WO2018027940A1 - Transcutaneous analyte sensing system and methods of installation thereof - Google Patents

Transcutaneous analyte sensing system and methods of installation thereof Download PDF

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Publication number
WO2018027940A1
WO2018027940A1 PCT/CN2016/094970 CN2016094970W WO2018027940A1 WO 2018027940 A1 WO2018027940 A1 WO 2018027940A1 CN 2016094970 W CN2016094970 W CN 2016094970W WO 2018027940 A1 WO2018027940 A1 WO 2018027940A1
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WO
WIPO (PCT)
Prior art keywords
inserter
sensing system
support mount
analyte sensing
transcutaneous analyte
Prior art date
Application number
PCT/CN2016/094970
Other languages
French (fr)
Inventor
Cuijun YANG
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Medtrum Technologies Inc.
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.)
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Publication date
Application filed by Medtrum Technologies Inc. filed Critical Medtrum Technologies Inc.
Priority to PCT/CN2016/094970 priority Critical patent/WO2018027940A1/en
Publication of WO2018027940A1 publication Critical patent/WO2018027940A1/en

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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
    • A61B5/14532—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
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • 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
    • A61B5/6848—Needles
    • A61B5/6849—Needles in combination with a needle set
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • 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
    • A61B5/6848—Needles
    • 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
    • A61B5/685—Microneedles

Definitions

  • the present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, relates to a transcutaneous analyte sensing system and methods of installation thereof.
  • a pancreas in a normal human body may automatically monitor the changes of glucose in the blood, and automatically secretes insulin required.
  • a pancreas in a diabetic patient cannot secrete the insulin required as normal, in other words, the pancreatic function is abnormal.
  • Diabetes is a lifelong disease which has no cure using current medical technology, and the only way to control diabetes is to stabilize glucose. In referring to stabilizing glucose thus controlling diabetes using insulin therapy, accurate knowledge of the glucose level information plays a crucial role.
  • glucose monitoring usually uses a test strip and a glucose meter, and blood glucose is detected by a magnitude of current produced as a result of reactions between glucose in blood and glucose oxidase in the test strip.
  • the conventional glucose detection typically requires uncomfortable finger pricking methods. Besides the lack of comfort and convenience brought by repeated pricking, instantaneous glucose is normally detected at seven times of a day, including empty stomach, after breakfast, before lunch, after lunch, before dinner, after dinner, and before sleep.
  • the instantaneous glucose is likely to be influenced by many factors such as movement, diet, drug, mood swing and etc., and only reflects glucose situation at limited time points of a day, but not all ⁇ day glucose situation of the diabetic patient, so asymptomatic hypoglycemia and hyperglycemia are difficult to be found, sometimes may incur dangerous side effects.
  • the patient will not know his or her blood glucose value going up or down until too late based on conventional method. This insufficient knowledge of the glucose level information inhibits the application of insulin therapy.
  • CGM continuous glucose monitoring
  • the CGM system mainly includes a sensor probe and an electronic device configured to record glucose information and display.
  • the CGM system has advantages of small size, portability, accurate and continuous glucose information, etc.
  • the sensor probe is implanted subcutaneously, then the CGM system monitors the changes of glucose 24 ⁇ hour continuously and draws a curve representing the changes of glucose, which can provide an important reference for the insulin therapy.
  • the CGM system can make an alarm to the user when an abnormality such as hypoglycemia or hyperglycemia occurs, preventing treatment delay.
  • EP2327362A1 disclosed a transcutaneous analyte sensing system which can implant the sensor under the host’s skin and realize continuous glucose detection, but a plurality of additional members as a plunger, a push rod and a guide tube assembly configured to insert the needle and sensor as well as retract the needle are needed, which compromised the compactness of the system. More importantly, the insertion and the retraction of the needle both depend on manual operation of the patient, which is not only inconvenient but also insecure.
  • one purpose of the present invention is to provide a transcutaneous analyte sensing system, comprising,
  • the support mount fixed on the medical adhesive tape, wherein the support mount comprises a first installation structure, a second installation structure and a third installation structure;
  • a sensor body matching the first installation structure comprising a sensor probe and a sensor probe shell;
  • an inserter matching the second installation structure configured to install the sensor probe transcutaneously and install the sensor probe shell on a support mount, wherein the inserter comprises an instant ejection ⁇ retraction mechanism and release buttons;
  • a transmitter matching the third installation structure configured to electrically connect with the sensor probe and convert analyte content information received from the sensor probe into a radio signal and send to a receiver;
  • a hole to let through the guide needle is set on the sensor probe shell and the support mount respectively.
  • the instant ejection ⁇ retraction mechanism comprises a guide needle, an ejecting spring, a retracting spring and two sliding blocks, configured to complete the ejection and retraction of the guide needle instantly; and the guide needle is a groove needle.
  • the sensor probe comprises a sensing part configured to detect analyte contents in the human body and a connecting part configured to connect the transmitter; and the sensing part of the sensor probe is initially set in the groove of the groove needle.
  • the sensor body is initially located inside the inserter
  • the inserter is initially mounted on the support mount
  • the guide needle initially penetrates through the sensor probe shell via the hole on the sensor probe shell but not through the support mount.
  • the number of the release buttons is two, and the two release buttons are set opposite to each other on the circumference of the inserter.
  • the first installation structure is three blocks set on the support mount.
  • the structure on the sensor body matching the blocks is a ring with hooks.
  • a silica gel plug is set between the ring with hooks and the support mount on the sensor body, configured to realize the waterproof function.
  • the second installation structure is a pair of release tabs with each tab comprising a clamp part and a ribbed part; and the clamp parts are configured to match both the inserter and the transmitter.
  • the third installation structure comprises a pair of flanges located on the inner side of the second installation structure, configured to snap ⁇ fit the grooves on both sides of the transmitter; and a pair of hooks, configured to hook the rear part of the transmitter.
  • two O ⁇ shape sealing rings are further set on the sensor body, configured to realize the waterproof function by matching a sealing chamber on the bottom of the shell of the transmitter.
  • an arrow mark is set on the support mount or the inserter, configured to guide the user to complete the installation of the sensor body on the support mount and remove the inserter according to the arrow mark.
  • the transcutaneous analyte sensing system further comprises a safety lock.
  • the safety lock is initially arranged around the inserter in the circumferential direction and connected with the support mount, configured to cover the release buttons and prevent accidental button press.
  • the safety lock further has a structure being able to clamp half ⁇ around one end of the inserter from which the guide needle protrudes along the longitudinal direction, configured to prevent the tip of the guide needle from being exposed after the inserter is removed.
  • the structures configured to connect the support mount and the inserter are clamping hooks, and the structures on the support mount and the inserter matching the clamping hooks are slots.
  • the safety lock further comprises an operating handle configured to control the clamping hooks to hook on or separate from the slots.
  • the other purpose of the present invention is to provide a method of installation of the transcutaneous analyte sensing system identified above.
  • the installation includes the following steps:
  • Unpack the transcutaneous analyte sensing system including the medical adhesive tape, the support mount fixed on the medical adhesive tape, the inserter installed on the second installation structure of the support mount, and the sensor body located inside the inserter, peel off the protective liner on the other side of the medical adhesive tape and adhere the tape to a body part to be tested;
  • the instant ejection ⁇ retraction mechanism is triggered to push the guide needle to penetrate a skin with the sensor probe and retract the guide needle instantly leaving the sensor probe under the skin, while the sensor body initially located inside the inserter is pushed to reach the first installation structure of the support mount also by the instant ejection ⁇ retraction mechanism;
  • the installation includes the following steps:
  • Unpack the transcutaneous analyte sensing system including the medical adhesive tape, the support mount fixed on the medical adhesive tape, the inserter installed on the second installation structure of the support mount, the sensor body located inside the inserter and the safety lock, peel off the protective liner on the other side of the medical adhesive tape and adhere the tape to a body part to be tested;
  • the transcutaneous analyte sensing system in the present invention has preferential features in the following aspects. Firstly, it is able to monitor the changes of glucose 24 ⁇ hour continuously and draw a curve representing the changes of glucose, which can provide an important reference for the insulin therapy. At the same time, it can make an alarm to the user when an abnormality such as hypoglycemia or hyperglycemia occurs, preventing treatment delay. Secondly, it has a very sophisticatedly ⁇ designed compact structure which enables the installation of the sensor body without any extra mating component needed. The unique structure of the instant ejection ⁇ retraction mechanism in the present invention enables the actions of ejection and retraction to be completed instantly without any manual operation of the user needed, minimizing the safety risks.
  • the unique structure of the support mount in the present invention can be releasably mated with the inserter, the sensor body and the transmitter, which enables the user to easily remove the inserter and install the transmitter after the installation of the sensor body without complicated operation instructions.
  • the safety lock in the present invention further enhances the safety of the installation by preventing the release buttons from being pressed accidentally to trigger the instant ejection ⁇ retraction mechanism unintentionally and covering one end of the inserter from which the guide needle protrudes to prevent accident caused by the tip of the guide needle being exposed after the inserter is removed.
  • the transcutaneous analyte sensing system in the present invention has advantages as compactness, convenience of wearing, easy and safe installation operation which provides a desirable solution for the users willing to self ⁇ test their glucose continuously and an indispensable support to rational treatment for diabetes using the insulin therapy.
  • FIG. 1 illustrates a schematic diagram of a transcutaneous analyte sensing system according to the present invention
  • FIG. 2 illustrates a schematic diagram of a sensor probe in a transcutaneous analyte sensing system according to the present invention
  • FIG. 3 illustrates an exploded view of a transmitter, a support mount and a medical adhesive tape in a transcutaneous analyte sensing system according to the present invention
  • FIG. 4 illustrates a schematic diagram of a support mount in a transcutaneous analyte sensing system according to the present invention
  • FIG. 5 illustrates a schematic diagram of an inserter in a transcutaneous analyte sensing system according to the present invention
  • FIG. 6 illustrates an initial status of the inserter mounted on the support mount in a transcutaneous analyte sensing system according to the present invention
  • FIG. 7 illustrates a separate status of the inserter and the support mount in a transcutaneous analyte sensing system according to the present invention
  • FIG. 8 illustrates a separate status of a sensor body and the support mount in a transcutaneous analyte sensing system according to the present invention
  • FIG. 9 illustrates a top view of the sensor body installed on the support mount in a transcutaneous analyte sensing system according to the present invention.
  • FIG. 10 illustrates a schematic diagram of an instant ejection ⁇ retraction mechanism in a transcutaneous analyte sensing system according to the present invention
  • FIG. 11 illustrates a cross ⁇ sectional view 1 of the instant ejection ⁇ retraction mechanism in a transcutaneous analyte sensing system according to the present invention
  • FIG. 12 illustrates a cross ⁇ sectional view 2 of the instant ejection ⁇ retraction mechanism in a transcutaneous analyte sensing system according to the present invention
  • FIG. 13 illustrates a schematic diagram of a transcutaneous analyte sensing system with O ⁇ shape rings according to the present invention
  • FIG. 14 illustrates a cross ⁇ sectional view of a transcutaneous analyte sensing system with O ⁇ shape rings and a silica gel plug according to the present invention
  • FIG. 15 illustrates a schematic diagram 1 of the transmitter in a transcutaneous analyte sensing system according to the present invention
  • FIG. 16 illustrates a schematic diagram 2 of the transmitter in a transcutaneous analyte sensing system according to the present invention
  • FIG. 17 illustrates the installation completion status of the transmitter on the support mount in a transcutaneous analyte sensing system according to the present invention
  • FIG. 18 illustrates a separate status of a safety lock and the support mount in a transcutaneous analyte sensing system according to the present invention
  • FIG. 19 illustrates an initial status of the transcutaneous analyte sensing system with the safety lock according to the present invention
  • FIG. 20 illustrates a schematic diagram of the safety lock coupled with the inserter in a transcutaneous analyte sensing system according to the present invention
  • FIG. 21 illustrates a separate status of the safety lock and the inserter in a transcutaneous analyte sensing system according to the present invention.
  • the present invention provides a transcutaneous analyte sensing system, which is configured to dynamically monitor change of an analyte content in the human body in real time by a sensor probe implanted subcutaneously into the patient.
  • the sensor probe is implanted subcutaneously into a patient, and the continuous glucose monitoring system monitors the changes of the glucose 24 ⁇ hour continuously and draws a curve of it, which provides an important reference to proper insulin therapies.
  • FIG. 1 to 3 a transcutaneous analyte sensing system which has been installed completely is illustrated, including a medical adhesive tape 1, a support mount 2, a transmitter 3 and a sensor body 4 installed on the support mount 2 and electrically connected with the transmitter 3 which further comprises a sensor probe 40.
  • the transcutaneous analyte sensing system which was installed completely is ready to detect an analyte content in the human body, with the support mount 2 fixed on the medical tape 1, and the transmitter 3 installed on the support mount 2.
  • the sensor probe 40 is configured to detect the analyte content in the human body and send the detected analyte content information.
  • the sensor probe 40 comprises a sensing part 41 configured to detect the analyte content in the human body and a connecting part 42 configured to connect the transmitter 3.
  • the sensing part 41 senses an analyte in the human body after being implanted subcutaneously via the aid of the guide needle, then the data of the analyte content is sent to the transmitter 3 by the connecting part 42 via the electrical connection between the transmitter 3 and the connecting part 42 which is then converted to a radio signal and finally transmitted to a receiver.
  • FIG. 3 illustrates an exploded view of the transcutaneous analyte sensing system installed completely, showing the sensor body 4 installed on the support mount 2, and the connecting part 42 of the sensor probe 40 electrically connected with the transmitter 3.
  • FIG. 4 to FIG. 9 an embodiment of the installation of the transcutaneous analyte sensing system without a safety lock in the present invention is provided, showing how the sensor body 4 is installed on the support mount 2 properly and how the inserter 5 is removed from the support mount 2 after installation of the sensor body 4.
  • FIG. 4 illustrates an exploded view of the detailed structures of the support mount 2.
  • the support mount 2 is fixed on the medical adhesive tape 1, comprising a first installation structure, in this embodiment, three blocks 22, configured to mate the sensor body 4; a second installation structure, in this embodiment, a pair of release tabs 21, each of which further comprises a clamp part 211 and a ribbed part 212, configured to mate both the inserter 5 and the transmitter 3; a third installation structure, in this embodiment, a pair of flanges 23, configured to mate the groove on the transmitter 3; and a pair of hooks 24, configured to hook the rear part of the transmitter 3.
  • a first installation structure in this embodiment, three blocks 22, configured to mate the sensor body 4
  • a second installation structure in this embodiment, a pair of release tabs 21, each of which further comprises a clamp part 211 and a ribbed part 212, configured to mate both the inserter 5 and the transmitter 3
  • a third installation structure in this embodiment, a pair of flanges 23, configured to
  • an arrow mark 51 is set on the top of the shell of the inserter 5, configured to guide the user to rotate the inserter 5 according to the arrow mark 51 to complete the installation of the sensor body on the support mount and remove the inserter 5.
  • the inserter 5 is initially mounted on the support mount 2 by the clamp part 211 from the second installation structure.
  • the two release buttons 53 protruded from the inserter 5 at the same time, so the instant ejection ⁇ retraction mechanism inside the inserter 5 is triggered to push the guide needle 8 in FIG.
  • FIG. 8 and FIG. 9 There are three slots set on the three blocks 22 from the first installation structure which are configured to accommodate the hooks on the ring with hooks 43.
  • the guide needle 8 goes through the hole on the support mount 2 with the sensing part 41 of the sensor probe 40, and the hooks on the ring of hooks 43 snap ⁇ fit the slots on the three blocks 22 by rotating together with the inserter 5.
  • the instant ejection ⁇ retraction mechanism comprises a first sliding block 71, a second sliding block 72, an ejecting spring 73, a retracting spring 74 and a guide needle 8, and the instant ejection ⁇ retraction mechanism cooperates with the release buttons 53 to realize the instant ejection and retraction process of the guide needle 8.
  • the first sliding block 71 comprises a hollow guide column 710 arranged vertically, a needle seat parallel to the hollow guide column 710, and a first locking part 711 which is a bump located on an inner wall of the hollow guide column 710.
  • the second sliding block 72 comprises a second locking part 721 which is a clamping hook matching the bump shape of the first locking part 711, and the second locking part 721 penetrates through the lumen of the hollow guide column 710.
  • the first locking part 711 and the second locking part 721 are initially locked with each other.
  • the ejecting spring 73 is arranged circumferentially outside of the hollow guide column 710, and the retracting spring 74 is located in the lumen of the hollow guide column 710.
  • the two release buttons 53 configured to trigger the instant ejection ⁇ retraction mechanism are located opposite to each other on the circumference of the inserter 5.
  • the ejecting spring 73 is initially in its compressed state, and the two ends of the ejecting spring 73 cling to the second sliding block 72 and two fixed baffles 75 located inside the inserter 5.
  • the retracting spring 74 is initially in its compressed state too, and the two ends of the retracting spring 74 cling to the first sliding block 71 and the second sliding block 72.
  • the guide needle 8 is fixed at the needle seat of the first sliding block 71.
  • the two release buttons 53 are two wedges with the thin parts pressing against two outer baffles 54 set on the outer wall of the inserter 5 and the thick parts protruding from the outer wall of the inserter 5. As shown in FIG. 10, the two release buttons 53 cooperate with the second sliding block 72 by locking the second sliding block 72 at its initial position. When an external force is applied on the release buttons 53, the release buttons 53 are pressed inward to enter the inserter 5 completely and are subsequently pushed downward along the inner wall of the inserter 5 by the force released from the ejecting spring 73.
  • the ejecting spring 73 is released from the compressed state and drives the second sliding block 72 to move downward, bringing the whole instant ejection ⁇ retraction mechanism including the first sliding block 71, the second sliding block 72, the retracting spring 74 and the guide needle downward, so the guide needle 8 is pushed out of the support mount to penetrate a human skin.
  • the retracting spring 74 maintains in its compressed state.
  • the instant ejection ⁇ retraction mechanism When the instant ejection ⁇ retraction mechanism reaches a designated position, the bump ⁇ shaped locking part 711 from the first sliding block 71 and the clamping ⁇ hook ⁇ shaped locking part 721 from the second sliding block 72 are released from each other, so the retracting spring 74 is released from the compressed state, and pushes the first sliding block 71 and the guide needle 8 to move upward and go back into the inserter 5, so the guide needle 8 is retracted from the human body by the retracting spring 74.
  • the ejection and retraction actions of the guide needle 8 are completed instantly by the instant ejection ⁇ retraction mechanism, during which process no manual operation is needed.
  • one end of the guide needle 8 which has a groove 81 configured to accommodate the sensing part 41 of the sensor probe 40 is fixed inside the needle bed of the first sliding block 71, and the guide needle 8 penetrates through the second sliding block 72 and extends outside of the second sliding block 72.
  • the guide needle 8 is ejected downward, and when the retracting spring 74 is released, the guide needle 8 is retracted upward.
  • the cross section of the groove 81 is curved, and the sensing part 41 of the sensor probe 40 configured to detect the analyte content in the human body is arranged in the groove 81.
  • the guide needle 8 penetrates a human skin with the sensing part 41, so the sensing part 41 is implanted subcutaneously through the lead of the guide needle 8, after which process the retracting spring 74 is released, and the guide needle 8 is retracted upward, leaving the sensing part 41 indwelling in the human body and continuously detecting the analyte content.
  • an embodiment of the transcutaneous analyte sensing system with waterproof functions is provided.
  • two O ⁇ shape sealing rings 45 are set on the sensor body 4, configured to match a sealing chamber 34 on the bottom of the shell of the transmitter 3 for the waterproof purpose.
  • a silica gel plug 44 is further set on the sensor body 4. When the sensor body is installed on the support mount 2, the silica gel plug 44 is squeezed against the support mount 2 to realize waterproof function.
  • the third installation structure comprises a pair of flanges 23 and a pair of hooks 24, and the clamp part 211 of the release tabs 21 of the second installation structure is also configured to match the transmitter.
  • two grooves 31 are set on both sides of the transmitter 3 configured to match the flanges 23 of the third installation structure; and an arcuate slot 32 is set on the head part of the transmitter 3 configured to match the clamp part 211 from the second installation structure; and two slots 33 are set on the rear part of the transmitter 3 configured to match the hooks 24 from the third installation structure.
  • FIG. 17 illustrates the installation completion status of the transmitter 3 on the support mount 2.
  • an embodiment of the transcutaneous analyte sensing system with a safety lock is provided.
  • two slots 210 are arranged on both release tabs 21 of the second installation structure, configured to match two clamping hooks 61 arranged on the safety lock 6.
  • An operating handle 62 configured to control the clamping hooks 61 to hook on or separate from the slots 210 is further arranged on the safety lock 6.
  • the safety lock 6 is initially arranged around the outer wall of the inserter 5 in the circumferential direction and hooked on the support mount 2 with the clamping hooks 61 as shown in FIG. 19, configured to prevent the release buttons 53 from being pressed accidentally.
  • an embodiment of another function of the safety lock 6 besides covering the release buttons 53 is provided.
  • the safety lock 6 When the safety lock 6 is removed from the inserter 5 and the support mount 2, it can be clamped half ⁇ around one end of the inserter 5 from which the guide needle 8 protrudes along the longitudinal direction with four additional hooks 63 as shown in FIG. 20 and FIG. 21, configured to prevent the tip of the guide needle 8 from being exposed after the inserter 5 is removed from the support mount 2.

Abstract

A transcutaneous analyte sensing system and methods of installation thereof are provided. The transcutaneous analyte sensing system comprises a medical adhesive tape(1), a support mount(2) comprising a first installation structure, a second installation structure and a third installation structure configured to mate with a sensor body(4), an inserter(5), and a transmitter(3). The inserter(5) comprises an instant ejection-retraction mechanism and release buttons(53) which can complete the ejection and retraction process instantly without any manual operation. After the installation of the sensor body(4), the inserter(5) can be easily removed and the transmitter(3) can be easily installed or removed. A safety lock(6) is further set on the transcutaneous analyte sensing system which can be mated with the support mount(2) and the inserter(5). The transcutaneous analyte sensing system has advantages as compactness, convenience of wearing, easy and safe installation operation which provides a desirable solution for the users willing to self-test their glucose continuously.

Description

[Title established by the ISA under Rule 37.2] TRANSCUTANEOUS ANALYTE SENSING SYSTEM AND METHODS OF INSTALLATION THEREOF FIELD OF THE INVENTION
The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, relates to a transcutaneous analyte sensing system and methods of installation thereof.
BACKGROUND TECHNOLOGY
A pancreas in a normal human body may automatically monitor the changes of glucose in the blood, and automatically secretes insulin required. However, a pancreas in a diabetic patient cannot secrete the insulin required as normal, in other words, the pancreatic function is abnormal. Diabetes is a lifelong disease which has no cure using current medical technology, and the only way to control diabetes is to stabilize glucose. In referring to stabilizing glucose thus controlling diabetes using insulin therapy, accurate knowledge of the glucose level information plays a crucial role.
Conventionally, glucose monitoring usually uses a test strip and a glucose meter, and blood glucose is detected by a magnitude of current produced as a result of reactions between glucose in blood and glucose oxidase in the test strip. The conventional glucose detection typically requires uncomfortable finger pricking methods. Besides the lack of comfort and convenience brought by repeated pricking, instantaneous glucose is normally detected at seven times of a day, including empty stomach, after breakfast, before lunch, after lunch, before dinner, after dinner, and before sleep. Unfortunately, the instantaneous glucose is likely to be influenced by many factors such as movement, diet, drug, mood swing and etc., and only reflects glucose situation at limited time points of a day, but not all‐day glucose situation of the diabetic patient, so asymptomatic hypoglycemia and hyperglycemia are difficult to be found, sometimes may incur dangerous side effects. Usually the patient will not know his or her blood glucose value going up or down until too late based on conventional method. This insufficient knowledge of the glucose level information inhibits the application of insulin therapy.
To overcome the problem of insufficient information provided by instantaneous glucose, continuous glucose monitoring (CGM) system appeared on the market which can continuously monitor the changes of glucose by using a glucose sensor probe implanted in the subcutaneous tissue of a patient. The CGM system mainly  includes a sensor probe and an electronic device configured to record glucose information and display. The CGM system has advantages of small size, portability, accurate and continuous glucose information, etc. When glucose is to be detected, the sensor probe is implanted subcutaneously, then the CGM system monitors the changes of glucose 24‐hour continuously and draws a curve representing the changes of glucose, which can provide an important reference for the insulin therapy. Furthermore, the CGM system can make an alarm to the user when an abnormality such as hypoglycemia or hyperglycemia occurs, preventing treatment delay. However, CGM products in the current market still lack safety and convenience in using. EP2327362A1 disclosed a transcutaneous analyte sensing system which can implant the sensor under the host’s skin and realize continuous glucose detection, but a plurality of additional members as a plunger, a push rod and a guide tube assembly configured to insert the needle and sensor as well as retract the needle are needed, which compromised the compactness of the system. More importantly, the insertion and the retraction of the needle both depend on manual operation of the patient, which is not only inconvenient but also insecure.
SUMMARY OF THE INVENTION
To overcome shortcomings in the prior art mentioned above, one purpose of the present invention is to provide a transcutaneous analyte sensing system, comprising,
a medical adhesive tape；
a support mount fixed on the medical adhesive tape, wherein the support mount comprises a first installation structure, a second installation structure and a third installation structure；
a sensor body matching the first installation structure, comprising a sensor probe and a sensor probe shell；
an inserter matching the second installation structure, configured to install the sensor probe transcutaneously and install the sensor probe shell on a support mount, wherein the inserter comprises an instant ejection‐retraction mechanism and release buttons；
a transmitter matching the third installation structure, configured to electrically connect with the sensor probe and convert analyte content information received from the sensor probe into a radio signal and send to a receiver；
a hole to let through the guide needle is set on the sensor probe shell and the  support mount respectively.
Alternatively, the instant ejection‐retraction mechanism comprises a guide needle, an ejecting spring, a retracting spring and two sliding blocks, configured to complete the ejection and retraction of the guide needle instantly； and the guide needle is a groove needle.
Alternatively, the sensor probe comprises a sensing part configured to detect analyte contents in the human body and a connecting part configured to connect the transmitter； and the sensing part of the sensor probe is initially set in the groove of the groove needle.
Alternatively, the sensor body is initially located inside the inserter；
the inserter is initially mounted on the support mount；
the guide needle initially penetrates through the sensor probe shell via the hole on the sensor probe shell but not through the support mount.
Alternatively, the number of the release buttons is two, and the two release buttons are set opposite to each other on the circumference of the inserter.
Alternatively, the first installation structure is three blocks set on the support mount.
Alternatively, the structure on the sensor body matching the blocks is a ring with hooks.
Alternatively, a silica gel plug is set between the ring with hooks and the support mount on the sensor body, configured to realize the waterproof function.
Alternatively, the second installation structure is a pair of release tabs with each tab comprising a clamp part and a ribbed part； and the clamp parts are configured to match both the inserter and the transmitter.
Alternatively, the third installation structure comprises a pair of flanges located on the inner side of the second installation structure, configured to snap‐fit the grooves on both sides of the transmitter； and a pair of hooks, configured to hook the rear part of the transmitter.
Alternatively, two O‐shape sealing rings are further set on the sensor body, configured to realize the waterproof function by matching a sealing chamber on the bottom of the shell of the transmitter.
Alternatively, an arrow mark is set on the support mount or the inserter, configured to guide the user to complete the installation of the sensor body on the support mount and remove the inserter according to the arrow mark.
Alternatively, the transcutaneous analyte sensing system further comprises a safety lock.
Alternatively, the safety lock is initially arranged around the inserter in the circumferential direction and connected with the support mount, configured to cover the release buttons and prevent accidental button press.
Alternatively, the safety lock further has a structure being able to clamp half‐around one end of the inserter from which the guide needle protrudes along the longitudinal direction, configured to prevent the tip of the guide needle from being exposed after the inserter is removed.
Alternatively, the structures configured to connect the support mount and the inserter are clamping hooks, and the structures on the support mount and the inserter matching the clamping hooks are slots.
Alternatively, the safety lock further comprises an operating handle configured to control the clamping hooks to hook on or separate from the slots.
The other purpose of the present invention is to provide a method of installation of the transcutaneous analyte sensing system identified above.
For the transcutaneous analyte sensing system without a safety lock, the installation includes the following steps:
Unpack the transcutaneous analyte sensing system including the medical adhesive tape, the support mount fixed on the medical adhesive tape, the inserter installed on the second installation structure of the support mount, and the sensor body located inside the inserter, peel off the protective liner on the other side of the medical adhesive tape and adhere the tape to a body part to be tested；
Press the two release buttons protruded from the inserter at the same time, so the instant ejection‐retraction mechanism is triggered to push the guide needle to penetrate a skin with the sensor probe and retract the guide needle instantly leaving the sensor probe under the skin, while the sensor body initially located inside the inserter is pushed to reach the first installation structure of the support mount also by the instant ejection‐retraction mechanism；
Rotate the inserter according to the arrow mark on the support mount to interlock the hook ring on the sensor body with the first installation structure, then remove the inserter along the longitudinal direction from the second installation structure after completing the installation of the sensor body；
Snap the transmitter into the third installation structure of the support mount  to realize electrical connection between the sensor body and the transmitter, and the installation of the transcutaneous analyte sensing system is completed；
When the transmitter needs to be removed, press the rear arms of the release tabs to remove the transmitter easily.
For the transcutaneous analyte sensing system with a safety lock, the installation includes the following steps:
Unpack the transcutaneous analyte sensing system including the medical adhesive tape, the support mount fixed on the medical adhesive tape, the inserter installed on the second installation structure of the support mount, the sensor body located inside the inserter and the safety lock, peel off the protective liner on the other side of the medical adhesive tape and adhere the tape to a body part to be tested；
Remove the safety lock from the circumference of the inserter and press the two release buttons protruded from the inserter at the same time, so the instant ejection‐retraction mechanism is triggered to push the guide needle to penetrate a skin with the sensor probe and retract the guide needle instantly leaving the sensor probe under the skin, while the sensor body initially located inside the inserter is pushed to reach the first installation structure of the support mount also by the instant ejection‐retraction mechanism；
Rotate the inserter according to the arrow mark on the support mount to interlock the hook ring on the sensor body with the first installation structure, then remove the inserter along the longitudinal direction from the second installation structure after completing the installation of the sensor body；
Clamp the safety lock onto the end of the inserter from which the guide needle protrude along the longitudinal direction with the hooks；
Snap the transmitter into the third installation structure of the support mount to realize electrical connection between the sensor body and the transmitter, and the installation of the transcutaneous analyte sensing system is completed；
When the transmitter needs to be removed, press the rear arms of the release tabs to remove the transmitter easily.
The transcutaneous analyte sensing system in the present invention has preferential features in the following aspects. Firstly, it is able to monitor the changes of glucose 24‐hour continuously and draw a curve representing the changes of glucose, which can provide an important reference for the insulin therapy. At the  same time, it can make an alarm to the user when an abnormality such as hypoglycemia or hyperglycemia occurs, preventing treatment delay. Secondly, it has a very sophisticatedly‐designed compact structure which enables the installation of the sensor body without any extra mating component needed. The unique structure of the instant ejection‐retraction mechanism in the present invention enables the actions of ejection and retraction to be completed instantly without any manual operation of the user needed, minimizing the safety risks. Thirdly, the unique structure of the support mount in the present invention can be releasably mated with the inserter, the sensor body and the transmitter, which enables the user to easily remove the inserter and install the transmitter after the installation of the sensor body without complicated operation instructions. Last but not least, the safety lock in the present invention further enhances the safety of the installation by preventing the release buttons from being pressed accidentally to trigger the instant ejection‐retraction mechanism unintentionally and covering one end of the inserter from which the guide needle protrudes to prevent accident caused by the tip of the guide needle being exposed after the inserter is removed. To sum up, the transcutaneous analyte sensing system in the present invention has advantages as compactness, convenience of wearing, easy and safe installation operation which provides a desirable solution for the users willing to self‐test their glucose continuously and an indispensable support to rational treatment for diabetes using the insulin therapy.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates a schematic diagram of a transcutaneous analyte sensing system according to the present invention；
FIG. 2 illustrates a schematic diagram of a sensor probe in a transcutaneous analyte sensing system according to the present invention；
FIG. 3 illustrates an exploded view of a transmitter, a support mount and a medical adhesive tape in a transcutaneous analyte sensing system according to the present invention；
FIG. 4 illustrates a schematic diagram of a support mount in a transcutaneous analyte sensing system according to the present invention；
FIG. 5 illustrates a schematic diagram of an inserter in a transcutaneous analyte sensing system according to the present invention；
FIG. 6 illustrates an initial status of the inserter mounted on the support mount  in a transcutaneous analyte sensing system according to the present invention；
FIG. 7 illustrates a separate status of the inserter and the support mount in a transcutaneous analyte sensing system according to the present invention；
FIG. 8 illustrates a separate status of a sensor body and the support mount in a transcutaneous analyte sensing system according to the present invention；
FIG. 9 illustrates a top view of the sensor body installed on the support mount in a transcutaneous analyte sensing system according to the present invention；
FIG. 10 illustrates a schematic diagram of an instant ejection‐retraction mechanism in a transcutaneous analyte sensing system according to the present invention；
FIG. 11 illustrates a cross‐sectional view 1 of the instant ejection‐retraction mechanism in a transcutaneous analyte sensing system according to the present invention；
FIG. 12 illustrates a cross‐sectional view 2 of the instant ejection‐retraction mechanism in a transcutaneous analyte sensing system according to the present invention；
FIG. 13 illustrates a schematic diagram of a transcutaneous analyte sensing system with O‐shape rings according to the present invention
FIG. 14 illustrates a cross‐sectional view of a transcutaneous analyte sensing system with O‐shape rings and a silica gel plug according to the present invention；
FIG. 15 illustrates a schematic diagram 1 of the transmitter in a transcutaneous analyte sensing system according to the present invention；
FIG. 16 illustrates a schematic diagram 2 of the transmitter in a transcutaneous analyte sensing system according to the present invention；
FIG. 17 illustrates the installation completion status of the transmitter on the support mount in a transcutaneous analyte sensing system according to the present invention；
FIG. 18 illustrates a separate status of a safety lock and the support mount in a transcutaneous analyte sensing system according to the present invention；
FIG. 19 illustrates an initial status of the transcutaneous analyte sensing system with the safety lock according to the present invention；
FIG. 20 illustrates a schematic diagram of the safety lock coupled with the inserter in a transcutaneous analyte sensing system according to the present invention；
FIG. 21 illustrates a separate status of the safety lock and the inserter in a transcutaneous analyte sensing system according to the present invention.
DETAILED DESCRIPTION
The present invention provides a transcutaneous analyte sensing system, which is configured to dynamically monitor change of an analyte content in the human body in real time by a sensor probe implanted subcutaneously into the patient. In practice, the sensor probe is implanted subcutaneously into a patient, and the continuous glucose monitoring system monitors the changes of the glucose 24‐hour continuously and draws a curve of it, which provides an important reference to proper insulin therapies. Referring to FIG. 1 to 3, a transcutaneous analyte sensing system which has been installed completely is illustrated, including a medical adhesive tape 1, a support mount 2, a transmitter 3 and a sensor body 4 installed on the support mount 2 and electrically connected with the transmitter 3 which further comprises a sensor probe 40.
As shown in FIG. 1, the transcutaneous analyte sensing system which was installed completely is ready to detect an analyte content in the human body, with the support mount 2 fixed on the medical tape 1, and the transmitter 3 installed on the support mount 2.
The sensor probe 40 is configured to detect the analyte content in the human body and send the detected analyte content information. As shown in FIG. 2, the sensor probe 40 comprises a sensing part 41 configured to detect the analyte content in the human body and a connecting part 42 configured to connect the transmitter 3. The sensing part 41 senses an analyte in the human body after being implanted subcutaneously via the aid of the guide needle, then the data of the analyte content is sent to the transmitter 3 by the connecting part 42 via the electrical connection between the transmitter 3 and the connecting part 42 which is then converted to a radio signal and finally transmitted to a receiver.
FIG. 3 illustrates an exploded view of the transcutaneous analyte sensing system installed completely, showing the sensor body 4 installed on the support mount 2, and the connecting part 42 of the sensor probe 40 electrically connected with the transmitter 3.
Referring to FIG. 4 to FIG. 9, an embodiment of the installation of the transcutaneous analyte sensing system without a safety lock in the present invention is provided, showing how the sensor body 4 is installed on the support mount 2  properly and how the inserter 5 is removed from the support mount 2 after installation of the sensor body 4.
FIG. 4 illustrates an exploded view of the detailed structures of the support mount 2. As shown in FIG. 4, the support mount 2 is fixed on the medical adhesive tape 1, comprising a first installation structure, in this embodiment, three blocks 22, configured to mate the sensor body 4； a second installation structure, in this embodiment, a pair of release tabs 21, each of which further comprises a clamp part 211 and a ribbed part 212, configured to mate both the inserter 5 and the transmitter 3； a third installation structure, in this embodiment, a pair of flanges 23, configured to mate the groove on the transmitter 3； and a pair of hooks 24, configured to hook the rear part of the transmitter 3.
As shown in FIG. 5, an arrow mark 51 is set on the top of the shell of the inserter 5, configured to guide the user to rotate the inserter 5 according to the arrow mark 51 to complete the installation of the sensor body on the support mount and remove the inserter 5.
One may understand the method of the installation of the transcutaneous analyte sensing system in the present invention according to FIG. 6 to FIG. 9. As shown in FIG. 6, the inserter 5 is initially mounted on the support mount 2 by the clamp part 211 from the second installation structure. When an installation of the transcutaneous analyte sensing system is needed, press the two release buttons 53 protruded from the inserter 5 at the same time, so the instant ejection‐retraction mechanism inside the inserter 5 is triggered to push the guide needle 8 in FIG. 8 to penetrate a skin through a hole on the support mount 2 with the sensing part 41 of the sensor probe 40 and retract the guide needle 8 instantly, leaving the sensing part 41 of the sensor probe 40 subcutaneously； while the sensor body 4 initially located inside the inserter 5 is pushed to reach the blocks 22 from the first installation structure on the support mount 2 also by the instant ejection‐retraction mechanism.
When the transcutaneous installation process of the sensing part 41 of the sensor probe 40 is finished, one needs to fix the sensor body 4 on the support mount 2 and remove the inserter 5 referring to FIG. 7. Rotate the inserter 5 according to the arrow mark 51 on the top of the shell of the inserter 5 to interlock the ring with hooks 43 on the sensor body 4 with the blocks 22 from the first installation structure until the inserter 5 reaches to a designated position and cannot be rotated anymore, during which process one may hear a snap sound from the ring with hooks 43  snap‐fitting the blocks 22. Then press the ribbed parts 212 of the release tabs 21 from the second installation structure to open the clamp parts 211 of the release tabs 21 and pull the inserter 5 along the longitudinal direction from the second installation structure of the support mount 2 to remove the inserter 5.
One may obtain a better understanding of the connection between the sensor body 4 and the support mount 2 referring to FIG. 8 and FIG. 9. There are three slots set on the three blocks 22 from the first installation structure which are configured to accommodate the hooks on the ring with hooks 43. During the installation process, the guide needle 8 goes through the hole on the support mount 2 with the sensing part 41 of the sensor probe 40, and the hooks on the ring of hooks 43 snap‐fit the slots on the three blocks 22 by rotating together with the inserter 5.
Referring to FIG. 10 to FIG. 12, an embodiment of the instant ejection‐retraction mechanism in the present invention is provided. The instant ejection‐retraction mechanism comprises a first sliding block 71, a second sliding block 72, an ejecting spring 73, a retracting spring 74 and a guide needle 8, and the instant ejection‐retraction mechanism cooperates with the release buttons 53 to realize the instant ejection and retraction process of the guide needle 8.
As shown in FIG. 11, the first sliding block 71 comprises a hollow guide column 710 arranged vertically, a needle seat parallel to the hollow guide column 710, and a first locking part 711 which is a bump located on an inner wall of the hollow guide column 710. The second sliding block 72 comprises a second locking part 721 which is a clamping hook matching the bump shape of the first locking part 711, and the second locking part 721 penetrates through the lumen of the hollow guide column 710. The first locking part 711 and the second locking part 721 are initially locked with each other. The ejecting spring 73 is arranged circumferentially outside of the hollow guide column 710, and the retracting spring 74 is located in the lumen of the hollow guide column 710. The two release buttons 53 configured to trigger the instant ejection‐retraction mechanism are located opposite to each other on the circumference of the inserter 5.
As shown in FIG. 11 and FIG. 12, the ejecting spring 73 is initially in its compressed state, and the two ends of the ejecting spring 73 cling to the second sliding block 72 and two fixed baffles 75 located inside the inserter 5. The retracting spring 74 is initially in its compressed state too, and the two ends of the retracting spring 74 cling to the first sliding block 71 and the second sliding block 72. The guide  needle 8 is fixed at the needle seat of the first sliding block 71.
As shown in FIG. 12, the two release buttons 53 are two wedges with the thin parts pressing against two outer baffles 54 set on the outer wall of the inserter 5 and the thick parts protruding from the outer wall of the inserter 5. As shown in FIG. 10, the two release buttons 53 cooperate with the second sliding block 72 by locking the second sliding block 72 at its initial position. When an external force is applied on the release buttons 53, the release buttons 53 are pressed inward to enter the inserter 5 completely and are subsequently pushed downward along the inner wall of the inserter 5 by the force released from the ejecting spring 73. When the release buttons 53 are pressed to enter the inserter 5 completely, the ejecting spring 73 is released from the compressed state and drives the second sliding block 72 to move downward, bringing the whole instant ejection‐retraction mechanism including the first sliding block 71, the second sliding block 72, the retracting spring 74 and the guide needle downward, so the guide needle 8 is pushed out of the support mount to penetrate a human skin. During this process, because the first sliding block 71 and the second sliding block 72 are moved downward together, the retracting spring 74 maintains in its compressed state.
When the instant ejection‐retraction mechanism reaches a designated position, the bump‐shaped locking part 711 from the first sliding block 71 and the clamping‐hook‐shaped locking part 721 from the second sliding block 72 are released from each other, so the retracting spring 74 is released from the compressed state, and pushes the first sliding block 71 and the guide needle 8 to move upward and go back into the inserter 5, so the guide needle 8 is retracted from the human body by the retracting spring 74. The ejection and retraction actions of the guide needle 8 are completed instantly by the instant ejection‐retraction mechanism, during which process no manual operation is needed.
Referring to FIG. 10 and FIG. 2, one end of the guide needle 8 which has a groove 81 configured to accommodate the sensing part 41 of the sensor probe 40 is fixed inside the needle bed of the first sliding block 71, and the guide needle 8 penetrates through the second sliding block 72 and extends outside of the second sliding block 72. When the ejecting spring 73 is released, the guide needle 8 is ejected downward, and when the retracting spring 74 is released, the guide needle 8 is retracted upward. The cross section of the groove 81 is curved, and the sensing part 41 of the sensor probe 40 configured to detect the analyte content in the human body is arranged in  the groove 81. When the ejecting spring 73 is released, the guide needle 8 penetrates a human skin with the sensing part 41, so the sensing part 41 is implanted subcutaneously through the lead of the guide needle 8, after which process the retracting spring 74 is released, and the guide needle 8 is retracted upward, leaving the sensing part 41 indwelling in the human body and continuously detecting the analyte content.
Referring to FIG. 13 to FIG. 15, an embodiment of the transcutaneous analyte sensing system with waterproof functions is provided. As shown in FIG. 13 and FIG. 14, two O‐shape sealing rings 45 are set on the sensor body 4, configured to match a sealing chamber 34 on the bottom of the shell of the transmitter 3 for the waterproof purpose. A silica gel plug 44 is further set on the sensor body 4. When the sensor body is installed on the support mount 2, the silica gel plug 44 is squeezed against the support mount 2 to realize waterproof function.
Referring to FIG. 15 to FIG. 17 and FIG. 13, an embodiment of the installation of the transmitter 3 on the third installation of support mount 2 is provided. As shown in FIG. 13, the third installation structure comprises a pair of flanges 23 and a pair of hooks 24, and the clamp part 211 of the release tabs 21 of the second installation structure is also configured to match the transmitter. As shown in FIG. 15 and FIG. 16, two grooves 31 are set on both sides of the transmitter 3 configured to match the flanges 23 of the third installation structure； and an arcuate slot 32 is set on the head part of the transmitter 3 configured to match the clamp part 211 from the second installation structure； and two slots 33 are set on the rear part of the transmitter 3 configured to match the hooks 24 from the third installation structure. When an installation of the transmitter 3 is needed, snap‐fit the parts of the above‐identified three places to match, in specific, match the grooves 31 with the flanges 23, the arcuate slot 32 with the clamp part 211, and the slots 33 with the hooks 24 to complete the installation of the transmitter 3 on the support mount 2 and realize electrical connection between the transmitter 3 and the connecting part 42 of the sensor probe 40. FIG. 17 illustrates the installation completion status of the transmitter 3 on the support mount 2.
When the transmitter 3 needs to be removed from the support mount 2, press the ribbed parts 212 of the release tabs 21 to open the clamp parts 211, so the clamp parts 211 are released from clamping the arcuate slot 32 of the transmitter 3 resulting in the transmitter 3 easily removed from the support mount 2.
Referring to FIG. 18 and FIG. 19, an embodiment of the transcutaneous analyte sensing system with a safety lock is provided. As shown in FIG. 18, two slots 210 are arranged on both release tabs 21 of the second installation structure, configured to match two clamping hooks 61 arranged on the safety lock 6. An operating handle 62 configured to control the clamping hooks 61 to hook on or separate from the slots 210 is further arranged on the safety lock 6. The safety lock 6 is initially arranged around the outer wall of the inserter 5 in the circumferential direction and hooked on the support mount 2 with the clamping hooks 61 as shown in FIG. 19, configured to prevent the release buttons 53 from being pressed accidentally. When an installation of the transcutaneous analyte sensing system is needed, first press the operating handles 62 to remove the safety lock 6 and expose the release buttons, then repeat the operation steps identified above to complete the installation.
Referring to FIG. 20 and FIG. 21, an embodiment of another function of the safety lock 6 besides covering the release buttons 53 is provided. When the safety lock 6 is removed from the inserter 5 and the support mount 2, it can be clamped half‐around one end of the inserter 5 from which the guide needle 8 protrudes along the longitudinal direction with four additional hooks 63 as shown in FIG. 20 and FIG. 21, configured to prevent the tip of the guide needle 8 from being exposed after the inserter 5 is removed from the support mount 2.
Although the present invention has been disclosed as above with reference to preferred embodiments thereof but will not be limited thereto. Those skilled in the art can modify and vary the embodiments without departing from the spirit and scope of the present invention. Accordingly, without departing from the scope of the present invented technology scheme, whatever simple modification and equivalent variation belong to the protection range of the present invented technology scheme.

Claims (19)

  1. A transcutaneous analyte sensing system, comprising:
    a medical adhesive tape；
    a support mount fixed on the medical adhesive tape, wherein the support mount comprises a first installation structure, a second installation structure and a third installation structure；
    a sensor body matching the first installation structure, comprising a sensor probe and a sensor probe shell；
    an inserter matching the second installation structure, configured to install the sensor probe transcutaneously and install the sensor probe shell on a support mount, wherein the inserter comprises an instant ejection‐retraction mechanism and release buttons；
    a transmitter matching the third installation structure, configured to electrically connect with the sensor probe and convert analyte content information received from the sensor probe into a radio signal and send to a receiver；
    a hole to let through the guide needle is set on the sensor probe shell and the support mount respectively.
  2. A transcutaneous analyte sensing system according to claim 1, wherein,
    the instant ejection‐retraction mechanism comprises a guide needle, an ejecting spring, a retracting spring and two sliding blocks, configured to complete the ejection and retraction of the guide needle instantly；
    the guide needle is a groove needle.
  3. A transcutaneous analyte sensing system according to claim 2, wherein,
    the sensor probe comprises a sensing part configured to detect analyte contents in the human body and a connecting part configured to connect the transmitter；
    the sensing part of the sensor probe is initially set in the groove of the groove needle.
  4. A transcutaneous analyte sensing system according to claim 1, wherein,
    the sensor body is initially located inside the inserter；
    the inserter is initially mounted on the support mount；
    the guide needle initially penetrates through the sensor probe shell via the hole on the sensor probe shell but not through the support mount.
  5. A transcutaneous analyte sensing system according to claim 1, wherein,
    the number of the release buttons is two, and the two release buttons are set opposite to each other on the circumference of the inserter.
  6. A transcutaneous analyte sensing system according to claim 1, wherein,
    the first installation structure is three blocks set on the support mount.
  7. A transcutaneous analyte sensing system according to claim 6, wherein,
    the structure on the sensor body matching the blocks is a ring with hooks.
  8. A transcutaneous analyte sensing system according to claim 7, wherein,
    a silica gel plug is set between the ring with hooks and the support mount on the sensor body, configured to realize the waterproof function.
  9. A transcutaneous analyte sensing system according to claim 1, wherein,
    the second installation structure is a pair of release tabs with each tab comprising a clamp part and a ribbed part；
    the clamp parts are configured to match both the inserter and the transmitter.
  10. A transcutaneous analyte sensing system according to claim 1, wherein,
    the third installation structure comprises a pair of flanges located on the inner side of the second installation structure, configured to snap‐fit the grooves on both sides of the transmitter； and a pair of hooks, configured to hook the rear part of the transmitter.
  11. A transcutaneous analyte sensing system according to claim 1, wherein,
    two O‐shape sealing rings are further set on the sensor body, configured to realize the waterproof function by matching a sealing chamber on the bottom of the shell of the transmitter.
  12. A transcutaneous analyte sensing system according to claim 1, wherein,
    an arrow mark is set on the support mount or the inserter, configured to guide the user to complete the installation of the sensor body on the support mount and remove the inserter according to the arrow mark.
  13. A method of installation of the transcutaneous analyte sensing system according to any claim from claim 1 to 12, wherein including the following steps,
    I. Unpack the transcutaneous analyte sensing system including the medical adhesive tape, the support mount fixed on the medical adhesive tape, the inserter installed on the second installation structure of the support mount, and the sensor body located inside the inserter, peel off the protective liner on the other side of the medical adhesive tape and adhere the tape to a body part to be tested；
    II. Press the two release buttons protruded from the inserter at the same time, so the instant ejection‐retraction mechanism is triggered to push the  guide needle to penetrate a skin with the sensor probe and retract the guide needle instantly leaving the sensor probe under the skin, while the sensor body initially located inside the inserter is pushed to reach the first installation structure of the support mount also by the instant ejection‐retraction mechanism；
    III. Rotate the inserter according to the arrow mark on the support mount to interlock the ring with hooks on the sensor body with the first installation structure, then remove the inserter along the longitudinal direction from the second installation structure after completing the installation of the sensor body；
    IV. Snap the transmitter into the third installation structure of the support mount to realize electrical connection between the sensor body and the transmitter, and the installation of the transcutaneous analyte sensing system is completed；
    V. When the transmitter needs to be removed, press the rear arms of the release tabs to remove the transmitter easily.
  14. A transcutaneous analyte sensing system according to claim 1, wherein,
    further comprises a safety lock.
  15. A transcutaneous analyte sensing system according to claim 14, wherein,
    the safety lock is initially arranged around the inserter in the circumferential direction and connected with the support mount, configured to cover the release buttons and prevent accidental button press.
  16. A transcutaneous analyte sensing system according to claim 15, wherein,
    The safety lock further has a structure being able to clamp half‐around one end of the inserter from which the guide needle protrudes along the longitudinal direction, configured to prevent the tip of the guide needle from being exposed after the inserter is removed.
  17. A transcutaneous analyte sensing system according to claim 16, wherein,
    The structures configured to connect the support mount and the inserter are clamping hooks, and the structures on the support mount and the inserter matching the clamping hooks are slots.
  18. A transcutaneous analyte sensing system according to claim 17, wherein,
    the safety lock further comprises an operating handle configured to control the clamping hooks to hook on or separate from the slots.
  19. A method of installation of the transcutaneous analyte sensing system according to any claim from claim 14 to 18, wherein including the following steps,
    I. Unpack the transcutaneous analyte sensing system including the medical adhesive tape, the support mount fixed on the medical adhesive tape, the inserter installed on the second installation structure of the support mount, the sensor body located inside the inserter and the safety lock, peel off the protective liner on the other side of the medical adhesive tape and adhere the tape to a body part to be tested；
    II. Remove the safety lock from the circumference of the inserter and press the two release buttons protruded from the inserter at the same time, so the instant ejection‐retraction mechanism is triggered to push the guide needle to penetrate a skin with the sensor probe and retract the guide needle instantly leaving the sensor probe under the skin, while the sensor body initially located inside the inserter is pushed to reach the first installation structure of the support mount also by the instant ejection‐retraction mechanism；
    III. Rotate the inserter according to the arrow mark on the support mount to interlock the ring with hooks on the sensor body with the first installation structure, then remove the inserter along the longitudinal direction from the second installation structure after completing the installation of the sensor body；
    IV. Clamp the safety lock onto the end of the inserter from which the guide needle protrude along the longitudinal direction with the hooks；
    V. Snap the transmitter into the third installation structure of the support mount to realize electrical connection between the sensor body and the transmitter, and the installation of the transcutaneous analyte sensing system is completed；
    VI. When the transmitter needs to be removed, press the rear arms of the release tabs to remove the transmitter easily.
PCT/CN2016/094970 2016-08-12 2016-08-12 Transcutaneous analyte sensing system and methods of installation thereof WO2018027940A1 (en)

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Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110007089A (en) * 2019-04-30 2019-07-12 深圳恩多克医疗有限公司 It is a kind of to continue blood sugar monitoring transmitter and sensor unlocking mechanism
WO2021031542A1 (en) * 2019-08-19 2021-02-25 Medtrum Technologies Inc. Micro-analyte detection device
CN113274004A (en) * 2020-02-20 2021-08-20 上海移宇科技股份有限公司 High reliability analyte detection device
WO2021164182A1 (en) * 2020-02-20 2021-08-26 Medtrum Technologies Inc. A mounting unit of an analyte detection device and a mounting method thereof
CN113456066A (en) * 2021-08-05 2021-10-01 天津九安医疗电子股份有限公司 Percutaneous analyte sensor insertion device
CN113842141A (en) * 2021-11-30 2021-12-28 上海微创生命科技有限公司 Implanter, needle, sensor base, emitter assembly, sterilization case and implantation system
WO2022049229A1 (en) * 2020-09-07 2022-03-10 Ascensia Diabetes Care Holdings Ag Methods and apparatus enabling coupling of an electronics unit to a base unit of a continuous analyte monitoring device
WO2023010538A1 (en) * 2021-08-06 2023-02-09 Medtrum Technologies Inc. A body fluid analyte detection device
US11602373B2 (en) 2019-08-20 2023-03-14 Ascensia Diabetes Care Holdings Ag Biosensor inserter apparatus and methods
US11707297B2 (en) 2019-08-20 2023-07-25 Ascensia Diabetes Care Holdings Ag Continuous analyte monitor inserter apparatus and methods
US11806134B2 (en) 2017-05-09 2023-11-07 Ascensia Diabetes Care Holdings Ag Sensor assembly apparatus and methods for continuous glucose monitors
US11839406B2 (en) 2021-01-21 2023-12-12 Ascensia Diabetes Care Holdings Ag Biosensor inserters and methods with reduced medical waste

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090102678A1 (en) * 2006-02-28 2009-04-23 Abbott Diabetes Care, Inc. Analyte sensor transmitter unit configuration for a data monitoring and management system
CN102378595A (en) * 2009-03-31 2012-03-14 森西勒Pat股份公司 Medical device for measuring an analyte concentration
CN103750819A (en) * 2013-12-25 2014-04-30 浙江凯立特医疗器械有限公司 Sensor device capable of controlling insertion angle in subcutaneous tissue
CN104887242A (en) * 2014-03-07 2015-09-09 上海移宇科技有限公司 Analyte sensing system
CN105311702A (en) * 2014-09-03 2016-02-10 上海移宇科技有限公司 Throwable duct-free drug delivery system
CN205107679U (en) * 2014-09-29 2016-03-30 贝克顿·迪金森公司 Insert monitor and monitor is inserted to intubate
CN106137214A (en) * 2016-08-12 2016-11-23 上海移宇科技股份有限公司 A kind of transcutaneous analyte sensing equipment and installation method thereof

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090102678A1 (en) * 2006-02-28 2009-04-23 Abbott Diabetes Care, Inc. Analyte sensor transmitter unit configuration for a data monitoring and management system
CN102378595A (en) * 2009-03-31 2012-03-14 森西勒Pat股份公司 Medical device for measuring an analyte concentration
CN103750819A (en) * 2013-12-25 2014-04-30 浙江凯立特医疗器械有限公司 Sensor device capable of controlling insertion angle in subcutaneous tissue
CN104887242A (en) * 2014-03-07 2015-09-09 上海移宇科技有限公司 Analyte sensing system
CN105311702A (en) * 2014-09-03 2016-02-10 上海移宇科技有限公司 Throwable duct-free drug delivery system
CN205107679U (en) * 2014-09-29 2016-03-30 贝克顿·迪金森公司 Insert monitor and monitor is inserted to intubate
CN106137214A (en) * 2016-08-12 2016-11-23 上海移宇科技股份有限公司 A kind of transcutaneous analyte sensing equipment and installation method thereof

Cited By (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11806134B2 (en) 2017-05-09 2023-11-07 Ascensia Diabetes Care Holdings Ag Sensor assembly apparatus and methods for continuous glucose monitors
CN110007089A (en) * 2019-04-30 2019-07-12 深圳恩多克医疗有限公司 It is a kind of to continue blood sugar monitoring transmitter and sensor unlocking mechanism
EP4106613A4 (en) * 2019-08-19 2024-04-17 Medtrum Tech Inc A body fluid analyte detection device
WO2021031541A1 (en) * 2019-08-19 2021-02-25 Medtrum Technologies Inc. Highly integrated analyte detection device
WO2021164185A1 (en) * 2019-08-19 2021-08-26 Medtrum Technologies Inc. Highly integrated analyte detection device
WO2021164184A1 (en) * 2019-08-19 2021-08-26 Medtrum Technologies Inc. Highly integrated intelligent analyte detection device
WO2021031057A1 (en) * 2019-08-19 2021-02-25 Medtrum Technologies Inc. Sensing device
WO2021031542A1 (en) * 2019-08-19 2021-02-25 Medtrum Technologies Inc. Micro-analyte detection device
US11602373B2 (en) 2019-08-20 2023-03-14 Ascensia Diabetes Care Holdings Ag Biosensor inserter apparatus and methods
US11707297B2 (en) 2019-08-20 2023-07-25 Ascensia Diabetes Care Holdings Ag Continuous analyte monitor inserter apparatus and methods
CN113274004A (en) * 2020-02-20 2021-08-20 上海移宇科技股份有限公司 High reliability analyte detection device
WO2021164182A1 (en) * 2020-02-20 2021-08-26 Medtrum Technologies Inc. A mounting unit of an analyte detection device and a mounting method thereof
WO2021164181A1 (en) * 2020-02-20 2021-08-26 Medtrum Technologies Inc. A mounting unit of an analyte detection device and a mounting method thereof
WO2022007537A1 (en) * 2020-03-18 2022-01-13 上海移宇科技股份有限公司 Installation unit of analyte detection device
CN113907752A (en) * 2020-03-18 2022-01-11 上海移宇科技股份有限公司 Mounting unit for analyte detection device
CN113907752B (en) * 2020-03-18 2024-02-23 上海移宇科技股份有限公司 Mounting unit for analyte detection device
CN113940670A (en) * 2020-07-07 2022-01-18 上海移宇科技股份有限公司 High reliability analyte detection device
CN113940670B (en) * 2020-07-07 2024-02-23 上海移宇科技有限公司 High reliability analyte detection device
WO2022049229A1 (en) * 2020-09-07 2022-03-10 Ascensia Diabetes Care Holdings Ag Methods and apparatus enabling coupling of an electronics unit to a base unit of a continuous analyte monitoring device
US11839406B2 (en) 2021-01-21 2023-12-12 Ascensia Diabetes Care Holdings Ag Biosensor inserters and methods with reduced medical waste
CN113456066B (en) * 2021-08-05 2023-08-11 天津九安医疗电子股份有限公司 Percutaneous analyte sensor insertion device
CN113456066A (en) * 2021-08-05 2021-10-01 天津九安医疗电子股份有限公司 Percutaneous analyte sensor insertion device
WO2023010538A1 (en) * 2021-08-06 2023-02-09 Medtrum Technologies Inc. A body fluid analyte detection device
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