Multi-electrode patch for MyoTrace measurements

Abstract

A streamlined system for non-invasively measuring a patient's neurorespiratory drive (NRD) index includes an EMG patch that provides three integrated EMG electrodes, two signal EMG electrodes to be located in the second intercostal space on either side of the sternum, and one reference EMG electrode to be located on the sternum above the two signal electrodes. Integrating all three EMG electrodes into a single patch allows a clinician to spend less time determining where to place the patch compared to having to determine the proper location of three separate EMG electrodes. Additionally, the disclosed system provides a single cable that can electrically connect to all three EMG electrodes when inserted into the plug of the EMG patch, thereby reducing cable clutter that would otherwise result from having to provide a separate cable for each EMG electrode.

Description

[Technical field]

[0001]

[01] The disclosed concepts relate to a system for quantifying a patient's respiratory effort, and in particular to a system for monitoring a patient's neuromuscular drive (NMD). [Background technology]

[0002]

[02] Electromyography (EMG) can be used to non-invasively assess a patient's respiratory status by monitoring the activity of the muscles involved in breathing, such as the intercostal spaces on either side of the sternum (parasternal), or the abdominal area near the diaphragm. EMG measurements of inspiratory muscle activity are an index of the balance between respiratory muscle load and respiratory muscle capacity, and can also be used to obtain an objective measure of respiratory effort. In particular, respiratory EMG activity measured during inspiration may be correlated with neural respiratory drive (NRD). NRD is the signal the brain outputs to the respiratory muscles and is an index of the balance between respiratory muscle load and respiratory muscle capacity.

[0003]

[03] Objective measures of respiratory muscle activity obtained from EMG signals are considered important for monitoring the respiratory status of patients, such as hospitalized patients with chronic obstructive pulmonary disease (COPD). Although respiratory rate is easily and non-invasively measured, respiratory rate does not indicate how much effort the patient is expending to breathe. For example, if a COPD patient and a relatively healthy person breathe at the same respiratory rate, it is understood that the COPD patient expends more effort to breathe at that respiratory rate than the healthy person, but the respiratory rate alone does not indicate how much effort each person is expending to breathe at that respiratory rate. In contrast, EMG activity of the respiratory muscles can be used to calculate NRD to provide an objective quantification of the effort a given patient requires to breathe at a particular respiratory rate, but EMG activity needs to be monitored at several locations on the patient's chest, requiring several electrodes and cables to be properly positioned and connected to the monitor. It should be understood that clinicians are often busy and each hour spent properly setting up equipment for NRD index calculation is time not spent interacting directly with the patient.

[0004]

[04] Thus, there is room for improvement in systems used to monitor neural respiratory drive. Summary of the Invention [Problem to be solved by the invention]

[0005]

[05] It is therefore an object of the present invention to provide a streamlined system for non-invasively measuring a patient's neural respiratory drive (NRD) index using a single EMG patch with three integrated EMG electrodes, two signal EMG electrodes to be located in the second intercostal spaces on either side of the sternum, and one reference EMG electrode to be located on the sternum above the two signal electrodes. The patch includes connector hardware with a socket structured to receive a plug of a single cable structured to electrically connect to all three EMG electrodes when inserted into the plug, thereby reducing cable clutter that would normally result from having to provide a separate cable for each EMG electrode in conventional EMG systems. [Means for solving the problem]

[0006] In one embodiment, an EMG patch for use with a neural respiratory drive monitoring system includes an adhesive layer structured to be adhered to a patient's chest and including a plurality of cutouts and structured to removably adhere the EMG patch to the patient's chest, a plurality of electrolyte gel pads corresponding to the plurality of cutouts, each gel pad inserted into a corresponding one of the plurality of cutouts to fill the cutout, a circuit coupled to the adhesive layer and structured to sense EMG signal activity during the patient's respiratory activity through each of the plurality of electrolyte gel pads, and connection hardware coupled to and electrically connected to the circuit and including a socket. The EMG patch is structured such that positioning the EMG patch on the patient's chest for EMG monitoring disposes a first cutout of the plurality of cutouts over a second intercostal space on a first side of the patient's sternum, a second cutout of the plurality of cutouts over a second intercostal space on a second side of the patient's sternum, and a third cutout of the plurality of cutouts on the patient's sternum. The socket is configured to receive a single cable structured to transmit all EMG signal activity sensed by the circuitry to a control device.

[0007]

[06] In another embodiment, a system for monitoring a patient's neural respiratory drive during breathing includes a controller configured to calculate a neural respiratory drive index based on received EMG signal activity, a single cable electrically connected to the controller, an EMG patch structured to adhere to the patient's chest, and connection hardware. The EMG patch includes an adhesive layer having a plurality of cutouts and structured to removably adhere the EMG patch to the patient's chest, a plurality of electrolyte gel pads corresponding to the number of cutouts, each gel pad inserted into a corresponding one of the plurality of cutouts to fill the cutout, and a circuit coupled to the adhesive layer and structured to sense EMG signal activity during the patient's respiratory activity through each of the plurality of electrolyte gel pads. The connection hardware includes a socket coupled to the circuit and a plug coupled to and electrically connected to the cable and structured to mate with the socket. The EMG patch is structured to position the EMG patch on the patient's chest for EMG monitoring such that a first cutout of the plurality of cutouts is disposed over a second intercostal space on a first side of the patient's sternum, a second cutout of the plurality of cutouts is disposed over a second intercostal space on a second side of the patient's sternum, and a third cutout of the plurality of cutouts is disposed at the patient's sternum. The cable is structured to transmit any EMG signal activity sensed by the circuitry to the controller.

[0008]

[07] A system for monitoring a patient's neural respiratory drive during breathing includes a single cable structured to electrically connect to a controller, an EMG patch, and connection hardware. The EMG patch is structured to removably adhere the EMG patch to the patient's chest and includes an adhesive layer with a plurality of electrolyte gel pad inserts, and a circuit coupled to the adhesive layer and structured to sense EMG signal activity during the patient's respiratory activity through each of the plurality of electrolyte gel pad inserts. The connection hardware includes a socket coupled to the circuit and a plug coupled to and electrically connected to the cable and structured to mate with the socket. The EMG patch is structured such that positioning the EMG patch on the patient's chest for EMG monitoring positions the circuit such that it can sense EMG signals that can be used to calculate a neural respiratory drive index. The cable is structured to send all EMG signal activity sensed by the circuit to the controller.

[0009]

[08] These and other objects, features, and characteristics of the present invention, its method of operation and function of its associated elements of structure, combination of parts, and economy of manufacture will become more apparent from a study of the following description and appended claims, with reference to the accompanying drawings, all of which form a part hereof, and in which like reference characters indicate corresponding parts in the various views. It is, however, to be expressly understood that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention. [Brief description of the drawings]

[0010] [Figure 1]

[09] FIG. 1 illustrates a known system used to monitor EMG activity during breathing. [Diagram 2]

[10] FIG. 1 illustrates a neural respiratory drive (NRD) monitoring system, according to an exemplary embodiment of the present invention. [Figure 3A]

[11] FIG. 3 is an elevational view of an adhesive underlayer of an EMG patch for use with the NRD monitoring system shown in FIG. 2, in accordance with an exemplary embodiment of the present invention. [Figure 3B]

[12] FIG. 3 is an elevational view of the adhesive layer of the EMG patch shown in FIG. 2, according to an exemplary embodiment of the present invention. [Figure 3C]

[13] FIG. 3C illustrates a cutout of the adhesive layer shown in FIG. 3B filled with an electrolyte gel pad, according to an exemplary embodiment of the present invention. [Figure 3D]

[14] FIG. 3D illustrates an EMG sensing circuit coupled to the configuration shown in FIG. 3C, according to an exemplary embodiment of the present invention. [Figure 3E]

[15] FIG. 3D illustrates an insulating hardware underlay coupled to the configuration shown in FIG. 3E, according to an exemplary embodiment of the present invention. [Figure 3F]

[16] FIG. 3F illustrates connection hardware coupled to the configuration shown in FIG. 3E, in accordance with an exemplary embodiment of the present invention. [Figure 4A]

[17] FIG. 3C is an elevation view of a socket component of the connector hardware shown in FIG. 3F in accordance with an exemplary embodiment of the present invention. [Figure 4B]

[18] FIG. 4B is a cross-sectional view of the socket component taken along line 4B-4B shown in FIG. 4A. [Figure 4C]

[19] FIG. 3F is an elevational view of the cable plug component of the connector hardware shown in FIG. 3F with a portion of the housing removed to show the internal components, according to an exemplary embodiment of the invention. [Figure 4D]

[20] FIG. 4D is an elevational view of the cable plug component shown in FIG. 4C with the housing intact, according to an exemplary embodiment of the invention. [Figure 4E]

[21] FIG. 4E is a cross-sectional view of the cable plug component taken along line 4E-4E shown in FIG. 4D. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011]

[22] As used herein, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise.

[0012]

[23] As used herein, a statement that two or more parts or components are “coupled” means that the parts are joined or operate together either directly, or indirectly, i.e., through one or more intermediate parts or components, to the extent that a connection occurs.

[0013]

[24] As used herein, the term "controller" refers to any programmable analog and / or digital device (including associated memory portions or parts) that can store, retrieve, execute, and process data (e.g., software routines and / or information used by such routines), including, without limitation, a field programmable gate array (FPGA), a complex programmable logic device (CPLD), a programmable system on a chip (PSOC), an application specific integrated circuit (ASIC), a microprocessor, a microcontroller, a programmable logic controller, or any other suitable processing device or apparatus. The memory portion may be any one or more of various types of internal and / or external storage media, such as, without limitation, RAM, ROM, EPROM, EEPROM, FLASH, etc., that provide storage registers, i.e., non-transitory machine-readable media, for data and program code storage, such as in the manner of a computer's internal storage area, and may be volatile or non-volatile memory.

[0014]

[25] As used herein, the term "number" means one or an integer greater than one (i.e., a plurality).

[0015]

[26] Directional terms used herein, such as, for example and without limitation, up, down, left, right, upper, lower, front, rear, and derivatives thereof, relate to the orientation of the elements illustrated in the drawings and do not limit the scope of the claims unless expressly stated in the claims.

[0016]

[27] As described in more detail herein in connection with various specific exemplary embodiments, the present invention provides a streamlined system for non-invasively measuring a patient's Neural Respiratory Drive (NRD) index. Since NRD is considered an objective quantification of respiratory effort and EMG measurements obtained during inhalation are considered an index of the balance between respiratory muscle load and respiratory muscle capacity, non-invasive quantification of NRD requires the use of EMG electrodes to detect respiratory muscle activity during inspiration. As detailed herein below with respect to FIG. 1, an optimal EMG configuration for measuring the NRD index requires the placement of three EMG electrodes at precise locations on the patient's chest with precise distances between the electrodes. It will be appreciated that the precise locations and distances need to be redetermined each time the electrodes need to be replaced. In addition, electrical leads need to be fitted to all three electrodes and three different cables (one for each electrode) need to be connected to the leads. Depending on the mechanism available for connecting the cables to the leads, connecting the cables to the leads requires the application of undesirable pressure to the patient's chest. The system disclosed in this specification and shown in Figures 2, 3A-3F, and 4A-4E provides a streamlined EMG monitoring configuration used to measure NRD indices that avoids the shortcomings repeated above.

[0017]

[28] Referring now to FIG. 1, there is shown a system 1 which represents a known system for sensing inspiration EMG signals. Measuring the NRD index on a patient P using known devices such as that shown in system 1 requires the placement of two signal EMG electrodes 2 and one reference EMG electrode 4 on the upper chest of the patient P. A first signal EMG electrode 2 is placed in the second intercostal space on one side of the sternum, a second signal EMG electrode 2 is placed in the second intercostal space on the other side of the sternum, and a reference EMG electrode 4 is placed on the sternum above the two signal electrodes 2 (with respect to the view shown in FIG. 1). It should be noted that when the term "upper" is used herein with respect to two or more components (e.g., electrodes) located on the chest of the patient P, "upper" means closer to the neck of the patient P, such that if a first component is disposed above a second component on the chest of the patient P, the first component is disposed closer to the neck of the patient P than the second component.

[0018]

[29] In Figure 1, each electrode 2, 4 is connected to a control unit 8 by its own designated cable 6. Three different leads (not numbered in Figure 1), one for each electrode 2, 4, must be fitted to each electrode to provide a connection point for each cable 6 to connect to the electrode 2, 4. It will be appreciated that it is desirable to reduce the time required to properly position the three separate electrodes 2, 4, to eliminate the need to apply pressure to the patient P's chest to fit the leads to each electrode 2, 4, and to reduce the cable clutter caused by having three separate cables 6.

[0019]

[30] Referring now to FIG. 2, an NRD monitoring system 100 according to an exemplary embodiment of the present invention is shown. Rather than having three separate EMG electrodes as in system 1 of FIG. 1, system 100 of FIG. 2 includes a single EMG patch 101 with two EMG signal electrodes 102 and one reference EMG electrode 104 integrated into the patch 101. In an exemplary embodiment, the patch 101 is produced to be disposable. Rather than using separate cables for each electrode as in known systems such as system 1, system 100 further includes a single cable 106 structured to couple to the patch 101 at a first end and to couple to a controller 108 at a second end disposed opposite the first end. By coupling cable 106 to patch 101 and controller 108, electrical communication is established between patch 101 and controller 108. It should be appreciated that controller 108 is configured to calculate an NRD index using the EMG signal sensed by patch 101 after the signal is sent to controller 108 via cable 106.

[0020]

[31] Referring now to Figures 3A-3F, there are shown elevational views of each of the layers used to construct the patch 101 shown in Figure 2. These layers, which will be described in more detail herein below, include an adhesive substrate 110, an adhesive layer 120, a gel layer 130, a circuit layer 140, a hardware substrate 150, and a connector hardware layer 160. Each layer illustrated in Figures 3A-3F is substantially planar and has two sides, one side being a chest-facing side and the other side being an outwardly facing side disposed opposite the chest-facing side. It should be understood that the term "chest-facing" as used herein with respect to the patch 101 and any of its components indicates that the patch 101 faces toward the chest of the patient P when placed on the patient P's chest. Conversely, it should be understood that the term "outwardly" as used herein with respect to the patch 101 and any of its components indicates that the patch 101 faces away from the patient P's body and not toward the patient P's chest when placed on the patient P's chest.

[0021]

[32] It should be noted that in Figures 3B-3F only the outward facing surface of each layer is shown, and Figure 3A is the adhesive substrate which is removed before patch 101 is placed on patient P for use in NRD monitoring. Before each of layers 110, 120, 130, 140, 150, and 160 are described in detail, it should be noted that patch 101 is assembled by bonding a chest-facing surface of adhesive layer 120 to the outward facing surface of adhesive substrate 110, bonding a chest-facing surface of gel layer 130 to the outward facing surface of adhesive layer 120, bonding a chest-facing surface of circuit layer 140 to the outward facing surface of gel layer 130, bonding a chest-facing surface of hardware substrate 150 to the outward facing surface of circuit layer 140, and bonding a chest-facing surface of connector hardware 160 to the outward facing surface of hardware substrate 150.

[0022]

[33] Referring now to Figures 3A and 3B, an adhesive substrate 110 and adhesive layer 120 are shown. The adhesive substrate 110 and adhesive layer 120 are of the type commonly found in self-adhesive patches. The adhesive substrate 110 is structured to preserve the adhesive qualities of the adhesive layer 120 prior to use of the patch 101, and may comprise, for example, without limitation, two pieces of thin, flexible plastic or wax paper that are placed on the chest-facing side of the adhesive layer 120 during assembly of the patch 101 and structured to be pulled off to expose the adhesive layer 120 when adhering the patch 101 to the skin of the patient P. The adhesive layer 120 is formed with cutouts 122 and may comprise any type of material suitable for adhering a wearable patch to skin, including, for example, without limitation, a polymeric glue or silicone. In Figure 3C, a gel layer 130 is shown. The gel layer 130 comprises three separate electrolyte gel pads 132 that are structured to insert within and fill the cutouts 122 in the adhesive layer 120 such that the chest-facing surface of each gel pad 132 contacts the skin of the patient P's chest when the patch 101 is placed on the patient P.

[0023]

[34] In Figure 3D, circuit layer 140 is shown. Circuit layer 140 comprises two signal electrodes 102 and one reference electrode 104 (also shown in Figure 2). Each signal electrode 102 comprises a signal sensing terminal 143 connected to a conductor 145 connected to a signal sending terminal 147, and the reference electrode portion similarly comprises a skin conduction terminal 144 connected to a conductor 146 connected to a reference sending terminal 148. In an exemplary embodiment of the invention, each signal electrode 102 and reference electrode 104 are all formed as a unitary body, i.e., the signal sensing terminal, conductor, and communication terminal simply refer to a particular region of each electrode 102 or 104. The signal sensing terminal 143, 144 of each electrode 102, 104 is configured to sense EMG activity directly from the chest of patient P. It should be appreciated that to enable the signal sensing terminals 143, 144 to sense EMG signal activity from the skin of the patient P via the electrolyte gel pads 132, the circuit layer 140, the gel layer 130, and the adhesive layer 120 are structured such that the signal sensing terminals 143, 144 of the circuit layer 140 align with the electrolyte gel pads 132 of the gel layer 130 and the cutouts 122 of the adhesive layer 120 when the layers 120, 130, 140 are bonded together. The conductors 145, 146 conduct signals sensed by the signal sensing terminals 143, 144 to the sending terminals 147, 148 so that the signals can be sent from the sending terminals 147, 148 to the controller 108 as further detailed herein with respect to Figures 4A-4D. As shown in Figure 3D, both the signal electrode 102 and the reference electrode 104 are electrically isolated from each other.

[0024]

[35] The hardware underlayment layer 150 shown in Figure 3E includes an insulating underlayment 152 formed with three cutouts 154 and is structured to protect all of the circuitry of the circuit layer 140, except for the sending terminals 147, 148, from the environment external to the hardware underlayment layer 150. It should be understood that in Figure 3E the terminals 147, 148 are shown filling the space provided by the cutouts 154, which allow the connector hardware 160 shown in Figures 3F and 4A-4E (described in further detail herein below) to electrically connect with the sending terminals 147, 148 for sending sensed EMG signals to the controller 108 (Figure 2).

[0025]

[36] Referring now to Figures 4A, 4B, 4C, 4D, and 4E, several views of the components of the connector hardware 160 are shown to clarify various features of the connector hardware 160 in detail. As mentioned above, the connector hardware 160 comprises two main components, a socket 161 (shown in Figure 4A) and a plug 181 (shown in Figure 4C). These two main components are structured to be releasably coupled to each other via a sliding action (described in further detail herein below). Herein, the socket 161 is also referred to as the patch side 161 of the connector hardware 160 since it is the component of the connector hardware 160 that is directly coupled with the hardware underlayer 150 of the patch 101. Herein, the plug 181 is also referred to as the cable side 181 of the connector hardware 160 since it comprises the cable 106 (shown in Figure 2) that transmits signals from the patch 101 to the controller 108. Please note that with respect to Figures 4A-4F, the terms "lateral" and "laterally" refer to the direction indicated by arrow 201 in Figures 4A and 4C. Additionally, please note that with respect to Figures 4A-4F, the terms "inward," "inwardly," and "inwardly" refer to the direction indicated by arrow 202 in Figures 4A and 4C.

[0026]

[37] Referring now to Figures 4A and 4B, the socket / patch side 161 is shown in detail. Figure 4A is an elevational view of the socket 161, and Figure 4B is a cross-sectional view of the socket 161 taken along line 4B-4B shown in Figure 4A. As shown in Figure 4A, the socket 161 comprises a socket housing portion 162. As shown in Figure 4B, the socket housing portion 162 comprises both a floor 163 and a wall portion 164. Note that the floor 163 directly bonds with the hardware substrate layer 150 when the patch 101 is fully assembled. The floor 163 is formed with gaps structured to receive the launch terminals 147, 148, such that the launch terminals 147, 148 extend outwardly relative to the floor 163. It should be understood that the face 149 of the signal launch terminal 147 shown in Figure 4B is the outward facing surface of the terminal 147.

[0027]

[38] Referring again to Figure 4A, note that there is a section of the socket housing portion 162 having gaps formed in the walls 164. These gaps include a plug-receiving opening 165 and a side opening 166. These openings 165, 166 allow the plug / cable side 181 to slide into the socket / patch side 161, as will be described in more detail later herein with respect to Figures 4C-4E. Finally, the socket 161 includes an insulating material 167 configured to electrically isolate the delivery terminals 147, 148 from one another.

[0028]

[39] In Figures 4C-4E, the plug / cable side 181 of the connector hardware 160 is shown in detail. As shown in Figures 4C-4E, the plug 181 comprises a plug housing 182. Figure 4C shows an elevational view of the cable side 181 with the outer facing portion 183 of the plug housing 182 removed (the outer facing portion 183 is shown numbered in Figures 4D and 4E) to show the components contained within the plug 181. Meanwhile, Figure 4D shows an elevational view of the plug 181 with the plug housing 182 intact, i.e., with the outer facing portion 183 as the plug housing 182 is actually produced. Figure 4E is a cross-sectional view of the plug 181 taken along line 4E-4E shown in Figure 4D.

[0029]

[40] As shown in Figures 4C-4E, plug housing 182 is formed with two flared portions 184, one formed on a first side of housing 182 and the other formed on a second side of housing 182 disposed opposite the first side. With reference to Figures 4A and 4D, it should be understood that plug 181 is structured to be inserted into socket 161 by inserting top end 185 of plug 181 into plug-receiving opening 165 of socket 161, as indicated by arrow 203 in Figures 4A and 4D. In an exemplary embodiment, a user recognizes that plug 181 has been properly inserted into socket 161 by a click felt as flared portion 184 expands laterally (i.e., in the direction indicated by arrow 201) from the interior of socket housing portion 162 through side opening 166 to the exterior of socket housing portion 162. It should be noted that the top end 185 is disposed on the opposite side of the cable 106 (also shown in FIG. 2). The flares 184 and the side opening 166 form a sliding mechanism that allows the plug 181 to be inserted into the socket 161 and prevents the plug 181 from sliding out of the socket 161 unless the flares 184 are forced inwardly towards each other (i.e., in the direction indicated by the arrows 202 in FIGS. 4A and 4C ) such that the flares no longer extend outside the socket housing part 162 through the side opening 166. The plug housing 182 may be produced, for example but not limited to, from any type of semi-flexible polymer that allows the flares 184 to be forced inwardly towards each other when they are forced towards each other with sufficient force. It should be appreciated that by squeezing the protrusions 184 inwardly toward each other, the plug 181 can be removed from the socket 161 by pulling the plug 181 away from the socket 161 in the direction opposite that indicated by the arrow 203.

[0030]

[41] In FIG. 4C, two cable signal terminals 187 and one cable reference terminal 188 are shown. The terminals 187, 188 are electrically connected to the cable 106. Note that the outer-facing surface of the plug 181 is shown in FIG. 4C, and the cable 106 is electrically connected to the terminals 187, 188 via connections on the chest-facing surface of the plug 181, which is disposed opposite the outer-facing surface and is not visible in the figure. In the exemplary embodiment, the cable 106 includes a three-core medical wire. The plug 181 is structured such that when the plug 181 is fully inserted into the socket 161, each of the two cable signal terminals 187 aligns with and electrically connects to a corresponding signal out terminal 147 of the socket 161, and the cable reference terminal 188 aligns with and electrically connects to a reference out terminal 148 of the socket 161. Specifically, the chest-facing surface of each cable terminal 187, 188 is in physical contact with the outward-facing surface of the corresponding socket delivery terminal 147, 188 (thus enabling electrical communication between the corresponding cable terminal 187, 188 and the socket delivery terminal 147, 148). For example, when plug 181 is fully inserted into socket 161, chest-facing surface 189 (as numbered in FIG. 4E) of signal terminal 187 is in contact with outward-facing surface 149 of delivery terminal 147 shown in FIG. 4B.

[0031]

[42] There are many advantages of the NRD monitoring system 100 over conventional EMG monitoring configurations such as System 1. The integration of both signal EMG electrodes 102 and one reference electrode 104 into a single patch 101 significantly reduces both the time and effort that would normally be required to properly position both signal electrodes 102 and one reference electrode 104 to optimally measure the NRD index. To obtain high quality EMG signal data for calculation of the NRD index, it is necessary to accurately place both signal electrodes 102 over the second intercostal space on either side of the sternum and the reference electrode 104 on the sternum, and ensure that all three electrodes are appropriately spaced from each other. The patch 101 significantly reduces the effort and time required to properly position and space the EMG electrodes 102, 104 because the electrodes 102, 104 are already spaced apart a precise distance on the patch 101 such that the care provider only needs to determine the location of the second intercostal space on either side of the sternum to place the patch 101 on the chest of the patient P such that the signal electrode 102 is located over the second intercostal space. That is, with the patch 101, the care provider no longer needs to determine the distance from the intercostal space to the sternum to determine where to place the reference electrode 104 relative to the signal electrode 102, and no longer needs to precisely space the two signal electrodes 102 from each other in the second intercostal space on either side of the sternum. Additionally, by providing a single cable 106 structured to electrically connect with all three electrodes 102, 104 instead of the three separate cables 6 used for each electrode 2, 4 in the system 1, cable clutter is significantly reduced and ease of use of the system 100 is improved. Furthermore, the sliding connection design of the flared portion 184 of the plug 181 and the side opening 166 of the socket 161 also allows the patch 101 and cable 106 to be connected with low insertion force and with virtually no pressure on the chest of the patient P. Finally, because the patch 101 does not contain any active electronics and is not dismantlable except for the adhesive substrate 110 which is structured to be removed from the adhesive layer 120, the patch 101 can be produced relatively inexpensively and is designed to be disposable.

[0032]

[43] In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word "comprises" or "including" does not exclude the presence of other elements or steps than those listed in a claim. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The word "a" or "an" does not exclude the presence of a plurality of such elements. In any device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain elements are recited in mutually different dependent claims does not indicate that these elements cannot be used in combination.

[0033]

[44] While the invention has been described in detail for purposes of illustration based on what are presently considered to be the most practical and preferred embodiments, it is to be understood that such detail is for this purpose only, and that the invention is not limited to the disclosed embodiments, but is instead intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to be understood that the invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. 1. An EMG patch for use with a neural respiratory drive monitoring system, said EMG patch comprising: an adhesive layer including a plurality of cutouts and structured to removably adhere the EMG patch to a patient's chest; a plurality of electrolyte gel pads, the same number as the plurality of cutouts, each gel pad inserted into a corresponding one of the plurality of cutouts to fill the cutout; a circuit coupled to the adhesive layer and structured to sense EMG signal activity during respiratory activity of the patient through each of the plurality of electrolytic gel pads; connection hardware coupled to and electrically connected to the circuit, the connection hardware comprising a socket; the EMG patch is structured such that positioning the EMG patch on the patient's chest for EMG monitoring positions a first cutout of the plurality of cutouts over a second intercostal space on a first side of the patient's sternum, a second cutout of the plurality of cutouts over a second intercostal space on a second side of the patient's sternum, and a third cutout of the plurality of cutouts on the patient's sternum; An EMG patch wherein the socket receives a single cable structured to transmit all EMG signal activity sensed by the circuitry to a control device.

2. The EMG patch of claim 1 , wherein the plurality of cutouts comprises three cutouts and the plurality of electrolyte gel pads comprises three electrolyte gel pads.

3. the circuit comprises a plurality of electrodes; each of the plurality of electrodes being electrically isolated from each other of the plurality of electrodes; The EMG patch of claim 1 , wherein each of the plurality of electrodes is coupled to the socket.

4. each of the plurality of electrodes includes a signal sensing terminal electrically connected to a sending terminal via a conductor; The EMG patch of claim 3 , wherein each signal sensing terminal is coupled to a corresponding one of the plurality of electrolyte gel pads, and each delivery terminal is coupled to the socket.

5. The EMG patch of claim 1 , wherein the socket receives the cable via a sliding mechanism.

6. 1. A monitoring system for monitoring neural respiratory drive in a patient during breathing, the monitoring system comprising: a control unit that calculates a neural respiratory drive index based on the received EMG signal activity; a single cable electrically connected to the controller; An EMG patch; connection hardware; The EMG patch an adhesive layer including a plurality of cutouts, the adhesive layer being structured to removably adhere the EMG patch to the patient's chest; a plurality of electrolyte gel pads, the same number as the plurality of cutouts, each gel pad inserted into a corresponding one of the plurality of cutouts to fill the cutout; a circuit coupled to the adhesive layer and structured to sense EMG signal activity during respiratory activity of the patient through each of the plurality of electrolytic gel pads; The connection hardware: a socket coupled to the circuit; a plug coupled to and electrically connected to the cable, the plug being structured to mate with the socket; the EMG patch is structured such that positioning the EMG patch on the patient's chest for EMG monitoring positions a first cutout of the plurality of cutouts over a second intercostal space on a first side of the patient's sternum, a second cutout of the plurality of cutouts over a second intercostal space on a second side of the patient's sternum, and a third cutout of the plurality of cutouts on the patient's sternum; A monitoring system wherein the cable is structured to transmit all EMG signal activity sensed by the circuitry to the control device.

7. The monitoring system of claim 6 , wherein the plurality of cutouts comprises three cutouts and the plurality of electrolyte gel pads comprises three electrolyte gel pads.

8. the circuit comprises a plurality of electrodes; each of the plurality of electrodes being electrically isolated from each other of the plurality of electrodes; The monitoring system of claim 6 , wherein each of the plurality of electrodes is coupled to the socket.

9. each of the plurality of electrodes includes a signal sensing terminal electrically connected to a sending terminal via a conductor; 9. The monitoring system of claim 8, wherein each signal sensing terminal is coupled to a corresponding one of the plurality of electrolyte gel pads, and each delivery terminal is coupled to the socket.

10. The monitoring system of claim 6 , wherein the socket receives the plug via a sliding mechanism.

11. the plug includes a plurality of cable terminals, the number of which corresponds to the number of the electrodes; 9. The monitoring system of claim 8, wherein the socket and the plug are structured such that when the socket receives the plug, each of the plurality of cable terminals is electrically connected to a corresponding one of the plurality of electrodes.

12. the socket comprises a socket housing having a socket wall; the plug comprises a plug housing; the sliding mechanism includes a side opening formed in the socket wall and a protrusion formed in the plug housing; the protrusion extends from the interior of the plug housing and is structured to extend through the side opening to the exterior of the socket housing when the plug is inserted into the socket; 11. The monitoring system of claim 10, wherein the protrusion and the side opening are structured such that when the plug is inserted into the socket, an inward force must be applied to the protrusion against the plug housing to remove the plug from the socket.

13. 1. A monitoring system for monitoring neural respiratory drive in a patient during breathing, the monitoring system comprising: a single cable structured to electrically connect to a control device; An EMG patch; connection hardware; The EMG patch an adhesive layer structured to removably adhere the EMG patch to the patient's chest, the adhesive layer comprising a plurality of electrolyte gel pad inserts; a circuit coupled to the adhesive layer and structured to sense EMG signal activity during respiratory activity of the patient through each of the plurality of electrolyte gel pad inserts; The connection hardware: a socket coupled to the circuit; a plug coupled to and electrically connected to the cable, the plug being structured to mate with the socket; the EMG patch is structured to position the circuitry such that placing the EMG patch on the patient's chest for EMG monitoring can sense EMG signals that can be used to calculate a neural respiratory drive index; A monitoring system wherein the cable is structured to transmit all EMG signal activity sensed by the circuitry to the control device.

14. The monitoring system of claim 13 , wherein the socket receives the cable via a sliding mechanism.

15. 14. The monitoring system of claim 13, wherein the circuit comprises a plurality of electrodes, each of the plurality of electrodes being electrically isolated from each other of the plurality of electrodes.

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