WO2020098583A1 - 用于植入式分析物传感器的固定件和传感器系统 - Google Patents

用于植入式分析物传感器的固定件和传感器系统 Download PDF

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Publication number
WO2020098583A1
WO2020098583A1 PCT/CN2019/117011 CN2019117011W WO2020098583A1 WO 2020098583 A1 WO2020098583 A1 WO 2020098583A1 CN 2019117011 W CN2019117011 W CN 2019117011W WO 2020098583 A1 WO2020098583 A1 WO 2020098583A1
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WO
WIPO (PCT)
Prior art keywords
analyte sensor
sensor
fixing member
accommodating part
accommodating
Prior art date
Application number
PCT/CN2019/117011
Other languages
English (en)
French (fr)
Inventor
郑敏
Original Assignee
利多(香港)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 利多(香港)有限公司 filed Critical 利多(香港)有限公司
Priority to US17/293,420 priority Critical patent/US20220117519A1/en
Priority to EP19884806.1A priority patent/EP3881762B1/en
Publication of WO2020098583A1 publication Critical patent/WO2020098583A1/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
    • 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
    • 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
    • A61B5/14503—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 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • 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
    • A61B5/14532—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 for measuring glucose, e.g. by tissue impedance measurement
    • 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
    • A61B5/14546—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 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6879—Means for maintaining contact with the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6879—Means for maintaining contact with the body
    • A61B5/6882—Anchoring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/22—Arrangements of medical sensors with cables or leads; Connectors or couplings specifically adapted for medical sensors
    • A61B2562/225—Connectors or couplings
    • A61B2562/227—Sensors with electrical connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed 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
    • A61B5/14539—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 for measuring pH

Definitions

  • the invention relates to a fixing member for an implantable analyte sensor and an implantable analyte sensor system including the fixing member, belonging to the technical field of electroanalytical chemical detection.
  • the method of electrochemical analysis is generally used.
  • the sensor for detecting the analyte is equipped with at least a working electrode, a counter electrode and a reference electrode. These electrodes are generally on the same side, or distributed on opposite sides.
  • the patents with publication Nos. CN102665549B, CN104887242A, and CN103750819B disclose a method of distributing electrodes on the same side of the sensor. This distribution method requires distributing multiple electrodes in a limited area, which undoubtedly increases the process difficulty and technical requirements.
  • the patents with publication numbers CN102469964B and US9795326B2 disclose the method of distributing the electrodes on both sides of the sensor. This method can reduce the difficulty of the sensor manufacturing process, but the fixing parts that fix the sensor need to be provided with electrical contacts on different sides Point, thus increasing the complexity of the fixture or the difficulty of installing the sensor.
  • the present invention provides a fixture for an implantable analyte sensor, which is particularly suitable for sensors with double-sided microelectrodes.
  • the basic idea of the present invention is to face the microelectrode (reverse side) A first end is provided on one side of the electrode), and the first end is electrically connected to the interface of the opposite electrode. At the same time, the second end is electrically connected to the first end, and the second end is connected to the interface corresponding to the sensor current data generating device, so that the sensor current data generating device can be connected to the sensor microelectrode having a double-sided structure For analyte testing.
  • the invention provides a fixing member for an implantable analyte sensor, the fixing member includes a supporting portion, a receiving portion, a conductive path and a through hole; the supporting portion includes a supporting portion side wall, a supporting portion top and a supporting portion bottom;
  • the accommodating part is located in the side wall of the supporting part in a recessed manner, and the accommodating part includes a side wall of the accommodating part, an inner wall of the accommodating part, a bottom of the accommodating part, and a top of the accommodating part;
  • the conductive path includes an input end and an output end, The input end is located on the inner wall of the accommodating part, and the output end is located on the surface of the support part; the input end and the output end are electrically connected by a connecting part; an opening of the through-hole is located in the accommodating part At the bottom of the section, another opening is located at the bottom of the support section.
  • the top of the receiving portion is an opening.
  • At least a part of the connecting portion is located in the supporting portion.
  • the input end protrudes from the inner wall of the receiving portion.
  • the output end protrudes from the surface of the support portion.
  • At least a part of the connecting portion is located on the surface of the supporting portion.
  • a conductive sheet is provided on the inner wall of the accommodating portion, and the conductive sheet is electrically connected to the input terminal; or a conductive sheet is provided on the surface of the supporting portion, and the conductive sheet and the output terminal are electrically Connection; or the inner wall of the accommodating part and the surface of the supporting part are respectively provided with conductive sheets, and the conductive sheets are electrically connected to the input end and the output end, respectively.
  • a groove is provided on the bottom of the accommodating part; or a groove is provided on the side wall of the accommodating part; or a groove is provided on the bottom of the accommodating part and the side wall of the accommodating part.
  • an opening of the through-hole is provided in the groove at the bottom of the receiving portion.
  • the present invention provides another fixing member for an implantable analyte sensor for a sensor having double-sided microelectrodes.
  • the fixing member includes a supporting portion, a receiving portion, a conductive path, and a through hole; The top of the part, the side wall of the accommodating part, the bottom of the accommodating part and the inner wall of the accommodating part are formed.
  • the supporting part is connected to the bottom of the accommodating part to form a platform of the bottom of the accommodating part;
  • the conductive path includes at least two ends.
  • the conductive path includes a first end and a second end, and the second end is electrically connected to the first end.
  • the conductive path penetrates the receiving portion.
  • the conductive path is located on the outer surface of the receiving portion.
  • a part of the conductive path penetrates the receiving part, and the other part is located on the outer surface of the receiving part.
  • the accommodating part has a conductive hole accommodating the conductive path.
  • the first end is located on the inner wall of the receiving portion, and the second end is located on the top or side wall of the receiving portion.
  • the conductive path further includes a third end located on the receiving portion; the third end is electrically connected to the second end and the first end.
  • the receiving portion is provided with one to three grooves; the groove is located on the inner wall or bottom of the receiving portion.
  • the fixing member further includes a conductive sheet on the receiving portion; the conductive sheet is electrically connected to the end of the conductive path.
  • a sealing ring is further included, and the sealing ring surrounds the side wall of the support portion.
  • it further includes a connecting portion, and the connecting portion is connected to the supporting portion.
  • the present invention also provides an implantable analyte sensor system, including a detection unit, a signal transmission device, and a data processing unit;
  • the detection unit and the signal transmission device are fixed in a housing, and a power supply is also provided in the housing for powering the electronic components in the housing;
  • the detection unit includes an implanted analyte sensor, the fixture for fixing the implanted analyte sensor of the present invention, and a sensor current data generation device.
  • the fixing member includes a supporting portion, an accommodating portion, a conductive path, and a through hole;
  • the accommodating portion is composed of an accommodating portion top, an accommodating portion side wall, an accommodating portion bottom, and an accommodating portion inner wall, and the supporting portion is connected to the accommodating portion bottom to form the accommodating portion bottom
  • the through hole is located on the supporting part, and one end is opened to the platform at the bottom of the accommodating part;
  • the conductive path is located on the accommodating part; the conductive path includes at least two ends.
  • the fixing member is fixed on the housing base through a connecting part connected to the support part.
  • the conductive path includes a first end and a second end, and the second end is electrically connected to the first end.
  • the conductive path penetrates the receiving portion.
  • the conductive path is located on the outer surface of the receiving portion.
  • a part of the conductive path penetrates the receiving part, and the other part is located on the outer surface of the receiving part.
  • the accommodating part has a conductive hole accommodating the conductive path.
  • the first end is located on the inner wall of the receiving portion, and the second end is located on the top or side wall of the receiving portion.
  • the conductive path further includes a third end located on the receiving portion; the third end is electrically connected to the second end and the first end.
  • the receiving portion is provided with one to three grooves; the groove is located on the inner wall or bottom of the receiving portion.
  • the fixing member further includes a conductive sheet on the receiving portion; the conductive sheet is electrically connected to the end of the conductive path.
  • the fixing member relatively reduces the difficulty of preparing the double-sided microelectrode sensor, and can effectively reduce the cost.
  • the fixing member has a simple structure and a low manufacturing process, and the replacement of the sensor is simple and convenient.
  • the detection efficiency of the implantable analyte sensor system with the fixture is improved.
  • Figure 1 is a schematic diagram of the structure of the front and back sides of the sensor
  • FIG. 2-1 Figure 2-1 ( Figure 2-1-a, Figure 2-1-b, Figure 2-1-c, Figure 2-1-d, Figure 2-1-e, Figure 2-1-f, Figure 2 -1-g, Fig. 2- 1-h), Fig. 2- 1-a, Fig. 2- 1-b and Fig. 2- 1-c are schematic front views of the fixing member in different embodiments, Fig. 2- 1- d.
  • Figures 2-1-1 and 2--1-f are schematic diagrams of the reverse side of the fixing member in different embodiments, and Figures 2--1-g and 2--1-h are schematic diagrams of the combination of the fixing member and the sensor;
  • Figure 2-2 ( Figure 2-2-a, Figure 2-2-b) is a schematic front view of the fixing member in different embodiments;
  • FIG. 1 Figure 3-2 and Figure 3-3 are top schematic views of the fixing member
  • FIGS. 4-1 to 4-8 are schematic diagrams of different embodiments of the fixing member
  • FIGS. 4-9 and 4-10 are schematic diagrams of the combination of fixing parts and sensors
  • FIG. 5 is a schematic top view of the conductive path partially penetrating the accommodating portion and partially located on the surface of the accommodating portion;
  • FIG. 6 is a schematic diagram of an implantable analyte sensing system.
  • An implantable analyte sensor system (can be used to continuously monitor the concentration of analyte in human blood, including but not limited to glucose, sodium ions, and potassium ions), as shown in Figure 6, including a detection unit, signal transmission device, and data Processing unit
  • the detection unit and the signal transmission device are fixed in a housing, which serves to protect the internal electronic components, and a power supply (not shown in the drawings) is also provided in the housing for the electronics in the housing Component power supply.
  • the detection unit includes an implanted analyte sensor 2, a fixture for fixing the implanted analyte sensor, and a sensor current data generating device.
  • the sensor 2 in the present invention is preferably a sensor with double-sided microelectrodes. Sensors with surface electrodes are also suitable.
  • the sensor 2 of the double-sided microelectrode includes a reverse surface (the surface in contact with the inner wall of the accommodating portion is called a reverse surface) and a front surface, and an electrode interface 23 is provided on the upper end portions of the front surface and the reverse surface.
  • Functional electrodes such as the working electrode 241, the counter electrode 242, and the reference electrode 243, the working electrode 241 and the counter electrode 242 are placed on the front of the sensor 2, and the reference electrode 243 is placed on the back of the sensor 2.
  • the working electrode 241, the counter electrode 242 and the reference electrode 243 are respectively connected to the electrode interface 23 through conductive traces, so that the working electrode 241, the counter electrode 242 and the reference electrode 243 transmit signals to other related components through the electrode interface 23.
  • the portion where the functional electrode is placed is summarized as the electrode area 22, and the portion where the electrode interface 23 is placed is summarized as the interface area 21.
  • the electrode area 22 and the interface area 21 are indicated by boxes in the figure.
  • the sensor with double-sided electrodes described above is just a relatively common structure. Those skilled in the art can selectively change the arrangement of these functional electrodes or add other functional electrodes such as measuring pH and temperature.
  • the fixing member for the implantable analyte sensor includes a supporting portion 3, a receiving portion 1, a conductive path 400 and a through hole 5.
  • the supporting portion 3 is composed of a supporting portion top 31, a supporting portion side wall 32, and a supporting portion bottom 33.
  • the accommodating portion 1 is provided on the side wall 32 of the supporting portion in a concave manner, and is biased closer to the top 31 of the supporting portion.
  • the accommodating portion 1 is used to accommodate the interface area 21 of the sensor 2.
  • the accommodating part 1 includes an accommodating part side wall 13, an accommodating part bottom 12, an accommodating part inner wall 14, and an accommodating part top.
  • the top of the accommodating part is disposed relative to the bottom of the accommodating part, and may be closed or open.
  • the side wall 13 of the accommodating portion and the bottom 12 of the accommodating portion are respectively used to restrict the left-right movement of the interface area 21 of the sensor 2 and the movement toward the bottom 33 of the supporting portion.
  • the through hole 5 extends from the opening on the bottom 12 of the receiving portion to the opening on the bottom 33 of the supporting portion in a penetrating manner.
  • the electrode area 22 of the sensor 2 enters from the bottom 12 of the accommodating portion, and finally extends from the bottom 33 of the supporting portion.
  • the conductive path 400 is divided into a receiving end 41 and an output end 42, and the receiving end 41 and the output end 42 are connected by a connecting portion, and the connecting portion is made of a conductive material.
  • the total number of the receiving end 41 and the output end 42 is not less than two.
  • the receiving end 41 is used to receive the data information from the sensor 2, and the output end 42 outputs the information to other electronic components, such as a central processing unit.
  • the receiving end 41 is located on the inner wall 14 of the receiving portion, the output end 42 is located on the side wall 32 of the supporting portion, and the receiving end 41 and the output end 42 are electrically connected.
  • the accommodating part 1 is composed of an accommodating part top opening 11, an accommodating part side wall 13, an accommodating part bottom 12 and an accommodating part inner wall 14.
  • the interface area 21 of the sensor 2 enters from the top opening 11 of the accommodating portion and moves down along the side wall 13 of the accommodating portion, and the electrode area 22 below the interface area 21 enters from the through hole 5 of the bottom 12 of the accommodating portion.
  • the interface area 21 is blocked by the bottom 12 of the receiving portion and stops moving, and the electrode area 22 protrudes from the bottom 33 of the supporting portion and is located below the bottom 33 of the supporting portion.
  • the top of the accommodating part is in an open state to form a top opening 11 of the accommodating part.
  • the opening 11 provides an entrance for the insertion of the sensor 2 to facilitate the insertion of the sensor 2.
  • the shape of the opening is not limited to a top opening 11 of the accommodating part.
  • the fixing member is fixed on the base of the housing, and the base has a hole corresponding to the through hole 5 for the electrode area 22 of the implanted analyte sensor 2 to pass through.
  • the working electrode 241, the counter electrode 242, the reference electrode 243 and the like, which are implanted into the human body, are generally referred to as the electrode area 22.
  • the electrode area 22 of the implanted analyte sensor 2 is implanted under the skin of the human body through the through hole 5.
  • the interface on the reverse side of the implanted analyte sensor 2 is electrically connected to the sensor current data generating device through the conductive path 400.
  • Other existing conductive materials can also be added between the sensor current data generating devices for electrical connection.
  • the interface on the front of the implanted analyte sensor 2 is electrically connected with existing conductive materials, including but not limited to graphite, conductive tape and copper wires.
  • the data transmission between the signal transmission device and the sensor current data generating device can be performed through the data line, or through the wireless signal (such as Bluetooth, WiFi, RF signal and other existing wireless data exchange methods) .
  • the signal transmission device needs to use the corresponding element in the prior art.
  • Data exchange is performed between the data processing unit and the signal transmission device.
  • the two can exchange data through the data line or through wireless signals.
  • the sensor current data generation device controls the implanted analyte sensor to detect the subcutaneous analyte through the electrical signal, and receives the data generated by the implanted analyte sensor 2, the received data is transmitted to the data processing unit for processing and display through the signal transmission device .
  • a micro-processing chip on the market can achieve this function.
  • the data processing unit can be a smart terminal (smartphone, computer, tablet, etc.), or a component that includes a display screen and a data processing chip, where the data processing chip is installed in the housing and the display screen is installed on the housing.
  • the invention provides a fixing piece for an implantable analyte sensor, which is used for fixing an analyte sensor, and is particularly suitable for a sensor with double-sided microelectrodes.
  • the cross-section of the through-hole 5 may be triangular, circular, or semi-circular, etc., for the sensor 2 to pass through the implanted part (including the electrode area).
  • the through hole 5 is equidistant from the side walls 13 of the two accommodating parts of the accommodating part 1, as shown in Fig. 3-1 to Fig. 3-2; it can also be biased to one side, as shown in Fig. 3-3. Since the sensor 2 may not be enough to pierce the skin, it needs to be combined with a puncture needle commonly used in the art to enable the detection electrode of the sensor 2 to be smoothly implanted under the skin.
  • the receiving end of the conductive path 400 41 is used to contact the electrode interface 23 on the reverse side of the sensor 20 to receive information from the sensor 2.
  • the output terminal 42 is used to output information to other electronic components.
  • the conductive path 400 has two output terminals, as shown in FIGS. 4-5.
  • the output terminals are output terminal 421 and output terminal 422.
  • the number of conductive vias 400 is at least one, and may be two or more. The number is related to the number of electrode interfaces on the reverse side of the sensor 2. If a temperature sensing electrode is added on the reverse side, the number of conductive paths needs to be increased by one. When the number of conductive vias 400 is greater than one, the conductive vias 400 may be arranged in the same layout manner, or may be arranged in multiple ways.
  • the material of the conductive path 400 may be a conductive metal, a conductive polymer, or other conductive materials (e.g., graphite), and the shape thereof may be selectively linear, columnar, or sheet-like.
  • the present invention takes the conductive path 400 having one input end 41 and one output end 42 as an example, specifically the first end 41 and the second end 42.
  • the first end 41 is located on the inner wall 14 of the accommodating portion, and is interposed between the electrode interface 23 of the back electrode and the fixing member, and the second end 42 is located on the other side of the fixing member, and corresponds to the sensor current data generating device The interface is connected.
  • the first end 41 needs to slightly protrude from the inner wall 14 of the accommodating portion, and the protruding distance is greater than 0 mm, preferably 0.01 to 1 mm. It is more preferably 0.01 to 0.5 mm.
  • the back electrode refers to an electrode facing the inner wall 14 of the accommodating portion.
  • the side on the right side of FIG. 1 is the back surface.
  • this side serves as the reverse side.
  • the side on the right side of FIG. 1 is taken as the reverse side
  • the reference electrode 143 is distributed on the reverse side
  • the counter electrode 242 and the working electrode 241 are distributed on the other side.
  • the counter electrode 242, the working electrode 241 and the reference electrode 243 are common technologies in the field of electrochemical analysis, and have no other creative technical features.
  • the accommodating portion 1 is accommodated by the side wall 13 of the accommodating portion.
  • the top opening 11, the bottom 12 of the accommodating part and the inner wall 14 of the accommodating part are formed.
  • the accommodating part 1 is provided with a groove 6 for fitting the edge of the sensor interface area 21.
  • the groove 6 is located on the bottom 12 of the receiving portion and is in contact with the inner wall 14 of the receiving portion, and the opening of the through hole 5 is located in the groove 6, as shown in FIGS. 3-1 and 3-3, so as to fit the interface area 21 Lower edge, and further play the role of fixing and limiting the interface area 21.
  • one side wall 13 of the receiving portion 1 (see FIG. 3-1, FIG. 3-1) or two side walls 13 of the receiving portion (see FIGS. 2-1-1 and 3-2)
  • the groove 6 is provided on the upper portion, and the groove 6 is in contact with the inner wall 14 of the accommodating portion.
  • the groove 6 on the side wall 13 of the accommodating portion can play a guiding role, so that the electrode area 22 can enter the through hole 5.
  • it can further serve to fix and restrict the movement of the interface area 21.
  • the fixing member may further include a connecting portion (not shown in the figure).
  • the connecting portion is used to fix the fixing member on the base of the analyte detection device.
  • the fixing method may be a detachable type (snap, screw connection, Plug-in) or non-removable (use adhesive to bond, integrally formed with the base). Among them, the fixing method of the buckle is the best.
  • the sensor 2 can be directly inserted into the corresponding position of the fixing member or pulled out. In this way, the sensor 2 can be quickly replaced, which not only reduces the replacement time, but also simplifies the replacement procedure.
  • the analyte detection device refers to a device that includes a detection unit, a signal transmission device, and a power source.
  • the device is fixed on the skin by means of bonding, binding, and the like.
  • the fixing member may further include a sealing ring 7, such as an O-shaped rubber ring in FIG. 2-1, or a hydrophobic film, or other existing materials having a sealing function, and the number of sealing rings is at least one. It is arranged on the side wall of the supporting part in a surrounding manner and is located below the bottom of the accommodating part.
  • the sealing ring 7 is used for waterproofing, specifically, to prevent the fixed parts of the human body from touching the water (such as bathing, swimming, etc.), the water penetrates into the inside of the monitoring device, thereby affecting the internal electronic components.
  • the number of the grooves 6 is 1 to 3, which are located on the side wall 13 of the receiving portion, or the bottom 12 of the receiving portion, or a combination of both. Refer to Fig. 2-1, Fig. 2-2 and Fig. 3-1 to Fig. 3-3 for the arrangement and distribution of some recesses 6.
  • the groove 6 is used to locate the interface area 21 of the sensor 2 and restrict the movement of the interface area 21.
  • the groove 6 located on the side wall 13 also has a function of guiding the insertion of the interface area 21.
  • the width x of the groove 6 is greater than the edge thickness of the interface area 21, and the difference is greater than 0mm, less than or equal to 0.5mm, and may further be 0.05 to 0.2mm, preferably 0.1mm, to prevent the difference from being too small to cause difficulty in insertion, and to prevent the difference from being too large to reduce the effect of limiting the interface area 21; similarly, the width y of the inner wall 14 of the receiving portion is greater than the length of the interface area 21, the range of the difference It is greater than 0 mm, less than or equal to 0.5 mm, and may further be 0.05 to 0.2 mm, preferably 0.1 mm, to prevent insertion difficulties due to too small differences, and to reduce the effect of limiting the interface area 21 due to excessive differences.
  • the width y of the inner wall of the housing is in the range of 2 to 5 mm.
  • conductive sheet 401 The material used may be a conductive metal, a conductive polymer, or other conductive materials (such as graphite). The number of the conductive sheets 401 may be one, or plural.
  • the conductive sheet 401 is electrically connected to one end or a plurality of ends of the conductive path 400, respectively.
  • the conductive sheet 6 can be electrically connected to the first end 41 and / or the second end 422 with a conductive adhesive material (conductive adhesive, conductive tape).
  • a conductive adhesive material conductive adhesive, conductive tape
  • the conductive path 400 may penetrate the accommodating portion 1 of the fixing member, so that the two ports of the conductive path 400 are respectively located in the inner wall 14 of the accommodating portion and the supporting portion side wall 32 / supporting portion top 31.
  • the fixing member is provided with a conductive hole 40, as shown in Figure 2-1-1, Figure 2-1-d, Figure 3-1 ⁇ Figure 3-3, the conductive hole 40 is used for the conductive path 400 to pass, so that The first end 41 of the conductive path 400 points toward the inner wall 14 of the receiving portion of the fixing member.
  • the second end 42 of the conductive path 400 is located on the other surface of the support 3, and the second end 42 in FIG. 2-1-e is located on the back of the side wall 32 of the support relative to the housing 1.
  • the second end portion 42 must be located on this surface, and may also be located on the side of the support portion side wall 32 of the accommodating portion 1, such as FIG. 2-2-a.
  • the conductive path 400 penetrates the supporting portion 3, and the second end 42 is located at the top 31 of the supporting portion, as shown in FIG. 2-2-b.
  • a conductive sheet 401 is provided between the first end 41 and the back electrode of the sensor 2, the electrode interface 23 of the back electrode is electrically connected to the conductive sheet 401, and between the first end 41 and the conductive sheet 401 Electrically connected, the conductive sheet 401 is located on the surface of the inner wall 14 of the receiving portion, as shown in FIG. 2-1-g.
  • the second end portion 42 is located on the back side of the side wall 32 of the supporting portion relative to the accommodating portion 1, so that it can be electrically connected to the interface of the sensor current data generating device, as shown in FIG. .
  • a conductive sheet 401 is provided on the back of the side wall 32 of the supporting portion of the accommodating portion 1, the second end 42 is electrically connected to the conductive sheet 401, and the conductive sheet 401 can also be connected to the sensor current data generating device
  • the interface is electrically connected, and the connection strength of the electrical signal is enhanced, as shown in Figure 2-1-h.
  • the conductive hole 40 is a curve or a polyline
  • the first end 41 of the conductive path 400 points toward the inner wall 14 of the receiving portion
  • the second end 42 points toward the side wall 32 or the top 31 of the support, as shown in FIG. 5.
  • a conductive sheet 401 is provided between the first end 41 and the back electrode of the sensor 2, a conductive sheet 401 is also provided on the back of the fixing member, and the second end 42 is electrically connected to the conductive sheet 401 After the sensor 2 is inserted into the fixing member 10, the effect is shown in Figure 2-1-g and Figure 2-1-h.
  • the conductive path 400 may be located on the outer surface of the fixing member, and the two ports of the conductive path 400 are respectively located on the inner wall 14 of the receiving portion, and the supporting portion side wall 32 or the supporting portion top 31, that is, one port is located on the receiving portion
  • the inner wall 14 and the other port are located on the side wall 32 or the top 31 of the support.
  • the conductive hole 40 is not provided in the fixing member, and the conductive path 400 is distributed along the surface of the fixing member of the receiving portion, so that the first end 41 of the conductive path 400 is located on the inner wall 14 of the receiving portion (see FIGS. 2. As shown in Figs. 4-7 and 4-8), the second end 42 is located on the top 31 of the support portion (shown in Fig.
  • an adhesive layer may be provided between the conductive path 400 and the surface of the fixing member or bonded with an adhesive.
  • inlaid Way to fix in order to increase the adhesion strength of the conductive path 400 on the surface of the fixing member, an adhesive layer may be provided between the conductive path 400 and the surface of the fixing member or bonded with an adhesive.
  • a part of the conductive channel 400 may penetrate through the supporting part 3, another part is located on the outer surface of the side wall 32 of the supporting part, and the first end 41 of the conductive channel 400 is located on the inner wall 14 of the receiving part, and the second end 42 is located on the support The side or back of the side wall 32.
  • a part of the conductive path 400 black dotted line part
  • another part black solid line part

Abstract

用于植入式分析物传感器（2）的固定件和包括固定件的植入式分析物传感系统，固定件用于具有双面微电极的传感器（2），固定件包括支撑部（3），容纳部（1），导电通路（400）和贯穿孔（5）；容纳部（1）由容纳部顶部、容纳部侧壁（13）、容纳部底部（12）和容纳部内壁（14）构成；贯穿孔（5）位于支撑部（3）上，一端开口于容纳部底部（12）；导电通路（400）位于容纳部（1）上；导电通路（400）包括至少两个端部（41,42）。固定件使双面微电极传感器（2）制备难度相对降低，可有效降低成本。另外固定件结构简单，制作工艺低，传感器（2）的更换简单方便。

Description

用于植入式分析物传感器的固定件和传感器系统 技术领域
本发明涉及用于植入式分析物传感器的固定件和包括该固定件的植入式分析物传感器系统，属于电分析化学检测技术领域。
背景技术
对于以往的分析物检测技术，以患有糖尿病的患者为例，他们需要定期检测血液中的葡萄糖含量，则要通过穿刺针刺破皮肤，采集血液后利用比色法、电化学分析法或光学检测法进行检测。这些方法不仅繁琐而且也增加了病人的负担。因此，为了解决上面的问题，以及出于对体内分析物浓度变化进行连续检测的需要，许多用于连续分析物检测的装置被开发出来。
在现有技术中，一般采用电化学分析的方法。为此，用于检测分析物的传感器至少配有工作电极、对电极和参比电极。这些电极一般处于同一侧，或者分布在相反的两侧。如公开号为CN102665549B、CN104887242A、CN103750819B的专利公开了将电极分布在传感器同一侧的方法，这种分布方式需要在有限的面积里分布多种电极，无疑增加了工艺难度以及技术要求。而如公开号为CN102469964B、US9795326B2的专利公开了将电极分布在传感器两侧的方法，采用这种方法可以降低传感器制作的工艺难度，但是固定该传感器的固定件需要在不同的侧面上设置电触点，因此增加了固定件的复杂程度或者安装传感器的难度。
发明内容
针对现有技术的不足之处，本发明提供了一种用于植入式分析物传感器的固定件，特别适用于具有双面微电极的传感器，本发明的基本思路是在面向微电极(反面电极)的一侧设置第一端部，该第一端部与反面电极的接口电性连接。与此同时，第二端部与第一端部电性连接，并且该第二端部与传感器电流数据发生装置对应的接口相连，使得传感器电流数据发生装置可以连接具有双面结构的传感器微电极，从而进行分析物测试。
本发明提供了一种植入式分析物传感器的固定件，所述固定件包括支撑部，容纳部，导电通路和贯穿孔；所述支撑部包括支撑部侧壁、支撑部顶部和支撑部底部；所述容纳部以凹陷的方式位于所述支撑部侧壁中，所述容纳部包括容纳部侧壁、容纳部内壁、容纳部底部和容纳部顶部；所述导电通路包括输入端和输出端，所述输入端位于所述容纳部内壁，所述输出端位于所述支撑部的表面；所述输入端和所述输出端通过连接部电性连接；所述贯穿孔的一个开口位 于所述容纳部底部，另一个开口位于所述支撑部底部。
优选地，所述容纳部顶部为开口。
优选地，所述连接部至少有一部分位于所述支撑部内。
优选地，所述输入端突出所述容纳部内壁。
优选地，所述输出端突出所述支撑部的表面。
优选地，所述连接部至少有一部分位于所述支撑部的表面。
优选地，所述容纳部内壁上设有导电片，所述导电片与所述输入端电性连接；或者所述支撑部表面上设有导电片，所述导电片与所述输出端电性连接；或者所述容纳部内壁和所述支撑部表面上分别设有导电片，所述导电片分别与所述输入端和所述输出端电性连接。
优选地，所述容纳部底部上设有凹槽；或者所述容纳部侧壁上设有凹槽；或者所述容纳部底部和所述容纳部侧壁上设有凹槽。
优选地，所述贯穿孔的一个开口设于所述容纳部底部的所述凹槽中。
本发明提供了另一种用于植入式分析物传感器的固定件，用于具有双面微电极的传感器，所述固定件包括支撑部，容纳部，导电通路和贯穿孔；容纳部由容纳部顶部、容纳部侧壁、容纳部底部和容纳部内壁构成，支撑部连接在容纳部底部形成容纳部底部平台；贯穿孔位于支撑部上，一端开口于容纳部底部平台；导电通路位于容纳部上；所述导电通路包括至少两个端部。
一些优选的实施方式中，所述导电通路包括第一端部和第二端部，第二端部与第一端部电性连接。
一些优选的实施方式中，导电通路贯穿容纳部。
一些优选的实施方式中，导电通路位于容纳部外表面。
一些优选的实施方式中，导电通路一部分贯穿容纳部，另一部分位于容纳部外表面。
一些优选的实施方式中，容纳部具有容纳导电通路的导电孔道。
一些优选的实施方式中，第一端部位于容纳部内壁，第二端部位于容纳部顶部或侧壁。
一些优选的实施方式中，导电通路还包括位于容纳部上的第三端部；第三端部与第二端部和第一端部电性连接。
一些优选的实施方式中，所述容纳部上设有一个至三个凹槽；凹槽位于容纳部内壁或底部。
一些优选的实施方式中，所述固定件还包位于容纳部上的导电片；所述导电片与导电通路的端部电性连接。
一些优选的实施方式中，还包括密封圈，密封圈环绕于支撑部侧壁。
一些优选的实施方式中，还包括连接部，连接部连接在支撑部上。
另一方面，本发明还提供一种植入式分析物传感器系统，包括检测单元、信号传输装置、数据处理单元；
检测单元和信号传输装置被固定在一外壳内，并且在该外壳内还设有一电源，用于为外壳内的电子元件供电；
检测单元包括植入式分析物传感器、本发明的用于固定植入式分析物传感器的固定件和传感器电流数据发生装置。
具体的，固定件包括支撑部，容纳部，导电通路和贯穿孔；容纳部由容纳部顶部、容纳部侧壁、容纳部底部和容纳部内壁构成，支撑部连接在容纳部底部形成容纳部底部平台；贯穿孔位于支撑部上，一端开口于容纳部底部平台；导电通路位于容纳部上；所述导电通路包括至少两个端部。
一些优选的实施方式中，固定件通过连接在支撑部上的连接部固定在外壳底座上。
一些优选的实施方式中，所述导电通路包括第一端部和第二端部，第二端部与第一端部电性连接。
一些优选的实施方式中，导电通路贯穿容纳部。
一些优选的实施方式中，导电通路位于容纳部外表面。
一些优选的实施方式中，导电通路一部分贯穿容纳部，另一部分位于容纳部外表面。
一些优选的实施方式中，容纳部具有容纳导电通路的导电孔道。
一些优选的实施方式中，第一端部位于容纳部内壁，第二端部位于容纳部顶部或侧壁。
一些优选的实施方式中，导电通路还包括位于容纳部上的第三端部；第三端部与第二端部和第一端部电性连接。
一些优选的实施方式中，所述容纳部上设有一个至三个凹槽；凹槽位于容纳部内壁或底部。
一些优选的实施方式中，所述固定件还包位于容纳部上的导电片；所述导电片与导电通路的端部电性连接。
本发明的有益效果为：该固定件使双面微电极传感器制备难度相对降低，可有效降低成本。另外该固定件结构简单，制作工艺低，传感器的更换简单方便。并且，具有该固定件的植入式分析物传感器系统检测效率提高。
附图说明
图1为传感器正反两面的结构示意图；
在图2-1(图2-1-a，图2-1-b，图2-1-c，图2-1-d，图2-1-e，图2-1-f，图2-1-g，图2-1-h)中，图2-1-a、图2-1-b和图2-1-c为不同实施例中固定件的正面示意图，图2-1-d、图2-1-e和图2-1-f为不同实施例中固定件的反面示意图，图2-1-g和图2-1-h为固定件和传感器相组合的示意图；
图2-2(图2-2-a，图2-2-b)为不同实施例中固定件的正面示意图；
图3-1，图3-2和图3-3为固定件的俯视示意图；
图4-1～图4-8为固定件不同实施例中的示意图；
图4-9和图4-10为固定件与传感器相组合的示意图；
图5为导电通路部分贯穿容纳部，部分位于容纳部表面的俯视示意图；
图6为植入式分析物传感系统示意图。
具体实施方式
以下实施例进一步说明本发明。这些实施例不是用来限制本发明范围，而是提供对本发明的进一步理解。
一种植入式分析物传感器系统(能够用于持续监测人体血液中的分析物浓度，包括但不限于葡萄糖、钠离子和钾离子)，如图6所示，包括检测单元、信号传输装置、数据处理单元；
检测单元和信号传输装置被固定在一外壳内，该外壳起到保护内部电子元件的作用，并且在该外壳内还设有一电源(未在附图中示出)，用于为外壳内的电子元件供电。
检测单元包括植入式分析物传感器2、用于固定植入式分析物传感器的固定件和传感器电流数据发生装置，本发明中的传感器2优选的是具有双面微电极的传感器，对于具有单面电极的传感器同样适用。
通常，如图1所示，双面微电极的传感器2包括反面(与容纳部内壁接触的一面称为反面)和正面，在正面和反面的上端部分别具有电极接口23，在下端部设有功能电极，如工作电极241、对电极242和参比电极243，工作电极241和对电极242放在传感器2的正面，参比电极243放在传感器2的反面。工作电极241、对电极242和参比电极243分别与电极接口23通过导电迹线连接，从而工作电极241、对电极242和参比电极243通过电极接口23向其它相关组件传输信号。其中，放置功能电极的部分概括为电极区22，放置电极接口23的部分概括为接口区21。电极区22和接口区21在图中，均用方框进行标示。以上介绍的具有双面电极的传感器只是一种较为常见的结构，本领域技术人员可以有选择性的改变这些功能电极的 排布方式，或者加入其它如测量pH、温度等功能电极。
如图2-1-b、图2-1-e、图2-2-a、图2-2-b、图4-1、图4-3和图4-6所示，本发明的用于植入式分析物传感器的固定件包括支撑部3，容纳部1，导电通路400和贯穿孔5。支撑部3由支撑部顶部31、支撑部侧壁32和支撑部底部33组成。其中，容纳部1以凹陷的方式设置在支撑部侧壁32上，并且偏向于靠近支撑部顶部31，该容纳部1用于容纳传感器2的接口区21。容纳部1包括容纳部侧壁13、容纳部底部12、容纳部内壁14和容纳部顶部。容纳部顶部相对于容纳部底部设置，可以是封闭的，也可以是开口。容纳部侧壁13和容纳部底部12分别用于限制传感器2的接口区21左右运动以及向支撑部底部33移动。
贯穿孔5以贯通的方式，从容纳部底部12上的开口一直延伸到支撑部底部33上的开口。从而使传感器2的电极区22从容纳部底部12进入，最终从支撑部底部33伸出。导电通路400分为接收端41和输出端42，接收端41和输出端42之间用连接部连接，连接部由导电材料制成。接收端41和输出端42的数量总和不小于二，接收端41用于接收来自传感器2上的数据信息，输出端42将信息输出至其它的电子元件，如中央处理器。其中接收端41位于容纳部内壁14，输出端42位于支撑部侧壁32上，接收端41和输出端42之间电性连接。
在一个实施例中，如图2-1-b、图2-1-e、图2-2-a、图2-2-b、图4-1、图4-3和图4-6所示，容纳部1由容纳部顶部开口11、容纳部侧壁13、容纳部底部12和容纳部内壁14构成。使用时，传感器2的接口区21从容纳部顶部开口11进入，沿着容纳部侧壁13向下移动，而接口区21下方的电极区22则从容纳部底部12的贯穿孔5进入。最终，接口区21受到容纳部底部12阻挡而停止移动，而电极区22则从支撑部底部33伸出后位于支撑部底部33下方。
容纳部顶部为开口状态形成容纳部顶部开口11，如图2-1-a所示，该开口11为传感器2插入提供入口，从而方便传感器2插入，下面的实施例中的容纳部顶部都是开口的形状。
固定件固定在外壳的底座上，底座上有一孔洞，与贯穿孔5对应，供植入式分析物传感器2的电极区22通过。其中，工作电极241、对电极242和参比电极243等植入到人体内的检测电极概括为电极区22。
植入式分析物传感器2的电极区22通过贯穿孔5植入到人体皮肤下，植入式分析物传感器2反面的接口通过导电通路400与传感器电流数据发生装置电性连接，导电通路400与传感器电流数据发生装置之间也可以增加其它现有的导电材料，进行电性连接。植入式分析物传感器2正面的接口则用现有的导电材料进行电性连接，导电材料包括但不限于石墨、导电胶带和 铜导线。
信号传输装置与传感器电流数据发生装置之间进行数据交换，两者可通过数据线进行数据交换，也可通过无线信号(如蓝牙、WiFi、射频信号等现有的无线数据交换方式)进行数据交换。为实现现有技术中任一数据传输方式，信号传输装置需采用现有技术中对应的元件。
数据处理单元与信号传输装置之间进行数据交换，两者可通过数据线进行数据交换，也可通过无线信号。
传感器电流数据发生装置通过电信号控制植入式分析物传感器检测皮下分析物，以及接收植入式分析物传感器2产生的数据，接收到的数据通过信号传输装置传送到数据处理单元进行处理和显示。例如市面上的微型处理芯片可以实现该功能。
数据处理单元可以是智能终端(智能手机、电脑、平板等)，也可以是包含了显示屏、数据处理芯片的一个组件，其中数据处理芯片安装在外壳内，显示屏安装在外壳上。
上述的植入式分析物传感器系统中，除固定件外，其它的部件以及连接方式并无创造性的技术特征。
本发明提供了一种用于植入式分析物传感器的固定件，用于固定分析物传感器，特别适合具有双面微电极的传感器。
贯穿孔5的横截面可以是三角形、圆形或半圆形等，用于供传感器2植入部分(包含电极区)通过，植入部分通过贯穿孔5后插入到人体皮下，数量为一个。贯穿孔5与容纳部1两个容纳部侧壁13等距，如图3-1～图3-2；也可以偏向一边，如图3-3。由于传感器2有可能不足以刺穿皮肤，为此需要与本领域中常用的穿刺针相互结合，使传感器2的检测电极能够顺利植入到皮下。
如图2-1-b、图2-1-e、图2-2-a、图2-2-b、图4-1、图4-3和图4-6，导电通路400的接收端41用于与传感器20反面的电极接口23接触，接收来自传感器2的信息。而输出端42则用于将信息输出至其它电子元件。
在一些实施例中，导电通路400具有两个输出端，如图4-5，该实施例中，输出端为输出端一421和输出端422。或者也可以具有三个或超过三个输出端。导电通路400数量至少为一个，也可以为两个及以上，其数量与传感器2的反面电极接口数量相关。如在反面增加一温度感应电极时，导电通路的数量需增加一个。当导电通路400的数量大于一个时，导电通路400可以沿同一布局方式排布，也可以采用多种方式进行排布。导电通路400的材料可以是导电金属、导电聚合物或者其它具有导电作用的材料(例如石墨)，其形状可以选择性地为线状、柱 状、片状等。在以下实施例中，本发明以具有一个输入端41和一个输出端42的导电通路400为例，具体的为第一端部41和第二端部42。其中，第一端部41位于容纳部内壁14，并且介于反面电极的电极接口23与固定件之间，第二端部42位于固定件的另外一侧，并与传感器电流数据发生装置对应的接口相连。为了更好地与电极接口23接触，第一端部41需略微的突出容纳部内壁14，突出距离大于0mm，优选地为0.01～1mm。更为优选地为0.01～0.5mm。
反面电极指面向容纳部内壁14的电极，本发明中，将图1右侧的一面作为反面。当然如果图1左侧的一面朝向容纳部内壁14，那么这一面作为反面。本发明的技术方案描述都以图1右侧的一面作为反面为例，并且该反面分布参比电极143，另一面分布对电极242和工作电极241。另，对电极242、工作电极241和参比电极243为电化学分析领域的常用技术，无其它创造性的技术特征。
在一个优选的实施例中，参考图2-1、图2-2、图3-1～图3-3和图4-1～图4～10，容纳部1由容纳部侧壁13、容纳部顶部开口11、容纳部底部12和容纳部内壁14构成，容纳部1内设有凹槽6，该凹槽6用于契合传感器接口区21的边沿。作为一个优选，凹槽6位于容纳部底部12上，并且与容纳部内壁14接触，贯穿孔5的开口位于凹槽6内，如图3-1和图3-3，从而可以契合接口区21的下边沿，并进一步起到固定和限制接口区21的效果。作为另一个优选，在容纳部1的一个容纳部侧壁13(如图3-1、图3-1)或者两个容纳部侧壁13(如图2-1-a和图3-2)上设置凹槽6，并且凹槽6与容纳部内壁14接触。将传感器2插入固定件时，容纳部侧壁13上的凹槽6可以起到引导的作用，方便电极区22进入贯穿孔5。传感器2插入固定件后，还能进一步起到固定和限制接口区21移动的作用。
本发明中，固定件还可以包括连接部(未在图中表示)，连接部用于将固定件固定在分析物检测装置的底座上，固定的方式可以是拆卸式(卡扣、旋接、插拔)或不可拆卸式(使用胶黏剂进行粘接、与底座一体成型)。其中，卡扣的固定方式为最佳。使用时，可直接将传感器2插入固定件的相应位置处或者将其拔出。采用这种方式可以快速更换传感器2，不仅减少了更换时间，也简化了更换步骤。
分析物检测装置指包含了检测单元、信号传输装置和电源的装置，该装置通过粘结、捆绑等方式固定在皮肤上。
本发明中，固定件还可以包括密封圈7，如图2-1中的O型橡胶圈，也可以用疏水薄膜，或其它具有密封作用的现有材料代替，密封圈数量至少为1个，以环绕的方式设置在支撑部侧 壁上，并且位于容纳部底部的下方。密封圈7用于防水，具体地，为防止人体的固定部位触碰水时(如洗澡、游泳等)，水渗入到监测装置内部，从而影响内部的电子元件。
凹槽6数量为1～3个，位于容纳部侧壁13，或容纳部底部12，或是其两者的组合。部分凹糟6的设置分布可参考图2-1、图2-2和图3-1～图3-3。凹槽6用于定位传感器2的接口区21并限制接口区21移动，位于侧壁13的凹槽6还具有引导接口区21插入的作用。其中，如图3-1～图3-3，凹槽6的宽度x大于接口区21的边缘厚度，差值的范围为大于0mm，小于或等于0.5mm，进一步可以是0.05～0.2mm，优选为0.1mm，防止差值过小导致插入困难，也为了防止差值过大导致限制接口区21的效果降低；类似地，容纳部内壁14的宽度y大于接口区21的长度，差值的范围为大于0mm，小于或等于0.5mm，进一步可以是0.05～0.2mm，优选为0.1mm，防止差值过小导致插入困难，也为了防止差值过大导致限制接口区21的效果降低。上述的容纳内壁宽度y，其数值范围为2～5mm。
如图2-1-c，图2-1-f，图2-1-h，图4-2，图4-4，图4-7，图4-8和图4-10，导电片401使用的材料可以是导电金属、导电聚合物或者其它具有导电作用的材料(例如石墨)。导电片401数量可以1个，也可以为多个。导电片401分别与导电通路400的一个端部或多个端部电性连接。当需要增加连接强度时，可以用导电的粘接材料(导电胶、导电胶带)将导电片6与第一端部41和/或第二端部422电性连接。与第一端部41连接时，可以使得第一端部41与反面电极的电极接口23导电连接得更好；与第二端部42连接时，也可以使第二端部42与传感器电流数据发生装置的导电性更加稳定出色。
本发明中，导电通路400可以贯穿固定件的容纳部1，使导电通路400的两个端口分别位于容纳部内壁14和支撑部侧壁32/支撑部顶部31。具体地，固定件设有导电孔道40，如图2-1-a、图2-1-d、图3-1～图3-3，该导电孔道40用于供导电通路400通过，从而使导电通路400的第一端部41指向固定件的容纳部内壁14。而导电通路400的第二端部42位于支撑部3的其它面上，如图2-1-e中的第二端部42位于相对于容纳部1的支撑部侧壁32的背面。但这并不意味着第二端部42必须位于该面，也可以位于相对于容纳部1的支撑部侧壁32的侧面，例如图2-2-a。以及在另外的实施例中，导电通路400贯穿支撑部3，第二端部42位于支撑部顶部31，如图2-2-b。
在一个实施例中，第一端部41与传感器2的反面电极之间设有导电片401，反面电极的电极接口23与导电片401电性连接，第一端部41与导电片401之间电性连接，导电片401位于容纳部内壁14表面，如图2-1-g所示。
在一个实施例中，第二端部42位于相对于容纳部1的支撑部侧壁32的背面，使其能够与传感器电流数据发生装置的接口电性连接，如图2-1-e所示。
在一个实施例中，相对于容纳部1的支撑部侧壁32的背面设有导电片401，第二端部42与导电片401电性连接，同时导电片401也能够与传感器电流数据发生装置的接口电性连接，并且增强电信号的连接强度，如图2-1-h所示。
在一个实施例中，导电孔道40为曲线或折线，导电通路400的第一端部41指向容纳部内壁14，而第二端部42指向支撑部侧壁32或支撑部顶部31上，如图5。
在一个优选的实施例中，第一端部41与传感器2的反面电极之间设有导电片401，固定件的背面也设有一导电片401，第二端部42与导电片401电性连接，传感器2插入固定件10后的效果如图2-1-g和图2-1-h所示。
本发明中，导电通路400可以位于固定件的外表面，并且，导电通路400的两个端口分别位于容纳部内壁14，以及支撑部侧壁32或者支撑部顶部31，也就是一个端口位于容纳部内壁14，另一个端口位于支撑部侧壁32或者支撑部顶部31。此时，固定件中不设导电孔道40，导电通路400沿容纳部固定件的表面分布，从而使导电通路400的第一端部41位于容纳部内壁14(如图4-1、图4-2、图4-7、图4-8所示)，第二端部42位于支撑部顶部31(图4-3所示)，或者第二端部42位于相对于容纳部1的支撑部侧壁32的侧面(图4-6和图4-7所示)，或第二端部42位于相对于容纳部1的支撑部侧壁32的背面(图4-4、图4-5和图4-10所示)。为了增加导电通路400在固定件表面的粘附强度，可以在导电通路400与固定件表面之间设置一层粘附层或者用胶黏剂进行粘接，除此之外，也可以用镶嵌的方式进行固定。
本发明中，导电通道400可以一部分贯穿支撑部3，另一部分位于支撑部侧壁32的外表面，并且，导电通道400的第一端部41位于容纳部内壁14，第二端部42位于支撑部侧壁32的侧面或背面。例如图5所示，导电通路400的一部分(黑色虚线部分)贯穿通过固定件，另一部分(黑色实线部分)沿支撑部侧壁32表面延伸至支撑部侧壁32的背面，也可以是支撑部顶部31或支撑部侧壁32的侧面，反之也可以。

Claims (10)

  1. 一种植入式分析物传感器的固定件，其特征在于，
    所述固定件包括支撑部，容纳部，导电通路和贯穿孔；
    所述支撑部包括支撑部侧壁、支撑部顶部和支撑部底部；
    所述容纳部以凹陷的方式位于所述支撑部侧壁中，所述容纳部包括容纳部侧壁、容纳部内壁、容纳部底部和容纳部顶部；
    所述导电通路包括输入端和输出端，所述输入端位于所述容纳部内壁，所述输出端位于所述支撑部的表面；所述输入端和所述输出端通过连接部电性连接；
    所述贯穿孔的一个开口位于所述容纳部底部，另一个开口位于所述支撑部底部。
  2. 根据权利要求1所述的植入式分析物传感器的固定件，其特征在于，
    所述容纳部顶部为开口。
  3. 根据权利要求2所述的植入式分析物传感器的固定件，其特征在于，
    所述连接部至少有一部分位于所述支撑部内。
  4. 根据权利要求3所述的植入式分析物传感器的固定件，其特征在于，
    所述输入端突出所述容纳部内壁。
  5. 根据权利要求3所述的植入式分析物传感器的固定件，其特征在于，
    所述输出端突出所述支撑部的表面。
  6. 根据权利要求2所述的植入式分析物传感器的固定件，其特征在于，
    所述连接部至少有一部分位于所述支撑部的表面。
  7. 根据权利要求1～6任一所述的植入式分析物传感器的固定件，其特征在于，
    所述容纳部内壁上设有导电片，所述导电片与所述输入端电性连接；
    或者所述支撑部表面上设有导电片，所述导电片与所述输出端电性连接；
    或者所述容纳部内壁和所述支撑部表面上分别设有导电片，所述导电片分别与所述输入端和所述输出端电性连接。
  8. 根据权利要求1～6任一所述的植入式分析物传感器的固定件，其特征在于，
    所述容纳部底部上设有凹槽；
    或者所述容纳部侧壁上设有凹槽；
    或者所述容纳部底部和所述容纳部侧壁上设有凹槽。
  9. 根据权利要求7所述的植入式分析物传感器的固定件，其特征在于，
    所述贯穿孔的一个开口设于所述容纳部底部的所述凹槽中。
  10. 一种植入式分析物传感器系统，其特征在于，包括检测单元、信号传输装置、数据处理单元；
    检测单元和信号传输装置被固定在一外壳内，并且在该外壳内还设有一电源，用于为外壳内的电子元件供电；
    检测单元包括植入式分析物传感器、权利要求1～9之一的所述用于固定植入式分析物传感器的固定件和传感器电流数据发生装置。
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