技术领域technical field
本发明涉及检测分析物的装置及方法，具体地说，涉及一种经皮分析物传感设备及其安装方法。The invention relates to a device and a method for detecting an analyte, in particular to a transdermal analyte sensing device and an installation method thereof.
背景技术Background technique
正常人的身体中的胰腺可自动监测人体血液中的葡萄糖含量的变化，并自动分泌所需的胰岛素，而糖尿病患者体内无法正常分泌人体所需胰岛素，即人体胰腺功能出现异常状况。糖尿病为终身疾病，目前医疗技术尚无法根治，只能通过稳定血糖来控制。而对于利用胰岛素疗法来稳定血糖进而控制糖尿病而言，准确掌握血糖水平信息起到至关重要的作用。The pancreas in a normal person can automatically monitor changes in the glucose content in the blood of the human body and automatically secrete the required insulin. However, in diabetic patients, the body cannot normally secrete the insulin required by the human body, that is, the human pancreas function is abnormal. Diabetes is a lifelong disease, and current medical technology cannot cure it. It can only be controlled by stabilizing blood sugar. For the use of insulin therapy to stabilize blood sugar and control diabetes, accurate information on blood sugar levels plays a vital role.
传统的血糖检测通常采用试纸及血糖仪，通过测量血液中的葡萄糖与试纸中的葡萄糖氧化酶反应产生的电流量测量血糖。普通血糖监测多采用令人不快的指尖检测法，除需反复针刺采血引起的不便和不快外，这种方法一般只能检查空腹、早餐后、午餐前、午餐后、晚餐前、晚餐后，以及睡前这7个时间点的瞬间血糖。而瞬间血糖容易受运动、饮食、药物、情绪波动等诸多因素的影响，只能反映一天中几个时间点的血糖情况，不能反映全天血糖状况，很难发现无症状的高血糖和低血糖，有时会导致危险的副作用。用传统方法测血糖的病人通常太晚得知血糖升高或降低的状况。这种对血糖水平掌握的不充分限制了胰岛素疗法的应用。Traditional blood glucose testing usually uses test strips and blood glucose meters to measure blood glucose by measuring the amount of current generated by the reaction of glucose in the blood with glucose oxidase in the test strip. Ordinary blood sugar monitoring mostly uses the unpleasant fingertip detection method. In addition to the inconvenience and discomfort caused by repeated acupuncture blood collection, this method can generally only check fasting, after breakfast, before lunch, after lunch, before dinner, and after dinner. , and the instant blood sugar at these 7 time points before going to bed. Instantaneous blood sugar is easily affected by many factors such as exercise, diet, drugs, mood swings, etc. It can only reflect the blood sugar situation at several points in a day, but cannot reflect the blood sugar situation throughout the day. It is difficult to find asymptomatic hyperglycemia and hypoglycemia , sometimes causing dangerous side effects. Patients who measure their blood sugar traditionally often learn of a rise or fall too late. This insufficient control of blood glucose levels limits the use of insulin therapy.
为了解决指尖血糖提供的信息不充分的问题，市场上出现了实时动态血糖监测系统，通过植入人体皮下组织的葡萄糖传感器探头，能够实时动态监测人体血糖变化。动态血糖监测系统主要由传感器探头和用于记录及显示的电子设备组成，它具备体积小、携带方便、数据准确连续等优点。监测时，将传感器探头植入患者的皮下，动态血糖监测系统将连续24小时不间断的监测血糖并绘制血糖变化曲线，为胰岛素治疗提供重要参考。而且系统会对高低血糖等异常事件等对用户报警，避免造成治疗延误。但是，市场上目前存在的动态血糖检测产品使用上仍然欠缺安全性和便利性。如EP2327362A1中公开的检测设备，虽可以将传感器探头通过针植入皮下实现连续监测，但其需要多个部件如柱塞，推杆和引导管专用组件用于刺入针和传感器以及收针，牺牲了部分紧凑性，且针的刺入和抽出都靠病人手动操作，不仅不方便，还存在一定的危险性。In order to solve the problem of insufficient information provided by fingertip blood glucose, a real-time dynamic blood glucose monitoring system has appeared on the market. Through the glucose sensor probe implanted in the subcutaneous tissue of the human body, it can dynamically monitor the changes in human blood glucose in real time. The continuous blood glucose monitoring system is mainly composed of sensor probes and electronic equipment for recording and displaying. It has the advantages of small size, easy to carry, accurate and continuous data, etc. During monitoring, the sensor probe is implanted under the patient's skin, and the continuous blood glucose monitoring system will continuously monitor blood glucose and draw blood glucose change curves for 24 hours, providing an important reference for insulin therapy. Moreover, the system will alert users to abnormal events such as high and low blood sugar to avoid delays in treatment. However, the current continuous blood glucose detection products on the market still lack safety and convenience. As disclosed in EP2327362A1, although the sensor probe can be implanted subcutaneously through the needle to realize continuous monitoring, it requires multiple components such as plunger, push rod and guide tube special assembly for piercing the needle and sensor and retracting the needle. Part of the compactness is sacrificed, and the insertion and extraction of the needle are all manually operated by the patient, which is not only inconvenient, but also has certain risks.
发明内容Contents of the invention
为克服上述现有技术的不足，本发明的目的之一是提供一种经皮分析物传感设备，包括：In order to overcome the above-mentioned deficiencies in the prior art, one of the objects of the present invention is to provide a transdermal analyte sensing device, comprising:
一片医用胶布；A piece of medical tape;
一个固定在医用胶布上的探头底座，其特征在于，包括用于装设探头本体的第一安装结构，用于装设探头安装器的第二安装结构及用于装设发射器的第三安装结构；A probe base fixed on the medical adhesive plaster is characterized in that it includes a first mounting structure for mounting the probe body, a second mounting structure for mounting the probe mount and a third mounting structure for mounting the transmitter. structure;
一个可安装于所述第一安装结构的探头本体，包含探头和探头壳体；a probe body mountable to the first mounting structure, comprising a probe and a probe housing;
一个可安装于所述第二安装结构的探头安装器，其特征在于包含瞬间弹射‐回收机构和释放按键，用于将所述探头安装于人体皮下并将所述探头壳体安装于探头底座；A probe installer that can be installed on the second installation structure, characterized in that it includes an instant ejection-recovery mechanism and a release button, used to install the probe under the human skin and install the probe housing on the probe base;
一个可安装于所述第三安装结构的发射器，用于电连接探头本体并将探头获取的分析物信息转换为无线信号并传送给接收器；a transmitter that can be installed on the third installation structure, and is used to electrically connect the probe body and convert the analyte information obtained by the probe into a wireless signal and transmit it to the receiver;
所述探头壳体和探头底座上均开有可容引导针通过的通孔。Both the probe housing and the probe base are provided with through holes that can accommodate the guide needle.
优选地，所述瞬间弹射‐回收机构包括一引导针、一弹出弹簧，一回针弹簧，以及两个滑块，用于瞬间完成引导针穿刺和收回的动作；Preferably, the instant ejection-recovery mechanism includes a guide needle, an ejection spring, a needle return spring, and two sliders, which are used to instantly complete the puncture and retraction of the guide needle;
所述引导针为剖口针。The guide needle is a split needle.
优选地，所述探头包括采集人体血糖含量的感测部分及连接所述发射器的连接部分；Preferably, the probe includes a sensing part for collecting the blood sugar content of the human body and a connecting part for connecting the transmitter;
所述感测部分初始位于所述剖口针的凹槽内。The sensing portion is initially located within the groove of the split needle.
优选地，所述探头本体初始位于所述探头安装器内；Preferably, said probe body is initially located within said probe mount;
所述探头安装器初始安装于所述探头底座；The probe mounter is initially installed on the probe base;
所述引导针初始通过所述探头壳体上的通孔穿出探头壳体，不穿出所述探头底座。The guide needle initially passes out of the probe housing through the through hole in the probe housing and does not pass out of the probe base.
优选地，所述释放按键为两个，位于探头安装器圆周方向上正对的位置。Preferably, there are two release buttons, which are located at positions facing each other in the circumferential direction of the probe installer.
优选地，所述第一安装结构是探头底座上的三个有槽卡块。Preferably, the first installation structure is three slotted blocks on the probe base.
优选地，所述探头本体上与所述卡块配合的结构是一卡环。Preferably, the structure on the probe body that cooperates with the block is a snap ring.
优选地，所述探头本体上在所述卡环与探头底座之间还设有一硅胶堵头，用于实现防水功能。Preferably, a silicone plug is further provided on the probe body between the snap ring and the probe base to realize the waterproof function.
优选地，所述第二安装结构为一对释放卡舌，所述释放卡舌设有夹合部和波纹部；Preferably, the second installation structure is a pair of release tabs, and the release tabs are provided with a clamping portion and a corrugated portion;
所述夹合部既用于结合所述探头安装器也用于结合所述发射器。The clip is used to engage both the probe mount and the transmitter.
优选地，所述第三安装结构为位于所述第二安装结构内侧的一对凸缘，用于卡住发射器两侧的凹槽；以及一对卡勾，用于卡住发射器尾部。Preferably, the third installation structure is a pair of flanges on the inner side of the second installation structure, used to clamp the grooves on both sides of the transmitter; and a pair of hooks, used to clamp the tail of the transmitter.
优选地，所述探头本体上还设有两个O型密封圈，用于配合发射器壳底的密封腔实现防水功能。Preferably, the probe body is further provided with two O-rings, which are used to cooperate with the sealing cavity at the bottom of the transmitter shell to realize the waterproof function.
优选地，所述探头底座上还设有箭头标识，用于指引用户参照所述箭头标识完成探头本体在探头底座上的安装并取下探头安装器。Preferably, the probe base is also provided with an arrow mark, which is used to guide the user to complete the installation of the probe body on the probe base and remove the probe installer by referring to the arrow mark.
优选地，还包括一个保护罩。Preferably, a protective cover is also included.
优选地，所述保护罩初始罩设于探头安装器的圆周方向并卡合于探头底座，用于遮蔽所述释放按键避免被不恰当地按下。Preferably, the protective cover is initially arranged in the circumferential direction of the probe mounter and engaged with the probe base, so as to shield the release button from being improperly pressed.
优选地，所述保护罩还有可沿纵向方向卡合于探头安装器伸出引导针一端的结构，用于在取下探头安装器后防止所述引导针针头裸露在外。Preferably, the protective cover also has a structure that can be engaged with the protruding end of the guide needle of the probe installer along the longitudinal direction, so as to prevent the needle of the guide needle from being exposed outside after the probe installer is removed.
优选地，所述保护罩用于结合探头底座以及探头安装器一端的结构为卡勾，探头底座和探头安装器上与之配合的结构为卡槽。Preferably, the structure of the protective cover used to combine the probe base and one end of the probe installer is a hook, and the matching structure on the probe base and the probe installer is a slot.
优选地，所述保护罩还设有用于操控所述卡勾卡住所述卡块或从所述卡块脱离的手柄。Preferably, the protective cover is further provided with a handle for manipulating the hook to engage with the block or disengage from the block.
本发明的另一个目的是提供上述经皮分析物传感设备的安装方法。Another object of the present invention is to provide a method for installing the above-mentioned transdermal analyte sensing device.
对于不含保护罩的经皮分析物传感设备，其安装方法包括以下步骤：For transdermal analyte sensing devices without a protective cover, the installation method includes the following steps:
从包装中拆出经皮分析物传感设备，包括医用胶布及固定于其上的探头底座和卡合在第二安装结构上的探头安装器及其内的探头本体，撕去医用胶布另一侧的贴纸并将医用胶布粘于身体待测部位；Remove the percutaneous analyte sensing device from the package, including the medical adhesive tape and the probe base fixed on it, the probe mounter and the probe body inside the second installation structure, and tear off the other part of the medical adhesive tape. Stick the sticker on the side and stick the medical tape to the part of the body to be tested;
同时按下探头安装器上的两个释放按键，瞬间弹射‐回收机构被触发，使引导针引导探头刺入皮下并瞬间抽回引导针，初始位于探头安装器内的探头本体同样被瞬间弹射‐回收机构推出并到达探头底座上的第一安装结构；Simultaneously press the two release buttons on the probe installer, and the instant ejection-recovery mechanism is triggered, so that the guide needle guides the probe into the subcutaneous and withdraws the guide needle instantly, and the probe body initially located in the probe installer is also instantly ejected- The recovery mechanism pushes out and reaches the first installation structure on the probe base;
参照探头底座上的箭头标识转动探头安装器使探头本体上的卡环与第一安装结构卡合，完成探头本体的安装后沿纵向方向从第二安装结构取下探头安装器；Referring to the arrow mark on the probe base, turn the probe mounter so that the snap ring on the probe body engages with the first mounting structure. After completing the installation of the probe body, remove the probe mounter from the second mounting structure along the longitudinal direction;
将发射器卡合于探头底座上的第三安装结构，使探头本体和发射器实现电连接，完成经皮分析物传感设备的安装；The transmitter is engaged with the third installation structure on the probe base, so that the probe body and the transmitter are electrically connected, and the installation of the transcutaneous analyte sensing device is completed;
需要取下发射器时，捏住所述释放卡舌的后臂即可轻松取下。When the transmitter needs to be removed, it is easily removed by pinching the rear arm of the release tab.
对于含有保护罩的经皮分析物传感设备，其安装方法包括以下步骤：For transdermal analyte sensing devices with protective covers, the installation method includes the following steps:
从包装中拆出经皮分析物传感设备，包括医用胶布及固定于其上的探头底座和卡合在第二安装结构上的探头安装器，其内的探头本体及保护罩，撕去医用胶布另一侧的贴纸并将医用胶布粘于身体待测部位；Take out the transdermal analyte sensing device from the package, including the medical adhesive tape and the probe base fixed on it, the probe installer snapped on the second installation structure, the probe body and the protective cover inside, and remove the medical adhesive tape. Sticker on the other side of the tape and stick the medical tape to the part of the body to be tested;
从圆周方向取下保护罩，同时按下探头安装器上的两个释放按键，瞬间弹射‐回收机构被触发，使引导针引导探头刺入皮下并瞬间抽回引导针，初始位于探头安装器内的探头本体同样被瞬间弹射‐回收机构推出并到达探头底座上的第一安装结构；Remove the protective cover from the circumferential direction, press the two release buttons on the probe installer at the same time, the instant ejection-recovery mechanism is triggered, so that the guide needle guides the probe into the subcutaneous and instantly withdraws the guide needle, initially located in the probe installer The probe body is also pushed out by the instant ejection-recovery mechanism and reaches the first installation structure on the probe base;
参照探头底座上的箭头标识转动探头安装器使探头本体上的卡环与第一安装结构卡合，完成探头本体的安装后沿纵向方向从第二安装结构取下探头安装器；Referring to the arrow mark on the probe base, turn the probe mounter so that the snap ring on the probe body engages with the first mounting structure. After completing the installation of the probe body, remove the probe mounter from the second mounting structure along the longitudinal direction;
将取下的保护罩沿纵向方向通过卡勾卡合于探头安装器伸出引导针的一端；Attach the removed protective cover to the end of the probe installer protruding from the guide needle through the hook along the longitudinal direction;
将发射器夹合于探头底座上的第三安装结构，使探头本体和发射器实现电连接，完成经皮分析物传感设备的安装；Clamping the transmitter to the third installation structure on the probe base, so that the probe body and the transmitter are electrically connected, and the installation of the percutaneous analyte sensing device is completed;
需要取下发射器时，捏住所述释放卡舌的后臂即可轻松取下。When the transmitter needs to be removed, it is easily removed by pinching the rear arm of the release tab.
本发明的经皮分析物传感设备有如下优点：首先，它可连续24小时不间断的监测血糖并绘制血糖变化曲线，为胰岛素治疗提供重要参考。同时，系统会对高低血糖等异常事件等对用户报警，避免造成治疗延误。其次，它通过巧妙地设计而拥有紧凑的结构，不需要额外的配合用部件即可完成探头本体的安装，其独有的瞬间弹射‐回收机构可瞬间完成引导针的刺入和回收，无需用户手动操作将探头植入皮下，最小化安全隐患。再次，本发明的探头底座采用独特的结构设计，可以与探头安装器、探头本体、发射器三者方便地结合与分离，使用户在探头本体安装完成后能够轻易地取下探头安装器并装上发射器，无需复杂的操作指示。最后但不限于，本发明独有的保护罩进一步提升了安装操作的安全性：其在安装探头前遮蔽释放按键避免无意触发瞬间弹射‐回收机构，探头安装器被取下后，又可罩住探头安装器露出针头的一端，避免针尖裸露发生意外。综上所述，本发明的经皮分析物传感设备体积小，佩戴方便，安装操作简单安全，为用户自助实现连续血糖监测提供了完美的解决方案，也为合理的胰岛素法治疗糖尿病提供了不可或缺的可靠支援。The transdermal analyte sensing device of the present invention has the following advantages: First, it can continuously monitor blood sugar and draw blood sugar change curves for 24 hours continuously, providing an important reference for insulin therapy. At the same time, the system will alert users to abnormal events such as high and low blood sugar to avoid delays in treatment. Secondly, it has a compact structure through ingenious design, and the installation of the probe body can be completed without additional matching parts. Its unique instant ejection-recovery mechanism can complete the insertion and recovery of the guide needle in an instant, without the need for users The probe is implanted subcutaneously by manual operation, minimizing safety hazards. Again, the probe base of the present invention adopts a unique structural design, which can be conveniently combined and separated from the probe mounter, probe body, and transmitter, so that the user can easily remove the probe mounter and install it after the probe body is installed. On the transmitter, no complicated operation instructions are required. Last but not limited to, the unique protective cover of the present invention further improves the safety of the installation operation: it shields the release button before installing the probe to avoid unintentional triggering of the instant ejection-recovery mechanism, and after the probe installer is removed, it can be covered again The probe mounter exposes one end of the needle to avoid accidental exposure of the needle tip. In summary, the transdermal analyte sensing device of the present invention is small in size, easy to wear, simple and safe to install and operate, and provides a perfect solution for self-service continuous blood glucose monitoring for users, and also provides a reasonable solution for treating diabetes with insulin. Indispensable and reliable support.
附图说明Description of drawings
图1是本发明经皮分析物传感设备的示意图；1 is a schematic diagram of a transdermal analyte sensing device of the present invention;
图2是本发明经皮分析物传感设备探头本体的示意图；2 is a schematic diagram of the probe body of the transdermal analyte sensing device of the present invention;
图3是本发明经皮分析物传感设备中发射器、探头底座和医用胶布的分解图；Fig. 3 is an exploded view of the transmitter, the probe base and the medical adhesive tape in the transdermal analyte sensing device of the present invention;
图4是本发明经皮分析物传感设备探头底座的示意图；Fig. 4 is a schematic diagram of the probe base of the transdermal analyte sensing device of the present invention;
图5是本发明经皮分析物传感设备探头安装器的示意图；Fig. 5 is a schematic diagram of the probe installer of the transdermal analyte sensing device of the present invention;
图6是本发明经皮分析物传感设备中探头安装器初始安装于探头底座的示意图；6 is a schematic diagram of the initial installation of the probe mounter on the probe base in the transdermal analyte sensing device of the present invention;
图7是本发明经皮分析物传感设备中探头安装器与探头底座分离的示意图；7 is a schematic diagram of the separation of the probe mounter and the probe base in the transdermal analyte sensing device of the present invention;
图8是本发明经皮分析物传感设备中探头本体与探头底座分离的示意图；Fig. 8 is a schematic diagram of the separation of the probe body and the probe base in the transdermal analyte sensing device of the present invention;
图9是本发明经皮分析物传感设备中探头本体安装于探头底座的俯视图；9 is a top view of the probe body installed on the probe base in the transdermal analyte sensing device of the present invention;
图10是本发明经皮分析物传感设备瞬间弹射‐回收机构的示意图；Fig. 10 is a schematic diagram of the instantaneous ejection-recovery mechanism of the transdermal analyte sensing device of the present invention;
图11是本发明经皮分析物传感设备瞬间弹射‐回收机构的剖视图1；Fig. 11 is a cross-sectional view 1 of the instantaneous ejection-recovery mechanism of the transdermal analyte sensing device of the present invention;
图12是本发明经皮分析物传感设备瞬间弹射‐回收机构的剖视图2；Fig. 12 is a cross-sectional view 2 of the instantaneous ejection-recovery mechanism of the transdermal analyte sensing device of the present invention;
图13是本发明经皮分析物传感设备带有O型密封圈的实施例的示意图；Fig. 13 is a schematic diagram of an embodiment of a transdermal analyte sensing device with an O-ring of the present invention;
图14是本发明经皮分析物传感设备带有O型密封圈和硅胶堵头的实施例的剖视图；14 is a cross-sectional view of an embodiment of the transdermal analyte sensing device of the present invention with an O-ring and a silicone plug;
图15是本发明经皮分析物传感设备中发射器的示意图1；Fig. 15 is a schematic diagram 1 of the transmitter in the transdermal analyte sensing device of the present invention;
图16是本发明经皮分析物传感设备中发射器的示意图2；Fig. 16 is a schematic diagram 2 of the transmitter in the transdermal analyte sensing device of the present invention;
图17是本发明经皮分析物传感设备中发射器在探头底座上安装完成的示意图；Fig. 17 is a schematic diagram of the installation of the transmitter on the probe base in the transdermal analyte sensing device of the present invention;
图18是本发明经皮分析物传感设备中保护罩与探头底座分离的示意图；Fig. 18 is a schematic diagram of the separation of the protective cover from the probe base in the transdermal analyte sensing device of the present invention;
图19是本发明经皮分析物传感设备含有保护罩的初始状态的示意图；Figure 19 is a schematic diagram of the initial state of the transdermal analyte sensing device of the present invention containing a protective cover;
图20是本发明经皮分析物传感设备中保护罩与探头安装器结合状态的示意图；Fig. 20 is a schematic diagram of the combined state of the protective cover and the probe mounter in the transdermal analyte sensing device of the present invention;
图21是本发明经皮分析物传感设备中保护罩与探头安装器分离状态的示意图。Fig. 21 is a schematic diagram of the separation state of the protective cover and the probe mounter in the transdermal analyte sensing device of the present invention.
具体实施方式detailed description
本发明提供一种测量人体物质含量的经皮分析物传感设备，通过植入人体皮下组织的葡萄糖探头，实时动态监测人体分析物的变化。在实际的应用监测时，将探头植入患者皮下，动态分析物监测系统将连续24小时不间断的监测分析物并绘制分析物变化曲线，为合理的胰岛素治疗提供重要参考。参阅图1-3，显示为本发明的经皮分析物传感设备安装完成的示意图，包括：医用胶布1，探头底座2，发射器3，以及安装于探头底座2和电连接于发射器3的探头本体4，所述探头本体4包括探头40。The invention provides a transdermal analyte sensing device for measuring the substance content of a human body. Through a glucose probe implanted in the subcutaneous tissue of a human body, the change of the analyte in the human body can be dynamically monitored in real time. In actual application monitoring, the probe is implanted under the skin of the patient, and the dynamic analyte monitoring system will continuously monitor the analyte for 24 hours and draw the change curve of the analyte, providing an important reference for reasonable insulin therapy. Referring to Figures 1-3, it shows a schematic diagram of the installation of the transdermal analyte sensing device of the present invention, including: medical adhesive tape 1, probe base 2, transmitter 3, and installed on the probe base 2 and electrically connected to the transmitter 3 The probe body 4 includes a probe 40 .
如图1所示，经皮分析物传感设备安装完成，探头底座2固定于医用胶布1，发射器3安装于探头底座2，随时可测人体内分析物含量。As shown in Figure 1, the installation of the transdermal analyte sensing device is completed, the probe base 2 is fixed on the medical adhesive tape 1, the transmitter 3 is installed on the probe base 2, and the analyte content in the human body can be measured at any time.
所述探头40用于采集人体分析物含量并传输所述分析物含量信息。参阅图2，所述探头40包括采集人体分析物含量的感测部分41及连接所述发射器的连接部分42。当所述感测部分41通过引导针完成在人体内的安装后感测人体内分析物，感测到的分析物信息通过连接部分42通过电连接传送给发射器3，再转化为无线电信号发送给接收器。The probe 40 is used to collect the analyte content of the human body and transmit the analyte content information. Referring to FIG. 2 , the probe 40 includes a sensing part 41 for collecting the content of human body analytes and a connecting part 42 for connecting the transmitter. When the sensing part 41 is installed in the human body through the guide needle to sense the analyte in the human body, the sensed analyte information is transmitted to the transmitter 3 through the connecting part 42 through an electrical connection, and then converted into a radio signal for transmission. to the receiver.
图3是本发明经皮分析物传感设备安装完成的分解图，如图所示，探头本体4安装于探头底座2，探头40的连接部分42电连接于发射器3。FIG. 3 is an exploded view of the installed transdermal analyte sensing device of the present invention. As shown in the figure, the probe body 4 is installed on the probe base 2 , and the connecting part 42 of the probe 40 is electrically connected to the transmitter 3 .
参阅图4至图9理解本发明中没有保护罩的经皮分析物传感设备的安装方式，可知如何将探头本体4正确安装于探头底座2以及如何在探头本体4安装完成后取下探头安装器5。Referring to Fig. 4 to Fig. 9 to understand the installation method of the percutaneous analyte sensing device without a protective cover in the present invention, we can know how to correctly install the probe body 4 on the probe base 2 and how to remove the probe body 4 after the installation is completed. device 5.
图4显示为本发明探头底座具体结构的分解示意图，参照图4，探头底座2固定于医用胶布1，所述探头底座2包含第一安装结构，本实施例中为三个有槽卡块22，用于结合探头本体4；第二安装结构，本实施例中为一对释放卡舌21，分为夹合部211和波纹部212，既用于结合探头安装器5也用于结合发射器3；第三安装结构，本实施例中为一对凸缘23，用于结合发射器3上的凹槽，以及一对卡勾24，用于钩住发射器3的尾部。Fig. 4 shows an exploded schematic view of the specific structure of the probe base of the present invention. Referring to Fig. 4, the probe base 2 is fixed on the medical adhesive tape 1, and the probe base 2 includes a first installation structure, which is three slotted blocks 22 in this embodiment. , used to combine with the probe body 4; the second installation structure, in this embodiment, is a pair of release tabs 21, which are divided into a clamping part 211 and a corrugated part 212, which are used for combining the probe mounter 5 and the transmitter 3. The third installation structure, in this embodiment, is a pair of flanges 23 for combining with the grooves on the transmitter 3 and a pair of hooks 24 for hooking the tail of the transmitter 3 .
参照图5，探头安装器5外壳顶部设有一个箭头标识51，用于引导用户参照箭头标识51完成探头本体在探头底座上的安装并取下探头安装器5。Referring to FIG. 5 , an arrow mark 51 is provided on the top of the shell of the probe installer 5 for guiding the user to refer to the arrow mark 51 to complete the installation of the probe body on the probe base and remove the probe mounter 5 .
参照图6-9可理解本发明经皮分析物传感设备的安装方法。如图6所示，探头安装器5通过第二安装结构的夹合部211初始安装于探头底座2上。需要安装时，同时按下突出探头安装器5外的两个释放按键53，探头安装器5内的瞬间弹射-回收机构被触发，推动如图8所示的引导针8带着探头40上的感测部分41经由探头底座2上的通孔刺穿人体皮肤，然后瞬间抽回引导针8，将探头40上的感测部分41留在人体皮下；同时初始处于探头安装器5内的探头本体4被所述瞬间弹射-回收机构推至探头底座2上的第一安装结构，即三个有槽卡块22上。The installation method of the transdermal analyte sensing device of the present invention can be understood with reference to FIGS. 6-9. As shown in FIG. 6 , the probe mounter 5 is initially installed on the probe base 2 through the clamping portion 211 of the second mounting structure. When installation is required, press the two release buttons 53 protruding outside the probe installer 5 at the same time, and the instant ejection-recovery mechanism in the probe installer 5 is triggered, and the guide pin 8 shown in Figure 8 is pushed to take the probe 40 with it. The sensing part 41 pierces the human skin through the through hole on the probe base 2, and then withdraws the guide needle 8 instantaneously, leaving the sensing part 41 on the probe 40 under the human skin; at the same time, the probe body initially in the probe mount 5 4 is pushed to the first installation structure on the probe base 2 by the instant ejection-recovery mechanism, that is, the three slotted blocks 22 .
当探头40上的感测部分41在人体皮下安装完成，需要参照图7所示将探头本体4固定在探头底座2上并取下探头安装器5。按照探头安装器5外壳顶部的箭头标识51指引方向转动探头安装器5，将探头本体4上的卡环43锁合于第一安装结构上的有槽卡块22，直至探头安装器5到达指定位置不能再转，此时可听见卡环43锁合于有槽卡块22的卡合声。再捏住释放卡舌21的波纹部212使夹合部211张开，并将探头安装器5沿纵向从所述探头底座2的第二安装结构上拔出取下。When the sensing part 41 on the probe 40 is installed under the skin of the human body, it is necessary to fix the probe body 4 on the probe base 2 and remove the probe mounter 5 as shown in FIG. 7 . Turn the probe installer 5 in the direction indicated by the arrow mark 51 on the top of the probe installer 5 casing, and lock the snap ring 43 on the probe body 4 with the slotted block 22 on the first installation structure until the probe installer 5 reaches the specified position. The position cannot be turned any further, and at this moment, the click sound of the snap ring 43 being locked to the slotted block 22 can be heard. Then pinch the corrugated portion 212 of the release tab 21 to open the clamping portion 211 , and pull out the probe mounter 5 from the second mounting structure of the probe base 2 along the longitudinal direction.
参照图8和图9可更好的理解探头本体4和探头底座2的结合。所述第一安装结构的三个有槽卡块22上设有三个凹槽已容纳卡环43上的卡勾。安装过程中，通过转动探头安装器5，引导针8带领探头40上的感测部分41向下穿过探头底座2上的通孔，同时探头本体跟着探头安装器转动，带动卡环43上的卡勾卡合于三个有槽卡块22上的凹槽。The combination of the probe body 4 and the probe base 2 can be better understood with reference to FIGS. 8 and 9 . The three grooved blocks 22 of the first installation structure are provided with three grooves to accommodate the hooks on the snap ring 43 . During the installation process, by rotating the probe installer 5, the guide pin 8 leads the sensing part 41 on the probe 40 to pass through the through hole on the probe base 2 downwards, and at the same time, the probe body rotates with the probe installer to drive the sensing part 41 on the snap ring 43. The hooks engage with the grooves on the three grooved blocks 22 .
参考图10至图12，给出一个本发明瞬间弹射-回收机构的实施例，所述弹射机构包括第一滑块71，第二滑块72，弹出弹簧73，回针弹簧74以及引导针8。所述瞬间弹射-回收机构与释放按键53协作，完成引导针8的瞬间弹出与回收过程。Referring to Fig. 10 to Fig. 12, an embodiment of the instant ejection-recovery mechanism of the present invention is provided, the ejection mechanism includes a first slider 71, a second slider 72, an ejection spring 73, a return needle spring 74 and a guide needle 8 . The instant ejection-recovery mechanism cooperates with the release button 53 to complete the instant ejection and recovery process of the guide pin 8 .
如图11所示，第一滑块71具有一垂向设置的空心导柱710，平行所述空心导柱710设置的针座，以及形成在所述空心导柱710内壁上的第一锁合部711，所述第一锁合部711为一凸块。所述空心导柱710的内部具有一弹射空间。第二滑块72具有一个第二锁合部721，所述第二锁合部721是与所述第一锁合部711的凸块形状相配合一个卡勾，其穿过所述空心导柱710内部。所述第一锁合部711与所述第二锁合部721初始时相互卡扣。弹出弹簧73套设于所述空心导柱710外，回针弹簧74设于所述弹射空间内。两个用于触发所述瞬间弹射-回收机构的释放按键53设于探头安装器5圆周方向的正对面。As shown in FIG. 11 , the first slider 71 has a vertically arranged hollow guide post 710 , a needle seat arranged parallel to the hollow guide post 710 , and a first lock formed on the inner wall of the hollow guide post 710 part 711, the first locking part 711 is a protrusion. The interior of the hollow guide post 710 has an ejection space. The second slider 72 has a second locking portion 721, the second locking portion 721 is a hook matched with the shape of the protrusion of the first locking portion 711, and passes through the hollow guide post 710 interior. The first locking portion 711 and the second locking portion 721 are initially engaged with each other. The pop-up spring 73 is sleeved on the outside of the hollow guide post 710 , and the return spring 74 is set in the ejection space. Two release buttons 53 for triggering the instant ejection-recovery mechanism are arranged on the opposite sides of the probe installer 5 in the circumferential direction.
如图11和12所示，弹出弹簧73初始处于压缩状态，所述弹出弹簧73的两端抵靠于所述第二滑块72与探头安装器5内两块位置固定的挡板75之间。回针弹簧74初始也处于压缩状态，所述弹出弹簧74的两端抵靠于所述第一滑块71和第二滑块72之间。引导针8固定于第一滑块71的针座上。As shown in Figures 11 and 12, the pop-up spring 73 is initially in a compressed state, and the two ends of the pop-up spring 73 abut between the second slider 72 and the two fixed baffle plates 75 in the probe installer 5 . The return spring 74 is also initially in a compressed state, and the two ends of the pop-up spring 74 abut against between the first slider 71 and the second slider 72 . The guide needle 8 is fixed on the needle seat of the first slider 71 .
如图12所示，两个释放按键53具有楔形形状，其薄处抵住探头安装器5外壁上的两块外挡板54，其厚处伸出探头安装器5外壁之外。如图10所示，释放按键53与第二滑块72配合，将第二滑块72锁定于其初始位置。当在释放按键53上施加外力，释放按键53被整个按入探头安装器5内，并在弹出弹簧73释放的张力作用下沿着探头安装器5内壁向下运动。当释放按键53被整个按入探头安装器5内，弹出弹簧73从压缩状态释放，驱动第二滑块72向下运动，并由此带动包括第一滑块71、第二滑块72、回针弹簧74和引导针8的瞬间弹出-回收机构作为一个整体向下运动，于是引导针8被推出探头底座并穿刺人体皮肤。在此过程中，由于第一滑块71和第二滑块72一起向下运动，所以回针弹簧74仍处于压缩状态。As shown in FIG. 12 , the two release buttons 53 have a wedge shape, and their thinner parts are against the two outer baffles 54 on the outer wall of the probe installer 5 , and their thicker parts extend out of the outer wall of the probe installer 5 . As shown in FIG. 10 , the release button 53 cooperates with the second slider 72 to lock the second slider 72 at its initial position. When an external force is applied to the release button 53 , the release button 53 is entirely pressed into the probe mounter 5 , and moves downward along the inner wall of the probe mounter 5 under the tension released by the pop-up spring 73 . When the release button 53 is completely pressed into the probe mounter 5, the pop-up spring 73 is released from the compressed state, driving the second slider 72 to move downward, and thereby driving the first slider 71, the second slider 72, the back The instant ejection-recovery mechanism of the needle spring 74 and the guide needle 8 moves downward as a whole, so the guide needle 8 is pushed out of the probe base and punctures the human skin. During this process, since the first slider 71 and the second slider 72 move downward together, the return spring 74 is still in a compressed state.
当瞬间弹出-回收机构到达指定位置，第一滑块71上的具有凸块形状的第一锁合部711和第二滑块72上具有卡勾形状的第二锁合部721松开，回针弹簧74从压缩状态释放，推动第一滑块71和固定其上的引导针8向上运动回到探头安装器5内，则引导针8被回针弹簧74从人体内抽回。所述引导针8的弹出及抽回动作由瞬间弹出-回收机构瞬时完成，此过程不需要任何手动操作的介入。When the momentary pop-up-recovery mechanism reaches the designated position, the first locking part 711 with a bump shape on the first slider 71 and the second locking part 721 with a hook shape on the second slider 72 are released, and the The needle spring 74 is released from the compressed state, pushing the first slider 71 and the guide needle 8 fixed thereon to move upwards back into the probe installer 5 , and then the guide needle 8 is withdrawn from the human body by the return needle spring 74 . The ejection and retraction of the guide needle 8 are instantaneously completed by the instant ejection-recovery mechanism, and this process does not require any manual intervention.
参照图10和图2可见，设于第一滑块71的针座上的所述引导针8上设有用于容纳探头40的感测部分41的剖口区81，所述引导针8穿过所述第二滑块72伸出令所述剖口区81露出所述第二滑块72。所述引导针8在所述弹出弹簧73释放弹力时朝下刺出，在所述回针弹簧74释放弹力时朝上收回。所述剖口区81的截面为弧形，用于采集人体分析物含量的探头40的感测部分41就设于该剖口区81内。当弹出弹簧73释放弹力时，引导针8引领所述感测部分41刺入人体皮肤，所述感测部分41即随着引导针8植入皮下；此过程后所述回针弹簧74释放弹力，引导针8朝上收回，所述感测部分41则留置人体皮下，进而实现对人体分析物的持续监测。Referring to Fig. 10 and Fig. 2, it can be seen that the guide needle 8 provided on the needle seat of the first slider 71 is provided with a cutout area 81 for accommodating the sensing part 41 of the probe 40, and the guide needle 8 passes through The second sliding block 72 protrudes so that the cutout area 81 exposes the second sliding block 72 . The guide needle 8 thrusts downward when the ejection spring 73 releases the elastic force, and retracts upward when the return needle spring 74 releases the elastic force. The section of the cutout area 81 is arc-shaped, and the sensing part 41 of the probe 40 for collecting the content of the human body analyte is set in the cutout area 81 . When the pop-up spring 73 releases the elastic force, the guide needle 8 leads the sensing part 41 to penetrate the skin of the human body, and the sensing part 41 is implanted under the skin along with the guide needle 8; after this process, the returning needle spring 74 releases the elastic force , the guide needle 8 is retracted upwards, and the sensing part 41 is placed under the skin of the human body, thereby realizing continuous monitoring of human body analytes.
参阅图13至图15，提供了本发明经皮分析物传感设备防水功能的实施例。如图13图14所示，探头本体4上设有两个O型密封圈45，用于与发射器3底壳上的密封腔34配合防水。探头本体4上还设有一硅胶堵头44，在探头本体4安装于探头底座2时挤压探头底座2实现防水功能。Referring to FIG. 13 to FIG. 15 , examples of the waterproof function of the transdermal analyte sensing device of the present invention are provided. As shown in FIGS. 13 and 14 , the probe body 4 is provided with two O-rings 45 for waterproofing with the sealing chamber 34 on the bottom shell of the transmitter 3 . A silicone plug 44 is also provided on the probe body 4 , and when the probe body 4 is installed on the probe base 2 , the probe base 2 is squeezed to realize the waterproof function.
参阅图15至图17和图13，提供了本发明经皮分析物传感设备的发射器3安装于探头底座2上的第三安装结构的实施例。如图13所示，第三安装结构包括一对凸缘23和一对卡勾24，第二安装结构中释放卡舌21上的夹合部211也用于配合发射器3.如图15和16所示，发射器3两侧各设有凹槽31以配合第三安装结构的凸缘23；发射器3头部还设有一段弧形槽32以配合第二安装结构的夹合部211；发射器3尾部还设有两个凹槽33以配合第三安装结构的两个卡勾24。当需要安装发射器3时，将上述三处与探头底座2配合的部件相卡合，具体地，将凸缘23卡进凹槽31，将夹合部211夹住弧形槽32，将卡勾24卡进凹槽33中，即可完成发射器3在探头底座2上的安装并实现与探头40的连接部分42的电连接。图17展示了发射器3在探头底座2上安装完成的状态。Referring to FIG. 15 to FIG. 17 and FIG. 13 , an embodiment of the third installation structure in which the transmitter 3 of the transcutaneous analyte sensing device of the present invention is installed on the probe base 2 is provided. As shown in Figure 13, the third installation structure includes a pair of flanges 23 and a pair of hooks 24, and the clamping part 211 on the release tab 21 in the second installation structure is also used to cooperate with the transmitter 3. As shown in Figure 15 and As shown in 16, grooves 31 are provided on both sides of the transmitter 3 to match the flange 23 of the third installation structure; the head of the transmitter 3 is also provided with an arc-shaped groove 32 to cooperate with the clamping part 211 of the second installation structure ; The tail of the transmitter 3 is also provided with two grooves 33 to match the two hooks 24 of the third installation structure. When it is necessary to install the transmitter 3, engage the above three parts that cooperate with the probe base 2, specifically, insert the flange 23 into the groove 31, clamp the clamping part 211 to the arc groove 32, and clamp the clamp The hook 24 snaps into the groove 33 to complete the installation of the transmitter 3 on the probe base 2 and realize the electrical connection with the connection part 42 of the probe 40 . FIG. 17 shows the state where the transmitter 3 is installed on the probe base 2 .
当需要取下发射器3时，捏住释放卡舌21的波纹部212使夹合部211张开，遂夹合部211从卡紧发射器3的弧形槽32的状态松开，使发射器3得以轻松的被从探头底座2上取下。When it is necessary to take off the transmitter 3, pinch the corrugated part 212 of the release tab 21 to open the clamping part 211, and then the clamping part 211 is released from the state of clamping the arc groove 32 of the transmitter 3, so that the transmitter can be launched. The device 3 can be easily removed from the probe base 2.
参照图18-19，提供了本发明经皮分析物传感设备的一个包含保护罩的实施例。如图18所示，第二安装结构的释放卡舌21上有两个槽210，用于配合保护罩6上的两个爪勾61。保护罩6上还设有用于控制所述两个爪勾61钩住或脱出槽210的手柄62.保护罩6初始沿圆周方向罩设于探头安装器5外壁并用图19所示的两个爪勾61钩住探头底座2，用于遮蔽释放按键53以防被错误地按下。当需要安装本发明的经皮分析物传感设备，先捏住手柄62取下保护罩6露出释放按键53，然后重复上文描述过的步骤完成安装。Referring to Figures 18-19, an embodiment of a transdermal analyte sensing device of the present invention including a protective cover is provided. As shown in FIG. 18 , there are two grooves 210 on the release tab 21 of the second installation structure, which are used to cooperate with the two claws 61 on the protective cover 6 . The protective cover 6 is also provided with a handle 62 for controlling the two claw hooks 61 to hook or escape from the groove 210. The protective cover 6 is initially covered on the outer wall of the probe mounter 5 along the circumferential direction and uses the two claws shown in FIG. 19 . The hook 61 hooks the probe base 2 and is used to cover the release button 53 to prevent it from being pressed by mistake. When the transdermal analyte sensing device of the present invention needs to be installed, first pinch the handle 62 to remove the protective cover 6 to expose the release button 53, and then repeat the steps described above to complete the installation.
参照图20-21，提供了保护罩6除遮蔽释放按键53外另一功能的一个实施例。当保护罩6被从探头安装器5和探头底座2上取下，探头安装器5也从探头底座2上取下后，保护罩6可如图20、21所示通过4个另设的卡勾63半环形罩于探头安装器5用于伸出引导针8的一端防止针尖暴露。Referring to FIGS. 20-21 , an embodiment of another function of the protective cover 6 besides covering the release button 53 is provided. When the protective cover 6 is removed from the probe mounter 5 and the probe base 2, and the probe mounter 5 is also removed from the probe base 2, the protective cover 6 can pass through four additional cards as shown in Figures 20 and 21. The half-ring cover of the hook 63 is used to extend one end of the guide needle 8 on the probe installer 5 to prevent the needle tip from being exposed.
虽然本发明披露如上，但本发明并非限定于此。任何本领域技术人员，在不脱离本发明的精神和范围内，均可作各种更动与修改，因此本发明的保护范围应当以权利要求所限定的范围为准。Although the present invention is disclosed above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention, so the protection scope of the present invention should be based on the scope defined in the claims.
| Application Number | Priority Date | Filing Date | Title |
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| CN201610666079.0ACN106137214A (en) | 2016-08-12 | 2016-08-12 | A kind of transcutaneous analyte sensing equipment and installation method thereof |
| Application Number | Priority Date | Filing Date | Title |
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| CN201610666079.0ACN106137214A (en) | 2016-08-12 | 2016-08-12 | A kind of transcutaneous analyte sensing equipment and installation method thereof |
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| CN106137214Atrue CN106137214A (en) | 2016-11-23 |
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| CN201610666079.0APendingCN106137214A (en) | 2016-08-12 | 2016-08-12 | A kind of transcutaneous analyte sensing equipment and installation method thereof |
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| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication | Application publication date:20161123 |