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CN116236192A - Continuous blood glucose monitoring device and continuous blood glucose monitoring system - Google Patents

Continuous blood glucose monitoring device and continuous blood glucose monitoring system
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CN116236192A
CN116236192ACN202111485299.0ACN202111485299ACN116236192ACN 116236192 ACN116236192 ACN 116236192ACN 202111485299 ACN202111485299 ACN 202111485299ACN 116236192 ACN116236192 ACN 116236192A
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blood glucose
continuous blood
glucose monitoring
monitoring device
lead
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张自洁
刘文杰
请求不公布姓名
裘丹
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Shanghai Microport Lifesciences Co Ltd
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Shanghai Microport Lifesciences Co Ltd
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Priority to PCT/CN2022/081758prioritypatent/WO2023103212A1/en
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Abstract

Translated fromChinese

本发明涉及血糖监测技术领域,特别是涉及一种连续血糖监测装置及连续血糖监测系统。所述连续血糖监测装置,包括柔性基材和发射器元器件,所述柔性基材能够固定在皮肤表面,所述柔性基材上绘制有第一印制线,所述发射器元器件焊接在所述柔性基材上并与所述第一印制线电气连接,所述柔性基材包括伸长的引出端,所述引出端上设置有用于监测血糖水平的第二印制线,所述第二印制线与所述第一印制线连通。本发明的连续血糖监测装置及连续血糖监测系统,将传感器组件与发射器组件合二为一而不再有PAD区的存在,从而使得连续血糖测量装置整体厚度较薄,而且传感器组件与发射器组件之间具有可靠的信号连接。

Figure 202111485299

The invention relates to the technical field of blood sugar monitoring, in particular to a continuous blood sugar monitoring device and a continuous blood sugar monitoring system. The continuous blood glucose monitoring device includes a flexible base material and a transmitter component, the flexible base material can be fixed on the skin surface, a first printed line is drawn on the flexible base material, and the transmitter component is welded on The flexible base material is electrically connected with the first printed line, the flexible base material includes an elongated lead-out end, and a second printed line for monitoring blood sugar level is arranged on the lead-out end, the The second printing line communicates with the first printing line. The continuous blood glucose monitoring device and the continuous blood glucose monitoring system of the present invention combine the sensor assembly and the transmitter assembly into one without the existence of the PAD area, so that the overall thickness of the continuous blood glucose measurement device is thinner, and the sensor assembly and the transmitter There are reliable signal connections between components.

Figure 202111485299

Description

Translated fromChinese
一种连续血糖监测装置及连续血糖监测系统A continuous blood glucose monitoring device and continuous blood glucose monitoring system

技术领域technical field

本发明涉及血糖监测技术领域,特别是涉及一种连续血糖监测装置及连续血糖监测系统。The invention relates to the technical field of blood sugar monitoring, in particular to a continuous blood sugar monitoring device and a continuous blood sugar monitoring system.

背景技术Background technique

血糖监测是糖尿病管理中的重要组成部分,血糖监测的结果有助于医生对糖尿病患者糖代谢紊乱的程度进行评估,从而合理地制定降糖方案,后期可以根据血糖监测的结果反映治疗的效果,进一步对降糖方案进行调整。Blood glucose monitoring is an important part of diabetes management. The results of blood glucose monitoring can help doctors evaluate the degree of glucose metabolism disorder in diabetic patients, so as to formulate a hypoglycemic plan reasonably. In the later stage, the results of blood glucose monitoring can reflect the effect of treatment. Further adjustments to the hypoglycemic regimen.

传统血糖监测方法是采集指血监测,但是这种方法不仅会长期地对患者造成生理上的不适,更会增加患者心理上的负担,更重要的是这种方法无法展现患者全天血糖图谱,在时间维度上存在监测盲区。因此,近年发展出一种连续血糖监测产品,能够实现患者全天的连续血糖监测。The traditional blood sugar monitoring method is to collect finger blood for monitoring, but this method will not only cause long-term physical discomfort to the patient, but also increase the psychological burden on the patient. More importantly, this method cannot display the patient's blood sugar map throughout the day. There are monitoring blind spots in the time dimension. Therefore, in recent years, a continuous blood glucose monitoring product has been developed, which can realize continuous blood glucose monitoring of patients throughout the day.

然而,目前的连续血糖测量仪,大多包括结构上分离的传感器和发射器两部分,使用之前两者需要组装在一起。因此现有技术中的这种连续血糖测量仪不可避免地需要设置用于将传感器与发射器电气连接的PAD(焊盘)区,导致整个产品的机械厚度增加,增加患者的佩戴异物感。不仅如此,这种PAD区的存在就要求传感器与发射器之间必须采用机械硬接触或导电橡胶接触的方式,而这种连接方式容易受到机械运动及水汽的影响,导致传感器与发射器之间短路或接触不良,从而对患者的连续血糖监测产生不利影响。However, most of the current continuous blood glucose measuring instruments include two parts, the sensor and the transmitter, which are structurally separated, and the two parts need to be assembled together before use. Therefore, this continuous blood glucose measuring instrument in the prior art inevitably needs to be provided with a PAD (pad) area for electrically connecting the sensor and the transmitter, resulting in an increase in the mechanical thickness of the entire product and increasing the foreign body feeling of the patient. Not only that, the existence of this PAD area requires that the sensor and the emitter must be in mechanical hard contact or conductive rubber contact, and this connection method is easily affected by mechanical movement and water vapor, resulting in a gap between the sensor and the emitter. Short circuit or poor contact, thereby adversely affecting the patient's continuous blood glucose monitoring.

发明内容Contents of the invention

基于此,有必要提供一种连续血糖监测装置,将传感器组件与发射器组件合二为一而不再有PAD区的存在,从而使得连续血糖监测装置整体厚度较薄,而且传感器组件与发射器组件之间具有可靠的信号连接。Based on this, it is necessary to provide a continuous blood glucose monitoring device, which combines the sensor assembly and the transmitter assembly into one without the existence of the PAD area, so that the overall thickness of the continuous blood glucose monitoring device is relatively thin, and the sensor assembly and the transmitter assembly There are reliable signal connections between components.

本发明公开了一种连续血糖监测装置,包括柔性基材和发射器元器件,所述柔性基材能够固定在皮肤表面,所述柔性基材上绘制有第一印制线,所述发射器元器件设置在所述柔性基材上并与所述第一印制线电气连接,所述柔性基材包括引出端,所述引出端上设置有用于监测血糖水平的第二印制线,所述第二印制线与所述第一印制线连通。The invention discloses a continuous blood glucose monitoring device, which comprises a flexible base material and a transmitter component, the flexible base material can be fixed on the skin surface, a first printed line is drawn on the flexible base material, and the transmitter The components are arranged on the flexible base material and electrically connected with the first printed line, the flexible base material includes a lead-out end, and a second printed line for monitoring blood sugar level is arranged on the lead-out end, so The second printed line communicates with the first printed line.

在其中一个实施例中,所述柔性基材设置有狭缝和被所述狭缝围绕的电极区,所述引出端由所述电极区沿所述狭缝向下弯折而成。In one embodiment, the flexible substrate is provided with a slit and an electrode area surrounded by the slit, and the lead-out end is formed by bending the electrode area downward along the slit.

在其中一个实施例中,所述引出端具有能够穿透皮肤的穿刺结构。In one of the embodiments, the lead-out end has a puncture structure capable of penetrating the skin.

在其中一个实施例中,所述引出端上设置有三条第二印制线,分别作为辅助电极CE、参比电极RE和工作电极WE。In one of the embodiments, three second printed lines are arranged on the lead-out end, serving as the auxiliary electrode CE, the reference electrode RE and the working electrode WE respectively.

在其中一个实施例中,所述辅助电极CE和参比电极RE设置于所述引出端的同侧,所述工作电极WE设置于所述引出端的另一侧。In one of the embodiments, the auxiliary electrode CE and the reference electrode RE are arranged on the same side of the lead-out end, and the working electrode WE is arranged on the other side of the lead-out end.

在其中一个实施例中,所述第二印制线由金箔通过激光刻蚀制得。In one embodiment, the second printed line is made of gold foil by laser etching.

在其中一个实施例中,连续血糖监测装置还包括用于连接在皮肤表面的固定结构,所述发射器元器件与所述固定结构分别设置于所述柔性基材的两侧。In one of the embodiments, the continuous blood glucose monitoring device further includes a fixing structure for being connected to the surface of the skin, and the transmitter component and the fixing structure are respectively arranged on two sides of the flexible substrate.

在其中一个实施例中,所述固定结构为粘接层。In one of the embodiments, the fixing structure is an adhesive layer.

本发明另一方面公开了一种连续血糖监测系统,包括前述任一所述的连续血糖监测装置和用于装载所述连续血糖监测装置的弹射器,所述弹射器包括穿刺针,所述穿刺针带动所述引出端植入患者皮下组织。Another aspect of the present invention discloses a continuous blood glucose monitoring system, comprising any one of the aforementioned continuous blood glucose monitoring devices and an ejector for loading the continuous blood glucose monitoring device, the ejector includes a puncture needle, and the puncture The needle drives the lead-in end to be implanted in the patient's subcutaneous tissue.

在其中一个实施例中,所述弹射器设置有磁铁,所述连续血糖监测装置包括常闭性干簧管,所述常闭性干簧管随所述弹射器与所述连续血糖监测装置的分离而导通所述发射器元器件与所述第一印制线。In one of the embodiments, the catapult is provided with a magnet, and the continuous blood glucose monitoring device includes a normally closed reed switch, and the normally closed reed switch is connected with the catapult and the continuous blood glucose monitoring device. separating and conducting the emitter component and the first printed line.

有益效果Beneficial effect

本发明的所述连续血糖监测装置,创造性地将传统意义上的血糖监测传感器通过第二印制线来加以实现,并且让发射器元器件之间同样通过第一印制线加以连通,由于第一印制线与第二印制线连通,那么传统意义上的发射器组件与传感器组件便同时集成在柔性基材上,换句话说,现有技术中的传感器组件和发射器组件在本发明的所述连续血糖监测装置中已合为一体。如此,本发明的所述连续血糖监测装置根本上地去除了用于传感器组件和发射器组件连接的PAD区,从而避免了传统设计的方式因PAD区的存在而引入的接触不良、进水短路的问题。The continuous blood glucose monitoring device of the present invention creatively realizes the blood glucose monitoring sensor in the traditional sense through the second printed line, and allows the transmitter components to be connected through the first printed line as well. One printed line communicates with the second printed line, then the emitter assembly and sensor assembly in the traditional sense are integrated on the flexible substrate at the same time, in other words, the sensor assembly and emitter assembly in the prior art are integrated in the present invention has been integrated in the continuous blood glucose monitoring device. In this way, the continuous blood glucose monitoring device of the present invention fundamentally removes the PAD area used for the connection of the sensor assembly and the transmitter assembly, thus avoiding the poor contact and water short circuit caused by the existence of the PAD area in the traditional design The problem.

在此基础上,本发明的所述连续血糖监测装置也不再需要设置类似现有技术中的外壳等厚重的防护结构,对柔性基材上的第一印刷线、第二印制线及发射器元器件之间的连接焊点处涂覆三防漆等简单操作后即可实现可靠防护,大大减少了本发明的连续血糖监测装置的厚度和重量,极大减小了患者佩戴时的异物感。On this basis, the continuous blood glucose monitoring device of the present invention no longer needs to be equipped with a thick and heavy protective structure similar to the casing in the prior art. Reliable protection can be achieved after simple operations such as coating the joint solder joints between the device components with three-proof paint, which greatly reduces the thickness and weight of the continuous blood glucose monitoring device of the present invention, and greatly reduces the foreign matter when the patient wears it feel.

附图说明Description of drawings

图1为部分实施例中本发明的所述连续血糖监测装置的示意图;Fig. 1 is a schematic diagram of the continuous blood glucose monitoring device of the present invention in some embodiments;

图2为图1中所述连续血糖监测装置的爆炸示意图;Fig. 2 is an exploded schematic diagram of the continuous blood glucose monitoring device described in Fig. 1;

图3为部分实施例中本发明的所述连续血糖监测装置的柔性基材的示意图;Fig. 3 is a schematic diagram of the flexible substrate of the continuous blood glucose monitoring device of the present invention in some embodiments;

图4(1)为部分实施例中本发明的所述连续血糖监测装置的引出端的示意图;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;

图4(2)为部分实施例中本发明的所述连续血糖监测装置的引出端另一侧的示意图;Fig. 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;

图5为部分实施例中本发明的所述连续血糖监测装置的使用示意图;Fig. 5 is a schematic diagram of the use of the continuous blood glucose monitoring device of the present invention in some embodiments;

其中,1为柔性基材,2为发射器元器件,3为固定结构,11为引出端,12为狭缝,4为连续血糖监测装置,5为弹射器,51为发射弹簧,52为穿刺针,53为回针弹簧,54为连接件,55为固定台。Among them, 1 is a flexible substrate, 2 is a transmitter component, 3 is a fixed 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 launch spring, and 52 is a puncture Needle, 53 is a return needle spring, 54 is a connector, and 55 is a fixed platform.

具体实施方式Detailed ways

为使本发明的上述目的、特征和优点能够更加明显易懂,下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施,本领域技术人员可以在不违背本发明内涵的情况下做类似改进,因此本发明不受下面公开的具体实施例的限制。In order to make the above objects, features and advantages of the present invention more comprehensible, specific implementations of the present invention will be described in detail below in conjunction with the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, the present invention can be implemented in many other ways different from those described here, and those skilled in the art can make similar improvements without departing from the connotation of the present invention, so the present invention is not limited by the specific embodiments disclosed below.

在本发明的描述中,需要理解的是,术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”、“轴向”、“径向”、“周向”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。In describing the present invention, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", " Back", "Left", "Right", "Vertical", "Horizontal", "Top", "Bottom", "Inner", "Outer", "Clockwise", "Counterclockwise", "Axial" , "radial", "circumferential" and other indicated orientations or positional relationships are based on the orientations or positional relationships shown in the drawings, which are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying the referred device or Elements must have certain orientations, be constructed and operate in certain orientations, and therefore should not be construed as limitations on the invention.

此外,术语“第一”、“第二”仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。在本发明的描述中,“多个”的含义是至少两个,例如两个,三个等,除非另有明确具体的限定。In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, the features defined as "first" and "second" may explicitly or implicitly include at least one of these features. In the description of the present invention, "plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

在本发明中,除非另有明确的规定和限定,术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或成一体;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通或两个元件的相互作用关系,除非另有明确的限定。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本发明中的具体含义。In the present invention, unless otherwise clearly specified and limited, terms such as "installation", "connection", "connection" and "fixation" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection , or integrated; it may be mechanically connected or electrically connected; it may be directly connected or indirectly connected through an intermediary, and it may be the internal communication of two components or the interaction relationship between two components, unless otherwise specified limit. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.

在本发明中,除非另有明确的规定和限定,第一特征在第二特征“上”或“下”可以是第一和第二特征直接接触,或第一和第二特征通过中间媒介间接接触。而且,第一特征在第二特征“之上”、“上方”和“上面”可是第一特征在第二特征正上方或斜上方,或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”可以是第一特征在第二特征正下方或斜下方,或仅仅表示第一特征水平高度小于第二特征。In the present invention, unless otherwise clearly specified and limited, the first feature may be in direct contact with the first feature or the first and second feature may be in direct contact with the second feature through an intermediary. touch. Moreover, "above", "above" and "above" the first feature on the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. "Below", "beneath" and "beneath" the first feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is less horizontally than the second feature.

需要说明的是,当元件被称为“固定于”或“设置于”另一个元件,它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件,它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“上”、“下”、“左”、“右”以及类似的表述只是为了说明的目的,并不表示是唯一的实施方式。It should be noted that when an element is referred to as being “fixed on” or “disposed on” another element, it may be directly on the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or intervening elements may also be present. As used herein, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions are for the purpose of illustration only and are not intended to represent the only embodiments.

参阅图1、图2,图1为本发明部分实施例中的所述连续血糖监测装置的示意图,如图2所示为图1中所述连续血糖监测装置的爆炸示意图,本发明的所述连续血糖监测装置包括柔性基材1和发射器元器件2,所述柔性基材1能够固定在皮肤表面,所述柔性基材1上绘制有第一印制线(图中未示出),所述若干个发射器元器件2焊接在所述柔性基材1上并通过所述第一印制线电气连接,所述柔性基材1具有伸长的引出端11,所述引出端11上设置有用于监测血糖水平的第二印制线,所述第二印制线与所述第一印制线连通,所述引出端11可以植入皮肤下方。Referring to Figure 1 and Figure 2, Figure 1 is a schematic diagram of the continuous blood glucose monitoring device in some embodiments of the present invention, and Figure 2 is an exploded schematic diagram of the continuous blood glucose monitoring device in Figure 1, the present invention The continuous blood glucose monitoring device includes aflexible substrate 1 and atransmitter component 2, theflexible substrate 1 can be fixed on the skin surface, and a first printed line (not shown in the figure) is drawn on theflexible substrate 1, Theseveral emitter components 2 are welded on theflexible base material 1 and electrically connected through the first printed wire, theflexible base material 1 has an elongated lead-outend 11, and the lead-outend 11 is A second printed line for monitoring the blood sugar level is provided, the second printed line communicates with the first printed line, and the lead-outend 11 can be implanted under the skin.

本发明的所述连续血糖监测装置,由于柔性基材1的柔软特性,其可以良好地贴附在人体上如上臂等非平面的弧面上,有效降低患者佩戴过程中的不适感,并且可以减小本发明连续血糖监测装置从皮肤上意外脱落的风险。在使用时,将引出端11植入患者的皮肤下方,引出端11上的第二印制线便可以对血液进行检测,并持续收集目标数据。由于柔性基材1上的第一印制线与第二印制线连通,而所述第一印制线又与发射器元器件2电气连接,因此目标数据便依次通过第二印制线、第一印制线传递给发射器元器件2,所述发射器元器件2便可以将目标数据发送给外部设备,以便进行进一步的处理或显示连续的血糖数据。The continuous blood glucose monitoring device of the present invention, due to the softness of theflexible substrate 1, can be well attached to a non-planar curved surface on the human body such as the upper arm, effectively reducing the discomfort of the patient during wearing, and can The risk of accidental detachment of the continuous blood glucose monitoring device of the present invention from the skin is reduced. When in use, the lead-outend 11 is implanted under the patient's skin, and the second printed line on the lead-outend 11 can detect blood and continuously collect target data. Since the first printed line on theflexible substrate 1 communicates with the second printed line, and the first printed line is electrically connected with theemitter component 2, the target data passes through the second printed line, The first track passes to thetransmitter component 2, which can then send the target data to an external device for further processing or display of continuous blood glucose data.

本发明的所述连续血糖监测装置,创造性地将传统意义上的血糖监测传感器通过第二印制线来加以实现,并且让发射器元器件2之间同样通过第一印制线加以连通,由于第一印制线与第二印制线连通,那么传统意义上的发射器组件与传感器组件便同时集成在柔性基材1上,换句话说,现有技术中的传感器组件和发射器组件在本发明的所述连续血糖监测装置中已合为一体。如此,本发明的所述连续血糖监测装置根本上地去除了用于传感器组件和发射器组件连接的PAD区,从而避免了传统设计的方式因PAD区的存在而引入的接触不良、进水短路的问题。在此基础上,本发明的所述连续血糖监测装置也不再需要设置类似现有技术中的外壳等厚重的防护结构,对柔性基材上的第一印刷线、第二印制线及发射器元器件2之间的连接焊点处涂覆三防漆等简单操作后即可实现可靠防护,大大减少了本发明的连续血糖监测装置的厚度和重量。根据申请人的实验,本发明的所述连续血糖监测装置的总厚度可以仅为3±1mm,极大减小了患者佩戴时的异物感。The continuous blood glucose monitoring device of the present invention creatively realizes the blood glucose monitoring sensor in the traditional sense through the second printed line, and allows thetransmitter components 2 to be connected through the first printed line as well, because The first printed line communicates with the second printed line, then the emitter assembly and the sensor assembly in the traditional sense are integrated on theflexible substrate 1 at the same time, in other words, the sensor assembly and the emitter assembly in the prior art are The continuous blood glucose monitoring device of the present invention has been integrated. In this way, the continuous blood glucose monitoring device of the present invention fundamentally removes the PAD area used for the connection of the sensor assembly and the transmitter assembly, thus avoiding the poor contact and water short circuit caused by the existence of the PAD area in the traditional design The problem. On this basis, the continuous blood glucose monitoring device of the present invention no longer needs to be equipped with a thick and heavy protective structure similar to the casing in the prior art. Reliable protection can be achieved after simple operations such as coating the joint solder joints between thedevice components 2 with conformal paint, which greatly reduces the thickness and weight of the continuous blood glucose monitoring device of the present invention. According to the applicant's experiment, 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 worn by the patient.

可以理解的,本发明的所述连续血糖监测装置对于所述柔性基材1及其引出端11的具体布置形式并不加以限定。举例来说,在部分实施例中,所述引出端11可以设置在所述柔性基材1的外缘,使得所述引出端11构成从所述柔性基材1的边缘向外伸出的形式。在另一些实施例中,如图3所示,所述柔性基材1内部设置有狭缝12,所述狭缝12所围绕的长条形区域为电极区,在使用时,所述引出端11由所述电极区沿所述狭缝12向下弯折而成。如此设置,引出端11将位于柔性基材1的内部,在贴附在患者皮肤上使用时,即使柔性基材1受到外力而相对原位置发生偏移,所述引出端11也将牢牢地植入在患者皮肤下而不易发生脱离,能够保证本发明的所述连续血糖监测装置的使用稳定性。It can be understood that the continuous blood glucose monitoring device of the present invention does not limit the specific arrangement of theflexible substrate 1 and its leadingend 11 . For example, in some embodiments, the lead-outend 11 can be arranged on the outer edge of theflexible substrate 1, so that the lead-outend 11 forms a form protruding outward from the edge of theflexible substrate 1 . In some other embodiments, as shown in FIG. 3, aslit 12 is provided inside theflexible substrate 1, and the strip-shaped area surrounded by theslit 12 is an electrode area. When in use, the lead-outend 11 is formed by bending the electrode area downwards along theslit 12 . In this way, the lead-outend 11 will be located inside theflexible base material 1, and when it is attached to the patient's skin, even if theflexible base material 1 is subjected to an external force and deviates from its original position, the lead-outend 11 will also be firmly attached to the patient's skin. Implanted under the patient's skin without easy detachment can ensure the stability of the continuous blood glucose monitoring device of the present invention.

需要指出的是,虽然前述实施例中,所述引出端11只设置了一个,但是本发明的所述连续血糖监测装置也可以根据实际需要设置不止一个引出端11。例如,部分引出端11上的第二印制线还可以用于检测除了血糖以外其他的数据,如此,若干个引出端11可以同时收集具有时间相关性的多组数据,并通过发射器元器件2发送给外部设备,以便医生可以更好的对患者的血糖治疗或其他疾病情况进行分析。It should be pointed out that although in the foregoing embodiments, only one lead-outend 11 is provided, the continuous blood glucose monitoring device of the present invention may also be provided with more than one lead-outend 11 according to actual needs. For example, the second printed line on part of the lead-outs 11 can also be used to detect data other than blood sugar. In this way, several lead-outs 11 can simultaneously collect multiple sets of data with time correlation, and transmit them through the transmitter components. 2 Send it to external devices so that doctors can better analyze the patient's blood sugar treatment or other diseases.

具体来说,所述引出端11优选被配置为能够轻松穿透皮肤的形式。在部分实施例中,所述引出端11具有能够穿透皮肤的穿刺结构,所述穿刺结构例如可以为针状、片状、杆状等。在另一些实施例中,可以进一步地对所述引出端11的厚度进行调整,通过合理地减少引出端11的厚度,在保证其刚度的前提下,可以增加引出端11对皮肤的压强,从而可以更有效地穿透皮肤。而在又一些实施例中,还可以设置所述引出端11的材料与柔性基材1不同,例如可以设置所述引出端11所用材料的刚度大于所述柔性基材1所用材料的刚度,从而使得所述引出端11具有更好的穿透皮肤的能力。Specifically, the lead-outend 11 is preferably configured in a form that can easily penetrate the skin. In some embodiments, the lead-outend 11 has a puncture structure capable of penetrating the skin, and the puncture structure may be, for example, a needle shape, a sheet shape, a rod shape, or the like. In some other embodiments, the thickness of theleading end 11 can be further adjusted. By reasonably reducing the thickness of theleading end 11, the pressure of theleading end 11 on the skin can be increased under the premise of ensuring its rigidity, thereby Can penetrate the skin more effectively. In still some embodiments, the material of the lead-outend 11 can also be set to be different from theflexible base material 1, for example, the rigidity of the material used for the lead-outend 11 can be set to be greater than the rigidity of the material used for theflexible base material 1, so that This makes theleading end 11 have a better ability to penetrate the skin.

具体来说,在部分实施例中,如图4(1)、图4(2)所示,所述引出端11上设置有三条第二印制线,分别作为辅助电极CE、参比电极RE和工作电极WE,如此在所述引出端11上便构成了三电极测试体系,通过所述三电极测试体系可以对血糖进行监测。其中优选的,所述第二印制线均使用金箔制得,且使用激光刻蚀的加工工艺,从而可以做到极高的加工精度,使本发明的所述连续血糖监测装置具有非常优秀的血糖测试能力。在该实施例中,如图4(1)所示,所述辅助电极CE、参比电极RE设置在所述引出端11的同一个面上,如图4(2)所示,所述工作电极WE设置在引出端11的另一个面上。Specifically, in some embodiments, as shown in Fig. 4(1) and Fig. 4(2), three second printed lines are arranged on the lead-outend 11, serving as the auxiliary electrode CE and the reference electrode RE respectively. and the working electrode WE, so that a three-electrode test system is formed on the lead-outend 11, and blood glucose can be monitored through the three-electrode test system. Among them, preferably, the second printed lines are all made of gold foil, and the processing technology of laser etching is used, so that extremely high processing accuracy can be achieved, so that the continuous blood glucose monitoring device of the present invention has very excellent Blood glucose testing capabilities. In this embodiment, as shown in Figure 4(1), the auxiliary electrode CE and the reference electrode RE are arranged on the same surface of the lead-out terminal 11, as shown in Figure 4(2), the working The electrode WE is provided on the other face of the lead-outterminal 11 .

当然,在其他实施例中,所述辅助电极CE、参比电极RE、工作电极WE也可以设置在同一个面上,或者将辅助电极CE或者参比电极RE设置在一个面,另外两个电极设置在另一个面上。又或者在某些情况下,本发明的所述引出端11也可以劣化设置为两电极测试体系。所述第二印制线的材质选择也可以不为金,还可以为铂、钯、钛,碳、铝、铜、银、氯化银、合金等常见的印制线材料,本领域技术人员可以根据实际情况自行选择。Of course, in other embodiments, the auxiliary electrode CE, reference electrode RE, and working electrode WE can also be arranged on the same surface, or the auxiliary electrode CE or the reference electrode RE can be arranged on one surface, and the other two electrodes set on the other side. Or in some cases, the lead-outterminal 11 of the present invention can also be configured as a two-electrode test system. The material selection of the second printed line may not be gold, but may also be common printed line materials such as platinum, palladium, titanium, carbon, aluminum, copper, silver, silver chloride, and alloys. Those skilled in the art You can choose according to the actual situation.

为了将本发明的所述连续血糖监测装置固定在患者的皮肤表面,在部分实施例中,如图2所示,本发明的所述连续血糖监测装置还可以包括用于连接在患者皮肤表面的固定结构3,所述固定结构3设置在所述柔性基材1的一侧。优选地,所述发射器元器件2与所述固定结构3分别设置于所述柔性基材1的两侧。如此,当本发明的所述连续血糖监测装置固定在患者的皮肤表面时,发射器元器件2不会对患者的皮肤造成压迫,为患者提供更加良好的佩戴感受。In order to fix the continuous blood glucose monitoring device of the present invention on the patient's skin surface, in some embodiments, as shown in Figure 2, the continuous blood glucose monitoring device of the present invention may also include aA fixing structure 3 , the fixingstructure 3 is arranged on one side of theflexible substrate 1 . Preferably, theemitter component 2 and the fixingstructure 3 are respectively arranged on two sides of theflexible substrate 1 . In this way, when the continuous blood glucose monitoring device of the present invention is fixed on the patient's skin surface, thetransmitter component 2 will not cause pressure on the patient's skin, providing the patient with a better wearing experience.

显而易见的,所述固定结构3可以具有多种实现形式。在部分实施例中,所述固定结构3为粘接层,所述粘接层与柔性基材1固定,所述粘接层包括粘接表面,所述粘接表面与患者皮肤能够形成牢固固定。所述粘接层例如可以通过胶贴或者胶水来实现。Obviously, the fixingstructure 3 may have various implementation forms. In some embodiments, the fixingstructure 3 is an adhesive layer, the adhesive layer is fixed to theflexible substrate 1, the adhesive layer includes an adhesive surface, and the adhesive surface can form a firm fixation with the patient's skin . The adhesive layer can be realized by adhesive tape or glue, for example.

至于设置在柔性基材1上的发射器元器件2以及第一印制线,本发明的所述连续血糖监测装置对此并不加以具体限制。所述发射器元器件2例如可以包括电池、发射天线、微控制器、温度传感器等,所述第一印制线可以选择与第二印制线相同的金作为导电材料,也可以选择例如铂、钯、钛,碳、铝、铜、银、氯化银、合金等作为导电材料,绘制方式上不仅可以选择激光刻蚀,也可以选择使用沉积技术等,本领域技术人员可以根据实际情况自行调整,在此不再继续赘述。As for thetransmitter component 2 and the first printed line disposed on theflexible substrate 1, the continuous blood glucose monitoring device of the present invention does not impose specific limitations on this. Thetransmitter component 2 may include, for example, a battery, a transmitting antenna, a microcontroller, a temperature sensor, etc., and the first printed wire may use the same gold as the second printed wire as the conductive material, or platinum may be selected, for example. , palladium, titanium, carbon, aluminum, copper, silver, silver chloride, alloy, etc. adjustment, and will not go into details here.

可以理解的,本发明的所述柔性基材1的材料及厚度可以依据实际情况进行自行选择,只要制得的柔性基材1能够支撑印制线及其上的发射器元器件2的强度即可。在部分实施例中,所述柔性基材1的材料为聚酰亚胺(PI),所述柔性基材1的厚度为5mil。当然,在另一些实施例中,所述柔性基材1也可以选择使用聚对苯二甲酸乙二醇酯(PET)、聚对二甲苯或其它材料。It can be understood that the material and thickness of theflexible base material 1 of the present invention can be selected according to the actual situation, as long as the preparedflexible base material 1 can support the strength of the printed line and theemitter component 2 on it. Can. In some embodiments, the material of theflexible substrate 1 is polyimide (PI), and the thickness of theflexible substrate 1 is 5mil. Of course, in some other embodiments, theflexible substrate 1 may also be made of polyethylene terephthalate (PET), parylene or other materials.

本发明另一方面公开了一种连续血糖监测系统,如图5所示,所述连续血糖监测系统包括前述的连续血糖监测装置4和弹射器5,发明所述连续血糖监测装置4安装在弹射器5上,所述弹射器5用于将本发明的连续血糖监测装置4弹射分离,所述弹射器5还包括穿刺针,当所述连续血糖监测装置4带着初始速度与弹射器5分离,穿刺针带动连续血糖监测装置4的引出端11穿透皮肤植入皮肤下方。Another aspect of the present invention discloses a continuous blood glucose monitoring system. As shown in FIG. 5, the continuous blood glucose monitoring system includes the aforementioned continuous blood glucose monitoring device 4 and anejector 5. Theejector 5 is used to eject and separate the continuous blood glucose monitoring device 4 of the present invention. Theejector 5 also includes a puncture needle. When the continuous blood glucose monitoring device 4 is separated from theejector 5 with an initial speed , the puncture needle drives the leadingend 11 of the continuous blood glucose monitoring device 4 to penetrate the skin and implant it under the skin.

在某些实施例中,本发明的所述连续血糖监测装置还包括常闭性干簧管,所述弹射器5设置有磁铁,当连续监测装置4与弹射器5分离时,所述常闭性干簧管将所述连续血糖监测装置的发射器元器件与第一印制线导通。In some embodiments, the continuous blood glucose monitoring device of the present invention further includes a normally closed reed switch, and theejector 5 is provided with a magnet. When the continuous monitoring device 4 is separated from theejector 5, the normally closed A dry reed switch conducts the transmitter component of the continuous blood glucose monitoring device with the first printed line.

为了便于理解,这里需要补充介绍所述常闭性干簧管是一种在不受到磁力作用时将保持连通状态,在受到磁力作用时将处于断开状态的开关。For the sake of easy understanding, it needs to be added here that the normally closed reed switch is a switch that will maintain a connected state when it is not subjected to a magnetic force, and will be in a disconnected state when it is subjected to a magnetic force.

本发明的所述连续血糖监测装置在出厂时,所述连续血糖监测装置4通常被安装在弹射器5上,以便患者在取得产品后可以立刻使用。如此,弹射器5在将所述连续血糖监测装置4弹射分离之前,所述常闭性干簧管会与弹射器5的磁铁相互配合,使所述连续血糖监测装置4的所述发射器元器件2与第一印制线之间为断路,换句话说,所述连续血糖监测装置4没有被通电启动,也就不会发生损耗。而当弹射器5在将所述连续血糖监测装置4弹射分离后,连续血糖监测装置4的常闭性干簧管便与弹射器5的磁铁相互远离,所述常闭性干簧管失去磁力作用后处于连通状态,从而将发射器元器件2与第一印制线之间连通。换句话说,当本发明的所述连续血糖监测装置4的引出端11被植入患者皮肤下,所述连续血糖监测装置4才会被通电启动。如此,本发明的所述连续血糖监测装置4具有安装完成后自启动的功能,相比现有技术本发明的连续血糖监测装置4简化了使用步骤,优化了用户的使用体验。When the continuous blood glucose monitoring device of the present invention leaves the factory, the continuous blood glucose monitoring device 4 is usually installed on theejector 5 so that the patient can use it immediately after obtaining the product. In this way, before theejector 5 ejects and separates the continuous blood glucose monitoring device 4, the normally closed reed switch cooperates with the magnet of theejector 5, so that the transmitter element of the continuous blood glucose monitoring device 4 There is an open circuit between thedevice 2 and the first printed line, in other words, the continuous blood glucose monitoring device 4 is not powered on, so no loss occurs. And when theejector 5 ejects and separates the continuous blood glucose monitoring device 4, the normally closed reed switch of the continuous blood glucose monitoring device 4 is far away from the magnet of theejector 5, and the normally closed reed switch loses its magnetic force. After acting, it is in a connected state, thereby connecting theemitter component 2 with the first printed line. In other words, when theoutlet 11 of the continuous blood glucose monitoring device 4 of the present invention is implanted under the patient's skin, the continuous blood glucose monitoring device 4 will be energized and activated. In this way, the continuous blood glucose monitoring device 4 of the present invention has a self-starting function after installation, and compared with the prior art, the continuous blood glucose monitoring device 4 of the present invention simplifies the use steps and optimizes the user experience.

具体来说,在部分实施例中,如图5所示,所述弹射器5还包括发射弹簧51、穿刺针52、回针弹簧53、连接件54以及固定台55,所述发射弹簧51的一端连接固定台55,另一端设置有连接件54,所述连接件54朝向患者的皮肤,所述连接件54用于连接本发明的所述连续血糖监测装置4,所述回针弹簧53的一端连接在连接件54上,其另一端设置有穿刺针52并与固定台55抵接,所述穿刺针52与本发明的所述连续血糖监测装置4的引出端11相连,所述发射弹簧51与回针弹簧53均处于压缩状态。Specifically, in some embodiments, as shown in FIG. 5 , theejector 5 also includes afiring spring 51, apuncture needle 52, areturn needle spring 53, a connectingpiece 54, and a fixing table 55. The firingspring 51 One end is connected to the fixedplatform 55, and the other end is provided with a connectingpiece 54 facing the patient's skin. The connectingpiece 54 is used to connect the continuous blood glucose monitoring device 4 of the present invention. Thereturn needle spring 53 One end is connected to theconnector 54, and the other end is provided with apuncture needle 52 and abuts against the fixed table 55. Thepuncture needle 52 is connected to theleading end 11 of the continuous blood glucose monitoring device 4 of the present invention, and the launchingspring 51 and returnneedle spring 53 are both in compressed state.

所述弹射器5在使用时,发射弹簧51从压缩状态释能而伸长,带动连接件54远离固定台55向患者皮肤方向运动,连接件54也通过回针弹簧53带动穿刺针52向患者皮肤方向运动,直至穿刺针52穿过皮肤将引出端11引入皮肤下方。由于回针弹簧53在向皮肤方向运动的过程中不再受到固定台55的限制,所以穿刺针52在穿过皮肤后受到回针弹簧53的弹力作用又反方向运动从皮肤下退出,完成将引出端11植入皮肤下方的操作。此时,将弹射器5从患者皮肤上移开,由于连接件54与所述连续血糖监测装置4的连接力小于所述连续血糖监测装置4与皮肤的连接力,所述连接件54便与所述连续血糖监测装置4分离,本发明的所述连续血糖监测装置4至此安装完成。When theejector 5 is in use, thelaunch spring 51 is released from the compressed state and stretched, driving the connectingpiece 54 to move away from the fixed table 55 towards the patient's skin, and the connectingpiece 54 also drives thepuncture needle 52 to the patient through thereturn needle spring 53. Move in the direction of the skin until thepuncture needle 52 passes through the skin and introduces theleading end 11 under the skin. Because thereturn needle spring 53 is no longer restricted by the fixedplatform 55 in the process of moving towards the skin, thepuncture needle 52 is subjected to the elastic force of thereturn needle spring 53 after passing through the skin and then moves in the opposite direction and withdraws from under the skin, completing the insertion. The operation of implanting the lead-outend 11 under the skin. At this time, theejector 5 is removed from the patient's skin, and since the connecting force between the connectingpiece 54 and the continuous blood glucose monitoring device 4 is smaller than the connecting force between the continuous blood glucose monitoring device 4 and the skin, the connectingpiece 54 is in contact with the patient's skin. The continuous blood glucose monitoring device 4 is separated, and the installation of the continuous blood glucose monitoring device 4 of the present invention is completed so far.

以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。The technical features of the above-mentioned embodiments can be combined arbitrarily. To make the description concise, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, should be considered as within the scope of this specification.

以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。The above-mentioned embodiments only express several implementation modes of the present invention, and the descriptions thereof are relatively specific and detailed, but should not be construed as limiting the patent scope of the invention. It should be noted that, for those skilled in the art, several modifications and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent for the present invention should be based on the appended claims.

Claims (10)

Translated fromChinese
1.一种连续血糖监测装置,其特征在于,包括柔性基材和发射器元器件,所述柔性基材能够固定在皮肤表面,所述柔性基材上绘制有第一印制线,所述发射器元器件设置在所述柔性基材上并与所述第一印制线电气连接,所述柔性基材包括引出端,所述引出端上设置有用于监测血糖水平的第二印制线,所述第二印制线与所述第一印制线连通。1. A continuous blood glucose monitoring device, characterized in that it includes a flexible base material and a transmitter component, the flexible base material can be fixed on the skin surface, the first printed line is drawn on the flexible base material, and the The transmitter component is arranged on the flexible base material and is electrically connected with the first printed line, the flexible base material includes a lead-out end, and a second printed line for monitoring blood sugar level is arranged on the lead-out end , the second printed line communicates with the first printed line.2.根据权利要求1所述的连续血糖监测装置,其特征在于,所述柔性基材设置有狭缝和被所述狭缝围绕的电极区,所述引出端由所述电极区沿所述狭缝向下弯折而成。2. The continuous blood glucose monitoring device according to claim 1, wherein the flexible base material is provided with a slit and an electrode area surrounded by the slit, and the lead-out end is formed by the electrode area along the The slit is bent downwards.3.根据权利要求1所述的连续血糖监测装置,其特征在于,所述引出端具有能够穿透皮肤的穿刺结构。3 . The continuous blood glucose monitoring device according to claim 1 , wherein the lead-out end has a puncture structure capable of penetrating the skin. 4 .4.根据权利要求1所述的连续血糖监测装置,其特征在于,所述引出端上设置有三条第二印制线,分别作为辅助电极CE、参比电极RE和工作电极WE。4 . The continuous blood glucose monitoring device according to claim 1 , wherein three second printed lines are arranged on the lead-out end, serving as the auxiliary electrode CE, the reference electrode RE and the working electrode WE respectively.5.根据权利要求4所述的连续血糖监测装置,其特征在于,所述辅助电极CE和参比电极RE设置于所述引出端的同侧,所述工作电极WE设置于所述引出端的另一侧。5. The continuous blood glucose monitoring device according to claim 4, wherein the auxiliary electrode CE and the reference electrode RE are arranged on the same side of the lead-out end, and the working electrode WE is arranged on the other end of the lead-out end side.6.根据权利要求4所述的连续血糖监测装置,其特征在于,所述第二印制线由金箔通过激光刻蚀制得。6. The continuous blood glucose monitoring device according to claim 4, wherein the second printed line is made of gold foil by laser etching.7.根据权利要求1所述的连续血糖监测装置,其特征在于,还包括用于连接在皮肤表面的固定结构,所述发射器元器件与所述固定结构分别设置于所述柔性基材的两侧。7. The continuous blood glucose monitoring device according to claim 1, further comprising a fixed structure for connecting to the surface of the skin, the transmitter component and the fixed structure are respectively arranged on the flexible substrate. sides.8.根据权利要求7所述的连续血糖监测装置,其特征在于,所述固定结构为粘接层。8. The continuous blood glucose monitoring device according to claim 7, wherein the fixing structure is an adhesive layer.9.一种连续血糖监测系统,其特征在于,包括如权利要求1-8任一项所述的连续血糖监测装置和用于装载所述连续血糖监测装置的弹射器,所述弹射器包括穿刺针,所述穿刺针带动所述引出端植入患者皮下组织。9. A continuous blood glucose monitoring system, characterized in that it comprises the continuous blood glucose monitoring device according to any one of claims 1-8 and an ejector for loading the continuous blood glucose monitoring device, the ejector includes a puncture The puncture needle drives the leading end to be implanted into the patient's subcutaneous tissue.10.根据权利要求9所述的连续血糖监测系统,其特征在于,所述弹射器设置有磁铁,所述连续血糖监测装置包括常闭性干簧管,所述常闭性干簧管随所述弹射器与所述连续血糖监测装置的分离而导通所述发射器元器件与所述第一印制线。10. The continuous blood glucose monitoring system according to claim 9, wherein the ejector is provided with a magnet, and the continuous blood glucose monitoring device comprises a normally closed reed switch, and the normally closed reed switch is The ejector is separated from the continuous blood glucose monitoring device to conduct the transmitter component and the first printed line.
CN202111485299.0A2021-12-072021-12-07Continuous blood glucose monitoring device and continuous blood glucose monitoring systemPendingCN116236192A (en)

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