Surveillance patch

Abstract

A monitoring patch comprising a substrate having an adhesive surface and a plurality of sensors disposed in and / or on the substrate. In some embodiments, the plurality of sensors may include one or more sensors configured to measure oxygen saturation, a lactate sensor, and one or more impedance cardiography electrodes. In some embodiments, the plurality of sensors may include an accelerometer and a strain gauge, and may not include at least one of a sensor configured to measure oxygen saturation, a lactate sensor, or an impedance cardiography electrode.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 296,992, filed January 6, 2022, and No. 63 / 346,091, filed May 26, 2022. The contents of each of these applications are each incorporated by reference herein in their entirety.

[0002] Technical Field The present disclosure relates to patient monitoring, and more particularly, to patient monitoring devices configured to monitor a physiological condition (eg, pulse rate, oxygenation level, etc.) of a subject. [Background technology]

[0003] background

[0003] Patients undergoing medical procedures or who have recently undergone such procedures are often monitored to ensure that various physiological conditions are within acceptable parameters. Current techniques for short-term (e.g., during the procedure and for a short period thereafter) or long-term (e.g., weeks or months) monitoring often require invasive and / or expensive devices, and long-term monitoring may require different devices than those used for short-term monitoring.

[0004]

[0004] Mechanical circulatory support (MCS) devices, such as ventricular assist devices (VADs) and catheter-based ventricular assist devices (such as intravascular blood pumps), may be used to mechanically relieve the load on the heart, such as by increasing the left ventricle (e.g., reducing the left ventricular volume, resulting in reduced pressure) and / or by decompressing the left ventricle (e.g., reducing the left ventricular volume, which may be facilitated by a hole in the wall between the left and right atria, resulting in reduced left ventricular preload). Summary of the Invention [Means for solving the problem]

[0005] overview The monitoring patch may include a substrate having an adhesive surface and a number of sensors disposed in and / or on the substrate.

[0006]

[0006] According to a first aspect of the present disclosure, the multiple sensors may include one or more sensors configured to measure oxygen saturation, a lactate sensor, and one or more impedance cardiography electrodes.

[0007] In some embodiments, the monitoring patch may also include a perspiration biosensor array. In some embodiments, the perspiration biosensor array may include a Na + , K + In some embodiments, the sweat biosensor array may be configured to detect at least pH, glucose, lactate, alkali metal ions, alkaline earth metal ions, or combinations thereof. In some embodiments, the sweat biosensor array may be configured to measure sodium, pH, potassium, glucose, lactate, or combinations thereof.

[0008] In some embodiments, the lactate sensor may include a subcutaneous lactate sensor. In some embodiments, the substrate may include a first side and a second side opposite the first side, with the lactate sensor positioned on the first side of the substrate. In some embodiments, the monitoring patch may also include a power source, or a connection for a power source, which may be disposed on the second side. In some embodiments, one or more impedance cardiology electrodes may be disposed on the second side.

[0009] In some embodiments, the monitoring patch may also include a temperature sensor. In some embodiments, the monitoring patch may also include electrocardiogram (ECG) surface electrodes. In some embodiments, the monitoring patch may also include a strain gauge. In some embodiments, the monitoring patch may also include an accelerometer.

[0010] In some embodiments, the one or more sensors configured to measure oxygen saturation may include an NIR emitter / detector, an IR emitter / detector, or both.

[0011] In some embodiments, the monitoring patch may also include circuitry on a second surface of the substrate, the second surface being opposite the first surface, the circuitry operably connected to the multiple different sensors on the first surface, and including a connector for connecting to a power source. In some embodiments, the power source may be operably coupled to the substrate. In some embodiments, the power source may be located remotely from the patch.

[0012] In some embodiments, the monitoring patch may include a detachable wireless transmitter or transceiver configured to operably connect to the circuit. In some embodiments, the detachable wireless transmitter or transceiver may be a detachable Bluetooth transmitter or transceiver.

[0013] In some embodiments, the monitoring patch may be configured to connect to a mobile phone, a tablet, or a desktop computer. In some embodiments, the monitoring patch may be configured to operatively communicate with a remote server.

[0014] In some embodiments, the substrate may be configured to be bilaterally symmetric, having a left portion and a right portion, and in some embodiments, each impedance cardiography electrode may have a portion on a first surface of the substrate and a portion on a second surface of the substrate, the second surface being opposite the first surface.

[0015]

[0015] In some embodiments, the substrate may be configured to be bilaterally symmetrical, having a left portion and a right portion, with the first impedance cardiography electrode in the left portion and the second impedance electrode in the right portion.

[0016] In some embodiments, the substrate may be composed of two or more layers.

[0017] According to a second aspect of the present disclosure, the plurality of sensors include:

[0018]

[0018] The monitoring patch may include an accelerometer and a strain gauge, and may not include at least one of a sensor configured to measure oxygen saturation, a lactate sensor, and / or impedance cardiography electrodes.

[0019] In some embodiments, the monitoring patch may also include circuitry on a second surface of the substrate, the second surface being opposite the first surface, the circuitry being operably connected to the multiple different sensors on the first surface, and including a connector for connecting to a power source. In some embodiments, the power source may be operably coupled to the substrate. In some embodiments, the power source may be located remotely from the patch.

[0020] In some embodiments, the monitoring patch may include a detachable wireless transmitter or transceiver configured to operably connect to the circuit. In some embodiments, the detachable wireless transmitter or transceiver may be a detachable Bluetooth transmitter or transceiver.

[0021] In some embodiments, the monitoring patch may be configured to connect to a mobile phone, a tablet, or a desktop computer. In some embodiments, the monitoring patch may be configured to operatively communicate with a remote server.

[0022] In some embodiments, the monitoring patch may also include a perspiration biosensor array. In some embodiments, the perspiration biosensor array may include a Na + , K +In some embodiments, the sweat biosensor array may be configured to detect at least pH, glucose, lactate, alkali metal ions, alkaline earth metal ions, or combinations thereof. In some embodiments, the sweat biosensor array may be configured to measure sodium, pH, potassium, glucose, lactate, or combinations thereof.

[0023] In some embodiments, the monitoring patch may also include a body temperature sensor. In some embodiments, the monitoring patch may also include electrocardiogram (ECG) surface electrodes.

[0024] In some embodiments, the monitoring patch can include a lactate sensor. In some embodiments, the lactate sensor can include a subcutaneous lactate sensor. In some embodiments, the substrate can include a first side and a second side opposite the first side, and the lactate sensor is positioned on the first side of the substrate.

[0025] In some embodiments, the monitoring patch may also include a power source, or a connection for a power source, which may be disposed on the second surface.

[0026] In some embodiments, the monitoring patch may include one or more impedance cardiology electrodes disposed in and / or on the substrate. In some embodiments, the one or more impedance cardiology electrodes may be disposed on the second surface. In some embodiments, each impedance cardiography electrode may have a portion on the first surface and a portion on the second surface of the substrate.

[0027] In some embodiments, the monitoring patch may include one or more sensors configured to measure oxygen saturation. In some embodiments, the one or more sensors configured to measure oxygen saturation may include a NIR emitter / detector, an IR emitter / detector, or both.

[0028] In some embodiments, the substrate may be configured to be bilaterally symmetric, having a left portion and a right portion, and in some embodiments, each impedance cardiography electrode may have a portion on a first surface of the substrate and a portion on a second surface of the substrate, the second surface being opposite the first surface.

[0029]

[0029] In some embodiments, the substrate may be configured to be bilaterally symmetrical, having a left portion and a right portion, with the first impedance cardiography electrode in the left portion and the second impedance electrode in the right portion.

[0030]

[0030] In some embodiments, the substrate may be composed of two or more layers. In some embodiments, a system for combined use may be provided. The system may include an embodiment of a monitoring patch as disclosed herein operably coupled to a patient, and a mechanical circulatory assist device operably coupled to the patient. In some embodiments, the mechanical circulatory assist device may be a percutaneous blood pump.

[0031]

[0031] According to a third aspect of the present disclosure, a monitoring patch kit may have a plurality of patches, including a first patch which is a monitoring patch according to any of the embodiments described herein, and a second patch.

[0032]

[0032] In some embodiments, the second patch may include a substrate having an adhesive surface and a plurality of different sensors disposed in and / or on the substrate of the second patch, where at least one of the plurality of sensors disposed in and / or on the substrate of the first patch is different from any of the plurality of different sensors disposed in and / or on the substrate of the second patch.

[0033]

[0033] In some embodiments, the monitoring patch kit may include a third and a fourth patch, each of which may be a monitoring patch according to any of the embodiments described in this specification.

[0034]

[0034] In some embodiments, the monitoring patch kit may include third and fourth patches, each of the third and fourth patches having a substrate having an adhesive surface and a plurality of different sensors disposed in and / or on the substrate of each of the third and fourth patches, and at least one of the plurality of sensors disposed in and / or on the substrate of the first patch is different from any of the plurality of different sensors disposed in and / or on the substrate of the third patch and any of the plurality of different sensors disposed in and / or on the substrate of the fourth patch.

[0035] In some embodiments, the first patch may be configured to be placed on a first portion of the subject's body, and the second patch may be configured to be placed on a different portion of the subject's body. In some embodiments, the first portion of the subject's body may be the torso, the thigh, or a combination thereof. In some embodiments, the different portion may be the forearm, the wrist, the neck, the calf, the ankle, or a combination thereof.

[0036]

[0036] In some embodiments, the first or second patch is configured to be placed on the subject's torso, upper arm, thigh, neck, or a combination thereof, and the other of the first or second patch is configured to be placed on the subject's forearm, wrist, calf, ankle, or a combination thereof.

[0037]

[0037] In some embodiments, the monitoring patch kit includes at least two patches configured to be placed on the torso and at least one patch configured to be placed on the thigh. In some embodiments, the monitoring patch kit includes at least one patch configured to be placed on the left calf or ankle and at least one patch configured to be placed on the right calf or ankle. In some embodiments, the monitoring patch kit includes at least one patch configured to be placed on the neck.

[0038]

[0038] In some embodiments, the monitoring patch kit may include one or more additional patches including a first additional patch having a first set of different sensors disposed in and / or on a first substrate, and a second additional patch having a second set of different sensors disposed in and / or on a second substrate, where the first set of different sensors is different from the second set of different sensors, the first substrate is different from the second substrate, and / or the shape of the first substrate is different from the shape of the second substrate.

[0039] In some embodiments, the monitoring patch kit may include a controller configured to receive data from the sensor on each of the plurality of patches. In some embodiments, the controller is operably connected to the wireless transceiver. In some embodiments, the monitoring patch kit may include a plurality of leads, each lead configured to operably connect at least one sensor on one of the plurality of patches to the controller.

[0040] In some embodiments, the first patch and the second patch are configured to communicate with the controller and / or with each other.

[0041]

[0041] According to a fourth aspect of the present disclosure, a method may include receiving data from one or more sensors on one or more monitoring patches according to any of the embodiments described herein, the one or more monitoring patches being positioned on a subject.

[0042]

[0042] In some embodiments, the method may include storing the received data on one or more non-transitory computer readable media, displaying the received data on a display, or a combination thereof. In some embodiments, the method may include transmitting the data to a remote server, a mobile device, a patient console, or a combination thereof. In some embodiments, the method may include determining whether the data received from the sensor is outside a first predetermined range. In some embodiments, the method may include displaying a value represented by the received data. In some embodiments, the value may be an oxygenation level, a lactate level, a glucose level, a potassium level, a sodium level, a pulse rate, a pH, and / or a body temperature.

[0043]

[0043] In some embodiments, a difference between the measurements may be determined. In some embodiments, the data may include a first value from a sensor on the first patch and a second value from a sensor on the second patch, and the method may further include determining a first difference between the first value and the second value at a first time point. In some embodiments, the data may include a first value from a first sensor on the first patch and a second value from a second sensor on the first patch, and the method may include determining a first difference between the first value and the second value at a first time point. In some embodiments, the method may include determining whether the first difference is outside a second predetermined range.

[0044]

[0044] In some embodiments, the method further includes determining a second difference between the first and second values ​​at a second time. In some embodiments, the first value is a first pulse value and the second value is a second pulse value.

[0045]

[0045] In some embodiments, the method may include alerting the subject and / or medical professional when the received data is outside the first and / or second predetermined ranges. In some embodiments, alerting the subject and / or medical professional may include sending an alert to a remote server, a desktop computer, a laptop, a mobile device, a patient console, or a combination thereof. In some embodiments, alerting the subject and / or medical professional may include generating an audio indication, a visual indication, a message, or a combination thereof. In some embodiments, the visual indication may include a visual change in a display screen. In some embodiments, the method may include automatically determining and suggesting a treatment plan based on the received data, the first difference, the change from the first difference to the second difference, or a combination thereof.

[0046]

[0046] It should be understood that the above-mentioned concepts, and further concepts described below, may be arranged in any suitable combination, as the disclosure is not limited in this respect.

[0047]

[0047] The above and other aspects, embodiments, and features of the present teachings may be more fully understood from the following description taken in conjunction with the accompanying drawings.

[0048] BRIEF DESCRIPTION OF THE DRAWINGS

[0048] The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component shown in various figures is represented by a similar reference numeral. For purposes of clarity, not every component may be labeled in every figure. [Brief description of the drawings]

[0049] [Figure 1A] FIG. 1A is a schematic diagram of one embodiment of a monitoring patch showing details of a first side of the patch. [Figure 1B] FIG. 1B is a schematic diagram of one embodiment of a monitoring patch showing details of the second side of the patch. [Diagram 2]

[0050] FIG. 2 is a diagram of one embodiment of a monitoring patch in communication with various components. [Figure 3A]

[0051] FIG. 3A is a 2D diagram of different configurations of an embodiment of a substrate. [Figure 3B] FIG. 3B is a 2D diagram of different configurations of an embodiment of a substrate. [Figure 3C] FIG. 3C is a 2D diagram of different configurations of an embodiment of a substrate. [Figure 3D] FIG. 3D is a 2D diagram of different configurations of an embodiment of a substrate. [Figure 4]

[0052] FIG. 4 is a diagram of one embodiment of a substrate having multiple layers. [Figure 5A]

[0053] FIG. 5A is a 2D diagram of different embodiments of sensor configurations on a monitoring patch. [Figure 5B] FIG. 5B is a 2D diagram of a different embodiment of a sensor configuration on a monitoring patch. [Figure 5C] FIG. 5C is a 2D diagram of a different embodiment of a sensor configuration on a monitoring patch. [Figure 5D] FIG. 5D is a 2D diagram of a different embodiment of a sensor configuration on a monitoring patch. [Figure 5E] FIG. 5E is a 2D diagram of a different embodiment of a sensor configuration on a monitoring patch. [Figure 5F] FIG. 5F is a 2D diagram of a different embodiment of a sensor configuration on a monitoring patch. [Figure 5G] FIG. 5G is a 2D diagram of a different embodiment of a sensor configuration on a monitoring patch. [Figure 5H] FIG. 5H is a 2D diagram of a different embodiment of a sensor configuration on a monitoring patch. [Figure 6]

[0054] FIG. 6 is a diagram of one embodiment of a monitoring patch kit. [Figure 7A]

[0055] FIG. 7A illustrates an embodiment in which one or more monitoring patches are applied to a patient. [Figure 7B]

[0056] FIG. 7B shows another embodiment in which one or more patches are applied to a patient receiving mechanical circulatory assistance. [Figure 8]

[0057] FIG. 8 illustrates a method according to one embodiment. [Figure 9]

[0058] FIG. 9 illustrates an example of a percutaneous blood pump according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0050] Detailed Description

[0059] Patients undergoing, recently undergoing, or scheduled to undergo a medical procedure may be monitored to ensure that various physiological conditions are within acceptable parameters. Patients may also be monitored to determine whether medical treatment is necessary and / or that medical treatment may be altered or discontinued (e.g., whether the patient has recovered to a desired extent).

[0051]

[0060] Current techniques for short-term (e.g., during a medical procedure or treatment and for a short period thereafter) or long-term (e.g., weeks or months) monitoring often require invasive and / or expensive devices and / or may require multiple devices to be able to monitor all desired parameters.

[0052]

[0061] In light of the above, the inventors have recognized the advantages of a non-invasive monitoring system capable of monitoring multiple parameters (e.g., of a patient). In some embodiments, the monitoring system includes a monitoring patch having one or more sensors configured to monitor one or more parameters of the patient, such as oxygen saturation, lactate, glucose, temperature, heart rate, pH, and / or potassium. For example, in some embodiments, one or more monitoring patches may be placed on various parts of the patient's body to monitor one or more parameters. In some embodiments, the system may include a kit having multiple monitoring patches. In some embodiments, the monitoring patches in the kit may be the same (e.g., each having the same sensor) or the monitoring patches may be different (e.g., having different sensors on some of the patches). In such embodiments, a clinician may determine which monitoring patch (and where) to apply to the patient to monitor the desired parameters.

[0053]

[0062] 1A and 1B show a monitoring patch 1 according to an embodiment of the present disclosure. As shown in these figures, the monitoring patch may include a substrate 10 having an adhesive surface 11 and a number of sensors (20-28, 30, 31) disposed in and / or on the substrate 10.

[0054]

[0063] In some embodiments of the present disclosure, the multiple sensors may include one or more sensors 20, 21, 22 configured to measure oxygen saturation, a lactate sensor 23, and one or more impedance cardiography electrodes 24, 25 configured to monitor mechanical function of the heart.

[0055]

[0064] In some embodiments, the substrate may include a first side 12 (or first surface) and a second side 13 (or second surface) opposite the first side (or first surface). In some embodiments, the first side 12 is the side of the substrate 10 that faces and is attachable to the skin of a subject (e.g., a patient). In some embodiments, the sensors 20, 21, 22 configured to measure oxygen saturation are positioned on the first side of the substrate. In some embodiments, the lactate sensor 23 is also positioned on the first side of the substrate. In some embodiments, at least a portion of one or more impedance cardiography electrodes 24, 25 are positioned on the first side of the substrate. As will be appreciated, the sensors may be disposed in other suitable manners in or on the substrate in other embodiments.

[0056]

[0065] In some embodiments, the one or more impedance cardiography electrodes 24, 25 may include or consist of a plurality of impedance cardiography electrodes 24, 25. In some embodiments, the one or more impedance cardiography electrodes 24, 25 may be at least partially disposed on the second side. In some embodiments, each impedance cardiography electrode may have a portion on the first side 12 (or surface) of the substrate and another portion on the second side 13 (or surface) of the substrate.

[0057]

[0066] In some embodiments, the one or more sensors 20, 21, 22 configured to measure oxygen saturation may include or consist of an NIR emitter / detector, an IR emitter / detector, or both. In some embodiments, the monitoring patch may include multiple sensors for measuring oxygen saturation, each sensor being an NIR emitter / detector. In some embodiments, the monitoring patch may include multiple sensors for measuring oxygen saturation, each sensor being an IR emitter / detector. In some embodiments, the monitoring patch may include multiple sensors for measuring oxygen saturation, each sensor being an IR emitter / detector. In some embodiments, the monitoring patch may include multiple sensors for measuring oxygen saturation (e.g., StO 2 / SmO 2In some embodiments, the one or more sensors configured to measure oxygen saturation may include a plurality of sensors for measuring HbO saturation (TSI), where at least one of the plurality of sensors is a NIR emitter / detector and at least one of the plurality of sensors is an IR emitter / detector. In some embodiments, the one or more sensors configured to measure oxygen saturation may include or consist of at least three sensors. In some embodiments, the one or more sensors may measure a light intensity difference after absorption and scattering. In some embodiments, the detector may measure HbO 2 In some embodiments, the light may travel in a banana-like fashion. In some embodiments, the penetration may include ½ to ⅓ of the source-detector separation, although other suitable penetration depths may be used. In some embodiments, the IR emitter / detector may include a gel and adhesive around the sensor.

[0058]

[0067] In some embodiments, lactate sensor 23 may include or consist of a subcutaneous lactate sensor.

[0059]

[0068] In some embodiments, one or more additional sensors may be incorporated into the monitoring patch, such as in or on the substrate (e.g., on or in a first side of the substrate). For example, in some embodiments, the monitoring patch may also include a sweat biosensor array 26. In some embodiments, the sweat biosensor array 26 may be positioned on the first side of the substrate. In some embodiments, the sweat biosensor array may include a sensor array for measuring sodium (Na + ), potassium (K +), or a combination thereof. In some embodiments, the sweat biosensor array may be configured to detect at least pH, glucose, lactate, alkali metal ions, alkaline earth metal ions, or a combination thereof. In some embodiments, the sweat biosensor array may be configured to measure sodium, pH, potassium, glucose, lactate, or a combination thereof. As will be appreciated, blood chemistry may be used to indicate one or more conditions of a patient. For example, in some embodiments, a lactate sensor may be configured to measure blood lactate levels, which in some embodiments may indicate muscle fatigue (e.g., myocardial fatigue). As described herein, such patient information may be used to determine a patient's level of recovery and / or the need for further or new treatments.

[0060]

[0069] In some embodiments, the monitoring patch may also include a body temperature sensor 27. In such embodiments, the body temperature sensor 27 may also be positioned on the first side of the substrate.

[0061]

[0070] In some embodiments, the monitoring patch may also include an electrocardiogram (ECG) surface electrode 28 configured to monitor the patient's heart rate. In some embodiments, the ECG surface electrode 28 is positioned on the first side of the substrate. In some embodiments, the ECG surface electrode may include an electrode, as well as a gel and an adhesive around the electrode.

[0062]

[0071] In some embodiments, the monitoring patch may also include strain gauges 30, 31, 32, 33. In some embodiments, the monitoring patch may include only a single strain gauge. In other embodiments, there may be pairs of strain gauges. In some embodiments, each strain gauge may extend beyond the edge of the substrate. For example, in some embodiments, each strain gauge of a strain gauge pair may extend beyond the edge of the substrate on opposite sides of the substrate (e.g., strain gauges 30, 31 or strain gauges 32, 33). In some embodiments, each strain gauge of a strain gauge pair may extend beyond the edge of the substrate on adjacent sides of the substrate (e.g., strain gauges 30, 32 or strain gauges 30, 33). In some embodiments, each pair of strain gauges is configured to measure strain in a parallel direction (i.e., both gauges of a pair are configured to measure strain either transversely or longitudinally relative to the substrate). In some embodiments, there may be four strain gauges 30, 31, 32, 33.

[0063]

[0072] As known in the art, strain gauges can compress and expand, and as they do so, a measurable property (such as resistance) changes, which may indicate expansion (or contraction). Thus, in some embodiments, one or more strain gauges may be configured to measure swelling and / or stretching of a part of the patient's body, such as the skin of the patient's hand, arm, foot, ankle, and / or leg. In some embodiments, the strain gauges may monitor, and in some embodiments, measure, swelling and / or expansion of the patient's body, such as due to retention of fluid volume, or bloating. In some embodiments, the strain gauges on the monitoring patch may be capable of indicating a medical condition (e.g., heart failure) or a problem with a prescribed medication.

[0064]

[0073] In some embodiments, the monitoring patch may also include an accelerometer 43. In some embodiments, the accelerometer may include a six-axis accelerometer. In other embodiments, the accelerometer may include a three-axis accelerometer. In yet other embodiments, the accelerometer may include a two-axis accelerometer. In some embodiments, the accelerometer may be configured to monitor the movement of the patient. For example, the accelerometer may indicate when the patient is standing and walking and / or if the patient has fallen.

[0065]

[0074] In some embodiments, the monitoring patch 1 may also include circuitry 40, which may be located on a second side 13 of the substrate, the second side 13 being opposite the first side 12, with the circuitry 40 operably connected to at least one of the plurality of different sensors 20-28, 30-33, 43. In some embodiments, the circuitry 40 is operably connected to all of the plurality of different sensors 20-28, 30-33, 43. In some embodiments, the circuitry 40 is operably connected to the plurality of different sensors 20-28, 30-33 on the first surface. The circuitry may also be connected to the plurality of different sensors on the second surface.

[0066]

[0075] In some embodiments, the circuitry 40 includes a connector 41 for connecting to a power source 50. In some embodiments, the power source may be a separate battery pack or other medically acceptable DC power source, although in other embodiments, other suitable power sources may be used. In some embodiments, the power source may be operably coupled to the substrate. For example, a coin cell or battery pack may be mounted directly on the substrate. In some embodiments, the power source may be located remotely from the patch.

[0067]

[0076] In some embodiments, circuitry 40 may include one or more processors 44 and one or more non-transitory computer-readable storage media 45 (eg, flash memory, etc.).

[0068]

[0077] In some embodiments, the monitoring patch 1 may include a detachable wireless transmitter or transceiver 60 configured to operably connect to the circuitry. In some embodiments, the detachable wireless transmitter or transceiver may be a detachable Bluetooth transmitter or transceiver.

[0069]

[0078] As seen in FIG. 2, in some embodiments, the monitoring patch 1 may be configured to connect to a mobile device, such as a mobile phone 100 and / or a tablet 101, a computer (e.g., a desktop computer 102 and / or a laptop), and / or a patient console 108. In some embodiments, the monitoring patch 1 may be configured to operatively communicate with a remote server 103, such as a cloud-based server, such as through one or more routers 104. As will be appreciated, the remote server may also be operatively connected to one or more of the mobile device, the computer, and / or the patient console. As will be appreciated, the monitoring patch may also be directly connected to the patient console in other embodiments. In some embodiments, the console (and / or the cloud) may include an integrated dashboard.

[0070]

[0079] As seen in Figures 3A-3C, in some embodiments, the substrate may be configured to be symmetrical about a central plane 300 and have first and second portions, e.g., a left portion 301 and a right portion 302. As shown in Figure 3B, in some embodiments, a first impedance cardiography electrode 25 may be disposed in the left portion 301 of the substrate and a second impedance electrode 24 may be disposed in the right portion 302 of the substrate. As seen in Figure 3C, in some embodiments, the substrate may be configured to be symmetrical about a central plane 300 perpendicular to a surface that bisects the length 304 of the substrate and about a central plane 303 perpendicular to a surface that bisects the width 305 of the substrate.

[0071]

[0080] In some embodiments, a substrate may be configured to be asymmetric in a first direction but symmetric in a perpendicular direction, For example, as seen in Figure 3D, a substrate may be asymmetric about a surface-normal central plane 300 oriented in a direction that bisects the length of the substrate, but symmetric about a surface-normal central plane 303 oriented in a direction that is perpendicular to the length and bisects the width of the substrate.

[0072]

[0081] As will be appreciated, the substrate may have other suitable shapes and sizes in other embodiments. As will be further appreciated, in some embodiments, a first monitoring patch may have a first shape and size and a second monitoring patch may have a second shape and size. For example, in some embodiments, a kit may include multiple monitoring patches having different shapes and sizes. In such embodiments, the patches may be sized and shaped according to the part of the body to which the patch is to be attached.

[0073]

[0082] In some embodiments, the substrate may include multiple layers, such as two or more layers. As seen in FIG. 4, in some embodiments, the substrate 3 may include a first layer 401, a second layer 402, and a third layer 403. In some embodiments, the substrate may be comprised of two layers (e.g., 401, 402). In some embodiments, the substrate may be comprised of three layers (e.g., 401, 402, 403). In some embodiments, additional layers may be included. For example, in some embodiments, each layer may include a stretchable and / or elastomeric material. In some embodiments, at least one layer may include a stretchable and / or elastomeric material. In some embodiments, the substrate does not include a stretchable and / or elastomeric material. For purposes herein, the terms "elastomeric" and "stretchable" refer to materials that stretch in at least one direction when a force is applied to the material and return to approximately their original dimensions after the force is released. In some embodiments, at least one layer may include a nonwoven material. In some embodiments, at least one layer may include a foam material.

[0074]

[0083] Any combination of sensors is envisioned, many non-limiting examples of which can be seen in Figures 5A-5H.

[0075]

[0084] As described herein, in some embodiments, the monitoring patch may include one or more sensors configured to measure oxygen saturation, a lactate sensor, and one or more impedance cardiography electrodes, with other sensors, such as accelerometers and strain gauges, being optional. For example, in FIG. 5A, the monitoring patch may include only a sensor 20 configured to measure oxygen saturation, a lactate sensor 23, and an impedance cardiography electrode 24. In FIG. 5B, a temperature sensor 27 may be added to the three sensors from FIG. 5A. As shown in FIG. 5C, the monitoring patch may include three sensors 20, 21, 22 configured to measure oxygen saturation, a lactate sensor 23, and two impedance cardiography electrodes 24, 25. As shown in FIG. 5D, the monitoring patch may include two sensors 20, 21 configured to measure oxygen saturation, a lactate sensor 23, an impedance cardiography electrode 24, a sweat biosensor array 26, a temperature sensor 27, and strain gauges 30, 31. As shown in FIG. 5E, the monitoring patch may include a sensor 20 configured to measure oxygen saturation, a lactate sensor 23, impedance cardiography electrodes 24, a sweat biosensor array 26, ECG surface electrodes 28, and an accelerometer 43.

[0076]

[0085] In other embodiments, the monitoring patch may include an accelerometer and a strain gauge, with other sensors being optional. In some embodiments, the monitoring patch may not include a sensor configured to measure oxygen saturation, a lactate sensor, and / or an impedance cardiography electrode. This can be seen, for example, in Figures 5F-5H. In Figure 5F, the patch is shown with only an accelerometer 43 and a single strain gauge 32. In Figure 5G, the patch is shown with an accelerometer 43, two strain gauges 30, 31, a sensor 20 configured to measure oxygen saturation, and an ECG surface electrode 28 (but no lactate sensor or impedance cardiography electrodes). In Figure 5H, the patch is shown with only an accelerometer 43, four strain gauges 30, 31, 32, 33, a lactate sensor 23, an impedance cardiography electrode 24, a sweat biosensor array 26, and a temperature sensor 27 (but no sensors configured to measure oxygen saturation). As will be understood in light of the present disclosure, the number and type of sensors on a monitoring patch may be selected based on the type of monitoring desired and the particular location where the patch will be placed on the patient.

[0077]

[0086] In some embodiments, the patch shown in FIGS. 5A-5H may be otherwise identical (e.g., with respect to size, shape, number of layers) to those described herein. For example, as described herein, in some embodiments, the monitoring patch may also include circuitry on a second surface of the substrate, the second surface being opposite the first surface. The circuitry may be operably connected to some or all of the multiple different sensors, as described herein. In some embodiments, the circuitry includes a connector for connecting to a power source. In some embodiments, the power source may be operably coupled to the substrate. In some embodiments, the power source may be located remotely from the patch. As described herein, in some embodiments, the monitoring patch may include a detachable wireless transmitter or transceiver configured to operably connect to the circuitry. In some embodiments, the detachable wireless transmitter or transceiver may be a detachable Bluetooth transmitter or transceiver.

[0078]

[0087] Also as described herein, in some embodiments, the monitoring patch may be configured to connect to a mobile phone, tablet, or desktop computer, hi some embodiments, the monitoring patch may be configured to operatively communicate with a remote server.

[0079]

[0088] As also described herein, in some embodiments, the monitoring patch may also include a perspiration biosensor array. In some embodiments, the perspiration biosensor array may include a Na + , K + In some embodiments, the sweat biosensor array may be configured to detect at least pH, glucose, lactate, alkali metal ions, alkaline earth metal ions, or combinations thereof. In some embodiments, the sweat biosensor array may be configured to measure sodium, pH, potassium, glucose, lactate, or combinations thereof.

[0080]

[0089] As also described herein, in some embodiments, the monitoring patch may also include a temperature sensor. In some embodiments, the monitoring patch may also include electrocardiogram (ECG) surface electrodes.

[0081]

[0090] As described further herein, in some embodiments, the monitoring patch can include a lactate sensor. In some embodiments, the lactate sensor can include a subcutaneous lactate sensor. In some embodiments, the substrate can include a first side and a second side opposite the first side, and the lactate sensor is positioned on the first side of the substrate.

[0082]

[0091] As described further herein, in some embodiments, the monitoring patch may also include a power source, or a connection for a power source, which may be disposed on the second surface. As described herein, in some embodiments, the monitoring patch may include one or more impedance cardiography electrodes disposed in and / or on the substrate. In some embodiments, the one or more impedance cardiography electrodes may be disposed on the second surface. In some embodiments, each impedance cardiography electrode may have a portion on the first surface and a portion on the second surface of the substrate.

[0083]

[0092] As also described herein, in some embodiments, the monitoring patch may include one or more sensors configured to measure oxygen saturation. In some embodiments, the one or more sensors configured to measure oxygen saturation may include a NIR emitter / detector, an IR emitter / detector, or both.

[0084]

[0093] As also described herein, in some embodiments, the substrate may be configured to be bilaterally symmetrical, having a left portion and a right portion. In some embodiments, each impedance cardiography electrode may have a portion on a first surface of the substrate and a portion on a second surface of the substrate, the second surface being opposite the first surface. As also described herein, in some embodiments, the substrate may be configured to be bilaterally symmetrical, having a left portion and a right portion, with the first impedance cardiography electrode in the left portion and the second impedance electrode in the right portion.

[0085]

[0094] As described still further herein, in some embodiments, the substrate may be composed of two or more layers.

[0086]

[0095] As seen in FIG. 6, some embodiments of the present disclosure include a monitoring patch kit 600. As shown in this figure, the monitoring patch kit 600 may comprise or consist of multiple patches 1, 5, 3, 4. In some embodiments, a container 601 may be used to house each of the patches in the kit. In some embodiments, the container 601 may include sterile packaging. In some embodiments, some or all of the patches in the kit may be housed in their own separate compartments 602, 603, 604. In some embodiments, each of the separate compartments 602, 603, 604 may include sterile packaging.

[0087]

[0096] In some embodiments, the plurality of patches may include a first patch 1 comprising a monitoring patch according to any of the embodiments described herein, and a second patch 5. In some embodiments, the second patch 5 comprises a substrate 610 having an adhesive surface 611 and a plurality of different sensors disposed in and / or on the substrate of the second patch, at least one of the plurality of sensors disposed in and / or on the substrate of the first patch 1 being different from any of the plurality of different sensors disposed in and / or on the substrate of the second patch 5. For example, as seen in FIG. 6, the first patch 1 is shown as having a strain gauge 630 that is not present on the second patch 5. Other configurations are expressly envisioned, for example, the first patch 1 may comprise the sensor seen in FIG. 5E, while the second patch 5 may comprise the sensor seen in FIG. 5A.

[0088]

[0097] In some embodiments, the kit 600 may include a third patch 3 and a fourth patch 4, each of which independently comprises a monitoring patch according to any of the embodiments described herein. In some embodiments, each of the third and fourth patches may comprise a substrate having an adhesive surface and a plurality of different sensors disposed in and / or on the substrate of each of the third and fourth patches, with at least one of the plurality of sensors disposed in and / or on the substrate of the first patch being different from any of the plurality of different sensors disposed in and / or on the substrate of the third patch and any of the plurality of different sensors disposed in and / or on the substrate of the fourth patch. As seen in FIG. 6, the first patch 1 is shown as having a strain gauge 630 that is not present on either the third patch 3 or the fourth patch 4.

[0089]

[0098] In some embodiments, the first, second, third, and fourth patches each have a different configuration. In some embodiments, at least two of the second, third, or fourth patches are identical. For example, a kit may include a first patch having a first configuration, and the second, third, and fourth patches each have a second configuration.

[0090]

[0099] 7A, in some embodiments, monitoring patches 710, 711, 712, 713, 714, and 715 may be configured to be placed on different portions of a body of a subject 700. In some embodiments, a first patch (e.g., patch 710, 711, or 712) is configured to be placed on a first portion of the subject's body, and a second patch (e.g., patch 713, 714, or 715) is configured to be placed on a different portion of the subject's body. In some embodiments, the first portion of the subject's body is the torso, thighs, or a combination thereof (e.g., patches 710, 711, and 712 are shown to be on the torso and thighs of the subject). In some embodiments, the different portions are the forearm, wrist, neck, calf, ankle, or a combination thereof (eg, patches 713, 714, and 715 are shown as being present on the subject's neck and calf).

[0091]

[0100] In some embodiments, the first or second patch (e.g., patch 710) is configured to be placed on the subject's torso, upper arm, thigh, neck, or a combination thereof, and the other of the first or second patch (e.g., patch 714) is configured to be placed on the subject's forearm, wrist, calf, ankle, or a combination thereof.

[0092]

[0101] In some embodiments, the monitoring patch kit includes at least two patches (e.g., patches 710 and 711) configured to be placed on the torso and at least one patch (e.g., patch 712) configured to be placed on the thigh.

[0093]

[0102] In some embodiments, the monitoring patch kit includes at least one patch configured to be placed on the left calf or ankle (e.g., patch 714) and at least one patch configured to be placed on the right calf or ankle (e.g., patch 715).

[0094]

[0103] In some embodiments, the monitoring patch kit comprises at least one patch configured to be placed on the neck.

[0095]

[0104] In some embodiments, there may be a surgical insertion site 705 (see FIGS. 7A and 7B) where one or more medical devices are inserted into the subject's body. For example, as shown in FIG. 7B, one or more patches may be used on a patient receiving mechanical circulatory support (1110). In such an embodiment, one or more patches (e.g., patches 712, 714, 715) may be configured to monitor the patient, such as measuring the patient's temperature, heart rate, and / or oxygen saturation of the surrounding tissue. As described herein, the sensed values ​​may be displayed (e.g., on a patient console) and / or sent to a clinician. For example, one or more sensors may provide information about the patient and about the operation of a pump providing the mechanical circulatory support. As also described herein, the sensed values ​​may be compared to acceptable predetermined ranges and an alert may be provided to the clinician. In some embodiments, the one or more processors may be in operative communication with both the monitoring patch and the mechanical circulatory support device (e.g., receiving information from them, sending information to them, or a combination thereof).

[0096]

[0105] As will be appreciated in light of the above, in some embodiments, patches 710, 711, 712, 713, 714, and 715 of kit 700 may each include the same number and types of sensors. In other embodiments, the patches may include more than one type of patch.

[0097]

[0106] In some embodiments, various monitoring patches may allow for convenient hemodynamic and organ monitoring, including monitoring of cardiac output (e.g., via impedance cardiography), pulse pressure (e.g., via NIR sensors), oximetry (e.g., via NIR sensors), vascular resistance (e.g., via NIR sensors and changes in pulse propagation across the body), heart rate (e.g., via ECG leads), and ECG (e.g., via ECG leads).

[0098]

[0107] Additionally, more advanced monitoring may occur, such as local infection detection (e.g., via a temperature sensor, such as one placed near the insertion site), limb ischemia detection (e.g., via a NIR sensor placed distal to the insertion site), end-organ perfusion readings (e.g., via a lactate sensor), arrhythmia detection (e.g., via ECG leads), or ascites (e.g., via a strain gauge), or measurement of the patient's whole body motion (e.g., via an accelerometer).

[0099]

[0108] In some embodiments, a patch 713 containing an NIR sensor positioned on the subject's neck may be used to add a measurement representative of cerebral oxygenation.

[0100]

[0109] In some embodiments, dual or triple lactate and analyte measurements from patches 710, 711, and / or 712 may be used to provide real-time data regarding measurements of end-organ perfusion.

[0101]

[0110] In some embodiments, multiple impedance cardiography measurements from patches 710, 711, 712, 714, and 715 may allow cardiac output measurements.

[0102]

[0111] In some embodiments, NIR measurements may be used, allowing for measurements of pulse oximetry, pulse pressure, and vascular resistance.

[0103]

[0112] In some embodiments, patient movement may be detected and monitored, for example, using an accelerometer may allow medical staff to be alerted if the patient has moved too much or is not at an acceptable angle in bed.

[0104]

[0113] Referring again to FIG. 6, in some embodiments, the monitoring patch kit 600 may also include one or more additional patches 6, 7. In some embodiments, the one or more additional patches may comprise or consist of a first additional patch 6 having a first set of different sensors disposed in and / or on a first substrate, and a second additional patch 7 having a second set of different sensors disposed in and / or on a second substrate. The first set of different sensors may be different from the second set of different sensors, the first substrate may be different from the second substrate, and / or the shape of the first substrate may be different from the shape of the second substrate. While FIG. 6 illustrates the first additional patch 6 having a different set of sensors than the second additional patch 7, it will be appreciated that other variations are readily made.

[0105]

[0114] The monitoring patch kit 600 may also include a controller 650. The controller 650 may include one or more processors 651. The one or more processors 651 may be operably connected to a display 652 and / or one or more buttons or adjustment knobs 653. The controller 650 may be configured to receive data from one or more sensors on each of the multiple patches. In some embodiments, the controller 650 may be operably connected to a wireless transceiver 654. In some embodiments, the one or more processors 651 may be operably connected to the wireless transceiver 654. In some embodiments, the patches may transmit raw sensor data to the controller. In some embodiments, the sensors may provide data to a processor on each respective patch, which may calculate a value (such as heart rate) based on the raw sensor data, which may then be transmitted to the controller.

[0106]

[0115] The monitoring patch kit 600 may also include a number of leads 660, 661. Each lead 660, 661 may be configured to operatively connect at least one sensor on one of the multiple patches to a controller. In this manner, sensor information may be communicated to the controller even if the monitoring patch is not capable of wirelessly communicating with the controller.

[0107]

[0116] As will be appreciated, communication of sensor information may occur in a variety of ways. For example, in some embodiments, some or all of the patches are connected to the controller by leads. In other embodiments, some or all of the patches communicate wirelessly directly with the controller. In some embodiments, a first patch may communicate wirelessly directly with the controller while the other patches communicate with the controller via one or more leads. In other embodiments, a first patch may communicate wirelessly directly with the controller while the other patches communicate with the first patch. In such embodiments, the other patches may communicate with the controller via the first patch. For example, as shown in FIG. 2, a first patch 1 may communicate with a controller 105 (which may include a processor 106 and a wireless transceiver 107). The first patch 1 may also communicate with a second patch 2. As will be appreciated, although the second patch 2 is shown to only communicate with the first patch 1, the second patch 2 could also be configured to communicate with any of the components shown to communicate with the first patch 1 (or to another patch).

[0108]

[0117] According to another embodiment, a method of using a monitoring patch is disclosed. This can be understood with reference to FIG. 7A and FIG. 8. In some embodiments, the method 800 can include receiving (805) data from one or more sensors on one or more monitoring patches according to any of the embodiments described herein, the one or more monitoring patches being positioned on the subject. FIG. 7A shows sensors on at least patches 711, 712, and 714 in communication with the controller 105, which can receive data from the sensors. In some embodiments, additional steps can be performed in the method. As will be understood, these additional steps can be performed in any order.

[0109]

[0118] In some embodiments, the method 800 may also include storing 810 the received data on one or more non-transitory computer readable media (e.g., a non-transitory computer readable medium 720 on a remote server, such as a database on a cloud-based server, etc.), displaying 815 the data (e.g., the received data from the sensor and / or a value derived from the received data) on a display (e.g., the secondary display 725 and / or a display screen on the patient console 108), or a combination thereof. This may occur at any time after the data is received. In some embodiments, the displayed value may be oxygenation level, lactate level, glucose level, potassium level, sodium level, pulse rate, pH, body temperature, and / or the difference between two received data points.

[0110]

[0119] In some embodiments, the data may be received by a non-transitory computer readable medium and then sent to a display.

[0111]

[0120] In some embodiments, the method 800 may also include transmitting (820) the data to a remote server (e.g., the remote server and / or database 730), a mobile device (e.g., the smartphone 100), a patient console (e.g., the patient console 108), or a combination thereof. This may occur at any time after the data is received.

[0112]

[0121] In some embodiments, the method 800 may also include processing data from at least one of the one or more sensors. For example, the method may include determining 825 whether the received data, or a value calculated from the received data, is outside a predetermined value or range.

[0113]

[0122] In some embodiments, the determining step may include comparing the first value from the first sensor to a predetermined value or range. For example, in some embodiments, data from a temperature sensor may be expected to result in a body temperature within a predetermined range (e.g., a normal body temperature range for the monitored patient). As will be appreciated, in such an example, if the body temperature is determined to be outside the predetermined range, it may be indicative of an infection.

[0114]

[0123] In some embodiments, if the data indicates a trend, the slope, or other variate representing the trend, may be used to assess the patient (e.g., whether the slope or other variate is outside of an acceptable predetermined range). As an example, in some embodiments, skin temperature may have a predetermined range, e.g., 92°F to 99°F. In some cases, if the measured temperature increases from 93°F to 95°F, an alert may be triggered. However, in other cases, if that 2 degree increase in body temperature occurs over a defined period of time, such as 10 minutes, the rate of change (e.g., 1 degree every 5 minutes) may be outside of a predetermined range and an alert may be generated.

[0115]

[0124] In other embodiments, the determining step may include comparing a first value of a first sensor to a second value from a second sensor. For example, the method may include determining a first difference between a first value from a first sensor on a first patch and a second value from a second sensor on a second patch at a first time. In some embodiments, the first value is a first pulse value and the second value is a second pulse value.

[0116]

[0125] In some embodiments, the determining step may include determining a second difference between a first value from the first sensor measured at a second time and a second value from the second sensor measured at the second time.

[0117]

[0126] In other embodiments, the determining step may include comparing whether the difference between the sensor values ​​is within acceptable limits. For example, the method may include determining whether a first difference is outside a second predetermined range. For example, comparing pulse oximetry data from patches 714 and 715 allows for detection of limb ischemia when a medical device is inserted through insertion site 705. In some embodiments, a limb not including an insertion site may be used as a control.

[0118]

[0127] In other embodiments, the determining step may include comparing tissue oxygenation data from patches 714 and 715 to enable detection of limb ischemia when the medical device is inserted through the insertion site. In some embodiments, the determining step includes comparing each of the sensed values ​​to a predetermined value or baseline (e.g., 70%). In some embodiments, a likelihood of an ischemic event may be determined if tissue oxygenation is below 60% for a predetermined period of time, such as more than 3 minutes. In some embodiments, a likelihood of an ischemic event may be determined if sensed tissue oxygenation drops by more than 5% for a predetermined period of time, such as 30 minutes.

[0119]

[0128] In some embodiments, a limb not encompassing the insertion site could be used as a control. For example, in one embodiment, if the difference in tissue oxygenation between the two limbs is greater than 20%, the determining step could determine a likelihood of an ischemic event in the limb.

[0120]

[0129] If a value (e.g., sensor data, a calculated value based on the sensor data, a difference, etc.) is outside of a predetermined value or range, the method may include generating an alert 830, such as a visual signal or an audio alert (e.g., a beep, tone, etc.). In some embodiments, generating an alert may be the only step in method 800 that cannot be performed in any order - they must occur at least following a determining step that any value is outside of a predetermined range (such as determining step 825).

[0121]

[0130] In some embodiments, the alert is intended to alert the subject and / or a medical professional. In such embodiments, alerting the subject and / or a medical professional may include generating an audio indication, a visual indication, a message (such as a text message, an email message, etc.), or a combination thereof. In some embodiments, the visual indication includes a visual change on a display screen (such as the secondary display 725 and / or a display screen on the patient console 108).

[0122]

[0131] In some embodiments, method 800 may include determining and suggesting (835) a treatment plan based on the received data, the first difference, the change from the first difference to the second difference, or a combination thereof. For example, the controller 105 may receive the data, and based on the trained machine learning algorithm and the treatment stored on the database on the non-transitory computer readable medium 720, a treatment plan may be automatically determined and suggested (e.g., displayed or otherwise communicated to one or more people).

[0123]

[0132] The subject may then be treated based on the received data or a value derived from the received data, such as the first difference, the change from the first difference to the second difference, the proposed treatment, or a combination thereof (840).

[0124]

[0133] An example of a mechanical circulatory assist device (also referred to as a "heart pump" or simply a "pump") is shown in FIG. 9 and may include a percutaneous, catheter-based device that provides hemodynamic assistance to a patient's heart. As shown in this figure, the heart pump 1110 may include a pigtail 1111, an inlet area 1112, a cannula 1113, a pressure sensor 1114, an outlet area 1115, a motor housing 1116, and / or a catheter tube 1117. The pigtail 1111 may help stabilize the heart pump 1110 within the patient's heart. It should be understood that some embodiments of the heart pump 1110 may not include the pigtail 1111, and the heart pump 1110 may be stabilized in other ways or not stabilized at all. During operation, blood may be drawn into one or more openings in the inlet area 1112, directed through the cannula 1113, and expelled through one or more openings in the outlet area 1115 by a motor (not shown) disposed in the motor housing 1116. In some implementations, the pressure sensor 114 may include a flexible membrane integrated into the cannula 1113. One side of the pressure sensor 114 may be exposed to blood pressure outside the cannula 1113, and the other side may be exposed to the pressure of blood inside the cannula 1113. In some such implementations, the pressure sensor 1114 may generate an electrical signal proportional to the difference between the pressure outside the cannula 1113 and the pressure inside the cannula 1113. In some implementations, the pressure sensor 1114 may include an optical pressure sensor. The catheter tube 1117 may provide one or more fluid and / or electrical connections between the heart pump 1110 and one or more other devices of the ventricular assist system.

[0125]

[0134] Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein which equivalents are intended to be encompassed by the claims appended hereto.

[0126]

[0135] While the present teachings have been described in conjunction with various embodiments and examples, it is not intended that the present teachings be limited to such embodiments or examples. On the contrary, the present teachings encompass various alternatives, modifications, and equivalents, as will be appreciated by those skilled in the art. Accordingly, the foregoing description and drawings are by way of example only.

[0127]

[0136] Various aspects of the invention may be used alone, in combination, or in various configurations not specifically discussed in the embodiments described above, and therefore are not limited in their application to the details and arrangements of components set forth in the foregoing description or illustrated in the drawings. For example, aspects described in one embodiment may be combined in any manner with aspects described in other embodiments.

[0128]

[0137] The invention may also be embodied as a method, of which an example has been provided. The acts performed as part of the method may be ordered in any suitable manner. Thus, embodiments may be constructed in which the acts are performed in an order different from that illustrated. This may include performing some acts simultaneously even though in the illustrated embodiment they are shown as sequential acts.

[0129]

[0138] The use of ordinal terms such as "first," "second," "third," etc. in the claims to modify claim elements does not, by itself, imply any priority, ranking, or order of the claim element relative to another, or the temporal order in which acts of a method are performed, but rather is merely used to distinguish one claim element having a particular name from other elements that have the same name (in the absence of the use of the ordinal terminology) and as a label to distinguish the claim elements.

[0130]

[0139] Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," "having," "containing," "involving," and variations thereof herein are intended to encompass the items listed thereafter, and equivalents thereof, as well as additional items.

Claims

1. A monitoring patch, a substrate having an adhesive surface; a plurality of sensors disposed in and / or on the substrate; wherein the plurality of sensors one or more sensors configured to measure oxygen saturation; Lactate sensor, and one or more impedance cardiography electrodes; Includes monitoring patches.

2. The monitoring patch of claim 1 further comprising a perspiration biosensor array.

3. The sweat biosensor array ＋ , K. ＋ or a combination thereof; the sweat biosensor array is configured to detect at least pH, glucose, lactate, alkali metal ions, alkaline earth metal ions, or a combination thereof; or The monitoring patch of claim 2 , wherein the perspiration biosensor array is configured to measure sodium, pH, potassium, glucose, lactate, or a combination thereof.

4. The monitoring patch of claim 1 , wherein the lactate sensor comprises a subcutaneous lactate sensor.

5. The monitoring patch of claim 4 , wherein a substrate includes a first side and a second side opposite the first side, and the lactate sensor is positioned on the first side of the substrate.

6. further comprising a power source, or a connection for a power source, disposed on the second side; and / or The monitoring patch of claim 5 , wherein the one or more impedance cardiography electrodes are disposed on the second side.

7. Body temperature sensor, electrocardiogram (ECG) surface electrodes, Strain gauges, and / or The monitoring patch of claim 1 further comprising an accelerometer.

8. The monitoring patch of claim 1 , wherein the one or more sensors configured to measure oxygen saturation include an NIR emitter / detector, an IR emitter / detector, or both.

9. 10. The monitoring patch of claim 1, further comprising circuitry on a second side of the substrate, the second side being opposite the first side, the plurality of sensors including at least one sensor disposed in and / or on the first side, the circuitry operably connected to the at least one sensor disposed in and / or on the first side, and including a connector for connecting to a power source.

10. The monitoring patch of claim 9 , wherein the power source is operably coupled to the substrate.

11. The monitoring patch of claim 10 , wherein the power source is located remotely from the patch.

12. The monitoring patch of claim 9 further comprising a detachable wireless transmitter or transceiver configured to operably connect to the circuitry.

13. the monitoring patch is configured to connect to a mobile phone, a tablet, or a desktop computer; the monitoring patch is configured to operatively communicate with a remote server; the substrate is configured to be bilaterally symmetrical and has a left portion and a right portion; each impedance cardiography electrode includes a portion on a first surface and a portion on a second surface of the substrate, the second surface being opposite the first surface; and / or The monitoring patch of claim 1 , wherein the substrate is comprised of two or more layers.

14. A monitoring patch, a substrate having an adhesive surface; a plurality of sensors disposed in and / or on the substrate; wherein the plurality of sensors accelerometer, and Strain gauges, Including, A monitoring patch, wherein the monitoring patch does not include a sensor configured to measure oxygen saturation, a lactate sensor, an impedance cardiography electrode, or a combination thereof.

15. circuitry on a second side of the substrate, the second side opposite the first side, the circuitry operably connected to the plurality of different sensors on the first side, and including a connector for connecting to a power source; a detachable wireless transmitter or transceiver configured to operably connect to said circuit; Sweat biosensor array, Body temperature sensor, electrocardiogram (ECG) surface electrodes, and / or Lactate sensor, The monitoring patch of claim 14 further comprising:

16. the detachable wireless transmitter or transceiver is a detachable Bluetooth transmitter or transceiver; the monitoring patch is configured to connect to a mobile phone, tablet, or desktop computer; and / or The monitoring patch of claim 15 , wherein the monitoring patch is configured to operatively communicate with a remote server.

17. The monitoring patch of claim 14 further comprising one or more sensors configured to measure oxygen saturation.

18. 1. A system for combined use, comprising: a monitoring patch according to any one of claims 1 to 17 operably coupled to a patient; a mechanical circulatory assist device operably coupled to the patient; A system comprising:

19. A surveillance patch kit comprising a plurality of patches, the plurality of patches comprising: a first patch comprising a monitoring patch according to any one of claims 1 to 17, and The second patch, Includes a monitoring patch kit.

20. 1. A method comprising: A method comprising receiving data from one or more sensors on one or more monitoring patches according to any one of claims 1 to 17, wherein the one or more monitoring patches are positioned on a subject.

Images