CN114431855B - Transcutaneous analyte sensor systems and methods of use - Google Patents
Transcutaneous analyte sensor systems and methods of use Download PDFInfo
- Publication number
- CN114431855B CN114431855B CN202210066360.6A CN202210066360A CN114431855B CN 114431855 B CN114431855 B CN 114431855B CN 202210066360 A CN202210066360 A CN 202210066360A CN 114431855 B CN114431855 B CN 114431855B
- Authority
- CN
- China
- Prior art keywords
- cap
- locking member
- locking
- assembly
- analyte sensor
- 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.)
- Active
Links
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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
- A61B5/14503—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/24—Hygienic packaging for medical sensors; Maintaining apparatus for sensor hygiene
- A61B2562/247—Hygienic covers, i.e. for covering the sensor or apparatus during use
Landscapes
- 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
本发明提供一种经皮分析物传感器系统及使用方法，系统包括植入器组件和灭菌组件，所述灭菌组件包括传感器电极和帽，所述帽内形成有密封的灭菌腔体，所述传感器电极的体内部分被配置在灭菌腔体中，仅在所述灭菌组件耦合到植入器组件上时允许帽与传感器电极分离以使得传感器电极离开灭菌腔体。本发明能够避免在正式使用前以转动的方式分离帽与传感器电极，确保传感器电极在正式使用前均处于无菌环境。
The present invention provides a transcutaneous analyte sensor system and a method of using the same. The system includes an implanter assembly and a sterilization assembly. The sterilization assembly includes a sensor electrode and a cap. A sealed sterilization cavity is formed in the cap. The internal part of the sensor electrode is arranged in the sterilization cavity. The cap is allowed to separate from the sensor electrode only when the sterilization assembly is coupled to the implanter assembly so that the sensor electrode leaves the sterilization cavity. The present invention can avoid separating the cap from the sensor electrode in a rotating manner before formal use, and ensure that the sensor electrode is in a sterile environment before formal use.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a percutaneous analyte sensor system and a using method thereof.
Background
Some physiological diseases have long disease course and prolonged illness, and certain physiological parameters of a host need to be monitored in real time to better track treatment. Such as diabetes, requires real-time monitoring of the host's blood glucose. Accurate blood glucose self-monitoring is a key for realizing good blood glucose control, is beneficial to evaluating the degree of glucose metabolic disturbance of diabetics, and makes a blood glucose reducing scheme, and simultaneously reflects the blood glucose reducing treatment effect and guides the adjustment of the treatment scheme.
Currently, the most widely used blood glucose meter is available on the market, and the patient needs to collect finger peripheral blood by himself to measure the blood glucose level at that time. However, this method has the following drawbacks: 1. the condition of the blood glucose level change between two measurements cannot be known, and a patient may miss blood glucose peaks and valleys, so that complications are caused, and irreversible injury is caused to the patient; 2. the finger tips puncture and blood sampling for many times every day causes great pain to diabetics. In order to overcome the above-mentioned drawbacks, it is necessary to provide a method for continuously monitoring the blood sugar of a patient, which is convenient for the patient to know his or her blood sugar status in real time and to take countermeasures accordingly in time, so as to effectively control the illness state, prevent complications and obtain higher quality of life.
In response to the above-mentioned needs, the skilled person has developed a monitoring technology capable of being implanted into subcutaneous tissue to continuously monitor subcutaneous blood sugar, the technology is characterized in that a sensor electrode is penetrated into subcutaneous tissue, the sensor electrode generates an electric signal when the liquid between tissues of a patient and glucose in the body react, the electric signal is converted into blood sugar readings through a transmitter, the blood sugar readings are transmitted to a wireless receiver every 1-5 minutes, and corresponding blood sugar data are displayed on the wireless receiver and a map is formed for reference of the patient and doctors.
The sensor electrode and the lancet are required to be sterile when inserted into the subcutaneous tissue, and some continuous blood glucose monitoring systems employ a separate sterilization process to sterilize the sensor electrode and the electronic components, such as radiation sterilization, which can harm the electronic components associated with the sensor electrode and thus typically sterilize the electronic components using, for example, ethylene oxide. However, ethylene oxide may damage chemicals on the sensor electrode, and thus, integrating the sensor electrode and electronic components into one unit may complicate the sterilization process.
These problems can be bypassed by separating the components into a sensor unit (comprising sensor electrodes) and an emitter unit (comprising electronic components), so that each component can be individually packaged and sterilized using appropriate sterilization methods. For example, the sensor unit may be stored in a cap after sterilization, and a sterile cavity for accommodating the sensor electrode is formed between the cap and the sensor unit, and the cap and the sensor unit may be assembled or separated by rotating the cap, which may cause the cap to be mishandled, so that the cap and the sensor unit may be separated before formal use, and the sterile environment of the sensor unit may be damaged, so that the sensor unit may not be used.
Disclosure of Invention
The invention aims to provide a percutaneous analyte sensor system and a using method thereof, which can avoid separating a cap and a sensor electrode in a rotating way before formal use and ensure that the sensor electrode is in a sterile environment before formal use.
In order to achieve the aim of the invention, the invention adopts the following technical scheme: a transdermal analyte sensor system includes an implant assembly and a sterilization assembly including a sensor electrode and a cap having a sealed sterilization cavity formed therein, an in-vivo portion of the sensor electrode being configured in the sterilization cavity, the cap being allowed to separate from the sensor electrode only when the sterilization assembly is coupled to the implant assembly such that the sensor electrode exits the sterilization cavity.
In the above-described aspect, the cap is configured to be rotationally separated from the sensor electrode along the first direction.
In the above aspect, the sterilization assembly further includes a retaining portion formed with a first locking portion therebetween, the first locking portion configured to prevent rotation of the cap relative to the retaining portion in a first direction, the first locking portion being released when the sterilization assembly is coupled to the implant assembly.
In the above technical solution, the first locking portion includes a first locking member disposed on the holding portion and a second locking member disposed on the cap, and the first locking member and the second locking member are cooperatively locked.
In the above technical solution, the first locking member is located radially inside or radially outside the second locking member.
In the above-described aspect, the second locking member has a step formed thereon, and the step moves from the base portion of the first locking member to the free end of the first locking member in the second direction such that the free end of the first locking member abuts in the step.
In the above technical solution, the free end of the first locking member has an elastic tendency to open towards the second locking member.
In the above technical solution, the second locking member is an arc rib extending along a circumferential direction.
In the above technical solution, the second locking member is an arc rib extending and arranged along the second direction and the radially inward direction at the same time.
In the above aspect, the implant assembly is formed with a release member for releasing the first locking portion.
In the above aspect, the cap is coupled to the implanter component via the retainer.
In the above-described aspect, the sterilization assembly further includes a body surface attachment unit mounted into the cap, a second locking portion being 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 scheme, 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 of the corresponding bayonets distributed on the holding part, and the bayonets are matched and locked with the clamping blocks.
In the above-described aspect, 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 locking portion being formed between the needle hub and the body surface attachment unit, the third locking portion being configured to prevent rotation of the needle hub relative to the body surface attachment unit in the first or second direction.
In the above technical scheme, 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 mounted 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.
In the above technical solution, a fourth locking portion is formed between the needle holder and the cap, and the fourth locking portion is configured to prevent the cap from rotating relative to the needle holder in the second direction and prevent the cap from moving in a direction away from the needle holder.
In the above technical solution, the fourth locking portion includes a third locking member disposed on the needle holder and a fourth locking member disposed on the cap, and the third locking member and the fourth locking member are cooperatively locked.
In the technical scheme, a sleeve for limiting a sterilization cavity is formed in the cap;
The third locking component comprises at least two limiting grooves arranged on the outer surface of the needle seat, the fourth locking component comprises limiting protrusions arranged on the end part of the sleeve and corresponding to the limiting grooves, and the limiting protrusions are matched with the limiting grooves for positioning;
The opening of the limiting groove faces to the first direction.
In the technical scheme, the limit grooves are distributed on the outer surface of the needle seat at equal intervals along the circumferential direction.
In the technical scheme, the puncture needle is sleeved on the inner body part of the sensor electrode and is arranged in the sterilization cavity together with the inner body part of the sensor electrode.
The present invention also provides a method of using a transdermal analyte sensor system, comprising allowing separation of the cap from the sensor electrode such that the sensor electrode exits the sterilization chamber only when the sterilization assembly is coupled to the implanter assembly.
In the above-described aspect, the cap is separated from the sensor electrode in such a manner that the cap is rotated in the first direction.
In the above technical solution, the fourth locking portion is released during rotation of the cap in the first direction.
Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:
the invention enables the cap to be rotationally decoupled from the sensor electrode only when the sterilization assembly is coupled to the implanter assembly, thereby avoiding rotational decoupling of the cap from the sensor electrode prior to actual use and ensuring that the sensor electrode is in a sterile environment prior to actual use.
Drawings
FIG. 1 is a schematic diagram of a continuous blood glucose monitoring system in accordance with an embodiment of the present invention.
Fig. 2 is a schematic diagram of a continuous blood glucose monitoring system in accordance with an embodiment of the present invention.
Fig. 3 is a schematic view showing a structure of a sterilization module in an initial state of installation of a holding portion according to an embodiment of the present invention.
Fig. 4 is a schematic view showing a structure of a sterilization module in a completed state of installation of a holding portion according to an embodiment of the present invention.
Fig. 5 is a schematic cross-sectional view of a sterilization assembly of an embodiment of the present invention mounted to an implant assembly.
Fig. 6 is a schematic view of the limit bump according to the embodiment of the present invention not being installed in the limit groove.
FIG. 7 is a schematic view of the limit projection of the embodiment of the present invention beginning to be fitted into the limit groove.
Fig. 8 is a schematic view of the limit projection of the embodiment of the present invention fully fitting into the limit groove.
Wherein: 100. a host; 200. a body surface attachment unit; 210. a sensor electrode; 300. a receiver; 400. an implanter component; 410. a release member; 500. a sterilization assembly; 510. a cap; 520. a holding section; 530. a first locking portion; 531. a first locking member; 532. a second locking member; 533. a step; 534. a base; 535. a free end; 540. a second locking portion; 541. a bayonet; 542. a clamping block; 550. a needle assembly; 551. a needle stand; 552. a puncture needle; 560. a third locking portion; 561. a profiled waist; 562. a boss; 570. a fourth locking part; 571. a third locking member; 572. a fourth locking member; 573. a guide groove; 580. a sleeve.
Detailed Description
The following description and examples illustrate some exemplary embodiments of the disclosed invention. Those skilled in the art will recognize that many variations and modifications may exist to the embodiments of the present invention.
Continuous blood glucose monitoring (CGM, continuous Glucose Monitoring) system
Referring to fig. 1, a schematic diagram of a continuous blood glucose monitoring system attached to a host 100 is shown. There is shown a continuous blood glucose monitoring system comprising a body surface attachment unit 200 with sensor electrodes 210 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 electrode 210, through which the information of the glucose concentration monitored by the sensor electrode 210 is transmitted to the receiver 300, and the receiver 300 may be typically a smart phone, a smart watch, a dedicated device, and the like. In use, the sensor electrode 210 is partially positioned under the skin of the host 100 and in contact with the subcutaneous tissue fluid.
The sensor electrode 210 includes an in-vivo portion, which refers to a portion that is implanted subcutaneously in the host 100 in contact with the subcutaneous tissue fluid, and an in-vitro portion, which refers to a portion that is left outside the skin of the host 100. In one embodiment, the external portion of the sensor electrode 210 protrudes 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, which is a schematic structural view of a continuous blood glucose monitoring system, including an implant assembly 400 and a sterilization assembly 500, the implant assembly 400 and the sterilization assembly 500 are placed in two separate packages, respectively, after sterilization, and the sterilization assembly 500 includes a cap 510 and a body surface attachment unit 200 with sensor electrodes 210 disposed in the cap 510. In use, the two packages are opened separately, and only when the sterilization assembly 500 is mounted to the implanter assembly 400, the cap 510 is allowed to be removed from the implanter assembly 400 by rotating the cap 510 of the sterilization assembly 500 such that the cap 510 is separated from the sensor electrode 210, thereby exposing the sensor electrode 210, and then the open end of the implanter assembly 400 is attached to the skin surface of the host 100, and 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 body part of the sensor electrode 210 is implanted under the skin of the host 100 and 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, leaving only the body surface attachment unit 200 on the skin surface of the host 100.
The present invention selects the manner of rotating the cap 510 in the first direction as the optimal scheme for achieving the separation of the cap 510 from the sensor electrode 210, but is not limited thereto, and the scheme of achieving the separation of the cap 510 from the sensor electrode 210 in other manners should be understood as an approximation of the optimal scheme described above and is included in the scope of the present invention. For example, the cap 510 may be separated from the sensor electrode 210 by plugging in the axial direction of the sterilization assembly 500, or in a radial direction or in an angular direction relative to the axial direction.
The adhesive layer may be, for example, a medical nonwoven tape.
Referring now to fig. 3, the present invention provides a transdermal analyte sensor system, such as the continuous blood glucose monitoring system described above, and more particularly, a new sterilization assembly 500 configuration that improves the removal of cap 510, the sterilization assembly 500 allowing the cap 510 to be rotationally decoupled from the sensor electrode 210 in a first direction only when coupled to the implant assembly 400. In one embodiment, the first direction may be a clockwise direction.
With continued reference to fig. 3, the sterilization assembly 500 includes a cap 510, a body surface attachment unit 200 disposed in the cap 510, a sensor electrode 210 attached to the body surface attachment unit 200, and a holding portion 520 disposed in the cap 510, with a first locking portion 530 formed between the holding portion 520 and the cap 510, the first locking portion 530 including two operating states, a locked state and a released state. When the sterilization assembly 500 is not mounted to the implant assembly 400, the first locking portion 530 is in a locked state; the first locking portion 530 is in a released state when the sterilization assembly 500 is mounted to the implant assembly 400. When the first locking part 530 is in the locked state, the first locking part 530 is configured to prevent the cap 510 from rotating relative to the holding part 520 in the first direction; when the first locking portion 530 is in the released state, the first locking portion 530 is configured to allow the cap 510 to rotate in a first direction.
With continued reference to fig. 3, the first locking part 530 includes a first locking member 531 disposed on the holding part 520 and a second locking member 532 disposed on the cap 510, and the first locking member 531 is cooperatively locked with the second locking member 532.
In one embodiment, the first locking member 531 is located radially inward of the second locking member 532; in another embodiment, the first locking member 531 is located radially outward of 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 the step 533 is formed on the second locking member 532, and when the holding portion 520 is mounted on the cap 510, by rotating the cap 510 in the second direction, the step 533 on the second locking member 532 moves along the second direction from the base 534 of the first locking member 531 to the free end 535 of the first locking member 531 along with the rotation of the cap 510, so that the free end 535 of the first locking member 531 abuts in the step 533, and at this time, the mounting of the holding portion 520 is completed, and the first locking member 531 is engaged with the second locking member 532. Fig. 3 shows an initial state of the mounting of the holding portion 520, and fig. 4 shows a completed state of the mounting of the holding portion 520. In one embodiment, the second direction may be a counterclockwise direction.
In one embodiment, the first locking member 531 is a piece of resilient plastic having a free end 535 with a resilient tendency to splay toward the second locking member 532. For example, during movement of the step 533 on the second locking member 532 in the second direction from the base 534 of the first locking member 531 to the free end 535 of the first locking member 531, the free end 535 of the first locking member 531 will move in the first direction from the end of the second locking member 532 remote from the step 533 into the step 533, during movement of the free end 535 of the first locking member 531 the second locking member 532 will provide a force pushing the free end 535 of the first locking member 531 in a radial direction, and upon movement of the free end 535 of the first locking member 531 to the step 533 the elastic tendency of the free end 535 of the first locking member 531 will overcome the force causing the free end 535 of the first locking member 531 to abut in the step 533.
In one embodiment, the second locking member 532 is an arcuate rib, i.e., a co-radial rib, disposed to extend in a circumferential direction; in another embodiment, the second locking member 532 is an arcuate rib, i.e., a variable diameter rib, extending in both the second direction and the radially inward direction. Based on both embodiments, during the movement of the free end 535 of the first locking member 531, the free end 535 of the first locking member 531 contacts and slides over one side surface of the arcuate rib.
Referring to fig. 5, the implant assembly 400 is formed with a release member 410 for releasing the first locking portion 530, and the implant assembly 400 includes an implant housing and an inner member disposed within the implant housing. In one embodiment, the release member 410 is configured on the implant housing; in another embodiment, the release member 410 is disposed on the inner member. When sterilization assembly 500 is mounted to implant assembly 400, release member 410 drives first locking member 531 away from second locking member 532 such that first locking member 531 is offset from second locking member 532, thereby disengaging free end 535 of first locking member 531 from step 533, at which point first locking portion 530 is in a released state, allowing cap 510 to rotate in a first direction. The surface of the release member 410 facing the first locking member 531 may be a guiding slope, which is advantageous in that the first locking member 531 is pushed away by the release member 410 in a linear manner during the mounting of the sterilization assembly 500 to the implanter assembly 400, thereby improving the smoothness of the mounting of the sterilization assembly 500 to the implanter assembly 400.
With continued reference to fig. 5, the cap 510 is coupled to the implant assembly 400 by a retaining portion 520, e.g., the retaining portion 520 has a plurality of hooks formed thereon that extend toward the implant assembly 400, and the implant housing or inner member of the implant has a corresponding hole formed therein that passes through the hole and hooks around the edge of the hole when the sterilization assembly 500 is mounted to the implant assembly 400, thereby coupling the retaining portion 520 to the implant assembly 400.
With continued reference to fig. 3, a second locking portion 540 is formed between the body surface attachment unit 200 and the holding portion 520, the second locking portion 540 being configured to prevent the holding portion 520 from rotating relative to the body surface attachment unit 200 in the first or second direction. In one embodiment, the second locking part 540 includes a plurality of bayonets 541 circumferentially distributed at the edge of the body surface attachment unit 200 and a plurality of cartridges 542 distributed on the holding part 520 corresponding to the bayonets 541, and when the holding part 520 is mounted on the cap 510, the cartridges 542 are embedded in the bayonets 541 and are cooperatively locked with the bayonets 541.
The sterilization assembly 500 further includes a needle assembly 550, the needle assembly 550 including a needle hub 551 and a piercing needle 552 attached to the needle hub 551, a third locking portion 560 being formed between the needle hub 551 and the body surface attachment unit 200, the third locking portion 560 being configured to prevent rotation of the needle hub 551 relative to the body surface attachment unit 200 in the first or second direction. In one embodiment, the third locking portion 560 includes 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, the shaped waist 561 being inserted into and locked with the shaped hole of the boss 562 when the needle assembly 550 is mounted to the body surface attachment unit 200.
Referring to fig. 6, a fourth locking portion 570 is formed between the cap 510 and the needle assembly 550, the fourth locking portion 570 being configured to prevent the cap 510 from rotating relative to the needle mount 551 in the second direction and to prevent the cap 510 from moving in a direction away from the needle mount 551. The state of the fourth locking portion 570 is closely related to the state of the first locking portion 530. When the first locking part 530 is in the locked state, the fourth locking part 570 is also in the locked state; when the first locking part 530 is in the released state, the fourth locking part 570 is allowed to be converted to the released state. That is, releasing the first locking part 530 is a precondition for releasing the fourth locking part 570.
With continued reference to fig. 6, the fourth locking portion 570 includes a third locking member 571 disposed on the needle mount 551 and a fourth locking member 572 disposed on the cap 510, the third locking member 571 and the fourth locking member 572 cooperatively locking.
A sleeve 580 defining a sterilization chamber is formed within cap 510, and when third locking member 571 and fourth locking member 572 are cooperatively locked, sleeve 580 and hub 551 together define a sealed sterilization chamber, with needle 552 being sleeved over and disposed within the sterilization chamber along with the inner portion of sensor electrode 210 such that needle 552 is sterilized along with sensor electrode 210. In order to improve the sealing property of the sterilization chamber, a sealing member may be disposed between the sleeve 580 and the needle holder 551, for example, a rubber seal may be disposed on the needle holder 551, or a rubber seal may be disposed at an end portion of the sleeve 580.
With continued reference to fig. 6, in one embodiment, the third locking member 571 and the fourth locking member 572 cooperate in such a way that the third locking member 571 includes at least two limit grooves disposed on an outer surface of the hub 551, and the fourth locking member 572 includes limit protrusions disposed on an end portion of the sleeve 580 corresponding to the limit grooves, the limit protrusions being cooperatively positioned with the limit grooves; the opening of the limit groove faces to the first direction. For example, the limiting grooves are circumferentially and equally spaced on the outer surface of the needle seat 551, and two limiting grooves and two limiting protrusions are selected for cost saving.
In order to facilitate the assembly of the needle seat 551 and the cap 510, a guiding groove 573 is further provided at the opening of the limiting groove, for example, the guiding groove 573 is communicated with the limiting groove through the opening of the limiting groove and is perpendicular to the limiting groove, and the opening of the guiding groove 573 faces the cap 510.
The sterilization assembly 500 may be assembled by first installing the body surface attachment unit 200, then installing the needle assembly 550, and finally installing the holder 520.
In mounting the body surface attachment unit 200, the external portion of the sensor electrode 210 is first attached into the body surface attachment unit 200, and then the body surface attachment unit 200 is mounted into the cap 510.
When the needle assembly 550 is mounted, the shaped waist 561 of the needle holder 551 is inserted into the shaped hole of the body surface attachment unit 200, and the puncture needle 552 protrudes from the lower surface of the body surface attachment unit 200 together with the sensor electrode 210 after passing through the shaped hole, at this time, as shown in fig. 7, the stopper protrusion on the sleeve 580 is aligned with the guide groove 573 and the cap 510 is moved in the axial direction until the stopper protrusion reaches the junction of the guide groove 573 and the stopper groove.
Upon mounting the holding portion 520, please continue to refer to fig. 3, mounting the clip block 542 on the holding portion 520 into the cap 510 in alignment with the bayonet 541 on the body surface attachment unit 200; then, as shown in continued reference to fig. 4, rotating the cap 510 in the second direction until the free end 535 of the first locking member 531 abuts in the step 533 of the second locking member 532; during the rotation of the cap 510 in the second direction, as shown in fig. 8, the stopper protrusion moves from the junction of the guide groove 573 and the stopper groove to the closure of the stopper groove, and reaches the closure of the stopper groove while the free end 535 of the first locking member 531 abuts in the step 533 of the second locking member 532.
The first, second, third and fourth locking parts 530, 540, 560 and 570 of the present invention are engaged with each other. The release of the first locking portion 530 is premised on the release of the fourth locking portion 570 such that the cap 510 can be rotated in a first direction to release the fourth locking portion 570 only when the first locking portion 530 is released upon mounting the sterilization assembly 500 to the implant assembly 400. The second locking portion 540 ensures that the body surface attachment unit 200 is relatively stationary with respect to the holding portion 520 when the cap 510 is turned, and the third locking portion 560 ensures that the body surface attachment unit 200 is relatively stationary with respect to the needle mount 551 when the cap 510 is turned, and in combination, the cooperation of the second locking portion 540 with the third locking portion 560 achieves that the holding portion 520, the body surface attachment unit 200 and the needle mount 551 are all in a relatively stationary state when the cap 510 is turned, which ensures that the cap 510 is turned in the second direction when the sterilization assembly 500 is assembled such that the first locking portion 530 and the second locking portion 540 reach the locked state simultaneously.
The invention can effectively prevent the sensor electrode 210 and the puncture needle 552 from being exposed outside due to the separation of the cap 510 and the needle seat 551 (i.e. the sensor electrode 210) caused 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 unable to be used normally.
The body surface attachment unit 200 and the mounting structure of the body surface attachment unit 200 and the needle assembly 550 according to the present invention are disclosed in detail in the chinese patent 202111426719.8 of the prior application, and thus are not described in detail in the present invention.
The foregoing description provides the best mode contemplated for carrying out the present invention, as well as the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains to make and use the same. However, the invention is susceptible to fully equivalent modifications and alternative constructions from the above description. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed. On the contrary, the invention is intended to cover all modifications and alternative constructions falling within the spirit and scope of the invention, which is 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) have the same meaning as commonly understood by one of ordinary skill in the art and are not intended to be limited to one of ordinary skill in the art to which this application belongs unless explicitly defined herein. It should be noted that the use of a particular term when describing certain disclosed features or aspects should not be taken to imply that the term is being redefined herein to be restricted to including any disclosed features or aspects with which that term is associated. The terms and phrases used in the present application and variations thereof, particularly in the appended claims, should be construed in an open-ended, and not limiting sense, unless expressly stated otherwise. As an example of the foregoing, the term "comprising" shall mean "including but not limited to" or the like.
Furthermore, while 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 skilled in the art that certain changes and modifications may be practiced. Therefore, the description and examples should not be considered 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 (19)
1. A transdermal analyte sensor system comprising an implanter assembly and a sterilization assembly, the sterilization assembly comprising a body surface attachment unit with a sensor electrode and a cap having a sealed sterilization cavity formed therein, an in vivo portion of the sensor electrode being disposed in the sterilization cavity, characterized in that: allowing the cap to separate from the sensor electrode only when the sterilization assembly is coupled to the implanter assembly such that the sensor electrode exits the sterilization chamber;
the cap is configured to rotationally separate from the sensor electrode along a first direction;
The sterilization assembly further includes a retaining portion coupled to the implant assembly, the retaining portion and the cap defining a first locking portion therebetween, the first locking portion configured to prevent rotation of the cap relative to the retaining portion in a first direction, the first locking portion being released when the sterilization assembly is coupled to the implant assembly;
The first locking part comprises a first locking member arranged on the holding part and a second locking member arranged on the cap, and the first locking member and the second locking member are matched and locked;
Wherein 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.
2. The transdermal analyte sensor system of claim 1, wherein: the first locking member is located radially inward or radially outward of the second locking member.
3. The transdermal analyte sensor system of claim 1, wherein: the second locking member has a step formed thereon that moves in a second direction from the base of the first locking member to the free end of the first locking member such that the free end of the first locking member abuts in the step.
4. A transdermal analyte sensor system according to claim 3, wherein: the free end of the first locking member has a resilient tendency to splay towards the second locking member.
5. A transdermal analyte sensor system according to claim 3, wherein: the second locking member is an arc rib arranged along the circumferential extension.
6. A transdermal analyte sensor system according to claim 3, wherein: the second locking member is an arcuate rib extending in both the second direction and the radially inward direction.
7. The transdermal analyte sensor system of claim 1, wherein: the implant assembly has a release member formed thereon for releasing the first locking portion.
8. The transdermal analyte sensor system of claim 1, wherein: the cap is coupled to the implanter assembly via the retainer.
9. The transdermal analyte sensor system of claim 1, 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 of corresponding bayonets distributed on the holding part, and the bayonets are matched and locked with the clamping blocks.
10. The transdermal analyte sensor system of claim 9, wherein: the sterilization assembly further includes a needle assembly mounted to the body surface attachment unit, the needle assembly including a hub and a piercing needle attached to the hub, a third locking portion being formed between the hub and the body surface attachment unit, the third locking portion being configured to prevent rotation of the hub relative to the body surface attachment unit in the first or second direction.
11. The transdermal analyte sensor system of claim 10, 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.
12. The transdermal analyte sensor system of claim 10, wherein: a fourth locking portion is formed between the hub and the cap, the fourth locking portion being configured to prevent rotation of the cap relative to the hub in the second direction and to prevent movement of the cap in a direction away from the hub.
13. The transdermal analyte sensor system of claim 12, wherein: the fourth locking part comprises a third locking member arranged on the needle seat and a fourth locking member arranged on the cap, and the third locking member and the fourth locking member are matched and locked.
14. The transdermal analyte sensor system of claim 13, wherein: a sleeve defining a sterilization cavity is formed in the cap;
The third locking component comprises at least two limiting grooves arranged on the outer surface of the needle seat, the fourth locking component comprises limiting protrusions arranged on the end part of the sleeve and corresponding to the limiting grooves, and the limiting protrusions are matched with the limiting grooves for positioning;
The opening of the limiting groove faces to the first direction.
15. The transdermal analyte sensor system of claim 14, wherein: the limit grooves are distributed on the outer surface of the needle seat at equal intervals along the circumferential direction.
16. The transdermal analyte sensor system of claim 10, wherein: the piercing needle is sleeved on the inner body part of the sensor electrode and is configured in the sterilizing cavity together with the inner body part of the sensor electrode.
17. A method of using a transdermal analyte sensor system, based on the transdermal analyte sensor system of any one of claims 1-16, characterized in that: including allowing separation of the cap from the sensor electrode such that the sensor electrode exits the sterilization chamber only when the sterilization assembly is coupled to the implant assembly.
18. A method of using a transdermal analyte sensor system according to claim 17, wherein: the cap is separated from the sensor electrode in such a way that the cap is turned in a first direction.
19. A method of using a transdermal analyte sensor system according to claim 18, wherein: the fourth locking portion is released during rotation of the cap in the first direction.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210066360.6A CN114431855B (en) | 2022-01-20 | 2022-01-20 | Transcutaneous analyte sensor systems and methods of use |
| PCT/CN2023/072589 WO2023138571A1 (en) | 2022-01-20 | 2023-01-17 | Transdermal analyte sensor system and method of use |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210066360.6A CN114431855B (en) | 2022-01-20 | 2022-01-20 | Transcutaneous analyte sensor systems and methods of use |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN114431855A CN114431855A (en) | 2022-05-06 |
| CN114431855B true CN114431855B (en) | 2024-11-12 |
Family
ID=81367093
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210066360.6A Active CN114431855B (en) | 2022-01-20 | 2022-01-20 | Transcutaneous analyte sensor systems and methods of use |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN114431855B (en) |
| WO (1) | WO2023138571A1 (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114431855B (en) * | 2022-01-20 | 2024-11-12 | 苏州百孝医疗科技有限公司 | Transcutaneous analyte sensor systems and methods of use |
| CN114680882A (en) * | 2022-06-01 | 2022-07-01 | 苏州百孝医疗科技有限公司 | Analyte concentration monitoring system and method of use |
| CN115770306A (en) * | 2022-12-06 | 2023-03-10 | 江苏鱼跃凯立特生物科技有限公司 | Continuous blood glucose monitor sterilization assembly and sterilization method |
| CN115844396A (en) * | 2022-12-06 | 2023-03-28 | 江苏鱼跃凯立特生物科技有限公司 | In-vivo blood glucose monitoring device and continuous blood glucose monitor assembly |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104688332A (en) * | 2013-12-05 | 2015-06-10 | 韦伯斯特生物官能(以色列)有限公司 | Needle catheters utilizing optical spectroscopy for tumor identification and ablation |
| CN112423664A (en) * | 2018-06-07 | 2021-02-26 | 雅培糖尿病护理公司 | Focused sterilization and sterilized subassemblies for analyte monitoring systems |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP4214274B2 (en) * | 2001-06-11 | 2009-01-28 | アークレイ株式会社 | Puncture element integrated body |
| EP1900321A4 (en) * | 2005-06-27 | 2010-09-22 | Nat Inst Of Advanced Ind Scien | INTEGRATED BIOCAPTOR NEEDLE |
| WO2012118872A2 (en) * | 2011-02-28 | 2012-09-07 | Abbott Diabetes Care Inc. | Medical device inserters and processes of inserting and using medical devices |
| EP3922172B1 (en) * | 2015-12-30 | 2024-08-28 | Dexcom, Inc. | Transcutaneous analyte sensor systems and methods |
| US20170290535A1 (en) * | 2016-04-08 | 2017-10-12 | Medtronic Minimed, Inc. | Analyte sensor with indicators |
| CN206729891U (en) * | 2016-10-28 | 2017-12-12 | 三诺生物传感股份有限公司 | A kind of dynamic glucose instrument system and its sensor |
| EP4480412A3 (en) * | 2017-06-02 | 2025-03-26 | i-Sens, Inc. | Sensor applicator assembly for continuous glucose monitoring system |
| AU2018289327B2 (en) * | 2017-06-19 | 2021-07-01 | Dexcom, Inc. | Applicators for applying transcutaneous analyte sensors and associated methods of manufacture |
| CN211704640U (en) * | 2019-11-05 | 2020-10-20 | 微泰医疗器械(杭州)有限公司 | Needle assisting device for percutaneous implantation of sensor and medical system |
| CN113499126B (en) * | 2021-06-28 | 2022-07-19 | 苏州百孝医疗科技有限公司 | Implanter and implantation method |
| CN116172549B (en) * | 2021-11-26 | 2025-08-12 | 上海微创生命科技有限公司 | medical devices |
| CN113842141B (en) * | 2021-11-30 | 2022-03-29 | 上海微创生命科技有限公司 | Implanter, needle, sensor base, emitter assembly, sterilization case and implantation system |
| CN114431855B (en) * | 2022-01-20 | 2024-11-12 | 苏州百孝医疗科技有限公司 | Transcutaneous analyte sensor systems and methods of use |
-
2022
- 2022-01-20 CN CN202210066360.6A patent/CN114431855B/en active Active
-
2023
- 2023-01-17 WO PCT/CN2023/072589 patent/WO2023138571A1/en not_active Ceased
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104688332A (en) * | 2013-12-05 | 2015-06-10 | 韦伯斯特生物官能(以色列)有限公司 | Needle catheters utilizing optical spectroscopy for tumor identification and ablation |
| CN112423664A (en) * | 2018-06-07 | 2021-02-26 | 雅培糖尿病护理公司 | Focused sterilization and sterilized subassemblies for analyte monitoring systems |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2023138571A1 (en) | 2023-07-27 |
| CN114431855A (en) | 2022-05-06 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN114431855B (en) | Transcutaneous analyte sensor systems and methods of use | |
| US11246519B2 (en) | Medical device inserters and processes of inserting and using medical devices | |
| CN112294257B (en) | Physiological signal sensing device | |
| CN113499126B (en) | Implanter and implantation method | |
| CN114391834A (en) | Body surface attachment unit | |
| JP4562920B2 (en) | Holter type monitoring system with analyte sensor | |
| CN114391836B (en) | Transdermal analyte sensor system | |
| CN114391838B (en) | Implant and method of using the same | |
| CN113499067B (en) | Separate sensor electrode fixing structure | |
| CN114391835B (en) | Transdermal analyte sensor system | |
| CN216167445U (en) | Continuous blood glucose monitoring system | |
| CN118490217B (en) | An integrated invasive biosensor assembly | |
| CN217090730U (en) | Sterilization assembly | |
| CN217219010U (en) | Pre-attached analyte sensors | |
| CN114680882A (en) | Analyte concentration monitoring system and method of use | |
| CN116984858B (en) | An assembled implantable device for invasive biosensors | |
| CN215261825U (en) | Sensor base | |
| CN217090725U (en) | Mounting structure of sensor electrode | |
| CN215227657U (en) | Electrode assembly transfer device | |
| CN114391837B (en) | Continuous blood glucose monitoring system and method of use | |
| CN217090726U (en) | Sealing structure of body surface attachment unit | |
| CN215227656U (en) | Sensor with a sensor element | |
| CN222657058U (en) | In-body blood glucose monitoring device | |
| WO2024254033A1 (en) | Systems, devices, and methods for analyte monitoring | |
| CN119498837A (en) | Analyte detection device installation unit with sterile barrier |
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 | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Percutaneous analyte sensor system and methods of use Granted publication date: 20241112 Pledgee: Guangdong Didi Sha Tech Co., Ltd. Pledgor: Suzhou Baixiao Medical Technology Co.,Ltd. Registration number: Y2026980001457 |