CN114431855A

CN114431855A - Transdermal analyte sensor system and method of use

Info

Publication number: CN114431855A
Application number: CN202210066360.6A
Authority: CN
Inventors: 钱成
Original assignee: Diascience Medical Co Ltd
Current assignee: Diascience Medical Co Ltd
Priority date: 2022-01-20
Filing date: 2022-01-20
Publication date: 2022-05-06
Also published as: WO2023138571A1

Abstract

A transcutaneous analyte sensor system and method of use is provided, the system including an implanter assembly and a sterilization assembly, the sterilization assembly including a sensor electrode and a cap, the cap having a sealed sterilization chamber formed therein, an in vivo portion of the sensor electrode being configured in the sterilization chamber, the cap being permitted to separate from the sensor electrode only when the sterilization assembly is coupled to the implanter assembly such that the sensor electrode exits the sterilization chamber. The invention can avoid separating the cap and the sensor electrode in a rotating way before formal use, and ensure that the sensor electrode is in a sterile environment before formal use.

Description

Transdermal analyte sensor system and method of use

Technical Field

The invention relates to the technical field of medical instruments, in particular to a transcutaneous analyte sensor system and a using method thereof.

Background

Some physiological diseases, which are long-lasting and have no cure, require real-time monitoring of certain physiological parameters of the host to better track the treatment. Such as diabetes, require real-time monitoring of the host's blood glucose. Accurate blood sugar self-monitoring is the key to realizing good blood sugar control, is beneficial to evaluating the degree of glucose metabolism disorder of diabetics, formulating a blood sugar reduction scheme, and simultaneously reflecting the blood sugar reduction treatment effect and guiding the adjustment of the treatment scheme.

Currently, most commercially available instruments refer to blood glucose meters, and patients need to collect finger peripheral blood by themselves to measure the blood glucose level at that moment. However, this method has the following drawbacks: firstly, the change of the blood sugar level between two measurements cannot be known, and the peak value and the valley value of the blood sugar can be missed by a patient, so that complications are caused, and irreversible damage is caused to the patient; secondly, the finger tip puncture blood sampling is carried out for a plurality of times every day, which causes great pain for the diabetic. In order to overcome the above-mentioned drawbacks, it is necessary to provide a method for continuously monitoring blood sugar of a patient, so that the patient can conveniently know the blood sugar status of the patient in real time, and take measures in time to effectively control the state of an illness and prevent complications, thereby achieving a high quality of life.

Aiming at the requirements, technical personnel develop a monitoring technology which can be implanted into subcutaneous tissues to continuously monitor subcutaneous blood sugar, the technology is characterized in that a sensor electrode is inserted into the subcutaneous tissues, the sensor electrode generates oxidation reaction between interstitial fluid of a patient and glucose in a body, an electric signal is formed during the reaction, the electric signal is converted into blood sugar reading through a transmitter, the blood sugar reading is transmitted to a wireless receiver every 1-5 minutes, corresponding blood sugar data are displayed on the wireless receiver, and a map is formed for the patient and a doctor to refer.

While the sensor electrodes and needles are required to be sterile when inserted into the subcutaneous tissue, some continuous blood glucose monitoring systems employ a separate sterilization process to sterilize the sensor electrodes and electronic components, such as may be employed, since radiation sterilization can compromise the electronic components associated with the sensor electrodes, and thus, typically, ethylene oxide, for example, is used to sterilize the electronic components. However, ethylene oxide can damage the chemicals on the sensor electrodes, and therefore, integrating the sensor electrodes and electronic components into one unit can complicate the sterilization process.

These problems can be circumvented by separating the components into a sensor unit (containing the sensor electrodes) and a transmitter unit (containing the electronic components) so that each component can be individually packaged and sterilized using a suitable sterilization method. For example, the sensor unit can be received in a cap after sterilization, and a sterile cavity for accommodating the sensor electrode is formed between the cap and the sensor unit, and the cap and the sensor unit can be assembled or separated by rotating the cap, so that the cap can be separated from the sensor unit by misoperation before formal use, the sterile environment of the sensor unit is destroyed, and the sensor unit cannot be used.

Disclosure of Invention

The present invention is directed to a transdermal analyte sensor system and method of use that avoids the need to rotationally separate the cap from the sensor electrode prior to actual use, and ensures that the sensor electrode is in a sterile environment prior to actual use.

In order to achieve the purpose of the invention, the technical scheme adopted by the invention is as follows: a transcutaneous analyte sensor system comprising an implanter assembly and a sterilization assembly, the sterilization assembly including a sensor electrode and a cap, the cap having a sealed sterilization chamber formed therein, an in vivo portion of the sensor electrode being configured in the sterilization chamber, the cap being permitted to separate from the sensor electrode only when the sterilization assembly is coupled to the implanter assembly such that the sensor electrode exits the sterilization chamber.

In the above-described aspect, the cap is configured to be separated from the sensor electrode in a rotational manner along the first direction.

In the above solution, the sterilization assembly further comprises a holding portion, a first locking portion is formed between the holding portion and the cap, the first locking portion is configured to prevent the cap from rotating relative to the holding portion along the first direction, and the first locking portion is released when the sterilization assembly is coupled to the implanter assembly.

In the above-described aspect, the first locking portion includes a first locking member disposed on the holding portion and a second locking member disposed on the cap, and the first locking member and the second locking member are cooperatively locked.

In the above technical solution, the first locking member is located radially inside or radially outside the second locking member.

In the above-described aspect, the second locking member has a step formed thereon, and the step moves from the base portion of the first locking member to the free end of the first locking member in the second direction so that the free end of the first locking member abuts in the step.

In the above solution, the free end of the first locking member has an elastic tendency to expand towards the second locking member.

In the above technical solution, the second locking member is an arc rib extending along the circumferential direction.

In the above technical solution, the second locking member is an arc rib extending along the second direction and the radially inward direction at the same time.

In the above technical solution, a release member for releasing the first locking portion is formed on the implanter assembly.

In the above solution, the cap is coupled to the implanter assembly via the retaining portion.

In the above-described aspect, the sterilization assembly further includes a body surface attachment unit that is attached to the cap, and a second locking portion is formed between the body surface attachment unit and the holding portion, the second locking portion being configured to prevent the holding portion from rotating relative to the body surface attachment unit in the first or second direction.

In the above technical solution, the second locking portion includes a plurality of bayonets circumferentially distributed on an edge of the body surface attachment unit and locking blocks distributed on the holding portion and corresponding to the bayonets, and the bayonets and the locking blocks are locked in a fitting manner.

In the above technical solution, the sterilization assembly further comprises a needle assembly mounted to the body surface attachment unit, the needle assembly comprising a needle holder and a puncture needle attached to the needle holder, a third locking portion is formed between the needle holder and the body surface attachment unit, and the third locking portion is configured to prevent the needle holder from rotating relative to the body surface attachment unit in the first or second direction.

In the above technical solution, the third locking portion includes a shaped waist portion formed on the needle holder and a boss with a shaped hole formed on the body surface attachment unit, and when the needle assembly is mounted on the body surface attachment unit, the shaped waist portion is inserted into the shaped hole of the boss and is locked in cooperation with the shaped hole.

In the above technical solution, a fourth locking portion is formed between the needle holder and the cap, and the fourth locking portion is configured to prevent the cap from rotating relative to the needle holder in the second direction and prevent the cap from moving in a direction away from the needle holder.

In the above technical solution, the fourth locking portion includes a third locking member disposed on the needle holder and a fourth locking member disposed on the cap, and the third locking member and the fourth locking member are cooperatively locked.

In the technical scheme, a sleeve for limiting a sterilization cavity is formed in the cap;

the third locking component comprises at least two limiting grooves arranged on the outer surface of the needle seat, the fourth locking component comprises limiting bulges arranged at the end part of the sleeve and corresponding to the limiting grooves, and the limiting bulges are matched with the limiting grooves for positioning;

the opening of the limiting groove faces to the first direction.

In the technical scheme, the limiting grooves are distributed on the outer surface of the needle seat at equal intervals along the circumferential direction.

In the above technical solution, the puncture needle is sleeved on the internal part of the sensor electrode and is disposed in the sterilization cavity together with the internal part of the sensor electrode.

The present disclosure also provides for a method of using a transcutaneous analyte sensor system including allowing a cap to be separated from a sensor electrode only when the sterilization assembly is coupled to an implanter assembly such that the sensor electrode exits the sterilization chamber.

In the above technical solution, the cap is separated from the sensor electrode in such a manner that the cap is rotated in the first direction.

In the above technical solution, the fourth locking portion is released in the process of rotating the cap in the first direction.

Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:

the present disclosure enables the cap to be rotatably separated from the sensor electrode only when the sterilization assembly is coupled to the implanter assembly, thereby avoiding rotatably separating the cap from the sensor electrode prior to actual use and ensuring that the sensor electrode is in a sterile environment prior to actual use.

Drawings

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

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

Fig. 3 is a schematic structural view of the sterilization assembly in an initial state in which the holder is mounted according to the embodiment of the present invention.

Fig. 4 is a schematic structural view of the sterilization assembly in a state where the installation of the holder is completed according to the embodiment of the present invention.

Fig. 5 is a cross-sectional view of a sterilization assembly of an embodiment of the present disclosure mounted to an implanter assembly.

FIG. 6 is a schematic view of the embodiment of the invention in which the position-limiting protrusion is not installed in the position-limiting groove.

Fig. 7 is a schematic view of the start of insertion of a stopper protrusion into a stopper groove according to an embodiment of the present invention.

Fig. 8 is a schematic view of the embodiment of the present invention in which the stopper protrusion is completely fitted into the stopper groove.

Wherein: 100. a host; 200. a body surface attachment unit; 210. a sensor electrode; 300. a receiver; 400. an implanter assembly; 410. a release member; 500. a sterilization assembly; 510. a cap; 520. a holding section; 530. a first locking section; 531. a first locking member; 532. a second locking member; 533. a step; 534. a base; 535. a free end; 540. a second locking portion; 541. a bayonet; 542. a clamping block; 550. a needle assembly; 551. a needle seat; 552. puncturing needle; 560. a third locking portion; 561. a special-shaped waist part; 562. a boss; 570. a fourth locking portion; 571. a third locking member; 572. a fourth locking member; 573. a guide groove; 580. a sleeve.

Detailed Description

The following description and examples illustrate some exemplary embodiments of the disclosed invention. Those skilled in the art will recognize that there may be many variations and modifications of the embodiments of the present invention.

Continuous blood Glucose Monitoring (CGM) system

Referring to FIG. 1, a schematic of a continuous blood glucose monitoring system attached to a host 100 is shown. A continuous blood glucose monitoring system comprising a body surface attachment unit 200 with sensor electrodes 210 is shown attached to the skin surface of a host 100 by an adhesive layer. The body surface attachment unit 200 houses a circuit module electrically connected to the sensor electrodes 210, and transmits information on the glucose concentration monitored by the sensor electrodes 210 to the receiver 300 through the circuit module, and the receiver 300 may be a smartphone, a smart watch, a dedicated device, and the like. During use, the sensor electrodes 210 are positioned partially beneath the skin of the host 100, in contact with subcutaneous interstitial fluid.

The sensor electrode 210 includes an in vivo portion, which refers to a portion implanted under the skin of the host 100 in contact with subcutaneous tissue fluid, and an in vitro portion, which refers to a portion left outside the skin of the host 100. In one embodiment, the external portion of the sensor electrodes 210 extends into the body surface attachment unit 200 and attaches to the circuit module to establish electrical connection with the circuit module.

Referring to FIG. 2, a schematic diagram of a continuous blood glucose monitoring system is shown, including an implanter assembly 400 and a sterilization assembly 500, the implanter assembly 400 and the sterilization assembly 500 being separately housed in two separate packages after sterilization, the sterilization assembly 500 including a cap 510 and a body surface attachment unit 200 with a sensor electrode 210 disposed in the cap 510. In use, the two packages are opened, respectively, and only when the sterilization assembly 500 is mounted on the implanter assembly 400, the cap 510 is removed from the implanter assembly 400 by rotating the cap 510 of the sterilization assembly 500, so that the cap 510 is separated from the sensor electrode 210, thereby exposing the sensor electrode 210, the end with the opening of the implanter assembly 400 is attached to the skin surface of the host 100, the body surface attachment unit 200 is applied to the skin surface of the host 100 by operating the implanter assembly 400, at which time the in vivo portion of the sensor electrode 210 is 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, and after the application operation of the body surface attachment unit 200 is completed, the implanter assembly 400 is removed, and only the body surface attachment unit 200 is left on the skin surface of the host 100.

The present invention selects the manner of rotating the cap 510 along the first direction as the optimal solution for achieving the separation of the cap 510 from the sensor electrode 210, but not as a limitation on the solution for achieving the separation of the cap 510 from the sensor electrode 210, and the solution of achieving the separation of the cap 510 from the sensor electrode 210 in other manners should be understood as an approximation of the above optimal solution and included in the protection scope of the present invention. For example, the cap 510 may be separated from the sensor electrode 210 by plugging, and the plugging direction may be along the axial direction or the radial direction of the sterilization assembly 500 or a direction at an angle with the axial direction.

The adhesive layer can be, for example, a medical nonwoven tape.

Referring to fig. 3, the present invention provides a transcutaneous analyte sensor system, such as the continuous blood glucose monitoring system described above, and more particularly provides a new sterilization assembly 500 configuration that improves the manner in which cap 510 is removed, which sterilization assembly 500 allows cap 510 to be rotatably separated from sensor electrode 210 in a first direction only when coupled to implanter assembly 400. In one embodiment, the first direction may be a clockwise direction.

Continuing to refer to fig. 3, sterilization assembly 500 includes cap 510, body surface attachment unit 200 disposed in cap 510, sensor electrode 210 attached to body surface attachment unit 200, and holder 520 disposed in cap 510, with first lock 530 formed between holder 520 and cap 510, first lock 530 including two operating states, a locked state and a released state. When the sterilization assembly 500 is not installed on the implanter assembly 400, the first locking portion 530 is in a locked state; when the sterilization assembly 500 is installed on the implanter assembly 400, the first locking portion 530 is in a released state. When the first locking portion 530 is in the locked state, the first locking portion 530 is configured to prevent the cap 510 from rotating in the first direction with respect to the holding portion 520; when the first locking portion 530 is in the released state, the first locking portion 530 is configured to allow the cap 510 to rotate in the first direction.

With continued reference to fig. 3, the first locking portion 530 includes a first locking member 531 disposed on the holder 520 and a second locking member 532 disposed on the cap 510, the first locking member 531 cooperatively locking with the second locking member 532.

In one embodiment, the first locking member 531 is located radially inward of the second locking member 532; in another embodiment, the first locking member 531 is located radially outward of the second locking member 532.

In one embodiment, the first locking member 531 and the second locking member 532 are engaged in such a manner that the second locking member 532 has a step 533 formed thereon, and when the holding portion 520 is mounted on the cap 510, by rotating the cap 510 in the second direction, the step 533 on the second locking member 532 moves from the base 534 of the first locking member 531 to the free end 535 of the first locking member 531 in the second direction along with the rotation of the cap 510, so that the free end 535 of the first locking member 531 abuts against the step 533, and at this time, the mounting of the holding portion 520 is completed, and the first locking member 531 is engaged and locked with the second locking member 532. Fig. 3 shows an illustration of an initial state of mounting of the holding portion 520, and fig. 4 shows an illustration of a completed state of mounting of the holding portion 520. In one embodiment, the second direction may be a counterclockwise direction.

In one embodiment, the first locking member 531 is a piece of resilient plastic with a free end 535 having a resilient tendency to splay toward the second locking member 532. For example, during movement of the step 533 on the second locking member 532 in the second direction from the base 534 of the first locking member 531 to the free end 535 of the first locking member 531, the free end 535 of the first locking member 531 may move in the first direction from the end of the second locking member 532 distal from the step 533 into the step 533, and during movement of the free end 535 of the first locking member 531, the second locking member 532 may provide a force that urges the free end 535 of the first locking member 531 radially, and as the free end 535 of the first locking member 531 moves to the step 533, the resilient tendency of the free end 535 of the first locking member 531 may overcome the force to abut the free end 535 of the first locking member 531 in the step 533.

In one embodiment, the second locking member 532 is an arc-shaped rib, i.e., a constant diameter rib, arranged to extend in the circumferential direction; in another embodiment, the second locking member 532 is an arc rib, i.e. a reducer rib, arranged to extend in both the second direction and the radially inward direction. Based on the two embodiments, during the movement of the free end 535 of the first locking member 531, the free end 535 of the first locking member 531 contacts and slides on one side surface of the arc rib.

Referring to fig. 5, a release member 410 for releasing the first locking portion 530 is formed on the implanter assembly 400. the implanter assembly 400 includes an implanter housing and an internal member disposed within the implanter housing. In one embodiment, release member 410 is disposed on the implanter housing; in another embodiment, the release member 410 is disposed on the inner member. When sterilization assembly 500 is installed on implanter assembly 400, release member 410 drives first locking member 531 away from second locking member 532 such that first locking member 531 is misaligned with second locking member 532 such that free end 535 of first locking member 531 disengages step 533, at which time first locking portion 530 is in a released state allowing cap 510 to be rotated in a first direction. The surface of release member 410 facing first locking member 531 may be a guide ramp, which facilitates the linear pushing away of first locking member 531 by release member 410 during installation of sterilization assembly 500 into implanter assembly 400, and improves the smoothness of the installation of sterilization assembly 500 into implanter assembly 400.

With continued reference to fig. 5, cap 510 is coupled to implanter assembly 400 via a retaining portion 520, e.g., retaining portion 520 has a plurality of hooks formed thereon that extend toward implanter assembly 400, and the implanter housing or an interior component of the implanter has apertures formed therein that correspond to the hooks, such that when sterilization assembly 500 is installed on implanter assembly 400, the hooks pass through the apertures and hook over the edges of the apertures, thereby coupling retaining portion 520 to implanter assembly 400.

With continued reference to fig. 3, a second locking part 540 is formed between the body surface attachment unit 200 and the holding part 520, the second locking part 540 being configured to prevent the holding part 520 from rotating relative to the body surface attachment unit 200 in the first or second direction. In one embodiment, the second locking part 540 includes a plurality of bayonets 541 circumferentially distributed on the edge of the body surface attachment unit 200 and catches 542 distributed on the holding part 520 corresponding to the bayonets 541, and when the holding part 520 is mounted on the cap 510, the catches 542 are inserted into the bayonets 541 and are cooperatively locked with the bayonets 541.

The sterilization assembly 500 further comprises a needle assembly 550, the needle assembly 550 comprising a hub 551 and a puncture needle 552 attached to the hub 551, a third lock 560 formed between the hub 551 and the body surface attachment unit 200, the third lock 560 configured to prevent rotation of the hub 551 relative to the body surface attachment unit 200 in the first or second direction. In one embodiment, the third locking portion 560 comprises a shaped waist 561 formed on the hub 551 and a boss 562 with a shaped hole formed on the body surface attachment unit 200, and when the needle assembly 550 is mounted on the body surface attachment unit 200, the shaped waist 561 is inserted into the shaped hole of the boss 562 and is locked in cooperation with the shaped hole.

Referring to fig. 6, a fourth lock 570 is formed between the cap 510 and the needle assembly 550, the fourth lock 570 being configured to prevent the cap 510 from rotating relative to the hub 551 in the second direction and to prevent the cap 510 from moving in a direction away from the hub 551. The state of the fourth locking part 570 is closely related to the state of the first locking part 530. When the first locking part 530 is in the locked state, the fourth locking part 570 is also in the locked state; when the first locking part 530 is in the released state, the fourth locking part 570 is allowed to be shifted to the released state. That is, releasing the first locking part 530 is a precondition for releasing the fourth locking part 570.

With continued reference to fig. 6, the fourth locking portion 570 comprises a third locking member 571 arranged on the hub 551 and a fourth locking member 572 arranged on the cap 510, the third locking member 571 and the fourth locking member 572 being cooperatively locked.

A cannula 580 defining a sterile cavity is formed within the cap 510, the cannula 580 and the hub 551 together defining a sealed sterile cavity in which the piercing needle 552 is received over and disposed with the internal portion of the sensor electrode 210 when the third locking member 571 and the fourth locking member 572 are matingly locked, such that the piercing needle 552 and the sensor electrode 210 are sterilized together. To improve the sealing of the sterile cavity, a sealing member may be arranged between the cannula 580 and the hub 551, for example, a rubber sealing ring may be arranged on the hub 551 or on the end of the cannula 580.

With continued reference to fig. 6, in one embodiment, the third locking member 571 is engaged with the fourth locking member 572 in such a manner that the third locking member 571 includes at least two retaining grooves disposed on the outer surface of the hub 551, and the fourth locking member 572 includes retaining protrusions disposed on the end of the sleeve 580 corresponding to the retaining grooves, the retaining protrusions being engaged with the retaining grooves; the opening of the limiting groove faces to the first direction. For example, the limiting grooves are distributed on the outer surface of the needle seat 551 at equal intervals along the circumferential direction, and two limiting grooves and two limiting protrusions are selected for cost saving.

To facilitate assembly of the hub 551 with the cap 510, a guide groove 573 is further provided at an opening of the limiting groove, for example, the guide groove 573 communicates with the limiting groove through the opening of the limiting groove and is perpendicular to the limiting groove, and the opening of the guide groove 573 faces the cap 510.

Specifically, the sterilization assembly 500 may be assembled in the order of first mounting the body surface attachment unit 200, then mounting the needle assembly 550, and finally mounting the holding part 520.

In mounting the body surface attachment unit 200, the extracorporeal portion of the sensor electrode 210 is first attached to the body surface attachment unit 200, and then the body surface attachment unit 200 is mounted to the cap 510.

When the needle assembly 550 is mounted, the shaped waist 561 of the needle holder 551 is fitted into the shaped hole of the body surface attachment unit 200, and the puncture needle 552 passes through the shaped hole and then protrudes from the lower surface of the body surface attachment unit 200 together with the sensor electrode 210, and at this time, as shown in fig. 7, the stopper projection on the cannula 580 is aligned with the guide groove 573 and the cap 510 is moved in the axial direction until the stopper projection reaches the transition of the guide groove 573 and the stopper groove.

In mounting the holder 520, please continue to refer to fig. 3, the latch 542 on the holder 520 is mounted into the cap 510 in alignment with the bayonet 541 on the body surface attachment unit 200; then, continuing to refer to fig. 4, the cap 510 is rotated in the second direction until the free end 535 of the first locking member 531 abuts in the step 533 of the second locking member 532; in the process of rotating the cap 510 in the second direction, as shown in fig. 8, the stopper projection moves from the junction of the guide groove 573 and the stopper groove to the closing of the stopper groove, and reaches the closed end of the stopper groove while the free end 535 of the first locking member 531 abuts in the step 533 of the second locking member 532.

The first locking part 530, the second locking part 540, the third locking part 560 and the fourth locking part 570 of the present invention are fitted to each other. The release of the first locking portion 530 is premised on the release of the fourth locking portion 570, such that the cap 510 can be rotated in the first direction to release the fourth locking portion 570 only when the first locking portion 530 is released upon installation of the sterilization assembly 500 onto the implanter assembly 400. Second lock 540 ensures body surface attachment unit 200 is relatively stationary with holder 520 when cap 510 is turned and third lock 560 ensures body surface attachment unit 200 is relatively stationary with hub 551 when cap 510 is turned, and in sum, the cooperation of second lock 540 with third lock 560 achieves that holder 520, body surface attachment unit 200, and hub 551 are all in a relatively stationary state when cap 510 is turned, which ensures that cap 510 is turned in the second direction so that first lock 530 and second lock 540 reach a locked state simultaneously when sterilization assembly 500 is assembled.

The invention can effectively prevent the sensor electrode 210 and the puncture needle 552 from being exposed outside because the cap 510 is separated from the needle seat 551 (namely, the sensor electrode 210) by manual operation before the product is formally used, and prevent the sensor electrode 210 and the puncture needle 552 from being polluted by bacteria and being incapable of being normally used.

The body surface attaching unit 200 and the mounting structure of the body surface attaching unit 200 and the needle assembly 550 in the present invention are disclosed in detail in the previously filed chinese patent 202111426719.8, and thus, they are not described in detail in the present invention.

The foregoing description, in such full, clear, concise and exact terms, provides the best mode contemplated of carrying out the present invention, and the manner and process of making and using it, to enable any person skilled in the art to which it pertains, to make and use the same. The invention is, however, susceptible to modifications and alternative constructions from that described above which are fully equivalent. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed. Rather, the invention is to cover all modifications and alternative constructions falling within the spirit and scope of the invention as generally expressed by the following claims, which particularly point out and distinctly define the subject matter of the invention. While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative and not restrictive.

Unless otherwise defined, all terms (including technical and scientific terms) are to be given their ordinary and customary meaning to those skilled in the art, and are not to be taken as limiting to a specific or special meaning unless expressly defined herein. It should be noted that the use of particular terminology when describing certain features or aspects of the disclosure should not be taken to imply that the terminology is being redefined herein to be restricted to including any specific characteristics or aspects of the disclosure with which that terminology is associated. The terms and phrases used in this application, and variations thereof, particularly in the appended claims, should be construed to be open ended and not limiting unless otherwise expressly stated. As an example of the foregoing, the term "including" shall mean "including but not limited to" or the like.

Furthermore, although the foregoing has been described in some detail by way of illustration and example for purposes of clarity and understanding, it will be apparent to those of ordinary skill in the art that certain changes and modifications may be practiced. Therefore, the description and examples should not be construed as limiting the scope of the invention to the particular embodiments and examples described herein, but rather as covering all modifications and alternatives falling within the true scope and spirit of the invention.

Claims

1. A transcutaneous analyte sensor system comprising an implanter assembly and a sterilization assembly, the sterilization assembly including a sensor electrode and a cap having a sealed sterilization chamber formed therein, an in vivo portion of the sensor electrode being disposed in the sterilization chamber, wherein: the cap is allowed to separate from the sensor electrode only when the sterilization assembly is coupled to the implanter assembly such that the sensor electrode exits the sterilization chamber.

2. The transdermal analyte sensor system of claim 1, wherein: the cap is configured to be rotationally separated from the sensor electrode in a first direction.

3. The transdermal analyte sensor system of claim 2, wherein: the sterilization assembly also includes a holder with a first locking portion formed therebetween, the first locking portion configured to prevent rotation of the cap relative to the holder in a first direction, the first locking portion being released when the sterilization assembly is coupled to the implanter assembly.

4. The transdermal analyte sensor system of claim 3, wherein: the first locking portion includes a first locking member disposed on the holding portion and a second locking member disposed on the cap, the first locking member cooperatively locking with the second locking member.

5. The transdermal analyte sensor system of claim 4, wherein: the first locking member is located radially inward or radially outward of the second locking member.

6. The transdermal analyte sensor system of claim 4, wherein: the second locking member has a step formed thereon that moves from the base of the first locking member to the free end of the first locking member in the second direction such that the free end of the first locking member abuts in the step.

7. The transdermal analyte sensor system of claim 6, wherein: the free end of the first locking member has a resilient tendency to splay towards the second locking member.

8. The transdermal analyte sensor system of claim 6, wherein: the second locking member is an arc-shaped rib which extends along the circumferential direction.

9. The transdermal analyte sensor system of claim 6, wherein: the second locking member is an arc-shaped rib extending in both the second direction and the radially inward direction.

10. The transdermal analyte sensor system of claim 3, wherein: a release member is formed on the implanter assembly for releasing the first locking portion.

11. The transdermal analyte sensor system of claim 3, wherein: the cap is coupled to the implanter assembly via the retaining portion.

12. The transdermal analyte sensor system of claim 3, wherein: the sterilization assembly further includes a body surface attachment unit mounted within the cap, a second locking portion formed between the body surface attachment unit and the holding portion, the second locking portion configured to prevent the holding portion from rotating relative to the body surface attachment unit in the first or second direction.

13. The transdermal analyte sensor system of claim 12, wherein: the second locking part comprises a plurality of bayonets distributed on the edge of the body surface attachment unit along the circumferential direction and clamping blocks distributed on the holding part and corresponding to the bayonets, and the bayonets and the clamping blocks are matched and locked.

14. The transdermal analyte sensor system of claim 13, wherein: the sterilization assembly further includes a needle assembly mounted to the body surface attachment unit, the needle assembly including a needle hub and a puncture needle attached to the needle hub, a third lock portion formed between the needle hub and the body surface attachment unit, the third lock portion configured to prevent rotation of the needle hub relative to the body surface attachment unit in the first or second direction.

15. The transdermal analyte sensor system of claim 14, wherein: the third locking part comprises a special-shaped waist part formed on the needle seat and a boss with a special-shaped hole formed on the body surface attachment unit, and when the needle assembly is installed on the body surface attachment unit, the special-shaped waist part is embedded into the special-shaped hole of the boss and is matched and locked with the special-shaped hole.

16. The transdermal analyte sensor system of claim 14, wherein: a fourth locking portion is formed between the hub and the cap, the fourth locking portion being configured to prevent the cap from rotating relative to the hub in the second direction and from moving in a direction away from the hub.

17. The transdermal analyte sensor system of claim 16, wherein: the fourth locking portion includes a third locking member disposed on the hub and a fourth locking member disposed on the cap, the third and fourth locking members cooperatively locking.

18. The transdermal analyte sensor system of claim 17, wherein: a sleeve defining a sterilization cavity is formed in the cap;

the opening of the limiting groove faces to the first direction.

19. The transdermal analyte sensor system of claim 18, wherein: the limiting grooves are distributed on the outer surface of the needle seat at equal intervals along the circumferential direction.

20. The transdermal analyte sensor system of claim 14, wherein: the puncture needle is sleeved on the internal part of the sensor electrode and is configured in the sterilization cavity together with the internal part of the sensor electrode.

21. A method of using a transcutaneous analyte sensor system, based on a transcutaneous analyte sensor system as claimed in any of claims 1-20, wherein: including allowing the cap to be separated from the sensor electrode only when the sterilization assembly is coupled to the implanter assembly such that the sensor electrode exits the sterilization chamber.

22. The method of using a transdermal analyte sensor system of claim 21, wherein: the cap is separated from the sensor electrode by rotating the cap in a first direction.

23. The method of using a transdermal analyte sensor system of claim 22, wherein: releasing the fourth locking portion during rotation of the cap in the first direction.