Vital sign monitor and vital sign detection system

Abstract

This application relates to a vital signs monitor and a vital signs detection system. The vital signs monitor includes: an implantable component configured to be implanted into the subcutaneous region of a human body; the implantable component includes: a circuit board on which a blood glucose sensor is disposed; the blood glucose sensor includes at least one first light-emitting element, a photosensitive element, and at least one first light-receiving element, wherein the first light-emitting element is used to emit a light signal of a first wavelength; the photosensitive element is used to contact glucose molecules in human tissue fluid and form a fluorescent group, the fluorescent group being used to receive the light signal of the first wavelength and excite a light signal of a second wavelength, the first wavelength being different from the second wavelength; the first light-receiving element is used to receive the light signal of the second wavelength, the second wavelength being used to determine the blood glucose information of the human body. The above-mentioned vital signs monitor enables long-term and accurate monitoring of vital signs information such as blood glucose.

Description

Technical Field

[0001] This application relates to the field of vital sign monitoring, and more particularly to a vital sign monitoring instrument and a vital sign detection system. Background Technology

[0002] With changes in people's lifestyles and habits, the incidence of diabetes in my country has remained high in recent years. As a global chronic disease, diabetes brings severe physical and mental suffering and economic burden to many patients and their families. Currently, there is no medical means to completely cure diabetes; the disease can only be controlled by regulating blood glucose levels. Therefore, blood glucose monitoring is the prerequisite and foundation for the diagnosis and treatment of diabetes. Summary of the Invention

[0003] This application provides a vital signs monitor and a vital signs detection system that can achieve long-term and accurate blood glucose monitoring.

[0004] Specifically, this application is implemented through the following technical solution:

[0005] A first aspect of this application provides a vital signs monitoring device, comprising:

[0006] Implantable components are configured to be implanted into the subcutaneous region of the human body.

[0007] The implantable device includes: a circuit board, on which a blood glucose sensor is disposed, the blood glucose sensor including at least one first light-emitting element, a photosensitive element, and at least one first light-receiving element, wherein...

[0008] The first light-emitting element is used to emit a light signal of a first wavelength;

[0009] The photosensitive element is used to contact glucose molecules in human tissue fluid and form a fluorescent group. The fluorescent group is used to receive the light signal of the first wavelength and excite the light signal of the second wavelength. The first wavelength is different from the second wavelength.

[0010] The first light receiver is used to receive the light signal of the second wavelength, and the light signal of the second wavelength is used to determine the blood glucose information of the human body.

[0011] In some embodiments, the photosensitive element is located between the first light-emitting element and the first light-receiving element, and the photosensitive element is also used to block the light signal of the first wavelength emitted by the first light-emitting element from directly reaching the first light-receiving element.

[0012] In some embodiments, the implantable member includes an elongated portion, at least a portion of which is configured to be implantable into a subcutaneous region of the human body, wherein the first light-emitting element, the photosensitive element, and the first light-receiving element are arranged sequentially along the length extension direction of the elongated portion.

[0013] In some embodiments, the implantable component further includes a light-transmitting layer for converging light signals, the light-transmitting layer being coated on the surface of the first light-emitting component and / or the first light-receiving component.

[0014] In some embodiments, the first light-emitting element is used to emit a light signal of the first wavelength through a side surface facing the photosensitive element.

[0015] In some embodiments, the implantable device further includes a pulse wave sensor disposed on the circuit board, the pulse wave sensor being used to detect pulse wave signals of the human body, the pulse wave signals being used to determine pulse information of the human body.

[0016] In some embodiments, the pulse wave sensor includes at least one second light-emitting element and at least one second light-receiving element, the second light-emitting element being used to emit a light signal of a third wavelength, and the second light-receiving element being used to receive the light signal of the third wavelength incident on and returned to the human body, wherein the at least one first light-receiving element shares at least a portion of the at least one second light-receiving element.

[0017] In some embodiments, the pulse wave sensor and the blood glucose sensor are respectively disposed on opposite surfaces of the circuit board.

[0018] In some embodiments, the system further includes: an analog front-end module electrically connected to the blood glucose sensor, used to perform analog-to-digital conversion processing on the signal output by the blood glucose sensor in a first instant to obtain a first digital signal, the first digital signal being used to determine the blood glucose information.

[0019] In some embodiments, the analog front-end module is also electrically connected to the output of the pulse wave sensor to perform analog-to-digital conversion on the signal output by the pulse wave sensor at a second time different from the first time to obtain a second digital signal, which is used to determine the pulse wave information.

[0020] In some embodiments, the pulse sensor further includes a temperature sensor for monitoring the temperature of a human body, wherein at least one parameter of the pulse sensor depends on the temperature monitored by the temperature sensor.

[0021] In some embodiments, it also includes:

[0022] The processor is used to process the digital signal obtained from the analog front-end module to obtain the blood glucose information and / or pulse wave information; or

[0023] A communication module is used to transmit the digital signal obtained by the analog-to-digital front-end module to an external device via a wireless connection, so that the external device can use the digital signal to obtain the blood glucose information and / or pulse wave information.

[0024] In some embodiments, it also includes:

[0025] A retainer, which is connected to the implantable member, is used to contact and hold the implantable member on the surface of human skin when the implantable member is implanted into a subcutaneous region of the human body.

[0026] A second aspect of this application provides a vital signs monitoring device, comprising:

[0027] An implantable device, which can be implanted into the subcutaneous region of the human body, includes: a circuit board, wherein the circuit board is provided with a blood glucose sensor for detecting blood glucose information and a pulse wave sensor for detecting pulse wave information of the human body, wherein...

[0028] The blood glucose sensor and the pulse wave sensor are disposed on opposite surfaces of the circuit board, or

[0029] The blood glucose sensor and the pulse wave sensor are disposed on the same surface of the circuit board, and the blood glucose sensor and the pulse wave sensor share at least a portion of the optical components.

[0030] In some embodiments, the blood glucose sensor includes at least one first light-emitting element, a photosensitive element, and at least one first light-receiving element, wherein the first light-emitting element is used to emit a light signal of a first wavelength, the photosensitive element is used to contact glucose molecules in human tissue fluid and form a fluorescent group, the fluorescent group is used to receive the light signal of the first wavelength and excite a light signal of a second wavelength, the first wavelength being different from the second wavelength, and the first light-receiving element is used to receive the light signal of the second wavelength.

[0031] A third aspect of this application provides a vital signs monitor, including an analog front-end module, a blood glucose sensor, and a pulse wave sensor.

[0032] The input terminal of the analog front-end module is connected to the output terminals of the blood glucose sensor and the pulse wave sensor respectively. The analog front-end module is used to receive the output signal of the blood glucose sensor at the first time and process the output signal of the blood glucose sensor to obtain a first digital signal. The first digital signal is used to determine the blood glucose information of the human body.

[0033] The analog front-end module is also used to receive the output signal of the pulse wave sensor at a second time, and process the output signal of the pulse wave sensor to obtain a second digital signal, which is used to determine the pulse information of the human body.

[0034] In some embodiments, it also includes:

[0035] The blood glucose sensor and the pulse sensor are mounted on the same circuit board.

[0036] In some embodiments, the device further includes: a temperature sensor, the output of which is connected to the input of the analog front-end module, the temperature sensor being used to detect the temperature of a human body, and the human body temperature detected by the temperature sensor being used for at least one of measuring the blood glucose information and pulse information of the human body.

[0037] In some embodiments, the blood glucose sensor includes an oxidase layer and an electrode layer, and the human body temperature detected by the temperature sensor is used to determine the activity parameter of the oxidase layer, the activity parameter being used to determine the blood glucose information of the human body; or

[0038] The human body temperature detected by the temperature sensor is used to determine the signal transmission parameters of the pulse wave sensor.

[0039] A fourth aspect of this application provides a vital signs monitoring system, including an auxiliary implantation device and a vital signs monitor according to any one of the above claims, wherein the auxiliary implantation device is detachably connected to the vital signs monitor, and the auxiliary implantation device is used to implant an implantable component of the vital signs monitor into the subcutaneous region of the human body.

[0040] This application utilizes a photosensitive element to monitor blood glucose information. The photosensitive element comes into contact with glucose molecules in the subcutaneous tissue fluid of the human body, forming a fluorescent group. Under irradiation with a first-wavelength light signal, the fluorescent group can excite a second-wavelength light signal with a different wavelength. This second-wavelength light signal can be used to determine the human body's blood glucose information. Because the photosensitive element undergoes a reversible bonding reaction with glucose molecules to generate a fluorescent group, the photosensitive element is not easily consumed and can be used for a long time, which is beneficial for achieving continuous blood glucose monitoring over a longer period using the same vital signs monitor. Attached Figure Description

[0041] To more clearly illustrate the technical solutions in the embodiments or related technologies of this application, the accompanying drawings used in the description of the embodiments or related technologies will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0042] Figure 1 This is a schematic diagram of a vital signs monitor according to an exemplary embodiment of this application;

[0043] Figure 2 This is another schematic diagram of a vital signs monitor according to an exemplary embodiment of this application;

[0044] Figure 3 This is another schematic diagram of a vital signs monitor according to an exemplary embodiment of this application;

[0045] Figure 4 This is another schematic diagram of a vital signs monitor according to an exemplary embodiment of this application;

[0046] Figure 5 This is a schematic diagram of a vital signs monitoring system according to an exemplary embodiment of this application;

[0047] Figure 6 This is a schematic diagram of a vital signs monitoring structure according to an exemplary embodiment of this application;

[0048] Figure 7 This is another schematic diagram of a vital sign monitoring structure according to an exemplary embodiment of this application;

[0049] Figure 8 This is another structural schematic diagram of a vital signs monitoring system according to an exemplary embodiment of this application. Detailed Implementation

[0050] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numbers in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this application. Rather, they are merely examples of apparatuses and methods consistent with some aspects of this application as detailed in the appended claims.

[0051] The terminology used in this disclosure is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. The singular forms “a,” “the,” and “the” as used in this disclosure and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used herein refers to and includes any and all possible combinations of one or more of the associated listed items.

[0052] It should be understood that, depending on the context, the word “if” as used here can be interpreted as “when”, “when”, or “in response to determination”.

[0053] Currently, there are two common methods for blood glucose monitoring. One method uses screen-printed test strips, which greatly simplifies the monitoring process but cannot provide continuous blood glucose monitoring, thus failing to promptly alert users to high or low blood glucose levels. Furthermore, this method requires blood collection, which can easily cause physical pain and increase the risk of infection. The other method uses electrochemical blood glucose sensors with glucose oxidase-coated electrodes. These sensors can provide continuous blood glucose monitoring for a period of time; however, their lifespan is currently less than two weeks, making long-term monitoring impossible and requiring frequent electrode replacements. Replacing vital signs monitors often requires minimally invasive surgery, causing significant pain and infection risks for patients, and also increasing their financial burden.

[0054] This patent application discloses a vital signs monitor and a vital signs monitoring system, which can achieve continuous blood glucose monitoring for a longer period of time. The following is a combination of... Figures 1 to 4 The vital signs monitoring device provided in the embodiments of this application is described in detail.

[0055] The vital signs monitor 1 provided in this application embodiment includes an implantable component 100. The implantable component 100 is configured to be implanted into the subcutaneous region of the human body, which includes the epidermis, dermis, and tissue fluid. The implantable component 100 can be implanted from the surface of the skin, passing through the dermis and epidermis to reach the tissue fluid.

[0056] Please refer to Figures 1 to 5 The implantable device 100 includes a circuit board 101 on which a blood glucose sensor 11 is mounted. The blood glucose sensor 11 includes at least one first light-emitting element 111, a photosensitive element 120, and at least one first light-receiving element 131. The first light-emitting element 111 is configured to emit a light signal of a first wavelength. This light signal illuminates the photosensitive element 120, which is configured to, when the implantable device 100 is implanted in the subcutaneous region of the human body, contact glucose molecules in the tissue fluid to form a fluorescent group. In response to receiving the first wavelength light signal, the fluorescent group emits a second wavelength light signal, different from the first wavelength. The wavelength range of the second wavelength is related to the first wavelength and the concentration of glucose molecules in the tissue fluid. The first light-receiving element 131 is configured to receive the second wavelength light signal and obtain a blood glucose monitoring signal based on the second wavelength light signal. As an example, the first light receiver 131 may include a photoelectric sensor, which converts the light signal of the second wavelength into an electrical signal and outputs it through a photoelectric signal conversion circuit. Alternatively, it may further transmit the electrical signal to an analog-to-digital converter 521 through the circuit on the circuit board 101, thereby converting the electrical signal into a digital signal, and then determining the blood glucose information of the human body based on the digital signal.

[0057] It should be noted that the first wavelength and the second wavelength can be specific wavelengths or specific wavelength ranges. In this case, the phrase "the second wavelength is different from the first wavelength" mentioned above means that the wavelength range corresponding to the first wavelength and the wavelength range corresponding to the second wavelength are not completely the same. There may be some overlap between the two, or they may be completely different.

[0058] Since the intensity and / or other parameters of the second wavelength light signal are dependent on the concentration of glucose molecules, after determining the dependence between the intensity and / or other parameters of the light signal obtained by the first light receiver 131 and the known concentration of glucose molecules, the concentration of glucose molecules in human tissue fluid can be calculated using the second wavelength light signal, thereby achieving the monitoring of glucose molecule concentration and obtaining the blood glucose measurement value of the human body. Furthermore, the bonding reaction between the photosensitive element 120 and glucose molecules to generate fluorescent groups is reversible, therefore the photosensitive element 120 is not easily consumed and can be used for a long time. Compared to the blood glucose sensor 11 implemented using glucose oxidase, the vital signs monitor 1 of this application embodiment can achieve continuous blood glucose monitoring over a longer period, and the analysis signal is highly sensitive to the response of glucose molecules. Even if the glucose molecule content in the tissue fluid is very low, it can still be detected, thus avoiding the problem of low response due to low concentration of screen-printed test strips. In addition, in this embodiment of the application, the first light-emitting element 111 and the first light-receiving element 131 are implanted into the human subcutaneous tissue. The propagation path of light is short and the propagation medium is more uniform in the human subcutaneous tissue, which can improve the quality of the light signal and eliminate interference from the external environment, thereby achieving more accurate continuous blood glucose monitoring in a larger dynamic range.

[0059] Please refer to Figures 1 to 4 The implantable component 100 can be a thin rod, needle, or strip-shaped component suitable for implantation into the subcutaneous region of the human body. The extension length of the implantable component 100 in its implantation direction is greater than the thickness of the epidermis and dermis, so that when the implantable component 100 is implanted into the subcutaneous region of the human body, the blood glucose sensor 11 comes into contact with the tissue fluid of the human body.

[0060] In some embodiments, the photosensitive element 120 may include a fluorescent hydrogel. The fluorescent hydrogel can undergo a reversible bonding reaction with glucose molecules to form a fluorescent group, exhibiting stronger stability compared to enzymes such as glucose oxidase. The fluorescent hydrogel can be integrated into the implantable element 100 in a solid form without diffusing into the tissue fluid. Alternatively, a cavity can be provided to accommodate the fluorescent hydrogel, with the cavity wall allowing glucose molecules to pass through. This application does not limit the specific implementation form of the fluorescent hydrogel in the blood glucose sensor 11.

[0061] In some embodiments, the first light-emitting element 111 may include an LED, and the first light-receiving element 131 may include a photodiode. The first light-emitting element 111 serves as a fluorescent excitation light source, emitting a light signal of a first wavelength, which is incident on the photosensitive element 120. The photosensitive element 120 is located between the first light-emitting element 111 and the first light-receiving element 131, and is configured to emit a second wavelength light signal in response to receiving the first wavelength light signal. Furthermore, the photosensitive element 120 also serves to block the first wavelength light signal emitted by the first light-emitting element 111 from directly reaching the first light-receiving element 131, thereby affecting the accuracy of the determined human blood glucose information. Specifically, the photosensitive element 120 is located in the optical path direction of the first light-emitting element 111 and the first light-receiving element 131; for example, the first light-emitting element 111, the photosensitive element 120, and the first light-receiving element 131 are arranged sequentially in a straight line. At this time, in the line direction connecting the first light-emitting element 111 and the first light-receiving element 131, due to the presence of the photosensitive element 120, the photosensitive element 120 can block at least a portion of the light signal emitted by the first light-emitting element 111 from reaching the first light-receiving element 131, thereby reducing the interference of the first wavelength light signal to the first light-receiving element 131.

[0062] In some embodiments, such as Figures 1 to 3 As shown, in at least one first direction, the size of the photosensitive element 120 is greater than or equal to the size of the first light-emitting element 111. Thus, the first light-emitting element 111 emits a light signal of a first wavelength in all directions, and the presence of the photosensitive element 120 blocks the propagation of light in the overlapping portion of the photosensitive element 120 and the first light-emitting element 111. Furthermore, since the size of the photosensitive element 120 is greater than or equal to that of the first light-emitting element 111 in at least one first direction, most of the light signal emitted by the first light-emitting element 111 can be incident on the photosensitive element 120, improving the photosensitivity of the photosensitive element 120, and the photosensitive element 120 can block most of the first wavelength light signal from propagating to the first light-receiving element 131.

[0063] In other embodiments, in at least one second direction, the size of the photosensitive element 120 is greater than or equal to the size of the first light-receiving element 131. The first and second directions can be the same or different, such as a height direction or a direction perpendicular to the line connecting the first light-emitting element and the first light-receiving element. In this way, the photosensitive element 120 can block the path of the first wavelength light signal emitted by the first light-emitting element 111 directly to the first light-receiving element 131 in the second direction, thereby improving the signal quality of the light signal received by the first light-receiving element 131.

[0064] As an example, in at least one first direction, the ratio of the size of the first light-emitting element 111 to the size of the photosensitive element 120 is less than or equal to one-third; and in at least one second direction, the ratio of the size of the first light-receiving element 131 to the size of the photosensitive element 120 is less than or equal to one-third. This allows for better blocking of the first wavelength light signal, preventing its influence on the first light-receiving element 131 and improving the accuracy of the measurement results. Of course, in addition to using the photosensitive element 120 for light blocking, other light-shielding components can also be used to block the light signal of the first wavelength emitted by the first light-emitting element 111 from propagating to the first light-receiving element 131; this is not limited to this method.

[0065] In some embodiments, such as Figure 4 As shown, the blood glucose sensor 11 may further include a light-transmitting layer 140, which is used to converge light signals. The light-transmitting layer 140 is coated on the surface of the first light-emitting element 111 and / or the first light-receiving element 131. The light-transmitting layer 140 can cover the surface of the first light-emitting element, so that the light signals of the first wavelength emitted by the first light-emitting element 111 to the surroundings are more converged after passing through the light-transmitting layer 140, so that more light signals are transmitted to the photosensitive element 120. The light-transmitting layer 140 can cover the surface of the first light-receiving element 131, so that the second wavelength light signals transmitted from the surroundings can be more converged, so that more light signals are received by the first light-receiving element 131, which helps to reduce signal transmission power and power consumption, and improve the accuracy of measurement results.

[0066] In some embodiments, such as Figures 1 to 4 The vital signs monitor 1 shown has a first light-emitting element 111 and a photosensitive element 120 disposed on the same surface of a circuit board. In this configuration, the first light-emitting element 111 can emit a light signal of a first wavelength through its side surface facing the photosensitive element 120. That is, the first light-emitting element 111 emits light through the side adjacent to the photosensitive element 120. The light emitted by the first light-emitting element 111 travels through a shorter path to the photosensitive element 120, reducing light loss and preventing light from being scattered by the first light-receiving element 131 when other sides are also emitting light, thus affecting the light signal received by the first light-receiving element 131. When other sides emit light, the photosensitive element 120 cannot directly receive the light emitted by the first light-emitting element 111 from those other sides, often only receiving a small amount of light through scattering. This embodiment avoids the waste of resources due to low utilization of the light emitted by the first light-emitting element 111 and improves the utilization rate of the first wavelength light signal.

[0067] Currently, commercially available electrochemical blood glucose sensors 11 can only measure a limited range of analytes and cannot simultaneously measure multiple biosignature signals, thus limiting their application scenarios and scope. To address these issues, in some embodiments, such as... Figure 1As shown, the implantable device 100 also includes a pulse wave sensor 12 disposed on the circuit board 101. The pulse wave sensor 12 is used to detect the pulse wave signal of the human body, and the pulse wave signal is used to determine the pulse information of the human body. The solution of this application embodiment can simultaneously detect blood glucose information and pulse wave information.

[0068] The pulse wave sensor 12 can be an optical sensor, a pressure sensor, or implemented in other ways, and this application embodiment does not limit this. In some embodiments, the pulse wave sensor 12 is an optical sensor, such as a photoplethysmograph (PPG) sensor. The pulse wave sensor 12 may include at least one second light-emitting element 112 and at least one second light-receiving element 132. The second light-emitting element 112 is used to emit a light signal of a third wavelength, and the second light-receiving element 132 is used to receive the light signal of the third wavelength that is incident on the human body and returns. The third wavelength is different from the first wavelength. The light signal of the third wavelength is emitted to the human skin, and after being reflected or projected by the human blood and tissues, it is received by the second light-receiving element 132 to obtain the human pulse wave signal. In one example, the change of blood vessel volume during the cardiac cycle can be recorded based on the different intensities of the reflected light signal after absorption by the human blood and tissues detected by the photoelectric sensor, and the heart rate and / or other biometric information can be calculated from the obtained pulse waveform.

[0069] The above-described scheme, which places the second light-emitting element 112 on an implantable device and implants it into the human body to monitor biometric information, offers several advantages. Because the second light-emitting element 112 is placed inside the body, the propagation path of the third wavelength light signal is short and the medium is relatively uniform, eliminating interference from the external environment. This results in a significant improvement in signal strength and signal-to-noise ratio of the light signal received by the second light-receiving element 132. The biometric information can include heart rate (HR), blood oxygen saturation (SpO2), blood pressure, and heart rate variability (HRV), overcoming the limitations of traditional electrochemical sensors that measure only a single signal and can only measure blood glucose.

[0070] In one embodiment, please refer to Figures 1 to 4 The pulse wave sensor 12 and the blood glucose sensor 11 are mounted on a single circuit board 101. Compared to mounting them on separate circuit boards, this reduces the space and size occupied by the implantable component 100, thereby reducing the pain caused to the patient during implantation.

[0071] Combination Figure 3 and Figure 4In the example shown, circuit board 101 can be made of flexible printed circuit board (FPC), which has single-layer double-sided characteristics. Having a first plane 151 and a second plane 152 arranged opposite each other along a first direction z, the pulse wave sensor 12 and the blood glucose sensor 11 can be respectively disposed on opposite surfaces of circuit board 101, i.e., the first plane 151 and the second plane 152. This allows for the monitoring of blood glucose signals on one surface of the implantable component 100 and the monitoring of other biometric signals on the other surface within a vital signs monitor 1. Furthermore, because the first plane 151 and the second plane 152 are arranged opposite each other, mutual interference between different second-wavelength and third-wavelength light signals can be reduced, improving the accuracy of the test signals.

[0072] In other embodiments, at least a portion of the pulse wave sensor 12 and the blood glucose sensor 11 may be disposed on the same surface of the circuit board 101. For example, at least one first light receiver 131 shares at least a portion of the light receiver in at least one second light receiver 132, which can further save space for the implantable component.

[0073] In one embodiment, the first light-emitting element 111 and the second light-emitting element 112 are different light sources, or the first light-emitting element 111 and the second light-emitting element 112 can be the same tri-color or multi-color light-emitting diode (LED), and the first light-receiving element 131 and the second light-receiving element 132 can be photodiodes (PDs). LEDs and photodiodes can be fixed on a flexible printed circuit board using die-casting technology, but the embodiments of this application are not limited thereto.

[0074] Please refer to Figure 5 As shown, in one embodiment, the signals output by the blood glucose sensor 11 and / or the pulse wave sensor 12 can be wirelessly transmitted to an external processing device for processing. In another embodiment, the vital signs detector further includes an analog front-end module 20, which is electrically connected to the blood glucose sensor 11 and is used to perform analog-to-digital conversion processing on the signal output by the blood glucose sensor 11 in a first-time manner to obtain a first digital signal, which is used to determine blood glucose information. As an example, the analog front-end module 20 can be electrically connected to the first optical receiver 131 for processing the signal output by the first optical receiver 131.

[0075] The pulse wave sensor 12 can be connected to a different analog front-end module than the blood glucose sensor 11, or the pulse wave sensor 12 and the blood glucose sensor 11 can be connected to the same analog front-end module. In one embodiment, please refer to... Figure 5The analog front-end module 20 is also electrically connected to the output of the pulse wave sensor 12, and is used to perform analog-to-digital conversion processing on the signal output by the pulse wave sensor 12 at a second time different from the first time to obtain a second digital signal. The second digital signal is used to determine the pulse wave information. As an example, the analog front-end module 20 can be electrically connected to the second optical receiver 132 to process the signal output by the second optical receiver 132. In some examples, the first optical receiver 131 and the second optical receiver 132 share at least a portion of the optical receivers, and the analog front-end module 20 can be electrically connected to the shared optical receivers to perform time-division processing of the blood glucose measurement signal and the pulse wave measurement signal output by the optical receivers. In this solution, integrating the analog front-end module 20 into one unit can effectively save hardware resources and further solve the problem of equipment space occupation.

[0076] In one embodiment, the blood glucose sensor 11, the pulse wave sensor 12, and the analog front-end module 20 can be disposed on the same circuit board. For example, the analog front-end module 20 and the blood glucose sensor 11 and / or the pulse wave sensor 12 can be disposed on the same surface of the circuit board, or the analog front-end module 20 and the blood glucose sensor 11 and / or the pulse wave sensor 12 can be disposed on opposite surfaces of the circuit board. For example, the blood glucose sensor 11 and the pulse wave sensor 12 can be disposed on a first surface of the circuit board, while the analog front-end module 20 can be disposed on a second surface of the circuit board. In another embodiment, the analog front-end module 20 can be disposed on another circuit board of the implantable component, or on other components besides the implantable component of the vital signs monitor 1. This application does not limit this.

[0077] In one embodiment, the vital signs monitor 1 further includes a wireless communication unit for wirelessly transmitting the signal output by the analog front-end module 20 to an external processing device for processing. The external processing device can be, for example, a mobile phone, computer, cloud cluster, or other electronic device with computing capabilities. The external processing device can utilize the received signal to obtain the human body's blood glucose information and / or pulse wave information, reducing the computational burden and power consumption of the vital signs monitor 1, while also allowing the vital signs monitor 1 to be made smaller and more portable.

[0078] Please refer to Figure 5 In another embodiment, the vital signs monitor 1 further includes a processor for processing the signals output by the analog front-end module 20 to obtain blood glucose information and / or pulse wave information. In one example, the processor may be a microprocessor 30, and the signals output by the analog front-end module 20 are transmitted to the microprocessor 30 via an electrical connection, which can improve signal processing efficiency compared to wireless communication.

[0079] In one embodiment, please refer to Figure 5The vital signs monitor 1 also includes a temperature sensor 13 for monitoring human body temperature. At least one operating parameter of the pulse wave sensor 12 depends on the temperature monitored by the temperature sensor 13. For example, it may also include a controller for controlling at least one operating parameter of the pulse wave sensor 12 based on the temperature monitored by the temperature sensor 13. As an example, at low temperatures, the perfusion index is low, the light signal received by the second light receiver is weak, and the accuracy of the obtained pulse wave measurement results is low. In this case, at least one operating parameter of the pulse wave sensor 12 can be adjusted according to the temperature detected by the temperature sensor 13. For example, when the temperature sensor 13 detects a low current temperature, such as below a certain threshold, the emission power of the second light emitter 112 is increased, thereby increasing the signal strength of the light signal received by the second light emitter 112 and thus improving the accuracy of the pulse wave detection results. Conversely, when the temperature sensor 13 detects a high current temperature, such as above a certain threshold, the perfusion index is high, and the signal strength of the light signal received by the second light receiver is strong. The emission power of the second light emitter 112 can be reduced accordingly, thereby saving system power consumption.

[0080] In other embodiments, the signals output by the blood glucose sensor 11 and / or the pulse wave sensor 12 can be processed based on the temperature detected by the temperature sensor 13 to obtain vital sign measurement results, thereby reducing the influence of human body temperature during measurement on the vital sign detection results.

[0081] In one embodiment, the vital signs monitor 1 may further include an analog front-end module 20 electrically connected to the temperature sensor 13. In another embodiment, the temperature sensor 13 may share the same analog front-end module 20 with the blood glucose sensor 11 and / or the pulse wave sensor 12, which can save hardware resources.

[0082] Those skilled in the art should understand that Figures 1 to 5 The examples are for illustrative purposes only. Implantable devices may include only one part of the components and omit another part. For example, they may include the analog front-end module 20 but not the temperature sensor 13, or they may include the temperature sensor 13 but not the pulse wave sensor 12, and so on. These will not be elaborated here.

[0083] In one embodiment, please refer to Figures 1 to 4In the example shown, the vital signs monitor 1 also includes a retainer 200, which is connected to the implantable component 100. This connection can be detachable, fixed, or integral. The retainer 200 is used to contact and hold the implantable component 100 on the skin surface when it is implanted into the subcutaneous region of the body, thus maintaining the vital signs monitor 1 in a fixed position. Specifically, the retainer 200 can be fixed to the skin using adhesives, adsorption, binding, or other methods, making the position of the implantable component 100 more stable and less prone to falling off or shifting even after long-term wear.

[0084] In one embodiment, the retainer 200 includes a housing 210 and hardware circuitry 220. The housing 210 may be made of a waterproof material to prevent the vital signs monitor 1 from being affected by human sweat or other liquids when in contact with human skin. The hardware circuitry 220 includes a control circuit and a power supply. The power supply can be electrically connected to the first light-emitting element 111 and the first light-receiving element 131 to provide power to them. The hardware circuitry 220 may also include any one or more of an analog signal front-end, a processor, and a communication module. The communication module may be a wireless transmission unit or a wired transmission unit, used to transmit received signals to an external processing device such as a host computer or mobile device, for example, a mobile phone, tablet, or monitor. The external processing device processes the received signals and generates curves indicating continuous changes in blood glucose levels over time, which are then provided to the user.

[0085] In one embodiment, the implantable component 100 is microneedle-shaped, which facilitates piercing the skin and implanting into the human body. The retainer 200 includes a housing 210. The take-up portion is disposed on the surface of the housing 210 opposite to the extension direction of the implantable component 100. The take-up portion facilitates the take-up and implantation of the vital signs monitor 1. The angle at which the microneedle formed by the implantable component 100 is implanted into the human body, that is, the angle between the flexible printed circuit board in the shape of the microneedle and the skin plane of the implantation site, can be 90°, 30°, 45°, 60°, 75°, etc.

[0086] Please refer to Figure 6 and Figure 7This application provides another vital signs monitor 2, including an implantable component 300, which can be implanted into the subcutaneous region of the human body. The implantable component 300 includes a circuit board 301, on which a blood glucose sensor 31 for detecting blood glucose information and a pulse wave sensor 32 for detecting pulse wave information are disposed, enabling simultaneous monitoring of blood glucose and pulse wave information. The blood glucose sensor 31 can be the blood glucose sensor 11 described in the above embodiments or an electrochemical sensor, etc. The pulse sensor 32 can be any type of pulse wave sensor, such as a PPG sensor. The blood glucose sensor 31 and the pulse wave sensor 32 can be disposed on opposite surfaces of the circuit board 301 to avoid mutual interference, or they can be disposed on the same surface of the circuit board 301. In this case, the blood glucose sensor 31 and the pulse wave sensor 32 can share at least a portion of the optical components to save hardware costs and reduce device space.

[0087] In one embodiment, the blood glucose sensor 31 is the blood glucose sensor 11 described in the above embodiments.

[0088] In one embodiment, the blood glucose sensor 31 and the pulse wave sensor 32 share at least one first light receiver. In this case, the first light emitter 111, the second light emitter 112, and the first light receiver 131 can be disposed within the first plane 151. The first light receiver 131 can receive a second wavelength light signal and a third wavelength light signal in a time-division or simultaneous manner, thereby realizing time-division or simultaneous measurement of blood glucose signals and other biometric signals. As an example, the first light emitter and the second light emitter can be a multi-color LED. A multi-color LED can emit light of multiple different wavelengths. The two light emitters are disposed in one plane. Due to light scattering, the first light receiver 131 can receive the second wavelength light signal and the third wavelength light signal, realizing the simultaneous monitoring of continuous changes in blood glucose values ​​and pulse wave signal values ​​using one LED and / or one light receiver, reducing hardware costs and space occupation. As another example, the first light emitter and the second light emitter can be two different monochromatic LEDs, but the embodiments of this application are not limited to this.

[0089] Other implementation methods of the vital signs monitor 2 can be referred to the description of the vital signs monitor 1 above, and will not be repeated here.

[0090] like Figures 5 to 8As shown in the illustration, this application provides another vital signs monitor 3, including an analog front-end module 50, a blood glucose sensor 41, and a pulse wave sensor 42. The input terminals of the analog front-end module 50 are connected to the output terminals of the blood glucose sensor 41 and the pulse wave sensor 42, respectively. The analog front-end module 50 is used to receive the output signal of the blood glucose sensor 41 at a first time, and process the output signal of the blood glucose sensor 41 to obtain a first digital signal, which is used to determine the blood glucose information of the human body. The analog front-end module 50 is also used to receive the output signal of the pulse wave sensor 42 at a second time, and process the output signal of the pulse wave sensor 42 to obtain a second digital signal, which is used to determine the pulse information of the human body, thus realizing that the blood glucose sensor and the pulse wave sensor share the same analog front-end module.

[0091] The types of blood glucose sensor 41 and pulse wave sensor 42 are not limited. For example, blood glucose sensor 41 can be an electrochemical sensor based on oxidase and electrode layer, or blood glucose sensor 41 can be based on blood glucose sensor 11 described above. As another example, pulse wave sensor 42 can be an optical sensor, or pulse wave sensor 42 can be a pressure sensor; this embodiment of the application does not limit these types.

[0092] In one embodiment, the analog front-end module 50 includes an analog-to-digital converter 521 for converting received analog signals into digital signals. In another embodiment, the analog front-end module 50 may further include a signal processing circuit, the output of which is connected to the input of the analog-to-digital converter 521, for preprocessing the received signals.

[0093] In one embodiment, the vital signs monitor 3 also includes at least one circuit board 401. The blood glucose sensor 41 and the pulse sensor 42 can be set on different circuit boards or on the same circuit board, which can save layout space.

[0094] In one embodiment, the vital signs monitor 3 further includes a temperature sensor 43, which is used to detect the temperature of the human body. The human body temperature detected by the temperature sensor 43 is used for at least one of the following: measuring blood glucose information and measuring pulse information. As an example, the operating parameters of the blood glucose sensor 41 and / or the pulse wave sensor 42 can be controlled based on the temperature detected by the temperature sensor 43. As another example, the blood glucose measurement signal obtained by the blood glucose sensor 41 and / or the pulse wave measurement signal obtained by the pulse wave sensor 42 can be processed based on the current temperature measured by the temperature sensor 43 to obtain the corresponding measurement results. As yet another example, the blood glucose measurement results and / or the pulse wave measurement results can be corrected based on the current temperature measured by the temperature sensor 43 to obtain the final measurement results, avoiding the influence of temperature on the measurement results.

[0095] In one embodiment, the blood glucose sensor 41 includes an oxidase layer and an electrode layer. The body temperature detected by the temperature sensor 43 is used to determine the activity parameter of the oxidase layer, which serves as a reference value for determining the blood glucose information of the human body. When measuring human blood glucose using electrochemical methods, at low temperatures, such as below a certain threshold, the activity of the oxidase is inhibited, and the sensitivity of the blood glucose sensor 41 decreases. Conversely, at high temperatures, such as above a certain threshold, the activity of the oxidase increases, and the sensitivity of the blood glucose sensor 41 increases. Therefore, temperature changes affect the accuracy of blood glucose measurement results. To address this, the activity parameter value can be determined based on the measurement results of the temperature sensor 43, and the blood glucose measurement result can be obtained using the activity parameter value and the blood glucose measurement signal, thus making the obtained blood glucose measurement result more accurate.

[0096] In another embodiment, the human body temperature detected by the temperature sensor 43 can also be used to determine the signal transmission parameters of the pulse wave sensor 42.

[0097] In one embodiment, the output terminal of the temperature sensor 43 is connected to the input terminal of the analog front-end module 50. In this case, the temperature sensor 43 also shares the same analog front-end module 50 with the blood glucose sensor 41 and the pulse wave sensor 42.

[0098] refer to Figure 8 For example, taking a blood glucose sensor 41 as an electrochemical sensor, the analog front-end module 50 may include a transmitting unit 51 and a receiving unit 52. The transmitting unit 51 includes a power supply 501, which can be a current source or a voltage source (provided to the electrochemical sensor) to supply power to one or more sensors, such as a pulse wave sensor, a blood glucose sensor, and / or a temperature sensor 43. The receiving unit 52 may include at least one preprocessing circuit and an analog-to-digital converter. The preprocessing circuit can be used to process the received signal. For example, the receiving unit 52 can receive the measurement signal output from the photodiode of the pulse wave sensor, the blood glucose sensor, and / or the temperature sensor 43, process the signal through the corresponding preprocessing circuit, and then output it to the analog-to-digital converter.

[0099] In one example, the pulse wave sensor 42 can be an optical sensor that outputs an electrical signal via a photodiode. Its corresponding preprocessing circuit may include an ambient light suppression unit 421, a transimpedance amplifier 422, and a filter 423. As another example, the blood glucose sensor can be an electrochemical sensor, and its corresponding preprocessing circuit may include a filter. The signals output from multiple preprocessing circuits are processed by an analog-to-digital converter 521 to obtain digital signals. The analog front-end module 50 can receive signals from multiple sensors in a time-sharing manner, thus enabling the sharing of the analog front-end module.

[0100] This application also provides a vital signs monitoring system, which includes an auxiliary implantation device and the aforementioned vital signs monitor. The auxiliary implantation device is detachably connected to the vital signs monitor and is used to implant the implantable component of the vital signs monitor into the subcutaneous region of the human body. Specifically, the vital signs monitor may include a retrieval part, which is fixedly connected to the implantable component. The retrieval part is mounted on a retainer and is used outside the skin of the human body. The retrieval part can be used to retrieve the vital signs monitor or to implant the implantable component of the vital signs monitor into the human body. Specifically, the auxiliary implantation device has a locking component and a pressing component. The locking component can be a mechanical locking device that can lock or release. The pressing component can be a mechanical pressing method or can be pressed by the operator. The structure of the locking component and the pressing component includes, but is not limited to, these. The locking assembly is detachably connected to the receiving part. The auxiliary implantation device can include a pushed-in state and an idle state. When the auxiliary implantation device is in the pushed-in state, the locking assembly is locked to the vital signs monitor. The pressing assembly is used to provide pressure along the implantation direction of the implantation part to press the vital signs monitor into the subcutaneous tissue, enabling the vital signs monitor to continuously monitor changes in blood glucose levels under the skin. When the auxiliary implantation device is in the idle state, the locking assembly and the pressing assembly are detached from the vital signs monitor. The above-described vital signs monitoring system and its usage process allow users to implant the vital signs monitor themselves at home, avoiding the need to go to the hospital for sensor implantation, and simply and conveniently achieving continuous monitoring of blood glucose levels.

[0101] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. A vital signs monitoring device, characterized in that, include: Implantable components are configured to pierce the skin and be implanted into the subcutaneous region of the human body. The implantable device includes rod-shaped, needle-shaped, strip-shaped, or microneedle-shaped structures configured to pierce the skin and enter the subcutaneous region; The implantable device further includes a flexible circuit board extending along the length of the implantable device. A blood glucose sensor is disposed on the circuit board, the blood glucose sensor comprising at least one first light-emitting element, a photosensitive element, and at least one first light-receiving element, wherein… The first light-emitting element is used to emit a light signal of a first wavelength; The photosensitive element is used to contact glucose molecules in human tissue fluid and form a fluorescent group. The fluorescent group is used to receive the light signal of the first wavelength and excite the light signal of the second wavelength. The first wavelength is different from the second wavelength. The first light receiver is used to receive the light signal of the second wavelength, and the light signal of the second wavelength is used to determine the blood glucose information of the human body; The first light-emitting element, the photosensitive element, and the first light-receiving element are fixed on the same circuit board; the first light-emitting element, the photosensitive element, and the first light-receiving element are arranged sequentially along the extension direction of the circuit board.

2. The vital signs monitor as described in claim 1, characterized in that, The photosensitive element is located between the first light-emitting element and the first light-receiving element, and the photosensitive element is also used to block the light signal of the first wavelength emitted by the first light-emitting element from directly reaching the first light-receiving element.

3. The vital signs monitor as described in claim 1, characterized in that, The implantable component includes an elongated portion, at least a portion of which is configured to be implanted into a subcutaneous region of the human body.

4. The vital signs monitoring device as described in any one of claims 1 to 3, characterized in that, The implantable component further includes a light-transmitting layer for converging light signals, and the light-transmitting layer is coated on the surface of the first light-emitting component and / or the first light-receiving component.

5. The vital signs monitor as described in any one of claims 1 to 3, characterized in that, The first light-emitting element is used to emit a light signal of the first wavelength through the side surface facing the photosensitive element.

6. The vital signs monitoring device as described in any one of claims 1 to 3, characterized in that, The implantable device also includes a pulse wave sensor disposed on the circuit board, the pulse wave sensor being used to detect the pulse wave signal of the human body, the pulse wave signal being used to determine the pulse information of the human body.

7. The vital signs monitor as described in claim 6, characterized in that, The pulse wave sensor includes at least one second light-emitting element and at least one second light-receiving element. The second light-emitting element is used to emit a light signal of a third wavelength, and the second light-receiving element is used to receive the light signal of the third wavelength incident on the human body and returned. The at least one first light-receiving element shares at least a portion of the at least one second light-receiving element.

8. The vital signs monitor as described in claim 6, characterized in that, The pulse wave sensor and the blood glucose sensor are respectively disposed on opposite surfaces of the circuit board.

9. The vital signs monitor as described in claim 6, characterized in that, Also includes: An analog front-end module is electrically connected to the blood glucose sensor and is used to perform analog-to-digital conversion processing on the signal output by the blood glucose sensor in a first time to obtain a first digital signal, which is used to determine the blood glucose information.

10. The vital signs monitor as described in claim 9, characterized in that, The analog front-end module is also electrically connected to the output terminal of the pulse wave sensor, and is used to perform analog-to-digital conversion processing on the signal output by the pulse wave sensor at a second time different from the first time to obtain a second digital signal, which is used to determine the pulse wave information.

11. The vital signs monitor as described in claim 6, characterized in that, Also includes: A temperature sensor for monitoring the temperature of a human body, wherein at least one parameter of the pulse wave sensor depends on the temperature monitored by the temperature sensor.

12. The vital signs monitor as described in claim 9, characterized in that, Also includes: The processor is used to process the digital signals obtained by the analog front-end module to obtain the blood glucose information and / or pulse wave information; or A communication module is used to transmit the digital signal obtained by the analog-to-digital front-end module to an external device via a wireless connection, so that the external device can use the digital signal to obtain the blood glucose information and / or pulse wave information.

13. The vital signs monitor as described in any one of claims 1 to 3, characterized in that, Also includes: A retainer, which is connected to the implantable member, is used to contact and hold the implantable member on the surface of human skin when the implantable member is implanted into a subcutaneous region of the human body.

14. A vital signs monitoring system, characterized in that, The invention includes an auxiliary implantation device and a vital signs monitor according to any one of claims 1 to 13, wherein the auxiliary implantation device is detachably connected to the vital signs monitor, and the auxiliary implantation device is used to implant the implantable component of the vital signs monitor into the subcutaneous region of the human body.

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