WO2023092913A1

WO2023092913A1 - Transcutaneous analyte sensor system

Info

Publication number: WO2023092913A1
Application number: PCT/CN2022/082904
Authority: WO
Inventors: 钱成
Original assignee: 苏州百孝医疗科技有限公司
Priority date: 2021-11-27
Filing date: 2022-03-25
Publication date: 2023-06-01
Also published as: CN114391835A

Abstract

A transcutaneous analyte sensor system, comprising an implanter unit (400); a body surface attachment unit (200) coupled in the implanter unit (400), the body surface attachment unit (200) comprising a sensor unit (230) for measuring a subcutaneous analyte level of a host (100) and an adhesive layer for applying the sensor unit (230) onto the skin surface of the host (100), a release layer (220) covering the adhesive layer, the sensor unit (230) comprising a sensor electrode (210), and the implanter unit (400) being configured to implant part of the sensor electrode (210) subcutaneously in the host (100); and a cap (500) coupled to the implanter unit (400) or the sensor unit (230), the cap (500) being configured to be removable before the implanter unit (400) implants the sensor electrode (210), and the release layer (220) being configured to be peeled off the adhesive layer when removing the cap (500).

Description

Transdermal Analyte Sensor System

This application claims the priority of a Chinese patent application with a filing date of November 27, 2021 and application number 202111428966.1, the entire content of which is incorporated by reference in this application.

technical field

The present application relates to the technical field of medical devices, for example, to a transdermal analyte sensor system.

Background technique

For some physiological diseases, the course of the disease is long and the disease is protracted. It is necessary to monitor certain physiological parameters of the host in real time, so as to better track the treatment. For example, diabetes requires real-time monitoring of the host's blood sugar. Accurate self-monitoring of blood sugar is the key to achieving good blood sugar control. It is helpful to assess the degree of glucose metabolism disorder in diabetic patients, formulate a hypoglycemic plan, reflect the effect of hypoglycemic treatment and guide the adjustment of the treatment plan.

The blood glucose meter is the most widely used on the market. Patients need to collect blood from the tip of their finger to measure the blood sugar level at that moment. However, this method has the following defects: 1. It is impossible to know the change of blood glucose level between two measurements, and the patient may miss the peak and valley of blood glucose, which will cause some complications and cause irreversible damage to the patient; 2. Multiple fingertip punctures for blood collection have caused great pain to diabetic patients. In order to overcome the above defects, it is necessary to provide a method that can continuously monitor the blood sugar of patients, so that patients can know their blood sugar status in real time, and take timely countermeasures accordingly, so as to effectively control the disease and prevent complications, so as to obtain a higher blood sugar level. Quality of Life.

In response to the above needs, technicians have developed a monitoring technology that can be implanted into the subcutaneous tissue for continuous monitoring of subcutaneous blood sugar. This technology penetrates a sensor electrode into the subcutaneous tissue, and the sensor electrode undergoes an oxidation reaction between the patient's interstitial fluid and glucose in the body. An electrical signal will be formed when the transmitter converts the electrical signal into blood sugar readings, and the blood sugar readings will be transmitted to the wireless receiver every 1-5 minutes, and the corresponding blood sugar data will be displayed on the wireless receiver and a graph will be formed for the patient and physician reference.

In the related art, the body surface attachment unit of the transdermal analyte sensor system, which takes the continuous blood glucose monitoring technology as an example, needs to be attached to the host skin surface through an adhesive layer. In order to maintain the effectiveness of the adhesive layer, it is generally necessary to The release paper is covered on the adhesive layer, so the release paper needs to be peeled off from the adhesive layer before sensor electrodes are implanted. In the related art, the release paper is peeled off by hand directly from Since the body surface attachment unit with sensor electrodes needs to be pre-installed in the implanter before implantation, it is easy to cause body surface attachment due to improper operation when tearing off the release paper The unit fell off from the implanter, causing the sensor electrodes to be implanted incorrectly and affecting user experience.

Contents of the invention

The present application provides a transdermal analyte sensor system, which can prevent sensor electrodes from being implanted normally due to peeling off the release paper, thereby improving user experience.

A transdermal analyte sensor system comprising an implanter unit; a body surface attachment unit coupled within the implanter unit, the body surface attachment unit comprising a sensor unit configured to detect subcutaneous analyte levels of a host; and Applying the sensor unit to the adhesive layer on the surface of the skin of the host, the adhesive layer is covered with a release layer, the sensor unit includes sensor electrodes, and the implanter unit is configured to insert the a sensor electrode partially implanted under the skin of the host; and a cap coupled to the implanter unit or the sensor unit, the cap being configured to be removable before the implanter unit implants the sensor electrode , and the release layer is configured to be peeled from the adhesive layer when the cap is removed.

Description of drawings

FIG. 1 is a schematic diagram of a continuous blood glucose monitoring system according to an embodiment of the present application.

FIG. 2 is a schematic structural diagram of a continuous blood glucose monitoring system according to an embodiment of the present application.

FIG. 3 is a schematic diagram of an initial state of cap removal according to an embodiment of the present application.

FIG. 4 is a schematic diagram of a completed state of cap removal according to an embodiment of the present application.

Fig. 5 is a schematic diagram of a release layer arranged in a helical manner according to an embodiment of the present application.

Fig. 6 is an exploded view of an assembly in which the release layer is arranged in a spiral manner according to an embodiment of the present invention.

Fig. 7 is an assembled cross-sectional view of the release layer arranged in a spiral manner according to an embodiment of the present invention.

Fig. 8 is a schematic bottom view of a cap with a release layer arranged in a helical manner according to an embodiment of the present invention.

Fig. 9 is a schematic diagram of the arrangement of the release layer in the form of a release fan ring according to an embodiment of the present invention.

Fig. 10 is an exploded view of an assembly in which the release layer is arranged in the form of a release fan ring according to an embodiment of the present invention.

Fig. 11 is an assembly sectional view of the release layer arranged in the form of a release fan ring according to an embodiment of the present invention.

Fig. 12 is a schematic diagram of the bottom of the cap with the release layer arranged in the form of a release fan ring according to an embodiment of the present invention.

Among them: 100, host; 200, body surface attachment unit; 210, sensor electrode; 220, release layer; 221, fixed part; 222, positioning hole; 223, guide part; 224, cutting line; 225, release Fan ring; 230, sensor unit; 300, receiver; 400, implanter unit; 410, puncture needle; 500, cap; 510, fixing groove; 511, positioning block; 520, positioning plug; 530, sterilization cavity ; 531, hollow column; 532, rubber sealing ring; 540, label.

Detailed ways

For the Continuous Glucose Monitoring (CGM, Continuous Glucose Monitoring) system, please refer to FIG. 1 , which is a schematic diagram of the continuous glucose monitoring system attached to the host 100 . Fig. 2 shows that the continuous blood glucose monitoring system includes a body surface attachment unit 200 with sensor electrodes 210, and the body surface attachment unit 200 is attached to the skin surface of the host 100 through an adhesive layer. The body surface attachment unit 200 has a built-in circuit module electrically connected to the sensor electrode 210. The circuit module is configured to send the glucose concentration information monitored by the sensor electrode 210 to the receiver 300. The receiver 300 can usually be a smart phone, smart watch, Special equipment and the like. During use, the sensor electrode 210 is partially located under the skin of the host 100, in contact with the subcutaneous tissue fluid.

Please refer to FIG. 2, which is a schematic structural diagram of a continuous blood glucose monitoring system, including an implanter unit 400, a body surface attachment unit 200, and a cap 500. The body surface attachment unit 200 is pre-installed in the cap 500, followed by the cap 500 is installed on the implanter unit 400 together, and during use, the cap 500 is removed from the implanter unit 400 by turning the cap 500, and at the same time, the adhesive layer covering the body surface attachment unit 200 The release layer 220 will be peeled off together with the removal of the cap 500; then the opening side of the implanter unit 400 will be attached to the skin surface of the host 100, and the body surface in the implanter unit 400 will be removed by operating the implanter unit 400. The attachment unit 200 is attached to the skin surface of the host 100. At this time, the sensor electrode 210 is partially implanted under the skin of the host 100, and is in contact with the subcutaneous tissue fluid to continuously monitor the glucose concentration in the tissue fluid.

In one embodiment, the adhesive layer can be medical non-woven adhesive tape.

In one embodiment, the release layer 220 is a release paper or a release film, and a layer of release agent is coated on the surface.

The peeling method of the release layer 220 will be described in detail below.

Please continue to refer to FIG. 2 , the present application provides a transdermal analyte sensor system taking a continuous blood glucose monitoring system as an example, including an implanter unit 400 and a body surface attachment unit coupled in the implanter unit 400 200, the body surface attachment unit 200 includes a sensor unit 230 configured to detect the subcutaneous analyte level of the host 100 and an adhesive layer for applying the sensor unit 230 to the skin surface of the host 100, the adhesive layer is covered with a release layer 220, the sensor unit 230 includes the sensor electrode 210, the implanter unit 400 is configured to partially implant the sensor electrode 210 under the skin of the host 100, and the transcutaneous analyte sensor system further includes a device coupled to the implanter unit 400 or the sensor unit 230 The cap 500 is configured to be removable before the implanter unit 400 implants the sensor electrode 210, and the release layer 220 is peeled off from the adhesive layer while the cap 500 is removed.

In the present application, by coupling the release layer 220 to the cap 500, the release layer 220 can be peeled off when the cap 500 is removed, which is easy to operate and easy to use, and improves user experience.

The release layer 220 of the present application is peeled off following the removal of the cap 500, which regulates the peeling operation of the release layer 220 and avoids the body surface attachment unit 200 falling off due to improper operation when peeling off the release layer 220 by hand. The effectiveness of electrode implantation is guaranteed.

The implanter unit 400 of the present application includes a puncture needle 410 that guides the sensor electrode 210 into the skin of the host 100. The sensor electrode 210 is partially preset in the puncture needle 410 before implantation, and the puncture needle 410 is implanted in the sensor electrode 210. During the process, in response to the action of the implanter unit 400, the sensor electrode 210 is pierced into the skin of the host 100 together. The action of 400 exits the skin of the host 100, at which point the sensor electrodes 210 are left on the skin of the host 100 and continuously monitor the analyte concentration. Please continue to refer to FIG. 2, when the body surface attachment unit 200 is coupled to the implanter unit 400, the ends of the sensor electrodes 210 and puncture needles 410 extend from the side of the adhesive layer of the body surface attachment unit 200. Out, the protruding portion is implanted subcutaneously in the host 100 during implantation. Since the sensor electrode 210 is a flexible sensor electrode 210 with a diameter of 0.28 ± 0.05 mm, and the puncture needle 410 is a fine needle with a diameter of 0.5 ± 0.03 mm, both the sensor electrode 210 and the puncture needle 410 are easily deformed when subjected to external force, for example, tearing the needle with bare hands. When the release layer 220 is lowered, it is easy for the hand or the release layer 220 to touch the puncture needle 410 due to improper operation, causing the puncture needle 410 to be deformed, and then the sensor electrode 210 cannot be implanted normally, resulting in waste. In order to overcome the above problems, when the application removes the cap 500, the release layer 220 is not in contact with the puncture needle 410, and since the release layer 220 is peeled off with the cap 500, the hand will not touch the puncture needle 410 , solve the problem of the deformation of the puncture needle 410 from the root.

In an embodiment, the cap 500 is configured to be removed in a rotational manner. Referring to FIGS. 3 and 4 , for example, the cap 500 is rotated counterclockwise to separate the cap 500 from the implanter unit 400 , and then the cap 500 is removed along the axial direction of the implanter unit 400 . The following embodiments assume that the cap 500 is removed by rotation.

The release layer 220 of the present application is peeled off following the rotation direction of the cap 500, so that the release layer 220 does not contact the puncture needle 410 during the peeling process, avoiding the bending deformation of the puncture needle 410 caused by contact, and further ensuring the electrode The effectiveness of the implant.

In order to facilitate the smooth peeling of the release layer 220 , the rotation direction of the cap 500 is the same as the peeling direction of the release layer 220 .

In one embodiment, as shown in FIG. 5 , the release layer 220 is configured to be arranged on the adhesive layer in a spiral manner. When the cap 500 is removed, the release layer 220 will be peeled off sequentially from the edge of the adhesive layer to the middle following the rotation direction of the cap 500, that is, when the cap 500 is rotated, the release layer 220 will be peeled from the edge of the corresponding adhesive layer. The end of the release layer 220 is uncovered, and the uncovered end is called the beginning of the release layer 220 . A fixed portion 221 is configured at the beginning of the release layer 220 , and the release layer 220 is coupled to the cap 500 through the fixed portion 221 . 6 to 8, for example, a fixing groove 510 is provided on the cap 500, a positioning hole 222 is disposed on the fixing portion 221, and a positioning block 511 corresponding to the positioning hole 222 is disposed on the inner wall of the fixing groove 510, and the fixing portion 221 is buckled on the positioning block 511 through the positioning hole 222; a positioning plug 520 is also inserted in the fixing groove 510, and the positioning plug 520 is inserted into the fixing groove 510 from the outside of the cap 500 to prevent the fixing part 221 from detaching from the positioning block 511. The fixed part 221 is formed at the beginning of the release layer 220 and is a flexible structure made of the same material as the release layer 220. When the fixed part 221 is installed on the cap 500, the fixed part 221 is easily bent by force and the fixed groove 510 is narrow. Therefore, it is likely that the fixing part 221 cannot be inserted into the fixing groove 510 smoothly, which affects the assembly efficiency. In view of this, a guide part 223 is arranged on the fixed part 221. The guide part 223 is a rigid structure, such as hard plastic. On the outside of the cap 500, pull the guide part 223 on the outside of the cap 500 until the fixing part 221 is located in the fixing groove 510, buckle the positioning hole 222 on the fixing part 221 on the positioning block 511 on the inner wall of the fixing groove 510, and place the positioning plug 520 Inserted into the fixing groove 510 , the positioning plug 520 is located between the inner wall of the fixing groove 510 facing the positioning block 511 and the fixing portion 221 , thereby preventing the fixing portion 221 from detaching from the positioning block 511 . The guide part 223 is separated from the fixing part 221 after the positioning plug 520 is inserted into the fixing groove 510 . For example, a shearing line 224 is provided between the fixed part 221 and the guide part 223 to make a weak connection between the fixed part 221 and the guide part 223. After the positioning plug 520 is inserted into the fixing groove 510, the guide part 223 is directly cut along the The tangent line 224 can be torn off from the fixing part 221 .

Please refer to FIG. 9 , in one embodiment, the release layer 220 includes two release rings 225 , and the two release rings 225 are spliced together to form a ring-shaped release layer 220 . When the cap 500 is removed, the two release sector rings 225 are configured to peel off following the rotation direction of the cap 500 . For example, two release fan rings 225 are configured to be adjacent in sequence along the ring direction, that is, the start end of one release fan ring 225 is adjacent to the terminal end of the other release fan ring 225, and the terminal end of one release fan ring 225 Adjacent to the beginning of another release fan ring 225 . The two release sector rings 225 are respectively configured with a fixing portion 221 at their starting ends, and the two release sector rings 225 are respectively coupled to the cap 500 through the respective fixing portions 221 . Similar to the above-mentioned embodiments, please refer to FIGS. 10 to 12 , each fixing portion 221 is provided with a guiding portion 223, and the cap 500 is provided with two fixing grooves 510, and the two guiding portions 223 pass through the two fixing grooves respectively. 510 guides the fastening part 221 into the fastening groove 510 . For the coupling manner between the fixing portion 221 and the cap 500 , please refer to the above-mentioned embodiments, and details are not repeated here. The difference from the above embodiment is that, for the two fixing parts 221 , two fixing grooves 510 need to be provided, and two positioning plugs 520 need to be configured. For example, one of the fixing parts 221 is fixed in one of the fixing slots 510 by one of the positioning plugs 520 , and the other fixing part 221 is fixed in the other fixing slot 510 by another positioning plug 520 . In one embodiment, the two positioning plugs 520 are an integral structure.

Please continue to refer to Fig. 9, two release fan rings 225 are symmetrically arranged on the adhesive layer with the central point of the ring-shaped release layer 220 as the symmetry center, and this arrangement can ensure two release rings The sector rings 225 are peeled off synchronously, and the adhesive force of the two release sector rings 225 on the adhesive layer is equal, so that the two release sector rings 225 do not touch during the stripping process, thereby avoiding deformation of the puncture needle 410 .

In one embodiment, please continue to refer to FIG. 7 or 11, a sterilizing cavity 530 is configured in the cap 500, and the sterilizing cavity 530 is configured to accommodate at least the sensor electrode 210 and provide a sealed sterilizing environment for the sensor electrode 210. . For example, the sterilization chamber 530 may be defined by a hollow column 531 disposed in the cap 500, and the hollow column 531 is provided with an opening for entering the end of the puncture needle 410 and the sensor electrode 210, and the opening edge of the hollow column 531 is in contact with the end of the sensor electrode 210. The body surface attachment unit 200 is sealed and connected, and the sealing method may be a rubber sealing ring 532 .

Analyte levels for the present application may be other indicators than glucose concentration.

A label 540 indicating the rotation direction of the cap 500 is pasted on the bottom of the cap 500, and the label 540 can cover the fixing groove 510 on the cap 500, making the bottom of the cap 500 more beautiful.

The release layer 220 provided by the present application no matter what implementation mode is used, the center is formed with a through hole for the puncture needle 410 and the sensor electrode 210 to pass through, and by setting the through hole, the release layer 220 is peeled off in a rotating manner , the release layer 220 is not in contact with the puncture needle 410 all the time.

Claims

A transdermal analyte sensor system comprising:

implanter unit;

a body surface attachment unit coupled within the implanter unit, the body surface attachment unit comprising a sensor unit configured to detect subcutaneous analyte levels of the host and an adhesive for applying the sensor unit to the skin surface of the host a mixture layer, the adhesive layer is covered with a release layer, the sensor unit includes sensor electrodes, and the implanter unit is configured to partially implant the sensor electrodes under the skin of the host; and

a cap coupled to the implanter unit or the sensor unit, the cap configured to be removable before the implanter unit implants the sensor electrodes, and the release layer is configured to When the cap is removed, it peels from the adhesive layer.
The transdermal analyte sensor system according to claim 1, wherein: said implanter unit includes a puncture needle for guiding said sensor electrode into the host subcutaneously, and said release layer is configured such that when said cap is removed, , without contact with the puncture needle.
The transdermal analyte sensor system of claim 1, wherein the cap is configured to be rotationally removed.
The transdermal analyte sensor system according to claim 3, wherein the rotation direction of the cap is the same as the peeling direction of the release layer.
The transdermal analyte sensor system according to claim 4, wherein: said release layer is configured to be arranged in a helical manner on said adhesive layer.
The transdermal analyte sensor system according to claim 5, wherein: the release layer is configured to be peeled sequentially from the edge to the middle of the adhesive layer following the rotation direction of the cap.
The transdermal analyte sensor system according to claim 5, wherein: a fixed portion is configured at the beginning of the release layer, and the release layer is coupled to the cap through the fixed portion.
The transcutaneous analyte sensor system according to claim 7, wherein: the fixing part is provided with a guiding part, and the cap is provided with a fixing groove, and the guiding part is configured to pass through the fixing groove and guide the The fixing part is guided into the fixing groove.
The transcutaneous analyte sensor system according to claim 8, wherein a positioning hole is arranged on the fixing part, a positioning block is arranged on the inner wall of the fixing groove, and the fixing part is fastened to the fixing part through the positioning hole. on the positioning block;

A positioning plug is inserted into the fixing groove, and the positioning plug is configured to prevent the fixing part from detaching from the positioning block.
The transcutaneous analyte sensor system according to claim 4, wherein: the release layer comprises two release sector rings, and the two release sector rings are spliced to form the annular release layer.
The transdermal analyte sensor system according to claim 10, wherein: two said release segments are configured to peel off following the rotation direction of said cap.
The transcutaneous analyte sensor system according to claim 11, wherein: two said release sector rings are configured to be sequentially adjacent in a circular direction.
The transdermal analyte sensor system according to claim 12, wherein: the starting ends of the two release fan rings are each equipped with a fixing part, and each of the release fan rings is respectively coupled via one of the fixing parts. attached to the cap.
The transcutaneous analyte sensor system according to claim 13, wherein: each of the two fixing parts is provided with a guide part, and the cap is provided with two fixing grooves, and the guide part on each of the fixing parts The fixing portion is configured to pass through one of the fixing grooves to guide the fixing portion into the corresponding fixing groove.
The transcutaneous analyte sensor system according to claim 14, wherein: each of the two fixing parts is equipped with a positioning hole, and the inner walls of the two fixing grooves are each equipped with a positioning block, each of the The fixing parts are buckled on the positioning block respectively through one of the positioning holes;

A positioning plug is inserted into each of the two fixing slots, and the two positioning plugs are configured to prevent the fixing portion in the fixing slot from detaching from the positioning block.
The transdermal analyte sensor system according to claim 10, wherein: two said release fan rings are symmetrically arranged on the adhesive layer with the central point of the ring-shaped release layer as a symmetrical center .
The transdermal analyte sensor system of claim 1 , wherein: a sterilized cavity is disposed within said cap, said sterilized cavity configured to accommodate at least said sensor electrode and provide a seal for said sensor electrode sterilization environment.
The transdermal analyte sensor system of claim 1, wherein said analyte level is a glucose concentration.