CN101862489B - Medicament injector - Google Patents
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- CN101862489B CN101862489BCN2010102007261ACN201010200726ACN101862489BCN 101862489 BCN101862489 BCN 101862489BCN 2010102007261 ACN2010102007261 ACN 2010102007261ACN 201010200726 ACN201010200726 ACN 201010200726ACN 101862489 BCN101862489 BCN 101862489B
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Abstract
Translated fromChineseDescription
Translated fromChinese技术领域technical field
本发明属于医疗用品技术领域，用于药剂注射，具体为一种药剂注射器。The invention belongs to the technical field of medical supplies and is used for medicament injection, in particular to a medicament injector.
背景技术Background technique
目前，糖尿病已成为继心血管病、脑血管病、癌症之后的第四大杀手。针对糖尿病患者最有效的治疗方法就是长期注射胰岛素，而患糖尿病的人群往往是较高年龄段。目前市场上常见的胰岛素注射器多为普通注射器：分为一次性和可再用性；市场上流通的可再用性的胰岛素注射用的器具，一种是纯机械的注射笔，另一种是价格昂贵的注射泵。胰岛素笔如诺和笔，优伴笔等，存在如下缺点：剂量设置麻烦，每次使用前均需要调整刻度：旋转胰岛素笔尾部的螺纹结构，对准所需的刻度线用来设置每次的胰岛素注射剂量，因患者大多为老年群体，视力不佳，且很多糖尿病患者都伴有视力受损的并发症，使得每次注射前的剂量设置，主要是将细密的刻度线对齐，成为一个很大的困难。且一旦剂量设置不对将会造成严重的后果。另外，很多老年人容易健忘，容易造成多次注射的风险。At present, diabetes has become the fourth biggest killer after cardiovascular disease, cerebrovascular disease and cancer. The most effective treatment for people with diabetes, which tends to be in the older age groups, is long-term insulin injections. At present, the common insulin syringes on the market are mostly ordinary syringes: they are divided into disposable and reusable; the reusable insulin injection devices circulating on the market are purely mechanical injection pens, and the other is Expensive syringe pumps. Insulin pens, such as Novo pens and Youban pens, have the following disadvantages: dosage setting is troublesome, and the scale needs to be adjusted before each use: rotate the thread structure at the end of the insulin pen to align with the required scale line to set the dose each time. Insulin injection dosage, because most of the patients are elderly people with poor eyesight, and many diabetic patients are accompanied by complications of vision impairment, so the dosage setting before each injection is mainly to align the fine scale lines, which becomes a very difficult task. big difficulty. And once the dose is set incorrectly, it will cause serious consequences. In addition, many elderly people are prone to forgetfulness, which can easily cause the risk of multiple injections.
鉴于对二种产品的分析，了解病人的心声，希望有一种价格能承受和使用方便的注射产品。有一些老年病人，经济差，老眼昏花，看不清注射笔刻度，调整进药量困难，误操作机率大，潜在风险性高，多次误操作会加剧病情。In view of the analysis of the two products and understanding the voice of the patients, it is hoped that there will be an injection product that is affordable and easy to use. There are some elderly patients with poor finances, old eyesight, blurred vision, difficulty in seeing the scale of the injection pen, difficulty in adjusting the dose of medicine, high probability of misuse, high potential risk, and repeated misuse will aggravate the condition.
因此如何依据医嘱按时、精确调整剂量、安全无误地对自己在身体的有效部位进行穿刺和推药是关系到患者能科学、正确地进行治疗，最终达到提高生活质量、保持生命活力和身体康健的大问题。Therefore, how to puncture and push the medicine on the effective part of the body safely and accurately according to the doctor's order is related to the patient's scientific and correct treatment, and finally to improve the quality of life, maintain vitality and physical health. big problem.
发明内容Contents of the invention
本发明要解决的问题是：现有药剂注射用品，特别是胰岛素注射产品大多操作不够精确，患者自行注射存在操作风险，不适于老年群体使用，而且制造成本高，需要提供性能好，易于精确操作，成本低的新产品。The problem to be solved by the present invention is: most of the existing medicament injection products, especially insulin injection products, are not accurate enough to operate, and there are operational risks in patients' self-injection, which is not suitable for use by the elderly, and the manufacturing cost is high. It needs to provide good performance and easy to operate accurately. , new products with low cost.
本发明的技术方案为：一种药剂注射器，其特征是包括电机驱动部分，注射推进部分，注射部分，控制部分和电源部分，及注射器壳体。The technical solution of the present invention is: a medicament injector, which is characterized by comprising a motor drive part, an injection propulsion part, an injection part, a control part, a power supply part, and a syringe housing.
控制部分为微处理器电路板；The control part is a microprocessor circuit board;
电机驱动部分包括：步进电机总成和感应结构，步进电机总成包括定子线圈、磁钢转子和电机轴，控制部分发出脉冲信号至定子线圈，驱动磁钢转子旋转，电机轴与磁钢转子同步旋转，感应结构包括感应盘和光电感应器，感应盘为齿轮状结构，感应盘中心与电机轴固定连接，并与电机轴同步旋转，光电感应器设置在感应盘边缘，其感应光路对应于齿轮状结构的齿的位置，用于监测感应盘的旋转，光电感应器与控制部分电连接；The motor drive part includes: stepping motor assembly and induction structure. The stepping motor assembly includes stator coil, magnetic steel rotor and motor shaft. The control part sends pulse signals to the stator coil to drive the magnetic steel rotor to rotate. The motor shaft and magnetic steel The rotor rotates synchronously. The induction structure includes an induction disk and a photoelectric sensor. The induction disk is a gear-shaped structure. The center of the induction disk is fixedly connected with the motor shaft and rotates synchronously with the motor shaft. The position of the teeth of the gear-like structure is used to monitor the rotation of the induction disc, and the photoelectric sensor is electrically connected to the control part;
注射推进部分包括：螺杆和顶出管，螺杆设置在顶出管内，螺杆和顶出管通过滑配的螺纹连接，将螺杆的旋转转化为顶出管的直线运动；The injection propulsion part includes: a screw and an ejector tube, the screw is set in the ejector tube, and the screw and the ejector tube are connected through a slip-fit thread, which converts the rotation of the screw into the linear motion of the ejector tube;
注射部分包括：注射液总成和注射针，注射液总成包括活塞、药液筒和注射针固定套，活塞设置在药液筒内，并与顶出管连接，注射针固定套与药液筒连为一体，注射针通过注射针固定套固定在药液筒上，并与药液筒连通；The injection part includes: an injection solution assembly and an injection needle. The injection solution assembly includes a piston, a liquid medicine cylinder and an injection needle fixing sleeve. The barrel is connected as a whole, and the injection needle is fixed on the liquid medicine barrel through the injection needle fixing sleeve, and communicated with the liquid medicine barrel;
电机驱动部分的电机轴通过连轴节与螺杆连接，螺杆与电机轴同步旋转，螺杆随电机轴的同步旋转转化为顶出管沿电机轴向的直线运动，活塞随顶出管的移动在药液筒中移动，顶出管的长度不小于活塞在药液筒内的移动行程长度。The motor shaft of the motor drive part is connected to the screw through the coupling joint, the screw and the motor shaft rotate synchronously, the synchronous rotation of the screw with the motor shaft is transformed into the linear motion of the ejector tube along the motor axis, and the piston moves with the ejector tube in the medicine The length of the ejection tube is not less than the moving stroke length of the piston in the liquid cartridge.
做为优选方式，注射推进部分设有顶出管保护套，顶出管在顶出管保护套内滑动，顶出管与活塞之间设有顶出盘，通过顶出盘连接顶出管和活塞。As an optimal method, the injection propelling part is provided with a protective cover of the ejector tube, and the ejector tube slides in the protective cover of the ejector tube, and an ejector plate is provided between the ejector tube and the piston, and the ejector tube and the piston.
优选的，顶出管保护套内侧设有T型槽，顶出管外侧设有与T型槽对应的凸块，所述凸块在T型槽内滑动。Preferably, a T-shaped groove is provided on the inner side of the ejector tube protective sleeve, and a protrusion corresponding to the T-shaped groove is provided on the outer side of the ejector tube, and the protrusion slides in the T-shaped groove.
进一步的，电机驱动部分、注射推进部分，注射部分，控制部分和电源部分均设置在注射器壳体中，注射器壳体为笔型，电机驱动部分，注射推进部分和注射部分设置在同一轴线上，电机驱动部分位于笔型注射器壳体的笔尾端，注射部分位于笔头端，注射部分的注射针伸出注射器壳体，对应设置帽盖，密闭注射针。Further, the motor drive part, the injection propulsion part, the injection part, the control part and the power supply part are all arranged in the syringe housing, the syringe housing is pen-shaped, the motor drive part, the injection propulsion part and the injection part are arranged on the same axis, The motor drive part is located at the tail end of the pen-type syringe casing, the injection part is located at the tip end of the pen, the injection needle of the injection part protrudes from the syringe casing, and a cap is provided correspondingly to seal the injection needle.
注射部分结构具体为：药液筒连接注射针的一端伸出注射器壳体，伸出的部分外设有药液筒护套，帽盖与药液筒护套配合密闭注射针，帽盖中对应注射针设有注射针护套。The specific structure of the injection part is as follows: one end of the liquid medicine cylinder connected to the injection needle protrudes from the syringe housing, and the protruding part is provided with a liquid medicine cylinder sheath, and the cap and the medicine liquid cylinder sheath cooperate to seal the injection needle. The injection needle is provided with an injection needle sheath.
药剂注射器设有显示屏、按键、蜂鸣器和USB接口，显示屏、按键、蜂鸣器和USB接口分别连接控制部分。The medicament injector is provided with a display screen, a key, a buzzer and a USB interface, and the display screen, the key, the buzzer and the USB interface are respectively connected to the control part.
上述药剂注射器的控制方法包括：The control method of the above-mentioned medicament injector comprises:
1)、控制部分的微处理器发出脉冲信号，通过步进电机驱动器来驱动步进电机按设定的方向转动相应的角度及步进角，与步进电机连接的螺杆相应旋转，顶出管在内壁与螺杆相配的螺纹作用下，与螺杆相对轴向位移，推动活塞在药液筒内移动，进而推动药液筒内的药液，步进电机转动的角位移由此转化为活塞的直线位移，由这一线性关系控制胰岛素的注射剂量；1) The microprocessor in the control part sends a pulse signal, and the stepper motor is driven to rotate the corresponding angle and step angle in the set direction through the stepper motor driver, and the screw connected to the stepper motor rotates correspondingly, and the ejector tube Under the action of the threads matching the inner wall and the screw, the relative axial displacement of the screw pushes the piston to move in the liquid medicine cartridge, and then pushes the liquid medicine in the liquid medicine cartridge, and the angular displacement of the stepping motor is transformed into a straight line of the piston. Displacement, the injection dose of insulin is controlled by this linear relationship;
2)、步进电机上设置的感应盘及光电感应器监测电机的转动，感应盘为齿轮状结构，光电感应器设置在感应盘边缘，其感应光路对应于齿轮状结构的齿的位置，由于感应盘随电机同步旋转，电机转动时，感应盘的轮齿间歇性的隔断光电感应器的感应光路，由此而产生和电机转动情况紧密相关的脉冲信号，控制部分根据光电感应器的监测信号判断电机的转动状态，根据当前设定的电机工作状态与光电感应器的监测结果，判断电机是否正常工作，当电机因为异常情况停转、堵转或者异速转动时，进行报警；2) The induction plate and photoelectric sensor installed on the stepping motor monitor the rotation of the motor. The induction plate is a gear-shaped structure, and the photoelectric sensor is arranged on the edge of the induction plate. The induction disc rotates synchronously with the motor. When the motor rotates, the teeth of the induction disc intermittently block the induction light path of the photoelectric sensor, thereby generating a pulse signal closely related to the rotation of the motor. The control part is based on the monitoring signal of the photoelectric sensor. Judging the rotation state of the motor, judging whether the motor is working normally according to the currently set working state of the motor and the monitoring results of the photoelectric sensor, and giving an alarm when the motor stops, stalls or rotates at different speeds due to abnormal conditions;
3)、控制部分连接人机接口，包括显示屏、按键、蜂鸣器和USB接口，显示屏用于注射器状态和注射数据显示，按键用于设定注射器的工作，蜂鸣器用于提醒，USB接口用于与计算机设备连接和充电。3) The control part is connected to the human-machine interface, including display screen, buttons, buzzer and USB interface. The display screen is used to display the status of the syringe and injection data. The interface is used to connect and charge computer equipment.
控制部分的微处理器设有Flash存储器，通过软件方式实现以下控制：The microprocessor in the control part is equipped with Flash memory, and the following control is realized through software:
1)、注射模式设定快捷模式或分时模式：1), injection mode setting shortcut mode or time-sharing mode:
快捷模式下，每次设定完注射剂量的时候，将参数存入Flash存储器中，之后每次注射前如果不重新设置新的注射剂量，就直接从Flash存储器中读取出上一次保存的注射剂量参数，作为当前注射的注射剂量；In the shortcut mode, each time the injection dose is set, the parameters are stored in the Flash memory, and if the new injection dose is not reset before each injection, the last saved injection is directly read from the Flash memory Dose parameter, as the injection dose for the current injection;
分时模式下，对不同时刻设置不同注射剂量值，并设定时间提醒；In time-sharing mode, set different injection dose values at different times, and set time reminders;
2)、存储注射信息，采用FIFO模式实现信息的存储，存储区中保存最近20次的历史注射信息，包括注射开始时刻、注射剂量和注射模式；2) Store injection information, use FIFO mode to store information, save the latest 20 historical injection information in the storage area, including injection start time, injection dose and injection mode;
3)、历史注射数据的浏览，通过按键选择将Flash存储器中存储的信息直接在显示屏上逐条显示出来，或将存储的信息通过USB接口传输到上位机上，在上位机上的软件中进行浏览和查阅；3) To browse the historical injection data, the information stored in the Flash memory can be directly displayed on the display screen one by one by pressing the button, or the stored information can be transmitted to the host computer through the USB interface, and the software on the host computer can be used for browsing and consult;
4)两次注射时间间隔太短则禁止注射，设定注射时间间隔阈值，根据存储的最近一次注射信息，本次注射时间间隔小于阈值则禁止本次注射；4) If the time interval between two injections is too short, the injection is prohibited, and the injection time interval threshold is set. According to the stored latest injection information, if the injection time interval is less than the threshold, this injection is prohibited;
5)设定省电模式，经过设定的时间如果没有操作，注射器进入低功耗状态，以此来节约电量，处在低功耗状态下的控制部分在遇到按键中断的时候跳出低功耗状态，回到正常的工作模式。5) Set the power saving mode. If there is no operation after the set time, the syringe will enter the low power consumption state to save power. The control part in the low power consumption state will jump out of the low power consumption state when it encounters a key interruption. consumption status, back to normal working mode.
药剂注射器设有以下操作提醒方式：The drug syringe has the following operation reminder methods:
1)、当一次注射结束时，控制部分根据光电感应器的监测信号，控制蜂鸣器提示使用者本次注射结束，同时在显示屏显示本次注射的设定剂量，并显示注射结束信息；1) When an injection is over, the control part controls the buzzer to remind the user that the injection is over according to the monitoring signal of the photoelectric sensor, and at the same time displays the set dose of this injection on the display screen, and displays the injection end message;
2)、控制部分根据存储的注射信息，计算药液筒的剩余剂量，当药液筒中的剩余剂量小于本次设定的注射剂量时，蜂鸣器发出警报以提醒使用者更换药液筒；药液筒剂量全部注射完后，控制部分控制电机自动回到初始位置，准备使用新的药液筒的药液进行注射；2) The control part calculates the remaining dose of the liquid medicine cartridge according to the stored injection information. When the remaining dose in the liquid medicine cartridge is less than the injection dose set this time, the buzzer sends out an alarm to remind the user to replace the liquid medicine cartridge; After all the doses of the liquid medicine cartridge are injected, the control part controls the motor to automatically return to the initial position, ready to use the liquid medicine in the new liquid medicine cartridge for injection;
3)、实时监测电池的电压，电压信息通过A/D转换传输到控制部分，当小于设定的阈值时就进行报警，提醒使用者进行充电或更换电池，电池剩余电量低于设定阈值时禁止注射；3) Monitor the voltage of the battery in real time. The voltage information is transmitted to the control part through A/D conversion. When the voltage is lower than the set threshold, an alarm will be issued to remind the user to charge or replace the battery. When the remaining battery power is lower than the set threshold No injections;
4)、设定注射时刻提醒，包括蜂鸣器声音提示和屏幕显示。4) Set the injection time reminder, including buzzer sound prompt and screen display.
本发明由控制部分发出脉冲信号驱动步进电机，再经螺杆、顶出管推动活塞在药瓶内移动，步进电机转动的角位移由此转化为活塞的直线位移，由这一线性关系精确控制胰岛素的注射剂量，传动环节少，精确度高，误差≤0.1U。In the present invention, the control part sends a pulse signal to drive the stepping motor, and then pushes the piston to move in the medicine bottle through the screw rod and the ejector tube, and the angular displacement of the stepping motor is converted into the linear displacement of the piston. This linear relationship is accurate Control the injection dose of insulin, less transmission links, high precision, error ≤ 0.1U.
现有胰岛素注射器都是患者设定好注射量后，注射器进行注射，期间注射器是否正常工作没有明确的提示，由于注射行为的特殊性，是否正确完成了注射不易察觉，特别是药剂瓶不透明的话，患者仅凭自身感觉很难判断注射是否成功。如注射器无传感反馈装置，轻则增加病情，病人还不知何原因，重则有生命危险。本发明特别在注射器中设置了光电感应装置，利用光电感应反馈步进电机运转信息。光电传感器检测到的信号与控制部分发送给步进电机的脉冲信号相对应，则电机运转正常；若光电传感器检测到的信号与发送给步进电机的脉冲信号不匹配，则电机运转异常；没有检测到信号，则表示电机停转；如根据控制部分的设置显示电机工作在异常状态，则发出警示提醒患者，注射器没有正常工作，等于没有用药，以此减少用药隐患。Existing insulin syringes are used after the patient sets the injection volume, and the syringe is injected. During this period, there is no clear reminder whether the syringe is working normally. Due to the particularity of the injection behavior, it is not easy to detect whether the injection is completed correctly, especially if the medicine bottle is opaque. It is difficult for patients to judge whether the injection is successful based on their own feelings. If there is no sensory feedback device in the syringe, it will increase the severity of the disease, and the patient does not know the reason, or it will be life-threatening. In the present invention, a photoelectric induction device is specially arranged in the injector, and the operation information of the stepping motor is fed back by the photoelectric induction. If the signal detected by the photoelectric sensor corresponds to the pulse signal sent by the control part to the stepping motor, the motor is running normally; if the signal detected by the photoelectric sensor does not match the pulse signal sent to the stepping motor, the motor is running abnormally; If the signal is detected, it means that the motor is stopped; if the setting of the control part shows that the motor is working in an abnormal state, a warning will be issued to remind the patient that if the syringe is not working normally, it means that there is no medication, so as to reduce the hidden danger of medication.
本发明螺杆与步进电机通过联轴节相连，减少不必要的传动环节，螺杆与顶出管通过螺纹配合，调整螺纹角度可以调节螺杆将电机轴圆周运动转化为顶出管的轴向直线运动的速度，顶出管螺纹材料采用聚四氟乙烯或聚甲醛等耐磨材料，在运动过程中，几乎是零磨损，所以使用起来寿命长，出现咬牙机率很微小。同时本发明顶出管特意加设了顶出管护套，并设计了T型槽，保证在顶出管沿着护套与电机轴同一轴线上平稳移动，并且防止螺杆旋转带动顶出管同时旋转，完成注射动作。In the present invention, the screw rod and the stepping motor are connected through a coupling to reduce unnecessary transmission links. The screw rod and the ejector pipe are threaded, and the thread angle can be adjusted to adjust the screw rod to convert the circular motion of the motor shaft into the axial linear motion of the ejector pipe. The speed of the ejector pipe thread is made of wear-resistant materials such as polytetrafluoroethylene or polyoxymethylene. During the movement, there is almost zero wear, so the service life is long and the chance of teeth bite is very small. At the same time, the ejector pipe of the present invention is specially provided with an ejector pipe sheath, and a T-shaped groove is designed to ensure that the ejector pipe moves smoothly along the same axis as the sheath and the motor shaft, and prevents the screw from rotating to drive the ejector pipe at the same time. Rotate to complete the injection action.
本发明在控制器上也有诸多改进，实现智能化。本发明通过USB接口和内部Flash的作用，可以记忆患者的注射信息，方便用户查询、使用，同时也方便医生进行跟踪、分析。在软件的智能控制上也极大地考虑患者使用的方便性及安全性。快捷模式直接取代原有纯机械注射器的功能，同时记忆上一次注射剂量值，简单、易于患者操作；分时模式极大的体现智能化控制的特点，拒绝错误设置，一旦设置好参数，智能判定注射条件，通过显示屏提示、声音提示等人机交互方式，避免了患者因记忆力下降、视力不佳而导致的非预期注射事件的发生，使患者能够更好的操作注射器，存储注射信息便于患者查询、使用，多样的提醒极大地保证了注射的安全性。The present invention also has many improvements on the controller to realize intelligence. The invention can memorize the patient's injection information through the function of the USB interface and the internal Flash, which is convenient for the user to inquire and use, and also convenient for the doctor to track and analyze. The convenience and safety of patients are also greatly considered in the intelligent control of the software. The shortcut mode directly replaces the function of the original pure mechanical syringe, and at the same time remembers the last injection dose value, which is simple and easy for patients to operate; the time-sharing mode greatly reflects the characteristics of intelligent control, rejects wrong settings, and once the parameters are set, it can be judged intelligently Injection conditions, through human-computer interaction methods such as display prompts and voice prompts, avoid unexpected injection events caused by memory loss and poor vision, so that patients can better operate the syringe, and the storage of injection information is convenient for patients Inquiry, use, and various reminders greatly ensure the safety of injections.
附图说明Description of drawings
图1为本发明注射器的结构示意图。Fig. 1 is a schematic structural view of the syringe of the present invention.
图2为本发明注射器的电机驱动部分局部放大结构示意图。Fig. 2 is a partially enlarged structural schematic diagram of the motor drive part of the syringe of the present invention.
图3为本发明注射器的注射推进部分局部放大结构示意图。Fig. 3 is a partially enlarged structure schematic diagram of the injection advancing part of the syringe of the present invention.
图4为本发明注射器的注射部分局部放大结构示意图。Fig. 4 is a partially enlarged structural schematic diagram of the injection part of the syringe of the present invention.
图5为本发明注射器电机驱动部分与注射推进部分的连接图。Fig. 5 is a connection diagram of the motor drive part and the injection propulsion part of the syringe of the present invention.
图6为本发明注射推进部分的截面图。Fig. 6 is a sectional view of the injection advancing part of the present invention.
图7为本发明电源部分和控制部分的框图。Fig. 7 is a block diagram of the power supply part and the control part of the present invention.
图8为本发明注射器的操作流程图。Fig. 8 is a flowchart of the operation of the syringe of the present invention.
具体实施方式Detailed ways
本发明提供了一种使用便捷，操作精确的药剂注射器，下面具体说明本发明药剂注射器的结构和其控制方法。The present invention provides a medicament injector that is easy to use and precise in operation. The structure and control method of the medicament injector of the present invention will be described in detail below.
如图1，胰岛素注射器包括电机驱动部分，注射推进部分，注射部分，控制部分和电源部分13，图2-4为各部分的局部当大示意图，其中As shown in Figure 1, the insulin syringe includes a motor drive part, an injection propulsion part, an injection part, a control part and a
控制部分为微处理器；The control part is a microprocessor;
电机驱动部分包括：步进电机22，控制部分发出脉冲信号，通过芯片解码驱动步进电机22的磁钢转子旋转，电机轴21与磁钢转子同步旋转，电机轴21上固定一感应盘23，感应盘23中心设有一个鼓形孔，与电机轴21后端的鼓形部分紧配安装，使感应盘23与电机轴21同步旋转，感应盘23的截面为齿轮形状，光电感应器24设置在感应盘23边缘，其感应光路对应于齿轮状结构的齿的位置，由于感应盘23随步进电机同步旋转，电机转动时，感应盘23的齿轮间歇性的隔断光电感应器24的感应光路，监测感应盘23的旋转，光电感应器24与控制部分电连接；The motor drive part includes: a stepping
注射推进部分包括：螺杆15和顶出管16，螺杆15外和顶出管16内壁设有相互滑配的螺纹，顶出管16与螺杆15通过所述螺纹相对轴向移动，螺杆的旋转转化为顶出管的直线运动，调整所述螺纹角度可以调节顶出管相对螺杆的直线运动的速度；The injection propulsion part includes: a
注射部分包括：注射液总成5，注射针3，注射液总成5包括活塞7、药液筒和注射针固定套4，活塞7设置在药液筒内，并与顶出管16连接，注射针固定套4与药液筒连为一体，注射针3通过注射针固定套4固定在药液筒上，并与药液筒连通；药液注射总成5可以选择现有的市售产品，注射针3是一次性使用的。The injection part includes: an injection
如图5，电机驱动部分的电机轴21通过连轴接20与螺杆15连接，螺杆15与电机轴21同步旋转，螺杆15随电机轴21的同步旋转转化为顶出管16沿电机轴向的直线运动，活塞7位于注射液总成5的药液筒内，随顶出管16的移动在药液筒中移动，顶出管16的长度不小于活塞7在药液筒内的移动行程长度。其中，连轴节20是连接电机轴21与螺杆15的一种软连接的接头，它的内截面是鼓形孔，与螺杆15、电机轴21前端的外截面鼓形状配合。As shown in Figure 5, the motor shaft 21 of the motor drive part is connected to the
注射推进部分设有顶出管保护套17，顶出管16在顶出管保护套17内滑动，顶出管16与活塞7之间设有顶出盘10，以在顶出管16的移动中平稳推动活塞7移动。The injection propelling part is provided with an ejector tube
如图6，顶出管保护套17内侧设有T型槽，顶出管16外侧设有与T型槽对应的凸块，所述凸块在T型槽内滑动。顶出管保护套17结合T型槽和凸块使顶出管16的运动更加稳定，保证注射器的精确工作。As shown in FIG. 6 , a T-shaped groove is provided on the inner side of the ejector tube
做为本发明的一种具体优选实现方式，电机驱动部分、注射推进部分、注射部分、控制部分和电源部分均设置在注射器壳体中，注射器壳体为笔型，电机驱动部分，注射推进部分和注射部分设置在同一轴线上，电机驱动部分位于笔型注射器壳体的笔尾端，注射部分位于笔头端，注射部分的注射针伸出注射器壳体，对应设置帽盖1，密闭注射针；控制部分设置在笔尾端，电源部分13设置在注射推进部分与注射器壳体之间的空隙中，合理的布局使得本发明注射器具有小巧的体积，便于携带。As a specific preferred implementation of the present invention, the motor drive part, the injection propulsion part, the injection part, the control part and the power supply part are all arranged in the syringe housing, the syringe housing is pen-shaped, the motor drive part, the injection propulsion part Set on the same axis as the injection part, the motor drive part is located at the tail end of the pen-type syringe housing, the injection part is located at the tip end, the injection needle of the injection part protrudes out of the syringe housing, and a
注射部分结构具体为：药瓶连接注射针3的一端伸出注射器壳体，伸出的部分外设有药液筒护套6，帽盖1与药液筒护套6配合密闭注射针，帽盖1中对应注射针设有注射针护套2。这样的设计使得本发明注射器可以适应不同长度的注射液总成5，当需要不同规格的注射部分，主要是注射液总成5的药瓶容积不同的情况下，注射器壳体、电机驱动部分，注射推进部分，控制部分和电源部分13可以批量生产，只要对应注射液总成5的药液筒对应配置不同规格的药液筒护套即可。The structure of the injection part is specifically: one end of the medicine bottle connected to the
药剂注射器设有显示屏18、按键9、蜂鸣器和USB接口25，显示屏18、按键9、蜂鸣器和USB接口25分别连接控制部分，同样，为使整个注射器内部结构布局合理，显示屏18和按键9利用注射推进部分与注射器壳体的空隙，设置在与电源部分相对的另一侧，USB接口25设置在控制部分旁。The medicament injector is provided with
显示屏18采用LCD显示屏，按键9采用薄膜按键开关，通过将LCD显示与按键相配合使用，来实现菜单式显示，记下每级菜单的层标，然后通过按键来转向需要的那一层，从而实现菜单式显示。The
LCD状态屏幕显示内容：LCD status screen display content:
(1)电池的实时电量；(1) The real-time power of the battery;
(2)胰岛素药液筒剩余剂量；(2) The remaining dose of the insulin solution cartridge;
(3)当前注射剂量动态显示；(3) Dynamic display of the current injection dose;
(4)当前模式状态；(4) Current mode status;
(5)已注射次数；(5) Number of injections;
(6)日期和时间。(6) Date and time.
选用的LCD尺寸为128×32，将其上半部分作为状态显示栏，下半部分作为菜单栏。通过监测电池容量和胰岛素药液筒剩余剂量，可以在LCD屏上来实时显示这些信息。通过读取单片机内部的实时时钟，可以将当前的日期和时间显示在LCD屏上。当正在进行注射时在LCD屏上实时动态显示注射，告诉使用者此时正在进行注射。每完成一次注射就会将注射时间和剂量等相关信息存在Flash中，并可以通过菜单中“回顾”项来查看这些历史信息。The size of the selected LCD is 128×32, the upper part is used as the status display bar, and the lower part is used as the menu bar. By monitoring the battery capacity and the remaining dose of the insulin cartridge, this information can be displayed in real time on the LCD screen. By reading the real-time clock inside the microcontroller, the current date and time can be displayed on the LCD screen. When the injection is in progress, the injection is dynamically displayed on the LCD screen in real time, telling the user that the injection is in progress at this time. Every time an injection is completed, relevant information such as injection time and dose will be stored in Flash, and these historical information can be viewed through the "Review" item in the menu.
按键9设定的内容包括：实时时钟、注射剂量、注射次数及每次的注射时刻，菜单共有时间、剂量和回顾三个选项，其中剂量选项下有一个二级菜单，二级菜单的内容为快捷模式和分时模式，与菜单显示配合的按键有四个，分别是“退出(ESC)”、“确认(ACT)”、“上翻(UP)”、“下翻(DOWN)”，通过这四个按键的配合和LCD屏上的对应提示，可以进行设定系统实时时钟，注射剂量(快捷模式和最多五个时刻点的分时模式所对应的剂量设置)，通过菜单中“回顾”选项可以浏览之前注射的相关信息。The content set by
本发明注射器通过控制部分进行控制，个电控模块框图如图7所示，整个注射器中涉及的电控部分主要由微处理器MCU、按键模块、点阵式LCD显示器，电机驱动单元，光电开关监测单元，蜂鸣器报警单元，USB接口单元，电量监测单元，存储单元，实时时钟RTC单元，可充电锂电池以及电源模块组成。The injector of the present invention is controlled by the control part, and the block diagram of an electric control module is shown in Figure 7. The electric control part involved in the whole injector is mainly composed of a microprocessor MCU, a key module, a dot matrix LCD display, a motor drive unit, and a photoelectric switch. Monitoring unit, buzzer alarm unit, USB interface unit, power monitoring unit, storage unit, real-time clock RTC unit, rechargeable lithium battery and power supply module.
其中微处理器MCU为系统的核心，它由低功耗高性能处理器MSP430F5437构成，用来完成胰岛素注射剂量的精确设定、注射信息的存贮和显示，驱动步进电机完成注射器的准确推药，出现异常情况报警处理；按键模块和点阵式LCD构成了整个系统的人机交互部分，由人机交互单元完成实时时钟的设置，胰岛素注射模式和注射剂量的设置，点阵式LCD采用菜单化的操作模式，对注射器相关信息进行显示，以及各种提示和报警信息等；电机驱动单元主要由电机驱动芯片A3901构成，用来提供足够的驱动电流，驱动步进电机按照要求的速度转动；实时时钟RTC为MCU内部单元，为整个系统工作提供一个时间基准；存储单元为MCU内部Flash，用来保存一些设置参数和注射信息；蜂鸣器报警电路主要用来进行注射结束事件的声音提示和异常情况的声音报警；光电开关监测单元主要用于电机转动状态的反馈监测，当出现堵转和停转等异常情况时，及时通知MCU进行异常情况处理；电量监测单元由MCU的A/D通道实时采集锂电池的电压，当电压低于设定的阈值时，进行低电量报警；USB接口单元用于胰岛素注射器与上位机之间进行数据传输，将胰岛素注射器中保存的历史注射信息传输到上位机中，同时还可以利用USB接口给锂电池充电；可充电锂电池为整个系统提供能量，锂电池输出的电压经电源模块TP63031稳压为3.3V，为系统的各个部分提供一个稳定的工作电压。Among them, the microprocessor MCU is the core of the system, which is composed of a low-power high-performance processor MSP430F5437, which is used to complete the precise setting of insulin injection dose, storage and display of injection information, and drive the stepping motor to complete the accurate push of the syringe. The human-computer interaction part of the whole system is formed by the button module and the dot-matrix LCD. The menu-based operation mode displays the relevant information of the syringe, as well as various prompts and alarm information, etc.; the motor drive unit is mainly composed of a motor drive chip A3901, which is used to provide sufficient drive current to drive the stepper motor to rotate at the required speed ;The real-time clock RTC is the internal unit of the MCU, which provides a time reference for the whole system; the storage unit is the internal Flash of the MCU, which is used to save some setting parameters and injection information; the buzzer alarm circuit is mainly used for the voice prompt of the injection end event and sound alarm for abnormal situations; the photoelectric switch monitoring unit is mainly used for feedback monitoring of motor rotation status, and when abnormal situations such as stalling and stalling occur, the MCU will be notified in time to handle the abnormal situation; the power monitoring unit is controlled by the A/D of the MCU The channel collects the voltage of the lithium battery in real time, and when the voltage is lower than the set threshold, a low battery alarm is issued; the USB interface unit is used for data transmission between the insulin syringe and the host computer, and transmits the historical injection information saved in the insulin syringe to the In the upper computer, the USB interface can also be used to charge the lithium battery at the same time; the rechargeable lithium battery provides energy for the entire system, and the output voltage of the lithium battery is regulated to 3.3V by the power module TP63031, providing a stable work for each part of the system Voltage.
本发明可采用单节锂电池供电，通过DC/DC模块TPS63031将锂电池的输出电压转换为3.3V的直流电压，给微处理器，LCD以及步进电机驱动器以及步进电机等单元供电。利用通用的USB接口，采用电池充电管理芯片BQ24072进行控制和管理，可以对锂电池进行充电，控制器MSP430F5437监控整个充电的过程，LCD屏幕上动态显示锂电池的充电状态和实时电量，充电结束后，LCD屏幕给出充电结束的文字提示。The present invention can be powered by a single-cell lithium battery, and the output voltage of the lithium battery is converted into a 3.3V DC voltage through the DC/DC module TPS63031, and supplies power to units such as a microprocessor, an LCD, a stepping motor driver, and a stepping motor. The lithium battery can be charged by using the general-purpose USB interface and using the battery charging management chip BQ24072 for control and management. The controller MSP430F5437 monitors the entire charging process, and the LCD screen dynamically displays the charging status and real-time power of the lithium battery. , the LCD screen gives a text prompt of the end of charging.
如图8，为本发明注射器的操作流程图，药剂注射器的控制方法包括：As shown in Figure 8, it is an operation flowchart of the injector of the present invention, and the control method of the medicament injector includes:
1)、控制部分的微处理器发出脉冲信号，本发明中使用的微处理器为TI公司的MSP430F5437，通过步进电机驱动器来驱动步进电机按设定的方向转动相应的角度及步进角，与步进电机连接的螺杆相应旋转，顶出管在内壁与螺杆相配的螺纹作用下，与螺杆相对轴向位移，推动活塞在药液筒内移动，进而推动药液筒内的药液，步进电机转动的角位移由此转化为活塞的直线位移，由这一线性关系控制胰岛素的注射剂量；1), the microprocessor of control part sends pulse signal, and the microprocessor used in the present invention is the MSP430F5437 of TI company, drives stepper motor to rotate corresponding angle and step angle by the direction of setting by stepper motor driver , the screw connected with the stepping motor rotates accordingly, and under the action of the threads matching the screw on the inner wall of the ejector tube, it is axially displaced relative to the screw, pushing the piston to move in the liquid medicine cylinder, and then pushes the liquid medicine in the liquid medicine cylinder, The angular displacement of the stepper motor is converted into the linear displacement of the piston, and the injection dose of insulin is controlled by this linear relationship;
2)、步进电机上设置的感应盘及对应设置的光电感应器监测电机的转动，由于感应盘随电机同步旋转，控制部分根据光电感应器的监测信号判断电机的转动状态，根据当前设定的电机工作状态与光电感应器的监测结果，判断电机是否正常工作，当电机因为异常情况停转或者堵转时，进行报警；感应盘的截面为齿轮形状，光电感应器的感应光路对应齿的位置，光电感应器工作时，一直有连续不断的光信号发出穿过感应盘齿型处，如信号不间断感应则表示感应盘不在旋转，也就是电机轴不运转，反之光电感应器信号有间断反馈，则是被感应盘时挡时通，表示感应盘在旋转，也就是电机轴与螺杆在旋转，螺杆旋转带动顶出杆在顶出杆护套内向前移动，推进药液筒内活塞，活塞挤压药液通过注射针进入人体，完成用药过程。如注射过程中由于故障，电机停转，则光电感应器感应不到感应盘旋转，光电感应器无均匀间断信号反馈到系统，系统则根据设定的程序，报警提示病人，注射动作没有正常完成。如注射器在进行注射动作表现为螺杆匀速在旋转，同理电机轴在匀速旋转，带动感应盘匀速旋转，则光电感应器感应到均匀的间断信号，反馈到控制系统的芯片，芯片会根据输入的程序，判断注射运作正常，不发出警报提示。2) The induction disk set on the stepping motor and the corresponding photoelectric sensor monitor the rotation of the motor. Since the induction disk rotates synchronously with the motor, the control part judges the rotation state of the motor according to the monitoring signal of the photoelectric sensor. According to the current setting The working state of the motor and the monitoring results of the photoelectric sensor can determine whether the motor is working normally. When the motor stops or is blocked due to abnormal conditions, an alarm will be given; the cross section of the induction disc is in the shape of a gear, and the induction optical path of the photoelectric sensor corresponds to the tooth. Position, when the photoelectric sensor is working, there will always be continuous light signals passing through the tooth profile of the induction disc. If the signal is continuously sensed, it means that the induction disc is not rotating, that is, the motor shaft is not rotating, otherwise the signal of the photoelectric sensor is intermittent. Feedback means that the induction disc is turned on and off, indicating that the induction disc is rotating, that is, the motor shaft and the screw are rotating, and the rotation of the screw drives the ejector rod to move forward in the ejector rod sheath, pushing the piston in the liquid medicine cylinder, The piston extrudes the liquid medicine and enters the human body through the injection needle to complete the medication process. If the motor stops due to a fault during the injection process, the photoelectric sensor cannot detect the rotation of the induction disc, and the photoelectric sensor has no uniform intermittent signal feedback to the system, and the system will alarm and remind the patient according to the set program that the injection action has not been completed normally. . If the injector is performing an injection action, the screw is rotating at a constant speed. Similarly, the motor shaft is rotating at a constant speed, driving the induction disc to rotate at a constant speed. The photoelectric sensor senses a uniform intermittent signal and feeds it back to the chip of the control system. program, judging that the injection is functioning normally, and not issuing an alarm prompt.
3)、控制部分连接人机接口，包括显示屏、按键、蜂鸣器和USB接口，显示屏用于注射器状态和注射数据显示，按键用于设定注射器的工作，蜂鸣器用于提醒，USB接口用于与计算机设备连接和充电。3) The control part is connected to the human-machine interface, including display screen, buttons, buzzer and USB interface. The display screen is used to display the status of the syringe and injection data. The interface is used to connect and charge computer equipment.
控制部分的微处理器设有Flash存储器，并能智能化判断注射条件，进行以下操作：The microprocessor in the control part is equipped with a Flash memory, and can intelligently judge the injection conditions, and perform the following operations:
1)、注射模式设定快捷模式或分时模式：1), injection mode setting shortcut mode or time-sharing mode:
快捷模式下，每次设定完注射剂量的时候，将参数存入Flash存储器中，之后每次注射前如果不重新设置新的注射剂量，就直接从Flash存储器中读取出上一次保存的注射剂量参数，作为当前注射的注射剂量；In the shortcut mode, each time the injection dose is set, the parameters are stored in the Flash memory, and if the new injection dose is not reset before each injection, the last saved injection is directly read from the Flash memory Dose parameter, as the injection dose for the current injection;
分时模式下，对不同时刻设置不同注射剂量值，并设定闹铃时间提醒；In the time-sharing mode, set different injection dosage values at different times, and set the alarm time reminder;
快捷模式完全取代现有纯机械式胰岛素注射器的功能，设定剂量即可进行注射，方便使用；分时模式根据病人的不同饮食习惯设定单日内最多五个时刻点的不同注射剂量满足患者不同进食状态下对不同剂量的胰岛素的需求；The shortcut mode completely replaces the function of the existing purely mechanical insulin injector, and the injection can be performed after setting the dose, which is convenient to use; the time-sharing mode can set different injection doses at up to five time points in a single day according to the different eating habits of the patient to meet the needs of different patients. The need for different doses of insulin in the fed state;
特别是分时模式下，智能判断设定值的有效性，错误的设定，如两次注射时间过短，闹铃的时间远远超出注射时刻有效作用区段等，将被禁止也不会被保存至Flash中。完成有效的设定后，不同时刻注射时自动选择相应剂量，未到注射时刻有效区段时禁止注射，同时禁止相同时间段内的连续注射；Especially in the time-sharing mode, intelligently judge the validity of the set value, wrong settings, such as the two injection time is too short, the alarm time is far beyond the effective range of the injection time, etc., will be prohibited and will not Saved to Flash. After the effective setting is completed, the corresponding dose will be automatically selected when injecting at different times, and the injection is prohibited when the injection time is not valid, and the continuous injection within the same time period is prohibited at the same time;
2)、存储注射信息，采用FIFO模式实现信息的存储，存储区中保存最近20次的历史注射信息，包括注射开始时刻、注射剂量；2) Store injection information, use FIFO mode to store information, save the latest 20 historical injection information in the storage area, including injection start time and injection dose;
3)、历史注射数据的浏览，通过按键选择将Flash存储器中存储的信息直接在显示屏上逐条显示出来，或将存储的信息通过USB接口传输到上位机上，在上位机上的软件中进行浏览和查阅；3) To browse the historical injection data, the information stored in the Flash memory can be directly displayed on the display screen one by one by pressing the button, or the stored information can be transmitted to the host computer through the USB interface, and the software on the host computer can be used for browsing and consult;
4)考虑到药效和安全等问题，两次注射时间间隔过短会对身体产生不利的影响，因此两次注射时间间隔太短则禁止注射，设定注射时间间隔阈值，根据存储的最近一次注射信息，本次注射时间间隔小于阈值则禁止本次注射；4) Considering issues such as drug efficacy and safety, if the time interval between two injections is too short, it will have adverse effects on the body. Therefore, if the time interval between two injections is too short, injections are prohibited. Set the threshold value of the injection time interval. According to the latest stored Injection information, if the injection time interval is less than the threshold, the injection is prohibited;
5)设定省电模式，经过设定的时间如果没有操作，注射器进入低功耗状态，以此来节约电量，处在低功耗状态下的控制部分在遇到按键中断的时候跳出低功耗状态，回到正常的工作模式。5) Set the power saving mode. If there is no operation after the set time, the syringe will enter the low power consumption state to save power. The control part in the low power consumption state will jump out of the low power consumption state when it encounters a key interruption. consumption status, back to normal working mode.
注射器设有以下操作提醒方式：The syringe has the following operation reminder methods:
1)、注射过程中检测电机转动情况，一旦出现停转、堵转、异速转动，电机停止转动，并发出蜂鸣器警报；1) Detect the rotation of the motor during the injection process. Once stalled, blocked, or rotated at different speeds, the motor will stop rotating and a buzzer will sound an alarm;
2)、当一次注射结束时，控制部分根据光电感应器的监测信号，控制蜂鸣器提示使用者本次注射结束，同时在显示屏显示本次注射的设定剂量，并显示注射结束；2) When an injection is over, the control part controls the buzzer to remind the user that the injection is over according to the monitoring signal of the photoelectric sensor, and at the same time displays the set dose of this injection on the display screen, and indicates that the injection is over;
3)、控制部分根据存储的注射信息，计算药液筒的剩余剂量，当药液筒中的剩余剂量小于本次设定的注射剂量时，蜂鸣器发出警报以提醒使用者更换药液筒；药液筒剂量全部注射完后，控制部分控制电机自动回到初始位置，准备使用新的药液筒的药液进行注射；3) The control part calculates the remaining dose of the liquid medicine cartridge according to the stored injection information. When the remaining dose in the liquid medicine cartridge is less than the injection dose set this time, the buzzer sends out an alarm to remind the user to replace the liquid medicine cartridge; After all the doses of the liquid medicine cartridge are injected, the control part controls the motor to automatically return to the initial position, ready to use the liquid medicine in the new liquid medicine cartridge for injection;
4)、实时监测电池的电压，电压信息通过A/D转换传输到控制部分，当小于设定的阈值时就进行报警，提醒使用者进行充电或更换电池，电池剩余电量低于设定阈值时禁止注射；4) Monitor the voltage of the battery in real time. The voltage information is transmitted to the control part through A/D conversion. When the voltage is lower than the set threshold, an alarm will be issued to remind the user to charge or replace the battery. When the remaining battery power is lower than the set threshold No injections;
5)、设定注射时刻提醒，包括蜂鸣器声音提示和屏幕显示。5) Set the injection time reminder, including buzzer sound prompt and screen display.
6)、设定剂量、时间等不符合既定规则时，通过显示屏显示错误提示，并且放弃保存当前设置的参数，所述既定规则可以是预先在注射器中设置的警告阈值，或是用户在之前的剂量、时间设置；6) When the set dose, time, etc. do not conform to the established rules, an error prompt will be displayed on the display screen, and the parameters currently set will be abandoned. dosage and time setting;
7)、注射时刻未到，或者试图在规定时间段内连续注射时，注射将被禁止，并在显示屏上显示警示信息。7) When the time for injection is not up, or if continuous injection is attempted within the specified time period, the injection will be prohibited and a warning message will be displayed on the display.
Claims (7)
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| CN2010102007261ACN101862489B (en) | 2010-06-13 | 2010-06-13 | Medicament injector |
| PCT/CN2011/075659WO2011157209A1 (en) | 2010-06-13 | 2011-06-13 | Medicine injector, control methods and driving assembly thereof |
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