CN114391835A - Transcutaneous analyte sensor system - Google Patents
Transcutaneous analyte sensor system Download PDFInfo
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- CN114391835A CN114391835A CN202111428966.1A CN202111428966A CN114391835A CN 114391835 A CN114391835 A CN 114391835A CN 202111428966 A CN202111428966 A CN 202111428966A CN 114391835 A CN114391835 A CN 114391835A
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- 239000012790 adhesive layer Substances 0.000 claims abstract description 31
- 238000002513 implantation Methods 0.000 claims abstract description 10
- 239000007943 implant Substances 0.000 claims abstract description 4
- 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 claims description 17
- 239000008103 glucose Substances 0.000 claims description 17
- 230000001954 sterilising effect Effects 0.000 claims description 11
- 238000004659 sterilization and disinfection Methods 0.000 claims description 10
- 238000007920 subcutaneous administration Methods 0.000 claims description 5
- 210000004369 blood Anatomy 0.000 description 23
- 239000008280 blood Substances 0.000 description 23
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14503—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
- A61B2560/04—Constructional details of apparatus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
- A61B2560/06—Accessories for medical measuring apparatus
Abstract
The present invention provides a transcutaneous analyte sensor system comprising an implanter unit and a body surface attachment unit coupled within the implanter unit, the body surface attachment unit comprising a sensor unit for detecting a level of an analyte beneath the skin of a host and an adhesive layer for applying the sensor unit to the skin surface of the host, the adhesive layer being covered with a release layer, the sensor unit comprising an electrode, the implanter unit being configured to implant the electrode partially beneath the skin of the host, and a cap coupled to the implanter unit or the sensor unit, the cap being configured to be removable prior to implantation of the electrode by the implanter unit and to peel the release layer from the adhesive layer simultaneously with removal of the cap. The invention can avoid that the sensor electrode can not be normally implanted due to stripping of the release paper, thereby improving the user experience.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a transcutaneous analyte sensor system.
Background
Some physiological diseases, which have long disease course and prolonged disease duration, need to monitor some physiological parameters of the host in real time to better track the treatment. Such as diabetes, require real-time monitoring of the host blood glucose. Accurate blood sugar self-monitoring is a key for realizing good blood sugar control, is beneficial to evaluating the degree of glucose metabolism disorder of a diabetic patient, formulating a blood sugar reduction scheme, and simultaneously reflecting the blood sugar reduction treatment effect and guiding the adjustment of the treatment scheme.
Currently, most commercially available instruments refer to blood glucose meters, and patients need to collect finger peripheral blood by themselves to measure the blood glucose level at that moment. However, this method has the following drawbacks: firstly, the change of the blood sugar level between two measurements cannot be known, and the peak value and the valley value of the blood sugar can be missed by a patient, so that complications are caused, and irreversible damage is caused to the patient; secondly, the finger tip puncture blood sampling is carried out for a plurality of times every day, which causes great pain for the diabetic. In order to overcome the above-mentioned drawbacks, it is necessary to provide a method for continuously monitoring blood sugar of a patient, so that the patient can conveniently know the blood sugar status of the patient in real time, and take measures in time to effectively control the state of an illness and prevent complications, thereby achieving a high quality of life.
Aiming at the requirements, technical personnel develop a monitoring technology which can be implanted into subcutaneous tissues to continuously monitor subcutaneous blood sugar, the technology is characterized in that a sensor electrode is inserted into the subcutaneous tissues, the sensor electrode generates oxidation reaction between interstitial fluid of a patient and glucose in a body, an electric signal is formed during the reaction, the electric signal is converted into blood sugar reading through a transmitter, the blood sugar reading is transmitted to a wireless receiver every 1-5 minutes, corresponding blood sugar data are displayed on the wireless receiver, and a map is formed for the patient and a doctor to refer.
Currently, a body surface attachment unit of a transdermal analyte sensor system, for example, a continuous blood glucose monitoring technology, needs to be attached to the skin surface of a host through an adhesive layer, in order to maintain the effectiveness of the adhesive layer, a release paper generally needs to be covered on the adhesive layer, and therefore, the release paper needs to be peeled off from the adhesive layer before implantation of a sensor electrode.
Disclosure of Invention
The invention aims to provide a transdermal analyte sensor system, which avoids the problem that sensor electrodes cannot be normally implanted due to stripping of release paper, and improves user experience.
In order to achieve the purpose of the invention, the technical scheme adopted by the invention is as follows: a transcutaneous analyte sensor system comprising an implanter unit and a body surface attachment unit coupled within the implanter unit, the body surface attachment unit comprising a sensor unit for sensing a level of an analyte beneath the skin of a host and an adhesive layer for applying the sensor unit to the skin surface of the host, the adhesive layer being covered with a release layer, the sensor unit comprising a sensor electrode, the implanter unit being configured to partially implant the sensor electrode beneath the skin of the host, and a cap coupled to the implanter unit or the sensor unit, the cap being configured to be removable prior to implantation of the sensor electrode by the implanter unit and to peel the release layer from the adhesive layer simultaneously with removal of the cap.
In the above technical solution, the implanter unit includes a puncture needle for guiding the sensor electrode into the host subcutaneous tissue, and the release layer is not in contact with the puncture needle when the cap is removed.
In the above solution, the cap is configured to be removed in a rotational manner.
In the technical scheme, the rotation direction of the cap is the same as the peeling direction of the release layer.
In the above-described aspect, the release layer is configured to be arranged on the adhesive layer in a spiral manner.
In the above technical solution, the release layer is configured to be sequentially peeled from an edge of the adhesive layer toward the middle following a rotation direction of the cap.
In the above technical scheme, the starting end of the release layer is provided with a fixing portion, and the release layer is coupled to the cap through the fixing portion.
In the above technical solution, the fixing portion is provided with a guide portion, the cap is provided with a fixing groove, and the guide portion is configured to guide the fixing portion into the fixing groove by passing through the fixing groove in an operation manner.
In the technical scheme, the fixing part is provided with a positioning hole, the inner wall of the fixing groove is provided with a positioning block, and the fixing part is buckled on the positioning block through the positioning hole;
the fixing groove is also inserted with a positioning plug, and the positioning plug is configured to prevent the fixing part from being separated from the positioning block.
In the above technical scheme, the release layer comprises two release fan rings, and the two release fan rings are spliced to form the annular release layer.
In the above technical solution, both the release fan rings are configured to peel off following the rotation direction of the cap.
In the above technical solution, the two release fan rings are configured to be sequentially adjacent to each other in the annular direction.
In the above technical solution, the two starting ends of the two release fan rings are respectively provided with a fixing portion, and the two release fan rings are respectively coupled to the cap through the respective fixing portions.
In the above technical solution, two fixing portions are respectively provided with one guide portion, the cap is provided with two fixing grooves, and the guide portions of the two fixing portions are configured to respectively pass through one fixing groove in an operation manner so as to guide the fixing portions into the corresponding fixing grooves.
In the above technical solution, two fixing portions are respectively provided with a positioning hole, inner walls of the two fixing grooves are respectively provided with a positioning block, and the two fixing portions are respectively buckled on the positioning block through the respective positioning holes;
the two fixing grooves are respectively inserted with a positioning plug, and the two positioning plugs are configured to prevent the fixing parts in the fixing grooves from being separated from the positioning blocks.
In the above technical scheme, the two release fan rings are arranged on the adhesive layer in a centrosymmetric manner by taking the central point of the annular release layer as a symmetric center.
In the above technical solution, a sterilization chamber is configured in the cap, and the sterilization chamber is configured to at least accommodate the sensor electrode and provide a sealed sterilization environment for the sensor electrode.
In the above technical solution, the analyte level is a glucose concentration.
Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:
1. according to the invention, the release layer is coupled on the cap, so that the release layer can be peeled off while the cap is removed, the operation is simple, the use is convenient, and the user experience is improved;
2. the release layer is peeled along with the removal of the cap, so that the peeling operation of the release layer is standardized, the falling of the body surface attachment unit caused by improper operation when the release layer is peeled by hands is avoided, and the effectiveness of electrode implantation is ensured;
3. the release layer is peeled along the rotation direction of the cap, so that the release layer is not contacted with the puncture needle in the peeling process, the bending deformation of the puncture needle caused by contact is avoided, and the effectiveness of electrode implantation is further ensured.
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 a schematic view of an initial state of cap removal according to an embodiment of the present invention.
Fig. 4 is a schematic view of a cap removal completion state according to an embodiment of the present invention.
Fig. 5 is a schematic view of a release layer of an embodiment of the present invention arranged in a spiral manner.
Fig. 6 is an assembled exploded view of a release layer of an embodiment of the present invention arranged in a spiral fashion.
Fig. 7 is an assembled cross-sectional view of a release layer of an embodiment of the present invention arranged in a spiral fashion.
Fig. 8 is a bottom schematic view of a cap with a release layer arranged in a spiral manner according to an embodiment of the present invention.
Fig. 9 is a schematic view of a release layer arranged in a release fan ring manner according to an embodiment of the present invention.
Fig. 10 is an assembled exploded view of the release layer of the embodiment of the present invention arranged in a release fan ring manner.
Fig. 11 is an assembled cross-sectional view of the release layer of the embodiment of the present invention arranged in a release fan ring manner.
Fig. 12 is a bottom schematic view of a cap with a release layer arranged in a release fan ring manner according to an embodiment of the present invention.
Wherein: 100. a host; 200. a body surface attachment unit; 210. a sensor electrode; 220. a release layer; 221. a fixed part; 222. positioning holes; 223. a guide portion; 224. cutting a line; 225. a release fan ring; 230. a sensor unit; 300. a receiver; 400. an implanter unit; 410. puncturing needle; 500. a cap; 510. fixing grooves; 511. positioning blocks; 520. a positioning plug; 530. sterilizing the cavity; 531. a hollow column; 532. a rubber seal ring; 540. and (5) labeling.
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
FIG. 1 is a schematic illustration of a continuous blood glucose monitoring system attached to a host 100. 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 for transmitting information on the glucose concentration monitored by the sensor electrodes 210 to the receiver 300, 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.
FIG. 2 is a schematic view of a continuous blood glucose monitoring system, which includes an implanter unit 400, a body surface attachment unit 200 and a cap 500, wherein the body surface attachment unit 200 is pre-assembled in the cap 500 and then assembled to the implanter unit 400 together with the cap 500, and when in use, the cap 500 is removed from the implanter unit 400 by rotating the cap 500, and at the same time, the release layer 220 covering the adhesive layer of the body surface attachment unit 200 is peeled off together with the removal of the cap 500; the open side of the implanter unit 400 is then fitted to the skin surface of the host 100, and the body surface attachment unit 200 inside the implanter unit 400 is applied to the skin surface of the host 100 by operating the implanter unit 400 while the sensor electrodes 210 are partially implanted under the skin of the host 100 in contact with the subcutaneous tissue fluid to continuously monitor the glucose concentration in the tissue fluid.
For example, the adhesive layer may be a medical grade nonwoven tape.
For example, the release layer 220 is release paper or release film, and the surface is coated with a release agent.
The following describes the peeling-off manner of the release layer 220 in detail
Continuing to refer to fig. 2, the present invention provides a transcutaneous analyte sensor system, for example, a continuous blood glucose monitoring system, comprising an implanter unit 400 and a body surface attachment unit 200 coupled within the implanter unit 400, the body surface attachment unit 200 comprising a sensor unit 230 for detecting a subcutaneous analyte level of the host 100 and an adhesive layer for applying the sensor unit 230 to a skin surface of the host 100, the adhesive layer being covered with a release layer 220, the sensor unit 230 comprising a sensor electrode 210, the implanter unit 400 being configured to implant the sensor electrode 210 partially under the host 100, and a cap 500 coupled to the implanter unit 400 or the sensor unit 230, the cap 500 being configured to be removable prior to implantation of the sensor electrode 210 by the implanter unit 400, and the release layer 220 being peeled from the adhesive layer while removing the cap 500.
The implanter unit 400 of the present invention includes a puncture needle 410 for introducing the sensor electrode 210 into the skin of the host 100, the sensor electrode 210 being partially pre-positioned in the puncture needle 410 prior to implantation, the puncture needle 410 piercing the skin of the host 100 in response to the action of the implanter unit 400 during the implantation of the sensor electrode 210, the puncture needle 410 being withdrawn from the skin of the host 100 again in response to the action of the implanter unit 400 when the sensor electrode 210 is partially positioned under the skin of the host 100 and in contact with the subcutaneous interstitial fluid, while the sensor electrode 210 is left in the skin of the host 100 and continuously monitoring the analyte concentration. With continued reference to fig. 2, when the body surface attachment unit 200 is coupled to the implanter unit 400, the ends of the sensor electrodes 210 and the puncture needle 410 protrude from the adhesive layer side of the body surface attachment unit 200, and the protruding portion is implanted subcutaneously in the host 100 during the implantation process. Since the sensor electrode 210 is a flexible sensor electrode 210 with a diameter of 0.28 ± 0.05mm, and the puncture needle 410 is a thin needle with a diameter of 0.5 ± 0.03mm, the sensor electrode 210 and the puncture needle 410 are easily deformed when being subjected to an external force, for example, when the release layer 220 is torn off by a bare hand, a hand or the release layer 220 touches the puncture needle 410 due to improper operation, so that the puncture needle 410 is deformed, and the sensor electrode 210 cannot be implanted normally, thereby causing waste. In order to overcome the problems, when the cap 500 is removed, the release layer 220 is not in contact with the puncture needle 410, and the release layer 220 is peeled off along with the cap 500, so that the hand does not touch the puncture needle 410, and the problem of deformation of the puncture needle 410 is solved fundamentally.
In one embodiment, the cap 500 is configured to be removed in a rotational manner. Referring to fig. 3 and 4, for example, the cap 500 may be rotated counterclockwise to separate the cap 500 from the implanter unit 400 and the cap 500 may be removed in the axial direction of the implanter unit 400. The following embodiments are all premised on cap 500 being removed in a rotational manner.
In order to facilitate smooth peeling of the release layer 220, the cap 500 is rotated in the same direction as the peeling direction of the release layer 220.
In one embodiment, referring to fig. 5, the release layer 220 is configured to be disposed on the adhesive layer in a spiral manner. When the cap 500 is removed, the release layer 220 is sequentially peeled from the edge of the adhesive layer toward the middle following the rotation direction of the cap 500, that is, when the cap 500 is rotated, the release layer 220 is peeled from the end corresponding to the edge of the adhesive layer, and the peeled end is referred to as the start of the release layer 220. The release layer 220 is provided with a fixing portion 221 at the beginning, and the release layer 220 is coupled to the cap 500 through the fixing portion 221. Referring to fig. 6 to 8, for example, a fixing groove 510 is formed on the cap 500, a positioning hole 222 is disposed on the fixing portion 221, a positioning block 511 corresponding to the positioning hole 222 is disposed on an inner wall of the fixing groove 510, and the fixing portion 221 is fastened to the positioning block 511 through the positioning hole 222; a positioning plug 520 is inserted into the fixing groove 510, and the positioning plug 520 is inserted into the fixing groove 510 from the outside of the cap 500 to prevent the fixing part 221 from being separated from the positioning block 511. The fixing portion 221 is a flexible structure formed at the beginning of the release layer 220 and made of the same material as the release layer 220, and when the fixing portion 221 is mounted on the cap 500, since the fixing portion 221 is easily bent by a force and the fixing groove 510 is a narrow groove, the fixing portion 221 is easily inserted into the fixing groove 510 without a smooth effect, which affects the assembly efficiency. Therefore, when the fixing part 221 is installed, the guide part 223 is disposed on the fixing part 221, the guide part 223 is a rigid structure, for example, a hard plastic, and when the fixing part 221 is installed, the guide part 223 penetrates the fixing groove 510 from the inner side of the cap 500 to the outer side of the cap 500, the guide part 223 is pulled on the outer side of the cap 500 until the fixing part 221 is located in the fixing groove 510, the positioning hole 222 on the fixing part 221 is fastened on the positioning block 511 on the inner wall of the fixing groove 510, the positioning plug 520 is inserted into the fixing groove 510, and the positioning plug 520 is located between the inner wall of the fixing groove 510 facing the positioning block 511 and the fixing part 221, thereby preventing the fixing part 221 from being separated from the positioning block 511. The guide part 223 is separated from the fixing part 221 after the positioning plug 520 is inserted into the fixing groove 510. For example, a weak connection of the cut line 224 may be provided between the fixing part 221 and the guide part 223, and the guide part 223 may be directly torn from the fixing part 221 along the cut line 224 after the positioning plugs 520 are inserted into the fixing slots 510.
In another embodiment, as shown in fig. 9, the release layer 220 includes two release fan rings 225, and the two release fan rings 225 are spliced to form an annular release layer 220. When the cap 500 is removed, both the release fan rings 225 are configured to peel following the rotational direction of the cap 500. For example, two release fan rings 225 are arranged to be sequentially adjacent in the annular direction, i.e., the beginning of one of the release fan rings 225 is adjacent to the end of the other release fan ring 225, and the end of the one release fan ring 225 is adjacent to the beginning of the other release fan ring 225. The two fan rings 225 are respectively provided with a fixing portion 221 at the beginning thereof, and the two fan rings 225 are respectively coupled to the cap 500 through the respective fixing portions 221. Similar to the above embodiment, referring to fig. 10 to 12, each fixing portion 221 is provided with a guide portion 223, the cap 500 is provided with two fixing slots 510, and the two guide portions 223 respectively penetrate through the two fixing slots 510 to guide the fixing portion 221 into the fixing slots 510. Please refer to the previous embodiment for the coupling between the fixing portion 221 and the cap 500, which is not described herein. The difference from the above embodiment is that two fixing grooves 510 need to be provided and two positioning plugs 520 need to be provided for the two fixing portions 221. For example, one of the fixing portions 221 is fixed in one of the fixing grooves 510 by one of the positioning plugs 520, and the other fixing portion 221 is fixed in the other fixing groove 510 by the other positioning plug 520. In one embodiment, the two locating plugs 520 are of unitary construction.
As shown in fig. 9, the two release fan rings 225 are arranged on the adhesive layer in a central symmetry manner with the central point of the annular release layer 220 as the center of symmetry, so that the two release fan rings 225 can be ensured to be simultaneously peeled off, and the adhesive force of the two release fan rings 225 on the adhesive layer is equal, so that the two release fan rings 225 are not in contact with each other during the peeling process, thereby avoiding the deformation of the puncture needle 410.
In one embodiment, and with continued reference to fig. 7 or 11, a sterilization chamber 530 is disposed within the cap 500, the sterilization chamber 530 being configured to house at least the sensor electrode 210 and to provide a sealed sterilization environment for the sensor electrode 210. For example, the sterilization chamber 530 may be defined by a hollow column 531 disposed in the cap 500, the hollow column 531 being opened with an opening for the puncture needle 410 and the end of the sensor electrode 210 to enter, and an opening edge of the hollow column 531 being hermetically connected to the body surface attachment unit 200, for example, by using a rubber gasket 532.
The analyte level of the present invention may be other than intended for glucose concentration.
The label 540 indicating the rotation direction of the cap 500 is stuck to the bottom of the cap 500, and the label 540 can cover the fixing groove 510 on the cap 500, so that the bottom of the cap 500 is more beautiful.
In any embodiment of the release layer 220 of the present invention, a through hole is formed in the center of the release layer, through which the puncture needle 410 and the sensor electrode 210 pass, and the through hole is provided, so that the release layer 220 does not contact the puncture needle 410 at all times when the release layer 220 is peeled off in a rotating manner.
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 (18)
1. A transcutaneous analyte sensor system comprising an implanter unit and a body surface attachment unit coupled within the implanter unit, the body surface attachment unit comprising a sensor unit for sensing a level of an analyte beneath the skin of a host and an adhesive layer for applying the sensor unit to the skin surface of the host, the adhesive layer being covered with a release layer, the sensor unit comprising a sensor electrode, the implanter unit being configured to partially implant the sensor electrode beneath the skin of the host, the system comprising: also included is a cap coupled to the implanter unit or the sensor unit, the cap configured to be removable prior to implantation of the sensor electrode by the implanter unit, and the release layer is peeled from the adhesive layer while the cap is removed.
2. The transdermal analyte sensor system of claim 1, wherein: the implanter unit includes a puncture needle for guiding the sensor electrode into the host subcutaneous space, and the release layer is not in contact with the puncture needle when the cap is removed.
3. The transdermal analyte sensor system of claim 1, wherein: the cap is configured to be removed in a rotational manner.
4. The transdermal analyte sensor system of claim 3, wherein: the rotation direction of the cap is the same as the peeling direction of the release layer.
5. The transdermal analyte sensor system of claim 4, wherein: the release layer is configured to be arranged on the adhesive layer in a spiral manner.
6. The transdermal analyte sensor system of claim 5, wherein: the release layer is configured to be sequentially peeled from an edge of the adhesive layer toward the middle following a rotation direction of the cap.
7. The transdermal analyte sensor system of claim 5, wherein: the starting end of the release layer is provided with a fixing part, and the release layer is coupled to the cap through the fixing part.
8. The transdermal analyte sensor system of claim 7, wherein: a guide portion is disposed on the fixing portion, a fixing groove is disposed on the cap, and the guide portion is configured to operatively guide the fixing portion into the fixing groove through the fixing groove.
9. The transdermal analyte sensor system of claim 8, wherein: the fixing part is provided with a positioning hole, the inner wall of the fixing groove is provided with a positioning block, and the fixing part is buckled on the positioning block through the positioning hole;
the fixing groove is also inserted with a positioning plug, and the positioning plug is configured to prevent the fixing part from being separated from the positioning block.
10. The transdermal analyte sensor system of claim 4, wherein: the release layer comprises two release fan rings, and the two release fan rings are spliced to form an annular release layer.
11. The transdermal analyte sensor system of claim 10, wherein: both of the release fan rings are configured to peel following a rotational direction of the cap.
12. The transdermal analyte sensor system of claim 11, wherein: two of the release fan rings are arranged to be sequentially adjacent in an annular direction.
13. The transdermal analyte sensor system of claim 12, wherein: the starting ends of the two release fan rings are respectively provided with a fixing part, and the two release fan rings are respectively coupled to the cap through the respective fixing parts.
14. The transdermal analyte sensor system of claim 13, wherein: the two fixing portions are each provided with one guide portion, the cap is provided with two fixing grooves, and the guide portions of the two fixing portions are configured to operatively pass through one fixing groove each to guide the fixing portion into the corresponding fixing groove.
15. The transdermal analyte sensor system of claim 14, wherein: the two fixing parts are respectively provided with a positioning hole, the inner walls of the two fixing grooves are respectively provided with a positioning block, and the two fixing parts are respectively buckled on the positioning blocks through the respective positioning holes;
the two fixing grooves are respectively inserted with a positioning plug, and the two positioning plugs are configured to prevent the fixing parts in the fixing grooves from being separated from the positioning blocks.
16. The transdermal analyte sensor system of claim 10, wherein: the two release fan rings are arranged on the adhesive layer in a centrosymmetric manner by taking the central point of the annular release layer as a symmetric center.
17. The transdermal analyte sensor system of claim 1, wherein: a sterilization chamber is configured within the cap, the sterilization chamber configured to house at least the sensor electrode and provide a sealed sterilization environment for the sensor electrode.
18. The transdermal analyte sensor system of claim 1, wherein: the analyte level is glucose concentration.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111428966.1A CN114391835A (en) | 2021-11-27 | 2021-11-27 | Transcutaneous analyte sensor system |
| PCT/CN2022/082904 WO2023092913A1 (en) | 2021-11-27 | 2022-03-25 | Transcutaneous analyte sensor system |
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| CN202111428966.1A CN114391835A (en) | 2021-11-27 | 2021-11-27 | Transcutaneous analyte sensor system |
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| CN114391835A true CN114391835A (en) | 2022-04-26 |
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| CN202111428966.1A Pending CN114391835A (en) | 2021-11-27 | 2021-11-27 | Transcutaneous analyte sensor system |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2024061018A1 (en) * | 2022-09-19 | 2024-03-28 | 苏州百孝医疗科技有限公司 | Sensitivity determination method, implantation effect judgment method, and related apparatus |
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| WO2023092913A1 (en) | 2023-06-01 |
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