CN115844389A

CN115844389A - Biological monitoring sensor implantation device and continuous blood sugar monitor

Info

Publication number: CN115844389A
Application number: CN202211695858.5A
Authority: CN
Inventors: 杨凯洪; 张亚南; 支佳佳; 周华龙; 蒲继瑞; 陈�峰
Original assignee: Jiangsu Yuekai Biotechnology Co ltd; Zhejiang Poctech Corp; Jiangsu Yuyue Kailite Biotechnology Co ltd
Current assignee: Jiangsu Yuekai Biotechnology Co ltd; Zhejiang Poctech Corp; Jiangsu Yuyue Kailite Biotechnology Co ltd
Priority date: 2022-12-28
Filing date: 2022-12-28
Publication date: 2023-03-28

Abstract

The application discloses biological monitoring sensor implantation device and continuous blood sugar monitor, implantation device includes the shell and arranges the assistor assembly in the shell in, the one end of shell is equipped with the opening, implantation device still including setting up the trigger cover in assistor assembly one end, the trigger cover has the top of support that is used for with skin contact, the assistor assembly can move towards the opening with the trigger cover is synchronous, and when the top of support receives the backstop relative to the trigger cover motion to make the assistor assembly can move in order to have first near-end position and first distal end position relative to the trigger cover. The trigger cover can prevent the error triggering of the needle assembly, and can reset the needle assembly through simple operation after the error triggering without influencing the next implantation operation. Therefore, a retrieval measure is provided for the implanting device after the implanting device is triggered by mistake, a user is given more chance of trial and error, the problem that the whole product is scrapped due to one-time misoperation is further avoided, the use cost is reduced, and the use experience is improved.

Description

Biological monitoring sensor implantation device and continuous blood sugar monitor

Technical Field

The application belongs to the technical field of medical equipment, concretely relates to biological monitoring sensor implantation device and continuous blood sugar monitor.

Background

A biosensor is an instrument that is sensitive to a bioactive substance and converts the sensed concentration of the bioactive substance into an electrical signal for detection. Among them, the glucose sensor is a common biosensor. CGM (continuous blood glucose monitoring) is a technical means of indirectly reflecting blood glucose levels by continuously monitoring the glucose concentration of subcutaneous interstitial fluid through a glucose sensor.

When the CGM product is used, a user needs to place the shell of the CGM product on skin, then presses the trigger button, the puncture needle and the sensor pin inside the shell move towards the skin and puncture the skin of a human body, and the biological enzyme on the sensor and subcutaneous tissue fluid generate electrochemical reaction, are converted into electric signals and are converted into blood sugar values to be provided for the user.

In order to ensure the cleanness of the puncture needle and the sensor, the CGM product is generally a disposable product, i.e., the user presses a trigger button to make the puncture needle and the sensor move to complete the implantation action, and then the product cannot be used again. And because the trigger button is generally arranged on the outer surface of the shell, in the transportation process of the CGM product or when a user takes and holds the shell, the situation of mistakenly touching the trigger button is very easy to occur, so that the puncture needle and the sensor complete the implantation movement in advance when the user does not press the shell on the skin, and further the product is scrapped, thus not only leading to poor use experience of the existing monitoring device applicator, but also increasing the use cost of the user.

Therefore, CGM products are generally provided with a safety lock to prevent a user from being triggered by mistake before use. Therefore, the safety lock is required to be released before the sensor is implanted. However, during the period from the time when the user contacts the safety lock to the time before the user is actually implanted, since the user holds the implant device with his hand and there is a fear in the user's mind before the implantation, there is still a risk that the implant device is erroneously triggered.

In addition, once the implantation device is triggered by mistake, the internal puncture needle completes the implantation and needle withdrawing actions rapidly, and the actions are irreversible, so the puncture needle can not be reset for reuse, the implantation device is directly scrapped, and the sensor is not implanted into the subcutaneous part of a patient at the moment, so the implantation device is wasted, and the use cost is greatly increased.

Disclosure of Invention

The present application provides a biological monitoring sensor implant device and a continuous blood glucose monitor to address at least one of the above technical problems.

The technical scheme adopted by the application is as follows:

a biological monitoring sensor implantation device comprises a shell and an assistant needle assembly arranged in the shell, wherein an opening is formed in one end of the shell, the implantation device further comprises a trigger cover arranged at one end of the assistant needle assembly, the trigger cover is provided with an abutting part used for contacting with skin, the assistant needle assembly can move towards the opening synchronously with the trigger cover and moves relative to the trigger cover when the abutting part is stopped, so that the assistant needle assembly can move relative to the trigger cover to have a first proximal end position and a first distal end position.

The trigger cover is arranged in the shell, the shell is provided with a limiting part, the trigger cover is provided with a stopping part, and the stopping part is abutted to the limiting part.

One end of the trigger cover and one end of the shell are located on the same end face.

The trigger cover has first joint structure, the helping hand subassembly has second joint structure, first joint structure with the cooperation of second joint structure joint.

One of the outer wall of the trigger cover and the inner wall of the shell is provided with a guide rib position, the other one of the outer wall of the trigger cover and the inner wall of the shell is provided with a guide groove matched with the guide rib position, and the guide groove and the guide rib position extend towards the opening.

The needle assisting assembly comprises a pushing piece and a puncture piece, the puncture piece can move relative to the pushing piece to have a second near-end position and a second far-end position, the pushing piece is provided with a limiting structure used for limiting the puncture piece at the second near-end position, the trigger cover is provided with an unlocking structure, and when the needle assisting assembly moves to the first near-end position, the unlocking structure can release the limiting of the limiting structure, so that the puncture piece moves to the second far-end position.

The propelling part has the guide part, the direction passageway has in the guide part, the puncture piece is arranged in the direction passageway, limit structure including set up in the butt wing of guide part, the butt wing has the orientation the inside convex backstop of direction passageway is protruding, the backstop protruding with the puncture piece backstop is spacing, in order to restrict the puncture piece to the distal end position motion.

The puncture piece is provided with a matching plane, and the stop bulge is in butt fit with the matching plane.

The unlocking structure comprises an unlocking convex rib arranged on the trigger cover, and the unlocking convex rib can support against the abutting wing to enable the stopping protrusion to move and be separated from the puncture piece.

The trigger cover is provided with a slide way, the abutting wings are located in the slide way and move along the slide way, and the unlocking convex ribs are located at one end of the slide way.

The butt wing orientation the slope of direction passageway outside extends in order to have stiff end and free end, backstop arch set up in the free end, unlocking structure can support the free end.

One of the inner wall of the guide channel and the outer wall of the puncture piece is provided with a guide sliding strip, and the other one of the inner wall of the guide channel and the outer wall of the puncture piece is provided with a guide sliding groove matched with the guide sliding strip.

The puncture piece includes needle body and needle file, implant device still includes the extension spring, the one end of extension spring with the needle file is connected, the other end with the propelling movement piece is connected.

The implant device further includes a trigger having a connecting end and an operating end, the connecting end being hingedly connected to the housing, the trigger further having a push top portion capable of pushing the needle assembly to move the needle assembly toward the opening.

The needle assisting assembly comprises a pushing piece and a transmission piece arranged in the shell, the transmission piece is fixedly connected with the pushing piece, a positioning column is arranged at the pushing top, a positioning slide way is arranged on the transmission piece, the positioning column is arranged in the positioning slide way, and when the connecting end rotates, the positioning column can slide in the positioning slide way.

The application also discloses a continuous blood glucose monitor, including above-mentioned biological monitoring sensor implantation device, still including being fixed in the helping hand needle subassembly orientation the skin fixing base of opening one end, the skin fixing base includes base, sensor and sensor electronic unit, the sensor is fixed in the base, sensor electronic unit with base detachably connects.

Due to the adoption of the technical scheme, the beneficial effects obtained by the application are as follows:

1. the trigger cover is arranged at one end of the needle assisting assembly, the trigger cover can serve as a false touch prevention component of the implanting device, false touch prevention of the needle assisting assembly is achieved, the needle assisting assembly can be reset through simple operation after the false touch is achieved, and the next implanting operation cannot be influenced. Because the trigger cover is connected with the needle assembly, when a user does not enable the abutting part of the trigger cover to be tightly attached to the skin, the trigger cover is not stopped, so that the needle assembly and the trigger cover can move towards the opening together, at the moment, the implantation action is finished, but the needle withdrawing action of the puncture piece in the needle assembly is not triggered, the rejection of the implantation device cannot be caused, and the user can push the needle assembly and the trigger cover back to reset without influencing the next use of the implantation device. Only when the abutting part of the trigger cover is tightly attached to the skin of a user, the trigger cover cannot move along with the needle assisting assembly, and the needle assisting assembly moves to the first proximal end position independently, the trigger cover can trigger the needle withdrawing movement of the puncture piece, so that the complete implantation and needle withdrawing actions are completed. Through the design, a recovery measure is provided for the implanted device after the implanted device is triggered by mistake, and before the implanted device is correctly triggered to be implanted by a correct operation method, a user is given more times of trial and error opportunities, so that the problem that the whole product is scrapped due to one-time misoperation is avoided, the use cost is reduced, and the use experience is improved.

2. As a preferred embodiment of this application, trigger the cover and arrange in inside the shell, the shell is equipped with spacing portion, triggers the cover and is equipped with the backstop portion, backstop portion and spacing portion butt joint. After the limiting part is matched with the stopping part, the limiting part is formed for limiting the trigger cover, when a user triggers by mistake, the trigger cover moves towards the opening along with the needle assisting assembly, at the moment, a partial area of the trigger cover extends out of the opening, the user can visually see the position of the trigger cover at the moment, and the states of the trigger cover and the needle assisting assembly are known, so that the trigger cover and the needle assisting assembly can be directly pushed back and reset by pushing the trigger cover from bottom to top. After the trigger cover resets, the stopping part is matched with the stopping part of the limiting part, and the trigger cover cannot move upwards at the moment, so that the user is prompted to reset in place through force feedback.

3. As a preferred embodiment of the present application, one of the outer wall of the trigger hood and the inner wall of the housing is provided with a guide rib portion, and the other of the outer wall of the trigger hood and the inner wall of the housing is provided with a guide groove engaged with the guide rib portion, the guide groove and the guide rib portion extending toward the opening. The guide rib position and the guide groove are matched to form movement limitation on the trigger cover, so that the trigger cover can only move along the axial direction of the shell, the rotation cannot occur, and the movement reliability of the trigger cover is improved.

4. As a preferred embodiment of the present application, the needle assembly includes a pushing member and a puncturing member, the puncturing member is movable relative to the pushing member to have a second proximal end position and a second distal end position, the pushing member is provided with a limiting structure for limiting the puncturing member at the second proximal end position, the trigger cover is provided with an unlocking structure, and when the needle assembly is moved to the first proximal end position, the unlocking structure can release the limiting of the limiting structure, so that the puncturing member is moved to the second distal end position. The limiting structure limits the puncture piece to enable the puncture piece to keep synchronous motion with the pushing piece, after implantation is completed, the puncture piece is located at the first near end position, the puncture piece is triggered by the unlocking structure at the moment, and therefore the limitation of the limiting structure is relieved, and the puncture piece can move relative to the pushing piece. At this time, the pushing component still stays at the first proximal end position, and the puncturing component retracts to the second distal end position independently, so that the needle withdrawing operation is completed. The unlocking structure is located at the first near-end position and located on the movement path of the puncture piece, so that when the pushing piece carries the puncture piece to move to the first near-end position together, the unlocking structure can automatically realize the triggering unlocking of the puncture piece, the user does not need to additionally perform needle withdrawing operation, the continuous implementation of the steps of implanting and needle withdrawing can be automatically completed in one step, the operation steps of the user are simplified, the operation difficulty is reduced, and the use experience is greatly improved.

5. As a preferred embodiment of the present application, the implant device further comprises a trigger having a connecting end and an operating end, the connecting end being hinged to the housing, the trigger further having a pushing top capable of pushing the pushing member to move the pushing member and the implant assembly towards the opening. This application trigger's link is articulated with the shell for trigger can rotate the switching that realizes initial position and helping the needle position for the shell, and trigger promptly realizes the triggering to implantation device through rotating. Compare in the mode of pressing the button, carry out the transmission with the help of the articulated shaft, not only improved the operation and felt to the distance between operation end and the link is far away, therefore arm of force length is longer, makes the user operation more light laborsaving when triggering the trigger piece. Trigger piece and shell are articulated to be connected, can make trigger piece obtain more apparent visual effect, and the user can dodge trigger piece with the finger consciously when gripping the shell to the mistake triggers trigger piece when reducing and gripping the implantation device leads to the probability of spurious triggering.

Drawings

The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the application and together with the description serve to explain the application and not to limit the application. In the drawings:

FIG. 1 is an exploded view of a monitor according to one embodiment of the present application;

FIG. 2 is a cross-sectional view of the monitor of FIG. 1;

FIG. 3 is an enlarged view of area A of FIG. 2;

FIG. 4 is a schematic structural diagram of a trigger according to an embodiment of the present application;

FIG. 5 is a schematic structural view of a housing according to an embodiment of the present application;

FIG. 6 is a schematic view of a transmission member according to an embodiment of the present application;

FIG. 7 is a schematic view of the other side of the driving member shown in FIG. 6;

FIG. 8 is a schematic view of a pusher according to one embodiment of the present disclosure;

FIG. 9 is a schematic structural view of a trigger hood according to an embodiment of the present application;

FIG. 10 is a schematic view of a skin anchor according to an embodiment of the present application;

FIG. 11 is a schematic structural view of the base of FIG. 10;

FIG. 12 is a schematic diagram of the sensor electronics unit of FIG. 10;

FIG. 13 is a cross-sectional view of a piercing member according to one embodiment of the present application;

FIG. 14 is a schematic view of the needle body of FIG. 13;

fig. 15 is a structural schematic view of the needle holder in fig. 13.

Wherein:

1, a shell; 11, passing through a port; 12 a guide projection; 13 a hinged seat; 14 a limiting part;

2, assisting the needle assembly; 21 a transmission member; 211 a positioning slide way; 212 a positioning rib; 213 limiting ribs; 214 avoiding the gap; 215 a guide groove; 216 an initial end; 217 a trigger end; 218 a first clamping portion; 22 a pusher; 221 a guide part; 2211 a guide channel; 2212 the abutment wings; 2213 stop boss; 2214 reinforcing ribs; 2215 a guide slide; 222 a second clamping part; 223 a second clamping structure; 2231 a guide surface; 23 a piercing member; 231 needle bodies; 232 needle base; 2321 fitting plane; 2322 guiding the chute;

3, a trigger piece; 31 pushing the top; 311 a positioning column; 32 a connecting end; 321 an articulated arm; 322 a hinged shaft; 33 an operation end;

4 triggering the cover; 41 butting portion; 42 a slideway; 43 unlocking the convex rib; 44 a first clamping structure; 45 a guide groove; 46 a stop;

5, fixing the skin; 51 a base; 511 an installation position; 512 a first clamping rib position; 52 a sensor; 53 sensor electronics unit; 531 second card connection rib position; 532 positioning structure;

6 a tension spring.

Detailed Description

In order to more clearly explain the overall concept of the present application, the following detailed description is given by way of example in conjunction with the accompanying drawings.

In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application, however, the present application may be practiced in other ways than those described herein, and therefore the scope of the present application is not limited by the specific embodiments disclosed below.

In addition, in the description of the present application, it is to be understood that the terms "top," "bottom," "inner," "outer," "axial," "radial," "circumferential," and the like are used in the positional or orientational relationship shown in the drawings for the purpose of convenience and simplicity of description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are therefore not to be considered limiting of the present invention.

In this application, unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can include, for example, fixed connections, removable connections, or integral parts; the connection can be mechanical connection, electrical connection or communication; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood according to specific situations by those of ordinary skill in the art.

In this application, unless expressly stated or limited otherwise, the first feature "on" or "under" the second feature may be directly contacting the first and second features or indirectly contacting the first and second features through intervening media. In the description herein, reference to the terms "implementation," "embodiment," "one embodiment," "example" or "specific example" or the like means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the application. In this specification, the schematic representations of the terms used above are not necessarily intended to refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

As shown in fig. 1 to 15, a biological monitoring sensor implanting device comprises a housing 1 and an assistant needle assembly 2 arranged in the housing 1, wherein an opening is arranged at one end of the housing 1, the implanting device further comprises a trigger cover 4 arranged at one end of the assistant needle assembly 2, the trigger cover 4 is provided with an abutting part 41 used for contacting with the skin, the assistant needle assembly 2 can move towards the opening synchronously with the trigger cover 4 and moves relative to the trigger cover 4 when the abutting part 41 is stopped, so that the assistant needle assembly 2 can move relative to the trigger cover 4 to have a first proximal end position and a first distal end position.

It will be appreciated that the first distal position is an initial position of the needle assembly 2, in use the opening of the housing 1 is placed against the skin of the patient, and that after the trigger has been triggered by the user, the needle assembly 2 performs an implantation movement, i.e. moves towards the opening to a position in which the puncture needle pierces the skin of the patient, whereupon the needle assembly 2 reaches the first proximal position.

The trigger cover 4 is arranged at one end of the needle assembly 2, the trigger cover 4 can be used as a false touch prevention component of the implantation device, the false touch prevention of the needle assembly 2 is realized, and the needle assembly 2 can be reset through simple operation after the false touch, so that the next implantation operation cannot be influenced.

When the user does not place the abutment portion of the trigger cap 4 against the skin, this indicates that the user has not operated the implant device according to the correct method of use, and this may be interpreted as a false trigger operation. Because the trigger cover 4 is connected with the needle assisting assembly 2, when the trigger cover 4 is not stopped, the needle assisting assembly 2 and the trigger cover 4 can move towards the opening together, at this time, although the implantation action is completed, the needle withdrawing action of the puncture piece 23 in the needle assisting assembly 2 is not triggered, so that the rejection of the implantation device is not caused, and a user can push the needle assisting assembly 2 and the trigger cover 4 back to reset without influencing the next use of the implantation device.

When a user pastes the opening on the surface of the skin, the abutting part 41 of the trigger cover 4 is in contact with the skin and is stopped by the skin, the user is indicated to use the device in a correct mode, at the moment, after the implantation device is triggered, the trigger cover 4 cannot move along with the needle assisting assembly 2, the needle assisting assembly 2 moves to the first proximal end position independently, and the trigger cover 4 can trigger the needle withdrawing movement of the puncture piece 23 to complete the complete implantation and needle withdrawing actions.

Through the design, a recovery measure is provided for the implanted device after the implanted device is triggered by mistake, and before the implanted device is correctly triggered to be implanted by a correct operation method, a user is given more times of trial and error opportunities, so that the problem that the whole product is scrapped due to one-time misoperation is avoided, the use cost is reduced, and the use experience is improved.

As a preferred embodiment of the present invention, as shown in fig. 2 and 3, the trigger cap 4 is disposed inside the housing 1, the housing is provided with the limit portion 14, the trigger cap 4 is provided with the stopper portion 46, and the stopper portion 46 abuts against the limit portion 14.

As shown in fig. 2, after the limiting portion 14 is matched with the stopping portion 46, a limit is formed on the trigger cover 4, when a user triggers by mistake, the trigger cover 4 moves towards the opening along with the needle assembly 2, at this time, a partial region of the trigger cover 4 extends out of the opening, at this time, the user can visually see the position of the trigger cover 4, and know the states of the trigger cover 4 and the needle assembly 2, so that the trigger cover 4 and the needle assembly 2 can be pushed back and reset directly by pushing the trigger cover 4 from bottom to top. After the trigger cover 4 is reset, the stopping portion 46 is matched with the stopping portion 14 in a stopping manner, and at the moment, the trigger cover 4 cannot move upwards continuously, so that the user is prompted to reset in place through force feedback.

Preferably, as shown in fig. 3, the housing 1 is folded outward at the opening to form a limiting groove, the wall of the limiting groove forms the limiting portion 14, the bottom end of the trigger cover 4 is also folded outward to form an outward flange, the outward flange is located in the limiting groove, the upper end surface of the outward flange forms the stopper portion 46, and the lower end surface forms the abutting portion 41. Meanwhile, the contact area between the abutting part 41 and the skin is increased due to the flanging structure, the touch feeling of a user is improved, and the use comfort is improved.

As shown in fig. 2 and 3, one end of the trigger cover 4 is located on the same end surface as one end of the housing 1.

In the initial state, the shell 1 surrounds the trigger cover 4, the hidden design of the trigger cover 4 is realized, the appearance of the implant device is simpler, and when the trigger cover 4 extends out of the opening due to misoperation of a user, the state of the trigger cover 4 can be obviously seen by the user.

It should be noted that the connection manner of the trigger shield 4 and the needle assembly assistant component 2 is not limited in particular, and in a preferred embodiment, as shown in fig. 8 and 9, the trigger shield 4 has a first snap structure 44, the needle assembly assistant component 2 has a second snap structure 223, and the first snap structure 44 and the second snap structure 223 are in snap fit.

Specifically, as shown in fig. 8 and 9, the first clamping structure 44 is a clamping protrusion disposed on the trigger cover 4, the second clamping structure 223 is a clamping groove disposed on the needle assisting assembly 2, the clamping protrusion is located in the clamping groove, and a groove wall on an upper side of the clamping groove is provided with a guide surface 2231, so that when the trigger cover 4 is stopped, the clamping protrusion can slide out of the clamping groove along the guide surface 2231 above the clamping groove, and the trigger cover 4 and the needle assisting assembly 2 are disconnected.

Of course, the first clamping structure 44 may also be a clamping groove, the second clamping structure 223 is correspondingly a clamping protrusion, and the groove wall of the lower side of the clamping groove is provided with a guiding surface, so that the second clamping structure 223 is separated from the clamping groove from the lower side. Alternatively, the first clamping structure 44 and the second clamping structure 223 are clamping protrusions, and a guide surface is disposed on the opposite side of the clamping protrusions, which is not limited herein.

As a preferred embodiment of the present application, as shown in fig. 9, one of the outer wall of the trigger cover 4 and the inner wall of the housing 1 is provided with a guide rib portion, and the other is provided with a guide groove 45 engaged with the guide rib portion, and the guide groove 45 and the guide rib portion extend toward the opening.

The guide rib position and the guide groove 45 are matched to form the motion limit of the trigger cover 4, so that the trigger cover can only move along the axial direction of the shell 1, the rotation cannot occur, and the motion reliability of the trigger cover 4 is improved.

As shown in fig. 9, in one embodiment, the guiding rib positions are arranged on the inner wall of the housing 1, and the guiding grooves 45 are arranged on the outer wall of the trigger cover 4, but of course, the guiding rib positions may also be arranged on the outer wall of the trigger cover 4, and correspondingly, the guiding rib positions are arranged on the inner wall of the housing 1. Furthermore, the length of the guide groove 45 can be set to limit the movement amount of the trigger cover 4.

In a preferred embodiment, as shown in fig. 2, the needle assembly 2 comprises a pusher 22 and a puncture member 23, the puncture member 23 is movable relative to the pusher 22 to have a second proximal end position and a second distal end position, the pusher 22 is provided with a stop structure for stopping the puncture member 23 in the second proximal end position, the trigger shield 4 is provided with an unlocking structure, and when the needle assembly 2 is moved to the first proximal end position, the unlocking structure can release the stop structure to move the puncture member 23 to the second distal end position.

When the user triggers the implantation operation, the pushing component 22 and the puncturing component 23 move synchronously to move from the first far-end position to the first near-end position together, and at the moment, the puncturing component 23 punctures the skin of the patient, and the sensor contact pin in the skin fixing seat 5 is implanted into the subcutaneous part of the patient. The limiting structure limits the puncture element 23 to keep the puncture element and the pushing element 22 moving synchronously, when the implantation is completed, the puncture element 23 is located at the first proximal end position, and the puncture element 23 is triggered by the unlocking structure, so that the limitation of the limiting structure is released, and the puncture element 23 can move relative to the pushing element 22. At this point, the pusher 22 remains in the first proximal position and the piercing member 23 is retracted to the second distal position alone, completing the needle withdrawal operation.

The unlocking structure is located at the first near-end position and located on the movement path of the puncture piece 23, so that when the pushing piece 22 carries the puncture piece 23 to move to the first near-end position together, the unlocking structure can automatically realize the triggering unlocking of the puncture piece 23, the user does not need to additionally perform needle withdrawing operation, the continuous operation of the implantation and needle withdrawing steps is automatically completed in one step, the operation steps of the user are simplified, the operation difficulty is reduced, and the use experience is greatly improved.

Further, as shown in fig. 2, 13 to 15, the puncture member 23 includes a needle body 231 and a needle hub 232, and the implantation device further includes a tension spring 6, one end of the tension spring 6 is connected with the needle hub 232, and the other end is connected with the needle assembly 2. The tension spring 6 provides power required by needle withdrawing movement for the puncture piece 23, and when the unlocking structure unlocks the limiting structure, the puncture piece 23 moves to the second far-end position under the pulling of the tension spring 6 to complete needle withdrawing.

In a preferred embodiment, as shown in fig. 8, the pushing member 22 has a guiding portion 221, the guiding portion 221 has a guiding channel 2211 therein, the puncturing member 23 is disposed in the guiding channel 2211, the limiting structure includes an abutting wing 2212 disposed on the guiding portion 221, the abutting wing 2212 has a stopping protrusion 2213 protruding toward the inside of the guiding channel 2211, and the stopping protrusion 2213 stops the limiting structure with the puncturing member 23 to limit the movement of the puncturing member 23 to the second distal position.

As shown in fig. 8, the guide portion 221 is provided with an abutting wing 2212 extending outside the guide passage 2211, the abutting wing 2212 is provided with a stopping protrusion 2213 inside, and the stopping protrusion 2213 stops against the puncturing member 23 to form a limit for the puncturing member 23.

As shown in fig. 8, the contact wing 2212 extends obliquely toward the outside of the guide passage 2211 to have a fixed end and a free end, the stop protrusion 2213 is disposed at the free end, and the unlocking structure can contact the free end to change the position of the contact wing 2212 to the puncturing part 23 in a deformation manner.

As shown in fig. 8, the contact wing 2212 is further provided with a rib 2214 to improve the strength of the contact wing 2212 and prevent the contact wing 2212 from being broken due to large deformation when being pressed.

Further, as shown in fig. 15, the puncture piece 23 has a fitting flat surface 2321, and the stopper projection 2213 is abuttingly fitted with the fitting flat surface 2321.

The stop protrusion 2213 and the matching plane 2321 stop the puncture piece 23, so that the contact area of the stop protrusion 2213 and the matching plane 2321 is increased, the stop of the puncture piece 23 by the stop protrusion 2213 is more stable and stable, the stability is improved, and the puncture piece 23 is prevented from being triggered by mistake.

Preferably, as shown in fig. 13 and 15, the puncturing element 23 includes a needle 231 and a needle seat 232, the needle seat 232 is used as a carrier of the needle 231, and the engagement plane 2321 is disposed on the needle seat 232.

Further, as shown in fig. 8 and 15, one of the inner wall of the guide passage 2211 and the outer wall of the puncturing element 23 is provided with a guide sliding bar 2215, and the other of the inner wall and the outer wall is provided with a guide sliding groove 2322 which is matched with the guide sliding bar 2215, and the two are matched to form a limit for the puncturing element 23, so that the puncturing element 23 can further move along the axial direction of the housing 1. And prevents the puncture member 23 from deflecting itself during needle withdrawal.

As shown in fig. 9, the unlocking structure includes an unlocking rib 43 disposed on the trigger cap 4, and the unlocking rib 43 can abut against the abutting wing 2212 to move the stopping projection 2213 and disengage from the puncturing member 23.

When the pushing member 22 and the puncturing member 23 move together to the first proximal position, the unlocking rib 43 presses the abutting wing 2212, so that the abutting wing 2212 deforms and opens towards the outside of the guiding channel 2211, the stopping protrusion 2213 on the inner side of the abutting wing 2212 synchronously opens outwards, the stopping on the puncturing member 23 is lost, and at the moment, the puncturing member 23 can move upwards under the action of the tension spring 6, and the needle withdrawing is completed.

Further, as shown in fig. 9, the trigger cover 4 is provided with a slide way 42, the abutting wing 2212 is located in the slide way 42 and moves along the slide way 42, and the unlocking rib 43 is located at one end of the slide way 42.

The slide way 42 can further play a role in guiding the movement of the pushing piece 22 by matching with the abutting wings 2212, and meanwhile, the unlocking convex rib 43 is positioned at one end of the slide way 42, so that effective triggering of the abutting wings 2212 by the unlocking structure can be ensured, the probability of failure of the unlocking structure caused by assembly errors is reduced, and the reliability of matching between the sliding way and the unlocking structure is improved.

Preferably, as shown in fig. 8 and 9, two abutting wings 2212 are symmetrically arranged on both sides of the guide passage 2211, and two slide ways 42 are correspondingly arranged and distributed on both sides of the guide portion 221, so that the abutting wings 2212 on both sides are positioned in the slide ways 42 and move along the slide ways 42.

In a preferred embodiment, as shown in fig. 1 and 2, the implant device further comprises a trigger 3, the trigger 3 having a connecting end 32 and an operating end 33, the connecting end 32 being hinged to said housing 1, the trigger 3 further having a pushing top 31, the pushing top 31 being capable of pushing the needle assembly 2 to move the needle assembly 2 towards the opening.

The connecting end 32 of the trigger 3 is hinged to the housing 1, so that the trigger 3 can rotate relative to the housing 1 to switch between the initial position and the needle assisting position, namely, the trigger 3 can rotate to trigger the implantation device. Compared with a button pressing mode, the operation is performed by means of the hinged shaft, operation hand feeling is improved, the distance between the operation end 33 and the connecting end 32 is long, the length of the force arm is long, and the user can operate the trigger piece 3 easily and labor-saving.

In addition, trigger 3 is connected with shell 1 is articulated, can make trigger 3 obtain more apparent visual effect, and the user can dodge trigger 3 with the finger consciously when holding shell 1 to the probability that trigger 3 leads to the spurious triggering is touched to the mistake when reducing and holding the implantation device.

Moreover, at trigger 3 pivoted in-process, user and medical personnel can see trigger 3's state in real time to learn inside helping needle subassembly 2's implantation state, be convenient for carry out accurate the accuse to the implantation process, improve and use experience.

In a specific embodiment, as shown in fig. 4 and 5, the connection end 32 of the trigger 3 is provided with a hinge arm 321, the housing 1 is provided with a hinge seat 13, a side wall of the hinge arm 321 protrudes to form a hinge shaft 322, and the hinge shaft 322 extends into a hole of the hinge seat 13 to complete the hinge. Of course, the hinge shaft may be fixed to the hinge base 13, and a hole may be correspondingly formed in the hinge arm 321 to pass the hinge shaft therethrough. For another example, the hinge arm 321 and the hinge base 13 are both provided with openings, the hinge shaft is of a separate structure, and the hinge shaft passes through the openings of the hinge arm 321 and the hinge base 13 to realize hinge fit.

It should be noted that the manner of triggering the needle assembly 2 by the trigger 3 is not specifically limited in the present application, and in one embodiment, the housing is provided with a stopping structure for limiting the position of the needle assembly 2, so as to limit the needle assembly 2 at the first distal position, and when the user operates the trigger 3, the trigger 3 pushes the needle assembly 2 to disengage from the stopping structure, and automatically moves towards the first proximal position to complete the implantation. For example, a spring or the like may be provided within the housing to provide a pushing force for the movement of the needle assembly 2 towards the first proximal position.

In another embodiment, the needle assembly aid 2 is a manually implanted structure, that is, when the user operates the trigger 3, the user needs to press the trigger 3 all the time, so that the trigger 3 continuously exerts an ejecting force on the needle assembly aid 2, and then continuously pushes the needle assembly aid 2 to move to the first proximal position, the implantation process needs the user to press the trigger 3 all the time, and the magnitude of the pushing force of the trigger 3 on the needle assembly aid 2 and the movement speed of the needle assembly aid 2 are completely controlled by the user.

Specifically, as shown in fig. 5, a top wall of the housing 1 is provided with an opening 11, the ejector part 31 extends into the housing 1 from the opening 11 to be matched with the needle assisting assembly 2, and when the trigger 3 is at the needle assisting position, the trigger 3 covers the opening 11.

Preferably, the angle between the initial position and the implantation position of the trigger 3 is 30-60 °.

The rotation motion of the trigger component 3 is converted into the driving force of the needle assisting component 2 along the axial direction of the shell 1, the trigger component 3 only needs to rotate by a small angle, the needle assisting component 2 can complete the implantation action, meanwhile, the user can operate more conveniently, and the pressing of the trigger component 3 can be completed only by one-hand operation.

Further, as shown in fig. 1 and 6, the needle assisting assembly 2 includes a pushing member 22 and a transmission member 21 disposed in the housing 1, the transmission member 21 is fixedly connected to the pushing member 22, the pushing portion 31 has a positioning column 311, the transmission member 21 is provided with a positioning slide 211, the positioning column 311 is disposed in the positioning slide 211, and when the operation end 33 rotates around the connection end 32, the positioning column 311 can slide in the positioning slide 211.

The positioning slide way 211 can limit the positioning column 311, the movement of the positioning column is limited in the positioning slide way 211, when the trigger piece 3 rotates around the hinge shaft, the positioning column 311 not only forms ejection force towards the opening to the needle assisting assembly 2, so that the needle assisting assembly 2 moves, but also transversely slides along the positioning slide way 211, so that the movement of the trigger piece 3 is more reliable, the trigger piece can move along a preset path, and the operation hand feeling of a user is more stable.

Further, as shown in fig. 6, the positioning slide 211 extends laterally to have an initial end 216 and an initiation end 217, and a limiting rib 213 is further disposed in the positioning slide 211, and the limiting rib 213 can be in stop-fit with the positioning pillar 311 to limit the positioning pillar 311 at the initial end 216.

Spacing muscle 213 restricts reference column 311 at initial end 216 to with reference column 311 backstop cooperation, therefore the user is pressing trigger 3 when, can not trigger 3 easily and rotate, but need exert great power, make reference column 311 cross spacing muscle 213, just can slide in location slide 211, with this operation degree of difficulty that has suitably increased trigger 3, further improved trigger 3's the effect of preventing the mistake and touching.

Preferably, as shown in fig. 4 and 6, the positioning column 311 is a cylindrical structure, and the surface of the limiting rib 213 is also provided with a transition arc surface, so that the positioning column 311 is smoother when crossing the limiting rib 213, the jamming feeling of the positioning column 311 during movement is reduced, and the operation hand feeling is improved.

Taking fig. 2 and fig. 6 as an example, the left end of the positioning slide 211 is an initial end 216, the right end is an activation end 217, when the operation end 33 of the trigger 3 rotates downward, the end of the pushing top 31, i.e. the positioning post 311, slides to the right under the limitation of the positioning slide 211, and when the trigger 3 rotates to the needle assisting position, the positioning post 311 moves to the activation end 217.

In a preferred embodiment, as shown in fig. 7 and 8, the driving member 21 has a first engaging portion 218, and the pushing member 22 has a second engaging portion 222 engaged with the first engaging portion 218, so that the driving member 21 and the pushing member 22 are engaged and fixed. Of course, the transmission part 21 and the pushing element 22 may be fixed by other means, such as magnetic attraction, screw connection, etc.

In another embodiment, the driving member 21 and the pushing member 22 are integrally formed to simplify the structure of the needle assembly 2, eliminate the assembly step, and improve the assembly efficiency.

Furthermore, as shown in fig. 6, a positioning rib 212 is disposed at the top end of the transmission member 21, the positioning rib 212 cooperates with the surface of the pushing member 22 to form a positioning slideway 211, and the positioning rib 212 is provided with an avoiding notch 214, so that the positioning column 311 can enter the positioning slideway 211 from the avoiding notch 214.

Specifically, as shown in fig. 7 and 8, the pushing element 22 is provided with at least two channels, a second clamping portion 222 is provided on a channel wall of each channel, and the transmission element 21 is provided with a first clamping portion 218 corresponding to the second clamping portion 222, so that the transmission element 21 and the pushing element 22 are clamped at multiple positions, the connection strength is improved, the coaxiality of the two is ensured, and the inclination is avoided.

Preferably, as shown in fig. 5 and 6, one of the outer wall of the transmission member 21 and the inner wall of the housing 1 is provided with a guide groove 215 extending toward the opening, and the other is provided with a guide projection 12 engaged with the guide groove 215.

The guide groove 215 is matched with the guide protrusion 12 to limit the transmission member 21 and the pushing member 22, so that the transmission member can only move along the axial direction of the shell 1, and the movement reliability of the needle assisting assembly 2 is improved.

Preferably, as shown in fig. 6, the plurality of guide grooves 215 are provided and are uniformly spaced along the circumferential direction of the transmission member 21, and the guide protrusions 12 are provided in one-to-one correspondence with the guide grooves 215.

As shown in fig. 1 and 10, the present application further discloses a monitor, which comprises the above-mentioned implant device, and further comprises a skin fixing base 5 fixed on one end of the needle assembly 2 facing the opening, wherein the skin fixing base 5 comprises a base 51, a sensor 52 and a sensor electronic unit 53, the sensor 52 is fixed on the base 51, and the sensor electronic unit 53 is detachably connected with the base 51.

As shown in fig. 10, the stylus of the sensor 52 projects outside the skin-holding base 5, the lancet 23 penetrates the skin-holding base 5, and the stylus of the sensor 52 is accommodated inside the lancet 23.

The skin fixing seat 5 is provided with an adhesive sheet on one side, and when the adhesive sheet is contacted with the skin of a patient, the adhesive sheet can be adhered to the skin surface of the patient, so that after the implantation is completed, the contact pin of the sensor 52 inside the adhesive sheet extends into the subcutaneous space of the patient, and the skin fixing seat 5 is fixed on the skin surface of the patient.

When the monitor is used and a user triggers an implantation operation, the needle assisting assembly 2 and the skin fixing seat 5 synchronously move together to move from the first far-end position to the first near-end position, and at the moment, the puncture piece 23 punctures the skin of a patient, and the contact needle of the sensor 52 is implanted under the skin of the patient.

After implantation is completed, the unlocking structure releases the limitation of the limiting structure, so that the puncture piece 23 independently retracts to the second far-end position, and needle withdrawing operation is completed. Finally, the user removes the housing assembly and the skin anchor 5 is left on the surface of the patient's skin.

It should be noted that the assembly manner of the sensor electronic unit 53 and the base 51 is not specifically limited in the present application, and may be one of the following embodiments:

example 1: in the present embodiment, the sensor electronic unit 53 and the base 51 are detachably connected before shipping, so that the sensor electronic unit 53 and the sensor 52 can be mounted to the base 51 step by step, thereby achieving step sterilization, for example, the sensor 52 is fixed to the base 51, the sensor 52 is subjected to radiation sterilization, then the sensor electronic unit 53 is mounted to the base 51, and gas sterilization is performed on the sensor 53, thereby avoiding cross sterilization from causing damage to the sensor 52 and the sensor electronic unit 53 to different degrees.

When the monitor leaves the factory, the sensor electronic unit 53 and the base 51 are fixed, and at this time, after the user implants, the sensor electronic unit 53 does not need to be installed manually, so that the operation steps of the user are saved, and the use experience is improved.

Example 2: in this embodiment, the sensor electronic unit 53 and the base 51 are detachable from each other when the skin fixing base 53 is shipped from the factory, so that the sensor electronic unit 53 is not included on the skin fixing base 53 when the skin fixing base 53 is fixed on the needle assembly 2, and after the user is implanted, the sensor electronic unit 53 needs to be manually installed on the base 51, and at this time, the skin fixing base 5 can achieve the blood glucose monitoring function.

Further, as shown in fig. 11 and 12, the base 51 is provided with a first clamping rib position 512 along the circumferential direction thereof, the sensor electronic unit 53 is correspondingly provided with a second clamping rib position 531, the base 51 has a mounting position 511 for mounting the sensor 52, and the sensor electronic unit 53 has a positioning structure 532 adapted to the mounting position 511 in shape.

The clamping and fixing mode is adopted, so that the assembly is simpler and more convenient, and the assembly and disassembly are convenient. Of course, the base 51 and the sensor electronic unit 53 may be fixed in other manners, such as screw thread fixing, magnetic attraction fixing, etc., and are not limited in detail herein.

The positioning structure 532 is provided on the sensor electronic unit 53 corresponding to the shape of the mounting position 511, thereby performing a mounting positioning function for mounting the sensor electronic unit 53. Specifically, as shown in fig. 11 and 12, the mounting portion 511 has a positioning ring protruding upward, the sensor electronic unit 53 is correspondingly provided with a positioning groove to form a positioning structure 532, and the positioning structure are inserted and positioned to reduce the positioning difficulty of the sensor electronic unit 53, thereby further improving the assembly efficiency.

Where not mentioned in this application, can be accomplished using or referencing existing technology.

The embodiments in the present specification are described in a progressive manner, and the same and similar parts among the embodiments are referred to each other, and each embodiment focuses on the differences from the other embodiments.

The above description is only an example of the present application and is not intended to limit the present application. Various modifications and changes may occur to those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application should be included in the scope of the claims of the present application.

Claims

1. A biological monitoring sensor implantation device comprises a shell and an auxiliary needle assembly arranged in the shell, wherein one end of the shell is provided with an opening, and the biological monitoring sensor implantation device is characterized in that,

the implant device further includes a trigger shield disposed at one end of the needle assembly, the trigger shield having an abutment portion for contact with the skin, the needle assembly being movable toward the opening in synchronization with the trigger shield and relative to the trigger shield when the abutment portion is stopped to enable the needle assembly to move relative to the trigger shield to have a first proximal position and a first distal position.

2. The biological monitoring sensor implant device of claim 1,

3. The biological monitoring sensor implant device of claim 2,

4. The biological monitoring sensor implant device of claim 1,

the trigger cover has first joint structure, the helping hand needle subassembly has second joint structure, first joint structure with the cooperation of second joint structure joint.

5. The biological monitoring sensor implant device of claim 1,

6. The biological monitoring sensor implant device of claim 1,

7. The biological monitoring sensor implant device of claim 6,

the propelling part has the guide part, direction passageway has in the guide part, the puncture piece is arranged in the direction passageway, limit structure including set up in the butt wing of guide part, the butt wing has the orientation the inside convex backstop of direction passageway is protruding, the backstop protruding with the puncture piece backstop is spacing, in order to restrict the puncture piece to the distal end position motion.

8. The biological monitoring sensor implant device of claim 7,

9. The biological monitoring sensor implant device of claim 7,

10. The biological monitoring sensor implant device of claim 9,

the trigger cover is provided with a slide way, the butt wing is located in the slide way and moves along the slide way, and the unlocking convex rib is located at one end of the slide way.

11. The biological monitoring sensor implant device of claim 7,

the butt joint wing orientation the guide way outside slope extend in order to have stiff end and free end, backstop arch set up in the free end, unlocking structure can support the free end.

12. The biological monitoring sensor implant device of claim 7,

13. The biological monitoring sensor implant device of claim 6,

14. The biological monitoring sensor implant device of claim 1,

15. The biological monitoring sensor implant device of claim 14,

16. A continuous blood glucose monitor, characterized in that,

a biological monitoring sensor implant device comprising any one of claims 1-15;

the monitor also comprises a skin fixing seat fixed at one end of the needle assisting assembly facing the opening, wherein the skin fixing seat comprises a base, a sensor and a sensor electronic unit, the sensor is fixed at the base, and the sensor electronic unit is detachably connected with the base.