EP3893752A1 - A wearable device for monitoring labor during child birth - Google Patents

A wearable device for monitoring labor during child birth

Info

Publication number
EP3893752A1
EP3893752A1 EP19829435.7A EP19829435A EP3893752A1 EP 3893752 A1 EP3893752 A1 EP 3893752A1 EP 19829435 A EP19829435 A EP 19829435A EP 3893752 A1 EP3893752 A1 EP 3893752A1
Authority
EP
European Patent Office
Prior art keywords
sensor
lactic acid
detecting
person
strain gauge
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP19829435.7A
Other languages
German (de)
French (fr)
Inventor
Shrutin ULMAN
Santosh NARASIMHASWAMY VASIST
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Koninklijke Philips NV
Original Assignee
Koninklijke Philips NV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Koninklijke Philips NV filed Critical Koninklijke Philips NV
Publication of EP3893752A1 publication Critical patent/EP3893752A1/en
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
    • A61B5/4343—Pregnancy and labour monitoring, e.g. for labour onset detection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/1107—Measuring contraction of parts of the body, e.g. organ or muscle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • A61B5/14517—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for sweat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0261—Strain gauges

Definitions

  • the invention relates to a wearable device for monitoring labor during child birth. More particularly, the invention relates to a wearable device for monitoring the descent of the fetus and of the fatigue level of the mother, during the child birth.
  • vaginal delivery involves three stages namely, the shortening and opening of the cervix, descent of the fetus and its birth, and pushing out the placenta.
  • Regular uterine contractions occur during delivery which enables the descent of the fetus and of its birth.
  • vaginal delivery it is imperative that the mother is able to push the fetus through the pelvic passage. Pushing the fetus through the pelvic passage by the mother requires sustained strength and energy. Often, such activity introduces fatigue to the mother.
  • the anaerobic metabolism referred here relate to a condition called glycolysis which is an oxygen independent metabolic pathway that converts glucose so as to release energy.
  • glycolysis is an oxygen independent metabolic pathway that converts glucose so as to release energy.
  • the descent of the fetus which is crucial in monitoring the progression of the labor and of the child birth encountered during vaginal delivery. Since the descent of the fetus is also related to the pushing of the fetus through the pelvic passage by the mother, the fatigue encountered by the mother during this stage cannot be neglected. Hence it is not unimportant to neglect monitoring the fatigue level along with the descent of the fetus. Hence the monitoring of the descent of the fetus and of the fatigue level of the mother, together provides a holistic observation and insight into the progression of the labor, and enables to make appropriate clinical decision based on such observations, present condition and other related factors of the mother.
  • US 2015/0126834 A1 discloses a wearable electrochemical sensor for detecting chemical analyses within an external environment.
  • the electric potential generated by the muscle cells is detected by recording the electrical activity produced by the skeletal muscles using a technique called Electromyography (EMG).
  • EMG Electromyography
  • the EMG potential caused due to the movement in the body affects the measurement of the electrochemical sensor and causes error in such measurements.
  • fluctuation in the temperature of the body affects the conductivity of the analyses and impacts the measurement thereof.
  • the present invention provides a system for monitoring labor of a person during child birth.
  • the system of the invention comprises a first sensor, a second sensor, a processing unit and a data transmission unit.
  • a first sensor is provided for detecting lactic acid in the sweat from the body of a person.
  • a second sensor is provided for detecting muscular movement of the abdominal surface of the body of a person.
  • Processing unit of the system determines the fatigue level and the descent of the fetus and of the respective patterns thereof, based on the corresponding and respective signals from the first sensor and second sensor, received and transmitted by data transmission unit.
  • the first sensor is a lactic acid sensor provided for detecting lactic acid in the sweat from the body of a person.
  • the second sensor comprises at least one strain gauge sensor.
  • the strain gauge sensors are provided for detecting the muscular movement of the abdominal surface of the body of a person caused by the uterine contraction.
  • the strain gauge sensors may be disposed in a linear and / or vertical arrangement over the abdominal surface of the body of the person.
  • the first sensor, second sensor, processing unit and data transmission unit are individual elements as such. These elements of the system purporting to first sensor, second sensor, processing unit and data transmission unit, are arranged separately or one or more of such elements been integrated therewith. These elements are arranged in corresponding relationship to each other and are electrically connected thereto.
  • the one or more elements of the system purporting to first sensor, second sensor, processing unit and data transmission unit is a wearable component.
  • the present invention also provides a sensor for detecting lactic acid.
  • the sensor for detecting lactic acid comprises a plurality of resistive arms of a bridge circuit.
  • One of the resistive arm of the plurality of the resistive arms is an electrode capable of making direct contact with the surface of the skin to detect lactic acid.
  • the other resistive arms of the plurality of the resistive arms are located on a substrate to provide insulation from sweat.
  • the electrode of the sensor for detecting lactic acid is composed of silver ink and nitrite salt.
  • the substrate of the sensor for detecting lactic acid is composed of conductive rubber.
  • the electrode and other resistive arms of the plurality of the resistive arms of the sensor for detecting lactic acid are electrically connected therewith to form a bridge circuit.
  • the senor for detecting lactic acid is a wearable component such as a biosensor patch or the like. Accordingly, the present invention also provides a sensor for detecting muscular movement.
  • the sensor for detecting muscular movement comprises a plurality of resistive arms of a bridge circuit.
  • One of the resistive arm of the plurality of the resistive arms is a strain gauge disposed on a substrate and provided to detect muscular movement of the abdominal surface of the body of a person.
  • the strain gauge is separated from other resistive arms of the plurality of the resistive arms located on a separate substrate.
  • the substrate of the strain gauge or of the other resistive arms is composed of a non-conductive and non-permeable material such as rubber etc.
  • the strain gauge and other resistive arms of the plurality of the resistive arms are electrically connected therewith to form a bridge circuit.
  • the senor for detecting muscular movement is a wearable component such as a biosensor patch or the like.
  • the present invention also provides a method for monitoring labor of a person during child birth.
  • the method of the invention comprises the steps of detecting lactic acid in the sweat from the body of a person by a first sensor, detecting muscular movement of the abdominal surface of the body of a person by a second sensor, and determining the fatigue level and the descent of the fetus and of the respective patterns thereof by a processing unit. Determining the fatigue level and the descent of the fetus is based on the corresponding and respective signals from the first sensor and second sensor, received and transmitted by a data transmission unit.
  • Figure 1 shows a system for monitoring labor of a person during child birth, in accordance with an embodiment of the invention
  • Figure 2 shows a representation of a lactic acid sensor, in accordance with an embodiment of the invention
  • Figure 3 shows a representation of the electrode of the lactic acid sensor of Figure 2;
  • Figure 4 shows a circuit diagram of lactic acid sensor of Figure 2
  • Figure 5 shows a representation of a strain gauge sensor, in accordance with an embodiment of the invention
  • Figure 6 shows a circuit diagram of strain gauge of Figure 5
  • Figure 7 illustrates an arrangement of biosensors as patches over the skin surface
  • FIG 8 shows a circuit diagram of the system of Figure 1, in accordance with the invention.
  • FIG 9 shows one exemplary arrangement of the system of Figure 1, in accordance with the invention.
  • FIG 10 shows another exemplary arrangement of the system of Figure 1, in accordance with the invention.
  • FIG 11 shows further exemplary arrangement of the system of Figure 1, in accordance with the invention.
  • Figure 12 shows a method for monitoring labor of a person during child birth, in accordance with the invention.
  • the monitoring of the descent of the fetus is imperative to make clinical decision during the child birth.
  • the monitoring of the fatigue level of the person undergoing labor is not unimportant, in order to understand the endurance level of the person to continue with the labor and to decide on any medical intervention that may be required. This differs from person to person, and hence an individualized pattern of the descent of the fetus and of the fatigue level provide a greater insight on the present condition of the labor and of the person thereof.
  • the invention is aimed at providing such a solution that monitors the descent of the fetus and of the fatigue level.
  • FIG. 1 shows a system (100) for monitoring labor of a person during child birth.
  • the system (100) of the invention essentially comprises a lactic acid sensor (101), strain gauge sensor (102), a data transmission unit (103) and a processing unit (104).
  • the lactic acid sensor (101) is provided for detecting the lactic acid in the sweat perspiring from the body of the person undergoing labor during childbirth.
  • the lactic acid sensor (101) may be placed directly over the skin of the person.
  • the body of the person perspires producing sweat containing lactic acid in it, when there is an onset of anaerobic metabolism in the body, which eventually leads to tiredness and fatigue. This condition will impact the process of vaginal delivery, and hence needs to be monitored.
  • the lactic acid sensor (101) senses the lactic acid in the sweat thereby enables the determination of fatigue level.
  • strain gauge sensor (102) is provided for detecting the muscular movements of the abdominal region of the person caused by the uterine contraction. Monitoring of this movement specifically provides an insight of the descent of the fetus from the abdomen through the cervical passage.
  • the strain gauge sensor (102) is adapted to detect the stretches and compressions in the abdominal region.
  • the data transmission unit (103) is provided to receive and transmit the signal from the lactic acid sensor (101) and the strain gauge sensor (102) to the processing unit (104).
  • the processing unit (104) is provided to process the signals pertaining to the lactic acid sensor (101) and the strain gauge sensor (102) to determine the fatigue level and of the descent of the fetus respectively.
  • the data transmission unit (103) and the processing unit (104) may be provided as independent or separate elements or may be integrated together to offer the required functionality.
  • the data transmission unit (103) is also provided to transmit the data to other processing device, hand held device, communication gateway, etc. Such transmission may be effected wirelessly through available means like Bluetooth, Near Field Communication etc.
  • FIG. 2 shows a lactic acid sensor (101) of the invention.
  • the lactic acid sensor has a component (201) that reacts with or analyses the lactic acid.
  • the component (201) includes but not limited to silver ink.
  • the silver ink mixed with a nitrate salt is placed in direct contact with the skin.
  • the component (201) essentially forms an electrode.
  • the lactic acid sensor (101) has plurality resistive elements along with the electrode to form a bridge circuit (202).
  • the resistive elements (202) along with the electrical circuitry of the bridge circuit are placed on a conductive rubber surface (203), so as to insulate the same from the sweat. This arrangement allows the stray Electromyograph (EMG) signals to pass through the conductive rubber surface (203) and therefore negate the EMG signal totally, if any produced.
  • EMG Electromyograph
  • Figure 3 shows the component (201), being the electrode of the lactic acid sensor (101). The presence of nitrate salt (301) along with the silver ink is shown. This can be placed directly over the surface of the skin.
  • Figure 4 shows a representation of a bridge circuit (400) that purports to the electrical circuit or connection of the component (201) and other resistive arms (401a, 401b and 401c) pertaining to the resistive elements (202).
  • the component (201) essentially serves as one of the arm of the bridge circuit, besides the resistive arms (401a, 401b and 401c) each forming a separate arm of the bridge circuit thereof.
  • the bridge circuit of the lactic acid sensor having resistive arms purporting to the component (201) and other resistive arms (401a, 401b and 401c), will be in a balanced condition in the absence of lactic acid.
  • the output voltage V out is as follows,
  • VCD is the voltage across the nodes C and D
  • Vc is the voltage drop ta node C
  • VD is the voltage drop at node D.
  • the presence of lactic acid in the sweat reacts with the nitre salt present in the lactic acid sensor, and accordingly increases the conductivity of the component (201) of the lactic acid sensor (101).
  • the resistance of the component (201) being an electrode and forming one of the arms of the bridge circuit of the lactic acid sensor, decreases.
  • the current l to tai takes the path with least resistance, and h will be greater than li. Therefore, Vc will be greater than VD.
  • the output voltage V ou t is as follows
  • FIG. 5 shows a representation of a strain gauge sensor (102).
  • the strain gauge sensor (102) has a strain gauge component (501) made of material like conductive rubber (503) etc.
  • the strain gauge component (501) is placed on a non-permeable and non-conductive material (504) like non-conductive rubber etc., to insulate the strain gauge component (501) from the sweat.
  • the strain gauge component (501) is capable and adaptable to stretch and compression. Hence the stretch and compression on the abdominal surface directly affects the strain gauge component (501), and its stretch and compression changes its electrical resistance value. Since the strain gauge component (501) is placed on a non-permeable and non-conductive material (504) that is also adapted to stretch and compression, the resistance values are not affected.
  • the strain gauge component (501) and other resistive elements (502) of the bridge circuit pertaining to the strain gauge sensor (102) forms a bridge circuit to detect the change in resistance that may be used to determine the muscular movement.
  • the resistive elements may be placed on separate non-permeable and non-conductive surface (505) like plastic or rubber etc.
  • Figure 6 shows a representation of a bridge circuit (600) that purports to the electrical circuit or connection of the strain gauge component (501) and other resistive arms (601a, 601b and 601c) pertaining to the resistive elements (502).
  • the strain gauge component (501) essentially serves as one of the arm of the bridge circuit, besides the resistive arms (601a, 601b and 601c) each forming a separate arm of the bridge circuit thereof.
  • Strain gauge component (501) is characterized by the aspect that when stretched, the length of the strain gauge component increases and the area decreases, and therefore the resistance increases. Similarly, when the strain gauge component (501) contracts due to compression, the resistance decreases. This is expressed in terms of gauge factor, GF of the strain gauge component.
  • GF is the gauge factor
  • AR is the change in resistance
  • R is the resistance when the gauge is not deformed
  • the strain is determined by detecting the change in resistance.
  • the bridge circuit of the strain gauge sensor having resistive arms purporting to the strain gauge component (501) and other resistive arms (601a, 601b and 601c), will be in a balanced condition when the strain gauge is in a normal state i.e. neither stretched nor compressed.
  • the output voltage V out is as follows,
  • VAB is the voltage across the nodes A and D
  • VA is the voltage drop ta node A
  • VB is the voltage drop at node B.
  • the strain gauge component when the strain gauge component is compressed, its resistance decreases.
  • the current l totai takes the path with least resistance, and h will be greater than li. Therefore, VA will be greater than VB, and the voltage difference is positive.
  • the output voltage V ou t is as follows,
  • FIG. 7 illustrates an arrangement (700) of biosensors as patches over the skin surface (701).
  • the patches (702) pertain to the strain gauge sensor (102) and / or lactic acid sensor (101) that can be provided separately or integrated together to form a single patch.
  • the lactic acid sensor (101) and the strain gauge sensor (102) either independent or integrated thereto may be provided as a wearable patch.
  • the skin surface (701) may be the abdominal surface of the person undergoing labor during child birth.
  • the strain gauges are encountered with compression, since the abdomen returns to its original shape.
  • the pattern of this can be used to determine the fetal descent.
  • a plurality of strain gauges is applied at the beginning of the labor, and the fetal descent has not yet started, then all the strain gauges are in stretched condition.
  • the top few strain gauges experiences compression, and the top most strain gauge would be experiencing the maximum compression amongst them.
  • the amount of compression experienced by each of the strain gauges at different stages of the fetal descent will differ. Artificial neural networks may be employed to determine the stage or status of the fetal descent from these patterns.
  • Figure 8 shows a representation of an electrical circuit (800) showing the electrical connection of the bridge circuit of the lactic acid sensor (400) and the bridge circuit of the strain gauge sensor (600).
  • bridge circuit of the lactic acid sensor (400) having component (201) and other resistive arms (401a, 401b and 401c) pertaining to the resistive elements (202) are shown in the same context as shown in Figure 4.
  • the bridge circuit of the strain gauge sensor (600) having strain gauge component (501) and other resistive arms (601a, 601b and 601c) pertaining to the resistive elements (502) are shown in the same context as shown in Figure 6.
  • Figure 9 shows one exemplary arrangement of the system (900), in accordance with the invention.
  • the system (900) is shown having the lactic acid sensor and strain gauge sensor arranged next to each other. They may be made available as separate biosensor patches as well.
  • the system (900) has a component (201) of the lactic acid sensor connected to other resistive elements (202) of the bridge circuit of the lactic acid sensor (101).
  • a strain gauge component (501) made of conductive rubber (503) placed on a non-permeable and non-conductive material (504).
  • the strain gauge component (501) is electrically connected to other resistive elements (502) of the bridge circuit of the strain gauge sensor (102).
  • FIG. 10 shows another exemplary arrangement of the system, in accordance with the invention.
  • the system (1000) is shown having the lactic acid sensor and strain gauge sensor in a stacked or sandwich arrangement.
  • the system (1000) has a component (201) of the lactic acid sensor connected to other resistive elements (202) of the bridge circuit of the lactic acid sensor (101).
  • strain gauge component (501) made of conductive rubber (503) placed on a non-permeable and non-conductive material (504).
  • the strain gauge component (501) is electrically connected to other resistive elements (502) of the bridge circuit of the strain gauge sensor (102).
  • the bridge circuit of the strain gauge sensor is placed on a non- permeable and non-conductive surface like plastic etc.
  • the data transmission unit (103) is provided to receive and transmit the signals from the lactic acid sensor and strain gauge sensor to the processing unit (104).
  • the processing unit (104) processes these signals to determine the fatigue level and the descent of the fetus accordingly.
  • FIG 11 shows further exemplary arrangement of the system, in accordance with the invention.
  • the system (1100) is shown having the lactic acid sensor and strain gauge sensor in an integrated arrangement. They may be made available as a single biosensor patch.
  • the system (1100) has a component (201) of the lactic acid sensor connected to other resistive elements (202) of the bridge circuit of the lactic acid sensor (101).
  • the resistive elements (202) are placed on a conductive rubber surface (203).
  • a strain gauge component (501) made of conductive rubber placed on a non-permeable and non-conductive material (504).
  • the strain gauge component (501) is electrically connected to other resistive elements (502) of the bridge circuit of the strain gauge sensor (102).
  • the bridge circuit of the strain gauge sensor is placed on a non-permeable and non-conductive surface like plastic etc.
  • the data transmission unit (103) is provided to receive and transmit the signals from the lactic acid sensor and strain gauge sensor to the processing unit (104).
  • the processing unit (104) processes these signals to determine the fatigue level and the descent of the fetus accordingly.
  • Figure 12 illustrates a method (1200) for monitoring labor of a person during child birth.
  • the method (1200) of the invention essentially comprises the steps of detecting lactic acid (1201), detecting muscular movement (1202) and determining the fatigue level and the descent of the fetus (1203).
  • the method of the invention is primarily performed by the system of the invention described herein before.
  • the step of detecting lactic acid (1201) in the sweat from the body of a person is performed by a lactic acid sensor (101).
  • the step of detecting muscular movement (1202) of the abdominal surface of the body of a person is performed by a strain gauge sensor (102).
  • the step of determining the fatigue level and the descent of the fetus and of the respective patterns thereof is performed by a processing unit (104), based on the corresponding and respective signals from the lactic acid sensor (101) and strain gauge sensor (102), received and transmitted by a data transmission unit (103).

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Abstract

The invention relates to a system for monitoring labor of a person during child birth. The system of the invention comprises a first sensor, a second sensor, a processing unit and a data transmission unit. A first sensor is provided for detecting lactic acid in the sweat from the body of a person. A second sensor is provided for detecting muscular movement of the abdominal surface of the body of a person. Processing unit of the system determines the fatigue level and the descent of the fetus and of the respective patterns thereof, based on the corresponding and respective signals from the first sensor and second sensor, received and transmitted by data transmission unit. The invention also relates to a sensor for detecting lactic acid, a sensor for detecting muscular movement, and to a method for monitoring labor of a person during child birth.

Description

A WEARABLE DEVICE FOR MONITORING LABOR DURING CHILD BIRTH
FIELD OF THE INVENTION
The invention relates to a wearable device for monitoring labor during child birth. More particularly, the invention relates to a wearable device for monitoring the descent of the fetus and of the fatigue level of the mother, during the child birth.
BACKGROUND
Generally, child birth through vaginal delivery involves three stages namely, the shortening and opening of the cervix, descent of the fetus and its birth, and pushing out the placenta. Regular uterine contractions occur during delivery which enables the descent of the fetus and of its birth. However, in vaginal delivery, it is imperative that the mother is able to push the fetus through the pelvic passage. Pushing the fetus through the pelvic passage by the mother requires sustained strength and energy. Often, such activity introduces fatigue to the mother.
Usually fatigue occurs when the energy and strength required by the body cannot be met by the aerobic respiration. Therefore, in order to provide the required strength, the body shifts to anaerobic metabolism. This also introduces exhaustion or fatigue in the body. Also, the anaerobic metabolism referred here relate to a condition called glycolysis which is an oxygen independent metabolic pathway that converts glucose so as to release energy. This characterized by the presence of lactic acid in the sweat produced by the body during the process and the presence of lactic acid is encountered in the sweat that perspires through the skin. The presence of lactic acid in the sweat provides an indication of the glycolysis or of the anaerobic metabolism, which correlates to the fatigue level encountered by the body.
The onset and continuance of fatigue makes the mother tired and weak to summon the required the strength to push the fetus through the pelvic passage, and hence cannot continue for long.
Thus, it is required to monitor the descent of the fetus, which is crucial in monitoring the progression of the labor and of the child birth encountered during vaginal delivery. Since the descent of the fetus is also related to the pushing of the fetus through the pelvic passage by the mother, the fatigue encountered by the mother during this stage cannot be neglected. Hence it is not unimportant to neglect monitoring the fatigue level along with the descent of the fetus. Hence the monitoring of the descent of the fetus and of the fatigue level of the mother, together provides a holistic observation and insight into the progression of the labor, and enables to make appropriate clinical decision based on such observations, present condition and other related factors of the mother.
US 2015/0126834 A1 discloses a wearable electrochemical sensor for detecting chemical analyses within an external environment. The electric potential generated by the muscle cells is detected by recording the electrical activity produced by the skeletal muscles using a technique called Electromyography (EMG). Here, the EMG potential caused due to the movement in the body affects the measurement of the electrochemical sensor and causes error in such measurements. Also, fluctuation in the temperature of the body affects the conductivity of the analyses and impacts the measurement thereof.
Hence, there is a need for an invention that monitors the descent of the fetus along with the fatigue level and overcoming the limitations discussed herein before.
SUMMARY OF THE INVENTION
Accordingly, the present invention provides a system for monitoring labor of a person during child birth. The system of the invention comprises a first sensor, a second sensor, a processing unit and a data transmission unit. A first sensor is provided for detecting lactic acid in the sweat from the body of a person. A second sensor is provided for detecting muscular movement of the abdominal surface of the body of a person. Processing unit of the system determines the fatigue level and the descent of the fetus and of the respective patterns thereof, based on the corresponding and respective signals from the first sensor and second sensor, received and transmitted by data transmission unit.
According to one aspect of the invention, the first sensor is a lactic acid sensor provided for detecting lactic acid in the sweat from the body of a person. According to another aspect of the invention, the second sensor comprises at least one strain gauge sensor. The strain gauge sensors are provided for detecting the muscular movement of the abdominal surface of the body of a person caused by the uterine contraction. The strain gauge sensors may be disposed in a linear and / or vertical arrangement over the abdominal surface of the body of the person.
According to yet another aspect of the invention, the first sensor, second sensor, processing unit and data transmission unit are individual elements as such. These elements of the system purporting to first sensor, second sensor, processing unit and data transmission unit, are arranged separately or one or more of such elements been integrated therewith. These elements are arranged in corresponding relationship to each other and are electrically connected thereto.
According to further aspect of the invention, the one or more elements of the system purporting to first sensor, second sensor, processing unit and data transmission unit is a wearable component.
Accordingly, the present invention also provides a sensor for detecting lactic acid. The sensor for detecting lactic acid comprises a plurality of resistive arms of a bridge circuit. One of the resistive arm of the plurality of the resistive arms is an electrode capable of making direct contact with the surface of the skin to detect lactic acid. The other resistive arms of the plurality of the resistive arms are located on a substrate to provide insulation from sweat.
According to one embodiment of the invention, the electrode of the sensor for detecting lactic acid is composed of silver ink and nitrite salt.
According to another embodiment of the invention, the substrate of the sensor for detecting lactic acid is composed of conductive rubber.
According to yet another embodiment of the invention, the electrode and other resistive arms of the plurality of the resistive arms of the sensor for detecting lactic acid are electrically connected therewith to form a bridge circuit.
According to further embodiment of the invention, the sensor for detecting lactic acid is a wearable component such as a biosensor patch or the like. Accordingly, the present invention also provides a sensor for detecting muscular movement. The sensor for detecting muscular movement comprises a plurality of resistive arms of a bridge circuit. One of the resistive arm of the plurality of the resistive arms is a strain gauge disposed on a substrate and provided to detect muscular movement of the abdominal surface of the body of a person. The strain gauge is separated from other resistive arms of the plurality of the resistive arms located on a separate substrate.
According to one aspect of the invention, the substrate of the strain gauge or of the other resistive arms is composed of a non-conductive and non-permeable material such as rubber etc.
According to another aspect of the invention, the strain gauge and other resistive arms of the plurality of the resistive arms are electrically connected therewith to form a bridge circuit.
According to yet another aspect of the invention, the sensor for detecting muscular movement is a wearable component such as a biosensor patch or the like.
Accordingly, the present invention also provides a method for monitoring labor of a person during child birth. The method of the invention comprises the steps of detecting lactic acid in the sweat from the body of a person by a first sensor, detecting muscular movement of the abdominal surface of the body of a person by a second sensor, and determining the fatigue level and the descent of the fetus and of the respective patterns thereof by a processing unit. Determining the fatigue level and the descent of the fetus is based on the corresponding and respective signals from the first sensor and second sensor, received and transmitted by a data transmission unit.
BRIEF DESCRIPTION OF THE DRAWINGS
With reference to the accompanying drawings in which:
Figure 1 shows a system for monitoring labor of a person during child birth, in accordance with an embodiment of the invention;
Figure 2 shows a representation of a lactic acid sensor, in accordance with an embodiment of the invention;
Figure 3 shows a representation of the electrode of the lactic acid sensor of Figure 2;
Figure 4 shows a circuit diagram of lactic acid sensor of Figure 2; Figure 5 shows a representation of a strain gauge sensor, in accordance with an embodiment of the invention;
Figure 6 shows a circuit diagram of strain gauge of Figure 5;
Figure 7 illustrates an arrangement of biosensors as patches over the skin surface;
Figure 8 shows a circuit diagram of the system of Figure 1, in accordance with the invention;
Figure 9 shows one exemplary arrangement of the system of Figure 1, in accordance with the invention;
Figure 10 shows another exemplary arrangement of the system of Figure 1, in accordance with the invention;
Figure 11 shows further exemplary arrangement of the system of Figure 1, in accordance with the invention; and
Figure 12 shows a method for monitoring labor of a person during child birth, in accordance with the invention.
DETAILED DESCRIPTION
The monitoring of the descent of the fetus is imperative to make clinical decision during the child birth. Likewise, the monitoring of the fatigue level of the person undergoing labor is not unimportant, in order to understand the endurance level of the person to continue with the labor and to decide on any medical intervention that may be required. This differs from person to person, and hence an individualized pattern of the descent of the fetus and of the fatigue level provide a greater insight on the present condition of the labor and of the person thereof.
The invention is aimed at providing such a solution that monitors the descent of the fetus and of the fatigue level.
The invention is further described herein after with reference to a non-exhaustive exemplary embodiment through Figures 1 to 12.
Figure 1 shows a system (100) for monitoring labor of a person during child birth. The system (100) of the invention essentially comprises a lactic acid sensor (101), strain gauge sensor (102), a data transmission unit (103) and a processing unit (104). The lactic acid sensor (101) is provided for detecting the lactic acid in the sweat perspiring from the body of the person undergoing labor during childbirth. The lactic acid sensor (101) may be placed directly over the skin of the person. The body of the person perspires producing sweat containing lactic acid in it, when there is an onset of anaerobic metabolism in the body, which eventually leads to tiredness and fatigue. This condition will impact the process of vaginal delivery, and hence needs to be monitored. The lactic acid sensor (101) senses the lactic acid in the sweat thereby enables the determination of fatigue level.
On the other hand, strain gauge sensor (102) is provided for detecting the muscular movements of the abdominal region of the person caused by the uterine contraction. Monitoring of this movement specifically provides an insight of the descent of the fetus from the abdomen through the cervical passage. The strain gauge sensor (102) is adapted to detect the stretches and compressions in the abdominal region.
The data transmission unit (103) is provided to receive and transmit the signal from the lactic acid sensor (101) and the strain gauge sensor (102) to the processing unit (104). The processing unit (104) is provided to process the signals pertaining to the lactic acid sensor (101) and the strain gauge sensor (102) to determine the fatigue level and of the descent of the fetus respectively. The data transmission unit (103) and the processing unit (104) may be provided as independent or separate elements or may be integrated together to offer the required functionality. The data transmission unit (103) is also provided to transmit the data to other processing device, hand held device, communication gateway, etc. Such transmission may be effected wirelessly through available means like Bluetooth, Near Field Communication etc.
Figure 2 shows a lactic acid sensor (101) of the invention. The lactic acid sensor has a component (201) that reacts with or analyses the lactic acid. The component (201) includes but not limited to silver ink. The silver ink mixed with a nitrate salt is placed in direct contact with the skin. The component (201) essentially forms an electrode. The lactic acid sensor (101) has plurality resistive elements along with the electrode to form a bridge circuit (202). The resistive elements (202) along with the electrical circuitry of the bridge circuit are placed on a conductive rubber surface (203), so as to insulate the same from the sweat. This arrangement allows the stray Electromyograph (EMG) signals to pass through the conductive rubber surface (203) and therefore negate the EMG signal totally, if any produced.
Figure 3 shows the component (201), being the electrode of the lactic acid sensor (101). The presence of nitrate salt (301) along with the silver ink is shown. This can be placed directly over the surface of the skin.
Figure 4 shows a representation of a bridge circuit (400) that purports to the electrical circuit or connection of the component (201) and other resistive arms (401a, 401b and 401c) pertaining to the resistive elements (202). Here, the component (201) essentially serves as one of the arm of the bridge circuit, besides the resistive arms (401a, 401b and 401c) each forming a separate arm of the bridge circuit thereof.
The bridge circuit of the lactic acid sensor, having resistive arms purporting to the component (201) and other resistive arms (401a, 401b and 401c), will be in a balanced condition in the absence of lactic acid. Hence, the output voltage Vout is as follows,
V0ut = VCD = Vc VD = 0 . equation (1)
Where, VCD is the voltage across the nodes C and D,
Vc is the voltage drop ta node C,
VD is the voltage drop at node D.
However, the presence of lactic acid in the sweat reacts with the nitre salt present in the lactic acid sensor, and accordingly increases the conductivity of the component (201) of the lactic acid sensor (101). In other words, the resistance of the component (201), being an electrode and forming one of the arms of the bridge circuit of the lactic acid sensor, decreases. The current ltotai takes the path with least resistance, and h will be greater than li. Therefore, Vc will be greater than VD. Hence, the output voltage Vout is as follows
Vout = VCD = VC - VD ¹ 0 . equation (2)
Higher the concentration of lactic acid in the sweat, higher will be the value of Vout. Therefore, there is a direct correlation between the concentration of the lactic acid in the sweat and of the output voltage. This enables to determine the fatigue level accordingly.
Figure 5 shows a representation of a strain gauge sensor (102). The strain gauge sensor (102) has a strain gauge component (501) made of material like conductive rubber (503) etc. The strain gauge component (501) is placed on a non-permeable and non-conductive material (504) like non-conductive rubber etc., to insulate the strain gauge component (501) from the sweat. The strain gauge component (501) is capable and adaptable to stretch and compression. Hence the stretch and compression on the abdominal surface directly affects the strain gauge component (501), and its stretch and compression changes its electrical resistance value. Since the strain gauge component (501) is placed on a non-permeable and non-conductive material (504) that is also adapted to stretch and compression, the resistance values are not affected. The strain gauge component (501) and other resistive elements (502) of the bridge circuit pertaining to the strain gauge sensor (102) forms a bridge circuit to detect the change in resistance that may be used to determine the muscular movement. The resistive elements may be placed on separate non-permeable and non-conductive surface (505) like plastic or rubber etc.
Figure 6 shows a representation of a bridge circuit (600) that purports to the electrical circuit or connection of the strain gauge component (501) and other resistive arms (601a, 601b and 601c) pertaining to the resistive elements (502). Here, the strain gauge component (501) essentially serves as one of the arm of the bridge circuit, besides the resistive arms (601a, 601b and 601c) each forming a separate arm of the bridge circuit thereof.
Strain gauge component (501) is characterized by the aspect that when stretched, the length of the strain gauge component increases and the area decreases, and therefore the resistance increases. Similarly, when the strain gauge component (501) contracts due to compression, the resistance decreases. This is expressed in terms of gauge factor, GF of the strain gauge component.
GF = (AR / R) /€ . equation (3)
Where, GF is the gauge factor,
AR is the change in resistance,
R is the resistance when the gauge is not deformed,
€ is the strain
For a particular strain gauge, the strain is determined by detecting the change in resistance. The bridge circuit of the strain gauge sensor, having resistive arms purporting to the strain gauge component (501) and other resistive arms (601a, 601b and 601c), will be in a balanced condition when the strain gauge is in a normal state i.e. neither stretched nor compressed. Hence, the output voltage Vout is as follows,
V0ut = VAB = VA VB = 0 . equation (4)
Where, VAB is the voltage across the nodes A and D,
VA is the voltage drop ta node A,
VB is the voltage drop at node B.
However, when the strain gauge component is stretched, its resistance increases. In other words, the resistance of the component (201), being an electrode and forming one of the arms of the bridge circuit of the strain gauge sensor, increases. The current ltotai takes the path with least resistance, and h will be smaller than li. Therefore, VA will be smaller than VB, and the voltage difference is negative. Hence, the output voltage Vout is as follows,
Vout = VAB = VA - VB ¹ 0 . equation (5)
On the other hand, when the strain gauge component is compressed, its resistance decreases. In other words, the resistance of the component (201), being an electrode and forming one of the arms of the bridge circuit of the strain gauge sensor, decreases. The current ltotai takes the path with least resistance, and h will be greater than li. Therefore, VA will be greater than VB, and the voltage difference is positive. Hence, the output voltage Vout is as follows,
Vout = VAB = VA - VB ¹ 0 . equation (6)
Figure 7 illustrates an arrangement (700) of biosensors as patches over the skin surface (701). Here the patches (702) pertain to the strain gauge sensor (102) and / or lactic acid sensor (101) that can be provided separately or integrated together to form a single patch. However, the lactic acid sensor (101) and the strain gauge sensor (102) either independent or integrated thereto may be provided as a wearable patch. The skin surface (701) may be the abdominal surface of the person undergoing labor during child birth.
As the fetus descents, the strain gauges are encountered with compression, since the abdomen returns to its original shape. The pattern of this can be used to determine the fetal descent. Consider, a plurality of strain gauges is applied at the beginning of the labor, and the fetal descent has not yet started, then all the strain gauges are in stretched condition. Now, consider the condition that the fetal descent has started and is at the zeroth station. At this state, the top few strain gauges experiences compression, and the top most strain gauge would be experiencing the maximum compression amongst them. Similarly, the amount of compression experienced by each of the strain gauges at different stages of the fetal descent will differ. Artificial neural networks may be employed to determine the stage or status of the fetal descent from these patterns.
Figure 8 shows a representation of an electrical circuit (800) showing the electrical connection of the bridge circuit of the lactic acid sensor (400) and the bridge circuit of the strain gauge sensor (600). Here, bridge circuit of the lactic acid sensor (400) having component (201) and other resistive arms (401a, 401b and 401c) pertaining to the resistive elements (202) are shown in the same context as shown in Figure 4. Similarly, the bridge circuit of the strain gauge sensor (600) having strain gauge component (501) and other resistive arms (601a, 601b and 601c) pertaining to the resistive elements (502) are shown in the same context as shown in Figure 6.
Figure 9 shows one exemplary arrangement of the system (900), in accordance with the invention. Here, the system (900) is shown having the lactic acid sensor and strain gauge sensor arranged next to each other. They may be made available as separate biosensor patches as well. Here, the system (900) has a component (201) of the lactic acid sensor connected to other resistive elements (202) of the bridge circuit of the lactic acid sensor (101). Also shown here is a strain gauge component (501) made of conductive rubber (503) placed on a non-permeable and non-conductive material (504). The strain gauge component (501) is electrically connected to other resistive elements (502) of the bridge circuit of the strain gauge sensor (102). The bridge circuit of the strain gauge sensor is placed on a non-permeable and non-conductive surface (505) like plastic etc. The data transmission unit (103) is provided to receive and transmit the signals from the lactic acid sensor and strain gauge sensor to the processing unit (104). The processing unit (104) processes these signals to determine the fatigue level and the descent of the fetus accordingly. Figure 10 shows another exemplary arrangement of the system, in accordance with the invention. Here, the system (1000) is shown having the lactic acid sensor and strain gauge sensor in a stacked or sandwich arrangement. Here, the system (1000) has a component (201) of the lactic acid sensor connected to other resistive elements (202) of the bridge circuit of the lactic acid sensor (101). Also shown here is a strain gauge component (501) made of conductive rubber (503) placed on a non-permeable and non-conductive material (504). The strain gauge component (501) is electrically connected to other resistive elements (502) of the bridge circuit of the strain gauge sensor (102). The bridge circuit of the strain gauge sensor is placed on a non- permeable and non-conductive surface like plastic etc. The data transmission unit (103) is provided to receive and transmit the signals from the lactic acid sensor and strain gauge sensor to the processing unit (104). The processing unit (104) processes these signals to determine the fatigue level and the descent of the fetus accordingly.
Figure 11 shows further exemplary arrangement of the system, in accordance with the invention. Here, the system (1100) is shown having the lactic acid sensor and strain gauge sensor in an integrated arrangement. They may be made available as a single biosensor patch. Here, the system (1100) has a component (201) of the lactic acid sensor connected to other resistive elements (202) of the bridge circuit of the lactic acid sensor (101). The resistive elements (202) are placed on a conductive rubber surface (203). Also shown here is a strain gauge component (501) made of conductive rubber placed on a non-permeable and non-conductive material (504). The strain gauge component (501) is electrically connected to other resistive elements (502) of the bridge circuit of the strain gauge sensor (102). The bridge circuit of the strain gauge sensor is placed on a non-permeable and non-conductive surface like plastic etc. The data transmission unit (103) is provided to receive and transmit the signals from the lactic acid sensor and strain gauge sensor to the processing unit (104). The processing unit (104) processes these signals to determine the fatigue level and the descent of the fetus accordingly.
Figure 12 illustrates a method (1200) for monitoring labor of a person during child birth. The method (1200) of the invention essentially comprises the steps of detecting lactic acid (1201), detecting muscular movement (1202) and determining the fatigue level and the descent of the fetus (1203). The method of the invention is primarily performed by the system of the invention described herein before. The step of detecting lactic acid (1201) in the sweat from the body of a person is performed by a lactic acid sensor (101). The step of detecting muscular movement (1202) of the abdominal surface of the body of a person is performed by a strain gauge sensor (102). The step of determining the fatigue level and the descent of the fetus and of the respective patterns thereof is performed by a processing unit (104), based on the corresponding and respective signals from the lactic acid sensor (101) and strain gauge sensor (102), received and transmitted by a data transmission unit (103).
Only certain features of the invention have been specifically illustrated and described herein, and many modifications and changes will occur to those skilled in the art. The invention is not restricted by the preferred embodiment described herein in the description. It is to be noted that the invention is explained by way of exemplary embodiment and is neither exhaustive nor limiting. Certain aspects of the invention that not been elaborated herein in the description are well understood by one skilled in the art. Also, the terms relating to singular form used herein in the description also include its plurality and vice versa, wherever applicable. Any relevant modification or variation, which is not described specifically in the specification are in fact to be construed of being well within the scope of the invention. The appended claims are intended to cover all such modifications and changes which fall within the spirit of the invention.
Thus, it will be appreciated by those skilled in the art that the present invention can be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The presently disclosed embodiments are therefore considered in all respects to be illustrative and not restricted. The scope of the invention is indicated by the appended claims rather than the foregoing description and all changes that come within the meaning and range and equivalence thereof are intended to be embraced therein.

Claims

CLAIMS:
1. A system for monitoring labor of a person during child birth, comprising:
a first sensor for detecting lactic acid in the sweat from the body of a person;
a second sensor for detecting muscular movement of the abdominal surface of the body of a person; and
a processing unit for determining the fatigue level and the descent of the fetus and of the respective patterns thereof, based on the corresponding and respective signals from the first sensor and second sensor, received and transmitted by a data transmission unit.
2. The system as claimed in claim 1, wherein the first sensor is a lactic acid sensor provided therein for detecting lactic acid in the sweat from the body of a person.
3. The system as claimed in claim 1, wherein the second sensor comprises at least one strain gauge sensor provided therein for detecting the muscular movement of the abdominal surface of the body of a person caused by the uterine contraction.
4. The system as claimed in claim 3, wherein the second sensor has a plurality of strain gauge sensors disposed in a linear and / or vertical arrangement over the abdominal surface of the body of the person.
5. The system as claimed in claims 1 to 4, wherein the first sensor, second sensor, processing unit and data transmission unit, being individual elements of the system, are arranged separately or one or more of such elements been integrated therewith in corresponding relationship to each other and electrically connected thereto.
6. The system as claimed in any one of the claims 5, wherein the system or one or more of its elements being first sensor, second sensor, processing unit and data transmission unit thereof is a wearable component.
7. A sensor for detecting lactic acid, comprising:
a plurality of resistive arms of a bridge circuit, wherein
one of the resistive arm of the plurality of the resistive arms is an electrode capable of making direct contact with the surface of the skin to detect lactic acid, and the other resistive arms of the plurality of the resistive arms are located on a substrate to provide insulation from sweat.
8. The sensor for detecting lactic acid as claimed in claim 7, wherein the electrode is composed of silver ink and nitrite salt.
9. The sensor for detecting lactic acid as claimed in claim 7, wherein the substrate is composed of conductive rubber.
10. The sensor for detecting lactic acid as claimed in claims 7 to 9, wherein the electrode and other resistive arms of the plurality of the resistive arms are electrically connected therewith to form a bridge circuit.
11. The sensor for detecting lactic acid as claimed in claims 7 to 10, wherein the sensor for detecting lactic acid is a wearable component such as a biosensor patch or the like.
12. A sensor for detecting muscular movement, comprising:
a plurality of resistive arms of a bridge circuit, wherein
one of the resistive arm of the plurality of the resistive arms is a strain gauge disposed on a substrate and provided to detect muscular movement of the abdominal surface of the body of a person, and separated from other resistive arms of the plurality of the resistive arms located on a separate substrate.
13. The sensor for detecting muscular movement as claimed in claim 12, wherein the substrate of the strain gauge or of the other resistive arms is composed of a non-conductive and non-permeable material such as rubber etc.
14. The sensor for detecting muscular movement as claimed in claims 12 and 13, wherein the strain gauge and other resistive arms of the plurality of the resistive arms are electrically connected therewith to form a bridge circuit.
15. The sensor for detecting muscular movement as claimed in claims 12 to 14, wherein the sensor for detecting muscular movement is a wearable component such as a biosensor patch or the like.
16. A method for monitoring labor of a person during child birth, comprising:
detecting lactic acid in the sweat from the body of a person by a first sensor;
detecting muscular movement of the abdominal surface of the body of a person by a second sensor; and
determining the fatigue level and the descent of the fetus and of the respective patterns thereof by a processing unit, based on the corresponding and respective signals from the first sensor and second sensor, received and transmitted by a data transmission unit.
EP19829435.7A 2018-12-11 2019-12-11 A wearable device for monitoring labor during child birth Pending EP3893752A1 (en)

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