WO2022252002A1 - 体液分析物检测器件 - Google Patents

体液分析物检测器件 Download PDF

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Publication number
WO2022252002A1
WO2022252002A1 PCT/CN2021/097178 CN2021097178W WO2022252002A1 WO 2022252002 A1 WO2022252002 A1 WO 2022252002A1 CN 2021097178 W CN2021097178 W CN 2021097178W WO 2022252002 A1 WO2022252002 A1 WO 2022252002A1
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WO
WIPO (PCT)
Prior art keywords
transmitter
detection device
body fluid
fluid analyte
analyte detection
Prior art date
Application number
PCT/CN2021/097178
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English (en)
French (fr)
Inventor
杨翠军
Original Assignee
上海移宇科技股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海移宇科技股份有限公司 filed Critical 上海移宇科技股份有限公司
Priority to PCT/CN2021/097178 priority Critical patent/WO2022252002A1/zh
Publication of WO2022252002A1 publication Critical patent/WO2022252002A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter

Definitions

  • the invention mainly relates to the field of medical devices, in particular to a body fluid analyte detection device.
  • the pancreas in a normal human body can automatically monitor the glucose content in the human blood and automatically secrete the required insulin/glucagon.
  • the function of the pancreas in diabetic patients is abnormal and cannot normally secrete the insulin needed by the human body. Therefore, diabetes is a metabolic disease caused by abnormal pancreatic function, and diabetes is a lifelong disease. At present, medical technology is still unable to cure diabetes, and the occurrence and development of diabetes and its complications can only be controlled by stabilizing blood sugar.
  • Diabetics need to check their blood sugar before injecting insulin into their body.
  • Most detection methods can continuously detect blood glucose, and send blood glucose data to remote devices in real time, which is convenient for users to view.
  • This detection method is called Continuous Glucose Monitoring (CGM) method.
  • CGM Continuous Glucose Monitoring
  • This method requires the detection device to be attached to the skin surface, and the sensor probe carried by it is inserted into the subcutaneous tissue fluid to complete the detection.
  • the embodiment of the invention discloses a body fluid analyte detection device.
  • a waterproof structure is provided in the electrical connection area of the body fluid analyte detection device.
  • the waterproof structure includes a groove and a sealing ring arranged on the bottom shell. One end of the sealing ring is placed in the groove, and the other end is in contact with the transmitter housing to prevent water droplets. Enter the electrical connection area to avoid short circuit and current intensity disturbance. Users do not need to remove the detector from their body when bathing, washing, swimming and other underwater actions, which enhances user experience and improves the reliability of detection data.
  • the invention discloses a body fluid analyte detection device, which comprises: a transmitter, which is used to transmit a detection data indication signal to a user; a bottom case, which is used to stick on the surface of a human body; a sensor installed on the bottom case, including a probe And the conductive strip, the probe is used to detect the parameter information of the body fluid analyte, and is electrically connected to the sensor through the conductive strip to transmit the detection data indication signal to the transmitter; the battery is electrically connected to the transmitter to provide electrical energy for the transmitter and a waterproof structure, the waterproof structure includes a groove and a sealing ring arranged on the bottom shell, the lower end surface of the sealing ring is placed in the groove, and the upper end surface is in contact with the shell of the transmitter, which is used for the body fluid analyte detection device
  • the electrical connection area provides waterproof protection.
  • the battery is sealed in the transmitter, and the waterproof structure is located in the electrical connection area between the sensor and the transmitter.
  • the battery is sealed in the bottom case to form a battery sealed chamber, and at least two electrodes are led out from the battery sealed chamber, and the electrodes include at least one positive electrode and one negative electrode.
  • the transmitters are respectively electrically connected to the positive pole and the negative pole to obtain electric energy of the battery.
  • the waterproof structure is located in the electrical connection area of the emitter and the positive and negative electrodes.
  • the electrodes are elastic conductive materials.
  • the sealing ring is an insulating rubber ring.
  • the diameter of the sealing ring is larger than the inner diameter of the groove.
  • the upper end surface of the sealing ring is higher than the upper end surface of the groove.
  • sealing rings which are respectively located on the upper side and the lower side of the probe.
  • the present invention also discloses a continuous glucose monitoring device, which includes the body fluid analyte detection device as described above, and also includes a receiver for receiving parameter signals transmitted by the transmitter.
  • a waterproof structure is provided in each electrical connection area to prevent water droplets from entering the electrical connection area, avoiding short circuit and current intensity disturbance. , it is not necessary to remove the detector from the body, which enhances the user experience, and on the other hand reduces the interference of the detection data beating caused by the disturbance of the current intensity, and improves the reliability of the detection data.
  • the battery can be directly sealed in the transmitter to provide electric energy for the transmitter, and the waterproof effect between the battery and the transmitter can be realized without an additional waterproof structure, so as to avoid short circuit and damage the transmitter, and improve the performance of the body fluid analyte detection device. reliability.
  • the battery can be sealed in the bottom case and discarded together with the bottom case. Every time the user replaces the bottom case, the battery is replaced at the same time, and the battery always maintains a high-performance working state.
  • a waterproof structure is provided in the electrical connection area of the transmitter and the battery lead-out electrode to prevent water droplets from entering the electrical connection area and avoid causing short circuits and current intensity disturbances.
  • the electrode is made of conductive elastic material, and the emitter squeezes the electrode when it contacts the electrode, so that the electrode is in a state of continuous compression, indented into the groove, and maintains elasticity.
  • the electrode and the emitter are kept in close contact to ensure the transmission of electric energy. Stability, on the other hand, facilitates the close contact between the transmitter housing and the sealing ring, improves the waterproof performance, prevents water droplets from entering the electrical connection area, and avoids causing short circuits and current intensity disturbances.
  • the sealing ring is made of insulating rubber. Since the rubber is a flexible material and has certain compressive elasticity, when the transmitter is installed on the bottom shell, there is a certain extrusion force on the sealing ring, which can better maintain the sealing ring and the transmitter. The tight contact of the shell prevents water droplets from entering the electrical connection area, avoiding short circuit and current intensity disturbance.
  • the diameter of the sealing ring is larger than the inner diameter of the groove, and the sealing ring can be more tightly fixed in the groove, increasing the reliability of the waterproof structure.
  • the upper end surface of the sealing ring is higher than the upper end surface of the groove, so that the transmitter housing and the sealing ring can be in closer contact, increasing the reliability of the waterproof structure.
  • sealing rings which are respectively located on the upper and lower sides of the probe.
  • Fig. 1a is a schematic structural diagram of a body fluid analyte detection device according to an embodiment of the present invention
  • Fig. 1b is a schematic structural diagram of a body fluid analyte detection device according to yet another embodiment of the present invention.
  • FIG. 2 is a schematic diagram of a three-dimensional structure of a sensor according to an embodiment of the present invention.
  • Fig. 3a is a schematic cross-sectional structure diagram of an electrical connection area of a sensor according to an embodiment of the present invention
  • Fig. 3b is a schematic cross-sectional structure diagram of the waterproof structure of the electrical connection area of the sensor according to an embodiment of the present invention
  • Fig. 3c is a schematic cross-sectional structure diagram of the waterproof structure of the electrical connection area of the sensor after the transmitter is installed according to an embodiment of the present invention
  • Fig. 4 is a top view of a bottom case with a battery according to an embodiment of the present invention.
  • Fig. 5a is a schematic cross-sectional structure diagram of an electrode electrical connection area according to an embodiment of the present invention.
  • Fig. 5b is a schematic cross-sectional structure diagram of the waterproof structure of the electrode electrical connection area according to an embodiment of the present invention.
  • Fig. 5c is a schematic cross-sectional structure diagram of the waterproof structure of the electrode electrical connection area after the transmitter is installed according to an embodiment of the present invention
  • FIG. 6 is a schematic diagram of a continuous glucose monitoring device according to one embodiment of the present invention.
  • the detection device in the prior art cannot achieve a good waterproof effect.
  • water droplets will enter the detection device. Once it contacts the electrical connection area, it will cause Short-circuit faults or current intensity disturbances affect the accuracy and reliability of detection. Therefore, users often need to remove the detection device from their body before performing underwater activities, causing great inconvenience.
  • the present invention provides a body fluid analyte detection device, in which a waterproof structure is provided in each electrical connection area to prevent water droplets from entering the electrical connection area, avoiding short circuit and current intensity disturbance, and the user is bathing, washing, swimming, etc.
  • a waterproof structure is provided in each electrical connection area to prevent water droplets from entering the electrical connection area, avoiding short circuit and current intensity disturbance, and the user is bathing, washing, swimming, etc.
  • Fig. 1a is a schematic diagram of the three-dimensional structure of a body fluid analyte detection device according to an embodiment of the present invention.
  • the detection device includes a bottom case 10 , a sensor 11 and a transmitter 12 .
  • the bottom shell 10 is used to assemble the transmitter 12 and the sensor 11, and stick the detection device on the skin surface through the bottom adhesive tape (not shown in the figure).
  • the bottom case 10 includes a fixing part and a force applying part.
  • At least one second engaging portion 101 is disposed on the bottom case 10 .
  • the second engaging portion 101 is used for engaging the transmitter 12 .
  • the two second engaging portions 101 are correspondingly disposed on the sidewall of the bottom case 10 .
  • the fixed portion and the biasing portion are relative concepts. According to the structural design of the bottom case 10 and the transmitter 12, the positions of the fixing part and the force applying part can be selected differently, which will be described in detail below.
  • At least one first engaging portion 121 is disposed on the transmitter 12 .
  • the first engaging portion 121 corresponds to the second engaging portion 101 .
  • the transmitter 12 is assembled on the bottom case 10 through the mutual engagement of the second engaging portion 101 and the first engaging portion 121 .
  • the transmitter 12 is provided with two first engaging portions 121 , that is, two pairs of first engaging portions 121 and second engaging portions 101 that engage with each other.
  • the first engaging portion 121 corresponds to the second engaging portion 101 means that the number of the two is equal and their positions correspond.
  • the fixing part When separating the bottom case 10 and the transmitter 12, the fixing part is fixed by a finger or other equipment, and another finger or other auxiliary equipment is used to apply force to the force application part in one direction, the bottom case 10 will fail, and the second The engaging portion 101 and the first engaging portion 121 are separated from each other, thereby separating the transmitter 12 from the bottom case 10 . That is, when the user separates the bottom case 10 from the transmitter 12 , he only needs to use one finger to apply force to the force application part in one direction, and the two can be separated, which is convenient for the user to operate. After separation, the transmitter can be reused, reducing the cost for the user.
  • the failure of the bottom case 10 includes failure of the bottom plate, the side wall of the bottom case 10 or the failure of the second engaging portion 101 . Therefore, the failure mode of the bottom case 10 includes one or more of bottom plate or sidewall fracture of the bottom case 10 , breakage of the bottom case 10 , fracture of the second engaging portion 101 , and plastic deformation of the bottom case 10 . Obviously, after the failure of the bottom case 10 , the bottom case 10 loses the function and effect of engaging the transmitter 12 .
  • the way of fixing the fixing part includes clamping, supporting and other ways, which are not specifically limited here, as long as the conditions for fixing the fixing part can be satisfied.
  • the senor 11 is installed on the bottom shell 10, and at least includes a probe 113 and a conductive strip 114.
  • the probe 113 is used to penetrate the human skin, detect the parameter information of the body fluid analyte, and convert it into an electrical signal , the electrical signal is transmitted to the conductive electrode 122 of the transmitter 12 through the conductive adhesive strip 114, and the transmitter 12 then transmits the parameter information of the body fluid analyte to the user.
  • the battery is located within the housing of the transmitter 12, forming a good watertight seal.
  • the conductive electrode 122 is electrically connected to the conductive rubber strip 114.
  • a groove 131 is provided on the bottom shell 111 of the sensor and around the conductive rubber strip 114 for placing the sealing ring 130. The contour of the sealing ring is consistent with the contour of the groove.
  • the profile of the sealing ring and the profile of the groove may also be inconsistent, for example, the groove is square, circular, arc-shaped or a combination thereof, and the corresponding sealing ring is circular, arc-shaped, square or a combination thereof shape.
  • FIG. 3 a For a clearer understanding of the waterproof principle of the waterproof structure composed of the groove 131 and the sealing ring 130 , refer to FIG. 3 a , FIG. 3 b , and FIG. 3 c .
  • Fig. 3a is a C-C' sectional view of the sensor 11 shown in Fig. 2 before the sealing ring 130 is installed.
  • the probe 113 is divided into an internal body part 113 b and an external body part 113 a , and the external body part 113 a is bent or bent toward the upper end of the bottom shell 111 , and laid flat on the bottom shell 111 .
  • Figure 3b is a CC' sectional view of the sensor 11 shown in Figure 2 after the sealing ring 130 is installed, the outline of the sealing ring 130 is consistent with the outline of the groove 131, and the sealing ring 130 closely fits the groove 131, the probe 13 and the conductive strip 114, and the upper end surface of the sealing ring 130 is slightly higher than the upper end surface of the conductive adhesive strip 114.
  • “slightly higher” means that the upper end surface of the sealing ring 130 is 0-5 mm higher than the upper end surface of the conductive rubber strip 114 , preferably 1 mm.
  • Fig. 3 c is after installing sealing ring 130 and emitter 12, the CC' sectional view of sensor 11 shown in Fig.
  • conductive electrode 122 is in contact with conductive rubber strip 114, and emitter housing is in contact with sealing ring 130 upper surface, can It is envisioned that the transmitter housing 12, sealing ring 130 and groove 131 may form a sealed chamber 132 within which the probe body portion 113a, conductive strip 114 and conductive electrode 122 are located.
  • the water droplets are blocked by the transmitter housing 12, the sealing ring 130 and the groove 131, and cannot enter the chamber 132, thereby electrically connecting the conductive electrode 122 and the conductive adhesive strip 114 area forms a waterproof protection.
  • the size of the sealing ring is slightly larger than the size of the groove, so that the sealing ring 130 can be more tightly installed in the groove 131 and is not easy to fall off, and the edge of the sealing ring 130 can form a more airtight seal with the groove 131. Contact, to achieve a more ideal waterproof protection.
  • a layer of sealing ring (not shown) can also be added below the probe body part 113a and above the bottom shell 111 to form a waterproof seal together with the seal ring and the groove above the probe body part 113a.
  • the structure can better prevent water droplets from entering the electrical connection area and achieve a better waterproof effect.
  • the material of the sealing ring is preferably insulating rubber. Since the rubber is a flexible material and has certain compressive elasticity, when the transmitter 12 is installed on the bottom case 10, there is a certain extrusion force on the sealing ring 130. , can better maintain the tight contact between the sealing ring 130 and the casing of the transmitter 10, prevent water droplets from entering the electrical connection area, and avoid causing short circuits and current intensity disturbances.
  • Fig. 1b is a schematic structural diagram of a body fluid analyte detection device according to another embodiment of the invention.
  • the detection device includes a bottom case 20 , a sensor 11 and a transmitter 22 .
  • the fixing part and the force applying part are relative concepts. According to the structural design of the bottom case 20 and the transmitter 22, the positions of the fixing part and the force applying part can be selected in different ways.
  • the connecting line l1 of the two second engaging portions 202 divides the bottom case 20 into a side A and a side B.
  • a force application part is provided on the A side, and a fixing part is provided on the B side.
  • the process of separating the bottom case 20 and the transmitter 22 is as follows: fix the fixing part on the side B with a finger, apply a force F to the force applying part with another finger in one direction, and make the second card
  • the engaging portion 202 fails, and then the second engaging portion 202 is separated from the first engaging portion 221 , so that the transmitter 22 is separated from the bottom case 20 .
  • the embodiment of the present invention does not limit the position of the second engaging portion 202 , for example, the two second engaging portions 202 may be disposed on the bottom plate of the bottom case 20 , which is not specifically limited here.
  • Embodiments of the present invention do not specifically limit the shape of the detection device in a top view, and the shape may also be a rounded rectangle, rectangle, circle, ellipse or other shapes.
  • the detection device in the embodiment of the present invention also includes a battery 208 .
  • the battery 208 is used for powering the transmitter and is disposed in the bottom case 20 .
  • the location where the battery 208 is disposed in the bottom case 20 is the battery sealed chamber 203 .
  • the battery 208 can be replaced at the same time when the bottom shell 20 is replaced every time, and the transmitter 22 can be reused because the battery is no longer provided, which reduces the cost for the user to replace the transmitter 22.
  • the battery can ensure the continuous high-performance working state of the transmitter 22.
  • the top of the battery sealed chamber 203 is flush with the top of the emitter 22, so that the thickness of the detection device can be reduced.
  • the battery sealing chamber 203 can be directly used as a force applying part, therefore, the battery is arranged on the A side of l1 . Since the battery sealing chamber 203 is thicker and has a relatively larger area, as a force applying part, it is easier for the user to apply force on the battery sealing chamber 203 , which optimizes the user's operation steps.
  • FIG. 4 is a top view of the bottom case 20 .
  • the bottom case 20 is further provided with at least two electrodes 204 .
  • the electrical contacts 223 of the transmitter 22 are respectively electrically connected to the positive and negative electrodes of the battery through the electrodes 204 to form an electrical connection area.
  • the battery 208 supplies power to the transmitter through the electrode 204 and the electrical contact 223.
  • the waterproof structure of the electrical connection area includes a groove 207 and a sealing ring 205 .
  • FIG. 5 a For a clearer understanding of the waterproof principle of the waterproof structure composed of the groove 207 and the sealing ring 205 , refer to FIG. 5 a , FIG. 5 b , and FIG. 5 c .
  • Figure 5a is a DD' sectional view of the bottom case 20 shown in Figure 4 before the sealing ring 205 is installed. It is composed of the shell of the bottom case 20 to form a completely enclosed space, water droplets cannot enter the battery sealed chamber, the positive and negative electrode conductive strips 209 continue to extend outside the battery sealed chamber 203 to the groove 207 and cover the bottom surface of the groove 207, and the electrodes 204 is located in the middle of the groove 207, and one end is fixed on the positive and negative conductive strips 209.
  • Figure 5b is a DD' cross-sectional view of the bottom case 20 shown in Figure 4 after the sealing ring 205 is installed, the sealing ring 205 is located on the upper end surface of the groove 207, its contour is consistent with the groove contour, and can envelop the electrode 204,
  • the upper end surface of the sealing ring 205 is slightly higher than the upper end surface of the groove 207, and "slightly higher" here means that the upper end surface of the sealing ring 205 is 0-5 mm higher than the upper end surface of the groove 207, preferably 1 mm.
  • Figure 5c is a DD' cross-sectional view of the bottom case 20 shown in Figure 4 after the sealing ring 205 and the transmitter 22 are installed, the transmitter power supply electrode 223 is in contact with the electrode 204 to obtain the electric energy of the battery 208, and the housing of the transmitter 22 In contact with the upper surface of the sealing ring 205, it can be foreseen that the shell of the transmitter 22, the sealing ring 205, the groove 207 and the positive and negative electrode conductive strips 209 form a sealed chamber 210, and the transmitter power supply electrode 223 and the electrode 204 are located in the sealed chamber. within 210.
  • the water droplet is blocked by the shell of the transmitter 22, the sealing ring 205 and the groove 207, and cannot enter the chamber 210, thereby affecting the transmitter power electrode 223, electrode 204, positive and negative
  • the electrical connection area of the pole conductive strip 209 forms a waterproof protection.
  • the size of the seal ring is slightly larger than the size of the groove, so that the seal ring 205 can be more tightly installed in the groove 207, and it is not easy to fall off, and the edge of the seal ring 205 can form a more airtight seal with the groove 207. Contact, to achieve a more ideal waterproof protection.
  • the electrode 204 is an elastic conductive material that can be electrically connected to the transmitter power electrode 223, such as a conductive spring or a conductive shrapnel.
  • the transmitter power electrode 223 squeezes the electrode 204 to make the electrode 204 continue to compress and maintain elastic force, so that the electrode 204 can maintain continuous close contact with the transmitter power supply electrode 223 to ensure that the battery 208 supplies stable electric energy to the transmitter 22 .
  • the material of the sealing ring is preferably insulating rubber. Since the rubber is a flexible material and has a certain compression resistance, when the transmitter 22 is installed on the bottom case 20, there is a certain extrusion force on the sealing ring 205. , can better keep the sealing ring 205 in close contact with the housing of the transmitter 20, prevent water droplets from entering the electrical connection area, and avoid causing short circuits and current intensity disturbances.
  • the waterproof structure of the conductive electrode 222 of the sensor 11 and the transmitter 22 is the same as that of the first embodiment, and will not be repeated here.
  • the compressed sealing ring 105 exerts a certain elastic force on the launcher 22 , and when the force F is applied to the force application part, the sealing ring 105 provides elastic force to promote the separation of the launcher 22 from the bottom case 20 .
  • the present invention discloses a body fluid analyte detection device.
  • a waterproof structure is provided in the electrical connection area of the device to prevent water droplets from entering the electrical connection area, avoiding short circuits and current intensity disturbances. Users are bathing, washing, swimming, etc. When operating underwater, there is no need to remove the detector from the body, which enhances the user experience and improves the reliability of the detection data.
  • the present invention also discloses a continuous glucose monitoring device.
  • the sensor 11 is installed on the bottom shell 10 (20), and after the transmitter 12 (22) is installed on the bottom shell 20, the transmitter 12 ( 22)
  • the detection data indication signal of the sensor 11 can be obtained, and the transmitter 12 (22) is connected with the receiver 30 for wireless data to transmit the detection data indication signal to the receiver 30 for the user to know the detection data.

Abstract

本发明公开了一种体液分析物检测器件，包括：发射器；用于向发射器供电的电池；底壳，粘贴在人体表面；传感器，用于检测体液分析物参数信息，传感器与发射器电连接，以传输参数信号；和防水结构，用于阻止水滴进入到电连接区，提高体液分析物检测器件的使用可靠性，改善用户使用的便利性。

Description

体液分析物检测器件 技术领域
本发明主要涉及医疗器械领域，特别涉及一种体液分析物检测器件。
背景技术
正常人身体中的胰腺可自动监测人体血液中的葡萄糖含量，并自动分泌所需的胰岛素/胰高血糖素。而糖尿病患者胰腺的功能出现异常状况，无法正常分泌人体所需胰岛素。因此糖尿病是人体胰腺功能出现异常而导致的代谢类疾病，糖尿病为终身疾病。目前医疗技术尚无法根治糖尿病，只能通过稳定血糖来控制糖尿病及其并发症的发生和发展。
糖尿病患者在向体内注射胰岛素之前需要检测血糖。目前多数的检测手段可以对血糖连续检测，并将血糖数据实时发送至远程设备，便于用户查看，这种检测方法称为连续葡萄糖检测(Continuous Glucose Monitoring，CGM)法。该方法需要检测器件贴在皮肤表面，将其携带的传感器探头刺入皮下的组织液完成检测。
现有体液分析物检测器件无法做到良好的防水效果，当用户进行沐浴、冲洗、游泳等水下活动时，水滴会进入到检测器件内，一旦与电连接区接触，会引起短路故障或者电流强度扰动，影响检测准确性和可靠性，因此用户往往在进行水下活动前，需要先将检测器件从身上取下，造成极大的不便。
因此，现有技术亟需一种防水性能良好的体液分析物检测器件。
发明内容
本发明实施例公开了一种体液分析物检测器件。在体液分析物检测器件内的电连接区设置防水结构，防水结构包括设置在底壳上的凹槽和密封环，密封环一端放置在凹槽内，另一端与发射器壳体接触，阻止水滴进入电连接区，避免引起短路和电流强度扰动，用户在进行沐浴、冲洗、游泳等水下动作时，无需将检测器从身上取下，增强了用户体验，提高了检测数据的可靠性。
本发明公开了一种体液分析物检测器件，包括：发射器，发射器用于向用户发射检测数据指示信号；底壳，底壳用于粘贴在人体表面；安装至底壳上的传感器，包括探头和导电胶条，探头用于检测体液分析物参数信息，并通过导电胶条与传感器电连接，以向发射器传输检测数据指示信号；电池，与发射器电连接，用于为发射器提供电能；和防水结构，防水结构包括设置在底壳上的凹槽和密封环，密封环的下端面放置于凹槽内，上端面与发 射器的壳体接触，用于为体液分析物检测器件的电连接区提供防水保护。
根据本发明的一个方面，电池密封在发射器内，防水结构位于传感器与发射器的电连接区。
根据本发明的一个方面，电池密封在底壳内，形成电池密封腔室，并从电池密封腔室引出至少2个电极，电极至少包括1个正极和1个负极。
根据本发明的一个方面，发射器分别与正极、负极电连接，以获取电池的电能。
根据本发明的一个方面，防水结构位于发射器与正极和负极的电连接区。
根据本发明的一个方面，电极为弹性导电材料。
根据本发明的一个方面，密封环为绝缘橡胶环。
根据本发明的一个方面，密封环的直径大于凹槽的内径。
根据本发明的一个方面，密封环的上端面高于凹槽的上端面。
根据本发明的一个方面，密封环有2个，分别位于探头的上、下侧。
本发明还公开了一种连续葡萄糖监测装置，包括如上所述的体液分析物检测器件，还包括接收器，用于接收发射器传输的参数信号。
与现有技术相比，本发明的技术方案具备以下优点：
本发明公开的体液分析物检测器件中，在各电连接区设置防水结构，阻止水滴进入电连接区，避免引起短路和电流强度扰动，一方面用户在进行沐浴、冲洗、游泳等水下动作时，无需将检测器从身上取下，增强了用户体验，另一方面减少因电流强度扰动带来的检测数据跳动的干扰，提高了检测数据的可靠性。
进一步的，电池可直接密封在发射器内，为发射器提供电能，无需额外的防水结构即可实现电池与发射器间的防水效果，避免引起短路而损坏发射器，提高了体液分析物检测器件的可靠性。
进一步的，电池可密封在底壳内，随底壳抛弃，用户每次更换底壳同时更换了电池，电池始终保持高性能工作状态。在发射器和电池引出电极的电连接区设置防水结构，阻止水滴进入电连接区，避免引起短路和电流强度扰动。
进一步的，电极采用导电弹性材料，发射器与电极接触时挤压电极，使电极处于持续压缩状态，缩进凹槽内，并保持弹力，一方面电极与发射器保持紧密接触，保证电能输送的稳定性，另一方面便于发射器壳体与密封环紧密接触，提高防水性能，阻止水滴进入电连接区，避免引起短路和电流强度扰动。
进一步的，密封环采用绝缘橡胶，由于橡胶为柔性材料，且具备一定的抗压弹性，发 射器安装到底壳上时对密封环有一定的挤压力，能更好的保持密封环与发射器壳体的紧密接触，阻止水滴进入电连接区，避免引起短路和电流强度扰动。
进一步的，密封环直径大于凹槽内径，密封环可以更加紧密的固定在凹槽内，增加防水结构的可靠性。
进一步的，密封环的上端面高于凹槽的上端面，发射器壳体与密封环可以更加紧密的接触，增加防水结构的可靠性。
进一步的，密封环数量为2个，分别位于探头的上、下侧。
附图说明
图1a为根据本发明一个实施例体液分析物检测器件的结构示意图；
图1b为根据本发明再一个实施例体液分析物检测器件的结构示意图；
图2为根据本发明一个实施例传感器的立体结构示意图；
图3a为根据本发明一个实施例传感器电连接区的剖面结构示意图；
图3b为根据本发明一个实施例传感器电连接区防水结构的剖面结构示意图；
图3c为根据本发明一个实施例安装发射器后传感器电连接区防水结构的剖面结构示意图；
图4为根据本发明一个实施例底壳带电池的俯视图；
图5a为根据本发明一个实施例电极电连接区的剖面结构示意图；
图5b为根据本发明一个实施例电极电连接区防水结构的剖面结构示意图；
图5c为根据本发明一个实施例安装发射器后电极电连接区防水结构的剖面结构示意图；
图6为根据本发明一个实施例连续葡萄糖监测装置的示意图。
具体实施方式
如前所述，现有技术的检测器件无法做到良好的防水效果，当用户进行沐浴、冲洗、游泳等水下活动时，水滴会进入到检测器件内，一旦与电连接区接触，会引起短路故障或者电流强度扰动，影响检测准确性和可靠性，因此用户往往在进行水下活动前，需要先将检测器件从身上取下，造成极大的不便。
为了解决该问题，本发明提供了一种体液分析物检测器件，在各电连接区设置防水结构，阻止水滴进入电连接区，避免引起短路和电流强度扰动，用户在进行沐浴、冲洗、游泳等水下动作时，无需将检测器从身上取下，增强了用户体验，提高了检测数据的可靠性。
现在将参照附图来详细描述本发明的各种示例性实施例。应理解，除非另外具体说明，否则在这些实施例中阐述的部件和步骤的相对布置、数字表达式和数值不应被理解为对本发明范围的限制。
此外，应当理解，为了便于描述，附图中所示出的各个部件的尺寸并不必然按照实际的比例关系绘制，例如某些单元的厚度、宽度、长度或距离可以相对于其他结构有所放大。
以下对示例性实施例的描述仅仅是说明性的，在任何意义上都不作为对本发明及其应用或使用的任何限制。这里对于相关领域普通技术人员已知的技术、方法和装置可能不作详细讨论，但在适用这些技术、方法和装置情况下，这些技术、方法和装置应当被视为本说明书的一部分。
应注意，相似的标号和字母在下面的附图中表示类似项，因此，一旦某一项在一个附图中被定义或说明，则在随后的附图说明中将不需要对其进行进一步讨论。
第一实施例
图1a为本发明实施例体液分析物检测器件的立体结构示意图。
检测器件包括底壳10、传感器11和发射器12。
底壳10用于装配发射器12和传感器11，并通过底部粘结胶布(图中未示出)将检测器件粘贴在皮肤表面。底壳10包括固定部与施力部。底壳10上设置有至少一个第二卡合部101。第二卡合部101用于卡合发射器12。具体的，在本发明实施例中，第二卡合部101的数量为两个。两个第二卡合部101对应设置于底壳10的侧壁。
在这里，固定部与施力部是相对的概念。根据底壳10与发射器12的结构设计，固定部与施力部的位置可以有不同的选择，下文将详细叙述。
发射器12上设置有至少一个第一卡合部121。第一卡合部121与第二卡合部101相对应。通过第二卡合部101和第一卡合部121互相卡合，发射器12装配于底壳10上。明显的，在本发明实施例中，发射器12上设置有两个第一卡合部121，即，两对互相卡合的第一卡合部121与第二卡合部101。
在这里，第一卡合部121与第二卡合部101相对应是指两者的数量相等、位置对应。
当在分离底壳10与发射器12时，固定部被手指或者其他设备固定，利用另一个手指或者其他辅助设备在一个方向上对施力部施加力的作用，底壳10将失效，第二卡合部101和第一卡合部121互相分离，进而使发射器12与底壳10分离。即，用户在分离底壳10与发射器12时，仅用一根手指在一个方向对施力部施加作用力，就可将两者分离，便于用户操作。分离之后，发射器能够重复使用，降低了用户的成本。
在这里需要说明的是，失效为工程材料领域的常规概念。失效后，材料失去原有的功能作用，失效部位不能再次复原。由于第二卡合部101为底壳10的一部分，底壳10失效包括底壳10的底板、侧壁或者第二卡合部101失效。因此，底壳10的失效方式包括底壳10的底板或侧壁断裂、底壳10折损、第二卡合部101断裂、底壳10塑性形变中的一种或者多种。明显的，底壳10失效后，底壳10失去卡合发射器12的功能和作用。
固定固定部的方式包括夹持，支撑等方式，在这里并不作具体限制，只要能够满足将固定部固定的条件即可。
结合图2所示传感器立体结构示意图，传感器11安装在底壳10上，至少包括探头113和导电胶条114，探头113用于刺入人体皮肤，检测体液分析物参数信息，并转换为电信号，电信号通过导电胶条114传递到发射器12的导电电极122，发射器12再向用户传输体液分析物参数信息。
在本发明实施例中，电池位于发射器12壳体内，形成良好的防水密封。导电电极122与导电胶条114形成电连接，在传感器底壳111上、导电胶条114四周设有凹槽131，用于放置密封环130，密封环轮廓与凹槽轮廓保持一致。
在本发明其他实施例中，密封环轮廓与凹槽轮廓也可以不一致，例如凹槽为方形、圆形、弧形或其组合形状，相应的密封环为圆形、弧形、方形或其组合形状。
为更清楚的理解凹槽131及密封环130组成的防水结构的防水原理，参照图3a、图3b、图3c。
图3a为安装密封环130前，图2所示传感器11的C-C’剖面图，凹槽131设置在传感器底壳111上，环绕在探头113和导电硅胶114四周。探头113分为体内部分113b和体外部分113a，体外部分113a向底壳111上端弯折或者弯曲，并平铺在底壳111上。图3b为安装密封环130后，图2所示传感器11的C-C’剖面图，密封环130轮廓与凹槽131轮廓一致，密封环130紧密贴合凹槽131、探头13和导电胶条114，并且密封环130的上端面略高于导电胶条114的上端面。这里“略高”指密封环130上端面高于导电胶条114上端面0～5mm，优选为1mm。图3c为安装密封环130和发射器12后，图2所示传感器11的C-C’剖面图，导电电极122与导电胶条114接触，发射器壳体与密封环130上表面接触，可以预见的是发射器壳体12、密封环130和凹槽131可以形成密封的容室132，探头体外部分113a、导电胶条114和导电电极122位于该容室132内。当体液分析物检测器件进入水下时，水滴被发射器壳体12、密封环130和凹槽131阻挡，无法进入到容室132内，由此对导电电极122和导电胶条114的电连接区形成防水保护。
在本发明的其他实施例中，密封环尺寸略大于凹槽尺寸，这样可以使得密封环130更加紧密安装在凹槽131中，不易脱落，并且密封环130边缘可与凹槽131形成更密闭的接触，达到更理想的防水保护。
在本发明的其他实施例中，也可在探头体外部分113a下方、底壳111上方增设一层密封环(图中未示出)，与探头体外部分113a上方的密封环、凹槽共同组成防水结构，能更好的阻止水滴进入到电连接区，起到更好的防水效果。
在本发明的其他实施例中，密封环材料优选为绝缘橡胶，由于橡胶为柔性材料，且具备一定的抗压弹性，发射器12安装到底壳10上时对密封环130有一定的挤压力，能更好的保持密封环130与发射器10壳体的紧密接触，阻止水滴进入电连接区，避免引起短路和电流强度扰动。
第二实施例
图1b为发明另一个实施例体液分析物检测器件的结构示意图。
检测器件包括底壳20、传感器11和发射器22。
在本发明实施例中，固定部与施力部是相对的概念。根据底壳20与发射器22的结构设计，固定部与施力部的位置可以有不同的选择
在本发明其他实施例中，两个第二卡合部202的连线l 1将底壳20分为A侧与B侧。A侧设置有施力部，B侧设置有固定部。
因此，在本发明实施例中，分离底壳20和发射器22的过程如下：用手指固定B侧的固定部，用另一个手指沿一个方向对施力部施加作用力F，使第二卡合部202失效，进而分离第二卡合部202与第一卡合部221，使发射器22与底壳20分离。
需要说明的是，本发明实施例并不限制第二卡合部202的位置，如两个第二卡合部202可以设置于底壳20的底板上，在这里并不做具体限制。
本发明的实施例对检测器件俯视图的形状并不作具体限制，其形状还可以为圆角矩形、矩形、圆形、椭圆形或者其它形状。
本发明实施例的检测器件还包括电池208。电池208用于向发射器供电，并设置于底壳20内。底壳20中设置电池208的部位为电池密封腔室203。这样在每次更换底壳20时可以同时更换电池208，发射器22因不再设置电池而可以一直重复使用，减小了用户更换发射器22的成本，同时底壳20一直使用高性能的新电池，可以保证发射器22的持续高性能工作状态。
优选的，在本发明实施例中，电池密封腔室203的顶部与发射器22的顶部平齐，这样 能够减小检测器件的厚度尺寸。
电池密封腔室203可直接作为施力部，因此，电池设置于l 1的A侧。由于电池密封腔室203较厚，面积相对较大，作为施力部，用户更容易将作用力施加在电池密封腔室203上，优化用户的操作步骤。
图4为底壳20的俯视图。
由于电池208需要向发射器22供电，因此，在本发明实施例中，底壳20还设置有至少两个电极204。发射器22的电触点223通过电极204分别与电池的正负极电连接，形成电连接区。电池208通过电极204及电触点223向发射器供电，一旦电连接区进入水滴，导致短路，造成电池208供电不稳定，发射器22接收到的电流强度出现波动，可能导致发射器22接收到探头113的体液分析物参数信息以及发射的参数信息出现跳动，影响分析物检测器件的可靠性，因此需要对该电连接区进行防水保护。该电连接区防水结构包括凹槽207和密封环205。
为更清楚的理解凹槽207及密封环205组成的防水结构的防水原理，参照图5a、图5b、图5c。
图5a为安装密封环205前，图4所示底壳20的D-D’剖面图，电池208放置在电池密封腔室203内，电池密封腔室203由电池208的正负极导电条209和底壳20的壳体构成，形成完全密闭空间，水滴无法进入电池密封腔室内，正负极导电条209持续向电池密封腔室203外延伸至凹槽207并覆盖凹槽207底端面，电极204位于凹槽207中间，一端固定于正负极导电条209上。图5b为安装密封环205后，图4所示底壳20的D-D’剖面图，密封环205位于凹槽207上端面，其轮廓与凹槽轮廓一致，并能包络住电极204，密封环205上端面略高于凹槽207上端面，这里“略高”指密封环205上端面高于凹槽207上端面0～5mm，优选为1mm。图5c为安装密封环205和发射器22后，图4所示底壳20的D-D’剖面图，发射器电源电极223与电极204接触，以获取电池208电能，发射器22的壳体与密封环205上表面接触，可以预见的是发射器22壳体、密封环205、凹槽207和正负极导电条209形成密封的容室210，发射器电源电极223、电极204位于该密封容室210内。当体液分析物检测器件进入水下时，水滴被发射器22壳体、密封环205和凹槽207阻挡，无法进入到容室210内，由此对发射器电源电极223、电极204、正负极导电条209的电连接区形成防水保护。
在本发明的其他实施例中，密封环尺寸略大于凹槽尺寸，这样可以使得密封环205更加紧密安装在凹槽207中，不易脱落，并且密封环205边缘可与凹槽207形成更密闭的接 触，达到更理想的防水保护。
在本发明的其他实施例中，电极204为能够与发射器电源电极223电连接的弹性导电材料，例如可以是导电弹簧或者导电弹片，发射器22安装在底壳20上时，发射器电源电极223挤压电极204，使电极204持续压缩并保持弹力，这样电极204可与发射器电源电极223保持持续的紧密接触，保证电池208为发射器22输送稳定的电能。
在本发明的其他实施例中，密封环材料优选为绝缘橡胶，由于橡胶为柔性材料，且具备一定的抗压弹性，发射器22安装到底壳20上时对密封环205有一定的挤压力，能更好的保持密封环205与发射器20壳体的紧密接触，阻止水滴进入电连接区，避免引起短路和电流强度扰动。
在本发明实施例中，传感器11与发射器22的导电电极222的防水结构与第一实施例相同，在此不再赘述。
在本发明实施例中，受到挤压的密封环105对发射器22施加一定的弹力，在对施力部施加作用力F时，密封环105提供促进发射器22与底壳20分离的弹力。
综上所述，本发明公开了一种体液分析物检测器件，在器件电连接区设置防水结构，阻止水滴进入电连接区，避免引起短路和电流强度扰动，用户在进行沐浴、冲洗、游泳等水下动作时，无需将检测器从身上取下，增强了用户体验，提高了检测数据的可靠性。
本发明还公开了一种连续葡萄糖监测装置，如图6所示，将传感器11安装到底壳10(20)上，后再将发射器12(22)安装到底壳20上后，发射器12(22)可以获取传感器11的检测数据指示信号，发射器12(22)再与接收器30无线数据连接，以向接收器30传输检测数据指示信号，供用户知晓检测数据。
虽然已经通过示例对本发明的一些特定实施例进行了详细说明，但是本领域的技术人员应该理解，以上示例仅是为了进行说明，而不是为了限制本发明的范围。本领域的技术人员应该理解，可在不脱离本发明的范围和精神的情况下，对以上实施例进行修改。本发明的范围由所附权利要求来限定。

Claims (12)

  1. 一种体液分析物检测器件，其特征在于，包括：
    发射器，用于向用户发射检测数据指示信号；
    电池，与发射器电连接，用于为发射器提供电能；
    底壳，粘贴在人体表面；
    安装至所述底壳上的传感器，包括探头和导电胶条，所述探头用于检测体液分析物参数信息，并通过所述导电胶条与所述传感器电连接，以向所述发射器传输检测数据指示信号；和
    防水结构，所述防水结构包括设置在所述底壳上的凹槽和密封环，所述密封环的下端面放置于凹槽内，上端面与所述发射器的壳体接触，用于为所述体液分析物检测器件的电连接区提供防水保护。
  2. 根据权利要求1所述的体液分析物检测器件，其特征在于，所述电池密封在所述发射器内。
  3. 根据权利要求1所述的体液分析物检测器件，其特征在于，所述电池密封在所述底壳内，形成电池密封腔室，并从所述电池密封腔室引出至少2个电极，所述电极至少包括1个正极和1个负极。
  4. 根据权利要求3所述的体液分析物检测器件，其特征在于，所述发射器与所述正极和所述负极分别电连接，以获取电池的电能。
  5. 根据权利要求4所述的体液分析物检测器件，其特征在于，所述防水结构分别位于所述发射器与所述正极、所述负极的电连接区。
  6. 根据权利要求2或5所述的体液分析物检测器件，其特征在于，所述防水结构还位于所述传感器与所述发射器的电连接区。
  7. 根据权利要求3～5任一所述的体液分析物检测器件，其特征在于，所述电极为弹性导电材料。
  8. 根据权利要求1所述的体液分析物检测器件，其特征在于，所述密封环为绝缘橡胶环。
  9. 根据权利要求1所述的体液分析物检测器件，其特征在于，所述密封环的直径大于所述凹槽的内径。
  10. 根据权利要求1所述的体液分析物检测器件，其特征在于，所述密封环的上端面高于所述凹槽的上端面。
  11. 根据权利要求1所述的体液分析物检测器件，其特征在于，所述密封环有2个，分别位于所述探头的上、下侧。
  12. 一种连续葡萄糖监测装置，包括接收器和如权利要求1所述的体液分析物检测器件，所述接收器用于接收所述发射器传输的参数信号。
PCT/CN2021/097178 2021-05-31 2021-05-31 体液分析物检测器件 WO2022252002A1 (zh)

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