SURVEILLANCE PATCH

Abstract

A monitoring patch comprising a substrate with an adhesive surface and a plurality of sensors arranged in and / or on the substrate. In some embodiments, the plurality of sensors may include one or more sensors arranged for measuring 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 be free of at least one sensor for measuring oxygen saturation, a lactate sensor, or an impedance cardiography electrode.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application Nos. 63 / 296,992, filed January 6, 2022, and 63 / 346,091, filed May 26, 2022, the contents of each of which are incorporated herein in their entirety. TECHNICAL FIELD

[0002] The present disclosure relates to patient monitoring and, more particularly, to patient monitoring devices configured to monitor a patient's physiological conditions (e.g., pulse rate, oxygen level, etc.). BACKGROUND

[0003] Patients undergoing or recently undergoing a medical procedure are often monitored to ensure that various physiological conditions remain within acceptable parameters. Current techniques for short-term (e.g., during the procedure and a short time afterward) or long-term monitoring (e.g., several weeks or months) often require invasive and / or expensive devices, and long-term monitoring typically requires different devices than short-term monitoring.

[0004] Mechanical circulatory support devices (MCS), such as ventricular assist devices (VADs) and catheter-based ventricular assist devices (e.g., intravascular blood pumps), can be used to mechanically unload the heart, e.g., the left ventricle (e.g., reducing the volume of the left ventricle, resulting in a reduction in pressure) and / or decompress the left ventricle (e.g., reducing the volume of the left ventricle, which can be achieved by creating a hole in the wall between the left atrium and the right atrium, resulting in a reduced preload of the left ventricle). SHORT SUMMARY

[0005] A monitoring patch may comprise a substrate having an adhesive surface and a plurality of sensors disposed in and / or on the substrate.

[0006] According to a first aspect of the present disclosure, the plurality of sensors may include: one or more sensors arranged 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 sweat biosensor array. In some embodiments, the sweat biosensor array may be configured to detect Na + , K + or a combination thereof. In some embodiments, the sweat biosensor array can be configured to detect at least pH, glucose, lactate, an alkali metal ion, an alkaline earth metal ion, or a combination thereof. In some embodiments, the sweat biosensor array can be configured to measure sodium, pH, potassium, glucose, lactate, or a combination thereof.

[0008] In some embodiments, the lactate sensor may comprise a subcutaneous lactate sensor. In some embodiments, the substrate may comprise a first side and a second side opposite the first side, with the lactate sensor disposed on the first side of the substrate. In some embodiments, the monitoring patch may also include a power source or a connector for a power source, which may be disposed on the second side. In some embodiments, the one or more impedance cardiography 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 an electrocardiogram (ECG) surface electrode. 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 for measuring oxygen saturation may comprise NIR emitters / detectors, IR emitters / detectors, 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 being operatively connected to the plurality of different sensors on the first surface, and including a connector for connection to a power source. In some embodiments, the power source may be operatively connected 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 removable wireless transmitter or transceiver configured to be connected to the circuitry. In some embodiments, the removable wireless transmitter or transceiver may be a removable 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 communicate with a remote server.

[0014] In some embodiments, the substrate may be configured to be bilaterally symmetrical and have a left 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.

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

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

[0017] According to a second aspect of the present disclosure, the plurality of sensors an accelerometer and a strain gauge, wherein the monitoring patch is free of at least one oxygen saturation sensor, a lactate sensor and / or an impedance cardiography electrode.

[0018] 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 operatively connected to the plurality of different sensors on the first surface, and including a connector for connection to a power source. In some embodiments, the power source may be operatively connected to the substrate. In some embodiments, the power source may be located remotely from the patch.

[0019] In some embodiments, the monitoring patch may include a removable wireless transmitter or transceiver configured to be connected to the circuitry. In some embodiments, the removable wireless transmitter or transceiver may be a removable Bluetooth transmitter or transceiver.

[0020] 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 communicate with a remote server.

[0021] In some embodiments, the monitoring patch may also include a sweat biosensor array. In some embodiments, the sweat biosensor array may be configured to detect Na + , K + or a combination thereof. In some embodiments, the sweat biosensor array can be configured to detect at least pH, glucose, lactate, an alkali metal ion, an alkaline earth metal ion, or a combination thereof. In some embodiments, the sweat biosensor array can be configured to measure sodium, pH, potassium, glucose, lactate, or a combination thereof.

[0022] In some embodiments, the monitoring patch may also include a temperature sensor. In some embodiments, the monitoring patch may also include an electrocardiogram (ECG) surface electrode.

[0023] In some embodiments, the monitoring patch may include a lactate sensor. In some embodiments, the lactate sensor may comprise a subcutaneous lactate sensor. In some embodiments, the substrate may have a first side and a second side opposite the first side, with the lactate sensor disposed on the first side of the substrate.

[0024] In some embodiments, the monitoring patch may also include a power source or a connector for a power source that may be disposed on the second surface.

[0025] 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.

[0026] In some embodiments, the monitoring patch may include one or more sensors arranged to measure oxygen saturation. In some embodiments, the one or more sensors for measuring oxygen saturation may include NIR emitters / detectors, IR emitters / detectors, or both.

[0027] In some embodiments, the substrate may be configured to be bilaterally symmetrical and have a left 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.

[0028] In some embodiments, the substrate may be configured to be bilaterally symmetrical and have a left and a right portion, with a first impedance cardiography electrode located in the left portion and a second impedance electrode located in the right portion.

[0029] In some embodiments, the substrate may consist 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, operatively connected to a patient; and a mechanical circulatory support device operatively connected to the patient. In some embodiments, the mechanical circulatory support device may be a percutaneous blood pump.

[0030] According to a third aspect of the present disclosure, a monitoring patch kit may include a plurality of patches, including a first patch that is a monitoring patch according to any of the embodiments described herein, and a second patch.

[0031] In some embodiments, the second patch may comprise a substrate having an adhesive surface and a plurality of different sensors disposed in and / or on the substrate of the second patch, wherein at least one of the plurality of sensors disposed in and / or on the substrate of the first patch is different from one of the plurality of different sensors disposed in and / or on the substrate of the second patch.

[0032] In some embodiments, the monitoring patch set may include a third and fourth patch, wherein each of the third and fourth patches may be a monitoring patch according to any of the embodiments described herein.

[0033] In some embodiments, the monitoring patch set may comprise a third and a fourth patch, wherein each of the third and fourth patches has a substrate with an adhesive surface and a plurality of different sensors disposed in and / or on the substrate of each of the third and fourth patches, wherein at least one of the plurality of sensors disposed in and / or on the substrate of the first patch is different from each of the plurality of different sensors disposed in and / or on the substrate of the third patch and each of the plurality of different sensors disposed in and / or on the substrate of the fourth patch.

[0034] In some embodiments, the first patch may be configured to be applied to a first portion of a subject's body, and the second patch may be configured to be applied to a different portion of the subject's body. In some embodiments, the first portion of the subject's body may be a torso, a thigh, or a combination thereof. In some embodiments, the different portion may be a forearm, a wrist, a neck, a calf, an ankle, or a combination thereof.

[0035] In some embodiments, the first or second patch is configured to be applied to the torso, upper arm, thigh, neck, or a combination thereof, and the other of the first or second patch is configured to be applied to the forearm, wrist, calf, ankle, or a combination thereof.

[0036] In some embodiments, the monitoring patch kit includes at least two patches configured to be applied to an upper torso and at least one patch configured to be applied to a thigh. In some embodiments, the monitoring patch kit includes at least one patch configured to be applied to the left calf or ankle and at least one patch configured to be applied to the right calf or ankle. In some embodiments, the monitoring patch kit includes at least one patch configured to be applied to the neck.

[0037] In some embodiments, the monitoring patch set 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, wherein 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 a shape of the first substrate is different from a shape of the second substrate.

[0038] In some embodiments, the monitoring patch set may include a controller configured to receive data from sensors on each of the plurality of patches. In some embodiments, the controller is operatively connected to a wireless transceiver. In some embodiments, the monitoring patch set may include a plurality of lines, each line configured to connect at least one sensor on one of the plurality of patches to the controller.

[0039] In some embodiments, the first patch and the second patch are configured to communicate with a controller and / or with each other.

[0040] 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, wherein the one or more monitoring patches are applied to a person.

[0041] 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 oxygen level, a lactate level, a glucose level, a potassium level, a sodium level, a pulse rate, a pH level, and / or a temperature.

[0042] In some embodiments, differences between measured values ​​may be determined. In some embodiments, the data may include a first value from a sensor on a first patch and a second value from a sensor on the second patch, and the method may include determining a first difference between the first value and the second value at a first time. In some embodiments, the data may include a first value from a first sensor on a 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. In some embodiments, the method may include determining whether the first difference is outside a second predetermined range.

[0043] In some embodiments, the method further comprises determining a second difference between the first value and the second value at a second time. In some embodiments, the first value is a first pulse value and a second value is a second pulse value.

[0044] In some embodiments, the method may include alerting a person and / or medical professional when the received data is outside the first predetermined range and / or the second predetermined range. In some embodiments, alerting the person and / or medical professional may include transmitting an alarm to a remote server, a desktop computer, a laptop, a mobile device, a patient console, or a combination thereof. In some embodiments, alerting the person and / or medical professional may include generating an audible signal, a visual signal, a message, or a combination thereof. In some embodiments, the visual cue may include a visual change on a screen.In some embodiments, the method may include automatically determining and suggesting a treatment plan based on the received data, the first difference, a change from the first difference to the second difference, or a combination thereof.

[0045] It should be noted that the above concepts and the additional concepts discussed below may be arranged in any suitable combination, as the present disclosure is not limited in this regard.

[0046] The foregoing and other aspects, embodiments and features of the present teachings may be better understood from the following description taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] The attached drawings are not to be considered to scale. In the drawings, each identical or nearly identical component shown in the various figures is represented by a similar number. For reasons of clarity, not every component is labeled in every drawing. In the drawings: Fig. 1A and Fig. 1B are schematic representations of an embodiment of a monitoring patch and show details of a first side (1A) and a second side (1B) of the patch. Fig. Figure 2 is an illustration of one embodiment of a monitoring patch communicating with various components. Fig. 3A-3D are 2D representations of various embodiments of substrates. Fig. 4 shows an embodiment of a multi-layer substrate. Fig. 5A-5H are 2D illustrations of various embodiments of sensor configurations on a monitoring patch. Fig. 6 shows an embodiment of a monitoring patch set. Fig. Figure 7A shows an embodiment in which one or more monitoring patches are applied to a patient. Fig. Figure 7B shows another embodiment in which one or more patches are applied to a patient receiving mechanical circulatory support. Fig. 8 illustrates a method according to one embodiment. Fig. 9 shows an example of a percutaneous blood pump according to an embodiment. DETAILED DESCRIPTION

[0048] Patients undergoing, recently undergoing, or scheduled for a medical procedure may be monitored to ensure that various physiological conditions are within acceptable parameters. Patients may also be monitored to determine if medical treatment is needed and / or if medical treatment can be changed or discontinued (e.g., if the patient has recovered to a desired level).

[0049] Current techniques for short-term (e.g., during a medical procedure or treatment and for a short period thereafter) or long-term (e.g., several weeks or months) monitoring often require invasive and / or costly devices and / or multiple devices to monitor all desired parameters.

[0050] In view of the above, the inventors have recognized the benefit of a non-invasive monitoring system capable of monitoring multiple parameters (e.g., of the patient). In some embodiments, the monitoring system comprises a monitoring patch having one or more sensors arranged to monitor one or more patient parameters, such as oxygen saturation, lactate, glucose, temperature, heart rate, pH, and / or potassium. In some embodiments, for example, one or more monitoring patches may be applied to different parts of a patient's body to monitor one or more parameters. In some embodiments, the system may comprise a set of multiple monitoring patches. In some embodiments, the monitoring patches in the set may be the same (e.g., all have the same sensors) or the monitoring patches may be different (e.g.,Some patches have different sensors. In such cases, a physician can decide which monitoring patches to apply to the patient (and where) to monitor the desired parameters.

[0051] The Fig. 1A and Fig. 1B show a monitoring patch 1 according to embodiments of the present disclosure. As shown in these views, the monitoring patch may include a substrate 10 having an adhesive surface 11 and a plurality of sensors (20-28, 30, 31) disposed in and / or on the substrate 10.

[0052] In some embodiments of the present disclosure, the plurality of sensors may include: one or more oxygen saturation sensors 20, 21, 22; a lactate sensor 23; and one or more impedance cardiography electrodes 24, 25 for monitoring the mechanical function of the heart.

[0053] In some embodiments, the substrate may have 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 can be attached to the skin of a subject (e.g., a patient). In some embodiments, each oxygen saturation sensor 20, 21, 22 is disposed on the first side of the substrate. In some embodiments, the lactate sensor 23 is also located on the first side of the substrate. In some embodiments, at least a portion of the one or more impedance cardiography electrodes 24, 25 are disposed on the first side of the substrate. In other embodiments, the sensors may be disposed in or on the substrate in other suitable ways.

[0054] In some embodiments, the one or more impedance cardiography electrodes 24, 25 may comprise 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 disposed at least partially on the second side. In some embodiments, each impedance cardiography electrode may have a portion on a first side 12 (or surface) of the substrate and another portion on a second side 13 (or surface) of the substrate.

[0055] In some embodiments, the one or more sensors arranged to measure oxygen saturation 20, 21, 22 may comprise or consist of NIR emitters / detectors, IR emitters / detectors, or both. In some embodiments, the monitoring patch may comprise a plurality of sensors for measuring oxygen saturation, each sensor being an NIR emitter / detector. In some embodiments, the monitoring patch may have a plurality of sensors for measuring oxygen saturation, each sensor being an IR emitter / detector. In some embodiments, the monitoring patch may have a plurality of sensors for measuring oxygen saturation (e.g., StO2 / SmO2 / TSI), at least one of the plurality of sensors being an NIR emitter / detector and at least one of the plurality of sensors being an IR emitter / detector.In some embodiments, the one or more sensors arranged to measure oxygen saturation may include or consist of at least three sensors. In some embodiments, the one or more sensors may measure the difference in light intensity after absorption and scattering. In some embodiments, the detectors may indicate changes in HbO2. In some embodiments, the light may propagate in the shape of a banana. In some embodiments, the penetration depth may be between 1 / 2 and 1 / 3 of the source-detector distance, although other suitable penetration depths may be used. In some embodiments, the IR emitter / detector may include gel and adhesive around the sensor.

[0056] In some embodiments, the lactate sensor 23 may include or consist of a subcutaneous lactate sensor.

[0057] In some embodiments, one or more additional sensors may be integrated into the monitoring patch, for example, in or on the substrate (e.g., on or in the first side of the substrate). In some embodiments, the monitoring patch may also include, for example, a sweat biosensor array 26.

[0058] In some embodiments, the sweat biosensor array 26 may be disposed on the first side of the substrate. In some embodiments, the sweat biosensor array may be configured to detect sodium (Na + ), potassium (K +) or a combination thereof. In some embodiments, the sweat biosensor array can be configured to detect at least pH, glucose, lactate, an alkali metal ion, an alkaline earth metal ion, or a combination thereof. In some embodiments, the sweat biosensor array can be configured to measure sodium, pH, potassium, glucose, lactate, or a combination thereof. As can be appreciated, blood chemistry can be used to indicate one or more patient conditions. For example, in some embodiments, the lactate sensor can be configured to measure the level of lactate in the blood, which in some embodiments can indicate muscle fatigue (e.g., cardiac muscle fatigue). As described herein, such patient information can be used to determine the patient's degree of recovery and / or the need for further or new treatment.

[0059] In some embodiments, the monitoring patch may also include a temperature sensor 27. In such embodiments, the temperature sensor 27 may also be mounted on the first side of the substrate.

[0060] In some embodiments, the monitoring patch may also include an electrocardiogram (ECG) surface electrode 28 arranged to monitor the patient's heart rate. In some embodiments, the ECG surface electrode 28 is arranged on the first side of the substrate. In some embodiments, the ECG surface electrode may comprise an electrode, as well as a gel and an adhesive around the electrode.

[0061] In some embodiments, the monitoring patch may also include a strain gauge 30, 31, 32, 33. In some embodiments, the monitoring patch may include only a single strain gauge. In other embodiments, a pair of strain gauges may be present. In some embodiments, each strain gauge may extend beyond an edge of the substrate. For example, in some embodiments, each strain gauge of the pair of strain gauges may extend beyond an 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 the pair of strain gauges may extend beyond an 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 strain gauge pair is configured to measure strain in parallel directions (i.e., both strain gauges of a pair are configured to measure strain across or along the substrate). In some embodiments, there may be four strain gauges 30, 31, 32, 33.

[0062] As known in the art, strain gauges can compress and expand, and when they do, a measurable property (e.g., resistance) changes, which may indicate expansion (or contraction). Accordingly, in some embodiments, the one or more strain gauges may be arranged to measure the swelling and / or expansion of a portion of a patient's body, such as the skin of the patient's hand, arms, foot, ankles, and / or legs. In some embodiments, the strain gauge(s) may monitor, and in some embodiments, measure, swelling and / or expansion of the patient's body, e.g., due to retention of a volume of fluid or flatulence. In some embodiments, the strain gauge(s) on the monitoring patch may detect a medical condition (e.g.,heart failure) or a problem with a prescribed medication.

[0063] In some embodiments, the monitoring patch may also include an accelerometer 43. In some embodiments, the accelerometer may comprise a six-axis accelerometer. In other embodiments, the accelerometer may comprise a three-axis accelerometer. In still other embodiments, the accelerometer may comprise a two-axis accelerometer. In some embodiments, the accelerometer may be arranged to monitor patient movement. For example, the accelerometer may indicate when a patient stands up and walks and / or when a patient falls.

[0064] In some embodiments, the monitoring patch 1 may also include a circuit 40 that may be disposed on a second side 13 of the substrate, wherein the second side 13 is opposite the first side 12 and the circuit 40 is operatively connected to at least one of the plurality of different sensors 20-28, 30-33, 43. In some embodiments, the circuit 40 is operatively connected to all of the plurality of different sensors 20-28, 30-33, 43. In some embodiments, the circuit 40 is operatively connected to the plurality of different sensors 20-28, 30-33 on the first surface. The circuit may also be connected to the plurality of different sensors on the second surface.

[0065] In some embodiments, circuitry 40 includes a terminal 41 for connection 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 operatively connected to the substrate. For example, a button cell or battery pack may be mounted directly on the substrate. In some embodiments, the power source may be remote from the patch.

[0066] In some embodiments, circuitry 40 may include one or more processors 44 and one or more non-transitory computer-readable storage media 45 (e.g., flash memory, etc.).

[0067] In some embodiments, the monitoring patch 1 may include a removable wireless transmitter or transceiver 60 configured to be operatively connected to the circuitry. In some embodiments, the removable wireless transmitter or transceiver may be a removable Bluetooth transmitter or transceiver.

[0068] As 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 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, e.g., a cloud-based server, for example, via one or more routers 104. As can be seen, the remote server may also be connected to one or more mobile devices, computers, and / or the patient console. In other embodiments, the monitoring patches may also be connected directly to the patient console. In some embodiments, the console (and / or the cloud) may include an integrated dashboard.

[0069] As in the Fig. 3A-3C, in some embodiments, the substrate may be formed to be bilaterally symmetric about a central plane 300 and to have a first and a second portion, e.g., a left portion 301 and a right portion 302. As shown in Fig. 3B, in some embodiments, a first impedance cardiography electrode 25 may be arranged in the left portion 301 of the substrate and a second impedance electrode 24 may be arranged in the right portion 302 of the substrate. As shown in Fig. 3C, in some embodiments, the substrate may be formed to be bilaterally symmetric about a central plane 300 perpendicular to the surface that bisects the length 304 of the substrate, and a central plane 303 perpendicular to the surface that bisects the width 305 of the substrate.

[0070] In some embodiments, the substrate may be configured to be bilaterally asymmetric in a first direction, but bilaterally symmetric in a perpendicular direction. For example, as in Fig. As seen in 3D, the substrate may be bilaterally asymmetric about a central plane 300 normal to the surface, oriented in a direction that bisects the length of the substrate, but also about a central plane 303 normal to the surface, oriented in a direction perpendicular to the length and bisecting the width of the substrate.

[0071] As will be appreciated, in other embodiments, the substrate may have other suitable shapes and sizes. As will be seen, 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 of different shapes and sizes. In such embodiments, the patches may vary in size and shape depending on the body part to which the patch is to be applied.

[0072] In some embodiments, the substrate may comprise a plurality of layers, e.g., two or more layers. As 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 consist of two layers (e.g., 401, 402). In some embodiments, the substrate may consist of three layers (e.g., 401, 402, 403). In some embodiments, additional layers may be included. For example, in some embodiments, each layer may comprise a stretchable and / or elastomeric material. In some embodiments, at least one layer may comprise a stretchable and / or elastomeric material. In some embodiments, the substrate is free of a stretchable and / or elastomeric material.For the purposes of this document, the terms "elastomeric" and "stretchable" refer to materials that expand in at least one direction when a force is applied to the material and that return to approximately their original dimension(s) after the force is removed. In some embodiments, at least one layer may comprise a nonwoven material. In some embodiments, at least one layer may comprise a foam material.

[0073] Any combination of sensors is conceivable, of which numerous, non-limiting examples are given in the Fig. 5A-5H can be seen.

[0074] As described herein, in some embodiments, the monitoring patches may include one or more oxygen saturation sensors, a lactate sensor, and one or more impedance cardiography electrodes, with other sensors, such as an accelerometer and a strain gauge, being optional. Fig. 5A, the monitoring patch may, for example, comprise only an oxygen saturation sensor 20, a lactate sensor 23, and an impedance cardiography electrode 24. In Fig. 5B, a temperature sensor 27 can be added to the three sensors of Fig. 5A. As in Fig. 5C, the monitoring patch may comprise three oxygen saturation sensors 20, 21, 22, a lactate sensor 23, and two impedance cardiography electrodes 24, 25. As shown in Fig. 5D, the monitoring patch may comprise two oxygen saturation sensors 20, 21, 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 an oxygen saturation sensor 20, a lactate sensor 23, an impedance cardiography electrode 24, a sweat biosensor array 26, an ECG surface electrode 28, and an accelerometer 43.

[0075] In other embodiments, the monitoring patches may include an accelerometer and a strain gauge, with other sensors being optional. In some embodiments, the monitoring patch may be free of an oxygen saturation sensor, a lactate sensor, and / or an impedance cardiography electrode. This can be seen, for example, in FIGS. 5F-5H. Fig. 5F, the patch is shown with only an accelerometer 43 and a single strain gauge 32. In Fig. 5G shows the patch with an accelerometer 43 and two strain gauges 30, 31, an oxygen saturation sensor 20, and an ECG surface electrode 28 (but without a lactate sensor or impedance cardiography electrode). Fig. In Figure 5H, the patch is illustrated as including only one accelerometer 43 and four strain gauges 30, 31, 32, 33, one lactate sensor 23, one impedance cardiography electrode 24, one sweat biosensor array 26, and one temperature sensor 27 (but no oxygen saturation sensor). As will be appreciated from the present disclosure, the number and type of sensors on the monitoring patch can be selected depending on the type of monitoring desired and the specific location where the patch is to be applied to the patient.

[0076] In some embodiments, the Fig. 5A-5H may otherwise be identical to those described herein (e.g., in terms of size, shape, number of layers). As described herein, in some embodiments, the monitoring patch may also include circuitry on a second surface of the substrate, wherein the second surface is opposite the first surface. The circuitry may be operatively connected to some or all of the various sensors as described herein. In some embodiments, the circuitry includes a terminal for connection to a power source. In some embodiments, the power source may be operatively connected to the substrate. In some embodiments, the power source may be located remote from the patch.As described herein, in some embodiments, the monitoring patch may include a detachable wireless transmitter or transceiver configured to be operatively connected to the circuitry. In some embodiments, the detachable wireless transmitter or transceiver may be a detachable Bluetooth transmitter or transceiver.

[0077] As also described herein, 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 communicate with a remote server.

[0078] As also described herein, in some embodiments, the monitoring patch may also include a sweat biosensor array. In some embodiments, the sweat biosensor array may be configured to detect Na + , K + or a combination thereof. In some embodiments, the sweat biosensor array can be configured to detect at least pH, glucose, lactate, an alkali metal ion, an alkaline earth metal ion, or combinations thereof. In some embodiments, the sweat biosensor array can be configured to measure sodium, pH, potassium, glucose, lactate, or combinations thereof.

[0079] 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 an electrocardiogram (ECG) surface electrode.

[0080] As further described herein, in some embodiments, the monitoring patch may include a lactate sensor. In some embodiments, the lactate sensor may comprise a subcutaneous lactate sensor. In some embodiments, the substrate may have a first side and a second side opposite the first side, with the lactate sensor disposed on the first side of the substrate.

[0081] As further described herein, in some embodiments, the monitoring patch may also include a power source or a connector for a power source that 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.

[0082] As also described herein, in some embodiments, the monitoring patch may include one or more sensors arranged to measure oxygen saturation. In some embodiments, the one or more sensors arranged to measure oxygen saturation may include NIR emitters / detectors, IR emitters / detectors, or both.

[0083] As also described herein, in some embodiments, the substrate may be configured to be bilaterally symmetrical and have a left 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, wherein the second surface is opposite the first surface. As described herein, in some embodiments, the substrate may be configured to be bilaterally symmetrical and have a left and a right portion, wherein a first impedance cardiography electrode is in the left portion and a second impedance electrode is in the right portion.

[0084] As further described herein, in some embodiments, the substrate may consist of two or more layers.

[0085] As in Fig. 6, some embodiments of the present disclosure include a monitoring patch kit 600. As shown in this view, the monitoring patch kit 600 may include or consist of a plurality of patches 1, 5, 3, 4. In some embodiments, a container 601 may be used to contain each of the patches of the kit. In some embodiments, the container 601 may include sterile packaging. In some embodiments, some or all of the patches of the kit may be housed in their own separate compartment 602, 603, 604. In some embodiments, each of the separate compartments 602, 603, 604 may include sterile packaging.

[0086] In some embodiments, the plurality of patches may comprise 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 arranged in and / or on the substrate of the second patch, wherein at least one of the plurality of sensors arranged in and / or on the substrate of the first patch 1 is different from one of the plurality of different sensors arranged in and / or on the substrate of the second patch 5. As in Fig. 6, the first patch 1 has, for example, a strain gauge 630, which is not present on the second patch 5. Of course, other arrangements are also conceivable; for example, the first patch 1 can have the Fig. 5E, while the second patch 5 has the sensors shown in Fig. 5A shown sensors.

[0087] In some embodiments, the set 600 may include a third patch 3 and a fourth patch 4, wherein the third patch and the fourth patch each independently comprise 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, and at least one of the plurality of sensors disposed in and / or on the substrate of the first patch is different from each of the plurality of different sensors disposed in and / or on the substrate of the third patch and each of the plurality of different sensors disposed in and / or on the substrate of the fourth patch. As in Fig. 6, the first patch 1 has a strain gauge 630 which is not present on either the third patch 3 or the fourth patch 4.

[0088] In some embodiments, the configuration of the first, second, third, and fourth patches is different. In some embodiments, at least two of the second, third, or fourth patches are identical. For example, a set may include a first patch having a first configuration and a second, third, and fourth patch having a second configuration.

[0089] As in Fig. 7A, in some embodiments, the monitoring patches 710, 711, 712, 713, 714, and 715 may be configured to be applied to different parts of a person's 700 body. In some embodiments, the first patch (e.g., patch 710, 711, or 712) is configured to be applied to a first part of a patient's body, and the second patch (e.g., patch 713, 714, or 715) is configured to be applied to a different part of the patient's body. In some embodiments, the first part of the patient's body is a torso, a thigh, or a combination thereof (e.g., patches 710, 711, and 712 are shown to be on the patient's torso and thigh). In some embodiments, the other part is a forearm, a wrist, a neck, a calf, an ankle, or a combination thereof (e.g.,Patches 713, 714 and 715 are shown as being on the patient's neck and calves).

[0090] In some embodiments, the first or second patch (e.g., patch 710) is configured to be applied to the 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 applied to the forearm, wrist, calf, ankle, or a combination thereof.

[0091] In some embodiments, the monitoring patch kit includes at least two patches configured to be applied to the upper body (e.g., patches 710 and 711) and at least one patch configured to be applied to the thigh (e.g., patch 712).

[0092] In some embodiments, the monitoring patch kit includes at least one patch (e.g., patch 714) configured to be applied to the left calf or ankle and at least one patch (e.g., patch 715) configured to be applied to the right calf or ankle.

[0093] In some embodiments, the monitoring patch kit includes at least one patch configured to be applied to the neck.

[0094] In some embodiments, a surgical insertion site 705 (see Fig. 7A and Fig. 7B) through which one or more medical devices are introduced into the patient'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 embodiments, the one or more patches (e.g., patches 712, 714, 715) may be configured to monitor the patient, e.g., to measure 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 physician. The one or more sensors may, for example, provide information about the patient and about the operation of the mechanical circulatory support pump.As also described herein, the sensed values ​​can be compared to acceptable predetermined ranges, and alerts can be transmitted to the physician. In some embodiments, one or more processors can communicate with both the monitoring patches and a mechanical circulatory support device (e.g., receive information from them, send information to them, or a combination thereof).

[0095] As will be appreciated in light of the foregoing, in some embodiments, patches 710, 711, 712, 713, 714, and 715 of set 700 may each include the same number and type of sensors. In other embodiments, the patches may include more than one type of patch.

[0096] In some embodiments, the various monitoring patches may enable simplified monitoring of hemodynamics and vital signs, 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 in the body), heart rate (e.g., via ECG leads), and ECG (e.g., via ECG leads).

[0097] In addition, further monitoring can be performed. For example, the detection of local infections (e.g., via temperature sensors placed near the puncture site), the detection of limb ischemia (e.g., via NIR sensors placed distal to the puncture site), the display of end-organ perfusion (e.g., via lactate sensors), the detection of arrhythmias (e.g., via ECG leads), the measurement of ascites (e.g., via strain gauges), or the general movement of the patient (e.g., via an accelerometer).

[0098] In some embodiments, a patch 713 with NIR sensors applied to the neck of a person may be used to take a measurement representative of brain oxygenation.

[0099] In some embodiments, duplicate or triple lactate and analyte measurements from patches 710, 711, and / or 712 may be used to obtain real-time data for measuring end-organ perfusion.

[0100] In some embodiments, multiple impedance cardiography measurements from patches 710, 711, 712, 714, and 715 may enable measurements of cardiac output.

[0101] In some embodiments, NIR measurements may be used to enable pulse oximetry, pulse pressure, and vascular resistance measurement.

[0102] In some embodiments, patient movements can be detected and monitored. For example, accelerometers can be used to alert medical personnel if a patient has moved too much or is not positioned at an acceptable angle in a bed.

[0103] Again referring to Fig. 6, in some embodiments, the monitoring patch set 600 may also include one or more additional patches 6, 7. In some embodiments, the one or more additional patches may include 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 a shape of the first substrate may be different from a shape of the second substrate. Fig. Figure 6 shows the first additional patch 6 with a different set of sensors than the second additional patch 7, but it is recognized that other variations can easily be manufactured.

[0104] The monitoring patch set 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 connected to a display 652 and / or one or more buttons or controls 653. The controller 650 may be configured to receive data from one or more sensors on each of the plurality of patches. In some embodiments, the controller 650 may be operatively connected to a wireless transceiver 654. In some embodiments, the one or more processors 651 may be operatively 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, and the processor may provide a value (e.g.,the heart rate) based on the raw sensor data, and the calculated value can then be transmitted to the control unit.

[0105] The monitoring patch set 600 may also include a plurality of lines 660, 661. Each line 660, 661 may be configured to connect at least one sensor on one of the plurality of patches to the control unit. Even if the monitoring patches cannot communicate wirelessly with the control unit, sensor information may be forwarded to the control unit in this manner.

[0106] As can be seen, the transmission of sensor information can occur in various ways. For example, in some embodiments, some or all of the patches are connected to the controller via wires. In other embodiments, some or all of the patches communicate wirelessly directly with the controller. In some embodiments, a first patch can communicate wirelessly directly with the controller, while the other patches communicate with the controller via the one or more wires. In other embodiments, the first patch can communicate wirelessly directly with the controller, while the other patches communicate with the first patch. In such embodiments, the other patches can communicate with the controller via the first patch. As in Fig. For example, as shown in Figure 2, the 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 the second patch 2. Although the second patch 2 communicates only with the first patch 1, the second patch 2 may also be configured to communicate with any of the components that communicate with the first patch 1 (or another patch).

[0107] According to another embodiment, a method for using the monitoring patches is disclosed. This can be described with reference to Fig. 7A and Fig. 8. In some embodiments, method 800 may include receiving 805 data from one or more sensors on one or more monitoring patches according to any embodiment described herein, wherein the one or more monitoring patches are positioned on a person. Fig. 7A shows sensors on at least patches 711, 712, and 714 that communicate with a controller 105, and controller 105 can receive data from these sensors. In some embodiments, additional steps may occur in the method. It should be understood that these additional steps may be performed in any order.

[0108] In some embodiments, method 800 may also include storing 810 the received data on one or more non-transitory computer-readable media (e.g., non-transitory computer-readable medium 720, on a remote server, such as a database on a cloud-based server, etc.), displaying data 815 (e.g., the data received from the sensors and / or values ​​derived from the received data) on a display (e.g., a secondary display 725 and / or a display screen on patient console 108), or a combination thereof. This may occur at any time after receiving the data. In some embodiments, the displayed value may be an oxygen level, a lactate level, a glucose level, a potassium level, a sodium level, a pulse rate, a pH level, a temperature, and / or a difference between two received data points.

[0109] In some embodiments, the data may be sent to the display after being received from the non-transitory computer-readable medium.

[0110] In some embodiments, method 800 may also include transmitting 820 the data to a remote server (e.g., remote server and / or databases 730), a mobile device (e.g., smartphone 100), a patient console (e.g., patient console 108), or a combination thereof. This may occur at any time after receiving the data.

[0111] In some embodiments, 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.

[0112] In some embodiments, the determining step may include comparing a first value from a first sensor with a predetermined value or range. For example, in some embodiments, the data from the temperature sensors may be expected to provide temperatures within a predetermined range (e.g., a normal temperature range for the monitored patient). In such an example, if the temperature is determined to be outside the predetermined range, this may indicate an infection.

[0113] In some embodiments, if the data shows a trend, the slope or other variable representative of the trend may be used to evaluate the patient (e.g., if the slope or other variable representative of the trend falls outside an acceptable predetermined range). In some embodiments, for example, skin temperature may have a predetermined range between, e.g., 92°F and 99°F. In some cases, no alarm is triggered if the measured temperature rises from 93°F to 95°F. In other cases, however, if this temperature rise of 2 degrees occurs over a prescribed period of time, e.g., 10 minutes, this rate of change (e.g., 1 degree every 5 minutes) may be outside a predetermined range, and an alarm may be triggered.

[0114] In other embodiments, the determining step may comprise comparing a first value from the first sensor with a second value from a second sensor. For example, the method may comprise determining a first difference between a first value from a first sensor at a first spot and a second value from a second sensor at a second spot at a first time. In some embodiments, the first value is a first pulse value and a second value is a second pulse value.

[0115] In some embodiments, the step of determining may include determining a second difference between the first value of the first sensor measured at a second time and the second value of the second sensor measured at the second time.

[0116] In other embodiments, the determining step may include comparing whether a difference between sensor values ​​is within acceptable limits. For example, the method may include determining whether the first difference is outside a second predetermined range. For example, comparing the pulse oximetry data from patches 714 and 715 may detect limb ischemia when medical devices have been inserted through insertion site 705. In some embodiments, the limb not including the insertion site may be used as a control.

[0117] In other embodiments, the determining step may include comparing tissue oxygenation data from patches 714 and 715 to enable detection of limb ischemia if a medical device has been 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 possible ischemic event may be determined if tissue oxygenation is less than 60% for a predetermined period of time, e.g., for more than 3 minutes. In some embodiments, a possible ischemic event may be determined if the sensed tissue oxygenation decreases by more than 5% over a predetermined period of time, e.g., 30 minutes.

[0118] In some embodiments, the limb not containing the puncture 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 may detect a possible ischemic event in the limb.

[0119] If the values ​​(e.g., sensor data, values ​​calculated based on the sensor data, differences, etc.) are outside a predetermined value or range, the method may include generating an alert 830, such as a visual signal or an audible alarm (e.g., a beep, a tone, etc.). In some embodiments, generating alerts may be the only steps in method 800 that cannot be performed in any order—they must follow a determining step (such as the step of determining 825) that at least one value is outside a predetermined range.

[0120] In some embodiments, the alert is intended to warn a person and / or medical personnel. In such embodiments, alerting the person and / or medical personnel may include generating an audible signal, a visual signal, a message (e.g., a text message, an email message, etc.), or a combination thereof. In some embodiments, the visual signal includes a visual change on a display screen (e.g., a secondary display 725 and / or a display screen on the patient console 108).

[0121] In some embodiments, method 800 may also include determining and proposing 835 a treatment plan based on the received data, the first difference, a change from the first difference to the second difference, or a combination thereof. For example, controller 105 may receive the data, and a treatment plan may be automatically determined and proposed (e.g., displayed or otherwise communicated to one or more individuals) based on a trained machine learning algorithm and treatments stored in a database on non-transferable computer-readable media 720.

[0122] The patient may then be treated based on the received data or values ​​derived from the received data, such as the first difference, a change from the first difference to the second difference, the proposed treatment, or a combination thereof 840.

[0123] An example of a mechanical circulatory support device (also called a “heart pump” or simply a “pump”) is Fig.9 and may include a percutaneous, catheter-based device that provides hemodynamic support to a patient's heart. As shown in this view, a heart pump 1110 may include a pigtail 1111, an inlet region 1112, a cannula 1113, a pressure sensor 1114, an outlet region 1115, a motor housing 1116, and / or a catheter tube 1117. The pigtail 1111 may contribute to stabilizing the heart pump 1110 within a patient's heart. It should be noted that some embodiments of the heart pump 1110 do not include a pigtail 1111, and the heart pump 1110 may be stabilized in other ways or not at all. During operation, blood may be drawn into one or more openings of the inlet region 1112, directed through the cannula 1113, and expelled through one or more openings of the outlet region 1115 by a motor (not shown) in the motor housing 1116.In some embodiments, the pressure sensor 114 may comprise a flexible membrane integrated into the cannula 1113. One side of the pressure sensor 114 may be exposed to the blood pressure on the outside of the cannula 1113, while the other side may be exposed to the blood pressure inside the cannula 1113. In some of these embodiments, 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 embodiments, the pressure sensor 114 may comprise an optical pressure sensor. The catheter tube 1117 may establish one or more fluidic and / or electrical connections between the heart pump 1110 and one or more other devices of a ventricular assist system.

[0124] Those skilled in the art will recognize, or be able to discover through routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are intended to be covered by the following claims.

[0125] Although the present teachings have been described in connection with various embodiments and examples, it is not intended that the present teachings be limited to these embodiments or examples. On the contrary, the present teachings encompass various alternatives, modifications, and equivalents, as would be apparent to those skilled in the art. Accordingly, the foregoing description and drawings are to be considered as examples only.

[0126] Various aspects of the present invention may be used alone, in combination, or in a variety of arrangements not specifically discussed in the above-described embodiments, and therefore are not limited in their application to the details and arrangement of the components set forth in the above description or depicted in the drawings. For example, the aspects described in one embodiment may be combined in any manner with the aspects described in other embodiments.

[0127] The invention may also be embodied in the form of a method, of which an example has been given. The acts performed within the method may be arranged in any suitable manner. Accordingly, embodiments may be constructed in which the acts are performed in a different order than that shown, which may include the simultaneous performance of some acts, even if they are shown as sequential acts in the illustrated embodiments.

[0128] The use of ordering terms such as "first", "second", "third", etc. in the claims to modify a claim element does not in itself imply any priority, precedence, or order of one claim element over another, or the chronological order in which acts of a method are performed, but is used merely as a label to distinguish one claim element with a particular designation from another element with the same designation (without use of the ordering term).

[0129] The phraseology and terminology used herein is for descriptive purposes only and should not be construed as limiting. The use of "including," "comprising," "having," "incorporating," and variations thereof is intended to encompass the elements listed below and their equivalents, as well as additional elements. QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] US 63 / 296,992

[0001] US 63 / 346,091

[0001]

Claims

[1] Surveillance patch, comprising: a substrate having an adhesive surface; a plurality of sensors arranged in and / or on the substrate, the plurality of sensors comprising: one or more sensors for measuring oxygen saturation; a lactate sensor; and one or more impedance cardiography electrodes. [2] The monitoring patch of claim 1, further comprising a sweat biosensor array. [3] The monitoring patch of claim 2, wherein the sweat biosensor array is configured to detect Na + , K + or a combination thereof. [4] The monitoring patch of any one of claims 2, wherein the sweat biosensor array is configured to detect at least pH, glucose, lactate, an alkali metal ion, an alkaline earth metal ion, or a combination thereof. [5] The monitoring patch of claim 2, wherein the sweat biosensor array is configured to measure sodium, pH, potassium, glucose, lactate, or a combination thereof. [6] A monitoring patch according to any one of claims 1 to 5, wherein the lactate sensor comprises a subcutaneous lactate sensor. [7] The monitoring patch of claim 6, wherein the substrate has a first side and a second side opposite the first side, and wherein the lactate sensor is disposed on the first side of the substrate. [8] The monitoring patch of claim 7, further comprising a power source or a connector for a power source disposed on the second side. [9] A monitoring patch according to claim 7 or 8, wherein the one or more impedance cardiography electrodes are arranged on the second side. [10] A monitoring patch according to any one of claims 1 to 9, further comprising a temperature sensor. [11] A monitoring patch according to any one of claims 1 to 10, further comprising an electrocardiogram (ECG) surface electrode. [12] A monitoring patch according to any one of claims 1 to 11, further comprising a strain gauge. [13] A monitoring patch according to any one of claims 1 to 12, further comprising an accelerometer. [14] A monitoring patch according to any one of claims 1 to 13, wherein the one or more sensors arranged to measure oxygen saturation comprise NIR emitters / detectors, IR emitters / detectors, or both. [15] The monitoring patch of any one of claims 1 to 14, further comprising a circuit on a second side of the substrate, the second side being opposite a first side, the plurality of sensors comprising at least one sensor disposed in and / or on the first side, the circuit being operatively connected to the at least one sensor disposed in and / or on the first side and comprising a connector for connection to a power source. [16] The monitoring patch of claim 15, wherein the power source is operatively coupled to the substrate. [17] The monitoring patch of claim 16, wherein the power source is located remote from the patch. [18] A monitoring patch according to any one of claims 15 to 17, further comprising a detachable wireless transmitter or transceiver adapted to be operatively connected to the circuit. [19] The monitoring patch of claim 18, wherein the removable wireless transmitter or transceiver is a removable Bluetooth transmitter or transceiver. [20] A monitoring patch according to any one of claims 1 to 19, wherein the monitoring patch is adapted to be connected to a mobile phone, a tablet or a desktop computer. [21] Monitoring patch according to one of claims 1 to 20, wherein the monitoring patch is configured to communicate with a remote server. [22] The monitoring patch according to any one of claims 1 to 21, wherein the substrate is formed to be bilaterally symmetrical and to have a left and a right portion. [23] The monitoring patch of any one of claims 1 to 22, wherein each impedance cardiography electrode comprises a portion on a first surface and a portion on a second surface of the substrate, the second surface being opposite the first surface. [24] The monitoring patch of claim 23, wherein the substrate is formed to be bilaterally symmetrical and to have a first portion and a second portion opposite the first portion, and wherein a first impedance cardiography electrode is disposed within the first portion and a second impedance electrode is disposed within the second portion. [25] A monitoring patch according to any one of claims 1 to 24, wherein the substrate consists of two or more layers. [26] Monitoring patch, comprising: a substrate having an adhesive surface; a plurality of sensors arranged in and / or on the substrate, the plurality of sensors comprising: an accelerometer; and a strain gauge, wherein the monitoring patch is free of an oxygen saturation sensor, a lactate sensor, an impedance cardiography electrode, or a combination thereof. [27] The monitoring patch of any one of claims 26, further comprising a circuit on a second side of the substrate, the second side being opposite a first side, the circuit being operatively connected to the plurality of different sensors on the first side, and comprising a terminal for connecting to a power source. [28] The monitoring patch of claim 27, wherein the power source is operatively coupled to the substrate. [29] The monitoring patch of claim 28, wherein the power source is located remote from the patch. [30] A monitoring patch according to any one of claims 26 to 29, further comprising a detachable wireless transmitter or transceiver adapted to be operatively connected to the circuit. [31] The monitoring patch of claim 30, wherein the removable wireless transmitter or transceiver is a removable Bluetooth transmitter or transceiver. [32] A monitoring patch according to any one of claims 26 to 31, wherein the monitoring patch is adapted to be connected to a mobile phone, a tablet or a desktop computer. [33] A monitoring patch according to any one of claims 26 to 32, wherein the monitoring patch is configured to communicate with a remote server. [34] The monitoring patch of any one of claims 26 to 33, further comprising a sweat biosensor array. [35] The monitoring patch of claim 34, wherein the sweat biosensor array is configured to detect Na+, K+, or a combination thereof. [36] The monitoring patch of any one of claims 35, wherein the sweat biosensor array is configured to detect at least pH, glucose, lactate, an alkali metal ion, an alkaline earth metal ion, or a combination thereof. [37] The monitoring patch of claim 35, wherein the sweat biosensor array is configured to measure sodium, pH, potassium, glucose, lactate, or a combination thereof. [38] A monitoring patch according to any one of claims 26 to 37, further comprising a temperature sensor. [39] A monitoring patch according to any one of claims 26 to 38, further comprising an electrocardiogram (ECG) surface electrode. [40] A monitoring patch according to any one of claims 26 to 39, further comprising a lactate sensor. [41] A monitoring patch according to any one of claims 40, wherein the lactate sensor comprises a subcutaneous lactate sensor. [42] The monitoring patch of claim 41, wherein the substrate has a first side and a second side opposite the first side, and wherein the lactate sensor is disposed on the first side of the substrate. [43] The monitoring patch of claim 42, further comprising a power source or a connector for a power source disposed on the second side. [44] The monitoring patch of claims 26-39, further comprising one or more impedance cardiography electrodes disposed in and / or on the substrate. [45] The monitoring patch of claim 44, wherein the one or more impedance cardiography electrodes are disposed on a second surface, the second surface opposite a first surface. [46] A monitoring patch according to any one of claims 44, wherein each impedance cardiography electrode comprises a portion on a first surface and a portion on a second surface of the substrate, the second surface being opposite a first surface. [47] The monitoring patch of claim 44, wherein the substrate is formed to be bilaterally symmetrical and to have a left portion and a right portion, wherein one or more impedance cardiography electrodes comprise a first impedance cardiography electrode and a second impedance cardiography electrode, and wherein a first impedance cardiography electrode is disposed in the left portion and a second impedance electrode is disposed in the right portion. [48] ​​A monitoring patch according to any one of claims 26 to 39, further comprising one or more sensors arranged to measure oxygen saturation. [49] The monitoring patch of claim 48, wherein the one or more sensors arranged to measure oxygen saturation comprise NIR emitters / detectors, IR emitters / detectors, or both. [50] A monitoring patch according to any one of claims 26 to 49, wherein the substrate is formed to be bilaterally symmetrical. [51] A monitoring patch according to any one of claims 26 to 50, wherein the substrate consists of two or more layers. [52] System for combined use, comprising: a monitoring patch according to any one of claims 1 to 51, which is operatively connected to a patient; and a mechanical circulatory support device that is functionally connected to the patient. [53] The system of claim 52, wherein the mechanical circulatory support device is a percutaneous blood pump. [54] Surveillance patch set, comprising: a plurality of patches comprising: a first patch comprising a monitoring patch according to any one of claims 1 to 51; and a second patch. [55] Monitoring patch set according to claim 54, wherein the second patch comprises a substrate having an adhesive surface and a plurality of different sensors arranged in and / or on the substrate of the second patch; and wherein at least one of the plurality of sensors disposed in and / or on the substrate of the first patch is different from one of the plurality of different sensors disposed in and / or on the substrate of the second patch. [56] A monitoring patch kit according to claim 54 or 55, further comprising a third and fourth patch, wherein the third patch and the fourth patch each independently comprise a monitoring patch according to any one of claims 1 to 51. [57] Monitoring patch kit according to any one of claims 54 to 56, further comprising a third and a fourth patch, wherein each of the third and fourth patches comprises 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 wherein at least one of the plurality of sensors arranged in and / or on the substrate of the first patch is different from each of the plurality of different sensors arranged in and / or arranged on the substrate of the third patch, and from each of the plurality of different sensors arranged in and / or on the substrate of the fourth patch. [58] A monitoring patch kit according to any one of claims 54 to 57, wherein the first patch is adapted to be placed on a first part of a patient's body and the second patch is adapted to be placed on another part of the patient's body. [59] The monitoring patch kit of claim 58, wherein the first part of the patient's body is an upper torso, a thigh, or a combination thereof. [60] The monitoring patch kit of claim 59, wherein the other part is a forearm, a wrist, a neck, a calf, an ankle, or a combination thereof. [61] A monitoring patch kit according to any one of claims 54 to 60, further comprising one or more additional patches comprising a first additional patch having a first set of different sensors arranged in and / or on a first substrate and a second additional patch having a second set of different sensors arranged in and / or on a second substrate, wherein 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 a shape of the first substrate is different from a shape of the second substrate. [62] The monitoring patch kit of any one of claims 54 to 61, further comprising a controller configured to receive data from sensors on each of the plurality of patches. [63] The monitoring patch kit of claim 62, wherein the controller is operably connected to a wireless transceiver. [64] The monitoring patch kit of claim 62 or 63, further comprising a plurality of leads, each lead being configured to operatively connect at least one sensor on one of the plurality of patches to the controller. [65] A monitoring patch kit according to any one of claims 54 to 64, wherein the first or second patch is adapted to be applied to the torso, upper arm, thigh, neck, or a combination thereof of a patient, and wherein the other of the first or second patch is adapted to be applied to the forearm, wrist, calf, ankle, or a combination thereof of a patient. [66] A monitoring patch kit according to any one of claims 54 to 65, wherein the monitoring patch kit comprises at least two patches adapted to be applied to an upper body and at least one patch adapted to be applied to a thigh. [67] A monitoring patch kit according to any one of claims 54 to 66, wherein the monitoring patch kit comprises at least one patch adapted to be applied to a left calf or a left ankle and at least one patch adapted to be applied to a right calf or a right ankle. [68] A monitoring patch kit according to any one of claims 54 to 67, wherein the monitoring patch kit comprises at least one patch adapted to be applied to the neck. [69] Monitoring patch set according to one of claims 54 to 68, wherein the first patch and the second patch are configured to communicate with a control device and / or with each other. [70] Procedure comprising: Receiving data from one or more sensors on one or more monitoring patches according to any one of claims 1 to 51, wherein the one or more monitoring patches are placed on a patient. [71] The method of claim 70, further comprising storing the received data on one or more non-transitory computer-readable media, displaying the received data on a display, or a combination thereof. [72] The method of claim 70 or 71, further comprising transmitting the data to a remote server, a mobile device, a patient console, or a combination thereof. [73] The method of claim 72, wherein the remote server is a cloud-based server. [74] A method according to any one of claims 70 to 73, wherein for at least one of the sensors it is determined whether the data received by the sensor is outside a first predetermined range. [75] The method of claim 74, further comprising displaying a value represented by the received data. [76] The method of claim 73, wherein the value is an oxygen level, a lactate level, a glucose level, a potassium level, a sodium level, a pulse rate, a pH value and / or a temperature. [77] A method according to any one of claims 70 to 76, wherein the data comprises a first value from a sensor on a first patch and a second value from a sensor on the second patch, and wherein the method further comprises determining a first difference between the first value and the second value at a first time. [78] A method according to any one of claims 70 to 76, wherein the data comprises a first value from a first sensor on a first patch and a second value from a second sensor on the first patch, and wherein the method further comprises determining a first difference between the first value and the second value at a first time. [79] The method according to claim 77 or 78 further comprises determining whether the first difference is outside a second predetermined range. [80] The method of any one of claims 70 to 76, further comprising determining a second difference between the first value and the second value at a second time. [81] A method according to any one of claims 77-80, wherein the first value is a first pulse value and a second value is a second pulse value. [82] The method of any one of claims 77 to 81, further comprising warning a person and / or a medical professional if the received data is outside the first predetermined range and / or the second predetermined range. [83] The method of claim 82, wherein alerting the person and / or medical personnel comprises transmitting an alarm to a remote server, a desktop computer, a laptop, a mobile device, a patient console, or a combination thereof. [84] The method of claim 83, wherein alerting the person and / or the healthcare professional comprises generating an audible signal, a visual signal, a message, or a combination thereof. [85] The method of claim 84, wherein the visual cue includes a visual change on a screen. [86] The method of any one of claims 70 to 85, further comprising determining and proposing a treatment plan based on the received data, the first difference, a change from the first difference to the second difference, or a combination thereof. [87] A method according to any one of claims 70 to 85, further comprising operating a mechanical circulatory support device. [88] The method of claim 58, wherein the mechanical circulatory support device is a percutaneous blood pump.

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