Patent Application
20230270385
The present invention is directed at a method of manufacturing a flexible sensor belt suitable for being worn around an abdominal part of a human body, in particular a baby, the method comprising the steps of: casting, using a first mould part, a support layer using a flexible material; and applying the one or more electrodes onto the support layer, wherein the electrodes are made of an electrically conductive material. The invention further relates to a flexible belt manufactured in this manner, as well as a mould part and a casting arrangement including mould parts.
The present document is particularly concerned with the manufacturing of medical aids for the nursing and caring of premature babies, i.e. babies having had a preterm birth. Preterm babies, i.e. babies that were born after a pregnancy of less than 37 weeks, are typically cared for by neonatal intensive care units (NICU) in hospitals, in isolation in an incubator while their vital signs are continuously monitored. Conventionally, such vital signs are monitored using conventional means for providing an electrocardiogram (ECG), such as to monitor their cardiac signal.
An ECG is commonly provided using adhesive electrodes adhered to the baby's body. Such electrodes are adhered to various parts of the body to detect different electrical physiological signals. Adhering of these electrodes is desired to ensure sufficient contact between the electrode and the skin, and to prevent accidental moving of the electrodes from their desired location on the body.
Although this method allows the baby's vital signs to be monitored in a reliable manner continuously, there are a number of disadvantages associated therewith. A main disadvantage is that the adhering of electrodes to the skin of the premature baby itself is not desired because the skin of preterm babies is very sensible. The use of adhesive electrodes is for that reason unpleasant and even harmful. Removal of the electrodes hurts the baby, causing stress to both the baby and his or her parents. Such removal occasionally may even damage the skin, causing small wounds and increasing the risk of infection. Taking into account that typically the electrodes are to be replaced every few days (e.g. every five days), it may be understood that this disadvantage is not negligible—in particular for babies that are to be monitored over a period of multiple weeks.
Recently, a new alternative manner for monitoring vital signs of a baby has been introduced in the form of a belt that can be worn around an abdominal part of a baby's body without the use of adhesives. This alternative is easy to apply, more comfortable to the baby and not harmful to the skin, while enabling reliable detection of the baby's vital signs for medical purposes and continuous monitoring. The belt is made of a polypropylene textile with a second layer of viscose fibers in order to absorb sweat. Electronics, connecting the sensing electrodes, are printed on a stretchable polyester substrate which is heat-bonded onto the viscose fibers. Furthermore, in addition to the cardiac signal, the proposed belt also enables to monitor the respiratory signal by enabling to provide an electromyogram (EMG) using the electrodes described.
Although the belt provides a highly advantageous alternative to the conventional methods of monitoring the vital signs of preterm babies, a disadvantage of the above construction is that the use of these different materials and their integration into the final belt is cumbersome during manufacturing and expensive. Furthermore, the belt is worn on the baby and attracts dirt, and therefore must be exchanged frequently. Textiles in particular attract and retain dirt. As may be appreciated, the belt described above is preferably a disposable product, and in view of these disadvantages the construction may become too expensive in use.
It is an object of the present invention to provide a method of manufacturing a flexible sensor belt, which overcomes the abovementioned disadvantages and provides an effective and low-cost manner of producing the flexible sensor belt.
To this end, in accordance with a first aspect of the invention, method of manufacturing a flexible sensor belt suitable for being worn around an abdominal part of a human body, in particular a baby, the method comprising the steps of: applying, one or more electrodes in a mould; casting, using the mould, a belt containing the electrodes by injecting a flexible material, such as to immerse the electrodes in the belt, and such that a contact area of the electrodes protrudes from the belt; wherein the step of casting the belt comprises a step of retaining the one or more electrodes using one or more retaining elements.
The casting takes place under high pressure and because of the lack of adhering, this may cause any other parts to move or deform. By retaining the electrodes, movement or destructive deformation thereof—which may be detrimental to a successful manufacturing process—is prevented. Therefore, after curing of the flexible material this method yields a flexible sensor belt with integrated electrodes, which are immersed in the flexible material.
In some embodiments, the method comprising the steps of: providing a support layer made of the flexible material; applying, onto the support layer, the one or more electrodes; and casting, a complementary layer onto the support layer using the flexible material, such as to cover the one or more electrodes with the complementary layer formed on the support layer to thereby immerse the electrodes in the flexible material.
In accordance with a preferred embodiment, there is provided a method of manufacturing a flexible sensor belt suitable for being worn around an abdominal part of a human body, in particular a baby, the method comprising the steps of: casting, using a first mould part, a support layer using a flexible material, such that the support layer comprises one or more holes; applying, onto the support layer, one or more electrodes, such that the one or more electrodes protrude the one or more holes, and wherein the electrodes are made of an electrically conductive material; casting, using a second mould part complementary to the first mould part, a longitudinal belt section onto the support layer using the flexible material, such as to cover the one or more electrodes with the belt section formed on the support layer to thereby immerse the electrodes in the flexible material; wherein the step of casting the belt section comprises a step of retaining the one or more electrodes using one or more retaining elements.
The manufacturing method described above yields a flexible sensor belt with integrated electrodes, which are fully immersed in the flexible material and thereby sealed from the exterior of the belt. Preferably, the material that is used is a liquid silicone rubber. Although these materials do not easily adhere to parts made of a different material, such as the electrodes or potentially any parts, by using the method of the invention the various parts may be retained in place during casting. The casting takes place under high pressure, and because of the lack of adhering, this may cause any other parts to move or deform. By retaining the electrodes, movement or destructive deformation thereof—which may be detrimental to a successful manufacturing process—is prevented. Therefore, after curing of the flexible material this method yields a flexible sensor belt with integrated electrodes, which are immersed in the flexible material. It is not essential that the support layer is the layer that comprises holes for the electrodes. Alternatively, the first layer may be the complementary layer, i.e. the longitudinal belt section. The electrodes are then retained on the complementary layer and the a further layer is injected immersing the electrodes (except the contact areas). Furthermore, the retaining may optionally be obtained by designing the electrodes or an electronic circuit with anchoring points (e.g. holes) and/or by the use of bonding agents.
The flexible sensor belt so produced is thus easy to manufacture, using a minimum of materials, and yields a low cost product that is therefore very suitable for disposable use. Also, the further advantage of a single piece sensor belt with integrated electronics that are immersed in the flexible material, is that dirt does not penetrate the material and may easily be removed. Therefore, the belt does not need to be replaced as frequent as conventional versions thereof. The belt is therefore more easy to use and it's use is less labor intensive. Any parts that are immersed in this way in the flexible material, are effectively sealed from the exterior, which therefore are protected and do not pose a threat to the child wearing the belt.
The advantages of the invention are already to some extend achieved in those embodiments wherein only the electrodes are embedded in the belt (between the support layer and the longitudinal belt part) and wiring for connecting the electrodes to a sensor module or other processing device is provided on a back side of the belt. However, in preferred embodiments the method further comprises a step of setting of the flexible material of belt section after casting thereof, wherein during said setting the method comprises retracting of the one or more retaining elements. In accordance with these embodiment, retracting of the retaining elements enables the—still liquid—flexible material to flow and fill up the spaces left by the retaining elements. Except for the parts protruding the holes of the support layer, the electrodes are thereafter sealed from the exterior of the belt.
The wiring, if present on an exterior part of the belt, may be connected to the electrodes and extend out of the flexible material to the exterior of the belt. The electrical conductive paths to a processing device or sensor module may, in accordance with some of these embodiments of the flexible sensor belt, be provided by an electronic circuit embedded in the belt. In these cases, in the method of the invention, in accordance with some embodiments, the step of applying the one or more electrodes comprises applying a flexible electronic circuit such as to electrically connect the one or one or electrodes to the support layer. This may be achieved in various ways. In some embodiments, the electronic circuit is attached to the one or more electrodes after applying the electrodes onto the support layer. A conductive glue or silicone adhesive may be used to apply glue layer to adhere the electrodes to the electronic circuit, e.g. to prevent elevated temperatures required for soldering. The glue for example may be a cyanoacrylate or a two-part conductive epoxy, although the skilled person will recognize suitable alternatives for the glue. In some other embodiments, another way to apply the electronic circuit may be, to attach the electronic circuit to the one or more electrodes, and thereafter to apply the electronic circuit including the electrodes onto the support layer. In these embodiments, as an alternative to the application of glue (which also in these embodiments is a possible implementation), it is also possible to perform soldering in order to attach the electrodes to the circuit. As a further alternative embodiment, the electronic circuit and the one or more electrodes may be integrally formed, and the integrally formed circuit is applied to the support layer. This prevents the need for bonding by soldering or gluing, as the electrodes and the circuit form an integral part.
In some embodiments, the flexible electronic circuit comprises one or more conductive paths, the one or more conductive paths being shaped such as to form at least one of: a wavy path; a zigzag path; or a meandering path. In some of these embodiments, the method may comprise, during said casting of the belt section, a step of retaining the one or more conductive paths using one or more retaining elements. Here retaining elements are applied to retain the conductive paths in place, which may otherwise tend to bend, curl or displace during casting.
The present invention, in accordance with a second aspect thereof, provides a flexible sensor belt manufactured using a method according to the first aspect, wherein the sensor belt is suitable for being worn around an abdominal part of a human body, in particular a baby, the sensor belt comprising a support layer made of a flexible material including one or more holes, one or more electrodes made of a conductive material and protruding through the one or more holes such as to be in contact with a skin of the body in use, and a longitudinal belt section covering the one or more electrodes on the support layer, wherein the electrodes are immersed in the flexible material between the support layer and the longitudinal belt section. The flexible material preferably comprises a liquid silicone rubber, but may alternatively or additionally comprise at least one of: a thermoplastic elastomer, latex.
The present invention, in accordance with a third aspect thereof, provides a mould part for use as a second mould part complementary to a first mould part in a method according to the first aspect, the first and second mould parts being comprised by a casting assembly, wherein the mould part comprises a recess which in use cooperates with a complementary recess in the first mould part such as to form an internal space, wherein the internal space is suitably shaped to enable forming a longitudinal belt section by means of casting of a flexible material, such that the longitudinal belt section is thereby formed onto a support layer in the complementary recess of the first mould part for covering one or more electrodes on the support layer, wherein the mould part is configured for providing one or more retaining elements in the internal space such as to retain the one or more electrodes in place during casting of the flexible material, for covering the one or more electrodes with the belt section formed on the support layer to thereby immerse the electrodes in the flexible material.
In some embodiments, the mould part comprises one or more through holes or slots for receiving the one or more retaining elements therethrough such as to retain the one or more electrodes in place during casting of the flexible material. The benefits thereof are that the one or more retaining elements may be extended through the holes to retain the electrodes or the conductive path of a circuit, whereas during casting they may optionally be retracted via the holes. Also, retractable retaining elements may be mounted in the holes, from which they may be extended into the internal space. Hence, in some embodiments, the mould part itself comprises the one or more retaining elements, the one or more retaining elements extending in or are extendable into the internal space. In other embodiments, these may be external to the mould and extended therein via the holes.
In some embodiments, the mould part is configured for providing the one or more retaining elements in at least one of: one or more positions opposite an area or circumference of an area corresponding with a location of one or more holes in a support layer to be formed in the first mould part; or one or more positions corresponding with a location of a conductive path of an electronic circuit interconnecting the one or more electrodes. The abovementioned positions correspond with positions of the elements to be retained, such as the electrodes or the circuit paths. Of course, the retaining elements may additionally or alternatively be present in other parts of mould.
The invention, in accordance with a fourth aspect thereof, provides a casting assembly comprising a mould part in accordance with the third aspect for use as a second mould part in a method according to the first aspect of the invention. The casting assembly further includes a first mould part for use in said method, wherein the casting assembly further includes a third mould part for applying one or more electrodes to a support layer formed in the first mould part, and such that the electrodes protrude one or more holes in the support layer.
The invention will further be elucidated by description of some specific embodiments thereof, making reference to the attached drawings. The detailed description provides examples of possible implementations of the invention, but is not to be regarded as describing the only embodiments falling under the scope. The scope of the invention is defined in the claims, and the description is to be regarded as illustrative without being restrictive on the invention. In the drawings:
The belt 3 comprises a plurality of electrodes 8 that make contact with the skin of the baby 2. The electrodes 8 receive electric physiological signals from the body 2 of the baby, in particular from the muscles from which the respiratory signal may be obtained, and from the heart of the baby 2. The belt 3 is connected to a sensor unit 4 which receives the electric physiological signals from the electrodes 8, and amplifies these using amplifier circuitry 29. The sensor unit 4, from the signals received from the electrodes 8, generates a sensor signal. The sensor signal is transmitted to a receiver unit 5, which processes the signal, and provided to a monitor unit 6 for presentation on a display 20.
The sensor signals from the sensor unit 4 will be transmitted wirelessly, via wireless signal 31, to the receiver unit 5. To this end, the sensor unit 4 comprises a data communication unit 30. Similarly, the receiver unit 5 likewise comprises a data communication unit 26. For example, the communication units 30 and 26, may be configured for enabling data communication via Bluetooth low energy. however, alternative data communication protocols may likewise be applied by the units 26 and 30. The receiver unit 5 further comprises a processor 25 that is configured for processing the sensor signals and provide vital signs signals to the monitor 6. The processor may apply certain algorithms that are stored in a memory of the receiver module 5 to perform this task.
The receiver unit 5 is connected to that monitor 6 using a third connector 17 which is received in a cradle or fourth connector 18 in the monitor unit 6. As mentioned herein before, Dependent on the embodiment, the receiver unit 5 may be connected in a different way to the monitor 6. For example, the receiver unit 5 may have a wired connection and a plug that connects to a socket in the monitor 6. The receiver unit 5 may alternatively apply wireless communication to the monitor 6 in yet a different embodiment, without departing from the present invention. Also, in a preferred embodiment, receiver unit 5 may be integrated into the monitor 6 via the cradle 18.
The monitor 6 comprises a display 20 in which the vital sign signals our present it two, for example, the medical staff. For example, the monitor unit 6 may present a heart rate signal 20 and a respiratory signal 21.
The connection between the belt 3 and the sensor unit 4 is provided via a connector assembly 11. The connector assembly 11 consists of eight first connector 12 and a second connector 13 that are complementary to each other, in the sense that they are cooperatively shaped to enable a tight mechanical and electrical connection. The electric physiological signals from the electrodes 8 are provided to the first connector 12 via a conductive path 10. The conductive path 10 is provided by an electric circuit 40 (not shown) That is sufficiently flexible for the flexible belt 3.
Furthermore a close-up of an electrode 8 and the circuitry around the electrode 8 is illustrated in
Another way to apply the electronic circuit 40 to the electrodes 8, in accordance with some other embodiments, may be, to attach the electronic circuit 40 to the one or more electrodes 8, and thereafter to apply the electronic circuit 40 including the electrodes 8 onto the upper layer of the belt 3. In these embodiments, as an alternative to the application of glue, it may also be possible to perform soldering. Furthermore, in yet an alternative embodiment, the electronic circuit 40 and the electrodes 8 may be integrally formed as one element. The integrally formed circuit 40 with electrodes 8 and conductive paths 10 may then be applied to the upper layer of the belt 3 at once.
Furthermore, during casting of the longitudinal belt section 47 onto the support layer 46, the electrodes 8 and optionally, but preferably, the meandering conductive paths 10, are held in place by retaining elements. The flexible material will, during moulding, be injected into the second mould part 72 under high pressure. Without maintaining the electrodes and the conductive paths 10 in place, they may be displaced or deformed during the moulding. The manufacturing process will be described further down below.
As can be seen in
A further synergy is obtained by enabling the receiver unit 5 to be connected directly to the belt 3. To this end, as illustrated in
The receiver unit 5 may be connected to the monitor 6 using an adapter or cradle 18. The cradle 18 may be mounted to a monitor unit 6 that is dedicated for use with the receiver unit 5, and allows to mount the cradle 18. The cradle 18 is fixed to the monitor by mounting screws 60, and a data exchange port 61 enables connection to a corresponding port on the receiver unit 5. The cradle 18 is designed to receive the backside 17 of the receiver unit 5, forming a third connector 17 and a fourth connector 18. Instead of the cradle 18 applied in this embodiment, it is of course also possible to use smaller connectors or a simple plug and socket type connection to exchange data signals, such as the vital sign signals.
By enabling the receiver unit 5 to be connected to the belt 3 via the first connector 12, it becomes possible to store the identification key date in a secure manner into the memory chip 42 of the belt 3. This can be used in various ways to increase the safety of use of the disposable belts 3 using a pairing method in order to associate the respective belt 3 with the receiver module. For example, the identification key data can be obtained by the sensor unit 4 in order to enable secure data communication between the communications units 30 and 26 of the sensor unit 4 and the receiver unit 5 respectively. Hereto, the unique identification key can be used to encrypt or encode the data, or to signal to the receiver unit 5 that the sensor signal that is wirelessly transmitted is indeed coming from the correct sensor unit 4. Furthermore, the presence of identification key data 115 (see
Next, a sensor unit 4—which may be any arbitrary sensor unit—will be connected to the belt 3 in step 120, and in step 122 the identification key data 115 will be retrieved by the sensor unit 4 from the memory 42 in the belt 3. The belt 3 and the connected sensor unit 4 are now operational to obtain the electric physiological signals from the electrodes 8 and provide a sensor signal wirelessly to the receiver unit 5, where it is processed by the processor 25 and presented via the monitor 6. After a while, when the battery 52 of the sensor unit 4 becomes drained, the sensor unit 4 is disconnected in step 124 and connected to one of the ports 63 of the receiver unit 5 for charging. Directly upon disconnecting in step 124, a new sensor unit 4 will be connected in step 126 and in step 128 the identification key data 115 will be retrieved by the sensor unit 4 from the memory 42 in the belt 3. Again, when the battery 52 of this second sensor unit 4 becomes drained, the sensor unit 4 is disconnected in step 130 and connected to one of the ports 63 of the receiver unit 5 for charging. A further sensor unit may then be connected (e.g. the first sensor unit which has been charged in the meantime) and so on. In
A monitor unit 6 that may be used in a system 1 in accordance with an embodiment, is illustrated in
Various Implementations of the System
Below, some variants and suggestions are described relating to the system described above. The system has been designed to provide a flexible solution that is sufficiently robust and can be easily and securely applied in a hospital where multiple babies may have to be monitored continuously over a longer period of time.
To this end, there is provided a system for monitoring one or more vital signs of a human body, in particular a baby, the system including a wearable device comprising a carrier suitable for being worn around an abdominal part of the body, and an electrode arrangement comprising a plurality of conductive electrodes, wherein the electrodes are arranged on the carrier such as to be brought in contact with a skin of the body in use, and wherein the electrodes are arranged for receiving electric physiological signals from the body for enabling said monitoring of the one or more vital signs, wherein the system further includes a sensor unit configured for receiving the electric physiological signals from the electrodes and for providing a sensor signal based on the received electric physiological signals; wherein system comprises a connector assembly comprising a first connector and a second connector, the first and the second connector being complementary such as to enable establishing a connection between the first and the second connector, wherein first connector is comprised by the wearable device, and wherein the wearable device comprises one or more conductive paths between the electrode arrangement and the first connector for electrically connecting the electrode arrangement with the connector; and wherein the second connector is comprised by the sensor unit for enabling to establish a detachable connection between the sensor unit and the wearable device for receiving the electric physiological signals.
The system of the present invention applies a connector assembly to enable disconnecting the sensor unit from the wearable device. As a result, the wearable device can be easily replaced without having to replace the sensor unit. Furthermore, the sensor unit can be easily disconnected in order to perform charging or maintenance, independent from the replacement period of the disposable wearable device. For example, suppose the wearable device needs to be replaced once every three days, and the sensor unit needs to be charged once every two days, the charging can be performed without having to replace the disposable wearable device, and the disposable wearable device can be replaced without having to exchange the sensor unit at half charge. Periodic replacement of the disposable wearable device is needed to prevent buildup of filth and pathogens on the wearable device worn by the baby. The possibility to exchange the wearable device and sensor units each within their own maintenance cycle, provides a flexible and low-cost solution that allows to provide a disposable wearable device in combination with good quality or even the high end sensor units. A disposable belt or wearable device can thus be achieved without trade-off with respect to the use of good quality electronic components and functionality implemented therein.
In accordance with some embodiments, the system further comprises a receiver unit configured for receiving the sensor signal from the sensor unit, the receiver unit being configured for providing a vital signs signal to a monitor for presentation of the vital signs signal on a display. The use of a separate receiver unit provides additional flexibility to the system of the invention in order to enable the use thereof with any arbitrary type of monitoring equipment. The receiver unit may be a separate unit, or may have been integrated in a monitoring unit. Furthermore, as a separate unit, communication between the receiver unit and the monitor may be by means of a wireline signal or a wireless signal without departing from the claimed invention. The used of a wireline signal, via a cable or a connector to the monitor, has the benefit of being more secure in terms of data protection and more reliable because the risk of picking up a different signal accidentally is prevented. The benefits of a wireless signal is provided by the absence of a cable and the increased range at which a receiver unit may be remote from the monitor. However, these latter benefits of the wireless signal may be diminished if other components of the system will be enabled to communicate wirelessly, as in the embodiments below.
In some embodiments, the sensor unit is configured for establishing a wireless connection with the receiver unit for providing the sensor signal to the receiver unit as a wireless signal. The application of a wireless signal between the sensor unit and the receiver unit is beneficial over the application of a wireless signal between the receiver unit and the monitor. In order to enable the wearable device to be as low cost as possible, the electronics are preferably implemented on the sensor unit rather than the carrier or any other part of the wearable device. Preferably, the carrier comprises the electrodes and the conductive paths to the first connector. In a preferred embodiment, the sensor unit is therefore connected to the wearable device via the connector and therefore resides close to the baby. Therefore, there are benefits in wirelessly communicating the sensor signal to the receiver unit, enabling the sensor unit to be remote from that receiver unit which resides at the monitor.
In some embodiments, the sensor unit is configured for providing the wireless signal including an identification key data for enabling identification of the sensor unit providing the sensor signal after receipt thereof by the receiver unit. The application of identification key data in order to uniquely identify the sensor signal after received thereof, provides the advantage of enabling secure communication with the receiver unit. Furthermore, once the receiver unit and monitor our parents with the sensor unit, do use of the identification key data in the center signal prevents the inadvertent mixing up of sensor signals from different sensor units connected to different wearable devices.
In some embodiments, the receiver unit comprises a processor for processing the sensor signal such as to provide the vital signs signal based on the received sensor signal. The processor may be applied for adding additional intelligence to the receiver unit. For example, the receiver unit may comprise the algorithms for analyzing the sensor signals and providing the vital sign signals to the monitor. Furthermore, in accordance with just a further embodiment, the processor is configured for establishing the identification key data based on a unique identification key, and wherein the receiver unit is configured for providing the identification key data to the sensor unit prior to receiving the wireless signal. In these embodiment, the processor of the receiver unit is able to generate a unique identification key that can be used for establishing the identification key data to be provided to the center unit, for example. Communication to the sensor unit may take place in various different ways, however in some embodiments a pairing method is applied in order to associate the receiver unit with the sensor unit.
In certain embodiments, in addition to the sensor unit, the receiver unit comprises a further second connector complementary to the first connector for enabling to establish a detachable connection between the receiver unit and the wearable device. In these embodiments, the receiver unit can be connected to the wearable device via the same first connector of the wearable device. This enables direct communication between the receiver unit and the wearable device, such as for example in order to perform in initialization or pairing method.
In some embodiments, the receiver unit is configured for communicating the identification data to the wearable device during a pairing method via a wireline connection through the first and further second connector, and wherein the wearable device is configured for storing the identification key data in a memory comprised by the wearable device. For example, if in these embodiments that receiver unit is connected to the wearable device via the connector assembly, the identification key data can be stored in the memory of the wearable device. Thereafter, the receiver unit may be disconnected from the wearable device, and the sensor unit may be connected to the wearable device for the connector assembly. The sensor unit may then obtain the identification key data directly from the memory on the wearable device. This provides a secure way of exchanging the identification key data between the receiver unit and the sensor unit.
In further embodiments, the sensor unit is configured for receiving the identification key data through the connector assembly via an established connection between the sensor unit and the wearable device, for using the received identification key data with the wireless signal. These embodiments have been briefly discussed above, and enable the sensor unit to obtain the identification key data from the memory of the wearable device.
In some embodiment, the receiver unit is an integral part of the monitor. For example, the receiver unit may be integrated on chip on a controller of the monitor, or may be an implemented module or unit within the housing of the monitor. In other embodiments, the receiver unit may comprise a third connector, the third connector being configured for cooperating with a fourth connector comprised by the monitor to establish an electrical connection between the receiver unit and the monitor. In these embodiments, the connector may be a standard type connector for data communication with a peripheral device, already present on most monitors. However, the monitor may also include a dedicated connector for connecting a receiver unit of the system, the latter allowing the supplier of the system to selectively implement compatibility on certain types of monitors that fulfill specific technical requirements required for monitoring pre-term babies. Yet, in other embodiments, the receiver unit is configured for establishing a further wireless connection with the monitor for providing the vital signs signal via a further wireless signal. This may be beneficial in some implementations, for example where power supply to the sensor unit may be implemented passively (e.g. passive RFID or remote charging by electromagnetic waves) and the receiver unit is typically located close to the sensor unit to provide the charging functionality. The above embodiments have already been briefly touched upon above, and enable the receiver unit to be part of the monitor, or to be separate therefrom, and perform communication with the monitor in different ways.
In some embodiments, the sensor unit is configured for performing wireless data communication via at least one of: Bluetooth, such as Bluetooth low energy; Radio Frequency Identification; Zigbee; or Wi-fl. The skilled person may appreciate that the above wireless communication protocols are not the only protocols that may be implemented by the sensor unit and receiver unit to exchange sensor signals and/or data. however these data protocols maybe applied indoor and over short distances, and some of them such as Bluetooth low energy or RFID, maybe performs in low energy instruments such as some embodiments of the system of the present invention.
In some embodiments, the receiver unit, for cooperating with the second connector of the sensor unit, further comprises at least one of: one or more fifth connectors, or one or more first connectors. This allows the receiver unit to be connected to the sensor units directly, or to a further peripheral device. In particular, in some embodiments, the sensor unit comprises a battery, and wherein the at least one of the one or more fifth connectors or the one or more first connectors comprised by the receiver unit are configured for powering the battery of the sensor unit. With use of the one or more fifth connectors or the one or more the first connectors as described above, the sensor units can easily be charged via the receiver unit. For example the sensor units can be connected to the first or fifth connectors of the receiver units, which may comprise a power supply line in order to charge the battery of the sensor units. Multiple of these connectors may be present on the receiver unit.
In accordance with a second aspect of the invention, there is provided a wearable device for use in a system according to the first aspect, wherein the wearable device comprises a carrier suitable for being worn around an abdominal part of the body, and an electrode arrangement comprising a plurality of conductive electrodes, wherein the electrodes are arranged on the carrier such as to be brought in contact with a skin of the body in use, and wherein the electrodes are arranged for receiving electric physiological signals from the body for enabling said monitoring of the one or more vital signs; wherein the wearable device further comprises a first connector, the first connector being configured for cooperating with a second connector or a further second connector for forming a connector assembly for establishing a detachable connection through which electrical signals can be exchanged between the wearable device and a further unit; and wherein the wearable device comprises one or more conductive paths between the electrode arrangement and the first connector for bearing the electric physiological signals.
Yet in accordance with a second aspect of the invention, there is provided a sensor unit for use in a system according to the first aspect, or configured for cooperating with a wearable device according to the second aspect, the sensor unit being configured for receiving electric physiological signals from one or more electrodes of the wearable device, and for providing a sensor signal based on the received electric physiological signals; wherein the sensor unit further comprises a second connector being complementary to a first connector of the wearable device such as to cooperate therewith for forming a connector assembly, for enabling to establish a detachable connection between the sensor unit and the wearable device for receiving the electric physiological signals.
In some embodiments, as explained above, the sensor unit may be configured for establishing a wireless connection with a receiver unit for providing the sensor signal to the receiver unit as a wireless signal. Furthermore, in some embodiments, the sensor unit is configured for obtaining identification key data stored in a memory of the wearable device, and for providing the wireless signal including the identification key data, for enabling identification of the sensor unit after receipt of the sensor signal by a receiver unit.
Yet in accordance with a fourth aspect of the invention, there is provided a receiver unit for use in a system according to the first aspect, or configured for cooperating with a wearable device according to the second aspect, or configured for cooperating with a sensor unit according to the third aspect, wherein the receiver unit comprises a communication unit for receiving the sensor signal from the sensor unit, the receiver unit being configured for providing a vital signs signal to a monitor for presentation of the vital signs signal on a display. The receiver unit, in some embodiments, comprises a processor, wherein the processor is configured for establishing identification key data based on a unique identification key, and wherein the receiver unit is configured for providing the identification key data to the sensor unit prior to receiving a wireless signal from the sensor unit. Furthermore, the receiver unit may in some embodiments comprise a second connector complementary to a first connector comprised by the wearable unit, the first and the second connecter together forming a connector assembly, for enabling to establish a detachable connection between the receiver unit and the wearable device; wherein the receiver unit is configured for communicating the identification data to the wearable device during a pairing method via a wireline connection through the connector assembly, and wherein the wearable device is configured for storing the identification key data in a memory comprised by the wearable device.
Yet in accordance with a fifth aspect of the invention, there is provided a method of pairing a sensor unit and a receiver unit in a system according to the first aspect, wherein the receiver unit comprises a processor, wherein the processor is configured for establishing identification key data based on a unique identification key, and wherein the sensor unit is configured for establishing a wireless connection with the receiver unit for providing the sensor signal to the receiver unit as a wireless signal, and wherein the sensor unit is configured for providing the wireless signal including an identification key data, the method comprising: transmitting, via a wireline connection between the receiver unit and a wearable device, the identification key data to the wearable device and storing the identification key data in a memory of the wearable device; disconnecting the receiver unit from the wearable device; establishing a wireline connection between a sensor unit and the wearable device; and obtaining, by the sensor unit, the identification key data from the memory. An advantage of the method in accordance with this fifth aspect of the invention, is that by connecting the receiver unit to the wearable device, a secure wireline connection is obtained that enables to securely transmit the identification key data to the disposable wearable device. Once stored therein in a memory of the wearable, any sensor unit can be connected to the wearable device in order to obtain the identification key data from the memory and start transmitting securely to the paired receiver unit. Multiple sensor units may thus be used in order to charge one or more sensor units, while using another one with the wearable device.
The present invention has been described in terms of some specific embodiments thereof. It will be appreciated that the embodiments shown in the drawings and described herein are intended for illustrated purposes only and are not by any manner or means intended to be restrictive on the invention. It is believed that the operation and construction of the present invention will be apparent from the foregoing description and drawings appended thereto. It will be clear to the skilled person that the invention is not limited to any embodiment herein described and that modifications are possible which should be considered within the scope of the appended claims. Also kinematic inversions are considered inherently disclosed and to be within the scope of the invention. Moreover, any of the components and elements of the various embodiments disclosed may be combined or may be incorporated in other embodiments where considered necessary, desired or preferred, without departing from the scope of the invention as defined in the claims.
In the claims, any reference signs shall not be construed as limiting the claim. The term ‘comprising’ and ‘including’ when used in this description or the appended claims should not be construed in an exclusive or exhaustive sense but rather in an inclusive sense. Thus the expression ‘comprising’ as used herein does not exclude the presence of other elements or steps in addition to those listed in any claim. Furthermore, the words ‘a’ and ‘an’ shall not be construed as limited to ‘only one’, but instead are used to mean ‘at least one’, and do not exclude a plurality. Features that are not specifically or explicitly described or claimed may be additionally included in the structure of the invention within its scope. Expressions such as: “means for . . . ” should be read as: “component configured for . . . ” or “member constructed to . . . ” and should be construed to include equivalents for the structures disclosed. The use of expressions like: “critical”, “preferred”, “especially preferred” etc. is not intended to limit the invention. Additions, deletions, and modifications within the purview of the skilled person may generally be made without departing from the spirit and scope of the invention, as is determined by the claims. The invention may be practiced otherwise then as specifically described herein, and is only limited by the appended claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2026206 | Aug 2020 | NL | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/NL2021/050488 | 8/3/2021 | WO |
