CN114680882A - Analyte concentration monitoring system and method of use - Google Patents
Analyte concentration monitoring system and method of use Download PDFInfo
- Publication number
- CN114680882A CN114680882A CN202210610737.XA CN202210610737A CN114680882A CN 114680882 A CN114680882 A CN 114680882A CN 202210610737 A CN202210610737 A CN 202210610737A CN 114680882 A CN114680882 A CN 114680882A
- Authority
- CN
- China
- Prior art keywords
- protective cap
- monitoring system
- analyte concentration
- locking
- concentration monitoring
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000012544 monitoring process Methods 0.000 title claims abstract description 44
- 239000012491 analyte Substances 0.000 title claims abstract description 33
- 238000000034 method Methods 0.000 title claims abstract description 16
- 230000001681 protective effect Effects 0.000 claims abstract description 112
- 230000001954 sterilising effect Effects 0.000 claims abstract description 43
- 238000004659 sterilization and disinfection Methods 0.000 claims abstract description 43
- 238000001727 in vivo Methods 0.000 claims abstract description 7
- 230000000994 depressogenic effect Effects 0.000 claims description 4
- 230000004044 response Effects 0.000 claims description 2
- 239000008103 glucose Substances 0.000 description 16
- 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 15
- 239000008280 blood Substances 0.000 description 14
- 210000004369 blood Anatomy 0.000 description 14
- 238000000926 separation method Methods 0.000 description 6
- 238000012986 modification Methods 0.000 description 5
- 230000004048 modification Effects 0.000 description 5
- 206010033675 panniculitis Diseases 0.000 description 5
- 210000004304 subcutaneous tissue Anatomy 0.000 description 5
- 238000010586 diagram Methods 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- 239000012530 fluid Substances 0.000 description 3
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 2
- 239000012790 adhesive layer Substances 0.000 description 2
- 238000010276 construction Methods 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 238000007920 subcutaneous administration Methods 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 210000003722 extracellular fluid Anatomy 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
Images
Classifications
-
- 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
- A61B5/1468—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 chemical or electrochemical methods, e.g. by polarographic means
- A61B5/1473—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 chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
Abstract
The invention provides an analyte concentration monitoring system and a method of use, the system comprising an implanter assembly and a sterilization assembly, the sterilization assembly comprising a sensor electrode and a protective cap, the interior of the protective cap forming a sealed sterilization cavity, the in vivo portion of the sensor electrode being disposed in the sterilization cavity, the protective cap being configured with a trigger member, the trigger member being configured to be responsive to an operation to detach the protective cap from the sensor electrode, the sterilization assembly further comprising a holder, a first locking portion being formed between the holder and the protective cap, the first locking portion being configured to prevent rotation of the protective cap relative to the holder in a first direction; when the trigger member is operated, the first locking portion is released. The invention can avoid separating the protective cap and the sensor electrode in a rotating way before the formal use, particularly avoid rotating the protective cap due to misoperation when the protective cap is installed on the implanter, and ensure that the sensor electrode is in a sterile environment before the formal use.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to an analyte concentration monitoring system and a using method thereof.
Background
Some physiological disorders require monitoring of specific analyte concentrations in vivo, for example, diabetics require monitoring of blood glucose in vivo. Currently, the more used technology is a blood glucose meter, and a patient collects blood at the end of a finger to monitor the blood glucose level, but the method is discontinuous in monitoring, so that pain is caused to the patient in the using process. In order to overcome the defects of a blood-glucose meter, a monitoring technology which can be implanted into subcutaneous tissues to continuously monitor subcutaneous blood glucose is provided, a sensor electrode is implanted into the subcutaneous tissues, an oxidation reaction is generated between the sensor electrode and the tissues of a patient to generate an electric signal, and then the electric signal is converted into a blood glucose reading by a transmitter and is transmitted to a wireless receiver for the patient and a doctor to refer.
While the sensor electrodes and needles are required to be sterile when inserted into the subcutaneous tissue, some continuous blood glucose monitoring systems employ a separate sterilization process to sterilize the sensor electrodes and electronic components, such as may be employed, since radiation sterilization can compromise the electronic components associated with the sensor electrodes, and thus, typically, ethylene oxide, for example, is used to sterilize the electronic components. However, ethylene oxide can damage the chemicals on the sensor electrodes, and therefore, integrating the sensor electrodes and electronic components into one unit can complicate the sterilization process.
These problems can be circumvented by separating the components into a sensor unit (containing the sensor electrodes) and a transmitter unit (containing the electronic components) so that each component can be individually packaged and sterilized using a suitable sterilization method. For example, the sensor unit may be received in a protective cap after being sterilized, a sterile cavity for accommodating the sensor electrode is formed between the protective cap and the sensor unit, and the protective cap and the sensor unit can be assembled or separated by rotating the protective cap, which may cause the protective cap to be mishandled and the protective cap and the sensor unit to be separated before being used, which destroys the sterile environment of the sensor unit and prevents the sensor unit from being used.
In order to solve the above problems, the existing analyte concentration monitoring system allows the protective cap to be rotated relative to the sensor unit only when the protective cap is mounted on the implanter, which only prevents the protective cap from being separated from the sensor unit due to misoperation before the protective cap is mounted on the implanter, and the separation of the protective cap from the sensor unit due to misoperation still exists after the protective cap is mounted on the implanter, for example, after the protective cap is mounted on the implanter, the protective cap is rotated and separated when the protective cap is not used, so that the sterile environment of the sensor unit is destroyed, and no effective method is adopted for solving the problems.
Disclosure of Invention
The invention aims to provide an analyte concentration monitoring system and a using method thereof, which can avoid separating a protective cap and a sensor electrode in a rotating mode before formal use, particularly avoid rotating the protective cap due to misoperation when the protective cap is installed on an implanter, and ensure that the sensor electrode is in a sterile environment before formal use.
In order to achieve the purpose of the invention, the technical scheme adopted by the invention is as follows: an analyte concentration monitoring system comprising an implanter assembly and a sterilization assembly, the sterilization assembly comprising a sensor electrode and a protective cap, the protective cap having a sealed sterilization chamber formed therein, an in vivo portion of the sensor electrode being disposed in the sterilization chamber, the protective cap being configured with a trigger member configured to be responsive to an operation to detach the protective cap from the sensor electrode.
In the above solution, the triggering means is allowed to be operated to detach the protective cap from the sensor electrode when the sterilization assembly is coupled to the implanter assembly.
In the above technical solution, the sterilization assembly further comprises a holding portion, a first locking portion is formed between the holding portion and the protection cap, and the first locking portion is configured to prevent the protection cap from rotating relative to the holding portion along the first direction;
when the trigger member is operated, the first locking portion is released.
In the above-described aspect, the first locking portion includes a first locking member disposed on the holding portion and a second locking member disposed on the protective cap, and the first locking member and the second locking member are cooperatively locked.
In the above technical solution, the first locking member and the second locking member are located on the same circumference.
In the above solution, the free end of the first locking member has an elastic tendency to expand towards the second locking member.
In the above solution, the free end of the first locking member is displaced in a direction away from the second locking member in response to the action of the trigger member.
In the above technical solution, the trigger member is a button disposed on the protective cap.
In the above technical solution, a guide slope facing the first locking member is formed on the button.
In the above technical solution, the button is a disposable button disposed on the protective cap.
In the above technical solution, an operation hole for accommodating the button is formed in the protective cap, a first limiting portion is formed in the operation hole, a second limiting portion is formed on the button, and the first limiting portion is configured to be interlocked and limited with the second limiting portion when the button is pressed.
In the above technical solution, the second locking member is an arc rib extending along the circumferential direction, and a passage for the first locking member to pass through is formed between the second locking member and the protective cap.
In the above technical solution, the second locking member is an arc rib extending along a second direction and a radially inward direction, and the second direction is a direction opposite to the first direction.
In the above solution, the protective cap is coupled to the implanter assembly via the retaining portion.
In the above-described aspect, the sterilization assembly further includes a body surface attachment unit mounted inside the protective cap, and a second locking portion is formed between the body surface attachment unit and the holding portion, the second locking portion being configured to prevent the holding portion from rotating relative to the body surface attachment unit in the first or second direction.
In the above technical solution, the second locking portion includes a plurality of bayonets circumferentially distributed on an edge of the body surface attachment unit and locking blocks distributed on the holding portion and corresponding to the bayonets, and the bayonets and the locking blocks are locked in a fitting manner.
In the above technical solution, the sterilization assembly further comprises a needle assembly mounted to the body surface attachment unit, the needle assembly comprising a needle holder and a puncture needle attached to the needle holder, a third locking portion is formed between the needle holder and the body surface attachment unit, and the third locking portion is configured to prevent the needle holder from rotating relative to the body surface attachment unit in the first or second direction.
In the above technical solution, the third locking part includes a specially-shaped waist part formed on the needle holder and a boss with a specially-shaped hole formed on the body surface attachment unit, and when the needle assembly is mounted on the body surface attachment unit, the specially-shaped waist part is embedded into the specially-shaped hole of the boss and is matched and locked with the specially-shaped hole.
In the above solution, a fourth locking portion is formed between the protective cap and the implanter assembly, the fourth locking portion being configured to prevent the protective cap from rotating relative to the implanter assembly in the second direction and from moving in a direction away from the implanter assembly.
In the above technical solution, the fourth locking portion includes a third locking member disposed on the implanter assembly and a fourth locking member disposed on the protective cap, and the third locking member and the fourth locking member are locked in cooperation.
In the above technical solution, the puncture needle is sleeved on the internal part of the sensor electrode and is disposed in the sterilization cavity together with the internal part of the sensor electrode.
The invention also provides a method of using an analyte concentration monitoring system comprising separating the protective cap from the sensor electrode only when the trigger member is operated.
In the above technical solution, the trigger member is a button, and the protective cap is separated from the sensor electrode only when the button is pressed.
Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:
the invention can realize that the protective cap and the sensor electrode are allowed to be separated only when the trigger component is operated, thereby avoiding the separation of the protective cap and the sensor electrode before formal use, particularly avoiding the rotation of the protective cap due to misoperation when the protective cap is installed on the implanter, and ensuring that the sensor electrode is in a sterile environment before formal use.
Drawings
FIG. 1 is a schematic diagram of a continuous blood glucose monitoring system according to an embodiment of the present invention.
Fig. 2 is a schematic structural diagram of a continuous blood glucose monitoring system according to an embodiment of the present invention.
Fig. 3 is an enlarged partial schematic view of the shaped hole of fig. 2.
Fig. 4 is a structural diagram of the sterilization assembly in an initial state in which the trigger member is operated according to the embodiment of the present invention.
Fig. 5 is a partially enlarged schematic view at B in fig. 4.
Fig. 6 is a schematic view of a sterilization assembly during operation of a trigger member according to an embodiment of the present invention.
Fig. 7 is a partially enlarged schematic view at C in fig. 6.
Fig. 8 is a schematic view of an implanter assembly in accordance with an embodiment of the invention.
Fig. 9 is a schematic view of an implanter assembly and protective cap assembly in accordance with an embodiment of the invention.
Wherein: 100. a host; 200. a body surface attachment unit; 210. a sensor electrode; 300. a receiver; 400. an implanter assembly; 500. a sterilization assembly; 510. a protective cap; 511. an operation hole; 512. a first limiting part; 520. a holding section; 530. a first locking section; 531. a first locking member; 532. a second locking member; 5321. a channel; 533. a trigger member; 5331. a second limiting part; 5332. a guide slope; 540. a second locking portion; 541. a bayonet; 542. a clamping block; 550. a needle assembly; 551. a needle seat; 552. puncturing needle; 560. a third locking portion; 561. a special-shaped waist part; 562. a boss; 571. a third locking member; 572. a fourth locking member; 573. a guide groove.
Detailed Description
The following description and examples illustrate some exemplary embodiments of the disclosed invention. Those skilled in the art will recognize that there may be many variations and modifications of the embodiments of the present invention.
Continuous blood Glucose Monitoring (CGM) system
Referring to fig. 1, a schematic of a continuous blood glucose monitoring system attached to a host 100 is shown. A continuous blood glucose monitoring system comprising a body surface attachment unit 200 with sensor electrodes 210 is shown attached to the skin surface of a host 100 by an adhesive layer. The body surface attachment unit 200 houses a circuit module electrically connected to the sensor electrodes 210, and transmits information on the glucose concentration monitored by the sensor electrodes 210 to the receiver 300 through the circuit module, and the receiver 300 may be a smartphone, a smart watch, a dedicated device, and the like. During use, the sensor electrodes 210 are positioned partially beneath the skin of the host 100, in contact with subcutaneous interstitial fluid.
The sensor electrode 210 includes an in vivo portion, which refers to a portion implanted under the skin of the host 100 in contact with subcutaneous tissue fluid, and an in vitro portion, which refers to a portion left outside the skin of the host 100. In one embodiment, the external portion of the sensor electrode 210 extends into the body surface attachment unit 200 and is attached to the circuit module to establish electrical connection with the circuit module.
Referring to fig. 2 and 3, a schematic diagram of a continuous blood glucose monitoring system is shown, comprising an implanter assembly 400 and a sterilization assembly 500, wherein the implanter assembly 400 and the sterilization assembly 500 are separately placed in two separate packages after sterilization, and the sterilization assembly 500 comprises a protective cap 510 and a body surface attachment unit 200 with a sensor electrode 210 disposed in the protective cap 510. In use, the two packages are opened, respectively, and when the sterilization assembly 500 is mounted on the implanter assembly 400, the protective cap 510 is removed from the implanter assembly 400 by rotating the protective cap 510 of the sterilization assembly 500 only when the trigger member 533 is depressed, so that the protective cap 510 is separated from the sensor electrode 210 to expose the sensor electrode 210, the end with the opening of the implanter assembly 400 is attached to the skin surface of the host 100, the body surface attachment unit 200 is applied to the skin surface of the host 100 by operating the implanter assembly 400, at which time the in vivo portion of the sensor electrode 210 is implanted under the skin of the host 100 and is in contact with the subcutaneous tissue fluid to continuously monitor the glucose concentration in the tissue fluid, and after the application operation of the body surface attachment unit 200 is completed, the implanter assembly 400 is removed, and only the body surface attachment unit 200 is left on the skin surface of the host 100.
The present invention selects the way of rotating the protective cap 510 along the first direction as the optimal solution for achieving the separation of the protective cap 510 from the sensor electrode 210, but not as a limitation on the solution for achieving the separation of the protective cap 510 from the sensor electrode 210, and the solution for achieving the separation of the protective cap 510 from the sensor electrode 210 in other ways should be understood as an approximation of the above optimal solution and included in the scope of the present invention. For example, the separation of the protective cap 510 from the sensor electrode 210 may also be achieved by plugging, and the plugging direction may be along the axial direction or the radial direction of the sterilization assembly 500 or a direction at an angle to the axial direction.
The adhesive layer can be, for example, a medical nonwoven tape.
Referring to fig. 4 and 5, the present invention provides an analyte concentration monitoring system, such as the continuous blood glucose monitoring system described above, and more particularly provides a new sterilization assembly 500 structure that improves the manner of removing the protective cap 510, the sterilization assembly 500 allowing the protective cap 510 to be rotatably separated from the sensor electrode 210 in a first direction only when the trigger member 533 is depressed. In one embodiment, the first direction may be a counterclockwise direction. In one embodiment, the trigger member 533 may be a button.
With continued reference to fig. 4 and 5, the sterilization assembly 500 includes a protective cap 510, a body surface attachment unit 200 disposed in the protective cap 510, a sensor electrode 210 attached to the body surface attachment unit 200, and a holding portion 520 disposed in the protective cap 510, a first locking portion 530 is formed between the holding portion 520 and the protective cap 510, and the first locking portion 530 includes two operation states of a locked state and a released state. When the trigger member 533 is not pressed, the first locking portion 530 is in a locked state; when the trigger member 533 is pressed, the first locking portion 530 is in a released state. When the first locking portion 530 is in the locked state, the first locking portion 530 is configured to prevent the protective cap 510 from rotating in the first direction with respect to the holding portion 520; when the first locking portion 530 is in a released state, the first locking portion 530 is configured to allow the protective cap 510 to rotate in a first direction.
With continued reference to fig. 4, the first locking portion 530 includes a first locking member 531 disposed on the holding portion 520 and a second locking member 532 disposed on the protective cap 510, the first locking member 531 cooperatively locking with the second locking member 532.
In an embodiment, the first and second locking members 531, 532 are located on the same circumference.
In one embodiment, the free end of the first locking member 531 has a spring tendency to expand toward the second locking member 532, and will return to its original shape when the first locking member 531 is deformed by a force.
In one embodiment, the button is formed with a guide slope 5332 facing the first locking member 531.
In one embodiment, the button is a disposable button configured on the protective cap 510, i.e., the button cannot be reused after being pressed.
In one embodiment, the protective cap 510 has an operation hole 511 formed therein for receiving a button, a first position-limiting portion 512 is formed in the operation hole 511, a second position-limiting portion 5331 is formed on the button, and the first position-limiting portion 512 is configured to form an interlocking position-limiting with the second position-limiting portion 5331 when the button is pressed. As shown in fig. 4 and 5, before the button is pressed, the button is limited in the operation hole 511, the operation hole 511 may be provided with a ring of flange at the opening to prevent the button from being separated from the operation hole 511, and the first limiting portion 512 and the second limiting portion 5331 are in a free state; as shown in fig. 6 and 7, when the button is pressed, the first position-limiting portion 512 catches the second position-limiting portion 5331 to form an interlocking position-limiting portion, and meanwhile, since the button enters the inside of the protective cap 510, the button cannot be operated from the inside of the protective cap 510, and thus the button cannot be reused after being pressed.
In one embodiment, the second locking member 532 is an arc-shaped rib extending along the circumferential direction, and a channel 5321 is formed between the second locking member 532 and the protective cap 510 for passing the first locking member 531. When the holding part 520 is mounted together with the protective cap 510, the protective cap 510 is turned in the second direction, at which time the first locking member 531 is moved along the second locking member 532 into the passage 5321, the first locking member 531 coming back after passing over the second locking member 532 and forming an interlock with the second locking member 532.
In one embodiment, the first locking member 531 and the second locking member 532 are engaged in such a manner that, as shown in fig. 4 and 5, when the trigger member 533 is not depressed, if the protective cap 510 is to be rotated in the first direction, the first locking member 531 is located on a moving path of the second locking member 532, and at this time, the first locking member 531 and the second locking member 532 are interlocked, and the protective cap 510 cannot be rotated relative to the holder 520; referring to fig. 6 and 7, during depression of the trigger member 533, the guide ramp 5332 of the trigger member 533 drives the first lock member 531 to move away from the second lock member 532, such that the first lock member 531 is misaligned with the second lock member 532, thereby allowing the protective cap 510 to be rotated in the first direction relative to the retaining part 520, and subsequently the protective cap 510 is rotated in the first direction, at which time the first lock member 531 moves along the passage 5321 past the second lock member, with the retaining part 520 and the protective cap 510 in an unlocked state.
In one embodiment, the first locking member 531 is a piece of resilient plastic with a free end having a resilient tendency to splay toward the second locking member 532.
Referring to fig. 4, the protective cap 510 is coupled to the implanter assembly 400 by a retainer 520, for example, the retainer 520 has a plurality of hooks formed thereon that extend toward the implanter assembly 400, and the implanter housing or an inner member of the implanter has notches formed therein that correspond to the hooks, the hooks passing through the notches and hooking edges of the notches when the sterilization assembly 500 is installed on the implanter assembly 400, thereby coupling the retainer 520 to the implanter assembly 400.
With continued reference to fig. 2, a second locking part 540 is formed between the body surface attachment unit 200 and the holding part 520, the second locking part 540 being configured to prevent the holding part 520 from rotating relative to the body surface attachment unit 200 in the first or second direction. In an embodiment, the second locking part 540 comprises a plurality of bayonets 541 circumferentially distributed on the edge of the body surface attachment unit 200 and catches 542 distributed on the holding part 520 corresponding to the bayonets 541, and when the holding part 520 is mounted on the protective cap 510, the catches 542 are embedded in the bayonets 541 and are cooperatively locked with the bayonets 541.
With continued reference to fig. 2, the sterilization assembly 500 further includes a needle assembly 550, the needle assembly 550 including a hub 551 and a puncture needle 552 attached to the hub 551, a third lock 560 formed between the hub 551 and the body surface attachment unit 200, the third lock 560 configured to prevent rotation of the hub 551 relative to the body surface attachment unit 200 in the first or second direction. In one embodiment, the third locking portion 560 comprises a shaped waist 561 formed on the hub 551 and a boss 562 with a shaped hole formed on the body surface attachment unit 200, and when the needle assembly 550 is mounted on the body surface attachment unit 200, the shaped waist 561 is inserted into the shaped hole of the boss 562 and is locked in cooperation with the shaped hole.
Referring to fig. 8 and 9, fourth locking portions are formed between the protective cap 510 and the implanter assembly 400 and configured to prevent rotation of the protective cap 510 relative to the implanter assembly 400 in the second direction and movement of the protective cap 510 in a direction away from the implanter assembly 400. The state of the fourth locking part is closely related to the state of the first locking part 530. When the first locking portion 530 is in the locked state, the fourth locking portion is also in the locked state; when the first locking part 530 is in the released state, the fourth locking part is allowed to be shifted to the released state. That is, releasing the first locking part 530 is a precondition for releasing the fourth locking part.
With continued reference to fig. 8 and 9, the fourth locking portion includes a third locking member 571 configured on the injector assembly 400 and a fourth locking member 572 configured on the protective cap 510, the third locking member 571 and the fourth locking member 572 cooperatively locking.
With continued reference to fig. 9, in one embodiment, the third locking member 571 and the fourth locking member 572 are engaged such that the third locking member 571 includes at least two retaining protrusions disposed on the implanter assembly 400, and the fourth locking member 572 includes retaining grooves disposed on the protective cap 510 corresponding to the retaining protrusions, and the retaining protrusions are engaged with the retaining grooves for positioning. For example, the two limiting grooves and the two limiting protrusions are distributed on the outer surface of the protective cap 510 at equal intervals along the circumferential direction, so that cost is saved.
To facilitate assembly of the implanter assembly 400 with the protective cap 510, a guide slot 573 is further provided at an opening of the limiting slot, for example, the guide slot 573 communicates with the limiting slot through the opening of the limiting slot and is perpendicular to the limiting slot, the opening of the guide slot 573 facing the implanter assembly 400.
In one embodiment, as shown in fig. 8 and 9, the third locking member 571 is located on the inner wall of the implanter assembly 400, the protective cap 510 is provided with a ring of flange, and the fourth locking member 572 and the guide groove 573 are located on the flange.
The first locking part 530, the second locking part 540, the third locking part 560 and the fourth locking part of the present invention are fitted to each other. The release of the first locking portion 530 is premised on the release of the fourth locking portion, so that the protective cap 510 can be rotated in the first direction to release the fourth locking portion only when the trigger member 533 is pressed to release the first locking portion 530. Second lock 540 ensures that body surface attachment unit 200 is relatively stationary with holding portion 520 when cap 510 is turned and third lock 560 ensures that body surface attachment unit 200 is relatively stationary with hub 551 when cap 510 is turned, and in sum, the cooperation of second lock 540 with third lock 560 achieves that holding portion 520, body surface attachment unit 200 and hub 551 are all in a relatively stationary state when cap 510 is turned, which ensures that turning cap 510 in the second direction brings first lock 530 and second lock 540 to a locked state simultaneously when sterilization assembly 500 is assembled.
The invention can effectively prevent the sensor electrode 210 and the puncture needle 552 from being exposed outside because the protective cap 510 is separated from the needle seat 551 (namely, the sensor electrode 210) by manual operation before the product is formally used, and prevent the sensor electrode 210 and the puncture needle 552 from being polluted by bacteria and being incapable of being normally used.
The body surface attaching unit 200 and the mounting structure of the body surface attaching unit 200 and the needle assembly 550 in the present invention are disclosed in detail in the previously filed chinese patent 202111426719.8, and thus, they are not described in detail in the present invention.
The foregoing description, in such full, clear, concise and exact terms, provides the best mode contemplated of carrying out the present invention, and the manner and process of making and using it, to enable any person skilled in the art to which it pertains, to make and use the same. The invention is, however, susceptible to modifications and alternative constructions from that described above which are fully equivalent. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed. Rather, the invention is to cover all modifications and alternative constructions falling within the spirit and scope of the invention as generally expressed by the following claims, which particularly point out and distinctly define the subject matter of the invention. While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative and not restrictive.
Unless otherwise defined, all terms (including technical and scientific terms) are to be given their ordinary and customary meaning to those skilled in the art, and are not to be taken as limiting to a specific or special meaning unless expressly defined herein. It should be noted that the use of particular terminology when describing certain features or aspects of the disclosure should not be taken to imply that the terminology is being redefined herein to be restricted to including any specific characteristics or aspects of the disclosure with which that terminology is associated. The terms and phrases used in this application, and variations thereof, particularly in the appended claims, should be construed to be open ended and not limiting unless otherwise expressly stated. As an example of the foregoing, the term "including" shall mean "including but not limited to" or the like.
Furthermore, although the foregoing has been described in some detail by way of illustration and example for purposes of clarity and understanding, it will be apparent to those of ordinary skill in the art that certain changes and modifications may be practiced. Therefore, the description and examples should not be construed as limiting the scope of the invention to the particular embodiments and examples described herein, but rather as covering all modifications and alternatives falling within the true scope and spirit of the invention.
Claims (22)
1. An analyte concentration monitoring system comprising an implanter assembly and a sterilization assembly, the sterilization assembly comprising a sensor electrode and a protective cap, the protective cap having a sealed sterilization chamber formed therein, an in vivo portion of the sensor electrode being disposed in the sterilization chamber, characterized in that: the protective cap is provided with a trigger member configured to be operated to separate the protective cap from the sensor electrode, the sterilization assembly further comprising a holder with a first locking portion formed therebetween, the first locking portion being configured to prevent rotation of the protective cap relative to the holder in a first direction;
the first locking portion is released when the trigger member is operated.
2. The analyte concentration monitoring system of claim 1, wherein: allowing operation of the trigger means to detach the protective cap from the sensor electrode when the sterilization assembly is coupled to the implanter assembly.
3. The analyte concentration monitoring system of claim 1, wherein: the first locking portion includes a first locking member disposed on the holding portion and a second locking member disposed on the protective cap, the first locking member being cooperatively locked with the second locking member.
4. The analyte concentration monitoring system of claim 3, wherein: the first and second locking members are located on the same circumference.
5. The analyte concentration monitoring system of claim 3, wherein: the free end of the first locking member has a resilient tendency to splay towards the second locking member.
6. The analyte concentration monitoring system of claim 5, wherein: the free end of the first locking member is biased in a direction away from the second locking member in response to actuation of the trigger member.
7. The analyte concentration monitoring system of claim 6, wherein: the trigger member is a button disposed on the protective cap.
8. The analyte concentration monitoring system of claim 7, wherein: the button is formed with a guide slope facing the first locking member.
9. The analyte concentration monitoring system of claim 7, wherein: the button is a disposable button arranged on the protective cap.
10. The analyte concentration monitoring system of claim 9, wherein: the protective cap is provided with an operation hole for accommodating a button, a first limiting part is formed inside the operation hole, a second limiting part is formed on the button, and the first limiting part and the second limiting part form interlocking limiting when the button is pressed down.
11. The analyte concentration monitoring system of claim 3, wherein: the second locking component is an arc-shaped rib which extends along the circumferential direction, and a channel for the first locking component to pass through is formed between the second locking component and the protective cap.
12. The analyte concentration monitoring system of claim 11, wherein: the second locking member is an arc-shaped rib extending in both a second direction and a radially inward direction, the second direction being opposite to the first direction.
13. The analyte concentration monitoring system of claim 1, wherein: the protective cap is coupled to the implanter assembly via a retaining portion.
14. The analyte concentration monitoring system of claim 1, wherein: the sterilization assembly further includes a body surface attachment unit mounted into the protective cap, a second locking portion formed between the body surface attachment unit and the holding portion, the second locking portion being configured to prevent the holding portion from rotating relative to the body surface attachment unit in the first or second direction.
15. The analyte concentration monitoring system of claim 14, wherein: the second locking part comprises a plurality of bayonets distributed on the edge of the body surface attachment unit along the circumferential direction and clamping blocks distributed on the holding part and corresponding to the bayonets, and the bayonets and the clamping blocks are matched and locked.
16. The analyte concentration monitoring system of claim 14, wherein: the sterilization assembly further includes a needle assembly mounted to the body surface attachment unit, the needle assembly including a needle hub and a puncture needle attached to the needle hub, a third lock portion formed between the needle hub and the body surface attachment unit, the third lock portion configured to prevent rotation of the needle hub relative to the body surface attachment unit in the first or second direction.
17. The analyte concentration monitoring system of claim 16, wherein: the third locking part comprises a special-shaped waist part formed on the needle seat and a boss with a special-shaped hole formed on the body surface attachment unit, and when the needle assembly is installed on the body surface attachment unit, the special-shaped waist part is embedded into the special-shaped hole of the boss and is matched and locked with the special-shaped hole.
18. The analyte concentration monitoring system of claim 16, wherein: a fourth locking portion is formed between the protective cap and the implanter assembly and configured to prevent rotation of the protective cap relative to the implanter assembly in the second direction and to prevent movement of the protective cap in a direction away from the implanter assembly.
19. The analyte concentration monitoring system of claim 18, wherein: the fourth locking portion includes a third locking member disposed on the implanter assembly and a fourth locking member disposed on the protective cap, the third and fourth locking members cooperatively locking.
20. The analyte concentration monitoring system of claim 16, wherein: the puncture needle is sleeved on the internal part of the sensor electrode and is configured in the sterilization cavity together with the internal part of the sensor electrode.
21. A method of using an analyte concentration monitoring system, the method being implemented by the analyte concentration monitoring system according to any one of claims 1 to 20, wherein: comprising detaching the protective cap from the sensor electrode only upon operation of said trigger member.
22. The method of using an analyte concentration monitoring system according to claim 21, wherein: the trigger member is a button which only causes the protective cap to be separated from the sensor electrode when the button is depressed.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210610737.XA CN114680882A (en) | 2022-06-01 | 2022-06-01 | Analyte concentration monitoring system and method of use |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210610737.XA CN114680882A (en) | 2022-06-01 | 2022-06-01 | Analyte concentration monitoring system and method of use |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN114680882A true CN114680882A (en) | 2022-07-01 |
Family
ID=82131182
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210610737.XA Pending CN114680882A (en) | 2022-06-01 | 2022-06-01 | Analyte concentration monitoring system and method of use |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN114680882A (en) |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107949314A (en) * | 2015-12-30 | 2018-04-20 | 德克斯康公司 | Transcutaneous analyte sensors system and method |
| CN109952072A (en) * | 2016-11-11 | 2019-06-28 | 德尔格制造股份两合公司 | The protective cover of component for Medical Devices |
| US20200178899A1 (en) * | 2017-06-02 | 2020-06-11 | I-Sens, Inc. | Sensor applicator assembly for continuous glucose monitoring system |
| CN211511817U (en) * | 2019-06-26 | 2020-09-18 | 三诺生物传感股份有限公司 | Automatic push pin takes out from mechanism and dynamic blood glucose meter with implanting instrument |
| CN215227644U (en) * | 2020-12-23 | 2021-12-21 | 三诺生物传感股份有限公司 | Implant device and sensor implanting mechanism thereof |
| CN114391834A (en) * | 2021-11-27 | 2022-04-26 | 苏州百孝医疗科技有限公司 | Body surface attachment unit |
| CN114431855A (en) * | 2022-01-20 | 2022-05-06 | 苏州百孝医疗科技有限公司 | Transdermal analyte sensor system and method of use |
-
2022
- 2022-06-01 CN CN202210610737.XA patent/CN114680882A/en active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107949314A (en) * | 2015-12-30 | 2018-04-20 | 德克斯康公司 | Transcutaneous analyte sensors system and method |
| CN109952072A (en) * | 2016-11-11 | 2019-06-28 | 德尔格制造股份两合公司 | The protective cover of component for Medical Devices |
| US20200178899A1 (en) * | 2017-06-02 | 2020-06-11 | I-Sens, Inc. | Sensor applicator assembly for continuous glucose monitoring system |
| CN211511817U (en) * | 2019-06-26 | 2020-09-18 | 三诺生物传感股份有限公司 | Automatic push pin takes out from mechanism and dynamic blood glucose meter with implanting instrument |
| CN215227644U (en) * | 2020-12-23 | 2021-12-21 | 三诺生物传感股份有限公司 | Implant device and sensor implanting mechanism thereof |
| CN114391834A (en) * | 2021-11-27 | 2022-04-26 | 苏州百孝医疗科技有限公司 | Body surface attachment unit |
| CN114431855A (en) * | 2022-01-20 | 2022-05-06 | 苏州百孝医疗科技有限公司 | Transdermal analyte sensor system and method of use |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US20230046619A1 (en) | Analyte sensor devices, connections, and methods | |
| US20230125528A1 (en) | Medical device inserters and processes of inserting and using medical devices | |
| CN113499126B (en) | Implanter and implantation method | |
| WO2023138571A1 (en) | Transdermal analyte sensor system and method of use | |
| WO2023092912A1 (en) | Body surface attachment unit | |
| CN113499067A (en) | Electrode fixing structure of separated sensor | |
| WO2023108943A1 (en) | Implantable device and method for using same | |
| CN114391836B (en) | Transdermal analyte sensor system | |
| CN114680882A (en) | Analyte concentration monitoring system and method of use | |
| CN216060518U (en) | Medical equipment and medical auxiliary device | |
| CN117897091A (en) | Analyte sensor immobilization device | |
| CN115919301A (en) | Analyte detection device mounting unit | |
| CN117715586A (en) | Systems, devices, and methods for analyte monitoring | |
| CN219166414U (en) | Continuous blood glucose monitor | |
| CN115868973A (en) | Analyte detection device mounting unit | |
| CN219167165U (en) | Continuous blood glucose monitor sterilization assembly and continuous blood glucose monitor | |
| CA3197901A1 (en) | Devices for analyte monitoring | |
| CN116033869A (en) | Systems, devices, and methods for analyte monitoring | |
| CN116723796A (en) | Systems, devices, and methods for analyte monitoring | |
| CN219166415U (en) | In-vivo blood sugar monitoring device | |
| CN219166416U (en) | Continuous blood sugar monitoring device | |
| CN216907974U (en) | Needle assisting device assembly and automatic implanting installation mechanism of dynamic blood glucose meter | |
| CN115770306A (en) | Continuous blood glucose monitor sterilization assembly and sterilization method | |
| EP4005478A1 (en) | Insertion device | |
| CN115868970A (en) | Analyte detection device mounting unit |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination |