CN114451889B - Percutaneous analyte sensor insertion device - Google Patents
Percutaneous analyte sensor insertion device Download PDFInfo
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- CN114451889B CN114451889B CN202111577670.6A CN202111577670A CN114451889B CN 114451889 B CN114451889 B CN 114451889B CN 202111577670 A CN202111577670 A CN 202111577670A CN 114451889 B CN114451889 B CN 114451889B
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- 239000012491 analyte Substances 0.000 title claims abstract description 25
- 238000003780 insertion Methods 0.000 title claims description 46
- 230000037431 insertion Effects 0.000 title claims description 46
- 239000000284 extract Substances 0.000 claims description 2
- 210000003205 muscle Anatomy 0.000 claims 2
- 230000008878 coupling Effects 0.000 claims 1
- 238000010168 coupling process Methods 0.000 claims 1
- 238000005859 coupling reaction Methods 0.000 claims 1
- 230000033001 locomotion Effects 0.000 description 9
- 238000000034 method Methods 0.000 description 7
- 230000035515 penetration Effects 0.000 description 7
- 238000010586 diagram Methods 0.000 description 6
- 238000000605 extraction Methods 0.000 description 6
- 230000001960 triggered effect Effects 0.000 description 6
- 239000008280 blood Substances 0.000 description 5
- 210000004369 blood Anatomy 0.000 description 5
- 230000000149 penetrating effect Effects 0.000 description 5
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 4
- 239000008103 glucose Substances 0.000 description 4
- 206010012601 diabetes mellitus Diseases 0.000 description 3
- 239000002184 metal Substances 0.000 description 3
- 238000001514 detection method Methods 0.000 description 2
- 210000003722 extracellular fluid Anatomy 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- 208000017667 Chronic Disease Diseases 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 230000000712 assembly Effects 0.000 description 1
- 238000000429 assembly Methods 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000003139 buffering effect Effects 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000000452 restraining effect Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000001360 synchronised effect Effects 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14503—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
- A61B5/14865—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Physics & Mathematics (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Pathology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Optics & Photonics (AREA)
- Medical Informatics (AREA)
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- Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Emergency Medicine (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Abstract
The invention discloses a percutaneous analyte sensor inserting device, which comprises a shell, a framework, a sensor component, a needle pulling device, a support, a rotating piece and an elastic piece, wherein the shell is provided with a structure capable of triggering a device, the framework is arranged in the shell, the support is arranged in the framework, the sensor component is arranged in the support, the needle pulling device is limited by the shell, the rotating piece is arranged in the support, and the elastic piece is arranged between the needle pulling device and the rotating piece. The device is configured such that after the sensor unit is in place, the recipient skin triggers a needle withdrawal action. The problem that the sensor is not inserted in place and is generated is avoided, the structure is simple, the whole cost is reduced, and the use is more convenient.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a percutaneous analyte sensor insertion device.
Background
Diabetes is one of the common chronic diseases. With the improvement of living standard, aging population, etc., the incidence of diabetes is on the rise. The traditional diabetes detection mode is to collect finger blood and measure the blood glucose value at a certain time point. With the development of technology, a dynamic blood glucose monitoring system (CGMS) has emerged, which can dynamically monitor blood glucose in human body. The function of the insertion device is to apply the sensor unit to the skin and insert the transdermal analyte sensor into the interstitial fluid of the human skin, and the reactive enzymes located on the sensor react with certain substances in the interstitial fluid and transmit signals through the transmitter to the receiver end.
There are two general ways of applying sensor assemblies, one is that the sensor assembly is directly applied to the skin surface, and then the percutaneous analyte sensor is inserted into the skin by an insertion device; secondly, the sensor assembly is placed in an insertion device, and the sensor assembly is delivered to the skin by the insertion device, so that the percutaneous analyte sensor is inserted. In the first way, the sensor assembly needs to be manually applied to the skin surface, so that an application step is added, and the application is not convenient. In the second mode, the insertion device is required to complete three actions of applying the sensor assembly to the skin, inserting the percutaneous analyte sensor and pulling the needle, the structure of the device is complex, and the number of parts is large, so that the cost of the device is increased; and sometimes the application action is not finished or the needle is pulled out just after finishing, so that the percutaneous analyte sensor is not inserted in place, the detection result is further influenced, and the sensor is further bent, so that the use is influenced. Moreover, the skin has different degrees of bulges in the application process, so that the displacement of the sensor component is uncertain, and the interference on the needle pulling action is increased. These problems result in inaccurate or non-measurable measurement data, requiring reinsertion, affecting the operation of the dynamic monitoring blood glucose system, and also increasing the rejection rate of the device, resulting in poor use.
Disclosure of Invention
It is an object of the present invention to provide a percutaneous analyte sensor insertion device that overcomes the disadvantages of the prior art, simplifies construction, reduces cost, and allows for the sensor unit to be applied in place and the percutaneous analyte sensor to be inserted in place.
For this purpose, the technical scheme of the invention is as follows:
a percutaneous analyte sensor insertion device, comprising:
a housing having a trigger structure;
the framework is accommodated in the shell and used for limiting the shell, and the framework and the shell can slide relatively;
the sensor assembly comprises a sensor unit and an introduction needle, wherein an insertion hole is formed in the sensor unit, the lower part of the introduction needle penetrates through the insertion hole, a sensor is arranged in the introduction needle, and a cross rod is arranged at the top of the introduction needle;
the needle puller is limited on the shell and provided with a through hole for the leading-in needle to pass through;
the bracket can move relative to the framework, the bottom is coupled with the sensor unit, a through hole for the guide needle to pass through is formed in the middle of the bracket, a clamping and clamping piece for fixing the guide needle extends out from the upper part of the bracket to the needle puller end, a supporting piece concentric with the clamping and clamping piece is arranged on the outer side of the clamping and clamping piece, and a guide groove is formed in the supporting piece;
the rotating piece is arranged in the supporting piece and can rotate in the supporting piece, the limit of the shell on the needle extractor can be relieved, the clamping part is arranged at the upper part of the rotating piece, the guiding part capable of moving in the guiding groove is arranged at the lower part of the rotating piece, a through hole for the guide needle to pass through is formed in the rotating piece, and the rotating piece is spliced with the needle extractor;
the elastic piece is used for energizing the device, is arranged between the needle extractor and the rotating piece and is used for driving the sensor component to move towards the skin end of the receptor;
the device is configured such that the housing triggering structure cooperates with the clamping portion to unlock the device, the rotating member, the bracket and the sensor assembly move as a unit to the skin of the recipient, and the recipient skin can trigger the rotating member to rotate in the guide slot to release the limit of the housing on the needle extractor, and the needle extractor extracts the introduction needle from the skin.
Preferably, the shell lower part is equipped with the end cover with its joint, and the spacing casing of end cover moves to acceptor skin side, be equipped with spacing arch in the casing, the skeleton top is equipped with the elasticity buckle with it complex, and the spacing casing of elasticity buckle moves with the skeleton relatively.
Preferably, the side of the bracket support piece is provided with a guide groove, the guide groove comprises a horizontal part and an inclined part communicated with the horizontal part, and when the needle extractor, the rotating piece and the bracket move as a whole, the guide part is positioned at the critical position of the horizontal part and the inclined part, and the receptor skin triggers the guide part to rotate along the inclined part.
Preferably, the upper part of the shell is symmetrically provided with first limiting ribs for limiting the needle extractor, the top of the needle extractor is provided with first grooves corresponding to the first limiting ribs, the needle extractor rotates by a preset angle, and the first grooves are aligned with the first limiting ribs to release the limit of the needle extractor.
Preferably, the guide pin is provided with a bump, the clamping fastener comprises arc-shaped parts which are symmetrically arranged, the upper ends of the arc-shaped parts are clamping connectors, the clamping connectors fix the bump, the lower part of the rotating part is provided with an opening corresponding to the arc-shaped parts, the skin of a recipient triggers the needle puller, the rotating part rotates by a preset angle, the opening is aligned with the arc-shaped parts, and the limit of the clamping fastener is relieved.
Preferably, a first guide groove is formed in the shell, a first guide rib matched with the first guide groove is arranged on the framework, the shell can slide on the framework, and the elastic buckle limits the shell to move towards the end far away from the sensor assembly.
Preferably, a first limiting groove is formed in the upper portion of the shell, the rotating piece clamping portion can move along the first limiting groove, and the first limiting groove comprises an inclined portion.
The framework is provided with a second limit groove matched with the first limit groove, the rotating piece clamping part can move along the second limit groove, the second limit groove comprises a horizontal part and an opening part, the horizontal part and the opening part are communicated through a vertical part, and the vertical movement of the shell relative to the framework can be converted into circular movement of the rotating piece clamping part.
Preferably, the skeleton is spacing to be clamped the portion, and is equipped with the button of unblock joint portion on the casing.
The framework is provided with a second limiting groove, the second limiting groove comprises a vertical portion and an opening portion, the clamping portion penetrates through the second limiting groove, and a limiting convex rib of the limiting clamping portion is arranged in the vertical portion of the second limiting groove. Preferably, the bottom of the bracket is provided with an elastic arm coupled with the sensor assembly, the framework is provided with a second limit rib which is matched with the elastic arm to clamp the sensor unit, and the distance from the end, close to the sensor assembly, of the second limit rib to the end face of the framework is greater than the height of the support arm.
Preferably, the side surface of the rotating piece is provided with a supporting bulge, and the supporting bulge is contacted with the inner wall of the framework.
Preferably, the side surface of the bracket is provided with a second guide rib, the framework is internally provided with a second guide groove matched with the second guide rib, and the bracket can slide in the second guide groove.
The invention has the following beneficial effects:
(1) According to the insertion device, the needle is pulled out according to the self-adaptive unlocking of the skin of the receptor, so that the sensor component is ensured to be pulled out after reaching the stability of the skin of the receptor, the lead-in needle is inserted in place, and the situation that the sensor in the lead-in needle is not inserted in place or is bent is avoided;
(2) The elastic piece of the insertion device can be loaded secondarily, so that the risk of part deformation caused by the elastic force of the elastic piece in the storage process of the insertion device can be effectively reduced; the wall thickness of the related parts can be further reduced, so that the weight of the product is reduced, and the cost of the product is also reduced;
(3) The insertion device can realize automatic penetration and extraction of the guide needle, and is simple in operation and good in comfort for a user;
(4) The insertion device is reliable in use, avoids false triggering, ensures the insertion depth, and is more suitable for people with different body types.
Drawings
FIG. 1 is an exploded view of the present invention;
FIG. 2 is a schematic view of the structure of the invention in an initial state after the end cover is removed;
FIG. 3 is a schematic view of the structure of the end cap of the present invention in an initial state with a partial skeleton cut away;
FIG. 4 is a schematic diagram showing a connection structure between the clamping part and the first limiting groove in an initial state after the end cover is removed;
FIG. 5 is a schematic cross-sectional view of the clamping part of the present invention after releasing the limit;
FIG. 6 is a schematic diagram showing a connection structure between the clamping portion and the second limiting groove after the clamping portion is released from the limiting structure;
FIG. 7 is a schematic diagram showing a connection structure between the clamping portion and the first limiting groove after the clamping portion is released from the limit;
FIG. 8 is a schematic diagram of a cross-sectional structure of the invention before triggering the needle withdrawal;
FIG. 9 is a schematic diagram showing the connection structure between the clamping part and the second limiting groove before triggering the needle pulling of the present invention;
FIG. 10 is a cross-sectional view of the structure of FIG. 8A-A in accordance with the present invention;
FIG. 11 is a cross-sectional view of the structure of FIG. 9B-B in accordance with the present invention;
FIG. 12 is a schematic cross-sectional view of the present invention after needle withdrawal is triggered;
FIG. 13 is a schematic view showing the connection structure of the guide part and the guide groove after the needle is pulled out by triggering in the invention;
FIG. 14a is a schematic perspective view of a housing according to the present invention;
FIG. 14b is a schematic cross-sectional view of the housing of the present invention;
FIG. 14c is a schematic view of another cross-sectional view of the housing of the present invention;
FIG. 15a is a schematic view of a skeleton in a three-dimensional configuration of the present invention;
FIG. 15b is a schematic cross-sectional view of a framework of the present invention;
FIG. 16a is a schematic perspective view of a bracket according to the present invention;
FIG. 16b is a schematic cross-sectional view of a stent of the present invention;
FIG. 17 is a perspective view of a rotor according to the present invention;
FIG. 18 is a schematic view showing the three-dimensional structure of the needle extractor of the present invention;
FIG. 19a is a schematic view of a sensor unit according to the present invention;
FIG. 19b is a schematic view of the back structure of the sensor unit of the present invention;
FIG. 20 is a schematic view showing the perspective structure of an introducing needle according to the present invention;
FIG. 21 is a schematic view of an alternative structure of the first limiting groove of the present invention;
FIG. 22 is a schematic diagram of an embodiment 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. 1-22, a percutaneous analyte sensor insertion device, comprising: the sensor assembly 3 comprises a sensor unit 301 and an introduction needle 302, an insertion hole 3011 is formed in the sensor unit 301, the lower portion of the introduction needle 302 penetrates through the insertion hole 3011, a sensor is arranged in the introduction needle 302, a cross rod 3021 is arranged at the top of the introduction needle 302, the shell 1 is internally provided with the framework 2 capable of sliding relatively with the framework, the framework 2 is limited to the shell 1, the framework 2 is internally provided with the support 5 capable of sliding relatively with the framework, the bottom of the support 5 is coupled with the sensor unit 301, the introduction needle 302 penetrates through the support 5 to be connected with the sensor unit 301 and clamped by the support 5, the rotation piece 6 is arranged in the support 5 and can rotate in the support 5, the upper end of the needle extractor 4 is limited by the shell 1 and is provided with a through hole for the introduction needle 302 to penetrate through, the elastic piece 7 is provided with device energy, is arranged between the needle extractor 4 and the rotation piece 6, and the sensor assembly is used for driving the sensor assembly to move towards the skin end. In particular, the elastic member 7 includes, but is not limited to, a cylindrical coil spring.
The middle of the bracket 5 is provided with a through hole for the leading-in needle 302 to pass through, the upper part of the bracket 5 extends to the end of the needle extractor 4 to fix the clamping and clamping piece 501 of the leading-in needle 302, the upper part of the rotating piece 6 is provided with a clamping part 601, the shell 1 is provided with a structure of a triggering device, and the structure is matched with the clamping part 601 to release limit, so that the triggering device enables the rotating piece 6, the bracket 5 and the sensor assembly to move to the skin of a receptor as a whole.
The outer side of the clamping and clamping piece 501 is provided with a supporting piece 502 concentric with the clamping and clamping piece, the supporting piece 502 is provided with a guide groove 5021, the lower part of the rotating piece 6 is provided with a guide part 602 which can move in the guide groove 5021, the rotating piece 6 is inserted with the needle puller 4, and the rotating piece 6 is internally provided with a through hole for the leading-in needle 302 to pass through. After the sensor component reaches the skin of the receptor, the skin of the receptor can trigger the rotating piece 6 to rotate in the guide groove 5021 so as to release the limit of the clamping and clamping piece 501, and then release the limit of the shell 1 to the needle extractor 4, and the cross rod 3021 on the leading needle 302 is limited by the needle extractor 4 during needle extraction, so that the leading needle 302 is conveniently extracted. Preferably, a gasket 9 is arranged between the needle extractor 4 and the cross bar 3021, which plays a role in buffering during needle extraction and reduces impact force. Specifically, a third guide groove 605 is provided in the rotating member 6, a third guide rib 402 matched with the lower portion of the needle extractor 4 is provided at the lower portion of the needle extractor, and the rotating member 6 and the needle extractor 4 keep synchronous during rotation.
As shown in fig. 16a and 16b, a guide groove 5021 is formed on the side surface of the support 502 of the bracket 5, the guide groove 5021 comprises a horizontal part and an inclined part communicated with the horizontal part, and when the rotating member 6, the bracket 5 and the sensor assembly move as a whole, the guide part 602 is positioned at the critical position of the horizontal part and the inclined part; before the sensor is pierced in place, the bracket 5 and the rotating member 6 are moved as a whole toward the skin side of the subject, and after the sensor is pierced in place, the bracket 5 is completely stopped by the skin. Under the action of the elasticity of the elastic piece 7 and the inclined part of the guide groove 5021, the rotating piece 6 continuously moves downwards and drives the needle puller 4 to rotate, so that the needle pulling action is triggered. Therefore, after the needle pulling action is performed in place, the condition of different protruding degrees of insertion parts of different fat and thin people is adapted, the accuracy of sensor penetration is ensured, and the bending condition is avoided.
As shown in fig. 14b and fig. 18, the upper portion of the housing 1 is provided with a first limit rib 102 for limiting the needle extractor 4, the top of the needle extractor 4 is provided with a first groove 401 corresponding to the first limit rib, the needle extractor 4 rotates by a preset angle, the first groove 401 is aligned with the first limit rib 102, and the limit of the needle extractor 4 is released. Specifically, the preset angle may be 60 degrees, 80 degrees, 100 degrees, 120 degrees, 140 degrees, and the preferable preset is 100 degrees.
As shown in fig. 16b, fig. 17 and fig. 20, the insertion needle 302 is provided with a protruding block 3022, the clamping fixture 501 includes an arc portion that is symmetrically disposed, the upper end of the arc portion is a clamping head, the clamping head fixes the protruding block 3022, and an opening 603 corresponding to the arc portion is provided at the lower portion of the rotating member 6. In the original state and during the insertion of the introducer needle 302, the clamping fixture 501 is not aligned with the opening 603, and the rotating member 6 strengthens the limit of the clamping joint to the protruding block 3022, so that the stability and accuracy of the movement during the insertion of the introducer needle 302 are ensured. When the sensor assembly reaches the skin, the rotating member 6 rotates by a preset angle, the opening 603 is aligned with the arc portion, and the limit of the clamping fixture 501 is released. Wherein, the preset angle of rotation of the rotating piece 6 is the same as the preset angle of rotation of the needle puller 4. Because the upper end of the bump 3022 is a bevel, the bevel may be at an angle greater than 90 degrees to the center line of the introducer needle 302. Specifically, the included angle may be 145 degrees.
When the needle pulling action is triggered, unlocking must be completed twice, firstly, the rotating piece 6 unlocks to limit the clamping and clamping piece 501, so that the guide needle protruding block 3022 is conveniently released, and secondly, the first limiting rib 102 unlocks the needle pulling device. The device releases the clamping and clamping piece 501 firstly and then unlocks the needle extractor 4, so that the problem of needle extraction failure caused by that the needle extractor releases firstly because the clamping and clamping piece 501 is not released is avoided.
As shown in fig. 14c and 15a, the housing 1 is provided with a first guiding groove 104, the frame 2 is provided with a first guiding rib 204 matched with the first guiding groove, and the housing can slide on the frame 2. In the original state, the elastic member 7 is in a semi-compressed state. When the shell 1 unlocks the rotating piece 6, the shell 1 is pressed to enable the shell 1 to move towards the skin side of a receptor along the framework 2, and secondary loading of the elastic piece 7 is achieved. When the device is in an unused state such as transportation and storage, the elastic piece 7 is in a semi-compressed state, and the elastic piece 7 can be compressed (secondarily loaded) only when the device is used, so that the energy required by the insertion device to puncture and withdraw the needle is ensured. Therefore, the load applied to the housing 1 before the device is used is small, and the strength requirement of the housing 1 is low. Accordingly, the wall thickness of the shell 1 can be reduced, the overall weight of the device is reduced, the cost is reduced, and the energy is saved.
As shown in fig. 2, an end cover 8 is arranged at the lower part of the shell 1 and is clamped with the shell, the end cover 8 limits the shell 1 to move towards the skin side of a receptor, a limiting protrusion 101 is arranged in the shell 1, an elastic buckle 201 matched with the top end of the framework 2 is arranged at the top end of the framework 2, and the elastic buckle 201 limits the shell 1 to move relative to the framework 2.
In one embodiment of the present invention, as shown in fig. 14a, a first limiting groove 103 is formed in the upper portion of the housing 1, the locking portion 601 of the rotating member 6 may move along the first limiting groove 103, and the first limiting groove 103 includes an inclined portion. In the original state, the clamping part 601 is limited by the second limiting groove 202; pressing the shell, the clamping part 601 is acted by the inclined part of the first limiting groove 103, the vertical motion of the shell 1 relative to the framework 2 can be converted into the circular motion of the clamping part 601 of the rotating piece 6, and the limiting of the clamping part 601 is released. As shown in fig. 15a, the skeleton 2 is provided with a second limit groove 202 that is matched with the first limit groove 103, the clamping part 601 of the rotating member 6 can move along the second limit groove 202, and the second limit groove 202 includes a horizontal part and an opening part, which are communicated through a vertical part. Before the device is triggered, the horizontal part of the second limiting groove 202 plays a limiting role on the clamping part 601 of the rotating piece; the vertical portion of the second limit groove 202 can limit the rotation member 6 during the sensor assembly penetration process.
Specifically, the first limiting groove 103 includes an inclined portion, a cavity portion, and a vertical portion communicating the inclined portion and the cavity portion, and the vertical portion is communicated with the top of the inclined portion. The vertical part and the cavity part of the first limiting groove 103 are matched with the vertical part and the opening part of the second limiting groove 202, so that the movement of the clamping part 601 is facilitated.
Alternatively, as shown in fig. 21, the first limiting groove 103 extends a slant rib 1031 from the interior of the housing, and the clamping portion 601 is located on a side of the slant rib 1031 close to the skin.
As shown in fig. 22, in another embodiment of the present invention, the skeleton 2 is provided with a limiting and locking portion 601, and the housing 1 is provided with a key 104 for unlocking the locking portion 601. The framework is provided with a second limiting groove 202, the second limiting groove comprises a vertical part and an opening part, the clamping part 601 penetrates through the second limiting groove 202, and a limiting convex rib 2021 of the limiting clamping part 601 is arranged in the vertical part of the second limiting groove 202. The key 104 is pressed inwards to release the limit on the clamping part 601 so as to unlock the device, and the clamping part moves downwards along the vertical part of the second limiting groove 202 after triggering, so that the penetrating action is completed.
In the sensor assembly penetrating process, when the distance between the end face of the sensor assembly and the end face of the framework 2 close to the end face of the sensor assembly is 3mm, the vertical part of the second limiting groove 202 releases the limit on the rotating piece 6. The distance may also be 2mm, 4mm, 6mm, 8mm, 10mm, depending on the condition of the skin bulge.
It should be noted that the triggering mechanism of the present invention includes, but is not limited to, the triggering mechanism described above.
The housing 1 and the end cap 8 ensure that the device does not trigger during transport. After the end cover 8 is taken down, the first limit groove 103 on the shell 1 ensures that the device is still in a locking state until the shell is pressed for secondary loading. And the false triggering is avoided to a great extent, and the loss of the device is caused.
As shown in fig. 15b and 16a, the side surface of the support 5 is provided with a second guiding rib 504, the skeleton is provided with a second guiding groove 205 matched with the second guiding rib, the support 5 can slide in the second guiding groove 205, the parallel of the introducing needle 302 with the axis of the skeleton during the penetration is ensured, and the movement of the tip of the needle is reduced.
As shown in fig. 15b and 16a, a supporting arm 503 coupled to the sensor assembly is disposed at the bottom of the bracket 5, a second limiting rib 203 is disposed on the frame 2 and cooperates with the supporting arm 503 to clamp the sensor unit 301, and a distance from an end of the second limiting rib 203 near the sensor assembly to an end face of the frame 2 near the sensor assembly is greater than a height of the supporting arm 503. Ensuring the stability of the connection of the sensor unit 301 to the holder 5 before penetration, and also ensuring the release of the sensor unit 301 after reaching the skin of the recipient.
As shown in fig. 16b and 17, the supporting member 502 is a cylindrical wall body of the bracket 5 extending upward around the periphery of the clamping fixture 501, and the rotating member 6 is disposed between the clamping fixture 501 and the supporting member 502. The rotating member 6 is higher than the supporting member 502, and the clamping portion 601 is higher than the supporting member 502, and passes through the second limiting groove 202 of the framework 2 to be limited by the housing 1. The side of the rotating member 6 is provided with a supporting protrusion 604, and the supporting protrusion 604 is contacted with the inner wall of the frame 2, so that the movement of the tip of the needle 302 during the penetration and extraction is reduced.
As shown in fig. 19-20, the lower portion of the introducing needle 302 is a metal penetrating portion 3023, the sensor is disposed in a needle groove of the metal penetrating portion 3023, a clamping rib 3024 is disposed on the introducing needle body portion above the metal penetrating portion 3023, and a groove 3012 is disposed at a position corresponding to the clamping rib 3024 of the sensor unit 301, and the sensor unit and the clamping rib are fixed in a matched and clamped manner. It should be noted that the present invention is adaptable to different types of sensor units, such as a split sensor unit (the transmitter is installed by a user when it is needed), an integrated sensor unit (the transmitter is not needed to be installed by a user).
Description of the working process of the insertion device:
(1) Initial state
As shown in fig. 2-4 (end cap not shown), the needle puller 4 is restrained by the first restraint bar 102 and the elastic member 2 is in a semi-compressed state. The end cap 8 limits the movement of the housing 1 to the skin side of the recipient, and the secondary loading is locked. The limit projection 101 and the elastic buckle 201 ensure that the shell 1 and the framework 2 cannot move relatively. The rotating member 6 is restrained by the second restraining groove 202.
(2) Triggering the insertion device to reach the recipient's skin
First removing the end cap 8 to expose the frame 2; the insertion device is then placed on the recipient's skin. The shell 1 is pressed down, the elastic piece 7 continues to compress, and the second limiting groove 202 on the framework 2 releases the limit on the clamping part 601 of the rotating piece 6 in the vertical direction, namely, the rotating piece 6 and the framework 2 are unlocked, as shown in fig. 5-7. Before the introduction needle 302 reaches the skin of the subject, the rotating member 6, the holder 5, the introduction needle 302, and the sensor unit 301 move together toward the skin of the subject by the elastic action of the elastic member 7, and an application and penetration operation is performed. The sensor unit 301 and the introducing needle 302 are penetrated by the stent 5 to the skin of the recipient under the driving of the elastic member 6, and the sensor in the introducing needle 302 is inserted in place as shown in fig. 8 to 9.
(3) Needle for pulling out device
Before the needle pulling action is triggered, the vertical part of the second limiting groove 202 releases the limit of the rotating piece 6. After the sensor unit 301 and the introduction needle 302 are in place, the rotating member 6 continues to move downwards and drives the needle extractor 4 to rotate under the action of the elastic member 7 and the inclined part of the guide groove 5021, so that the limit of the rotating member on the clamping and clamping piece 501 is released. And the guide groove 5021 drives the needle extractor 4 to rotate, so that the limit of the first limit rib 102 of the shell 1 to the first groove 401 of the needle extractor 4 is released, and the needle extraction (return) action is started under the action of the elastic piece 7, as shown in fig. 12-13. The needle extractor 4 moves away from the skin side, the inclined surface structure of the projection 3022 of the introducing needle 302 is better separated from the clamping fixture 501, and the introducing needle 302 moves away from the skin side and is retracted into the insertion device.
Only when the sensor reaches the skin of a receptor, namely the sensor is penetrated in place, the rotating piece 6 can move continuously under the action of the elastic piece 7 so as to trigger the needle pulling action, and the sensor assembly 3 is ensured to adapt to different convex skin states and be accurately applied to the skin of the receptor.
(4) Removal device
The insertion device is removed by hand, and the application process of the sensor unit is completed.
In summary, compared with the prior art, the sensor has more accurate insertion depth, and the needle pulling action can be triggered only when the sensor reaches the skin of a receptor, so that the problem of early needle pulling is avoided; the rotating piece penetrates through the initial triggering of the device and the triggering of the needle pulling action, reduces the parts and the cost, is simple to operate and reliable to use in the use process, and is applicable to a wider range of people.
Claims (12)
1. A percutaneous analyte sensor insertion device, comprising:
a housing having a trigger structure;
the framework is accommodated in the shell and used for limiting the shell, and the framework and the shell can slide relatively;
the sensor assembly comprises a sensor unit and an introduction needle, wherein an insertion hole is formed in the sensor unit, the lower part of the introduction needle penetrates through the insertion hole, a sensor is arranged in the introduction needle, and a cross rod is arranged at the top of the introduction needle;
the needle puller is limited on the shell and provided with a through hole for the leading-in needle to pass through;
the bracket can move relative to the framework, the bottom is coupled with the sensor unit, a through hole for the guide needle to pass through is formed in the middle of the bracket, a clamping and clamping piece for fixing the guide needle extends out from the upper part of the bracket to the needle puller end, a supporting piece concentric with the clamping and clamping piece is arranged on the outer side of the clamping and clamping piece, and a guide groove is formed in the supporting piece;
the rotating piece is arranged in the supporting piece and can rotate in the supporting piece, the limit of the shell on the needle extractor can be relieved, the clamping part is arranged at the upper part of the rotating piece, the guiding part capable of moving in the guiding groove is arranged at the lower part of the rotating piece, a through hole for the guide needle to pass through is formed in the rotating piece, and the rotating piece is spliced with the needle extractor;
the elastic piece is used for energizing the device, is arranged between the needle extractor and the rotating piece and is used for driving the sensor component to move towards the skin end of the receptor;
the side surface of the bracket support piece is provided with a guide groove, the guide groove comprises a horizontal part and an inclined part communicated with the horizontal part, and when the rotating piece, the bracket and the sensor assembly move as a whole, the guide part is positioned at the critical position of the horizontal part and the inclined part, and the receptor skin triggers the guide part to rotate along the inclined part;
the device is configured such that the housing triggering structure cooperates with the clamping portion to unlock the device, the rotating member, the bracket and the sensor assembly move as a unit to the skin of the recipient, and the recipient skin can trigger the rotating member to rotate in the guide slot to release the limit of the housing on the needle extractor, and the needle extractor extracts the introduction needle from the skin.
2. A percutaneous analyte sensor insertion device according to claim 1, wherein: the shell lower part is equipped with the end cover with its joint, and the spacing casing of end cover moves to acceptor skin side, be equipped with spacing arch in the casing, the skeleton top is equipped with the elasticity buckle with it complex, and the spacing casing of elasticity buckle moves with the skeleton relatively.
3. A percutaneous analyte sensor insertion device according to claim 1, wherein: the upper part of the shell is symmetrically provided with first limiting ribs for limiting the needle extractor, the top of the needle extractor is provided with first grooves corresponding to the first limiting ribs, the needle extractor rotates by a preset angle, and the first grooves are aligned with the first limiting ribs to release the limit of the needle extractor.
4. A percutaneous analyte sensor insertion device according to claim 1, wherein: the guide pin is provided with a protruding block, the clamping and clamping piece comprises arc-shaped parts which are symmetrically arranged, the upper ends of the arc-shaped parts are clamping connectors, the protruding block is fixed by the clamping connectors, the lower part of the rotating piece is provided with an opening corresponding to the arc-shaped parts, the skin of a receptor triggers the rotating piece, the rotating piece rotates by a preset angle, the opening is aligned to the arc-shaped parts, and the limit of the clamping and clamping piece is relieved.
5. A percutaneous analyte sensor insertion device according to claim 1, wherein: the shell is internally provided with a first guide groove, the framework is provided with a first guide rib matched with the first guide groove, the shell can slide on the framework, and the elastic buckle limit shell moves towards the end far away from the sensor assembly.
6. A percutaneous analyte sensor insertion device according to claim 1, wherein: the upper part of the shell is provided with a first limit groove, the clamping part of the rotating piece can move along the first limit groove, and the first limit groove comprises an inclined part.
7. A percutaneous analyte sensor insertion device according to claim 6, wherein: the framework is provided with a second limiting groove matched with the first limiting groove, the clamping part of the rotating piece can move along the second limiting groove, the second limiting groove comprises a horizontal part and an opening part, and the horizontal part and the opening part are communicated through a vertical part.
8. A percutaneous analyte sensor insertion device according to claim 1, wherein: the framework limiting clamping part is provided with a key for unlocking the clamping part.
9. A percutaneous analyte sensor insertion device according to claim 8, wherein: the framework is provided with a second limiting groove, the second limiting groove comprises a vertical portion and an opening portion, the clamping portion penetrates through the second limiting groove, and a limiting convex rib of the limiting clamping portion is arranged in the vertical portion of the second limiting groove.
10. A percutaneous analyte sensor insertion device according to claim 1, wherein: the support bottom is equipped with the elastic arm of coupling sensor assembly, be equipped with the spacing muscle of second on the skeleton, its cooperation elastic arm presss from both sides tight sensor unit, the spacing muscle of second is close to sensor assembly end to the distance of skeleton terminal surface be greater than the height of support arm.
11. A percutaneous analyte sensor insertion device according to claim 1, wherein: the side of the rotating piece is provided with a supporting bulge, and the supporting bulge is contacted with the inner wall of the framework.
12. A percutaneous analyte sensor insertion device according to claim 1, wherein: the side of the bracket is provided with a second guide rib, the framework is internally provided with a second guide groove matched with the second guide rib, and the bracket can slide in the second guide groove.
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