JP2008183239A - Device for confirming lumen passage - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a device for confirming lumen passage capable of certainly keeping a capsular shape for a definite time necessary for confirming passing properties. <P>SOLUTION: The dissolving part 41 provided in the first non-dissolving part 42 for keeping a capsular shape is internally divided by a second non-dissolving part 63 to form the dissolving route 62 advancing into the dissolving part 41 from a part 43 of its surface. The dissolving time of the dissolving part 41 in a lumen is structurally made long by making the dissolving route 62 long to keep the capsular shape for a long time. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  Before actually using a capsule medical device such as a capsule endoscope, the present invention confirms in advance whether it can be introduced into the body of a subject and pass through a luminal organ such as the small intestine. The present invention relates to a lumen passage confirmation device.

  2. Description of the Related Art In recent years, capsule medical devices such as capsule endoscopes that pass through a luminal organ of a subject and perform observation, examination, or treatment in the lumen have been proposed and put into practical use. When such a capsule medical device is used, if there is an abnormality such as a stenosis in a relatively narrow luminal organ of a subject, such as the small intestine, the swallowed capsule medical device is tubed at the stenosis. There is a problem of staying in the cavity.

  In order to deal with such a problem, it is formed in the same size and shape as an actual capsule medical device and introduced into the body of the subject before using the capsule medical device, so that There has been proposed a capsule for confirming passage of lumen (pretest capsule for endoscope) for confirming the presence or absence of a portion where a capsule-type medical device such as a stenosis may stay for a long time (for example, Patent Document 1). To 4). As a result, if the capsule for confirming passage of lumen is normally discharged from the body, it is determined that there is no abnormality such as stenosis and the capsule endoscope can be applied, and the capsule for checking passage of lumen is normally discharged from the body. If it is possible, there is an abnormality such as stenosis, and it is judged that application of the capsule endoscope is inappropriate. This type of capsule for confirming passage through the lumen maintains the original shape of the capsule for a certain period of time in order to confirm non-passage due to stenosis, etc., and dissolves in order to avoid retention in the stenotic part after a certain period of time. Or it needs to be disassembled and discharged. In order to respond to such a request, as a constituent material of the capsule for confirming passage through the lumen, an alkali-soluble enteric material such as hydroxypropylmethylcellulose (acetic acid / succinic acid) that does not dissolve in the stomach but dissolves in the intestine is used. The material is devised. As an enteric material, a natural polysaccharide / polyhydric alcohol composition and the like are also known (see, for example, Patent Documents 5 and 6).

JP 2005-508668 Gazette JP 2004-248956 A US Patent Application Publication No. 2005/0063906 JP 2006-142013 A Japanese Patent Laid-Open No. 3-232815 JP 11-49668 A

  However, according to Patent Documents 1 and 2, etc., the complete dissolution time (time for maintaining the capsule shape) of the capsule for confirming passage of lumen is set to, for example, 100 hours or more, or from 1 day to 7 days. However, it depends on the enteric material, and it is difficult to control the dissolution time with the material. In the case of an enteric material as exemplified, the dissolution time is limited to about one day because of the size of the capsule for confirming passage through the lumen, and the desired complete dissolution time cannot be secured. The passage time in the body, such as capsules for confirming passage of lumens, often takes 2 to 3 days even for a normal person, and it is not possible to secure a certain amount of time necessary for confirming passage regardless of the subject. It is something that cannot be confirmed reliably.

  The present invention has been made in view of the above, and an object of the present invention is to provide a lumen passage confirmation device that can reliably maintain the capsule shape for a certain period of time necessary for confirming passage. .

  In order to solve the above-described problems and achieve the object, a lumen passage confirmation device according to the present invention is a lumen passage confirmation device having a capsule shape that can be introduced into the body, and does not dissolve in the body. A first non-dissolved portion made of a material and excluding a part of the capsule-shaped surface, and a portion of the capsule-shaped surface exposed to the outside, made of a material that dissolves in the body. And a dissolution path that is made of a material that does not dissolve in the body and that divides the inside of the dissolution part and advances from the part of the surface into the dissolution part. And a second non-dissolving part that forms the structure.

  Moreover, the lumen passage confirmation device according to the present invention is characterized in that, in the above invention, the second non-dissolving part is provided so as to extend in the center direction of the capsule shape.

  In addition, the lumen passage confirmation device according to the present invention is characterized in that, in the above-mentioned invention, the lumen non-dissolving part is made of a material that does not dissolve in the body and further divides and subdivides the dissolution path.

  Moreover, the lumen passage confirmation device according to the present invention is characterized in that, in the above invention, the end of the second non-dissolving portion is connected to the end of the first non-dissolving portion on the capsule-shaped surface. And

  Moreover, the lumen passage confirmation device according to the present invention is characterized in that, in the above invention, the second non-dissolving part is provided in a layer form substantially parallel to the first non-dissolving part. .

  Moreover, the lumen passage confirmation device according to the present invention is characterized in that in the above invention, a recognized member is provided.

  Moreover, the lumen passage confirmation apparatus according to the present invention is characterized in that, in the above invention, the member to be recognized is an X-ray opaque material.

  Moreover, the lumen passage confirmation apparatus according to the present invention is characterized in that, in the above invention, the X-ray opaque material is provided in the non-dissolving portion.

  Moreover, the lumen passage confirmation apparatus according to the present invention is characterized in that, in the above invention, the non-dissolving part is made of a metal film.

  Moreover, the lumen passage confirmation apparatus according to the present invention is characterized in that, in the above-mentioned invention, the X-ray opaque material is built in at least a part of the dissolving portion.

  Moreover, the lumen passage confirmation apparatus according to the present invention is characterized in that, in the above invention, the X-ray impermeable material is disposed in the innermost part of the dissolution path.

  Moreover, the lumen passage confirmation device according to the present invention is characterized in that, in the above invention, the X-ray impermeable material is spaced apart at a plurality of locations.

  Moreover, the lumen passage confirmation apparatus according to the present invention is characterized in that, in the above-mentioned invention, the member to be recognized is an RF-ID tag built in the dissolving portion.

  Moreover, the lumen passage confirmation device according to the present invention is characterized in that, in the above invention, at least a part of the dissolving portion is made of an enteric material.

  Moreover, the lumen passage confirmation device according to the present invention is characterized in that, in the above invention, the capsule shape is a dome-shaped capsule shape having convex portions at both ends in the longitudinal axis direction.

  The lumen passage confirmation device according to the present invention is characterized in that, in the above invention, the capsule shape is a spherical capsule shape.

  Further, the lumen passage confirmation device according to the present invention is the above invention, wherein the non-dissolved part made of a material that does not dissolve in the body dissolves relatively in the body because the dissolution time in the body is longer than the dissolution part. It is characterized by not exhibiting characteristics.

  Moreover, the lumen passage confirmation apparatus according to the present invention is characterized in that, in the above invention, the dissolving portion is made of an X-ray opaque member and also serves as the recognized portion.

  Moreover, the lumen passage confirmation apparatus according to the present invention is characterized in that, in the above invention, the recognized portion includes barium or metal.

  According to the lumen passage confirmation device according to the present invention, the dissolving portion provided in the first non-dissolving portion that maintains the capsule shape is divided by the second non-dissolving portion so that a part of the surface enters the dissolving portion. Since the dissolution path that progresses inside is formed, the dissolution time can be structurally lengthened by lengthening the dissolution path, thereby maintaining the capsule shape for a long time. The capsule shape can be reliably maintained for a certain period of time necessary for confirming passage, and the lumen passage can be reliably confirmed.

  Further, according to the lumen passage confirmation device according to the present invention, since the second non-dissolving part forming the dissolution path is provided so as to extend in the center direction of the capsule shape, the capsule-shaped center portion is outside. The dissolution path for dissolving the dissolution portion toward the surface can be formed, and the time until the dissolution portion in the vicinity of the first non-dissolution portion that forms the outer surface of the capsule shape can be increased. There is an effect that the time capsule shape can be maintained.

  Further, according to the lumen passage confirmation device according to the present invention, the dissolution path is further divided and subdivided by the third non-dissolution part, so that the dissolution path is further lengthened and the capsule shape is further increased for a longer time. There is an effect that it can be maintained.

  Further, according to the lumen passage confirmation device according to the present invention, since the end of the second non-dissolving part is connected to the end of the first non-dissolving part, the first non-dissolving is performed on the capsule-shaped outer surface. The continuity between the part and the second non-dissolving part can be ensured, so that the capsule shape does not collapse from the end of the first non-dissolving part, and the capsule shape can be maintained for a long time. There is an effect.

  Further, according to the lumen passage confirmation device according to the present invention, since the second non-dissolving portion is provided in layers in parallel with the first non-dissolving portion, the dissolution path is arranged in the capsule-shaped circumferential direction. Therefore, it is possible to increase the time until the dissolution part of the dissolution path is dissolved, and to maintain the capsule shape for a long time.

  Hereinafter, a lumen passage confirmation capsule which is a preferred embodiment of a lumen passage confirmation device according to the present invention will be described with reference to the accompanying drawings. The lumen passage confirmation capsule in each embodiment and each modification will be described with an example in which, for example, the gastrointestinal tract is applied as a lumen for confirming passage. In addition, this invention is not limited by each embodiment. In the description of the drawings, the same or corresponding parts are denoted by the same reference numerals.

(Embodiment 1)
A lumen passage confirmation capsule according to Embodiment 1 of the present invention will be described with reference to FIG. 1 and FIG. FIG. 1 is a schematic perspective view showing a configuration example of a lumen passage confirmation capsule 10 according to the first embodiment, and FIG. 2 is a central longitudinal side view thereof.

  The lumen passage confirmation capsule 10 according to the first embodiment is generally covered with a shape and size that is the same as or substantially the same as a capsule endoscope for the purpose of intraluminal inspection / observation such as gastrointestinal tract. It can be introduced into the examiner's body and has a dome-shaped capsule shape having hemispherical dome-shaped convex portions 11a and 11b at both ends in the longitudinal axis direction. Such a dome-shaped capsule-shaped lumen passage confirmation capsule 10 includes a non-dissolving part 12, a dissolving part 13, a second dissolving part 14, and a recognized part 15.

  The non-dissolving part 12 is basically made of a material that does not dissolve in the body and is substantially impermeable (impermeable) to body fluids, such as a soft metal or resin. This is a thin-walled portion forming a structure that forms the outer shape of the dome-shaped capsule shape and forms a surface layer of the capsular shape. The dissolving portion 13 is made of a material that dissolves in the body, and is provided on a part of the dome-shaped capsule-shaped surface layer that is linearly formed so as to be deformed in a direction in which the non-dissolving portion 12 becomes smaller when dissolved. . That is, a surface layer in which a linear chipped portion is formed in a part of the non-dissolved portion 12 so that the rigidity cannot be maintained, and the melted portion 13 is filled in the chipped portion to ensure rigidity and maintain a dome-shaped capsule shape. Is formed. In the first embodiment, the dissolving portion 13 is linearly provided linearly in the longitudinal direction of the dome-shaped capsule shape across at least the convex-shaped portions 11a and 11b at both ends in the longitudinal direction of the dome-shaped capsule shape. It has been. The dissolving portion 13 is provided so as to enter not only the notch portion of the non-dissolving portion 12 but also the inner wall surface portion in the vicinity of the notch portion. ~ 2 days or more).

  The second dissolving part 14 is provided inside the non-dissolving part 12 forming the surface layer so as to dissolve after the dissolving part 13 is dissolved in the lumen, and constitutes the contents of the lumen passage confirmation capsule 10 It is. Here, the second dissolving portion 14 is made of a material having a solubility higher than that of the dissolving portion 13. In the first embodiment, the dissolving portion 13 is an enteric material that is difficult to dissolve in the stomach and dissolves in the process of passing from the small intestine to the large intestine, for example, (acetic acid / succinic acid) hydroxy as shown in Patent Document 3. Among at least one system selected from alkali-soluble materials such as propylmethylcellulose, polyhydric alcohols, sugar alcohols, monosaccharides, disaccharides, trisaccharides and oligosaccharides as shown in Patent Documents 4 and 5 Obtained by uniformly kneading at least one natural polysaccharide selected from carrageenan, alginic acid, alginates, alginic acid derivatives, agar, locust bean gum, guar gum, amylopectin, pectin, xanthan gum, glucomannan, chitin and pullulan Natural polysaccharide / polyhydric alcohol composition. On the other hand, the second dissolving portion 14 is formed of a dissolving material that is easy to dissolve, for example, a material mainly composed of natural polymers such as chitosan, gelatin, and cellulose.

  The recognition unit 15 is for confirming the presence in the body such as the lumen passage confirmation capsule 10 and the current passage position by recognizing its presence from the outside of the subject's body by the recognition device. An impermeable member such as barium sulfate, metal (gold, titanium, stainless steel, etc.), an electronic ID tag, such as an RF-ID (Radio Frequency Identification) tag, or the like. When the recognition unit 15 is an X-ray opaque member such as barium sulfate or metal, the presence of the X-ray opaque member is confirmed by seeing through the body of the subject with an X-ray fluoroscope. It is possible to confirm whether or not the lumen passage confirmation capsule 10 stays in the stenosis portion or the like. On the other hand, when the recognized portion 15 is an electronic ID tag such as an RF-ID tag, power is transmitted to the electronic tag using a reader / writer for the tag to operate the IC chip, and the necessary tag is used. The presence of the tag can be recognized by receiving the information. The recognized part 15 is a single part having a size that can pass even if it is a stenosis part or the like, and is arranged in the center of the lumen passage confirmation capsule 10 in the second dissolving part 14. However, the arrangement location is not particularly limited to the central portion. Further, when the non-dissolving portion 12 on the surface layer is made of metal, the non-dissolving portion 12 itself may be used as the recognized portion 15 so that it does not have to be provided in the second dissolving portion 14.

  Such a lumen passage confirmation capsule 10 is filled with the second dissolving portion 14 including the recognized portion 15 in the non-dissolving portion 12 in which the notched portion is formed in a part of the dome-shaped capsule shape, for example. It is formed by filling the melting part 13 along the part.

  The luminal passage confirmation capsule 10 configured in this way is used by the subject from the oral cavity a predetermined time (for example, several days ago) prior to the intraluminal examination / observation by the capsule endoscope to be applied. Whether it can pass through a hollow organ such as the small intestine by being introduced into the body is confirmed in advance.

  Here, the lumen passage confirmation capsule 10 introduced into the body is formed in the same size and shape as the original capsule endoscope, and is abnormally narrowed due to a stenosis or the like in the lumen. If there is no such part, according to the peristaltic movement of the lumen, etc., it sequentially passes through the lumen of the stomach, small intestine, large intestine, etc., and is finally discharged out of the body. At this time, most of the surface layer of the lumen passage confirmation capsule 10 is formed as the non-dissolved portion 12, and the linear dissolved portion 13 exposed to the outside as a part of the surface layer is formed of an enteric material. Therefore, the lumen passage confirmation capsule 10 proceeds without being dissolved by body fluid such as gastric fluid until it passes through the stomach. In the process of passing through the small intestine to the large intestine, the lumen passage confirmation capsule 10 proceeds while the dissolution part 13 made of the enteric material is gradually dissolved, but it remains constant until the dissolution part 13 dissolves. During the time, the dome-shaped capsule shape is maintained. Accordingly, if there is no abnormality such as a stenosis in the small intestine or the like, the lumen passage confirmation capsule 10 proceeds without staying in the small intestine to the large intestine while maintaining the dome-shaped capsule shape, and is discharged outside the body within a predetermined time. Thus, it is confirmed that there is no abnormality such as a stenosis in the lumen, that is, the original capsule endoscope can pass without any trouble.

  On the other hand, if there is an abnormality such as a stenosis in a region such as the small intestine, the progression of the lumen passage confirmation capsule 10 is inhibited and stays in the stenosis or the like even when subjected to peristalsis. Then, as the residence time elapses, the dissolution of the linear dissolution part 13 proceeds, and when a certain time elapses, all the dissolution parts 13 are dissolved, and finally the second dissolution part 14 is exposed to the outside and dissolved. To get started. At this time, since the second dissolving portion 14 is made of a material having higher solubility than the dissolving portion 13, the second dissolving portion 14 is dissolved in a short time and the missing portion of the non-dissolving portion 12 where the dissolving portion 13 disappears. It flows out from the portion into the small intestine, and the inside of the non-dissolving portion 12 is hollowed out in a short time. The non-dissolving part 12 remaining in the hollow passage confirmation capsule 10 thus hollowed out loses the rigidity for maintaining the dome-shaped capsule shape by eliminating the dissolving part 13 of the chipped part formed in a linear shape. It is easy to deform in the direction of decreasing, and it is crushed so that the outer diameter decreases by receiving the peristaltic motion of the small intestine. As a result, even if it cannot pass through the small intestine within a certain period of time and stays in the stenosis, etc., it can be crushed and reduced after a certain period of time so that the stenosis can be reliably passed through and discharged. Will not stay in the water. In particular, in the first embodiment, the melting portion 13 is formed linearly in the longitudinal axis direction across the both ends of the dome-shaped capsule shape in the longitudinal axis direction. The non-dissolving portion 12 having a capsule shape can be easily crushed in the radial direction, the diameter in the traveling direction can be reduced, and the passage through the constricted portion can be enhanced.

  Further, after a predetermined time or more has elapsed, the presence / absence of the recognition unit 15 is recognized by the recognition device from outside the subject's body, so that the lumen passage confirmation capsule 10 remains in the lumen even after a certain time or more has elapsed. It can be reconfirmed whether or not it is staying.

(Modification 1)
FIG. 3 is a schematic longitudinal side view showing the lumen passage confirmation capsule 10A of the first modification. The lumen passage confirmation capsule 10A of the first modification is obtained by giving elasticity to the non-dissolving portion 12 that forms the surface layer of the dome-shaped capsule shape. At this time, as shown in FIG. 3A, the end portions of the chipped portions of the non-dissolved portion 12 are stepped in the radial direction so as not to overlap each other, and the melted portion 13 is filled. According to the lumen passage confirmation capsule 10A of the modified example 1 formed as shown in FIG. 3 (a) according to the case of FIG. 2, it stays in the small intestine, and the linear dissolution part 13 dissolves to dissolve the inside. When the second dissolution part 14 flows out to the outside while being melted to form a cavity, the lumen passage confirmation capsule 10A maintaining the dome-shaped capsule shape due to the presence of the dissolution part 13 is as shown in FIG. The non-dissolved portion 12 is deformed so as to be rounded in a direction in which the diameter is forcibly reduced due to the elasticity of the non-dissolved portion 12, and easily passes through the staying portion.

(Modification 2)
FIG. 4 is a schematic perspective view showing a lumen passage confirmation capsule 10B of the second modification. In the lumen passage confirmation capsule 10B of the second modification, the dissolving portion 13 for the non-dissolving portion 12 is provided in a spiral shape in the circumferential direction around the longitudinal axis of the dome-shaped capsule shape. According to the lumen passage confirmation capsule 10B of the modified example 2, when the capsule stays in the small intestine, the spiral dissolving portion 13 dissolves and the inner second dissolving portion 14 dissolves and flows out to the outside and becomes hollow. The non-dissolving portion 12 of the lumen passage confirmation capsule 10B that has maintained the dome-shaped capsule shape due to the presence of the dissolving portion 13 is so stiff that the dome-shaped capsule shape cannot be maintained due to a decrease in rigidity. It is easy to be crushed and pass through the staying part. In addition, what is necessary is just to set the number of strips which make a spiral shape suitably. Further, it is preferable that the spiral end portion is formed up to the end portions of the convex shape portions 11a and 11b as much as possible.

(Modification 3)
FIG. 5 is a schematic perspective view showing a lumen passage confirmation capsule 10C of Modification 3, and FIG. 6 is an end side view thereof. The lumen passage confirmation capsule 10C of Modification 2 is provided with the dissolving portion 13 for the non-dissolving portion 12 in a line shape that intersects in an X shape at the convex shape portions 11a and 11b at both ends of the dome-shaped capsule shape. . According to the lumen passage confirmation capsule 10C of the third modification, the capsule stays in the small intestine, and when the spiral dissolving portion 13 dissolves and the second second dissolving portion 14 dissolves and flows out to the outside, it becomes hollow. In the non-dissolving portion 12 of the lumen passage confirmation capsule 10C that has maintained the dome-shaped capsule shape due to the presence of the dissolving portion 13, the rigidity of the convex-shaped portions 11a and 11b at both ends with high rigidity decreases, and the dome-shaped capsule shape Cannot be maintained, and is hollowed into a cylindrical shape as a whole and easily crushed, and easily passes through the staying portion. Note that the number of lines intersecting at the convex portions 11a and 11b is not limited to two, and the number of lines may be further increased to make it easier to collapse. Moreover, the linear melt | dissolution part 13 formed in the convex-shaped parts 11a and 11b may be formed so that it may extend to the position near the center of a longitudinal axis direction, and may be crushed more easily.

(Embodiment 2)
A lumen passage confirmation capsule according to Embodiment 2 of the present invention will be described with reference to FIGS. FIG. 7 is a schematic perspective view showing a configuration example of the lumen passage confirmation capsule 20 according to the second embodiment, and FIG. 8 is a central longitudinal side view thereof.

  The lumen passage confirmation capsule 20 according to the second embodiment is basically configured according to the lumen passage confirmation capsule 10 according to the first embodiment, but is formed linearly with respect to the non-dissolving portion 12. By rotating the two melting portions 13 in the direction of the line and dividing the non-dissolving portion 12, a plurality of, for example, four sheet-like members 12 a connected to the non-dissolving portion 12 by the linear melting portion 13. It is comprised so that it may consist of. That is, the melting part 13 is a combination of the first embodiment and the third modification, and the part formed linearly in the longitudinal axis direction and the part formed linearly in the convex parts 11a, 11b are longitudinal axes. The non-dissolving part 12 is divided continuously in the direction, and the dome-shaped capsule shape can be maintained by the presence of the dissolving part 13.

  According to the lumen passage confirmation capsule 20 of the second embodiment, when the linear dissolution portion 13 is retained in the small intestine and dissolved, the passage through the lumen that has maintained the dome-shaped capsule shape due to the presence of the dissolution portion 13 is achieved. The non-dissolving portion 12 of the confirmation capsule 20 cannot maintain the dome-shaped capsule shape, and is surely divided by the sheet-like member 12a and deformed in a smaller direction, and easily passes through the constricted portion or the like. In addition, the number of the melt | dissolution parts 13 is not restricted to two, You may make it increase by increasing the number of the sheet-like members of the non-dissolution part 12 divided | segmented by increasing the number, and each may become small.

(Modification 4)
FIG. 9 is a schematic perspective view showing the lumen passage confirmation capsule 20A of the fourth modification. The lumen passage confirmation capsule 20A according to the modified example 4 is provided not only with a linear shape that circulates in the longitudinal axis direction but also with a linear shape that circulates in the circumferential direction around the longitudinal axis. The non-dissolving part 12 is divided into a plurality of further divided sheet-like members 12b. According to the lumen passage confirmation capsule 20A of the modified example 4, when the dissolving portion 13 is dissolved, the non-dissolving portion 12 can be subdivided into the sheet-like member 12b and can be made smaller, making it easier to pass through the staying portion. Become. In this case, the number of the melting portions 13 may be set as appropriate, and both the longitudinal axis direction and the circumferential direction may be oblique directions, or a combination with a spiral shape.

(Modification 5)
FIG. 10 is a central longitudinal cross-sectional side view showing the lumen passage confirmation capsule 20B of Modification 5, and FIG. 11 is a cross-sectional view showing a state of deformation of the divided non-dissolving part. As shown in FIG. 10A, the lumen passage confirmation capsule 20B according to the modified example 5 includes a second non-dissolving portion 16 made of a material that does not dissolve inside the non-dissolving portion 12 via the dissolving portion 13. Are provided in a substantially parallel layered manner so that the non-dissolved portion has a two-layer structure, and the second non-dissolved portion 16 is also provided in a part of the second non-dissolved portion 16 as shown in FIG. A chipped portion divided into a line along the longitudinal axis direction is formed into a plurality of sheet-like members 16a, and the melted portion 13 is filled and connected to the chipped portions. As a result, the second non-dissolving part 16 divides the inside of the dissolving part (dissolving part 13 and second dissolving part 14), and a part of the surface (the chipped part) is introduced into these dissolving parts 13 and 14 from the inside. The proceeding dissolution path 17 is formed in an intermittent cross-sectional arc shape along the circumferential direction. Here, the dividing position (chip portion) of the non-dissolving portion 12 by the dissolving portion 13 and the dividing position (chip portion) of the second non-dissolving portion 16 by the dissolving portion 13 are the circumferences around the longitudinal axis of the capsule type capsule shape. It is shifted in the direction. In the modified example 5, it has shifted | deviated at equal intervals and the melt | dissolution path | route 17 is set so that it may become as long as possible equally. Further, the sheet-like members 12a and 16a constituting the non-dissolving parts 12 and 16 are formed of an elastic member having a characteristic of being rounded by elasticity.

  According to the lumen passage confirmation capsule 20B of the modified example 5, when the linear dissolution part 13 stays in the small intestine and the surface dissolution part 13 dissolves, the dissolution is the second non-dissolution as shown in FIG. It progresses from the surface side to the inside along the melting path 17 having a circular arc cross section formed by the portion 16. And when all the melt | dissolution parts 13 between the non-dissolution part 12 and the 2nd non-dissolution part 16 melt | dissolve, the non-dissolution of the lumen passage confirmation capsule 20B which maintained the external shape of the dome-shaped capsule shape by presence of the melt | dissolution part 13 The parts 12 cannot maintain the dome-shaped capsule shape and are reliably divided into the sheet-like members 12a. Thereafter, when the melted portion 13 filled in the chipped portion of the second non-dissolved portion 16 is melted and the melted portion 13 of this portion is melted, the second non-dissolved portion 16 is transferred to the sheet-like member 16a. Divided.

  Since the divided sheet-like members 12a and 16a are made of an elastic member having a property of being rounded by elasticity, the flat sheet-like state as shown in FIG. 11 (a) is forced as shown in FIG. 11 (b). As a result, it becomes rounder and smaller, and it becomes easier to pass through a constricted portion or the like. Further, in the case of the lumen passage confirmation capsule 20B of the modified example 5, the dissolution path 17 is formed by the second non-dissolving part 16 so that it takes time for the dissolving part 13 to dissolve. Can be structurally extended, for example, to be 3 days or longer, and the dome-shaped capsule shape can be maintained for a long time.

(Modification 6)
FIG. 12 is a central longitudinal side view showing the lumen passage confirmation capsule 20C of the sixth modification. In the lumen passage confirmation capsule 20C of the modified example 6, the non-dissolving part 12 is formed in a spiral shape, and a part thereof, for example, a half circumference overlaps substantially parallel and in layers via the sheet-like dissolving part 13. It is provided. Here, the exposed portion of the dissolving portion 13 in the surface layer is provided in a line along the longitudinal axis direction of the dome-shaped capsule shape. Moreover, the part which exists inside among the non-dissolution parts 12 divides the inside of a dissolution part (between the 2nd dissolution part 14 and dissolution part 13), and follows the dissolution path 17 by dissolution part 13 along the peripheral direction. The second non-dissolving portion 18 formed in a circular arc shape is formed.

  According to the lumen passage confirmation capsule 20C of the modified example 6, when it stays in the small intestine, the dissolution starts from the linear portion of the surface layer that is exposed to the outside in the dissolution part 13 and enters the inside according to the dissolution path 17 having a circular arc cross section. Dissolution progresses toward. And when all the melt | dissolution parts 13 in the melt | dissolution path | route 17 melt | dissolve, while the 2nd melt | dissolution part 14 inside melt | dissolves in a short time and it cavitates, the dome-shaped capsule shape is maintained by presence of the melt | dissolution part 13. The non-dissolving portion 12 of the lumen passage confirmation capsule 20C cannot maintain the dome-shaped capsule shape, for example, is rounded and deformed in a smaller direction, and easily passes through the narrowed portion. Further, in the case of the lumen passage confirmation capsule 20C of the modified example 6, the dissolution path 17 is formed by the second non-dissolution part 16 so that the dissolution of the dissolution part 13 takes time. Can be structurally extended, and the dome-shaped capsule shape can be maintained for a long time.

(Embodiment 3)
A lumen passage confirmation capsule according to Embodiment 3 of the present invention will be described with reference to FIG. FIG. 13 is a central longitudinal sectional front view showing a configuration example of the lumen passage confirmation capsule 30 according to the third embodiment. In the lumen passage confirmation capsule 30 according to the third embodiment, the non-dissolving portion 31 using a material that does not dissolve in the body includes a large number of microspheres 31a, and includes a material that dissolves the large number of microspheres 31a in the body. It is molded so as to form a dome-shaped capsule-shaped surface layer by connecting it in a bead shape in a thin state by the dissolving portion 32. Thereby, the melt | dissolution part 32 will exist linearly in all directions in the longitudinal direction of a dome-shaped capsule shape, the circumferential direction around a longitudinal axis, and the convex-shaped parts 11a and 11b according to the arrangement | sequence of the non-dissolution part 31. . The material of the non-dissolving part 31 and the dissolving part 32 may be the same as that described in the first and second embodiments. In addition, the second dissolving portion 14 and the recognized portion 15 are appropriately incorporated inside the non-dissolving portion 31.

  According to the lumen passage confirmation capsule 30 of the third embodiment, when it stays in the small intestine, dissolution starts from the dissolution part 32 exposed to the surface layer. At this time, since the dissolving portion 32 is partially provided so as to fill the space between the microspheres 31a, the surface where the dissolving portion 32 contacts the body fluid is small, it takes time to dissolve, and the dome-shaped capsule shape is structurally Can be maintained for a long time. In addition, even if there is a difference in the degree of progress of dissolution of the dissolving portions 32 around each microsphere 31a and some of the microspheres 31a may be separated from or dropped from the surface layer, the remaining portions connected by the dissolving portion 32 will remain. The dome-shaped capsule shape does not collapse in the microsphere 31a portion. Therefore, although the unevenness is partially generated, the dome-shaped capsule shape can be structurally maintained for a long time. After that, when most of the dissolving parts 32 are dissolved, the non-dissolving part 31 that has maintained the dome-shaped capsule shape by the dissolving part 32 loses the connection state between the microspheres 31a and is in a state of being decomposed into individual microspheres 31a. , It deforms in a smaller direction. Individually disassembled microspheres 31a are easy to pass even in a constricted portion or the like. Further, if the microsphere 31a is included in the stool that the subject defecates, it becomes an index indicating that the lumen passage confirmation capsule 30 has stayed in the body cavity for a certain period of time, such as X-rays. It is also possible to omit the stay confirmation.

(Modification 7)
FIG. 14 is a partial cross-sectional view showing a lumen passage confirmation capsule 30A of Modification 7. The lumen passage confirmation capsule 30A of the modified example 7 is formed by laminating a large number of microspheres 31a constituting the non-dissolving part 31 into a plurality of layers, for example, two layers through the connecting dissolving part 32. is there. According to the lumen passage confirmation capsule 30A of the modified example 7, when dissolution of the dissolution part 32 proceeds in the small intestine, even if the dissolution part 32 of the surface layer part dissolves, the dissolution part 32 of the lower layer part causes the surface layer to dissolve. The connected state of the microspheres 31a of the non-dissolving part 31 is maintained. Therefore, the dome-shaped capsule shape can be structurally maintained for a long time. After that, when the dissolution part 32 of the lower layer part is dissolved, the microspheres 31a on the surface layer are individually decomposed to form a slightly dome-shaped capsule shape. Further, when the remaining dissolving portion 32 is dissolved, the lower microspheres 31a are also individually decomposed and deformed in a smaller direction. Although FIG. 14 shows an example of a two-layer stack, the number of layers, the size of the microspheres 31a in each layer, and the ratio of the microspheres 31a to the dissolution part 32 can be appropriately modified depending on the desired dissolution time. is there.

(Embodiment 4)
A lumen passage confirmation capsule according to Embodiment 4 of the present invention will be described with reference to FIG. FIG. 15 is a longitudinal front view showing the lumen passage confirmation capsule 40 according to the fourth embodiment. The lumen passage confirmation capsule 40 according to the fourth embodiment includes a dissolving part 41, a non-dissolving part 42, and a recognized part 15.

  The dissolution part 41 is made of a material that dissolves in the body and forms a dome-shaped capsule-shaped structure. As the material constituting the dissolving portion 41, the same enteric material as in the above-described embodiment is used. In addition, the non-dissolving part 42 is brittle, has no mechanical strength, has a characteristic that the shape cannot be maintained alone, and is basically made of a material that does not dissolve in the body, for example, a metal thin film such as gold, A part of the dissolving part 41 forming a capsule-shaped structure is exposed to the surface by the opening 43 and is formed as a thin film covering the surface of the dissolving part 41. The opening 43 is formed, for example, at the center of the convex portions 11a and 11b at both ends in the longitudinal axis direction. Further, the non-dissolving part 42 is provided in a state of being fixed to the dissolving part 41. Thereby, the non-dissolving part 42 can maintain a capsule shape.

  When the lumen passage confirmation capsule 40 having such a configuration stays in the small intestine, as shown in FIG. 15B, the dissolving portion 41 is dissolved from the portion exposed to the outside through the opening 43 toward the inside. Gradually progresses. During this time, the non-dissolving part 42 on the surface layer is integrated with the internal dissolving part 41 to maintain a dome-shaped capsule shape. After that, when a certain period of time has passed and most of the melting portion 41 inside has melted and hollowed out, the melting portion 41 cannot maintain the dome-shaped capsule shape and collapses. At this time, the non-dissolving portion 42 made of a thin film itself cannot maintain the dome-shaped capsule shape, and therefore, the disintegrating portion 41 is disintegrated almost simultaneously with the disintegration of the dissolving portion 41, and even a constricted portion or the like can pass through.

  Here, a manufacturing method of the lumen passage confirmation capsule 40 according to the fourth embodiment will be described. As a first example, first, a process of forming a dissolving part 41 that dissolves in the body as a dome-shaped capsule-shaped structure is performed, and then a part of the structure (opening 43) including the dissolving part 41 is removed. Thus, it is manufactured by performing a step of forming a thin film of the non-dissolving portion 42 that does not dissolve in the body. At this time, the thin film of the non-dissolving part 42 is fixed to the surface of the dissolving part 41.

  As a second example, first, the step of forming the dissolving portion 41 that dissolves in the body as a dome-shaped capsule-shaped structure is performed, and then the non-dissolving that does not dissolve in the body on the entire surface of the structure including the dissolving portion 41 It is manufactured by performing a process of forming and fixing the thin film of the part 42 and further removing a part of the thin film (opening 43) by the non-dissolving part 42.

  The step of forming the thin film of the non-dissolving part 42 on the surface of the structure composed of the dissolving part 41 may be a method of vapor-depositing a material constituting the non-dissolving part 42 or a method of curing after spraying. Alternatively, a method may be used in which a liquid material is used as the non-dissolving portion 42 and the structure made of the dissolving portion 41 is immersed in the liquid material and then taken out and cured. Moreover, as a process of forming a thin film of the non-dissolved portion 42 except for a part of the structure composed of the dissolved portion 41 in the first example, masking is performed on the surface of the structure composed of the dissolved portion 41, and a thin film is formed on the surface. By removing the masking portion after the formation, the thin film of the non-dissolved portion 42 can be formed only in the unmasked portion. Here, the recognizable portion 15 may be a radiopaque metal or barium. Further, the non-dissolving part 42 or the dissolving part 41 may be radiopaque and serve also as the recognized part 15. In this case, the structure is simplified, the manufacture is facilitated, and the dissolved state can be confirmed by X-rays.

(Modification 8)
FIG. 16 is a longitudinal front view showing a lumen passage confirmation capsule 40A of Modification 8. The lumen passage confirmation capsule 40A according to the modified example 8 is formed by forming multiple thin films, for example, triple layers, as indicated by 42a, 42b, and 42c on the surface of the structure formed by the dissolved portion 41 as indicated by 42a, 42b, and 42c. According to the lumen passage confirmation capsule 40A of the modified example 8, even if the surface of the lumen passage confirmation capsule 40a is damaged before swallowing or in the body cavity, the non-dissolving parts 42a, 42b, 42c prevents the inner dissolution part 41 from being exposed. Therefore, the dissolution of the dissolving portion 41 does not proceed from a portion other than the opening 43, and it is possible to prevent the time during which the dome-shaped capsule shape cannot be maintained from being shortened.

  When manufacturing the lumen passage confirmation capsule 40A of the modified example 8, first, after performing the step of forming the dissolving portion 41 that dissolves in the body as a dome-shaped capsule-shaped structure, It is manufactured by repeating the process of forming and fixing the thin film of the non-dissolved part 42 that does not dissolve in the body except the part (opening 43). Here, when performing the step of forming the melting portion 41 as a dome-shaped capsule-shaped structure, it is finally manufactured by forming it in a size slightly smaller than the size of the target dome-shaped capsule shape. The size of the lumen passage confirmation capsule 40A can be adjusted to the size of the target dome-shaped capsule shape. Further, when the non-dissolving part 42 is formed on the surface of the dissolving part 41, the dissolving part 41 and the non-dissolving part 42 are fixed, and when the non-dissolving part 42 is formed on the surface of the non-dissolving part 42, the non-dissolving part 42 42 are fixed to each other.

  In the case of the lumen passage confirmation capsules 40 and 40A according to the fourth embodiment and the modification 8, the dissolving portion 41 is formed as a dome-shaped capsule-shaped structure, but the non-dissolving portion 42 side is a dome shape. The present invention can be similarly applied even when it is provided in a thin-walled shape having flexibility, for example, so as to form a capsule-shaped structure. At this time, the non-dissolving part 42 becomes small by being crushed after the dissolving part 41 is dissolved.

(Embodiment 5)
A lumen passage confirmation capsule according to Embodiment 5 of the present invention will be described with reference to FIGS. 17 and 18. FIG. 17 is a longitudinal front view showing a configuration example of the lumen passage confirmation capsule 50 according to the fifth embodiment, and FIG. 18 is a side view thereof.

  The lumen passage confirmation capsule 50 according to the fifth embodiment is formed with a through-hole 51 that is located in the axial center of the dissolving portion 41 that forms a dome-shaped capsule-shaped structure and penetrates in the longitudinal axis direction. In the fifth embodiment, the second non-dissolving portion 53 is provided on the inner surface of the dissolving portion 41 except for the central opening portion 52 in the longitudinal axis direction in part of the hole 51. Here, the end 53a in the longitudinal axis direction of the second non-dissolving portion 53 made of a material that does not dissolve in the body is connected to be integrated with the end 42a of the non-dissolving portion 42 on the surface of the dome-shaped capsule. Yes. Further, the second non-dissolving part 53 may be the same material as the non-dissolving part 42 or may be a different material. Furthermore, the recognized portion 15 incorporated in the lumen passage confirmation capsule 50 is divided and separated as recognized portions 15a and 15b at the innermost ends of the longitudinal direction farthest from the opening 52 in the dissolving portion 41. Has been placed. At this time, the non-dissolving parts 42 and 53 are brittle and have characteristics that do not have mechanical strength, and are formed in a state of being fixed to the dissolving part 41.

  When the lumen passage confirmation capsule 50 having such a configuration stays in the small intestine, as shown in FIG. 17B, the dissolution part 41 exposed to the outside through the central opening 52 in the through hole 51. Dissolution proceeds gradually from the part toward the inside. During this time, the non-dissolving part 42 on the surface layer maintains a dome-shaped capsule shape by the dissolving part 41 inside. After that, when a certain period of time has passed and most of the melting portion 41 inside has melted and hollowed out, the melting portion 41 cannot maintain the dome-shaped capsule shape and collapses. At this time, the non-dissolving portion 42 made of a thin film itself cannot maintain the dome-shaped capsule shape, and therefore, the disintegrating portion 41 is disintegrated almost simultaneously with the disintegration of the dissolving portion 41, and even a constricted portion or the like can pass through. Further, due to the collapse of the dissolving portion 41 and the non-dissolving portions 42 and 53, the recognized portions 15a and 15b are also separated and discharged through the narrowed portion and the like.

  According to the lumen passage confirmation capsule 50 according to the fifth embodiment, the dissolving portion 41 is dissolved from the opening 52 formed in the center through the through hole 51 as a portion not related to the maintenance of the dome-shaped capsule shape. Since it proceeds, the capsule shape can be maintained structurally for a long time. Further, since the end portion 42 a of the non-dissolving portion 42 is also continuously protected by being connected to the end portion 53 a of the second non-dissolving portion 53, the dissolving portion 41 is dissolved from the vicinity of the end portion 42 a of the non-dissolving portion 42. In this respect, the capsule shape can be maintained for a long time.

  In addition, according to the lumen passage confirmation capsule 50 according to the fifth embodiment, the recognition unit 15 is divided and separated as the recognition units 15a and 15b, so that the recognition device is used after a predetermined time or more has elapsed. Thus, the capsule state can be confirmed when the presence or absence of the recognized portions 15a and 15b is confirmed. That is, if the recognized recognized portions 15a and 15b are in different states, it can be determined that the lumen passage confirmation capsule 50 is in a collapsed state in the lumen, while the recognized recognized portions 15a and 15b If the state remains in the initially spaced state, it can be determined that the lumen passage confirmation capsule 50 is staying in the lumen without collapsing. In particular, since the recognized portions 15a and 15b are arranged at the innermost portion farthest from the opening 52, the positional relationship between the recognized portions 15a and 15b is maintained until the lumen passage confirmation capsule 50 is finally collapsed. Therefore, the presence or absence of the collapse of the lumen passage confirmation capsule 50 in the lumen can be appropriately determined. Further, the recognized portion may be a metal that does not transmit X-rays and is not dissolved in the intestine, or may be barium that can be dissolved in the intestine. Similarly to the fourth embodiment, the dissolving portion 41 and the non-dissolving portions 42 and 53 may have radiopacity and may also serve as the recognized portion 15.

  In the case of the lumen passage confirmation capsule 50 according to the fifth embodiment, the dissolving part 41 forms a dome-shaped capsule-shaped structure, but the non-dissolving part 42 side is replaced with a dome-shaped capsule-shaped structure. For example, even if it is provided in a thin wall shape having flexibility, it can be similarly applied. At this time, the non-dissolving part 42 becomes small by being crushed after the dissolving part 41 is dissolved.

(Embodiment 6)
A lumen passage confirmation capsule according to Embodiment 6 of the present invention will be described with reference to FIG. FIG. 19 is a longitudinal front view showing a configuration example of the lumen passage confirmation capsule 60 according to the sixth embodiment.

  The lumen passage confirmation capsule 60 according to the sixth embodiment is provided so as to extend in the central direction of the longitudinal axis with respect to the dissolving portion 41 forming the dome-shaped capsule-shaped structure, and the inside of the dissolving portion 41 is moved to the longitudinal axis. A second non-dividing part that is divided into a cylindrical shape along the direction to form a dissolution path 62 that progresses inward from the outer opening 43 that is a part of the surface through the inner central opening 61 in the melting part 41. A melting part 63 is provided. Here, the end 63a in the longitudinal axis direction of the second non-dissolving portion 63 made of a material that does not dissolve in the body is connected so as to be integrated with the end 42a of the non-dissolving portion 42 on the surface of the dome-shaped capsule. Yes. The second non-dissolving part 63 may be the same material as the non-dissolving part 42 or may be a different material. Further, the recognized portion 15 incorporated in the lumen passage confirmation capsule 60 is divided and separated as recognized portions 15 a and 15 b at the innermost end of the dissolving path 62 in the dissolving portion 41. At this time, the non-dissolving parts 42 and 63 are brittle, have a characteristic that does not have mechanical strength, and are formed in a state of being fixed to the dissolving part 41.

  The lumen passage confirmation capsule 60 according to the sixth embodiment is provided with a second non-dissolving portion 63 except for the openings 43 and 61 on the surface of the dissolving portion 41a formed in a columnar shape, and further dissolving on the surface. The part 41b is formed in a desired dome-shaped capsule shape to form a structure, and the non-dissolved part 42 is formed and fixed on the surface of the structure.

  When the lumen passage confirmation capsule 60 having such a configuration stays in the small intestine, as shown in FIG. 19B, dissolution starts from the dissolution portion 41 exposed to the outside through the opening 43, and the dissolution route It proceeds in the second non-dissolving part 63 according to 62, and further proceeds to the outside of the second non-dissolving part 63 through the opening 61. During this time, the non-dissolving part 42 on the surface layer maintains a dome-shaped capsule shape by the dissolving part 41 inside. After that, when a certain period of time has passed and most of the melting portion 41 inside has melted and hollowed out, the melting portion 41 cannot maintain the dome-shaped capsule shape and collapses. At this time, the non-dissolving portion 42 made of a thin film itself cannot maintain the dome-shaped capsule shape, and therefore, the disintegrating portion 41 is disintegrated almost simultaneously with the disintegration of the dissolving portion 41, and even a constricted portion or the like can pass through. In addition, due to the collapse of the dissolving portion 41 and the non-dissolving portions 42 and 63, the recognized portions 15a and 15b are also separated and discharged through the constricted portion and the like.

  According to the lumen passage confirmation capsule 60 according to the sixth embodiment, the dissolution path 62 is divided into the dissolution part 41 by the second non-dissolution part 63 and proceeds from a part of the surface into the dissolution part 41. Therefore, by increasing the length of the dissolution path 62, the dissolution time of the dissolution part 41 in the lumen can be structurally increased, for example, to be 3 days or longer. Can be maintained for hours. Therefore, the capsule shape can be reliably maintained for a certain period of time necessary for confirming passage, and lumen passage can be confirmed with certainty. In particular, since the second non-dissolving portion 63 forming the dissolution path 62 is provided so as to extend in the center direction of the dome-shaped capsule shape, the portion not related to the maintenance of the dome-shaped capsule shape is dissolved first. It is possible to form a dissolution path 62 for dissolving the dissolving portion 41 from the center portion of the dome-shaped capsule shape toward the outside, and until the dissolving portion 41 in the vicinity of the non-dissolving portion 42 forming the outer surface of the dome-shaped capsule shape is dissolved. Can be lengthened. Further, since the end portion 42a of the non-dissolving portion 42 is also continuously protected by being connected to the end portion 63a of the second non-dissolving portion 63, the dissolving portion 41 is dissolved from the vicinity of the end portion 42a of the non-dissolving portion 42. In this respect, the capsule shape can be maintained for a long time. Further, since the capsule shape can be maintained for a long time by the dissolution path 62, the choices of materials that can be used for the dissolution part 41 are widened, and manufacturing can be simplified and the cost can be reduced.

  Further, according to the lumen passage confirmation capsule 60 according to the sixth embodiment, as in the case of the fifth embodiment, the recognized portion 15 is divided and disposed as the recognized portions 15a and 15b. When the presence / absence of the recognized portions 15a and 15b is confirmed using the recognition device after a predetermined time or more has elapsed, the capsule state can be confirmed. That is, if the recognized parts 15a and 15b are in different states, it can be determined that the lumen passage confirmation capsule 60 is in a collapsed state in the lumen, while the recognized parts 15a and 15b are recognized. If the state remains in the initially spaced state, it can be determined that the lumen passage confirmation capsule 60 is in a state of staying without collapsing in the lumen. In particular, since the recognized parts 15a and 15b are arranged at the innermost part of the dissolution path 62, the positional relationship between the recognized parts 15a and 15b is maintained until the lumen passage confirmation capsule 60 is finally collapsed. Therefore, the presence or absence of the collapse of the lumen passage confirmation capsule 60 in the lumen can be properly determined. Further, the recognized portion may be a metal that does not transmit X-rays and is not dissolved in the intestine, or may be barium that can be dissolved in the intestine. Similarly to the fourth embodiment, the dissolving portion 41 and the non-dissolving portions 42 and 63 may have radiopacity and may also serve as the recognized portion 15.

(Modification 9)
FIG. 20 is a longitudinal front view showing a lumen passage confirmation capsule 60A of the ninth modification. The lumen passage confirmation capsule 60A of the modification 9 is provided with a cylindrical third non-dissolving portion 64 made of a material that does not dissolve in the body outside the cylindrical second non-dissolving portion 63 in the dissolving portion 41. The dissolution path 62 is further divided and subdivided. Here, the third non-dissolving portion 64 is provided around the central portion including the periphery of the opening 61, and the dissolution path 62 is formed in the opening 43 → the second non-dissolving portion 63 → the opening 61 → the second and second. The distance between the third non-dissolving part 63 and 64 is set to be between the third non-dissolving part 64 and the non-dissolving part 42. According to the lumen passage confirmation capsule 60A of the modified example 9, since the dissolution path 62 is formed to be longer by subdivision, the time required for the dissolution part 41 to dissolve can be structurally extended. The dome-shaped capsule shape can be maintained for a longer time. Further, since the capsule shape can be maintained for a long time by the dissolution path 62, the choices of materials that can be used for the dissolution part 41 are widened, and manufacturing can be simplified and the cost can be reduced.

  In the case of the lumen passage confirmation capsules 60 and 60A according to the sixth embodiment and the modification 9, the dissolving portion 41 is formed as a dome-shaped capsule-shaped structure. The present invention can be similarly applied even when it is provided in a thin-walled shape having flexibility, for example, so as to form a capsule-shaped structure. At this time, the non-dissolving part 42 becomes small by being crushed after the dissolving part 41 is dissolved.

(Embodiment 7)
A lumen passage confirmation capsule according to Embodiment 7 of the present invention will be described with reference to FIG. FIG. 21 is a longitudinal front view showing a configuration example of the lumen passage confirmation capsule 70 according to the seventh embodiment.

  The lumen passage confirmation capsule 70 according to the seventh embodiment has an opening portion by dividing the dissolution portion 41 in a direction crossing the longitudinal axis at both ends in the longitudinal axis direction of the dissolution portion 41 forming a dome-shaped capsule-shaped structure. The second non-dissolving portion 72 that forms the dissolution path 71 that progresses from 43 to the inner center side is provided in a comb-like shape, and the dissolving portion 41 extends in the direction across the longitudinal axis from the opposite side of the second non-dissolving portion 72 A third non-dissolving portion 73 is provided in a comb-teeth shape to further divide the dissolution path 71 and further subdivide it. That is, the second and third non-dissolving parts 72 and 73 made of a material that does not dissolve in the body are formed in a comb-tooth shape that alternately enters, and the dissolution path 71 starting from the opening 43 is folded back into a labyrinth and formed long. is doing. At this time, the non-dissolving parts 42, 72, and 73 are brittle, have characteristics that do not have mechanical strength, and are formed in a state of being fixed to the dissolving part 41.

  When the luminal passage confirmation capsule 70 having such a structure stays in the small intestine, the dissolution starts from the dissolution portion 41 exposed to the outside by the opening 43 and follows the dissolution path 71 formed in the maze shape. Proceed through 41. During this time, the non-dissolving part 42 on the surface layer maintains a dome-shaped capsule shape by the dissolving part 41 inside. After that, when a certain period of time has passed and most of the melting portion 41 inside has melted and hollowed out, the melting portion 41 cannot maintain the dome-shaped capsule shape and collapses. At this time, the non-dissolving portion 42 made of a thin film itself cannot maintain the dome-shaped capsule shape, and therefore, the disintegrating portion 41 is disintegrated almost simultaneously with the disintegration of the dissolving portion 41, and even a constricted portion or the like can pass through.

  According to the lumen passage confirmation capsule 70 according to the seventh embodiment, the dissolution path 71 is divided by dividing the inside of the dissolution part 41 by the second and third non-dissolution parts 72 and 73 to form the dissolution path 71. Therefore, by lengthening the dissolution path 71, the time for the dissolution part 41 to dissolve in the lumen can be structurally lengthened, and thus the capsule shape can be maintained for a long time. Therefore, the capsule shape can be reliably maintained for a certain period of time necessary for confirming passage, and lumen passage can be confirmed with certainty. Further, the recognized portion may be a metal that does not transmit X-rays and is not dissolved in the intestine, or may be barium that can be dissolved in the intestine. Similarly to the fourth embodiment, the dissolving portion 41 and the non-dissolving portions 42, 72, and 73 may have radiopacity and may also serve as the recognized portion 15.

(Embodiment 8)
A lumen passage confirmation capsule according to Embodiment 8 of the present invention will be described with reference to FIG. 22 and FIG. FIG. 22 is a vertical cross-sectional side view of the central portion showing a configuration example of the lumen passage confirmation capsule 80 according to the eighth embodiment, and FIG. 23 is a front view.

  In the lumen passage confirmation capsule 80 according to the eighth embodiment, the dissolution part 41 is exposed from the non-dissolution part 42 to the surface at several places, for example, four places on the surface of the dissolution part 41 forming the dome-shaped capsule-shaped structure. The opening 81 is formed linearly in the longitudinal axis direction.

  When the lumen passage confirmation capsule 80 having such a configuration stays in the small intestine, as shown in FIG. 22 (b), the dissolving portion 41 is dissolved from the opening 81 portion exposed on the surface toward the inside. Progress gradually. During this time, the non-dissolving part 42 on the surface layer maintains a dome-shaped capsule shape by the dissolving part 41 inside. Thereafter, when most of the inner dissolution portion 41 is dissolved after a certain time has elapsed, the non-dissolution portion 42 made of a thin film cannot maintain the dome-shaped capsule shape by itself and breaks apart or is crushed. Even so, it can pass.

(Modification 10)
FIG. 24 is a vertical cross-sectional side view of the central portion showing the lumen passage confirmation capsule 80A of the modified example 10. In the lumen passage confirmation capsule 80A of the modified example 10, the inner dissolution part 41 is divided in the radial direction on the inner peripheral surface side of the non-dissolution part 42, and the dissolution progresses into the dissolution part 41 from the surface opening 81 to the inside. A second non-dissolving portion 83 that forms the path 82 is provided radially. That is, the second non-dissolving part 83 forms a dissolution path 82 that is folded back in the radial direction so as to go to the inner surface of the opening 81 → the axial center → the non-dissolving part 42.

  When the lumen passage confirmation capsule 80A having such a configuration stays in the small intestine, as shown in FIG. 24B, the dissolution starts from the dissolution portion 41 exposed to the outside through the opening 81, and the second It progresses toward the inside of the axial center according to the dissolution path 82 by the non-dissolving part 83. During this time, the non-dissolving part 42 on the surface layer maintains a dome-shaped capsule shape by the dissolving part 41 inside. After that, when a certain period of time elapses and the melting portion 41 of the inner surface portion of the non-dissolving portion 42 is melted, the non-dissolving portion 42 by the thin film itself cannot maintain the dome-shaped capsule shape and will be disintegrated or crushed apart. Even a narrowed portion or the like can pass through.

  According to the lumen passage confirmation capsule 80A according to the modified example 10, the inside of the dissolution part 41 is divided by the second non-dissolution part 83 to form the dissolution path 82 that has a structurally long dissolution time. The time for the portion 41 to dissolve in the lumen can be structurally increased, and thus the capsule shape can be maintained for a long time. Therefore, the capsule shape can be reliably maintained for a certain period of time necessary for confirming passage, and lumen passage can be confirmed with certainty.

  In the case of the lumen passage confirmation capsules 80, 80A according to the eighth embodiment and the tenth modification, the dissolving portion 41 is formed as a dome-shaped capsule-shaped structure. The present invention can be similarly applied even when it is provided in a thin shape so as to have, for example, flexibility so as to form a capsule-shaped structure. At this time, the non-dissolving part 42 becomes small by being crushed after the dissolving part 41 is dissolved.

  The present invention is not limited to the above-described embodiment, and various modifications can be made without departing from the spirit of the present invention. For example, in the above-described embodiments and modifications, the capsule shape of the lumen passage confirmation capsule has been described as an example of a dome-shaped capsule shape having dome-shaped convex portions 11a and 11b at both ends in the longitudinal axis direction. However, the present invention can also be applied to a spherical capsule shape having a diameter approximately equal to the diameter in the short axis direction of the capsule endoscope to be applied. In addition, although the example in which the non-dissolving part is basically formed of a material that does not dissolve in the body has been described, any material that does not dissolve relatively in the body in relation to the dissolving part may be used. In addition, any material can be used as long as the material dissolves in a longer time than the material constituting the melted part (is difficult to dissolve).

It is a schematic perspective view which shows the structural example of the lumen passage confirmation capsule which concerns on Embodiment 1 of this invention. It is a center longitudinal cross-sectional side view of FIG. It is a schematic longitudinal cross-sectional side view which shows the lumen passage confirmation capsule of the modification 1. 10 is a schematic perspective view showing a lumen passage confirmation capsule of a second modification. FIG. FIG. 10 is a schematic perspective view showing a lumen passage confirmation capsule of a third modification. It is an end surface side view of FIG. It is a schematic perspective view which shows the structural example of the lumen passage confirmation capsule which concerns on Embodiment 2 of this invention. It is a center longitudinal cross-sectional side view of FIG. It is a schematic perspective view which shows the lumen passage confirmation capsule of the modification 4. It is a center longitudinal cross-sectional side view which shows the lumen passage confirmation capsule of the modification 5. FIG. It is sectional drawing which shows the mode of a deformation | transformation of the non-dissolved part parted. It is a center longitudinal cross-sectional side view which shows the lumen passage confirmation capsule of the modification 6. FIG. It is a center longitudinal cross-section front view which shows the structural example of the lumen passage confirmation capsule which concerns on Embodiment 3 of this invention. FIG. 10 is a partial cross-sectional view showing a lumen passage confirmation capsule of a modification 7. It is a vertical front view which shows the lumen passage confirmation capsule which concerns on Embodiment 4 of this invention. It is a vertical front view which shows the lumen passage confirmation capsule of the modification 8. It is a vertical front view which shows the structural example of the lumen passage confirmation capsule which concerns on Embodiment 5 of this invention. It is a side view of FIG. It is a vertical front view which shows the structural example of the lumen passage confirmation capsule which concerns on Embodiment 6 of this invention. It is a vertical front view which shows the lumen passage confirmation capsule of the modification 9. It is a vertical front view which shows the structural example of the lumen passage confirmation capsule which concerns on Embodiment 7 of this invention. It is a center part vertical side view which shows the structural example of the lumen passage confirmation capsule which concerns on Embodiment 8 of this invention. FIG. 23 is a front view of FIG. 22. It is a center part vertical side view which shows the lumen passage confirmation capsule of the modification 10. FIG.

Explanation of symbols

11a, 11b Convex-shaped portion 12 Non-dissolving portion 13 Dissolving portion 14 Dissolving portion 15, 15a, 15b Recognized portion 16 Non-dissolving portion 17 Dissolution path 18 Non-dissolving portion 41 Dissolving portion 42 Non-dissolving portion 42a End portion 43 Opening portion 61 Opening Part 62 Dissolution path 63 Non-dissolution part 63a End part 64 Non-dissolution part 81 Opening part 82 Dissolution path 83 Non-dissolution part

Claims (19)

A lumen passage confirmation device having a capsule shape that can be introduced into the body,
A first non-dissolving portion made of a material that does not dissolve in the body and provided in a thin shape excluding a part of the capsule-shaped surface;
A dissolving portion made of a material that dissolves in the body, including a part of the capsule-shaped surface exposed to the outside, and provided inside the first non-dissolving portion;
A second non-dissolving part that is made of a material that does not dissolve in the body, divides the inside of the dissolving part, and forms a dissolution path that proceeds from the part of the surface to the inside in the dissolving part;
A lumen passage confirmation device comprising:   The lumen passage confirmation device according to claim 1, wherein the second non-dissolving part is provided so as to extend in a center direction of the capsule shape.   The luminal passage confirmation device according to claim 2, further comprising a third non-dissolving portion made of a material that does not dissolve in the body and further dividing and subdividing the dissolution path.   4. The lumen passage confirmation device according to claim 2, wherein an end portion of the second non-dissolving portion is connected to an end portion of the first non-dissolving portion on a capsule-shaped surface.   2. The lumen passage confirmation device according to claim 1, wherein the second non-dissolving part is provided in a layer shape substantially parallel to the first non-dissolving part.   6. The lumen passage confirmation device according to claim 1, further comprising a member to be recognized.   The lumen recognition device according to claim 6, wherein the member to be recognized is a radiopaque material.   The lumen passage confirmation device according to claim 7, wherein the radiopaque material is provided in at least a part of the non-dissolving part.   9. The lumen passage confirmation device according to claim 1, wherein the non-dissolving part is made of a metal film.   The luminal passage confirmation device according to claim 7, wherein the radiopaque material is built in the dissolution part.   The lumen passage confirmation device according to claim 10, wherein the radiopaque material is disposed in the innermost part of the dissolution path.   12. The lumen passage confirmation device according to claim 10 or 11, wherein the radiopaque material is spaced apart at a plurality of locations.   The lumen recognition device according to claim 6, wherein the member to be recognized is an RF-ID tag built in the dissolving portion.   The lumen passage confirmation device according to claim 1, wherein at least a part of the dissolving portion is made of an enteric material.   The lumen passage confirmation device according to any one of claims 1 to 14, wherein the capsule shape is a dome-shaped capsule shape having convex portions at both ends in the longitudinal axis direction.   The lumen passage confirmation device according to any one of claims 1 to 14, wherein the capsule shape is a spherical capsule shape.   17. The non-dissolving part made of a material that does not dissolve in the body exhibits a characteristic that the non-dissolving part is relatively insoluble in the body by being longer in the body than the dissolving part. The lumen passage confirmation device according to one.   8. The lumen passage confirmation device according to claim 7, wherein the dissolving portion is made of an X-ray opaque member and also serves as the recognized portion.   The lumen recognition device according to any one of claims 7, 8, 10, 11, 12, and 18, wherein the recognized portion includes barium or metal.

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