (b).

[0055] Figure 6 shows a multifield skin electrode for (A) inhalation TERM stimulation and (B) expiratory TERM stimulation according to one or more embodiments of the present disclosure.

[0056] Figure 7 Another schematic diagram shows a method for synchronizing diaphragmatic electrical stimulation according to one or more embodiments of the present disclosure.

[0057] Figure 8 Another schematic diagram shows a method for synchronizing diaphragmatic electrical stimulation according to one or more embodiments of the present disclosure.

[0058] Figure 9 A table showing the range of fields and currents that generate one or more biometric measurements without distortion or with minimal distortion, performed on 13 subjects by one or more monitoring devices, according to one or more embodiments of this disclosure.

[0059] Figure 10 A table showing the minimum and maximum shrinkage currents and their relationship according to one or more embodiments of this disclosure is provided.

[0060] Figure 11 The diagram illustrates the relationship between threshold strength and maximum contractile strength for all patients for each body mass index, according to one or more embodiments of the present disclosure. Detailed Implementation

[0061] definition It should be noted that, as used herein, the singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise. Furthermore, unless otherwise stated, the term “at least” preceding a series of elements should be understood to refer to each element in that series. Those skilled in the art will recognize or be able to determine many equivalents of the specific embodiments of this disclosure described herein using only conventional experimentation. These equivalents are intended to be covered by this disclosure.

[0062] It should be noted that the term “about” as used herein refers to + / - 30% of the mentioned value, preferably + / - 20%, more preferably + / - 15%, and even more preferably + / - 10%.

[0063] As used herein, the conjunction “and / or” connecting multiple enumerated elements is understood to encompass both individual and combined options. For example, when two elements are connected by “and / or”, the first option refers to the applicability of the first element in the absence of the second element. The second option refers to the applicability of the second element in the absence of the first element. The third option refers to the applicability of the first and second elements together. Any one of these options is understood to fall within the meaning of the term “and / or” as used herein and therefore satisfies its requirements. The simultaneous applicability of more than one option is also understood to fall within the said meaning and therefore satisfies the requirements of the term “and / or”.

[0064] Throughout this specification and the following claims, unless the context otherwise requires, the word “comprising” and its variations such as “including” and “comprising of” will be understood to imply inclusion of the said integer or step or group of integers or steps, but not to exclude any other integer or step or group of integers or steps. The term “comprising” as used herein may be replaced by the terms “containing” or “including” or sometimes “having”. Any of the foregoing terms (including, containing, including, having) may be replaced herein with the term “consisting of” when referring to aspects or embodiments of this disclosure, although less preferred.

[0065] As used herein, "consisting of..." excludes any element, step, or component not specified in the elements of the claim. As used herein, "consisting substantially of..." does not exclude materials or steps that do not substantially affect the essential and novel features of the claim.

[0066] The term "electrode" refers to a conductor through which electricity enters or leaves an object, substance, or area. In the context of this disclosure, the term "electrode" preferably refers to a conductor through which electricity enters or leaves a patient. In some embodiments, the term "electrode" may refer indiscriminately to any one of a working electrode, a counter electrode, or a reference electrode.

[0067] The term "respiratory muscles" refers to muscles that are directly or indirectly involved in the respiratory process. This includes inspiratory and expiratory muscles.

[0068] The term "respiratory state" refers to the state of a mammal's respiratory process, including inhalation and exhalation. In this disclosure, the term "inhalation" may be referred to indiscriminately as "inhalation" or "inspiratory"; and "exhalation" may be referred to indiscriminately as "exhalation" or "exhalation".

[0069] The term "biometric measurement" refers to any measurement of a parameter or signal generated in a living organism. This also includes evoked signals such as evoked potentials. In the context of this disclosure, it preferably refers to measurements related to clinically relevant parameters, such as electroencephalography (EEG), electrocardiography (ECG), or electromyography (EMG).

[0070] The term "anthropometry parameter" refers to parameters related to the physical proportions and measurements of the human body. In the context of this disclosure, it preferably refers to the physical proportions and measurements of a patient, including body mass index (BMI), skinfold, waist circumference, skin temperature, blood flow, bioimpedance measurements, baseline strength, and time values.

[0071] The term "demographic parameter" refers to a parameter related to data concerning a human population. In the context of this disclosure, it preferably refers to a parameter including age or sex.

[0072] The term "base strength" refers to the minimum current required to depolarize a nerve under an infinite duration of stimulation. In the context of this disclosure, it preferably refers to the minimum current required to depolarize a nerve associated with a specific muscle of the patient under an infinite duration of stimulation.

[0073] The term "duration" refers to the duration of a current when the current required to depolarize a nerve to a threshold is twice the base strength. In the context of this disclosure, it preferably refers to the duration of a current when the current required to depolarize a nerve associated with a specific muscle of the patient to a threshold is twice the base strength.

[0074] describe Each embodiment disclosed herein is contemplated for applicability to every other disclosed embodiment. Therefore, all combinations of the various elements described herein are within the scope of this disclosure. It should also be understood that, unless expressly indicated to the contrary, in any method claimed herein that includes more than one step or action, the order of the steps or actions of the method is not necessarily limited to the order in which the steps or actions of the method are narrated.

[0075] The first aspect of this disclosure relates to a system 100 for synchronized respiratory electromyography (EMG) of a patient. For example... Figure 1 As shown, the system includes a transcutaneous electrical stimulation (TERM) system 10 for respiratory muscles, at least one sensor 20 for sensing the patient’s respiratory status, and a processor 30.

[0076] The TERM system 10 includes one or more skin electrodes 11 configured to be placed on the respiratory muscles of a patient. The TERM system 10 can be any type of system configured to provide respiratory muscle electrical stimulation known to those skilled in the art. Therefore, the TERM system 10 can be configured to apply different types of stimulation via one or more electrodes and can also be configured to work with other different types of electrodes, including non-invasive electrodes 11, preferably surface skin electrodes 11. While the TERM system 10 may be primarily designed for respiratory muscle electrical stimulation, in the context of this disclosure, the TERM system may also be configured to further stimulate other types of muscles besides the respiratory muscles. In some embodiments, the TERM system 10 may include many other elements such as a processor, signal processing unit, oscillator, power supply unit, communication module, and any other elements that may further contribute to generating and / or providing muscle electrical stimulation.

[0077] One or more skin electrodes 11, such as 11a or 11b, may comprise different types of skin electrodes. Therefore, one or more electrodes 11 may be dry electrodes or wet electrodes, such as gel electrodes. One or more electrodes 11 may also be reusable or disposable and may comprise different materials, such as Ag, Ag-AgCl, Pt, Au, and other materials known to those skilled in the art. One or more electrodes 11 may also have different shapes and sizes, including shapes and sizes designed for specific locations of the skin or muscle to be stimulated. When the TERM system 10 includes more than one skin electrode 11, the skin electrodes 11 may be different types of electrodes, and each electrode may comprise different materials, shapes, and sizes.

[0078] It should be noted that the one or more skin electrodes 11 are configured, in terms of type, material, shape, and size, to be placed on the patient's respiratory muscles. Therefore, a particular skin electrode can be of a specific type, including specific materials, and has a specific shape and size depending on the nature of the muscle to which the skin electrode 11 is configured to stimulate. For these electrode parameters, muscle size, fiber type, depth from the skin, and location may be considered.

[0079] At least one sensor 20 for sensing a patient's respiratory status can be one of a variety of different types of sensors. Thus, the respiratory sensor 20 can be a flow sensor or a switch associated with the mechanical ventilation system output, or it can be a thoracic diameter sensor configured to detect patient inspiration and expiration, etc. Therefore, in some embodiments, and as will be further explained below, the at least one sensor 20 for sensing a patient's respiratory status may be included within the mechanical ventilation system. It should also be noted that the system may include more than one sensor 20, which can operate as a safety layer through redundancy, or can be configured to detect different respiratory states.

[0080] It should be noted that the processor 30 may include one or more processing units, such as a microprocessor, GPU, CPU, multi-core processor, etc. In some embodiments, it may be associated with memory, which may include one or more volatile or non-volatile storage devices, such as DRAM, SRAM, flash memory, read-only memory, ferroelectric RAM, hard disk drive, floppy disk, magnetic tape, optical disk, etc.

[0081] The processor 30 is configured to receive the patient's respiratory status from the at least one sensor 20. This can be accomplished via a wired connection (such as a data communication cable) or a wireless connection (such as Bluetooth, Wi-Fi, NFC, ZigBee). Those skilled in the art can envision many other alternative methods in which the processor 30 is configured to receive the patient's respiratory status from the at least one sensor 20, including different protocols and ad-hoc communication implementations.

[0082] The processor 30 is also configured to actuate the TERM system 10 during the inspiratory and / or expiratory phases of the respiratory state. As defined above, the processor 30 can determine whether the patient is in the inspiratory or expiratory phase based on the respiratory state. Therefore, the processor 30 can be configured to actuate the TERM system 10 during either or both of these phases of the respiratory state. This can be selected by the user according to the patient's needs. Actuating the TERM system 10 during the inspiratory phase will stimulate the inspiratory muscles, while actuating the TERM system 10 during the expiratory phase will stimulate the expiratory muscles. Therefore, the one or more skin electrodes 11 are preferably configured to be placed on the patient's inspiratory and / or expiratory respiratory muscles, respectively. In some embodiments, the processor 30 may be a processor of the TERM system 10.

[0083] In a preferred embodiment of the first aspect of this disclosure, the TERM system 10 is configured to apply at least two electrical stimuli, the intensity of which distorts one or more biometric measurements performed by one or more monitoring devices, and the period between consecutive electrical stimuli is at least 200 milliseconds.

[0084] The minimum intensity or magnitude at which the at least two electrical stimuli cause distortion of one or more biometric measurements performed by one or more monitoring devices depends on the patient characteristics interfering with the propagation of the stimuli, the recording points of the monitoring devices, and the one or more biometric measurements being monitored.

[0085] When an electrical stimulus is applied immediately following a previous stimulus, the distortion of that stimulus can be a continuation of the distortion produced by the previous stimulus. Therefore, as shown in Example 2, a period of at least 200 milliseconds is sufficient for the signals of one or more monitored biometric measurements to recover from the distortion of the previous electrical stimulus. Thus, even if the at least two electrical stimuli are applied at an intensity that would distort one or more biometric measurements, the signals of the one or more monitored biometric measurements are recovered between stimuli because the minimum period between the at least two electrical stimuli is at least 100 ms.

[0086] Advantageously, this means that the continuous provision of electrical stimulation by the TERM system 10 will not interfere with the monitoring of one or more biometric measurements performed by one or more monitoring devices. In turn, this means that effective synchronized respiratory electromyography can be applied to patients without interfering with routine ICU work, thus providing staff with a seamless system. It should be noted that although the term "biometric measurement" is plural, since one or more monitoring devices typically monitor more than one measurement, this disclosure can be applied with necessary modifications when only one biometric measurement is being monitored.

[0087] As shown in Example 2, a period of at least 200 milliseconds between the at least two electrical stimuli is sufficient to allow the signal to recover properly, such that the distortion caused by the stimulation does not interfere with one or more biometric measurements.

[0088] It should be noted that the period refers to the time interval between two consecutive electrical stimulations. However, when the TERM system 10 is configured to provide more than two electrical stimulations, the period refers to the time interval between each pair of any two consecutive electrical stimulations. It should also be noted that when the TERM system 10 is configured to provide more than two electrical stimulations, the period between each pair of consecutive electrical stimulations can be different, as long as it is at least 200 milliseconds.

[0089] It should be noted that Figure 1 It includes many other optional elements that are not included in all embodiments of the first aspect of this disclosure, marked with dashed borders. For example, Figure 1 A system 100 having a second skin electrode 11b is shown. However, it should be noted that, according to a first aspect of this disclosure, the system may include only one skin electrode 11a. Figure 1 A system 100 with other sensors 40, 50 is also shown, wherein the other sensors 40, 50 are different from at least one sensor 20 used to sense the patient’s respiratory status, as described below in some embodiments.

[0090] According to another preferred embodiment of the first aspect of this disclosure, the one or more biometric measurements require a minimum measurement period to obtain the parameter of interest, and the period between consecutive electrical stimulations is extended by an additional period corresponding to the measurement period required for the one or more biometric measurements. Advantageously, this allows for the efficient use of the one or more biometric measurements to obtain the parameter of interest while providing synchronized respiratory electromyographic stimulation.

[0091] The parameter of interest can be any clinically relevant parameter obtained through one or more of the aforementioned biometric measurements. For example, heart rate (HR) is a parameter of interest obtained through electrocardiography (ECG). The minimum measurement period required to obtain HR via ECG is 1 / HR, although 2 / HR is generally expected to be useful for comparing interpulsive parameters. Similarly, root mean square (RMS) or mean frequency (MF) are parameters obtained through electromyography (EMG), which provide information about muscle fatigue. The minimum measurement period required to obtain these values ​​via EMG is the duration of one contraction, although two contractions are useful for observing evolution. The duration of a contraction can be determined dynamically, for example, through an EMG intensity threshold that can determine the number of contractions performed since a specific point in time.

[0092] However, it should be noted that not all biometric measurements require a minimum measurement period to obtain the parameter of interest. For example, EEG is a continuously monitored biometric measurement, and typically no parameter of interest needs to be monitored other than the signal itself. Therefore, it should be noted that in some other embodiments of the first aspect of this disclosure, the period between consecutive electrical stimulations may not be extended at all with any additional period. Thus, such extension of the period between consecutive electrical stimulations is optional for one or more embodiments of the first aspect of this disclosure and is not essential to the invention described herein.

[0093] According to another preferred embodiment of the first aspect of this disclosure, the intensity of distortion in one or more biometric measurements performed by one or more monitoring devices is at least 20 mA.

[0094] Advantageously, and as shown in Example 3, this intensity has been found to be sufficient to provide effective stimulation of the respiratory muscles. When at least two electrical stimulations are provided with an intensity of at least 20 mA and a period of at least 100 ms, the distortion of each electrical stimulation does not interfere with the proper monitoring of one or more biometric measurement signals. Therefore, one or more biometric measurements can be performed as usual, just as in a UCI setting, while effectively preventing muscle atrophy.

[0095] According to a more preferred embodiment of the first aspect of this disclosure, the intensity of distortion in one or more biometric measurements performed by one or more monitoring devices is at least 60 mA.

[0096] Advantageously, and as shown in Example 2, this intensity has been found to provide further effective stimulation of the respiratory muscles. When at least two electrical stimulations are provided with an intensity of at least 60 mA and a period of at least 100 ms, the distortion of each electrical stimulation does not interfere with the proper monitoring of one or more biometric measurement signals. Therefore, the respiratory muscles can be stimulated more effectively while one or more biometric measurements can be performed as usual, as in a UCI setting.

[0097] In another preferred embodiment of any of the first aspects of this disclosure, the period is at least 225 milliseconds, more preferably 250 milliseconds, and even more preferably 300 milliseconds.

[0098] In a more preferred embodiment of the first aspect of this disclosure, the TERM system (10) is configured to apply at least two electrical stimuli, the intensity of which causes one or more biometric measurements performed by one or more monitoring devices to be distorted, and the period between consecutive electrical stimuli is at least 325 milliseconds.

[0099] Advantageously, and as illustrated in Example 2, this further facilitates providing sufficient time for the signals of one or more monitored biometric measurements to recover from distortions caused by previous electrical stimulation. This further prevents electrical stimulation of the respiratory muscles from interfering with the monitoring of one or more required biometric measurements within the ICU setting.

[0100] According to a more preferred embodiment of the first aspect of this disclosure, the period is at least 1 second.

[0101] Advantageously, and as illustrated in Example 2, this further ensures that the signals of one or more monitored biometric measurements are recovered from distortions caused by previous electrical stimulation. This further prevents electrical stimulation of the respiratory muscles from interfering with the monitoring of one or more required biometric measurements within the ICU environment. In another preferred embodiment of any of the first aspects of this disclosure, when the processor is configured to actuate the TERM system 10 during the inspiratory phase of the respiratory state, the one or more electrodes 11 are configured to be placed in the anterior, lateral, and / or posterior regions of the patient's torso.

[0102] It should be noted that the inspiratory phase of breathing involves many muscles that can be stimulated from many different parts of the patient's body, including the anterior, lateral, and / or posterior regions of the trunk. Therefore, by configuring the TERM system 10 to include one or more electrodes 11 configured to be placed in the anterior, lateral, and / or posterior regions of the patient's trunk, the system is further configured to non-invasively stimulate the inspiratory respiratory muscles.

[0103] More preferably, the one or more electrodes 11 are configured to be placed on the skin of the trunk closest to the inspiratory respiratory muscles, as described below.

[0104] According to a more preferred embodiment of the first aspect of this disclosure, and as Figure 2 As shown in Figure A, the one or more electrodes 11 are configured to be placed on the intercostal muscles, more preferably on the patient's external intercostal muscles 201, 201'. For example, as Figure 2 As shown in Figure A, the one or more electrodes 11 may be located in the 7th intercostal space along the midaxillary line.

[0105] Advantageously, the TERM system 10 includes one or more electrodes 11, which are further configured to be placed non-invasively on muscle groups that have relevant functions during the inspiratory phase of breathing.

[0106] It should be noted that, according to this preferred embodiment, the one or more electrodes 11 can be configured to be placed in different areas of the patient's torso, as long as they are configured to be placed on any part of the external intercostal muscles.

[0107] It should be noted that Figure 2 A shows many other electrode locations on the patient's torso, where, according to one or more embodiments of this preferred embodiment, the one or more electrodes 11 may not be configured to be placed. Therefore, many electrode locations can be alternative and / or available for other respiratory states. It should also be noted that, according to… Figure 2 A. Each type of electrode location has two electrode locations; however, in some embodiments according to this preferred embodiment, the TERM system 10 may include only one electrode 11 or more than two electrodes 11 configured to be placed on such regions. Finally, it should be noted that most regions 201-205 are indicated as circular, while some are more elongated. However, embodiments according to this preferred embodiment are not limited to the specific shape of each region 201-205 and may be related to… Figure 2 The result shown in A is different.

[0108] In another preferred embodiment of any embodiment of the first aspect of this disclosure, and as Figure 2 As shown in Figure A, the one or more electrodes 11 are configured to be placed on the patient's diaphragm 202, 202'.

[0109] Advantageously, the TERM system 10 includes one or more electrodes 11, which are further configured to be noninvasively placed on muscle groups that have a relevant role in the inspiratory phase of breathing. It should be noted that, according to this more preferred embodiment, the one or more electrodes 11 can be configured to be placed in different areas of the patient's torso, as long as they are configured to be placed on any part of the diaphragm.

[0110] In another preferred embodiment of any of the first aspects of this disclosure, when the processor is configured to actuate the TERM system 10 during the expiratory phase of the respiratory state, the one or more electrodes 11 are configured to be placed in the anterior, lateral and / or posterior regions of the patient's torso.

[0111] It should be noted that the expiratory phase of breathing involves many muscles that can be stimulated from many different parts of the patient's body, including the anterior, lateral, and / or posterior regions of the trunk. Therefore, by configuring the TERM system 10 to include one or more electrodes 11 configured to be placed in the anterior, lateral, and / or posterior regions of the patient's trunk, the system is further configured to non-invasively stimulate the expiratory respiratory muscles.

[0112] More preferably, the one or more electrodes 11 are configured to be placed on the skin of the trunk closest to the expiratory respiratory muscles, as described below.

[0113] According to a more preferred embodiment of the first aspect of this disclosure, and as Figure 2 As shown in Figure A, the one or more electrodes 11 are configured to be placed on the patient's abdominal muscles 203, 203', oblique muscles, internal oblique muscles and / or transverse muscles 204, 204'.

[0114] Advantageously, the TERM system 10 includes one or more electrodes 11, which are further configured to be placed non-invasively on muscle groups that have relevant functions during the expiratory phase of breathing.

[0115] It should be noted that, according to this preferred embodiment, the one or more electrodes 11 may be configured to be placed in different areas of the patient's trunk, such as at the anterior superior iliac spine and inclined along the costal margin toward the xiphoid process 203, 203', or at the intersection of the posterior midline of the axilla and the iliac crest and at an angle to the midline of the axilla 204, 204', as long as they are configured to be placed on any part of the abdominal muscles, oblique muscles, internal oblique muscles and / or transverse muscles.

[0116] In another preferred embodiment of any of the embodiments of the first aspect of this disclosure, and as Figure 1 As shown, the system 100 also includes at least one electromyography (EMG) sensor 40, which is configured to measure the activity of one or more respiratory muscles of the patient.

[0117] An EMG sensor is a sensor configured to record the electrical activity of a patient's muscles. It should be noted that the EMG sensor 40 can be of different types, including bipolar electrodes. Advantageously, the system 100, including at least one EMG sensor, can further utilize the activity of one or more respiratory muscles of the patient measured by the EMG sensor to modulate at least two electrical stimuli provided by the TERM system 10. This, in turn, can be used to infer different properties of the patient, such as muscle fatigue, respiratory cycle, maximal muscle contraction, and / or muscle fiber contraction rate, which can be used to adjust stimulation properties, such as amplitude and / or cycle. For example, if muscle fatigue is detected, it can be determined that a rest period of a certain time, such as one respiratory cycle, should be set until the fatigue subsides or until a predetermined time threshold is reached. Alternatively or additionally, the amplitude of the stimulation can be reduced to decrease fatigue induced by new stimulation.

[0118] It should be noted that, based on the above disclosure, those skilled in the art can envision that the TERM system 10 can be configured to ensure that muscle fatigue is controlled through many other different strategies, such as alternating different series of stimulation with rest series. Similarly, high-intensity electrical stimulation series can be alternating with low-intensity electrical stimulation series. These can even be combined. All the different possible combinations of these periodic and intensity variations that can be envisioned from the above are also included within the first aspect of this disclosure.

[0119] This further facilitates the provision of appropriate stimulation in complex environments and in complex patients, such as ICU patients, who are often unable to provide feedback on fatigue due to lack of autonomy and / or unconsciousness. If the stimulated respiratory muscles are fatigued, muscle recovery and / or strengthening may be impaired. Therefore, further including a device that monitors muscle fatigue while applying respiratory electrical stimulation is a highly preferred option.

[0120] It should be noted that Figure 1 Only one EMG sensor 40 is depicted in this description; however, in other embodiments of this preferred embodiment of the first aspect of this disclosure, the system 100 may include more than one EMG sensor. It should also be noted that when the system 100 includes more than one EMG sensor, the EMG sensors may be different from each other. The system 100 may include more than one EMG sensor to measure the activity of different respiratory muscles and / or for redundancy purposes.

[0121] According to a more preferred embodiment of the first aspect of this disclosure, the at least one EMG sensor 40 is a surface EMG (sEMG) sensor. Advantageously, this further ensures that the system 100 is non-invasive when using the EMG sensor, which in turn further simplifies its use in complex environments and critically ill patients, such as those in the ICU.

[0122] In a further preferred embodiment of the first aspect of this disclosure, and as Figure 2 As shown in Figure B, the at least one EMG sensor 40 is configured to be located on the sternocleidomastoid muscle 241, intercostal muscles 242, diaphragm 243, and / or rectus abdominis muscle 244. Advantageously, these muscles are easily accessible to patients in an ICU setting.

[0123] For example, and as Figure 2 As shown in Figure B, the at least one EMG sensor 40 may be configured to be located on the sternocleidomastoid muscle 241, at 20% of the distance between the mastoid process and the sternal notch, and on the line connecting them. In another example, the at least one EMG sensor 40 may be configured to be located on the intercostal muscles 242, at the second intercostal space, bilaterally to the parasternal line. In yet another example, the at least one EMG sensor 40 may be configured to be located on the diaphragm 243, at the lower border of the costal margin, bilaterally to the midclavicular line. In yet another example, the at least one EMG sensor 40 may be configured to be located on the rectus abdominis muscle 244, at the midclavicular line, at the level of the umbilicus.

[0124] It should be noted that Figure 2 B shows numerous electrode locations on the patient's torso, where, according to one or more embodiments of this preferred embodiment, the sEMG sensor 40 may not be configured to be placed. Therefore, many electrode locations can be alternative and / or can be used in other muscles or locations. It should also be noted that, according to… Figure 2 B. Each type of electrode location has one or two sEMG sensor 40 locations; however, in some embodiments according to this preferred embodiment, the TERM system 10 may include only one sEMG sensor 40 or more than two sEMG sensors 40 configured to be placed on such areas. Finally, it should be noted that areas 241-244 are indicated as circular. However, embodiments according to this preferred embodiment are not limited to the specific shape of each area 241-244 and may be different from those of other regions. Figure 2 The difference is shown in B. Furthermore, when the sEMG sensor is a bipolar sensor, Figure 2 Each region shown in B represents the location of two electrodes.

[0125] In another further preferred embodiment of the first aspect of this disclosure, the EMG sensor includes a reference electrode. It is preferably placed on the patient's sternum, ankle, or wrist. Advantageously, these locations provide a good reference element because they are readily accessible to bone and located away from the sEMG electrode.

[0126] Different patients have different physiological characteristics, meaning they require different electrical stimuli to effectively stimulate respiratory muscles and prevent muscle atrophy. In another preferred embodiment of any of the first aspects of this disclosure, the TERM system 11 is further configured to apply the at least two electrical stimuli suitable for the patient based on the patient's physiological, anthropometric, and / or demographic parameters. The at least two electrical stimuli are applied to the patient by adjusting the amplitude, frequency, shape, and / or duration of the at least two stimuli.

[0127] Advantageously, this further configures system 100 to provide effective stimulation suitable for the patient. Thus, given the patient's physiological, anthropometric, and / or demographic parameters, appropriate amplitude, frequency, shape, and / or duration of two or more stimuli can be effectively provided to the patient.

[0128] According to a more preferred embodiment of the first aspect of this disclosure, the anthropometry parameters include one or more parameters selected from: body mass index (BMI), skinfold, waist circumference, skin temperature, blood flow, bioimpedance measurement, baseline strength, and time value.

[0129] BMI, skinfold, and waist circumference are correlated with body fat mass and can therefore be used to estimate a user's body fat percentage. Since fat is stored between the skin and muscles, body fat can interfere with the delivery of the at least two stimuli to the respiratory muscles. Therefore, knowing a patient's BMI, skinfold, and / or waist circumference can be used to apply the at least two electrical stimuli appropriate for that patient.

[0130] Skin temperature is related to skin blood flow, which in turn is related to skin resistance. Therefore, knowing a patient's skin temperature and / or skin blood flow can be used to apply at least two electrical stimuli appropriate to the patient.

[0131] Bioimpedance indicates the body's resistance to electricity. Therefore, understanding a patient's bioimpedance can be used to apply at least two electrical stimuli appropriate to that patient.

[0132] Base intensity is the minimum current amplitude that, when applied for an infinite duration, will induce muscle fiber activation, while time value is the duration of current stimulation required for fiber activation, which is twice the stimulation of the base intensity. These variables provide information about the response of muscle fibers under different stimulation times and current amplitudes. Therefore, knowing the patient's base intensity and / or time value can be used to apply the at least two electrical stimuli appropriate to the patient.

[0133] It should be noted that, according to this more preferred embodiment of the first aspect of this disclosure, any combination of BMI, skinfold, abdominal circumference, skin temperature, blood flow, bioimpedance measurements, base intensity, and / or time value can be used to apply the at least two electrical stimuli suitable for the patient. It should also be noted that any of the above parameters can be used in different combinations to adapt the at least two electrical stimuli to different respiratory muscles.

[0134] According to another preferred embodiment of the first aspect of this disclosure, the system 100 further includes a device 50 for determining one or more anthropometric parameters selected from: skin temperature, blood flow, bioimpedance measurement, baseline strength, and time value.

[0135] Advantageously, the system 100, including a device 50 for determining one or more anthropometric parameters selected from: skin temperature, blood flow, bioimpedance measurements, base intensity, and time value, can further determine these anthropometric parameters without relying on external systems. This further simplifies the system 100, making it simpler, easier to control, and less invasive for medical personnel. For example, the device 50 for determining one or more anthropometric parameters can connect autonomously upon activation, making its use seamless for medical personnel and further facilitating the use of the system 100 for synchronized respiratory electromyography in ICU conditions.

[0136] In another preferred embodiment of any of the first aspects of this disclosure, the at least one sensor 20 for sensing the patient's respiratory status is included within a mechanical ventilation system. The mechanical ventilation system may include a mechanical ventilator and its accessories, which may be included in a typical setup, including nozzles and air inlets. Those skilled in the art will note the various accessories that may be connected to the mechanical ventilator in an ICU setting, all of which are considered to be included within the mechanical ventilation system in this disclosure.

[0137] Advantageously, when the at least one sensor 20 for sensing the patient's respiratory status is included within a mechanical ventilation system connected to the patient, no additional sensors are required to determine the patient's respiratory status. This reduces costs, system complexity (because sensors in the mechanical ventilation system are reused), and supervision of the resources required by staff (including additional sensors). The at least one sensor 20 can be included within a mechanical ventilation system connected to the patient in different ways. For example, the status of the mechanical ventilation system, or the flow meter of the mechanical ventilation system, or any other parameter or variable of the mechanical ventilation system, can be used as sensor 20. Based on this disclosure, those skilled in the art can envision many other different ways in which the at least one sensor 20 for sensing the patient's respiratory status can be included within a mechanical ventilation system connected to the patient.

[0138] It should be noted that in some embodiments of this preferred embodiment, when the system 100 includes more than one sensor 20, at least one sensor 20 is included within the mechanical ventilation system, while other sensors 20 may not be included within the mechanical ventilation system.

[0139] In another preferred embodiment of any of the first aspects of this disclosure, the at least two electrical stimulations are further adjusted based on mechanical ventilation-related variables, preferably including any one of the following: airway pressure (Paw), flow rate, and volumetric pressure. These mechanical ventilation-related variables can be appropriately synchronized with the patient's respiratory status because the respiratory status can be inferred from readings of one or more of these variables.

[0140] In another preferred embodiment of any of the first aspects of this disclosure, the biometric measurement is an electrocardiogram (ECG), and the monitoring device is an ECG monitoring device.

[0141] As shown in Example 1, the system for synchronous respiratory muscle electrical stimulation of a patient according to any embodiment of the first aspect of this disclosure can effectively stimulate the patient's respiratory muscles without affecting ECG measurement, so that ECG measurement can still be used by medical personnel and controlled by an automatic monitoring system.

[0142] A second aspect of this disclosure relates to a method for performing synchronized electrical stimulation using a system 100 for synchronized respiratory electromyography of a patient according to any embodiment of the first aspect of this disclosure. For example... Figure 3 As shown, the method includes the following steps.

[0143] In the first step 301, information about the patient's respiratory status is preferably received from sensor 20 connected to the mechanical ventilation system. It should be noted that the respiratory status can be received directly as a state, i.e., either inhalation or exhalation, or it can be received indirectly as a signal or a set of values ​​from which the respiratory status can be calculated. For example, an airflow measurement can be received, where the flow is depicted as positive if inserted into the patient and negative if withdrawn. Based on such a signal, the respiratory status can be calculated to be inhalation when the signal is positive and exhalation when the signal is negative.

[0144] In the second step 302, the method involves determining whether the respiratory state corresponds to a selected respiratory phase of the patient based on the information. Therefore, in this step, the received respiratory state is compared with a selected respiratory phase (which may be inspiratory and / or expiratory) of the patient of interest.

[0145] In the third step 303, the method involves instructing the processor 30 that the respiratory state corresponds to the selected respiratory phase of the patient when the respiratory state corresponds to the selected respiratory phase of the patient.

[0146] Advantageously, given that the system 100 for synchronized respiratory electromyography (EMG) of a patient according to any embodiment of the first aspect of this disclosure includes a TERM system 10 and a processor 30, and the processor 30 is configured to actuate the TERM system 10 during the inspiratory and / or expiratory phases of the respiratory state, when the processor 30 is instructed that the respiratory state corresponds to a selected respiratory phase of the patient, the patient's respiratory muscles are provided with at least two electrical stimulations, the intensity of which distorts one or more biometric measurements performed by one or more monitoring devices, and the period of the at least two electrical stimulations is at least 200 milliseconds. Therefore, the method according to the second aspect of this disclosure ensures synchronized electrical stimulation using the system 100 for synchronized respiratory EMG of a patient according to any embodiment of the first aspect of this disclosure.

[0147] In a preferred embodiment, the method according to the second aspect of this disclosure is a computer-implemented method.

[0148] A third aspect of this disclosure relates to a computer program product comprising instructions configured to perform the methods described in accordance with a second and / or a sixth aspect of this disclosure.

[0149] The fourth aspect of this disclosure relates to a system for synchronized respiratory electromyography stimulation of a patient according to any embodiment of the first aspect of this disclosure, the system further comprising at least one electromyography (EMG) sensor configured to measure the activity of one or more respiratory muscles of the patient.

[0150] Therefore, it should be understood that the fourth aspect of this disclosure relates to a system for synchronized respiratory electromyography in a patient, the system comprising: A transcutaneous electrical stimulation (TERM) system for respiratory muscles, comprising one or more skin electrodes configured to be placed on the respiratory muscles of a patient; At least one sensor is used to sense the patient's respiratory status; At least one electromyography (EMG) sensor is configured to measure the activity of one or more respiratory muscles in a patient; and The processor is configured to receive the patient’s respiratory status from the at least one sensor and to actuate the TERM system when the respiratory status is in the inspiratory and / or expiratory phases.

[0151] It should be noted that all notes, explanations and advantages relating to the TERM system, at least one sensor and processor in the first aspect of this disclosure shall be regarded as the same for the fourth aspect of this disclosure, with the necessary modifications.

[0152] Furthermore, in a fourth aspect of this disclosure, the processor is further configured to determine the fatigue level of the patient's respiratory muscles based on the activity recorded by the at least one EMG sensor, and to actuate the TERM system based on the fatigue state of the patient's respiratory muscles.

[0153] An EMG sensor is a sensor configured to record a patient's electrical muscle activity. It should be noted that EMG sensors can be of different types, including bipolar electrodes.

[0154] A system including at least one EMG sensor can further utilize the activity of one or more respiratory muscles in the patient measured by the EMG sensor to modulate at least two electrical stimuli provided by the TERM system. This, in turn, can be used to infer different properties of the patient, such as muscle fatigue, respiratory cycle, maximum muscle contraction, and / or muscle fiber contraction rate, which can be used to adjust stimulation properties, such as amplitude and / or cycle.

[0155] It should be noted that, based on the above disclosure, those skilled in the art can envision that the TERM system can be configured to employ many different strategies to ensure that muscle fatigue is controlled. For example, if muscle fatigue is detected, it can be determined that a rest period of a certain duration, such as one respiratory cycle, should be set until the fatigue subsides or until a predetermined time threshold is reached. Alternatively or additionally, the amplitude of the stimulus can be reduced to decrease fatigue induced by new stimuli.

[0156] Those skilled in the art will envision that the TERM system can be configured to ensure control of muscle fatigue using a variety of strategies, such as alternating different series of stimulation with rest series. Similarly, high-intensity electrical stimulation series can be alternating with low-intensity electrical stimulation series. These can even be combined. All the different possible combinations of these periodic and intensity variations conceivable from the above are also included within the first aspect of this disclosure.

[0157] Advantageously, the system for synchronous respiratory muscle electrical stimulation of a patient according to the fourth aspect of this disclosure can effectively ensure the provision of electrical stimulation to the respiratory muscles while preventing fatigue of the same muscle.

[0158] It should be noted that all preferred embodiments of the first aspect of this disclosure are also preferred embodiments of the fourth aspect of this disclosure, and their notes, explanations and advantages should be regarded as the same and modified as necessary.

[0159] The fifth aspect of this disclosure relates to a system (100) for patient-synchronized respiratory electromyography according to any embodiment of the first aspect of this disclosure, wherein the TERM system includes at least one calibrable element, and wherein the processor (30) is further configured to actuate the TERM system (10) in a predetermined manner according to a prior calibration.

[0160] Therefore, it should be understood that the fifth aspect of this disclosure relates to a system for synchronized respiratory electromyography in a patient, the system comprising: A transcutaneous electrical stimulation (TERM) system for respiratory muscles (10), the TERM system comprising one or more skin electrodes (11a, 11b) configured to be placed on the respiratory muscles of a patient; At least one sensor (20) is used to sense the patient's respiratory status; and The processor (30) is configured to receive the patient’s respiratory status from the at least one sensor (20) and actuate the TERM system (10) when the respiratory status is in the inspiratory and / or expiratory phases. The TERM system includes at least one calibrable element, and the processor (30) is further configured to actuate the TERM system (10) in a predetermined manner according to a previous calibration.

[0161] Advantageously, according to the first aspect of this disclosure, the TERM system includes at least one calibrable element and the processor (30) is further configured to actuate the TERM system (10) in a predetermined manner according to prior calibration, and the system (100) is capable of customizing synchronized respiratory electromyography stimulation according to the patient's physiology, medical condition, medical treatment and / or environment.

[0162] A preferred embodiment of the fifth aspect of this disclosure relates to a system (100) for synchronized respiratory electromyography of a patient according to any embodiment of the first aspect of this disclosure, wherein each of the one or more skin electrodes (11a, 11b) is a multi-field electrode including an anode and a cathode.

[0163] A multi-field electrode is a type of electrode that includes multiple distinct regions or fields within a single electrode unit. These fields can be selectively activated to allow precise targeting of specific muscle groups or regions, thus providing greater control in electrical stimulation therapy. The multi-field configuration enhances the flexibility of stimulation patterns, enabling more effective and focused treatment for respiratory muscle stimulation.

[0164] like Figure 6A and 6B As shown, a multi-field electrode can include different fields for the anode and cathode. This means that within the same electrode unit, there can be independent designated areas used as the anode and cathode, respectively. The spatial arrangement of these fields allows for the generation of currents that can be more accurately directed to stimulate the desired muscle area. By setting independent fields for the anode and cathode, the system can optimize the flow of electrical pulses, thereby improving the therapeutic effect. It should be noted that, although Figure 6A and 6BThe multi-field electrodes in the present invention have specific field distributions, field shapes, and field sizes, but the fifth aspect of this disclosure is not necessarily limited to the specific shape or relative arrangement of the fields, nor is it limited to a specific field size. It should also be noted that several fields can define a larger field, and therefore fields of different sizes can be defined by combining adjacent fields. Therefore, those skilled in the art will conceive of this. Figure 6A and 6B Many other alternatives to the multi-field electrodes disclosed herein are all included within the fifth aspect of this disclosure.

[0165] Furthermore, it should be noted that at any given time, only a portion or even just one field of the electrodes can be activated. Activating only a subset of the fields allows electrical stimulation to be focused on a specific location, reducing unnecessary stimulation of adjacent tissues, which could cause discomfort to the patient or interfere with the signal of another monitoring device.

[0166] In this preferred fifth aspect of the present disclosure, the processor (30) is further configured to actuate the one or more multi-field skin electrodes (11a, 11b) under a current within a predetermined field and a predetermined current range.

[0167] The term "predetermined field" refers to a specific field or region of a multi-field electrode that has been pre-selected for activation, as described below. Similarly, the term "predetermined current range" refers to a specific current range pre-selected based on the patient's treatment needs and tolerance level. This current range defines a set of values ​​within the minimum and maximum current levels that can be applied to the selected field of the electrode, as described below. By operating within this predetermined current range, the system ensures safe, controlled, and effective stimulation of the patient's condition without interfering with or distorting signals from other monitoring devices.

[0168] In this preferred fifth aspect of the present disclosure, the minimum value of the predetermined region and the predetermined current range has been predetermined according to a specific set of steps, as disclosed below.

[0169] It should be noted that although only the minimum value of the predetermined current range is provided, those skilled in the art can still deduce the current within that predetermined current range. For example, the current within the predetermined current range for which only the minimum value of the current range is provided may be that minimum value.

[0170] In this preferred fifth aspect of the present disclosure, the minimum values ​​of the predetermined region and the predetermined current range have been predetermined according to the following steps: a. Stimulate the first cathode field of the electrode at a minimum current. This minimum current is determined by the TERM system. It should be noted that the minimum current can be the minimum current that the TERM system can provide, a minimum current value predefined by the TERM system, or a minimum current value set by a technician into the TERM system based on the patient's body shape. For example, the minimum current can be 0 mA.

[0171] The first cathode field can be a random cathode field or a predefined cathode field. For example, the first cathode field can be the field of a multi-field electrode, which, when placed on the patient's respiratory muscles, is positioned between the 8th and 10th intercostal spaces at the level of the mid-axillary line. Those skilled in the art can envision many other alternatives in which the cathode field can be predefined as the first cathode field, for example, based on its position relative to other cathode fields or its position relative to a specific anatomical location when placed on the patient's respiratory muscles.

[0172] b. Increase the current from step a until a detectable respiratory muscle contraction occurs. This increase in current can be continuous or discrete, and different current rates can be used. It should be noted that respiratory muscle contraction can be detected in many different ways as can be conceived by those skilled in the art. For example, respiratory muscle contraction can be detected by an accelerometer, breathing belt, electromyography electrodes, or the same device. Alternatively, a computer vision system can determine the contraction through image recognition, or an additional object can provide such an indication. All of the above, and any other alternatives conceived by those skilled in the art, are considered to be included within the scope of this embodiment.

[0173] c. Associate the current in step (b) with the cathode field in step (a).

[0174] d. Repeat steps (a) through (c) for at least one additional cathode field of the one or more multi-field skin electrodes (11a, 11b). Thus, for each cathode field of the one or more multi-field skin electrodes, the minimum current that causes muscle contraction will be associated with that cathode field.

[0175] e. The cathode field that generates the minimum current required to detect respiratory muscle contraction is determined as the predetermined field, and the current required to generate detectable respiratory muscle contraction in the predetermined field is determined as the minimum value of the predetermined current range.

[0176] Therefore, it should be understood that this preferred fifth aspect of the disclosure relates to a system for synchronized respiratory electromyography in a patient, the system comprising: A transcutaneous electrical stimulation (TERM) system for respiratory muscles (10), the TERM system comprising one or more skin electrodes (11a, 11b) configured to be placed on the respiratory muscles of a patient; At least one sensor (20) is used to sense the patient's respiratory status; and The processor (30) is configured to receive the patient’s respiratory status from the at least one sensor (20) and actuate the TERM system (10) when the respiratory status is in the inspiratory and / or expiratory phases. Each of the one or more skin electrodes (11a, 11b) is a multi-field electrode including an anode and a cathode; The processor (30) is further configured to actuate the one or more multi-field skin electrodes (11a, 11b) under a current within a predetermined field and a predetermined current range. The minimum values ​​of the predetermined region and the predetermined current range have been predetermined according to the following steps: a. Stimulating the first cathode field of the electrode at a minimum current, wherein the minimum current is a minimum current determined by the TERM system; b. Increase the current in step (a) until detectable respiratory muscle contraction occurs; c. Associate the current in step (b) with the cathode field in step (a); d. Repeat steps (a) to (c) for at least an additional cathode field of the one or more multi-field skin electrodes (11a, 11b). e. The cathode field that generates the minimum current required to detect respiratory muscle contraction is determined as the predetermined field, and the current required to generate detectable respiratory muscle contraction in the predetermined field is determined as the minimum value of the predetermined current range.

[0177] Advantageously, as shown in Example 4, the system according to this preferred fifth aspect of the present disclosure ensures effective stimulation of the patient's respiratory muscles without distorting one or more biometric measurements performed by one or more monitoring devices.

[0178] In a more preferred embodiment of the fifth aspect of this disclosure, the processor is configured to actuate the TERM system during the inspiratory phase of the respiratory state.

[0179] In another preferred embodiment of the fifth aspect of this disclosure, step (d) includes repeating steps (a) to (c) for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40 or 50 additional cathode fields for the one or more multi-field skin electrodes (11a, 11b), preferably wherein the additional 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40 or 50 cathode fields are selected based on their proximity to the first cathode field.

[0180] In another preferred embodiment of the fifth aspect of this disclosure, step (d) includes repeating steps (a) to (c) for each cathode field of the one or more multi-field skin electrodes (11a, 11b).

[0181] In another preferred embodiment of the fifth aspect of this disclosure, at least one of the one or more skin electrodes (11a, 11b) includes a positioning mark (61) configured to guide placement on the patient's respiratory muscles. More preferably, each of the one or more skin electrodes (11a, 11b) includes a positioning mark (61) configured to guide placement on the patient's respiratory muscles.

[0182] The positioning marker (61) can be any visual or tactile element configured to indicate that a portion of the multifield electrode is configured to be placed on an anatomical site on the patient's body, such as the xiphoid process or the anterior superior iliac spine. For example, for one or more skin electrodes (11a, 11b) configured to be placed on inspiratory respiratory muscles, such as... Figure 6A As shown, a multifield electrode may include a positioning mark (61) located between the two anodes to indicate that, in use, the position should be placed on the xiphoid process. Similarly, for one or more skin electrodes (11a, 11b) configured to be placed on the expiratory respiratory muscles, as... Figure 6B As shown, the multifield electrode may include a positioning mark (61) located between each anode and cathode to indicate that, in use, the position should be placed on the anterior superior iliac spine. In this way, the positioning mark (61) is configured to guide placement on the patient's respiratory muscles. Those skilled in the art can envision many types of positioning marks, such as shapes, words, graphics, textures, and / or colors, that can be used to indicate that a portion of the multifield electrode is configured to be placed on a specific anatomical location on the patient's body, all of which are included in this embodiment.

[0183] In another preferred embodiment of the fifth aspect of this disclosure, when the processor is configured to actuate the TERM system during the inspiratory phase of the respiratory state, at least one of the one or more skin electrodes (11a, 11b), preferably each skin electrode, includes a positioning mark configured to guide placement on the patient's respiratory muscles, and a first cathode field is the field of a multi-field electrode positioned relative to the positioning mark, such that when placed on the patient's respiratory muscles, it is positioned between the 8th and 10th intercostal spaces at the level of the mid-axillary line.

[0184] Advantageously, the region between the 8th and 10th intercostal spaces at the midaxillary level is the region requiring the least current to generate respiratory muscle contraction. Therefore, by selecting the field of the multi-field electrode positioned relative to the positioning mark (such that it is placed between the 8th and 10th intercostal spaces at the midaxillary level when placed on the patient's respiratory muscles) as the first cathode field, the possibility of finding the predetermined field in the first measurement is increased.

[0185] In another more preferred embodiment of the fifth aspect of this disclosure, the maximum value of the predetermined current range has been predetermined according to the following steps: f. Stimulate the predetermined field determined in step (a) at the minimum value of the predetermined current range defined in step (e).

[0186] g. Increase the current from step (f) until detectable respiratory muscle contraction no longer increases further. This increase in current can be continuous or discrete, and different current rates can be used. Respiratory muscle contraction can be recorded using various methods, such as accelerometers, breathing belts, electromyographic electrodes, or the same device. Many alternatives can be envisioned by those skilled in the art, in which respiratory muscle contraction can be determined.

[0187] h. Finally, the minimum intensity required to provide maximum detectable respiratory muscle contraction in the predetermined field is determined as the maximum value of the predetermined current range. Since the minimum intensity required to provide maximum detectable respiratory muscle contraction is the minimum current required to achieve maximum detectable respiratory muscle contraction for this patient, it can be selected as the maximum value of the predetermined current range.

[0188] Advantageously, the system is further configured to provide a maximum value within a predetermined current range, which ensures the highest effectiveness of maximal respiratory muscle contraction at minimum current, thereby minimizing the risk of distortion in one or more biometric measurements performed by one or more monitoring devices. Furthermore, in conjunction with the minimum value, it defines the current range for effective respiratory muscle contraction that minimizes distortion in one or more biometric measurements performed by one or more monitoring devices.

[0189] In another preferred embodiment of the fifth aspect of this disclosure, steps (a) to (d) for determining the predetermined region and the minimum value of the predetermined current range are performed using a minimized cathode field, wherein the minimized cathode field is a cathode field smaller than the anode field. Therefore, during steps (a) to (d) of finding the minimum value of the predetermined region and the predetermined current range, the area of ​​the activated cathode field is smaller than the area of ​​the activated anode field. Advantageously, since current density is inversely proportional to area, the minimized cathode field has an increased current density, while the resolution of the cathode relative to the respiratory muscle increases, thereby allowing the optimal region to be found.

[0190] Then, according to this more preferred embodiment, the step of determining the predetermined region and the minimum value of the predetermined current range further includes, after step (d) and before step (e): d1. Select the cathode field that generates the minimum current required to detect respiratory muscle contraction as the minimized cathode field. In this step, the cathode field that generates the minimum current required to detect respiratory muscle contraction is selected from all cathode fields as the minimized cathode field. The term "minimized cathode field" refers to a cathode field with an area smaller than the activated anode field.

[0191] d2. Increase the area of ​​the cathode field to be the same as the area of ​​the anode field.

[0192] d3. Repeat steps (a) to (c) for each cathode field of the one or more multi-field skin electrodes (11a, 11b) including the minimized cathode field of step (d1).

[0193] Advantageously, the predetermined region selected in step (e) includes a minimized cathode region, i.e., a region with lower resolution that requires minimal current to produce detectable respiratory muscle contraction.

[0194] In another preferred embodiment of the fifth aspect of this disclosure, the processor is configured to actuate the TERM system during the inspiratory and expiratory phases of the respiratory state.

[0195] In another preferred embodiment of the fifth aspect of this disclosure, when the processor is configured to actuate the TERM system during the expiratory phase of the respiratory state, the predetermined current range has been predetermined according to the following steps: a. Stimulating the cathode field of the electrode at a minimum current, wherein the minimum current is a minimum current determined by the TERM system; b. Increase the current in step (a) until detectable respiratory muscle contraction no longer increases further; and c. The minimum intensity of detectable respiratory muscle contraction that no longer increases is determined as the maximum value of the predetermined current range.

[0196] In another preferred embodiment of the fifth aspect of this disclosure, the TERM system is configured to actuate the one or more multi-field skin electrodes (11a, 11b) using an anodic and cathode field with an area between 10 and 50 cm², preferably 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 cm². Advantageously, an area between 10 and 50 cm², preferably 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 or 50 cm², provides an appropriate area to achieve detectable muscle stimulation without causing pain to the patient.

[0197] In another preferred embodiment of the fifth aspect of this disclosure, the maximum value of the predetermined current range is determined as a factor of the minimum value of the predetermined current range, wherein the factor is selected based on the patient's body mass index.

[0198] Advantageously, the maximum value of the predetermined current range can be determined more quickly, reducing the time required to predetermine the current range.

[0199] It should be noted that all preferred embodiments of the first aspect of this disclosure are also preferred embodiments of the fifth aspect of this disclosure, and their notes, explanations and advantages should be regarded as the same and modified as necessary.

[0200] A sixth aspect of this disclosure relates to a computer-implemented method for determining the field and current ranges of one or more multi-field skin electrodes (11a, 11b) for actuating a system (100) for synchronized respiratory electromyography of a patient according to any embodiment of a first, fourth, or fifth aspect of this disclosure. Figure 7 As shown, the method includes the following steps.

[0201] In the first step 701, the first cathode field of the electrode is stimulated at a minimum current, which is a minimum current determined by the TERM system. It should be noted that the minimum current can be the minimum current that the TERM system can provide, or a minimum current value predefined by the TERM system, or a minimum current value set into the TERM system by a technician based on the patient's body shape. The first cathode field can be a random cathode field or a predefined cathode field. For example, the first cathode field can be the field of a multi-field electrode, which, when placed on the patient's respiratory muscles, is positioned between the 8th and 10th intercostal spaces at the level of the mid-axillary line.

[0202] In the second step 702, the method involves increasing the current from step 701 until a detectable respiratory muscle contraction occurs. This increase in current can be continuous or discrete. It should be noted that respiratory muscle contraction can be detected in many different ways as can be conceived by those skilled in the art. For example, respiratory muscle contraction can be detected by an accelerometer, breathing belt, electromyography electrodes, or the same device. Alternatively, a computer vision system can determine the contraction through image recognition, or an additional object can provide such an indication. All of the above, and any other alternatives conceived by those skilled in the art, are considered to be included within the scope of this embodiment.

[0203] In the third step 703, the method involves associating the current of step 702 with the cathode field of step 701.

[0204] The fourth step 704 of the method involves repeating steps 701 to 703 for at least an additional cathode field for the one or more multi-field skin electrodes (11a, 11b). Thus, for each cathode field of the one or more multi-field skin electrodes, the minimum current that would cause muscle contraction is associated with that cathode field.

[0205] Finally, step 705 of the method involves determining the predetermined field as the cathode field that minimizes the current required to generate detectable respiratory muscle contraction, and determining the minimum value of the predetermined current range in the predetermined field that minimizes the current required to generate detectable respiratory muscle contraction.

[0206] Advantageously, this method ensures that the field and current ranges of the one or more multi-field skin electrodes (11a, 11b) used to actuate the system (100) for synchronized respiratory electromyography (EMG) of any embodiment of the first, fourth, or fifth aspect of this disclosure are determined with consideration of the minimum current required to generate respiratory muscle contraction. In turn, this means that the stimulation provided by the TERM system (10) of the system (100) for synchronized respiratory EMG does not interfere with or distort the signal of another monitoring device, or interferes as little as possible. Therefore, the method according to the sixth aspect of this disclosure ensures that when electrical stimulation is performed using the system 100 for synchronized respiratory EMG of any embodiment of the first, fourth, or fifth aspect of this disclosure, interference with any other monitoring devices monitoring the patient is minimized. It should be noted that in the embodiments of the first, fourth, or fifth aspect of this disclosure where patients require respiratory assistance, they are typically continuously monitored, so it is crucial that TERM stimulation does not interfere with such monitoring.

[0207] It should be noted that, Figure 7 In the process, there are several steps indicated by dashed lines. These are optional steps, which will now be described in the preferred aspect of the sixth aspect of this disclosure.

[0208] In a preferred embodiment of the sixth aspect of this disclosure, step 704 includes repeating steps 701 to 703 for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 additional cathode fields for the one or more multi-field skin electrodes (11a, 11b), preferably wherein the additional 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 cathode fields are selected based on their proximity to the first cathode field.

[0209] In another preferred embodiment of the sixth aspect of this disclosure, step (d) includes repeating steps (a) to (c) for each cathode field of the one or more multi-field skin electrodes (11a, 11b).

[0210] In another preferred embodiment of the sixth aspect of this disclosure, such as Figure 7 As shown, the method also includes the following steps: In the sixth step 706, the predetermined field determined in step 705 is stimulated at the minimum value of the predetermined current range defined in step 705.

[0211] Then, in step 707, the current from step 706 is increased until detectable respiratory muscle contraction no longer increases further. This increase in current can be continuous or discrete, and different current rates can be used. Respiratory muscle contraction can be recorded using different methods, such as accelerometers, breathing belts, electromyographic electrodes, or the same device. Many alternatives can be envisioned by those skilled in the art, in which respiratory muscle contraction can be determined.

[0212] Finally, in step 708, the minimum intensity required to provide maximum detectable respiratory muscle contraction in the predetermined field is determined as the maximum value of the predetermined current range. Since the minimum intensity required to provide maximum detectable respiratory muscle contraction is the minimum amount of current required to achieve maximum respiratory muscle contraction for this patient, it can be selected as the maximum value of the predetermined current range.

[0213] Advantageously, the method of the sixth aspect of this disclosure ensures that the current range of the one or more multi-field skin electrodes (11a, 11b) used to actuate the system (100) for synchronized respiratory electromyography of a patient according to any embodiment of the first, fourth, or fifth aspect of this disclosure has a maximum value of the predetermined current range, which ensures the highest effectiveness of achieving maximum respiratory muscle contraction at minimum current, thereby minimizing the risk of distortion of one or more biometric measurements performed by one or more monitoring devices. Furthermore, in conjunction with the minimum value, it provides a current range that provides effective respiratory muscle contraction and minimizes distortion of one or more biometric measurements performed by one or more monitoring devices.

[0214] In another preferred embodiment of the sixth aspect of this disclosure, such as Figure 7 As shown, steps 701 to 704 for determining the predetermined region and the minimum value of the predetermined current range have been performed using a minimized cathode field, wherein the minimized cathode field is a cathode field smaller than the anode field, and the method further includes the following steps after step 704 and before step 705: According to step 7041, the cathode field that generates the minimum current required to detect respiratory muscle contraction is selected as the minimized cathode field. In this step, the cathode field that generates the minimum current required to detect respiratory muscle contraction is selected from all cathode fields as the minimized cathode field. The term "minimized cathode field" refers to a cathode field with an area smaller than the activated anode field.

[0215] Then, in step 7042, the area of ​​the cathode field is increased to be the same as the area of ​​the anode field.

[0216] Finally, in step 7043, steps 701 to 703 are repeated for each cathode field of the one or more multi-field skin electrodes (11a, 11b), including the minimized cathode field of step 7041.

[0217] Advantageously, the predetermined region selected in step 705 includes a minimized cathode region, i.e., a region with lower resolution that requires minimal current to produce detectable respiratory muscle contraction.

[0218] In another preferred embodiment of the sixth aspect of this disclosure, such as Figure 8As shown, when the processor is configured to actuate the TERM system during the expiratory phase of the respiratory state, the predetermined current range has been predetermined according to the following steps: In the first step 801, the cathode field of the electrode is stimulated at a minimum current, which is a minimum current determined by the TERM system. It should be noted that the minimum current can be the minimum current that the TERM system can provide, or a minimum current value predefined by the TERM system, or a minimum current value set into the TERM system by a technician based on the patient's body shape. The first cathode field can be a random cathode field or a predefined cathode field. For example, the first cathode field can be the field of a multi-field electrode, which, when placed on the patient's respiratory muscles, is positioned between the 8th and 10th intercostal spaces at the mid-axillary line level.

[0219] Then, in the second step 802, the current from step 801 is increased until detectable respiratory muscle contraction no longer increases further. This increase in current can be continuous or discrete, and different current rates can be used. Respiratory muscle contraction can be recorded using different methods, such as accelerometers, breathing belts, electromyographic electrodes, or the same device. Many alternatives can be envisioned by those skilled in the art, in which respiratory muscle contraction can be determined.

[0220] Finally, in step 803, the minimum intensity required to provide maximum detectable respiratory muscle contraction in the predetermined field is determined as the maximum value of the predetermined current range. Since the minimum intensity required to provide maximum detectable respiratory muscle contraction is the minimum amount of current required to achieve maximum detectable respiratory muscle contraction for this patient, it can be selected as the maximum value of the predetermined current range.

[0221] All of the above is entirely within the scope of this disclosure and is considered to form the basis of alternative embodiments in which one or more combinations of the above features may be applied, but are not limited to the specific combinations described above.

[0222] In view of this, many alternative solutions will be available to implement the teachings of this disclosure. It is anticipated that those skilled in the art, based on their common general knowledge in the field, will be able to modify and adapt the above disclosure to the extent appropriate to their own circumstances and requirements, while retaining some or all of the same technical effects within the scope of this disclosure, whether disclosed or derived from the foregoing. All such equivalents, modifications, or adaptations fall within the scope of this disclosure.

[0223] Example Example 1: The impact of TERM on ECG monitoring During stimulation therapy, we observed that the current applied by the device distorted measurements of biomedical signals recorded in the ICU. One of the key signals affected was the ECG, which requires continuous monitoring.

[0224] The objective is to determine whether TERM (transcutaneous electrical stimulation of respiratory muscles) interferes with ECG monitoring. Considerations include: 1) The position of the electrodes; 2) Current intensity.

[0225] method Position 1: Inhale - Side 1. Electrodes used for electrical stimulation should be placed in the inspiratory position - on the side: - Two electrodes are placed in the 7th intercostal space along the midaxillary line.

[0226] - The two electrodes are located in the paraxiphoid region.

[0227] 2. Electrical stimulation will begin at 0 mA and increase in increments of 5 mA.

[0228] 3. For each intensity value, the following should be recorded: a) Is there any distortion in ECG monitoring? b) Is distortion permissible? c) Does the distortion trigger a monitoring alarm? d) At the moment the electrical stimulation stops, does the distortion disappear, or does the distortion persist for a few seconds?

[0229] Position 2: Inhale - Rear 1. Electrodes used for electrical stimulation should be placed in the posterior inspiratory position: 2. Electrical stimulation will begin at 0 mA and increase in increments of 5 mA.

[0230] 3. For each intensity value, the following should be recorded: a) Is there any distortion in ECG monitoring? b) Is distortion permissible? c) Does the distortion trigger a monitoring alarm? d) At the moment the electrical stimulation stops, does the distortion disappear, or does the distortion persist for a few seconds?

[0231] Position 3: Exhale 1. Electrodes used for electrical stimulation should be placed in the expiratory position: - The two electrodes (2 and 3) are placed 2 cm below the costal margin and parallel to the costal margin, starting from the midline and diagonally downward in the lower lateral direction, toward the anterior superior iliac spine.

[0232] - Two electrodes (1 and 4) extend obliquely from the 8th rib at the midaxillary line toward the posterolateral aspect of the iliac crest, covering the two lower intercostal spaces, the posterolateral abdominal wall, and many nerves that innervate the abdominal muscles.

[0233] 2. Electrical stimulation will begin at 0 mA and increase in increments of 5 mA.

[0234] 3. For each intensity value, the following should be recorded: a) Is there any distortion in ECG monitoring? b) Is distortion permissible? c) Does the distortion trigger a monitoring alarm? d) At the moment the electrical stimulation stops, does the distortion disappear, or does the distortion persist for a few seconds?

[0235] result

[0236] in conclusion In the first embodiment, the following facts can be concluded: Even at low intensities (e.g., 5 mA), ECG distortion occurs. As explained later with respect to Example 3, to have an effect on the diaphragm, stimulation at an intensity of at least approximately 20 mA is required. Therefore, intensity is not an adjustable parameter to avoid ECG distortion.

[0237] - Distortion becomes unacceptable starting at 15 mA during lateral inspiration and expiration, and 30 mA during posterior inspiration. Since these intensity values ​​are not suitable for all individuals, electrode placement is also not adjustable.

[0238] - In the lateral inspiratory and expiratory positions, an alarm is triggered when the intensity of electrical stimulation is at least 15 mA.

[0239] - It was observed that once stimulation was stopped, the ECG returned to normal almost immediately.

[0240] Example 2: Effects of different stimulation frequencies on the quiescent phase of ECG monitoring Our aim was to acquire ECG signals subjected to electrical stimulation at 30 and 70 Hz and then attempt to filter them. We analyzed the recovery time and examined whether there were differences between the 30 and 70 Hz stimulation.

[0241] However, ECG is not the only signal affected by applied electrical stimulation. Other biomedical signals, such as EMG (electromyography) and EEG (electroencephalography), also experience this interference. - EMG: Used in the ICU to record muscle fatigue in patients (as in our case). It is used during sedation to assess patients' voluntary muscle activity and to analyze neuromuscular transmission in patients with neuromuscular disorders.

[0242] - EEG: Provides information about a patient's neuronal activity, and is therefore valuable for diagnosing epilepsy, detecting cerebral ischemia, monitoring the depth of sedation, and assessing conditions such as encephalopathy or encephalitis.

[0243] method Measurements were taken in leads 1 and 2 (D. I and D. II, respectively). Four different recordings were made.

[0244] Record 1 Place the ECG recording electrodes as is standard procedure for ICU mechanical ventilation. Position the ECG stimulation electrodes in the inspiratory position.

[0245] - Two electrodes are placed in the 7th intercostal space along the midaxillary line.

[0246] - Two electrodes are located in the region beside the xiphoid process.

[0247] Stimulation was performed using the following parameters: - Sufficient intensity (not causing pain, but the stimulus is visually noticeable or noticeable to the subject); - Stimulation frequency is 30 Hz; - Pulse duration is 350 μs; - Working time: 4 seconds; Rest time: 5 seconds.

[0248] Record for 3 minutes = 180 seconds. Use 15mA for 2 minutes and 20mA for 1 minute.

[0249] Record 2 Place the ECG recording electrodes as per standard ICU mechanical ventilation procedures. Position the ECG stimulation electrodes in the inspiratory position.

[0250] - Two electrodes are placed in the 7th intercostal space along the midaxillary line; - Two electrodes are located in the region beside the xiphoid process.

[0251] Stimulation was performed using the following parameters: - Sufficient intensity (not causing pain, but the stimulus is visually noticeable or noticeable to the subject); - Stimulation frequency is 70 Hz; - Pulse duration is 350 μs; - Working time: 4 seconds; Rest time: 5 seconds.

[0252] Record for 3 minutes = 180 seconds. 1 minute uses 15mA; 1 minute uses 20mA; 1 minute uses 23mA.

[0253] Record 3 Place the ECG recording electrodes as per standard ICU mechanical ventilation procedures. Position the ECG stimulation electrodes in the expiratory position.

[0254] Stimulation was performed using the following parameters: 1. Sufficient intensity (not causing pain, but the stimulus is visually noticeable or noticeable to the subject); 2. The stimulation frequency is 30Hz; 3. The pulse duration is 350 μs; 4. Working time: 4 seconds; Rest time: 5 seconds Recording for 3 minutes = 180 seconds: 9mA for 30 seconds, 15mA for 30 seconds, 20mA for 30 seconds, 25mA for 1 minute, and 27mA for 30 seconds.

[0255] Record 4 Place the ECG recording electrodes as per standard ICU mechanical ventilation procedures. Position the ECG stimulation electrodes in the expiratory position.

[0256] Stimulation was performed using the following parameters: - Sufficient intensity (not causing pain, but the stimulus is visually noticeable or noticeable to the subject); - Stimulation frequency is 70 Hz; - Pulse duration is 350 μs; - Working time: 4 seconds; Rest time: 5 seconds.

[0257] Recording for 3 minutes = 180 seconds: 9mA for 30 seconds, 15mA for 30 seconds, 18mA for 1 minute, 20mA for 30 seconds, and 25mA for 30 seconds.

[0258] For each of these records, ECG signal recovery was measured using both manual and spectrogram analysis methods.

[0259] The spectrum analysis is performed as follows: Obtain the spectrogram using a Hamming window with a window size of 60 samples and an overlap of 20 samples.

[0260] 1. Calculate the signal energy using a window of 20 samples to obtain a measurement on the order of approximately 0.1 seconds (minimum observable). Calculations start from 40 Hz.

[0261] 2. Using a threshold of 450 energy units to detect the peak value and a threshold of 100 energy units to treat it as ECG information, calculate the time between the last maximum peak value and the next threshold for each cycle.

[0262] result Detailed capture of lead 1 at 20mA is recorded as follows: Figure 4 As shown in Figure A, the detailed capture of lead 2 at 23mA is as follows. Figure 4 As shown in B, the detailed capture of lead 1 at 27mA is as follows: Figure 4 As shown in C, and the detailed capture of lead 4 recorded at 23mA, as shown in Figure 4. Figure 4 As shown in D.

[0263] The resting period required for clinically useful ECG signals to recover is as follows: Manual method (measured in seconds):

[0264]

[0265]

[0266]

[0267]

[0268] Spectrum method (measured in seconds):

[0269]

[0270]

[0271]

[0272] in conclusion Attempts were made to filter the interference using a simple filter, but unreliable results were not obtained. The interference consisted of high frequencies, but fell within the ECG frequency range (0-100 Hz), therefore, we were losing necessary ECG information. There was no very significant difference between 30 and 70 Hz, so the idea of ​​changing the stimulus frequency was abandoned, as it seemed impossible to avoid the resulting noise, since the noise was embedded in the signal being recorded.

[0273] At first glance, the amplitude of the interference increases with the intensity. However, the recovery time remains the same.

[0274] There was no difference in amplitude or time when using different frequencies (30Hz and 70Hz); see [link to relevant documentation]. Figure 4 A to 4D. There is no amplitude difference between records 1 and 3 and records 2 and 4.

[0275] The amplitudes differed between the different leads (Di and D.ii); the interference amplitude was greater in DII. However, the recovery time remained unchanged (see results in the table above).

[0276] There was no difference in amplitude or duration between different positions (inhalation and exhalation).

[0277] ECG recovery time is defined as the time from when the interference stops at its maximum and the ECG signal begins to reappear until the interference is completely eliminated. ECG recovery time varies in each cardiac cycle, but ranges from 200 milliseconds to 1 second (in extreme cases). Based on these values, and assuming we want to recover at least two respiratory cycles to calculate heart rate, we suggest that the expected minimum time between stimulations could be 1 second plus 2 cardiac cycles, although some patients may achieve the same effect with shorter stimulation intervals, and some other biometric measurements may not require any specific number of cycles to recover, or may require a different number of cycles to perform certain measurements.

[0278] Example 3: Analysis of the effects of electrical stimulation via diaphragmatic pressure The ultimate goal of this study was to quantitatively demonstrate the beneficial effects of TERM in ICU patients. To this end, transdiaphragmatic pressure (Pdi) was measured as an indicator of inspiratory effort. Measurement of transdiaphragmatic pressure is fundamental to assessing diaphragmatic function as it represents the pressure across the diaphragm. During inspiration, diaphragmatic contraction produces two effects: first, it pushes the viscera downward and displaces the abdomen outward; second, it reduces pleural pressure, thereby expanding the lungs. The pressure generated by the diaphragm can be obtained by measuring the instantaneous difference between esophageal pressure (Pes) and gastric pressure (Pga) using a differential pressure sensor.

[0279] Research Design Researchers selected two ICU patients for inclusion in the study because they met the eligibility criteria collected in the protocol report. It is also important to note that all patients were under controlled ventilation, meaning the ventilator was responsible for the entire respiratory process, and the subjects' inspiratory effort was negligible.

[0280] The intervention involved receiving TERM stimulation in the chest and abdomen, with intensity increased to the point of visible muscle contraction or according to physician standards (maximum 100 mA), at a frequency of 30 Hz and a pulse width of 350 μs. Electrodes were placed to stimulate the inspiratory muscles. - Two electrodes are placed in the 7th intercostal space along the midaxillary line; - Two electrodes are located in the xiphoid process region.

[0281] For each patient and in each recording, the stimulus intensity was varied according to the subject's anthropometric variables to maximize efficacy while avoiding any discomfort. The table below shows the intensity values ​​observed in the recordings:

[0282] Each session will consist of four 4-minute (240-second) transdiaphragmatic pressure (Pdi) recordings from each patient. Each Pdi recording will include two minutes without TERM and two minutes with TERM. During the two-minute TERM recording, the stimulation cycle will be 10 seconds: 5 seconds working and 5 seconds rest, which translates to a stimulation frequency of 0.1 Hz. There will be a washout period of at least 5 minutes between recordings to allow the Pdi amplitude to return to baseline.

[0283] The analytical protocol aims to measure inspiratory effort, defined as the inspiratory negative swing of esophageal pressure during Cheyne-Stokes respiration. Transdiaphragmatic pressure will be obtained by simultaneously measuring esophageal and gastric pressures. Pdi will be calculated as the difference between Pga and Pes.

[0284] Material Electrical stimulation was applied using NeuroTrac® MyoPlus 2 (Verity Medical Ltd. Churchtown HouseTagoat, Co. Wexford Ireland).

[0285] - The software used to record respiratory muscle effort variables over a 4-minute period is FluxMed™, MBMED BuenosAires, Argentina, connected to an ICU ventilator.

[0286] The esophageal and gastric balloon (Nutrivent, Sidam, Italy) is connected to a pressure sensor that is linked to the FluxMed™ monitoring system.

[0287] The software MATLAB (version R202.a, MathWorks Inc., Natick, MA, USA) was used for the processing and analysis of the acquired data.

[0288] method The method begins with time-domain analysis of signals with TERM (hereinafter referred to as record number followed by 't') and signals without TERM (hereinafter referred to as record number without 't').

[0289] Following time-domain observation and analysis, spectral analysis is performed. Spectral analysis is the process of decomposing a signal into its frequency components, that is, examining which frequencies constitute the signal. Spectral analysis helps in understanding the frequency content of a signal, identifying patterns, and extracting relevant information.

[0290] Based on the FFT results, a high-pass filter (HPF), a low-pass filter (LPF), and a band-pass filter (BPF) are used to select the frequency of most interest.

[0291] Finally, the last method used to obtain the desired values ​​is window analysis, which can identify and quantify variations or interferences in the critical path of the signal, as well as visualize differences between signal categories. In this case, the window size is set to 15 seconds, designed to cover a complete respiratory cycle, including inspiration and expiration. To illustrate variations in cycle length, as respiratory rate may fluctuate slightly, a 3-second overlap is introduced between consecutive windows. This overlap ensures that critical information is not missed.

[0292] The primary objective of these methods is to analyze and compare the effects of TERM on the transdiaphragmatic pressure signal. Therefore, subsequent phases of the study involve identifying differences between stimulated and unstimulated signals. Once these differences are identified, the study aims to demonstrate that they do indeed lead to the increase in pressure. This increase is quantified by calculating the transdiaphragmatic pressure increment (Δpdi), also known as the transdiaphragmatic pressure oscillation. Δpdi is defined as the difference between the maximum and minimum pressure values ​​during each inspiration, providing an indicator of respiratory effort.

[0293] result The first batch of results obtained are summarized in Figure 5 In A and 5B, the transdiaphragmatic pressure increment was calculated to compare values ​​between recordings with and without TERM. It is worth noting that the term "trial" refers to each respiratory cycle during a single recording.

[0294] In addition, another informative analysis involved comparing the maximum Δpdi value with the initial Δpdi measurement taken without stimulation (also known as the baseline measurement). This evolution can be observed in the table below, which records the maximum value reached for each intensity, allowing us to assess the increments.

[0295]

[0296] in conclusion The minimum stimulus intensity required to produce an optimal effect on the diaphragm is 60 mA, although this varies depending on the patient's body mass index. While further research with more diverse patients is needed, it appears that the minimum intensity required to produce an optimal effect on the diaphragm is less than 20 mA in any case.

[0297] When comparing signals without and with TERM, we observed a common factor in all recordings: frequency activity around 0.1 Hz (the frequency at which we were stimulating). If we isolate this activity, we find that it contributes approximately 1 cmH2O to the increase in transdiaphragmatic pressure.

[0298] Example 4: Analysis of current determination within a predetermined field and current range using multi-field electrodes in a TERM system. The ultimate goal of this study is to determine a feasible method to identify the range of fields and currents that can generate detectable respiratory muscle contractions and minimize or eliminate distortion in one or more biometric measurements performed by one or more monitoring devices.

[0299] Research Design A) Multi-field electrode The multi-field electrode was divided into four multi-field surface electrodes and applied to the subject's torso.

[0300] These electrodes connect to an electrical stimulator and are designed to guide electrical currents and assist the patient's inhalation and exhalation. The multi-field electrode system allows for selective neural stimulation, tailored to the individual needs of each subject.

[0301] Four electrodes were used, each with two sets of pads: an anode (current emitter) and a cathode (current receiver). - Two electrodes for inhalation (one on each side of the torso) as follows Figure 6A As shown. These electrodes are designed to cover the anatomical areas described in the literature for stimulating inspiratory muscles.

[0302] - Two electrodes for exhalation (one on each side) as follows Figure 6B As shown. These electrodes are designed to cover the anatomical areas described in the literature for stimulating the expiratory muscles.

[0303] B) Electrode placement Electrodes should be placed according to standard anatomical reference points. For inspiratory electrodes, the xiphoid process is used as a reference point, and the electrode extends posteriorly to reach the intercostal region.

[0304] The expiratory electrode should be placed with the cathode close to the anterior superior iliac spine and obliquely towards the xiphoid process. The anode of the expiratory electrode should be located on the posterolateral abdominal wall, towards the 8th rib at the midaxillary line.

[0305] C) Subjects Fourteen volunteer subjects were recruited to participate in the study, and they were provided with detailed information about the study objectives and potential risks.

[0306] Figure 9 A table containing information about the volunteers participating in the study is displayed. The table includes their sex, age, body mass index (BMI), and relevant anthropometry measurements. The anthropometry measurements relate to anatomical regions of interest, including the distance between the xiphoid process of the sternum and the midaxillary line, and the distance between the umbilicus and the midaxillary line. The first measurement is compared with the inspiratory multifield electrode (…). Figure 6A The second measurement is related to the expiratory multi-field electrode ( ). Figure 6B (Related to)

[0307] D) Calibration - Calibration of the inhalation electrode To determine the field and current ranges used to actuate one or more inspiratory multi-field skin electrodes, the following steps were taken: a. Stimulating the first cathode field of the electrode at a minimum current; wherein the minimum current is a minimum current determined by the TERM system. In this case, the minimum current is set to 0 mA.

[0308] b. Increase the current in step (a) until detectable respiratory muscle contraction occurs; c. Associate the current in step (b) with the cathode field in step (a); d. Repeat steps (a) to (c) for at least an additional cathode field of the one or more multi-field skin electrodes (11a, 11b). d1. Select the cathode field that generates the minimum current required to detect respiratory muscle contraction as the minimized cathode field; d2. Increase the area of ​​the cathode field to be the same as the area of ​​the anode field; d3. Repeat steps (a) to (c) for each cathode field of the one or more multi-field skin electrodes (11a, 11b) including the minimized cathode field of step (d1). e. The cathode field that generates the minimum current required to detect respiratory muscle contraction is determined as the predetermined field, and the current required to generate detectable respiratory muscle contraction in the predetermined field is determined as the minimum value of the predetermined current range. f. Stimulate the predetermined field determined in step (e) at the minimum value of the predetermined current range defined in step (e); g. Increase the current in step (f) until detectable respiratory muscle contraction no longer increases further; and h. The minimum intensity that provides the maximum detectable respiratory muscle contraction in the predetermined field is determined as the maximum value of the predetermined current range.

[0309] All of these are based on Figure 7 The process was carried out. Specifically, the following steps were taken: 1. Initially, the anode region is fixed by activating pads 1 and 2. Pads 3 and 4 are reserved for extreme cases of body mass index, where contraction is insufficient under the established current amplitude limit.

[0310] 2. Select the first cathode field to be examined from the cathode fields located within the anatomical region, wherein the anatomical region is the area between the 8th and 10th intercostal spaces along the midaxillary line.

[0311] 3. Calibration begins with a current amplitude of 0 mA and gradually increases until the first visible and palpable muscle contraction is detected, as determined by an expert operator, and is tolerable to the subject. At this point, the current amplitude is recorded as the motor threshold (MLT). ).

[0312] 4. Next, with the same current intensity ( The process explores adjacent points in ascending order to determine the optimal placement of the cathode to approximate the motion point, where minimal visible and tangible muscle contraction is generated. If a field is found capable of achieving contraction at a lower intensity, it is designated as the motion threshold field, and the new intensity is recorded as the new motion threshold. ).

[0313] 5. Once the motion threshold pad is identified, test the combination of pads around it to form a 5x5 cm area, and check which one provides the lowest current intensity and the greatest comfort. C, INSP This provides the maximum visible and accessible shrinkage.

[0314] For safety reasons, a maximum current amplitude limit of 90 mA has been established. This amplitude is lower than the maximum current value of commercial electrical stimulation devices and has been verified as a safe parameter by muscle electrical stimulation experts.

[0315] Different combinations of stimulation were explored to identify areas that allowed for selective contraction, prioritizing pads that produced the greatest visible and palpable muscle contraction. In the data collection notebook, activated pads and corresponding electrical intensities, including the motor threshold, were recorded. ) and optimal contraction ( C, INSP ).

[0316] - Calibration of expiratory electrodes To determine the field and current ranges used to actuate one or more expiratory multi-field skin electrodes, the following steps were taken: a. Stimulating the cathode field of the electrode at a minimum current, wherein the minimum current is a minimum current determined by the TERM system; b. Increase the current in step (a) until detectable respiratory muscle contraction no longer increases further; and c. The minimum intensity of detectable respiratory muscle contraction that no longer increases is determined as the maximum value of the predetermined current range.

[0317] All of these are based on Figure 8 conduct.

[0318] In this scenario, based on the subject's BMI, anodic and cathodic fields are selected to seek maximum contraction of the expiratory muscles (posterolateral abdominal wall), causing them to contract and form what is known as a "wasp waist."

[0319] Materials and methods The following materials were used to carry out the research plan: - Stimulator: STIM 2.1, a stimulator designed by Tecnalia or Myoplus Neurotrac stimulator.

[0320] - Multi-field electrodes: manufactured in-house by TESAI CARE SL.

[0321] - Control system: Demultiplexing plate between electrodes and stimulator to determine which pads are activated.

[0322] - Hydrogel: Axelgaard hydrogel AG2530 / AG735.

[0323] In all cases, the relationship between threshold contraction (the minimum current required to produce detectable respiratory muscle contraction) and maximum contraction strength is evaluated to determine whether a relationship exists between the two values.

[0324] result The results of the predetermined electrode and the predetermined maximum strength range can be obtained Figure 9 Found it.

[0325] The research results on the relationship between threshold strength and maximum shrinkage strength can be found in Figure 10 Found it.

[0326] in conclusion The proposed method is able to determine the field (pad or pad group) within a multi-field electrode and the current range for actuating one or more multi-field skin electrodes for a specific patient, which can produce detectable respiratory muscle contraction without distorting or minimizing distortion of one or more biometric measurements performed by one or more monitoring devices.

[0327] also, Figure 11A graph was displayed showing the relationship between threshold strength and maximum contractile strength for all patients at each body mass index. Without considering BMI, the mean would be 2.58, the maximum 4.3, and the minimum 1.67. Therefore, using a factor of 2.58 for everyone would be risky, as it might be uncomfortable in some cases and ineffective in others. To attempt to personalize the value by range, a scatter plot was created and the mean was calculated for each range: for example, BMI below 24, BMI between 24 and 28, and BMI above 28. Thus, the mean is more personalized.

[0328] It should be noted that the methods described herein are based on one or more embodiments of this disclosure.

Claims

1. A system (100) for synchronized respiratory electromyography in a patient, the system comprising: A transcutaneous electrical stimulation (TERM) system for respiratory muscles (10) comprising one or more skin electrodes (11a, 11b) configured to be placed on the respiratory muscles of the patient; At least one sensor (20) is used to sense the patient's respiratory status; as well as The processor (30) is configured to receive the patient’s respiratory state from the at least one sensor (20) and actuate the TERM system (10) when the respiratory state is in the inspiratory phase. Each of the one or more skin electrodes (11a, 11b) is a multi-field electrode including an anode and a cathode; The processor (30) is further configured to actuate the one or more multi-field skin electrodes (11a, 11b) under a current within a predetermined field and a predetermined current range. The minimum values ​​of the predetermined region and the predetermined current range have been predetermined according to the following steps: a. Stimulating the first cathode field of the electrode at a minimum current, wherein the minimum current is a minimum current determined by the TERM system; b. Increase the current in step (a) until detectable respiratory muscle contraction occurs; c. Associate the current in step (b) with the cathode field in step (a); d. Repeat steps (a) to (c) for at least an additional cathode field of the one or more multi-field skin electrodes (11a, 11b). e. The cathode field that generates the minimum current required to detect respiratory muscle contraction is determined as the predetermined field, and the current required to generate detectable respiratory muscle contraction in the predetermined field is determined as the minimum value of the predetermined current range.

2. The system of claim 1, wherein at least one of the one or more skin electrodes (11a, 11b) includes a positioning mark configured to guide placement on the respiratory muscles of the patient, and wherein the first cathode field is a field of a multi-field electrode positioned relative to the positioning mark, such that when placed on the respiratory muscles of the patient, it is positioned between the 8th and 10th intercostal spaces at the level of the mid-axillary line.

3. The system according to any one of the preceding claims, wherein the maximum value of the predetermined current range has been predetermined according to the following steps: f. Stimulate the predetermined field determined in step (e) at the minimum value of the predetermined current range defined in step (e); g. Increase the current in step (f) until the detectable respiratory muscle contraction no longer increases further; and h. The minimum intensity that provides the maximum detectable respiratory muscle contraction in the predetermined field is determined as the maximum value of the predetermined current range.

4. The system according to any one of the preceding claims, wherein steps (a) to (d) for determining the minimum values ​​of the predetermined region and the predetermined current range are performed using a minimized cathode field, wherein the minimized cathode field is a cathode field smaller than the anode field, and The step of determining the minimum value of the predetermined region and the predetermined current range further includes, after step (d) and before step (e): d1. Select the cathode field that generates the minimum current required to detect respiratory muscle contraction as the minimized cathode field; d2. Increase the area of ​​the cathode field to be the same as the area of ​​the anode field; d3. Repeat steps (a) to (c) for each cathode field of the one or more multi-field skin electrodes (11a, 11b) that include the minimized cathode field of step (d1).

5. The system according to any one of the preceding claims, wherein the TERM system is configured to actuate the one or more multi-field skin electrodes (11a, 11b) using an anodic field and a cathode field with an area of ​​10 to 50 cm².

6. The system according to any one of the preceding claims, wherein when the processor is configured to actuate the TERM system (10) during the inspiratory phase of the respiratory state, the one or more electrodes (11) are configured to be placed in the anterior, lateral and / or posterior regions of the patient's trunk, more preferably on the patient's external intercostal muscles (201) and / or diaphragm (202).

7. The system according to any one of the preceding claims, wherein the processor (30) is further configured to actuate the TERM system (10) when the respiratory state is in the expiratory phase.

8. The system of claim 7, wherein when the processor (30) is configured to actuate the TERM system (10) during the expiratory phase of the respiratory state, the one or more electrodes (11) are configured to be placed on the patient's abdominal muscles (203), oblique muscles (204), internal oblique muscles (204') and / or transverse muscles (205).

9. The system according to any one of the preceding claims, wherein the system (100) further comprises at least one electromyography (EMG) sensor (40) configured to measure the activity of one or more respiratory muscles of the patient, preferably wherein the at least one EMG sensor (40) is a surface EMG sensor.

10. The system according to any one of the preceding claims, wherein the at least one sensor (20) for sensing the patient’s respiratory status is included within the mechanical ventilation system.

11. The system according to any one of the preceding claims, wherein the TERM system (10) is configured to apply at least two electrical stimuli, the intensity of which distorts one or more biometric measurements performed by one or more monitoring devices, and the period between consecutive electrical stimuli is at least 200 milliseconds.

12. The system of claim 11, wherein the one or more biometric measurements require a minimum measurement period to obtain the parameter of interest, and wherein the period between the continuous electrical stimulations is extended by an additional period corresponding to the measurement period required for the one or more biometric measurements.

13. The system of claim 11 or 12, wherein the intensity of distortion of one or more biometric measurements performed by one or more monitoring devices is at least 20 mA.

14. The system according to any one of claims 11 to 13, wherein the intensity of distortion of one or more biometric measurements performed by one or more monitoring devices is at least 60 mA.

15. The system according to any one of claims 11 to 14, wherein the period is at least 325 milliseconds, more preferably at least 1 second.

16. The system according to any one of claims 11 to 15, wherein the TERM system (10) is further configured to apply at least two electrical stimuli suitable to the patient by adjusting the amplitude, frequency, shape and / or duration of the at least two stimuli based on the patient's physiological, anthropometry and / or demographic parameters, preferably wherein the anthropometry parameters include one or more parameters selected from: BMI, skinfold, abdominal circumference, skin temperature, blood flow, bioimpedance measurement, base intensity and time value.

17. The system of claim 16, wherein the system (100) further comprises means (50) for determining one or more anthropometric parameters selected from: skin temperature, blood flow, bioimpedance measurement, baseline strength, and time value.

18. The system according to any one of claims 11 to 17, wherein the at least two electrical stimulations are further adjusted based on mechanical ventilation-related variables, preferably wherein the mechanical ventilation-related variables include any one of the following: airway pressure (Paw), flow rate, and volumetric pressure.

19. The system according to any one of claims 11 to 18, wherein the biometric measurement is an electrocardiogram (ECG) and the monitoring device is an ECG monitoring device.

20. The system according to any one of the preceding claims, wherein the system further comprises at least one electromyography (EMG) sensor configured to measure the activity of one or more respiratory muscles of the patient, and The processor (30) is further configured to determine the patient's respiratory muscle fatigue based on the activity recorded by the at least one EMG sensor; and The processor (30) is further configured to actuate the TERM system (10) taking into account the fatigue state of the patient's respiratory muscles.

21. A computer-implemented method for determining the field and current ranges of one or more multi-field skin electrodes (11a, 11b) for actuating a system (100) for synchronized respiratory electromyography of a patient according to any one of claims 1 to 20, the method comprising: a. Stimulating the first cathode field of the electrode at a minimum current, wherein the minimum current is a minimum current determined by the TERM system; b. Increase the current in step (a) until detectable respiratory muscle contraction occurs; c. Associate the current in step (b) with the cathode field in step (a); d. Repeat steps (a) to (c) for at least an additional cathode field of the one or more multi-field skin electrodes (11a, 11b). e. The cathode field that generates the minimum current required to detect respiratory muscle contraction is determined as the predetermined field, and the current required to generate detectable respiratory muscle contraction in the predetermined field is determined as the minimum value of the predetermined current range.

22. The computer-implemented method according to claim 21, wherein the method further comprises: f. Stimulate the predetermined field determined in step (e) at the minimum value of the predetermined current range defined in step (e); g. Increase the current in step (f) until the detectable respiratory muscle contraction no longer increases further; as well as h. The minimum intensity that provides the maximum detectable respiratory muscle contraction in the predetermined field is determined as the maximum value of the predetermined current range.

23. The computer-implemented method according to any one of claims 21 or 22, wherein steps (a) to (d) for determining a minimum value of the predetermined region and the predetermined current range are performed using a minimized cathode field, wherein the minimized cathode field is a cathode field smaller than the anode field, wherein the method further comprises, after step (d) and before step (e): d1. Select the cathode field that generates the minimum current required to detect respiratory muscle contraction as the minimized cathode field; d2. Increase the area of ​​the cathode field to be the same as the area of ​​the anode field; as well as d3. Repeat steps (a) to (c) for each cathode field of the one or more multi-field skin electrodes (11a, 11b) that include the minimized cathode field of step (d1).

24. A computer-implemented method for performing synchronized electrical stimulation using a system (100) for synchronized respiratory electromyography of a patient according to any one of claims 1 to 20, the method comprising: a) Receive information about the patient's respiratory status from a sensor (20) connected to the mechanical ventilator; b) Determine whether the respiratory state corresponds to the selected respiratory phase of the patient based on the information; c) When the respiratory state corresponds to the selected respiratory phase of the patient, instruct the processor (30) that the respiratory state corresponds to the selected respiratory phase of the patient; The selected breathing phase is chosen from the inspiratory phase and / or expiratory phase.

25. A computer program product comprising instructions configured to perform the method according to any one of claims 20 to 24.

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