Analyte detection device with siphon structure

Abstract

The utility model discloses an analyte detection device with a siphon structure, the siphon structure is arranged on a lower shell of the analyte detection device and comprises a hydrophilic film and a matching structure, and gaps are formed among the hydrophilic film, the matching structure and the lower shell; blood overflowing from the wound can be sucked along the gap to a position far away from the first through hole through the siphon structure, so that the blood is prevented from permeating into the analyte detection device through the first through hole to pollute the analyte detection device, and the normal use of the analyte detection device is ensured.

Description

Technical Field

[0001] This utility model mainly relates to the field of medical devices, and in particular to an analytical device with a siphon structure for detecting analytes. Background Technology

[0002] In a healthy person, the pancreas automatically monitors blood glucose levels and secretes the necessary insulin / glucagon. However, in diabetic patients, the pancreas malfunctions and cannot secrete insulin as needed. Therefore, diabetes is a metabolic disease caused by abnormal pancreatic function and is a lifelong condition. Currently, medical technology cannot cure diabetes; it can only control the occurrence and development of diabetes and its complications by stabilizing blood sugar levels.

[0003] Diabetic patients need to have their blood glucose levels checked before injecting insulin. Currently, most methods can continuously monitor blood glucose and send the data in real time to a remote device for user viewing; this method is called Continuous Glucose Monitoring (CGM). This method requires a device to be attached to the skin surface, with a sensor inserted into the subcutaneous tissue fluid via an applicator. However, when the sensor is inserted, it may puncture a blood vessel. Furthermore, the increased subcutaneous pressure caused by the sensor insertion can lead to blood flowing along the sensor's electrodes to the skin surface, or even seeping into the inner bottom of the analyte detection device, causing contamination and affecting its normal operation. In severe cases, it can even cause a short circuit at the sensor-transmitter electrical connection, rendering the device completely unusable.

[0004] Therefore, there is an urgent need in the current technology for an analyte detection device that can prevent blood from penetrating into the interior. Utility Model Content

[0005] This utility model discloses an analyte detection device with a siphon structure. The siphon structure is disposed on the lower shell of the analyte detection device and includes a hydrophilic membrane and a mating structure. A gap is formed between the hydrophilic membrane, the mating structure and the lower shell. The siphon structure can draw blood overflowing from the wound along the gap to a position away from the first through hole, preventing blood from seeping into the interior of the analyte detection device through the first through hole and contaminating the analyte detection device, thereby ensuring the normal use of the analyte detection device.

[0006] This utility model provides an analyte detection device with a siphon structure. The analyte detection device includes at least an emitter, a sensor, a housing, and a battery. The sensor includes an internal part and an external part. The housing includes an upper housing and a lower housing. The lower housing is provided with a first through hole through which the internal part passes. The siphon structure is provided on the lower housing. The siphon structure includes a hydrophilic membrane and a mating structure. A gap is formed between the hydrophilic membrane, the mating structure, and the lower housing.

[0007] According to one aspect of the present invention, the depth of the gap is 0.05-0.3 mm.

[0008] According to one aspect of the present invention, the depth of the gap is 0.1 mm.

[0009] According to one aspect of the present invention, the gap includes at least a groove-shaped gap.

[0010] According to one aspect of the present invention, the groove-shaped gap is symmetrically distributed along the circumference of the first through hole.

[0011] According to one aspect of this utility model, the cross-section of the groove gap is square, rectangular, circular, trapezoidal or irregular in shape.

[0012] According to one aspect of the present invention, the cross-sectional area of ​​the starting end of the groove gap is not less than the cross-sectional area of ​​the ending end of the groove gap.

[0013] According to one aspect of the present invention, the length of the groove gap is not less than the radial length of the hydrophilic membrane.

[0014] According to one aspect of the present invention, the gap includes at least one annular gap.

[0015] According to one aspect of the present invention, at least one annular gap includes a first annular gap, the starting end of the first annular gap being the edge of the first through hole, and the ending end of the first annular gap being the starting end of the mating structure.

[0016] According to one aspect of the present invention, at least one annular gap includes a second annular gap, the terminating end of the second annular gap being the terminating end of the hydrophilic membrane.

[0017] According to one aspect of the present invention, the outer shell is further provided with adhesive tape, and the adhesive tape and the hydrophilic membrane are an integral structure.

[0018] According to one aspect of the present invention, the mating structure includes double-sided adhesive.

[0019] According to one aspect of the present invention, the mating structure includes a guide groove formed on the lower outer shell.

[0020] According to one aspect of the present invention, the mating structure includes a ridge and / or a protrusion disposed on the lower housing.

[0021] According to one aspect of the present invention, the protrusion and / or the protrusion is integrally formed with the lower housing.

[0022] Compared with the prior art, the technical solution of this utility model has the following advantages:

[0023] This utility model discloses an analytical analyte detection device with a siphon structure. The siphon structure is disposed on the lower shell of the analytical analyte detection device and includes a hydrophilic membrane and a mating structure. A gap is formed between the hydrophilic membrane, the mating structure and the lower shell. The siphon structure can draw blood overflowing from the wound along the gap to a position away from the first through hole, preventing blood from seeping into the interior of the analytical analyte detection device through the first through hole and contaminating the analytical analyte detection device, thereby ensuring the normal use of the analytical analyte detection device.

[0024] Furthermore, the depth of the gap is 0.05-0.3mm, preferably 0.1mm. At this depth, the siphon effect generated by the siphon structure is strongest, which is beneficial for attracting blood and guiding the blood to a position away from the first through hole.

[0025] Furthermore, the gap includes a groove-shaped gap, the cross-sectional area of ​​the starting end of the groove-shaped gap is not less than the cross-sectional area of ​​the ending end, to meet the requirement that the blood flow is large near the wound and small far from the wound, ensuring that the blood can stay away from the first through hole and preventing the blood from penetrating into the interior of the analyte detection device through the first through hole.

[0026] Furthermore, the circumferentially symmetrical distribution of the first through-hole in the groove-shaped gap allows the attracted blood to diffuse evenly along the groove-shaped gap in all directions, preventing blood from accumulating in one direction and thus penetrating into the analyte detection device through the first through-hole.

[0027] Furthermore, the length of the groove gap is not less than the radial length of the hydrophilic membrane. When blood diffuses to the terminal end of the hydrophilic membrane and can continue to diffuse, it can diffuse towards the adhesive tape or diffuse along the extended gap of the groove gap to prevent blood accumulation.

[0028] Furthermore, the gap also includes a first annular gap, the starting end of which is the edge of the hydrophilic membrane positioning hole. This allows blood overflowing from the wound to be quickly drawn along the circumference of the positioning hole and further guided along the groove-shaped gap to a position away from the first through hole.

[0029] Furthermore, the gap also includes a second annular gap, the terminating end of which is the terminating end of the hydrophilic membrane. This allows blood that diffuses along the groove-shaped gap to further diffuse along the second annular gap, increasing the blood's capacity and preventing blood aggregation.

[0030] Furthermore, the terminating ends of the hydrophilic membrane and the mating structure are adjacent to the starting ends of the adhesive tape, and the overall thickness of the hydrophilic membrane and the mating structure is equal to the thickness of the adhesive tape. That is, the adhesive tape and the hydrophilic membrane are on the same horizontal plane, which reduces user discomfort and improves user experience.

[0031] Furthermore, the hydrophilic membrane and adhesive tape are integrated into one structure, which increases the integration of the adhesive tape and the hydrophilic membrane, while improving the wettability of the adhesive tape, extending its service life, and increasing the comfort of using the adhesive tape. Attached Figure Description

[0032] Figure 1 This is a schematic diagram of the external structure of the analyte detection device mounting unit according to an embodiment of the present invention;

[0033] Figure 2a This is a schematic diagram of the external structure of the housing according to an embodiment of the present utility model;

[0034] Figure 2b This is a schematic diagram of the structure of the protective cover according to an embodiment of the present utility model;

[0035] Figure 3 This is an exploded structural diagram of the installation unit of the analytical material detection device according to an embodiment of the present invention;

[0036] Figure 4 This is a schematic diagram of the analyte detection device according to the present invention;

[0037] Figure 5a This is a schematic diagram showing the elastic pad sleeve placed on the outside of the auxiliary needle before installation according to this utility model;

[0038] Figure 5b This is a schematic diagram showing the elastic pad being sleeved on the outside of the auxiliary needle after the auxiliary needle is inserted subcutaneously, according to the present invention.

[0039] Figure 5c This is a schematic diagram showing the elastic pad sleeved on the outside of the sensor after the auxiliary needle retracts, according to the present invention.

[0040] Figure 5d This is a schematic diagram of the external structure of the lower outer shell of the elastic pad embedded analyte detection device according to the present invention;

[0041] Figure 5e This is a schematic diagram of the internal structure of the lower shell of the elastic pad embedded in the analyte detection device according to the present invention;

[0042] Figure 5f This is a schematic diagram of the solid elastic pad according to the present invention;

[0043] Figure 5g This is a schematic diagram of the hollow elastic pad according to the present invention;

[0044] Figure 6a This is a schematic diagram of the analyte detection device with a siphon structure according to the present invention;

[0045] Figure 6b for Figure 6a A magnified schematic diagram of the local structure of region M in the middle;

[0046] Figures 6c-6f This is a top view of the siphon structure according to the present invention;

[0047] Figure 6g This is a schematic diagram of another analyte detection device with a siphon structure according to the present invention. Detailed Implementation

[0048] As mentioned earlier, during installation, existing analyte detection devices may puncture blood vessels when the sensor is inserted subcutaneously. Additionally, the increased subcutaneous pressure caused by the sensor insertion can lead to blood flowing along the sensor electrodes to the skin surface or even seeping into the inner bottom of the analyte detection device, causing internal contamination and affecting its normal operation. In some cases, it can even cause a short circuit at the electrical connection between the sensor and the transmitter, rendering the analyte detection device completely unusable.

[0049] To address this problem, this invention provides an analyte detection device with a siphon structure. The siphon structure is disposed on the lower outer shell of the analyte detection device and includes a hydrophilic membrane and a mating structure. A gap is formed between the hydrophilic membrane, the mating structure, and the lower outer shell. The siphon structure can draw blood overflowing from the wound along the gap to a position away from the first through hole, preventing blood from seeping into the interior of the analyte detection device through the first through hole and contaminating the analyte detection device, thereby ensuring the normal use of the analyte detection device.

[0050] Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be understood that, unless otherwise specifically stated, the relative arrangement, numerical expressions, and values ​​of the components and steps set forth in these embodiments should not be construed as limiting the scope of the present invention.

[0051] Furthermore, it should be understood that, for ease of description, the dimensions of the various components shown in the accompanying drawings are not necessarily drawn to actual scale; for example, the thickness, width, length, or distance of some units may be enlarged relative to other structures.

[0052] The following description of exemplary embodiments is merely illustrative and is not intended to limit the invention or its application or use in any way. Techniques, methods, and devices known to those skilled in the art may not be discussed in detail herein, but where applicable, such techniques, methods, and devices should be considered part of this specification.

[0053] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined or described in a figure, it will not need to be discussed further in the subsequent description of the figures.

[0054] The analyte detection system includes an installation unit for the analyte detection device and the analyte detection device built into the installation unit. Figure 1 This is a schematic diagram of the external structure of the mounting unit of the analyte detection device according to an embodiment of the present invention. The external structure of the mounting unit 100 includes a housing 101 and a protective cover 102. The housing 101 is used to support the internal structural components. In use, the end of the mounting unit 100 closest to the user's skin is the proximal end, and the end furthest from the skin is the distal end. A first opening is provided at the proximal end of the housing 101. The protective cover 102 is used to protect, seal, and prevent triggering of the internal structure and internal structural components of the housing 101.

[0055] Figure 2a This is a schematic diagram of the external structure of the shell according to an embodiment of the present invention. Figure 2b This is a schematic diagram of the protective cover. The protective cover 102 includes an outer cover body 1021, a clamp 1022, and an inner cover body 1023. A second opening is provided at the distal end of the outer cover body 1021, facing the first opening. Through the second opening, the outer cover body 1021 and the clamp 1022 are connected by breakable posts 10211, which are distributed at certain intervals between the outer cover body 1021 and the clamp 1022. When the outer cover body 1021 rotates relative to the clamp 1022, the posts 10211 can be broken, separating the outer cover body 1021 from the clamp 1022.

[0056] The inner side of the outer cover 1021 is provided with an internal thread 10212, and the outer side of the inner cover 1023 is provided with an external thread 10231. The internal thread 10212 and the external thread 10231 can be connected to connect the outer cover 1021 and the inner cover 1023 together and keep them fixed.

[0057] The inner side of the clamp 1022 is provided with a protrusion 10221, and correspondingly, the outer side of the housing 101 is provided with a groove 1011. The groove 1011 surrounds the outer side of the housing to form a circumference, and the protrusion 10221 can be embedded in the groove 1011. The outer cover 1021 is first fixed to the inner cover 1023 by thread engagement, and then connected to the housing 101 by the clamp 1022. The outer cover 1021 and the inner cover 1023 can protect, seal and prevent triggering of the internal structure of the housing 101.

[0058] In other embodiments of this utility model, the outer cover 1021 and the inner cover 1023 can also be fixedly connected by friction engagement or snap-fit ​​engagement.

[0059] In other embodiments of this utility model, the clamp 1022 and the housing 101 can also be connected by friction fit, snap fit or threaded fit.

[0060] Figure 3 This is an exploded structural diagram of the analytical substance detection device mounting unit according to an embodiment of the present invention. The dashed lines in the diagram indicate the installation and fitting relationships of the various structural components. The internal structural components of the analytical substance detection device mounting unit 100 include a parallel slider module 103, an analytical substance detection device 104, an auxiliary needle module 105, a trigger module 106, and an elastic module 107. The elastic module 107 includes a first elastic element 1071 and a second elastic element 1072.

[0061] The analyte detection device 104 and the mounting unit 100 are not limited to Figure 3 The aforementioned cooperation relationship. In some embodiments of this utility model, before installation, the analyte detection device 104 is built into the installation unit 100. When using it, the user can remove the installation unit 100 from the packaging box and then install the analyte detection device 104 onto the surface of human skin. In other embodiments of this utility model, before installation, the analyte detection device 104 and the installation unit 100 are in a separate state. That is, the user needs to remove the installation unit 100 and the analyte detection device 104 from the packaging box separately, and then assemble the analyte detection device 104 into the installation unit 100 before installing the analyte detection device 104 onto the surface of human skin.

[0062] Figure 4 This is a schematic diagram of the analyte detection device according to an embodiment of the present invention. (Refer to reference...) Figure 3In this embodiment of the invention, the analyte detection device 104 includes a housing 1041, a transmitter (not shown), a sensor 1042, a battery (not shown), and an internal circuit (not shown) disposed within the housing 1041 and electrically coupled to the sensor. The sensor 1042 is used to detect the analyte parameter information of the user's bodily fluids, and transmits the analyte parameter information to the transmitter through the internal circuit, and then the transmitter sends it to the external device 200.

[0063] In this embodiment of the invention, the outer shell 1041 includes an upper outer shell 10411 and a lower outer shell 10413, which are joined together to form an internal space. The sensor 1042 includes an external part and an internal part, with the external part bent relative to the internal part, as shown in Figure 5a. The external part, transmitter, battery, and internal circuitry are disposed within the internal space, and the external part is electrically coupled to the internal circuitry. The internal part is provided with electrodes, membranes, and other structures, and can be inserted subcutaneously to detect analyte parameters. When the internal part is inserted subcutaneously, a correct angle is required, such as perpendicular to the skin surface. After the analyte detection device 104 reaches the end of its lifespan, it is removed from the user's skin and discarded entirely.

[0064] In this embodiment of the present invention, the lower outer shell 10413 includes a through first through hole 10414, and correspondingly, on the axis of the first through hole 10414, the upper outer shell 10411 includes a through second through hole (not shown in the figure), and the inner part passes through the first through hole 10414 to the outside of the outer shell so as to be inserted under the user's skin.

[0065] In other embodiments of this invention, the analyte detection device 104 is not limited to the structure described above. In some other embodiments of this invention, the transmitter is disposed outside the housing 1041. After the user installs the housing 1041 onto the user's skin surface through the mounting unit 100, the transmitter is then installed onto the housing 1041.

[0066] In some other embodiments of this invention, when the transmitter is separated from the housing 1041, the battery is built into the transmitter.

[0067] In some other embodiments of this invention, when the transmitter is separated from the housing 1041, the battery is built into the housing 1041.

[0068] The auxiliary needle module 105 includes an auxiliary needle fixing structure 1051 and an auxiliary needle 1052. The auxiliary needle 1052 includes at least an opening area for accommodating the sensor 1042. In the mounting unit 100, the auxiliary needle 1052 passes through the second through hole and the first through hole 10414 in sequence, thereby penetrating the analyte detection device 104.

[0069] When using the installation unit 100, rotate the outer cover 1021 to break the column 10211, separating the protective cover 102 from the housing 101. Bring the proximal end of the installation unit 100 close to the user's skin until the outer ring of the trigger module 106 is in contact with the skin surface. The user presses the housing 101 at the distal end, and the housing 101 moves toward the skin. The trigger module 106 remains stationary, so the trigger module 106 moves distally relative to the housing 101. The parallel slider module 103 continues to move proximally under the thrust of the first elastic element 1071, while simultaneously driving the auxiliary needle module 105 and the analyte detection device 104 to move proximally. The auxiliary needle 1052 and the internal part of the sensor it envelops pierce the subcutaneous tissue until the analyte detection device 104 contacts the user's skin surface. Driven by the second elastic element 1072, the auxiliary needle module 105 moves to the distal end and eventually returns to the initial position. The internal part of the sensor of the analyte detection device 104 remains inside the body, and the auxiliary needle 1052 retracts into the housing 101 to prevent the auxiliary needle 1052 from being exposed outside the housing 101 and avoid causing unnecessary damage.

[0070] When the auxiliary needle 1052 is inserted into the subcutaneous tissue, it may puncture a blood vessel. At the same time, the increased subcutaneous pressure caused by the insertion of the auxiliary needle 1052 may cause blood to flow along the internal part of the analyte detection device 104 to the skin surface after the auxiliary needle 1052 is retracted. It may even seep into the inner bottom surface of the analyte detection device 104 through the first through hole 10414, causing contamination inside the analyte detection device 104, affecting the normal use of the analyte detection device, or even causing a short circuit at the electrical connection between the sensor and the transmitter, making the analyte detection device completely unusable.

[0071] Reference Figure 5a , Figure 5a To address the aforementioned issues, in some embodiments of this invention, before installation, an elastic pad 108 is fitted around the auxiliary needle 1052 at the contact point between the auxiliary needle 1052 and the analyte detection device 104 on the outside of the lower outer shell 10413. The needle body encloses the inner portion 10422 of the sensor 1042. During installation, the auxiliary needle 1052, carrying the inner portion 10422, pierces the subcutaneous tissue. The lower outer shell 10413 of the analyte detection device 104 contacts the skin surface and presses against the elastic pad 108. Figure 5b As shown, Figure 5b This is a schematic diagram showing that, according to the present invention, after the auxiliary needle is inserted subcutaneously, an elastic pad is fitted on the outside of the auxiliary needle.

[0072] Reference Figure 5c , Figure 5cAs shown in the schematic diagram of the auxiliary needle retracting and the elastic pad being sleeved on the outside of the sensor according to the present invention, in some embodiments of the present invention, the auxiliary needle 1052, carrying the internal portion 10422, is inserted subcutaneously to a predetermined position and then retracted, leaving the internal portion 10422 under the skin to detect analyte parameter information. The analyte detection device 104 is adhered to the skin surface by adhesive tape. Therefore, when the auxiliary needle 1052 retracts, the elastic pad 108 is sandwiched between the lower outer shell 10413 and the skin surface. After the auxiliary needle 1052 is fully retracted, the elastic pad 108 contracts under its own elasticity and sleeves on the outside of the internal portion 10422, pressing and covering the wound caused by the auxiliary needle 1052 piercing the subcutaneous tissue. This prevents blood from overflowing from the wound and entering the interior of the analyte detection device 104 through the first through hole 10414, thus preventing contamination of the analyte detection device 104 and ensuring the normal use of the analyte detection device 104. At the same time, it also prevents foreign objects from contaminating the wound and improves the wound healing speed.

[0073] The outer diameter d1 of the elastic pad 108 is larger than the diameter of the first through hole 10414, which can further prevent blood from penetrating into the interior of the analyte detection device 104.

[0074] To prevent the elastic pad 108 from moving during installation, such as when the auxiliary needle retracts, thus affecting its ability to block blood, in other embodiments of this invention, the elastic pad 108 is fixed to the outside of the lower housing 10413 of the analyte detection device 104 by means of double-sided adhesive, hot melt welding, or ultrasonic welding. The auxiliary needle 1052 passes concentrically through the first through hole 10414 and the elastic pad 108.

[0075] Reference Figure 5d , Figure 5d According to the structural diagram of the elastic pad embedded in the lower outer shell of the analyte detection device of this utility model, in some embodiments of this utility model, a first receiving groove 104131 is provided on the outside of the lower outer shell 10413 of the analyte detection device 104 to receive the first elastic pad 108. Correspondingly, the first through hole 10414 is recessed into the lower outer shell 10413. After installation, the elastic pad 108 is flush with the lower outer shell 10413, so the elastic pad 108 will not cause additional pressure on the skin surface, reducing discomfort. The outer diameter of the elastic pad 108 is larger than the diameter of the first through hole 10414, so the elastic pad can completely block the first through hole 10414, preventing blood from seeping into the interior of the analyte detection device 104 from the first through hole 10414. The outer diameter of the elastic pad 108 is slightly larger than the inner diameter of the first receiving groove 104131, so the elastic pad 108 is tightly embedded in the first receiving groove 104131 through an interference fit.

[0076] Reference Figure 5e , Figure 5eAccording to the structural diagram of the elastic pad embedded inside the lower shell of the analyte detection device of this utility model, in some embodiments of this utility model, the elastic pad 108 is disposed inside the lower shell 10413. The external part 10421 of the sensor 1042 is bent relative to the internal part 10422. The elastic pad 108 is sandwiched between the lower shell 10413 and the bent area of ​​the sensor 1042. After the auxiliary needle 1052 is fully retracted, the elastic pad 108 contracts and sleeves itself on the outside of the internal part 10422 under its own elasticity, thereby sealing the first through hole 10414. This prevents blood from entering the analyte detection device 104 through the first through hole 10414 and contaminating the analyte detection device 104, ensuring the normal use of the analyte detection device 104.

[0077] To prevent the elastic pad 108 from moving during installation, such as when the auxiliary needle retracts, thus affecting its ability to block blood, in other embodiments of this invention, the elastic pad 108 is fixed to the inner side of the lower housing 10413 of the analyte detection device 104 by means of double-sided adhesive, hot melt welding, or ultrasonic welding. The auxiliary needle 1052 passes concentrically through the first through hole 10414 and the elastic pad 108.

[0078] In another embodiment of this utility model, a second receiving groove 10413 is provided inside the lower outer shell 10413 of the analyte detection device 104 for accommodating the elastic pad 108. The depth of the second receiving groove 104132 is slightly less than the thickness of the elastic pad 108. Therefore, when the elastic pad 108 is accommodated in the second receiving groove 104132, in the vertical direction, the elastic pad is slightly compressed, and the elastic pad 108 abuts against the first layer of the lower outer shell 10413 with a certain elasticity. The through hole 10414 and the second receiving groove 104132 are connected. At the same time, the outer diameter of the elastic pad 108 is slightly larger than the inner diameter of the second receiving groove 104132. Therefore, the elastic pad 108 is tightly embedded in the second receiving groove 104132 through an interference fit. Thus, the elastic pad 108 can tightly seal the first through hole 10414, preventing blood from entering the analyte detection device 104 from the first through hole 10414 and contaminating the analyte detection device 104, thus ensuring the normal use of the analyte detection device 104.

[0079] Reference Figure 5f , Figure 5f According to the schematic diagram of the solid elastic pad of the present invention, in some embodiments of the present invention, the elastic pad 108 can be a solid structure. After the auxiliary needle 1052 pierces the elastic pad 108, the elastic pad 108 is sleeved on the outside of the auxiliary needle 1052.

[0080] Figure 5gThe diagram shows the hollow structure of the elastic pad according to the present invention. In some embodiments of the present invention, the elastic pad 108 can be a hollow structure. The inner diameter d2 of the elastic pad 108 is smaller than the outer diameter d of the auxiliary needle 1052, so that the elastic pad 108 can be tightly fitted on the outside of the auxiliary needle 1052 to prevent the inner part 10422 from detaching from the envelope of the auxiliary needle 1052. In a preferred embodiment of this utility model, the inner diameter d2 of the elastic pad 108 is smaller than the outer diameter of the inner part 10422. After the auxiliary needle 1052 retracts, the elastic pad 108 can shrink and tightly fit on the outside of the inner part 10422 to press and cover the wound caused by the auxiliary needle 1052 piercing the subcutaneous tissue (when the elastic pad 108 is set on the outside of the lower outer shell 10413), or to tightly seal the first through hole 10414 (when the elastic pad 108 is set on the inside of the lower outer shell 10413), preventing blood from overflowing from the wound and entering the analyte detection device 104 through the first through hole 10414, thus contaminating the analyte detection device 104.

[0081] In some embodiments of this invention, the thickness of the elastic pad 108 is 0.01–5 mm. When the elastic pad 108 is located on the outer side of the lower outer shell 10413, an excessively thick elastic pad 108 will increase the pressure of the analyte detection device 104 on the skin surface, causing discomfort. When the elastic pad 108 is located on the inner side of the lower outer shell 10413, an excessively thick elastic pad 108 will increase the height of the analyte detection device 104, which is not conducive to the miniaturization of the analyte detection device 104. An excessively thin elastic pad 108 is prone to deformation and cannot effectively restrain the internal part 10422. In a preferred embodiment of this invention, the thickness of the elastic pad 108 is 0.3 mm.

[0082] In some embodiments of this utility model, the elastic pad 108 is made of rubber, silicone or latex, which has good elasticity and can avoid contaminating the wound.

[0083] Figure 6a This is a schematic diagram of the analyte detection device with a siphon structure according to the present invention; Figure 6b for Figure 6a A magnified schematic diagram of the local structure of region M in the middle; Figures 6c-6f This is a top view of the siphon structure according to the present invention.

[0084] refer to Figures 6a-6fIn some other embodiments of this utility model, a siphon structure is provided on the lower outer shell 10413 of the analyte detection device 104. The siphon structure includes a hydrophilic membrane 601 and a mating structure 602. The mating structure 602 is disposed on the lower outer shell 10413, and the hydrophilic membrane 601 is disposed on the mating structure 602. A gap 603 is formed between the hydrophilic membrane 601, the mating structure 602, and the lower outer shell 10413. When the auxiliary needle 1052 retracts and blood overflows along the wound, the hydrophilic membrane 601 attracts the blood and draws it along the gap 603. Figures 6b-6f The arrows indicate the direction to guide the blood away from the first through hole 10414, thereby preventing blood from seeping into the interior of the analyte detection device 104 through the first through hole 10414, avoiding contamination inside the analyte detection device 104, affecting the normal use of the analyte detection device 104, or even causing short circuits at the electrical connections of the sensor 1042, internal circuits, and battery, thus damaging the analyte detection device 104.

[0085] The height or thickness h of the mating structure 602 is equivalent to the depth h of the gap 603. In this invention, the depth h of the gap 603 is 0.02mm-0.5mm, preferably 0.05mm-0.3mm, and more preferably 0.1mm. At this depth, the siphon effect generated by the siphon structure is strongest, which is beneficial for attracting blood and guiding it away from the first through hole.

[0086] The hydrophilic film 601 is made of one or more of the following materials: polymer film, glass film, polyester film, polyurethane film, polytetrafluoroethylene film, and polyacrylic film. Preferably, the hydrophilic film 601 is made of polymer film. Polymer materials have strong hydrophilicity, which can effectively improve the wetting properties of the material surface, giving it better adhesion and stability.

[0087] In one embodiment of the present invention, the gap 603 includes a groove-shaped gap 6031. Multiple mating structures 602 are distributed around the circumference of the first through hole 10414. A hydrophilic membrane 601 and multiple mating structures 602 form multiple groove-shaped gaps 6031 between the hydrophilic membrane 601 and the lower outer shell 10413. Preferably, the multiple mating structures 602 are evenly distributed on the lower outer shell 10413 along the circumference of the first through hole 10414. Therefore, the multiple groove-shaped gaps 6031 are also evenly distributed between the hydrophilic membrane 601 and the lower outer shell 10413 along the circumference of the first through hole 10414. When blood overflows from the wound, the hydrophilic membrane 601 attracts the blood and guides it to diffuse evenly in all radial directions from the circumference of the first through hole 10414. This prevents blood from being guided or diffused in a certain direction in a timely manner, causing blood accumulation in that direction. This allows the blood to enter the interior of the analyte detection device 104 from that direction of the first through hole 10414, avoiding contamination inside the analyte detection device 104 and affecting its normal operation.

[0088] In one embodiment of this utility model, the groove-shaped gap 6031 is a radial gap. The cross-section of the groove-shaped gap 6031 can be square, circular, trapezoidal, or other irregular shapes. Preferably, the cross-section is trapezoidal, and the side closer to the skin is the lower side of the trapezoid. The closer to the skin, the greater the blood flow, and the trapezoidal cross-section is more adaptable to changes in blood flow. The starting end of the groove-shaped gap 6031 is the end near the wound, and the cross-sectional area of ​​the starting end is k1. The ending end is the end near the ending end A2 of the hydrophilic membrane 601, and the cross-sectional area of ​​the ending end is k2. k1 is not less than k2. The bleeding volume is large near the wound, and the larger k1 is, the faster the blood can be drawn away from the first through hole 10414. When the blood diffuses to the ending end near the gap 603, the blood flow may be very small, or even no blood continues to diffuse. Therefore, k2 can be less than k1. However, in order to ensure that there is enough space for the blood to stay away from the first through hole 10414 and that the blood does not accumulate, k2 can be equal to k1.

[0089] In this invention, the gap 603 includes an annular gap 6032. The hydrophilic membrane 601 includes a positioning hole 6011, which corresponds to the first through hole 10414. This correspondence means that the positioning hole 6011 and the first through hole 10414 are in the same position and size, i.e., the positioning hole 6031 and the first through hole 10414 overlap in the vertical direction. The circumferential edge of the positioning hole 6011 is the starting end A1 of the hydrophilic membrane 601. The starting end B1 of the mating structure 602 is spaced l1 from the starting end A1 of the hydrophilic membrane 601. Therefore, a first annular gap 6032 with a height h and a width l1 can be formed along the circumference of the positioning hole 6011. The starting end of the first annular gap 6032 is the edge of the first through hole 10414 and the positioning hole 6011, and the ending end of the first annular gap 6032 is the starting end B1 of the mating structure 602. A siphon effect can be formed around the circumference of the positioning hole 6011, causing blood flowing out along the sensor body 10422 to be rapidly drawn from the circumference of the positioning hole 6011 to the first annular gap 6032, and then guided along the groove gap 6031 to a position away from the first through hole 10414, thereby further ensuring that blood does not seep into the interior of the analyte detection device 104 from the first through hole 10414. In this embodiment of the invention, the width l1 is 0.02-0.35 mm, preferably 0.1-0.2 mm.

[0090] In another embodiment of this utility model, the gap 603 may also include only the annular gap 6032, such as... Figure 6e and Figure 6f As shown, in order to accommodate sufficient blood in the annular gap 6032 and prevent blood from accumulating and entering the analyte detection device through the first through-hole 10414, the width l1 of the annular gap 6032 is 1.5-2 mm. Figure 6e In the middle, the mating structure 602 is a ring structure provided along the edge of the terminating end A2 of the hydrophilic membrane 601. Figure 6f In this process, the mating structure 602 consists of multiple discrete structures arranged along the edge of the termination end A2 of the hydrophilic membrane 601. Preferably, the multiple discrete structures are evenly distributed along the edge of the termination end A2 of the hydrophilic membrane 601. Since the hydrophilic membrane 601, the mating structure 602 and the lower shell 10413 also form gaps along the edge of the termination end A2 of the hydrophilic membrane 601, when there is a large amount of blood, it can diffuse further to the adhesive tape 604 after diffusing to the edge of the termination end A2 of the hydrophilic membrane. Since the adhesive tape 604 is a non-woven adhesive tape, the blood can be soaked in the adhesive tape 604, preventing the blood from accumulating and penetrating into the interior of the analyte detection device 104 through the first through hole 10414.

[0091] In this embodiment of the invention, the terminating end B2 of the mating structure 602 is aligned with the terminating end A2 of the hydrophilic membrane 601. Therefore, the length of the grooved gap 6031 is equal to the radial length L of the hydrophilic membrane 601. In other embodiments of the invention, the terminating end B2 of the mating structure 602 is not aligned with the terminating end A2 of the hydrophilic membrane 601. Therefore, the length of the grooved gap 6031 may not be equal to the radial length L of the hydrophilic membrane 601.

[0092] When the termination end B2 of the mating structure 602 is aligned with the termination end A2 of the hydrophilic membrane 601, if the blood is guided along the gap 603 to the termination end B2 of the mating structure 602 and can continue to diffuse, the blood will further diffuse to the adhesive tape 604. Since the adhesive tape 604 is a non-woven adhesive tape, the blood can be soaked in the adhesive tape 604, preventing the blood from agglomerating and penetrating into the interior of the analyte detection device 104 from the first through hole 10414.

[0093] When the termination end B2 of the mating structure 602 does not reach the termination end A2 of the hydrophilic membrane 601, and the distance is l2, as follows: Figure 6d As shown, at the outer circumference of the hydrophilic membrane 601, a second annular gap 6033 with a width of l2 and a depth of h is formed between the hydrophilic membrane 601, the mating structure 602, and the lower shell 10413. The starting end of the second annular gap 6033 is the ending end B2 of the mating structure, and the ending end of the second annular gap 6033 is the ending end A2 of the hydrophilic membrane 601. If blood is guided along the groove-shaped gap 6031 to the ending end B2 of the mating structure 602 and can continue to diffuse, it will diffuse radially to the ending end A2 of the hydrophilic membrane. That is, when the ending end B2 of the mating structure 602 does not reach the ending end A2 of the hydrophilic membrane 601, the length of the groove-shaped gap 6031 is also the radial length L of the hydrophilic membrane 601. Blood will diffuse circumferentially into the aforementioned second annular gap 6033 with a width of l2 and a depth of h, which can accommodate more blood and better prevent blood aggregation. In this embodiment of the utility model, the width l2 is 0.02-0.55mm, preferably 0.2-0.4mm, and more preferably 0.3mm.

[0094] In other embodiments of this utility model, by appropriately setting the mating structure 602, more annular gaps can be provided between the first annular gap 6032 and the second annular gap 6033. For example, by dividing the mating structure 602 along the circumferential direction at the midpoint of the radial direction, the width of the division is l3, and a third annular gap with a width of l3 and a height of h can be formed between the lower outer shell 10413, the mating structure 602 and the hydrophilic membrane 601.

[0095] When the terminating end B2 of the mating structure 602 extends beyond the terminating end A2 of the hydrophilic membrane 601, at least a portion of the adhesive tape 604 covers the mating structure 602. An extended gap is also formed between the adhesive tape 604, the mating structure 602, and the lower outer shell 10413. That is, when the terminating end B2 of the mating structure 602 extends beyond the terminating end A2 of the hydrophilic membrane 601, the length of the groove-shaped gap 6031 is greater than the radial length L of the hydrophilic membrane. This extended gap lies on the extension line of the groove-shaped gap 6031. If blood, after being guided along the groove-shaped gap 603 to the terminating end B2 of the mating structure 602, can continue to diffuse, it will further diffuse into this extended gap, further accommodating more blood and better preventing blood aggregation.

[0096] refer to Figure 6a and Figure 6b An adhesive tape 604 is provided on the lower outer shell 10413 of the analytical substance detection device 104 of this utility model. In order to avoid the auxiliary needle module 105 during puncture, the adhesive tape 604 is provided with an avoidance hole 6041. The avoidance hole 6041 is concentric with the first through hole 10414, but the diameter of the avoidance hole 6041 is larger than the diameter of the first through hole 10414. The hydrophilic membrane 601 and the mating structure 602 are disposed in the clearance hole 6041 of the adhesive tape 604. The edges of the hydrophilic membrane 601 and the mating structure 602 are adjacent to the edges of the clearance hole 6041 of the adhesive tape 604. That is, the terminating end A2 of the hydrophilic membrane 601 and the terminating end B2 of the mating structure 602 are adjacent to the starting end C1 of the adhesive tape 604. At the same time, the thickness of the adhesive tape 604 is equal to the sum of the thicknesses of the hydrophilic membrane 601 and the mating structure 602, so that the adhesive tape 604 and the hydrophilic membrane 601 on the lower outer shell 10413 of the analyte detection device 104 are on the same plane, reducing user discomfort and improving user experience.

[0097] In another embodiment of this utility model, the hydrophilic membrane 601 and the adhesive tape 604 are an integral structure. That is, the lower surface of the adhesive tape 604, i.e., the side closest to the skin, is cleaned and treated to remove grease and impurities, ensuring a clean surface. The hydrophilic membrane 601 is evenly coated onto the lower surface of the adhesive tape 604 using a suitable coating tool. After coating, the adhesive tape is allowed to air dry or dried with hot air to ensure the hydrophilic membrane adheres firmly to the tape. Simultaneously, a portion of the hydrophilic membrane 601 also covers the mating structure 602, such as... Figure 6e As shown, the hydrophilic membrane and adhesive tape are integrated into one structure. This increases the integration between the two, while the hydrophilic membrane 601 improves the wettability of the adhesive tape 604, making it easier to contact the skin and thus enhancing adhesion. The wettability of the hydrophilic membrane 604 helps prevent moisture penetration, extending the service life of the adhesive tape 604. By increasing wettability, the hydrophilic membrane 601 can reduce friction and discomfort during use of the adhesive tape 604.

[0098] In one embodiment of this utility model, the cooperating structure 602 is a double-sided adhesive layer, which includes multiple pieces of double-sided adhesive spaced apart on the hydrophilic membrane 601. One side of the double-sided adhesive is attached to the lower outer shell 10413, and the other side is attached to the hydrophilic membrane 601. A gap is formed between the double-sided adhesive layer, the hydrophilic membrane 601, and the lower outer shell 10413 of the analyte detection device 104. By setting the shape, thickness, length, quantity, position, etc. of the double-sided adhesive, the gap formed includes the aforementioned groove gap and annular gap. The characteristics of the groove gap and annular gap are also the same as those of the aforementioned groove gap and annular gap.

[0099] In another embodiment of this utility model, the cooperating structure 602 is a guide channel formed on the lower outer shell 10413. The hydrophilic membrane 601 is adhered to the lower outer shell 10413 by double-sided adhesive, or fixed to the lower outer shell 10413 by hot melting or ultrasonic welding. The guide channel includes a groove-shaped guide channel and an annular guide channel. By setting the shape, thickness, length, number, position, etc. of the guide channel, the aforementioned groove-shaped gap and annular gap can also be formed between the lower outer shell 10413, the guide channel, and the hydrophilic membrane 601. The characteristics of the groove-shaped gap and annular gap are the same as those of the aforementioned groove-shaped gap and annular gap.

[0100] In another embodiment of this utility model, the mating structure 602 is a protrusion and / or a protrusion provided on the lower outer shell 10413. The protrusion and / or the protrusion and the lower outer shell 10413 can be integrally formed, or they can be connected by friction fit, snap fit, or by double-sided adhesive, hot melt, or ultrasonic welding. Preferably, the protrusion and / or the protrusion and the lower outer shell 10413 can be integrally formed. The hydrophilic membrane 603 is then provided on the protrusion and / or the protrusion by double-sided adhesive, hot melt, or ultrasonic welding. By setting the shape, thickness, length, number, position, etc. of the protrusion and / or the protrusion, the gaps formed include the aforementioned groove gaps and annular gaps, and the characteristics of the groove gaps and annular gaps are the same as those of the aforementioned groove gaps and annular gaps.

[0101] In other embodiments of this utility model, the mating structure 602 can also be any other possible structure. Its specific structural form and the way the structure is set are not limited here. As long as the mating structure 602 can form a gap 603 with the lower outer shell 10413 and the hydrophilic membrane 601, when the auxiliary needle 1052 retracts and blood overflows along the wound, the hydrophilic membrane 601 attracts the blood and guides the blood along the gap 603 to a position away from the first through hole 10414, thereby preventing the blood from penetrating into the interior of the analyte detection device 104 through the first through hole 10414.

[0102] In summary, this utility model discloses an analyte detection device with a siphon structure. The siphon structure is disposed on the lower shell of the analyte detection device and includes a hydrophilic membrane and a mating structure. The siphon structure can attract blood overflowing from the body of the sensor to the edge of the hydrophilic membrane, preventing blood from penetrating into the interior of the analyte detection device and contaminating it, thereby ensuring the normal use of the analyte detection device.

[0103] While specific embodiments of the present invention have been described in detail by way of examples, those skilled in the art should understand that the above examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Those skilled in the art should understand that modifications can be made to the above embodiments without departing from the scope and spirit of the present invention. The scope of the present invention is defined by the appended claims.

Claims

1. An analyte detection device with a siphon structure, characterized in that: the analyte detection device comprises at least a transmitter, a sensor, a housing and a battery, the sensor comprises an in-vivo part and an in-vitro part, the housing comprises an upper housing and a lower housing, the lower housing is further provided with a first through hole, and the in-vivo part passes through the first through hole; and the siphon structure is arranged on the lower housing, the siphon structure comprises a hydrophilic film and a matching structure, and a gap is formed between the hydrophilic film, the matching structure and the lower housing. The depth of the gap is 0.05-0.3mm.

2. The analyte detection device with siphoning structure according to claim 1, wherein, The depth of the gap is 0.1mm.

3. The analyte detection device with siphoning structure according to claim 2, wherein, The gap comprises at least a slot-shaped gap.

4. The analytical device with siphoning structure of claim 1, wherein, The slot-shaped gap is symmetrically distributed along the circumference of the first through hole.

5. The analytical device with siphoning structure according to claim 4, wherein, The cross section of the slot-shaped gap is square, circular, trapezoidal or irregular.

6. The analytical device with siphoning structure according to claim 4, wherein, The cross-sectional area of the starting end of the slot-shaped gap is not less than that of the terminal end of the slot-shaped gap.

7. The siphon-structured analyte detection device according to claim 6, wherein, The length of the slot-shaped gap is not less than the radial length of the hydrophilic film.

8. The analytical device with siphoning structure of claim 4, wherein, The gap comprises at least one annular gap.

9. The siphon-structured analyte detection device according to any one of claims 1-8, wherein, The at least one annular gap comprises a first annular gap, the starting end of the first annular gap is the edge of the first through hole, and the terminal end of the first annular gap is the starting end of the matching structure.

10. The siphon-structured analyte detection device according to claim 9, wherein, The at least one annular gap comprises a second annular gap, the starting end of the second annular gap is the terminal end of the matching structure, and the terminal end of the second annular gap is the terminal end of the hydrophilic film.

11. The siphon-structured analyte detection device of claim 10, wherein, The lower housing is further provided with an adhesive tape, and the adhesive tape is an integral structure with the hydrophilic film.

12. The analytical device with siphoning structure of claim 1, wherein, The matching structure comprises double-sided tape.

13. The analytical device with siphoning structure of claim 1, wherein, The matching structure comprises a flow guide groove opened on the lower housing.

14. The analytical device with siphoning structure of claim 1, wherein, The matching structure comprises a convex strip and / or a convex block arranged on the lower housing.

15. The analytical device with siphoning structure of claim 1, wherein, The convex strip and / or the convex block are integrally formed with the lower housing.

16. The siphon-structured analyte detection device of claim 15, wherein, ​

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