CN201299646Y - System of non-invasive fixed micro device inside human esophagus - Google Patents
System of non-invasive fixed micro device inside human esophagus Download PDFInfo
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技术领域 technical field
本实用新型涉及医疗器械,尤其涉及食道疾病诊断和治疗用医疗器械,特别涉及一种食道内无创固定体内微型装置的系统。The utility model relates to a medical device, in particular to a medical device for diagnosing and treating esophageal diseases, in particular to a system for non-invasively fixing micro devices in the esophagus.
背景技术 Background technique
随着人们的生活节奏加快与饮食结构的不断改变,消化道功能性疾病的发病率日趋升高到第一位,其中常见食道疾病有反流性食道炎、食道癌、食道狭窄、食道静脉曲张、消化不良、功能性吞咽困难等等,给人们身心带来了痛苦。医学诊断和治疗过程中,往往需要对食道内特定立体空间进行连续监测或治疗,比如:对反流性食道炎的鉴别,是否存在酸反流或者碱反流,反流的程度如何;针对食道疾病,进行持续的电刺激、释药等治疗等;尤其是食道手术后,需要了解手术效果,是否存在排异反应,器官功能是否恢复正常,更需要进行长期的监测。With the acceleration of people's life rhythm and the continuous change of diet structure, the incidence of digestive tract functional diseases is increasing to the first place, among which common esophageal diseases include reflux esophagitis, esophageal cancer, esophageal stricture, esophageal varicose veins , indigestion, functional dysphagia, etc., have brought pain to people physically and mentally. In the process of medical diagnosis and treatment, continuous monitoring or treatment of specific three-dimensional space in the esophagus is often required, such as: identification of reflux esophagitis, whether there is acid reflux or alkali reflux, and the degree of reflux; for esophagus For diseases, continuous electrical stimulation, drug release and other treatments are carried out; especially after esophageal surgery, it is necessary to understand the effect of the surgery, whether there is rejection, whether the organ function returns to normal, and long-term monitoring is required.
现在已经有很多食道的诊断和治疗技术,比如纤维胃镜、电子胃镜、超声内镜等推进式上消化道内窥镜,能够进入食道内,观察病变区域的图像情况,可以进行采样、切除等治疗,由于耐受性差,不适合进行长时间的操作。现有技术还包括导管式的生理参数监测仪,比如导管式pH计、导管式测压计、导管式胆红素计等监测手段,这些技术均需导管留置,使人感觉痛苦、难堪,无法进食,也难以长时间使用。Now there are many diagnosis and treatment technologies for the esophagus, such as fiber-optic gastroscopy, electronic gastroscopy, ultrasonography and other push-type upper gastrointestinal endoscopes, which can enter the esophagus to observe the image of the lesion area, and can perform sampling, resection and other treatments. Not suitable for prolonged operations due to poor tolerance. The prior art also includes catheter-type physiological parameter monitors, such as catheter-type pH meters, catheter-type manometers, catheter-type bilirubin meters and other monitoring methods. These technologies all require catheter indwelling, which makes people feel painful, embarrassed, unable to It is hard to use it for a long time without eating, too.
近来,各种各样的无线电遥测技术已经被创造应用。专利ZL200410021933.5、ZL02137054.0、US2003191430中描述了几种胶囊状的体内微型装置,经吞服后,随消化道蠕动而运动,能够完成监测消化道内的图像、酸碱度、压力等参数,数据利用射频传输到体外的小型接收器,但是,由于这些胶囊状的体内微型装置位置无法固定,同样无法对特定立体空间进行长期监测。Recently, various radio telemetry techniques have been created and used. Patents ZL200410021933.5, ZL02137054.0, and US2003191430 describe several capsule-shaped micro-devices in the body. After being swallowed, they move with the peristalsis of the digestive tract and can monitor parameters such as images, pH, and pressure in the digestive tract. Radio frequency transmission to small receivers outside the body, however, because the position of these capsule-shaped micro-devices in the body cannot be fixed, it is also impossible to monitor a specific three-dimensional space for a long time.
专利US6285897描述了一种远程监视人体腔道内生理参数的方法,将包含生理参数传感器监视器固定到腔道壁,其中所述的监视器固定到所述的壁上采用的固定方法由以下的一种或几种物品组成:钉、针、钩、倒钩、夹子或者其他的至少部分探入所述腔道壁的黏膜内的物品。专利US6689056中提到一种在人体表面组织上固定一个装置的方法,该装置的壳体上有个凹腔和插针,由一个引导设备运送这个装置到某一位置,使空腔临近固定位置的表面组织,将人体组织抽到凹腔内,推动插针穿透组织,将器件固定在该位置上。以上所述的固定方式均是有创伤的,病人耐受性差,而且容易产生感染风险。The patent US6285897 describes a method for remotely monitoring physiological parameters in the human body cavity. The monitor containing the sensor of the physiological parameter is fixed to the wall of the cavity, and the fixing method adopted by the monitor on the wall is as follows: One or more items: nails, needles, hooks, barbs, clips or other items that at least partially penetrate into the mucosa of the cavity wall. Patent US6689056 mentions a method for fixing a device on the surface tissue of the human body. The housing of the device has a cavity and pins, and the device is transported to a certain position by a guiding device, so that the cavity is close to the fixed position The surface tissue of the device is drawn into the cavity, and the needle is pushed through the tissue to fix the device in place. The fixation methods mentioned above are all traumatic, poorly tolerated by patients, and prone to risk of infection.
本领域的人员可知,食道是连接咽部和胃的肌性管道,食道壁由粘膜、粘膜下层、肌层和外膜四层组织构成,食道壁上有较多粘液,因此表面光滑。在吞咽唾液或者食物过程中,食道由平滑肌层顺序舒缩的移行性波状运动,蠕动波产生一定的收缩力,因此要在食道内固定一个体内微型装置,必须能够克服自身的重力以及吞咽产生的推力,而且考虑到长期操作的需要,该技术最好是无痛无创、不影响日常生活,现有的技术都难以实现。Those skilled in the art know that the esophagus is a muscular conduit connecting the pharynx and the stomach, and the esophagus wall is composed of four layers of tissue: mucosa, submucosa, muscular layer, and adventitia. There is a lot of mucus on the esophagus wall, so the surface is smooth. In the process of swallowing saliva or food, the esophagus moves in a migratory wave-like motion in which the smooth muscle layer contracts sequentially, and the peristaltic wave produces a certain contraction force. Therefore, to fix a micro-device in the esophagus, it must be able to overcome its own gravity and the force generated by swallowing. Thrust, and considering the needs of long-term operation, the technology should preferably be painless, non-invasive, and not affect daily life, which is difficult to achieve with existing technologies.
发明内容 Contents of the invention
针对现有技术的不足,本实用新型的目的在于提供一种在食道内特定位置无创固定体内微型装置的系统,根据临床需要,该体内微型装置用来监测食道内的生理参数,或者也可以执行食道内电刺激或者释药,定位精确、操作安全。In view of the deficiencies in the prior art, the purpose of this utility model is to provide a system for non-invasively fixing micro-device in the esophagus at a specific position. According to clinical needs, the micro-device in the body is used to monitor the physiological parameters in the esophagus, or it can also perform Electrical stimulation or drug release in the esophagus, precise positioning and safe operation.
为实现本实用新型目的而采用的技术方案是这样的,即一种食道内无创固定体内微型装置的系统,包括体外磁场定位装置和体内微型装置;所述体外磁场定位装置包括永磁体及其定位载体,所述定位载体包括对永磁体的固定,及携带永磁体在人体特定部位上的定位;所述体内微型装置包括外壳、功能模块和永磁体,其中:功能模块和永磁体由外壳密封;体外磁场定位装置通过永磁体产生对体内微型装置内的永磁体的磁力吸引,完成对体内微型装的定位。The technical solution adopted to achieve the purpose of the utility model is as follows, that is, a system for non-invasively fixing micro-device in the esophagus, including an external magnetic field positioning device and a micro-device inside the body; the external magnetic field positioning device includes a permanent magnet and its positioning The carrier, the positioning carrier includes the fixing of the permanent magnet, and the positioning of the permanent magnet on a specific part of the human body; the micro-device in the body includes a shell, a functional module and a permanent magnet, wherein: the functional module and the permanent magnet are sealed by the shell; The external magnetic field positioning device generates magnetic attraction to the permanent magnet in the micro-device in the body through the permanent magnet, and completes the positioning of the micro-device in the body.
食道特定部位的所述体外磁场定位装置能够对食道指定区域的立体空间产生稳定的梯度磁场,体外磁场定位装置外部的磁场强度不超过100高斯;其永磁体的材料可以是钕铁硼、铝镍钴或者其他高磁能积参数的永磁材料中的一种,磁能积大于20MGOe;所述定位载体采用能够将永磁体固定在人体躯干上半部的、具有弹性的背心状固定带,或弹性的交叉状捆绑带。The external magnetic field positioning device at a specific part of the esophagus can generate a stable gradient magnetic field in the three-dimensional space of the designated area of the esophagus, and the magnetic field strength outside the external magnetic field positioning device does not exceed 100 gauss; the material of the permanent magnet can be NdFeB, AlNi One of cobalt or other permanent magnet materials with high magnetic energy product parameters, the magnetic energy product is greater than 20MGOe; the positioning carrier adopts an elastic vest-shaped fixing belt that can fix the permanent magnet on the upper half of the human torso, or an elastic Cross straps.
所述体内微型装置的外壳的材料是与人体内部组织相容的医用高分子塑料,具有疏水特性,不容易粘附溶液和食物残渣;外壳外径小于食道的内径,呈扁平胶囊状结构,具有与食道壁接触的相对平整壳体附着侧面,该外壳侧面与内嵌永磁体平行,其他外壳部分采用流线型外观;其永磁体的材料为钕铁硼、铝镍钴或者其他高磁能积参数的磁性材料,磁能积大于20MGOe;永磁体是片状结构,充磁方向为厚度方向。The material of the shell of the micro-device in the body is a medical polymer plastic compatible with the internal tissue of the human body, which has hydrophobic properties and is not easy to adhere to solution and food residue; The side of the relatively flat shell in contact with the esophageal wall is attached, the side of the shell is parallel to the embedded permanent magnet, and the other shell parts adopt a streamlined appearance; the material of the permanent magnet is NdFeB, AlNiCo or other magnetic materials with high energy product parameters Material, the magnetic energy product is greater than 20MGOe; the permanent magnet is a sheet structure, and the magnetization direction is the thickness direction.
为了防止体内微型装置在吞咽后立即脱落到胃内,也便于精确定位,在所述体内微型装置的外壳上具有与壳体内不连通的穿孔,便于将所述体内微型装置穿在拉线上,根据拉线的长度确定其进入体内,如食道内的位置,定位后,撤去或吞咽拉线。In order to prevent the micro-device in the body from falling off into the stomach immediately after swallowing, and to facilitate accurate positioning, the shell of the micro-device in the body has a perforation that is not connected to the inside of the shell, so that the micro-device in the body can be threaded on a pull wire, according to The length of the pullwire determines where it enters the body, such as the esophagus, and after positioning, the pullwire is removed or swallowed.
为了实现临床应用需要,所述功能模块内含有至少一种生理参数传感器或者执行器。比如,为了实现生理参数监测功能,所述功能模块内应含有至少一种传感器,监测的参数包括并不限于以下种类:图像、温度、压力、pH值、阻抗、酶、葡萄糖、胆红素、肌氨酸酐、血液尿素氮、尿氮、肾素、血管紧缩素、特定离子(如钠、钾、钙、碳酸盐、磷酸盐等)等等;为了实现治疗用途,体内微型装置应能够完成预定的动作或者根据体外控制器的命令执行相应操作,比如:电刺激、超声诊断、电磁波,或者进行组织采样、释放药物等功能。In order to meet the needs of clinical applications, the functional module contains at least one physiological parameter sensor or actuator. For example, in order to realize the physiological parameter monitoring function, the functional module should contain at least one sensor, and the monitored parameters include but are not limited to the following types: image, temperature, pressure, pH value, impedance, enzyme, glucose, bilirubin, muscle Amino acid anhydride, blood urea nitrogen, urine nitrogen, renin, angiotensin, specific ions (such as sodium, potassium, calcium, carbonate, phosphate, etc.); in order to achieve therapeutic purposes, micro-device in the body should be able to complete the predetermined Actions or perform corresponding operations according to the commands of the external controller, such as: electrical stimulation, ultrasonic diagnosis, electromagnetic waves, or tissue sampling, drug release and other functions.
基于上述结构,本实用新型公开一种在食道内无创固定体内微型装置的方法,如图1所示,在人体躯干上固定一个体外磁场定位装置,所述体外磁场定位装置能够在食道指定位置产生稳定的具有一定磁场梯度的静磁场;内嵌永磁体的胶囊状体内微型装置2外部结构按照流线型设计,患者自行吞服所述体内微型装置进入食道,当到达食道的所述梯度磁场范围时,体内微型装置在磁场作用下,体内微型装置会贴紧食道壁;在吞咽唾液或者食物过程中,粘液或者流质食物会对体内微型装置造成冲击,而流线型的外壳设计能够实现最小的冲击力;体内微型装置受到冲击后,会偏离平衡点,向胃的方向下滑,由于梯度磁场在向胃部移动的方向上,磁场强度会逐渐增大,而且方向均指向平衡点,对体内微型装置的吸引力加大,能够抵消流质食物或者粘液造成的冲击,并在吞咽动作结束后逐渐回到平衡位置,实现了在食道内无创固定体内微型装置的目的。如果不需要继续固定体内微型装置,只要将体外磁场定位装置取走,体内微型装置就会从食道壁滑落,经消化道自然排出。该装置结构简单、操作方便,对人体无损害,体内微型装置为一次性使用,避免交叉感染的风险。Based on the above structure, the utility model discloses a method for non-invasively fixing micro-device in the esophagus. As shown in Figure 1, an external magnetic field positioning device is fixed on the human trunk, and the external magnetic field positioning device can generate A stable static magnetic field with a certain magnetic field gradient; the external structure of the capsule-shaped internal micro-device 2 embedded with permanent magnets is designed in a streamlined shape, and the patient swallows the internal micro-device and enters the esophagus. When it reaches the range of the gradient magnetic field in the esophagus, Under the action of a magnetic field, the micro-device in the body will stick to the wall of the esophagus; in the process of swallowing saliva or food, mucus or liquid food will impact the micro-device in the body, and the streamlined shell design can achieve the smallest impact; After the micro-device is impacted, it will deviate from the balance point and slide towards the stomach. Since the gradient magnetic field moves in the direction of the stomach, the magnetic field strength will gradually increase, and the direction is all pointing to the balance point. The attraction of the micro-device in the body Increased size can offset the impact caused by liquid food or mucus, and gradually return to the equilibrium position after swallowing, realizing the purpose of non-invasively fixing the micro-device in the esophagus. If there is no need to continue to fix the micro-device in the body, as long as the external magnetic field positioning device is removed, the micro-device in the body will slide down from the wall of the esophagus and be naturally discharged through the digestive tract. The device has a simple structure, is convenient to operate, has no damage to the human body, and the micro-device in the body is for one-time use, thereby avoiding the risk of cross-infection.
由解剖知识和放射检查可知,食道基本上处于躯干的上中部,同一个人在空腹、饱食、站立、行走、睡卧等不同进食状态、不同体态的情况下,食道会相对人体躯干会产生一定的相对位移,而体外磁场定位装置和人体躯干相对位置固定,因此,体内微型装置会和食道的相对位置也会有一定的相对位移,临床应用过程中应考虑这一因素。为了保证系统使用的安全性、可靠性、舒适性,需要解决以下关键问题:It can be known from anatomical knowledge and radiological examination that the esophagus is basically located in the upper middle of the trunk. When the same person is fasting, full, standing, walking, sleeping and lying down in different eating states and different postures, the esophagus will have certain changes relative to the human trunk. The relative displacement of the external magnetic field positioning device and the human torso is fixed. Therefore, the relative position of the micro-device in the body and the esophagus will also have a certain relative displacement. This factor should be considered in the clinical application process. In order to ensure the safety, reliability and comfort of the system, the following key issues need to be resolved:
1.体内微型装置设计要求:外壳大小要合适,避免嵌顿,采用医用材料并牢固密封,耐酸碱腐蚀;吞咽唾液或者食物时,对体内微型装置的冲击力越小越好;与食道壁的接触面积不能太小,减小对食道的压强。1. Design requirements for the micro-device in the body: the size of the shell should be appropriate to avoid incarceration, use medical materials and be firmly sealed, and be resistant to acid and alkali corrosion; when swallowing saliva or food, the impact on the micro-device in the body should be as small as possible; The contact area should not be too small to reduce the pressure on the esophagus.
2.内嵌小永磁体:受体内微型装置总体的结构、重量限制,需要选用高磁能积参数的材料,并且合理设计磁体形状和充磁方向,让磁铁之间的作用力达到最大,进而降低系统总体重量的目标。2. Embedded small permanent magnets: Due to the overall structure and weight constraints of the micro-device in the body, materials with high magnetic energy product parameters need to be selected, and the shape of the magnet and the direction of magnetization should be reasonably designed to maximize the force between the magnets. The goal of reducing the overall weight of the system.
3.体外磁场定位装置:选择高磁能积参数的永磁材料,合理设计永磁体结构和磁路,以食道内“固定点”为中心的立体空间内,沿着食道方向构建梯度磁场;针对不同体型的人,采取不同的体外磁场定位装置,尽可能降低体外磁场定位装置的强度和重量,提高舒适性和安全性;体外磁场定位装置应该和躯干相对位置固定,穿着舒适,不影响睡眠和基本生活需要;目标区域以外的磁场需要削弱,避免吸引含铁的物品,发生意外。3. In vitro magnetic field positioning device: select permanent magnet materials with high magnetic energy product parameters, rationally design the permanent magnet structure and magnetic circuit, and build a gradient magnetic field along the direction of the esophagus in a three-dimensional space centered on the "fixed point" in the esophagus; for different For people with different body types, use different external magnetic field positioning devices to reduce the strength and weight of the external magnetic field positioning device as much as possible to improve comfort and safety; the external magnetic field positioning device should be fixed relative to the trunk, comfortable to wear, and does not affect sleep and basic functions. Life needs; the magnetic field outside the target area needs to be weakened to avoid attracting iron-containing items and accidents.
附图说明 Description of drawings
图1是本实用新型的功能示意图。Fig. 1 is a functional schematic diagram of the utility model.
图2是体内微型装置受流质液体冲击力作用示意图。Fig. 2 is a schematic diagram of the micro-device in the body being affected by the impact force of the fluid.
图3是实施例的pH体内微型装置功能示意图。Fig. 3 is a functional schematic diagram of the pH in vivo micro-device of the embodiment.
图4是实施例的数据记录仪的功能示意图。Fig. 4 is a functional schematic diagram of the data logger of the embodiment.
图5是实施例的pH体内微型装置在三种位置受力分析图。Fig. 5 is a force analysis diagram of the pH micro-device in the body in three positions.
附图中:1、体外磁场定位装置;2、体内微型装置;3、食道;11、永磁体;21、胶囊壳体;22、功能模块;23、永磁体;221、pH传感器、222、电池;数据223、处理器;224、存储器;225、A/D采样电路;226、射频发射模块;4、数据记录仪;41电池;42、信号接收模块;43、存储器;44、数据处理器;45、按键;46、指示灯、47、蜂鸣器;48、数据接口;49、记录仪外壳。In the drawings: 1. External magnetic field positioning device; 2. In vivo micro-device; 3. Esophagus; 11. Permanent magnet; 21. Capsule shell; 22. Functional module; 23. Permanent magnet; 221. pH sensor, 222. Battery ;
具体实施方式 Detailed ways
以下结合附图和实施例对本实用新型的技术方案做进一步的阐述。The technical solution of the present utility model will be further elaborated below in conjunction with the accompanying drawings and embodiments.
图1是本实用新型的功能示意图,在人体躯干上固定一个体外磁场定位装置1,对吞入食道3内的体内微型装置2产生吸引力,使体内微型装置2能够固定在食道壁上。Fig. 1 is a functional schematic diagram of the utility model. An external magnetic field positioning device 1 is fixed on the human trunk to generate an attraction force for the internal micro-device 2 swallowed into the esophagus 3, so that the internal micro-device 2 can be fixed on the wall of the esophagus.
如图2是体内微型装置受流质液体冲击力作用示意图所示,人在吞咽唾液和食物流质食物时,不可避免会对体内微型装置2造成冲击力,会严重影响固定效果,因此,外壳的外部形状进行流线型设计,如汽车、飞机、桥墩都是流线型,通常表现为平滑而规则的表面、没有大的起伏和尖锐的棱角。流体在流线型物体表面主要表现为层流,没有或很少有湍流,这保证了物体受到较小的阻力。尽可能减少此类冲击造成食道3内的体内微型装置2脱落的可能性。As shown in Figure 2 is a schematic diagram of the micro-device in the body being affected by the impact force of fluid liquid. When a person swallows saliva and liquid food, it will inevitably cause an impact force on the micro-device 2 in the body, which will seriously affect the fixing effect. Therefore, the outer shell Streamlined design of the shape, such as cars, airplanes, and bridge piers are all streamlined, usually showing a smooth and regular surface, without large undulations and sharp edges and corners. The fluid on the surface of a streamlined object is mainly laminar, with no or little turbulence, which ensures that the object is subject to less resistance. The possibility of such shocks causing the internal microdevice 2 in the esophagus 3 to fall off is minimized.
为了更好的说明本实用新型,现介绍一个实施例“食道酸碱度无线监测胶囊系统”,用于长期监测食道内LES(下括约肌)上方5cm处的pH值,包括体外磁场定位装置1、pH体内微型装置2和体外数据记录仪4三部份。当胶囊状的pH体内微型装置2经吞服进入食道,受体外磁场定位装置1的吸引力,pH体内微型装置2贴紧食道壁,长期监测食道内pH值,并通过射频信号将数据传送到体外的数据接收器,该发明的实施例用来实现无线监测食道内pH值,可用于反流性食道炎的诊断,也可以用于食道相关疾病的辅助诊断。In order to better illustrate the utility model, an embodiment of "Esophageal pH Wireless Monitoring Capsule System" is now introduced, which is used for long-term monitoring of the pH value at 5 cm above the LES (lower sphincter) in the esophagus, including an in vitro magnetic field positioning device 1, pH in vivo Micro device 2 and external data recorder 4 are three parts. When the capsule-like pH in vivo micro-device 2 is swallowed and enters the esophagus, attracted by the external magnetic field positioning device 1, the pH in-vivo micro-device 2 sticks to the wall of the esophagus, monitors the pH value in the esophagus for a long time, and transmits the data through radio frequency signals The embodiment of the invention is used to realize the wireless monitoring of the pH value in the esophagus, which can be used for the diagnosis of reflux esophagitis, and can also be used for the auxiliary diagnosis of esophagus-related diseases.
本实施例的永磁体11采用钕铁硼永磁材料,牌号N50,磁能积为50MGOe,棉、尼龙、橡皮筋等弹性材料做成短背心样式的定位载体12,穿在人体躯干上,其中,异型结构的永磁体产生的磁场保证能食道LES上方5cm附近2cm半径的特定立体空间范围内,形成一个稳定的梯度磁场。The permanent magnet 11 of the present embodiment adopts NdFeB permanent magnet material, brand N50, and the magnetic energy product is 50MGOe, and elastic materials such as cotton, nylon, rubber band are made the positioning carrier 12 of short vest style, wear on the human trunk, wherein, The magnetic field generated by the special-shaped permanent magnet ensures that a stable gradient magnetic field can be formed within a specific three-dimensional space with a radius of 2 cm near the 5 cm above the LES of the esophagus.
从生命安全性出发,本实用新型体外磁场定位装置1外部的磁场强度不超过100高斯,为了实现这个目的,将体外磁场定位装置1中的永磁体11设计成异型结构,比如:部分采取U型结构,或者采用多种充磁方向的组合磁体,使躯干以外的磁场均处于闭合磁路内,仅目标区域的躯干部分在开放的磁路中。对于静磁场的屏蔽,当然也可以采用软铁、硅钢、坡莫合金等磁屏蔽材料辅助,磁屏蔽材料的磁导率愈高,筒壁愈厚,屏蔽效果就愈显著;同时也可以通过增加弹性材料厚度的方法,保护人的生命安全,在实施的过程中,应分析磁屏蔽材料的重量、人体舒适程度、安全性等因素,在应用基础上进行设计。From the perspective of life safety, the external magnetic field strength of the external magnetic field positioning device 1 of the present utility model does not exceed 100 gauss. In order to achieve this purpose, the permanent magnet 11 in the external magnetic field positioning device 1 is designed as a special-shaped structure, such as: a part adopts a U shape structure, or use a combination of magnets with multiple magnetization directions, so that the magnetic field outside the torso is in a closed magnetic circuit, and only the torso in the target area is in an open magnetic circuit. For the shielding of the static magnetic field, of course, magnetic shielding materials such as soft iron, silicon steel, and permalloy can also be used to assist. The higher the magnetic permeability of the magnetic shielding material, the thicker the cylinder wall, the more significant the shielding effect; The method of elastic material thickness protects human life safety. During the implementation process, factors such as the weight of the magnetic shielding material, human comfort, and safety should be analyzed, and the design should be based on the application.
图4是作为实施例的pH体内微型装置2功能示意图。pH体内微型装置2由外壳21、功能模块22和永磁体23三部份组成,其中功能模块包括pH传感器221、电池222、数据处理器223、存储器224、A/D采样225、射频发射模块226,其中pH传感器221的传感部分暴露在胶囊外壳的外部;所述pH传感器通过A/D采样电路连接数据处理器,在数据处理器控制下,pH传感器将采集的pH值通过A/D采样电路转换成数据格式,暂存在胶囊内的存储器中,再通过信号发射模块将数据传送到体外的数据记录仪4。所述永磁体23的材料为钕铁硼材料,内嵌永磁体产生的磁场方向垂直于外壳的长度方向,pH体内微型装置2被吞服后沿食道下滑,内嵌永磁体的磁场方向就垂直于食道。其中,相应的器件可以如下选择:电池222采用3V氧化银纽扣电池,数据处理器223可采用型号为MSP430f2012的芯片,其内部集成了2Kflash、128B的RAM、10Bit的AD,能够满足数据存储和程序存储的需要,pH传感器221选用医用锑测量电极和Ag/AgCl参比电极组成的pH传感器,利用微型三运放,采用恒压恒流电路构建pH传感器的A/D采样电路225,经由数据处理器内置A/D进行数据采集,然后采用TH72015的信号发射模块226,FSK/ASK通讯方式,欧洲433MHz ISM频段将数据传输到体外的数据记录仪。Fig. 4 is a functional schematic diagram of the micro-device 2 in vivo as an embodiment. The micro-device 2 in the pH body consists of three parts: a
图5是实施例数据记录仪4的功能示意图。数据记录仪4由电池41,信号接收模块-42,存储器-43,数据处理器-44,按键45,指示灯-46,蜂鸣器-47,数据接口-48,记录仪外壳-49组成。其中:所述信号接收模块42接收功能模块22传输的数据,在数据处理器44控制下,将数据暂存于存储器43中,或通过数据接口48进行再次发送。所述的数据记录仪外壳49由对人体无毒、无害的材料制成;患者利用数据记录仪上的按键45来记录操作过程中进食、睡眠、反酸等事件;数据记录仪4中的存储器43用来存储pH数据,所述pH数据可以通过数据接口48与计算机PC等数据处理设备之间进行数据传送;计算机PC能完成记录仪时间校对,指导医生进行pH值定标等初始化操作,也可以对测试的数据进行显示、统计、分析等操作。其中,所述电池41可采用7#1.5伏碱性电池,利用LDO升压模块提供3V电压供系统应用,数据处理器44采用MSP430F1232,22个I/O,10位AD,程序存储器不少于8K,带1个串口,8MHZ时钟,信号接收模块22采用TH71101 FSK/FM/ASK 433MHz接收器,存储器43采用ATMEL公司64M BIT的FALSH存储器AT45DB642D,数据接口48采用RS232 MAX3221与PC进行双向的数据传输。FIG. 5 is a functional schematic diagram of the data recorder 4 of the embodiment. Data recorder 4 is made up of
以pH体内微型装置2为受力对象进行分析,主要包括本身的重力、食道的弹力、食物向下的推力、磁场吸引力、与食道的摩擦力等等,除了重力之外,各个力的大小和方向随着人的姿态、消化道蠕动、pH体内微型装置2下滑速度等因素而变化。以pH体内微型装置2为受力对象进行分析,主要包括重力G、磁场吸引力F、与食道的摩擦力f、食道的弹力N以及食物向下的推力T等等,除了重力之外,各个力的大小和方向随着人的姿态、消化道蠕动、pH胶囊下滑速度等因素而变化。如图5所示,左图是pH体内微型装置在食道的三种位置,右图是对应的受力分析图。pH体内微型装置2内嵌永磁体23紧贴外壳21的扁平侧面,在梯度磁场的不同位置。状态①,pH体内微型装置2刚吞咽进入食道,pH体内微型装置2主要受重力G和吞咽产生的推力T1,加速下降。随着吞咽的进行,食道的摩擦力让速度变慢,在磁场的作用力下,贴紧食道壁,进入第②状态,pH体内微型装置2在重力G、磁场的吸引力F1、食道弹力N1和食道壁摩擦力f1受力平衡,pH体内微型装置(2)相对食道壁静止不动。当吞咽唾液或者食物时,pH体内微型装置2受到瞬时冲击力,向胃部偏移,磁场吸引力迅速变大,方向指向平衡点,而冲击力T2迅速减小,磁场吸引力F2、摩擦力f2、冲击力T2、重力G的合力向上,pH体内微型装置2将回到平衡点。Taking the micro-device 2 in the body as the force object for analysis, it mainly includes its own gravity, the elasticity of the esophagus, the downward thrust of food, the attraction of the magnetic field, the friction with the esophagus, etc. In addition to gravity, the magnitude of each force The direction and direction change with factors such as the posture of the person, the peristalsis of the digestive tract, and the sliding speed of the micro-device 2 in the body. Taking the micro-device 2 in the body as the force object for analysis, it mainly includes gravity G, magnetic attraction F, friction force f with the esophagus, elasticity N of the esophagus, and downward thrust T of food, etc. In addition to gravity, each The magnitude and direction of the force vary with factors such as the person's posture, peristalsis of the digestive tract, and the sliding speed of the pH capsule. As shown in Figure 5, the left picture shows the three positions of the pH micro-device in the esophagus, and the right picture shows the corresponding force analysis pictures. The pH in vivo micro-device 2 is embedded with a
由临床试验可知,进食流质食物过程中对微型模块产生的推动力约为0.05N。按照极限受力情况分析,体外磁场定位装置1与pH体内微型装置2之间的吸引力大于重力和食道向下的推力,就能满足pH体内微型装置2的固定需要以身高170cm、体重60Kg的人为例,前胸到后背的距离为16cm,假设食道位于躯干正中间,两块永磁铁间隔8cm,胶囊状的pH体内微型装置2的重量为3g,pH体内微型装置2内嵌牌号N50的钕铁硼永磁体,磁能积的标准值为50MGOe,尺寸为8mm×20mm×2mm,充磁方向为厚度2mm方向,在体外设置一块50mm×50mm×25mm的牌号N50的钕铁硼磁体,充磁方向为厚度25mm的方向,两者的吸引力能达到0.2N,远远大于胶囊的重力和流质食物的推力的合力0.07N,就能够满足固定要求。实际应用过程中,为了减小系统重量,在满足临床需要的过程中,采用尽量少的永磁体,降低患者的负担,提高使用的舒适程度。According to clinical trials, the driving force on the micro-module is about 0.05N during the process of eating liquid food. According to the analysis of the ultimate stress situation, the attraction between the external magnetic field positioning device 1 and the pH micro-device 2 in the body is greater than the gravity and the downward thrust of the esophagus, which can meet the fixing needs of the pH micro-device 2 in the body. Take a human as an example, the distance from the front chest to the back is 16cm, assuming that the esophagus is located in the middle of the torso, the two permanent magnets are separated by 8cm, the capsule-shaped pH micro-device 2 weighs 3g, and the pH micro-device 2 is embedded with a brand N50 NdFeB permanent magnet, the standard value of the magnetic energy product is 50MGOe, the size is 8mm×20mm×2mm, the magnetization direction is the direction of thickness 2mm, a 50mm×50mm×25mm brand N50 NdFeB magnet is placed outside the body, and the magnetization The direction is the direction of the thickness of 25mm, and the attractive force of the two can reach 0.2N, which is far greater than the resultant force of 0.07N of the gravity of the capsule and the thrust of the liquid food, which can meet the fixing requirements. In the actual application process, in order to reduce the weight of the system and meet the clinical needs, as few permanent magnets as possible are used to reduce the burden on patients and improve the comfort of use.
针对不同体型、不同食道疾病的人,在食道内采用本实用新型固定体内微型装置,需综合分析食道距体表的距离、食道表面光滑程度、粘液粘稠程度、食道直径、食道运动等因素,固定位置的精度也跟梯度磁场的分布、体内微型装置的重量、外壳的材料、形状也有关系。For people with different body types and different esophageal diseases, using the utility model to fix the micro-device in the esophagus, it is necessary to comprehensively analyze the distance between the esophagus and the body surface, the smoothness of the esophagus surface, the degree of viscous mucus, the diameter of the esophagus, and the movement of the esophagus. The accuracy of the fixed position is also related to the distribution of the gradient magnetic field, the weight of the micro-device in the body, and the material and shape of the shell.
本实用新型中,如果体内微型装置2吞咽的速度过快,而梯度磁场作用范围太窄的话,可能会影响到体外磁场定位装置1吸引的效果,可以采取一些辅助的技术手段或者操作方法来提高操作的可靠性。在所述体内微型装置2的外壳21上具有与壳体内不连通的穿孔,便于将所述体内微型装置2穿在拉线上,根据拉线的长度确定其进入体内,如食道内的位置,定位后,撤去拉线,这种方法能够避免微型装置2在吞咽后很快掉落到胃内,也便于精确定位。但是拉线的撤回会对咽部造成一定的不适,也可以选用能够延时溶化的医用导线,比如医用蛋白线、医用PVA水溶性材料等等,确保定位完成后,将剩余拉线继续吞服,在一定时间后,拉线自动溶化。In the utility model, if the swallowing speed of the micro-device 2 in the body is too fast, and the gradient magnetic field is too narrow, it may affect the effect of attracting the magnetic field positioning device 1 outside the body, and some auxiliary technical means or operating methods can be adopted to improve operational reliability. The
同时,操作过程中,可以先将体外磁场定位装置1靠近喉管,限制住体内微型装置的运动速度,然后缓慢牵引体内微型装置到达指定位置。或者,病人采取卧姿吞服体内微型装置2,削弱体内微型装置2的重力对加速度的影响,或者在体内微型装置2上添加一根延时溶化的导线等等,都能够达到短时间内限制体内微型装置吞咽速度、提高固定可靠性的目的。At the same time, during the operation, the external magnetic field positioning device 1 can be brought close to the throat to limit the movement speed of the internal micro-device, and then slowly pull the internal micro-device to a designated position. Alternatively, the patient swallows the micro-device 2 in the body in a supine position, weakening the influence of the gravity of the micro-device 2 in the body on the acceleration, or adding a delay-melting wire to the micro-device 2 in the body, etc., all of which can reach the limit in a short time. The purpose of swallowing the micro-device in the body and improving the reliability of fixation.
除了以上提到的实施例“食道酸碱度无线监测胶囊系统”以外,为了实现临床应用需要,本实用新型可以产生多种不同类型的“食道生理参数无线监测胶囊系统”的实施例:将所述实施例“食道酸碱度无线监测胶囊系统”体内微型装置2的功能模块22中的pH传感器221,换为其他的生理传感器,和相关的转换电路即可。比如:采用透明光学前盖+微型广角镜头+CMOS集成成像芯片构成的图像采集系统;采用铂电极的温度采集系统;采用MEMS硅压力传感器+压力传感薄膜的压力采集系统;阻抗测试电路+壳外导电电极+壳内的电压采集电路构成的阻抗采集系统;随着离子敏场效应晶体管ISFET技术的发展,按照敏感膜的不同,能够检测多种参数,比如:无机离子FET,其敏感膜一般为无机栅、固态膜或者有机高分子PVC膜,用于检测钠离子、钙离子、铵离子等浓度;酶FET,在敏感栅表面固定一层酶膜,通过待测基质与酶之间的反应生成物引起酶膜局部pH值变化加以测量;用溶解氧电极来测试葡萄糖的浓度;以及其他传感器能用来测试胆红素、肌氨酸酐、血液尿素氮、尿氮、肾素、血管紧缩素等等食道内的生理参数,这里不再一一枚举。In addition to the above-mentioned embodiment "wireless monitoring capsule system for esophagus pH", in order to meet the needs of clinical applications, the utility model can produce many different types of embodiments of "wireless monitoring capsule system for esophagus physiological parameters": the implementation For example, the
本实用新型提供的在食道内特定位置无创固定体内微型装置的系统,可根据临床需要,将体内微型装置用来监测食道内各种生理参数,同时,为了实现治疗用途,本实用新型可以产生多种不同类型的“食道无线治疗用胶囊系统”的实施例:将所述实施例“食道酸碱度无线监测胶囊系统”的体内微型装置2的功能模块22中的pH传感器221,换为其他的执行器和相关的转换电路即可,体内微型装置应能够完成预定的动作或者根据体外控制器的命令执行相应操作,比如:通过数据处理器的数字逻辑电路驱动压控振荡器输出电流脉冲,通过壳体外的金属电极,来实现放电刺激的治疗功能;通过数据处理器的I/O端口、D/A输出控制MEMS微流控集成芯片,能够用于食道体液的采样功能;通过在壳体上固定缓释药物,就能够对食道指定位置进行缓释药物的方式进行长期治疗;以及其他的用于超声诊断、电磁波、组织采样等等治疗功能,这里不再一一枚举。The utility model provides a system for non-invasively fixing micro-device in a specific position in the esophagus. According to clinical needs, the micro-device in the body can be used to monitor various physiological parameters in the esophagus. At the same time, in order to achieve therapeutic purposes, the utility model can generate multiple A different type of embodiment of the "capsule system for wireless esophagus therapy": replace the
总之,本实用新型提供的在食道内特定位置无创固定体内微型装置的系统,根据需要,只要采用MEMS技术、纳米技术将医用传感器、执行器进行微型化、集成化处理,都可以采用本实用新型进行实施,制造出临床需要进行相应的诊断和治疗的设备,操作安全,病人使用无痛苦。In a word, the system provided by the utility model for non-invasively fixing micro-device in a specific position in the esophagus can adopt the utility model as long as the medical sensors and actuators are miniaturized and integrated by using MEMS technology and nanotechnology. Carry out implementation, manufacture the equipment that clinically needs to carry out corresponding diagnosis and treatment, the operation is safe, the patient uses without pain.
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|---|---|---|---|---|
| CN106667432A (en) * | 2015-11-11 | 2017-05-17 | 宣明智 | Fixing element of micro device and micro device |
| CN110201293A (en) * | 2019-07-03 | 2019-09-06 | 重庆金山科技(集团)有限公司 | A kind of hangnail circle, capsule component, capsule conveying and fixed device |
| CN121623118A (en) * | 2026-02-03 | 2026-03-10 | 湖北大学 | Drug release capsule device based on external rotating magnetic field |
| CN121623118B (en) * | 2026-02-03 | 2026-05-08 | 湖北大学 | Drug release capsule device based on external rotating magnetic field |
-
2008
- 2008-10-28 CN CNU2008201003702U patent/CN201299646Y/en not_active Expired - Lifetime
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106667432A (en) * | 2015-11-11 | 2017-05-17 | 宣明智 | Fixing element of micro device and micro device |
| CN110201293A (en) * | 2019-07-03 | 2019-09-06 | 重庆金山科技(集团)有限公司 | A kind of hangnail circle, capsule component, capsule conveying and fixed device |
| CN121623118A (en) * | 2026-02-03 | 2026-03-10 | 湖北大学 | Drug release capsule device based on external rotating magnetic field |
| CN121623118B (en) * | 2026-02-03 | 2026-05-08 | 湖北大学 | Drug release capsule device based on external rotating magnetic field |
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