CN106923787B - Capsule endoscope advanced lens and detection method thereof - Google Patents
Capsule endoscope advanced lens and detection method thereof Download PDFInfo
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- CN106923787B CN106923787B CN201511016667.1A CN201511016667A CN106923787B CN 106923787 B CN106923787 B CN 106923787B CN 201511016667 A CN201511016667 A CN 201511016667A CN 106923787 B CN106923787 B CN 106923787B
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
Abstract
The invention provides a capsule endoscope advanced lens and a detection method thereof. The capsule endoscope advanced sheet comprises an outer packaging structure body and a sheet core, wherein the sheet core is filled in a sealed cavity formed by the outer packaging structure body. The outer packaging structure comprises a time control part, wherein the time control part comprises a slow-release enteric material and a colon positioning dissolving material, and the tablet core comprises a material for changing the color of urine and/or excrement. The color change of urine and/or excrement is identified to judge whether the tested person is suitable for capsule endoscopy.
Description
Technical Field
The invention relates to a capsule endoscope advanced lens, in particular to a capsule endoscope advanced lens for detecting a small intestine unblocked state and a detection method thereof.
Background
The small intestine disease is taken as a high-incidence disease, and the specificity of clinical symptoms is not strong, so that the diagnosis and treatment of the small intestine disease are difficult. The traditional small intestine barium meal, angiography, radionuclide scanning and other small intestine disease diagnosis methods have the problems of low diagnosis positive rate, rough positioning, inaccurate qualitative, multiple complications and the like. The appearance of the capsule endoscope makes up the defects of the traditional diagnosis method, and the capsule endoscope can be used as the first-choice examination method for digestive tract diseases, especially small intestine diseases, because of the advantages of no pain, no wound, no cross infection, convenient examination and the like.
However, in the case of performing a small intestine disease examination using a capsule endoscope, a phenomenon of capsule endoscope retention often occurs. If the capsule endoscope stays, intervention measures (such as endoscope, operation extraction and the like) are needed to be taken out of the capsule endoscope. In order to avoid retention of the capsule endoscope in the small intestine, the examinee may swallow a capsule endoscope advanced tablet, which is a simulated capsule having a quality, shape and volume similar to those of the capsule endoscope, before performing the capsule endoscope examination. Whether the capsule endoscope is suitable for the capsule endoscope is detected by whether the capsule endoscope advanced lens is detained or not. However, the existing prior capsule endoscope has the defects of poor initiative judgment, incapability of automatic degradation during retention, long inspection time, and/or the need of X-ray assistance, and the like, so that the convenience of detection is reduced.
Therefore, it is necessary to design a safe, easily-identified and automatically-degradable advanced capsule endoscope and a detection method thereof.
Disclosure of Invention
The present invention is directed to the problems of the prior art, and an object of the present invention is to provide a capsule endoscope advanced lens and a detection method thereof, wherein the capsule endoscope advanced lens can be swallowed by a person to be inspected and detect the smooth state of the small intestine so as to determine whether the person to be inspected is suitable for capsule endoscope inspection.
In order to achieve the above object, the present invention provides a capsule endoscope advanced tablet, comprising an outer packaging structure body and a tablet core, wherein the tablet core is filled in a sealed cavity formed by the outer packaging structure body, the outer packaging structure body comprises a time control part, the time control part comprises a slow-release enteric material and a colon-specific dissolving material, and the tablet core comprises a material for changing the color of urine and/or excrement.
As a further improvement of the present invention, the exterior packaging body further includes an exterior film, both ends of which are opened with through holes and blocked by the time control part, so as to form the sealed cavity between the exterior film and the time control part.
As a further improvement of the invention, the time control part is a solid capsule body and is basically the same as the arc-shaped capsule body of the capsule endoscope in appearance and dimension.
As a further improvement of the present invention, a window for enlarging a contact area with the digestive juice is provided at the tip of the time control portion.
As a further improvement of the invention, the proportion of the slow-release enteric material and the colon-specific dissolution material in the time control part and the size of the window are adjusted, so that the time control part is kept stable in gastric juice, the dissolution time of the time control part in the small intestine digestive juice is longer than the emptying time of human digestive tract, and the dissolution time of the time control part in the colon digestive juice is within a specified time.
As a further improvement of the present invention, the time control portion includes an inner time control portion in the shape of a capsule formed of a colon-specific dissolution material, and an outer time control portion formed of a slow-release enteric material in the same shape as the inner time control portion and disposed outside the inner time control portion.
As a further improvement of the present invention, the thickness of the outer time control portion should ensure that the capsule endoscope advanced sheet exposes the inner time control portion before reaching the colon inside the small intestine, and the degradation time of the inner time portion under the action of colonic flora in the large intestine is within a set time.
As a further improvement of the present invention, the core is filled in the sealed cavity formed by the inner time control part to support and closely adhere the inner time control part to the inner wall of the outer time control part.
As a further improvement of the invention, the tablet core is made by uniformly mixing a tablet core material and an indicator, wherein the indicator is riboflavin and/or non-degradable and absorbable colored particulate matters of a human body.
As a further improvement of the present invention, the slow-release enteric material is acrylic resin Eudragit L30D or Eudragit L/S100, and the colon-specific dissolving material is chitosan, pectin, guar gum, or amylose.
As a further improvement of the invention, the indicator further comprises an X-ray developer.
In order to achieve the above object, a method for detecting a capsule endoscope advanced lens as described above, the method comprising: s1, enabling a person to be inspected to take the capsule endoscope advanced lens; s2, identifying whether the color of urine and/or excrement changes within a preset time; s3, judging that the checked person is suitable for capsule endoscopy when the color of urine and/or excrement changes in the preset time; and S4, judging that the tested person is not suitable for capsule endoscopy if the color of urine and/or excrement is not changed within the preset time.
As a further improvement of the present invention, the step S3 further includes: judging whether the color change of urine and/or excrement occurs within a preset time or not, wherein the preset time is smaller than the preset time; if the color of urine and/or excrement is changed within the preset time, judging that the intestinal peristalsis of the checked person is normal; and if the change of the urine and/or excrement color occurs outside the preset time and within the preset time, judging that the intestinal peristalsis of the checked person is slow.
As a further improvement of the present invention, the step S3 further includes: when the color change of urine and/or excrement of a checked person is not observed in preset time and the indicator comprises an X-ray developer, judging whether the position of the capsule endoscope advanced lens is changed in the preset time or not by checking the position of the capsule endoscope advanced lens through X-rays, wherein the preset time is smaller than the preset time; if the position of the capsule endoscope advanced sheet is not changed within the preset time, judging that the capsule endoscope advanced sheet is embedded in the small intestine, wherein the examinee is not applicable to capsule endoscope examination; and if the position of the capsule endoscope advanced lens is changed within the preset time, judging that the capsule endoscope advanced lens is not embedded in the small intestine, wherein the intestinal peristalsis of a person to be checked is slow, but the capsule endoscope inspection is applicable.
By using the capsule endoscope advanced lens and the detection method thereof, after the examinee swallows the capsule endoscope advanced lens, whether the capsule endoscope inspection is applicable can be judged automatically within preset time, and the capsule endoscope advanced lens can be automatically degraded when the capsule endoscope advanced lens is embedded but not applicable to the capsule endoscope inspection.
Drawings
Fig. 1 is a schematic structural diagram of a capsule endoscope advanced lens according to an embodiment of the present invention.
Fig. 2 is a schematic view showing degradation of a capsule endoscope advanced lens in colon digestive juice according to an embodiment of the present invention.
FIG. 3 is a schematic view showing the collapse of a advanced lens for a capsule endoscope in colon digestive juice according to an embodiment of the present invention.
FIG. 4 is a schematic view showing the degradation of a prior art capsule endoscope when encountering a lumen stricture in the small intestine.
FIG. 5 is a schematic view showing a prior art capsule endoscope collapsing when encountering a lumen stricture in the small intestine.
Fig. 6 is a schematic structural diagram of a two-capsule endoscope advanced lens according to an embodiment of the present invention.
Fig. 7 is a block flow chart of the examination of the state of the small intestine by using the capsule endoscope advanced lens of the present invention.
Detailed Description
The present invention will be described in detail below with reference to the embodiments shown in the drawings. However, these embodiments are not intended to limit the present invention, and structural or functional modifications thereof by those skilled in the art are intended to be included within the scope of the present invention.
Referring to fig. 1 to 5, a schematic diagram of a first embodiment is shown.
Referring to fig. 1, a schematic structure of a capsule endoscope advanced lens according to the present invention is shown, and the capsule endoscope advanced lens is used for simulating the quality, shape and volume of a capsule endoscope to detect whether a subject is suitable for capsule endoscopy. The capsule endoscope advanced sheet 1 includes an outer film 2, a time control section 3, a window 4, a sheet core 5, and an indicator 6.
The outer membrane 2 is a material which is harmless to the human body, has good biocompatibility and is stable in digestive juice for a long time (more than 2 weeks). The outer membrane 2 of the present invention is preferably parylene C, a latex polymer, or medical silicone, etc. And through holes are formed at two ends of the outer membrane 2.
Each through hole of the outer film 2 is blocked by a time control part 3. Each time control part 3 is connected with the corresponding through hole of the outer membrane 2 in an adapting way, so that the outer membrane 2 and the time control part 3 form a sealed cavity. The time control part 3 is connected with the through hole of the outer membrane 2 through a way of bio-glue or direct lamination. The time control part 3 is a solid capsule body and is basically the same as the arc-shaped capsule body of the capsule endoscope in appearance and dimension. The time control part 3 comprises a slow-release enteric material and a colon-specific dissolving material. The slow-release enteric material can be acrylic resin Eudragit L30D, eudragit L/S100 and the like. The colon-specific dissolving material can be natural polysaccharide materials such as chitosan, pectin, guar gum, amylose and the like, and the natural polysaccharide materials can be degraded under the action of colon flora.
The top end of the time control part 3 is provided with a window 4 for enlarging the contact area with the digestive juice, so that the digestive juice can enter the time control part 3. The window 4 may be of various shapes, for example, the present invention preferably uses a cylindrical hole punch with a diameter of about 6 to 8 mm to create the window 4.
In the present invention, by adjusting the ratio of the slow-release enteric material to the colon-specific dissolution material in the time control portion 3 and the size of the window 4, the time control portion 3 is kept stable in gastric juice, so that the dissolution time of the time control portion 3 in the small intestine digestive juice 8 is longer than the evacuation time of the human digestive tract, and so that the dissolution time of the time control portion 3 in the colon digestive juice 7 is within a prescribed time. Since the gastrointestinal tract evacuation time of the human body averages about 24 hours, in order to effectively distinguish whether the capsule endoscope advanced sheet 1 is dissolved by being embedded in the small intestine or dissolved in the colon, the present embodiment preferably sets the dissolution time of the time control section 3 in the small intestine digestive juice 8 to be more than 48 hours. The predetermined time can be flexibly designed according to clinical situations, and is preferably about 1 hour.
The tablet core 5 comprises a tablet core material (not shown in the figures) and an indicator 6. The tablet core material is harmless to human body and can disintegrate rapidly (less than 10 minutes) in the small intestine digestive juice 8 and the colon digestive juice 7. The core material comprises microcrystalline cellulose, lactose, pregelatinized starch, povidone, and the like. The tablet core material is homogeneously mixed with the indicator 6 to form the tablet core 5, two indicators 6 being shown in fig. 1 by way of example only.
The tablet core 5 is filled in a sealed cavity formed by the outer membrane 2 and the time control part 3, so as to support the outer membrane 2, and the capsule endoscope advanced tablet 1 is made into a capsule shape with the size, the quality and the appearance being basically the same as those of the capsule endoscope by adjusting the weight of the tablet core 5 and the time control part 3, and the capsule endoscope advanced tablet 1 is also made to maintain the outer diameter dimension approximately equal to that of the capsule endoscope under the condition that external pressure is applied to the capsule endoscope advanced tablet 1 through peristaltic movement of viscera.
The indicator 6 is a material which is harmless to the human body and causes the discharged urine or excrement to change color. The present invention is preferably a safe and non-toxic agent capable of causing color change in human urine, such as riboflavin. Riboflavin, also known as vitamin B2, is a water-soluble vitamin which, when consumed in large quantities by humans, is expelled from the urine in free form through the urinary system beyond the renal threshold due to its limited capacity to store riboflavin, causing the urine to appear bright yellow. The bright yellow color is different from yellow color which causes yellow urine due to little drinking water, and the bright yellow color and the yellow color can be distinguished by naked eyes of human body. For riboflavin, the maximum dose that can be absorbed by the human body once was 27 mg, and 50% of the excess riboflavin was excreted by urine. The human body peaks in urine after 8 hours after taking 32 mg of riboflavin. When the indicator 6 is riboflavin, the dosage of riboflavin is not less than 32 mg in order to make the color change of urine easily observable. In the present invention, it is preferable that the indicator 6 is 50 mg of riboflavin. In other embodiments, the safe and nontoxic agent capable of changing the color of human urine may be betalain or other natural plant pigments.
In other embodiments, the indicator 6 may be non-degradable, absorptive colored particulates to distinguish the unobstructed state of the small intestine from the color of the fecal matter. The nondegradable absorptive colored particulate matter can be used as an indicator 6 together with the material capable of changing the color of urine to distinguish the smooth state of the small intestine, or can be used as the indicator 6 alone to distinguish the smooth state of the small intestine. When the nondegradable and absorbable colored particulate matter and the material capable of changing the color of urine are used as the indicator 6, the identification of the state of smooth small intestine by the color of excrement can be used as an auxiliary means to avoid the problem that the change of the color of urine cannot be observed due to the reasons of color weakness and the like, so that whether the capsule endoscopy is applicable or not cannot be determined.
Referring to fig. 2, a schematic diagram of degradation of the advanced lens of the present invention in colon digestive juice is shown. The capsule endoscope advanced sheet 1 does not have any incarceration in the small intestine, and passes through the small intestine into the colon, and comes into contact with the colon digestive juice 7. After the dissolution time of the time control unit 3 has elapsed, the time control unit 3 in the vicinity of the window 4 is dissolved by the colonic digestive juice 7 first, and the colonic digestive juice 7 enters the capsule endoscope advanced sheet 1 to start to dissolve the sheet core 5, so that the indicator 6 is discharged to the outside after being digested and absorbed.
When the indicator 6 includes riboflavin, since the time average from the oral cavity to the colon of the capsule endoscope advanced lens 1 is about 13 hours, and the peak value in urine can be reached about 8 hours after the degradation and absorption of riboflavin, most (about 97% to 98%) of the examinees can observe the color change of urine (the urine is bright yellow) within 24 hours of oral administration of the capsule endoscope advanced lens 1, thereby knowing that own intestinal motility is normal and suitable for capsule endoscope examination. However, a small percentage (about 1%) of the subjects observed a change in urine color (yellow urine) within 48 hours beyond 24 hours of oral administration of the capsule endoscope advanced lens 1 due to slow intestinal peristalsis, and thus known that their own intestinal peristalsis was slow but also suitable for capsule endoscopy.
When the indicator 6 includes nondegradable absorptive colored particulates, since the human digestive tract emptying time averages about 24 hours, most (about 97% to 98%) of the examinees can observe the color change of the excreta (the occurrence of the above colored particulates in the excreta) within 24 hours of oral administration of the capsule endoscope advanced lens 1, thereby knowing that their own intestinal peristalsis is normal and that the capsule endoscope examination is applicable. However, a small percentage (about 1%) of the subjects were observed to change their color (the presence of the above colored particulate matters in the excreta) within 48 hours other than 24 hours of the oral administration of the capsule endoscope advanced lens 1 due to slow intestinal peristalsis, and it was found that the intestinal peristalsis was slow but the capsule endoscope examination was also applicable.
In other embodiments, the indicator 6 also includes an X-ray developer, such as barium sulfate. When the examinee does not observe the color change of urine (the urine is bright yellow) and/or the color change of excrement (the colored particulate matter appears in the excrement) within 24 hours of taking the capsule endoscope advanced lens 1 orally, the position of the capsule endoscope advanced lens 1 can be checked by X-rays to judge whether the position of the capsule endoscope advanced lens 1 is changed or not within a predetermined time. The predetermined time may be flexibly designed according to the clinical situation, for example, any time value of 3 to 4 hours. If the position of the preceding capsule lens 1 does not change within the predetermined time period, it is determined that the preceding capsule lens 1 is embedded in the small intestine, the subject is not suitable for the capsule endoscopy, and the subject can observe a change in the color of urine (the urine is bright yellow) and/or a change in the color of excrement (the colored particulate matter appears in the excrement) beyond 48 hours. If the position of the preceding capsule lens 1 is changed within the predetermined time period, it is determined that the preceding capsule lens 1 is not embedded in the small intestine, but the intestinal peristalsis of the examinee is slow, but the capsule endoscopy is applicable, but the examinee can observe the color change of urine (the urine is bright yellow) and/or the color change of excrement (the colored particulate matters appear in the excrement) within 48 hours beyond 24 hours due to the slow intestinal peristalsis.
Referring to fig. 3, a schematic representation of the collapse of the advanced lens of the present invention in the digestive juice of the colon is shown. Both the time control part 3 and the tablet core 5 are dissolved in the colon by the colon digestive juice 7, the capsule endoscope first tablet 1 collapses, and the outer membrane 2 which is not degraded is left to be discharged from the anus.
Referring to fig. 4, a schematic view of the degradation of the advanced lens of the present invention when it encounters a lumen stricture in the small intestine is shown. When the capsule endoscope advanced lens 1 encounters a lumen stenosis (including stenosis, occlusion, obstruction) in the small intestine and is embedded, it comes into contact with the small intestine digestive juice 8. After the dissolution time of the time control unit 3 has elapsed, the time control unit 3 in the vicinity of the window 4 is dissolved by the small intestine digestive juice 8 first, and the small intestine digestive juice 8 enters the capsule endoscope advanced lens 1 to start dissolution of the tablet core 5, so that the indicator 6 is discharged to the outside after being digested and absorbed. Since the dissolution time of the time control unit 3 in the intestinal digestive juice 8 is set to be more than 48 hours, the examinee will not observe the color change of urine (the urine is bright yellow) and/or the color change of excrement (the above colored particulate matters appear in the excrement) after the oral administration of the capsule endoscope advanced lens 1 for 48 hours, and thus know that he or she is not suitable for the capsule endoscope examination.
Referring to fig. 5, a schematic view of the prior art capsule endoscope is shown collapsing when encountering a lumen stricture in the small intestine. Both the time control part 3 and the tablet core 5 are dissolved in the small intestine by the small intestine digestive juice 8, the capsule endoscope first tablet 1 collapses, and the outer membrane 2 which is not degraded is left to be finally discharged from the anus through the lumen narrow part of the small intestine.
Referring to fig. 6, a schematic diagram of a second embodiment is shown.
Referring to fig. 6, a schematic structure of a prior art lens for a capsule endoscope according to the present invention is shown. The capsule endoscope advanced lens is used for simulating the quality, shape and volume of a capsule endoscope to detect whether a person to be checked is suitable for capsule endoscope examination. The capsule endoscope advanced sheet 1 in the present embodiment forms a sealed capsule space by the time control section 30 instead of the outer film 2 and the time control section 3 of the first embodiment, excluding the window 4. Other structures are the same as those of the first embodiment, and the same reference numerals are given to the same structural parts.
The time control unit 30 is a double-layered outer package structure, and includes an inner time control unit 30a formed in a capsule shape and an outer time control unit 30b formed in a capsule shape substantially similar to the inner time control unit 30a. In the present invention, the capsule shape is the shape of the capsule endoscope described above. The inner time control unit 30a is a capsule-shaped structure formed of a colon-specific dissolved material, and has a core 5 enclosed therein. The colon-specific dissolving material may be a natural polysaccharide material such as chitosan, pectin, guar gum, and amylose, so that the inner time control portion 30a can be degraded within a set time under the action of colon flora. In this embodiment, the colon-specific dissolving material is preferably chitosan. The setting time is flexibly designed according to clinical situations, and is preferably about 1 hour.
The outer time control portion 30b is a structure made of a slow-release enteric material, has a capsule shape substantially similar to that of the inner time control portion 30a, and is disposed outside the inner time control portion 30a. The outer time control unit 30b protects the inner time control unit 30a by covering the entire inner time control unit 30a. The outer time control portion 30b is a slow-release enteric material such as acrylic resin Eudragit L30D, eudragit L/S100, or the like. The outer time control part 30b is degraded by the digestive juice 8 of the small intestine during the passing of the advanced capsule endoscope 1 through the small intestine, and the thickness of the outer time control part 30b should ensure the extent to which the advanced capsule endoscope 1 passes through the inner time control part 30a before reaching the colon inside the small intestine, so that the inner time control part 30a is degraded by the digestive juice 7 of the colon within the set time after reaching the colon.
The capsule body is formed by the time control part 30, the capsule body core 5 is filled in a sealed capsule body cavity, the inner time control part 30a is supported and closely attached to the inner wall of the outer time control part 30b, the capsule endoscope advanced sheet 1 is made into a capsule shape with the size, the quality and the appearance basically the same as those of the capsule endoscope by adjusting the weight of the capsule body core 5, and the capsule endoscope advanced sheet 1 is also made to maintain the outer diameter dimension approximately equal to that of the capsule endoscope under the condition that the capsule endoscope advanced sheet 1 is externally pressed by the peristaltic movement of viscera.
The tablet core 5 comprises a tablet core material (not shown in the figures) and an indicator 6. The tablet core material is harmless to human body and can disintegrate rapidly (less than 10 minutes) in the small intestine digestive juice 8 and the colon digestive juice 7. The core material comprises microcrystalline cellulose, lactose, pregelatinized starch, povidone, and the like. The tablet core material is homogeneously mixed with the indicator 6 to form the tablet core 5, only two indicators 6 being shown by way of example in fig. 6. The indicator 6 is the same as in the first embodiment, and will not be described again.
When no embedding occurs in the small intestine, the capsule endoscope advanced lens 1 is degraded by the small intestine digestive juice 8 by the outer side time control part 30b in the process of passing through the small intestine, and the remaining inner side time control part 30a wraps the tablet core 5 and enters the colon to be contacted with the colon digestive juice 7. After the dissolution time of the inner time control unit 30a has elapsed, the colon-digestive juice 7 enters the capsule endoscope advanced sheet 1, and begins to dissolve the sheet core 5, so that the indicator 6 is discharged from the body after being digested and absorbed.
When the indicator 6 includes riboflavin, since the time average from the oral cavity to the colon of the capsule endoscope advanced lens 1 is about 13 hours, and the peak value in urine can be reached about 8 hours after the degradation and absorption of riboflavin, most (about 97% to 98%) of the examinees can observe the color change of urine (the urine is bright yellow) within 24 hours of oral administration of the capsule endoscope advanced lens 1, thereby knowing that own intestinal motility is normal and suitable for capsule endoscope examination. However, a small percentage (about 1%) of the subjects observed a change in urine color (yellow urine) within 48 hours beyond 24 hours of oral administration of the capsule endoscope advanced lens 1 due to slow intestinal peristalsis, and thus known that their own intestinal peristalsis was slow but also suitable for capsule endoscopy.
When the indicator 6 includes nondegradable absorptive colored particulates, since the human digestive tract emptying time averages about 24 hours, most (about 97% to 98%) of the examinees can observe the color change of the excreta (the occurrence of the above colored particulates in the excreta) within 24 hours of oral administration of the capsule endoscope advanced lens 1, thereby knowing that their own intestinal peristalsis is normal and that the capsule endoscope examination is applicable. However, a small percentage (about 1%) of the subjects were observed to change their color (the presence of the above colored particulate matters in the excreta) within 48 hours other than 24 hours of the oral administration of the capsule endoscope advanced lens 1 due to slow intestinal peristalsis, and it was found that the intestinal peristalsis was slow but the capsule endoscope examination was also applicable.
In other embodiments, the indicator 6 also includes an X-ray developer, such as barium sulfate. When the examinee does not observe the color change of urine (the urine is bright yellow) and/or the color change of excrement (the colored particulate matter appears in the excrement) within 24 hours of taking the capsule endoscope advanced lens 1 orally, the position of the capsule endoscope advanced lens 1 can be checked by X-rays to judge whether the position of the capsule endoscope advanced lens 1 is changed or not within a predetermined time. The predetermined time is flexibly designed according to the clinical situation, for example, any time value of 3 to 4 hours. If the position of the preceding capsule lens 1 has not changed within the predetermined time, it is determined that the preceding capsule lens 1 is embedded in the small intestine, and the subject is not suitable for the capsule endoscopy. Since the colon-specific dissolving material is not dissolved in the small intestine digestive juice 8, the inner side time control portion 30a is not dissolved in the small intestine, and the examinee needs to take orally a substance (for example, acetic acid) capable of dissolving the colon-specific dissolving material to degrade the inner side time control portion 30a, and the color change of urine (the urine is bright yellow) and/or the color change of excrement (the colored particulate matter appears in the excrement) can be observed. If the position of the preceding capsule lens 1 changes within the predetermined time period, it is determined that the preceding capsule lens 1 does not have any break-in the small intestine, but the capsule endoscopy is suitable for the examinee, but the examinee can observe the color change of urine (the urine is bright yellow) and/or the color change of excrement (the colored particulate matters appear in the excrement) within 48 hours other than 24 hours due to the slow intestinal peristalsis.
When the capsule endoscope advanced lens 1 encounters a narrow lumen (including a stenosis, a locking, and an obstruction) in the small intestine and is embedded, the outer time control portion 30b is degraded by the small intestine digestive juice 8, and the remaining inner time control portion 30a wraps the tablet core 5 and contacts the small intestine digestive juice 8. Since the colon-specific material is not dissolved in the small intestine digestive juice 8, the examinee cannot observe the color change of urine (the urine is bright yellow) and/or the color change of excrement (the colored particulate matter appears in the excrement) after 48 hours of oral administration of the capsule endoscope advanced lens 1, and thus knows that the examinee is not suitable for capsule endoscopy. Since the colon-specific dissolving material is not dissolved in the small intestine digestive juice 8, the inner side time control portion 30a is not dissolved in the small intestine, and the examinee needs to take orally a substance (for example, acetic acid) capable of dissolving the colon-specific dissolving material to degrade the inner side time control portion 30a, and the color change of urine (the urine is bright yellow) and/or the color change of excrement (the colored particulate matter appears in the excrement) can be observed.
Referring to fig. 7, a block flow chart of the method for checking the smooth state of small intestine by using the capsule endoscope advanced lens of the invention is shown. The examination requires the examinee to eat digestible food for intestinal preparation on the day before the examination. No hospitalization or doctor direction is required during the examination, and the examination is as follows:
the examinee swallows the capsule endoscope first lens 1 along with water, and then can normally live and work, and only needs to pay attention to observe whether the color of urine and/or excrement changes.
The examinee recognizes the color of urine and/or excrement and judges whether or not a change in the color of urine and/or excrement is observed within a preset time (48 hours).
The color change of urine and/or excrement is observed within the preset time, namely, the urine turns bright yellow and/or colored particles appear in the excrement, which indicates that the capsule endoscope advanced lens 1 does not have incarceration in the small intestine, and the examinee is judged to be suitable for capsule endoscope examination.
If a change in the color of urine (the urine is bright yellow) and/or a change in the color of excrement (colored particulate matter is present) of the subject's urine is observed within a preset time (24 hours), it is determined that the subject's intestinal peristalsis is normal, and that the capsule endoscope advanced lens 1 does not have any incarceration in the small intestine, and the subject is suitable for capsule endoscopy. If the color change of urine and/or excrement of the examinee is not observed within the preset time and the indicator 6 includes an X-ray developer (e.g., barium sulfate), the position of the capsule endoscope advanced lens 1 is checked by the X-ray to determine whether the position of the capsule endoscope advanced lens 1 is changed within a predetermined time. The predetermined time is flexibly designed according to the clinical situation, for example, any time value of 3 to 4 hours. If the position of the preceding capsule lens 1 has not changed within the predetermined time, it is determined that the preceding capsule lens 1 is embedded in the small intestine, and the subject is not suitable for the capsule endoscopy. If the position of the preceding capsule lens 1 is changed within the predetermined time, it is determined that the preceding capsule lens 1 is not embedded in the small intestine, but the capsule endoscopy is suitable for the examinee, however, the examinee can observe the color change of urine (the urine is bright yellow) and/or the color change of excrement (the colored particulate matters appear in the excrement) after and within the preset time due to the slow intestinal peristalsis. The judgment of whether the examinee is suitable for the capsule endoscopy can be quickened by the X-ray examination.
When no color change of urine and/or no color change of excrement is observed within the preset time, namely, the urine does not become too bright yellow and/or no colored particles are generated in the excrement, the capsule endoscope advanced lens 1 is indicated to be embedded in the small intestine, a lumen stenosis part is indicated to be present in the small intestine of the examinee, and the examinee is judged to be not suitable for capsule endoscope examination. The examinee uses the capsule endoscope advanced lens 1 shown in the first embodiment, and after a predetermined time, the examinee can observe a change in urine color (the urine is bright yellow) and/or a change in excrement color (colored particulate matter is present in excrement). After a predetermined time has elapsed, the examinee can observe a change in urine color (a bright yellow urine color) and/or a change in excrement color (colored particulate matter in excrement) by taking orally a substance (e.g., acetic acid) that dissolves the colon-specific dissolution material using the capsule endoscope advanced lens 1 shown in the second embodiment.
It should be understood that although the present disclosure describes embodiments, not every embodiment is provided with a separate embodiment, and that this description is for clarity only, and that the skilled artisan should recognize that the embodiments may be combined as appropriate to form other embodiments that will be understood by those skilled in the art.
The above list of detailed descriptions is only specific to practical embodiments of the present invention, and they are not intended to limit the scope of the present invention, and all equivalent embodiments or modifications that do not depart from the spirit of the present invention should be included in the scope of the present invention.
Claims (10)
1. The utility model provides a capsule endoscope advanced piece, includes extranal packing structure body and piece core, the piece core is filled in the sealed cavity that extranal packing structure body formed, its characterized in that: the outer packaging structure comprises a time control part, wherein the time control part comprises a slow-release enteric material and a colon positioning dissolving material, and the tablet core comprises a material for changing the color of urine and/or excrement;
the outer packaging structure body further comprises an outer film, wherein both ends of the outer film are provided with through holes and are blocked by the time control part, so that the sealed cavity is formed between the outer film and the time control part;
a window for enlarging the contact area with the digestive juice is arranged at the top end of the time control part;
the time control part is kept stable in gastric juice by adjusting the proportion of the slow-release enteric material in the time control part and the colon positioning dissolution material and the size of the window, so that the dissolution time of the time control part in the small intestine digestive juice is longer than the emptying time of human digestive tracts, and the dissolution time of the time control part in the colon digestive juice is within a specified time;
the slow-release enteric material is acrylic resin Eudragit L30D or Eudragit L/S100, and the colon-specific dissolving material is chitosan, pectin, guar gum or amylose.
2. The advanced capsule endoscopic lens according to claim 1, wherein: the time control part is a solid capsule body and is basically the same as the arc-shaped capsule body of the capsule endoscope in appearance and dimension.
3. The advanced capsule endoscopic lens according to claim 1, wherein: the time control part comprises an inner time control part in the shape of a capsule formed by colon positioning dissolution material and an outer time control part which is formed by slow release enteric material, has the same shape as the inner time control part and is arranged outside the inner time control part.
4. A capsule endoscopic advanced lens according to claim 3, wherein: the thickness of the outer time control part should ensure that the capsule endoscope advanced lens exposes the inner time control part before reaching the colon in the small intestine and the degradation time of the inner time control part under the action of colon flora in the large intestine is within a set time.
5. A capsule endoscopic advanced lens according to claim 3, wherein: the sheet core is filled in the sealed cavity formed by the inner time control part so as to support and closely attach the inner time control part to the inner wall of the outer time control part.
6. The advanced capsule endoscopic lens according to claim 1, wherein: the tablet core is prepared by uniformly mixing tablet core materials and an indicator, wherein the indicator is riboflavin and/or colored particles which are nondegradable and absorbed by a human body.
7. The advanced capsule endoscopic lens as defined in claim 6, wherein: the indicator also includes an X-ray developer.
8. A method for detecting a preceding lens for a capsule endoscope according to any of claims 1 to 7, characterized in that the method comprises:
s1, enabling a person to be inspected to take the capsule endoscope advanced lens;
s2, identifying whether the color of urine and/or excrement changes within a preset time;
s3, judging that the checked person is suitable for capsule endoscopy when the color of urine and/or excrement changes in the preset time; a kind of electronic device with high-pressure air-conditioning system
S4, judging that the tested person is not suitable for capsule endoscopy if the color of urine and/or excrement is not changed within the preset time.
9. The method for detecting a preceding lens for a capsule according to claim 8, wherein the step S3 further comprises:
judging whether the color change of urine and/or excrement occurs within a preset time or not, wherein the preset time is smaller than the preset time;
if the color of urine and/or excrement is changed within the preset time, judging that the intestinal peristalsis of the checked person is normal; a kind of electronic device with high-pressure air-conditioning system
If the change of the urine and/or excrement color occurs outside the preset time and within the preset time, the intestinal peristalsis of the checked person is judged to be slow.
10. The method for detecting a preceding lens for a capsule according to claim 8, wherein step S3 further comprises:
when the color change of urine and/or excrement of a checked person is not observed in preset time and the indicator comprises an X-ray developer, judging whether the position of the capsule endoscope advanced lens is changed in the preset time or not by checking the position of the capsule endoscope advanced lens through X-rays, wherein the preset time is smaller than the preset time;
if the position of the capsule endoscope advanced sheet is not changed within the preset time, judging that the capsule endoscope advanced sheet is embedded in the small intestine, wherein the examinee is not applicable to capsule endoscope examination; a kind of electronic device with high-pressure air-conditioning system
If the position of the preceding capsule endoscope is changed within the predetermined time, it is determined that the preceding capsule endoscope is not embedded in the small intestine, and the capsule endoscope is suitable for the examinee although the intestinal peristalsis is slow.
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| US10888277B1 (en) | 2017-01-30 | 2021-01-12 | Vibrant Ltd | Method for treating diarrhea and reducing Bristol stool scores using a vibrating ingestible capsule |
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| US11504024B2 (en) | 2018-03-30 | 2022-11-22 | Vibrant Ltd. | Gastrointestinal treatment system including a vibrating capsule, and method of use thereof |
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| US11510590B1 (en) | 2018-05-07 | 2022-11-29 | Vibrant Ltd. | Methods and systems for treating gastrointestinal disorders |
| EP3906086A4 (en) | 2019-01-03 | 2022-10-19 | Vibrant Ltd. | Device and method for delivering an ingestible medicament into the gastrointestinal tract of a user |
| GB201900780D0 (en) | 2019-01-21 | 2019-03-06 | Vibrant Ltd | Device and method for delivering a flowable ingestible medicament into the gastrointestinal tract of a user |
| GB201901470D0 (en) | 2019-02-04 | 2019-03-27 | Vibrant Ltd | Vibrating capsule for gastrointestinal treatment, and method of use thereof |
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