CN113456066B - Percutaneous analyte sensor insertion device - Google Patents

Percutaneous analyte sensor insertion device Download PDF

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Publication number
CN113456066B
CN113456066B CN202110894808.9A CN202110894808A CN113456066B CN 113456066 B CN113456066 B CN 113456066B CN 202110894808 A CN202110894808 A CN 202110894808A CN 113456066 B CN113456066 B CN 113456066B
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elastic component
elastic
base
needle
support
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CN113456066A (en
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李宁
施广平
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Andon Health Co Ltd
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Andon Health Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14503Measuring 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring 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

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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)
  • Biophysics (AREA)
  • 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 provides a percutaneous analyte sensor inserting device, which comprises a triggering component and a driving device, wherein the triggering component triggers the driving device, and the driving device moves along a preset track to drive a sensor base component and an introducing needle to the skin of a receptor and separate the introducing needle from the sensor base component; the driving device comprises a support, a base, a needle extractor, a sensor base assembly and an elastic piece, wherein the support is releasably connected with the base, the sensor base assembly is arranged in the base, and the elastic piece is positioned between the needle extractor and the support and energizes the driving device. In summary, compared with the prior art, the percutaneous analyte sensor is inserted in place, and the use process is simple to operate and reliable in use.

Description

Percutaneous analyte sensor insertion device
Technical Field
The present invention relates to the field of receptor analyte measurement, and more particularly to a percutaneous analyte sensor insertion device suitable for applying a sensor base assembly to the skin of a receptor.
Background
Diabetes is a disease in which the pancreas does not produce insulin or does not produce enough insulin, and current medical techniques are not radical cure. Diabetes can cause a series of complications, and is extremely harmful to human health. Currently, blood glucose meters and blood glucose test strips are available for measuring blood glucose levels of patients over a specified period of time. With the development of blood sugar calibration technology, products for dynamically monitoring blood sugar appear on the market, and the change of blood sugar of a human body can be continuously monitored through a glucose sensor inserted into subcutaneous tissue of the human body.
The invention patent with the publication number of CN110664415A discloses an application device, which comprises a shell, a touch back assembly and a sensor base assembly, wherein the touch back assembly and the sensor base assembly are arranged in the shell, the touch back assembly can move along a preset track, the first trigger mechanism is triggered by external force, the second trigger mechanism and the third trigger mechanism are automatically triggered, and the first trigger mechanism drives the sensor base assembly to an application position; the second trigger mechanism and the third trigger mechanism disengage the introducer needle from the sensor base assembly.
The applicator simplifies the structure of the applicator, reduces the use of parts and reduces the cost. However, the structure has the condition of early needle pulling, and meanwhile, the insertion depth also has a large difference due to the difference of the body weight and the thinness of the human body. The device does not adapt well to the situation of different degrees of protrusion, and the percutaneous analyte sensor cannot be guaranteed to be inserted in place.
Disclosure of Invention
The technical problem underlying the present invention is to overcome the drawbacks of the devices described above by providing a percutaneous analyte sensor insertion device that is adaptable to application surfaces of varying degrees of convexity, enabling application of a sensor base assembly to the skin of a subject while the percutaneous analyte sensor is in place.
The invention is realized by the following technical scheme, the percutaneous analyte sensor inserting device comprises a triggering component and a driving device, wherein the triggering component triggers the driving device, the driving device moves along a preset track to drive a sensor base component and an introduction needle to the skin of a receptor and separate the introduction needle from the sensor base component, the driving device comprises a support, a base, a needle extractor, elastic pieces and the sensor base component, two sides of the support are provided with extension arms, the triggering component comprises a framework, the upper part of the framework is provided with a first elastic buckle matched with the extension arms to limit, the first elastic buckle penetrates through the extension arms, the needle extractor is limited below the first elastic buckle, the elastic pieces are positioned between the needle extractor and the support and energize the driving device, the sensor base component is arranged in the base, the support is in releasable connection with the base, the sensor base component reaches the skin of the receptor, and the support can continuously move towards the direction of the sensor base component to release the needle extractor limit.
Further, third elastic buckles are symmetrically arranged on the side face of the bottom of the support, grooves corresponding to the third elastic buckles are formed in the base, limiting ribs are arranged on the framework, and the limiting ribs limit the third elastic buckles.
Further, the third elastic buckle slides relative to the limit rib under the action of the elastic piece and releases limit.
Further, the base is provided with symmetrical second elastic buckles, clamping joints extending to two sides are arranged on the upper portions of the second elastic buckles, the lower portions of the guide pins are arranged in the clamping joints, connecting portions are arranged between the lower portions of the clamping joints and the end faces of the base, and after the base stops moving, the support can move continuously relative to the connecting portions.
Further, the bottom of the support is provided with a clamping groove, the clamping connector is in limit fit with the clamping groove, the inner side of the second elastic buckle is provided with a guide pin groove, and the lower part of the guide pin is arranged in the guide pin groove.
Further, the support and the base are released from limiting, the sensor base component reaches the skin of a receptor, the support can continue to move towards the sensor base component, the extending arm enables the first elastic buckle to elastically deform towards two sides, and the first elastic buckle releases the limiting of the needle extractor.
Further, the trigger assembly comprises a shell, a framework and a slip ring, wherein a through sliding groove is formed in the framework, the slip ring capable of moving in the sliding groove is arranged in the sliding groove, the slip ring is connected with the shell and the support, and vertical movement between the shell and the framework can be converted into circular movement of the slip ring.
Further, the shell and the framework can slide up and down, the sliding ring is in contact with the support, the limiting support moves towards the sensor base assembly, and the sliding ring rotates to release the limit.
Further, the top of the shell is provided with an upper cover, the upper cover and the shell are rotatable, the side surface inside the upper cover is provided with a limit baffle, and the limit baffle limits the relative movement between the framework and the shell.
The invention discloses a percutaneous analyte sensor inserting device capable of self-adaptively unlocking according to the skin state of a receptor, wherein a sensor base assembly reaches the skin of the receptor, and a needle extractor starts a needle extracting (returning) action after an introducing needle is inserted in place, so that the situation that a percutaneous analyte sensor in the introducing needle is not inserted in place or bent is avoided. In conclusion, compared with the prior art, the invention has the advantages of simple operation in the using process, reliable use, false triggering prevention, more guarantee of the insertion depth and more adaptability to people with different body types.
Drawings
FIG. 1 is an exploded view of the present invention;
FIG. 2a is a schematic diagram of the front structure of the bracket of the present invention;
FIG. 2b is a schematic view of the back structure of the bracket of the present invention
FIG. 3a is a schematic view of the front structure of the base of the present invention;
FIG. 3b is a schematic view of the back structure of the base of the present invention;
FIG. 4a is a schematic diagram of the front structure of the skeleton of the present invention;
FIG. 4b is a schematic view of the back structure of the skeleton of the present invention;
FIG. 5a is a schematic view of a partial cross-sectional structure of a housing of the present invention;
FIG. 5b is a schematic view of the structure of the housing of the present invention;
FIG. 6 is a schematic view of the structure of the upper cover of the present invention;
FIG. 7a is a schematic view of the front structure of the needle extractor of the present invention;
FIG. 7b is a schematic view of the back structure of the needle extractor of the present invention;
FIG. 8 is a schematic view of a slip ring structure of the present invention;
FIG. 9 is a schematic view of the structure of the introducer needle of this invention;
FIG. 10 is a schematic view of the initial state structure of the present invention;
FIG. 11 is a schematic structural view of a third elastic buckle limiting state according to the present invention;
FIG. 12 is an enlarged view of a third spring clip limit state of the present invention;
fig. 13 is a schematic view of a structure of the third elastic buckle after releasing the limit according to the present invention;
FIG. 14 is an enlarged view of a portion of the third elastic buckle after releasing the limit according to the present invention;
FIG. 15 is a schematic view of the structure of the base before stopping movement;
FIG. 16 is an enlarged view of a partial structure of the base of the present invention before stopping movement;
FIG. 17 is a schematic view of the structure of the base of the present invention after stopping movement;
FIG. 18 is an enlarged view of a partial structure of the base of the present invention after stopping movement;
FIG. 19 is a schematic view of the structure of the needle pulling process of the present invention;
fig. 20 is an enlarged view of a partial structure during the needle drawing process 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. 1-20, a percutaneous analyte sensor insertion device includes a trigger assembly and a drive device, the trigger assembly triggering the drive device, the drive device moving along a predetermined trajectory, driving the sensor base assembly 4 and the introducer needle 6 to the skin of a subject, and disengaging the introducer needle from the sensor base assembly; the driving device comprises a bracket 1, a base 2, a needle extractor 3, a sensor base assembly 4 and an elastic piece 5, wherein the two sides of the bracket 1 are provided with extension arms 11, the triggering assembly comprises a framework 7, the upper part of the framework 7 is provided with a first elastic buckle 71 which is matched and limited with the extension arms 11, the first elastic buckle 71 penetrates through the extension arms 11, the needle extractor 3 is limited below the first elastic buckle 71, the elastic piece 5 is positioned between the needle extractor 3 and the bracket 1 and energizes the driving device, and the upper part of an introduction needle 6 is arranged in the needle extractor 3; the sensor base component 4 is arranged in the base 2, the support 1 is releasably connected with the base 2, the sensor base component 4 reaches the skin of a receptor, and the support 1 can move towards the sensor base component 4 continuously to release the limit of the needle extractor 3. In particular, the elastic member includes, but is not limited to, a cylindrical coil spring. Initially, the elastic member is in a compressed state.
In some embodiments, the third elastic buckle 13 is symmetrically arranged on the side surface of the bottom of the bracket 1, the groove 22 corresponding to the third elastic buckle 13 is arranged on the base 2, and the limiting rib 72 is arranged on the framework 7, and the limiting rib 72 limits the third elastic buckle 13. The third elastic buckle 13 slides relative to the limiting rib 72 under the action of the elastic piece 5 and releases the limiting, and preferably, the sliding distance of the third elastic buckle relative to the limiting rib 72 is smaller than 20mm in the use process of the insertion device. Specifically, it may be 5mm, 10mm, etc.
In some embodiments, the base 2 is provided with a symmetrical second elastic buckle 21, the upper part of the second elastic buckle 21 is provided with a clamping joint 211 extending to two sides, the lower part of the introducing needle 6 is arranged in the guiding needle groove 212 and used for driving the introducing needle 6 to be inserted into the skin, a connecting part 213 is arranged between the clamping joint 211 and the end face of the base 2 downwards, and after the base stops moving, the support 1 can move continuously relative to the connecting part.
Specifically, the bottom of the bracket 1 is provided with a clamping groove 12, the second elastic buckle is matched with the clamping groove 12, the inner side of the second elastic buckle 21 is provided with a guide pin groove 212, and the lower part of the guide pin 6 is arranged in the guide pin groove 212 for limiting the guide pin.
Guide posts 23 are symmetrically arranged on the upper end face of the base, and the guide posts 23 are inserted into guide holes 14 at the bottom of the bracket 1. The back of the base is symmetrically provided with elastic arms 24, the sensor base assembly 4 is arranged in the elastic arms 24, two sides of the needle puller 3 are provided with clamping arms 31, and the clamping arms 31 penetrate through the bracket 1 and clamp the elastic arms 24 to fix the sensor base assembly 4.
In some embodiments, the limiting rib 72 releases the limitation of the third elastic buckle 13, that is, the bracket 1 and the base 2 are unlocked, the sensor base component 4 reaches the skin of the recipient, the bracket 1 can continue to move towards the sensor base component 4, the extending arm 11 elastically deforms the first elastic buckle 71 towards two sides, the first elastic buckle 71 releases the limitation of the needle extractor 3, and the needle extractor 3 opens the needle extracting action under the action of the elastic piece.
In some embodiments, the triggering assembly includes a housing 8, a skeleton 7 and a slip ring 9, the skeleton 7 is provided with a through sliding groove 73, the sliding groove 73 is internally provided with the slip ring 9 capable of moving therein, the slip ring 9 is connected with the housing 8 and the bracket 1, and the vertical movement between the housing 8 and the skeleton 7 can be converted into the circular movement of the slip ring 9. Specifically, the outer side of the slip ring 9 is provided with a bump 91, the inner side of the slip ring is provided with an extension 92 at a corresponding position, the housing 8 is provided with a Z-shaped groove 83, and the bump 91 is disposed in the Z-shaped groove 83. It should be noted that the present invention includes, but is not limited to, such a manner of rotation triggering.
Specifically, the side of the shell 8 is provided with a first guide groove 84, the outer side of the framework 7 is provided with a first guide rib 74 corresponding to the first guide groove, the shell 8 and the framework 7 can slide up and down, the sliding ring 9 is in contact with the support 1, the limiting support 1 moves towards the sensor base assembly 4, and the sliding ring 9 rotates to release the limit. Specifically, a limit flange 15 is disposed on the bottom side of the bracket 1, and the limit flange 15 is located above the slip ring extension 92. The guide groove 84 is provided with a stop rib 85 at the upper part, which limits the maximum distance of displacement between the housing 8 and the frame 7.
In some embodiments, the top of the housing 8 is provided with an upper cover 81, the upper cover 81 and the housing 8 are rotatable, and a limit baffle 82 is disposed on the inner side surface of the upper cover 81, and the limit baffle 82 limits the relative movement between the framework 7 and the housing 8, so that the structure can prevent the false triggering of the insertion device. Specifically, the upper end face of the housing 8 is provided with a circular hole, fourth elastic buckles 89 corresponding to the circular hole are uniformly distributed in the middle of the inner side of the upper cover 81, the fourth elastic buckles 89 are clamped in the circular hole, transposition ribs 87 are arranged between the fourth elastic buckles 89, and transposition grooves 88 corresponding to the inner side face of the circular hole are formed in intervals. The user can conveniently perceive the rotation angle to trigger. The lower end of the shell 8 is provided with an end cover for protecting the whole insertion device from being polluted.
Specifically, the inner surface of the housing 8 is provided with a limit clamping block 810, and the side surface of the top end of the framework is provided with a fifth elastic clamping buckle 75 to be matched with the fifth elastic clamping buckle. When the limit baffle 82 releases the limit of the framework 7, the user applies a certain force on the housing to trigger the insertion device, and the force can be specifically 5N, 10N and the like, so that the user can conveniently sense the triggering process. The inner side of the framework is provided with a second guide rib 76, the side surface of the bottom of the bracket 1 is provided with a second guide groove 16 corresponding to the second guide rib, the bottom of the needle extractor 3 is provided with a third guide groove 32 corresponding to the needle extractor, so that the stable and smooth movement process of the driving device can be ensured, the movement track of the leading-in needle in and out process is ensured to be parallel to the axis of the framework, and the movement quantity of the tip of the needle is reduced.
Structure and motion principle of the embodiments:
(1) Initial state of insertion device
In the initial state, the elastic piece 5 is in a compressed state, the limiting baffle 82 limits the first guide rib 74, the framework 7 and the shell 8 are guaranteed to be incapable of moving relatively, and accidental triggering caused by misoperation is prevented. The first elastic buckle 71 of the framework limits the needle extractor 3, so that the needle extractor 3 can not move towards the upper cover 81; the slip ring extension 92 limits the support stop flange 15, ensuring that the support cannot move in the skin-side direction of the subject.
(2) Insertion device triggering
Firstly, removing the end cover to expose the framework 7; rotating the upper cover 81 of the shell 8 to release the false touch protection of the insertion device; then the insertion device is placed on the skin of a subject, the shell 8 is pressed down, the vertical movement between the shell 8 and the framework 7 is converted into the circular movement of the sliding ring 9, the limit of the support limit flange 15 is released, and under the elastic action of the elastic piece 5, the support 1, the base 2, the needle extractor 3, the introduction needle 6 and the sensor base component 4 move towards the skin side of the subject together to perform the insertion action of the analyte sensor. Before the sensor base assembly 4 reaches the skin of the recipient, the limiting ribs 72 release the limit of the third elastic buckle 13 of the base 2, i.e. the bracket 1 and the base 2 are unlocked. The sensor base assembly 4 and the leading-in needle 6 are driven by the base 2 to reach the skin of a receptor by the elastic piece 5, and the sensor in the leading-in needle 6 is inserted in place; the support 1 continues to move under the action of the elastic element 5, and the third elastic buckle 13 is disengaged from the groove 22. The limit of the limit rib 72 ensures that the front support 1 and the base 2 are relatively locked before the needle point pierces the skin; the releasable connection between the holder 1 and the base 2 ensures that the sensor base assembly 4 is adapted to different raised skin conditions, accurately applied to the skin of the subject, while the transcutaneous analyte sensor is inserted in place.
After the sensor base assembly 4 and the leading-in needle 6 are in place, when the support 1 continues to move towards the skin side of a receptor under the action of the elastic piece 5, the first elastic buckle 71 moves towards two sides due to the movement of the extending arm 11 in the vertical direction, so that the limit of the framework 7 on the needle extractor 3 is relieved, and the needle extraction (return) action is started under the action of the elastic piece 5. The needle puller 3 moves towards the upper cover 81, the upper end of the guide needle 6 is provided with a clamping protrusion 61, and the needle puller 3 is provided with a sliding baffle groove 33 extending downwards from the upper end surface. The lower part of the leading-in needle 6 is provided with an inclined plane, the inclined plane is separated from the second elastic buckle 21, and the leading-in needle moves towards the upper cover 81 under the drive of the sliding baffle groove 33 and is retracted into the insertion device. The insertion device is removed by hand, and the application process of the sensor base assembly is completed. After the sensor base assembly 4 is applied in place, the support 1 continues to move under the action of the elastic piece 5, so that the needle pulling action is triggered, the needle pulling action is guaranteed to be carried out after the application in place, and the condition that the percutaneous analyte sensor is not inserted in place due to the fact that the needle is pulled out prematurely is avoided.
In summary, compared with the prior art, the percutaneous analyte sensor has the advantages of more accurate insertion depth, simple operation in the using process, reliable use and wider applicable crowd.
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.

Claims (6)

1. The utility model provides a percutaneous analyte sensor insertion device, includes trigger subassembly and drive arrangement, trigger the drive arrangement, drive arrangement moves along predetermined orbit, drives sensor base subassembly and leading-in needle to the skin of acceptor to make leading-in needle break away from sensor base subassembly, a serial communication port, drive arrangement includes support, base, pulls out needle ware, elastic component and sensor base subassembly, the support both sides are equipped with the arm that stretches out, trigger subassembly includes the skeleton, skeleton upper portion is equipped with the first elastic buckle spacing with the cooperation of arm that stretches out, first elastic buckle passes the arm that stretches out, the needle ware is spacing in first elastic buckle below, the elastic component is located between needle ware and the support, and energizes for drive arrangement, sensor base subassembly is arranged in the base, support and base releasable connection, support bottom side symmetry be equipped with the third elastic buckle, be equipped with on the base with the corresponding recess of third elastic buckle, be equipped with spacing muscle spacing third elastic buckle on the skeleton, the first elastic buckle passes the arm that stretches out, the elastic buckle is in opposite to the elastic component and the elastic component is to the elastic component is pulled out the elastic component under the action of the support and is reached the elastic component under the elastic component to the elastic component is lifted to the elastic component under the direction of stretching out the elastic component, and is the elastic component is lifted to the elastic component is the elastic component under the elastic component's the direction of stretching out of the elastic component, and is vertical deformation is lifted to the elastic component under the elastic component.
2. The percutaneous analyte sensor insertion device according to claim 1, wherein the base is provided with a symmetrical second elastic clip, the upper part of the second elastic clip is provided with a clip extending to two sides, a connecting part is arranged between the clip and the end face of the base downward, and the bracket continues to move relative to the connecting part after the base stops moving.
3. The percutaneous analyte sensor insertion device according to claim 2, wherein the bottom of the bracket is provided with a clamping groove, the clamping head is limited by matching with the clamping groove, the inner side of the second elastic buckle is provided with a guide pin groove, and the lower part of the guide pin is arranged in the guide pin groove.
4. The percutaneous analyte sensor insertion device according to claim 1, wherein the trigger assembly comprises a housing, a frame and a slip ring, wherein the frame is provided with a through sliding groove, the sliding groove is internally provided with a slip ring capable of moving therein, the slip ring is connected with the housing and the bracket, and vertical movement between the housing and the frame is converted into circumferential movement of the slip ring.
5. The percutaneous analyte sensor insertion device of claim 4, wherein the housing and the frame are slidable up and down, the slip ring contacts the bracket, and the limit bracket moves in the direction of the sensor base assembly, and rotation of the slip ring releases the limit.
6. The percutaneous analyte sensor insertion device of claim 4, wherein an upper cover is provided on the top of the housing, the upper cover and the housing being rotatable, and a limit stop is provided on an inner side of the upper cover, the limit stop limiting relative movement between the housing and the housing.
CN202110894808.9A 2021-08-05 2021-08-05 Percutaneous analyte sensor insertion device Active CN113456066B (en)

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