Application deviceTechnical Field
The present invention relates to the field of receptor analyte measurement, and in particular to an application device suitable for applying a sensor assembly to the skin of a receptor.
Background
Diabetes is a disease in which the pancreas cannot produce enough insulin. In a diabetic condition, a patient suffers from hyperglycemia, which can cause a series of complications, such as renal failure, skin ulcers, or vitreous hemorrhage of the eye. At present, the medical technology cannot be radically cured, and can only be controlled by stabilizing blood sugar.
In general, diabetics have self-monitoring blood glucose monitors, i.e., blood glucose test strips and meters, which measure blood glucose by measuring the amount of current produced by the reaction of glucose in the blood and glucose oxidase in the strip. Because of the lack of comfort and convenience in the above blood glucose monitoring mostly using fingertip blood, a person suffering from diabetes typically needs to measure his or her glucose level daily for a specific period of time (fasting, after breakfast, before lunch, after lunch, before dinner, after dinner, before sleep). Not only is the instantaneous blood glucose level susceptible to external factors (diet, emotion, exercise, etc.), but also the point in time at which a diabetic patient is unable to timely find hyperglycemia or hypoglycemia may sometimes cause a greater risk.
The percutaneous analyte sensor can dynamically monitor the change of blood sugar value in a patient in real time through a subcutaneous tissue glucose sensor, and provides an important reference for insulin treatment. Blood glucose can be monitored continuously for 10-14 days by applying the transdermal sensor to the skin of the recipient through the applicator housing.
With the development of blood sugar calibration technology, products for monitoring dynamic blood sugar in real time appear on the market, and the change of the blood sugar of a human body is monitored in real time through a glucose sensor probe implanted into subcutaneous tissue of the human body. The dynamic blood sugar monitoring system mainly comprises a sensor probe and electronic equipment, and has the advantages of small volume, convenient operation, continuous data and the like. In use, the sensor is applied to the surface of the recipient's skin by a specific device or apparatus, with the sensor probe located in the subcutaneous interstitial fluid. The dynamic monitoring system can continuously monitor the change of blood sugar value, and provide reliable data information for medical staff, thereby better treating insulin patients.
Continuous blood glucose monitoring products on the market mainly comprise 3 application modes. Firstly, a user is required to assemble the sensor and the application device together for matching before applying, wherein a sensor transmitter (namely an electronic unit) is arranged in the application device; secondly, the sensor wire is driven into the skin of a receptor by using an application device, and then the transmitter is installed to the sensor unit by manual operation; third, the sensor wire is manually applied to the recipient's skin by the user without the application device, and then the emitter is mounted to the sensor. The above several ways are less experienced by the user. The structure is also more complicated, and the part is more, causes manufacturing cost higher, is unfavorable for market and civilian of this product.
Disclosure of Invention
The invention aims to overcome the defects of the prior art, and provides an application device which can apply a sensor assembly to the skin of a receptor so as to achieve the purpose of continuously monitoring and measuring blood sugar.
The invention is realized by the following technical proposal, the application device provided by the invention comprises a shell, a touch back component and a sensor component, wherein the touch back component and the sensor component are arranged in the shell, the touch back component can move along a preset track, an elastic component is arranged in the touch back component to energize the touch back component,
The touch back assembly comprises a first trigger mechanism, a second trigger mechanism and a third trigger mechanism, wherein the first trigger mechanism is triggered by external force, the second trigger mechanism and the third trigger mechanism are automatically triggered,
The sensor assembly comprises a needle and a sensor module, one end of the needle is arranged in the touch-back assembly, the other end of the needle is arranged in the sensor module, the sensor module is clamped with the first triggering mechanism in an interference manner, and the first triggering mechanism drives the sensor module to an application position; the second trigger mechanism and the third trigger mechanism disengage the needle from the sensor module.
Further, the first triggering mechanism comprises a key and a support, a first buckle is arranged on the side face of the support, a first limit rib and a key matched with the first buckle are arranged in the shell, the key is arranged at a position corresponding to the first buckle, and the first trigger mechanism is triggered through the key.
Furthermore, the bottom of the bracket is symmetrically provided with elastic arms, the elastic arms are oppositely provided with protruding parts, and the sensor module is arranged between the elastic arms.
Further, the second trigger mechanism comprises a needle seat, the support is coupled with the needle seat, the needle is arranged in the needle seat, a support column is arranged on the side face of the needle seat, a second buckle is arranged on the lower end face of the support column, a limiting block is arranged on the upper end face of the support column, a second limiting rib corresponding to the second buckle is arranged at the bottom of the shell, and the support and the needle seat are mutually matched to trigger after the sensor module reaches the application position.
Further, third trigger mechanism is including pulling out needle ware and spacing buckle, support bottom both sides are equipped with first arm that stretches out, are equipped with on the casing with it complex spacing buckle, and both combined action spacing needle ware that pulls out, after sensor module reached the position of applying ointment or plaster, because first arm that stretches out is spacing buckle no longer spacing needle ware, accomplish the trigger.
Further, an elastic piece is arranged between the bracket and the needle extractor, and is in a compressed state when the needle extractor is not triggered, and the elastic piece is a spring.
Further, the lower surface of the needle extractor is provided with second extending arms parallel to the axis of the shell, the second extending arms are in a group of two, and after the third triggering mechanism triggers, the second extending arms are clamped with the needle seat limiting block through elastic force and move away from the applying position side.
Further, a guide rib is arranged in the shell, and the support and the needle extractor move along the guide rib.
Further, an opening is formed in the lower surface of the shell and used for applying the sensor module, and a sterilizing gas permeable film is arranged at the opening.
Further, the sensor assembly comprises a needle and a sensor module, wherein the sensor module comprises a sensor wire, a conductive silica gel disc, an electronic unit, a sensor upper cover, a sensor lower cover and an application adhesive, and the sensor wire is connected with the electronic unit through the conductive silica gel disc; the outer edge of the sensor lower cover is provided with a raised ring rib, and the outer edge of the sensor upper cover is provided with a groove for injecting silica gel.
The invention only comprises 1 elastic piece, thus realizing 2 processes of needle penetration and extraction, and having less assembly quantity and convenient production and assembly; meanwhile, in the using process, a user does not need to energize and assemble; placing the applicator device on the skin of the recipient, and triggering the key to apply the sensor assembly to the skin of the recipient; during which the applicator housing experiences 3 triggers, the remaining 2 triggers being automated except for the first firing key trigger initiated by the user. Meanwhile, the sensor wire and the electronic unit are combined into a whole, so that the waterproofness of the sensor assembly in the using process is improved, and the risk of infection of the contact area between the sensor wire and the skin surface is reduced. Furthermore, the application device and the sensor are arranged as one device, so that reinstallation is not needed, and the operation steps are simplified. In conclusion, compared with the prior art, the invention has the advantages of more compact structure, simple operation in the using process and reliable use.
Drawings
FIG. 1 is an exploded view of the present invention;
FIG. 2a is a schematic diagram of the front structure of the housing of the present invention;
FIG. 2b is a schematic view of the back surface structure of the housing of the present invention
FIG. 3 is a schematic diagram of a key structure according to the present invention;
FIG. 4a is a schematic view of a back side mechanism of the bracket of the present invention;
FIG. 4b is a schematic view of a front mechanism of the bracket of the present invention;
FIG. 5 is a schematic view of a limiting buckle according to the present invention;
FIG. 6 shows the present invention a needle seat structure schematic diagram;
FIG. 7 is a schematic view of the structure of the needle extractor of the present invention;
FIG. 8 is a schematic diagram of a sensor assembly according to the present invention;
FIG. 9 is a schematic cross-sectional view of an initial state of the present invention;
FIG. 10 is a schematic cross-sectional view of the present invention in a position for application;
FIG. 11 is a schematic cross-sectional view of the third trigger mechanism of the present invention;
Fig. 12 is a schematic view of a semi-sectional structure of an initial state of the present invention.
Detailed Description
The structure, features and effects of the present invention will be described in detail below with reference to the accompanying drawings and preferred embodiments, in which:
As shown in fig. 1-12, an application device comprises a housing 1, a touch back assembly and a sensor assembly, wherein the touch back assembly and the sensor assembly are arranged in the housing 1, the touch back assembly can move along a preset track, the movement track is wholly parallel to the axis of the housing, an elastic piece is arranged in the touch back assembly to energize the touch back assembly,
The touch back assembly comprises a first trigger mechanism, a second trigger mechanism and a third trigger mechanism, wherein the first trigger mechanism is triggered by external force (namely artificial trigger), the second trigger mechanism and the third trigger mechanism are automatically triggered,
The sensor assembly comprises a needle 9 and a sensor module 8, one end of the needle 9 is arranged in the touch-back assembly, the other end of the needle is arranged in the sensor module 8, the sensor module 8 is connected with the first triggering mechanism in an interference clamping mode, and the first triggering mechanism drives the sensor module 8 to an application position; the second and third trigger mechanisms disengage the needle 9 from the sensor module 8.
The first triggering mechanism comprises a key 7 and a bracket 5, a first buckle 503 is arranged on the side face of the bracket 5, a first limit rib 1026 and the key 7 which are matched with the first buckle are arranged in the shell 1, the key 7 is arranged at the position corresponding to the first buckle 503, and triggering is performed through the key 7.
The lower part of the key 7 is provided with a protection protrusion 701, the upper part of the key 7 is provided with a limit protrusion 702, the limit protrusion 702 is fixedly assembled with the upper part of a first mounting structure 1024 corresponding to the limit protrusion 702 on the shell, the protection protrusion 701 is matched with the lower part of the first mounting structure 1024 to prevent triggering, the protection protrusion 701 is matched with the first buckle 503, and the key 7 can be triggered to an application position. Wherein, the key 7 interferes with the shell 1 in the pressing process, the pressing force increases to a certain value, the protection bulge 701 deforms and passes over the shell 1 to trigger the touch back component, and a small bulge is arranged on the side surface of the protection bulge 701, so that the structure prevents the false triggering before the use of a user. The first buckle 503, the first limit rib 1026 and the key 7 together form a first triggering mechanism. Preferably, the key 7 may be integrated with the housing 1 as one piece. Wherein the protective structure may be one or more parts of the surface of the key 7, which parts extend beyond the key 7, thereby preventing the key 7 from being easily pressed by the firing key 7 or the key 7 from being pressed after the protective structure has to be manually removed; this may also be accomplished by one or more frangible elements on the surface of the housing, the protective structure in the present invention being a small protrusion that protects the sides of protrusion 701.
Besides the key triggering mode, a key-free triggering mode can be adopted, a Z-shaped groove is formed in the shell, the support moves in a limiting mode through the Z-shaped groove, and the up-and-down movement is converted into rotary movement through manual pressing, so that the application device is triggered.
Elastic arms 501 are symmetrically arranged at the bottom of the support 5, protruding portions 502 are oppositely arranged on the elastic arms 501, and the sensor module 8 is arranged between the elastic arms 501.
The second triggering mechanism comprises a needle seat 4, a needle 9 is arranged in the needle seat 4, a third buckle 403 for fixing the needle is arranged at the position, corresponding to the sensor component 8, of the needle seat 4, a guide post 401 is arranged on the lower surface of the needle seat 4, a support column 402 is arranged on the side surface of the guide post, a second buckle 4021 is arranged on the lower end surface of the support column 402, and a limiting block 4022 is arranged on the upper end surface of the support column 402. The support 5 is provided with a first guide groove 504, the guide post 401 is inserted into the first guide groove 504, the support 5 is coupled with the needle seat 4, the bottom of the shell 1 is provided with a second limiting rib 1021 corresponding to the second buckle 4021, and after the sensor module 8 reaches the application position, the sensor module 8 and the second limiting rib are mutually matched to trigger, so that the needle seat 4 and the support 5 are decoupled.
The third trigger mechanism comprises a needle extractor 2 and limiting buckles 6, first extending arms 506 are arranged on two sides of the bottom of the support 5, the shell 1 is provided with the limiting buckles 6 matched with the first extending arms, the needle extractor 2 is limited by the two trigger mechanisms in a combined action mode, and after the sensor component reaches the application position, the limiting buckles 6 do not limit the needle extractor 2 any more due to the action of the first extending arms 506, and triggering is completed. The first projecting arm 506 is provided with a second guiding groove 505, the lower end surface of the limiting buckle 6 is an elastic supporting arm, the lower end surface of the limiting buckle is a plane 601 extending towards the axial direction of the shell 1, an inclined plane 602 is formed between the plane 601 and the lower portion of the elastic supporting arm, an elastic buckle 603 is arranged on the upper portion of the elastic supporting arm, the elastic buckle 603 is fixedly connected with a mounting groove 1022 on the shell 1 to prevent the elastic buckle from moving up and down, the lower plane 601 of the limiting buckle 6 is positioned in the second guiding groove 505, and when the whole application device is not triggered, the lower plane 601 is used for limiting the needle extractor 2. When the first triggering mechanism triggers the sensor assembly to the application position, the limiting buckle 6 moves to the application position side due to the first extending arm 506, so that the limiting buckle 6 moves to two sides, and the limiting of the needle extractor 2 is released. Preferably, the limit catch 6 can be injection molded with the housing 1 as 1 part to reduce the number of parts.
An elastic piece 3 is arranged between the bracket 5 and the needle puller 2, and when the needle puller is not triggered, the elastic piece 3 is in a compressed state, and the elastic piece 3 is a spring. The invention selects the spiral spring, which is compressed in the whole using process and is used as the force application main body of the whole driving mechanism. The preferred spring may be a belleville spring or the spring may be injection molded in 1 piece with the bracket 5to reduce the number of pieces.
The lower surface of the needle extractor 2 is provided with second extending arms 201 parallel to the axis of the shell 1, the second extending arms 201 are arranged in pairs, a fourth buckle 202 is arranged at the lower part of the second extending arms 201, protruding ribs are arranged on the second extending arms 201, and after the third triggering mechanism triggers, the second extending arms 201 are clamped with the limiting blocks 4022 of the needle stand 4 through elastic force, and move towards the side far away from the applying position. The second protruding arm 201 passes through the bracket 5, and the protruding rib is in interference fit with the elastic arm 501, so as to jointly clamp the sensor module 8. The assembly is preferably secured prior to the activation of the applicator device, and the first activation mechanism is released upon activation to facilitate removal of the applicator housing.
The shell 1 is internally provided with a guide rib, and the bracket 5 and the needle extractor 2 move along the guide rib. According to the invention, the inner side surface of the shell 1 is symmetrically provided with the first guide ribs 1023, the bracket 5 is provided with the third guide grooves 507 which move along the first guide ribs 1023, so that the movement axis of the third guide grooves coincides with the axis of the shell, the movement track of the third guide grooves is ensured to be parallel to the axis of the shell in the needling process, the movement amount of the needle tip is reduced, and the pain of a user is reduced. The inner side surface of the shell 1 is symmetrically provided with second guide ribs 1025, and the needle puller 2 is provided with a fourth guide groove 203 which moves along the second guide ribs 1025. The motion axis of the needle is overlapped with the axis of the shell 1, so that the motion track is parallel to the axis of the shell 1 in the needle extraction process, the needle extraction path and the penetration path are overlapped, the skin injury is reduced, and the pain of a user is reduced. At the same time, the proximal end of the housing also has a substantial number of protrusions 1027 for distraction of the user to break up the pain sensation of the user during lancing. Preferably, the first guide rib 1023 and the second guide rib 1025 are the same guide rib, i.e. the bracket 5 and the needle puller 2 can move along the same guide rib.
The lower surface of the housing 1 is provided with an opening for applying the sensor module, and a sterilizing gas permeable membrane 10 is arranged at the opening.
The sensor assembly comprises a needle 9 and a sensor module 8, the sensor module 8 comprising a sensor wire 801, a conductive silicone disc 807, an electronic unit 802, a sensor upper cover 803, a sensor lower cover 804, an application glue 805, a battery assembly 806. Sensor wire 801 is connected to electronics unit 802 by conductive silicone disk 807; the outer edge of the sensor lower cover 804 is provided with a raised ring rib 8041, and the outer edges of the sensor upper cover and the sensor lower cover are provided with grooves 8042 for injecting silica gel so as to realize integral waterproof of the sensor assembly.
Structure and motion principle of the embodiments:
(1) Initial state of the applicator device
In the initial state, the sensor assembly is fixed inside the applicator housing 1 and by the projections 502 of the elastic arms 501 of the bracket 5; the spring is in a fully energized state in which the first catch 503 of the bracket 5 is stopped by the first stop rib 1026 of the housing; the needle extractor 2 is limited by a plane 601 of the limiting buckle 6.
(2) The first time the applicator device is triggered
The button 7 is pressed by hand, the protection bulge 701 above the button 7 is contacted with the first buckle 503, deformation occurs under the action of external force, and then the protection bulge 701 enables the first buckle 503 of the bracket 5 to be separated from the first limit rib 1026 of the shell 1, under the action of elastic potential energy of the spring, the bracket 5 drives the needle seat 4 and the sensor module 8 to accelerate to move towards the side close to the skin, and the needle 9 and the sensor wire rod penetrate into the skin together.
(3) The second triggering of the application device
When the application position is reached, the second buckle 4021 of the needle seat 4 is disengaged from the bracket 5 under the action of the second limiting rib 1021 of the housing, and meanwhile, the application adhesive 805 on the sensor assembly 8 is adhered and fixed with the skin of the receptor. The penetration process is thus completed under the action of the spring.
(4) The third time triggering of the application device
At the same time or slightly before, the first projecting arm 506 of the bracket 5 acts with the inclined surface 602 of the limit catch 6, moving the plane 601 of the limit catch 6 away from the axis of the applicator device, so that the needle extractor 2 is disengaged from the stop of the limit catch 6. Under the action of elastic potential energy of the spring, the needle extractor 2 moves upwards, and at a later moment, the fourth buckle 202 on the needle extractor 2 is meshed with the limiting block 4022 of the needle seat 4, so that the needle seat 4 is driven to move upwards; as the third catch 403 of the needle holder 4 engages with the needle 9, the needle 9 is eventually pulled out of the skin. The pulling-out process is completed under the action of the spring.
(5) Removal of an applicator housing
The sensor module 8 is fixed to the recipient skin surface while the needle 9 is retracted to the applicator housing; at the same time, the protrusion 502 of the limit sensor assembly also greatly reduces the force of disengagement of the sensor module 8 from the bracket 5 due to the removal of the second projecting arm 201 of the needle puller 2. The applicator housing is removed by hand, and the application process of the sensor assembly is completed.
In conclusion, compared with the prior art, the invention has the advantages of more compact structure, simple operation in the using process and reliable use.
The foregoing is only a preferred embodiment of the present invention, and any simple modification and equivalent transformation of the above embodiment according to the technical solution of the present invention falls within the scope of the present invention.