Analyte detection device with siphon structure

Abstract

The invention 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] The present invention mainly relates to the field of medical devices, and in particular to an analyte detection device with a siphon structure. Background Art

[0002] The pancreas in a normal person's body can automatically monitor the glucose content in the human blood and automatically secrete the required insulin / glucagon. However, the pancreas of diabetic patients has abnormal function and cannot normally secrete the insulin required by the human body. Therefore, diabetes is a metabolic disease caused by abnormal pancreatic function in the human body, and diabetes is a lifelong disease. At present, medical technology cannot cure diabetes, and can only control the occurrence and development of diabetes and its complications by stabilizing blood sugar.

[0003] Diabetic patients need to test their blood sugar before injecting insulin into their bodies. Currently, most detection methods can continuously detect blood sugar and send blood sugar data to remote devices in real time for users to view. This detection method is called continuous glucose monitoring (CGM) method. This method requires the detection device to be attached to the surface of the skin, and the sensor carried by it is inserted into the subcutaneous tissue fluid by the installer to complete the detection. However, when the sensor is inserted into the subcutaneous tissue, it may pierce the blood vessels. At the same time, the subcutaneous pressure increases due to the insertion of the sensor into the subcutaneous tissue, which will cause blood to flow along the electrodes of the sensor to the surface of the skin, and even penetrate into the inner bottom surface of the analyte detection device, causing contamination inside the analyte detection device, affecting the normal use of the analyte detection device, and even causing a short circuit at the electrical connection between the sensor and the transmitter, making the analyte detection device completely unusable.

[0004] Therefore, the prior art urgently needs an analyte detection device that can prevent blood from penetrating into the interior. Summary of the invention

[0005] An embodiment of the present invention discloses an analyte detection device with a siphon structure. The siphon structure is arranged on the lower shell of the analyte detection device, and includes a hydrophilic membrane and a matching structure. A gap is formed between the hydrophilic membrane, the matching structure and the lower shell. The siphon structure can be used to suck blood overflowing from a wound along the gap to a position away from a first through hole, thereby preventing the blood from penetrating 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] The present invention provides an analyte detection device with a siphon structure. The analyte detection device at least includes a transmitter, a sensor, a shell and a battery. The sensor includes an internal part and an external part. The shell includes an upper shell and a lower shell. The lower shell is also provided with a first through hole, and the internal part passes through the first through hole. The siphon structure is provided on the lower shell. The siphon structure includes a hydrophilic membrane and a matching structure. A gap is formed between the hydrophilic membrane, the matching structure and the lower shell.

[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 comprises at least a slot-type gap.

[0010] According to one aspect of the present invention, the slot-shaped gaps are symmetrically distributed along the circumference of the first through hole.

[0011] According to one aspect of the present invention, the cross section of the slot-shaped gap is square, rectangular, circular, trapezoidal or irregular.

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

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

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

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

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

[0017] According to one aspect of the present invention, an adhesive tape is further provided on the housing, and the adhesive tape and the hydrophilic film are an integrated structure.

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

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

[0020] According to one aspect of the present invention, the matching structure includes a convex strip and / or a convex block arranged on the lower housing.

[0021] According to one aspect of the present invention, the convex strip and / or the convex block are integrally formed with the lower housing.

[0022] Compared with the prior art, the technical solution of the present invention has the following advantages:

[0023] The present invention 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 membrane and a matching structure. A gap is formed between the hydrophilic membrane, the matching structure and the lower shell. The siphon structure can be used to suck blood overflowing from a wound along the gap to a position away from a first through hole, thereby preventing the blood from penetrating into the interior of the analyte detection device through the first through hole and contaminating the analyte detection device, thereby ensuring normal use of the analyte detection device.

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

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

[0026] Furthermore, the first through holes of the slot-shaped gap are distributed symmetrically around the circumference, so the attracted blood can be evenly diffused along the slot-shaped gap in all directions, preventing the blood from gathering in a certain direction and then penetrating into the analyte detection device from the first through holes.

[0027] Furthermore, the length of the groove gap is not less than the radial length of the hydrophilic membrane. When the blood can continue to diffuse after diffusing to the terminal end of the hydrophilic membrane, it can diffuse toward 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, which can quickly attract blood overflowing from the wound along the circumference of the positioning hole and further guide it along the groove-shaped gap to a position away from the first through hole.

[0029] Furthermore, the gap also includes a second annular gap, and the terminal end of the second annular gap is the terminal end of the hydrophilic membrane, so that the blood diffused along the groove-shaped gap can be further diffused along the second annular gap, thereby increasing the blood holding volume and preventing blood aggregation.

[0030] Furthermore, the terminal ends of the hydrophilic film and the matching structure are adjacent to the starting end of the tape, and the overall thickness of the hydrophilic film and the matching structure is equal to the thickness of the tape, that is, the tape and the hydrophilic film are in the same horizontal plane, reducing user discomfort and improving user experience.

[0031] Furthermore, the hydrophilic film and the adhesive tape are an integrated structure, which increases the integration of the adhesive tape and the hydrophilic film, while improving the wettability of the adhesive tape, extending the service life of the adhesive tape, and increasing the comfort of the adhesive tape when used. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

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

[0035] Figure 3 It is a schematic diagram of the explosion structure of the installation unit of the analyte detection device according to an embodiment of the present invention;

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

[0037] Figure 5a is a schematic diagram of the elastic cushion sleeve being arranged outside the auxiliary needle before installation according to the present invention;

[0038] Figure 5b It is a schematic diagram of an elastic pad being arranged outside the auxiliary needle after the auxiliary needle is inserted into the subcutaneous tissue according to the present invention;

[0039] Figure 5c A schematic diagram of an elastic cushion sleeve disposed outside the sensor after the auxiliary needle is retracted according to the present invention;

[0040] Figure 5d It is a schematic diagram of the structure in which the elastic pad is embedded in the exterior of the lower housing of the analyte detection device according to the present invention;

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

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

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

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

[0045] Figure 6b for Figure 6a Schematic diagram of the local enlarged structure of the middle M area;

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

[0047] Figure 6g FIG. 4 is a schematic structural diagram of another analyte detection device with a siphon structure according to the present invention. DETAILED DESCRIPTION

[0048] As mentioned above, when the analyte detection device of the prior art is installed, the sensor may puncture the blood vessel when it penetrates the subcutaneous tissue. At the same time, the pressure under the skin increases due to the penetration of the sensor, which may cause blood to flow along the electrode of the sensor to the skin surface, or even penetrate to the inner bottom surface of the analyte detection device, causing contamination inside the analyte detection device, affecting the normal use of the analyte detection device, and even causing a short circuit at the electrical connection between the sensor and the transmitter, making the analyte detection device completely unusable.

[0049] In order to solve this problem, the present invention provides an analyte detection device with a siphon structure. The siphon structure is arranged on the lower shell of the analyte detection device, and includes a hydrophilic membrane and a matching structure. A gap is formed between the hydrophilic membrane, the matching structure and the lower shell. The siphon structure can be used to suck blood overflowing from the wound along the gap to a position away from the first through hole, thereby preventing the blood from penetrating 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 the relative arrangement of components and steps, numerical expressions and numerical values ​​set forth in these embodiments should not be construed as limiting the scope of the present invention unless otherwise specifically stated.

[0051] In addition, it should be understood that for ease of description, the sizes of the various components shown in the drawings are not necessarily drawn according to actual proportions. For example, the thickness, width, length or distance of certain 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 present invention and its application or use in any sense. Technologies, methods and devices known to ordinary technicians in the relevant field may not be discussed in detail here, but where applicable, these technologies, methods and devices should be considered as part of this specification.

[0053] It should be noted that like reference numerals and letters denote similar items in the following figures, and thus, once an item is defined or described in one figure, it will not require further discussion in the subsequent figure descriptions.

[0054] The analyte detection system includes a mounting unit for the analyte detection device and the analyte detection device built into the mounting unit. Figure 1 Schematic diagram of the external structure of the installation unit of the analyte detection device according to an embodiment of the present invention. The external structure of the installation unit 100 includes a shell 101 and a protective cover 102, and the shell 101 is used to carry internal structural parts. When the installation unit 100 is in use, the end close to the user's skin is the proximal end, and the end away from the skin is the distal end. A first opening is provided at the proximal end of the shell 101. The protective cover 102 is used to protect, seal and prevent triggering of the internal structure and internal structural parts of the shell 101.

[0055] Figure 2a Schematic diagram of the external structure of the housing of an embodiment of the present invention, Figure 2b Schematic diagram of the structure 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 in the distal direction of the outer cover body 1021, and the second opening faces the first opening. At the second opening, the outer cover body 1021 and the clamp 1022 are connected by a breakable column 10211, and the columns 10211 are distributed between the outer cover body 1021 and the clamp 1022 at a certain interval. When the outer cover body 1021 rotates relative to the clamp 1022, the columns 10211 can be broken, and the outer cover body 1021 is separated from the clamp 1022.

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

[0057] A protrusion 10221 is provided on the inner side of the clamp 1022, and correspondingly, a groove 1011 is provided on the outer side of the housing 101. 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 threaded cooperation, 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 the present invention, the outer cover body 1021 and the inner cover body 1023 may also be fixedly connected by friction fit or snap fit.

[0059] In other embodiments of the present invention, the clamp 1022 and the housing 101 may also be connected by friction fit, snap fit or thread fit.

[0060] Figure 3 The exploded structural diagram of the analyte detection device installation unit of the embodiment of the present invention is shown in FIG. The dotted lines in the figure represent the installation and matching relationship of each structural member. The internal structural members of the analyte detection device installation unit 100 include a parallel slider module 103, an analyte detection device 104, an auxiliary needle module 105, a trigger module 106 and an elastic module 107, and the elastic module 107 includes a first elastic member 1071 and a second elastic member 1072.

[0061] The analyte detection device 104 and the installation unit 100 are not limited to Figure 3 In some embodiments of the present invention, before installation, the analyte detection device 104 is built into the mounting unit 100. When in use, the user can install the analyte detection device 104 on the surface of human skin by taking out the mounting unit 100 from the packaging box. In other embodiments of the present invention, before installation, the analyte detection device 104 and the mounting unit 100 are in a separated state, that is, the user needs to take out the mounting unit 100 and the analyte detection device 104 from the packaging box separately, and then assemble the analyte detection device 104 into the mounting unit 100 before installing the analyte detection device 104 on the surface of human skin.

[0062] Figure 4 Schematic diagram of the structure of the analyte detection device according to the embodiment of the present invention. Figure 3 In the embodiment of the present invention, the analyte detection device 104 includes a housing 1041, a transmitter (not shown in the figure), a sensor 1042, a battery (not shown in the figure), and an internal circuit (not shown in the figure) disposed in the housing 1041 and electrically coupled to the sensor. The sensor 1042 is used to detect the analyte parameter information of the user's body fluid, 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 an embodiment of the present invention, the housing 1041 includes an upper housing 10411 and a lower housing 10413, and the upper housing 10411 and the lower housing 10413 are spliced ​​to form an internal space. The sensor 1042 includes an external part and an internal part, and the external part is bent relative to the internal part, as shown in Figure 5a. The external part, the transmitter, the battery and the internal circuit are arranged in the internal space, and the external part is electrically coupled with the internal circuit. The internal part is provided with structures such as electrodes and membrane layers, and the analyte parameter information can be detected by piercing the subcutaneous part of the user. When the internal part pierces the subcutaneous part, it needs to have a correct angle, for example, piercing perpendicular to the skin surface. After the life of the analyte detection device 104 ends, it is removed from the user's skin surface and discarded as a whole.

[0064] In an embodiment of the present invention, the lower shell 10413 includes a first through hole 10414 extending therethrough. Correspondingly, on the axis of the first through hole 10414, the upper shell 10411 includes a second through hole (not shown in the figure). The internal part of the body passes through the first through hole 10414 to the outside of the shell to facilitate penetration into the user's subcutaneous tissue.

[0065] In other embodiments of the present invention, the analyte detection device 104 is not limited to the above structure. In other embodiments of the present invention, the transmitter is arranged outside the housing 1041 , and the user installs the housing 1041 on the user's skin surface through the installation unit 100 , and then installs the transmitter on the housing 1041 .

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

[0067] In some further embodiments of the present 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 installation 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 body 1021 to break the column 10211, separate the protective cover 102 from the shell 101, and move the proximal end of the installation unit 100 close to the user's skin until the outer ring of the trigger module 106 fits the skin surface. The user presses the shell 101 at the distal end, and the shell 101 moves toward the skin. The trigger module 106 remains stationary, so the trigger module 106 moves distally relative to the shell 101, and the parallel slider module 103 continues to move proximally under the thrust of the first elastic member 1071, while driving the auxiliary needle module 105 and the analyte detection device 104 to move proximally. The auxiliary needle 1052 and the in vivo part of the sensor it envelops penetrate subcutaneously until the analyte detection device 104 contacts the user's skin surface. Driven by the second elastic member 1072, the auxiliary needle module 105 moves distally and eventually returns to the initial position. The in vivo part of the sensor of the analyte detection device 104 remains in the body, and the auxiliary needle 1052 retracts into the shell 101 to prevent the auxiliary needle 1052 from being exposed outside the shell 101 to avoid unnecessary damage.

[0070] When the auxiliary needle 1052 penetrates the subcutaneous tissue, it may puncture a blood vessel. At the same time, since the subcutaneous pressure increases after the auxiliary needle 1052 penetrates the subcutaneous tissue, after the auxiliary needle 1052 is retracted, blood may flow along the internal part of the analyte detection device 104 to the skin surface, or even penetrate through the first through hole 10414 to the inner bottom surface of the analyte detection device 104, causing contamination of the interior of the analyte detection device 104, affecting the normal use of the analyte detection device, and 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 Schematic diagram of an elastic pad being sleeved on the outside of the auxiliary needle before installation according to the present invention. In order to solve the above problems, in some embodiments of the present invention, before installation, an elastic pad 108 is sleeved on the outside of the auxiliary needle 1052 at the contact position between the auxiliary needle 1052 and the analyte detection device 104 on the outside of the lower shell 10413, and the needle body envelops the internal body part 10422 of the sensor 1042. During installation, the auxiliary needle 1052 carries the internal body part 10422 and penetrates subcutaneously, and the lower shell 10413 of the analyte detection device 104 contacts the skin surface and presses the elastic pad 108. Figure 5b As shown, Figure 5b This is a schematic diagram of an elastic pad being arranged outside the auxiliary needle after the auxiliary needle pierces the subcutaneous tissue according to the present invention.

[0072] Reference Figure 5c , Figure 5cThe figure is a schematic diagram of the elastic pad being sleeved on the outside of the sensor after the auxiliary needle is retracted according to the present invention. In some embodiments of the present invention, the auxiliary needle 1052 carries the internal body part 10422 and pierces the subcutaneous tissue to a predetermined position and then retracts, leaving the internal body part 10422 to remain under the skin to detect the analyte parameter information. The analyte detection device 104 is adhered to the skin surface under the action of the adhesive tape, so when the auxiliary needle 1052 is retracted, the elastic pad 108 is sandwiched between the lower outer shell 10413 and the skin surface. After the auxiliary needle 1052 is completely retracted, the elastic pad 108 shrinks and sleeves on the outside of the internal body part 10422 under its own elastic action, pressing and covering the wound caused by the auxiliary needle 1052 piercing the subcutaneous tissue, which can prevent blood from overflowing from the wound and entering the inside of the analyte detection device 104 from the first through hole 10414, contaminating the analyte detection device 104, ensuring the normal use of the analyte detection device 104, and at the same time preventing foreign matter from contaminating the wound and improving the wound healing speed.

[0073] The outer diameter d1 of the elastic pad 108 is greater 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] In order to prevent the elastic pad 108 from moving during the installation process, such as when the auxiliary needle is retracted, thereby affecting the elastic pad 108's blocking of blood, in other embodiments of the present invention, the elastic pad 108 is fixed to the outside of the lower shell 10413 of the analyte detection device 104 by double-sided tape, hot melt welding or ultrasonic welding, and the auxiliary needle 1052 passes concentrically through the first through hole 10414 and the elastic pad 108.

[0075] Reference Figure 5d , Figure 5d The schematic diagram of the structure of the elastic pad embedded in the outer part of the lower shell of the analyte detection device according to the present invention, in some embodiments of the present invention, the outer part of the lower shell 10413 of the analyte detection device 104 is provided with a first receiving groove 104131 for receiving the first elastic pad 108, and accordingly, the first through hole 10414 is sunken into the inner part of the lower shell 10413, and the elastic pad 108 is flush with the lower shell 10413 after installation, so that the elastic pad 108 does not cause additional compression 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 penetrating from the first through hole 10414 into the interior of the analyte detection device 104. 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 interference fit.

[0076] Reference Figure 5e , Figure 5eThis is a schematic diagram of the structure in which the elastic pad is embedded in the lower shell of the analyte detection device according to the present invention. In some embodiments of the present invention, the elastic pad 108 is arranged on the inner side of the lower shell 10413, the extracorporeal part 10421 of the sensor 1042 is bent relative to the intracorporeal part 10422, and the elastic pad 108 is clamped between the bending area of ​​the lower shell 10413 and the sensor 1042. After the auxiliary needle 1052 is fully retracted, the elastic pad 108 shrinks and is sleeved on the outer side of the intracorporeal part 10422 under the action of its own elasticity, thereby sealing the first through hole 10414, thereby preventing blood from entering the interior of the analyte detection device 104 from the first through hole 10414 and contaminating the analyte detection device 104, thereby ensuring the normal use of the analyte detection device 104.

[0077] In order to prevent the elastic pad 108 from moving during the installation process, such as when the auxiliary needle is retracted, thereby affecting the elastic pad 108's blocking of blood, in other embodiments of the present invention, the elastic pad 108 is fixed to the inner side of the lower shell 10413 of the analyte detection device 104 by double-sided tape, hot melt welding or ultrasonic welding, and the auxiliary needle 1052 passes concentrically through the first through hole 10414 and the elastic pad 108.

[0078] In another embodiment of the present invention, a second receiving groove 104132 is provided inside the lower housing 10413 of the analyte detection device 104 for receiving 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 received in the second receiving groove 104132, in the vertical direction, the elastic pad is slightly compressed when received in the second receiving groove, and the elastic pad 108 abuts against the first through hole of the lower housing 10413 with a certain elastic force. Hole 10414 and the second receiving groove 104132. 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 interference fit. Therefore, the elastic pad 108 can tightly seal the first through hole 10414 to prevent blood from entering the analyte detection device 104 from the first through hole 10414 and contaminating the analyte detection device 104, thereby ensuring the normal use of the analyte detection device 104.

[0079] Reference Figure 5f , Figure 5f Schematic diagram of a solid structure of the elastic pad according to the present invention. In some embodiments of the present invention, the elastic pad 108 may 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 5gThis is a schematic diagram of the hollow structure of the elastic pad according to the present invention. In some embodiments of the present invention, the elastic pad 108 may be a hollow structure, and 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 mounted on the outside of the auxiliary needle 1052 to prevent the internal part 10422 from escaping from the envelope of the auxiliary needle 1052. In a preferred embodiment of the present invention, the inner diameter d2 of the elastic pad 108 is also smaller than the outer diameter of the internal part 10422. After the auxiliary needle 1052 is retracted, the elastic pad 108 can shrink and be tightly mounted on the outside of the internal part 10422 to press and cover the wound caused by the auxiliary needle 1052 piercing the subcutaneous tissue (when the elastic pad 108 is arranged on the outside of the lower shell 10413), or tightly seal the first through hole 10414 (when the elastic pad 108 is arranged on the inside of the lower shell 10413) to prevent blood from overflowing from the wound and entering the interior of the analyte detection device 104 from the first through hole 10414, thereby contaminating the analyte detection device 104.

[0081] In some embodiments of the present invention, the thickness of the elastic pad 108 is 0.01-5 mm. When the elastic pad 108 is arranged on the outside of the lower housing 10413, the elastic pad 108 is too thick, which will increase the pressure of the analyte detection device 104 on the skin surface and cause discomfort. When the elastic pad 108 is arranged on the inside of the lower housing 10413, the elastic pad 108 is too thick, which will increase the height of the analyte detection device 104, which is not conducive to the miniaturization of the analyte detection device 104. If the elastic pad 108 is too thin, it is easy to deform itself and cannot form an effective constraint on the internal part 10422. In a preferred embodiment of the present invention, the thickness of the elastic pad 108 is 0.3 mm.

[0082] In some embodiments of the present invention, the elastic pad 108 is made of rubber, silicone or latex, which has good elasticity and can avoid contamination of the wound.

[0083] Figure 6a is a schematic structural diagram of an analyte detection device with a siphon structure according to the present invention; Figure 6b for Figure 6a Schematic diagram of the local enlarged structure of the middle M area; Figure 6c-6f 1 is a top view of the siphon structure according to the present invention.

[0084] refer to Figure 6a-6fIn other embodiments of the present invention, a siphon structure is provided on the lower housing 10413 of the analyte detection device 104, and the siphon structure includes a hydrophilic membrane 601 and a matching structure 602. The matching structure 602 is provided on the lower housing 10413, and the hydrophilic membrane 601 is provided on the matching structure 602. A gap 603 is formed between the hydrophilic membrane 601, the matching structure 602 and the lower housing 10413. When the auxiliary needle 1052 is retracted and blood overflows along the wound, the hydrophilic membrane 601 attracts the blood and transfers the blood along the gap 603. Figure 6b-6f The blood is guided in the direction indicated by the arrow in the figure 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, avoiding contamination of the interior of the analyte detection device 104, affecting the normal use of the analyte detection device 104, and even causing a short circuit in the electrical connections of the sensor 1042, the internal circuit, and the battery, thereby damaging the analyte detection device 104.

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

[0086] The material of the hydrophilic film 601 includes one or more of a polymer film, a glass film, a polyester film, a polyurethane film, a polytetrafluoroethylene film, and a polyacrylic acid film. Preferably, the material of the hydrophilic film 601 is a polymer film. The polymer material has strong hydrophilicity and can effectively improve the wetting performance of the material surface, so that it has better adhesion and stability.

[0087] In one embodiment of the present invention, the gap 603 includes a slot-shaped gap 6031 . There are multiple matching structures 602 distributed along the circumference of the first through hole 10414, and multiple groove gaps 6031 are formed between the hydrophilic membrane 601, the multiple matching structures 602 and the lower shell 10413. Preferably, the multiple matching structures 602 are evenly distributed along the circumference of the first through hole 10414 on the lower shell 10413. Therefore, the multiple groove gaps 6031 are also evenly distributed along the circumference of the first through hole 10414 between the hydrophilic membrane 601 and the lower shell 10413. When blood overflows from the wound, the hydrophilic membrane 601 attracts the blood and guides the blood to diffuse evenly in various radial directions from the circumference of the first through hole 10414, preventing blood in a certain direction from being guided or not diffusing in time, causing blood aggregation in a certain direction, so that the blood enters the interior of the analyte detection device 104 from the direction of the first through hole 10414, avoiding contamination of the interior of the analyte detection device 104 and affecting the normal use of the analyte detection device 104.

[0088] In one embodiment of the present invention, the slot gap 6031 is a gap along the radial direction. The cross section of the slot gap 6031 can be square, circular, trapezoidal or other irregular shapes. Preferably, the cross section is a trapezoid, and the side close to the skin is the lower side of the trapezoid. The closer to the skin, the greater the blood flow. The trapezoidal cross section is more adaptable to changes in blood flow. The starting end of the slot gap 6031 is the end close to the wound, and the cross-sectional area of ​​the starting end is k1. The terminal end is the terminal end A2 close to the hydrophilic membrane 601, and the cross-sectional area of ​​the terminal end is k2. k1 is not less than k2. The bleeding volume near the wound is large. The larger k1 is, the faster the blood can be attracted to the position away from the first through hole 10414. When the blood spreads to the terminal end close to the gap 603, the blood flow may be very small, or even no blood continues to spread. Therefore, k2 can be less than k1, but in order to ensure that there is enough space to keep the blood away from the first through hole 10414 and the blood does not gather, k2 can be equal to k1.

[0089] In the present invention, the gap 603 includes an annular gap 6032. The hydrophilic membrane 601 includes a positioning hole 6011, and the positioning hole 6011 corresponds to the first through hole 10414. The correspondence here means that the positions and sizes of the positioning hole 6011 and the first through hole 10414 are consistent, that is, 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, and the starting end B1 of the matching structure 602 is spaced from the starting end A1 of the hydrophilic membrane 601 by a distance l1. Therefore, a first annular gap 6032 with a height of h and a width of 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 terminal end of the first annular gap 6032 is the starting end B1 of the matching structure 602. A siphon phenomenon can be formed around the circumference of the positioning hole 6011, so that the blood flowing out along the inner part 10422 of the sensor body is quickly attracted to the first annular gap 6032 from the circumferential edge of the positioning hole 6011, and then guided to a position away from the first through hole 10414 along the groove gap 6031, thereby further ensuring that the blood will not penetrate into the interior of the analyte detection device 104 from the first through hole 10414. In the embodiment of the present invention, the width l1 is 0.02-0.35 mm, preferably, the width l1 is 0.1-0.2 mm.

[0090] In another embodiment of the present invention, the gap 603 may also include only the annular gap 6032. Figure 6e As shown in FIG. f, in order to allow the annular gap 6032 to contain enough blood and prevent the blood from entering the analyte detection device through the first through hole 10414 after aggregation, the width l1 of the annular gap 6032 is 1.5-2 mm. Figure 6e In the embodiment, the matching structure 602 is a circular ring structure arranged along the edge of the terminal end A2 of the hydrophilic membrane 601. Figure 6f In the figure, the matching structure 602 is a plurality of discrete structures arranged along the edge of the terminal end A2 of the hydrophilic membrane 601. Preferably, the plurality of discrete structures are evenly distributed along the edge of the terminal end A2 of the hydrophilic membrane 601. Because the hydrophilic membrane 601, the matching structure 602 and the lower shell 10413 also form a gap along the edge of the terminal end A2 of the hydrophilic membrane 601. When there is a lot of blood and it can continue to diffuse to the edge of the terminal end A2 of the hydrophilic membrane, the blood will further diffuse to the tape 604. Since the tape 604 is a non-woven tape, the blood can be soaked in the tape 604 to prevent blood from gathering and penetrating from the first through hole 10414 into the interior of the analyte detection device 104.

[0091] In the embodiment of the present invention, the terminal end B2 of the matching structure 602 is aligned with the terminal end A2 of the hydrophilic membrane 601, and therefore, the length of the slot gap 6031 is equal to the radial length L of the hydrophilic membrane 601. In other embodiments of the present invention, the terminal end B2 of the matching structure 602 is not aligned with the terminal end A2 of the hydrophilic membrane 601, and therefore, the length of the slot gap 6031 may not be equal to the radial length L of the hydrophilic membrane 601.

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

[0093] When the terminal end B2 of the matching structure 602 does not reach the terminal end A2 of the hydrophilic membrane 601, the distance is l2. 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 matching structure 602 and the lower shell 10413, the starting end of the second annular gap 6033 is the terminal end B2 of the matching structure, and the terminal end of the second annular gap 6033 is the terminal end A2 of the hydrophilic membrane 601. If the blood can continue to diffuse after being guided to the terminal end B2 of the matching structure 602 along the groove gap 6031, it will diffuse to the terminal end A2 of the hydrophilic membrane along the radial direction, that is, when the terminal end B2 of the matching structure 602 does not reach the terminal end A2 of the hydrophilic membrane 601, the length of the groove gap 6031 is also the radial length L of the hydrophilic membrane 601. The blood will diffuse to the second annular gap 6033 with a width of l2 and a depth of h along the circumferential direction, which can accommodate more blood and better prevent blood aggregation. In the embodiment of the present invention, the width l2 is 0.02-0.55 mm, preferably, the width l2 is 0.2-0.4 mm, and more preferably, the width l2 is 0.3 mm.

[0094] In other embodiments of the present invention, by properly setting the matching structure 602, more annular gaps can be set between the first annular gap 6032 and the second annular gap 6033, such as dividing the matching structure 602 in the circumferential direction at the radial midpoint, with a dividing width of l3, so that a third annular gap with a width of l3 and a height of h can be formed between the lower shell 10413, the matching structure 602 and the hydrophilic membrane 601.

[0095] When the terminal end B2 of the matching structure 602 exceeds the terminal end A2 of the hydrophilic membrane 601, the adhesive tape 604 at least partially covers the matching structure 602, and an extended gap is formed between the adhesive tape 604, the matching structure 602 and the lower shell 10413, that is, when the terminal end B2 of the matching structure 602 exceeds the terminal end A2 of the hydrophilic membrane 601, the length of the groove gap 6031 is greater than the radial length L of the hydrophilic membrane. The extended gap is on the extension line of the groove gap 6031. If the blood can continue to spread after being guided to the terminal end B2 of the matching structure 602 along the groove gap 603, it will further spread to the extended gap to further accommodate more blood and better prevent blood aggregation.

[0096] refer to Figure 6a and Figure 6b A tape 604 is provided on the lower shell 10413 of the analyte detection device 104 of the present invention. In order to avoid the puncture of the auxiliary needle module 105, an avoidance hole 6041 is opened on the tape 604. 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 matching structure 602 are arranged in the avoidance hole 6041 of the tape 604, and the edges of the hydrophilic membrane 601 and the matching structure 602 are adjacent to the edges of the avoidance hole 6041 of the tape 604, that is, the terminal end A2 of the hydrophilic membrane 601 and the terminal end B2 of the matching structure 602 are adjacent to the starting end C1 of the tape 604, and at the same time, the thickness of the tape 604 is equal to the sum of the thicknesses of the hydrophilic membrane 601 and the matching structure 602, so that the tape 604 and the hydrophilic membrane 601 on the lower shell 10413 of the analyte detection device 104 are in the same plane, thereby reducing the user's discomfort and improving the user experience.

[0097] In another embodiment of the present invention, the hydrophilic film 601 and the adhesive tape 604 are an integrated structure, that is, the lower surface of the adhesive tape 604, that is, the side close to the skin, is cleaned and treated to remove grease and impurities to ensure that the surface is clean. Use an appropriate coating tool to evenly coat the hydrophilic film 601 on the lower surface of the adhesive tape 604. After coating, let the adhesive tape dry naturally or use hot air to dry it to ensure that the hydrophilic film is firmly attached to the adhesive tape. At the same time, part of the hydrophilic film 601 is also covered on the matching structure 602, such as Figure 6e As shown. The hydrophilic film and the adhesive tape are an integrated structure, which increases the integration of the adhesive tape and the hydrophilic film. At the same time, the hydrophilic film 601 can improve the wettability of the adhesive tape 604, making it easier to contact the skin, thereby improving the adhesion. The wettability of the hydrophilic film 604 helps prevent water penetration and extend the service life of the adhesive tape 604. By increasing the wettability, the hydrophilic film 601 can reduce the friction and discomfort of the adhesive tape 604 during use.

[0098] In one embodiment of the present invention, the matching structure 602 is a double-sided adhesive layer, and the double-sided adhesive layer includes multiple double-sided adhesives arranged at intervals on the hydrophilic film 601. One side of the double-sided adhesive is adhered to the lower shell 10413, and the other side is adhered to the hydrophilic film 601. A gap is formed between the double-sided adhesive layer, the hydrophilic film 601 and the lower shell 10413 of the analyte detection device 104. By setting the shape, thickness, length, quantity, position and other aspects of the double-sided adhesive, the formed gap includes the aforementioned groove gap and annular gap, and the characteristics of the groove gap and the annular gap are also the same as the characteristics of the aforementioned groove gap and the annular gap.

[0099] In another embodiment of the present invention, the matching structure 602 is a guide groove opened on the lower shell 10413, and the hydrophilic membrane 601 is attached to the lower shell 10413 by double-sided adhesive, or fixed to the lower shell 10413 by hot melting or ultrasonic welding. The guide groove includes a groove-type guide groove and annular guide groove. By setting the shape, thickness, length, number, position, etc. of the guide groove, the aforementioned groove-type gap and annular gap can also be formed between the lower shell 10413, the guide groove and the hydrophilic membrane 601, and the characteristics of the groove-type gap and the annular gap are also the same as the characteristics of the aforementioned groove-type gap and the annular gap.

[0100] In another embodiment of the present invention, the matching structure 602 is a convex strip and / or a convex block arranged on the lower shell 10413. The convex strip and / or the convex block can be integrally formed with the lower shell 10413, or can be connected by friction fit, snap fit, or by double-sided adhesive, hot melt or ultrasonic welding. Preferably, the convex strip and / or the convex block and the lower shell 10413 can be integrally formed. The hydrophilic film 603 is then attached to the convex strip and / or the convex block by double-sided adhesive, hot melt or ultrasonic welding. By setting the shape, thickness, length, number, position and other aspects of the convex strip and / or the convex block, the gap formed includes the aforementioned groove gap and annular gap, and the characteristics of the groove gap and the annular gap are also the same as the characteristics of the aforementioned groove gap and annular gap.

[0101] In other embodiments of the present invention, the matching structure 602 can also be any other possible structure. Its specific structural form and the arrangement of the structure are not limited herein. As long as the matching structure 602 can form a gap 603 with the lower shell 10413 and the hydrophilic membrane 601, when the auxiliary needle 1052 is retracted 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, the present invention discloses an analyte detection device with a siphon structure. The siphon structure is arranged on the lower shell of the analyte detection device, and includes a hydrophilic membrane and a matching structure. The siphon structure can attract blood overflowing along the internal part of the sensor to the edge of the hydrophilic membrane, thereby preventing the blood from penetrating into the interior of the analyte detection device and contaminating the analyte detection device, thereby ensuring the normal use of the analyte detection device.

[0103] Although some specific embodiments of the present invention have been described in detail by way of example, it will be appreciated by those skilled in the art that the above examples are for illustration only and are not intended to limit the scope of the present invention. It will be appreciated by those skilled in the art that the above embodiments may be modified 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, wherein the sensor comprises an internal part and an external part, the housing comprises an upper housing and a lower housing, the lower housing is further provided with a first through hole, and the internal part passes through the first through hole; and The siphon structure is arranged on the lower shell, and the siphon structure comprises a hydrophilic film and a matching structure, and a gap is formed among the hydrophilic film, the matching structure and the lower shell.

2. The analyte detection device with a siphon structure according to claim 1, characterized in that: The depth of the gap is 0.05-0.3 mm.

3. The analyte detection device with a siphon structure according to claim 2, characterized in that: The depth of the gap is 0.1 mm.

4. The analyte detection device with a siphon structure according to claim 1, characterized in that: The gap includes at least a slot-shaped gap.

5. The analyte detection device with a siphon structure according to claim 4, characterized in that: The slot-shaped gaps are symmetrically distributed along the circumference of the first through hole.

6. The analyte detection device with a siphon structure according to claim 4, characterized in that: The cross section of the slot-shaped gap is square, circular, trapezoidal or irregular.

7. The analyte detection device with a siphon structure according to claim 6, characterized in that: The cross-sectional area of ​​the starting end of the slot gap is not less than the cross-sectional area of ​​the ending end of the slot gap.

8. The analyte detection device with a siphon structure according to claim 4, characterized in that: The length of the groove-shaped gap is not less than the radial length of the hydrophilic membrane.

9. The analyte detection device with a siphon structure according to any one of claims 1 to 8, characterized in that: The gap includes at least one annular gap.

10. The analyte detection device with a siphon structure according to claim 9, characterized in that: The at least one annular gap includes a first annular gap, the starting end of the first annular gap is the edge of the first through hole, and the ending end of the first annular gap is the starting end of the matching structure.

11. The analyte detection device with a siphon structure according to claim 10, characterized in that: The at least one annular gap includes a second annular gap, the starting end of the second annular gap is the terminating end of the matching structure, and the terminating end of the second annular gap is the terminating end of the hydrophilic membrane.

12. The analyte detection device with a siphon structure according to claim 1, characterized in that: The lower shell is also provided with adhesive tape, and the adhesive tape and the hydrophilic film are an integrated structure.

13. The analyte detection device with a siphon structure according to claim 1, characterized in that: The matching structure includes double-sided tape.

14. The analyte detection device with a siphon structure according to claim 1, characterized in that: The matching structure includes a guide groove opened on the lower shell.

15. The analyte detection device with a siphon structure according to claim 1, characterized in that: The matching structure includes convex strips and / or convex blocks arranged on the lower shell.

16. The analyte detection device with a siphon structure according to claim 15, characterized in that: The convex strip and / or the convex block are integrally formed with the lower shell.

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