CN100594837C - Capsule-type medical device - Google Patents

Abstract

The invention provides a capsule-type medical device. The capsule type medical device (1) is a capsule type medical device that is introduced into a living body to collect information in the living body, and includes: a capsule-shaped housing (1); in-vivo information acquisition means (2) for acquiring the in-vivo information; a communication device (4) for wirelessly transmitting the in-vivo information acquired by the in-vivo information acquisition device to the outside of the living body; at least one pair of first electrodes (6) disposed near one end along the axis of the housing for providing electrical stimulation to body tissue in the living body; a first current control means (3) for supplying a current to said first electrode; and inter-electrode distance changing means (7) for changing the distance between the electrodes.

Description

Translated fromChinese

囊型医疗装置capsule medical device

技术领域technical field

本发明涉及对活体进行观察的囊型医疗装置，更具体地说，涉及一种通过向身体组织提供电刺激而在活体内移动、从而使得可以对期望位置进行观察的装置。The present invention relates to a capsule-type medical device for observing a living body, and more particularly, to a device that moves within a living body by providing electrical stimulation to body tissues, thereby enabling observation of a desired position.

背景技术Background technique

对于对接受检查的人的健康状况进行检查的方法，诸如利用内窥镜进行医学检查或观察的方法已广为人知。而且，已知使用以下囊型医疗装置的检查方法(例如，参见日本未审专利申请、第一次公报No.2003-135388)，即，在该囊型医疗装置中，将成形为囊形的检查装置引入活体内，以进行容易的身体状况检查。可以利用与上述装置类似的各种类型的囊型医疗装置，其中的一种是电推进型装置，在该电推进型装置中，通过电极向身体组织提供局部电刺激，然后利用该身体组织的收缩而在活体内移动(例如，参见PCT国际公报No.WO 01/08548，以及美国专利申请公报NO.2003/0125788)。As a method of examining the health condition of a person to be examined, methods such as medical examination or observation using an endoscope are widely known. Also, there is known an inspection method (for example, see Japanese Unexamined Patent Application, First Publication No. 2003-135388) using a capsule-type medical device in which a The inspection device is introduced into the living body for easy physical condition inspection. Various types of capsule medical devices similar to those described above can be utilized, one of which is an electro-propulsion type device in which localized electrical stimulation is provided to body tissue via electrodes and then the body tissue's Contracted to move in vivo (see, eg, PCT International Publication No. WO 01/08548, and U.S. Patent Application Publication No. 2003/0125788).

通常，囊型医疗装置在被引入活体时，通过诸如小肠的内腔器官的蠕动，在消化道内自然地移动。然而，该电推进型囊型医疗装置通过向诸如内腔器官的身体组织提供局部电刺激，从而引起与对于该身体组织自然的(自主的)蠕动不同的收缩运动(引起强制蠕动或局部肌肉收缩)，来推进向前的移动或沿相反方向的移动。这使得可以快速到达待观察的位置，或者在一个位置处进行详细观察。因此，实现了有效的观察。Generally, a capsule-type medical device naturally moves within the digestive tract by peristalsis of a luminal organ such as the small intestine when introduced into a living body. However, the electro-propelled capsule medical device induces a contraction motion (causing forced peristalsis or local muscle contraction) different from natural (voluntary) peristalsis for the body tissue by providing local electrical stimulation to the body tissue such as a luminal organ. ), to advance forward movement or move in the opposite direction. This makes it possible to quickly reach the location to be observed, or to make detailed observations at one location. Therefore, efficient observation is achieved.

在PCT国际公报No.WO 01/08548中公开的囊型医疗装置中，为了应付内腔器官的直径的变化，电极被设置在可膨胀的气囊中。然而，在该装置中，必须通过使用管子等从活体的外部将诸如空气的流体吹入到该囊型医疗装置中，来使气囊膨胀。因此，需要相对大的管子来将流体吹入到气囊中，这使得难以在活体内部署该装置。而且，接受检查的人经常感觉不适或不方便。此外，如果管子在内腔器官内被卡住(caught)，则该囊型医疗装置的稳定推进可能被中断。而且，在PCT国际公报No.WO 01/08548中公开的囊型医疗装置中，并未给出与向电极供电的电源的结构和机构有关的详细描述，因而显然需要进一步改进。In the balloon-type medical device disclosed in PCT International Publication No. WO 01/08548, electrodes are placed in an inflatable balloon in order to cope with changes in the diameter of the lumen organ. However, in this device, it is necessary to inflate the air bag by blowing fluid such as air into the bag-type medical device from the outside of the living body using a tube or the like. Therefore, a relatively large tube is required to insufflate the fluid into the balloon, which makes it difficult to deploy the device in vivo. Also, the person being tested often feels uncomfortable or inconvenient. Furthermore, if the tube is caught within the luminal organ, the steady advancement of the balloon medical device may be interrupted. Also, in the capsule medical device disclosed in PCT International Publication No. WO 01/08548, no detailed description is given about the structure and mechanism of the power supply to the electrodes, and thus further improvement is clearly required.

在美国专利申请公报2003/0125788的说明书中公开的囊型医疗装置中，将用于电刺激的电极安装在可摆动的翼(flap)上，然后通过使用可膨胀的气囊打开该翼，使内腔器官的直径的变化问题得到了解决。然而，与日本未审专利申请、第一次公报No.2003-135388中公开的模型类似的是，需要管子来吹送空气等，以使气囊膨胀。另外，即使在将该翼打开到最大尺寸的情况下，电极之间的距离也大约与囊的直径相同，因此，出现以下问题：该装置显然不能用于直径比该囊的直径大的内腔器官。In the capsule medical device disclosed in the specification of U.S. Patent Application Publication 2003/0125788, electrodes for electrical stimulation are mounted on swingable flaps, and then the flaps are opened by using an inflatable balloon to make the inner The problem of changing the diameter of luminal organs has been resolved. However, similar to the model disclosed in Japanese Unexamined Patent Application, First Publication No. 2003-135388, a tube is required to blow air or the like to inflate the airbag. In addition, even with the flaps opened to their maximum size, the distance between the electrodes is about the same as the diameter of the capsule, so the problem arises that the device obviously cannot be used for a lumen with a diameter larger than the diameter of the capsule organ.

发明内容Contents of the invention

本发明的囊型医疗装置是一种被引入活体内以收集活体内信息的囊型医疗装置，该囊型医疗装置包括：囊形壳体；活体内信息获取装置，用于获取所述活体内信息；通信装置，用于将由所述活体内信息获取装置获取的所述活体内信息无线地发送到所述活体外部；至少一对第一电极，其设置在沿所述壳体的轴的一端附近，用于向所述活体中的身体组织提供电刺激；第一电流控制装置，用于向所述第一电极输送电流；以及第一电极间距离改变装置，用于改变所述第一电极之间的距离。The capsule medical device of the present invention is a capsule medical device that is introduced into a living body to collect information in the living body. The capsule medical device includes: a capsule-shaped housing; information; communication means for wirelessly transmitting the in vivo information acquired by the in vivo information acquisition means to the outside of the living body; at least a pair of first electrodes provided at one end along the axis of the housing Nearby, for providing electrical stimulation to body tissue in the living body; first current control means, for delivering current to the first electrode; and first inter-electrode distance changing means, for changing the first electrode the distance between.

根据本发明的囊型医疗装置，由于所述囊型医疗装置具有电极间距离改变装置，因此准确地使所述电极与身体组织接触并提供电刺激。因此，准确地实现了身体组织的收缩运动，这使得能够稳定地推进所述囊型医疗装置。According to the capsule-type medical device of the present invention, since the capsule-type medical device has inter-electrode distance changing means, the electrodes are accurately brought into contact with body tissue and electrical stimulation is provided. Therefore, the contraction motion of the body tissue is accurately realized, which enables stable advancement of the balloon-type medical device.

在本发明的囊型医疗装置中，优选的是，将可以由所述第一电极间距离改变装置改变的所述第一电极之间的最大距离设定为所述壳体的外径的至少两倍。In the capsule medical device of the present invention, it is preferable that the maximum distance between the first electrodes that can be changed by the first inter-electrode distance changing means is set to be at least the outer diameter of the casing. double.

根据本发明的囊型医疗装置，准确地使所述电极与直径明显大于所述壳体的直径的内腔器官接触。According to the capsule-type medical device of the present invention, the electrode is accurately brought into contact with a lumen organ whose diameter is significantly larger than that of the casing.

优选的是，本发明的囊型医疗装置还包括：至少一对第二电极，其设置在沿所述壳体的所述轴的另一端附近，并位于与所述活体内信息获取装置不重合的位置，用于向所述身体组织提供电刺激；第二电流控制装置，用于向所述第二电极输送电流；以及第二电极间距离改变装置，用于改变所述第二电极之间的距离。Preferably, the capsule-type medical device of the present invention further includes: at least one pair of second electrodes, which are arranged near the other end along the axis of the housing, and are located not coincident with the in vivo information acquisition device A position for providing electrical stimulation to the body tissue; a second current control device for delivering current to the second electrode; and a second inter-electrode distance changing device for changing the distance between the second electrodes distance.

根据本发明的囊型医疗装置，可以对向所述第一电极和所述第二电极输送的电流彼此独立地进行控制，因此，可以使所述囊型医疗装置自由地向前和向后移动。换言之，所述囊型医疗装置由于通过设置在所述壳体的一个边缘侧上的所述第一电极向所述身体组织提供的电刺激而向前移动。同样，所述囊型医疗装置由于通过设置在所述壳体的另一边缘侧上的所述第二电极向所述身体组织提供的电刺激而向后移动。According to the capsule-type medical device of the present invention, the electric currents supplied to the first electrode and the second electrode can be controlled independently of each other, and therefore, the capsule-type medical device can be freely moved forward and backward. . In other words, the capsule-type medical device moves forward due to electrical stimulation provided to the body tissue through the first electrode provided on one edge side of the housing. Also, the capsule-type medical device moves backward due to electrical stimulation provided to the body tissue through the second electrode provided on the other edge side of the casing.

在本发明的囊型医疗装置中，优选的是，所述第一电极间距离改变装置由在末端处支承所述第一电极的柔性线形成，并且所述柔性线在其基端(base end)处由所述壳体支承，并从所述壳体向外伸出。In the capsule-type medical device of the present invention, it is preferable that the first inter-electrode distance changing means is formed of a flexible wire supporting the first electrode at a distal end, and the flexible wire is formed at a base end thereof. ) is supported by the housing and protrudes outward from the housing.

根据本发明的囊型医疗装置，通过所述柔性线的弹性变形使所述电极与所述身体组织之间的接触更加准确。而且，当所述装置被引入所述内腔器官内时，所述内腔器官的直径的变化得到精确的补偿，并且所述电极与所述身体组织之间的恒定接触得到保证。According to the capsule medical device of the present invention, the contact between the electrode and the body tissue is made more accurate by the elastic deformation of the flexible wire. Furthermore, when the device is introduced into the luminal organ, variations in the diameter of the luminal organ are precisely compensated and constant contact between the electrodes and the body tissue is ensured.

在本发明的囊型医疗装置中，优选的是，所述柔性线是带形，并且所述第一电极的宽度与所述柔性线的宽度基本相同。In the capsule type medical device of the present invention, preferably, the flexible wire is strip-shaped, and the width of the first electrode is substantially the same as that of the flexible wire.

根据本发明的囊型医疗装置，与所述身体组织的较大面积的电接触得到保证，因此，以稳定的方式向所述身体组织输送收缩所必须的电流量。According to the capsule-type medical device of the present invention, a large area of electrical contact with the body tissue is ensured, and therefore, the amount of electric current necessary for contraction is delivered to the body tissue in a stable manner.

在本发明的囊型医疗装置中，优选的是，所述柔性线包括：导线构件，用于从所述基端向所述末端输送电流；以及绝缘覆盖构件，用于对所述导线构件进行绝缘和覆盖，并且所述导线构件和所述绝缘覆盖构件中的至少一种具有柔性和弹性。In the capsule medical device of the present invention, it is preferable that the flexible wire includes: a lead member for transmitting electric current from the base end to the distal end; and an insulating covering member for conducting the lead member Insulated and covered, and at least one of the lead member and the insulating covered member has flexibility and elasticity.

根据本发明的囊型医疗装置，使用绝缘覆盖材料对所述导线构件进行覆盖和绝缘，因此，可以精确地防止柔性线之间的短路，从而使得能够彼此靠近地设置柔性线。According to the capsule-type medical device of the present invention, the lead member is covered and insulated with an insulating covering material, and therefore, short circuit between flexible wires can be precisely prevented, thereby enabling the flexible wires to be disposed close to each other.

在本发明的囊型医疗装置中，优选的是，所述柔性线由超弹性合金和/或超弹性聚合物材料制成。In the capsule medical device of the present invention, preferably, the flexible wire is made of a superelastic alloy and/or a superelastic polymer material.

根据本发明的囊型医疗装置，实现了所述柔性线的大的弹性变形，因此所述活体内的所述内腔器官的直径的变化得到精确的补偿，并且所述电极与所述身体组织之间的恒定接触得到保证。According to the capsule-type medical device of the present invention, a large elastic deformation of the flexible wire is realized, so that the change in the diameter of the lumen organ in the living body is accurately compensated, and the electrode is in contact with the body tissue Constant contact between is guaranteed.

优选的是，本发明的囊型医疗装置还包括：线捆扎装置，用于在所述末端附近捆扎所述柔性线，并且该线捆扎装置在所述活体内溶解。Preferably, the capsule-type medical device of the present invention further includes: a wire binding device for binding the flexible wire near the end, and the wire binding device dissolves in the living body.

根据本发明的囊型医疗装置，在所述柔性线在所述末端侧被捆扎的情况下，使得能够容易地将囊型医疗装置引入到所述活体中，这是由于在例如通过吞下所述囊型医疗装置而将该囊型医疗装置置于所述活体中时，所述柔性线和电极不会成为障碍。在部署所述囊型医疗装置之后，所述线捆扎装置被胃酸等溶解，因此，所述导线散开，使得能够改变电极间距离。According to the balloon-type medical device of the present invention, in the case where the flexible wire is bundled on the distal end side, it is possible to easily introduce the balloon-type medical device into the living body, since the flexible wire is When the medical capsule device is placed in the living body, the flexible wires and electrodes do not become obstacles. After the capsule-type medical device is deployed, the wire binding device is dissolved by gastric acid or the like, and thus, the lead wires are spread out, enabling the inter-electrode distance to be changed.

在本发明的囊型医疗装置中，优选的是，所述第一电极间距离改变装置是可向外移动地安装到所述壳体上的外壳单元，并且所述第一电极固定在该外壳单元上。In the capsule medical device of the present invention, preferably, the first electrode-to-electrode distance changing device is a housing unit that is movably mounted outwardly on the housing, and the first electrode is fixed to the housing unit. on the unit.

根据本发明的囊型医疗装置，所述外壳单元中固定有多个电极，以形成一个单元，通过沿所述外壳单元的径向移动所述电极，准确地使所述电极与所述身体组织接触。According to the capsule medical device of the present invention, a plurality of electrodes are fixed in the housing unit to form a unit, and by moving the electrodes in the radial direction of the housing unit, the electrodes are accurately aligned with the body tissue. touch.

在本发明的囊型医疗装置中，优选的是，沿所述壳体的周边设置两个或更多个所述第一电极，并且所述囊型医疗装置还包括：电极选择器，用于在所述第一电极当中选择要被从所述电流控制装置输送电流的电极。In the capsule medical device of the present invention, preferably, two or more first electrodes are provided along the periphery of the casing, and the capsule medical device further includes: an electrode selector for An electrode to be supplied with current from the current control means is selected among the first electrodes.

根据本发明的囊型医疗装置，沿周边选择要提供电刺激的位置使得所述囊型医疗装置也能够沿水平方向精确地移动。According to the capsule-type medical device of the present invention, selecting a position along the periphery where electrical stimulation is to be provided enables the capsule-type medical device to move precisely in the horizontal direction as well.

在本发明的囊型医疗装置中，优选的是，所述电极选择器是电极面积改变装置，其通过在所述第一电极当中任意选择某些电极，来改变向所述身体组织提供电刺激的各第一电极的面积。In the capsule medical device of the present invention, preferably, the electrode selector is an electrode area changing device, which changes the electrical stimulation provided to the body tissue by arbitrarily selecting certain electrodes among the first electrodes. The area of each first electrode of .

根据本发明的囊型医疗装置，通过改变各电极的面积来保证各电极的最佳电极面积，向所述身体组织输送期望电流量变得简单。According to the capsule medical device of the present invention, by changing the area of each electrode to ensure an optimum electrode area of each electrode, it becomes easy to deliver a desired amount of current to the body tissue.

优选的是，本发明的囊型医疗装置还包括：线存储单元，用于将所述柔性线存储在所述壳体内。Preferably, the capsule medical device of the present invention further includes: a wire storage unit for storing the flexible wire in the housing.

根据本发明的囊型医疗装置，在所述电极没有被使用时，所述柔性线存储在所述壳体内，使得所述柔性线不从所述壳体中伸出。According to the pouch-type medical device of the present invention, when the electrodes are not used, the flexible wire is stored in the housing so that the flexible wire does not protrude from the housing.

优选的是，本发明的囊型医疗装置还包括：旋转轴，其连接到所述柔性线的所述基端，并被可旋转地支承在所述线存储单元内；以及致动器，用于驱动所述旋转轴。Preferably, the capsule medical device of the present invention further includes: a rotation shaft connected to the base end of the flexible wire and rotatably supported in the wire storage unit; and an actuator for to drive the rotating shaft.

根据本发明的囊型医疗装置，通过驱动所述致动器使所述旋转轴旋转，来实现所述柔性线的释放或缠绕，因此，可以任意地改变电极间距离。According to the capsule medical device of the present invention, the release or winding of the flexible wire is realized by driving the actuator to rotate the rotation shaft, and therefore, the distance between electrodes can be arbitrarily changed.

在本发明的囊型医疗装置中，优选的是，所述柔性线具有形状记忆特性，所述柔性线在30℃或更低温度下进入线圈状缠绕状态，而在35℃或更高温度下恢复成大致直线。In the capsule type medical device of the present invention, it is preferable that the flexible wire has shape memory characteristics, the flexible wire enters a coil-like winding state at a temperature of 30°C or lower, and the flexible wire enters a coil-like winding state at a temperature of 35°C or higher. Return to a roughly straight line.

根据本发明的囊型医疗装置，所述柔性线在引入到所述活体中之前处于接近室温条件(约25℃)下，因此所述柔性线以线圈状缠绕状态存储在所述线存储单元中。而且，在部署在所述活体内之后，所述柔性线处于接近体温条件(约35℃)下，因此所述柔性线恢复成接近直线状态。因此，一旦所述囊型医疗装置被吞下，所述柔性线就可以自主地从所述线存储单元中展开。According to the capsule-type medical device of the present invention, the flexible wire is under near-room temperature conditions (about 25° C.) before being introduced into the living body, so the flexible wire is stored in the wire storage unit in a coil-like winding state. . Also, after being deployed in the living body, the flexible thread is in a condition close to body temperature (about 35° C.), so the flexible thread returns to a nearly straight state. Thus, the flexible wire can be autonomously deployed from the wire storage unit once the balloon medical device is swallowed.

优选的是，本发明的囊型医疗装置还包括：加热装置，用于在所述线存储单元内进行加热，并且所述柔性线具有形状记忆特性，通过该特性，所述柔性线在40℃或更高温度下从大致线圈状缠绕状态恢复成直线形状。Preferably, the pouch-type medical device of the present invention further includes: a heating device for heating in the wire storage unit, and the flexible wire has a shape memory property, by which the flexible wire can be heated at 40°C At or higher temperature, it returns to a linear shape from a roughly coiled winding state.

根据本发明的囊型医疗装置，所述柔性线在进入所述活体之前处于正常室温状态(约25℃)下，因此，所述柔性线以大致线圈状地缠绕在所述旋转轴上的状态存储在所述线存储单元中。即使在进入所述活体之后，所述柔性线也保持在低于40℃的体温(约35℃)下，因此，所述柔性线维持初始形状地保持在所述线存储单元内。而且，当通过加热装置的操作使所述线存储单元内的温度升高到高于40℃时，所述柔性线恢复成基本直线形状。因此，通过在吞下所述囊型医疗装置之后驱动所述加热装置进行操作，使得可以在所述活体内的期望位置处从所述线存储单元中展开所述柔性线。According to the capsule medical device of the present invention, the flexible wire is in a normal room temperature state (about 25° C.) before entering the living body, and therefore, the flexible wire is wound around the rotation shaft in a substantially coiled state. stored in the line storage unit. Even after entering the living body, the flexible wire is maintained at a body temperature (about 35° C.) lower than 40° C., and thus, the flexible wire is held in the wire storage unit maintaining an original shape. Also, when the temperature inside the wire storage unit is raised above 40° C. by operation of the heating means, the flexible wire returns to a substantially straight shape. Therefore, by driving the heating device to operate after swallowing the capsule medical device, it is possible to deploy the flexible wire from the wire storage unit at a desired position in the living body.

优选的是，本发明的囊型医疗装置还包括：电源，用于向所述第一电极提供电力；以及导线，所述导线的至少一部分具有柔性，用于电和机械地连接所述电源和所述电极，其中，所述第一电极间距离改变装置包括可弹性膨胀并至少部分地安装在所述壳体上的弹性膨胀单元，并且所述第一电极被设置在所述弹性膨胀单元上。Preferably, the capsule medical device of the present invention further includes: a power supply for supplying power to the first electrode; and a wire, at least a part of which is flexible, for electrically and mechanically connecting the power supply and the first electrode. The electrode, wherein the first inter-electrode distance changing device includes an elastic expansion unit that is elastically expandable and at least partially installed on the housing, and the first electrode is arranged on the elastic expansion unit .

根据本发明的囊型医疗装置，通过所述弹性膨胀单元在所述活体内的期望位置处的膨胀，准确地使所述电极与内腔器官(例如，外径不均匀的消化道)的内壁接触。而且，由于连接所述电极与所述电源的导线的可弯性，所以可以应付所述弹性膨胀单元的膨胀和收缩。此外，可以几乎无中断(例如由导线断开而导致的)地提供稳定的电刺激。According to the capsule type medical device of the present invention, the electrode is accurately aligned with the inner wall of a lumen organ (for example, alimentary canal with uneven outer diameter) through expansion of the elastic expansion unit at a desired position in the living body. touch. Also, due to the bendability of the wire connecting the electrodes and the power source, expansion and contraction of the elastic expansion unit can be handled. In addition, stable electrical stimulation can be provided with little interruption (eg, caused by wire disconnection).

优选的是，本发明的囊型医疗装置还包括：膨胀装置，用于使所述弹性膨胀单元膨胀，其中，所述膨胀装置与所述壳体分开设置，并可拆卸地安装在所述壳体上。Preferably, the balloon medical device of the present invention further includes: an expansion device for expanding the elastic expansion unit, wherein the expansion device is provided separately from the casing and is detachably mounted on the casing physically.

根据本发明的囊型医疗装置，由于所述膨胀装置是与所述壳体分开设置的，所以可以充分简化所述壳体的结构。According to the balloon-type medical device of the present invention, since the expansion device is provided separately from the housing, the structure of the housing can be sufficiently simplified.

在本发明的囊型医疗装置中，优选的是，所述弹性膨胀单元可拆卸地安装在所述壳体上。In the balloon medical device of the present invention, preferably, the elastic expansion unit is detachably mounted on the casing.

根据本发明的囊型医疗装置，可以根据所述囊型医疗装置的用途将最适用的所述弹性膨胀单元安装在所述壳体上。而且，例如易于重复使用相对昂贵的主装置，而在每次使用之后丢弃相对便宜的弹性膨胀单元。According to the balloon-type medical device of the present invention, the most suitable elastic expansion unit can be mounted on the housing according to the use of the balloon-type medical device. Also, it is eg easy to reuse the relatively expensive main device while discarding the relatively inexpensive elastic expansion unit after each use.

在本发明的囊型医疗装置中，优选的是，所述弹性膨胀单元上设置有比所述弹性膨胀单元的其他部分硬的硬构件，并且所述第一电极被设置在所述硬构件上。In the capsule medical device of the present invention, preferably, the elastic expansion unit is provided with a hard member that is harder than other parts of the elastic expansion unit, and the first electrode is provided on the hard member .

根据本发明的囊型医疗装置，如果所述电极由如金属等的基本上不膨胀或收缩的材料制成，则可以通过将所述电极安装在所述硬构件中，使所述电极与所述弹性膨胀单元之间的收缩率和膨胀率的相互差别变小。因此，可以在较好的状态下将所述电极安装在所述弹性膨胀单元中，并保持在所述弹性膨胀单元中。According to the capsule type medical device of the present invention, if the electrode is made of a material that does not substantially expand or contract such as metal, it is possible to make the electrode and the electrode by installing the electrode in the hard member. The mutual difference between the shrinkage rate and the expansion rate between the elastic expansion units becomes small. Therefore, the electrode can be installed in the elastic expansion unit and held in the elastic expansion unit in a good state.

在本发明的囊型医疗装置中，优选的是，通过使用1000Hz或更高的脉冲信号对100Hz或更低的脉冲信号进行调制，来生成要向所述电极发送的电刺激信号。In the capsule medical device of the present invention, it is preferable that the electrical stimulation signal to be sent to the electrodes is generated by modulating a pulse signal of 100 Hz or lower with a pulse signal of 1000 Hz or higher.

附图说明Description of drawings

图1A是说明本发明第一实施例中的囊型医疗装置的基本结构的图，该图是该囊型医疗装置的侧视图。Fig. 1A is a diagram illustrating a basic structure of a balloon-type medical device in a first embodiment of the present invention, which is a side view of the balloon-type medical device.

图1B是说明本发明第一实施例中的囊型医疗装置的基本结构的图，该图是该囊型医疗装置的后视图。Fig. 1B is a diagram illustrating the basic structure of the capsule medical device in the first embodiment of the present invention, which is a rear view of the capsule medical device.

图1C是说明本发明第一实施例中的囊型医疗装置的基本结构的图，该图是要设置在图1A和图1B的囊型医疗装置中的电极和柔性线的变形示例的后视图。1C is a diagram illustrating the basic structure of the capsule medical device in the first embodiment of the present invention, which is a rear view of a modified example of electrodes and flexible wires to be provided in the capsule medical device of FIGS. 1A and 1B .

图2是示出本发明第一实施例中的囊型医疗装置和外部装置的框图。Fig. 2 is a block diagram showing a capsule medical device and an external device in the first embodiment of the present invention.

图3是示出本发明第一实施例中的囊型医疗装置在引入到活体中之前的状态的侧视图。Fig. 3 is a side view showing the state of the capsule-type medical device in the first embodiment of the present invention before being introduced into a living body.

图4A和图4B是示出本发明第一实施例中的囊型医疗装置在肠内的推进方式的示意图。4A and 4B are schematic diagrams showing how the capsule medical device is propelled in the intestine in the first embodiment of the present invention.

图5是示出本发明第一实施例中的囊型医疗装置的第一变形示例的侧视图。Fig. 5 is a side view showing a first modified example of the capsule-type medical device in the first embodiment of the present invention.

图6A是示出本发明第一实施例中的囊型医疗装置的第二变形示例的侧视图。Fig. 6A is a side view showing a second modified example of the capsule-type medical device in the first embodiment of the present invention.

图6B是示出本发明第一实施例中的囊型医疗装置的第二变形示例的后视图。Fig. 6B is a rear view showing a second modified example of the capsule-type medical device in the first embodiment of the present invention.

图7A是示出本发明第一实施例中的囊型医疗装置的第二变形示例的侧视图。Fig. 7A is a side view showing a second modified example of the capsule-type medical device in the first embodiment of the present invention.

图7B是示出本发明第一实施例中的囊型医疗装置的第二变形示例的后视图。Fig. 7B is a rear view showing a second modified example of the capsule-type medical device in the first embodiment of the present invention.

图8是示出本发明第一实施例中的囊型医疗装置的第三变形示例的侧视图。Fig. 8 is a side view showing a third modification example of the capsule-type medical device in the first embodiment of the present invention.

图9是该囊型医疗装置的由图8中的阴影线表示的主要部分的放大图。Fig. 9 is an enlarged view of a main part of the balloon medical device indicated by hatching in Fig. 8 .

图10A是示出本发明第一实施例中的囊型医疗装置的第四变形示例的侧视图。Fig. 10A is a side view showing a fourth modified example of the capsule-type medical device in the first embodiment of the present invention.

图10B是示出本发明第一实施例中的囊型医疗装置的第四变形示例的后视图。Fig. 10B is a rear view showing a fourth modified example of the capsule-type medical device in the first embodiment of the present invention.

图11A是示出本发明第一实施例中的囊型医疗装置的第四变形示例的侧视图。Fig. 11A is a side view showing a fourth modified example of the capsule-type medical device in the first embodiment of the present invention.

图11B是示出本发明第一实施例中的囊型医疗装置的第四变形示例的后视图。11B is a rear view showing a fourth modified example of the capsule-type medical device in the first embodiment of the present invention.

图12A至图12C是示出图10A和图10B的囊型医疗装置中的电极的变形示例的图，这些图是电极附近的剖面。12A to 12C are diagrams showing deformation examples of electrodes in the capsule-type medical device of FIGS. 10A and 10B , which are cross sections near the electrodes.

图13A是示出本发明第一实施例中的囊型医疗装置的第五变形示例的侧视图。Fig. 13A is a side view showing a fifth modified example of the capsule-type medical device in the first embodiment of the present invention.

图13B是示出本发明第一实施例中的囊型医疗装置的第五变形示例的后视图。Fig. 13B is a rear view showing a fifth modified example of the capsule-type medical device in the first embodiment of the present invention.

图14A至图14E是示出图13A和图13B的囊型医疗装置中的电极的变形示例的示意图。14A to 14E are schematic diagrams showing modified examples of electrodes in the capsule-type medical device of FIGS. 13A and 13B .

图15A至图15C是示出囊型医疗装置的第五变形示例在大肠内的推进方式的示意图。15A to 15C are schematic diagrams illustrating how the fifth modified example of the capsule medical device is advanced in the large intestine.

图16是示出同一囊型医疗装置的第六变形示例的侧视图。Fig. 16 is a side view showing a sixth modified example of the same balloon-type medical device.

图17A是说明本发明第二实施例中的囊型医疗装置的基本结构的图，该图是该囊型医疗装置的侧视图。Fig. 17A is a diagram illustrating a basic structure of a balloon-type medical device in a second embodiment of the present invention, which is a side view of the balloon-type medical device.

图17B是说明本发明第二实施例中的囊型医疗装置的基本结构的图，该图是该囊型医疗装置的后视图。Fig. 17B is a diagram illustrating a basic structure of a balloon-type medical device in a second embodiment of the present invention, which is a rear view of the balloon-type medical device.

图18是说明本发明第二实施例中的囊型医疗装置的框图。Fig. 18 is a block diagram illustrating a capsule-type medical device in a second embodiment of the present invention.

图19是图18中所示的囊型医疗装置的电极附近的放大图。Fig. 19 is an enlarged view of the vicinity of electrodes of the capsule medical device shown in Fig. 18 .

图20A是说明本发明第二实施例中的囊型医疗装置的基本结构的图，该图是该囊型医疗装置的侧视图。Fig. 20A is a diagram illustrating a basic structure of a balloon-type medical device in a second embodiment of the present invention, which is a side view of the balloon-type medical device.

图20B是说明本发明第二实施例中的囊型医疗装置的基本结构的图，该图是该囊型医疗装置的后视图。Fig. 20B is a diagram illustrating a basic structure of a balloon-type medical device in a second embodiment of the present invention, which is a rear view of the balloon-type medical device.

图21是示出将同一囊型医疗装置引入到活体内、以及根据位置提供电刺激的状态的图。Fig. 21 is a diagram showing a state where the same capsule-type medical device is introduced into a living body, and electrical stimulation is provided according to the position.

图22是示出由该囊型医疗装置拍摄的胃、小肠、大肠和肛门的照片画面的位置示例的图。FIG. 22 is a diagram showing an example of positions of photo frames of the stomach, small intestine, large intestine, and anus taken by the capsule medical device.

图23A是示出本发明第二实施例中的囊型医疗装置的第一变形示例的侧视图。Fig. 23A is a side view showing a first modified example of the capsule-type medical device in the second embodiment of the present invention.

图23B是示出本发明第二实施例中的囊型医疗装置的第一变形示例的后视图。Fig. 23B is a rear view showing a first modified example of the capsule-type medical device in the second embodiment of the present invention.

图24是示出同一囊型医疗装置的第二变形示例的部分剖面图。Fig. 24 is a partial sectional view showing a second modified example of the same balloon-type medical device.

图25A是示出同一囊型医疗装置的第三变形示例的侧视图。Fig. 25A is a side view showing a third modification example of the same balloon-type medical device.

图25B是示出同一囊型医疗装置的第三变形示例的后视图。Fig. 25B is a rear view showing a third modified example of the same balloon-type medical device.

图26是示出本发明第三实施例中的囊型医疗装置的结构的图。Fig. 26 is a diagram showing the structure of a capsule-type medical device in a third embodiment of the present invention.

图27A和图27B是示出在对身体组织提供电刺激时要向电极发送的脉冲信号的波型的示意图。27A and 27B are diagrams showing waveforms of pulse signals to be sent to electrodes when electrical stimulation is provided to body tissue.

图28A是示出本发明第三实施例中的囊型医疗装置的第一变形示例的剖面图。28A is a cross-sectional view showing a first modified example of the balloon-type medical device in the third embodiment of the present invention.

图28B是图28A中所示的囊型医疗装置的第一变形模型的部分放大图。Fig. 28B is a partially enlarged view of a first modified model of the capsule medical device shown in Fig. 28A.

图29A是示出本发明第三实施例中的囊型医疗装置的第二变形示例的侧视图。Fig. 29A is a side view showing a second modified example of the capsule-type medical device in the third embodiment of the present invention.

图29B是示出本发明第三实施例中的囊型医疗装置的第二变形示例的剖面图。Fig. 29B is a cross-sectional view showing a second modified example of the balloon-type medical device in the third embodiment of the present invention.

图30至图32是示出本发明第三实施例中的囊型医疗装置的第三变形示例的侧视图。30 to 32 are side views showing a third modified example of the balloon-type medical device in the third embodiment of the present invention.

图33至图34B是示出本发明第三实施例中的囊型医疗装置的第四变形示例的侧视图。33 to 34B are side views showing a fourth modified example of the capsule-type medical device in the third embodiment of the present invention.

图35是示出本发明第三实施例中的囊型医疗装置的第五变形示例的侧视图。Fig. 35 is a side view showing a fifth modification example of the capsule-type medical device in the third embodiment of the present invention.

图36是示出本发明第三实施例中的囊型医疗装置的第六变形示例的剖面图。Fig. 36 is a sectional view showing a sixth modified example of the balloon-type medical device in the third embodiment of the present invention.

图37是示出本发明第三实施例中的囊型医疗装置的第七变形示例的剖面图。Fig. 37 is a sectional view showing a seventh modified example of the capsule-type medical device in the third embodiment of the present invention.

图38是示出本发明第三实施例中的囊型医疗装置的第八变形示例的剖面图。Fig. 38 is a sectional view showing an eighth modified example of the balloon-type medical device in the third embodiment of the present invention.

图39A至图39C是示出本发明第三实施例中的囊型医疗装置的第九变形示例的剖面图。39A to 39C are cross-sectional views showing a ninth modified example of the balloon-type medical device in the third embodiment of the present invention.

图39D是示出设置在图39A至图39C中所示的囊型医疗装置中的移动构件的剖面图。Fig. 39D is a cross-sectional view showing a moving member provided in the capsule-type medical device shown in Figs. 39A to 39C.

图40A至图40B是示出本发明第三实施例中的囊型医疗装置的第十变形示例的侧视图。40A to 40B are side views showing a tenth modified example of the balloon-type medical device in the third embodiment of the present invention.

图40C是示出本发明第三实施例中的囊型医疗装置的第十变形示例的剖面图。40C is a cross-sectional view showing a tenth modified example of the balloon-type medical device in the third embodiment of the present invention.

图41A和图41B是示出本发明第三实施例中的囊型医疗装置的第十一变形示例的侧视图。41A and 41B are side views showing an eleventh modified example of the capsule-type medical device in the third embodiment of the present invention.

图42A是示出本发明第三实施例中的囊型医疗装置的第十二变形示例的剖面图。42A is a cross-sectional view showing a twelfth modified example of the balloon-type medical device in the third embodiment of the present invention.

图42B是示出本发明第三实施例中的囊型医疗装置的第十二变形示例的斜视图。Fig. 42B is a perspective view showing a twelfth modified example of the capsule-type medical device in the third embodiment of the present invention.

图43A是示出本发明第四实施例中的囊型医疗装置的侧视图。Fig. 43A is a side view showing a capsule-type medical device in a fourth embodiment of the present invention.

图43B和图43C是示出图43A中所示的囊型医疗装置的部分放大图的剖面图。43B and 43C are cross-sectional views showing partial enlarged views of the balloon-type medical device shown in FIG. 43A .

图44A和图44B是示出第四实施例中的囊型医疗装置被引入体腔内的状态的侧视图。44A and 44B are side views showing a state where the balloon-type medical device in the fourth embodiment is introduced into a body cavity.

图45A是示出本发明第五实施例中的囊型医疗装置的剖面图。Fig. 45A is a cross-sectional view showing a capsule-type medical device in a fifth embodiment of the present invention.

图45B是示出本发明第五实施例中的囊型医疗装置的正视图。Fig. 45B is a front view showing a capsule-type medical device in a fifth embodiment of the present invention.

图46A和图46B是示出本发明第六实施例中的内窥镜的部分剖面图的侧视图。46A and 46B are side views showing a partial sectional view of an endoscope in a sixth embodiment of the present invention.

图47A至图47C是示出本发明第六实施例的内窥镜被引入活体腔中的状态的侧视图。47A to 47C are side views showing a state where an endoscope of a sixth embodiment of the present invention is introduced into a living body cavity.

图48是示出本发明第六实施例中的内窥镜的侧视图。Fig. 48 is a side view showing an endoscope in a sixth embodiment of the present invention.

图49A是示出本发明第六实施例中的内窥镜的变形示例的侧视图。Fig. 49A is a side view showing a modified example of the endoscope in the sixth embodiment of the present invention.

图49B是示出本发明第六实施例中的内窥镜的变形示例的剖面图。Fig. 49B is a sectional view showing a modification example of the endoscope in the sixth embodiment of the present invention.

图50A是示出本发明第六实施例中的内窥镜的变形示例的剖面图。Fig. 50A is a sectional view showing a modification example of the endoscope in the sixth embodiment of the present invention.

图50B和图50C是示出本发明第六实施例的内窥镜被引入活体腔中的状态的侧视图。50B and 50C are side views showing a state where the endoscope of the sixth embodiment of the present invention is introduced into a living body cavity.

具体实施方式Detailed ways

下文中，参照附图说明本发明的囊型医疗装置的实施例。Hereinafter, embodiments of the capsule-type medical device of the present invention will be described with reference to the drawings.

参照图1A至图15说明本发明的第一实施例。图1A至图2中所示的囊型医疗装置C1是本实施例中的囊型医疗装置的基本结构。该囊型医疗装置C1包括：拍摄单元(活体内信息获取装置)2；控制单元(电流控制装置)3；无线收发器单元(通信装置)4；以及电池5，用于向作为壳体1内的一个整体的各结构单元供电。而且，该囊型医疗装置C1包括一对电极6及柔性线7。柔性线7用作改变该对电极6之间的距离的电极间距离改变装置。A first embodiment of the present invention will be described with reference to FIGS. 1A to 15 . The capsule medical device C1 shown in FIGS. 1A to 2 is the basic structure of the capsule medical device in this embodiment. The capsule medical device C1 includes: a photographing unit (in vivo information acquisition device) 2; a control unit (current control device) 3; a wireless transceiver unit (communication device) 4; Each structural unit of a whole is powered. Furthermore, the capsule medical device C1 includes a pair ofelectrodes 6 and aflexible wire 7 . Theflexible wire 7 serves as inter-electrode distance changing means that changes the distance between the pair ofelectrodes 6 .

壳体1是沿轴L延伸的囊形，并使用塑料等形成，以密封内部。壳体1的前部中设置有半球形透明圆顶1d。透明圆顶1d内(即前部(沿轴线L的前侧)中)设置有拍摄元件2a和发光元件2b。拍摄元件2a包括用于通过拍摄活体中的部分来获取照片画面的透镜、CCD(电荷耦合器件)等。发光元件2b包括通过发光来对拍摄元件2a的视野进行照明的EL(电致发光元件)、LED(发光二极管)等。通过在活体内进行拍摄来获取活体内信息的拍摄单元2包括拍摄元件2a和发光元件2b。Thehousing 1 is in the shape of a bladder extending along the axis L, and is formed using plastic or the like to seal the inside. A hemisphericaltransparent dome 1d is provided in the front portion of thehousing 1 . A photographingelement 2 a and alight emitting element 2 b are arranged inside thetransparent dome 1 d (ie, in the front part (front side along the axis L)). The photographingelement 2a includes a lens, a CCD (Charge Coupled Device), and the like for taking a picture frame by photographing a part in a living body. Thelight emitting element 2b includes EL (Electro Luminescence Element), LED (Light Emitting Diode), etc. which emit light to illuminate the field of view of theimaging element 2a. Theimaging unit 2 for acquiring in-vivo information by performing imaging in the living body includes animaging element 2 a and alight emitting element 2 b.

无线收发器单元4包括：发送/接收主体(未示出)；以及发送/接收天线(发送天线和接收天线)，其发送和接收无线电波。无线收发器单元4将活体内信息(即，由拍摄元件2a拍摄的照片画面)无线发送到外部装置100(稍后说明)。而且，无线收发器单元4接收从外部装置100无线发送的控制信号(命令)(稍后说明)，并将它们发送到控制单元3。Thewireless transceiver unit 4 includes: a transmitting/receiving body (not shown); and a transmitting/receiving antenna (a transmitting antenna and a receiving antenna) that transmits and receives radio waves. Thewireless transceiver unit 4 wirelessly transmits in-vivo information (ie, a picture frame taken by the photographingelement 2 a ) to an external device 100 (described later). Also, thewireless transceiver unit 4 receives control signals (commands) wirelessly transmitted from the external device 100 (described later) and transmits them to thecontrol unit 3 .

控制单元3具有根据来自无线收发器单元4的控制信号(命令)，综合地控制囊型医疗装置C1内的各部分的操作的功能。而且，在控制单元3中设置有用于通过柔性线7向电极6输送电流的电流生成单元3a。换言之，控制单元3具有作为用于控制要向电极6输送的电流的电流控制装置的功能。Thecontrol unit 3 has a function of comprehensively controlling the operations of various parts inside the capsule medical device C1 according to control signals (commands) from thewireless transceiver unit 4 . Furthermore, in thecontrol unit 3 there is provided acurrent generating unit 3 a for delivering current to theelectrode 6 via theflexible wire 7 . In other words, thecontrol unit 3 has a function as a current control device for controlling the current to be supplied to theelectrode 6 .

这些柔性线7由柔性导电构件制成，并且其基端分别被支承在壳体1的后侧(沿轴L的另一端)。柔性线7以使得各导线与其他导线分开的方式从壳体1伸出，并且各导线的末端支承电极6。换言之，电极6通过柔性线7设置在该壳体的后侧。柔性线7连接到壳体1中的控制单元3，并从电流生成电路3a向各电极6输送电流。而且，柔性线7具有通过弹性变形来改变电极之间的距离的功能。该功能使得能够精确地补偿活体中的内腔器官直径。柔性线优选地由超弹性合金制成。将超弹性合金用于柔性线使得柔性线7比普通金属更具有柔性，因此，活体中内腔器官直径的改变得到更加可靠地抵消(absorb)。Theseflexible wires 7 are made of a flexible conductive member, and base ends thereof are respectively supported on the rear side of the housing 1 (the other end along the axis L). Aflexible wire 7 protrudes from thehousing 1 in such a way that each wire is separated from the other wires, and the end of each wire supports theelectrode 6 . In other words, theelectrodes 6 are arranged on the rear side of the housing viaflexible wires 7 . Aflexible wire 7 is connected to thecontrol unit 3 in thehousing 1 and carries current from thecurrent generating circuit 3 a to therespective electrodes 6 . Also, theflexible wire 7 has a function of changing the distance between electrodes by elastic deformation. This feature enables precise compensation of luminal organ diameters in vivo. The flexible wire is preferably made of a superelastic alloy. Using a superelastic alloy for the flexible wire makes theflexible wire 7 more flexible than ordinary metals, and therefore, changes in the diameter of lumen organs in the living body are more reliably absorbed.

电极6与身体组织接触，并向该身体组织提供电刺激。为了不阻碍囊型医疗装置C1的推进，这些电极6为大致球形。电极6由不锈钢、铂和钛之中的至少一种材料制成，不锈钢、铂和钛均具有高导电率，因而使得能够实现有效的电流流动。而且，这使得电极与活体高度相容。Electrodes 6 are in contact with body tissue and provide electrical stimulation to the body tissue. Theseelectrodes 6 are substantially spherical in order not to impede the advancement of the medical capsule C1. Theelectrode 6 is made of at least one material among stainless steel, platinum, and titanium, each of which has high electrical conductivity, thus enabling efficient current flow. Also, this makes the electrodes highly compatible with living organisms.

电极6之间分离的最大距离(即，电极之间因柔性线7而改变的距离的最大值(X))优选地大于囊型医疗装置C1的外径(D)的两倍(X≥2D)，如图1A和图1B所示。考虑到将囊型医疗装置C1引入活体内的容易性，使囊型医疗装置C1的外径不必要地大不是优选的。例如，约10mm(优选的是约11mm)是适当的。然而，即使是被认为具有内腔器官当中最小的内径之一的小肠的内径也约为20～30mm。因此，为了使电极6向内腔内的身体组织准确地提供电刺激，电极6之间的最大间距应大于该囊型医疗装置的外径的两倍(优选的是大于3倍)。The maximum distance of separation between the electrodes 6 (that is, the maximum value (X) of the distance between electrodes changed by the flexible wire 7) is preferably greater than twice the outer diameter (D) of the capsule medical device C1 (X≥2D ), as shown in Figure 1A and Figure 1B. In consideration of the ease of introducing the capsule medical device C1 into the living body, it is not preferable to make the outer diameter of the capsule medical device C1 unnecessarily large. For example, about 10 mm (preferably about 11 mm) is suitable. However, even the small intestine, which is considered to have one of the smallest inner diameters among lumen organs, has an inner diameter of about 20 to 30 mm. Therefore, in order for theelectrodes 6 to accurately provide electrical stimulation to body tissues in the lumen, the maximum distance between theelectrodes 6 should be greater than twice (preferably greater than 3 times) the outer diameter of the capsule medical device.

而且，柔性线7可以包括：导线构件，其从基端向末端输送电流；以及绝缘构件(例如树脂)，用于对该导线构件进行绝缘和覆盖。或者，可以将裸导线构件与电极6集成，用于向身体组织提供电刺激。如果导线构件是裸露的，则可以保证较大的电接触面积来输送电流，因而可以在向身体组织提供电刺激时，提供电刺激所需的恒定电流量。这里，可以使柔性线为带形(例如由7w表示的导线)，并可以使电极为宽度与该柔性线的宽度基本相同的较宽电极6w，如图1C所示。由此，获得了更大的电接触面积，并且可以实现向身体组织更稳定地提供收缩所需的电流。Also, theflexible wire 7 may include: a lead member that feeds current from a base end to a tip end; and an insulating member (for example, resin) for insulating and covering the lead member. Alternatively, bare wire members may be integrated withelectrodes 6 for providing electrical stimulation to body tissue. If the lead member is bare, a larger electrical contact area can be ensured to carry current, thus providing a constant amount of current required for electrical stimulation when electrical stimulation is provided to body tissue. Here, the flexible wire can be made into a strip shape (for example, a wire indicated by 7w), and the electrode can be made into awider electrode 6w whose width is substantially the same as that of the flexible wire, as shown in FIG. 1C. Thereby, a larger electrical contact area is obtained, and a more stable supply of electric current required for contraction to body tissue can be achieved.

而且，导线本身并不象超弹性合金一样具有高弹性，因而对导线构件进行覆盖和绝缘的绝缘构件由具有超弹性的树脂(超弹性聚合物材料)等制成。因此，可以向柔性线7提供超弹性。此外，以180°的间隔围绕囊型医疗装置设置一对电极6和柔性线7的组合，也可以以90°的间隔设置两对电极(共4个电极)。这使得电极6能够与身体组织更准确地接触。Also, the wire itself does not have high elasticity like a superelastic alloy, so an insulating member covering and insulating the wire member is made of a resin (superelastic polymer material) or the like having superelasticity. Thus, superelasticity can be provided to theflexible wire 7 . In addition, a pair ofelectrodes 6 and aflexible wire 7 are arranged around the capsule medical device at intervals of 180°, and two pairs of electrodes (4 electrodes in total) may be arranged at intervals of 90°. This enables more accurate contact of theelectrodes 6 with body tissue.

外部装置100从活体外部控制囊型医疗装置。如图2所示，外部装置100在该装置的主体(101)内包括：无线收发器单元(发送单元和检测单元)102，用于向囊型医疗装置C1发送信息和从该囊型医疗装置C1接收信息；记录单元103(例如存储器)，用于存储上述活体内信息(即，照片图像)；控制单元104，用于控制各单元；以及电池105，用于向各单元供电。Theexternal device 100 controls the capsule medical device from outside the living body. As shown in Figure 2, theexternal device 100 includes in the main body (101) of the device: a wireless transceiver unit (transmitting unit and detecting unit) 102, which is used to send information to and from the capsule medical device C1 C1 receives information; a recording unit 103 (such as a memory) for storing the above-mentioned in-vivo information (ie, photographic images); acontrol unit 104 for controlling each unit; and abattery 105 for supplying power to each unit.

该装置的主体101由金属(例如，铝)和塑料形成为箱形，并且可以使用带(belt)等安装在接受检查的人的身上。由此，接受检查的人可以将外部装置100始终戴在活体上。与囊型医疗装置C1的无线收发器单元4相同的是，无线收发器单元102包括：发送/接收单元的主体(未示出)；以及发送/接收天线(发送天线和接收天线)，用于发送和接收无线电波。无线收发器单元102接收从囊型医疗装置C1无线发送的活体内信息(即，照片图像)，并将该图像发送到控制单元104。Themain body 101 of this device is formed in a box shape from metal (for example, aluminum) and plastic, and can be mounted on the body of a person to be examined using a belt or the like. Thus, the person to be examined can always wear theexternal device 100 on the living body. Same as thewireless transceiver unit 4 of the capsule medical device C1, thewireless transceiver unit 102 includes: a main body (not shown) of a transmitting/receiving unit; and a transmitting/receiving antenna (a transmitting antenna and a receiving antenna) for Send and receive radio waves. Thewireless transceiver unit 102 receives the in-vivo information (ie, photographic image) wirelessly transmitted from the capsule medical device C1 , and transmits the image to thecontrol unit 104 .

控制单元104执行预定处理，例如对接收到的照片图像进行图像处理，然后总是将该图像记录在记录单元103中。而且，控制单元104中嵌入有用于检测囊型医疗装置C1在活体内的位置的位置检测电路104a。在位置检测电路104a中，预设了设定图像(基准图像)，并且该电路通过将接收到的照片图像与该设定图像进行比较，来检测囊型医疗装置C1在活体内的位置。这里，位置检测电路104a通过将照片图像与设定图像进行比较来检测囊型医疗装置C1的位置，也可以根据照片图像内的预定颜色、形状等其他特征来检测囊型医疗装置C1的位置。Thecontrol unit 104 performs predetermined processing such as image processing on a received photo image, and then always records the image in therecording unit 103 . Also, aposition detection circuit 104a for detecting the position of the capsule medical device C1 within the living body is embedded in thecontrol unit 104 . In theposition detection circuit 104a, a set image (reference image) is preset, and the circuit detects the position of the capsule medical device C1 within the living body by comparing a received photograph image with the set image. Here, theposition detection circuit 104a detects the position of the capsule medical device C1 by comparing the photographic image with the set image, and may also detect the position of the capsule medical device C1 based on other features such as predetermined color and shape in the photographic image.

而且，位置检测电路104a可以根据从无线收发器单元4向活体外部发送的、或者从活体外接收到的无线电波的强度(而不是照片图像)来检测位置。在这种情况下，在外部装置100侧的无线发送/接收单元上设置有多个天线，根据多个天线的位置以及无线电波的强度，通过三角测量法等计算位置。此外，可以通过在囊型医疗装置C1或外部装置100上安装磁场生成线圈或磁传感器，并检测活体内生成的外部磁场或内部地检测该活体外部生成的磁场，来计算位置。Also, theposition detection circuit 104a can detect the position based on the intensity of radio waves transmitted from thewireless transceiver unit 4 to outside the living body or received from outside the living body instead of the photo image. In this case, multiple antennas are provided on the wireless transmission/reception unit on theexternal device 100 side, and the position is calculated by triangulation or the like based on the positions of the multiple antennas and the intensity of radio waves. In addition, the position can be calculated by installing a magnetic field generating coil or a magnetic sensor on the capsule medical device C1 or theexternal device 100 and detecting an external magnetic field generated inside the living body or internally detecting the magnetic field generated outside the living body.

而且，控制单元104通过无线收发器单元102发送与其位置由位置检测电路104a检测的囊型医疗装置周围的身体组织(例如，胃、小肠或大肠)相对应的控制信号。Also, thecontrol unit 104 transmits a control signal corresponding to the body tissue (eg, stomach, small intestine, or large intestine) around the capsule medical device whose position is detected by theposition detection circuit 104 a through thewireless transceiver unit 102 .

接下来，说明以下情况：使用具有上述结构的囊型医疗装置C1对接受检查的人的活体的内部进行检查。Next, a case will be described in which the inside of a living body of a person to be inspected is inspected using the capsule medical device C1 having the above-mentioned configuration.

首先，接受检查的人使用带等佩戴外部装置100。然后，该人从口中吃下(吞下)囊型医疗装置C1，以在活体内部署该囊型医疗装置C1。在吞下囊型医疗装置C1之前，使用可由身体吸收的材料(例如淀粉)制成的线捆扎带(线捆扎装置)对柔性线7进行相互预捆扎，如图3所示。这使得在吞下囊型医疗装置C1的过程中可能由柔性线7和电极6导致的障碍最小化。在囊型医疗装置C1中设置有开关(未示出)。在吞下囊型医疗装置C1时打开该开关，使得能够从电池5向各组件供电。由此，控制单元3驱动拍摄单元2(即，拍摄元件2a和发光元件2b)。First, a person to be examined wears theexternal device 100 using a belt or the like. Then, the person ingests (swallows) the capsule-type medical device C1 from the mouth to deploy the capsule-type medical device C1 in the living body. Before swallowing the capsule medical device C1 , theflexible wires 7 are mutually pre-bundled using a wire binding tape (wire binding device) made of a body absorbable material such as starch, as shown in FIG. 3 . This minimizes possible obstructions caused by theflexible wire 7 and theelectrodes 6 during swallowing of the medical capsule C1 . A switch (not shown) is provided in the capsule medical device C1. This switch is turned on when the medical capsule C1 is swallowed, so that power can be supplied from thebattery 5 to each component. Thus, thecontrol unit 3 drives the imaging unit 2 (that is, theimaging element 2a and thelight emitting element 2b).

被引入活体内的囊装医疗装置C1随着该装置在消化道内移动而使用拍摄元件2a拍摄活体内的部分。同时，其从无线收发器单元4向外部装置100发送照片图像。同时，外部装置100通过无线收发器单元102接收这些照片图像，并使用控制单元104对这些照片图像执行图像处理，并且将这些图像连续地存储在存储单元103中。控制单元104通过无线收发器单元102连续地发送与其位置由位置检测电路104a检测的囊装医疗装置周围的身体组织(例如，胃、小肠或大肠)相对应的控制信号。The packaged medical device C1 introduced into the living body uses theimaging element 2a to image parts of the living body as the device moves in the digestive tract. At the same time, it transmits photo images from thewireless transceiver unit 4 to theexternal device 100 . Meanwhile, theexternal device 100 receives these photo images through thewireless transceiver unit 102 , performs image processing on the photo images using thecontrol unit 104 , and continuously stores the images in thestorage unit 103 . Thecontrol unit 104 continuously sends control signals through thewireless transceiver unit 102 corresponding to the body tissue (eg, stomach, small intestine or large intestine) around the encapsulated medical device whose position is detected by theposition detection circuit 104a.

在到达胃时，囊型医疗装置C1的线捆扎带7B被胃酸溶解并在活体内被吸收。这使电极6和柔性线7从它们的捆扎状态中释放，使电极之间的距离发生改变。由此，操作者在观察照片图像的同时，通过根据需要向身体组织(例如，胃、小肠、大肠及其他)提供电刺激来推进囊型医疗装置C1。实际上，照片图像的快速变化表示囊型医疗装置C1移动太快。因此，操作者减少向电极6输送电流的次数，以减小囊型医疗装置C1的速度。另一方面，该照片图像的几乎不改变表示囊型医疗装置C1几乎不移动。因此，操作者提高向电极6输送电流的频率，这提高了囊型医疗装置C1的移动速度。When reaching the stomach, thewire binding band 7B of the capsule medical device C1 is dissolved by gastric acid and absorbed in the living body. This releases theelectrodes 6 and theflexible wire 7 from their bundled state, causing the distance between the electrodes to change. Thus, the operator advances the capsule-type medical device C1 by providing electrical stimulation to body tissues (eg, stomach, small intestine, large intestine, and others) as needed while observing the photographic image. In fact, the rapid change of the photo image indicates that the capsule medical device C1 is moving too fast. Therefore, the operator reduces the number of times the current is delivered to theelectrode 6 to reduce the speed of the medical capsule C1. On the other hand, little change in the photo image indicates that the capsule medical device C1 hardly moves. Therefore, the operator increases the frequency of delivering current to theelectrode 6, which increases the moving speed of the medical capsule C1.

接下来，图4A和图4B中示出了囊型医疗装置C1在经过胃和十二指肠之后到达小肠I的状态。在这种情况下，控制单元3从外部装置100接收到命令提供电刺激的控制信号而向电极6输送电流，并向小肠I的壁Iw提供电刺激，如图4B所示。电刺激位置附近的小肠I收缩，这导致向前推进被小肠I的收缩而推动的囊型医疗装置，如图4B所示。此时，柔性线随着小肠I的收缩而弹性变形，从而小肠I的直径的改变得到了精确的补偿。由此，囊型医疗装置在小肠I内的移动与通过小肠I的自主蠕动而移动的情况相比更加精确。因此，缩短了观察所需的时间，使得能够有效观察肠的内部。Next, a state where the capsule-type medical device C1 reaches the small intestine I after passing through the stomach and the duodenum is shown in FIGS. 4A and 4B . In this case, thecontrol unit 3 receives a control signal commanding to provide electrical stimulation from theexternal device 100 to deliver current to theelectrode 6 and provide electrical stimulation to the wall Iw of the small intestine I, as shown in FIG. 4B . The small intestine I near the site of electrical stimulation is contracted, which results in forward advancement of the balloon medical device pushed by the contraction of the small intestine I, as shown in Figure 4B. At this time, the flexible wire is elastically deformed with the contraction of the small intestine I, so that the change in the diameter of the small intestine I is accurately compensated. Thus, the movement of the capsule-type medical device in the small intestine I is more precise than the case of moving by the voluntary peristalsis of the small intestine I. Therefore, the time required for observation is shortened, enabling efficient observation of the inside of the intestine.

囊型医疗装置C1接下来按照与以上类似的方式通过大肠，并从肛门排出到活体外。医生等根据记录在外部装置100的记录单元103中的活体内信息(即，照片图像)对该人的健康状况进行检查。The capsule medical device C1 then passes through the large intestine in a manner similar to the above, and is discharged out of the living body through the anus. A doctor or the like checks the person's health status based on in-vivo information (ie, photographic images) recorded in therecording unit 103 of theexternal device 100 .

与如上所述根据照片图像的变化来估计囊型医疗装置C1的移动速度不同，可以设置诸如速度传感器或加速度传感器的移动速度检测装置来检测囊型医疗装置的移动速度，以根据该传感器的检测结果仅在囊型医疗装置C1内调整用于电刺激的电流的量和定时。由此，囊型医疗装置C1可以与外部装置100无关地以恒定速度自动地移动并获取活体内信息。仅需要外部装置100来接收和记录由囊型医疗装置C1获取的活体内信息，因此处理变得简单。Different from estimating the moving speed of the capsule medical device C1 according to the change of the photo image as described above, a moving speed detection device such as a speed sensor or an acceleration sensor can be provided to detect the moving speed of the capsule medical device, so as to detect the moving speed of the capsule medical device according to the sensor detection As a result the amount and timing of the electrical current used for electrical stimulation is adjusted only within medical capsule C1. Thus, the capsule medical device C1 can automatically move at a constant speed regardless of theexternal device 100 and acquire in-vivo information. Only theexternal device 100 is required to receive and record the in-vivo information acquired by the capsule medical device C1, so the processing becomes simple.

而且，由于未执行对照片图像的处理，所以没有必要在囊型医疗装置C1上安装照片传感器。因此，可以毫无问题地在囊型医疗装置上安装具有照片功能之外的功能的活体内信息获取传感器。顺便提及，该活体内信息获取传感器可以包括：pH传感器，用于获取活体中的pH值；超声波传感器或光断层(alight shielding layer)传感器，用于获取内腔器官的壁内部的剖面图像；微波图像传感器，用于生成诸如肿瘤的特定身体组织的图像；温度传感器，用于检测温度；出血传感器，用于检测活体内的出血；用于检测由特定疾病区域产生的诸如酶的化学物质的化学传感器；以及用于检测肠内的细菌的存在以及细菌的量的化学传感器。Also, since the processing of the photo image is not performed, it is not necessary to mount the photo sensor on the capsule medical device C1. Therefore, the in-vivo information acquisition sensor having functions other than the photographic function can be mounted on the capsule-type medical device without any problem. Incidentally, the in vivo information acquisition sensor may include: a pH sensor for acquiring a pH value in a living body; an ultrasonic sensor or an alight shielding layer sensor for acquiring a sectional image of the inside of a wall of a lumen organ; Microwave image sensors for generating images of specific body tissues such as tumors; temperature sensors for detecting temperature; bleeding sensors for detecting bleeding in living bodies; a chemical sensor; and a chemical sensor for detecting the presence and amount of bacteria in the intestine.

由于该囊型医疗装置C1包括柔性线7作为用于改变电极之间的距离的电极间距离改变装置，所以准确地使电极6与身体组织接触，并提供电刺激。这使得身体组织能够准确地执行收缩动作。因此，可以实现对囊型医疗装置C1的稳定推进。Since this capsule-type medical device C1 includes theflexible wire 7 as inter-electrode distance changing means for changing the distance between electrodes, theelectrodes 6 are accurately brought into contact with body tissue, and electrical stimulation is provided. This allows body tissues to perform contraction movements accurately. Therefore, stable propulsion of the capsule-type medical device C1 can be achieved.

而且，由于电极6是由不锈钢、铂、钛或其他材料制成的，所以实现了高导电率和有效电流流动。此外，还为电极6提供了高身体相容性。Also, since theelectrode 6 is made of stainless steel, platinum, titanium or other materials, high conductivity and efficient current flow are achieved. Furthermore, high body compatibility is also provided for theelectrode 6 .

而且，由于该电极间距离改变装置包括向外伸出的、基端由壳体1支承且末端支承电极6的柔性线，因此该电极间距离改变装置的结构简单。此外，柔性线7易于弹性变形。因此，通过在内腔器官内部署该囊型医疗装置C1，内腔器官直径的变化得到了精确的补偿，因而准确地使电极6与身体组织接触。Moreover, since the inter-electrode distance changing device includes a flexible wire protruding outward, the base end of which is supported by thehousing 1 and the distal end supports theelectrode 6, the structure of the inter-electrode distance changing device is simple. Furthermore, theflexible wire 7 is easily elastically deformable. Therefore, by deploying the medical capsule C1 within the luminal organ, variations in the diameter of the luminal organ are accurately compensated, thereby accurately bringing theelectrode 6 into contact with body tissue.

而且，在柔性线7由超弹性合金制成的情况下，该柔性线变得可以产生很大变形，这使得能够更加精确地补偿活体内的内腔器官直径的变化。Also, in the case where theflexible wire 7 is made of a superelastic alloy, the flexible wire becomes highly deformable, which makes it possible to more accurately compensate for variations in the diameter of lumen organs in the living body.

而且，由于利用由活体吸收材料制成的线捆扎带7B将柔性线7的末端相互捆扎在一起，所以在吞下囊型医疗装置C1时，电极6和柔性线7不会导致问题，使得能够在活体内容易地部署该囊型医疗装置。在吞下该囊型医疗装置之后，线捆扎带7B被胃酸溶解并在活体中被吸收。因此，松开了柔性线7之间的捆扎，使得能够改变电极6之间的距离。Also, since the ends of theflexible wire 7 are bound to each other with thewire binding tape 7B made of bioabsorbable material, theelectrodes 6 and theflexible wire 7 do not cause problems when the capsule-type medical device C1 is swallowed, making it possible to The balloon medical device is easily deployed in vivo. After swallowing the capsule-type medical device, thewire binding tape 7B is dissolved by gastric acid and absorbed in the living body. Thus, the binding between theflexible wires 7 is loosened, enabling the distance between theelectrodes 6 to be varied.

接下来，示出上述第一实施例中的囊型医疗装置C1的变形示例。Next, a modification example of the capsule-type medical device C1 in the first embodiment described above is shown.

这里，囊型医疗装置C1的诸如拍摄单元2(拍摄元件2a和发光元件2b)、控制单元3、无线收发器单元4和电池5的各个结构元件是按照类似的方式设置在以下囊型医疗装置的各个变形示例中的公共结构元件。这里，在以下示例中，省略对这些结构元件的表示和详细描述。而且，与囊型医疗装置C1中的结构元件类似的其他结构元件由相同的符号表示，并省略对其的详细描述。Here, the respective structural elements of the capsule medical device C1 such as the imaging unit 2 (imaging element 2a and light emittingelement 2b), thecontrol unit 3, thewireless transceiver unit 4 and thebattery 5 are arranged in the following capsule medical device in a similar manner The common structural elements in each variant example of . Here, in the following examples, representation and detailed description of these structural elements are omitted. Also, other structural elements similar to those in the capsule-type medical device C1 are denoted by the same symbols, and detailed descriptions thereof are omitted.

图5示出了第一变形示例。Fig. 5 shows a first modified example.

在囊型医疗装置C2中，在上述囊型医疗装置C1的壳体1的前侧(沿轴的另一边缘侧)上设置有一对前侧电极(第二电极)8。而且，设置有作为改变该对前侧电极8之间的距离的第二电极间距离改变装置的前侧柔性线9。这些前侧电极8和前侧柔性线9实质上具有与电极6和柔性线7相同的结构。In the capsule-type medical device C2, a pair of front-side electrodes (second electrodes) 8 are provided on the front side (the other edge side along the axis) of thecase 1 of the capsule-type medical device C1 described above. Also, a front-sideflexible wire 9 is provided as a second inter-electrode distance changing means for changing the distance between the pair of front-side electrodes 8 . Thesefront electrodes 8 and frontflexible wires 9 have substantially the same structure as theelectrodes 6 andflexible wires 7 .

在壳体1的前侧(沿轴L的另一端)处但在透明圆顶1d的后侧处支承前侧柔性线9的基端。前侧柔性线9以使得各导线可以远离另一导线移动的方式从壳体1伸出到外部，并支承前侧电极8。换言之，电极8通过柔性线9设置在壳体1的前侧，并与拍摄单元2分开。因此，电极8不妨碍由拍摄单元2进行的拍摄。The base end of the frontflexible wire 9 is supported at the front side of the housing 1 (the other end along the axis L) but at the rear side of thetransparent dome 1d. The front sideflexible wire 9 protrudes from thecase 1 to the outside in such a manner that each lead wire can move away from the other lead wire, and supports thefront side electrode 8 . In other words, theelectrode 8 is arranged on the front side of thehousing 1 through theflexible wire 9 and is separated from the photographingunit 2 . Therefore, theelectrode 8 does not interfere with the imaging by theimaging unit 2 .

而且，将前侧柔性线9连接到壳体1内的控制单元3(图2中所示的)，并从电流生成电路3a向各前侧电极8输送电流，并且通过弹性变形的方式来改变前侧电极8之间的距离。该控制单元具有作为第二电流控制装置的功能，其根据来自无线收发器单元4的控制信号(命令)控制要输送到前侧电极8的电流，而与对要输送到电极6的电流的控制无关。Moreover, the front sideflexible wire 9 is connected to the control unit 3 (shown in FIG. 2 ) inside thecasing 1, and the current is supplied from thecurrent generation circuit 3a to eachfront side electrode 8, and changes by means of elastic deformation. The distance between theelectrodes 8 on the front side. The control unit has a function as a second current control device, which controls the current to be delivered to thefront side electrode 8 according to the control signal (command) from thewireless transceiver unit 4, unlike the control of the current to be delivered to theelectrode 6. irrelevant.

在囊型医疗装置C2中，前侧电极8和前侧柔性线9与设置在壳体1的后部的电极6和柔性线7相分离地设置在壳体1的前部，并且对要输送的电流进行独立的控制，使得囊型医疗装置C2能够在活体内自由地向前和向后移动。换言之，囊型医疗装置C2通过设置在壳体1的后侧的电极6对身体组织进行电刺激而向前移动，并且通过设置在壳体1的前侧的前侧电极8对身体组织进行电刺激而向后移动。由此，操作者可以在诸如小肠和大肠的内腔器官中，例如在观察照片图像的同时，根据需要向前或向后移动囊型医疗装置C2，这提高了操作能力。而且，操作者可以容易地操纵该装置，而与囊型医疗装置C2从狭窄的内腔器官的哪个方向(前侧或后侧)进入无关。此外，由于向前和向后移动都是可用的，因此可以观察内腔器官中的任何可能的位置。In the capsule type medical device C2, thefront electrode 8 and the frontflexible wire 9 are provided at the front of thehousing 1 separately from theelectrodes 6 and theflexible wire 7 provided at the rear of thehousing 1, and are used to deliver The electric current is independently controlled, so that the capsule medical device C2 can freely move forward and backward in the living body. In other words, the capsule medical device C2 moves forward by electrically stimulating the body tissue through theelectrode 6 disposed on the rear side of thehousing 1, and electrically stimulates the body tissue through thefront electrode 8 disposed on the front side of thehousing 1. stimulated to move backwards. Thereby, the operator can move the capsule-type medical device C2 forward or backward as necessary, for example, while observing photographic images in lumen organs such as the small intestine and the large intestine, which improves operability. Also, the operator can easily manipulate the device regardless of which direction (front side or rear side) the capsule medical device C2 enters from the narrow lumen organ. Furthermore, since both forward and backward movements are available, any possible position in the luminal organ can be observed.

这里，控制单元3具有作为第一电流控制装置的功能和作为第二电流控制装置的功能，但是可以将两个控制单元3设置成一个用作第一电流控制装置而另一个用作第二电流控制装置。而且，可以将拍摄单元设置在壳体1的后部。由此，可以观察内腔器官中的任何可能的位置。Here, thecontrol unit 3 has a function as the first current control means and a function as the second current control means, but twocontrol units 3 may be provided such that one serves as the first current control means and the other serves as the second current control means. control device. Also, the photographing unit may be provided at the rear of thecasing 1 . Thereby, any possible position in the luminal organ can be observed.

图6A至图7B示出了第二变形示例。6A to 7B show a second modified example.

囊型医疗装置C3的壳体11的结构与上述囊型医疗装置C1的壳体的结构不同。在囊型医疗装置C3的壳体11中，沿外圆周形成有用于存储电极6和柔性线7的槽11g。在将囊型医疗装置C3部署在活体内之前，利用由活体吸收材料(例如淀粉)制成的线捆扎带(线固定装置)将电极6和柔性线7预先固定在槽11g内，如图6A和图6B所示。由此，在吞下囊型医疗装置C3时，柔性线7和电极6不会成为障碍。The structure of thehousing 11 of the capsule medical device C3 is different from the structure of the housing of the capsule medical device C1 described above. In thecase 11 of the capsule-type medical device C3, agroove 11g for thestorage electrode 6 and theflexible wire 7 is formed along the outer circumference. Before the capsule medical device C3 is deployed in the living body, theelectrode 6 and theflexible wire 7 are pre-fixed in thegroove 11g by using a wire binding tape (wire fixing device) made of bioabsorbable material (such as starch), as shown in Figure 6A and shown in Figure 6B. Thereby, theflexible wire 7 and theelectrode 6 do not become obstacles when the capsule medical device C3 is swallowed.

在到1达胃中时，囊型医疗装置C3的线捆扎带被胃酸溶解并在活体内被吸收。这使得电极6和柔性线7从它们的捆扎状态松开，使电极6之间的距离发生改变，如图7A和7B所示。When reaching the stomach, the wire binding band of the capsule medical device C3 is dissolved by gastric acid and absorbed in the living body. This causes theelectrodes 6 and theflexible wire 7 to be released from their bundled state, causing the distance between theelectrodes 6 to change, as shown in Figures 7A and 7B.

在囊型医疗装置C3中，沿壳体11的外圆周形成有用于存储电极6和柔性线7的槽11g。因此，以使存储空间最小化的方式存储柔性线7，并且在未使用电极6时，柔性线7不从壳体11的外表面伸出。In the capsule type medical device C3 , agroove 11 g for thestorage electrode 6 and theflexible wire 7 is formed along the outer circumference of thecase 11 . Therefore, theflexible wire 7 is stored in such a manner as to minimize the storage space, and theflexible wire 7 does not protrude from the outer surface of thecase 11 when theelectrode 6 is not used.

而且，由于使用由活体吸收材料制成的线捆扎带11B将电极6和柔性线7固定在槽11g内，所以在吞下囊型医疗装置C3时，电极6和柔性线7不会成为障碍，使得能够在活体内容易地部署。在部署之后，线捆扎带11B被胃酸溶解并在活体内被吸收，电极6和柔性线7被松开，因而电极6之间的距离自由地改变。因此，实现了在活体内精确操作电极6和柔性线。Moreover, since theelectrode 6 and theflexible wire 7 are fixed in thegroove 11g using thewire binding band 11B made of bioabsorbable material, theelectrode 6 and theflexible wire 7 do not become an obstacle when the capsule medical device C3 is swallowed, enabling easy deployment in vivo. After deployment, thewire binding tape 11B is dissolved by stomach acid and absorbed in the living body, theelectrodes 6 and theflexible wire 7 are loosened, and thus the distance between theelectrodes 6 is freely changed. Thus, precise manipulation of theelectrode 6 and the flexible wire within the living body is achieved.

图8和图9描述了第三变形示例。8 and 9 describe a third modified example.

囊型医疗装置C4的壳体12的结构与上述囊型医疗装置C1的壳体的结构不同。另外，柔性线71的结构与上述囊型医疗装置C1的柔性线的结构不同。在囊型医疗装置C4的壳体12中，在壳体12内设置有用于单独存储柔性线71和电极6的线存储单元21。The structure of thehousing 12 of the capsule medical device C4 is different from the structure of the housing of the capsule medical device C1 described above. In addition, the structure of theflexible wire 71 is different from the structure of the flexible wire of the balloon medical device C1 described above. In thehousing 12 of the capsule-type medical device C4 , awire storage unit 21 for individually storing theflexible wire 71 and theelectrodes 6 is provided inside thehousing 12 .

线存储单元21具有以凹槽形状形成在壳体12的后部的开口21h。电极6和柔性线71可以通过开口21h而出现在外部或从外部消失。线存储单元21内支承有自由旋转的旋转轴21r。将柔性线71的各基端连接到旋转轴21r。电流从控制单元3通过旋转轴21r和柔性线71流到电极6。Thewire storage unit 21 has anopening 21 h formed in a groove shape at the rear of thehousing 12 . Theelectrode 6 and theflexible wire 71 may appear or disappear from the outside through theopening 21h. In thewire storage unit 21, a rotating shaft 21r freely rotatable is supported. Each base end of theflexible wire 71 is connected to the rotation shaft 21r. Electric current flows from thecontrol unit 3 to theelectrode 6 through the rotating shaft 21r and theflexible wire 71 .

柔性线71由形状记忆合金制成，并被赋予以下的形状记忆特性：在30℃或更低的温度下处于线圈状缠绕状态，而在35℃或更高的温度下恢复成近似直线形状。在将囊型医疗装置C4部署到活体中之前，柔性线71处于室温(约25℃)下，因而柔性线71在它们的大致线圈状缠绕状态下存储在线存储单元21中。而且，在将囊型医疗装置C4部署到活体内之后，柔性线71处于接近体温条件(约36℃)下，因而该柔性线恢复成接近直线状态。因此，一旦吞下囊型医疗装置C4，柔性线71就可以从线存储单元21中自动地展开。Theflexible wire 71 is made of a shape memory alloy, and is endowed with a shape memory characteristic of being in a coil-like winding state at a temperature of 30°C or lower and returning to an approximately linear shape at a temperature of 35°C or higher. Before deploying the capsule-type medical device C4 into a living body, theflexible wires 71 are at room temperature (about 25° C.), and thus theflexible wires 71 are stored in thewire storage unit 21 in their substantially coil-like wound state. Also, after the medical capsule C4 is deployed into the living body, theflexible wire 71 is in a condition close to body temperature (about 36° C.), so the flexible wire returns to a nearly straight state. Thus, theflexible wire 71 can be automatically deployed from thewire storage unit 21 once the medical capsule C4 is swallowed.

在囊型医疗装置C4中，将电极6和柔性线71存储在电极存储单元21内，以使得在吞下囊型医疗装置C4时没有物体从壳体12伸出，从而使得能够容易地吞下囊型医疗装置C4。在该囊型医疗装置被引入到活体中并且温度上升到接近体温之后，电极6和柔性线71展开并进行操作，对身体组织准确地提供电刺激。In the capsule-type medical device C4, theelectrodes 6 and theflexible wire 71 are stored in theelectrode storage unit 21 so that no object protrudes from thehousing 12 when the capsule-type medical device C4 is swallowed, thereby enabling easy swallowing Capsule medical device C4. After the capsule-type medical device is introduced into a living body and the temperature rises to close to body temperature, theelectrodes 6 andflexible wires 71 are deployed and operated to accurately provide electrical stimulation to body tissues.

本发明的囊型医疗装置优选地还包括用于对线存储单元的内部进行加热的加热装置，并且柔性线优选地具有以下的形状记忆特性：在40℃或更高的温度下，从大致线圈状缠绕状态恢复成直线形状。The pouch-type medical device of the present invention preferably further includes heating means for heating the inside of the wire storage unit, and the flexible wire preferably has the following shape memory properties: The winding state returns to a linear shape.

这里，可以赋予柔性线71以下的形状记忆特性：在高于40℃的温度下，柔性线71从它们的线圈状缠绕状态恢复成接近直线形状。另外，可以设置由控制单元3控制并对线存储单元21的内部进行加热的加热装置(未示出)。如果在将囊型医疗装置C4引入到导活体中之前使柔性线71记忆这种形状，则由于柔性线71在部署到活体中之前处于室温(约25℃)下，所以可以以围绕旋转轴21r的大致线圈状缠绕状态存储柔性线71。即使在进入活体之后，柔性线71也保持在低于40℃的体温(约35℃)下，因此，柔性线71维持初始形状地保持在线存储单元21内。而且，当通过加热装置的操作使线存储单元21内的温度上升到高于40℃时，柔性线恢复成直线形状。因此，通过在吞下囊型医疗装置C4之后驱动加热装置进行操作，使得可以在活体内的期望位置处从线存储单元21中展开柔性线。Here, theflexible wires 71 can be imparted with a shape memory characteristic that, at a temperature higher than 40° C., theflexible wires 71 return from their coil-like winding state to a nearly linear shape. In addition, a heating device (not shown) controlled by thecontrol unit 3 and heating the inside of thewire storage unit 21 may be provided. If theflexible wire 71 memorizes this shape before introducing the capsule-type medical device C4 into the living body, since theflexible wire 71 is at room temperature (about 25° C.) before being deployed into the living body, it is possible to rotate around the rotation axis 21r Theflexible wire 71 is stored in a substantially coil-like wound state. Even after entering the living body, theflexible wire 71 is maintained at a body temperature (about 35° C.) lower than 40° C., and therefore, theflexible wire 71 is held in thewire storage unit 21 maintaining the original shape. Also, when the temperature inside thewire storage unit 21 rises above 40° C. by the operation of the heating device, the flexible wire returns to a straight shape. Therefore, by driving the heating device to operate after swallowing the capsule-type medical device C4, it becomes possible to deploy the flexible wire from thewire storage unit 21 at a desired position in the living body.

在囊型医疗装置C4中，将电极6和柔性线71存储在电极存储单元21内，以使得在吞下囊型医疗装置C4时没有物体从壳体12中伸出，从而使得能够容易地吞下囊型医疗装置C4。通过使加热装置在囊型医疗装置C4被引入到活体中之后进行操作，电极6和柔性线71被展开并进行操作，并对身体组织准确地提供电刺激。In the capsule medical device C4, theelectrode 6 and theflexible wire 71 are stored in theelectrode storage unit 21 so that no object protrudes from thecasing 12 when the capsule medical device C4 is swallowed, thereby enabling easy swallowing. Subcapsular medical device C4. By causing the heating device to operate after the capsule-type medical device C4 is introduced into the living body, theelectrodes 6 and theflexible wire 71 are deployed and operated, and accurately provide electrical stimulation to body tissues.

图10A至图12C描述了第四变形示例。10A to 12C describe a fourth modified example.

该囊型医疗装置C5的电极间距离改变装置的结构与上述囊型医疗装置C1的电极间距离改变装置的结构不同。该囊型医疗装置C5包括一对外壳单元72a、72b。在这对外壳单元72a、72b上固定有多个电极，并且该对外壳单元72a、72b以这些外壳单元相对于壳体13彼此远离地向外移动的方式安装在壳体13的外部。The configuration of the inter-electrode distance changing device of the capsule medical device C5 is different from the configuration of the inter-electrode distance changing device of the capsule medical device C1 described above. The capsule medical device C5 includes a pair ofhousing units 72a, 72b. A plurality of electrodes are fixed on the pair ofhousing units 72 a , 72 b , and the pair ofhousing units 72 a , 72 b are mounted outside thehousing 13 in such a manner that the housing units move outward relative to thehousing 13 away from each other.

各外壳单元72a、72b具有半球形状，并按照以下方式安装在壳体13上：该半球沿壳体13的长度从中心附近覆盖到壳体13的后边缘部分。在外壳单元72a、72b关闭的状态下，沿壳体13的长度从中心附近直到后边缘部分被外壳单元72a、72b覆盖，如图10A和10B所示。在外壳单元72a、72b与壳体13之间，安装有沿径向向外推各个外壳单元72a、72b的弹簧72s。而且，在外壳单元72a、72b的外部固定有多个电极61。各个电极61电连接到控制单元3，电流从该控制单元3中流出。Eachhousing unit 72a, 72b has a hemispherical shape, and is mounted on thehousing 13 in such a manner that the hemisphere covers from the vicinity of the center to the rear edge portion of thehousing 13 along the length of thehousing 13 . In a state where thehousing units 72a, 72b are closed, the length of thehousing 13 is partially covered by thehousing units 72a, 72b from near the center to the rear edge, as shown in FIGS. 10A and 10B. Between thehousing units 72a, 72b and thehousing 13, a spring 72s that urges therespective housing units 72a, 72b radially outward is installed. Furthermore, a plurality ofelectrodes 61 are fixed to the outside of thecasing units 72a, 72b. Eachelectrode 61 is electrically connected to thecontrol unit 3 from which the current flows.

而且，在囊型医疗装置C5中，设置有由控制单元3控制的、用于保持和释放外壳单元72a、72b的接合装置(未示出)。在将囊型医疗装置C5引入活体之前，通过该接合装置使外壳单元72a、72b停止在关闭状态，如图10A和图10B所示。在将囊型医疗装置C5引入到活体中之后，控制单元3控制该接合装置，解除外壳单元72a、72b的接合状态，如图11A和11B所示。外壳单元72a、72b被弹簧72s推动而向外移动，并开始操作，从而使得能够自由地改变电极61之间的距离。Also, in the capsule-type medical device C5, engaging means (not shown) for holding and releasing thehousing units 72a, 72b controlled by thecontrol unit 3 are provided. Before introducing the capsule-type medical device C5 into the living body, thehousing units 72a, 72b are stopped in the closed state by the engagement means, as shown in FIGS. 10A and 10B . After the capsule medical device C5 is introduced into the living body, thecontrol unit 3 controls the engagement means, releasing the engagement state of thehousing units 72a, 72b, as shown in FIGS. 11A and 11B. Thehousing units 72a, 72b are urged to move outward by the spring 72s, and start to operate, thereby enabling the distance between theelectrodes 61 to be freely changed.

在囊型医疗装置C5中，在外壳单元72a、72b上安装有作为一个整体向外和向内移动的多个电极61，并准确地使电极61与身体组织接触。而且，例如，如果来自内腔器官的压力强于弹簧72s的动量(momentum)，则外壳单元72a、72b移动，以使这些外壳单元根据需要而关闭，使得能够稳定地推进囊型医疗装置C5。In the capsule type medical device C5, a plurality ofelectrodes 61 moving outward and inward as a whole are mounted on thehousing units 72a, 72b, and theelectrodes 61 are accurately brought into contact with body tissue. Also, for example, if the pressure from the lumen organ is stronger than the momentum of the spring 72s, thehousing units 72a, 72b move so that these housing units are closed as required, so that the capsule medical device C5 can be pushed stably.

图12A至图12C示出了电极61的变形示例。电极61a是从外壳单元72a、72b的外表面突出的半球形电极，如图12A所示。利用这种电极，与身体组织的接触变得容易。而且，由于没有角，因此实现了在内腔器官中平稳地推进囊型医疗装置C5。12A to 12C show modified examples of theelectrode 61 . Theelectrodes 61a are hemispherical electrodes protruding from the outer surfaces of thehousing units 72a, 72b, as shown in FIG. 12A. With such electrodes, contact with body tissue is facilitated. Also, since there are no corners, smooth advancement of the capsule-type medical device C5 in the lumen organ is achieved.

电极61b是从外壳单元72a、72b的外表面突出的柱形电极，如图12B所示。利用这种电极，与身体组织的接触面积扩大，从而甚至对诸如黏膜的身体组织也可以准确地提供电刺激。Theelectrodes 61b are cylindrical electrodes protruding from the outer surfaces of thehousing units 72a, 72b, as shown in FIG. 12B. With such an electrode, the contact area with body tissue is enlarged, so that electrical stimulation can be accurately provided even to body tissue such as mucous membrane.

电极61c是嵌入在外壳单元72a、72b中的电极，以使得电极与外壳单元72a、72b的外表面平滑连续，如图12C所示。利用这种电极，没有从外壳单元72a、72b的外表面突出的部分，因此实现了对囊型医疗装置C5的平稳推进。Theelectrodes 61c are electrodes embedded in thehousing units 72a, 72b such that the electrodes are smoothly continuous with the outer surfaces of thehousing units 72a, 72b, as shown in FIG. 12C. With such electrodes, there is no protruding portion from the outer surfaces of thehousing units 72a, 72b, thus achieving smooth advancement of the capsule-type medical device C5.

实际上，虽然未示出该结构，但是可以将整个外壳单元72a、72b制成电极。在这种情况下，消除了电极的突出，因此，在保持稳定的电极接触面积的同时，实现了在内腔器官中更加平稳地推进囊型医疗装置C5。Actually, although the structure is not shown, theentire housing units 72a, 72b may be made into electrodes. In this case, protrusion of the electrode is eliminated, and therefore, more smooth advancement of the capsule-type medical device C5 in the lumen organ is achieved while maintaining a stable electrode contact area.

这里，在外壳单元72a、72b开始操作之后，外壳单元72a、72b可以接合在壳体13中。Here, thehousing units 72a, 72b may be engaged in thehousing 13 after thehousing units 72a, 72b start to operate.

可以在外壳单元72a、72b与壳体13之间安装吸水凝胶来代替弹簧72s。当具有吸水凝胶的囊型医疗装置C5被引入到活体中时，吸水凝胶通过吸收活体中的水而膨胀，这使外壳单元72a、72b向外移动，使得能够利用简单的结构来精确地改变电极61之间的距离。作为另一种结构，弹簧72s可以由形状记忆合金制成，并且弹簧72s可以随活体内的温度而伸展，从而使外壳单元72a、72b移动。Water-absorbing gel may be installed between thehousing units 72a, 72b and thehousing 13 instead of the spring 72s. When the capsule-type medical device C5 having a water-absorbing gel is introduced into a living body, the water-absorbing gel expands by absorbing water in the living body, which moves thehousing units 72a, 72b outward, making it possible to precisely The distance betweenelectrodes 61 was changed. As another structure, the spring 72s may be made of a shape memory alloy, and the spring 72s may expand with the temperature in the living body, thereby moving thehousing units 72a, 72b.

图13A至图15示出了第五变形示例。13A to 15 show a fifth modified example.

囊型医疗装置C6包括大量电极和柔性线，以及用于选择要被输送电流的电极的装置(电极选择器)。The capsule medical device C6 includes a large number of electrodes and flexible wires, and means for selecting the electrodes (electrode selectors) to which electric current is to be delivered.

如图13A和图13B所示，沿壳体14的周边，在囊型医疗装置C6中以大致相同的间隔，在壳体14的后部设置有大量电极6和柔性线7。将这些柔性线7的基端连接到设置在壳体14中的电极选择器。电极选择器6s由控制单元3控制，从多个电极6中选择出要被输送电流的一对电极。通过电极选择器6s和柔性线7将来自控制单元3的电流输送给一对电极6。As shown in FIGS. 13A and 13B , a large number ofelectrodes 6 andflexible wires 7 are provided at the rear of thehousing 14 at approximately the same intervals in the capsule medical device C6 along the periphery of thehousing 14 . The base ends of theseflexible wires 7 are connected to an electrode selector provided in thehousing 14 . The electrode selector 6 s is controlled by thecontrol unit 3 , and selects a pair of electrodes to which electric current is to be delivered from the plurality ofelectrodes 6 . The current from thecontrol unit 3 is delivered to the pair ofelectrodes 6 through the electrode selector 6s and theflexible wire 7 .

图14A至图14E示出了电极6的第六变形示例。14A to 14E show a sixth modification example of theelectrode 6 .

图14A中所示的电极6为近似球形。图14B中所示的电极6a为钩形。图14C中所示的电极6b为环形。图14D中所示的电极6c为杆形。图14E中所示的电极6d被加宽以保证更大的接触面积。根据囊型医疗装置C6的使用模式来选择不同的电极。Theelectrode 6 shown in Fig. 14A is approximately spherical. Theelectrodes 6a shown in FIG. 14B are hook-shaped. Theelectrode 6b shown in Fig. 14C has a ring shape. Theelectrode 6c shown in Fig. 14D is rod-shaped. Theelectrode 6d shown in Fig. 14E is widened to ensure a larger contact area. Different electrodes are selected according to the mode of use of the medical capsule C6.

图15A至图15C示出了具有以上结构的囊型医疗装置C6到达大肠R的状态。在诸如大肠R的相对大的内腔器官中，通常不仅需要前后移动而且需要左右移动囊型医疗装置C6，以改变视野。在左右移动囊型医疗装置C6时，通过选择处于与期望推进方向相反的方向上的电极6，并且使被输送电流的电极与内腔壁(肠壁Rw)接触，沿前后以及左右的组合方向推进囊型医疗装置C6。这里，通过向各电极6输送非常弱的试验电流并测量各次的阻抗以找出与肠壁Rw接触的电极6，从而实现对与肠壁Rw接触的电极6的选择。15A to 15C show the state where the capsule-type medical device C6 having the above structure reaches the large intestine R. FIG. In a relatively large luminal organ such as the large intestine R, it is often necessary to move the capsule medical device C6 not only back and forth but also side to side in order to change the field of view. When moving the capsule medical device C6 left and right, by selecting theelectrode 6 in the direction opposite to the desired propulsion direction, and making the electrode to which the current is delivered contact the lumen wall (intestinal wall Rw), along the combined direction of the front and back and the left and right Advance capsule medical device C6. Here, the selection of theelectrodes 6 in contact with the intestinal wall Rw is achieved by sending a very weak test current to eachelectrode 6 and measuring the impedance each time to find out theelectrodes 6 in contact with the intestinal wall Rw.

在囊型医疗装置C6中，在壳体14中设置有多个电极6和柔性线7，并从该多个电极6中选择要被输送电流的电极。这里，保证了囊型医疗装置C6的左右移动，使得能够在内腔器官内各个可能的位置处进行观察。In the capsule type medical device C6, a plurality ofelectrodes 6 andflexible wires 7 are provided in ahousing 14, and an electrode to which current is to be delivered is selected from among the plurality ofelectrodes 6. Here, left and right movement of the capsule medical device C6 is ensured, enabling observation at various possible positions in the endoluminal organ.

图16示出了第六变形示例。Fig. 16 shows a sixth modified example.

囊型医疗装置C7包括设置在外壳单元72a、72b的基本上整个表面上的电极，其中这些电极被分成多个电极61d的多个组。在该多个电极61d当中任意选择要被输送电流的电极。The capsule-type medical device C7 includes electrodes provided on substantially the entire surfaces of thehousing units 72a, 72b, wherein the electrodes are divided into groups of a plurality ofelectrodes 61d. An electrode to which current is to be supplied is arbitrarily selected among the plurality ofelectrodes 61d.

该多个电极61d是密集地布置在外壳单元72a、72b的外表面上的平面形电极。一组要进行配对的正极和负极设置有由极点(pole)分隔的多个正极和多个负极。将该多个电极61d连接到设置在壳体13内的电极选择器6s2。如上述囊型医疗装置C6中的电极选择器6s一样，电极选择器6s2是能够在多个电极61d当中任意选择要被输送电流的电极的装置。电极选择器6s2选择一组或更多组要进行配对的正极和负极，并同时向所有选择的电极输送电流。如果通过电极选择器6s2选择了较少数量的电极，则向身体组织提供电刺激的电极的面积较小，而如果选择较大数量的电极，则电极面积较大。The plurality ofelectrodes 61d are planar electrodes densely arranged on the outer surfaces of thehousing units 72a, 72b. A set of positive and negative electrodes to be paired is provided with a plurality of positive electrodes and a plurality of negative electrodes separated by poles. The plurality ofelectrodes 61d are connected to an electrode selector 6s2 provided in thehousing 13 . Like the electrode selector 6s in the capsule-type medical device C6 described above, the electrode selector 6s2 is a device capable of arbitrarily selecting an electrode to which electric current is to be delivered among a plurality ofelectrodes 61d. The electrode selector 6s2 selects one or more groups of positive and negative electrodes to be paired, and simultaneously delivers current to all the selected electrodes. If a smaller number of electrodes is selected by the electrode selector 6s2, the area of the electrodes providing electrical stimulation to the body tissue is smaller, and if a larger number of electrodes is selected, the electrode area is larger.

在囊型医疗装置C7中，用于对身体组织提供电刺激的电极面积随极点而改变，通过极点可以选择电极的最佳位置并且可以保证最佳电极面积。这使得能够容易地向身体组织提供期望的电流量。因此，例如用于输送肠的有效收缩所需的电流量的电极面积得到了保证，并且同时可以选择具有与诸如内肠壁的身体组织的有利的接触状态的电极。In the capsule medical device C7, the area of the electrode for providing electrical stimulation to the body tissue varies with the pole, through which the optimum position of the electrode can be selected and the optimum electrode area can be guaranteed. This makes it possible to easily supply a desired amount of current to body tissue. Thus, for example, an electrode area for delivering an amount of current required for effective contraction of the intestine is ensured, and at the same time an electrode having a favorable contact state with body tissue such as the inner intestinal wall can be selected.

参照图17A至图25B说明本发明的第二实施例。这里，使用相同的符号表示与第一实施例中的结构单元相似的结构单元，并省略对其的详细描述。A second embodiment of the present invention will be described with reference to FIGS. 17A to 25B. Here, structural units similar to those in the first embodiment are denoted by the same symbols, and detailed descriptions thereof are omitted.

如图17A至图20B所示，囊型医疗装置C10是本实施例中的囊型医疗装置的基本结构。囊型医疗装置C10能够如上述第一实施例中那样任意地展开和缠绕医疗装置C10中的柔性线和电极。事实上，囊型医疗装置C10中设置有电动机(致动器)M以及由电动机M驱动的旋转轴22r，而不是自由旋转的旋转轴21r。As shown in FIGS. 17A to 20B , the capsule medical device C10 is the basic structure of the capsule medical device in this embodiment. The capsule-type medical device C10 can arbitrarily unroll and wind the flexible wires and electrodes in the medical device C10 as in the first embodiment described above. In fact, a motor (actuator) M and arotation shaft 22r driven by the motor M are provided in the capsule medical device C10 instead of the rotation shaft 21r which rotates freely.

在壳体12内在线存储单元21附近分别设置有两个电动机M，并且这两个电动机M由控制单元3控制。通过诸如齿轮的功率传送装置将这些电动机M的旋转驱动功率传送到旋转轴22r。换言之，电动机M和旋转轴22r构成柔性线7的展开/缠绕机构。电动机M由外部控制信号控制，并且通过在任意位置处展开柔性线来驱动电极6。或者，电动机M通过缠绕柔性线7来将柔性线7和电极6完全存储在线存储单元21内。对于电动机M，可以使用诸如电磁电动机、超声波电动机或静电电动机的任何电动机/致动器。Two motors M are respectively provided near theline storage unit 21 inside thecasing 12 and controlled by thecontrol unit 3 . The rotational drive power of these motors M is transmitted to therotary shaft 22r through power transmission means such as gears. In other words, the motor M and therotating shaft 22r constitute an unwinding/winding mechanism of theflexible wire 7 . The motor M is controlled by an external control signal, and drives theelectrode 6 by unrolling the flexible wire at an arbitrary position. Alternatively, the motor M completely stores theflexible wire 7 and theelectrode 6 in thewire storage unit 21 by winding theflexible wire 7 . For the motor M, any motor/actuator such as an electromagnetic motor, an ultrasonic motor, or an electrostatic motor can be used.

这里，与上述囊型医疗装置C4不同，囊型医疗装置C10不利用柔性线的自动形状变化来展开/缠绕柔性线。因此，与囊型医疗装置C1相同，使用由超弹性合金等制成的柔性线7，而未将形状记忆合金用于柔性线。Here, unlike the above-described balloon-type medical device C4, the balloon-type medical device C10 does not deploy/wind the flexible wire by automatic shape change of the flexible wire. Therefore, like the capsule-type medical device C1, theflexible wire 7 made of a superelastic alloy or the like is used without using a shape memory alloy for the flexible wire.

图17A和图17B示出了几乎所有的柔性线7都被缠绕、从而电极6和柔性线7完全存储在线存储单元21中的状态。在吞下囊型医疗装置C10或从肛门排出它时，柔性线7保持为该状态，稍后将对其进行进一步的说明。同时，图20A和图20B中示出了以下状态：柔性线7被完全展开，并且电极6和柔性线7处于操作中。当囊型医疗装置到达胃等时，柔性线7处于该状态，稍后将对其进行进一步的说明。17A and 17B show a state where almost all theflexible wires 7 are wound so that theelectrodes 6 and theflexible wires 7 are completely stored in thewire storage unit 21 . Theflexible wire 7 remains in this state when the medical capsule C10 is swallowed or expelled from the anus, as will be further explained later. Meanwhile, a state is shown in FIGS. 20A and 20B : theflexible wire 7 is fully deployed, and theelectrode 6 and theflexible wire 7 are in operation. Theflexible wire 7 is in this state when the capsule medical device reaches the stomach or the like, which will be further explained later.

这里，通过控制电动机M可以任意改变柔性线7的展开和缠绕的量，并且例如可以产生以下状态：从完全存储状态稍微展开柔性线7，从而仅电极6从开口21h伸出，如图19所示。Here, the amount of unwinding and winding of theflexible wire 7 can be arbitrarily changed by controlling the motor M, and for example, a state can be produced in which theflexible wire 7 is slightly unrolled from a fully stored state so that only theelectrode 6 protrudes from theopening 21h, as shown in FIG. 19 Show.

接下来，说明使用具有上述结构的囊型医疗装置C10在人的活体内进行观察。Next, observation in a human living body using the capsule medical device C10 having the above configuration will be described.

首先，接受检查的人使用带等佩戴外部装置100。然后该人从口中吃下囊型医疗装置C10，以在活体内部署囊型医疗装置C10。在吞下囊型医疗装置C10之前，柔性线7和电极完全存储在线存储单元21中，如图17A和图17B所示。这使得在吞下囊型医疗装置C10的过程中可能由柔性线7和电极6导致的障碍最小化。在囊型医疗装置C10中设置有未示出的开关。在吞下囊型医疗装置C10时打开该开关，使得能够从电池5向各个组件供电。由此，控制单元3驱动拍摄单元2(即，拍摄元件2a和发光元件2b)。First, a person to be examined wears theexternal device 100 using a belt or the like. The person then swallows the medical capsule C10 from the mouth to deploy the medical capsule C10 in the living body. Before the capsule medical device C10 is swallowed, theflexible wire 7 and the electrodes are completely stored in thewire storage unit 21, as shown in FIGS. 17A and 17B . This minimizes obstructions that may be caused by theflexible wire 7 and theelectrodes 6 during swallowing of the medical capsule C10. An unillustrated switch is provided in the capsule-type medical device C10. This switch is turned on when the capsule-type medical device C10 is swallowed, so that power can be supplied from thebattery 5 to the respective components. Thus, thecontrol unit 3 drives the imaging unit 2 (that is, theimaging element 2a and thelight emitting element 2b).

被引入到活体内的囊型医疗装置C10随着该装置在消化道内移动而使用拍摄元件2a拍摄活体内的部分。同时，其从无线收发器单元4向外部装置100发送照片图像。同时，外部装置100通过无线收发器单元102接收这些照片图像，并使用控制单元104对始终记录在记录单元103中的照片图像进行图像处理。控制单元104始终通过无线收发器单元102发送与其中存在囊型医疗装置C10(其位置由位置检测电路104a检测)的身体组织(例如，胃、小肠或大肠)相对应的控制信号。The capsule medical device C10 introduced into the living body uses theimaging element 2a to image parts of the living body as the device moves in the digestive tract. At the same time, it transmits photo images from thewireless transceiver unit 4 to theexternal device 100 . Meanwhile, theexternal device 100 receives these photo images through thewireless transceiver unit 102 and performs image processing on the photo images always recorded in therecording unit 103 using thecontrol unit 104 . Thecontrol unit 104 always transmits a control signal corresponding to the body tissue (for example, stomach, small intestine or large intestine) in which the capsule medical device C10 exists (the position of which is detected by theposition detection circuit 104 a ) through thewireless transceiver unit 102 .

当囊型医疗装置C10到达胃(参见图21(1))时，拍摄元件2a在胃内照相，并将照片图像发送到外部装置100(参见图22(1))。位置检测电路104a通过在亮度、色频分布、黏膜的表面状态等方面对接收到的照片图像与设定图像进行比较，来确认囊型医疗装置C10位于胃中。由于胃是具有大内腔的器官，所以控制单元104将电极6和柔性线7驱动到它们的最大能力，如图21和图22所示。而且，控制单元104通过无线收发器单元102发送控制信号，以通过电极6向身体组织提供电刺激。通过这样的电刺激，引起了胃的蠕动，并且产生局部肌肉收缩。囊型医疗装置C10被胃的蠕动和局部肌肉收缩所推动，经过胃，然后到达十二指肠。When the capsule medical device C10 reaches the stomach (see FIG. 21(1)), the photographingelement 2a takes a picture inside the stomach and sends the photo image to the external device 100 (see FIG. 22(1)). Theposition detection circuit 104a confirms that the capsule medical device C10 is located in the stomach by comparing the received photo image with the set image in terms of brightness, color frequency distribution, surface state of the mucous membrane, and the like. Since the stomach is an organ with a large lumen, thecontrol unit 104 drives theelectrodes 6 and theflexible wire 7 to their maximum capacity, as shown in FIGS. 21 and 22 . Furthermore, thecontrol unit 104 sends control signals through thewireless transceiver unit 102 to provide electrical stimulation to body tissue through theelectrodes 6 . By such electrical stimulation, peristalsis of the stomach is induced, and local muscle contraction occurs. The capsule medical device C10 is propelled by gastric peristalsis and local muscle contraction, passes through the stomach, and then reaches the duodenum.

当囊型医疗装置C10到达十二指肠时，拍摄元件2a在十二指肠内照相，并将照片图像发送到外部装置100。位置检测电路104a通过将接收到的照片图像与设置图像进行比较，来确认囊型医疗装置C10位于十二指肠中。响应于此，控制单元104通过无线收发器单元102发送信号以缠绕柔性线7。囊型医疗装置C10在接收到该控制信号时缠绕柔性线7，然后从线存储单元21中稍微展开柔性线7，仅留下电极6从开口21h中伸出。When the capsule medical device C10 reaches the duodenum, theimaging device 2 a takes a picture in the duodenum and sends the photographed image to theexternal device 100 . Theposition detection circuit 104a confirms that the capsule type medical device C10 is located in the duodenum by comparing the received photo image with the setup image. In response thereto, thecontrol unit 104 sends a signal through thewireless transceiver unit 102 to wind theflexible wire 7 . The capsule medical device C10 winds theflexible wire 7 upon receiving the control signal, and then slightly unwinds theflexible wire 7 from thewire storage unit 21, leaving only theelectrode 6 protruding from theopening 21h.

当囊型医疗装置C10经过十二指肠并到达小肠(参见图21(2))时，拍摄元件2a在小肠内照相，并将照片图像发送到外部装置100(参见图22(2))。位置检测电路104a按照与以上类似的方式，通过将接收到的照片图像与设定图像进行比较，来确认囊型医疗装置C10位于小肠中。响应于此，控制单元104通过无线收发器单元102发送信号，以根据需要通过电极6向身体组织提供电刺激或缠绕柔性线7。囊型医疗装置C10在接收到该控制信号时，根据需要通过电极6向身体组织提供电刺激或者缠绕或展开柔性线7。由此，操作者在观察照片图像的同时，通过根据需要对身体组织(例如，胃、小肠、大肠等)提供电刺激来推动囊型医疗装置C10。实际上，照片图像的快速变化表示囊型医疗装置C10移动太快。因此，操作者减少向电极6输送电流的次数，以减小囊型医疗装置C10的速度。另一方面，照片图像几乎不变化表示囊型医疗装置C10几乎不移动。因此，操作者提高向电极6输送电流的频率，这提高了囊型医疗装置C10的移动速度。When the capsule medical device C10 passes through the duodenum and reaches the small intestine (see FIG. 21(2)), theimaging element 2a takes a picture in the small intestine and sends the photo image to the external device 100 (see FIG. 22(2)). Theposition detection circuit 104a confirms that the capsule-type medical device C10 is located in the small intestine by comparing the received photo image with the set image in a similar manner to the above. In response thereto, thecontrol unit 104 sends a signal through thewireless transceiver unit 102 to provide electrical stimulation to the body tissue through theelectrodes 6 or to wind theflexible wire 7 as desired. When receiving the control signal, the capsule medical device C10 provides electrical stimulation to body tissue through theelectrodes 6 or winds or unwinds theflexible wire 7 as required. Thereby, the operator pushes the capsule-type medical device C10 by providing electrical stimulation to body tissues (for example, stomach, small intestine, large intestine, etc.) as needed while observing the photographic image. In fact, rapid changes in the photo image indicate that capsule medical device C10 is moving too fast. Therefore, the operator reduces the number of times electric current is delivered to theelectrode 6 to reduce the speed of the medical capsule C10. On the other hand, almost no change in the photo image means that the capsule medical device C10 hardly moves. Therefore, the operator increases the frequency of delivering current to theelectrode 6, which increases the moving speed of the capsule-type medical device C10.

当囊型医疗装置C10位于小肠中时，无线收发器单元4接收从外部装置100发送的控制信号。控制单元3在接收到这些信号时，对要向电极6输送的电流量或电动机M的操作进行控制。电极6在接收到电流时，向身体组织(肠壁)提供电刺激以该身体组织收缩。通过身体组织的收缩，囊型医疗装置C10向前移动，如同被推出去一样。因此，与通过自主蠕动而移动的情况相比，囊型医疗装置C10可以在小肠内更精确地移动，使得能够用较短的观察时间在小肠内进行有效的观察。Thewireless transceiver unit 4 receives a control signal transmitted from theexternal device 100 when the capsule type medical device C10 is located in the small intestine. Thecontrol unit 3 controls the amount of current to be supplied to theelectrode 6 or the operation of the motor M when receiving these signals. Theelectrodes 6, when receiving an electric current, provide electrical stimulation to the body tissue (intestinal wall) to contract the body tissue. By the contraction of the body tissue, the capsule medical device C10 moves forward as if being pushed out. Therefore, the capsule-type medical device C10 can move more precisely in the small intestine compared to the case of moving by voluntary peristalsis, enabling effective observation in the small intestine with a shorter observation time.

当囊型医疗装置C10经过小肠并到达大肠(参见图21(3)、(4))时，拍摄元件2a在大肠内拍照，并将照片图像发送到外部装置100(参见图22(3)、(4))。位置检测电路104a按照与以上类似的方式，通过将接收到的照片图像与设定图像进行比较，来确认囊型医疗装置C10位于大肠中。响应于此，控制单元104驱动电极6，从电极6向身体组织提供电刺激，并通过无线收发器单元102发送信号。控制单元3在接收到这些信号时，启动电动机M并驱动电极6。此时，与在胃中的情况不同，没有使电极6以最大能力进行操作，而柔性线比在小肠中的情况展开得更长。这是由于大肠的内腔器官比小肠大，但大肠的内腔器官远小于胃。由此，在内腔器官比小肠大的大肠中，在将电极6准确地附着在身体组织上的同时，对身体组织(肠壁)提供电刺激。因此，以与小肠中类似的方式，利用较短的观察时间实现在大肠内有效且稳定的观察。When the capsule medical device C10 passes through the small intestine and reaches the large intestine (see Fig. 21(3), (4)), theimaging element 2a takes a picture in the large intestine, and sends the photo image to the external device 100 (see Fig. 22(3), (4) (4)). Theposition detection circuit 104a confirms that the capsule medical device C10 is located in the large intestine by comparing the received photo image with the set image in a similar manner to the above. In response thereto, thecontrol unit 104 drives theelectrodes 6 , provides electrical stimulation from theelectrodes 6 to the body tissue, and sends signals through thewireless transceiver unit 102 . Thecontrol unit 3, upon receiving these signals, activates the motor M and drives theelectrodes 6. At this time, unlike in the case in the stomach, theelectrodes 6 are not operated at maximum capacity, and the flexible wire is spread out longer than in the case of the small intestine. This is due to the fact that the luminal organ of the large intestine is larger than the small intestine, but the luminal organ of the large intestine is much smaller than the stomach. Thereby, in the large intestine whose lumen is larger than the small intestine, electrical stimulation is provided to the body tissue (intestinal wall) while accurately attaching theelectrode 6 to the body tissue. Thus, efficient and stable observation is achieved in the large intestine with a shorter observation time in a similar manner as in the small intestine.

当囊型医疗装置C10经过大肠并到达肛门(直肠附近)(参见图21(5))时，拍摄元件2a在肛门内照相，并将照片图像发送到外部装置100(参见图22(5))。位置检测电路104a按照与以上类似的方式，通过将接收到的照片图像与设定图像进行比较，来确认囊型医疗装置C10位于肛门(直肠附近)中。响应于此，控制单元104完全存储电极6和柔性线7，并通过无线收发器单元102发送信号，以停止由电极6进行的电刺激。控制单元3在接收到这些信号时，启动电动机M，并通过将电极6和柔性线7完全存储在线存储单元21中而恢复初始状态。这提高了囊型医疗装置C10在完成观察之后的排出能力。When the capsule medical device C10 passes through the large intestine and reaches the anus (near the rectum) (see FIG. 21(5)), theimaging element 2a takes a picture inside the anus, and sends the photo image to the external device 100 (see FIG. 22(5)) . Theposition detection circuit 104a confirms that the capsule-type medical device C10 is located in the anus (near the rectum) by comparing the received photo image with the set image in a similar manner to the above. In response thereto, thecontrol unit 104 fully stores theelectrodes 6 and theflexible wire 7 and sends a signal through thewireless transceiver unit 102 to stop electrical stimulation by theelectrodes 6 . Thecontrol unit 3 , upon receiving these signals, activates the motor M and restores the initial state by completely storing theelectrodes 6 and theflexible wire 7 in thewire storage unit 21 . This improves the discharge capability of the capsule-type medical device C10 after the observation is completed.

或者，可以通过使电极6可以从囊型医疗装置的外表面的上方稍微伸出，以在期望的排出定时(例如，期望去盥洗室时)在直肠内提供电刺激，来对排出进行主动的控制。在这种情况下，当在盥洗室中完成了对排出的准备时，成功地实现囊型医疗装置C10的排出。Alternatively, expulsion can be actively administered by allowing theelectrodes 6 to protrude slightly above the outer surface of the medical capsule to provide electrical stimulation in the rectum at the desired timing of the expulsion (e.g., when a trip to the bathroom is desired). control. In this case, when the preparation for the discharge is completed in the lavatory, the discharge of the capsule-type medical device C10 is successfully achieved.

而且，在外部装置100内设置用于发送囊型医疗装置C10在肛门(直肠附近)处的定位的通知装置，由此向医生等指示排出定时，这可以提高该装置的可用性。Also, providing a notification means for sending the location of the capsule-type medical device C10 at the anus (near the rectum) within theexternal device 100, thereby instructing the doctor or the like on the discharge timing, can improve the usability of the device.

同时，医生等根据记录在外部装置100的记录单元103中的活体内信息(即，照片图像)来诊断病人的身体状况。Meanwhile, a doctor or the like diagnoses a patient's physical condition based on in-vivo information (ie, photographic images) recorded in therecording unit 103 of theexternal device 100 .

在囊型医疗装置C10中，使用由控制单元3控制的电动机M来驱动旋转轴22r的旋转。因此，通过控制单元3的控制来任意地执行柔性线7的展开和缠绕，使得能够在任意位置处任意改变电极6之间的距离。由此，即使内腔器官的面积随器官而改变，也可以通过改变柔性线7的长度来容易地应付，使得无论位置如何，也能够精确地提供电刺激。而且，电动机M仅驱动薄的柔性线的展开/缠绕，因而电能消耗较小。因此，电动机M不会对由电池驱动的囊型医疗装置C10造成大的负担。In the capsule medical device C10 , the motor M controlled by thecontrol unit 3 is used to drive the rotation of therotation shaft 22 r. Therefore, unwinding and winding of theflexible wire 7 is arbitrarily performed by the control of thecontrol unit 3, so that the distance between theelectrodes 6 can be arbitrarily changed at an arbitrary position. Thereby, even if the area of the lumen organ varies from organ to organ, it can be easily handled by changing the length of theflexible wire 7, so that electrical stimulation can be accurately provided regardless of the position. Also, the motor M only drives the unwinding/winding of the thin flexible wire, so the power consumption is small. Therefore, the motor M does not impose a large burden on the battery-driven capsule medical device C10.

下文中，将说明上述第二实施例中的囊型医疗装置C10的变形示例。这里，囊型医疗装置C10的诸如拍摄单元2(拍摄元件2a和发光元件2b)、控制单元3、无线收发器单元4和电池5的各个结构元件是以类似的方式设置在以下囊型医疗装置的各个变形示例中的公共结构元件。因此，在以下示例中，省略对这些结构元件的表示和详细描述。而且，与囊型医疗装置C10中的结构元件相似的其他结构元件由相同的符号表示，并省略对其的详细描述。Hereinafter, a modified example of the capsule-type medical device C10 in the second embodiment described above will be described. Here, the respective structural elements of the capsule medical device C10 such as the imaging unit 2 (imaging element 2a and light emittingelement 2b), thecontrol unit 3, thewireless transceiver unit 4 and thebattery 5 are similarly arranged in the following capsule medical device The common structural elements in each variant example of . Therefore, in the following examples, representation and detailed description of these structural elements are omitted. Also, other structural elements similar to those in the capsule-type medical device C10 are denoted by the same symbols, and detailed descriptions thereof are omitted.

图23A和图23B示出了第一变形示例。在囊型医疗装置C11中，壳体上直接固定有一对电极，并且在该壳体内的固定有电极的一侧上设置有重物。23A and 23B show a first modified example. In the capsule medical device C11, a pair of electrodes is directly fixed to the case, and a weight is provided on the side of the case where the electrodes are fixed.

在壳体16的后部的一个位置处的凹槽中形成线存储单元21，并通过孔单元21h推入电极6和柔性线7和将电极6和柔性线7向外部推出。在壳体16的后侧处，在线存储单元21的横跨直径的相对侧上，在壳体16的外表面上作为一个整体地安装有与电极6成对的固定电极(电极)62。将柔性线7和电极6连接到壳体16内的控制单元3。在壳体16内在线存储单元21的横跨直径的相对侧上设置有重物G。由此，可以使固定电极62侧总是面朝下，因此准确地使固定电极62与黏膜等接触。Thewire storage unit 21 is formed in a groove at one position in the rear of thecase 16, and theelectrode 6 and theflexible wire 7 are pushed in and pushed out through thehole unit 21h. At the rear side of thehousing 16 , on the diametrically opposite side of theline storage unit 21 , a fixed electrode (electrode) 62 is integrally mounted on the outer surface of thehousing 16 as a pair with theelectrode 6 . Theflexible wire 7 and theelectrodes 6 are connected to thecontrol unit 3 inside thehousing 16 . On opposite sides across the diameter of theline storage unit 21 within the housing 16 a weight G is provided. As a result, the side of the fixedelectrode 62 can always face downward, so that the fixedelectrode 62 can be accurately brought into contact with the mucous membrane or the like.

在囊型医疗装置C11中，由于线存储单元21和电动机M是一个单元，所以结构简单，并且容易并精确地执行对柔性线7的展开和缠绕的控制。In the capsule type medical device C11, since thewire storage unit 21 and the motor M are one unit, the structure is simple, and control of unwinding and winding of theflexible wire 7 is easily and accurately performed.

这里，在该示例中，设置重物G以确保固定电极62与黏膜等接触，但是通过改变壳体16内的各部分的布置，使重心移到固定电极62侧的位置，可以省略重物G。Here, in this example, the weight G is provided to ensure that the fixedelectrode 62 is in contact with the mucous membrane or the like, but by changing the arrangement of each part inside thecase 16 so that the center of gravity is moved to a position on the side of the fixedelectrode 62, the weight G can be omitted. .

图24示出了第二变形示例。在囊型医疗装置C12中，在上述囊型医疗装置C的前部上安装有一对电极。Fig. 24 shows a second modified example. In the capsule medical device C12, a pair of electrodes are attached to the front portion of the capsule medical device C described above.

在壳体16的前侧(沿轴L的另一边缘侧)但在透明圆顶1d的后侧处支承前侧柔性线9的基端。前侧柔性线9以使导线远离壳体16向外移动的方式从该壳体16向外伸出，并支承前侧电极8。换言之，电极8通过柔性线9设置在壳体16的前侧，与拍摄单元2分开。因此，电极8不妨碍由拍摄单元2进行的拍摄。这里，前侧柔性线9设置在线存储单元21的同一侧上。The base end of the front sideflexible wire 9 is supported at the front side (the other edge side along the axis L) of thehousing 16 but at the back side of thetransparent dome 1d. The front sideflexible wire 9 projects outwardly from thecase 16 in such a manner that the wires move outwardly away from thecase 16 , and supports thefront side electrode 8 . In other words, theelectrodes 8 are arranged on the front side of thecasing 16 through theflexible wire 9 , separated from the photographingunit 2 . Therefore, theelectrode 8 does not interfere with the imaging by theimaging unit 2 . Here, the front sideflexible wire 9 is arranged on the same side of thewire storage unit 21 .

而且，在透明圆顶1d的外表面上，在前侧电极8的横跨直径的相对侧上(即，在与固定电极62相同的一侧上)，作为一个单元安装有与前侧电极8成对的前侧固定电极(第二电极)82。该前侧固定电极82设置在比拍摄元件2a的视野V更外部的位置处，以不妨碍由拍摄单元2进行的拍摄。这里，前侧固定电极82可以是透明电极，并且可以设置在视野V内。在这种情况下，可以使用具有更易于与身体组织接触的位置和尺寸的电极。Also, on the outer surface of thetransparent dome 1d, on the opposite side of thefront side electrode 8 across the diameter (that is, on the same side as the fixed electrode 62), there is mounted as a unit with thefront side electrode 8. A pair of front-side fixed electrodes (second electrodes) 82 . The front side fixedelectrode 82 is provided at a position outside the field of view V of theimaging element 2 a so as not to interfere with imaging by theimaging unit 2 . Here, the front-side fixedelectrode 82 may be a transparent electrode, and may be disposed within the field of view V. Referring to FIG. In this case, electrodes with a location and size that are more likely to make contact with body tissue can be used.

将前侧柔性线9和前侧固定电极82连接到壳体1内的控制单元3(图2中所示)。这里，控制单元3具有作为第二控制装置的功能，其用于根据来自无线收发器单元4的控制信号对要输送到前侧电极8和前侧固定电极82的电流进行控制，而与对要输送到电极6和固定电极62的电流的控制无关。The front sideflexible wire 9 and the front side fixedelectrode 82 are connected to thecontrol unit 3 inside the housing 1 (shown in FIG. 2 ). Here, thecontrol unit 3 has a function as a second control means for controlling the current to be supplied to thefront side electrode 8 and the front side fixedelectrode 82 according to the control signal from thewireless transceiver unit 4, and to control the current to be supplied to thefront side electrode 8 and the front side fixedelectrode 82, and to control the current to be supplied to thefront side electrode 8 and the front side fixedelectrode 82. The control of the current delivered to theelectrode 6 and the fixedelectrode 62 is independent.

而且，在壳体16内在线存储单元21的横跨直径的相对侧上设置有重物G，使得固定电极侧总是面朝下。这里，实现了固定电极62和前侧固定电极82与黏膜等的准确接触。Furthermore, weights G are provided on opposite sides across the diameter of thewire storage unit 21 within thehousing 16 so that the fixed electrode side always faces downwards. Here, accurate contact of the fixedelectrode 62 and the front side fixedelectrode 82 with the mucous membrane or the like is achieved.

这里，在吞下囊型医疗装置C12时，优选的是向后吞下，以防止前侧电极8和前侧柔性线成为障碍。Here, when swallowing the capsule medical device C12, it is preferable to swallow backward so that thefront electrode 8 and the front flexible wire will not become obstacles.

在囊型医疗装置C12中，除了设置在壳体16的后侧上的电极6和固定电极62之外，还在前侧上设置前侧电极8和前侧固定电极82，并且对到各电极的电流进行独立控制。为此，使线存储单元21和电动机M中的每一个成为一个单元，以使得在实现该装置在身体组织内的自由移动的同时，结构简单。换言之，通过使设置在壳体16的后侧上的电极6和固定电极62向身体组织提供电刺激，来实现囊型医疗装置C12的向前移动。相反的是，通过使设置在壳体16的前侧上的前侧电极8和前侧固定电极82向身体组织提供电刺激，来实现囊型医疗装置C12的向后移动。由此，操作者可以在诸如小肠或大肠的内腔器官中，例如在观察照片图像的同时，根据需要向前或向后移动囊型医疗装置C12，这提高了操作能力。而且，操作者可以容易地操纵该装置，而与囊型医疗装置C12进入狭窄的内腔器官的方向(前侧或后侧)无关。此外，由于向前和向后移动都是可用的，因此可以观察内腔器官中的任何可能的位置。In the capsule type medical device C12, in addition to theelectrode 6 and the fixedelectrode 62 provided on the rear side of thecase 16, thefront side electrode 8 and the front side fixedelectrode 82 are also provided on the front side, and each electrode The current is independently controlled. For this reason, each of thewire storage unit 21 and the motor M is made into one unit, so that the structure is simple while realizing free movement of the device within the body tissue. In other words, the forward movement of the capsule medical device C12 is achieved by causing theelectrodes 6 and the fixedelectrodes 62 provided on the rear side of thehousing 16 to provide electrical stimulation to body tissue. On the contrary, the backward movement of the capsule medical device C12 is achieved by causing thefront electrode 8 and the front fixedelectrode 82 provided on the front side of thehousing 16 to provide electrical stimulation to body tissue. Thereby, the operator can move the capsule-type medical device C12 forward or backward as needed in a luminal organ such as the small intestine or the large intestine, for example, while observing a photographic image, which improves operability. Also, the operator can easily manipulate the device regardless of the direction (front side or back side) in which the capsule medical device C12 enters the narrow lumen organ. Furthermore, since both forward and backward movements are available, any possible position in the luminal organ can be observed.

接下来，图25A和图25B示出了第三变形示例。在囊型医疗装置C13中，线存储单元和用于展开和缠绕柔性线的机构与上述囊型医疗装置C10的不同。Next, a third modification example is shown in FIGS. 25A and 25B . In the balloon-type medical device C13, the wire storage unit and the mechanism for unwinding and winding the flexible wire are different from those of the balloon-type medical device C10 described above.

在囊型医疗装置C13中，在壳体17内形成有用于存储柔性线7和电极6的线存储单元26。线存储单元26在接近壳体17的后部的位置处(即，在锥形部分内)形成为一空间，并使电极6和柔性线7通过开口26h出现在外部和从外部消失。在使这些开口相对于壳体17的轴L相互对称的位置形成各个开口26h。在线存储单元26内，按以下方式支承有大致盘形的旋转台26r：其旋转轴大致与轴L相同，并自由旋转。将柔性线7的基端分别连接到旋转台26r的外圆周侧上的相对于轴L彼此对称的两个位置。换言之，来自控制单元3的电流通过旋转台26r和柔性线7流到电极6。In the capsule type medical device C13 , awire storage unit 26 for storing theflexible wire 7 and theelectrodes 6 is formed inside thehousing 17 . Thewire storage unit 26 is formed as a space at a position close to the rear of the housing 17 (ie, within the tapered portion), and makes theelectrodes 6 and theflexible wire 7 appear and disappear from the outside through theopening 26h. Therespective openings 26 h are formed at positions where these openings are mutually symmetrical with respect to the axis L of thehousing 17 . In theonline storage unit 26, a substantially disk-shapedturntable 26r is supported in such a manner that its rotation axis is substantially the same as the axis L and is free to rotate. Base ends of theflexible wire 7 are respectively connected to two positions symmetrical to each other with respect to the axis L on the outer circumferential side of the rotary table 26r. In other words, the current from thecontrol unit 3 flows to theelectrode 6 through the rotary table 26r and theflexible wire 7 .

将旋转台26r连接到比线存储单元26设置得更后的电动机(致动器)M2。电动机M2的运动由控制单元3控制。来自电动机M2的旋转驱动力被传送到旋转台26r。换言之，电动机M2和旋转台26r构成用于展开/缠绕柔性线7的机构。在利用这种机构的展开/缠绕机构中，电动机M2的运动由外部控制信号控制，在任意位置处通过展开柔性线7使电极6进行操作。或者，可以通过缠绕将柔性线7和电极6完全存储在线存储单元26内。将诸如电磁电动机、超声波电动机、静电电动机等的任何电动机/致动器用作电动机M2。The rotary table 26r is connected to the motor (actuator) M2 disposed further behind than thewire storage unit 26 . The movement of the motor M2 is controlled by thecontrol unit 3 . The rotational driving force from the motor M2 is transmitted to the rotary table 26r. In other words, the motor M2 and the rotary table 26r constitute a mechanism for unwinding/winding theflexible wire 7 . In the unwinding/winding mechanism using this mechanism, the movement of the motor M2 is controlled by an external control signal, and theelectrode 6 is operated by unwinding theflexible wire 7 at an arbitrary position. Alternatively, theflexible wire 7 andelectrodes 6 can be stored entirely within thewire storage unit 26 by winding. Any motor/actuator such as an electromagnetic motor, an ultrasonic motor, an electrostatic motor, etc. is used as the motor M2.

在囊型医疗装置C13中，由于使一个电动机M2执行对该对柔性线7和电极6的全部展开/缠绕，因此结构简单，并且对展开/缠绕的控制容易而精确。而且，由于将线存储单元26和电动机M2设置在壳体17的后部附近的趋向于成为死区的锥部内，因此有效利用了壳体17中的有限空间。In the capsule type medical device C13, since one motor M2 is made to perform all of the unwinding/winding of the pair offlexible wires 7 andelectrodes 6, the structure is simple, and the control of unwinding/winding is easy and precise. Also, since thewire storage unit 26 and the motor M2 are disposed in the tapered portion, which tends to be a dead zone, near the rear of thehousing 17, the limited space in thehousing 17 is effectively utilized.

这里，在以上实施例中的每一个中，使用将本发明应用于无线囊型医疗装置的示例给出了描述。然而，本发明可以应用于利用线缆等提供电力的有线囊型医疗装置。由此，不必在囊型医疗装置上安装电池，或者使电池较小或低容量。而且，在大多数情况下，用于提供电力的线缆可以很细，对于接受检查的人来说，这使得不适最小化，并使线缆在内腔器官内成为障碍的顾虑降到最低。Here, in each of the above embodiments, a description has been given using an example in which the present invention is applied to a wireless capsule medical device. However, the present invention can be applied to a wired capsule type medical device that supplies electric power using a cable or the like. Thus, it is not necessary to mount a battery on the medical pouch, or to make the battery small or low capacity. Also, in most cases, the cables used to provide power can be thin, which minimizes discomfort for the person being examined and minimizes concerns about the cables becoming an obstacle within the luminal organ.

而且，在以上实施例中的每一个中，给出了对设置有用于获取活体内信息(例如图像)的活体内信息获取装置的结构的描述。然而，除了这种活体内信息获取装置以外，可以根据需要设置用于在期望部分处用药的药物治疗装置、用于灼烧患病部分的治疗装置、或用于提取体液的提取装置等。使用这种囊型医疗装置使得能够在获取活体内信息之后进行药物治疗、治疗或采样。因此，仅使用一个囊型医疗装置就可以在活体内执行一系列不同的操作。Also, in each of the above embodiments, a description has been given of the structure provided with an in-vivo information acquisition device for acquiring in-vivo information such as an image. However, in addition to such an in-vivo information acquisition device, a drug treatment device for administering medicine at a desired portion, a treatment device for burning a diseased portion, or an extraction device for extracting body fluid, etc. may be provided as required. Use of such a capsule-type medical device enables drug treatment, treatment or sampling after acquisition of in-vivo information. Therefore, a series of different operations can be performed in vivo using only one capsule medical device.

下面将参照图26至40说明本发明第三实施例。Next, a third embodiment of the present invention will be described with reference to FIGS. 26 to 40. FIG.

在该实施例中，弹性膨胀装置形成电极间距离改变装置。图26中所示的囊型医疗装置C14是本实施例的囊型医疗装置的基本结构。该囊型医疗装置C14设置有囊主体(装置主体或壳体)201、气囊(弹性膨胀部分)202、至少一对双极电极203、导线204、电池(电源)5以及膨胀和收缩机构单元(膨胀装置)16。气囊202安装在囊主体201的至少一部分上，并且能够弹性膨胀。电极203安装在气囊202上，并向活体腔中的可收缩组织(身体组织)提供电刺激。In this embodiment, the elastic expansion means form the inter-electrode distance varying means. The capsule medical device C14 shown in FIG. 26 is the basic structure of the capsule medical device of this embodiment. This capsule type medical device C14 is provided with a capsule body (device body or housing) 201, an airbag (elastic expansion portion) 202, at least a pair ofbipolar electrodes 203, alead wire 204, a battery (power supply) 5, and an expansion and contraction mechanism unit ( Expansion device) 16. Theairbag 202 is mounted on at least a part of the bagmain body 201, and is elastically inflatable.Electrodes 203 are mounted onballoon 202 and provide electrical stimulation to contractile tissue (body tissue) in a living body cavity.

囊主体201在壳体211内设置有在活体腔内获取活体内信息的拍摄单元(活体内信息获取装置)212、控制单元(控制装置)213、无线收发器(通信装置)214以及电池(电源)205，并具有囊型内窥镜的功能。另外，在壳体211内还设置有使气囊202膨胀和收缩的膨胀和收缩机构单元216。The capsulemain body 201 is provided with an imaging unit (in vivo information acquisition device) 212, a control unit (control device) 213, a wireless transceiver (communication device) 214, and a battery (power supply) in a housing 211. ) 205, and has the function of capsule endoscope. In addition, an expansion andcontraction mechanism unit 216 that inflates and contracts theairbag 202 is also provided inside thehousing 211 .

壳体211是从侧面观察时为椭圆形的囊，并由塑料等形成，以密封其内部。在壳体211的前面(图中的右侧)设置有由透明材料构成的被形成为圆顶形的观察窗(图26中未示出)。在该观察窗内，即，囊主体201的前面，容纳有在活体腔内获取活体内信息的拍摄单元212。拍摄单元212配置有用于拍摄活体腔内的各种区域并获取图像的拍摄元件单元212a，以及通过发出照明光对拍摄元件单元212a的视野进行照明的发光元件212b，通过获取活体腔内的照片图像来获得活体内信息。成像元件212a由透镜和CCD(电荷耦合器件)等组成。发光元件212b由EL(电致发光)元件、LED(发光二极管)等组成。除了拍摄单元212之外，可以根据需要在观察窗内设置各种传感器(例如，pH值传感器、血红蛋白传感器、特殊光反应传感器等)作为活体内信息获取装置。Thehousing 211 is an oval-shaped bag viewed from the side, and is formed of plastic or the like to seal the inside thereof. An observation window (not shown in FIG. 26 ) formed of a transparent material and formed into a dome shape is provided on the front surface (right side in the drawing) of thehousing 211 . Inside the observation window, that is, in front of the capsulemain body 201, animaging unit 212 for acquiring in-vivo information in a living-body cavity is housed. Theimaging unit 212 is equipped with animaging element unit 212a for photographing various areas in the living cavity and acquiring images, and alight emitting element 212b that illuminates the field of view of theimaging element unit 212a by emitting illumination light. to obtain in vivo information. Theimaging element 212a is composed of a lens, a CCD (Charge Coupled Device), and the like. Thelight emitting element 212b is composed of an EL (Electro Luminescence) element, an LED (Light Emitting Diode), or the like. In addition to the photographingunit 212, various sensors (eg, pH sensor, hemoglobin sensor, special photoresponse sensor, etc.) can be set in the observation window as required as an in vivo information acquisition device.

无线收发器单元214设置有未示出的收发器单元主体以及发送和接收无线电波的收发器天线(图中被省略)。无线收发器单元214向下述外部装置300无线地发送活体内信息(即，由拍摄单元212拍摄的照片图像)。另外，无线收发器单元214无线地接收从外部装置300无线地发送的各种控制信号(指令)，并将它们传送到控制单元213。Thewireless transceiver unit 214 is provided with a not-shown transceiver unit main body and a transceiver antenna (omitted in the figure) that transmits and receives radio waves. Thewireless transceiver unit 214 wirelessly transmits in-vivo information (ie, photographic images captured by the photographing unit 212 ) to theexternal device 300 described below. In addition, thewireless transceiver unit 214 wirelessly receives various control signals (commands) wirelessly transmitted from theexternal device 300 and transmits them to thecontrol unit 213 .

控制单元213具有以下功能：根据来自无线收发器单元214的控制信号(指令)，综合地控制囊型医疗装置C14的各个单元的动作。具体地说，该单元执行无线收发器控制(控制无线收发器单元214的动作)、拍摄和照明控制(控制拍摄单元212的动作)以及对气囊202的膨胀和收缩控制(控制膨胀和收缩机构单元216的动作)。另外，控制单元213中设置有方波(脉冲)发生电路213a，用于从电池205经由导线204向电极203输送电流。换言之，控制单元213具有用于控制流向电极203的电流的控制装置的功能，如下所述。方波发生电路213a中包括有限幅器功能，其确保超过设定值的电流不会流到电极203。Thecontrol unit 213 has the following function: according to the control signal (command) from thewireless transceiver unit 214, comprehensively controls the action of each unit of the capsule medical device C14. Specifically, this unit performs wireless transceiver control (controlling the action of the wireless transceiver unit 214), photographing and lighting control (controlling the action of the photographing unit 212), and inflation and contraction control of the airbag 202 (controlling the expansion andcontraction mechanism unit 216 actions). In addition, thecontrol unit 213 is provided with a square wave (pulse) generatingcircuit 213 a for sending current from thebattery 205 to theelectrode 203 via thewire 204 . In other words, thecontrol unit 213 has the function of a control means for controlling the current flowing to theelectrode 203, as described below. The squarewave generating circuit 213a includes a limiter function, which ensures that the current exceeding the set value will not flow to theelectrode 203 .

在图26中，按照与控制电路13集成的方式设置方波发生电路213a，但也可以按照与电池205集成的方式设置该电路。In FIG. 26 , the squarewave generating circuit 213 a is provided integrally with thecontrol circuit 13 , but this circuit may also be provided integrally with thebattery 205 .

将气囊202设置在囊主体201中，以覆盖壳体211的外表面的至少一部分。该气囊202由弹性膜(由表现出弹性的弹性材料制成，例如，柔性橡胶)构成，并由设置在壳体211内的膨胀和收缩机构单元216进行膨胀和收缩。膨胀和收缩机构单元216通过向气囊202中提供诸如空气或发泡剂的流体使气囊202膨胀，而通过从气囊202内吸出该流体使气囊202收缩。气囊202在收缩时与壳体211的外表面充分紧密接触，使得囊主体201易于经由口或肛门插入到活体腔中。Theair bag 202 is provided in the bagmain body 201 so as to cover at least a part of the outer surface of thehousing 211 . Theairbag 202 is composed of an elastic film (made of an elastic material exhibiting elasticity, for example, flexible rubber), and is expanded and contracted by an expansion andcontraction mechanism unit 216 provided in thehousing 211 . The inflation anddeflation mechanism unit 216 inflates theair bag 202 by supplying a fluid such as air or a blowing agent into theair bag 202 and deflates theair bag 202 by sucking the fluid out of theair bag 202 . Theairbag 202 is in sufficiently close contact with the outer surface of thecasing 211 when deflated, so that the bagmain body 201 is easily inserted into the cavity of the living body through the mouth or anus.

在图26中，囊主体201的前部和后部暴露，气囊202覆盖囊主体201以覆盖中部的外周，并且气囊202在囊主体201的前部和后部的两个固定单元220处以大致环形固定到囊主体201上。然而，仅暴露囊主体201的设置有观察窗的前部，而其后面的几乎整个表面都由气囊202覆盖，这也是可以的。在这种情况下，气囊202在设置在囊主体201的前部的观察窗后面的一个固定单元220处固定到囊主体201上。In FIG. 26 , the front and rear of the bagmain body 201 are exposed, theair bag 202 covers the bagmain body 201 to cover the outer periphery of the middle, and theair bag 202 is formed in a substantially annular shape at two fixingunits 220 at the front and rear of the bagmain body 201. fixed to thebladder body 201. However, it is also possible to expose only the front portion of the bagmain body 201 provided with the viewing window, while almost the entire surface of the rear thereof is covered by theair bag 202 . In this case, theairbag 202 is fixed to the bagmain body 201 at onefixing unit 220 provided behind the observation window at the front of the bagmain body 201 .

在气囊202的外表面上，安装有至少一对双极电极203。这些电极203与小肠和大肠的内壁(即，可收缩的组织)接触，并向这些可收缩的组织提供电刺激。电极203的形状为大致半球形或大致平面形，使得不妨碍囊型医疗装置C14的向前运动。这样，按照与气囊202集成的方式设置该至少一对电极203，因此该对电极203之间的距离随着气囊202的膨胀和收缩而改变。因此，即使内腔的直径改变，也可以向内腔器官内的可收缩的组织提供精确的电刺激。这些电极203优选地由与活体高度相容的金属(例如，不锈钢、铂、钛等)、或导电材料(例如，导电橡胶等)制成，如下所述。On the outer surface of theballoon 202, at least one pair ofbipolar electrodes 203 is mounted. Theseelectrodes 203 are in contact with the inner walls of the small and large intestines (ie, contractile tissues) and provide electrical stimulation to these contractile tissues. The shape of theelectrode 203 is substantially hemispherical or substantially planar so as not to hinder the forward movement of the capsule medical device C14. In this way, the at least one pair ofelectrodes 203 is provided in an integrated manner with theairbag 202 , so the distance between the pair ofelectrodes 203 changes as theairbag 202 expands and contracts. Thus, precise electrical stimulation can be provided to contractile tissue within a luminal organ even if the diameter of the lumen changes. Theseelectrodes 203 are preferably made of a metal highly compatible with a living body (for example, stainless steel, platinum, titanium, etc.), or a conductive material (for example, conductive rubber, etc.), as described below.

在图26中，设置有总共两对电极203，前侧(图中的右侧)上和后侧(图中的左侧)上各设置一对，但是可以适当地改变所安装的电极的数量及其安装位置。In FIG. 26, a total of two pairs ofelectrodes 203 are provided, one pair each on the front side (right side in the figure) and one pair on the rear side (left side in the figure), but the number of mounted electrodes can be appropriately changed. and its installation location.

导线204至少部分地由诸如金属等的柔性的导电材料构成。将导线204的基端连接到壳体211中的方波发生电路213a，并将末端连接到电极203。即，将电极203机械和电连接到容纳有电池205的囊主体201。由于这样使用柔性线204，所以导线204以折叠状态适应气囊202的收缩，而当气囊202膨胀时，导线204伸长。因此，可以从控制单元213中的方波发生电路213a向电极203恒定地提供电力。Thewire 204 is at least partially composed of a flexible conductive material such as metal. The base end of thewire 204 is connected to the squarewave generating circuit 213 a in thecase 211 , and the end is connected to theelectrode 203 . That is, theelectrode 203 is mechanically and electrically connected to the pouchmain body 201 housing thebattery 205 . Since theflexible wire 204 is used in this way, thewire 204 conforms to the contraction of theair bag 202 in a folded state, and when theair bag 202 is inflated, thewire 204 is stretched. Therefore, electric power can be constantly supplied to theelectrode 203 from the squarewave generating circuit 213 a in thecontrol unit 213 .

当气囊202收缩时，如上所示构成的囊型医疗装置C14的外径为大约15mm，使得该装置易于经过消化道和肛门。另外，当气囊202膨胀到其最大尺寸时，囊型医疗装置C14的外径为大约40mm，使得当该装置经过大肠时，电极203与身体组织适当地接触。When theballoon 202 is deflated, the balloon-type medical device C14 constructed as shown above has an outer diameter of about 15 mm, allowing easy passage of the device through the alimentary canal and anus. Additionally, whenballoon 202 is inflated to its maximum size, balloon medical device C14 has an outer diameter of approximately 40 mm such thatelectrodes 203 make proper contact with body tissue as the device passes through the large intestine.

外部装置300从活体的外部控制囊型医疗装置C14。如图26所示，外部装置300配置有：无线收发器单元(发送单元和检测单元)302，用于向囊型医疗装置C14发送信息和从囊型医疗装置C14接收信息；记录单元303(例如存储器等)，用于存储上述活体内信息(即，照片图像)；控制单元304，其控制各个单元；以及电池305，其向各个单元提供电力，这些单元都在装置主体301内。Theexternal device 300 controls the capsule medical device C14 from outside the living body. As shown in Figure 26, theexternal device 300 is configured with: a wireless transceiver unit (transmitting unit and detecting unit) 302 for sending information to the capsule medical device C14 and receiving information from the capsule medical device C14; a recording unit 303 (such as memory, etc.) for storing the above-mentioned in-vivo information (ie, photographic images); acontrol unit 304 that controls each unit;

装置主体301由塑料或诸如铝的金属形成为箱形，并且可以通过受检查者的带子安装在受检查者的身体上。由此，受检查者可以始终将外部装置300安装在其身体上。The devicemain body 301 is formed in a box shape from plastic or metal such as aluminum, and can be mounted on the examinee's body by the examinee's belt. Thus, the subject can always mount theexternal device 300 on his body.

与囊型医疗装置C14的无线收发器单元4相似，无线收发器单元302设置有未示出的收发单元主体和用于发送和接收无线电波的收发器天线(发送天线和接收天线)。无线收发器单元302接收照片图像，即，从囊型医疗装置C14无线发送的活体内信息，并将其传送到控制单元304。Similar to thewireless transceiver unit 4 of the capsule medical device C14, thewireless transceiver unit 302 is provided with a not-shown transceiver unit body and transceiver antennas (transmitting antenna and receiving antenna) for transmitting and receiving radio waves. Thewireless transceiver unit 302 receives a photo image, that is, in-vivo information wirelessly transmitted from the capsule medical device C14 , and transmits it to thecontrol unit 304 .

控制单元304根据位于活体中的囊型医疗装置C14周围的身体组织(例如，胃、小肠或大肠)，经由无线收发器单元302向囊型医疗装置C14发送控制信号。另外，控制单元304在执行诸如图像处理等的规定处理之后，在需要时将已接收到的照片图像记录在记录单元303中。Thecontrol unit 304 sends a control signal to the medical capsule device C14 via thewireless transceiver unit 302 according to the body tissue (eg, stomach, small intestine, or large intestine) around the medical capsule device C14 located in a living body. In addition, thecontrol unit 304 records the received photo image in therecording unit 303 as necessary after performing prescribed processing such as image processing.

下面是使用如上所述构成的囊型医疗装置C14对受检查者的体腔进行观察和研究的情况。The following is a case where the body cavity of the subject is observed and studied using the capsule medical device C14 configured as described above.

首先，受检查者通过带等将外部装置304安装到其腹部或其他地方。然后，通过将囊型医疗装置C14插入到口中(吞下)，将囊型医疗装置C14引入到活体腔中。在从口中插入时，气囊202收缩，使得不成为障碍。除了在沿消化道向下移动的同时通过拍摄元件单元212a对活体腔内的各个部分进行拍摄之外，还从无线收发器单元214向外部装置300无线地发送照片图像。另一方面，外部装置300经由无线收发器单元302接收照片图像，通过控制单元304对照片图像执行图像处理等，并在需要时将图像记录在记录单元303中。控制单元304在需要时经由无线收发器单元302向囊型医疗装置C14发送用于控制囊型医疗装置C14的控制信号。First, the subject attaches theexternal device 304 to his abdomen or other places through a belt or the like. Then, the capsule medical device C14 is introduced into the living body cavity by inserting the capsule medical device C14 into the mouth (swallowing). Upon insertion from the mouth, theballoon 202 deflates out of the way. In addition to photographing various parts within the living body cavity by the photographingelement unit 212 a while moving down the digestive tract, photograph images are wirelessly transmitted from thewireless transceiver unit 214 to theexternal device 300 . On the other hand, theexternal device 300 receives photo images via thewireless transceiver unit 302 , performs image processing and the like on the photo images by thecontrol unit 304 , and records the images in therecording unit 303 as necessary. Thecontrol unit 304 sends a control signal for controlling the capsule medical device C14 to the capsule medical device C14 via thewireless transceiver unit 302 when necessary.

当囊型医疗装置C14已经过胃和十二指肠并到达小肠时，控制单元213通过来自外部装置300的控制信号使气囊202膨胀，并通过向小肠的内壁提供适当的电刺激来推进囊型医疗装置C14。在小肠中，气囊202膨胀到约5-15mm，囊型医疗装置C14的外径(囊主体201连同气囊202一起的外径)变成约20-30mm，使得电极适当地接触小肠的内壁。When the balloon-type medical device C14 has passed through the stomach and duodenum and reached the small intestine, thecontrol unit 213 inflates theballoon 202 by a control signal from theexternal device 300 and advances the balloon-type medical device C14 by providing appropriate electrical stimulation to the inner wall of the small intestine. Medical Devices C14. In the small intestine, theballoon 202 is inflated to about 5-15mm, and the outer diameter of the balloon medical device C14 (the outer diameter of theballoon body 201 together with the balloon 202) becomes about 20-30mm, so that the electrodes properly contact the inner wall of the small intestine.

为了向小肠的可收缩的组织提供电刺激并使其收缩，并且使用该收缩力作为用于囊型医疗装置C14的推力，通常需要几毫瓦至几十毫瓦。因此，方波发生电路213a使几毫瓦至几十毫瓦的方波电流以预定周期的脉冲流到电极203。具体地说，此时的频率为几Hz至几十Hz，而脉冲宽度被设定在几毫秒至几十毫秒。使用由几千赫至几十千赫的高频信号调制的信号作为该脉冲信号也是可以的。这种调制波信号以几赫兹至几十赫兹的周期输出几千赫至几百千赫的脉冲。In order to provide electrical stimulation to the contractile tissue of the small intestine and cause it to contract, and to use the contraction force as a thrust force for the balloon-type medical device C14, several milliwatts to several tens of milliwatts are generally required. Therefore, the squarewave generating circuit 213a flows a square wave current of several milliwatts to several tens of milliwatts to theelectrode 203 in pulses of a predetermined cycle. Specifically, the frequency at this time is several Hz to several tens of Hz, and the pulse width is set at several milliseconds to several tens of milliseconds. It is also possible to use a signal modulated by a high-frequency signal of several kilohertz to several tens of kilohertz as the pulse signal. This modulated wave signal outputs pulses of several kilohertz to several hundred kilohertz at a period of several hertz to several tens of hertz.

该脉冲波的波形可以是方形或正弦形。另外，该方波通常可以是仅以正或负进行输出的波形，并且如图27A所示，可以是输出被反相并且在负侧和正侧上均输出(双侧幅值)的波形。此外，该正弦波形可以是一侧被整流的波形，如图27B所示。方波发生电路213a输出波形组合了各种上述波形的信号，并对身体组织提供电刺激。The waveform of the pulse wave can be square or sinusoidal. In addition, this square wave may generally be a waveform that is output only in positive or negative, and as shown in FIG. 27A , may be a waveform in which the output is inverted and output on both the negative side and the positive side (double-sided amplitude). In addition, the sinusoidal waveform may be a waveform rectified on one side, as shown in FIG. 27B. The squarewave generating circuit 213a outputs a signal whose waveform combines various above-mentioned waveforms, and provides electrical stimulation to body tissues.

当对小肠的内壁提供这种电刺激时，小肠的被刺激的地方发生收缩，因而囊型医疗装置C14受到挤压而向前沿收缩的小肠推进。此时，由于气囊202和导线204根据小肠的收缩而弹性变形，所以可以精确地抵消小肠的直径的改变。由此，可以通过加速小肠的蠕动来移动通过小肠，并且可以在缩短观察所需的时间的同时，有效地观察和研究小肠的内部。当囊型医疗装置C14已到达其目标位置时，可以通过停止电刺激将囊型医疗装置C14停止在该目标位置处。此时，在停止电刺激之后可以使气囊202膨胀，因而增大与小肠的接触压力，以更精确地停止囊型医疗装置C14。When such electrical stimulation is applied to the inner wall of the small intestine, the stimulated part of the small intestine contracts, and the capsule medical device C14 is pushed toward the contracted small intestine. At this time, since theballoon 202 and theguide wire 204 are elastically deformed according to the contraction of the small intestine, it is possible to precisely cancel the change in the diameter of the small intestine. Thereby, it is possible to move through the small intestine by accelerating the peristalsis of the small intestine, and it is possible to efficiently observe and study the inside of the small intestine while shortening the time required for observation. When the medical balloon device C14 has reached its target position, the medical balloon device C14 may be stopped at the target position by stopping the electrical stimulation. At this time, theballoon 202 may be inflated after the electrical stimulation is stopped, thereby increasing the contact pressure with the small intestine to more precisely stop the balloon medical device C14.

通过这种方式，囊型医疗装置C14接下来也可以按照以上讨论的要点经过大肠。当经过大肠时，使气囊202膨胀到5-25mm，从而囊型医疗装置C14的外径变成

以使电极准确地接触大肠的内壁。当囊型医疗装置C14接近肛门时，使气囊202与在从口中插入该装置时类似地收缩，以使囊型医疗装置C14的外径变得较小，从而可以从肛门排出该装置。In this way, medical capsule C14 may then also pass through the large intestine as discussed above. When passing through the large intestine, theballoon 202 is inflated to 5-25mm, so that the outer diameter of the balloon medical device C14 becomes

This allows the electrodes to accurately touch the lining of the large intestine. When the balloon-type medical device C14 approaches the anus, theballoon 202 is deflated similarly to when the device is inserted from the mouth, so that the outer diameter of the balloon-type medical device C14 becomes smaller so that the device can be expelled from the anus.

接下来，医生根据照片图像(这些照片图像是记录在外部装置300的记录单元303中的活体内信息)，对受检查者的健康状况进行诊断。Next, the doctor diagnoses the health condition of the examinee based on photographic images which are in-vivo information recorded in therecording unit 303 of theexternal device 300 .

在该囊型医疗装置C14中，可以通过使气囊202在期望位置处膨胀，使电极203准确地接触直径不同的消化道的内壁。另外，由于导线204是柔性的，所以它们可以适应气囊202的膨胀和收缩，并且可以提供稳定的电刺激，而几乎没有诸如断开等的不便发生。另外，通过在目标位置处停止电刺激，或者在停止电刺激之后使气囊202膨胀，可以将囊型医疗装置C14停止在该位置，然后可以对该位置进行观察，并且通过各种传感器进行详细研究。此外，通过使气囊202在完成观察和研究之后在排出侧收缩，可以使该装置迅速移动，并在短时间内将该装置排出到活体的外部。In this balloon-type medical device C14, by inflating theballoon 202 at a desired position, theelectrode 203 can be accurately brought into contact with the inner wall of the digestive tract having different diameters. In addition, since thewires 204 are flexible, they can adapt to the expansion and contraction of theballoon 202 and can provide stable electrical stimulation with little inconvenience such as disconnection. In addition, by stopping the electrical stimulation at the target location, or inflating theair bag 202 after stopping the electrical stimulation, the bladder type medical device C14 can be stopped at the location, and then the location can be observed and studied in detail by various sensors . In addition, by contracting theair bag 202 on the discharge side after completion of observation and research, it is possible to move the device quickly and discharge the device to the outside of the living body in a short time.

接下来，将说明上述第三实施例的囊型医疗装置C14的变型例。与囊型医疗装置C14的各个组成元件公共的组成元件标有相同的标号，并在这里省略对其的详细说明。另外，在下面参照的各个图中，存在导线204的图示被适当略去的情况，在这些情况下，与上述囊型医疗装置C14类似的是，各个电极203经由导线电和机械地连接到囊主体201。Next, a modified example of the capsule medical device C14 of the third embodiment described above will be described. Constituent elements common to respective constituent elements of the capsule-type medical device C14 are assigned the same reference numerals, and a detailed description thereof is omitted here. In addition, in each figure referred to below, there are cases where the illustration of thelead wire 204 is appropriately omitted, and in these cases, similarly to the above-mentioned capsule-type medical device C14, eachelectrode 203 is electrically and mechanically connected to theCapsule body 201 .

图28A和28B示出了第一变型例。28A and 28B show a first modification.

在该囊型医疗装置C15中，气囊202A通过安装单元220A可拆卸地安装在囊主体201A上。另外，导线204通过连接器204C可拆卸地连接到囊主体201A。In this bag-type medical device C15, theair bag 202A is detachably attached to the bagmain body 201A via the attachingunit 220A. In addition, thewire 204 is detachably connected to the bladdermain body 201A through aconnector 204C.

囊主体201的构成除了设置有壳体211A的事实之外，与上述囊型医疗装置C14中的囊主体201类似。壳体211A与上述壳体211的不同之处在于：其设置有槽211g，以使得易于安装和移动气囊202A；并且在后表面上形成有凹连接器242。标号211d表示观察窗。The configuration of the capsulemain body 201 is similar to that of the capsulemain body 201 in the above-described capsule medical device C14 except for the fact that thecasing 211A is provided. Thehousing 211A is different from the above-describedhousing 211 in that it is provided with agroove 211g for easy installation and removal of theairbag 202A, and that afemale connector 242 is formed on the rear surface.Reference numeral 211d denotes an observation window.

在形成在壳体211A中的槽211g中，通过形成在气囊202A中的与槽211g可拆卸地接合的可拆卸突出单元202t来形成安装单元220A。另外，凹连接器242与设置在导线204的基端上的凸连接器241成对地构成连接器204C，通过该连接器204C，可拆卸地连接导线204和壳体211A。此外，在气囊202的外部以整体的方式设置有电极203，电极203由导电橡胶(由导电硅橡胶或导电尼龙等制成)构成。In thegroove 211g formed in thehousing 211A, the mountingunit 220A is formed by a detachable protrudingunit 202t formed in theairbag 202A and detachably engaged with thegroove 211g. In addition, thefemale connector 242 forms a pair with themale connector 241 provided on the base end of thelead wire 204 to form aconnector 204C through which thelead wire 204 and thehousing 211A are detachably connected. In addition, anelectrode 203 is provided in an integral manner on the outside of theairbag 202, and theelectrode 203 is made of conductive rubber (made of conductive silicone rubber or conductive nylon, etc.).

由于电极203这样地由导电橡胶构成，所以当气囊202A膨胀时，气囊202A上的电极203可以类似地伸长，因而气囊202A可以更均匀地膨胀。Since theelectrodes 203 are thus composed of conductive rubber, theelectrodes 203 on theair bag 202A can be similarly stretched when theair bag 202A is inflated, and thus theair bag 202A can be inflated more uniformly.

另外，由于囊主体201A、气囊202A、电极203和导线204是可拆卸地安装的，所以易于根据囊型医疗装置C15的使用状况，用最佳项来替换气囊202A、电极203和导线204。此外，可以重复使用相对昂贵的囊主体201A，而在每次使用之后简单地丢弃相对便宜的气囊202A、电极203和导线204。In addition, since the bagmain body 201A, theballoon 202A, theelectrodes 203, and theleads 204 are detachably installed, it is easy to replace theballoon 202A, theelectrodes 203, and theleads 204 with optimum items according to the usage conditions of the bag-type medical device C15. Furthermore, the relativelyexpensive balloon body 201A can be reused, while the relativelyinexpensive balloon 202A,electrodes 203 and leads 204 are simply discarded after each use.

图29A和29B示出了第二变型例。29A and 29B show a second modification.

该囊型医疗装置C16a是气囊中设置有硬构件的示例。该硬构件形成在上述气囊202的一部分的厚部上，并且比其他部分硬。This balloon-type medical device C16a is an example in which a hard member is provided in the balloon. The hard member is formed on a thick portion of a part of theairbag 202 described above, and is harder than other parts.

在图29A和29B中所示的囊型医疗装置C16a中，气囊202B1通过固定单元220连接到囊主体201，以覆盖囊主体201的朝向观察窗211d后部的一侧。在该气囊202B1中，形成有硬构件221a，以在后侧上形成环，并且围绕该硬构件221a的周边安装有多个电极203。In the bag type medical device C16a shown in FIGS. 29A and 29B , the air bag 202B1 is connected to thebag body 201 through the fixingunit 220 so as to cover the side of thebag body 201 toward the rear of theobservation window 211d. In this airbag 202B1, ahard member 221a is formed to form a ring on the rear side, and a plurality ofelectrodes 203 are installed around the periphery of thehard member 221a.

如上所述，气囊202由诸如柔性橡胶的可伸缩材料形成，从而当电极203由金或其他基本上不能伸缩的材料形成时，二者的伸长率明显不同。换言之，电极203在气囊上的安装和保持变得困难，并且该设置经不起长时间地使用。因此，通过在气囊上至少在安装有电极203的区域中形成厚的硬单元，可以减小二者之间的伸长率的差异，使得可以将电极203更容易地安装和保持在气囊上。As noted above, theballoon 202 is formed from a stretchable material such as flexible rubber, so that when theelectrodes 203 are formed from gold or other substantially non-stretchable materials, the elongation of the two is significantly different. In other words, the installation and maintenance of theelectrode 203 on the balloon becomes difficult, and the arrangement does not stand up to prolonged use. Therefore, by forming a thick hard unit on the balloon at least in the region where theelectrode 203 is mounted, the difference in elongation between the two can be reduced so that theelectrode 203 can be mounted and held on the balloon more easily.

图30至图32示出了第三变型例。30 to 32 show a third modification.

这些囊型医疗装置C16b、C16c和C16d是囊型医疗装置C16a的变型例，其中硬构件形成在气囊上的位置有所不同。These balloon-type medical devices C16b, C16c, and C16d are modifications of the balloon-type medical device C16a in which the positions where the hard members are formed on the balloon are different.

在图30中所示的囊型医疗装置C16b中，气囊202B2通过固定单元220连接到囊主体201，以覆盖囊主体201的朝向观察窗211d后部的一侧。在该气囊202B2的前边缘和后边缘上，都形成有厚的硬构件221b，并且围绕该硬构件221b的外周安装有多个电极203。In the bag-type medical device C16b shown in FIG. 30, the air bag 202B2 is connected to the bagmain body 201 through the fixingunit 220 so as to cover the side of the bagmain body 201 toward the rear of theobservation window 211d. On both the front and rear edges of the airbag 202B2, a thick hard member 221b is formed, and a plurality ofelectrodes 203 are installed around the outer periphery of the hard member 221b.

另外，在图31中所示的囊型医疗装置C16c中，气囊202B3通过固定单元220安装到囊主体201上，以覆盖囊主体201的朝向观察窗211d后部的一侧。在该气囊202B3的顶部和底部上在电极203的边缘附近、以及与顶部和底部电极203相距预定距离的中央区域中形成有厚的硬构件221c。In addition, in the bag-type medical device C16c shown in FIG. 31 , the air bag 202B3 is mounted to the bagmain body 201 through the fixingunit 220 so as to cover the side of the bagmain body 201 facing the rear of theobservation window 211d. Thickhard members 221c are formed on the top and bottom of the balloon 202B3 in the vicinity of the edges of theelectrodes 203 and in central regions at a predetermined distance from the top andbottom electrodes 203 .

此外，在图32中所示的囊型医疗装置C16d中，气囊202B4通过固定单元220在前部和后部的两个位置处安装到囊主体201上，以覆盖囊主体201的中央部分，同时暴露前边缘和后边缘。在该气囊202B4的外周边上，以螺旋形状形成有厚的硬构件221d，并且该硬构件221d的外周上安装有多个电极203。Furthermore, in the bag-type medical device C16d shown in FIG. 32, the air bag 202B4 is attached to the bagmain body 201 at two positions of the front and the rear by the fixingunit 220 so as to cover the central portion of the bagmain body 201 while Expose the front and back edges. On the outer periphery of the airbag 202B4, a thickhard member 221d is formed in a spiral shape, and a plurality ofelectrodes 203 are mounted on the outer periphery of thehard member 221d.

通过这种方式，根据安装在气囊上的电极203的数量和排列，可以根据需要改变硬构件的形状和定位。In this way, according to the number and arrangement of theelectrodes 203 installed on the balloon, the shape and positioning of the hard member can be changed as desired.

图33和34示出了第四变型例。33 and 34 show a fourth modification.

这些囊型医疗装置C16e和C16f是囊型医疗装置C16a的其他变型例，并示出了以下示例：在上述气囊202上设置有独立的硬构件，并且该硬构件比其他区域硬。These balloon-type medical devices C16e and C16f are other modified examples of the balloon-type medical device C16a, and show an example in which an independent hard member is provided on the above-mentionedballoon 202 and is harder than other regions.

在图33中所示的囊型医疗装置C16e中，气囊202B5通过固定单元220安装到囊主体201上，以在观察窗211d的后侧覆盖囊主体201。在该气囊202B5中，在后侧上围绕周边设置有多个硬构件221e。这些硬构件221e通过使用粘合剂涂覆上述气囊202的外表面并使其硬化而形成。在各个硬构件221e上安装有电极203。In the bag-type medical device C16e shown in FIG. 33, the air bag 202B5 is attached to the bagmain body 201 through the fixingunit 220 so as to cover the bagmain body 201 on the rear side of theobservation window 211d. In this airbag 202B5, a plurality ofhard members 221e are provided around the periphery on the rear side. Thesehard members 221e are formed by coating the outer surface of the above-mentionedairbag 202 with an adhesive and hardening it. Theelectrodes 203 are attached to the respectivehard members 221e.

另外，在图34A和34B中所示的囊型医疗装置C16f中，气囊202B6通过固定单元220安装到囊主体201上，以在观察窗211d的后侧覆盖囊主体201。该气囊202B6安装有与硬构件221f一体的电极，这些硬构件由比气囊202硬的硬橡胶构成，并且这些硬构件设置在上述气囊202的后侧的外周边上。In addition, in the bag-type medical device C16f shown in FIGS. 34A and 34B , the air bag 202B6 is attached to the bagmain body 201 through the fixingunit 220 so as to cover the bagmain body 201 on the rear side of theobservation window 211d. This airbag 202B6 is equipped with electrodes integrated withhard members 221f made of hard rubber harder than theairbag 202 and provided on the outer periphery of the rear side of the above-mentionedairbag 202 .

通过这种方式，此后对由与气囊202不同的材料制成的硬构件进行安装，因此，使气囊202B5和气囊202B6的结构变得简单，并易于制造。In this way, a hard member made of a material different from that of theairbag 202 is installed thereafter, thus making the structure of the airbag 202B5 and the airbag 202B6 simple and easy to manufacture.

图35示出了第五变型例。Fig. 35 shows a fifth modification.

囊型医疗装置C17是以下示例：当气囊膨胀时，纵向剖面形状(从正面观察时的剖面形状)变形。The balloon-type medical device C17 is an example in which the longitudinal cross-sectional shape (the cross-sectional shape when viewed from the front) is deformed when the balloon is inflated.

图35中所示的囊型医疗装置C17中的气囊202C膨胀，使得纵向剖面为星形。在该星形气囊202C的末端处设置有电极203。当使这种星形气囊202C膨胀时，仅末端与内腔器官(这里由小肠I代表)的内壁接触。在这些末端中的每一个之间，气囊202C具有凹陷部分。结果，在这些凹陷部分和小肠I之间，沿小肠I的内部形成有沿囊型医疗装置C17前方和后方延伸的空间Ih。Theballoon 202C in the balloon-type medical device C17 shown in FIG. 35 is inflated so that the longitudinal section is star-shaped.Electrodes 203 are provided at the ends of the star-shapedballoon 202C. When such a star-shapedballoon 202C is inflated, only the tip is in contact with the inner wall of the luminal organ (represented here by the small intestine I). Between each of these ends, thebladder 202C has a recessed portion. As a result, between these depressed portions and the small intestine I, a space Ih extending in front and rear of the capsule medical device C17 is formed along the inside of the small intestine I.

由于形成了这些空间Ih，所以即使在气囊202C膨胀时，也不会阻塞小肠I的内部。因此，小肠I中存在的诸如已消化的物质的流体可以沿囊型医疗装置C17的长度适当地流动。Since these spaces Ih are formed, the inside of the small intestine I is not blocked even when theballoon 202C is inflated. Therefore, fluids such as digested substances present in the small intestine I can properly flow along the length of the balloon-type medical device C17.

图36中所示的囊型医疗装置C18、图37中所示的囊型医疗装置C19以及图38中所示的囊型医疗装置C20都是该囊型医疗装置C17的变型例。在这些变型例中的每一个中，改变了囊型医疗装置的纵向剖面形状。根据检查的目的或条件，可以适当地改变气囊膨胀时的这些纵向剖面形状。The medical capsule C18 shown in FIG. 36 , the medical capsule C19 shown in FIG. 37 , and the medical capsule C20 shown in FIG. 38 are all modifications of the medical capsule C17 . In each of these modification examples, the longitudinal sectional shape of the capsule-type medical device is changed. These longitudinal cross-sectional shapes when the airbag is inflated can be appropriately changed according to the purpose or conditions of the inspection.

图36示出了第六变型例。FIG. 36 shows a sixth modification example.

该囊型医疗装置C18中的气囊202D由固定单元220B固定，该固定单元220B形成在囊主体201的外周边上的对称位置处的两个位置(图中的顶部和底部位置)，并且当该气囊膨胀时，膨胀沿左方和右方大致对称。结果，在固定单元220B与小肠I之间形成有沿内腔器官中的囊型医疗装置C18从前到后穿过的空间Ih。The air bag 202D in this bag-type medical device C18 is fixed by fixing units 220B formed at two positions (top and bottom positions in the figure) at symmetrical positions on the outer periphery of the bagmain body 201, and when the When the airbag is inflated, the expansion is approximately symmetrical along the left and right sides. As a result, a space Ih through which the capsule-type medical device C18 in the lumen organ passes from front to back is formed between the fixing unit 220B and the small intestine I.

图37示出了第七变型例。Fig. 37 shows a seventh modification.

该囊型医疗装置C19中的气囊202E膨胀，以使纵向剖面为椭圆形。结果，在气囊202E的长边(图中的顶部和底部)与小肠I之间形成有空间Ih。Theair bag 202E in the bag-type medical device C19 is inflated so as to have an ellipse in longitudinal section. As a result, a space Ih is formed between the long sides (top and bottom in the drawing) of theballoon 202E and the small intestine I.

该囊型医疗装置C19设置有囊主体201B和电源单元(电源)205A。这里的囊主体201B是上述囊主体201B，但从中省略了用于对电极203施加电刺激的电池和方波发生电路。另外，将用于向电极203施加电刺激的电池和方波发生电路以集成的方式合并在电源单元205A中。该电源单元205A的操作由从外部装置300直接接收到的控制信号或者通过囊主体201B内的控制单元213(在该图中被省略)接收的控制信号来控制。This capsule medical device C19 is provided with a capsulemain body 201B and a power supply unit (power supply) 205A. The capsulemain body 201B here is the above-mentioned capsulemain body 201B, but a battery and a square wave generating circuit for applying electrical stimulation to theelectrodes 203 are omitted therefrom. In addition, a battery for applying electrical stimulation to theelectrodes 203 and a square wave generating circuit are incorporated in thepower supply unit 205A in an integrated manner. The operation of thepower supply unit 205A is controlled by a control signal received directly from theexternal device 300 or through a control unit 213 (omitted in the figure) inside the capsulemain body 201B.

通过这种方式，用于施加电刺激的电源和方波发生电路由与囊主体201B不同的材料制成，因此囊主体201B的结构简单。另外，囊主体201B内的电池205(在该图中被省略)并不用于施加电刺激，因此电池205可以长时间使用。In this way, the power supply and the square wave generating circuit for applying electrical stimulation are made of different materials from the capsulemain body 201B, so the structure of the capsulemain body 201B is simple. In addition, the battery 205 (omitted in the figure) inside the capsulemain body 201B is not used for applying electrical stimulation, so thebattery 205 can be used for a long time.

图38示出了第八变型例。Fig. 38 shows an eighth modification.

该囊型医疗装置C20中气囊202F设置有从前到后穿过囊型医疗装置C20的通孔222。因此，利用这些通孔222保证了与上述空间Ih相同的功能。Theairbag 202F of the balloon medical device C20 is provided with a throughhole 222 passing through the balloon medical device C20 from front to back. Therefore, using these throughholes 222 ensures the same function as the space Ih described above.

图39A至39D示出了第九变型例。39A to 39D show a ninth modification.

该囊型医疗装置C21的膨胀和收缩机构的结构与上述囊型医疗装置C14的不同。在该囊型医疗装置C21的囊主体201C中，将上述囊主体201的各种构成元件以集成的方式设置在壳体211B中。此外，在壳体211B中形成有存储室261、导向孔262a、导向孔262b以及螺纹孔263，并且移动构件264互锁到该螺纹孔263中。通过这些各种构成元件，保证了与上述膨胀和收缩机构单元216相对应的功能。The structure of the expansion and contraction mechanism of this balloon medical device C21 is different from that of the above-mentioned balloon medical device C14. In the capsulemain body 201C of this capsule-type medical device C21 , various constituent elements of the above-described capsulemain body 201 are provided in ahousing 211B in an integrated manner. Further, astorage chamber 261 , aguide hole 262 a , aguide hole 262 b , and ascrew hole 263 are formed in thehousing 211B, and the movingmember 264 is interlocked into thescrew hole 263 . By these various constituent elements, functions corresponding to the expansion andcontraction mechanism unit 216 described above are secured.

如图39A至39C所示，在设置在囊主体201C中的存储室261中，通过从外部贯穿的孔来存储加压气体g，并且在存储之后，该孔由橡胶帽261s阻塞。如下所述，可以用发泡剂来代替该加压气体g。另外，该存储室261经由导向孔262a连接到使得移动构件264能够进行旋转运动的螺纹孔263，并且该螺纹孔263还经由螺纹孔262b连接到囊型医疗装置C21的外部。该螺纹孔263的后边缘开口到囊型医疗装置C21的外部。As shown in FIGS. 39A to 39C , in thestorage chamber 261 provided in the bladdermain body 201C, the pressurized gas g is stored through a hole penetrating from the outside, and after storage, the hole is blocked by arubber cap 261s. As described below, the pressurized gas g may be replaced with a blowing agent. In addition, thisstorage chamber 261 is connected to a threadedhole 263 enabling rotational movement of the movingmember 264 via aguide hole 262a, and this threadedhole 263 is also connected to the outside of the capsule medical device C21 via a threadedhole 262b. The rear edge of the threadedhole 263 opens to the outside of the capsule medical device C21.

另外，囊主体201C的后边缘侧被气囊202覆盖，并且该气囊202的前边缘侧通过带状固定构件220以气密的方式固定在囊主体201B的中央附近。在气囊202的后边缘侧固定有电极203，并且这些电极通过柔性线204电和机械地连接到囊主体201C。In addition, the rear edge side of the bagmain body 201C is covered with theairbag 202 , and the front edge side of theairbag 202 is fixed near the center of the bagmain body 201B in an airtight manner by the belt-shaped fixingmember 220 .Electrodes 203 are fixed on the rear edge side of theair bag 202 , and these electrodes are electrically and mechanically connected to the bagmain body 201C throughflexible wires 204 .

移动构件264例如包括：条形的永磁体264m，其沿与其纵向方向正交的方向被磁化成北极和南极；以及外螺纹形的弹性橡胶264g，其覆盖该永磁体264m。The movingmember 264 includes, for example, a bar-shapedpermanent magnet 264m magnetized into north and south poles in a direction orthogonal to its longitudinal direction, and an external thread-shaped elastic rubber 264g covering thepermanent magnet 264m.

下面将对以下情况进行说明：使用如上所述构成的囊型医疗装置C21观察并研究受检查者的活体腔的内部。A case will be described below in which the inside of a living body cavity of a subject is observed and studied using the capsule medical device C21 configured as described above.

首先，受检查者通过带等将外部装置300和下述的旋转磁场产生装置安装到其腹部或其它地方。然后，通过从口中插入囊型医疗装置C21将囊型医疗装置C21引入到活体腔中。当将囊型医疗装置C21引入到活体腔中时，使气囊收缩，如图39A所示。First, the subject attaches theexternal device 300 and the rotating magnetic field generating device described below to his abdomen or other places via a belt or the like. Then, the capsule-type medical device C21 is introduced into the living body cavity by inserting the capsule-type medical device C21 from the mouth. When the balloon-type medical device C21 is introduced into a living body cavity, the balloon is deflated as shown in FIG. 39A .

在囊型医疗装置C21推进到十二指肠并到达待由观察窗211d内的各种传感器选择性地进行研究的位置之前，由放置在活体外的未示出的旋转磁场产生装置施加旋转磁场。由此，使移动构件264沿螺纹孔263旋转并使移动构件264移动到壳体的前部。Before the capsule-type medical device C21 advances into the duodenum and reaches a position to be selectively studied by various sensors inside theobservation window 211d, a rotating magnetic field is applied by an unillustrated rotating magnetic field generating device placed outside the living body . Thereby, the movingmember 264 is rotated along the threadedhole 263 and moved to the front of the housing.

当移动构件264移动到壳体的前部时，存储室261经由导向孔262a和螺纹孔263连接到气囊202，如图39B所示。由此，加压气体g如箭头所示流到气囊202中，使气囊202膨胀。可以使用发泡剂来代替加压气体g。在这种情况下，优选地用少量的水涂覆气囊202的内部以进行反应。When the movingmember 264 moves to the front of the housing, thestorage chamber 261 is connected to theairbag 202 via theguide hole 262a and the threadedhole 263, as shown in FIG. 39B. As a result, the pressurized gas g flows into theairbag 202 as indicated by the arrow, and theairbag 202 is inflated. A blowing agent may be used instead of the pressurized gas g. In this case, it is preferable to coat the inside of theair bag 202 with a small amount of water to react.

当气囊202由此膨胀时，气囊202上的电极203与该位置附近的消化道(内腔器官)的内壁接触。另外，通过以特定周期的脉冲向电极203输送几毫安培的方波电流，通过电刺激使该区域中的消化道的内壁收缩，并且通过将该收缩力转换成推进力，将该装置推进到目标位置。接下来，当到达该目标位置时，停止电流，使该装置保持在该位置处，并通过各种传感器完成检测。接下来，在足够各种传感器完成检测的时间之后，再次使电流流向电极203，并通过由电刺激导致的收缩力，将该装置推进到肛门。When theballoon 202 is thus inflated, theelectrodes 203 on theballoon 202 come into contact with the inner wall of the digestive tract (luminal organ) near the location. In addition, by delivering a square-wave current of several milliamperes to theelectrode 203 in pulses of a specific period, the inner wall of the digestive tract in this area is contracted by electrical stimulation, and by converting the contraction force into a propulsion force, the device is propelled into the target location. Next, when the target position is reached, the current flow is stopped, the device is held at that position, and detection is done by various sensors. Next, after a time sufficient for the various sensors to complete detection, the current is again flowed to theelectrode 203, and the device is pushed into the anus by the contraction force caused by the electrical stimulation.

此外，刚好在肛门之前施加旋转磁场，使移动构件264向前边缘侧移动，由此，将气囊202的内部经由螺纹孔263和导向孔262b连接到囊型医疗装置C21的外部。即，将使气囊202膨胀的加压气体被排出到外部，从而气囊202收缩，如图39C所示。接下来，容易地使囊型医疗装置C21通过肛门从活体中排出。Also, applying a rotating magnetic field just before the anus moves the movingmember 264 to the front edge side, thereby connecting the inside of theballoon 202 to the outside of the balloon medical device C21 via the threadedhole 263 and theguide hole 262b. That is, the pressurized gas that will inflate theairbag 202 is discharged to the outside, so that theairbag 202 contracts, as shown in FIG. 39C . Next, the capsule medical device C21 is easily expelled from the living body through the anus.

由于该膨胀和收缩机构单元具有这种构造，所以可以更容易且更精确地实现气囊202的膨胀和收缩。Since the expansion and contraction mechanism unit has such a configuration, the expansion and contraction of theairbag 202 can be achieved more easily and accurately.

接下来，图40A至40C示出了第十变型例。Next, a tenth modification example is shown in FIGS. 40A to 40C .

该囊型医疗装置C22的气囊202H与上述气囊202不同，其由基本上不弹性膨胀或收缩的材料构成。作为这种材料的具体示例，由PFA(四氟乙烯-全氟(烷氧基乙烯醚)共聚物)或PTFE(聚四氟乙烯)等构成的Teflon(注册商标)膜是适合的。另外，以集成的方式将导线204印刷在柔性印刷电路板204F上，并将该柔性印刷电路板204F粘贴在气囊202H的内表面上。Theairbag 202H of this bag-type medical device C22 is different from the above-mentionedairbag 202 in that it is composed of a material that does not substantially elastically expand or contract. As a specific example of such a material, a Teflon (registered trademark) film made of PFA (tetrafluoroethylene-perfluoro(alkoxyethylene ether) copolymer), PTFE (polytetrafluoroethylene), or the like is suitable. In addition, thewires 204 are printed on a flexible printedcircuit board 204F in an integrated manner, and the flexible printedcircuit board 204F is pasted on the inner surface of theairbag 202H.

当从口中插入该囊型医疗装置C22时，气囊202H裹在囊主体201周围，并被由淀粉、淀粉纸(oblate)等构成的带223绑住，如图40A所示。当该装置在该状态下到达胃时，带223被溶解，从而气囊202H可以膨胀。然后，使气囊202H膨胀，并在通过电极203对内腔器官的内壁施加电刺激的同时，使囊型医疗装置C22适当地推进。When the bladder type medical device C22 is inserted from the mouth, theballoon 202H is wrapped around thebladder body 201 and bound by aband 223 made of starch, starch oblate, etc., as shown in FIG. 40A . When the device reaches the stomach in this state, theband 223 is dissolved so that theballoon 202H can be inflated. Then, theballoon 202H is inflated, and the balloon-type medical device C22 is appropriately pushed while applying electrical stimulation to the inner wall of the lumen organ through theelectrodes 203 .

由于该气囊202H基本上不弹性膨胀或收缩，所以其不会膨胀超过预定的最大外径。因此，根据气囊202H的最大膨胀来设定导线204的长度，并且可以按照与柔性印刷电路板204F集成的方式将导线204粘贴在气囊202H内。因此，基本上可以不考虑由于重复使用导线204而导致的断开，因此该装置可以经受更长时间的使用。Since theballoon 202H does not substantially elastically expand or contract, it will not expand beyond a predetermined maximum outer diameter. Therefore, the length of thewire 204 is set according to the maximum inflation of theairbag 202H, and thewire 204 can be pasted inside theairbag 202H in such a manner as to be integrated with the flexible printedcircuit board 204F. Therefore, disconnection due to repeated use of thewire 204 can be substantially ignored, and thus the device can withstand a longer period of use.

图41A和41B示出了第十一变型例。在该囊型医疗装置C24中，通过形状记忆线圈(膨胀装置)216c连接囊主体201D和气囊202I。41A and 41B show an eleventh modification. In this balloon-type medical device C24, the balloon main body 201D and the balloon 202I are connected by a shape memory coil (expansion device) 216c.

在囊主体201D中，从上述囊主体201中省略了膨胀和收缩机构单元216。另外，气囊202I的材料与上述气囊202相同，但是被成形为在收缩时从囊主体201D的后边缘侧进一步向后伸出。将预定体积的流体(水、空气等)密封在该气囊202I内。另外，由形状记忆合金制成的形状记忆线圈216c从囊主体201D的后边缘延伸，并且其末端通过连接件216d连接到气囊202I的后边缘。该形状记忆线圈216c具有形状记忆特性，以使其在环境温度低于体温时伸展为较长的形状，而在环境温度达到体温时收缩成线圈形状。In the bag main body 201D, the expansion andcontraction mechanism unit 216 is omitted from the above-described bagmain body 201 . In addition, the material of the airbag 202I is the same as that of the above-mentionedairbag 202, but is shaped so as to protrude further rearward from the rear edge side of the bag main body 201D when deflated. A predetermined volume of fluid (water, air, etc.) is sealed within the bladder 202I. In addition, ashape memory coil 216c made of a shape memory alloy extends from the rear edge of the bag main body 201D, and an end thereof is connected to the rear edge of the air bag 202I by alink 216d. Theshape memory coil 216c has a shape memory property such that it expands into a longer shape when the ambient temperature is lower than body temperature, and contracts into a coil shape when the ambient temperature reaches body temperature.

受检查者将囊型医疗装置C24按图41A中所示的状态从口中插入到活体腔中。在活体腔中，囊型医疗装置C24的周围温度变得大致与体温相同，因此形状记忆线圈216c收缩。因此，气囊202I变形并横向膨胀，如图41B所示，使得气囊202I上的电极203与内腔器官的内壁接触。The subject inserts the capsule medical device C24 from the mouth into the cavity of the living body in the state shown in FIG. 41A . In the living cavity, since the surrounding temperature of the medical capsule C24 becomes substantially the same as the body temperature, theshape memory coil 216c contracts. Accordingly, the balloon 202I deforms and expands laterally, as shown in FIG. 41B , so that theelectrodes 203 on the balloon 202I come into contact with the inner wall of the luminal organ.

通过这种方式，使用形状记忆线圈216c使气囊膨胀和收缩，因此可以从囊主体中省略掉膨胀和收缩机构单元，由此使得其结构更简单。In this way, the airbag is inflated and deflated using theshape memory coil 216c, so the inflation and deflation mechanism unit can be omitted from the bag main body, thereby making its structure simpler.

除了将形状记忆线圈216c的形状记忆温度设定为高于体温之外，还可以具有以下结构：通过设置可以由控制单元213(在该图中被省略)控制的加热器等，可以在任意位置处使气囊202I膨胀或收缩。In addition to setting the shape-memory temperature of the shape-memory coil 216c to be higher than the body temperature, it is also possible to have a structure that can be set at any position by providing a heater or the like that can be controlled by the control unit 213 (omitted in the figure). The airbag 202I is inflated or deflated.

图42A和42B示出了第十二变型例。42A and 42B show a twelfth modification.

该囊型医疗装置C25是上述囊型医疗装置C24的变型例。在上述囊主体201D上设置由具有高弹性的柔性橡胶(人造橡胶)制成的弹性膨胀单元202J，用于代替上述气囊202。该人造橡胶内以水密状态存储有导线204(在该图中被省略)。This capsule medical device C25 is a modified example of the capsule medical device C24 described above. Anelastic expansion unit 202J made of flexible rubber (elastomer) having high elasticity is provided on the above-mentioned bag main body 201D in place of the above-mentionedair bag 202 . Lead wires 204 (omitted in the figure) are stored in a watertight state in the elastomer.

当从口中插入该囊型医疗装置C25时，使弹性膨胀单元202J折叠，以使得外径很小，并以直径减小的状态存储在由淀粉、淀粉纸等制成的囊224内。当其以该状态到达胃时，囊224溶解，使弹性膨胀单元202J弹性膨胀为宽直径状态。此后，在通过电极203对内腔器官的内壁施加电刺激的同时，适当地推进囊型医疗装置C25。由于该弹性膨胀单元202J具有高弹性，所以也易于变形。因此，当从肛门排出时，其可以弹性变形，以使得可以容易地将其排出。When this capsule type medical device C25 is inserted from the mouth, theelastic expansion unit 202J is folded so that the outer diameter is small, and stored in a diameter-reduced state in thecapsule 224 made of starch, starch paper, or the like. When it reaches the stomach in this state, theballoon 224 dissolves, elastically expanding theelastic expansion unit 202J into a wide-diameter state. Thereafter, the capsule-type medical device C25 is appropriately advanced while applying electrical stimulation to the inner wall of the luminal organ through theelectrodes 203 . Since theelastic expansion unit 202J has high elasticity, it is also easy to deform. Therefore, when expelled from the anus, it can be elastically deformed so that it can be easily expelled.

由于该装置配备有这种弹性膨胀单元202J，所以从囊主体中省略了膨胀和收缩机构单元，以使得其结构变得更简单。Since the device is equipped with such anelastic expansion unit 202J, the expansion and contraction mechanism unit is omitted from the bladder body to make its structure simpler.

下面将参照图43A至43C说明本发明的第四实施例。在该实施例中，与上述第三实施例中的构成元件公共的构成元件标有相同的标号，并省略对其的详细说明。Next, a fourth embodiment of the present invention will be described with reference to Figs. 43A to 43C. In this embodiment, constituent elements common to those in the third embodiment described above are assigned the same reference numerals, and detailed descriptions thereof are omitted.

图43A示出了该实施例的内窥镜装置(囊型医疗装置)的前边缘侧的结构。图43B和43C示出了该实施例的囊型医疗装置的插入口附近的结构。此外，图44A和44B示出了由该囊型医疗装置构成的内窥镜装置在消化道的内腔器官(诸如小肠)内被释放之后的状态。Fig. 43A shows the structure of the front edge side of the endoscope device (capsule medical device) of this embodiment. 43B and 43C show the structure near the insertion port of the capsule-type medical device of this embodiment. In addition, FIGS. 44A and 44B show the state after the endoscopic device constituted by the capsule-type medical device is released in a lumen organ of the digestive tract such as the small intestine.

如图43A至43C所示，内窥镜装置(囊型医疗装置)S1设置有：囊型医疗装置C26；空心管206，可以将其自由地安装到该囊型医疗装置C26上或从该囊型医疗装置C26拆卸；以及内窥镜207，其可插入到该管206中。囊型医疗装置C26使得可以从上述第三实施例中的囊型医疗装置C1省略膨胀和收缩机构单元216。As shown in FIGS. 43A to 43C, an endoscopic device (capsule medical device) S1 is provided with: a capsule medical device C26; type medical device C26 disassembly; andendoscope 207, which can be inserted into thetube 206. The balloon medical device C26 makes it possible to omit the expansion andcontraction mechanism unit 216 from the balloon medical device C1 in the third embodiment described above.

囊型医疗装置C26在囊主体201E的顶端处的观察窗中设置有：发光装置单元212b，例如白光LED等；以及拍摄元件单元212a，其由光学系统(诸如物镜)和固态拍摄元件(诸如CCD或CMOS成像器)构成，另外，在其后侧的侧面上，由诸如硅橡胶或乳胶橡胶等的弹性材料制成的、其整个外周可以容易地膨胀的气囊202K通过固定环等安装到固定单元220上，并且另外，为了向气囊202K的内部(严格地说是气囊202K与囊主体201E之间的空间)提供流体，在后边缘上设置有注入口217a。该注入口217a经由流体通道217连接到气囊202K的内部。为了向气囊202K提供流体，可以将管206自由地安装到该注入口217a上或从该注入口217a拆卸。The capsule medical device C26 is provided with, in an observation window at the top end of the capsulemain body 201E: a light emittingdevice unit 212b, such as a white light LED, etc.; or CMOS imager), and in addition, on the rear side thereof, anairbag 202K made of an elastic material such as silicon rubber or latex rubber, the entire periphery of which can be easily inflated is attached to the fixing unit through a fixing ring or the like 220, and in addition, in order to supply fluid to the inside of theairbag 202K (strictly speaking, the space between theairbag 202K and the bagmain body 201E), aninjection port 217a is provided on the rear edge. Thisinjection port 217a is connected to the inside of theairbag 202K via afluid passage 217 . In order to supply fluid to theair bag 202K, thetube 206 can be freely attached to or detached from theinjection port 217a.

管206的前边缘是可以容易地安装到注入口217a上的针形窄直径单元206t。另外，在未示出的封闭侧上，具有可以自由地连接流体注入工具(例如注射器)的封闭侧打开硬件。此外，通过从该注入口217a提供流体，经由流体通道217将流体注入到气囊202K中，以使该气囊202K可以膨胀到其可以至少与小肠I中的内腔器官紧密接触的程度(约20-30mm)。The front edge of thetube 206 is a needle-shapednarrow diameter unit 206t that can be easily fitted to theinjection port 217a. Additionally, on the closed side, not shown, there is closed side opening hardware to which a fluid injection tool such as a syringe can be freely attached. In addition, by providing fluid from theinjection port 217a, fluid is injected into theballoon 202K via thefluid channel 217, so that theballoon 202K can be inflated to the extent that it can be in close contact with at least the lumen organ in the small intestine 1 (about 20- 30mm).

设置在囊主体201的后边缘处的注入口217a具有如软式网球上的气门的弹性阀结构，以使得在吞下气囊202K之后，即使拆卸管206，气囊202K仍密封。另外，在囊主体201E内设置有作为电源的电池205，并且在气囊202K的后边缘表面的一侧上固定有一对双极电极203，通过柔性带形导线204电和机械地连接电极203和电池205。Theinjection port 217a provided at the rear edge of the bagmain body 201 has an elastic valve structure like a valve on a soft tennis ball so that theair bag 202K remains sealed even if thetube 206 is detached after swallowing theair bag 202K. In addition, abattery 205 as a power source is provided inside the bagmain body 201E, and a pair ofbipolar electrodes 203 are fixed on one side of the rear edge surface of theair bag 202K, and theelectrodes 203 and the battery are electrically and mechanically connected by a flexible ribbon-shapedwire 204. 205.

内窥镜207设置有沿长且窄的插入单元270的轴向的通道271。另一方面，管206的长度比该通道271的长度要长，并具有使得能够平滑地插入或拔出通道271的外径，可以从管206的基端向前边缘提供诸如空气或水的流体。Theendoscope 207 is provided with achannel 271 along the axial direction of a long andnarrow insertion unit 270 . On the other hand, the length of thetube 206 is longer than the length of thechannel 271, and has an outer diameter such that thechannel 271 can be inserted or pulled out smoothly, and a fluid such as air or water can be supplied from the base end of thetube 206 to the front edge. .

如图43B所示，注入口217a中安装有表现出弹性的橡胶帽217v。该橡胶帽217v中预先形成的窄通道217l在管206的前边缘上的针形窄直径单元206t未穿过它时处于阻塞状态。在这种情况下，该通道217l的后边缘具有标记，以使得可以知道插入位置，并且具有凹陷部分217u，以使得可以容易地插入针形窄直径单元206t。As shown in FIG. 43B, arubber cap 217v exhibiting elasticity is attached to theinjection port 217a. The pre-formed narrow passage 217l in thisrubber cap 217v is blocked when the needle-shapednarrow diameter unit 206t on the front edge of thetube 206 does not pass through it. In this case, the rear edge of this channel 217l has a mark so that the insertion position can be known, and has a recessedportion 217u so that the needle-shaped narrow-diameter unit 206t can be easily inserted.

如图43C所示，当将针形窄直径单元206t插入到注入口217a中时，针形窄直径单元206t穿过通道217l。通过在该状态下从针形窄直径单元206t注入诸如液体或气体的流体，可以使外部的包括流体存储单元的气囊202K膨胀，如图44A和44B所示。在将管206安装到囊主体201E的注入口217a的情况下，当从通道271的末端插入管206的基端时，管206的基端从通道271的基端伸出(在该图中被省略)。As shown in FIG. 43C, when the needle-shaped narrow-diameter unit 206t is inserted into theinjection port 217a, the needle-shaped narrow-diameter unit 206t passes through the passage 217l. By injecting fluid such as liquid or gas from the needle-shaped narrow-diameter unit 206t in this state, theexternal air bag 202K including the fluid storage unit can be inflated, as shown in FIGS. 44A and 44B . In the case of installing thetube 206 to theinjection port 217a of the bagmain body 201E, when the base end of thetube 206 is inserted from the distal end of thechannel 271, the base end of thetube 206 protrudes from the base end of the channel 271 (referred to as omitted).

通过对伸出的管206的基端施加使管206不掉出的拉力，或者通过经由通道271在囊型医疗装置C26的后边缘上进行抽吸，可以将囊型医疗装置C26可拆卸地固定到内窥镜207的末端，如图43A所示。当通过抽吸方式来固定囊型医疗装置C26时，为了增进吸收功能，可以在囊型医疗装置C26与内窥镜207的末端之间添加由弹性橡胶等构成的吸收剂7a。The bladder medical device C26 can be detachably secured by applying a pulling force to the proximal end of the protrudingtube 206 so that thetube 206 does not fall out, or by applying suction on the rear edge of the bladder medical device C26 via thechannel 271 to the tip of theendoscope 207, as shown in Figure 43A. When the capsule medical device C26 is fixed by suction, an absorbent 7a made of elastic rubber or the like may be added between the capsule medical device C26 and the end of theendoscope 207 in order to enhance the absorption function.

为了有助于释放囊型医疗装置C26，将具有抓取功能的抓取工具272F插入到设置在内窥镜207中的第二通道272中，并且该抓取工具272F的末端处的夹持单元抓取设置在囊型医疗装置C26的后边缘附近的抓取用突起201t，可以使气囊202K膨胀。In order to facilitate the release of the capsule medical device C26, a graspingtool 272F having a grasping function is inserted into thesecond channel 272 provided in theendoscope 207, and the gripping unit at the end of the graspingtool 272F Theballoon 202K can be inflated by grasping the graspingprotrusion 201t provided near the rear edge of the balloon medical device C26.

当从口中插入该内窥镜装置S1时，囊型医疗装置C26被设置为固定在内窥镜207的末端上的状态，并且气囊202K处于收缩状态(处于气囊202K与囊主体201E的外周充分紧密接触的状态)，如图43A所示，并以整体的方式将囊型医疗装置C26和内窥镜207插入到活体腔中。此外，使囊型医疗装置C26到达作为检查目标的位置，例如小肠I。When this endoscopic device S1 is inserted from the mouth, the capsule medical device C26 is set in a state fixed on the end of theendoscope 207, and theballoon 202K is in a contracted state (theballoon 202K is sufficiently tight to the periphery of the balloonmain body 201E contact state), as shown in FIG. 43A, and the capsule medical device C26 and theendoscope 207 are inserted into the living body cavity in an integrated manner. In addition, the capsule medical device C26 is brought to a position to be inspected, for example, the small intestine I.

在这种状态下，经由管206向气囊202K的内部提供流体，已围绕其整个外周充分膨胀的气囊202K与小肠I的内壁接触，然后当将囊型医疗装置C26大致固定在小肠I的内腔器官的内部的中央时，从注入口217a去除并拔出管206。通过去除管206，囊型医疗装置C26与管主体206之间的固定被释放，管主体206和内窥镜207被拔出到活体外部，而仅囊型医疗装置C26剩余在小肠I中。In this state, fluid is supplied to the inside of theballoon 202K via thetube 206, and theballoon 202K, which has been sufficiently inflated around its entire periphery, comes into contact with the inner wall of the small intestine I, and then the balloon-type medical device C26 is substantially fixed to the lumen of the small intestine I. When the center of the interior of the organ is removed, thetube 206 is removed from theinjection port 217a and pulled out. By removing thetube 206, the fixation between the balloon medical device C26 and the tubemain body 206 is released, the tubemain body 206 and theendoscope 207 are pulled out outside the living body, and only the balloon medical device C26 remains in the small intestine I.

由膨胀的气囊202K和小肠I的内壁产生的阻力控制囊型医疗装置C26的旋转和倾斜，并且在将囊型医疗装置C26留在小肠中之后，甚至在由蠕动导致的运动过程中，大致位于内腔器官的中心的拍摄元件单元212a的位置也得到保持。The resistance generated by theinflated balloon 202K and the inner wall of the small intestine I controls the rotation and tilt of the medical balloon device C26, and after leaving the medical balloon device C26 in the small intestine, even during the movement caused by peristalsis, approximately The position of theimaging element unit 212a in the center of the lumen is also maintained.

图44A和44B示出了囊型医疗装置C26的释放后的情况。图44A示出了将囊型医疗装置C26的轴线保持为沿着内腔的中心的状态，这是拍摄元件单元212a进行拍摄的状态，并且视野是内腔的前向侧。另外，图44B示出了以下状态：图44A中所示的囊型医疗装置C26的后部下降到内腔的底侧，从而使囊型医疗装置C26的轴线相对于内腔的中心倾斜。即使在该情况，也可以使用拍摄元件单元212a拍摄图像，并且视野是该内腔的前向侧。44A and 44B illustrate the post-release condition of medical capsule C26. FIG. 44A shows a state in which the axis of the capsule medical device C26 is kept along the center of the lumen, which is a state in which imaging is taken by theimaging element unit 212a, and the field of view is the front side of the lumen. In addition, FIG. 44B shows a state in which the rear portion of the medical capsule C26 shown in FIG. 44A is lowered to the bottom side of the lumen so that the axis of the medical capsule C26 is inclined relative to the center of the lumen. Even in this case, an image can be captured using theimaging element unit 212a, and the field of view is the front side of the lumen.

当使气囊202K膨胀时，气囊202K的外表面上的该对电极203与消化器官(例如小肠I)的内壁接触。在这种状态下，通过使电流从电池205间歇地流到电极203而导致的电刺激，可以促进蠕动或导致消化器官的局部收缩。因此，通过所激发的蠕动或局部收缩，囊型医疗装置C26可以被推进得比正常条件下更快。另外，气囊202K内的导线是柔性的，因此可以使气囊202K内的导线204自由地变形，以使得可以在使气囊膨胀和收缩时防止出现诸如导线204断开的问题。When theballoon 202K is inflated, the pair ofelectrodes 203 on the outer surface of theballoon 202K comes into contact with the inner wall of the digestive organ such as the small intestine I. In this state, electrical stimulation caused by intermittently flowing current from thebattery 205 to theelectrode 203 can promote peristalsis or cause local contraction of the digestive organs. Thus, the bladder medical device C26 can be advanced faster than normal by the peristalsis or partial contraction induced. In addition, the wires inside theairbag 202K are flexible, so that thewires 204 inside theairbag 202K can be freely deformed, so that problems such as disconnection of thewires 204 can be prevented when the airbag is inflated and deflated.

通过小肠I的主动蠕动或小肠I的由电刺激所导致的收缩动作，气囊202K被运送到大肠，同时视野为整个周边，并且此后还观察大肠直到肛门。当气囊202K难以传送到肛门的外部时，用于在气囊202K中形成孔的针可以从肛门外部刺穿该气囊。By the active peristalsis of the small intestine I or the contraction action of the small intestine I caused by electrical stimulation, theballoon 202K is delivered to the large intestine while viewing the entire periphery, and thereafter also observes the large intestine up to the anus. When theballoon 202K is difficult to deliver to the outside of the anus, the needle for forming a hole in theballoon 202K can pierce the balloon from the outside of the anus.

使囊型医疗装置C26的气囊202K膨胀的位置不必是小肠I，而可以是胃或十二指肠，并且此时使用常规的上消化道内窥镜。另外，可以使用简单的具有弯曲功能的导管内窥镜(导引构件)来代替具有观察装置的内窥镜。The place where theballoon 202K of the balloon medical device C26 is inflated does not have to be the small intestine I, but may be the stomach or the duodenum, and a conventional upper gastrointestinal endoscope is used at this time. In addition, a simple catheter endoscope (guide member) having a bending function may be used instead of the endoscope having an observation device.

在该内窥镜装置S1中，可以在不使囊型医疗装置C26更大的情况下使其结构简单，并且可以通过简单的方法使活体腔内的气囊202K膨胀。另外，可以在气囊膨胀之后仅将囊型医疗装置C26留在活体腔中(内腔器官内)，以实现良好的观察和研究。In this endoscope device S1, the structure can be simplified without making the balloon medical device C26 larger, and theballoon 202K in the living body cavity can be inflated by a simple method. In addition, it is possible to leave only the balloon-type medical device C26 in the living body cavity (inside the lumen organ) after the inflation of the balloon for good observation and research.

在上述第三和第四实施例中，所示出的结构是柔性膨胀单元上安装有至少一对双极电极的结构，但是这仅是说明性的，而不是限制性的，因为将至少一个电极(换言之，仅成对的电极中的一个电极)安装到弹性膨胀单元也是可以的。在这种情况下，可以将该对中的另一电极直接安装到囊主体上，从而电极之间的间距是可变的。In the above-mentioned third and fourth embodiments, the structure shown is a structure in which at least one pair of bipolar electrodes is installed on the flexible expansion unit, but this is only illustrative, not restrictive, because at least one It is also possible that an electrode (in other words only one electrode of a pair of electrodes) is mounted to the elastic expansion unit. In this case, the other electrode of the pair can be mounted directly to the capsule body so that the spacing between the electrodes is variable.

下面将参照图45A和45B说明本发明的第五实施例。在该实施例中，与上述第一或第四实施例中的组成元件公共的组成元件标有相同的标号，并省略对其的详细说明。Next, a fifth embodiment of the present invention will be described with reference to Figs. 45A and 45B. In this embodiment, constituent elements common to those in the above-described first or fourth embodiment are assigned the same reference numerals, and detailed description thereof is omitted.

在本发明的内窥镜装置(囊型医疗装置)S2的柔性内窥镜(装置主体)207S中，安装有与上述气囊202类似的气囊202L、电极203以及柔性线204。In the flexible endoscope (device body) 207S of the endoscope device (bag-type medical device) S2 of the present invention, aballoon 202L similar to the above-describedballoon 202 ,electrodes 203 , andflexible wires 204 are mounted.

如图45A所示，柔性内窥镜207S具有设置在柔性构件276的末端的硬构件275以及设置在基端上的连接器单元278。在硬构件275中，设置有物镜275a、照明透镜275b以及通道275c，如图45B所示。另外，连接器单元278位于活体外部，并且可拆卸地连接到下述外部装置310的连接器单元318。As shown in FIG. 45A , the flexible endoscope 207S has ahard member 275 provided at the distal end of aflexible member 276 and aconnector unit 278 provided at the base end. In thehard member 275, anobjective lens 275a, anillumination lens 275b, and achannel 275c are provided, as shown in FIG. 45B. In addition, theconnector unit 278 is located outside the living body, and is detachably connected to aconnector unit 318 of anexternal device 310 described below.

将气囊202L固定到内窥镜207S中的硬构件275的后侧上。图中的标号220e表示内窥镜207S和气囊202L。在该气囊202L的后侧表面上安装有至少一对双极电极203。通过柔性线204连接这些电极和连接器单元278。Theballoon 202L is secured to the rear side of thehard member 275 in the endoscope 207S.Reference numeral 220e in the figure denotes the endoscope 207S and theballoon 202L. At least one pair ofbipolar electrodes 203 is mounted on the rear side surface of theairbag 202L. These electrodes are connected byflexible wires 204 to aconnector unit 278 .

另外，为了将诸如空气或水的流体注入到气囊202L中，并从气囊202L的内部排出该流体，在位于气囊202L的内部的柔性构件276中形成有注入和排出口277。该注入和排出口277连接到连接器单元278，以使得可以注入和排出来自下述外部装置310的流体。In addition, in order to inject fluid such as air or water into theairbag 202L and discharge the fluid from the inside of theairbag 202L, an injection and discharge port 277 is formed in theflexible member 276 inside theairbag 202L. This injection and discharge port 277 is connected to aconnector unit 278 so that fluid from anexternal device 310 described below can be injected and discharged.

外部装置310设置有电源311、限幅器311L、光源装置312、流体注入和排出装置(膨胀装置)313、视频处理器314、监视器315以及连接器单元318。如果将连接器单元278连接到连接器单元318，则可以将来自光源装置312的照明光传送到照明透镜275b，并且可以将来自物镜275a的图像传送到视频处理器314，并将其存储在存储器中或显示在监视器315上。另外，通过导线204机械和电连接电源311和电极203，因而经由导线204可以将用于引起电刺激的电流从电源311引导到电极203。此外，将流体注入和排出装置313连接到注入和排出口，使得可以实现将流体注入到气囊202L中或从气囊202L中排出流体。Theexternal device 310 is provided with apower source 311 , alimiter 311L, alight source device 312 , a fluid injection and discharge device (expansion device) 313 , avideo processor 314 , amonitor 315 , and aconnector unit 318 . If theconnector unit 278 is connected to theconnector unit 318, the illumination light from thelight source device 312 can be transmitted to theillumination lens 275b, and the image from theobjective lens 275a can be transmitted to thevideo processor 314 and stored in the memory or displayed on themonitor 315. In addition, thepower source 311 and theelectrode 203 are mechanically and electrically connected by thewire 204 , and thus a current for inducing electrical stimulation can be guided from thepower source 311 to theelectrode 203 via thewire 204 . In addition, a fluid injection anddischarge device 313 is connected to the injection and discharge port, so that injection of fluid into theair bag 202L or discharge of fluid from theair bag 202L can be achieved.

在图45A中，示出了处于从肛门插入到大肠R中的状态下的内窥镜装置S2。当插入该内窥镜装置S2时，气囊202L处于收缩状态(气囊202L与柔性单元276的外表面充分紧密接触的状态)。此外，在插入之后，通过流体注入和排出装置313的动作使气囊202L膨胀，并使电源311进行操作，以使方波电流以脉冲的形式流到电极203，对大肠R的内壁施加电刺激，从而推进内窥镜装置S2。当该装置已到达目标位置时，停止电刺激，或在停止电刺激之后使气囊202L膨胀，以保持在该位置处，然后进行对大肠R的观察和研究。此时，通过限幅器311L防止设定值或更高的电流流到电极203。In FIG. 45A , the endoscope device S2 in a state of being inserted into the large intestine R from the anus is shown. When this endoscopic device S2 is inserted, theballoon 202L is in a contracted state (a state where theballoon 202L is in sufficiently close contact with the outer surface of the flexible unit 276 ). In addition, after insertion, theballoon 202L is inflated by the action of the fluid injection anddischarge device 313, and thepower supply 311 is operated so that a square wave current flows to theelectrode 203 in pulses to apply electrical stimulation to the inner wall of the large intestine R, The endoscopic device S2 is thereby advanced. When the device has reached the target location, the electrical stimulation is stopped, or theballoon 202L is inflated after stopping the electrical stimulation, to remain at that location, and then the observation and study of the large intestine R is performed. At this time, a current of a set value or higher is prevented from flowing to theelectrode 203 by thelimiter 311L.

此外，在结束观察和研究之后，当将内窥镜装置S2从大肠R中移出时，使气囊202L与在插入时相同地收缩，从而使其易于从肛门通过。In addition, when the endoscopic device S2 is removed from the large intestine R after the observation and study are finished, theballoon 202L is contracted in the same way as at the time of insertion, thereby making it easy to pass through the anus.

在该内窥镜装置S2中，柔性内窥镜的结构包括气囊、电极和柔性线，由此，可以向常规柔性内窥镜添加对可收缩的组织施加稳定的电刺激的功能。另外，由于施加电刺激的电源以及气囊的膨胀装置被设置在外部，因此该内窥镜装置的被插入到活体腔中的部分的结构可以变得简单。In this endoscope device S2, the structure of the flexible endoscope includes a balloon, electrodes, and flexible wires, whereby a function of applying stable electrical stimulation to shrinkable tissues can be added to conventional flexible endoscopes. In addition, since the power supply for applying electrical stimulation and the inflation device for the balloon are provided outside, the structure of the portion of the endoscope device that is inserted into the living body cavity can be simplified.

下面将参照图46A至50C说明本发明的第六实施例。在该实施例中，与上述第三、第四和第五实施例中的组成元件公共的组成元件标有相同的标号，并省略对其的详细说明。Next, a sixth embodiment of the present invention will be described with reference to FIGS. 46A to 50C. In this embodiment, constituent elements common to those in the third, fourth, and fifth embodiments described above are assigned the same reference numerals, and detailed descriptions thereof are omitted.

如图46A和46B所示，将气囊单元208安装到内窥镜装置(囊型医疗装置)S3的囊主体(装置主体)201G上。As shown in FIGS. 46A and 46B , theair bag unit 208 is attached to the bag main body (device main body) 201G of the endoscope device (bag type medical device) S3.

囊主体201G是通用囊状内窥镜，其在结构上从上述囊型医疗装置C14中的囊主体201中省略了方波发生电路213a以及膨胀和收缩机构单元216。可以将囊主体201G的壳体分成前壳体211x和后壳体211y，如图46B所示，并且可以在其内安装钮扣电池205。在该壳体(图46B中的后壳体211y)的外周中形成有槽211h。The capsulemain body 201G is a general-purpose capsule endoscope, which is structurally omitted from the capsulemain body 201 in the above-described capsule medical device C14, the squarewave generating circuit 213a and the expansion andcontraction mechanism unit 216. The case of the bagmain body 201G can be divided into afront case 211x and arear case 211y as shown in FIG. 46B, and abutton battery 205 can be installed therein. Agroove 211h is formed in the outer periphery of the case (rear case 211y in FIG. 46B).

气囊单元208设置有柔性管281、安装单元282、与上述气囊202相同的气囊(弹性膨胀单元)202M、至少一对电极203以及柔性线204。Theairbag unit 208 is provided with aflexible tube 281 , a mountingunit 282 , an airbag (elastic expansion unit) 202M identical to the above-describedairbag 202 , at least a pair ofelectrodes 203 , and aflexible wire 204 .

将管281的基端连接到未示出的外部装置，并将安装单元282以整体的方式安装到管281的末端。可以将安装单元282以整体的方式可拆卸地安装到囊主体201G上，并且其上设置有由弹性体制成的箍(band)单元282b，该箍单元282b与囊主体201G的槽单元211h互锁。气囊202M在该安装单元282的后侧固定到管281上。图中的标号220g表示固定管281和气囊202M的固定单元。气囊202M的后侧表面可拆卸地安装有至少一对双极电极203。这些电极203上安装有穿过管281的内部并且其基端连接到外部装置的柔性线204。也就是说，通过柔性线204机械和电连接电极203和外部装置，并且来自外部装置的电流可以经由柔性线204流到电极203。The base end of thetube 281 is connected to an external device not shown, and the mountingunit 282 is integrally mounted to the end of thetube 281 . The mountingunit 282 can be detachably mounted to the bagmain body 201G in an integral manner, and aband unit 282b made of elastic body interlocking with thegroove unit 211h of the bagmain body 201G is provided thereon. . Theairbag 202M is fixed to thetube 281 at the rear side of the mountingunit 282 .Reference numeral 220g in the figure denotes a fixing unit of the fixingpipe 281 and theairbag 202M. At least one pair ofbipolar electrodes 203 is detachably mounted on the rear side surface of theairbag 202M. Mounted on theseelectrodes 203 areflexible wires 204 which pass through the interior of thetube 281 and whose base ends are connected to external devices. That is, theelectrode 203 and the external device are mechanically and electrically connected through theflexible wire 204 , and current from the external device can flow to theelectrode 203 via theflexible wire 204 .

另外，在位于气囊202M内部的管281中，形成有用于将流体注入到气囊202M中和从气囊202M中排出流体的注入和排出口281h。该注入和排出口281h连接到外部装置，以使得可以将流体注入到该外部装置和从该外部装置排出流体。In addition, in thetube 281 located inside theairbag 202M, an injection and dischargeport 281h for injecting and discharging fluid into and out of theairbag 202M is formed. The injection and dischargeport 281h is connected to an external device so that fluid can be injected into and discharged from the external device.

图47A示出了将内窥镜装置S3从肛门P插入到大肠R中时的状态。当插入该内窥镜装置S3时，气囊202M处于收缩状态(气囊202M处于与管281的外表面充分紧密接触的状态)。在插入之后，对外部装置进行操作，如图47B和47C所示，使气囊202M膨胀，并使电源311进行操作，从而方波电流以脉冲的形式流到电极203，对大肠R的内壁施加电刺激，从而使内窥镜装置S3推进。当该装置已到达目标位置时，停止电刺激，或在停止电刺激之后使气囊202M膨胀，以保持在该位置，然后进行对大肠R的观察和研究。FIG. 47A shows the state when the endoscope device S3 is inserted into the large intestine R from the anus P. As shown in FIG. When this endoscopic device S3 is inserted, theballoon 202M is in a contracted state (theballoon 202M is in a state of being in sufficiently close contact with the outer surface of the tube 281 ). After insertion, the external device is operated, as shown in FIGS. 47B and 47C, theballoon 202M is inflated, and thepower supply 311 is operated so that a square wave current flows in pulses to theelectrode 203, applying an electric current to the inner wall of the large intestine R. Stimulation, thereby advancing endoscopic device S3. When the device has reached the target position, the electrical stimulation is stopped, or theballoon 202M is inflated after the electrical stimulation is stopped, to maintain the position, and then the observation and study of the large intestine R is performed.

此外，在结束观察和研究之后，当将内窥镜装置S3从大肠R中移出时，使气囊202M与在插入时相同地收缩，从而使其易于从肛门通过。Furthermore, when the endoscopic device S3 is removed from the large intestine R after the observation and study are finished, theballoon 202M is contracted in the same way as at the time of insertion, thereby making it easy to pass through the anus.

如图48所示，如果内窥镜装置S3与柔性内窥镜207W组合使用，则可以容易地实现对大肠R的最深区域(即，阑尾A和回盲肠瓣V)的观察和研究。具体地说，通过首先插入内窥镜装置S3，然后使用管281作为柔性内窥镜207W的导引线，可以容易地实现将该内窥镜插入到大肠R中(这需要插入操作的技能)。As shown in FIG. 48, if the endoscope device S3 is used in combination with theflexible endoscope 207W, observation and study of the deepest region of the large intestine R (ie, appendix A and ileocecal valve V) can be easily achieved. Specifically, by first inserting the endoscope device S3, and then using thetube 281 as a guide wire for theflexible endoscope 207W, insertion of the endoscope into the large intestine R can be easily achieved (this requires skill in the insertion operation) .

另外，优选的是，柔性内窥镜207W为如图48所示的双通道型。如果该内窥镜是双通道型，则可以将内窥镜装置S3的管281穿过第一通道Ch1，并可以将钳子F等穿过第二通道Ch2。也就是说，可以通过内窥镜S3实现观察和研究，并同时通过钳子F实现对病变(例如息肉)的治疗。In addition, it is preferable that theflexible endoscope 207W is a two-channel type as shown in FIG. 48 . If the endoscope is a two-channel type, thetube 281 of the endoscope device S3 can be passed through the first channel Ch1, and forceps F etc. can be passed through the second channel Ch2. That is to say, the observation and research can be realized through the endoscope S3, and the treatment of the lesion (such as a polyp) can be realized through the forceps F at the same time.

将气囊单元209安装到内窥镜装置(囊型医疗装置)S4的囊主体(装置主体)201H上，如图49A和49B所示。Theair bag unit 209 is mounted on the bag main body (device main body) 201H of the endoscope device (bag type medical device) S4, as shown in FIGS. 49A and 49B.

囊主体201H具有形成在上述囊主体201的前侧和后侧上的观察窗211d1和211d2，并且在这些观察窗211d1和211d2内设置有由上述拍摄单元212和各种传感器组成的活体内信息获取装置(这里在该图中被省略)。前侧与后侧之间的活体内信息获取装置的操作由各种控制单元213(这里在该图中被省略)适当控制。另外，在该囊主体201H的前侧和后侧中的每一个上都形成有一个槽单元211h。The capsulemain body 201H has observation windows 211d1 and 211d2 formed on the front and rear sides of the above capsulemain body 201, and within these observation windows 211d1 and 211d2 is provided an in-vivo information acquisition system composed of the above-described photographingunit 212 and various sensors. device (here omitted in this figure). The operation of the in-vivo information acquisition device between the front side and the rear side is appropriately controlled by various control units 213 (omitted here in the figure). In addition, agroove unit 211h is formed on each of the front side and the rear side of the bagmain body 201H.

气囊单元209设置有与上述气囊202类似的气囊(弹性膨胀单元)202N、安装箍单元291、至少一对电极203、柔性线204、管292以及线套293，如图49A、49B和50A所示。Theairbag unit 209 is provided with an airbag (elastic expansion unit) 202N similar to the above-mentionedairbag 202, a mountinghoop unit 291, at least one pair ofelectrodes 203, aflexible wire 204, atube 292, and awire sheath 293, as shown in FIGS. 49A, 49B, and 50A. .

在气囊202N的前边缘和后边缘上，分别以整体的方式设置有由弹性体构成的、分别与囊主体201H的槽单元211h互锁的安装箍单元291b。通过这些安装箍单元291b，将气囊202N以整体的方式可拆卸地安装到囊主体201H上。将柔性管292连接到该气囊202N的后侧。该管292的基端上形成有连接到外部装置的连接器292c。这里，示出了注射器(膨胀装置)321和二通阀(two-way valve)(膨胀装置)321v作为该外部装置的示例。通过操作注射器321和二通阀321v，可以将流体注入到气囊202N中并且可以从气囊202N中排出流体。On the front edge and the rear edge of theairbag 202N, mountinghoop units 291b made of elastic body and interlocking with thegroove units 211h of the bagmain body 201H, respectively, are integrally provided, respectively. Through these mountinghoop units 291b, theairbag 202N is detachably mounted to the bagmain body 201H in an integral manner. Aflexible tube 292 is connected to the rear side of thebladder 202N. The base end of thistube 292 is formed with aconnector 292c connected to an external device. Here, a syringe (expansion device) 321 and a two-way valve (expansion device) 321v are shown as examples of the external device. By operating thesyringe 321 and the two-way valve 321v, fluid can be injected into theair bag 202N and fluid can be discharged from theair bag 202N.

另外，气囊202N的前侧表面上安装有至少一对双极电极203。这些电极203上安装有穿过安装在气囊202N的后侧的柔性线套293并连接到基端连接器293c的柔性线204。将连接器293c连接到设置在外部装置的一个示例中的电源装置322上的连接器322c。也就是说，如果对连接器293c和连接器322c进行连接，则通过柔性线204机械和电连接电极203和电源装置322，从而来自电源装置322的电流可以经由导线204流到电极203。In addition, at least one pair ofbipolar electrodes 203 is mounted on the front side surface of theairbag 202N. Attached to theseelectrodes 203 areflexible wires 204 passing through aflexible wire sleeve 293 installed on the rear side of theballoon 202N and connected to a base-end connector 293c. Connect theconnector 293c to theconnector 322c provided on the power supply device 322 in one example of an external device. That is, if theconnector 293c and theconnector 322c are connected, theelectrode 203 and the power supply device 322 are mechanically and electrically connected by theflexible wire 204, so that the current from the power supply device 322 can flow to theelectrode 203 via thewire 204.

图50B示出了在将内窥镜装置S4从肛门P插入到大肠R中时的状态。当插入该内窥镜装置S4时，气囊202N处于收缩状态(气囊202N处于与囊主体201H的外表面充分紧密接触的状态)。此外，在囊主体201H的后侧面向前的情况下(即，在观察窗211d2位于前侧的情况下)，将该装置插入到大肠R中。当以这种方式插入该装置时，电极203位于后侧(肛门P侧)，使得可以将该装置朝向大肠R的深处部分推进。在已插入该装置之后，通过操作注射器321和二通阀321v使气囊202N膨胀，并且通过使电源装置322进行工作而使方波电流以脉冲的形式流到电极，从而对大肠R的内壁施加电刺激，来使内窥镜装置S4推进。此外，当到达目标位置时，停止电刺激，并且该装置保持在该位置处，从而通过前观察窗211d1和后观察窗211d2实现对大肠R的观察和研究。FIG. 50B shows the state when the endoscope device S4 is inserted into the large intestine R from the anus P. As shown in FIG. When this endoscopic device S4 is inserted, theair bag 202N is in a contracted state (theair bag 202N is in a state of being in sufficiently close contact with the outer surface of the bagmain body 201H). Also, the device is inserted into the large intestine R with the rear side of the balloonmain body 201H facing forward (ie, with the observation window 211d2 positioned on the front side). When the device is inserted in this way, theelectrode 203 is located on the rear side (anus P side), so that the device can be pushed toward the deep part of the large intestine R. After the device has been inserted, theballoon 202N is inflated by operating thesyringe 321 and the two-way valve 321v, and the square wave current flows in pulses to the electrodes by operating the power supply device 322, thereby applying electricity to the inner wall of the large intestine R. Stimulation to advance the endoscopic device S4. Furthermore, when the target position is reached, the electrical stimulation is stopped, and the device remains at this position, thereby enabling observation and study of the large intestine R through the front observation window 211d1 and the rear observation window 211d2.

此外，当在完成观察和研究之后从大肠R中移出内窥镜装置S4时，从活体外部拔该管292和线套293，从而囊主体201H面向与其到达该点的方向相反的方向。通过这种方式，将电极203定位在前侧(朝向大肠R的深处部分的一侧)，从而可以使该装置朝向肛门P推进。Furthermore, when the endoscopic device S4 is removed from the large intestine R after completion of observation and study, thetube 292 andwire sheath 293 are pulled out from the outside of the living body so that the balloonmain body 201H faces the direction opposite to the direction it reached the point. In this way, theelectrode 203 is positioned on the front side (the side toward the deep part of the large intestine R), so that the device can be advanced toward the anus P. FIG.

当囊主体201H接近肛门P时，使气囊202N与在插入时相同地收缩，使得可以容易地从肛门P中取出该装置。When the bagmain body 201H approaches the anus P, theair bag 202N is deflated in the same way as at the time of insertion, so that the device can be easily taken out from the anus P.

这些内窥镜装置S3和S4作为囊型医疗装置，其结构具有安装到囊主体上的气囊、电极和柔性线，由此，可以对常规囊型内窥镜添加对可收缩的组织施加稳定的电刺激的功能。另外，由于施加电刺激的电源和气囊的膨胀装置被设置在外部，因此该内窥镜装置的被插入到活体腔内的部分的结构可以变得简单。These endoscopic devices S3 and S4 are capsule-type medical devices, and their structure has a balloon, electrodes, and flexible wires mounted on the capsule body, thereby, it is possible to add a stable pressure on the contractile tissue to conventional capsule-type endoscopes. The function of electrical stimulation. In addition, since the power source for applying electrical stimulation and the inflation device for the balloon are provided outside, the structure of the portion of the endoscope device that is inserted into the living body cavity can be simplified.

在上述第五和第六实施例中，结构为气囊上安装有一对或多对电极，但这仅是说明性的，而不是限制性的，这是由于可以将至少一个电极(即，仅成对的电极中的一个)安装到气囊上。在这种情况下，将成对的电极中的另一个安装到受检查者的身体的表面上，从而提供电流从外部装置流到两个电极的单极电极结构。In the above-mentioned fifth and sixth embodiments, the structure is that one or more pairs of electrodes are installed on the air bag, but this is only illustrative and not restrictive, since at least one electrode (that is, only One of the pair of electrodes) is mounted on the balloon. In this case, the other of the paired electrodes is mounted on the surface of the subject's body, thereby providing a monopolar electrode structure in which current flows from an external device to both electrodes.

在本发明的囊型医疗装置中，还可以设置将上述柔性线固定在上述槽内并在活体内溶解的线固定装置。In the capsule medical device of the present invention, a wire fixing device for fixing the flexible wire in the groove and dissolving it in a living body may be further provided.

由于通过这种类型的线固定装置将柔性线固定在槽内，因此在将囊型医疗装置引入到活体中时(例如，在吞下该装置时)，柔性线和电极不会成为障碍，使得可以更容易地引入到活体中。此外，在引入该装置之后，例如通过胃酸溶解该线固定装置，由此，对柔性线的固定在活体内被释放，使得电极之间的间距可以变化。Since the flexible wire is fixed in the groove by this type of wire fixing device, the flexible wire and the electrodes do not become obstacles when the capsule medical device is introduced into a living body (for example, when the device is swallowed), so that Can be more easily introduced into the living body. Furthermore, after introducing the device, the wire fixation device is dissolved, for example by stomach acid, whereby the fixation to the flexible wire is released in vivo so that the spacing between the electrodes can be varied.

在本发明的囊型医疗装置中，可以在上述外壳单元和上述壳体之间设置将上述外壳单元推向外部的弹簧。In the capsule medical device of the present invention, a spring for urging the housing unit to the outside may be provided between the housing unit and the housing.

如果以这种方式使用弹簧，则可以通过预定的驱动力(energizingforce)使外壳单元向外部移动，使得电极之间的间距可以变化，从而可以精确地抵消活体内的内腔器官的直径的差别。If the spring is used in this way, the housing unit can be moved outward by a predetermined energizing force so that the spacing between the electrodes can be varied so that the difference in diameter of a lumen organ in a living body can be accurately offset.

在本发明的囊型医疗装置中，可以在上述外壳单元与上述壳体之间插入在吸水时膨胀的吸水凝胶。In the bladder-type medical device of the present invention, a water-absorbing gel that expands when water is absorbed may be inserted between the housing unit and the casing.

如果以这种方式使用吸水凝胶，则可以在已将该装置引入到活体中之后在吸水时使外壳单元向外部移动，因此，可以利用简单的结构精确地改变电极之间的距离。If the water-absorbing gel is used in this way, the housing unit can be moved outward when water is absorbed after the device has been introduced into the living body, and therefore, the distance between electrodes can be precisely changed with a simple structure.

在本发明的囊型医疗装置中，上述电极可以是形成从上述外壳单元的外表面突出的半球的半球形电极。In the capsule medical device of the present invention, the electrode may be a hemispherical electrode forming a hemisphere protruding from the outer surface of the housing unit.

如果电极具有这种半球形状，则可以使得易于接触身体组织，并且由于不存在角部，因此可以控制囊型医疗装置的前进受到阻塞的困扰。If the electrode has such a hemispherical shape, it is possible to make easy contact with body tissue, and since there are no corners, it is possible to control the advancement of the capsule medical device from being troubled by obstruction.

在本发明的囊型医疗装置中，上述电极可以是形成从上述外壳单元的外表面突出的圆柱的圆柱形电极。In the capsule-type medical device of the present invention, the above-mentioned electrode may be a cylindrical electrode forming a cylinder protruding from an outer surface of the above-mentioned housing unit.

如果电极具有这种圆柱形状，则可以扩展与身体组织接触的面积，因此，例如甚至对诸如黏膜的身体组织也可以准确地施加电刺激。If the electrode has such a cylindrical shape, the area in contact with body tissue can be expanded, and therefore, electrical stimulation can be accurately applied even to body tissue such as mucous membranes, for example.

在本发明的囊型医疗装置中，上述电极可以是嵌入在上述外壳单元中的嵌入式电极，以具有与上述外壳单元的外表面大致相同的表面。In the capsule medical device of the present invention, the electrode may be an embedded electrode embedded in the housing unit so as to have substantially the same surface as an outer surface of the housing unit.

如果以这种方式嵌入电极，则可以使该装置平滑地连续，而没有电极从外壳单元的外表面突出，因此，可以基本消除囊型医疗装置的前进受到阻塞的困扰。If the electrodes are embedded in this manner, the device can be made to continue smoothly without electrodes protruding from the outer surface of the housing unit, thus substantially eliminating obstructions to the advancement of the capsule medical device.

在本发明的囊型医疗装置中，上述电极可以从上述弹性膨胀单元拆卸。In the balloon-type medical device of the present invention, the electrodes are detachable from the elastic expansion unit.

在本发明的囊型医疗装置中，上述膨胀单元可以是在向内注入流体时膨胀的气囊。In the balloon-type medical device of the present invention, the inflation unit may be a balloon that expands when a fluid is injected therein.

在本发明的囊型医疗装置中，上述膨胀单元可以是可以通过折叠来收缩的柔性橡胶。In the bladder-type medical device of the present invention, the above-mentioned expansion unit may be flexible rubber that can be contracted by folding.

在本发明的囊型医疗装置中，上述电极可以是导电橡胶。In the bladder-type medical device of the present invention, the above-mentioned electrodes may be conductive rubber.

在本发明的囊型医疗装置中，上述装置主体可以使囊状内窥镜。In the capsule medical device of the present invention, the device main body may be a capsule endoscope.

在本发明的囊型医疗装置中，上述装置主体可以是柔性内窥镜。In the capsule medical device of the present invention, the device main body may be a flexible endoscope.

在本发明的囊型医疗装置中，上述弹性膨胀单元可以是以下形状：可以形成从前到后穿过该单元到上述身体组织的空间。In the balloon-type medical device of the present invention, the above-mentioned elastic expansion unit may have a shape that can form a space passing through the unit to the above-mentioned body tissue from front to back.

在本发明的囊型医疗装置中，上述膨胀装置可以是连接到活体外部的流体注入和排出装置的柔性管。In the balloon-type medical device of the present invention, the above-mentioned expansion means may be a flexible tube connected to a fluid injection and discharge means outside the living body.

在本发明的囊型医疗装置中，上述管可以在上述气囊膨胀之后拆卸。In the balloon-type medical device of the present invention, the tube can be detached after the balloon is inflated.

在本发明的囊型医疗装置中，上述膨胀装置可以是以下流体释放机构：其通过来自活体外部的操作，在上述装置主体内将加压气体或发泡剂排放到上述气囊中。In the balloon-type medical device of the present invention, the inflation device may be a fluid release mechanism that discharges pressurized gas or foaming agent into the balloon in the device main body by an operation from outside the living body.

在本发明的囊型医疗装置中，可以将上述弹性膨胀单元的外径设定为在收缩时大约15mm，而在膨胀到最大时大约40mm。In the balloon-type medical device of the present invention, the outer diameter of the above-mentioned elastic expansion unit may be set to be about 15 mm when contracted, and about 40 mm when expanded to the maximum.

在本发明的囊型医疗装置中，上述电极无需成对。In the capsule medical device of the present invention, the above-mentioned electrodes need not be paired.

以上说明了本发明的优选实施例，但是这些实施例仅是说明性的，而不是限制性的。在不偏离本发明的要点的情况下，可以对这些实施例进行添加、省略、变化和其他改变。本发明由所附权利要求的范围的限定，而不由上述说明的限定。另外，本发明涵盖适当地结合了上述各种实施例和其变型例的装置。The preferred embodiments of the present invention are described above, but these embodiments are only illustrative and not restrictive. Additions, omissions, changes, and other changes can be made to these embodiments without departing from the gist of the invention. The present invention is limited by the scope of the appended claims rather than by the foregoing description. In addition, the present invention covers devices that appropriately combine the above-described various embodiments and modifications thereof.

工业适用性Industrial Applicability

本发明的囊型医疗装置是一种被引入到活体中并检测活体内信息的囊型医疗装置，该装置配置有：囊形的壳体；设置在该壳体中的活体内信息获取装置，其获取活体内信息；通信装置，其将由活体内信息获取装置获取的活体内信息无线地发送到活体外部；至少一对第一电极，其设置在壳体的一个边缘处，并对活体内的身体组织施加电刺激；第一电流控制装置，其控制流向第一电极的电流；以及电极间距离改变装置，其使第一电极之间的距离改变。利用本发明的囊型医疗装置，可以大大改变活体内的电极之间的距离，因此可以使电极甚至在具有大的内腔器官的器官中也可与身体组织准确地接触。因此，可以使囊型医疗装置以稳定的方式在活体内推进。The capsule medical device of the present invention is a capsule medical device that is introduced into a living body and detects information in the living body. The device is configured with: a capsule-shaped housing; an in vivo information acquisition device disposed in the housing, which acquires in-vivo information; a communication device which wirelessly transmits the in-vivo information acquired by the in-vivo information acquiring means to the outside of the living body; at least a pair of first electrodes which are provided at one edge of the housing and communicate with the in-vivo Body tissue applies electrical stimulation; first current control means controls the current flowing to the first electrodes; and inter-electrode distance changing means changes the distance between the first electrodes. With the capsule-type medical device of the present invention, the distance between electrodes in a living body can be greatly changed, and thus the electrodes can be accurately brought into contact with body tissues even in organs with large lumens. Therefore, the capsule-type medical device can be propelled in a living body in a stable manner.

本专利申请要求于2004年9月8日提交的日本专利申请No.2004-261015以及于2004年10月8日提交的日本专利申请No.2004-296178的优先权，通过引用将其内容合并于此。This patent application claims the benefit of Japanese Patent Application No. 2004-261015 filed on September 8, 2004 and Japanese Patent Application No. 2004-296178 filed on October 8, 2004, the contents of which are incorporated by reference in this.

Claims (8)

Translated fromChinese

1、一种被引入到活体内以收集活体内信息的囊型医疗装置，该囊型医疗装置包括：1. A capsule medical device introduced into a living body to collect information in the living body, the capsule medical device comprising:囊形壳体；capsule shell;活体内信息获取装置，用于获取所述活体内信息；an in vivo information acquisition device, configured to acquire the in vivo information;通信装置，用于将由所述活体内信息获取装置获取的所述活体内信息无线地发送到所述活体外部；a communication device for wirelessly transmitting the in-vivo information acquired by the in-vivo information acquiring device to the outside of the living body;至少一对第一电极，其设置在沿所述壳体的轴线的一端附近；at least one pair of first electrodes disposed near one end along the axis of the housing;第一电流控制装置，用于向所述第一电极输送电流；a first current control device for delivering current to the first electrode;第一电极间距离改变装置，用于改变所述第一电极之间的距离；a first inter-electrode distance changing device, configured to change the distance between the first electrodes;电源，用于向所述第一电极提供电力；以及a power supply for providing power to the first electrode; and导线，所述导线的至少一部分是柔性的，用于电和机械地连接所述电源和所述电极；其中，A lead, at least a portion of which is flexible, for electrically and mechanically connecting the power source and the electrodes; wherein,所述第一电极间距离改变装置包括至少部分地安装在所述壳体上的弹性膨胀单元，The first inter-electrode distance changing device includes an elastic expansion unit at least partially mounted on the housing,所述第一电极设置在所述弹性膨胀单元上，The first electrode is arranged on the elastic expansion unit,在所述弹性膨胀单元膨胀的条件下，允许所述弹性膨胀单元弹性变形，并且所述第一电极由可伸长材料制成。Under the condition that the elastic expansion unit expands, elastic deformation of the elastic expansion unit is allowed, and the first electrode is made of an extensible material.2、根据权利要求1所述的囊型医疗装置，其中，2. The bladder medical device of claim 1, wherein:将可以由所述第一电极间距离改变装置改变的所述第一电极之间的最大距离设定为所述壳体的外径的至少两倍。A maximum distance between the first electrodes that can be changed by the first inter-electrode distance changing means is set to be at least twice the outer diameter of the housing.3、根据权利要求1所述的囊型医疗装置，该囊型医疗装置还包括：3. The capsule medical device according to claim 1, further comprising:至少一对第二电极，其设置在沿所述壳体的所述轴线的另一端附近，并位于与所述活体内信息获取装置不重合的位置，用于向所述活体中的身体组织提供电刺激；at least one pair of second electrodes, which are arranged near the other end along the axis of the casing, and are located at positions that do not coincide with the in-vivo information acquisition device, and are used to provide body tissues in the living body electrical stimulation;第二电流控制装置，用于向所述第二电极输送电流；以及second current control means for delivering current to said second electrode; and第二电极间距离改变装置，用于改变所述第二电极之间的距离，second inter-electrode distance changing means for changing the distance between said second electrodes,其中，所述第二电极由可伸长材料制成。Wherein, the second electrode is made of stretchable material.4、根据权利要求1所述的囊型医疗装置，该囊型医疗装置还包括膨胀装置，该膨胀装置用于使所述弹性膨胀单元膨胀，其中，4. The balloon-type medical device according to claim 1, further comprising an expansion device for expanding the elastic expansion unit, wherein,所述膨胀装置与所述壳体分开设置，并可拆卸地安装在所述壳体上。The expansion device is set separately from the casing and is detachably mounted on the casing.5、根据权利要求1所述的囊型医疗装置，其中，5. The balloon medical device of claim 1, wherein:所述弹性膨胀单元可拆卸地安装在所述壳体上。The elastic expansion unit is detachably installed on the housing.6、根据权利要求1所述的囊型医疗装置，其中，6. The balloon medical device of claim 1, wherein:所述弹性膨胀单元上设置有比所述弹性膨胀单元的其他部分硬的硬构件，并且所述第一电极设置在所述硬构件上。A hard member that is harder than other parts of the elastic expansion unit is disposed on the elastic expansion unit, and the first electrode is disposed on the hard member.7、根据权利要求1所述的囊型医疗装置，其中，7. The balloon medical device of claim 1, wherein:通过使用1000Hz或更高的脉冲信号对100Hz或更低的脉冲信号进行调制，来生成要发送给所述电极的电刺激信号。An electrical stimulation signal to be sent to the electrodes is generated by modulating a pulse signal of 100 Hz or lower with a pulse signal of 1000 Hz or higher.8、根据权利要求1所述的囊型医疗装置，其中，8. The balloon medical device of claim 1, wherein:所述电极向所述活体中的身体组织提供电刺激。The electrodes provide electrical stimulation to body tissue in the living body.

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