Digestive tract stenosis detection device

Abstract

The utility model relates to a digestive tract stenosis detection device which comprises an outer shell layer, an inner shell layer and filler. Wherein the inner shell layer comprises an inner shell and an inner shell cap; the inner shell and the inner shell cap are in butt joint to form a sealed cavity; the filler comprises a plurality of markers which are not mutually adhered, and all the markers are accommodated in the sealed cavity; and the outer shell layer wraps the inner shell layer. The digestive tract stenosis detection device is simple in structure, easy to manufacture and beneficial to reduction of production cost.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly relates to a digestive tract stenosis detection device. Background Art

[0002] A capsule endoscope is an oral endoscope in the shape of a capsule. By swallowing the capsule endoscope, the capsule endoscope sequentially passes through the esophagus, stomach, small intestine (including the duodenum, jejunum, and ileum), large intestine (including the colon, rectum, and anal canal) in the human body, and finally is excreted out of the body through the anus (the anus is the end of the anal canal). After taking pictures of the digestive tract images in the above digestive tract, the capsule endoscope sends the images to a data recorder outside the body for further diagnosis by doctors.

[0003] However, it is found in the actual application process that some subjects may have intestinal stenosis due to intestinal tumors or other diseases, resulting in the situation that the capsule endoscope remains in the body. Since a normal capsule endoscope is not degradable in the body, it is difficult to remove the capsule endoscope after it remains in the body, and even surgery may be required to remove it.

[0004] To avoid the occurrence of the above situation of the capsule endoscope remaining in the body, before officially using the capsule endoscope for detection, a timed-dissolvable pilot capsule can be used for testing first. That is, before the subject officially takes the capsule endoscope, let the subject take a pilot capsule that is similar in shape and volume to the capsule endoscope to judge the patency of the digestive tract. If the pilot capsule remains in the intestine, which is manifested as not being excreted out of the body after taking more than the preset time, it is considered that the subject may have intestinal stenosis and is prone to the risk of the capsule endoscope remaining in the body.

[0005] The pilot capsule is a degradable capsule that will degrade by itself after staying in the body for a longer time. Even if the subject has intestinal stenosis, it will not cause long-term retention in the subject's body and has high safety.

[0006] However, the currently commonly used pilot capsules either require chemical indicators to indicate whether the pilot capsule has disintegrated and been excreted out of the body, and these chemical indicators have side effects on the human body, or have a complex structure and high production costs. Utility Model Content

[0007] Based on this, this application provides a digestive tract detection device. The pilot capsule provided by this application has a simple structure and is easy to prepare, which is beneficial to reducing production costs.

[0008] This application provides a small intestine stenosis detection device, including an outer shell layer, an inner shell layer, and a filler; wherein:

[0009] The inner shell layer includes an inner shell body and an inner shell cap; the inner shell body is docked with the inner shell cap to form a sealed cavity; the filler includes a plurality of non-adhesive markers and is entirely accommodated in the sealed cavity;

[0010] The outer shell layer wraps the inner shell layer.

[0011] In the digestive tract stenosis detection device provided by the present application, the outer shell layer is a shell layer that degrades at a fixed time, and its dissolution time in the digestive tract is 20 to 22 hours, which is longer than the normal human digestive tract emptying time. The inner shell layer is a soluble shell layer that can gradually disintegrate when exposed to the digestive tract, releasing the markers filled in the inner shell body and unable to be digested in the digestive tract. If the subject does not have intestinal stenosis, the device can smoothly pass through the subject's digestive tract within the normal human digestive tract emptying time and be completely discharged out of the body through the anus. If the subject has intestinal stenosis, the device will be blocked at the digestive tract stenosis, resulting in the inability to smoothly pass through the digestive tract within the normal human digestive tract emptying time. When the normal human digestive tract emptying time is exceeded, the outer shell layer and the inner shell layer will gradually disintegrate in the digestive tract environment, and finally release the markers therein. After the subject defecates and finds that there are markers in the excrement, they can judge by themselves that they have digestive tract stenosis.

[0012] In one embodiment, a limiting plate is provided inside the inner shell body, and the limiting plate is used to limit all or part of the filler in the space on one side of the limiting plate.

[0013] In one embodiment, the digestive tract stenosis detection device further includes a push rod;

[0014] One end of the push rod is fixedly connected to the concave top end of the inner shell cap, and the other end is fixedly connected to the center of the limiting plate.

[0015] In one embodiment, threads are provided on the inner side wall of the inner shell body and the side wall of the limiting plate, and the diameter of the limiting plate is adapted to the inner diameter of the cross-section of the inner shell body.

[0016] In one embodiment, the inner shell body and the inner shell cap are connected by threads.

[0017] In one embodiment, the central axis of the push rod coincides with the longitudinal axis of symmetry of the digestive tract stenosis detection device.

[0018] In one embodiment, the filler includes a solid filler and / or a hollow filler;

[0019] Optionally, the filler further includes a counterweight;

[0020] In one embodiment, the filler further includes a counterweight and a counterweight shell layer, and the counterweight is wrapped inside the counterweight shell layer.

[0021] In one embodiment, the outer shell layer includes an outer shell body and an outer shell cap, and the outer shell body and the outer shell cap are connected to each other to wrap the inner shell layer.

[0022] In one embodiment, the outer shell layer and the inner shell layer are made of different materials. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 is a schematic diagram of the structure of a digestive tract stenosis detection device in some embodiments;

[0024] Figure 2 is a schematic diagram of the structure of a digestive tract stenosis detection device in some other embodiments;

[0025] Explanation of the reference numerals: 1. alimentary canal stenosis detection device; 10. outer shell layer; 101. outer shell body; 102. outer shell cap; 20. inner shell layer; 201. inner shell body; 202. inner shell cap; 203. sealed cavity; 204. limiting plate; 205. push rod; 30. filler; 310. marker; 320. counterweight. DETAILED DESCRIPTION

[0026] In order to facilitate the understanding of the present application, the present application will be described more fully below with reference to the relevant drawings. The preferred embodiments of the present application are given in the drawings. However, the present application can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the understanding of the disclosure of the present application more thorough and comprehensive.

[0027] In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present application.

[0028] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In the description of this application, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0029] In this application, unless otherwise clearly stipulated and defined, terms such as "installed", "connected", "linked", "fixed", etc. shall be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal communication of two components or the interaction relationship between two components, unless otherwise clearly defined. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0030] It should be noted that when an element is referred to as "fixed to" another element, it can be directly on the other element or there can also be an intermediate element. When an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be an intermediate element at the same time.

[0031] In this application, unless otherwise clearly stipulated and defined, the first feature being "on" or "under" the second feature can be that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on top of" the second feature can be that the first feature is directly above or obliquely above the second feature, or simply means that the first feature has a higher horizontal height than the second feature. The first feature being "under", "beneath" and "underneath" the second feature can be that the first feature is directly below or obliquely below the second feature, or simply means that the first feature has a lower horizontal height than the second feature.

[0032] In addition, the drawings are not drawn to a scale of 1:1, and the relative sizes of the components are only drawn by way of example in the drawings for the convenience of understanding this application, but are not necessarily drawn to the actual scale. The scale in the drawings does not constitute a limitation to this application.

[0033] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which this application belongs. The terms used in the description of this application herein are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0034] As Figure 1 shown, this application provides a digestive tract stenosis detection device 1, including a housing layer 10, an inner housing layer 20 and a filler 30;

[0035] Wherein: the inner housing layer 20 includes an inner housing body 201 and an inner housing cap 202; the inner housing body 201 and the inner housing cap 202 are butted to form a sealed cavity 203; the filler 30 includes a plurality of non-adhesive markers 310 and is all accommodated in the sealed cavity 203;

[0036] The outer shell layer 10 wraps the inner shell layer 20.

[0037] The digestive tract stenosis detection device 1 provided in this application is an analog of a capsule endoscope. It can enter the human body and pass through the esophagus, stomach, small intestine (including the duodenum, jejunum, and ileum), large intestine (including the colon, rectum, and anal canal) in sequence, and finally be excreted out of the body through the anus (the anus is the end of the anal canal). Combining with the clinical experience of the digestive tract digesting and absorbing food after swallowing food, according to whether the digestive tract stenosis detection device is swallowed by the subject and enters the human body, it can be judged whether there is digestive tract stenosis in the human body based on its excretion situation.

[0038] Among them, according to the different solubility of the material of the inner shell layer 20, it is possible to detect whether there is stenosis in the digestive tract. Since the small intestine in the digestive tract is the narrowest and most prone to blockage, the logic for the device to check whether there is intestinal stenosis in the small intestine includes:

[0039] (1) After the digestive tract stenosis detection device 1 is swallowed by the subject and enters the stomach, the maximum residence time in the stomach is 5 hours, which is less than the time for the outer shell layer 10 to degrade. Therefore, neither the outer shell layer 10 will dissolve inside or outside the stomach.

[0040] (2) After the digestive tract stenosis detection device 1 enters the small intestine from the stomach through the peristaltic action of the stomach, if there is no stenosis in the small intestine, that is, the device will not be stuck at the stenosis, the device will pass through the small intestine within 15 hours after being swallowed at the longest; if there is stenosis in the small intestine, that is, if the device is stuck at the stenosis in the small intestine, the outer shell layer 10 of the device will dissolve regularly 20 to 22 hours after being swallowed, and then the inner shell layer 20 will be exposed to the small intestine and also dissolve, and the marker 310 filled in the inner shell 201 will be released. Since the filler 30 is tiny in size, it will not be stuck even if there is stenosis in the small intestine and can be smoothly excreted out of the body.

[0041] Among them, the marker 310 is optionally a hollow capsule, and the hollow capsule is beneficial for floating out when excreted with the excrement for visual identification.

[0042] It can be understood that since the small intestine is the narrowest part of the human digestive tract and the most prone to intestinal stenosis, in clinical practice, the capsule endoscope is generally blocked in the small intestine in the digestive tract. The digestive tract stenosis detection device 1 provided in this application can not only detect whether there is intestinal stenosis in the small intestine, but also ensure that even if there is intestinal stenosis, both the outer shell layer 10 and the inner shell layer 20 of the digestive tract stenosis detection device 1 can be degraded, and the internal marker 310 can finally pass through the intestine smoothly without causing harm to the human body.

[0043] (3) After the digestive tract stenosis detection device 1 reaches the large intestine from the small intestine, if it passes through the large intestine smoothly within 20 hours to 22 hours after swallowing, it can be excreted from the body without the inner and outer shell layers 10 being completely dissolved. If the residence time in the digestive tract exceeds 20 hours to 22 hours after swallowing, the outer shell layer 10 will be dissolved.

[0044] (4) During the inspection period (1 to 3 days), observe whether the stool is completely discharged by the digestive tract stricture detection device 1. If so, there is no small intestinal stricture and capsule endoscopy can be performed.

[0045] If the marker 310 is detected to be discharged, it means that there is intestinal stenosis in the small intestine and it is not appropriate to perform capsule endoscopy.

[0046] (5) If the digestive tract stricture detection device 1 is not observed to be excreted from the body, it can be detected by a metal detector (such as X-ray) or confirmed by an abdominal X-ray.

[0047] The digestive tract stenosis detection device 1 provided by the present application can be used in any place (including daily living places) to detect whether the digestive tract is stenotic, eliminating the risk of subsequent capsule endoscopy detection, and the outer shell layer 10 of the digestive tract stenosis detection device 1 is degradable and will not be blocked in the body of the subject, which is safe and convenient. The digestive tract stenosis detection device 1 provided by the present application has a simple structure and a simple process, which can reduce both its manufacturing cost and its use cost.

[0048] In some embodiments, the outer shell 10 includes an outer shell body 101 and an outer shell cap 102, and the outer shell body 101 and the outer shell cap 102 are connected to wrap the inner shell 20. In some specific embodiments, the material of the outer shell 10 is a sustained-release enteric material, and the thickness of the outer shell 10 is controlled to ensure that the outer shell 10 can be completely dissolved in the normal human digestive tract emptying time (generally 20 hours to 22 hours). Therefore, the digestive tract stenosis detection device 11 can ensure the integrity of the capsule after passing through the normal (i.e., non-stenotic) stomach, small intestine, and large intestine and being discharged, and will not disintegrate. If the digestive tract is stenotic, the device will be retained in the stenosis. Since the outer shell 10 and the inner shell 20 are both enteric materials, these materials will gradually decompose after being digested by the digestive fluid in the intestine for a long time, so that the entire device disintegrates, and the marker 310 therein can also be smoothly discharged from the digestive tract. Optionally, the marker is a hollow capsule. The subject can identify these markers 310 in fecal excrement with the naked eye, and know that the device has been excreted from the body, which can relieve psychological burden and improve user experience.

[0049] It can be seen that the device can avoid being blocked at the narrow part of the digestive tract for a long time, thus bringing pathogenic risks to users. Further, the sustained-release enteric material can be, but is not limited to, one or more of polylactic acid, microcrystalline cellulose, and polyvinylpyrrolidone.

[0050] In some specific embodiments, the outer shell layer 10 is elliptical, the short diameter of the outer shell layer 10 is 10 mm to 12 mm, and the long diameter is 25 mm to 30 mm. The above shape and size are similar to the shape of a real capsule endoscope, which is more conducive to simulating the real evacuation process of the capsule endoscope.

[0051] In some embodiments, the materials of the outer shell layer 10 and the inner shell layer 20 are different. According to the different solubility of the material of the inner shell layer 20, the stenosis conditions at different positions of the digestive tract can be detected.

[0052] In some embodiments, the material of the inner shell layer 20 is a small intestine enteric material, also known as enteric coating. Such materials are insoluble or almost insoluble in acidic media such as gastric acid and in the large intestine, but can be mostly or completely dissolved in the small intestine environment. If there is a stenosis in the small intestine, the digestive tract stenosis detection device 11 cannot be discharged in time. After the outer shell layer 10 is dissolved, the inner shell layer 20 will also be further dissolved, avoiding the digestive tract stenosis detection device 11 being blocked in the narrow small intestine for a long time, and the marker 310 will be released after the inner shell layer 20 is dissolved.

[0053] Further, the small intestine enteric materials can be, but are not limited to, at least one of shellac, polyvinyl alcohol phthalate (PVAP), cellulose and its derivatives. Further still, the cellulose derivatives can be selected from at least one of cellulose acetate phthalate (CAP) and hydroxypropyl methylcellulose (HPMC).

[0054] In some specific embodiments, the shape and size of the inner shell layer 20 are used to meet the requirement of filling a sufficient amount of filler 30 into the sealed cavity 203.

[0055] In some embodiments, the inner housing 201 and the inner cap 202 are threadedly connected to form a sealed cavity 203 for accommodating the filler 30.

[0056] In some embodiments, as Figure 2 shown, a limiting plate 204 is arranged inside the inner housing 201. The limiting plate 204 is used to limit the moving space of all or part of the filler 30 to one side space of the limiting plate 204, avoiding the inner and outer shell layers 10 being broken due to the flipping of all or part of the filler 30 in the sealed cavity 203.

[0057] In some embodiments, threads are provided on the inner sidewall of the inner housing 201 and the sidewall of the limiting plate 204. The diameter of the limiting plate 204 is adapted to the inner diameter of the cross-section of the inner housing 201, so as to form a space for restricting the movement of all or part of the filling 30 by adjusting the position of the limiting plate 204 relative to the inner housing 201.

[0058] In some embodiments, in order to adjust the size of the space restricted by the limiting plate 204, the digestive tract stenosis detection device 1 further includes a push rod 205;

[0059] One end of the push rod 205 is fixedly connected to the concave top end of the inner housing cap 202, and the other end is fixedly connected to the center of the limiting plate 204. Pushing the whole of the inner housing cap 202 - push rod 205 - limiting plate 204 can adjust the size of the space restricted by the limiting plate 204.

[0060] In some embodiments, the central axis of the push rod 205 coincides with the axis of symmetry of the inner housing 201 extending along the long diameter direction, so as to adjust the size of the space restricted by the limiting plate 204 to a greater extent.

[0061] In some embodiments, the filling 30 includes a marker 310 and a weight 320. The marker 310 is used to indicate whether the inner shell layer 20 is dissolved, and the weight 320 is used to increase the weight so that the whole device can be immersed in the gastric digestive juice. The appearances of the marker 310 and the weight 320 are different. If the inner shell layer 20 is dissolved, the marker 310 will be released. If the inner shell layer 20 is not dissolved, the marker 310 will not be released, and the marker 310 cannot be directly observed in the excrement. The weight 320 can increase the weight of the whole device so that the whole device can be immersed in the digestive juice for normal digestion. The appearance of the weight 320 is different from that of the indicative filling 30, which allows the user to clearly distinguish whether the marker 310 is excreted. Further, the weight 320 can be different in color appearance from the marker 310, for example, one is red and the other is a color that is easy to distinguish from red.

[0062] In some embodiments, the shape of the marker 310 can be any shape, such as spherical, cylindrical, conical, capsule-shaped, etc. This application does not make special restrictions on this, and all should be understood to be within the protection scope of this application. Further, the material of the marker 310 can be PC2458 of Bayer of Germany. This material will not be digested and absorbed in the digestive tract. After being emptied by the human body, the marker 310 is still discharged in the original shape.

[0063] In some specific embodiments, the marker 310 is in the shape of a capsule, and the short diameter of the marker 310 is 2.5 mm to 4 mm, and the long diameter is 5 mm to 8 mm.

[0064] More specifically, the short diameter of the marker 310 can be 3 mm, and the long diameter can be 6 mm. Within the above size range, the marker 310 is easy to identify after being discharged alone. Moreover, even if intestinal stenosis of the small intestine occurs, it can be dissolved in the small intestine, and the marker 310 of the above size can also be smoothly discharged.

[0065] In some embodiments, the counterweight 320 includes a plurality of steel balls. Further, the diameter of the counterweight 320 can be 1.5 mm to 2.5 mm, and more preferably, it can be 2 mm.

[0066] In some embodiments, the counterweight 320 further includes a counterweight shell layer for wrapping the steel balls. It can be understood that the appearance of the counterweight 320 is different from that of the marker 310, for example, the colors are different.

[0067] The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification.

[0068] The above embodiments only represent several implementation manners of the present application, which are convenient for understanding the technical solutions of the present application specifically and in detail, but should not be construed as a limitation on the protection scope of the utility model patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can be made, and these all belong to the protection scope of the present application. It should be understood that the technical solutions obtained by those skilled in the art through logical analysis, reasoning or limited experiments based on the technical solutions provided in the present application are all within the protection scope of the appended claims of the present application. Therefore, the protection scope of the patent of the present application should be subject to the content of the appended claims, and the description and drawings can be used to explain the content of the claims.

Claims

1. A digestive tract stenosis detection device, characterized in that: It includes an outer shell layer, an inner shell layer and a filler; wherein: The inner shell layer includes an inner shell and an inner shell cap; the inner shell and the inner shell cap are butted together to form a sealed cavity; the filler includes a plurality of markers that are not adhered to each other and are all contained in the sealed cavity; The outer shell layer encapsulates the inner shell layer.

2. The digestive tract stenosis detection device according to claim 1, characterized in that: A limiting plate is arranged inside the inner shell, and the limiting plate is used to limit all or part of the filler in a space on one side of the limiting plate.

3. The digestive tract stenosis detection device according to claim 2, characterized in that: Also included is a putter; One end of the push rod is fixedly connected to the top end of the concave surface of the inner shell cap, and the other end is fixedly connected to the center of the limiting plate.

4. The digestive tract stenosis detection device according to claim 3, characterized in that: The inner side wall of the inner shell and the side wall of the limiting plate are both provided with threads, and the diameter of the limiting plate is matched with the inner diameter of the cross section of the inner shell.

5. The digestive tract stenosis detection device according to claim 4, characterized in that: The inner shell body and the inner shell cap are threadedly connected.

6. The digestive tract stenosis detection device according to claim 5, characterized in that: The center line of the push rod coincides with the longitudinal symmetry axis of the digestive tract stenosis detection device.

7. The digestive tract stenosis detection device according to claim 6, characterized in that: The filler includes a solid filler and / or a hollow filler; Optionally, the filler also includes a weight.

8. The digestive tract stenosis detection device according to claim 6, characterized in that: The filler also includes a weight and a weight shell, and the weight is wrapped inside the weight shell.

9. The digestive tract stenosis detection device according to any one of claims 1 to 8, characterized in that: The outer shell layer comprises an outer shell body and an outer shell cap, and the outer shell body and the outer shell cap are connected to each other to wrap the inner shell layer.

10. The digestive tract stenosis detection device according to any one of claims 1 to 8, characterized in that: The outer shell layer and the inner shell layer are made of different materials.

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