CN114720530B

CN114720530B - Method for detecting glucose, sensor insertion device, needle assisting device and application

Info

Publication number: CN114720530B
Application number: CN202210633421.2A
Authority: CN
Inventors: 葛从杰; 王佳; 蔡娅
Original assignee: Nanjing Jingjie Biotechnology Co ltd
Current assignee: Nanjing Jingjie Biotechnology Co ltd
Priority date: 2022-06-07
Filing date: 2022-06-07
Publication date: 2022-10-14
Anticipated expiration: 2042-06-07
Also published as: WO2023056791A1; CN114720530A

Abstract

The invention relates to the technical field of analyte detection, in particular to a method for detecting glucose, which uses a sensor insertion device to implant an insertion electrode of a sensor into an object to be detected; the present invention also provides a sensor insertion device comprising: an actuating assembly for driving the transmission assembly; a drive assembly for driving the needle assembly from the proximal position to the distal position and back from the distal position to the proximal position; a needle assembly for implanting an insertion subject beneath the skin. The invention also provides a needle assisting device which comprises a sensor inserting device, an emitter and a sensor. Also discloses a sensor inserting device and a needle assisting device which are applied to the detection of glucose, lactic acid, alcohol and the like; according to the invention, after the implantation needle is withdrawn, the stored energy of the actuating assembly is completely released, the needle assembly cannot rebound, the risk of accidental injury of a patient is reduced, and the user feels better. And the needle assembly is arranged in the transmission assembly, the structure is compact, the whole size of the insertion device is small, and the use and the carrying are convenient.

Description

Method for detecting glucose, sensor insertion device, needle assisting device and application

Technical Field

The invention relates to the technical field of monitoring of analytes, in particular to a method for detecting glucose, a sensor insertion device, a needle assisting device and application.

Background

For diabetic patients, it is important to monitor the blood glucose level in the blood in real time. The existing dynamic blood sugar monitoring system can monitor the change of blood sugar of a human body in real time by inserting a sensor electrode into subcutaneous tissue of the human body. Such small blood glucose monitoring devices also typically carry a transmitter to transmit data regarding blood glucose levels monitored by the sensor to a receiver. The patient can read and process the data at the receiver so that the in vivo blood glucose level can be known in real time. The sensor is implanted into the subcutaneous tissue of the human body by means of a needle assisting device or an inserting device, the needle assisting device or the inserting device is generally provided with an implanting needle, and the implanting operation of the implanting needle can implant the implanting needle and an inserting electrode of the sensor below the skin; and the needle withdrawing operation of the implantation needle can rapidly withdraw the implantation needle out of the skin of the human body, so that the insertion electrode of the sensor is kept under the skin, and the sensor monitors the change of blood sugar in the human body through the insertion electrode.

For example, chinese patent CN107014877a discloses a dynamic continuous blood glucose monitoring system, which includes a skin treatment system and a blood glucose monitoring system. The system grinds skin bleeds through a skin treatment system and continuously monitors the blood glucose level of the patient through a blood glucose monitoring system. Chinese patent application CN110023743A discloses an apparatus for supporting a sensing wire of an invasive biosensor. Invasive biosensors of this type, for example for use in wearable glucose monitoring devices, comprise a thread which can be inserted into the skin of a patient, through which a sensing circuit reads biological information about the patient. Chinese patent CN209606445U relates generally to a pre-attached analyte sensor and, more particularly, to an analyte sensor such as a continuous analyte sensor. Sensor systems of the kind comprising an on-skin sensor assembly may continuously monitor glucose levels, i.e. sensor systems of the kind may have a wireless transmitter which transmits measurement data to a receiver which may process and display information based on the measurement results.

A form of drive for needle boosters currently on the market, such as that disclosed in patent CN102573616B, comprises a sheath, a device support movable between proximal and distal positions, a tip support movable between proximal and distal positions, a handle movable between proximal and distal positions, and a driver. The insertion device is operated by a single hand, the insertion electrode of the sensor is implanted into the subcutaneous tissue of a human body through the implantation needle by external force applied to the shell by the hand, the spring inside the shell is compressed to store energy while the sensor is implanted, and the implantation needle is driven to withdraw from the skin by resilience of the stored energy spring.

To further improve the implantation approach, patent CN107949314B discloses a percutaneous monitor comprising a telescopic assembly, a sensor and a base with an adhesive coupling the sensor to the skin. The sensor may be positioned within the telescoping assembly when the base extends from a distal end of the system. The system can be configured to couple the sensor to the base by compressing the telescoping assembly. The percutaneous monitor firstly presses a trigger button, after the trigger button is triggered, a first spring which is compressed and stored energy in a shell acts on a needle assembly, a sensor electrode is implanted into subcutaneous tissue of a human body, and the needle assembly compresses a second spring to store energy; after the implantation is finished, the implantation needle is withdrawn from the skin by the rebound action of the second spring.

In summary, the glucose detection method and the sensor insertion device in the prior art have the problems of insufficient use convenience, discomfort feeling of patients and the like. Based on the use method of the insertion device and the user experience, a method for detecting physiological indexes, a sensor insertion device and a needle assisting device which are simple and rapid to use and have better user body feeling still need to be provided.

Disclosure of Invention

In order to solve the technical problems that a sensor insertion device in the prior art is not compact in structure and poor in user body feeling, the invention provides a method for detecting physiological indexes of an object to be detected, the sensor insertion device and a needle assisting device, and aims to increase the comfort level of the user body feeling, increase the structural compactness of the insertion device and reduce the processing cost by improving the driving form of a needle assembly; meanwhile, the implantation operation of the sensor is more stable.

In order to realize the purpose, the technical scheme of the invention is as follows:

a method of detecting glucose, comprising:

the insertion electrode of the sensor is implanted into the test object using the sensor insertion device,

the insertion of the electrodes results in a raw current signal,

processing the original current signal by a sensor to obtain a processed current signal;

obtaining glucose monitoring data according to the processed current signal,

the sensor insertion device includes: an actuation assembly, a transmission assembly and a needle assembly.

Furthermore, the insertion electrode implanted into the object to be measured and the object to be measured undergo a chemical reaction to obtain an original current signal.

Further, the sensor processing includes amplification and filtering of the raw current signal.

Further, the processed current signal is further processed by an algorithm to obtain glucose concentration data.

Furthermore, the insertion electrode comprises a substrate conductive layer, a sensing layer and a limiting layer. Wherein the limiting layer is a substrate of the electrode, and the conducting layer and the sensing layer are attached to the limiting layer; the sensing layer is made of biological enzyme or non-biological enzyme material with catalytic property, the biological enzyme and glucose generate oxidation-reduction reaction, voltage is applied to the conducting layer, and ionization promotes current to flow out of the conducting layer.

Further, the filtering processing method is selected from any one or more of single moving window mean filtering, median filtering, multiple moving window mean filtering, and multiple moving window mean and median combined filtering.

Further, the algorithm is selected from any one or more of a concentration conversion algorithm, a temperature calibration algorithm, a physiological delay calibration algorithm.

The present invention also provides a sensor insertion device comprising:

an actuating assembly for driving the transmission assembly;

a drive assembly for driving the needle assembly from the proximal position to the distal position and back from the distal position to the proximal position;

a needle assembly for implanting an insertion subject into skin.

Further, the transmission assembly includes a gear set and a rack set.

Further, the rack gear set includes a moving rack gear and a fixed rack gear.

Further, the fixed rack engages the gear set to effect movement of the needle assembly from the proximal position to the distal position; the moving rack is engaged with the gear set to effect retraction of the needle assembly from the distal position to the proximal position. Or the movable rack is meshed with the gear set to realize the movement of the needle assembly from the proximal position to the distal position; the fixed rack gear is engaged with the gear set to effect retraction of the needle assembly from the distal position to the proximal position.

Furthermore, the movable rack is an independent rack or a part with a rack tooth shape integrated thereon; the fixed rack is an independent rack or a part with a rack tooth shape integrated thereon.

Further, the gear set comprises one gear or a plurality of gears; when the gear set is a plurality of gears, the axes of the gears are overlapped; when the specifications of a plurality of gears are the same, the gear can be equivalent to one gear.

Further, the transmission assembly drives the needle assembly a distance that is a single or multiple of the travel that results from the engagement of the gear set with the rack set.

Further, the distance may be generated by the gear set including a plurality of gears, the plurality of gears including at least one large gear and one small gear, the large gear driving the needle assembly to move, and the small gear meshing with the rack and generated by the gear ratio of the large gear and the small gear. But also in such a way that the gear set follows the movement of the transmission assembly. Or a combination of the two.

If the transmission ratio of the large gear and the small gear is adopted to generate a distance which is several times, the large gear is used for driving the needle assembly, the small gear is meshed with the rack set, if the transmission ratio of the large gear and the small gear is n, the large gear and the small gear synchronously rotate, if the stroke of the rack set is s, the stroke of the needle assembly is ns, and the needle assembly can move by a distance which is n times of the stroke generated by the meshing of the rack set and the gear set. If the gear set moves along with the transmission assembly, the moving distance of the needle assembly is equal to the moving distance of the gear set and the sum of the strokes generated by the gear set and the rack set in a meshed mode. If the combination of the two modes is adopted, namely the gear set comprises a large gear and a small gear, the large gear drives the needle assembly to move, and the gear set also moves along with the transmission assembly, the distance for driving the needle assembly to move in the mode is n times the sum of the distance for driving the needle assembly to move and the distance for driving the gear set to move, and then the needle assembly can be moved in a large distance by using the small stroke s.

Further, the sensor insertion device further comprises a housing, and one end of the actuating assembly is coupled with the housing, and the other end of the actuating assembly is coupled with the transmission assembly.

Further, the housing contains components of the sensor insertion device within it, the distal end of the housing contacting the skin when the sensor insertion device is in use.

Further, the actuation assembly includes a spring.

Further, in the initial state, the spring is energized.

Further, the number of the springs is one or more.

When the number of the springs is one, one end of each spring is connected with the transmission assembly, and the other end of each spring is connected with the shell; wherein the effective enabling stage of the spring is a stage from energy storage to release.

When the quantity of spring was many, the one end of many springs all couples with drive assembly, and the other end couples with the casing, and the effective messenger of many springs stage is the stage of energy storage to release.

Further, the number of the springs is 1-4, preferably 2-3, and most preferably 2.

Further, when the quantity of spring was many, the spring equipartition setting on transmission assembly to improve the motion stability.

Further, the sensor insertion device further comprises a trigger assembly disposed on the housing for triggering the actuation assembly.

Further, in the initial state, the trigger assembly locks the transmission assembly in the initial position.

Further, the trigger component is a trigger button or a combination of the trigger button and a locking block.

Further, the transmission assembly further comprises a movable seat, wherein the gear set is installed inside the movable seat and can freely rotate around the axis of the gear set.

Further, the transmission assembly further comprises a driving seat, and the movable rack is arranged on the driving seat and can move synchronously with the driving seat.

Further, the movable seat is arranged in the driving seat, and in an initial state, the movable seat can keep an installation state to form self-locking.

Further, the sensor insertion device further comprises an emitter fixing seat, and the emitter fixing seat is arranged below the transmission assembly.

The invention also provides a needle assisting device which comprises the sensor inserting device, the emitter and the sensor arranged in the emitter.

Further, the transmitter sets up inside the transmitter fixing base, and the transmitter is connected with the sensor electricity, and the signal that the sensor produced is received to the transmitter.

Further, the sensor is arranged in the transmitter, and the sensor is provided with an insertion electrode which is contacted with the object to be measured to generate a current signal.

Further, the needle assembly of the sensor insertion device includes an implantation needle which is engaged with a tail portion of the insertion electrode of the sensor in an initial state, and a portion of the insertion electrode of the sensor other than the tail portion thereof is disposed outside the implantation needle.

Further, after the actuating assembly is triggered, the actuating assembly pushes the transmission assembly to act; the transmission assembly drives the needle assembly and the emitter to move from a proximal position to a distal position, and the needle assembly is inserted into a subject to be implanted in the skin; the actuating assembly continues to push the transmission assembly, the transmission assembly drives the needle assembly to move from the distal position to the proximal position, and the emitter and the sensor are detained on the skin surface.

The invention also provides an application of the sensor insertion device, which is applied to detecting the physiological index of the object to be detected.

Further, the physiological index is one of glucose, lactic acid, alcohol and blood ketone.

The invention also provides an application of the needle assisting device, which is applied to detecting the physiological index of the object to be detected.

Compared with the prior art, the invention has the following beneficial effects:

(1) According to the invention, the actuating assembly drives the transmission assembly, the transmission assembly drives the needle assembly to realize the implantation and retraction of the inserted object, the operation is convenient, the effect is stable, the needle assembly cannot rebound, the risk of accidental injury of a patient is reduced, and the user feels better.

(2) The transmission assembly adopts a gear rack structure to realize transmission of driving force, the implantation depth of an inserted object is more accurate and stable, the structure is compact, and the use and the carrying are convenient.

(3) This product has realized that the unpacking can use, need not to carry on sensor or some supplementary actions such as transmitter installation again before the use, has reduced the possibility that the user makes mistakes in loaded down with trivial details operation.

(4) The invention utilizes the trigger component to trigger the starting of the actuating component, and the trigger component is triggered by one key, thereby being convenient and fast to use without subsequent processing.

(5) The actuating assembly comprises a spring, the spring in an energized state is used for driving the rotating assembly, the springs with different strengths are replaced, products with different needle inserting strengths can be manufactured, and diversified selections can be provided for different groups.

(6) The trigger assembly can lock the transmission assembly at an initial position, the movable seat keeps self-locking in an installation state, and the interlocking or self-locking between parts is utilized without other auxiliary connecting parts, so that the whole structure is easy to assemble, and the automatic production is convenient to realize.

(7) According to the invention, the gear set moves along with the driving seat, the gear set and the needle assembly are meshed to drive the needle assembly to move, and further, the moving distance of the needle assembly is several times of the stroke generated by the meshing of the gear set and the rack set, or the gear set can also adopt the transmission ratio of a big gear and a small gear, so that the short stroke generated by the meshing of the gear set and the rack set can provide the moving distance of several times for the needle assembly; further, the volume of the insertion device can be reduced, which is advantageous for miniaturization.

(8) In an initial state, the implanting needle is matched with the tail part of the inserting electrode of the sensor and hidden, so that the implanting needle is prevented from accidentally injuring a user, meanwhile, the user is prevented from generating uncomfortable psychological reaction, and the comfort and experience of the user are improved.

Drawings

Fig. 1a is a schematic structural diagram of a first embodiment of the present invention.

Fig. 1b is an exploded schematic view of the first embodiment.

Fig. 2 is a schematic structural diagram of the housing according to the first embodiment.

Fig. 3a is a schematic structural diagram of an upper case according to a first embodiment.

Fig. 3b is another angle structure diagram of the upper case according to the first embodiment.

FIG. 3c is a front view of the upper housing according to the first embodiment.

Fig. 4a is a first perspective structural diagram of the driving seat according to the first embodiment.

Fig. 4b is a second perspective view of the driving base according to the first embodiment.

Fig. 4c is a third perspective view of the driving seat according to the first embodiment.

Fig. 5a is a schematic structural diagram of a movable base according to a first embodiment.

Fig. 5b is another angle structure diagram of the movable base according to the first embodiment.

FIG. 6 is a schematic structural diagram of a gear set according to an embodiment.

Fig. 7 is a schematic structural diagram of a fixed rack in the first embodiment.

FIG. 8a is a schematic view of an assembly structure of the movable base, the gear set and the needle assembly according to the first embodiment.

FIG. 8b is another perspective view of the assembled structure of the movable base, gear set and needle assembly according to the first embodiment.

FIG. 9a is a schematic view of the assembled structure of the transmission assembly and the needle assembly according to the first embodiment.

FIG. 9b is a top view of the drive assembly and needle assembly of the first embodiment.

Fig. 10a is a schematic structural diagram of a transmitter holder according to an embodiment.

Fig. 10b is a schematic view of another angle structure of the transmitter holder according to the first embodiment.

Fig. 11a is a schematic internal structure diagram of the first embodiment.

Fig. 11b is a bottom view of the internal structure of the first embodiment.

FIG. 12a is a schematic diagram of an internal structure in an initial state according to an embodiment.

FIG. 12b is a top view of the internal structure of the initial state of the embodiment.

FIG. 12c is a front view of the internal structure of the first embodiment in an initial state.

FIG. 13a is a schematic diagram illustrating an internal structure of an embodiment in a trigger state.

FIG. 13b is a top view of the internal structure in a triggered state according to an embodiment.

FIG. 13c is a front view of the internal structure of the trigger state of the first embodiment.

FIG. 14a is a schematic view showing the internal structure of an implantation needle inserted into a skin site according to an embodiment.

FIG. 14b is another angle view of the inner structure of the first embodiment with the implantation needle inserted into the skin.

FIG. 14c is a front view of the internal structure of the first embodiment with the needle inserted into position in the skin.

Fig. 15a is a schematic view of the internal structure of the implantation needle after withdrawing the needle according to the first embodiment.

Fig. 15b is another angle diagram illustrating the internal structure of the implantation needle after withdrawing the needle according to the first embodiment.

FIG. 15c is a front view of the internal structure of the implantation needle after being withdrawn according to the first embodiment.

Fig. 16a is a schematic structural diagram of a trigger button according to the first embodiment.

Fig. 16b is another angle structure diagram of the trigger button according to the first embodiment.

FIG. 17 is a schematic structural diagram of a gear set according to a second embodiment.

FIG. 18 is a schematic view of an assembly structure of the transmission assembly and the needle assembly according to the second embodiment.

Fig. 19 is a schematic structural diagram of a trigger button in the third embodiment.

FIG. 20a is a schematic structural diagram of a lock block in the third embodiment.

Fig. 20b is another angle structure diagram of the locking block in the third embodiment.

Fig. 21 is a schematic structural view of the upper case of the third embodiment, which is viewed from top to bottom, and the top cross section of the upper case is processed.

Fig. 22 is a schematic view of the internal structure of the third initial state of the embodiment.

Fig. 23 is a schematic diagram of an internal structure of the third embodiment in a triggered state.

Fig. 24a is a schematic structural diagram of a driving seat in the fourth embodiment.

Fig. 24b is another angle structure diagram of the driving seat in the fourth embodiment.

Fig. 25a is a schematic structural view of the positioning socket according to the fourth embodiment.

Fig. 25b is another schematic angle structure diagram of the positioning socket in the fourth embodiment.

FIG. 26 is a schematic structural diagram of an upper case in the fourth embodiment.

Fig. 27 is a schematic internal structure diagram of the fourth embodiment.

Fig. 28 is a schematic internal structure view of the fourth embodiment after hiding the housing.

Description of reference numerals:

1-upper shell, 101-guide post, 102-guide rib plate, 103-guide groove, 104-positioning lug, 105-limiting arm, 106-limiting ring, 107-ribbed plate, 108-ribbed plate, 109-hook groove, 110-rack groove, 111-support post, 112-limiting post, 113-trigger button groove, 121-support block, 122-support surface,

2-trigger button, 201-convex column, 202-abdicating groove, 203-hook, 204-hook, 205-guide column,

3-spring, 4-moving seat, 401-gear shaft hole, 402-groove, 403-limit boss, 404-guide groove, 405-guide block, 406-limit hook, 407-limit table, 408-top surface,

5-gear set, 501-gear shaft, 502-pinion, 503-bull gear, 504-pinion,

6-fixed rack, 7-needle assembly, 701-implantation needle, 702-moving rack,

8-driving seat, 801-lug, 802-guide strip, 803-guide groove, 804-limit surface, 805-limit surface, 806-top surface, 807-guide rib, 808-moving rack, 809-locking arm, 810-projection, 811-abdicating groove, 812-abdicating groove, 813-guide groove,

9-emitter fixing seat, 901-guide groove, 902-guide groove, 903-locking arm, 904-hook, 905-contact surface, 906-perforation,

10-launcher, 11-lower shell, 12-protective cover, 13-locking block, 1301-abdication hole, 1302-baffle, 1303-supporting foot, 1304-supporting foot, 1305-supporting arm, 1306-groove, 1307-hook, 1308-supporting block, 1309-convex hook,

14-trigger button, 1401-convex column, 1402-hook, 1403-guide column,

15-drive seat, 1501-guide bar, 1502-guide groove, 1503-limit surface, 1504-guide rib, 1505-moving rack, 1506-lock arm, 1507-projection, 1508-avoiding groove, 1509-guide groove,

16-positioning seat, 1601-positioning ring, 1602-limiting surface, 1603-protrusion, 1604-guide groove, 17-upper shell, 1701-positioning ring, 18-spring,

19-gear set, 1901-gear shaft, 1902-gear, 20-sensor assembly.

Detailed Description

The technical solutions of the present invention will be described in detail with reference to the accompanying drawings, and it is obvious that the described embodiments are not all embodiments of the present invention, and all other embodiments obtained by those skilled in the art without any inventive work belong to the protection scope of the present invention.

It should be noted that the relative arrangement of the components and steps, the numerical expressions, and numerical values set forth in these embodiments should not be construed as limiting the scope of the present invention unless it is specifically stated otherwise.

Further, it should be understood that the dimensions of the various elements shown in the figures are not necessarily drawn to scale, for example, the thickness, width, length or distance of some elements may be exaggerated relative to other structures for ease of illustration.

The following description of the exemplary embodiment(s) is merely illustrative and is not intended to limit the invention, its application, or uses in any way. Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail herein, but are intended to be part of the specification as applicable.

It should be noted that like reference numerals and letters refer to like items in the following figures, and thus, once an item is defined or illustrated in one figure, further discussion thereof will not be required in the subsequent figure description.

For custom word interpretation:

proximal end position: indicating a position away from the skin surface, where the sensor insertion device is located in the unused state of the needle assembly;

distal position: indicating the position close to the skin surface, i.e. the position where the needle assembly is closest to the skin surface in the situation of use of the sensor insertion device.

An initial state: i.e., the mounted state of each component when the sensor insertion device is not in use.

And (3) triggering a state: i.e., the state of the sensor insertion device after the activation assembly is triggered by the trigger assembly during use.

Initial position: indicating the position of the component in the initial state of the insertion device, e.g. the initial position of the drive socket indicates the position of the drive socket in the initial state of the insertion device.

Inserting the object: representing the portion that enters the interior of the skin for detecting the analyte, the insertion object in the embodiments herein is the insertion electrode of the sensor.

It is noted that the sensors of the present invention are used to monitor the level of analytes, including, for example, glucose, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glutamine, growth hormones, blood ketones, lactic acid, oxygen, peroxides, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. The concentration of drugs (such as, for example, antibiotics (e.g., gentamicin, vancomycin, etc.), digitoxin, digoxin), drugs of abuse, alcohol, theophylline, and warfarin may also be monitored. One or more analytes may be monitored with a given sensor; the sensor may also be other suitable sensors.

Method for detecting glucose

The method for detecting glucose provided by the invention comprises the following steps:

the insertion of the electrode results in the original current signal,

obtaining glucose monitoring data according to the processed current signal,

After the insertion electrode is implanted into the object to be detected, the insertion electrode and glucose in the object to be detected are subjected to chemical reaction to obtain an original current signal, the sensor amplifies the original current signal and performs moving window mean filtering processing to obtain a processed current signal, and the processed current signal is further processed by a concentration conversion algorithm to obtain analyte concentration data.

The insertion electrode comprises a substrate conducting layer, a sensing layer and a limiting layer, wherein the limiting layer is a substrate of the electrode, and the conducting layer and the sensing layer are attached to the limiting layer; the sensing layer is composed of glucose oxidase, the glucose oxidase and glucose generate oxidation-reduction reaction to generate hydrogen peroxide, voltage is applied to the conducting layer, the hydrogen peroxide is ionized to generate hydrogen ions, and current is promoted to flow out of the conducting layer.

The moving window filtering process of the original current signal can be one or a combination of a single moving window mean filtering, a median filtering, a multiple moving window mean filtering and a multiple moving window mean and median combined filtering; besides the concentration conversion algorithm, the processed current signal can also adopt a temperature calibration algorithm or a physiological delay calibration algorithm, or a combination of several algorithms.

The substance to be detected can be a reagent for experiments, human tissue fluid or other substances to be detected for detecting glucose level.

Sensor insertion device

In order to make the technical solution and the advantageous effects of the sensor insertion device of the present invention more apparent, the insertion device of the present invention will be described in further detail with reference to the following detailed description and the accompanying drawings.

The first embodiment is as follows: structure and action process of sensor insertion device

As shown in fig. 1a and 1b, the present invention provides a sensor insertion device, which comprises a housing, an actuating assembly, a transmission assembly, a needle assembly 7, and an emitter fixing seat 9 arranged inside the housing, a trigger assembly arranged on the housing, an actuating assembly arranged above the transmission assembly, an emitter fixing seat 9 arranged below the transmission assembly, an emitter and a sensor assembly 20 arranged inside the emitter fixing seat, a needle assembly 7 arranged inside the transmission assembly, the needle assembly 7 comprising an implantation needle 701, wherein the implantation needle 701 extends downwards and passes through the emitter to contact the sensor assembly 20.

In this embodiment, the actuating assembly is two springs, in other embodiments, the springs can be replaced by other parts with energizing function, and the number of the springs can be increased to 3, 4 or more.

In an initial state, the spring is in an energized state; pressing the trigger assembly can trigger a spring, and the spring once started causes the transmission assembly to move from a direction away from the skin contact surface to a direction close to the skin contact surface, and the movement of the transmission assembly drives the needle assembly to implant the insertion electrode of the sensor into the subcutaneous tissue of the human body and withdraw the needle assembly from the skin; meanwhile, the movement of the transmission component drives the emitter to move, so that the emitter is tightly attached to the surface of the skin.

In this embodiment, the trigger component is a trigger button 2. The spring 3 may be a cylindrical spring or a conical spring.

The structure of the shell is shown in fig. 2, the shell comprises an upper shell 1 and a lower shell 11, the upper shell 1 and the lower shell 11 are connected through a buckle, and an opening is formed in the middle of the lower shell 11 so that the emitter 10 can be applied to the surface of skin; specifically, the inner wall of the upper shell 1 is provided with a plurality of hook grooves 109, the hook grooves 109 are arranged along the circumference of the inner wall of the upper shell 1, the periphery of the lower shell 11 is provided with a plurality of buckles, and the buckles are clamped into the grooves to fix the upper shell 1 and the lower shell 11.

The shell further comprises a protective cover 12, the protective cover 12 is arranged below the lower shell 11, and the protective cover 12 is connected with the lower shell 11 through threads to seal the lower shell 11; specifically, inferior valve 11 below has outstanding boss, and the boss surface sets up the screw thread, and visor 12 upper surface sets up the recess, and the recess inner wall sets up the screw thread, makes boss and recess cooperation on screwing in visor 12 inferior valve 11, closes inferior valve 11's opening, plays dustproof effect.

As shown in fig. 3a, 3b and 3c, the lower part of the upper shell 1 is opened, one side of the upper shell is provided with a groove, the trigger button 2 is arranged in the groove, the trigger button groove 113 is arranged in the groove, the upper surface of the upper shell 1 is arc-shaped, and two side surfaces of the upper shell are provided with planes, so that the upper shell is convenient to hold; two guide posts 101 are arranged in the upper shell 1, and the guide posts 101 are sleeved with springs 3. A rib plate 107 is arranged on the inner wall of the upper shell close to the guide posts 101, a positioning lug 104 is arranged at the top of the inner wall of the upper shell between the two guide posts 101, a limiting ring 106 is arranged on the positioning lug 104, and the limiting ring 106 is abutted against the transmission assembly and used for limiting the transmission assembly to move upwards; two guide rib plates 102 are arranged on the inner wall of the upper shell far away from the trigger button groove 113, a limiting arm 105 is arranged between the two guide rib plates 102, and a rib plate 108 is arranged below the limiting arm 105; a rack groove 110 is arranged on the inner wall of the upper shell close to the trigger button groove 113 and used for installing the fixed rack 6, a support column 111 is arranged close to the rack groove 110, a limit column 112 is arranged on the other side close to the rack groove 110, and the side surface of the limit column 112 is used for fixing the driving seat 8; the guide groove 103 is provided near the stopper post 112.

As shown in fig. 1b, the transmission assembly comprises a driving seat 8, a movable seat 4, a gear set 5 and a fixed rack 6, as shown in fig. 4a, 4b and 4c, the driving seat 8 is in a horizontal U-shaped structure, lugs 801 are arranged on two sides of the driving seat, a through hole is arranged in the middle of each lug 801 for guiding the column 101 to pass through each lug 801, the spring 3 is arranged between the upper shell 1 and each lug 801, the upper end surface of the spring 3 is connected with the top wall of the upper shell 1, the lower end surface of the spring 3 is connected with the upper surface of each lug 801, and in an initial state, the spring 3 is compressed and can push the driving seat 8 to move by virtue of the action of the spring 3. The two lugs 801 are symmetrically arranged on the driving seat 8, so that the spring is symmetrically arranged relative to the driving seat 8, and the spring is ensured to apply symmetrical force to the driving seat 8, and the stability of the device in use is ensured. When the quantity of spring increases to 3, 4 or more, many springs equipartition settings on drive seat 8 to stability when guaranteeing the device and using.

A guide strip 802 is arranged on the outer wall of the driving seat 8 at a position close to the lug 801 on one side, the guide strip 802 is embedded into the guide groove 103, the front end of the side plate of the driving seat 8 on one side provided with the guide strip 802 is provided with a folded edge, the outer surface of the folded edge is provided with a locking arm 809, and the locking arm 809 is matched with the trigger button 2 and is used for locking the driving seat 8; the inner surface of the folded edge is provided with a guide groove 813; the moving rack 808 is arranged close to the inner surface of the guide groove 813; the outer wall of the driving seat is provided with a plurality of guide grooves 803, the guide rib plate 102 of the upper shell is embedded into the guide grooves 803 to provide guiding and limiting effects for the driving seat 8, and the inner wall of the driving seat 8 is provided with a plurality of guide ribs 807 for limiting the movable seat 4; a protrusion 810 is arranged on the end face of the side plate on the other side of the driving seat 8, a certain recess is formed on the upper surface of the driving seat 8 provided with the protrusion 810 to form a limiting surface 805, and a certain recess is formed on the upper surface of the driving seat 8 provided with the locking arm 809 to form a limiting surface 804; an abdicating groove 812 is arranged above the middle inner wall of the driving seat, and an abdicating groove 811 is arranged below the abdicating groove 812; the top surface 806 of the driving seat 8 contacts with the positioning projection 104 of the upper case 1, and limits the upper limit position of the driving seat 8.

In this embodiment, the moving rack 808 is a tooth surface integrated on the driving seat 8 and having a rack tooth shape; in other embodiments, the moving rack may also be a separate rack, and the separate moving rack may be disposed on the driving seat 8 by welding or bonding, or fixed on the driving seat 8 by other methods, and when the driving seat moves, the moving rack follows the driving seat to move synchronously.

In the embodiment, the fixed rack 6 is an independent rack, and is fixed in the housing by matching the fixed rack with the rack slot 110 on the housing; in other embodiments, the fixed rack 6 may also be a toothed surface integrated on the housing with a rack tooth profile, the fixed rack being integrally formed with the housing.

As shown in fig. 5a and 5b, the whole movable base 4 is embedded in the driving base 8, a groove 402 which is through up and down is arranged in the movable base 4, a needle assembly 7 is arranged in the groove 402, a gear shaft hole 401 which is through horizontally is also arranged in the movable base, and a gear set 5 is arranged in the gear shaft hole 401; the outer wall of the movable seat 4 is provided with a plurality of limiting bosses 403, two limiting bosses 403 on two sides of the movable seat are respectively arranged on the limiting surface 804 and the limiting surface 805, and the limiting bosses 403 on the rear side of the movable seat are arranged in the receding groove 812 and used for limiting the movable seat 4 to move downwards in the driving seat 8. Guide grooves 404 are formed in two sides of the moving seat 4, and guide ribs 807 are embedded in the guide grooves 404 to provide limiting and guiding functions for the moving seat; the front end of the movable seat 4 is provided with a guide block 405, and the guide block 405 is embedded into the guide groove 813 to further play a role in guiding; the front end of the movable seat 4 is also provided with a limit table 407, a limit hook 406 is arranged close to the limit table 407, and the limit hook 406 is arranged below the protrusion 810 and used for limiting the movable seat 4 to move upwards in the driving seat 8; in the initial state, the movable seat can keep the installation state to form self-locking, but if the driving seat is subjected to a large pushing force, the protrusion 810 can be prompted to push the limit hook 406 so that the limit hook 406 is elastically deformed, the protrusion 810 can penetrate through the side surface of the limit hook 406 to continue to move, and the self-locking state of the movable seat 4 is released. The top surface 408 of the movable seat is contacted with the limit ring 106 of the upper shell 1; the assembly structure of the movable seat 4 and the driving seat 8 is schematically shown in fig. 9a and 9 b.

As shown in fig. 6, the gear set 5 includes a gear shaft 501, the gear shaft 501 is disposed in the gear shaft hole 401, and the gear set 5 can freely rotate around the shaft center of the gear shaft 501; two

small gears

502 and 504 are arranged on the gear shaft 501, a large gear 503 is arranged between the two

small gears

502 and 504, the two

small gears

502 and 504 and the large gear 503 are fixedly connected with the gear shaft 501, and the axle centers of the two

small gears

502 and 504 and the large gear 503 are overlapped.

As shown in fig. 8a and 8b, the needle assembly 7 comprises a moving rack 702 and an implantation needle 701, the moving rack 702 is engaged with a large gear 503, the moving rack 808 is engaged with a small gear 504, and the fixed rack 6 is engaged with a small gear 502. The lower end of the implantation needle 701 is an angled tip, arranged for the purpose of facilitating penetration of the skin.

As shown in fig. 7, which is a schematic structural view of the fixed rack 6, one side of the fixed rack 6 is a tooth surface engaged with the gear set 5, a guide block is provided on the other side of the fixed rack 6, a rack groove 110 matched with the guide block of the fixed rack 6 is provided on the inner wall of the upper case, the upper surface of the fixed rack 6 is in contact with the inner wall above the rack groove 110 for limiting the upward movement of the fixed rack 6, the lower surface of the fixed rack 6 is in contact with the upper surface of the lower case 11, and the upper case 1 and the lower case 11 fix the fixed rack 6 inside the case.

As shown in fig. 10a and 10b, the emitter fixing base 9 has a circular base plate, guide grooves 901 are provided on two sides above the base plate, rib plates 107 are embedded in the guide grooves 901, guide grooves 902 are provided on the front side of the base plate, and rib plates 108 are embedded in the guide grooves 902, so as to provide a limiting and guiding function for the emitter fixing base 9; two locking arms 903 are arranged on two sides of the emitter fixing seat, a certain gap is formed between the locking arms 903 and the substrate, one end of each locking arm 903 is connected with the substrate, the locking arms 903 have certain elastic performance, and the emitter can be fixed in the emitter fixing seat.

As shown in fig. 11a, the launcher fixing base 9 is disposed below the driving base 8, and the basic outer size of the launcher fixing base 9 is set to be able to pass through the opening of the lower case 11 by moving up and down.

As shown in fig. 16a and 16b, the trigger button 2 comprises a pressing body, the outer surface of the pressing body forms a smooth transition with the outer surface of the upper shell, and the outer surface of the pressing body is provided with a groove to increase the touch feeling; a convex column 201 is arranged on the inner side of the pressing body, an abdicating groove 202 is arranged on the convex column 201, the abdicating groove 202 is used for abdicating the locking arm 809 when the driving seat 8 moves downwards, a hook 203 is arranged below the tail end of the convex column 201, and a hook 904 is embedded in the hook 203 to realize the locking of the emitter fixing seat 9; the lower part of the convex column 201 is provided with a hook 204, the upper shell is provided with a through hole corresponding to the hook 204, and the hook 204 passes through the through hole to lock the trigger button 2 on the upper shell 1. Two guide posts 205 are further arranged on the inner side of the pressing body, and the guide posts 205 play a positioning role in mounting the trigger button 2.

As shown in fig. 12a, 12b, and 12c, the structural schematic diagram of the initial state of this embodiment is shown, in the initial state, the spring 3 is in a compressed state, and the trigger button locks the transmission assembly at the initial position, specifically: the locking arm 809 of the driving seat 8 is located above the convex column 201, and the driving seat cannot move downwards due to the limitation of the convex column 201; the driving seat 8 can not move, so that the driving seat and the fixed rack 6 have no relative movement, and the movable seat 4 and the fixed rack have no relative movement due to the limitation of the limiting lug boss 403 and the limiting hook 406.

The hook 904 is positioned above the hook 203, and the emitter fixing seat 9 cannot move downwards due to the limitation of the hook 203; therefore, the gear set 5 cannot rotate under the limitation of the fixed rack 6 and the movable rack 808, and the moving rack 702 meshed with the gear set cannot move, so that the implantation needle 701 is locked in the shell, and the implantation needle 701 is prevented from vibrating and accidentally injuring a user.

When the trigger button 2 is pressed, the trigger button 2 can trigger the actuating assembly, the actuating assembly can further drive the transmission assembly to move, and the transmission assembly drives the needle assembly 7 to move from the proximal position to the distal position and retract from the distal position to the proximal position, so that the insertion of the object into the skin is realized. The specific process comprises the following steps:

and (3) triggering: the trigger button 2 is manually pressed, the trigger button 2 moves a certain distance towards the inside of the shell relative to the upper shell 1, the locking arm 809 is located above the abdicating groove 202, and the locking arm 809 can move downwards through the abdicating groove 202; meanwhile, the hook 904 is also staggered with the hook 203, and the hook 904 can move downwards through the abdicating groove 202; therefore, the driving base 8 is moved downward by the spring 3, and since the stopper hook 406 of the moving base 4 is restricted by the support column 111, the stopper hook 406 cannot be elastically deformed, and thus the moving base 4 cannot be released from the self-locking state, and moves downward following the driving base 8.

The needle implantation process: the driving seat 8 drives the movable seat 4 and the gear set 5 to move downwards, after the gear set 5 is meshed with the fixed rack 6, the fixed rack 6 cannot move due to the limitation of the upper shell 1 and the lower shell 11, therefore, the pinion 502 starts to rotate under the action of the fixed rack 6, the pinion 502 drives the large gear 503 to synchronously rotate, the large gear 503 is meshed with the moving rack 702 to drive the moving rack 702 to move downwards, and the moving rack 702 drives the implantation needle 701 to move downwards. Along with the downward movement of the moving rack 702, the lower surface of the moving rack 702 is in contact with the upper surface of the emitter fixing seat 9, and then the moving rack 702 pushes the emitter fixing seat to move downward, and along with the downward movement of the implantation needle 701, the inserted object enters the implantation needle 701 and moves downward along with the implantation needle 701 until being implanted into the skin.

Needle withdrawing process: due to the downward movement of the movable seat 4, the side surface of the limit hook 406 is separated from the side surface of the support column 111, the side surface of the limit hook 406 is free from blocking, meanwhile, the limit table 407 of the movable seat 4 is in contact with the upper surface of the fixed rack 6, the movable seat 4 cannot move downward, the driving seat 8 continues to move downward under the pushing action of the spring 3, the protrusion 810 pushes the limit hook 406 to elastically deform, the driving seat 8 can continue to move downward, the driving seat 8 moves downward relative to the movable seat 4 to enable the movable rack 808 to be meshed with the pinion 504, the pinion 504 rotates reversely, the pinion 504 drives the bull gear 503 to rotate reversely, and then the movable rack 702 meshed with the bull gear is driven to move upward, and the needle withdrawing is realized until the spring is in a non-energy storage state.

Example two: sensor insertion device with different gear set structures

The present embodiment is different from the first embodiment in that the structure of the gear set is different, the gear set 19 in the present embodiment includes a gear shaft 1901 as shown in fig. 17, a gear 1902 is disposed on the gear shaft 1901, and as shown in fig. 18, one side of the gear 1902 is meshed with the moving rack 702, and the other side of the gear 1902 is meshed with the fixed rack 6 and the moving rack 808.

In this embodiment, the travel of the fixed rack 6 or the moving rack 808 meshing with the gear 1902 is equal to the travel of the gear 1902 meshing with the moving rack 702, and therefore the distance traveled by the needle assembly 7 is equal to the sum of the travel of the rack set meshing with the gear 1902 plus the distance traveled by the gear set 5 itself.

Example three: sensor insertion device with different trigger assembly structures

The difference between the present embodiment and the first embodiment is that the trigger assembly includes a trigger button 14 and a locking block 13, as shown in fig. 19, the trigger button 14 includes a pressing body, a convex pillar 1401 is disposed inside the pressing body, two hooks 1402 and two guide pillars 1403 are further disposed inside the pressing body, and the hooks 1402 are used for locking the trigger button 14; the guide post 1403 is used for positioning the trigger button 14 when it is installed.

As shown in fig. 20a and 20b, the locking block 13 is of an inverted U-shaped structure, an abdicating hole 1301 is formed on a horizontal surface of the middle part of the locking block 13 for avoiding the moving rack 702, and a baffle 1302 is arranged on one side of the abdicating hole 1301; the front side plate and the rear side plate of the locking block 13 are provided with side plates to form an inverted U-shaped structure, the front side plate of the locking block 13 is a supporting arm 1305, the supporting arm 1305 is provided with a groove 1306 with a horizontal opening, and the locking arm 809 of the driving seat 8 is embedded into the groove 1306 and used for locking the driving seat 8; the lower end of the supporting arm 1305 is provided with a hook 1307 with a horizontal opening, and the hook 904 of the emitter fixing seat 9 is embedded into the hook 1307 for locking the emitter fixing seat 9. The lower end surface of the rear side plate of the locking block 13 is provided with a supporting block 1308 protruding outwards, and the supporting block 1308 is arranged on the upper surface of the supporting block 121 of the upper shell 1 and used for limiting the locking block 13 to move downwards; a convex hook 1309 is arranged on the inner side of the supporting block 1308, the convex hook 1309 hooks the abdicating groove 811 of the driving seat 8, and the driving seat 8 is further locked;

support legs

1303 and 1304 protruding downward are provided on both sides of the lock block 13, and the support legs 1303 and the support legs 1304 are provided on the support surface 122 of the upper case 1 to support the lock block 13 and restrict the lock block 13 from moving downward. A schematic view of the support block 121 and the support surface 122 is shown in fig. 21.

As shown in fig. 22, the locking block 13 is disposed above the driving socket 8, and in the initial state, the locking arm 809 is inserted into the groove 1306 to lock the driving socket 8, and the hook 904 is inserted into the hook 1307 to lock the emitter fixing base. As shown in fig. 23, when the trigger button 14 is pressed, the convex column 1401 of the trigger button 14 pushes the locking block 13 to move horizontally, after the locking block 13 moves horizontally for a distance, the locking arm 809 is dislocated with the groove 1306, the hook 904 is dislocated with the hook 1307, and the convex hook 1309 moves to the outside of the receding groove 811, so that the driving seat 8 moves downwards under the pushing action of the spring 3, and then the driving seat 8 drives the moving seat 4 to move downwards, the implantation of the implantation needle 701 is realized under the action of the fixed rack 6, and the insertion object is implanted into the skin; the needle withdrawing operation of the implantation needle 701 is realized by the action of the moving rack 808, and the insertion subject is left inside the skin.

Example four: sensor insertion device with different actuating assembly and transmission assembly structures

The difference between this embodiment and the first embodiment lies in the structural difference of the actuating assembly and the corresponding dimensional change of the transmission assembly, as shown in fig. 28, the actuating assembly in this embodiment is a spring 18, the upper end surface of the spring 18 contacts with the inner top wall of the upper shell 1, and a positioning seat 16 is disposed between the spring 18 and the driving seat 15. As shown in fig. 25a, a positioning ring 1601 is disposed on the upper surface of the positioning seat 16, and the lower end surface of the spring 18 is sleeved on the positioning ring 1601. As shown in fig. 24a and 24b, the height of the driving seat 15 is increased compared with the driving seat 8, no lug is arranged on both sides of the driving seat 15, a plurality of guide grooves 1502 are arranged on the periphery of the driving seat 15, and the guide rib plate 102 of the upper shell is embedded into the guide grooves 1502 to provide guiding and limiting effects for the driving seat 15; a guide bar 1501 of the driving socket 15 is inserted into the guide groove 103, and a locking arm 1506 is provided near the guide bar 1501 for locking the driving socket 15; a moving rack 1505 is provided near the inner wall of the lock arm 1506, the moving rack 1505 being engaged with the pinion 504; guide ribs 1504 are arranged on two sides of the inner wall of the driving seat 15, and the guide ribs 1504 are embedded into the guide grooves 404 of the movable seat 4; a guide groove 1509 is formed in the inner wall of one side of the driving seat 15, the driving seat 15 is not penetrated below the guide groove 1509, and a limiting boss 403 is embedded in the guide groove 1509 to limit the moving seat 4 to move downwards in the driving seat 15; the inner wall of the rear side of the driving seat 15 is provided with a yielding groove 1508, and another limiting boss 403 is embedded into the yielding groove 1508; the front side of the driving seat 15 is provided with a protrusion 1507, a limiting surface 1503 is arranged above the protrusion, the limiting surface 1503 is provided with a limiting boss 403, and the protrusion 1507 is matched with the limiting hook 406 to limit the moving seat 4 to move upwards in the driving seat 15.

As shown in fig. 25b, the outer dimension of the positioning seat 16 matches the upper surface dimension of the driving seat 15, the lower surface of the positioning seat 16 has a protrusion, the protrusion is embedded inside the driving seat 15, the limiting surface 1602 contacts the top surface of the driving seat 15, a protrusion 1603 and a guide groove 1604 are arranged on the side wall of the protrusion, the protrusion 1603 is embedded into the receding groove 1508, and a guide rib 1504 is arranged in the guide groove 1604.

The structure of the upper casing 17 in this embodiment is the same as the internal structure of the upper casing 1 in the first embodiment, and only the size of the upper casing 17 is adjusted to fit the driving seat 15, and as shown in fig. 26, the upper casing 17 includes a cylindrical upper portion and an arc-shaped lower portion. As shown in fig. 27, a positioning ring 1701 is provided on the top of the inner wall of the upper case 17, and the upper end surface of the spring 18 is fitted over the positioning ring 1701.

Needle assisting device

The invention also provides a needle assisting device which comprises the sensor inserting device, the ejector and the sensor in any one of the first embodiment to the fourth embodiment.

Example (b): needle assisting device

In this embodiment, the needle assisting device includes the sensor inserting device in the first embodiment, and further includes the emitter and the sensor assembly 20, and the exploded structural schematic diagram of this embodiment is shown in fig. 1 b. As shown in fig. 11b, the sensor assembly 20 is disposed inside the emitter 10, and the sensor assembly 20 is disposed on the perforation 906; the sensor assembly 20 includes a sensor housing and a sensor electrically connected to the transmitter.

The sensor has an insertion electrode that coincides with the location of the perforation 906. The insertion electrode of the sensor can generate a current signal when contacting with an object to be measured, and the transmitter receives the current signal of the sensor and transmits the current signal to an external receiver. The patient can read and process the data on the receiver.

The emitter and the sensor assembly are embedded into a locking arm 903 of the emitter fixing seat 9 together, and the emitter is fixed by using the friction force between the locking arm 903 and the emitter; the lower surface of the locking arms 903 protrudes out of the lower surface of the substrate, the emitter 10 is embedded between the two locking arms 903, the emitter 10 is locked below the substrate by utilizing the elastic deformation of the locking arms 903, and the upper surface of the emitter 10 is in contact with the contact surface 905 of the substrate; a hook 904 is arranged at the rear side of the substrate, and the hook 904 is matched with the trigger button 2 to lock the emitter fixing seat 9; the base plate is also provided with a through hole 906, and an implantation needle 701 passes through the through hole 906 and extends downwards. At this time, that is, in the initial state, the implant needle 701 is engaged with the tail portion of the insertion electrode of the sensor (the connection portion between the sensor body and the insertion electrode), and the insertion electrode of the sensor except for the tail portion is disposed outside the implant needle.

When in use, the protective cover 12 is screwed out, and then the lower surface of the lower shell 11 is attached to the skin surface for use, as shown in fig. 13a, 13b and 13c, the structure of the embodiment in the trigger state is shown, when the trigger button 2 is pressed, the trigger button 2 is in the trigger state, the trigger button 2 moves to the inside of the shell for a certain distance relative to the upper shell 1, the locking arm 809 is located above the yielding groove 202, and the locking arm 809 can move downwards through the yielding groove 202; meanwhile, the hook 904 is also dislocated with the hook 203, and the hook 904 can move downwards through the abdicating groove 202. Therefore, the driving base 8 moves downward by the spring 3, and since the limit hook 406 of the moving base 4 is restricted by the support column 111, the limit hook 406 cannot be elastically deformed, and thus the moving base 4 cannot release the self-locking state but moves downward following the driving base 8.

The driving seat 8 drives the movable seat 4 and the gear set 5 to move downwards, after the gear set 5 is meshed with the fixed rack 6, the fixed rack 6 cannot move due to the limitation of the upper shell 1 and the lower shell 11, therefore, the pinion 502 starts to rotate under the action of the fixed rack 6, the pinion 502 drives the large gear 503 to synchronously rotate, the large gear 503 is meshed with the moving rack 702 to drive the moving rack 702 to move downwards, and the moving rack 702 drives the implantation needle 701 to move downwards.

Along with the downward movement of the moving rack 702, the lower surface of the moving rack 702 is in contact with the upper surface of the emitter fixing seat 9, so that the moving rack 702 pushes the emitter fixing seat to move downwards, the emitter fixing seat drives the emitter to move downwards until the emitter is tightly attached to the surface of the skin, and the emitter is adhered to the surface of the skin by using the adhesive preset on the lower surface of the emitter.

With the downward movement of the implantation needle 701, the electrode of the sensor insertion part enters the implantation needle 701 and moves downward along with the implantation needle 701 until the electrode is implanted into the skin, as shown in fig. 14a, 14b and 14c, which are schematic structural diagrams of the implantation needle of the present embodiment after being inserted into the skin in place, at this time, due to the downward movement of the movable base 4, the side surface of the limit hook 406 is separated from the side surface of the support column 111, the side surface of the limit hook 406 is free from obstruction, meanwhile, the limit platform 407 of the movable base 4 is in contact with the upper surface of the fixed rack 6, the movable base 4 cannot move downward, the driving base 8 continues to move downward under the pushing action of the spring 3, and the protrusion 810 pushes the limit hook 406 to elastically deform, so that the driving base 8 can continue to move downward.

The driving seat 8 moves downwards relative to the moving seat 4 to enable the moving rack 808 to be meshed with the pinion 504, so that the pinion 504 rotates reversely, the pinion 504 drives the gearwheel 503 to rotate reversely, and further drives the moving rack 702 meshed with the gearwheel to move upwards to realize the needle withdrawing action, as shown in fig. 15a, 15b and 15c, the structure of the implanted needle 701 of the embodiment after needle withdrawing is schematically illustrated, after needle withdrawing, the spring is in a non-energy storage state, and the electrode of the insertion part of the sensor is left in the skin to monitor the blood sugar change in the human body. After needle withdrawal is complete the sensor insertion device is removed and the emitter 10 and sensor are left on the skin surface.

Although the present invention has been described in detail with reference to the examples, it will be understood by those skilled in the art that various changes and modifications may be made, and equivalents may be substituted, for example, for gear sets in the third and fourth embodiments without departing from the scope of the present invention.

Claims

1. A sensor insertion device, comprising:

an actuating assembly for driving the transmission assembly;

a needle assembly for implanting an insertion subject into skin;

the transmission assembly comprises a gear set and a rack set;

the rack set comprises a movable rack and a fixed rack;

the fixed rack is meshed with the gear set to realize the movement of the needle assembly from the proximal position to the distal position; the movable rack is meshed with the gear set to realize that the needle assembly is withdrawn from the far end position to the near end position; or the movable rack is meshed with the gear set to realize the movement of the needle assembly from the proximal position to the distal position; the fixed rack gear is engaged with the gear set to effect retraction of the needle assembly from the distal position to the proximal position.

2. The device according to claim 1, characterized in that the moving rack is a separate rack or a part with a rack tooth profile integrated thereon; the fixed rack is an independent rack or a part with a rack tooth form integrated thereon.

3. The device of claim 1, wherein the gear set comprises one gear or a plurality of gears; when the gear set is a plurality of gears, the axes of the plurality of gears are overlapped.

4. The device of claim 3, wherein the transmission assembly drives the needle assembly a distance that is a single or multiple of the travel of the gear set engaged with the rack set.

5. The device of claim 4, wherein the gear set comprises a plurality of gears, the plurality of gears comprising at least one large gear that drives movement of the needle assembly and a small gear that meshes with the rack.

6. The apparatus of claim 5, wherein the gear set moves with the drive assembly.

7. The device of claim 1, wherein the sensor insertion device further comprises a housing, and wherein the actuation assembly is coupled to the housing at one end and to the transmission assembly at the other end.

8. The device of claim 7, wherein the actuation assembly comprises a spring.

9. The device of claim 8, wherein in an initial state, the spring is energized.

10. The device of claim 9, wherein the number of springs is one or more.

11. The device of claim 10, wherein the number of springs is 1-4.

12. The device of claim 10, wherein the number of springs is 2-3.

13. The device of claim 10, wherein the number of springs is 2.

14. The device of claim 10, wherein when the number of the springs is multiple, the springs are uniformly distributed on the transmission component.

15. The device of claim 7, wherein the sensor insertion device further comprises a trigger assembly disposed on the housing for triggering the actuation assembly.

16. The device of claim 15, wherein in the initial state, the trigger assembly locks the transmission assembly in the initial position.

17. The device of claim 15, wherein the trigger component is a trigger button.

18. The device of claim 15, wherein the trigger assembly is a trigger button and a lockout block.

19. The apparatus of claim 1, wherein the transmission assembly further comprises a movable mount, wherein the gear set is mounted within the movable mount and is free to rotate about the axis.

20. The apparatus of claim 19, wherein the transmission assembly further comprises a drive block, and wherein the moving rack is disposed on the drive block and is capable of moving synchronously therewith.

21. The device of claim 20, wherein the movable seat is disposed inside the driving seat, and in an initial state, the movable seat can maintain an installation state to form a self-locking state.

22. The device of claim 1, wherein the sensor insertion device further comprises an emitter mount disposed below the transmission assembly.

23. A needle assist device, comprising:

the sensor insertion device of any one of claims 1-22,

a transmitter for transmitting the signal to the receiver,

a sensor disposed inside the emitter.

24. The needle aid of claim 23 wherein the transmitter is electrically connected to a sensor, the transmitter receiving a signal generated by the sensor.

25. The needle aid of claim 24 wherein the sensor has an insertion electrode that contacts the test object to generate a current signal.

26. The needle aid according to claim 25 wherein the needle assembly of the sensor insertion device comprises an implantation needle which in an initial state engages with a tail of the insertion electrode of the sensor, the insertion electrode of the sensor except for its tail being disposed outside the implantation needle.

27. The needle aid of claim 24 wherein the actuation assembly pushes the drive assembly to actuate upon being triggered; the transmission assembly drives the needle assembly and the emitter to move from a proximal position to a distal position, and the needle assembly is inserted into a subject to be implanted in the skin; the actuating assembly continues to push the transmission assembly, the transmission assembly drives the needle assembly to move from the distal position to the proximal position, and the emitter and the sensor are detained on the skin surface.

28. Use of a sensor insertion device according to any of claims 1 to 22 for detecting a physiological parameter of a test object.

29. The use of claim 28, wherein the physiological parameter is one of glucose, lactic acid, alcohol, and blood ketones.

30. The use of a needle aid according to any one of claims 23 to 27 for detecting a physiological marker of an analyte.

31. The use of claim 30, wherein the physiological parameter is one of glucose, lactic acid, alcohol, and blood ketones.

32. A method of detecting glucose, comprising:

the insertion electrode of the sensor is implanted into the object to be tested by the sensor insertion device,

the insertion electrode contacts with the object to be measured to generate an original current signal,

the raw current signal is processed by a sensor to obtain a processed current signal,

obtaining glucose monitoring data according to the processed current signal,

the sensor insertion device includes: an actuation assembly, a transmission assembly and a needle assembly;

an actuating assembly for driving the transmission assembly;

a needle assembly for implanting an insertion subject into skin;

the transmission assembly comprises a gear set and a rack set;

the rack set comprises a movable rack and a fixed rack;

33. The method of claim 32, wherein the insertion electrode implanted in the test subject chemically reacts with glucose to obtain the raw current signal.

34. The method of claim 32, wherein the sensor processing comprises amplification and filtering of the raw current signal.

35. The method of claim 32, wherein the processed current signal is further processed by an algorithm to obtain glucose concentration data.

36. The method of claim 33, wherein the insertion electrode comprises a base conductive layer, a sensing layer, and a confinement layer.

37. The method of claim 36, wherein the sensing layer is comprised of a bio-enzymatic or non-bio-enzymatic material.

38. The method of claim 37, wherein the non-bio-enzymatic material has catalytic properties.

39. The method of claim 34, wherein the filtering processing method is selected from one or more of single moving window mean filtering, median filtering, multiple moving window mean filtering, and multiple moving window mean and median combined filtering.

40. The method of claim 35, wherein the algorithm is selected from any one or more of a concentration conversion algorithm, a temperature calibration algorithm, a physiological delay calibration algorithm.