A continuous glucose monitoring device and a continuous glucose monitoring system

Abstract

The present application relates to the technical field of blood glucose monitoring, in particular to a continuous blood glucose monitoring device and a continuous blood glucose monitoring system. The continuous blood glucose monitoring device comprises a flexible substrate and a transmitter component, the flexible substrate can be fixed on the surface of the skin, the first printed line is drawn on the flexible substrate, the transmitter component is welded on the flexible substrate and is electrically connected with the first printed line, the flexible substrate comprises an elongated lead-out end, the second printed line for monitoring blood glucose level is arranged on the lead-out end, and the second printed line is communicated with the first printed line. The continuous blood glucose monitoring device and the continuous blood glucose monitoring system integrate the sensor component and the transmitter component, and there is no PAD area, so that the overall thickness of the continuous blood glucose measuring device is relatively thin, and the sensor component and the transmitter component have reliable signal connection.

Description

Technical Field

[0001] This invention relates to the field of blood glucose monitoring technology, and in particular to a continuous blood glucose monitoring device and a continuous blood glucose monitoring system. Background Technology

[0002] Blood glucose monitoring is an important part of diabetes management. The results of blood glucose monitoring help doctors assess the degree of glucose metabolism disorder in diabetic patients, thereby developing a reasonable blood glucose lowering plan. Later, the effectiveness of treatment can be reflected by the blood glucose monitoring results, and the blood glucose lowering plan can be further adjusted.

[0003] Traditional blood glucose monitoring methods involve finger-prick blood collection. However, this method not only causes long-term physical discomfort for patients but also increases their psychological burden. More importantly, it cannot display a patient's blood glucose profile throughout the day, creating a monitoring blind spot in the temporal dimension. Therefore, in recent years, continuous blood glucose monitoring products have been developed, enabling patients to monitor their blood glucose levels continuously throughout the day.

[0004] However, most current continuous glucose monitoring devices consist of two structurally separate parts: a sensor and a transmitter, which must be assembled together before use. Therefore, these existing continuous glucose monitoring devices inevitably require a PAD (pad) area for electrically connecting the sensor and transmitter, increasing the overall mechanical thickness of the product and increasing the patient's discomfort. Furthermore, the presence of this PAD area necessitates a mechanical hard contact or conductive rubber contact between the sensor and transmitter. This connection method is susceptible to mechanical movement and moisture, potentially leading to short circuits or poor contact between the sensor and transmitter, thus adversely affecting the patient's continuous glucose monitoring. Summary of the Invention

[0005] Therefore, it is necessary to provide a continuous blood glucose monitoring device that integrates the sensor assembly and the transmitter assembly into one unit, eliminating the need for a separate PAD area. This results in a thinner overall continuous blood glucose monitoring device, while ensuring a reliable signal connection between the sensor assembly and the transmitter assembly.

[0006] This invention discloses a continuous glucose monitoring device, comprising a flexible substrate and a transmitter component. The flexible substrate can be fixed to the skin surface, and a first printed line is drawn on the flexible substrate. The transmitter component is disposed on the flexible substrate and electrically connected to the first printed line. The flexible substrate includes a lead-out end, and a second printed line for monitoring glucose levels is disposed on the lead-out end. The second printed line is connected to the first printed line.

[0007] In one embodiment, the flexible substrate is provided with a slit and an electrode region surrounded by the slit, and the lead-out end is formed by bending the electrode region downward along the slit.

[0008] In one embodiment, the lead-out end has a puncture structure capable of penetrating the skin.

[0009] In one embodiment, the lead-out terminal is provided with three second printed lines, which serve as the auxiliary electrode CE, the reference electrode RE, and the working electrode WE, respectively.

[0010] In one embodiment, the auxiliary electrode CE and the reference electrode RE are located on the same side of the lead-out terminal, and the working electrode WE is located on the other side of the lead-out terminal.

[0011] In one embodiment, the second printed line is formed by laser etching of gold foil.

[0012] In one embodiment, the continuous glucose monitoring device further includes a fixing structure for attaching to the skin surface, wherein the transmitter components and the fixing structure are respectively disposed on both sides of the flexible substrate.

[0013] In one embodiment, the fixing structure is an adhesive layer.

[0014] Another aspect of the present invention discloses a continuous blood glucose monitoring system, including any of the aforementioned continuous blood glucose monitoring devices and an ejector for loading the continuous blood glucose monitoring devices, wherein the ejector includes a puncture needle, and the puncture needle drives the lead end to be implanted into the patient's subcutaneous tissue.

[0015] In one embodiment, the ejector is provided with a magnet, and the continuous blood glucose monitoring device includes a normally closed reed switch, which connects the transmitter components to the first printed line as the ejector separates from the continuous blood glucose monitoring device.

[0016] Beneficial effects

[0017] The continuous blood glucose monitoring device of the present invention creatively implements a conventional blood glucose monitoring sensor through a second printed line, and connects the transmitter components through a first printed line. Since the first and second printed lines are connected, the conventional transmitter assembly and sensor assembly are simultaneously integrated on a flexible substrate. In other words, the sensor assembly and transmitter assembly in the prior art are integrated into one unit in the continuous blood glucose monitoring device of the present invention. Thus, the continuous blood glucose monitoring device of the present invention fundamentally eliminates the PAD area used for connecting the sensor assembly and transmitter assembly, thereby avoiding the problems of poor contact and water ingress short circuits introduced by the presence of the PAD area in conventional designs.

[0018] Based on this, the continuous blood glucose monitoring device of the present invention no longer needs to set up a heavy protective structure such as a shell as in the prior art. Reliable protection can be achieved by simply applying conformal coating to the first printing line, the second printing line and the connection solder joints between the transmitter components on the flexible substrate. This greatly reduces the thickness and weight of the continuous blood glucose monitoring device of the present invention and greatly reduces the foreign body sensation when the patient wears it. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the continuous blood glucose monitoring device of the present invention in some embodiments;

[0020] Figure 2 for Figure 1 An explosion diagram of the continuous blood glucose monitoring device described in the diagram;

[0021] Figure 3 This is a schematic diagram of the flexible substrate of the continuous blood glucose monitoring device of the present invention in some embodiments;

[0022] Figure 4(1) is a schematic diagram of the lead-out end of the continuous blood glucose monitoring device of the present invention in some embodiments;

[0023] Figure 4(2) is a schematic diagram of the other side of the lead-out end of the continuous blood glucose monitoring device of the present invention in some embodiments;

[0024] Figure 5 This is a schematic diagram illustrating the use of the continuous blood glucose monitoring device of the present invention in some embodiments;

[0025] Among them, 1 is a flexible substrate, 2 is a transmitter component, 3 is a fixing structure, 11 is a lead-out end, 12 is a slit, 4 is a continuous blood glucose monitoring device, 5 is a catapult, 51 is a launching spring, 52 is a puncture needle, 53 is a return needle spring, 54 is a connector, and 55 is a fixing platform. Detailed Implementation

[0026] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0027] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0028] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0029] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0030] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0031] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0032] See Figure 1 , Figure 2 , Figure 1 This is a schematic diagram of the continuous blood glucose monitoring device in some embodiments of the present invention, such as... Figure 2 As shown Figure 1 The exploded view of the continuous blood glucose monitoring device described in the present invention shows that the continuous blood glucose monitoring device includes a flexible substrate 1 and transmitter components 2. The flexible substrate 1 can be fixed to the skin surface. A first printed line (not shown in the figure) is drawn on the flexible substrate 1. A plurality of transmitter components 2 are soldered on the flexible substrate 1 and electrically connected through the first printed line. The flexible substrate 1 has an elongated lead-out end 11. A second printed line for monitoring blood glucose levels is provided on the lead-out end 11. The second printed line is connected to the first printed line. The lead-out end 11 can be implanted under the skin.

[0033] The continuous blood glucose monitoring device of the present invention, due to the softness of the flexible substrate 1, can adhere well to non-planar curved surfaces of the human body, such as the upper arm, effectively reducing patient discomfort during wear and minimizing the risk of accidental detachment from the skin. In use, the lead-out end 11 is implanted under the patient's skin, and the second printed line on the lead-out end 11 can detect blood and continuously collect target data. Since the first and second printed lines on the flexible substrate 1 are connected, and the first printed line is electrically connected to the transmitter component 2, the target data is sequentially transmitted to the transmitter component 2 through the second and first printed lines. The transmitter component 2 can then send the target data to an external device for further processing or display of continuous blood glucose data.

[0034] The continuous blood glucose monitoring device of the present invention creatively implements a conventional blood glucose monitoring sensor through a second printed line, and connects the transmitter components 2 through a first printed line. Since the first and second printed lines are connected, the conventional transmitter assembly and sensor assembly are simultaneously integrated on the flexible substrate 1. In other words, the sensor assembly and transmitter assembly in the prior art are integrated into one unit in the continuous blood glucose monitoring device of the present invention. Thus, the continuous blood glucose monitoring device of the present invention fundamentally eliminates the PAD area used for connecting the sensor assembly and transmitter assembly, thereby avoiding the problems of poor contact and water ingress short circuits introduced by the presence of the PAD area in the conventional design. Furthermore, the continuous blood glucose monitoring device of the present invention no longer requires a heavy protective structure such as a shell as in the prior art. Reliable protection can be achieved by simply applying conformal coating to the first printed line, the second printed line, and the connection solder joints between the transmitter components 2 on the flexible substrate, greatly reducing the thickness and weight of the continuous blood glucose monitoring device of the present invention. According to the applicant's experiments, the total thickness of the continuous blood glucose monitoring device of the present invention can be only 3±1mm, which greatly reduces the foreign body sensation when the patient wears it.

[0035] It is understood that the continuous glucose monitoring device of the present invention does not limit the specific arrangement of the flexible substrate 1 and its lead-out end 11. For example, in some embodiments, the lead-out end 11 may be disposed on the outer edge of the flexible substrate 1, such that the lead-out end 11 extends outward from the edge of the flexible substrate 1. In other embodiments, such as Figure 3 As shown, a slit 12 is provided inside the flexible substrate 1, and the elongated area surrounded by the slit 12 is the electrode area. In use, the lead-out end 11 is formed by bending the electrode area downward along the slit 12. With this configuration, the lead-out end 11 will be located inside the flexible substrate 1. When used on the patient's skin, even if the flexible substrate 1 is displaced relative to its original position by external force, the lead-out end 11 will be firmly implanted under the patient's skin and will not easily detach, thus ensuring the stability of the continuous blood glucose monitoring device of the present invention.

[0036] It should be noted that although only one lead-out terminal 11 is provided in the aforementioned embodiment, the continuous blood glucose monitoring device of the present invention can also be provided with more than one lead-out terminal 11 according to actual needs. For example, the second printed line on some of the leads-out terminals 11 can also be used to detect data other than blood glucose. In this way, several leads-out terminals 11 can simultaneously collect multiple sets of time-correlated data and send them to external devices through the transmitter component 2, so that doctors can better analyze the patient's blood glucose treatment or other disease conditions.

[0037] Specifically, the lead-out end 11 is preferably configured to easily penetrate the skin. In some embodiments, the lead-out end 11 has a puncture structure capable of penetrating the skin, such as a needle-like, sheet-like, or rod-like structure. In other embodiments, the thickness of the lead-out end 11 can be further adjusted. By reasonably reducing the thickness of the lead-out end 11, the pressure exerted by the lead-out end 11 on the skin can be increased while maintaining its rigidity, thereby enabling more effective skin penetration. In still other embodiments, the material of the lead-out end 11 can be different from that of the flexible substrate 1. For example, the rigidity of the material used for the lead-out end 11 can be greater than that of the material used for the flexible substrate 1, thereby giving the lead-out end 11 a better ability to penetrate the skin.

[0038] Specifically, in some embodiments, as shown in Figures 4(1) and 4(2), three second printed lines are provided on the lead-out end 11, serving as the auxiliary electrode CE, the reference electrode RE, and the working electrode WE, respectively. This forms a three-electrode testing system on the lead-out end 11, through which blood glucose can be monitored. Preferably, the second printed lines are all made of gold foil and processed using laser etching, achieving extremely high processing precision and giving the continuous blood glucose monitoring device of the present invention excellent blood glucose testing capabilities. In this embodiment, as shown in Figure 4(1), the auxiliary electrode CE and the reference electrode RE are located on the same surface of the lead-out end 11, and as shown in Figure 4(2), the working electrode WE is located on another surface of the lead-out end 11.

[0039] Of course, in other embodiments, the auxiliary electrode CE, reference electrode RE, and working electrode WE can also be disposed on the same surface, or the auxiliary electrode CE or reference electrode RE can be disposed on one surface, and the other two electrodes can be disposed on another surface. Alternatively, in some cases, the lead-out terminal 11 of the present invention can also be degraded to a two-electrode test system. The material of the second printed line does not have to be gold; it can also be common printed line materials such as platinum, palladium, titanium, carbon, aluminum, copper, silver, silver chloride, and alloys. Those skilled in the art can choose according to the actual situation.

[0040] In order to fix the continuous blood glucose monitoring device of the present invention to the patient's skin surface, in some embodiments, such as Figure 2As shown, the continuous blood glucose monitoring device of the present invention may further include a fixing structure 3 for connecting to the patient's skin surface, the fixing structure 3 being disposed on one side of the flexible substrate 1. Preferably, the transmitter component 2 and the fixing structure 3 are respectively disposed on both sides of the flexible substrate 1. Thus, when the continuous blood glucose monitoring device of the present invention is fixed to the patient's skin surface, the transmitter component 2 will not cause pressure on the patient's skin, providing the patient with a better wearing experience.

[0041] Obviously, the fixing structure 3 can have various implementations. In some embodiments, the fixing structure 3 is an adhesive layer, which is fixed to the flexible substrate 1. The adhesive layer includes an adhesive surface that can form a firm bond with the patient's skin. The adhesive layer can be implemented, for example, using adhesive tape or glue.

[0042] Regarding the transmitter component 2 and the first printed line disposed on the flexible substrate 1, the continuous blood glucose monitoring device of the present invention does not impose specific limitations on them. The transmitter component 2 may include, for example, a battery, a transmitting antenna, a microcontroller, a temperature sensor, etc. The first printed line may be made of gold, the same as the second printed line, as the conductive material, or may be made of materials such as platinum, palladium, titanium, carbon, aluminum, copper, silver, silver chloride, alloys, etc. The drawing method may include laser etching or deposition technology, etc. Those skilled in the art can adjust it according to the actual situation, which will not be elaborated further here.

[0043] It is understood that the material and thickness of the flexible substrate 1 of the present invention can be selected according to actual conditions, as long as the resulting flexible substrate 1 can support the strength of the printed line and the transmitter components 2 on it. In some embodiments, the material of the flexible substrate 1 is polyimide (PI), and the thickness of the flexible substrate 1 is 5 mil. Of course, in other embodiments, the flexible substrate 1 can also be selected from polyethylene terephthalate (PET), parylene, or other materials.

[0044] Another aspect of the present invention discloses a continuous blood glucose monitoring system, such as Figure 5 As shown, the continuous blood glucose monitoring system includes the aforementioned continuous blood glucose monitoring device 4 and ejector 5. The continuous blood glucose monitoring device 4 is mounted on the ejector 5. The ejector 5 is used to eject and separate the continuous blood glucose monitoring device 4 of the present invention. The ejector 5 also includes a puncture needle. When the continuous blood glucose monitoring device 4 separates from the ejector 5 with an initial velocity, the puncture needle drives the lead end 11 of the continuous blood glucose monitoring device 4 to penetrate the skin and be implanted under the skin.

[0045] In some embodiments, the continuous blood glucose monitoring device of the present invention further includes a normally closed reed switch, and the ejector 5 is provided with a magnet. When the continuous monitoring device 4 is separated from the ejector 5, the normally closed reed switch connects the transmitter component of the continuous blood glucose monitoring device to the first printed line.

[0046] For ease of understanding, it is necessary to further explain that a normally closed reed switch is a switch that remains connected when not subjected to magnetic force and is disconnected when subjected to magnetic force.

[0047] In the present invention, the continuous blood glucose monitoring device 4 is typically mounted on an ejector 5 at the factory so that patients can use it immediately upon receiving the product. Thus, before the ejector 5 ejects the continuous blood glucose monitoring device 4, the normally closed reed switch interacts with the magnet of the ejector 5, creating an open circuit between the transmitter component 2 and the first printed line of the continuous blood glucose monitoring device 4. In other words, the continuous blood glucose monitoring device 4 is not powered on and therefore does not suffer damage. After the ejector 5 ejects the continuous blood glucose monitoring device 4, the normally closed reed switch moves away from the magnet of the ejector 5, and the normally closed reed switch, having lost its magnetic force, becomes connected, thereby connecting the transmitter component 2 and the first printed line. In other words, the continuous blood glucose monitoring device 4 is only powered on and activated when its lead-out end 11 is implanted under the patient's skin. Thus, the continuous blood glucose monitoring device 4 of the present invention has the function of automatically starting after installation. Compared with the prior art, the continuous blood glucose monitoring device 4 of the present invention simplifies the usage steps and optimizes the user experience.

[0048] Specifically, in some embodiments, such as Figure 5 As shown, the ejector 5 also includes a launching spring 51, a puncture needle 52, a return needle spring 53, a connector 54, and a fixing platform 55. One end of the launching spring 51 is connected to the fixing platform 55, and the other end is provided with the connector 54. The connector 54 faces the patient's skin and is used to connect the continuous blood glucose monitoring device 4 of the present invention. One end of the return needle spring 53 is connected to the connector 54, and the other end is provided with the puncture needle 52 and abuts against the fixing platform 55. The puncture needle 52 is connected to the lead-out end 11 of the continuous blood glucose monitoring device 4 of the present invention. Both the launching spring 51 and the return needle spring 53 are in a compressed state.

[0049] When the ejector 5 is in use, the launching spring 51 releases energy from its compressed state and extends, causing the connector 54 to move away from the fixing platform 55 and towards the patient's skin. The connector 54 also drives the puncture needle 52 towards the patient's skin via the return spring 53, until the puncture needle 52 penetrates the skin and introduces the lead-out end 11 under the skin. Since the return spring 53 is no longer restricted by the fixing platform 55 during its movement towards the skin, the puncture needle 52 moves in the opposite direction and withdraws from under the skin after penetrating the skin due to the elastic force of the return spring 53, completing the operation of implanting the lead-out end 11 under the skin. At this time, the ejector 5 is removed from the patient's skin. Since the connection force between the connector 54 and the continuous blood glucose monitoring device 4 is less than the connection force between the continuous blood glucose monitoring device 4 and the skin, the connector 54 separates from the continuous blood glucose monitoring device 4, and the installation of the continuous blood glucose monitoring device 4 of the present invention is thus completed.

[0050] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0051] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A continuous glucose monitoring device, characterized in that, The device includes an integrated flexible substrate and transmitter components. The flexible substrate can be fixed to the skin surface. A first printed line is drawn on the flexible substrate. The transmitter components are soldered to the flexible substrate and electrically connected to the first printed line. The flexible substrate includes a lead-out end, on which a second printed line for monitoring blood glucose levels is provided. The second printed line is connected to the first printed line. The flexible substrate has a slit and an electrode area surrounded by the slit. The lead-out end is formed by bending the electrode area downward along the slit. The stiffness of the material used for the lead-out end is greater than the stiffness of the material used for the flexible substrate.

2. The continuous blood glucose monitoring device according to claim 1, characterized in that, The lead-out end has a puncture structure capable of penetrating the skin.

3. The continuous glucose monitoring device according to claim 1, characterized in that, The lead-out terminal is provided with three second printed lines, which serve as the auxiliary electrode CE, the reference electrode RE, and the working electrode WE, respectively.

4. The continuous glucose monitoring device according to claim 3, characterized in that, The auxiliary electrode CE and the reference electrode RE are located on the same side of the lead-out terminal, and the working electrode WE is located on the other side of the lead-out terminal.

5. The continuous glucose monitoring device according to claim 3, characterized in that, The second printed line is made of gold foil by laser etching.

6. The continuous glucose monitoring device according to claim 1, characterized in that, It also includes a fixing structure for attaching to the skin surface, wherein the transmitter components and the fixing structure are respectively disposed on both sides of the flexible substrate.

7. The continuous glucose monitoring device according to claim 6, characterized in that, The fixing structure is an adhesive layer.

8. A continuous glucose monitoring system, characterized in that, Includes a continuous glucose monitoring device as described in any one of claims 1-7 and an ejector for loading the continuous glucose monitoring device, the ejector including a puncture needle that drives the exit end to be implanted into the patient's subcutaneous tissue.

9. The continuous blood glucose monitoring system according to claim 8, characterized in that, The ejector is equipped with a magnet, and the continuous blood glucose monitoring device includes a normally closed reed switch. The normally closed reed switch conducts the transmitter components and the first printed line when the ejector is separated from the continuous blood glucose monitoring device.

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