Devices used to monitor pregnancy or childbirth

Abstract

The present application relates to devices for monitoring pregnancy or labor. In one embodiment, the device includes an electromyography (EMG) sensor having two or more EMG electrodes that monitor fetal or maternal activity during pregnancy or labor, and one or more position sensors that monitor the relative positioning of the two or more EMG electrodes during fetal or maternal activity. In one embodiment, the device includes a monitoring apparatus that is placed on a body and has a plurality of sensors integrated into the monitoring apparatus, the plurality of sensors including at least a first sensor configured to detect a first type of signal from the body indicative of a first type of fetal or maternal activity during pregnancy or labor, and a second sensor configured to detect a second type of signal from the body different from the first type of signal also indicative of the first type of fetal or maternal activity during pregnancy or labor.

Description

[0001] This application is a divisional application of the application filed on December 7, 2017, with application number 201780085213.0 and invention title "Device for Monitoring Pregnancy or Childbirth".

[0002] Cross-references to related applications

[0003] This application claims priority from Australian Provisional Patent Application No. 2016905046, filed on 7 December 2016, the contents of which are incorporated herein by reference. Technical Field

[0004] This disclosure relates to a device for monitoring pregnancy or labor. background

[0005] Pregnancy and childbirth involve complex biological processes that are still poorly understood. Most women who experience childbirth and subsequent delivery do so without major medical intervention. However, a significant number of women are unable to or choose to give birth unnaturally. These situations require intervention, such as a cesarean section or surgical vaginal delivery. While medical interventions have improved maternal and infant outcomes and prevented death and trauma over the past few decades, they remain associated with significant risks and complications.

[0006] Technological advancements have made it possible to monitor the mechanisms of labor using minimally invasive and lower-cost techniques. A better understanding of the mechanisms of labor helps clinicians identify and assess the risk of adverse pregnancy or labor progression in the early stages.

[0007] Most current labor monitoring systems use cardiac labor plethysmography (CTG), more broadly known as electronic fetal monitoring (EFM). These systems use fetal heart rate and contraction frequency to predict whether labor is imminent and to detect any abnormalities or complications during pregnancy and labor. These systems tend to use Doppler ultrasound transducers or fetal electrocardiography (fECG) to monitor fetal heart rate. They also use a separate device called a labor force meter (TOCO) or electromyography (EMG) to detect the presence of contractions, which is essentially a strain gauge that measures the increased abdominal tension associated with contractions. However, such systems are relatively bulky and uncomfortable, and difficult to record data while moving or immersed in water (shower, bath, or similar situations). Furthermore, the data provided by such devices (i.e., fetal heart rate and contraction frequency) requires subjective interpretation, which is known to increase the rate of intervention. As a result of these combined factors, patients are often confined to a hospital setting where such systems are available and where a trained clinician is required to operate and interpret readings from such systems. Furthermore, these systems also only allow for limited assessment of activities during pregnancy and childbirth.

[0008] Any document, action, material, device, article, or discussion thereof included in this specification shall not be construed as an admission that any or all of these things, as they existed prior to the priority date of each claim of this application, form part of the prior art or constitute common general knowledge in the relevant field of this disclosure. Overview

[0009] According to an aspect of this disclosure, an apparatus for monitoring pregnancy or childbirth is provided, the apparatus comprising:

[0010] The monitoring device is placed on the body and includes multiple sensors integrated into the monitoring device, the multiple sensors including at least:

[0011] A first sensor is configured to detect a first type of signal from the body indicating fetal or maternal activity during pregnancy or childbirth; and

[0012] The second sensor is configured to detect a second type of signal from the body that is different from the first type of signal, indicating fetal or maternal activity during pregnancy or childbirth.

[0013] In some embodiments, both the first type of signal and the second type of signal can indicate body movement during pregnancy or childbirth. Body movement can be fetal movement and / or maternal movement.

[0014] The first sensor can be an electromyography (EMG) sensor, while the second sensor can be a temperature sensor. Alternatively, the first sensor can be an EMG sensor, while the second sensor can be an accelerometer. Still alternatively, the first sensor can be a temperature sensor, while the second sensor can be an accelerometer.

[0015] In some embodiments, fetal activity may include one or more of the following: fetal positioning, fetal movement, and fetal heart rate. In some embodiments, maternal activity may include one or more of the following: muscle and uterine contractions, maternal positioning, maternal movement, maternal heart rate, and maternal temperature.

[0016] In some embodiments, the types of fetal or maternal activities monitored by different sensors may be the same.

[0017] According to an aspect of this disclosure, an apparatus for monitoring pregnancy or childbirth is provided, the apparatus comprising:

[0018] The monitoring device is placed on the body and includes multiple sensors integrated into the monitoring device, the multiple sensors including at least:

[0019] The first sensor detects signals from the body provided to the fetus during pregnancy or childbirth.

[0020] The first type of signal indicating maternal activity; and

[0021] The second sensor detects a second type of signal from the body that provides the same type of fetal or maternal activity as the first sensor, but is different from the first type of signal.

[0022] In the foregoing aspects, the first sensor may be an electromyography (EMG) sensor, and the second sensor may be a temperature sensor. Alternatively, the first sensor may be an EMG sensor, and the second sensor may be an accelerometer. Still alternatively, the first sensor may be a temperature sensor, and the second sensor may be an accelerometer.

[0023] By providing different types of sensors that detect different signals from the body, but each sensor is configured to provide an indication of the same type of fetal or maternal activity, the collection of data related to pregnancy and / or childbirth can be more accurate and / or reliable. This can be particularly advantageous in environments where fetal and / or maternal movement, interventions, and the process of pregnancy or childbirth itself may otherwise lead to missed or lost data. For example, if a sensor is interrupted due to non-contact, poor contact, or other external influences, continuous and uninterrupted monitoring of at least one type of signal can still be performed because another sensor is provided. In some instances, the monitoring device may be exposed to different conditions during the monitoring period, such as patient movement or exposure to water, which may render one sensor unsuitable for monitoring under specific conditions. By detecting at least two different types of signals, each providing an indication of the same type of fetal or maternal activity, the loss or interruption of one sensor does not prevent continuous monitoring of that fetal or maternal activity, because a useful signal can still be obtained from another sensor.

[0024] In some embodiments of the device disclosed herein, the plurality of sensors may include a third sensor that detects a third type of signal from the body indicating fetal or maternal activity during pregnancy or childbirth. The third sensor may be selected from the group consisting of accelerometers, temperature sensors, electromyography sensors, and ultrasound sensors.

[0025] In some embodiments, the plurality of sensors may include a fourth or additional sensor selected from the group consisting of electromyography sensors and ultrasound sensors.

[0026] In some embodiments, the electromyography sensor may include, for example, a uterine electromyography sensor, i.e., an electromyography sensor configured to monitor the uterus.

[0027] In one embodiment, the first sensor is an electromyography (EMG) sensor or an accelerometer, and the second sensor is a temperature sensor; both the first and second sensors are configured to provide an indication of muscle or uterine contractions. In another embodiment, the first sensor is an EMG sensor, the second sensor is a temperature sensor, and a third sensor is provided as an accelerometer; the first, second, and third sensors are each configured to provide an indication of muscle or uterine contractions.

[0028] The monitoring device may include a housing that encloses the electronic components. The housing may be a sealed housing to prevent fluid ingress.

[0029] In some embodiments, the housing may include a top surface and a corrugated bottom surface adapted for placement on a body. In one embodiment, the first sensor may be an electromyography (EMG) sensor, and the second sensor may be a temperature sensor, and the plurality of sensors may also include an accelerometer. The EMG sensor may include at least one electrical contact disposed on the bottom surface of the housing. This contact may be considered to at least partially provide an EMG electrode. The at least one electrical contact may be configured to receive and electrically couple to an EMG surface electrode, and may also be configured to protrude from the bottom surface such that the bottom surface is spaced apart from the body when the monitoring device is placed on the body. The temperature sensor may also be disposed on the bottom surface of the housing, and the accelerometer may be disposed within the housing.

[0030] In some embodiments, the monitoring device may include a central portion and one or more flexible arm portions extending from the central portion. Each of the one or more flexible arm portions may be configured to be maneuverable relative to the central portion to facilitate placement of the monitoring device on a body. In some embodiments, the monitoring device may include four flexible arm portions arranged in a cross configuration. Each flexible arm portion may have an end with an opening and an adhesive seal disposed around the periphery of the opening. The adhesive seal may be configured to adhere to the body to secure the monitoring device to the body and form a waterproof barrier around the opening. In one embodiment, the first sensor may be an electromyography (EMG) sensor, and the second sensor may be a temperature sensor, and the plurality of sensors may further include accelerometers. The EMG sensor may include a plurality of EMG electrodes. Both the adhesive seal and the electrodes may be at least partially removable from the device to allow for replacement or cleaning as required by the method of use.

[0031] In any aspect and embodiment disclosed herein, the electromyography (EMG) sensor may include at least one EMG electrode disposed at a respective end. For example, at least one electrical contact may be disposed at the respective end, and at least one electrical contact may be configured to receive and electrically couple to the EMG surface electrode. A temperature sensor and an accelerometer may be disposed within a central portion. At least one arm portion may include a flexible sensor.

[0032] The use of flexible sensors allows for the detection of bending, flexion, stretching, contraction, deformation, and / or other types of movement (e.g., changes in shape and / or size) of the arm portion. This movement may be caused by body movement (e.g., abdominal movement due to contraction) and / or fetal movement. Body movement can lead to relative movement of the EMG electrodes of the electromyography (EMG) sensor. Therefore, one or more flexible sensors can allow for the monitoring of the relative positions of two or more EMG electrodes. In addition to or as alternatives to flexible sensors, one or more other types of sensors, such as tension sensors, can be used, for example, for the purpose of monitoring the relative positions of two or more EMG electrodes. Other sensors may also allow for the detection of changes in the shape and / or size of parts of the device structure.

[0033] According to an aspect of this disclosure, an apparatus for monitoring pregnancy or childbirth is provided, the apparatus comprising:

[0034] The monitoring device, which is placed on the body, includes:

[0035] Electromyography (EMG) sensors comprising two or more EMG electrodes for monitoring fetal or maternal activity during pregnancy or childbirth; and

[0036] One or more position sensors that monitor the relative positioning of two or more EMG electrodes during fetal or maternal activity.

[0037] One or more position sensors may be flexible sensors or other types of sensors capable of monitoring bending, deflection, stretching, contraction, deformation, and / or other types of changes in the structure of the monitoring device, such as tension sensors. For example, when a flexible or tension sensor is used, it may monitor changes based on, for example, changes in the resistance or capacitance of components included in the sensor. Two or more EMG electrodes may be located on corresponding arm portions, and the position sensors may monitor movement of the arm portions, such as bending or deflection. The position sensors may monitor changes in the relative positions of the two or more EMG electrodes during fetal or maternal activity. For example, when EMG electrodes are attached to the abdomen, changes in the relative positions of the two or more EMG electrodes may indicate deformation of the body (e.g., the abdomen) during fetal or maternal activity. Monitoring the relative positioning of the two or more EMG electrodes during fetal or maternal activity may include determining changes in the distance or distance between the two or more EMG electrodes.

[0038] By monitoring the position of two or more EMG electrodes during fetal or maternal activity, the EMG signals obtained from these electrodes can be interpreted based on their relative positioning, enabling a more complete analysis of the generated data. For example, it allows changes in EMG signals to be correlated with deformations in the body adjacent to the monitoring device, which may occur as a result of contraction or other factors.

[0039] Motion monitoring can be performed by referring to a reference position on the monitoring device. This reference position can be located at the center of the monitoring device. For example, the reference position could be at the central portion of the monitoring device, from which the arm can extend.

[0040] The EMG electrodes can be fixed to the body, for example, by adhering them to the body according to the techniques described above. The central portion can also be fixed to the body, for example, by adhering it to the body. Therefore, the electrodes and the reference position can maintain a corresponding fixed position relative to the body. The portion of the monitoring device between the reference position and the electrodes can be spaced apart from the body. For example, the arm portion can span the space between the central portion and the electrode contact position, with little or no contact with the body, ensuring that the monitoring device does not significantly impede the body's natural movements, such as deformation. As discussed above, the arm portion can be arched or otherwise protrude from the body and can be flexible.

[0041] The relative positioning of two or more EMG electrodes can be determined based on triangulation. The length between the first EMG electrode and a reference position provides the first side of an imaginary triangle, the length between the second EMG electrode and the reference position provides the second side, and the length between the two electrodes provides the third side. The angle between the first and second sides can be a substantially fixed angle, for example, if the flexible arm portion is flexible only in the length direction, and / or can be determined based on monitoring the deflection of the arm portion in two or more dimensions, for example, by a flexibility or tension sensor. The third side of the imaginary triangle can be calculated from the lengths of the first and second sides and their relative angles, and the distance between the two electrodes can be calculated from this. However, other types of calculations can be performed based on data from position sensors to monitor electrode positioning.

[0042] In any of the foregoing aspects and embodiments, the monitoring device may be adapted to be placed on the abdomen. For example, the monitoring device may be located above the fundus of the uterus. It has been found, for example, that the location of the monitoring device, and thus the location of multiple sensors above the fundus, allows different types of sensors to be used by the monitoring device to monitor the same type of fetal or maternal activity. It has been found, for example, that in addition to placing an electromyography sensor or accelerometer (e.g., as a first sensor) at the fundus to monitor activity such as muscle or uterine contractions, a temperature sensor may also be used as a second sensor to reliably monitor the same activity, such as the same muscle or uterine contractions, when at the fundus.

[0043] The device may also include a user interface coupled to the monitoring device, which includes a display for showing information derived from signals detected by multiple sensors. The user interface may include one or more of a desktop computer, laptop computer, smartphone, personal digital assistant, watch, data collection strap, and other similar devices configured to display information. Alternatively or additionally, the device may include a user interface integrated into the monitoring device. For example, the user interface may be an onboard indicator. The user interface can provide indications of the type of data collected by the monitoring device and / or indications regarding the device's attachment status to the body, power level, or other parameters.

[0044] The device can be configured to process signals received from each of multiple sensors such that each presents a similar indication on the user interface for the same type of fetal or maternal activity. The signals can be displayed as time-dependent graphs, and the amplitude of the graphs can be such that the corresponding type of fetal or maternal activity is presented in a similar manner. For example, the signals can be processed such that when uterine contractions occur, the corresponding change in the amplitude of the graph for a first signal can be the same as or similar to the change in the amplitude of the graph for a second or additional signal. The changes in the amplitude of the graphs can have the same direction. The changes in the amplitude of the graphs can be configured, for example, within a factor of 4, 3, 2, or 1.5. The scale of the graphs displayed by the user interface can be selected or programmed to provide this effect.

[0045] The monitoring device may also include at least one reference sensor adapted to be placed on the body at a location spaced apart from the monitoring device, to provide reference for multiple sensors at a location where fetal or maternal activity would be absent. In some embodiments, at least one reference sensor may be adapted to be placed at the ribs. In other embodiments, at least one reference sensor may be adapted to be placed at the hip or sternum. At least one reference sensor may include one or more of, for example, an electromyography sensor, a temperature sensor, an accelerometer, and an ultrasound sensor. At least one reference sensor may be located outside the housing and may be movable relative to the housing. At least one reference sensor may be connected to the housing via a wire maintaining a physical and / or electrical connection between the reference sensor and other components of the monitoring device, or may be connected wirelessly.

[0046] The device may also include one or more roving sensors independent of the monitoring equipment. One or more roving sensors may include, for example, a fetal heart rate monitor and / or a maternal heart rate monitor. Alternatively or additionally, one or more roving sensors may include electromyography (EMG) sensors.

[0047] In any of the aspects described herein, the device may be adapted for use in a clinical setting (e.g., a hospital, maternity center, or doctor's operating room). Alternatively or additionally, the device may be used in a non-clinical setting (e.g., at home). The device may be designed as a "point-of-care" device, whether for home use or other environments. The device may provide a means of remote patient monitoring. In this regard, signals and / or other data received by the device may be transmitted, for example, by the monitoring equipment to a remotely located user interface for observation or analysis by a third party. The device may be provided as a means of monitoring a patient during pregnancy and / or childbirth.

[0048] According to another aspect of this disclosure, a method is provided, the method comprising:

[0049] The monitoring device is placed on the body and includes multiple sensors integrated therein;

[0050] The first sensor among multiple sensors detects a first type of signal from the body; and

[0051] A second sensor among multiple sensors detects a second type of signal from the body that is different from the first type of signal.

[0052] Among them, the first type of signal and the second type of signal indicate fetal or maternal activity during pregnancy or childbirth.

[0053] According to another aspect of this disclosure, a method is provided, the method comprising:

[0054] The monitoring device is placed on the body and includes multiple sensors integrated therein;

[0055] The first sensor among multiple sensors detects a first type of signal from the body; and

[0056] A second type of signal, different from the first type of signal, is detected from the body by a second sensor among multiple sensors.

[0057] The type of fetal or maternal activity is monitored using signals detected from the first sensor; and

[0058] The signals detected from the second sensor are used to monitor the same type of fetal or maternal activity as those monitored using the first sensor.

[0059] This method may include detecting a third type of signal from the body via a third sensor among multiple sensors. This third type of signal may indicate fetal or maternal activity during pregnancy or childbirth.

[0060] The method may also include detecting signals from a fourth or additional sensor, for example, selected from the group consisting of electromyography sensors and ultrasound sensors.

[0061] The first sensor can be an electromyography (EMG) sensor, and the second sensor can be a temperature sensor. Alternatively, the first sensor can be an EMG sensor, and the second sensor can be an accelerometer. Still alternatively, the first sensor can be a temperature sensor, and the second sensor can be an accelerometer.

[0062] In one embodiment, the first sensor is an electromyography (EMG) sensor or an accelerometer, and the second sensor is a temperature sensor; both the first and second sensors are used to monitor muscle or uterine contractions. In another embodiment, the first sensor is an EMG sensor, the second sensor is a temperature sensor, and a third sensor is provided as an accelerometer; each of the first, second, and third sensors is used to monitor muscle or uterine contractions.

[0063] By providing different types of sensors that detect different signals from the body, but each sensor is used to monitor the same type of fetal or maternal activity, the collection of data related to pregnancy and / or childbirth can be more accurate and / or reliable for the reasons discussed above.

[0064] The method may also include displaying information based on the type of signals obtained from multiple sensors. The displayed information may include presenting the signals as time-related graphs on a display. This display may allow the amplitude of the graph to change in a similar manner for corresponding types of fetal or maternal activity. For example, the display may allow the corresponding change in the amplitude of the graph for a first signal when uterine contractions occur to be the same as or similar to the corresponding change in the amplitude of the graph for a second or additional signal. The changes in the amplitude of the graphs may have the same direction. The changes in the amplitude of the graphs may be within, for example, 4, 3, 2, or 1.5 times.

[0065] According to another aspect of this disclosure, a method for monitoring pregnancy or childbirth is provided, the method comprising:

[0066] The monitoring device is placed on the body and includes an electromyography (EMG) sensor and one or more position sensors, the EMG sensor including two or more EMG electrodes;

[0067] Using EMG electrodes from electromyography (EMG) sensors to monitor fetal or maternal activity during pregnancy or childbirth; and

[0068] Use one or more position sensors to monitor the relative positioning of two or more EMG electrodes during fetal or maternal activity.

[0069] In any aspect described herein, placing a monitoring device on the body may include placing the monitoring device on the fundus of the uterus in the abdomen. Brief description of the attached diagram

[0070] Embodiments of the invention will now be described by way of example only with reference to the accompanying drawings, in which:

[0071] Figure 1 This is a top view of an apparatus according to an embodiment of the present disclosure;

[0072] Figure 2 yes Figure 1 Front view of the device;

[0073] Figure 3a yes Figure 1 Bottom view of the device;

[0074] Figure 3b yes Figure 1 A bottom view of the device, showing the EMG surface electrodes of the device;

[0075] Figure 4a This shows the use of Figure 1 A graph showing the pattern of signals detected by the device during the period of uterine contraction;

[0076] Figure 4b This illustrates the use of an electromyography (EMG) sensor in the event of a poor or lost connection. Figure 1 A graph showing the pattern of signals detected by the device during the period of uterine contraction;

[0077] Figure 4c This demonstrates the use of two electromyography (EMG) sensors in the presence of noise interruption. Figure 1 A graph showing the pattern of signals detected by the device during the period of uterine contraction;

[0078] Figure 5 This is a top view of an apparatus according to another embodiment of the present disclosure;

[0079] Figure 6a yes Figure 5 Bottom view of the device in the middle;

[0080] Figure 6b yes Figure 5 A bottom view of the device, showing the EMG surface electrodes of the device;

[0081] Figure 7a and Figure 7b The following are examples showing the EMG electrodes in the first and second positions, respectively. Figure 6b A simplified bottom view of the device; and

[0082] Figure 8a and Figure 8b They are Figure 1 and Figure 5 A schematic diagram of the various electronic components of the device.

[0083] Description of the Implementation Examples

[0084] Figure 1 , Figure 2 , Figure 3a and Figure 3b A device 10 for monitoring pregnancy or childbirth according to an embodiment of the present disclosure is shown. The device 10 includes a monitoring device 11 adapted for placement on the body. The monitoring device 11 has a housing 12 housing the electronic components of the monitoring device 11. The housing 12 has a top surface 13 and a bottom surface 14. (As shown in...) Figure 2 As best seen in the interior, the bottom surface 14 has a wavy portion 15 that generally corresponds to the curvature of the mother's abdomen. The outer casing 12 is sealed to prevent fluid ingress.

[0085] The monitoring device 11 also includes multiple sensors integrated into it. These sensors include at least a first sensor and a second sensor. The first sensor is configured to detect a first type of signal from the body indicating fetal or maternal activity during pregnancy or childbirth, while the second sensor is configured to detect a second type of signal from the body, different from the first type, which also indicates fetal or maternal activity during pregnancy or childbirth. The types of fetal or maternal activity monitored by the different sensors can be the same. Detecting different types of signals allows for accurate data collection in environments where fetal and / or maternal movement, interventions, and the process of pregnancy or childbirth itself may otherwise lead to missed or lost data. For example, if a sensor is interrupted due to lack of contact, poor contact, or other external influences, continuous and uninterrupted monitoring of at least one type of signal can still be performed by providing another sensor. This disclosure recognizes that the monitoring device 11 may also be exposed to different conditions during the monitoring period, such as patient movement or exposure to water, which may render a sensor unsuitable for monitoring under specific conditions. However, because monitoring device 11 detects at least two different types of signals, the loss or interruption of one sensor does not hinder the continuous monitoring of fetal or maternal activity, as the detection of useful signals still comes from another sensor.

[0086] In some embodiments, both the first type of signal and the second type of signal indicate body movement during pregnancy or childbirth. Body movement can be, for example, fetal movement and / or maternal movement. Fetal activity may also include, for example, fetal position and / or fetal heart rate. Maternal activity may also include, for example, muscle and uterine contractions, maternal positioning, maternal heart rate, and / or maternal temperature.

[0087] The first and second sensors can be any combination of two different sensors selected from the group consisting of an electromyography (EMG) sensor for detecting uterine contractions, a temperature sensor for detecting fetal and / or maternal body temperature, and an accelerometer for detecting fetal and / or maternal positioning and movement. For example, the first sensor can be an EMG sensor, and the second sensor can be a temperature sensor. In another alternative example, the first sensor can be an EMG sensor, and the second sensor can be an accelerometer. In yet another alternative example, the first sensor can be a temperature sensor, and the second sensor can be an accelerometer.

[0088] The monitoring device 11 may further include a third sensor that detects a third type of signal from the body indicating fetal or maternal activity during pregnancy or childbirth. In some embodiments, the third type of signal may be the same as a first type of signal or a second type of signal. In other embodiments, the third type of signal may be different from the first type of signal and the second type of signal. The third sensor may be selected from, for example, the group including accelerometers, temperature sensors, EMG sensors, and ultrasound sensors.

[0089] The monitoring device 11 may also include additional sensors, such as any combination of four or more sensors, wherein at least two sensors are configured to detect signals of different types. The additional sensors may be selected from, for example, a group including accelerometers, temperature sensors, EMG sensors, and ultrasonic sensors.

[0090] Reference Figure 3a In the embodiment depicted, monitoring device 11 includes four sensors, three of which are configured to detect different types of signals. Specifically, monitoring device 11 includes two EMG sensors 16 and 17, a temperature sensor 18, and an accelerometer 101, all integrated into monitoring device 11. One of the three different sensors (e.g., one of EMG sensors 16 and 17) can be considered to provide a first sensor, configured to detect a first type of signal from the body indicating fetal or maternal activity during pregnancy or childbirth. Another sensor (e.g., temperature sensor 18 or accelerometer 101) can be considered to provide a second sensor, configured to detect a second type of signal from the body, different from the first type of signal, but again indicating fetal or maternal activity during pregnancy or childbirth.

[0091] Each of the EMG sensors 16, 17 includes a pair of contact points 16a, 16b, 17a, 17b disposed on the bottom surface 14 of the housing 12. The contact points 16a, 16b, 17a, 17b protrude from the bottom surface 14. This protrusion spacees the bottom surface 14 from the body when the monitoring device 11 is placed on the body, allowing ventilation or airflow between the body and the monitoring device 11, improving patient comfort. The contact points 16a, 16b, 17a, 17b can be considered as providing EMG electrodes. However, in this embodiment, each of the contact points 16a, 16b, 17a, 17b is also configured to receive and electrically couple to, for example, Figure 3b The corresponding removable EMG surface electrodes 161a, 161b, 171a, and 171b are shown. The EMG surface electrodes 161a, 161b, 171a, and 171b are configured to contact the skin. The EMG sensors 16 and 17 are configured, through electrical contact with the skin, to detect changes in potential difference (voltage) caused by uterine contractions or other fetal and / or maternal activities.

[0092] An accelerometer 101 is disposed within the housing 12 and configured to monitor maternal and / or fetal movement. A temperature sensor 18 is disposed on the bottom surface 14 of the housing 12 and configured to track fluctuations in maternal temperature. For example, the use of temperature sensor 18 can help identify fever due to infection. Additionally or alternatively, temperature sensor 16 can also be used to detect the onset and / or occurrence of uterine contractions. In this regard, the present disclosure recognizes that fluctuations in maternal temperature, particularly changes in body temperature deviating from baseline temperature, can be synonymous with the onset or occurrence of uterine contractions (discussed below).

[0093] Figures 4a to 4c An example of signals recorded using monitoring device 11 during a period of time when the patient experiences contraction, as presented by the user interface, is shown. The graphs illustrate two signals 1001 and 1002 detected from two EMG sensors 16 and 17, signal 1003 detected from temperature sensor 18, and three signals 1004a, 1004b, and 1004c detected along three different axes from accelerometer 101. Signals 1001 to 1004c are time-dependent in the graphs.

[0094] Figure 4a The diagram illustrates a recurring contraction pattern (indicated by the letter "C") that can be identified across all three sensor types. It can be recognized that, for example, fluctuations in maternal temperature (i.e., changes in body temperature deviating from baseline) can also be attributed to uterine contractions. In this example, an increase in body temperature could be attributed to uterine contractions, although other patterns of temperature change could also indicate uterine contractions in alternative examples. Therefore, as discussed above, multiple sensors can provide continuous monitoring of at least one type of signal indicative of fetal or maternal activity (e.g., uterine contractions), thus ensuring that no critical data may be missed or lost during the monitoring period.

[0095] Therefore, different curves for signals 1001 to 1004c can easily provide users with indications of the same type of fetal or maternal activity. The scale of the curves can be adjusted via the user interface so that the corresponding changes in amplitude of the curves for different signals 1001 to 1004c are the same or similar when uterine contractions occur. For example, refer to... Figure 4a The amplitude A1 of the contraction, as identifiable in EMG signal curve 1001b, is the same as or similar to the amplitude A2 of the contraction, as identifiable in temperature signal curve 1002.

[0096] This disclosure recognizes that patients may not necessarily be confined to the hospital environment used for monitoring an impending pregnancy or delivery. Monitoring may be necessary, for example, when the patient is moving (e.g., walking, turning over in bed, etc.) or when the patient is showering or bathing during pregnancy or delivery. The multiple sensors of monitoring device 11 may therefore be exposed to different conditions during the monitoring period. Such conditions may cause one or more types of signals detected by the multiple sensors to be lost or interrupted during the monitoring period. However, when monitoring device 11 detects at least two different types of signals, the loss or interruption of one type of signal does not hinder continuous monitoring of fetal or maternal activity, because useful signals still originate from the other sensors. This is due to… Figure 4b prove, Figure 4b For example, a poor connection or loss of connection of an EMG sensor is shown, resulting in a substantial lack of signal 1001. However, this does not prevent continuous monitoring of fetal or maternal activity because useful signals still come from other sensors. Similarly, as can be seen in... Figure 4c As seen in the image, continuous monitoring of fetal or maternal activity is not missed or lost, even if, for example, the signals 1001 and 1002 from the two EMG sensors are interrupted by noise due to the EMG sensors being exposed to water.

[0097] Refer again Figure 1 , Figure 3a and Figure 3b The monitoring device 11 may further include at least one reference sensor 19, which is adapted to be placed on the body at a location spaced apart from the monitoring device 11 (where fetal or maternal activity will be absent) to provide reference to multiple sensors and enable filtering of signals arising from maternal or fetal activity from signals obtained from other sources, such as whole-body movements (e.g., walking, turning over in bed, etc.) or normal temperature fluctuations. In some embodiments, at least one reference sensor 19 may be placed on the ribs. However, it will be appreciated that at least one reference sensor 19 may be placed elsewhere on the body, such as on the hips or sternum, or in other embodiments the reference sensor may be excluded.

[0098] In some embodiments, at least one reference sensor 19 may include one or more of an EMG sensor, a temperature sensor, an accelerometer, and an ultrasonic sensor. Figure 1 , Figure 3a and Figure 3bIn the embodiments depicted, the reference sensor 19 may be an EMG sensor of the type described above, used to provide a reference to EMG readings from EMG sensors 16, 17 of the monitoring device 11. The reference sensor may be wired to the monitoring device 11, or it may be a physically separate wireless unit, allowing it to be located on a more separable part of the body. In this particular embodiment, the reference sensor 19 may have features adapted for reception and electrical coupling to, for example... Figure 3b The contact point 20 of the removable EMG surface reference electrode 191 is shown. In this example, filtering of signals arising from maternal or fetal activity can be achieved by subtracting the signal obtained from the reference sensor 19 from the signal obtained from any of the EMG sensors 16, 17 of the self-monitoring device 11.

[0099] Figure 5 , Figure 6a and Figure 6b A device 21 for monitoring pregnancy or childbirth according to another embodiment of the present disclosure is shown. Device 21 includes a monitoring device 22 adapted for placement on the body. The monitoring device 22 has a central portion 24 and one or more flexible arm portions 25 connected to the central portion 24. Each of the one or more flexible arm portions 25 is configured to be independently operable relative to the central portion 24 to facilitate placement of the monitoring device 22 on the body regardless of the curvature of the maternal abdomen, and to bend and flex to conform to any deformation and movement of the body when worn. The monitoring device 22 also has a housing 23 at the central portion, which houses the electronic components of the monitoring device 22. The housing 23 is sealed to prevent fluid ingress, thus preventing the electronic components of the monitoring device 22 from being exposed to potentially harmful environmental factors such as water and dust.

[0100] exist Figure 5 , Figure 6a and Figure 6b In the embodiment depicted, the monitoring device 22 has four flexible arm portions 25a, 25b, 25c, 25d extending outward from a central portion 24, arranged in a cross configuration. The flexible arm portions 25a, 25b, 25c, 25d have ends 26a, 26b, 26c, 26d with openings 27a, 27b, 27c, 27d. Removable adhesive seals 28a, 28b, 28c, 28d may be disposed around the openings 27a, 27b, 27c, 27d and each configured to adhere to the body to secure the monitoring device 22 to the body and form a waterproof barrier around the openings 27a, 27b, 27c, 27d.

[0101] The monitoring device 22 also includes multiple sensors integrated into it, similar to the sensors described above for device 10. The multiple sensors include at least a first sensor and a second sensor. The first sensor is configured to detect a first type of signal from the body indicating fetal or maternal activity during pregnancy or childbirth, while the second sensor is configured to detect a second type of signal from the body, different from the first type of signal, that also indicates fetal or maternal activity during pregnancy or childbirth. The first and second sensors can be any combination of two different sensors selected from the group consisting of an EMG sensor, a temperature sensor, and an accelerometer.

[0102] The monitoring device 22 may also include a third sensor that detects a third type of signal from the body indicating fetal or maternal activity during pregnancy or childbirth. In some embodiments, the third type of signal may be the same as a first type of signal or a second type of signal. In other embodiments, the third type of signal may be different from the first type of signal and the second type of signal. The third sensor may be selected from, for example, the group including accelerometers, temperature sensors, EMG sensors, and ultrasound sensors.

[0103] The monitoring device 22 may also include additional sensors, such as any combination of four or more sensors, wherein at least two sensors are configured to detect different types of signals. The additional sensors may be selected from, for example, a group including accelerometers, temperature sensors, EMG sensors, and ultrasonic sensors.

[0104] Reference Figure 6a In the embodiment depicted, monitoring device 22 includes four sensors, three of which are configured to detect different types of signals. Specifically, monitoring device 22 includes two EMG sensors 29 and 30, a temperature sensor 102, and an accelerometer 103, all integrated into monitoring device 22. One of the three different sensors (e.g., one of the EMG sensors 29 and 30) can be considered to provide a first sensor, configured to detect a first type of signal from the body indicating fetal or maternal activity during pregnancy or childbirth. Another sensor (e.g., temperature sensor 102 or accelerometer 103) can be considered to provide a second sensor, configured to detect a second type of signal from the body, different from the first type of signal but again indicating fetal or maternal activity during pregnancy or childbirth.

[0105] Each of the EMG sensors 29 and 30 includes a pair of contact points 29a, 29b, 30a, 30b arranged at ends 26a, 26b, 26c, 26d. Each of the contact points 29a, 29b, 30a, 30b can be considered to provide an EMG electrode. However, in this embodiment, as... Figure 6bAs shown, contact points 29a, 29b, 30a, and 30b are each configured to receive and electrically couple to corresponding removable EMG surface electrodes 291a, 291b, 301a, and 301b. The EMG surface electrodes 291a, 291b, 301a, and 301b are configured to contact the skin via openings 27a, 27b, 27c, and 27d. EMG sensors 29 and 30 are configured to detect potential differences caused by uterine contractions through electrical contact with the skin.

[0106] An accelerometer 103 is arranged within the central portion 24 and configured to monitor maternal and / or fetal movements. A temperature sensor 102 is also arranged within the central portion 24 and configured to track fluctuations in maternal temperature in the same manner as described above for device 10.

[0107] In this embodiment, the monitoring device 22 further includes flexible sensors 104a, 104b, 104c, and 104d. The flexible sensors are arranged, for example, within corresponding flexible arm portions 25a, 25b, 25c, and 25d of the monitoring device 22. The flexible sensors 104a, 104b, 104c, and 104d can be configured to detect bending or deflection of the arm portions 25a, 25b, 25c, and 25d. For example, bending or deflection or other or related deformations (e.g., stretching and contraction of the arm portions 25a, 25b, 25c, and 25d) may occur due to maternal movement (e.g., abdominal movements caused by infant movement).

[0108] The flexible sensor can be used as a position sensor to monitor the relative positioning of two or more EMG electrodes provided by contact points 29a, 29b, 30a, 30b and / or EMG surface electrodes 291a, 291b, 301a, 301b attached to contact points 29a, 29b, 30a, 30b during fetal or maternal activity. Bending or flexing of the arm portions 25a, 25b, 25c, 25d corresponds to the relative movement of the corresponding EMG electrodes. For example, when the EMG electrodes are secured to the abdomen using adhesive seals 28a, 28b, 28c, 28d, changes in the relative position of the EMG electrodes will cause flexing or bending or other deformation of the arm portions 25a, 25b, 25c, 25d. Flexing or bending or other deformation of the arm portions indicates deformation of the body (e.g., the abdomen) during fetal or maternal activity.

[0109] As an alternative to flexible sensors, tensile sensors can be used. Generally, any sensor that allows for the detection of changes in the shape and / or size of a part of a device structure (e.g., a monitoring device) that results in relative movement of EMG electrodes supported by that structure can be used as a position sensor.

[0110] The central portion 24 can also be fixed (e.g., adhered) to the abdomen. The central portion 24 can provide a reference position for a monitoring device, for example, at the center 241 of the central portion 24. Thus, the electrodes and the reference position can be maintained in a corresponding fixed position relative to the body.

[0111] Although the electrodes and the central portion 24 can be fixed to the body, the arm portions 25a, 25b, 25c, and 25d between them are spaced apart from the body.

[0112] By monitoring the position of EMG electrodes during fetal or maternal activity, the EMG signals obtained from these electrodes can be interpreted based on their relative positioning, enabling a more complete analysis of the generated data. For example, it can correlate changes in EMG signals with deformations in the body adjacent to the monitoring device, which occur as a result of contractions or other maternal or fetal activity.

[0113] The relative positioning of the EMG electrodes can be determined based on triangulation. (Reference) Figure 7a The length between the first 301a in the EMG electrode and the reference position 241 can provide the first side 401 of the imaginary triangle 400, the length between the second 301b in the EMG electrode and the reference position 241 can provide the second side 402 of the imaginary triangle 400, and the length between the two electrodes 301a and 301b can provide the third side 403 of the imaginary triangle.

[0114] During maternal or fetal movement, EMG electrodes 301a and 301b can move to new relative positions, such as, for example, in... Figure 7b As indicated in the diagram. The movement is reflected by the flexion or bending of the arm portion and thus by the change in the geometry of the imaginary triangle 400', in this example, where the first side 401' of the triangle increases in length while the second side 402' of the triangle decreases in length.

[0115] The deflection or bending of the arm portion is sensed by flexible sensors 104c and 104d, enabling the determination of the distance between electrodes 301a and 301b and the central portion 24 (and thereby determining the length of the first side 401, 401' and the second side 402, 402' of the imaginary triangles 400 and 400').

[0116] The angle α between the first sides 401, 401' and the second sides 402, 402' can be a substantially fixed angle, for example, if the flexible arm portion is flexible only in the length direction, and / or can be determined based on monitoring the deflection of the arm portion in two or more dimensions. The third side 403, 403' of the imaginary triangle can be calculated from the knowledge of the lengths of the first sides 401, 401' and the second sides 402, 402' and their relative angle α, and thus the distance between the two electrodes 301a, 301b can be calculated. However, other types of calculations can be performed to monitor electrode positioning based on data from position sensors. Furthermore, the described techniques can be used to determine the relative positions between any combination of EMG electrodes 291a, 291b, 301a, 301b. In some embodiments, positioning monitoring can be performed in real time and in conjunction with signals from other sensors (e.g., in...). Figures 4a to 4c The signal it represents is directly related to this.

[0117] Refer again Figure 6a The device 21 may also include at least one reference sensor 31 coupled to the monitoring device 22, which is similar to the sensor described for device 10. The at least one reference sensor 31 may be adapted to be placed on the body at a location spaced apart from the monitoring device 22 (where fetal or maternal activity will be absent) to provide a reference to EMG readings and to enable filtering of signals arising from fetal or maternal activity from signals originating from other sources, such as whole-body movements (e.g., walking, turning over in bed, etc.) or normal temperature fluctuations. In some embodiments, the at least one reference sensor 31 may be placed on the ribs. However, it will be appreciated that the at least one reference sensor 31 may be placed elsewhere on the body, such as the hips or sternum. The at least one reference sensor 31 is located outside the housing of the monitoring device 22 and is movable relative to the housing. The at least one reference sensor 31 is connected via a wire maintaining a physical and electrical connection between the reference sensor and other components of the monitoring device 22, but in alternative embodiments, it may be connected wirelessly.

[0118] In some embodiments, the reference sensor 31 may be an EMG sensor of the type described above for device 10. The reference sensor 31 may have contact points 32 adapted to receive and electrically couple to a removable EMG surface reference electrode 311, such as... Figure 6b As shown in the image.

[0119] exist Figure 6bIn the embodiment depicted, the reference sensor 31 may also have an end 33 having an opening 34. An adhesive seal 35 may be disposed around the opening 34. The adhesive seal 35 may be configured to adhere to the body to form a waterproof barrier around the opening 34. The EMG surface reference electrode 311 is configured to contact the skin via the opening 34. In this example, filtering of signals arising from maternal or fetal activity can be achieved by subtracting the signal obtained from the reference sensor 31 from the signal obtained from any of the EMG sensors 29, 30 of the self-monitoring device 22.

[0120] For example, the monitoring device according to any of the above embodiments can be adapted to be placed on the maternal abdomen above the fundus of the uterus. This disclosure recognizes that the area of ​​greatest traceable maternal or fetal activity during contractions is above the fundus. However, it will be appreciated that the monitoring device can be placed elsewhere on the body where useful monitoring of fetal or maternal activity can be performed. The design and shape of the monitoring device make it suitable for placement in a relatively intuitive and simple manner in an appropriate location (e.g., at the fundus of the uterus on the maternal abdomen). The monitoring device can be configured to be operated by multiple stakeholders (e.g., clinicians, patients, partners, or rescue personnel) and can be relatively easy to locate and operate.

[0121] The apparatus according to any of the above embodiments may further include a user interface coupled to the monitoring device, the user interface including a display for displaying information derived from signals detected by a plurality of sensors. The user interface includes one or more of a desktop computer, laptop computer, smartphone, personal digital assistant, watch, data collection strap, and other similar devices configured to display information. The monitoring device may communicate with the user interface via a communication network (e.g., via the Internet, Wi-Fi, Bluetooth, or others). In some embodiments, the user interface may be remotely located for access by a clinician. This can allow patients to be monitored without the need for a clinician's presence. Additionally or alternatively, the apparatus may include a user interface integrated into the monitoring device. For example, the user interface may be an onboard indicator. The user interface can provide indications of the type of data collected by the monitoring device and / or indications regarding the device's attachment status to the body, power level, or other information.

[0122] exist Figure 8a A schematic diagram of the various electronic components of the device is shown. The operation of the electronic components can be applied to any embodiment of the device described above. However, in this particular embodiment, reference will be made to... Figure 1 Device 10 Description Figure 8aThe diagram illustrates the device. Monitoring device 11 may include a power supply 400, such as a battery, to power the electronic components of monitoring device 11. Monitoring device 11 may also include a controller 401 (e.g., a microcontroller) connected to multiple sensors of monitoring device 11. The multiple sensors of monitoring device 11 include two EMG sensors 16 and 17, a temperature sensor 18, and an accelerometer 101. Device 10 may also include a reference sensor 19.

[0123] The controller 401 includes a processor 402 that receives signals from multiple sensors 16, 17, 18, 101 and a reference sensor 19, and stores the signals in a memory 403. The processor 402 may optionally filter the signals detected by the multiple sensors 16, 17, 18, 101 based on the signal detected by the reference sensor 19. A transmitter 404 transmits information derived from the signals detected by the multiple sensors 16, 17, 18, 101 and / or the reference sensor 19 to a user interface 405, for example via wireless signals. Radio frequency signals or Bluetooth signals containing the information may be transmitted from the monitoring device 11 to the user interface 405. The user interface 405 has a receiver 406 that receives information from the controller 401 and a display 407 that displays the information. The information may be presented in a format that is recognizable and assessable by a clinician to facilitate or aid in monitoring pregnancy or childbirth. Alternatively, the information may be presented in a simpler format to allow patients to monitor their pregnancy or childbirth without a clinician.

[0124] exist Figure 8b Another schematic diagram of various electronic components is shown. In this particular embodiment, the schematic diagram corresponds to... Figure 5 Device 21. From an electrical point of view, this device is similar to, as referenced... Figure 8a The described device 10 is substantially the same. However, flexible sensors 104a-d are additionally provided connected to a controller 401', which includes a processor 402', a memory 403', and a transmitter 404', and is connected to a user interface 405' including a receiver 406' and a display 407'. Figure 8a and Figure 8b In this context, the connections between various components (including, for example, between monitoring devices and user interfaces) can be wired or wireless.

[0125] Generally, it will be appreciated that any controller used in this disclosure may include multiple control or processing modules for receiving and processing signals from multiple sensors, and may also include one or more storage elements for storing data (e.g., the type of signal). Modules and storage elements may be implemented using one or more processing devices and one or more data storage units, which may be located in one place or distributed across multiple locations and interconnected by one or more communication links.

[0126] Furthermore, the module may be implemented by a computer program or program code including program instructions. Computer program instructions may include source code, object code, machine code, or any other stored data operable to cause the controller to perform the steps described. The computer program may be written in any programming language (including compiled or interpreted languages) and may be deployed in any form (including as a standalone program or as a module, component, subroutine, or other unit suitable for use in a computing environment). Data storage devices may include suitable computer-readable media, such as volatile (e.g., RAM) and / or non-volatile (e.g., ROM, disk) memory or other media.

[0127] In any of the above embodiments, the device may include one or more circulating sensors for providing additional important diagnostic and prognostic information regarding pregnancy or childbirth. The circulating sensors may be independent of the monitoring device. The circulating sensors may include a fetal heart rate monitor enabling the determination of fetal distress during maternal contractions, a maternal heart rate monitor providing an indication of the mother's overall health during pregnancy or childbirth, and / or an additional EMG sensor. The circulating sensors may be coupled to the monitoring device and / or user interface via a wired or wireless connection.

[0128] The embodiments described above can have numerous advantages. For example, multiple sensors provide continuous monitoring of at least one type of signal, ensuring that no data is missed or lost, thus providing accurate data collection. Furthermore, the combination of sensors can help assess the state of pregnancy and labor, such as distinguishing between pseudo-labor and the onset of labor, monitoring the mother's health during pregnancy or labor, and / or monitoring the fetus's health before or during labor. Additionally, the embodiments can allow patients to operate the monitoring devices without the need for a trained clinician, thus allowing monitoring to occur outside of hospital settings.

[0129] Those skilled in the art will recognize that various changes and modifications can be made to the above embodiments without departing from the broad general scope of this disclosure. Therefore, the present embodiments should be considered illustrative rather than restrictive in all respects.

[0130] Various aspects of this disclosure may be implemented in one or more embodiments:

[0131] 1) A device for monitoring pregnancy or childbirth, the device comprising:

[0132] Electromyography (EMG) sensors comprising two or more EMG electrodes for monitoring fetal or maternal activity during pregnancy or childbirth; and

[0133] One or more position sensors that monitor the relative positioning of the two or more EMG electrodes during fetal or maternal activity.

[0134] 2) The apparatus according to 1), wherein the one or more position sensors include one or more flexible sensors or tension sensors.

[0135] 3) The apparatus according to 1) or 2), wherein the apparatus includes a monitoring device, and the electromyography sensor and the one or more position sensors are included in the monitoring device.

[0136] 4) The apparatus according to 3), wherein the one or more position sensors include one or more flexible or tensile sensors that monitor the flexure, bending or deformation of a portion of the monitoring device to determine the relative positioning of the two or more EMG electrodes.

[0137] 5) The device according to any one of the preceding items includes an adhesive for adhering the EMG electrode to the body.

[0138] 6) The apparatus according to 4) or 5), wherein the monitoring device includes a central portion and one or more flexible arm portions extending from the central portion, and wherein each of the one or more flexible arm portions is configured to be maneuverable relative to the central portion, and the position sensor monitors the deflection or bending of the arm portion.

[0139] 7) The apparatus according to 6) includes an adhesive for adhering the central portion to the body.

[0140] 8) The apparatus according to 6) or 7), wherein the monitoring device comprises at least four of the flexible arm portions arranged in a cross configuration.

[0141] 9) The apparatus according to 6), 7) or 8), wherein one of the EMG electrodes is located at the end of each of the arm portions.

[0142] 10) The apparatus according to any one of 6) to 9), wherein the one or more position sensors are located in the arm portion.

[0143] 11) The device according to any one of 6) to 10), wherein each arm portion has an end with an opening and an adhesive seal disposed around the periphery of the opening, wherein the adhesive seal is configured to adhere to the body in order to secure the monitoring device to the body and form a waterproof barrier around the opening.

[0144] 12) The apparatus according to any one of the preceding items further includes a temperature sensor and / or an accelerometer.

[0145] 13) The apparatus according to 12), when relying on any one of 6) to 11), wherein the temperature sensor and / or the accelerometer are arranged within the central portion.

[0146] 14) A device for monitoring pregnancy or childbirth, the device comprising:

[0147] Monitoring equipment, including:

[0148] A central portion and a plurality of flexible arm portions extending from the central portion, wherein each of the flexible arm portions is configured to be controllable relative to the central portion;

[0149] An electromyography (EMG) sensor comprising two or more EMG electrodes for monitoring fetal or maternal activity during pregnancy or childbirth, each EMG electrode located in the flexible arm.

[0150] At the end of the corresponding flexible arm portion in the segment; and

[0151] Flexible or tensile sensors are located in each arm section.

[0152] 15) The apparatus according to 14), wherein the monitoring device comprises at least four of the flexible arm portions arranged in a cross configuration.

[0153] 16) A device for monitoring pregnancy or childbirth, the device comprising:

[0154] A monitoring device, which is placed on the body and includes multiple sensors integrated into the monitoring device, the multiple sensors including at least:

[0155] A first sensor is configured to detect a first type of signal from the body indicating a first type of fetal or maternal activity during pregnancy or childbirth; and

[0156] A second sensor is configured to detect a second type of signal from the body that is different from the first type of signal and also indicates the first type of fetal or maternal activity during pregnancy or childbirth.

[0157] 17) The apparatus according to 16), wherein both the first type of signal and the second type of signal indicate body movement during pregnancy or childbirth.

[0158] 18) The apparatus according to 17), wherein the body movement is fetal movement and / or maternal movement.

[0159] 19) The apparatus according to any one of 16) to 18), wherein the first sensor is an electromyography sensor and the second sensor is a temperature sensor.

[0160] 20) The apparatus according to any one of 16) to 18), wherein the first sensor is an electromyography sensor and the second sensor is an accelerometer.

[0161] 21) The apparatus according to any one of 16) to 18), wherein the first sensor is a temperature sensor and the second sensor is an accelerometer.

[0162] 22) The apparatus according to any one of 16) to 21), wherein the plurality of sensors includes a third sensor that detects a third type of signal from the body indicating fetal or maternal activity during pregnancy or childbirth.

[0163] 23) The apparatus according to 22), wherein the third sensor is selected from the group consisting of an accelerometer, a temperature sensor, an electromyography sensor and an ultrasound sensor.

[0164] 24) The apparatus according to 22) or 23), wherein the plurality of sensors includes a fourth or additional sensor selected from the group consisting of electromyography sensors and ultrasound sensors.

[0165] 25) The apparatus according to any one of 16) to 24), wherein the fetal activity includes one or more of the following: fetal position, fetal movement and fetal heart rate.

[0166] 26) The apparatus according to any one of 16) to 25), wherein the maternal activity includes one or more of the following: muscle and uterine contractions, maternal positioning, maternal movement, maternal heart rate and maternal temperature.

[0167] 27) The apparatus according to any one of 16) to 26), wherein the monitoring device includes a housing therein housing electronic components.

[0168] 28) The device according to 27), wherein the housing is a sealed housing to prevent fluid from entering.

[0169] 29) The device according to 27) or 28), wherein the housing includes a top surface and a wavy bottom surface adapted to be placed on the body.

[0170] 30) The apparatus according to 29), wherein the first sensor is an electromyography sensor and the second sensor is a temperature sensor, and wherein the plurality of sensors further include an accelerometer.

[0171] 31) The device according to 30), wherein the electromyography sensor includes at least one electrical contact disposed on the bottom surface of the housing, the at least one electrical contact being configured to receive and electrically couple to an EMG surface electrode, the at least one electrical contact being further configured to protrude from the bottom surface such that the bottom surface is spaced apart from the body when the monitoring device is placed on the body.

[0172] 32) The apparatus according to 30) or 31), wherein the temperature sensor is disposed on the bottom surface of the housing, and the accelerometer is disposed inside the housing.

[0173] 33) The apparatus according to any one of 16) to 28), wherein the monitoring device includes a central portion and one or more flexible arm portions extending from the central portion, and wherein each of the one or more flexible arm portions is configured to be operable relative to the central portion in order to facilitate placement of the monitoring device on the body.

[0174] 34) The apparatus according to 33), wherein the monitoring device comprises four flexible arm portions arranged in a cross configuration.

[0175] 35) The device according to 33) or 34), wherein each of the flexible arm portions has an end with an opening and an adhesive seal disposed around the periphery of the opening, wherein the adhesive seal is configured to adhere to the body in order to secure the monitoring device to the body and form a waterproof barrier around the opening.

[0176] 36) The apparatus according to 35), wherein the first sensor is an electromyography sensor and the second sensor is a temperature sensor, and wherein the plurality of sensors further include an accelerometer.

[0177] 37) The apparatus according to 36), wherein the electromyography sensor includes at least one electrical contact disposed at a respective end, the at least one electrical contact being configured to receive and electrically couple to an EMG surface electrode.

[0178] 38) The apparatus according to 36) or 37), wherein the temperature sensor and the accelerometer are arranged within the central portion.

[0179] 39) The device according to any one of 33) to 38), wherein at least one of the arm portions accommodates a flexible or tensile sensor.

[0180] 40) The apparatus according to any one of 16) to 39), wherein the monitoring device is adapted to be placed on the abdomen.

[0181] 41) The apparatus according to 40), wherein the monitoring device is adapted to be located above the fundus of the uterus.

[0182] 42) The apparatus according to 16) to 41) further includes a user interface coupled to the monitoring device and / or included in the monitoring device for displaying information derived from signals detected by the plurality of sensors.

[0183] 43) The apparatus according to 42), wherein the user interface includes one or more of a desktop computer, a laptop computer, a smartphone, a personal digital assistant, a watch, a data collection belt, and other similar devices configured to display the information.

[0184] 44) The apparatus according to any one of 16) to 43) includes at least one reference sensor adapted to be placed on the body at a location spaced apart from the monitoring device to provide a reference to the plurality of sensors at a location where fetal or maternal activity would be absent, the reference sensor being connected to the monitoring device by wire or wirelessly.

[0185] 45) The apparatus according to 44), wherein the at least one reference sensor is adapted to be placed at the rib.

[0186] 46) The apparatus according to 44), wherein the at least one reference sensor is adapted to be placed at the hip or sternum.

[0187] 47) The apparatus according to any one of 44) to 46), wherein the at least one reference sensor comprises one or more of an electromyography sensor, a temperature sensor, an accelerometer, and an ultrasound sensor.

[0188] 48) The apparatus according to any one of 16) to 47) further includes one or more roving sensors independent of the monitoring device.

[0189] 49) The apparatus according to 48), wherein the one or more circulating sensors include a fetal heart rate monitor and / or a maternal heart rate monitor.

[0190] 50) The apparatus according to 48) or 49), wherein the one or more circulating sensors include electromyography sensors.

[0191] 51) A method comprising:

[0192] The monitoring device is placed on the body and includes multiple sensors integrated therein;

[0193] A first type of signal from the body is detected by a first sensor among the plurality of sensors; and

[0194] A second sensor among the plurality of sensors detects a second type of signal from the body that is different from the first type of signal.

[0195] The first type of signal and the second type of signal indicate fetal or maternal activity during pregnancy or childbirth.

[0196] 52) The method according to 51) further includes detecting a third type of signal from the body via a third sensor among the plurality of sensors, wherein the third type of signal indicates fetal or maternal activity during pregnancy or childbirth.

[0197] 53) The method according to 52) further includes detecting a signal from a fourth or additional sensor, said fourth or additional sensor being selected from the group consisting of an electromyography sensor and an ultrasound sensor.

[0198] 54) The method according to any one of 36) to 38), wherein the monitoring device is placed above the fundus of the uterus of the body.

[0199] 55) The method according to any one of 36) to 39) further includes displaying information based on the type of signal obtained from the plurality of sensors.

[0200] 56) A method comprising:

[0201] The monitoring device is placed on the body and includes multiple sensors integrated therein;

[0202] A first type of signal from the body is detected by a first sensor among the plurality of sensors; and

[0203] A second type of signal, different from the first type, is detected from the body by a second sensor among the plurality of sensors, and

[0204] The detected signals from the first sensor are used to monitor the type of fetal or maternal activity; and

[0205] The detected signals from the second sensor are used to monitor the same type of fetal or maternal activity as that monitored using the first sensor.

[0206] 57) A method for monitoring pregnancy or childbirth, the method comprising:

[0207] The monitoring device is placed on the body, the monitoring device including an electromyography (EMG) sensor and one or more position sensors, the EMG sensor including two or more EMG electrodes;

[0208] The EMG electrodes of the electromyography sensor are used to monitor fetal or maternal activity during pregnancy or childbirth; and

[0209] The one or more position sensors are used to monitor the relative positioning of the two or more EMG electrodes during fetal or maternal activity.

Claims

1. An apparatus for monitoring pregnancy or childbirth, the apparatus comprising: a monitoring device comprising: a central portion and a plurality of flexible arm portions extending from the central portion, and wherein each of the flexible arm portions is configured to be steerable relative to the central portion; an electromyography sensor comprising two or more EMG electrodes that monitor fetal activity or maternal activity during pregnancy or childbirth, each EMG electrode being located at an end of a respective one of the flexible arm portions; and an accelerometer.

2. The apparatus of claim 1, wherein, The monitoring device comprises at least four of the flexible arm portions arranged in a cross configuration.

3. The apparatus of claim 1, wherein, The electromyography sensor comprises at least one electrical contact arranged at the respective end, the at least one electrical contact being configured to receive and electrically couple to an EMG surface electrode.

4. The apparatus of claim 1, wherein, The monitoring device comprises a housing that houses electronic components therein, and the housing is a sealed housing so as to prevent fluid ingress.

5. The apparatus of claim 1, wherein, The monitoring device comprises a housing that houses electronic components therein, and the electromyography sensor comprises at least one electrical contact arranged on a bottom surface of the housing, the at least one electrical contact being configured to receive and electrically couple to an EMG surface electrode, the at least one electrical contact being further configured to protrude from the bottom surface such that, when the monitoring device is placed on a body, the bottom surface is spaced apart from the body.

6. An apparatus for monitoring pregnancy or childbirth, the apparatus comprising: a monitoring device comprising: a central portion and a plurality of flexible arm portions extending from the central portion, and wherein each of the flexible arm portions is configured to be steerable relative to the central portion; a temperature sensor; and one or more position sensors located in each arm portion.

7. The apparatus of claim 6, wherein, The one or more position sensors comprise one or more flexible sensors or stretch sensors that monitor flexing, bending, or deformation of a portion of the monitoring device.

8. The apparatus of claim 6, wherein, The monitoring device further comprises: an electromyography sensor comprising two or more EMG electrodes that monitor fetal activity or maternal activity during pregnancy or childbirth, each EMG electrode being located at an end of a respective one of the flexible arm portions.

9. The apparatus of claim 8, wherein, The electromyography sensor comprises at least one electrical contact arranged at the respective end, the at least one electrical contact being configured to receive and electrically couple to an EMG surface electrode.

10. The apparatus of claim 6, wherein, The monitoring device comprises a housing that houses electronic components therein, and the housing is a sealed housing so as to prevent fluid ingress.

11. An apparatus for monitoring pregnancy or childbirth, the apparatus comprising: a monitoring device comprising: a central portion and a plurality of flexible arm portions extending from the central portion, and wherein each of the flexible arm portions is configured to be steerable relative to the central portion; an accelerometer; and one or more position sensors located in each arm portion.

12. The apparatus of claim 11, wherein, The one or more position sensors include one or more flexible or stretch sensors that monitor flexing, bending, or deformation of a portion of the monitoring device.

13. The apparatus of claim 11, wherein, The monitoring device further includes: an electromyography sensor including two or more EMG electrodes that monitor fetal or maternal activity during pregnancy or childbirth, each EMG electrode being located at an end of a respective flexible arm portion in the flexible arm portion.

14. The apparatus of claim 13, wherein, The electromyography sensor includes at least one electrical contact disposed at the respective end, the at least one electrical contact being configured to receive and electrically couple to an EMG surface electrode.

15. The apparatus of claim 13, wherein, The monitoring device includes a housing that houses electronic components therein, and wherein the electromyography sensor includes at least one electrical contact disposed on a bottom surface of the housing, the at least one electrical contact being configured to receive and electrically couple to an EMG surface electrode, the at least one electrical contact being further configured to protrude from the bottom surface such that the bottom surface is spaced apart from a body when the monitoring device is placed on the body.

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