WO2023108943A1

WO2023108943A1 - Implantable device and method for using same

Info

Publication number: WO2023108943A1
Application number: PCT/CN2022/082919
Authority: WO
Inventors: 钱成; 张仕文
Original assignee: 苏州百孝医疗科技有限公司
Priority date: 2021-12-14
Filing date: 2022-03-25
Publication date: 2023-06-22
Also published as: CN114391838A

Abstract

An implantable device and a method for using same. The implantable device comprises: a housing; a drive member and a needle assembly which are arranged in the housing; and a cap coupled to a distal end of the housing, wherein a body surface attachment unit is pre-placed in the housing; the needle assembly is configured to be coupled to at least one of the body surface attachment unit and the drive member; the body surface attachment unit is configured to be applied to the skin surface of a host in response to the action of the drive member; the cap is configured to maintain the drive member and the body surface attachment unit in the housing; and at least one of the housing and the cap is provided with a first opening that is configured to provide a path along which an electronic component is mounted onto the body surface attachment unit.

Description

Implants and methods of use

This application claims priority to a Chinese patent application with a filing date of December 14, 2021 and application number 202111526385.1, the entire contents of which are incorporated herein by reference.

technical field

The present application relates to the technical field of medical devices, for example, to an implanter and a method for using the same.

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 continuous blood glucose monitoring system that can be implanted into the subcutaneous tissue for continuous monitoring of subcutaneous blood sugar. The system penetrates a sensor electrode into the subcutaneous tissue, and the sensor electrode oxidizes the glucose in the patient's interstitial fluid. , when reacting, an electrical signal will be formed, and the electrical signal will be converted into blood sugar readings through electronic components, 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 map will be formed. For patients and doctors reference.

The sensor electrodes need to be implanted under the skin of the host using an implanter. The sensor electrodes are attached to the body surface attachment unit and are pre-installed in the implanter through the body surface attachment unit. The body surface attachment unit in the related art is usually Electronic components are integrated, and the electronic components are discarded together when the body surface attachment unit is replaced, resulting in waste of electronic components. However, the reusable electronic components in the related art are usually installed on the body surface attachment unit after the implantation is completed. The installation method based on the skin surface of the host is not only inconvenient to operate, but also easily causes discomfort.

Contents of the invention

The present application provides an implanter and a method of use thereof, which can install electronic components on the body surface attachment unit before the body surface attachment unit is applied to the skin surface of the host, and realize the reusability of the electronic components at the same time.

An embodiment provides an implanter, comprising a housing in which a body surface attachment unit is preset; a driving member and a needle assembly arranged in the housing, and the needle assembly is configured to be coupled to the On at least one of the body surface attachment unit and the drive member, the body surface attachment unit is configured to be applied to the skin surface of the host in response to the action of the drive member; and coupled to the a cap at the distal end of the housing, the cap configured to retain the drive member and the body surface attachment unit in the housing, at least one of the housing and the cap having a first An opening, the first opening configured to provide a path for mounting the electronic component to the body surface attachment unit.

An embodiment of the present application also provides a method for using an implanter. Based on the above-mentioned implanter, the method includes applying the body surface attachment unit pre-installed in the shell of the implanter to The electronic component is mounted on the body surface attachment unit before being attached to the skin surface of the host.

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 structural exploded view of a body surface attachment unit according to an embodiment of the present application.

Fig. 4 is a schematic diagram of an electronic component installed in an implanter according to an embodiment of the present application.

Fig. 5 is a schematic diagram of an electronic component installed on a body surface attachment unit according to an embodiment of the present application.

FIG. 6 is a schematic view from another angle of installing an electronic component to a body surface attachment unit according to an embodiment of the present application.

Fig. 7 is a schematic diagram of a sterilization assembly according to an embodiment of the present application.

Fig. 8 is an exploded view of a sterilization assembly according to an embodiment of the present application.

Fig. 9 is a schematic diagram of a needle assembly according to an embodiment of the present application.

Fig. 10 is a cross-sectional view of a sterilization assembly according to an embodiment of the present application.

Fig. 11 is a schematic diagram of the cap moving toward the needle assembly according to an embodiment of the present application.

Fig. 12 is a schematic diagram of the rotation of the cap along the circumferential direction of the needle assembly according to an embodiment of the present application.

Fig. 13 is a schematic diagram of removing the cap from the needle assembly according to an embodiment of the present application.

Fig. 14 is a schematic diagram of an insurance mechanism according to an embodiment of the present application.

Fig. 15 is an exploded view of an implanter according to an embodiment of the present application.

Fig. 16 is a cross-sectional view of an implanter according to an embodiment of the present application.

Among them: 100, host; 200, body surface attachment unit; 210, sensor electrode; 211, internal body part; 212, external body part; 220, body surface attachment shell; 221, upper shell; 222, lower shell; 223 224, power base; 225, second conductive part; 226, power supply; 227, limit hole; 230, sleeve; 231, limit hook; 232, sealed cavity; 233, positioning plate; 234, positioning wing; 240, first sealing ring; 250, second sealing ring; 300, electronic component; 310, carrier; 311, connecting arm; 312, limit protrusion; 400, receiver; 500, implanter 510, needle assembly; 511, puncture needle; 512, hub; 513, groove; 514, limit groove; 515, first path; 516, second path; 517, third path; 520, first opening; 530 , shell; 531, knob; 532, bolt; 533, first hole; 534, first step; 535, elastic button; 540, cap; 541, guide column; 542, second step; 550, first driving mechanism; 551, base; 552, first holding part; 553, first driving spring; 554, connecting part; 555, groove; 556, second opening; 557, second hole; 558, first elastic hook part; 559 , the guide port; 560, the second driving mechanism; 561, the second holding part; 562, the second driving spring; 563, the jaw; 564, the second elastic hook part; 570, the third hole.

Detailed ways

For the Continuous Glucose Monitoring (CGM, Continuous Glucose Monitoring) system, please refer to FIG. 1 , which is a schematic diagram of a continuous glucose monitoring system attached to a host 100 . The figure shows a continuous blood glucose monitoring system including a body surface attachment unit 200 with sensor electrodes 210 , and the body surface attachment unit 200 is applied to the skin surface of a host 100 through an implanter 500 . An electronic component 300 is installed on the body surface attachment unit 200, and the electronic component 300 is electrically connected to the sensor electrode 210, and is configured to send the glucose concentration information monitored by the sensor electrode 210 to the receiver 400, and the receiver 400 can usually be a smart phone , smart watches, specialized devices 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 , the continuous blood glucose monitoring system of the present application includes an implanter 500 and a body surface attachment unit 200 , and the implanter 500 is configured to apply the body surface attachment unit 200 to the skin surface of the host 100 . In one embodiment, in order to reduce the user's assembly operations and prevent the product from being unusable due to improper assembly, the body surface attachment unit 200 can be pre-installed in the implanter 500 at the factory, and then packaged as a whole. On the premise that the body surface attachment unit 200 is pre-installed in the implanter 500, the needle assembly 510 of the implanter 500 may also be preinstalled on the body surface attachment unit 200. For example, the needle assembly 510 can be coupled to the body surface attachment unit 200, while the needle assembly 510 is also held by the internal components of the implanter 500, and the needle assembly 510 responds to the series of actions of the internal components of the implanter 500 . For example, the actions of the internal components of the implanter 500 in the related art include: 1. Driving the needle assembly 510 to introduce the part of the sensor electrode 210 into the host 100 subcutaneously; 2. After the sensor electrode 210 is introduced into the host 100 subcutaneously, , the drive needle assembly 510 is subcutaneously withdrawn from the host 100 and retracted into the implanter 500 .

Referring to FIG. 3 , the body surface attachment unit 200 includes a body surface attachment housing 220 , sensor electrodes 210 and electronic components 300 , and the sensor electrodes 210 are pre-connected to the body surface attachment housing 220 . Wherein, the sensor electrode 210 includes an internal body part 211 and an external body part 212. The internal body part 211 represents the part that is introduced into the subcutaneous tissue of the host 100 and is in contact with the subcutaneous tissue fluid. The external part 212 represents the part exposed outside the skin of the host 100. The sensor electrode 210 The extracorporeal portion 212 is attached to the interior of the body surface attachment shell 220 for pre-connection. The body surface attachment housing 220 may include an upper housing 221 and a lower housing 222. The extracorporeal part 212 of the sensor electrode 210 is attached to the lower housing 222. The upper housing 221 and the lower housing 222 may be connected by a buckle. A rubber sealing ring (not shown) is arranged at the connection between the housing 221 and the lower housing 222 to improve the sealing of the body surface attachment shell 220 and prevent the body surface attachment shell 220 from entering water; in one embodiment, The connection between the upper shell 221 and the lower shell 222 is treated with dispensing glue, so as to further improve the airtightness of the body surface attachment shell 220 .

The end of the extracorporeal part 212 of the sensor electrode 210 is applied to the lower housing 222 through the first conductive part 223 to form an electrode signal output terminal. The electronic component 300 includes an electrode signal input terminal, and the electrode signal output terminal is electrically connected to the electrode signal. input terminal. Wherein, the first conductive part 223 is made of flexible conductive material, for example, conductive foam.

The lower casing 222 is also equipped with a power base 224 and a second conductive part 225. A power source 226 is installed in the power base 224. The second conductive part 225 is electrically connected to the positive pole and the negative pole of the power supply 226 respectively to form a power output terminal. The component 300 includes a power input terminal, and the power output terminal is electrically connected to the power input terminal. Wherein, the power source 226 may be a button battery, and the second conductive part 225 may be a metal conductive sheet.

The electronic component 300 is detachably mounted on the body surface attachment housing 220 before the implanter 500 is applied to the body surface attachment unit 200 . That is, the electronic component 300 is installed on the body surface attachment shell 220 first, and then the implanter 500 is applied to the skin surface of the host 100 together with the body surface attachment shell 220 .

Please continue to refer to FIG. 2, the installation method of the electronic component 300 of the present application is especially suitable for a continuous blood glucose monitoring system in which the body surface attachment unit 200 is pre-installed on the implanter 500, and this continuous blood glucose monitoring system is packaged It may be installed with electronic components 300 or not installed with electronic components 300. The continuous blood glucose monitoring system with electronic components 300 is the situation when it is used for the first time. The continuous blood glucose monitoring system without electronic components 300 is Condition as a replacement. When using it for the first time, you only need to take the continuous blood glucose monitoring system out of the package, put the implanter 500 close to the skin surface of the host 100, and then operate the implanter 500 to apply the body surface attachment unit 200 equipped with the electronic components 300 to the The host 100 skin surface, and then the implanter 500 is separated from the body surface attachment unit 200 . When the sensor electrodes 210 on the body surface attachment unit 200 have reached the service life, the body surface attachment unit 200 is removed from the skin surface of the host 100, and the electronic component 300 is removed from the body surface attachment shell 220, and then the electronic component is removed. 300 can be loaded into another continuous blood glucose monitoring system without electronic component 300, and the above-mentioned implantation operation can be repeated. In this way, the electronic component 300 can be reused and the cost of use can be reduced. Please refer to FIG. 4 , in order to realize that the electronic component 300 can be installed on the continuous blood glucose monitoring system, a first opening 520 for inserting the electronic component 300 is formed on the implanter 500 , and the electronic component 300 is installed into the body through the first opening 520 . Table attachment unit 200 on. Through the implantation method of the present application, the electronic component 300 is installed on the body surface attachment unit 200 before the body surface attachment unit 200 is applied to the skin surface of the host 100. The electronic component 300 is installed after the connection unit 200 is applied to the skin surface of the host 100 . The installation of the electronic component 300 of the present application is simpler and does not require the host 100 to be stressed, so it will not cause discomfort. In the related art, since the body surface attachment unit 200 has been applied to the skin surface of the host 100, it is usually necessary to press the electronic component 300 when installing the electronic component 300, and the skin of the host 100 is easily damaged during the installation process of the electronic component 300. Discomfort caused by force. In order to realize the in vitro installation of the electronic component 300, this application has opened up a new installation method of the electronic component 300, and correspondingly, a new structure of the implanter 500 is provided, that is, a first opening 520 is opened on the implanter 500 , so that the electronic component 300 is installed on the body surface attachment unit 200 through the first opening 520 .

In this application, the body surface attachment unit 200 is preset in the implanter casing 530, and the electronic component 300 is installed on the body surface attachment unit 200 through the first opening 520 before performing the application operation, so as to realize the electronic The in vitro installation and reusability of the component 300 , the in vitro installation of the electronic component 300 is simpler and more convenient to operate than the body surface installation, and does not cause discomfort, and the reusable electronic component can reduce waste and reduce use costs.

Referring to FIGS. 5 and 6 , the electronic component 300 includes a carrier 310 and an electronic circuit (not shown) disposed in the carrier 310 and including a plurality of electronic components. The body surface attachment housing 220 may have a circular structure, and the carrier 310 of the electronic component 300 may be inserted into the body surface attachment housing 220 from the side of the body surface attachment housing 220 along the radial direction of the body surface attachment housing 220 . A U-shaped connecting arm 311 is formed on the carrier 310 , and the connecting arm 311 is located inside the body surface attaching shell 220 when the carrier 310 of the electronic component 300 is plugged into the body surface attaching shell 220 . The electrode signal input terminal and the power input terminal are arranged on the connecting arm 311, and extend into the body surface attachment shell 220 through the connecting arm 311, so that the electrode signal input terminal is electrically connected to the electrode signal output terminal, and the power input terminal is connected to the power supply. The output terminals are electrically connected.

Please continue to refer to FIG. 6, for example, a position-limiting protrusion 312 is formed under the carrier 310 of the electronic component 300, and a position-limiting hole 227 is formed on the body surface attachment shell 220. When the carrier 310 of the electronic component 300 is inserted into the body surface When the body surface of the attachment unit 200 is attached to the shell 220, the limit protrusion 312 snaps into the limit hole 227, preventing the carrier 310 of the electronic component 300 from falling off from the body surface attachment shell 220 of the body surface attachment unit 200 , but allow artificial force to remove the carrier 310 of the electronic component 300 from the body surface attachment shell 220 of the body surface attachment unit 200 .

In other embodiments, the installation and removal of the carrier 310 of the electronic component 300 can also be done in a manner similar to that of an SD card, that is, inserting the carrier 310 of the electronic component 300 into a body surface attachment When on the housing 220, the carrier 310 of the electronic component 300 is locked; when the carrier 310 of the electronic component 300 is to be removed, the carrier 310 of the electronic component 300 is pressed inward along the radial direction of the carrier. At this time, the carrier 310 of the electronic component 300 310 is unlocked and ejected outward along the radial direction of the carrier, and then the carrier 310 of the electronic component 300 can be removed. In this embodiment, the installation and removal of the carrier 310 of the electronic component 300 is more convenient and labor-saving, which can be used as a subsequent improvement.

The connection between the carrier 310 of the electronic component 300 and the body surface attachment housing 220 is equipped with a rubber sealing ring (not shown in the figure) to improve the sealing of the entire assembly and prevent the internal cavity of the body surface attachment unit 200 from entering .

Referring to FIGS. 7 and 8 , the sterilization assembly includes a body surface attachment unit 200 , a needle assembly 510 and a sheath 230 .

Referring to FIG. 9 , the needle assembly 510 includes a puncture needle 511 and a hub 512 attached to the blunt portion (ie, the proximal end) of the puncture needle 511 , and the puncture needle 511 passes through the lower housing 222 of the body surface attachment unit 200 And protrude from the lower surface of the lower housing 222 of the body surface attachment unit 200, the puncture needle 511 is formed with an elongated groove 513 extending to the sharp part (ie, the distal end) of the puncture needle 511, and the sensor electrode 210 The internal body part 211 is inserted into the puncture needle 511 through the groove 513, and is guided into the host subcutaneously by the puncture needle 511.

Please continue to refer to FIGS. 7 and 8 , the sleeve 230 is coupled to the needle assembly 510 , and the proximal end of the sleeve 230 is formed with two limiting hooks 231 . Set axisymmetrically to the axis of symmetry. Two limiting grooves 514 corresponding to the limiting hooks 231 are formed on the needle assembly 510. As shown in FIG. The limiting hook 231 moves along the direction towards the needle assembly 510 , and the second path 516 is configured to allow the limiting hook 231 to move along the circumferential direction of the needle assembly 510 . In one embodiment, the first path 515 may extend along a direction parallel to the central axis of the needle assembly 510 , at this time, the first path 515 is perpendicular to the second path 516 . In another embodiment, the first path 515 extends obliquely to the second path 516 , and at this time, the first path 515 and the second path 516 form an obtuse angle.

A third path 517 may also be formed on the needle assembly 510 , and the third path 517 allows the limiting hook 231 to move away from the needle assembly 510 . The third path 517 is a path for the limiting hook 231 to withdraw from the limiting groove 514 .

The first path 515 , the second path 516 and the third path 517 are configured at the distal end of the hub 512 of the needle assembly 510 , and the distal end of the hub 512 passes through the lower housing of the body surface attachment unit 200 The proximal end of the hub 512 is defined outside the lower housing 222 of the body surface attachment unit 200 at 222 .

Referring to FIG. 10 , a sealed cavity 232 is formed in the sleeve 230 to provide a sterile environment for the sensor electrode 210 and the needle assembly 510 . For example, the internal body portion 211 of the sensor electrode 210 and the piercing needle 511 of the needle assembly 510 are stored in the sterile sealed cavity 232 prior to use.

In order to ensure the airtightness of the sealed cavity 232, a first sealing ring 240 is disposed between the sleeve 230 and the lower surface of the lower housing 222 of the body surface attachment unit 200, and the needle assembly 510 and the body surface attachment unit 200 A second sealing ring 250 is disposed between the upper surfaces of the upper casing 221 .

A positioning plate 233 is formed on the sheath 230 along the circumferential direction of the sheath 230 . The positioning plate 233 provides a first force point for the fingers, and the finger abutting against the positioning plate 233 is more conducive to pushing the sheath 230 toward the needle assembly 510 . A positioning wing 234 is also formed on the lower surface of the positioning plate 233 . The positioning wing 234 provides a second point of force for the finger, and the finger abutting on the positioning wing 234 is more conducive to rotating the sleeve 230 along the circumferential direction of the needle assembly 510 .

The sleeve 230 is coupled to the needle assembly 510, the first sealing ring 240 provides a force to keep the sleeve 230 away from the needle assembly 510, and the stop hook 231 is positioned at the beginning of the first path 515. At this time, due to the first path 515 to The second path 516 has a height difference, and directly rotating the sleeve 230 cannot move the limiting hook 231 into the second path 516 , that is, the sleeve 230 cannot be removed from the needle assembly 510 by simply rotating the sleeve 230 .

Please continue to refer to FIG. 11 , when removing the sleeve 230 , it is first necessary to push the sleeve 230 in a direction toward the needle assembly 510 .

Please refer to FIG. 12 , when the limit hook 231 of the sleeve 230 moves in the first path 515 to the beginning of the second path 516 , the sleeve 230 is rotated so that the limit hook 231 moves in the second path 516 .

Please refer to FIG. 13 , when the limit hook 231 of the sleeve 230 moves to the beginning of the third path 517 in the second path 516 , pulling the sleeve 230 along the direction away from the needle assembly 510 can make the limit hook 231 Moving in and out of the third path 517, at which point the removal of the sleeve 230 is complete.

Please continue to refer to FIG. 15 and FIG. 16, the implanter 500 includes a housing 530 and a driving member (ie, the aforementioned internal member) and a needle assembly 510 arranged in the housing 530, and a body surface attachment unit is preset in the housing 530 200. In an embodiment, the needle assembly 510 is configured to be coupled to the body surface attachment unit 200 and the drive member. In other embodiments, the needle assembly 510 may also be configured to be coupled only to the body surface attachment unit 200 or to the drive member. As previously mentioned, the body surface attachment unit 200 is configured to be applied to the skin surface of the host 100 in response to the action of the driving member, and the distal end of the housing 530 is coupled with a cap 540 configured to drive the The component and body surface attachment unit 200 is held in the housing 530 . In one embodiment, all the first openings 520 are located on the housing 530 . In other implementation manners, the first opening 520 may also be entirely located on the cap 540 , or partially located on the housing 530 and partially located on the cap 540 . The first opening 520 allows the electronic component 300 to pass through, and the electronic component 300 is installed on the body surface attachment unit 200 after passing through the first opening 520 .

The proximal end of the housing 530 is provided with a safety mechanism configured to operatively release the drive member from the housing 530 . For example, the safety mechanism is configured to rotationally release the drive member from the housing 530 . For example, the safety mechanism is configured to lock the drive member to the housing 530 when rotated to the first position, and to release the drive member from the housing 530 when rotated to the second position.

In one embodiment, as shown in FIG. 14 , the safety mechanism includes a knob 531 disposed outside the casing 530 and a bolt 532 disposed inside the casing 530. The bolt 532 rotates with the knob 531, and the driving member is configured with a supply bolt. 532 embedded in the first hole 533; when the safety mechanism is rotated to the first position, the bolt 532 is not allowed to withdraw from the first hole 533, at this time, the driving mechanism is locked by the safety mechanism; when the safety mechanism is rotated to the second position, the bolt is allowed 532 withdraws from the first hole 533, at this time, the driving mechanism is released by the safety mechanism.

Referring to FIGS. 15 and 16 , the driving member includes a first driving mechanism 550 and a second driving mechanism 560; wherein, the first driving mechanism 550 applies the body surface attachment unit 200 to the host 100 along the direction toward the distal end. Skin surface; the second drive mechanism 560 withdraws the needle assembly 510 from the skin of the host 100 in a proximal direction when the body surface attachment unit 200 is applied to the skin surface of the host 100 .

The first driving mechanism 550 includes a base 551 and a first holding part 552. A first driving spring 553 is arranged between the proximal end of the base 551 and the housing 530. The first driving spring 553 is configured to provide a The direction of the end drives the force of the base 551, the distal end of the base 551 is coupled to the proximal end of the first holding part 552, and the distal end of the first holding part 552 is formed with a body surface attachment unit 200 of the connecting portion 554 .

Wherein, the connecting portion 554 includes a groove 555 for accommodating at least part of the body surface attachment unit 200 , and a second opening 556 through which the electronic component 300 passes is formed on a side wall of the groove 555 . In addition, as shown in FIGS. 15 and 16 , a second hole 557 through which the proximal end of the needle assembly 510 passes is formed on the connecting portion 554 , and the second hole 557 is configured to prevent the needle assembly 510 from rotating. For example, the second hole 557 is a special-shaped hole, and the section of the needle assembly 510 passing through the second hole 557 is a special-shaped cross section corresponding to the special-shaped hole. Therefore, the needle assembly 510 cannot rotate in the second hole 557 .

As shown in FIG. 15 , two mirror-symmetrical first elastic hooks 558 are formed on the first holding portion 552 along the proximal direction. The first elastic hooks 558 have a radial direction along the first holding portion 552. With a tendency to expand outward, a first step 534 corresponding to the first elastic hook portion 558 is formed on the inner surface of the housing 530 , and the first elastic hook portion 558 overlaps the first step 534 . Two mirror-symmetrical elastic buttons 535 are disposed on the housing 530, and the elastic buttons 535 are configured to drive the first elastic hook portion 558 along the radial direction of the first holding portion 552 so that the first elastic hook portion 558 moves from the first step 534 up and out.

A guiding hole 559 is formed on an edge of the first holding portion 552 , and a guiding post 541 corresponding to the guiding hole 559 is formed on the cap 540 along a direction toward the proximal end. By setting the guide port 559 and the guide post 541, when the cap 540 is installed on the implanter 500, the guide post 541 is inserted into the guide port 559, so that the cap 540 can be installed in place according to the predetermined position, preventing deviation from causing implantation. The injector 500 cannot be used normally.

The second driving mechanism 560 includes a second holding portion 561 and a second driving spring 562, the second holding portion 561 is coupled to the proximal end of the first holding portion 552; Formed with a jaw 563 coupled to the proximal end of the needle assembly 510, for example, the jaw 563 coupled to the hub 512 of the needle assembly 510, the second drive spring 562 is configured to provide a The direction of the end drives the force of the second holding part 561 .

At least two second elastic hooks 564 are formed on the second holding portion 561 along the direction toward the distal end, for example, there may be four second elastic hooks 564, and the four second elastic hooks 564 may form a matrix The distribution can also be butterfly-shaped. The second elastic hook portion 564 has a tendency to expand outward along the radial direction of the second holding portion 561. A third hole 570 corresponding to the second elastic hook portion 564 is formed on the first holding portion 552. The second elastic hook portion 564 overlaps the edge of the third hole 570 after passing through the third hole 570, and a second step 542 corresponding to the second elastic hook 564 is formed on the inner surface of the cap 540, and the second step 542 is configured to be along the second The radial direction of the holding portion 561 drives the second elastic hook portion 564 to disengage the second elastic hook portion 564 from the edge of the third hole 570 .

The far and near in the "distal end", "proximal end", "distal end" and "proximal end" in this application are relative to the sensor electrode during the process of implanting the sensor electrode, specifically For, the initial position of sensor electrode implantation was defined as proximal, and the final position of sensor electrode implantation was defined as distal.

Claims

An implanter, comprising a shell, in which a body surface attachment unit is preset;

a drive member disposed within the housing and a needle assembly coupled to at least one of the body surface attachment unit and the drive member, the body surface attachment unit being configured to respond to actuation of the drive member to be applied to the skin surface of the host; and

a cap coupled to the distal end of the housing, the cap configured to retain the drive member and the body surface attachment unit in the housing, at least one of the housing and the cap One is formed with a first opening configured to provide a path for mounting the electronic component on the body surface attachment unit.
The implanter of claim 1, wherein the proximal end of the housing is configured with a safety mechanism configured to operatively release the drive member from the housing.
The implanter of claim 2, wherein the safety mechanism is configured to rotationally release the drive member from the housing.
The implanter of claim 3, wherein said safety mechanism is configured to lock said drive member to said housing when rotated to a first position, and to lock said drive member to said housing when rotated to a second position. The drive member is released from the housing.
The implanter according to claim 4, wherein: the safety mechanism comprises a knob arranged outside the housing and a bolt arranged inside the casing, the bolt follows the rotation of the knob, and the driving The component is configured with a first hole for the plug to be embedded;

The peg is configured not to permit withdrawal from the first hole when the safety mechanism is rotated to a first position, and to allow withdrawal from the first hole when the safety mechanism is rotated to a second position.
The implanter of claim 1, wherein: the drive member includes a first drive mechanism and a second drive mechanism;

the first drive mechanism is configured to apply the body surface attachment unit to a host skin surface in a distal direction;

The second drive mechanism is configured to withdraw the needle assembly from the skin of the host in a proximal direction when the body surface attachment unit is applied to the skin surface of the host.
The implanter according to claim 6, wherein: the first driving mechanism comprises a base and a first holding part, a first driving spring is arranged between the proximal end of the base and the housing, The first drive spring is configured to provide a force driving the base in a distal direction, the distal end of the base is coupled to the proximal end of the first retaining portion, so The distal end of the first holding part is formed with a connection part for installing the body surface attachment unit.
The implanter according to claim 7, wherein: the connecting portion includes a groove for accommodating at least part of the body surface attachment unit, and a hole for the electronic component to pass through is formed on the side wall of the groove. Second opening.
The implanter according to claim 7, wherein: said connecting portion is formed with a second hole through which the proximal end of said needle assembly passes, said second hole being configured to prevent said needle assembly from turn.
The implanter according to claim 7, wherein: two mirror-symmetrical first elastic hooks are formed on the first holding part along the direction toward the proximal end, and the first elastic hooks have a The tendency of the first retaining portion to expand radially outward, a first step corresponding to the first elastic hook portion is formed on the inner surface of the housing, and the first elastic hook portion overlaps the On the first step.
The implanter according to claim 10, wherein: two mirror-symmetrical elastic buttons are arranged on the outer shell, and the elastic buttons are configured to drive the first holding part along the radial direction. The elastic hook is used to disengage the first elastic hook from the first step.
The implanter according to claim 6, wherein: a guide port is formed on the edge of the first holding part, and a guide column corresponding to the guide port is formed on the cap along a direction toward the proximal end.
The implanter of claim 6, wherein the second drive mechanism includes a second retaining portion and a second drive spring, the second retaining portion coupled to a proximal end of the first retaining portion ;

A jaw is formed on the second retaining portion along the direction toward the distal end, the jaw is coupled to the proximal end of the needle assembly, and the second drive spring is configured to provide a direction along the proximal end. The direction of the end drives the force of the second holding part.
The implanter according to claim 13, wherein: at least two second elastic hooks are formed on the second holding portion along the direction toward the distal end, and the second elastic hooks have The tendency of the radial outward expansion of the second holding part is described, and a third hole corresponding to the second elastic hook part is formed on the first holding part, and after the second elastic hook part passes through the third hole Overlapping on the edge of the third hole, a second step corresponding to the second elastic hook is formed on the inner surface of the cap, and the second step is configured to be along the edge of the second holding part. radially driving the second elastic hook to disengage the second elastic hook from the edge of the third hole.
A method of using an implanter, based on the implanter according to any one of claims 1-14, the method comprising: on the body surface to be preset in the shell of the implanter The electronic component is mounted on the body surface attachment unit before the attachment unit is applied to the skin surface of the host.
The method of using the implanter according to claim 15, wherein: the electronic component is mounted on the body surface attachment unit through a first opening formed in at least one of the housing and the cap .