US20190313930A1 - Apparatus and method for detecting an abdominal electrophysiological signal - Google Patents
Apparatus and method for detecting an abdominal electrophysiological signal Download PDFInfo
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- US20190313930A1 US20190313930A1 US16/396,309 US201916396309A US2019313930A1 US 20190313930 A1 US20190313930 A1 US 20190313930A1 US 201916396309 A US201916396309 A US 201916396309A US 2019313930 A1 US2019313930 A1 US 2019313930A1
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- A61B5/0448—
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- G—PHYSICS
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- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
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Definitions
- the present invention relates to a method and apparatus for detecting abdominal electrophysiological signals. More specifically, the present invention relates to an apparatus or method for detecting at least one of a maternal electrocardiogram, a fetal electrocardiogram, a maternal heart rate, a fetal heart rate, and uterine activity, and preferably a method or apparatus for detecting at least 2 or 3, or all of the above.
- fetal electrocardiogram fetal electrocardiogram
- Such devices use electrodes that are placed on the mother's skin to detect electrophysiological signals.
- the maternal electrocardiogram (mECG) will also tend to be detected by the electrodes, and it can be challenging to separate the fECG from the mECG.
- the electrical signals detected by the electrodes can be processed to determine: the fetal heart rate (from the fECG), the maternal heart rate (from the mECG).
- Maternal contractions, often referred to as uterine activity (UA) can be determined by electrohysterography (changes in electrical potential due to uterine contractions).
- WO2009/150440 discloses a multi-electrode patch for use in fetal heart rate monitoring, the patch comprising a flexible substrate attachable to the skin of a pregnant subject, Three sensing electrodes are positioned on the flexible substructure to approximate an arc that is substantially the same length as the arc formed by a uterus fundus of a pregnant subject. Connection ports are provided by which each sensing electrode may be connected to a fetal heart rate monitor which receives the electrical signals from the electrodes and determines the fetal heart rate from the fECG.
- a multi-electrode patch is disclosed that includes integrated circuitry configured to amplify and filter a detected fECG
- the wires or leads that electrically connect the electrodes to the readout circuit can also result in problems, One such problem is that of noise from the leads. Such noise may arise from a number of sources, including electromagnetic interference, cable microphony, and triboelectric effects. Furthermore, the leads are typically re-used, which present possible issues with cross infection.
- a multi-electrode patch for abdominal electrophysiological detection comprising: a flexible substrate interconnecting a plurality of electrodes, and a flexible substructure, wherein the electrodes are moveable or conformable to a surface such that the relative positions of at least some of the electrodes on the surface relative to each other can be adjusted by moving the electrodes and deforming the flexible substructure.
- each electrode may be moveable so that a position of the each electrode can be adjusted to conform to the surface.
- Each electrode may be substantially rigid.
- the surface may be non-planar.
- the ability to adjust the spacing between electrodes addresses two problems. Firstly, the patch can be made more comfortable for the subject, by accommodating movement of the subject (e.g. as a result of breathing or locomotion). Secondly, the patch can be reconfigured to provide a more optimal placement of the electrodes for the specific subject to be tested.
- the flexible substructure may comprise a corrugated portion (in the Z-direction relative to the surface or subject's abdomen, in use). This provides a useful alternative to flexible substructures formed by changing the layout of the substrate (in plan view).
- the electrodes may comprise a common electrode and a plurality of sensing electrodes, the sensing electrodes being spaced apart from the common electrode and each other.
- the patch may further comprise a drive electrode, for applying a voltage (other electrodes being sensing electrodes for sensing a voltage and/or current).
- the flexible substructure may be disposed between the common electrode and the sensing electrodes, so that the position of the common electrode on the surface can be adjusted relative to that of the sensing electrodes.
- Each sensing electrode may be connected to common, electrode by a respective flexible substructure. Alternatively, one or more sensing electrodes may be fixedly connected to the common electrode.
- the flexible substructure may be disposed between at least two of the sensing electrodes. This allows them to be positioned with varying distances between them in use, and accommodates relative movement of their attachment points (on the subject).
- a flexible substructure may be associated with each electrode, so that the position of each electrode is adjustable by deforming its respective flexible substructure.
- the flexible substrate may further comprise a reference feature for alignment with an umbilicus, and the flexible substructure allows the distance along the surface from the reference feature to at least one electrode to be adjusted.
- the reference feature may, comprise a through hole in the substrate, or a partially transparent region, or a detent or point in the layout of the substrate.
- An adhesive region may be provided, adjacent to the reference feature and/or at a central region of the patch, so that the patch and/or reference feature may be secured to the surface by the adhesive region.
- Each electrode may comprise an adhesive region, for example adjacent or encircling the electrode itself.
- the flexible substrate may comprise a conducting layer and an insulating layer, and a graphite layer between the conducting layer and the insulating layer.
- the graphite layer may be arranged to reduce triboelectric charging as a result of interactions between the conducting layer and the insulating layer.
- the shield layer may be disposed adjacent to a first side of the signal layer, and the plurality of conducting layers may comprise a further shield layer disposed adjacent to a second side of the signal layer, and the further shield layer may be separated from the signal layer by a further graphite layer and a further insulating layer.
- At least one electrode may comprise a plurality of biocompatible electrically conductive needles, wherein each needle has a length of between 10 ⁇ m and 200 ⁇ m.
- a biocompatible material is one that does not have a deleterious or injurious effect on a biological system as a result of it being used as intended.
- Examples of biocompatible materials for the conductive needles are doped silicon and gold coated plastics materials such as polycarbonates.
- an electrode for a patch according to any other aspect of the invention, wherein the electrode comprises a plurality of biocompatible electrically conductive needles having a length of between 10 ⁇ m and 200 ⁇ m.
- the electrode comprises at least 1000 needles.
- the plurality of biocompatible needles may have a length between 20 ⁇ m and 100 ⁇ m. This range of lengths is long enough to penetrate the typical thickness of the highly insulating stratum corneum so as to make electrical contact with the more conductive underlying layers, but not long enough to stimulate nerves so as to cause pain.
- the areal density of the needles may be between 200 and 1000 needles per square millimeter, preferably between 400 and 600 needles per square millimeter.
- An module unit may be provided (with any aspect of the invention) for removably engaging with an electronic readout device for detecting a fetal heart rate from the electrodes; wherein the module unit comprises a mechanical module unit for removable mechanical engagement with a housing of the readout device, and an electrical module unit for making an electrical connection from the electrodes to the readout device; and wherein engaging the patch with the readout device comprises engaging both the mechanical module unit and the electrical module unit.
- a multi-electrode patch for abdominal electrophysiological detection comprising: a flexible substrate interconnecting a plurality of electrodes; and a module unit for removably engaging with an electronic readout device for detecting a maternal and/or fetal electrophysiological signal from the electrodes; wherein the module comprises a mechanical module unit for removable mechanical engagement with a housing of the readout device, and an electrical module unit for making an electrical connection from the electrodes to the readout device; and wherein engaging the patch with the readout device comprises engaging both the mechanical module unit and the electrical module unit.
- Using a patch with such a module allows the use of removable readout circuit. This provides all of the advantages of an integrated readout circuit, including reduced cable noise and increased freedom of movement when wearing the patch, but without many of the drawbacks (e.g. increased patch cost, compromised readout electronics due to the need to control costs), because the removable readout circuit is re-usable.
- the mechanical module unit may, comprise a cradle connected to the flexible substrate that is mechanically engaged with the housing by sliding at least part of the housing into the cradle.
- a compression seal may be provided on the module unit or readout device, for example on the housing thereof.
- the seal may surround or otherwise isolate the electrical connection, for example in a waterproof manner.
- a multi-electrode patch for abdominal electrophysiological detection, the patch comprising: a flexible substrate interconnecting a plurality of electrodes; and a security device for electrically authenticating the patch to an electronic readout device for detecting the fetal electrocardiogram from the electrodes, so as to prevent use of the readout device with a patch that does not include the security device.
- an electronic readout device for use with a patch according to an embodiment to amplify and filter at least one signal from the electrodes of the patch, the readout device comprising: an electrical power source for storing and providing electrical power to the device; a housing having a mechanical module for mechanical engagement with the mechanical module unit of the patch; and an electrical module unit for electrical engagement with the electrical module unit of the patch.
- the mechanical module unit of the housing may comprise a magnet or ferromagnetic material.
- the readout device may comprise a wireless transmitter, for transmitting information derived from the signal.
- an electronic readout device for use with a patch according to an embodiment, to amplify and filter at least one signal from the electrodes of the patch, wherein the readout device comprises a security device that is arranged to prevent the readout device from functioning with the patch unless it receives appropriate authentication from the security device of the patch.
- the readout device may be configured to store a patch authentication code associated with a particular patient, so that the readout device becomes operable only with a patch having an authentication code associated with a particular patient.
- the display and dock may both be housed within a single housing enclosure.
- the display station may be configured to transmit at least one of: a fetal heart rate, a fetal ECG, a maternal heart rate, a maternal ECG and uterine activity to a further monitoring or display station, such as a cardiotocograph display device.
- a further monitoring or display station such as a cardiotocograph display device.
- Existing infrastructure can thereby be used to display information derived from the electrophysiological signals detected by the patch.
- the method may further comprise using the electrophysiological signals to determine at least one of a fetal heart rate, a fetal ECG, a maternal heart rate, a maternal ECG, and uterine activity, and such physiological signals may be displayed.
- Applying the patch to the abdomen of the subject may comprise the following, steps:
- Applying each electrode of the patch to the abdomen may comprise the following steps:
- the method may comprise detecting an electrophysiological signal from a voltage difference between a sensing electrode and a common electrode, and detecting a further electrophysiological signal from a voltage difference between a pair of sensing electrodes.
- the method may comprise determining at least one of: uterine activity, a fECG, a mECU, taking account the electrophysiological signal obtained from the pair of sensing electrodes.
- the method may comprise applying the patch electrodes to the abdomen of the subject without first preparing the skin by removing a region of the stratum corneum (for instance where the electrodes comprise a plurality of needles).
- the method may comprise engaging mechanical and electrical interface units of the readout device with the interface unit of the patch.
- the method may comprise using the readout circuit to electronically authenticate the patch using the security device of the patch and the security device of the readout device.
- the method may comprise configuring at least one readout device to work with a particular patch, based on the authentication code of the patch.
- the method may comprise configuring more than one readout device to work with a particular patch, based on the authentication code of the patch. Rapid switching between readout devices may thereby be achieved, with one readout device in use on the patch, and at least one further readout device ready for use.
- the at least one readout device ready for use may, for instance, be left charging on a receiving station.
- FIG. 1 is a layout diagram of a patch according to an embodiment of the invention.
- FIG. 4 is a perspective view of a receiving station according to an embodiment of the invention, with three different embodiments of a readout device according to an embodiment of the invention;
- FIG. 5 is a schematic of a readout device according to an embodiment of the invention.
- a patch 150 comprising a flexible substrate 100 , viewed from the side that is to be facing the abdomen, in use.
- the flexible substrate 100 comprises a plurality of layers 6 - 12 .
- the layers 6 - 12 are patterned so as to define the shape of the substrate 100 , and to form electrodes 1 - 5 .
- Each electrode 1 - 5 is connected via a conducting track 15 to an electrical module unit 16 , for electrically connecting the electrodes 1 - 5 to a readout device (not shown).
- a graphite layer 10 a , 10 b is in contact with each of the respective dielectric layers 11 a , 11 b .
- the graphite layers 10 a , 10 b substantially overlay the respective insulating layer 11 a , 11 b , and are oversized relative thereto.
- the graphite layers 10 a , 10 b may be omitted.
- a further insulating dielectric layer 8 is in contact with the first conducting shield layer 9 a , and an insulating overlaminate 6 a is in contact with this layer 8 .
- An insulating base layer 6 b is also in contact with the second conducting shield layer 9 b .
- the overlaminate 6 a and base layer 6 b are configured to substantially encapsulate the other layers of the substrate, except in the region of the electrodes 1 - 5 . In the region of the electrodes, the signal layer 12 is exposed so that the electrodes 1 - 5 can make contact with an underlying surface.
- the insulating overlaminate 6 a and base layer 6 b may comprise a plastics material, such as polyester.
- the insulating dielectric layers 8 , 11 a , 11 b may comprise a plastics material, such as polyester or polyimide.
- the base layer 6 b defines the external shape of the flexible substrate 100 , and includes a circular region corresponding with each electrode 1 - 5 .
- the electrodes 1 - 5 are substantially rectangular, and are surrounded by each respective circular region 21 - 25 .
- the electrodes 1 - 5 can be any appropriate shape, such as circular, square or rectangular.
- the circular regions 21 - 25 may be provided with an adhesive film around their perimeter, so that the each circular region can be adhered to the skin of a subject.
- a conducting medium (such as ECG gel) is preferably disposed between each electrode 1 - 5 and the skin of the subject, thereby securely coupling each electrode 1 - 5 to the skin of the subject.
- the conducting medium preferably comprises at least 9% (by mass) of an electrolyte such as sodium chloride or potassium chloride.
- the conducting medium (or gel) may be applied by a user (e.g. a nurse or doctor) to the subject's abdomen when applying the patch, or may be pre-existing on the patch when it is removed from packaging (not shown).
- the conducting medium may be retained in contact with the electrode by a sponge element (not shown).
- Each circular region 21 - 25 comprises a lobe, or flap, that is substantially free from adhesive film or conducting medium, protruding from the edge of the circular region 21 - 25 .
- Each electrode 1 - 5 can thereby be detached from the subject by peeling the circular region 21 - 25 away from the subject by the lobe.
- a PET material may be used and has been found to provide useful properties, i.e. resilience, for avoiding breakage of the signal layer 12 during flexing of the patch in use.
- the material thickness of the polymer/PET layer(s) may be matched to the properties of the signal conducting layer 12 to prevent deformation of the tracks in a manner that is likely to lead to a break in the signal layer 12 .
- the reference feature 17 may be secured at a reference point on the patient using the associated adhesive region.
- the electrodes 1 - 5 can subsequently be moved away from the abdomen to prepare the skin.
- each electrode 1 - 5 can then be placed in turn around the abdomen with, if necessary, suitable abrasive skin preparation.
- the impedance of the connection between the electrode 1 - 5 and the patient may be measured by an electronic readout device 200 (shown in FIG. 7 ). If the impedance is above a desired value, further preparation of the skin may be carried out to reduce the impedance to below the desired value.
- the desired value may, for example, be 5 kOhms.
- the skin region for the next electrode may be prepared by abrading the skin and the electrode subsequently applied electrode, and the impedance tested. This method may be repeated until all of the electrodes are successfully applied.
- the circular regions 21 , 23 respectively associated with the first and third sensing electrode 1 , 3 are arranged symmetrically on a horizontal line passing through the centre of the reference feature 17 .
- the circular regions 22 , 24 respectively associated with the second sensing electrode 2 and drive electrode 4 are arranged on a vertical line passing through the centre of the reference feature 17 .
- the flexible substructures 13 a and 13 b allow adjustment of the distance between the first sensing electrode 1 and the reference feature 17 and the distance between the third sensing electrode 3 and the reference feature 17 .
- the ability of the substrate to accommodate adjustment of the positions of these electrodes makes the patch more comfortable, because the natural movement of the subject's skin (for instance as a result of breathing) can be accommodated by the flexible substructures 13 a and 13 b .
- a similar structure may be used in relation to electrodes 2 and 4 .
- the patch may be configured to fit subjects with different sizes of abdomen, so that a single patch can be used on a wide range of subjects.
- the flexible substructures 13 a and 13 b are similar, these being rotationally symmetric about the centre of the reference feature 17 , and having a single folded elongate member (having an outward leg and a return leg), that extends in a substantially vertical direction. Horizontal relative movement between the first and third sensing electrode 1 , 3 is thereby accommodated.
- a permanent magnet is provided on either (or both) of the mechanical module 19 and housing 201 , which attracts a corresponding magnet (or ferromagnetic element) on the other of the mechanical module 19 or housing 201 .
- a hook and loop arrangement e.g. Velcro
- Velcro may be used to secure the readout device 200 to the patch 150 .
- an electrical module 204 (shown in FIG. 5 ) of the readout device 200 is in electrical engagement with the electrical module 16 of the patch 150 .
- the electrical module 204 of the readout device 200 may conveniently comprise a plurality of contacts mounted on resiliently deformable members (e.g. spring loaded contact pins).
- the readout device 200 is preferably configured to determine and output at least one of a: fetal heart rate, fetal ECG, maternal heart rate, maternal ECG, or uterine activity, Preferably the readout device is configured to output any two, three, four, or all five of the above.
- the readout device is preferably configured to transmit the output, so that it can be monitored.
- the readout device 200 comprises a wireless transmitter (e.g. according to the Bluetooth standard), operable to transmit the output of the readout device 200 .
- the analogue circuit 213 comprises an analogue to digital converter, and receives the electrical signals from the electrodes, and outputs a digitised version thereof, for processing by the digital signal processor.
- the analogue circuit 213 may comprise an amplifier and/or filter.
- one or more component of the device 200 may be combined, for example in a multi-chip module or system on chip.
- the processor 212 may comprise any combination of the analogue circuit 213 , the security device 203 and the wireless transmitter 211 .
- the electronic components of the readout device 200 are powered by an electrical power source, which is a battery 2 : 10 in this embodiment.
- the electrical power source may comprise a capacitor.
- the inductive coil 214 is operative to charge the battery 210 , optionally under the control of the processor 210 .
- a further Maternal ECG channel can be generated that can be used for mECG removal, further reducing confusion between the mECG and MEG.
- Such confusion is a common problem with Doppler ultrasound whereas with abdominal fECG the percentage confusion time is considerably reduced.
- the use of another mECG channel (for example, measured between sensing electrodes 1 and 3 ) can further reduce this confusion by providing an improved template for accurate mECG removal.
- the readout device 200 may comprise sensors 215 , which may comprise an inertial sensor such as accelerometer and/or gyroscope.
- the sensors 215 comprise a one, two or three axis accelerometer, and/or a one, two or three axis gyroscope.
- the sensors 215 may be MEMS (micro-electromechanical systems) devices.
- the readout device 200 may comprise an inertial measurement unit.
- the accelerometers and gyroscopes may be used to track the movement of the readout device 200 , thereby allowing both fetal ECG and electrohysterogram algorithms to differentiate between maternal/fetal movements and genuine contractions and fetal ECG signals.
- a gyroscope can provide useful additional rotational information that an accelerometer cannot provide, thereby allowing further separation of fetal movement from the acquired data.
- This fetal movement is a highly useful indicator that provides further fetal well-being indication.
- the use of the pair of devices allows separation of the maternal breathing signal which is a further indication of maternal health.
- a signal receiving and display station 300 comprising a screen 302 , and two dock areas 301 .
- the receiving station is operable to receive and display output signals from the readout device 200 on the screen 302 .
- the dock areas 301 are arranged to receiving part of the housing 201 of the readout device 200 , and are provided with a wireless charging device, that is operable to charge a readout device 200 placed in the dock area 301 .
- the wireless charging device preferably operates by inducing a current in a conductor of the readout device 200 using a coil.
- a number of alternative embodiments 200 a , 200 b , 200 c of readout devices 200 are shown in front of the receiving station, each having slightly different designs of housing 201 .
- the housing 200 is preferably waterproof, and is preferably IP57 rated.
- the integration of the readout circuit 200 and patch 150 allows the subject to move freely, without having to worry about leads, and minimising any deleterious cable noise that can arise due to triboelectric effects when leads are flexed. Furthermore, the short length of the connections to the readout circuit minimise the potential for other sources of noise.
- the readout device 200 preferably comprises a wireless transmitter (not shown), and is operable to wirelessly transmits the output, via the wireless transmitter, substantially in real time, to a monitoring station that is operable to display the output.
- the readout device 200 is compatible with a number of monitoring stations, but is preferably used with a receiving and display station 300 according to an embodiment of the invention.
- each flexible substructure comprises a serpentine flexure
- the flexible substructure may comprise a corrugated region of the substrate that can accommodate movement parallel to the plane of the substrate.
- Other compliant planar arrangements may also be used.
- the electrode may be coupled to the remainder of the patch via a ring shaped element, wherein the ring has geometry selected (e.g. large diameter, narrow width) to accommodate movement in the plane of the substrate.
Abstract
Description
- This application is a continuation of U.S. patent application Ser. No. 15/029,447, filed on Apr. 14, 2016, which claims priority to PCT/GB2014/053120, filed Oct. 17, 2014, and published in English on Apr. 23, 2015 as publication number WO 2015/056027, which claims priority to GB Application No. 1318413.0, filed Oct. 17, 2013, the disclosures of which are incorporated herein by reference.
- The present invention relates to a method and apparatus for detecting abdominal electrophysiological signals. More specifically, the present invention relates to an apparatus or method for detecting at least one of a maternal electrocardiogram, a fetal electrocardiogram, a maternal heart rate, a fetal heart rate, and uterine activity, and preferably a method or apparatus for detecting at least 2 or 3, or all of the above.
- Medical devices are known that can be used to detect a fetal electrocardiogram (fECG) without making physical contact with the fetus. Such devices use electrodes that are placed on the mother's skin to detect electrophysiological signals. The maternal electrocardiogram (mECG) will also tend to be detected by the electrodes, and it can be challenging to separate the fECG from the mECG. The electrical signals detected by the electrodes can be processed to determine: the fetal heart rate (from the fECG), the maternal heart rate (from the mECG). Maternal contractions, often referred to as uterine activity (UA) can be determined by electrohysterography (changes in electrical potential due to uterine contractions).
- WO2009/150440 (Monica Healthcare) discloses a multi-electrode patch for use in fetal heart rate monitoring, the patch comprising a flexible substrate attachable to the skin of a pregnant subject, Three sensing electrodes are positioned on the flexible substructure to approximate an arc that is substantially the same length as the arc formed by a uterus fundus of a pregnant subject. Connection ports are provided by which each sensing electrode may be connected to a fetal heart rate monitor which receives the electrical signals from the electrodes and determines the fetal heart rate from the fECG. A multi-electrode patch is disclosed that includes integrated circuitry configured to amplify and filter a detected fECG
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EP 1 854 403 (Meyer) discloses a radial electrode assembly for monitoring fECG and mECU signals. The assembly comprises a flexible substrate defining a central focal point, and a plurality of electrodes disposed on the periphery of the flexible substrate, at a substantially equal fixed radial distance from the focal point. - Although the patches disclosed in the prior art for fECG detection are promising, considerable room for improvement remains.
- A fixed patch arrangement results in a precise fixed spacing between the electrodes. This fixed electrode spacing is advantageous for repeatability of measurements, but limits the degree of flexibility in electrode placement. The optimum electrode location may, for instance, vary as a function of the size of the fetus and/or mother. The size of the fetus clearly varies as a function of gestational age. Furthermore, the fixed distance between electrodes of a patch arrangement does not accommodate movement of the subject (for example resulting from locomotion or breathing) in the same way that individual electrodes connected by leads to a signal processing unit can.
- In arrangements for fECG which use a readout circuit that is separate from the electrodes, the wires or leads that electrically connect the electrodes to the readout circuit can also result in problems, One such problem is that of noise from the leads. Such noise may arise from a number of sources, including electromagnetic interference, cable microphony, and triboelectric effects. Furthermore, the leads are typically re-used, which present possible issues with cross infection.
- Although fECG patches with integrated electronics can address some of the problems associated with cables, a further problem with fECG patches that include integrated electronics is that this greatly increases the cost of each patch. This can make them too expensive for routine monitoring applications, or can limit the sophistication of the electronics of the readout, compromising performance. The patches are often disposable single use patches.
- Another problem with obtaining high quality abdominal electrophysiological signals is that of making a good electrical contact with the skin of the subject. This is presently achieved by abrasion of the highly resistive stratum corneum, so as to make contact with the less resistive skin layers below. This skin preparation can be uncomfortable for the subject, and takes time and skill from the user of the apparatus.
- It is an object of the present invention to ameliorate or overcome at least some of the above mentioned problems.
- According to a first aspect of the present invention, there is provided: a multi-electrode patch for abdominal electrophysiological detection, the patch comprising: a flexible substrate interconnecting a plurality of electrodes, and a flexible substructure, wherein the electrodes are moveable or conformable to a surface such that the relative positions of at least some of the electrodes on the surface relative to each other can be adjusted by moving the electrodes and deforming the flexible substructure.
- The position of each electrode may be moveable so that a position of the each electrode can be adjusted to conform to the surface. Each electrode may be substantially rigid. The surface may be non-planar.
- The flexible substrate is preferably a unitary item (single part). The flexible substrate is preferably formed by printing a circuit onto a flexible support.
- Elongate conductors may extend along and/or be embedded in the flexible substrate and may depend from the electrodes. The conductors may or may not extend towards a common or central connector region of the patch. One or more via may be provided in the electrical substrate to define a conductor path, for example between one side of the flexible substrate and an opposing side. One or more via may be provided in a flexible support and/or the flexible substructure. Thus electrical signals may be communicated from an electrode on a side of the patch adjacent a wearer's skin in use to an opposing side, which faces away from the wearer.
- The circuit and/or conductors of the flexible substrate may comprise silver. A silver-containing ink may be used to print the conductors/circuit. Matching of the conducting material properties with a suitable flexible substrate material, such as a polymer has been found to be important in preventing breakage/discontinuity in the conducting material through use of the patch. A Polyethylene terephthalate (PET) substrate layer may be used.
- The flexible substrate may comprise the electrodes, so that the electrodes are formed integrally with the flexible substrate.
- The ability to adjust the spacing between electrodes addresses two problems. Firstly, the patch can be made more comfortable for the subject, by accommodating movement of the subject (e.g. as a result of breathing or locomotion). Secondly, the patch can be reconfigured to provide a more optimal placement of the electrodes for the specific subject to be tested.
- The flexible substructure may comprise an arched, curved or serpentine elongate portion. The flexible substructure may comprise features that are at least one of: convoluted, folded, nested, zig-zag, elongate and indirect, Elongate, narrow features that extend in a direction at an angle to the desired direction of compliance are preferably used. These are convenient and practical ways to provide a flexible substructure that can allow repositioning of one or more electrode relative to a central or common portion of the substrate. A serpentine portion has the advantage of being a compact way of providing a highly compliant substructure, which can be arranged to have a substantially linear stiffness over a relatively long displacement distance.
- The flexible substructure may comprise a corrugated portion (in the Z-direction relative to the surface or subject's abdomen, in use). This provides a useful alternative to flexible substructures formed by changing the layout of the substrate (in plan view).
- The patch, or at least a portion thereof, may remain substantially conformed to the surface as the relative position of at least some electrodes is adjusted. One or more electrode may be arranged on an elongate or arm portion of the patch which may depend from a common or central patch portion. A hinge, crease, line of weakness or other formation to promote flexing away from the plane of the patch may be provided in the patch or substrate between an electrode and the common/central patch portion. Such formation may be provided at an arm portion of the patch. Thus one electrode can be raised and repositioned independently of the remainder of the patch or other electrodes. In one example the formation comprises a line or region in which no adhesive is provided.
- The electrodes may comprise a common electrode and a plurality of sensing electrodes, the sensing electrodes being spaced apart from the common electrode and each other.
- The patch may further comprise a drive electrode, for applying a voltage (other electrodes being sensing electrodes for sensing a voltage and/or current).
- The flexible substructure may be disposed between the common electrode and the sensing electrodes, so that the position of the common electrode on the surface can be adjusted relative to that of the sensing electrodes. Each sensing electrode may be connected to common, electrode by a respective flexible substructure. Alternatively, one or more sensing electrodes may be fixedly connected to the common electrode.
- The flexible substructure may be disposed between at least two of the sensing electrodes. This allows them to be positioned with varying distances between them in use, and accommodates relative movement of their attachment points (on the subject).
- At least one further flexible substructure may be provided between at least two of the sensing electrodes.
- The sensing electrodes may be disposed along an arc, with a first sensing electrode at one end of the arc, a third sensing electrode at the other end of the arc, and a second sensing electrode on the arc, between the first and third sensors; wherein a first flexible substructure is arranged to allow the distance along the surface between the first and second sensing electrode to vary, and a second flexible substructure is arranged to allow the distance along the surface between the third and second sensing electrode to vary.
- A flexible substructure may be associated with each electrode, so that the position of each electrode is adjustable by deforming its respective flexible substructure.
- The flexible substrate may further comprise a reference feature for alignment with an umbilicus, and the flexible substructure allows the distance along the surface from the reference feature to at least one electrode to be adjusted. The reference feature may, comprise a through hole in the substrate, or a partially transparent region, or a detent or point in the layout of the substrate.
- An adhesive region may be provided, adjacent to the reference feature and/or at a central region of the patch, so that the patch and/or reference feature may be secured to the surface by the adhesive region. Each electrode may comprise an adhesive region, for example adjacent or encircling the electrode itself.
- The flexible substrate may comprise a conducting layer and an insulating layer, and a graphite layer between the conducting layer and the insulating layer. The graphite layer may be arranged to reduce triboelectric charging as a result of interactions between the conducting layer and the insulating layer.
- According to a second aspect of the invention, there is provided a multi-electrode patch for abdominal electrophysiological detection, the patch comprising: a flexible substrate that comprises a conducting layer and an insulating layer, and a graphite layer disposed between the conducting layer and the insulating layer. The graphite layer may reduce triboelectric effects arising from the interaction between the insulating layer and conducting layer.
- The patch may comprise a plurality of conducting layers, the plurality of conducting layers comprising: a signal layer, for communicating electrical signals from the electrodes; and a shield layer, for shielding the signal layer from electromagnetic interference; and the shield layer may be separated from the signal layer by the graphite layer and the insulating layer.
- The shield layer may be disposed adjacent to a first side of the signal layer, and the plurality of conducting layers may comprise a further shield layer disposed adjacent to a second side of the signal layer, and the further shield layer may be separated from the signal layer by a further graphite layer and a further insulating layer.
- An outer insulating layer may be disposed adjacent to an outward facing side (e.g. in use of the patch) of at least one of the shield layer and further shield layer.
- At least one electrode may comprise a plurality of biocompatible electrically conductive needles, wherein each needle has a length of between 10 μm and 200 μm. A biocompatible material is one that does not have a deleterious or injurious effect on a biological system as a result of it being used as intended. Examples of biocompatible materials for the conductive needles are doped silicon and gold coated plastics materials such as polycarbonates.
- According to a third aspect of the invention, there is provided an electrode for a patch according to any other aspect of the invention, wherein the electrode comprises a plurality of biocompatible electrically conductive needles having a length of between 10 μm and 200 μm. Preferably the electrode comprises at least 1000 needles.
- Using an electrode comprising electrically conducting biocompatible needles allows a good electrical contact to be made with the skin without the need for careful skin preparation before applying the electrodes. The skin preparation may comprise simply wiping the skin with an anti-septic or anti-bacterial wipe, or there may be no skin preparation.
- The plurality of biocompatible needles may have a length between 20 μm and 100 μm. This range of lengths is long enough to penetrate the typical thickness of the highly insulating stratum corneum so as to make electrical contact with the more conductive underlying layers, but not long enough to stimulate nerves so as to cause pain.
- Each of the plurality of biocompatible needles may have a mean diameter of between 10 μm and 100 μm. This range of diameters is a good compromise between manufacturability, sharpness and robustness. The needle may taper (for example, as a result of a wet etch following a silicon crystal plane).
- The areal density of the needles may be between 200 and 1000 needles per square millimeter, preferably between 400 and 600 needles per square millimeter.
- The needles may be configured to penetrate the median thickness of the stratum corneum of the abdomen of a pregnant human.
- An module unit may be provided (with any aspect of the invention) for removably engaging with an electronic readout device for detecting a fetal heart rate from the electrodes; wherein the module unit comprises a mechanical module unit for removable mechanical engagement with a housing of the readout device, and an electrical module unit for making an electrical connection from the electrodes to the readout device; and wherein engaging the patch with the readout device comprises engaging both the mechanical module unit and the electrical module unit.
- According to a fourth aspect of the invention, there is provided a multi-electrode patch for abdominal electrophysiological detection, the patch comprising: a flexible substrate interconnecting a plurality of electrodes; and a module unit for removably engaging with an electronic readout device for detecting a maternal and/or fetal electrophysiological signal from the electrodes; wherein the module comprises a mechanical module unit for removable mechanical engagement with a housing of the readout device, and an electrical module unit for making an electrical connection from the electrodes to the readout device; and wherein engaging the patch with the readout device comprises engaging both the mechanical module unit and the electrical module unit.
- Using a patch with such a module allows the use of removable readout circuit. This provides all of the advantages of an integrated readout circuit, including reduced cable noise and increased freedom of movement when wearing the patch, but without many of the drawbacks (e.g. increased patch cost, compromised readout electronics due to the need to control costs), because the removable readout circuit is re-usable.
- The mechanical module unit may comprise a magnet or ferromagnetic material.
- The mechanical module unit may, comprise a cradle connected to the flexible substrate that is mechanically engaged with the housing by sliding at least part of the housing into the cradle.
- The module unit may be disposed between, and preferably substantially equidistant from, at least two electrodes. In such a manner the device is positioned typically at the centre of gravity of the flexible structure.
- The electrical module unit may comprise a plurality of electrical contacts on the flexible substrate.
- The electrical connection between the module unit and the readout device may comprise one or more resilient contact member, which is typically a conductor, on one or more of the patch substrate, electrical module unit or readout device. The resilient contact member may comprise a spring contact or other resiliently deformable contact.
- A compression seal may be provided on the module unit or readout device, for example on the housing thereof. The seal may surround or otherwise isolate the electrical connection, for example in a waterproof manner.
- The patch may comprise a security device for providing an authentication code associated with the patch to an electronic readout device for detecting a fetal heart rate from the electrodes, so as to prevent use of the readout device with: a patch that does not include the security device, or a patch that provides the wrong authentication code. Furthermore the security device may provide a unique patient ID that ensures patient data is not compromised or confused with other patients in the hospital, health centre or at home within the community. Alternatively, the authentication code associated with the patch may be linked with a unique patient ID so that the patient ID can be identified from the authentication code of the patch.
- According to a fifth aspect of the invention, a multi-electrode patch is provided for abdominal electrophysiological detection, the patch comprising: a flexible substrate interconnecting a plurality of electrodes; and a security device for electrically authenticating the patch to an electronic readout device for detecting the fetal electrocardiogram from the electrodes, so as to prevent use of the readout device with a patch that does not include the security device.
- The use of electronic authentication between the patch and the readout circuit prevents the use of inferior patches with the readout circuit thereby providing greater control over the performance of the combined readout circuit and patch system (improving safety). Furthermore, they facilitate control over supply of compatible patches, so that a vendor of apparatus for electrophysiological monitoring can be certain that only consumables of appropriate quality are used in the system.
- According to a sixth aspect of the invention, an electronic readout device is provided for use with a patch according to an embodiment to amplify and filter at least one signal from the electrodes of the patch, the readout device comprising: an electrical power source for storing and providing electrical power to the device; a housing having a mechanical module for mechanical engagement with the mechanical module unit of the patch; and an electrical module unit for electrical engagement with the electrical module unit of the patch.
- Such a readout device may be considerably more convenient than a readout device that is connected to the patch via a cable, and is further advantageous in that lead noise is substantially reduced.
- The mechanical module unit of the housing may comprise a magnet or ferromagnetic material.
- The electrical module unit of the readout device may comprise at least one contact mounted on a resiliently deformable element.
- The readout device may be configured to determine at least one of: a fetal heart rate, a fetal ECU, a maternal heart rate, a maternal ECU, and uterine activity, or two or three or four or all five of them.
- The readout device may comprise a wireless transmitter, for transmitting information derived from the signal.
- The readout device may be operable to transmit an output, e.g. via the wireless transmitter, the output comprising at least one of: a fetal heart rate, a fetal ECU, a maternal heart rate, a maternal ECG, and uterine activity.
- The readout device may be configured to control the power of the wireless transmitter, based on at least one of a bit error rate at a receiver and a signal strength at the receiver. This enables far more efficient use of power, and consequently may greatly increase battery life for the readout device.
- According to a seventh aspect of the invention, there is provided a multi-electrode patch for abdominal electrophysiological detection, comprising an inertial sensor.
- The readout device may comprise an inertial sensor.
- The inertial sensor may comprise at least one of an accelerometer or a gyroscope.
- The inertial sensor may be configured to detect at least one of a maternal movement, maternal breathing, maternal contraction and fetal movement.
- The readout device may be configured to use information from an inertial sensor to reduce artefacts in at least one of a fetal heart rate and a fetal ECG output from the readout device.
- The readout device may comprise a security device that is arranged to prevent the readout device from functioning with the patch unless it receives an appropriate authentication code from a corresponding security device of the patch.
- According to a eighth aspect of the invention, there is provided an electronic readout device for use with a patch according to an embodiment, to amplify and filter at least one signal from the electrodes of the patch, wherein the readout device comprises a security device that is arranged to prevent the readout device from functioning with the patch unless it receives appropriate authentication from the security device of the patch.
- The readout device may be configured to store a patch authentication code associated with a particular patient, so that the readout device becomes operable only with a patch having an authentication code associated with a particular patient.
- The readout device may be configured to detect an electrophysiological signal from the voltage between two sensing electrodes of the patch. The two sensing electrodes may be those that are intended to be placed laterally on either side of a median line of the subject, adjacent to the umbilicus.
- According to an ninth aspect of the invention, there is provided a receiving and displaying station for receiving information from a readout device according to an embodiment, wherein the receiving and displaying station comprises: a display for displaying at least one of a fetal heart rate, a fetal ECG, a maternal heart rate, a maternal ECG, and uterine activity; and a dock area for receiving the housing of the readout device; wherein the dock comprises an inductive charger for charging the electrical power source of the readout device.
- The display and dock may both be housed within a single housing enclosure.
- The display station may be configured to transmit at least one of: a fetal heart rate, a fetal ECG, a maternal heart rate, a maternal ECG and uterine activity to a further monitoring or display station, such as a cardiotocograph display device. Existing infrastructure can thereby be used to display information derived from the electrophysiological signals detected by the patch.
- According to a tenth aspect of the invention, there is provided a system for abdominal electrophysiological detection, comprising a patch according to an embodiment of the invention, and a readout device for use with the patch, wherein the readout device is operable to determine at least one of: a fetal heart rate, a fetal ECG, a maternal heart rate, a maternal ECG, and uterine activity.
- The system may further comprise a receiving station for receiving and displaying information received from the readout device, the information comprising at least one of: a fetal heart rate, a fetal ECG, a maternal heart rate, a maternal ECG, and uterine activity.
- According to an eleventh aspect of the invention, there is provided an abdominal electrophysiological detection kit, comprising a plurality of patches, and optionally one or more of: instructions to use the patches; and at least one package, packaging up the patches in a sterile multi-patch pack. The patch and/or readout device may be in accordance with any other aspect of the invention.
- According to an twelfth aspect of the invention, there is provided a method of determining human abdominal electrophysiological signals, comprising using a patch according to an embodiment of the invention, comprising: applying the patch to the abdomen of a pregnant human subject, and using a readout circuit to detect electrophysiological signals via the electrodes of die patch, and preferably displaying an output derived from said signals.
- The method may further comprise using the electrophysiological signals to determine at least one of a fetal heart rate, a fetal ECG, a maternal heart rate, a maternal ECG, and uterine activity, and such physiological signals may be displayed.
- Applying the patch to the abdomen of the subject may comprise the following, steps:
- securing the reference feature to the abdomen;
- subsequently applying each of the electrodes of the patch in turn to the abdomen.
- Applying each electrode of the patch to the abdomen may comprise the following steps:
- applying the electrode to the skin;
- testing the impedance of the electrical connection between the electrode and the skin; and
- if the impedance is above a predetermined value:
- removing the electrode without detaching the reference feature or any other electrodes of the patch from the skin;
- preparing the skin to reduce the impedance thereof; and
- re-applying the electrode.
- The method may comprise detecting an electrophysiological signal from a voltage difference between a sensing electrode and a common electrode, and detecting a further electrophysiological signal from a voltage difference between a pair of sensing electrodes.
- The pair of sensing electrodes may be applied to the abdomen, spaced apart either side of the median line of the subject, adjacent to the umbilicus.
- The method may comprise determining at least one of: uterine activity, a fECG, a mECU, taking account the electrophysiological signal obtained from the pair of sensing electrodes.
- The method may comprise applying the patch electrodes to the abdomen of the subject without first preparing the skin by removing a region of the stratum corneum (for instance where the electrodes comprise a plurality of needles).
- The method may comprise engaging mechanical and electrical interface units of the readout device with the interface unit of the patch.
- The method may comprise using the readout circuit to electronically authenticate the patch using the security device of the patch and the security device of the readout device.
- The method may comprise configuring at least one readout device to work with a particular patch, based on the authentication code of the patch. The method may comprise configuring more than one readout device to work with a particular patch, based on the authentication code of the patch. Rapid switching between readout devices may thereby be achieved, with one readout device in use on the patch, and at least one further readout device ready for use. The at least one readout device ready for use may, for instance, be left charging on a receiving station.
- It will be appreciated that a number of essential or preferable features have been defined above in relation to one particular aspect of the invention for the sake of brevity. However the optional features of each of the specific forgoing aspects and embodiments of the invention can be combined with other aspects of the invention, as appropriate, wherever practicable.
- The invention will now be described, purely by way of example, with reference to the accompanying drawings, in which:
-
FIG. 1 is a layout diagram of a patch according to an embodiment of the invention; -
FIG. 2 is a layout diagram of the overlaminate layer of the embodiment ofFIG. 1 ; -
FIG. 3 is a perspective view of a patch and readout device according to an embodiment of the invention; -
FIG. 4 is a perspective view of a receiving station according to an embodiment of the invention, with three different embodiments of a readout device according to an embodiment of the invention; -
FIG. 5 is a schematic of a readout device according to an embodiment of the invention; -
FIG. 6 is a sectional schematic of an electrode according to an embodiment of the invention; -
FIG. 7 is a block diagram of a readout device according to an embodiment of the invention; and -
FIG. 8 is a schematic of a test subject and a patch according to an embodiment of the invention, in use on the subject. - Referring to
FIG. 1 , apatch 150 according to an embodiment is shown, comprising aflexible substrate 100, viewed from the side that is to be facing the abdomen, in use. Theflexible substrate 100, comprises a plurality of layers 6-12. The layers 6-12 are patterned so as to define the shape of thesubstrate 100, and to form electrodes 1-5. Each electrode 1-5 is connected via a conductingtrack 15 to anelectrical module unit 16, for electrically connecting the electrodes 1-5 to a readout device (not shown). - The electrodes 1-5 and/or the conducting tracks 15 are formed from the
signal layer 12, which comprises silver. For example, the conducting film used can be silver chloride which provides a good stoichiometric match to saline based electrode gels. A silver-containing ink may be used in particular to print the conducting tracks 15 and/orsignal layer 12. - An insulating
dielectric layer 11 a, 11 b is arranged on each respective side of thesignal layer 12. The insulating dielectric layers 11 a, 11 b have a similar pattern to the conducting tracks 15 of thesignal layer 12. The insulating layers 11 a, 11 b substantially overlay the conducting tracks 15, and are oversized relative thereto. The insulating layers 11 a, 11 b completely cover the conducting tracks between the electrodes 1-5 and theelectrical module unit 16, while leaving thesignal layer 12 exposed in the electrode andelectrical module unit 16 region. - A
graphite layer dielectric layers 11 a, 11 b. The graphite layers 10 a, 10 b substantially overlay the respective insulatinglayer 11 a, 11 b, and are oversized relative thereto. - A first
conducting shield layer 9 a is in contact with thegraphite layer 10 a, and a secondconducting shield layer 9 b is in contact with theoptional graphite layer 10 b. The first and secondconducting shield layers respective shield layers - In some embodiments the graphite layers 10 a, 10 b may be omitted.
- A further insulating
dielectric layer 8 is in contact with the firstconducting shield layer 9 a, and an insulatingoverlaminate 6 a is in contact with thislayer 8. Aninsulating base layer 6 b is also in contact with the secondconducting shield layer 9 b. Theoverlaminate 6 a andbase layer 6 b are configured to substantially encapsulate the other layers of the substrate, except in the region of the electrodes 1-5. In the region of the electrodes, thesignal layer 12 is exposed so that the electrodes 1-5 can make contact with an underlying surface. The insulatingoverlaminate 6 a andbase layer 6 b may comprise a plastics material, such as polyester. The insulatingdielectric layers - The
base layer 6 b defines the external shape of theflexible substrate 100, and includes a circular region corresponding with each electrode 1-5. The electrodes 1-5 are substantially rectangular, and are surrounded by each respective circular region 21-25. In will be appreciated that in other embodiments, the electrodes 1-5 can be any appropriate shape, such as circular, square or rectangular. The circular regions 21-25 may be provided with an adhesive film around their perimeter, so that the each circular region can be adhered to the skin of a subject. A conducting medium (such as ECG gel) is preferably disposed between each electrode 1-5 and the skin of the subject, thereby securely coupling each electrode 1-5 to the skin of the subject. - The conducting medium preferably comprises at least 9% (by mass) of an electrolyte such as sodium chloride or potassium chloride. The conducting medium (or gel) may be applied by a user (e.g. a nurse or doctor) to the subject's abdomen when applying the patch, or may be pre-existing on the patch when it is removed from packaging (not shown). The conducting medium may be retained in contact with the electrode by a sponge element (not shown). Each circular region 21-25 comprises a lobe, or flap, that is substantially free from adhesive film or conducting medium, protruding from the edge of the circular region 21-25. Each electrode 1-5 can thereby be detached from the subject by peeling the circular region 21-25 away from the subject by the lobe.
- For any polymer layer described above, a PET material may be used and has been found to provide useful properties, i.e. resilience, for avoiding breakage of the
signal layer 12 during flexing of the patch in use. The material thickness of the polymer/PET layer(s) may be matched to the properties of thesignal conducting layer 12 to prevent deformation of the tracks in a manner that is likely to lead to a break in thesignal layer 12. - Although not explicitly shown in the figures, a plurality of vias may be provided through one or more of the above described layers in order to allow signals to pass to/from either external surface of the patch. Thus electrical signals may pass from the electrodes to the
signal layer 12 and may pass form thesignal layer 12 to themodule unit 6 on the exterior of the patch substrate by way of a via formation passing through the intermediate layers. - The
substrate 100 comprises areference feature 17, for lining up with an umbilicus or other suitably recognisable feature of the subject. In this case, thereference feature 17 is defined by an aperture in theflexible substrate 100. In other embodiments thereference feature 17 may be a vertex, pointer or transparent region forming in theflexible substrate 100. Thereference feature 17 may be associated with an adjacent adhesive region, by which thereference feature 17 can be secured to the subject, for example adjacent to the umbilicus. - The structure lends itself to a straightforward method of application. For example, the
reference feature 17 may be secured at a reference point on the patient using the associated adhesive region. The electrodes 1-5 can subsequently be moved away from the abdomen to prepare the skin. For example each electrode 1-5 can then be placed in turn around the abdomen with, if necessary, suitable abrasive skin preparation. Once any skin preparation and the subsequent placement of an electrode 1-5 has been completed the impedance of the connection between the electrode 1-5 and the patient may be measured by an electronic readout device 200 (shown inFIG. 7 ). If the impedance is above a desired value, further preparation of the skin may be carried out to reduce the impedance to below the desired value. The desired value may, for example, be 5 kOhms. When the impedance is below the desired value, the skin region for the next electrode may be prepared by abrading the skin and the electrode subsequently applied electrode, and the impedance tested. This method may be repeated until all of the electrodes are successfully applied. - The electrodes 1-5 comprise a
first sensing electrode 1,second sensing electrode 2 andthird sensing electrode 3, adrive electrode 4 and acommon electrode 5. Each of the first, second andthird sensing electrodes reference feature 17 of the patch, in this embodiment equi-angularly spaced at about the same distance from thereference feature 17. Specifically, in the orientation shown inFIG. 1 , the first andthird sensing electrode second sense electrode 2 and thedrive electrode 4 are respectively above and below the reference feature. The length of thetracks 15 connecting each of the electrodes 1-4 to themodule 16 is thereby minimised, reducing any potential for noise (which may arise from electromagnetic interference, triboelectric effects etc). - In the embodiment the
circular regions third sensing electrode reference feature 17. Thecircular regions second sensing electrode 2 and driveelectrode 4 are arranged on a vertical line passing through the centre of thereference feature 17. - The circular region associated with the
common electrode 5 is arranged on the vertical line passing through thereference feature 17, below thedrive electrode 4. The drive electrode can be placed on any other part of the abdomen. - Each of the first and
third sensing electrodes common electrode 5 are attached to the region of thesubstrate 100 that carries thereference feature 17 by a respectiveflexible substructure flexible substructure 13 a-13 c is attached at a first end to a part of thesubstrate 100 that carries thereference feature 17, and at a second end to thecircular region electrodes other electrodes reference feature 17. In other embodiments a similar flexible substructure can be used to connectelectrodes substrate 100 that carries thereference feature 17. Such an arrangement may accommodate transverse (horizontal) stretching of the skin. - In this arrangement, the
flexible substructures first sensing electrode 1 and thereference feature 17 and the distance between thethird sensing electrode 3 and thereference feature 17. The ability of the substrate to accommodate adjustment of the positions of these electrodes makes the patch more comfortable, because the natural movement of the subject's skin (for instance as a result of breathing) can be accommodated by theflexible substructures electrodes - Each
flexible substructure 13 a-13 c in this embodiment comprises a serpentine arrangement, in which at least one folded elongate member is disposed substantially lateral with a direction of movement to be accommodated by the substructure. The stiffness of such a member is substantially proportional to the third power of its length, and the compliance of the substructures in each direction may readily be tailored by adjusting their length, or the number of folds in the serpentine substructure (each fold further increasing the compliance). Eachsubstructure 13 a-13 c carries the conductingtrack 15 of the electrode associated therewith. - The
flexible substructures reference feature 17, and having a single folded elongate member (having an outward leg and a return leg), that extends in a substantially vertical direction. Horizontal relative movement between the first andthird sensing electrode - The
substructure 13 c that connects thecommon electrode 5 to the part of the substrate carrying thereference feature 17 is different, and has two foldedelongate members 311, 32, each extending in a substantially horizontal direction. Thissubstructure 13 c is configured to accommodate a greater degree of relative movement than theother substructures -
FIG. 2 shows the shape of theoverlaminate layer 6 a, and substantially corresponds with the shape of thesubstrate 100, but with the circular regions 21-25 omitted. -
FIG. 3 shows a further patch according to an embodiment, comprising the sameflexible substrate 100 that is shown inFIG. 1 , with amechanical module unit 19 affixed to thesubstrate 100 adjacent to theelectrical module unit 16. Thepatch 150 is shown with a separateelectronic readout device 200 for detecting electrophysiological signals from the electrodes 1-5 of the patch. - The
electronic readout device 200 comprises areadout device housing 201 which is substantially cuboidal in shape, and which has anupper face 202 which is substantially square. Theupper face 202 is similar in extent to one of the circular regions 21-25 associated with each readout electrode. The thickness of thehousing 201, in a direction normal to theupper face 202, is less than half the edge length of theupper face 202, so that thereadout device 200 is compact and low profile. - The
mechanical module 19 comprises a cradle for receiving thereadout device housing 201 of thereadout device 200. Thehousing 201 is removably received and held within the cradle, which allows movement of thehousing 201 only in the direction of insertion/removal. The cradle comprises a stop, and thereadout device 200 is fully engaged with themechanical module unit 19 when thehousing 201 is in contact with the stop. Themechanical module 19 further comprises a latch or catch to retain thereadout device housing 201 in contact with the stop. In this embodiment the latch or catch comprises a magnetic catch. A permanent magnet is provided on either (or both) of themechanical module 19 andhousing 201, which attracts a corresponding magnet (or ferromagnetic element) on the other of themechanical module 19 orhousing 201. In alternative embodiments, a hook and loop arrangement (e.g. Velcro) may be used to secure thereadout device 200 to thepatch 150. - When the
readout device housing 201 is fully engaged with themechanical module 19, an electrical module 204 (shown inFIG. 5 ) of thereadout device 200 is in electrical engagement with theelectrical module 16 of thepatch 150. Theelectrical module 204 of thereadout device 200 may conveniently comprise a plurality of contacts mounted on resiliently deformable members (e.g. spring loaded contact pins). - The quality and reliability of the electrical contacts made to the module may be important when detecting electrophysiological signals (which are typically sub microvolt) and also for ensuring that stringent cleaning procedures associated with a hospital environment can be implemented on the
readout device 200. Planar connections on thereadout device 200 and resiliently biased connections on thepatch 150 may be used. This arrangement allows easy cleaning of thereadout device 200. Thepatch 150 may be disposed of after each use and hence not require cleaning, so the difficulty of cleaning the resiliently biased connections may not arise. Alternatively, eitherelectrical module 204, 16 (ofreadout device 200 or patch 150) may comprise resiliently biased contacts wherein each contact pin resides inside a tube with a secure seal between the tube and the contact pin. The pins and their respective tubes may be are separated from each other by a sufficient distance to enable them to be cleaned. In this way thereadout device 200 may be provided with resiliently biased contacts that may be readily cleaned. - In some situations it may be advantageous to seal the connected
electrical modules electrical module patch 150 or thereadout device 200. The seal element may compressed when thereadout device 200 is engaged with themechanical module 19. Themechanical module 19 may be configured to urge the seal element into sealing engagement with thepatch 150 and/or readout device 200 (for example by magnetic force). - A
security device 101 is provided on thepatch 150, for authenticating thepatch 150 to theelectrical readout device 200. In this embodiment thesecurity device 101 is provided in the cradle. When the respectiveelectrical modules patch 150 andreadout device 200 are engaged, thereadout device 200 checks the patch to determine whether it is authentic (i.e. checks Whether the patch is an unauthorised copy), The authentication is achieved by communication (e.g. electrical, optical, wireless) between asecurity device 203 of thereadout 200, and acorresponding security device 101 of the patch. Thesecurity devices - Each
electrical module patch 150. - The
readout device 200 is preferably configured to determine and output at least one of a: fetal heart rate, fetal ECG, maternal heart rate, maternal ECG, or uterine activity, Preferably the readout device is configured to output any two, three, four, or all five of the above. The readout device is preferably configured to transmit the output, so that it can be monitored. Preferably, thereadout device 200 comprises a wireless transmitter (e.g. according to the Bluetooth standard), operable to transmit the output of thereadout device 200. - In some embodiments, the
readout device 200 does not determine any of a fetal heart rate, fetal ECG, maternal heart rate, maternal ECU, or uterine activity, but instead transmits raw or partially processed voltage and/or current data from the electrodes, for processing by a further device into a suitable output (such as one, two, three, four or more of a fetal heart rate, fetal ECU, maternal heart rate, maternal ECG, or uterine activity). - Referring to
FIG. 7 , a block diagram of areadout device 200 according to an embodiment is shown. Thereadout device 200 comprises anelectrical module unit 204,analogue circuit 213, digital processor 2:12, wireless transmitter 2111,security device 203,battery 210 andinductive coil 214. - The
analogue circuit 213 comprises an analogue to digital converter, and receives the electrical signals from the electrodes, and outputs a digitised version thereof, for processing by the digital signal processor. In some embodiments theanalogue circuit 213 may comprise an amplifier and/or filter. - The
processor 212 receives a digitised signal from theanalogue circuit 213, and preferably processes it to determine an output, as described already. Theprocessor 212 subsequently outputs a signal to thewireless transmitter 211 for onward transmission, for example to a receiving anddisplay station 300 according to an embodiment of the invention. - In order to maximise the battery life of the removable electronic device it may be configured such that the power of the wireless transmitter is controlled based upon the signal strength index and/or hit error rate. This may greatly lengthen the monitoring period that can be carried under one single battery charge.
- In some embodiments, one or more component of the
device 200 may be combined, for example in a multi-chip module or system on chip. For example, theprocessor 212 may comprise any combination of theanalogue circuit 213, thesecurity device 203 and thewireless transmitter 211. - The electronic components of the
readout device 200 are powered by an electrical power source, which is a battery 2:10 in this embodiment. In other embodiments the electrical power source may comprise a capacitor. Theinductive coil 214 is operative to charge thebattery 210, optionally under the control of theprocessor 210. - The
readout device 200 may be configured to detect electrophysiological signals between a pair of sensing electrodes, rather than simply between a sensing electrode and the common electrode. For example, thereadout device 200 may be configured to detect electrophysiological signals betweensensing electrodes 1 and 3 (i.e. horizontally across the abdomen in use). This allows a further channel of UA and fetal ECG to be provided. The advantages for UA are that the separation is relatively fixed betweenelectrodes sensing electrodes 1 and 3) allows breech and transverse presentations to be more carefully monitored. In addition, by providing this channel a further Maternal ECG channel can be generated that can be used for mECG removal, further reducing confusion between the mECG and MEG. Such confusion is a common problem with Doppler ultrasound whereas with abdominal fECG the percentage confusion time is considerably reduced. The use of another mECG channel (for example, measured betweensensing electrodes 1 and 3) can further reduce this confusion by providing an improved template for accurate mECG removal. - The
readout device 200 may comprisesensors 215, which may comprise an inertial sensor such as accelerometer and/or gyroscope. Preferably, thesensors 215 comprise a one, two or three axis accelerometer, and/or a one, two or three axis gyroscope. Thesensors 215 may be MEMS (micro-electromechanical systems) devices. Thereadout device 200 may comprise an inertial measurement unit. The accelerometers and gyroscopes may be used to track the movement of thereadout device 200, thereby allowing both fetal ECG and electrohysterogram algorithms to differentiate between maternal/fetal movements and genuine contractions and fetal ECG signals. A gyroscope can provide useful additional rotational information that an accelerometer cannot provide, thereby allowing further separation of fetal movement from the acquired data. This fetal movement is a highly useful indicator that provides further fetal well-being indication. Additionally the use of the pair of devices allows separation of the maternal breathing signal which is a further indication of maternal health. - In
FIG. 4 , a signal receiving anddisplay station 300 is shown, comprising ascreen 302, and twodock areas 301. The receiving station is operable to receive and display output signals from thereadout device 200 on thescreen 302. Thedock areas 301 are arranged to receiving part of thehousing 201 of thereadout device 200, and are provided with a wireless charging device, that is operable to charge areadout device 200 placed in thedock area 301. The wireless charging device preferably operates by inducing a current in a conductor of thereadout device 200 using a coil. A number of alternative embodiments 200 a, 200 b, 200 c ofreadout devices 200 are shown in front of the receiving station, each having slightly different designs ofhousing 201. Thehousing 200 is preferably waterproof, and is preferably IP57 rated. - The receiving and
display station 300 can have two significant functions. The first is to display the full set of fetal and maternal parameters (i.e. ERR, MHR, UA, fetal movement etc) to the clinical care team or community midwife. A second significant function is that of an interface device that connects to existing installed CTG (cardiotocograph) machines. This latter function allows hospitals/health care units to efficiently use its existing resources without making equipment redundant whilst benefiting from the advantages of abdominal electrophysiological monitoring i.e. increased FHR accuracy; improved reliability of FHR/UA with BMI; maternal mobility; reduced FHR/MHR confusion etc. - At least two
readout devices 200 are preferably allotted for a single patient. When onereadout device 200 is connected to thepatch 150 it sends the patch unique ID to the receiving anddisplay station 300 so that thesecond readout device 200 can only be connected to thesame patch 150 when thereadout devices 200 are eventually swapped over. Readout devices may be swapped when the battery becomes discharged or when routine maintenance is required. The number ofreadout devices 200 associated with each patient, patch, or receiving anddisplay station 300 is not limited to two or three (as shown inFIG. 4 ) as labour or a maternal antenatal recording session can extend over a considerable time, for example from a few hours to several weeks. - The use of at least two
readout devices 200 allows a seamless swapping of thereadout devices 200. Thesubsequent readout device 200 may already have the appropriate patch ID loaded into its local memory so as to reduce set up time. - Referring to
FIG. 6 , anelectrode 400 is shown. Theelectrode 400 is for use as an electrode of a patch according to an embodiment of the invention, and comprises asubstrate 402, from which extend a plurality of electricallyconductive needles 401. The needles are formed from a bio-compatible material (such as doped silicon), and are configured to penetrate the stratum corneum to provide an electrical connection to the more conductive underlying layers, without penetrating far enough to stimulate nerves so as to cause pain. The needles therefore have a length of between 20 μm and 200 μm, preferably between 50 μm and 100 μm. The needles may be formed by reactive ion etching or wet etching of silicon, or may be formed by any other suitable process, from any other suitable material. Theelectrode 400 may be used as each electrode of a patch according to an invention. Apatch 150 that comprisessuch electrodes 400 may obviate the careful preparation of the skin that is usually necessary to achieve a low enough impedance contact to the subject, because the needles facilitate contact to be made through the stratum corneum. - Referring to
FIG. 8 , apatch 150 according to an embodiment of the invention is shown in use, applied to the abdomen of a pregnanthuman subject 500. The skin is preferably prepared to ensure a good contact is made between each electrode and the skin, and gel is preferably applied to electrically couple the electrodes to the skin. Thereference feature 17 of the patch is aligned with theumbilicus 501 of the subject 500, and thefirst sensing electrode 1 and driveelectrode 4 are arranged on the abdomen on the median plane of the subject. Thecommon electrode 5 is placed facing the symphis pubis, by extending theflexible substructure 13 c if necessary. Thepatch 150 is comfortable and low profile, and relative movement of the electrodes (e.g. as a result of breathing and locomotion) is accommodated. - The
readout device 200 is engaged with the module of thepatch 150, so that their respectiveelectrical modules patch 150, and provide any useful output, the patch is preferably first authenticated by the readout device, using therespective security devices - Once the
patch 150 is authenticated, thereadout device 200 amplifies and filters the electrophysiological signals detected by the sensing electrodes 1-3 to determine and output all of: a fetal ECG, a fetal heart rate, a maternal ECG, a maternal heart rate, and a uterine activity. More specifically, the voltage difference between the sensing electrodes and the common electrode is sensed and processed by the readout device to create an output signal from thereadout device 200. The common mode voltage of the three sense electrodes 1-3 is applied to the shield layers 9 a, 9 b of thepatch 150, to minimise leakage currents to the shield layers. The inverse of the common mode voltage is applied to thedrive electrode 4 to minimise common mode voltage noise. The term ‘common mode’ is used in the conventional sense of a signal that is shared by more than one conductor. - The integration of the
readout circuit 200 andpatch 150 allows the subject to move freely, without having to worry about leads, and minimising any deleterious cable noise that can arise due to triboelectric effects when leads are flexed. Furthermore, the short length of the connections to the readout circuit minimise the potential for other sources of noise. - The
readout device 200 preferably comprises a wireless transmitter (not shown), and is operable to wirelessly transmits the output, via the wireless transmitter, substantially in real time, to a monitoring station that is operable to display the output. Thereadout device 200 is compatible with a number of monitoring stations, but is preferably used with a receiving anddisplay station 300 according to an embodiment of the invention. - When the need for monitoring abdominal electrophysiological signals has passed, the
readout device 200 is removed from thepatch 150, and the patch can disposed of. Thereadout device 200 can be subsequently re-used with adifferent patch 150, preferably after thereadout device 200 is sterilised (e.g. by immersion in a sterilising fluid). Thepatch 150 may therefore be made relatively cheaply, and thereadout device 200 may include relatively sophisticated electronics without compromising the cost of using the system. When thereadout device 200 is not in use with apatch 150, it may preferably be placed on adocking area 301 of the receiving anddisplay station 300, so that it charges ready for another use. There may be two ormore readout devices 200 associated with eachmonitoring station 300, so that onereadout device 200 is always charging while the other is in use, thereby ensuring that a charged device is always ready for use. - It will be appreciated that the patch, readout, monitoring device and systems comprising combinations of these address a number of the problems with prior art devices.
- Although an embodiment of the patch has been described in which each flexible substructure comprises a serpentine flexure, any suitable arrangement may be used. For example, in some embodiments the flexible substructure may comprise a corrugated region of the substrate that can accommodate movement parallel to the plane of the substrate. Other compliant planar arrangements may also be used. For example, the electrode may be coupled to the remainder of the patch via a ring shaped element, wherein the ring has geometry selected (e.g. large diameter, narrow width) to accommodate movement in the plane of the substrate.
- In any examples of the invention, the patch may be provided with a backing material layer which is removable, e.g. by peeling, to expose the patch adhesive region(s) for attachment of the patch to the abdomen of a wearer. Separate or individual backing sheets may be applied to different electrodes/portions of the patch such that individual portions can be adhered and/or replaced as necessary.
- A number of other modifications and variations may be made, without departing from the scope of the invention, as defined by the appended claims.
Claims (23)
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AU2014335892B2 (en) | 2019-06-06 |
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