AND METHOD OF SMART POWER SUPPLY FOR GYNAECOLOGICAL TELEMETRY INSERT

The subject of the present invention is a gynaecological telemetry insert with a smart power supply and method of power supply for the gynaecological telemetry insert, that allow for reduction of the insert power demand and for charging the integrated battery, as well as determination of a reference potential and measurement of the surrounding tissues hydration level by means of integrated multimodal electrodes in a multi- mode access with time allocation, used in gynaecological telemetry.

There are known technical solutions for telemetry systems allowing for registration of biomedical data in the range necessary for the diagnostics of a menstrual cycle, for example EP2567680B1 or W02020013830A1 patent descriptions, where the at least one physical value is measured and the measurement result is transmitted in subsequent stages of the device operation to a device enabling analysis of the result and presentation to the user. There are also known from US10314540B2, US20170265789A1 and EP1487335B1 patent descriptions the solutions that play a supportive role in diagnostics of dysfunctions and conditions related to a female reproductive system. The aforementioned technical solutions rely on diverse mechanisms of biomedical data collection and acquisition. From simple temperature loggers, such as in the solution disclosed in EP2567680B1, up to complex biochemical sensors, such as for example US20170265789A1, or remotely controlled pelvic and perineum muscle structure stimulators, such as for example EP1487335B1.

They focus, however, on a basic functionality related to conditioning and acquisition of biomedical signals or generation of required stimulating signals and the power supply systems disclosed therein do not allow for multiple and long-term, that is going beyond a time span of several menstrual and ovulatory cycles, monitoring of the analysed data while ensuring unmanned measurement data transmission in real time, in the operational window of an insert covering a minimum of one menstrual and ovulatory cycle.

Thus, they do not allow to achieve the object of the invention which is to expand the functionality of gynaecological telemetry diagnostics with the possibility to monitor determined parameters in real time while ensuring the possibility for long-term observations, within periodically repeated operational intervals including a minimum of one menstrual and ovulatory cycle. Implementation of the disclosed solution will enable long-term monitoring of phenomena taking place in the insert surrounding while maintaining advantages of real time analysis. Thus, it will allow for immediate intervention in the case of patient life or health risk factors, for example in pharmacological and clinical treatment, ensuring the possibility to monitor and analyse subtle long-term trends and changes of the examined characteristics, such as for example intermediate monitoring of hormone balance or fertility period prediction.

FIELD OF THE INVENTION

A gynaecological telemetry insert with a smart power supply, reduced power consumption and set of multimodal electrodes, comprises a range of prior art subcomponents: battery power supply, temperature sensor, magnetic field sensor, biochemical sensor, hydration sensor, movement detector, communication transceiver, microcontroller, volatile memory and non-volatile memory. The insert comprises a power supply distribution block with integrated multimodal electrodes electrically connected by means of a controlled by a microcontroller analog demultiplexer of low ON impedance and a battery power supply set comprising a secondary cell. The battery power supply set is connected with a controlled ultra low power transistor switch operated by an active or passive magnetic field sensor via a time delay block. Whereas the magnetic field sensor interfaces with a miniature permanent magnet integrated in a protective and transport housing comprising an integrated charging control block compatible with an external power supply port and a contact resilient electrode set.

In the power supply distribution block, the ultra low power transistor switch is replaced by an in/out low power voltage regulator that enables stabilization and control of the power supply voltage of all the modules of the measurement unit.

In the power supply distribution block, the third output section of the analog demultiplexer is connected with a hydration sensor of the surrounding tissue. Whereas selection of the operational mode of the integrated multimodal electrodes is programme performed by the microcontroller via a MUX DRV port.

In the power supply distribution block, the second output section of the analog demultiplexer is connected with a biochemical sensor. Whereas selection of the operational mode of the integrated multimodal electrodes is programme performed by the microcontroller via the MUX DRV port.

A method of smart power supply for the gynaecological telemetry insert with reduced power consumption consisting in reduction of the device energy demand in selected and insignificant from the metrological point of view time intervals, consists in that on the basis of the data from the integrated magnetic field sensors and movement detector the automatic classification of activity levels of the gynaecological insert into active operational mode, reduced activity mode and deep sleep mode is performed, whereas activation of the deep sleep mode follows the placement of the gynaecological insert in the protective and transport housing, when the interaction of the permanent magnet magnetic field deactivates the integrated therewith magnetic field sensor, and then by means of the time delay block the transistor switch or in/out voltage regulator is deactivated thus disconnecting the power supply from all the blocks of the measurement unit.

Then, following removal of the gynaecological telemetry insert from the protective and transport housing the deep sleep mode is deactivated that triggers MS INT signal activation corresponding to the lack of magnetic field in the spatial range of the magnetic field sensor.

The signal at the MS INT port via the time delay block activates the transistor switch or in/out voltage regulator, thus turning on the power supply to all the blocks of the measurement unit. Upon registration of the signal at the MS INT port, the microcontroller performs measurement of all determined physical values by means of the sensors included in the measurement unit. In the following step, the gynaecological insert spatial movement analysis is made and in the case of movement detection the signal at a MD INT is activated and the microcontroller does incrementation of a programme movement counter, and then analyses whether the content of the movement counter exceeded a set value N and if exceeded then the value thereof is decremented, a programme idleness time indicator is zeroed out and the transceiver is activated in order to send out the registered measurement data. In the case of a small number of activations of the MD INT signal, that is when the movement counter does not exceed the set value N, the reduced operational mode is activated where the transceiver is temporarily deactivated and the data transfer in a full format is suspended until the number of activations increases above the set threshold N. In said mode the raw measurement data are archived locally in the internal volatile memory of the microcontroller. In the reduced operational mode the frequency and volume of the transferred data package are limited to reduce the power supply demand, whereas a level and range of the limitation is personalized in the pre-implementation configuration.

When entering the deep sleep mode the content of the internal volatile working memory of the microcontroller is transfered to the ultra low power non-volatile memory, whereas the memory content copying procedure is performed upon detection of signal deactivation at the MS INT port only when in the previous operational cycle the measurements were undertaken. The time delay block sets a minimum time Ta necessary to save collected data prior to hardware disconnection of the aquisition module power supply by the transistor switch or in/out low power voltage regulator.

The subject of the present invention is illustrated in the drawing where Fig. 1 shows the diagram presenting general operational rule for the disclosed telemetry diagnostics system, Fig. 2 diagram showing the defined activity levels of the gynaecological insert and possible paths of toggle between thereof, Fig. 3 shows the diagram of the disclosed power supply distribution and control block, Fig. 4a illustrates the structure and geometry of the disclosed integrated protective and transport housing module, and 4b the method of implementation of the intravaginal pessary with the gynaecological insert, Fig. 5. illustrates the control algorithm for the disclosed power reduction system.

The method according to the invention consists in that on the basis of the personalized configuration data provided by the telemetry system user of the structure as in Fig. 1, and the data from integrated magnetic field sensors 112 and a movement detector 113, classification and activation of the activity level of a gynaecological insert 109 are executed according to the diagram presented in Fig. 2. An active operational mode 200 where all the elements of the measurement unit are activated and the device performs full metrological and acquisition functionality, that is measurement of determined physical values with the defined frequency, analysis and processing of the collected data and in set time intervals full package transfer of the acquired results to a mobile reader 108, e.g. smart phone or calculation cloud 101. A reduced activity mode 202 where, depending on personalized configuration settings, frequency and range of registered parameters are reduced to the minimum necessary to detect and report an emergency, that is for example, detection of the pre-defined value of the selected diagnostic parameter, reaching certain physiological condition, exceedance of acceptable levels of the determined parameters or indication of critical failure of the measurement unit. Advantageously, the data transfer in said mode may solely and exclusively follow in the case when said emergencies have been identified. Furthermore, in said mode the size of the transferred package may be reduced to the data necessary for identification of the source of the reported emergency which efficiently reduces activity time of a short-range wireless transceiver 121, advantageously having impact on the insert power demand. It s also advantageous that the registered measurement data are neither transferred to the mobile reader 108 nor calculation cloud 101 but saved locally in a non-volatile ultra low power memory 119, for example produced in ReRAM technology (US20160111640A1, US8338814B2, etc.) or CBRAM (e.g. US10043972B2, US10181560B2, etc.). It enables further power consumption reduction and subsequent recovery thereof in service conditions or, depending on personalized settings, transfer at a later point in time. It is also an advantage that the device operation in said mode may be a priori imposed, at pre-implementation configuration (such a solution is applicable in the situations of, for example, long-term supervision of a gynaecological treatment), or triggered automatically in the situations of reduced activity of the person undergoing examination, e.g. when asleep.

A deep sleep mode 201, when none of the defined metrological tasks is being performed, allows for power supply disconnection from all the modules of a measurement unit 122. Due to that, the static consumption is advantageously reduced to a technological leakage of a power supply distribution block 117. In said mode, the device operates, for example, when stored.

Toggling between the modes of the active operational 200, deep sleep 201, and reduced operation 202 is performed under the algorithm presented in Fig. 5.

The disclosed technical solution consists in that a gynaecological insert 109 comprises integrated multimodal electrodes 300 connected with a hydration level measurement block 110 of surrounding tissues 600, a biochemical sensor 111 and with the power supply distribution block 117 by means of an analog demultiplexer 301 of low ON impedance. Whereas selection of the operational mode of the electrodes 300 is programme performed by a microcontroller 120 by means of a MUX DRV port 310, controlling the operation of the analog demultiplexer 301. Such connection provides for the possibility to charge a power supply cell 303 of the insert when the insert is placed in a protective and transport housing 401 and measurement of the hydration level and/or impedance of the surrounding tissues 600, as well as, when necessary, establishment of reference potential for the biochemical sensor 111 needs when the device operates in situ, whereas realization of said functionalities is possible by means of the same pair of the integrated multimodal electrodes. Whereas in order to do so, it is advantageous to use one pair of the integrated multimodal electrodes 300 as it minimizes the tissue area in contact with the electrode material and provides for lower technological and geometric complexity of the insert structure. The power supply distribution block, in addition to the aforementioned, comprises a battery power supply set 304 connected with a controlled low power transistor switch 305 controlled by the active or passive magnetic field sensor 112 by means of a time delay block 312. Whereas it is also possible to use alternatively/instead an in/out low power voltage regulator 314 which provides for, for example, the use of power supply cells of diverse electrochemical characteristics.

The magnetic field sensor 112 integrated in the power supply distribution block 117, interfaces with a miniature permanent magnet 406 integrated in the protective and transport housing 401 comprising an integrated charging control block 408 and external power supply port 410 (e.g. USB).

In the deep sleep mode 201, when the gyneacological insert 109 is located in the protective and transport housing 401 the interaction of the permanent magnet magnetic field 406 deactivates the magnetic field sensor 112 and then by means of the time delay block 312 deactivate the transistor switch 305 or the in/out low power voltage regulator 314, thus disconnecting the power supply from all the blocks of the measurement unit 122. Such a solution provides the advantageous reduction of static power consumption, for example when storing the device by the user or in a phase of factory warehousing of finished goods.

To use the time delay block 312 is necessary from the point of view of the system deactivation following the period of standard work when the current measurement results are included in a internal volatile working memory of a microcontroller 118. In order to prevent its loss, following the disconnection of the power supply from the measurement unit 122 when entering the deep sleep mode 201, it is required to transfer the content of said memory to the non-volatile ultra low power memory 119. The memory content copying procedure is performed upon detection of signal deactivation at a MS INT line 311 only when in the previous operation cycle the measurements were undertaken, which means the device was active and performing the diagnostic and measurement procedure provided for under the algorithm. In such a case, advantageously the time delay block provides a minimum time Ta 506 necessary to perform a collected data saving procedure 505 prior to hardware disconnection of the aquisition module power supply by the transistor switch 305 or in/out low power voltage regulator 314.

A hardware procedure 500 above provides reduction of static power consumption under warehousing, storage, or safekeeping conditions, when the device is placed in the protective and transport housing 401 that is outside the examination site. However, the procedure does not provide reduction of power consumption when the devices works in situ. For the reduction in this mode a power consumption dynamic reduction algorithm 501 is responsible that uses personalized configuration data of the user and the data from the integrated movement detector 113.

Upon receipt of information on activisation of a MS INT signal 503 corresponding to the lack of magnetic field in the spatial range of the magnetic field sensor 112, the time delay block 312 activates the transistor switch 305 or in/out voltage regulator 314, thus turning on the power supply of all the blocks of the measurement unit 122. In the following step, the microcontroller 120 performs measurement of all determined physical quantities by means of the sensors included in the measurement unit 122. The next stage involves analysis of absolute spatial movement of the gynaecological insert 109. In the case when movement is detected the microcontroller 120 does incrementation of a programme movement counter 515 and in the following step it examines if the value of the counter exceedes a set value N 516 (a parameter set by a user). If so, the content of a movement counter is decremented 517, a programme idleness time indicator 518 is zeroed out and the transceiver 121 is activated in order to send out the registered measurement data. It corresponds to the situation when the gynaecological insert 109 works in situ and the patient carries out daily routine activities that trigger a periodical activation of the signal at a MD_INT line 307.

In the case of a small number of activations of a MD INT 512, that is when the movement counter does not exceed the set value N 516, the reduced operation mode 202 is activated, the transceiver 121 is temporarily deactivated and the data transfer in a full format is suspended until the number of activations increases above the set threshold N, in this mode the raw measurement data are archived locally in the volatile internal memory of the microcontroller 118. Whereas in the case when there is no activation of the MD INT signal 512 during a period exceeding k minutes 513 (parameter set by the user), the movement counter is zeroed out 514 and in consequence the transceiver 121 is deactivated and the data transfer is stopped.

In the reduced operational mode 202 the frequency and volume of the transferred data package are limited to reduce the power supply demand, whereas the level and range of the limitation is personalized in the pre-implementation configuration of the device.

The subject of the present invention in the embodiment of a telemetry system is visually presented in Figs. 1- . The disclosed system comprises an intravaginal pessary 400 with a gynaecological insert 109 comprising: a microcontroller 120 comprising a volatile internal working memory 118, low power external non-volatile memory 119, power supply distribution block 117, semiconductor temperature sensor 114, integrated movement detector 113, magnetic field sensor 112, biochemical sensor 111, wireless short-range active transceiver 121 enabling measurement data transmission to a calculation cloud 101 by means of a communication gate 100 or alternatively to a mobile reader 108, for example a smart phone or multimodal integrated electrodes 300 connected with the power supply distribution block 117 by means of an analog demultiplexer 301 of low ON impedance. An integral component of the invention is also a protective and transport housing 401 with an integrated miniature permanent magnet 406, contact resilient electrode set 402 and charging control block 408 and external power supply port 410, which visual diagram is presented in Fig. 4.