CN106923787A - The leading piece of capsule endoscope and its detection method - Google Patents

The leading piece of capsule endoscope and its detection method Download PDF

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Publication number
CN106923787A
CN106923787A CN201511016667.1A CN201511016667A CN106923787A CN 106923787 A CN106923787 A CN 106923787A CN 201511016667 A CN201511016667 A CN 201511016667A CN 106923787 A CN106923787 A CN 106923787A
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capsule endoscope
control portion
leading piece
time control
time
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CN106923787B (en
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段晓东
宋宏姣
刘雷
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Ankon Medical Technologies Shanghai Ltd
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Ankon Medical Technologies Shanghai Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons

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Abstract

The invention provides a kind of leading piece of capsule endoscope and its detection method.The leading piece of capsule endoscope includes external packing structure body and label, and the label is filled in the sealing cavity of external packing structure body formation.The external packing structure body includes time control portion, and the time control portion includes enteric-coated sustained release material and site specific DDS for colon dissolved material, and the label includes making urine and/or excreta change the material of color.By recognizing the change of urine and/or excreta color to judge whether those who are investigated are applicable Capsule Endoscopy.

Description

The leading piece of capsule endoscope and its detection method
Technical field
A kind of leading piece of capsule endoscope of present invention design, especially designs a kind of leading piece of capsule endoscope and its detection method for detecting the unimpeded state of small intestine.
Background technology
, used as a kind of disease occurred frequently, its clinical symptoms specificity is not strong, so that the diagnosis and treatment difficulty of disease of intestine is big for disease of intestine.The diagnosis of small bowel diseases method such as traditional small intestine barium meal, angiogram, radionuclide scanning, with diagnosis positive rate it is low, position it is rough, qualitative it is inaccurate, complication is more the problems such as.The appearance of capsule endoscope, compensate for the deficiency of traditional diagnosis method, itself because it is painless and noninvasive, the advantages of facilitate without cross-infection, inspection, can be as the first-selected inspection method of disease of digestive tract especially disease of intestine.
But when disease of intestine inspection is carried out using capsule endoscope, often there is the phenomenon that capsule endoscope is detained.If capsule endoscope is detained, need to take intervening measure(Such as endoscope, operation is taken out)Take out capsule endoscope.In order to avoid capsule endoscope is detained in small intestine, those who are investigated can be allowed to swallow a leading piece of capsule endoscope before Capsule Endoscopy is carried out, the leading piece of the capsule endoscope is the simulation capsule similar to capsule endoscope quality, shape, volume.Detect whether those who are investigated are applicable Capsule Endoscopy by the way that whether the leading piece of the capsule endoscope occurs to be detained.But existing capsule endoscope leading piece cannot degrade automatically when there is poor actively judgement property, delay, the review time it is long and/or the shortcomings of need X-ray to aid in, reduce the convenience of detection.
Therefore, it is necessary to design a kind of safety, easily differentiate and the leading piece of automatically degradable capsule endoscope and its detection method.
The content of the invention
The problem that the present invention exists for prior art, its object is to provide a kind of leading piece of capsule endoscope and its detection method, this leading piece of capsule endoscope can be swallowed by those who are investigated and detect the unimpeded state of small intestine, to judge whether those who are investigated are applicable Capsule Endoscopy.
To achieve the above object, the invention provides a kind of leading piece of capsule endoscope, including external packing structure body and label, the label is filled in the sealing cavity of external packing structure body formation, the external packing structure body includes time control portion, the time control portion includes enteric-coated sustained release material and site specific DDS for colon dissolved material, and the label includes making urine and/or excreta change the material of color.
As a further improvement on the present invention, the external packing body also includes adventitia, and the two ends of the adventitia are provided with through hole and are blocked by the time control portion, to form the sealing cavity between control unit between adventitia is timely.
As a further improvement on the present invention, the time control portion is solid utricule, and is substantially the same in outer shape, size with the arc utricule of capsule endoscope.
As a further improvement on the present invention, the top in the time control portion is offered for expanding the window with digestive juice contact area.
As a further improvement on the present invention, by the size of the ratio and window of enteric-coated sustained release material and site specific DDS for colon dissolved material in adjustment time control unit, so that time control portion keeps stabilization in gastric juice, so that dissolution time of the time control portion in small intestine digestive juice is more than human body alimentary canal emptying time, and cause dissolution time of the time control portion in colon digestive juice at the appointed time.
As a further improvement on the present invention, the time control portion includes the inner side time control portion of the capsule shape that site specific DDS for colon dissolved material is formed, and formed identical with above-mentioned inner side time control portion shape of enteric-coated sustained release material and configures outside time control portion on the outside of the inner side time control portion.
As a further improvement on the present invention, the thickness in the outside time control portion should ensure that the leading piece of capsule endoscope reaches the degree for exposing above-mentioned inner side time control portion before colon inside the small intestine, and degradation time under colonic microflora effect of the inner side time portion in large intestine is in setting time.
As a further improvement on the present invention, the label is filled in the sealing cavity that the inner side time control portion is formed, and the inner side time control portion is propped up and the inwall in the outside time control portion is fitted tightly over.
As a further improvement on the present invention, the label is uniformly mixed by core material and indicator and is made, and the indicator is the coloured particle thing that riboflavin and/or human body non-degradable absorb.
As a further improvement on the present invention, the enteric-coated sustained release material is Eudragit E udragit L30D or Eudragit L/S100, and the site specific DDS for colon dissolved material is shitosan, pectin, guar gum or amylose.
As a further improvement on the present invention, the indicator also developer including X-ray.
To achieve the above object, a kind of detection method of the leading piece of capsule endoscope as described above, the detection method includes:S1, makes those who are investigated absorb the leading piece of capsule endoscope;Whether S2, identification urine and/or excreta color change in Preset Time;S3, urine and/or excreta color change in the Preset Time, then judge that those who are investigated are applicable Capsule Endoscopy;And S4, urine and/or excreta color do not change in the Preset Time, then judge that those who are investigated do not apply to Capsule Endoscopy.
As a further improvement on the present invention, the step S3 also includes:Judge whether urine and/or the change of excreta color occur in preset time, the preset time is less than the Preset Time;If the change of urine and/or excreta color occurs in the preset time, judge that the intestines peristalsis of those who are investigated are normal;And if the change of urine and/or excreta color occurs outside the preset time and in the Preset Time, to judge that the intestines peristalsis of those who are investigated are slow.
As a further improvement on the present invention, the step S3 also includes:Be not observed in preset time those who are investigated urine and/or excreta color change when, and during developer of the indicator including X-ray, by the position of the leading piece of X-ray examination capsule endoscope, judge whether the position of the leading piece of capsule endoscope in the given time changes, the preset time is less than the Preset Time;If the position of the leading piece of capsule endoscope does not change within the scheduled time, judge that the leading piece of capsule endoscope occurs incarceration in small intestine, those who are investigated do not apply to Capsule Endoscopy;And if the position of the leading piece of capsule endoscope changes within the scheduled time, judging that the leading piece of capsule endoscope does not occur incarceration in small intestine, though the slow applicable Capsule Endoscopy of those who are investigated's intestines peristalsis.
Using the leading piece of capsule endoscope of the present invention and its detection method, after those who are investigated swallow the leading piece of the capsule endoscope, can voluntarily judge whether to be applicable Capsule Endoscopy in Preset Time, and can voluntarily be degraded when the leading piece of capsule endoscope occurs incarceration and inapplicable Capsule Endoscopy, have the advantages that detection time is short, autonomous judgement strong, incarceration when can voluntarily degrade, and examiner can according to the observation arrive the time of urine and/or excreta color change to learn the intestines peristalsis situation of oneself, preferably to grasp the health of itself.
Brief description of the drawings
Fig. 1 is the structural representation of the leading piece of capsule endoscope of the embodiment of the present invention one.
Fig. 2 is the schematic diagram that the leading piece of capsule endoscope of the embodiment of the present invention one is degraded in colon digestive juice.
Fig. 3 is the schematic diagram that the leading piece of capsule endoscope of the embodiment of the present invention one is collapsed in colon digestive juice.
Fig. 4 runs into the schematic diagram degraded during luminal stenosis portion for the leading piece of capsule endoscope of the embodiment of the present invention one in small intestine.
Fig. 5 runs into the schematic diagram collapsed during luminal stenosis portion for the leading piece of capsule endoscope of the embodiment of the present invention one in small intestine.
Fig. 6 is the structural representation of the leading piece of capsule endoscope of the embodiment of the present invention two.
Fig. 7 is the FB(flow block) that the unimpeded status checkout of small intestine is carried out using the leading piece of capsule endoscope of the invention.
Specific embodiment
Below with reference to each implementation method shown in the drawings, the present invention will be described in detail.But these implementation methods are not intended to limit the present invention, the conversion in structure or function that one of ordinary skill in the art is made according to these implementation methods is all contained in protection scope of the present invention.
The schematic diagram of embodiment one is shown refering to Fig. 1 ~ 5.
The structural representation of the leading piece of capsule endoscope of the invention is shown refering to Fig. 1, the leading piece of the capsule endoscope detects whether those who are investigated are applicable Capsule Endoscopy for simulating quality, shape and the volume of capsule endoscope.The leading piece 1 of capsule endoscope includes adventitia 2, time control portion 3, window 4, label 5 and indicator 6.
The adventitia 2 is harmless, good biocompatibility and the long-time in digestive juice(More than 2 weeks)The material of stabilization.Adventitia of the invention 2 is preferably Parylene C, poly- latex or medical silica-gel etc..The two ends of the adventitia 2 are provided with through hole.
Each through hole of above-mentioned adventitia 2 is blocked by a time control portion 3.Each time control portion 3 is adapted to connection with the corresponding through hole of adventitia 2 so that adventitia 2 forms a sealing cavity with time control portion 3.The time control portion 3 is attached with the through hole of adventitia 2 by way of biogum or directly pressing.The time control portion 3 is solid utricule, and is substantially the same in outer shape, size with the arc utricule of capsule endoscope.The time control portion 3 includes enteric-coated sustained release material and site specific DDS for colon dissolved material.The enteric-coated sustained release material can be Eudragit E udragit L30D, Eudragit L/S100 etc..The site specific DDS for colon dissolved material can be the natural polysaccharide materials such as shitosan, pectin, guar gum, amylose, and the natural polysaccharide material can degrade in the presence of colonic microflora.
The top in the time control portion 3 is offered for expanding the window 4 with digestive juice contact area, is beneficial to inside digestive juice entry time control unit 3.The window 4 can be for variously-shaped, for example, being about 6 to 8 millimeters of cylindrical card punch present invention preferably uses diameter to produce window 4.
In the present invention, by the size of the ratio and window 4 of enteric-coated sustained release material and site specific DDS for colon dissolved material in adjustment time control unit 3, so that time control portion 3 keeps stabilization in gastric juice, so that dissolution time of the time control portion 3 in small intestine digestive juice 8 is more than human body alimentary canal emptying time, and cause dissolution time of the time control portion 3 in colon digestive juice 7 at the appointed time.Due to the averagely about 24 hours digestive tract evacuation time of human body, in order to effectively distinguish that the leading piece 1 of capsule endoscope is that incarceration occurs in small intestine and dissolve or dissolve in colon, dissolution time of the present embodiment preferably by time control portion 3 in small intestine digestive juice 8 be set greater than 48 hours.The stipulated time can be according to clinical setting flexible design, preferably 1 hour or so.
The label 5 includes core material(Not shown in figure)And indicator 6.The core material is harmless, and can be rapid in small intestine digestive juice 8 and colon digestive juice 7(Less than 10 minutes)The material of disintegration.The core material is including microcrystalline cellulose, lactose, pregelatinized starch, PVP etc..The core material is made the label 5 after uniformly mixing with indicator 6, agent 6 indicated at only exemplified two in Fig. 1.
The label 5 is filled in the sealing cavity of adventitia 2 and the composition of time control unit 3, propped up with by adventitia 2, and by adjusting the weight of label 5 and time control unit 3, so that the leading piece 1 of capsule endoscope is size, quality, outward appearance capsule shape essentially identical with above-mentioned capsule endoscope, and in the case where the vermicular movement by internal organs applies external pressure to the leading piece 1 of capsule endoscope so that the leading piece 1 of the capsule endoscope also maintains the outside dimension roughly equal with the capsule endoscope.
The indicator 6 is the material of urine or excreta change color that is harmless and causing discharge.The present invention is preferably able to make the safety non-toxic reagent of human urine color change, such as riboflavin.Riboflavin is also vitamin B2, is a kind of water miscible vitamin, after human body largely eats riboflavin, due to storing the limited in one's ability of riboflavin, is then excreted from urine in a free form by urinary system more than kidney threshold, makes urine that glassy yellow is presented.The glassy yellow causes the yellow hue that urine turns yellow different with human body due to drinking water less, and living human eye can substantially distinguish both.For riboflavin, the absorbable maximum dose of human body single is 27 milligrams, and unnecessary riboflavin 50% is discharged by urine.After oral 32 milligrams of riboflavin, the 8 hours riboflavin later in urine reaches peak value to human body.When indicator 6 is riboflavin, in order that the color change of urine is more easy to be observed, the dosage of the riboflavin is not less than 32 milligrams.In the present invention, it is preferred to indicator 6 is 50 milligrams of riboflavin.In other embodiments, it is described to make the others natural plant pigment such as the safety non-toxic reagent of human urine color change or beet red glycosides.
In other embodiments, the indicator 6 can be the coloured particle thing that non-degradable absorbs, to distinguish the unimpeded state of small intestine from the color of excreta.The coloured particle thing that the non-degradable absorbs can both distinguish the unimpeded state of small intestine with the above-mentioned material for making change of urine color together as indicator 6, and the unimpeded state of small intestine can be also distinguished separately as indicator 6.When the coloured particle thing that is absorbed using the non-degradable at the same time and the above-mentioned material for making change of urine color are used as indicator 6, distinguish that the unimpeded state of small intestine be able to cannot determine whether to be applicable Capsule Endoscopy as supplementary means to avoid to be observed because of the reasons such as anomalous trichromatism the change of urine color by the color of excreta.
The schematic diagram that the leading piece of capsule endoscope of the present invention is degraded in colon digestive juice is shown refering to Fig. 2.Not there is incarceration in the leading piece 1 of capsule endoscope, it passes through small intestine and enters into colon, is contacted with colon digestive juice 7 in small intestine.After the dissolution time in time control portion 3, the time control portion 3 near window 4 is dissolved by colon digestive juice 7 at first, and colon digestive juice 7 enters the inside of the leading piece 1 of capsule endoscope, starts to dissolve label 5 so that indicator 6 is excreted after digesting and assimilating.
It is due to after averagely about 13 hours time of the leading piece 1 of capsule endoscope from oral cavity to colon, and riboflavin degraded absorption peak value can be reached in urine within about 8 hours, then most of when indicator 6 includes riboflavin(About 97% to 98%)Those who are investigated can within 24 hours of the leading piece 1 of oral capsule scope observe urine color change(Urine is in glassy yellow), so as to learn that oneself intestines peristalsis is normal and applicable Capsule Endoscopy.However, fraction(About 1%)The those who are investigated's color change for observing urine for 24 hours within 48 hours in addition that can cause in the leading piece 1 of oral capsule scope because intestines peristalsis are slow(Urine is in glassy yellow), so as to learn that oneself intestines peristalsis is slow but equally applicable Capsule Endoscopy.
It is due to the averagely about 24 hours digestive tract evacuation time of human body, then most of when indicator 6 includes the coloured particle thing that non-degradable absorbs(About 97% to 98%)Those who are investigated can within 24 hours of the leading piece 1 of oral capsule scope observe excreta color change(Occurs above-mentioned coloured particle thing in excreta), so as to learn that oneself intestines peristalsis is normal and applicable Capsule Endoscopy.However, fraction(About 1%)The those who are investigated's color change for observing excreta for 24 hours within 48 hours in addition that can cause in the leading piece 1 of oral capsule scope because intestines peristalsis are slow(Occurs above-mentioned coloured particle thing in excreta), so as to learn that oneself intestines peristalsis is slow but equally applicable Capsule Endoscopy.
In other embodiments, the indicator 6 also developer including X-ray, such as barium sulfate.Those who are investigated are not observed the color change of urine within 24 hours of the leading piece 1 of oral capsule scope(Urine is in glassy yellow)And/or the color change of excreta(Occurs above-mentioned coloured particle thing in excreta)When, whether can be changed with the position for judging the leading piece 1 of capsule endoscope within a scheduled time by the position of the leading piece 1 of X-ray examination capsule endoscope.The scheduled time can be according to clinical setting flexible design, such as any time value in 3 to 4 hours.If the position of the leading piece 1 of capsule endoscope does not change within the scheduled time, then judge that the leading piece 1 of capsule endoscope occurs incarceration in small intestine, those who are investigated do not apply to Capsule Endoscopy, and those who are investigated by 48 hours in addition just it is observed that the color change of urine(Urine is in glassy yellow)And/or the color change of excreta(Occurs above-mentioned coloured particle thing in excreta).If the position of the leading piece 1 of capsule endoscope changes within the scheduled time, then judge that the leading piece 1 of capsule endoscope does not occur incarceration in small intestine, those who are investigated's intestines peristalsis are slow but applicable Capsule Endoscopy, however those who are investigated slowly cause because of intestines peristalsis its by within 24 hours in addition 48 hours just it is observed that the color change of urine(Urine is in glassy yellow)And/or the color change of excreta(Occurs above-mentioned coloured particle thing in excreta).
The schematic diagram that the leading piece of capsule endoscope of the present invention is collapsed in colon digestive juice is shown refering to Fig. 3.Time control portion 3 and label 5 are all dissolved in colon by colon digestive juice 7, and the leading piece 1 of capsule endoscope is collapsed, and are left still undegradable adventitia 2 and are excreted from anus.
The schematic diagram degraded when the leading piece of capsule endoscope of the present invention runs into luminal stenosis portion in small intestine is shown refering to Fig. 4.The leading piece 1 of capsule endoscope runs into luminal stenosis in small intestine(Including narrow, locking, obstruction)Portion and when there is incarceration, it is contacted with small intestine digestive juice 8.After the dissolution time in time control portion 3, the time control portion 3 near window 4 is dissolved by small intestine digestive juice 8 at first, and small intestine digestive juice 8 enters the inside of the leading piece 1 of capsule endoscope, starts to dissolve label 5 so that indicator 6 is excreted after digesting and assimilating.Because dissolution time of the time control portion 3 in small intestine digestive juice 8 is set greater than 48 hours, then those who are investigated by after 48 hours of the leading piece 1 of oral capsule scope just it is observed that the color change of urine(Urine is in glassy yellow)And/or the color change of excreta(Occurs above-mentioned coloured particle thing in excreta), so as to learn oneself inapplicable Capsule Endoscopy.
The schematic diagram collapsed when the leading piece of capsule endoscope of the present invention runs into luminal stenosis portion in small intestine is shown refering to Fig. 5.Time control portion 3 and label 5 are all dissolved in small intestine by small intestine digestive juice 8, and the leading piece 1 of capsule endoscope is collapsed, and are left still undegradable adventitia 2 and are finally excreted from anus by the luminal stenosis portion of small intestine.
The schematic diagram of embodiment two is shown refering to Fig. 6.
The structural representation of the leading piece of capsule endoscope of the invention is shown refering to Fig. 6.The leading piece of the capsule endoscope detects whether those who are investigated are applicable Capsule Endoscopy for simulating quality, shape and the volume of capsule endoscope.The leading piece 1 of capsule endoscope in the present embodiment forms a sealing utricule space instead of the adventitia 2 and time control unit 3 of embodiment one with time control portion 30, not including window 4.Other structures are identical with embodiment one, and same reference is added to same structure part.
The time control portion 30 is the external packing structure body of double-decker, including is formed as the inner side time control portion 30a of capsule shape and is formed as the outside time control portion 30b of the substantially similar capsule shapes of inner side time control portion 30a.In the present invention, the capsule shape is the shape of above-mentioned capsule endoscope.Inner side time control portion 30a is the structure of the capsule shape that site specific DDS for colon dissolved material is formed, and is inside surrounded by label 5.The site specific DDS for colon dissolved material can be the natural polysaccharide materials such as shitosan, pectin, guar gum, amylose, so that the inner side time control portion 30a can be in the presence of colonic microflora in degraded in setting time.In the present embodiment, the site specific DDS for colon dissolved material is preferably shitosan.The setting time was according to clinical setting flexible design, preferably 1 hour or so.
The outside time control portion 30b is the structure formed by enteric-coated sustained release material, forms the capsule shape roughly the same with above-mentioned inner side time control portion 30a and configures in the outside of inner side time control portion 30a.Above-mentioned outside time control portion 30b is by the whole inner side time control portion 30a of covering come time control portion 30a on the inside of protecting.Outside time control portion 30b is enteric-coated sustained release material, such as Eudragit E udragit L30D, Eudragit L/S100 etc..Outside time control portion 30b degrades during the leading piece 1 of capsule endoscope is by small intestine through small intestine digestive juice 8, the thickness of outside time control portion 30b should ensure that the leading piece 1 of capsule endoscope time control portion 30b on the outside of dew before arrival colon inside small intestine goes out the degree of above-mentioned inner side time control portion 30a, so that inner side time control portion 30a can be degraded by colon digestive juice 7 after colon is reached in above-mentioned setting time.
The label 5 is filled in the sealing utricule cavity of the formation of time control portion 30, so that inner side time control portion 30a to be propped up and the inwall of outside time control portion 30b is fitted tightly over, and by adjusting the weight of label 5, so that the leading piece 1 of capsule endoscope is size, quality, outward appearance capsule shape essentially identical with above-mentioned capsule endoscope, and in the case where the vermicular movement by internal organs applies external pressure to the leading piece 1 of capsule endoscope so that the leading piece 1 of the capsule endoscope also maintains the outside dimension roughly equal with the capsule endoscope.
The label 5 includes core material(Not shown in figure)And indicator 6.The core material is harmless, and can be rapid in small intestine digestive juice 8 and colon digestive juice 7(Less than 10 minutes)The material of disintegration.The core material is including microcrystalline cellulose, lactose, pregelatinized starch, PVP etc..The core material is made the label 5 after uniformly mixing with indicator 6, agent 6 indicated at only exemplified two in figure 6.The indicator 6 is identical with above-described embodiment one, will not be described in great detail herein.
When small intestine does not occur incarceration, outside time control portion 30b's leading piece 1 of capsule endoscope is degraded through small intestine digestive juice 8 during it passes through small intestine, and remaining inner side time control portion 30a parcel labels 5 are contacted into colon with colon digestive juice 7.After the dissolution time of inner side time control portion 30a, colon digestive juice 7 enters the inside of the leading piece 1 of capsule endoscope, starts to dissolve label 5 so that indicator 6 is excreted after digesting and assimilating.
It is due to after averagely about 13 hours time of the leading piece 1 of capsule endoscope from oral cavity to colon, and riboflavin degraded absorption peak value can be reached in urine within about 8 hours, then most of when indicator 6 includes riboflavin(About 97% to 98%)Those who are investigated can within 24 hours of the leading piece 1 of oral capsule scope observe urine color change(Urine is in glassy yellow), so as to learn that oneself intestines peristalsis is normal and applicable Capsule Endoscopy.However, fraction(About 1%)The those who are investigated's color change for observing urine for 24 hours within 48 hours in addition that can cause in the leading piece 1 of oral capsule scope because intestines peristalsis are slow(Urine is in glassy yellow), so as to learn that oneself intestines peristalsis is slow but equally applicable Capsule Endoscopy.
It is due to the averagely about 24 hours digestive tract evacuation time of human body, then most of when indicator 6 includes the coloured particle thing that non-degradable absorbs(About 97% to 98%)Those who are investigated can within 24 hours of the leading piece 1 of oral capsule scope observe excreta color change(Occurs above-mentioned coloured particle thing in excreta), so as to learn that oneself intestines peristalsis is normal and applicable Capsule Endoscopy.However, fraction(About 1%)The those who are investigated's color change for observing excreta for 24 hours within 48 hours in addition that can cause in the leading piece 1 of oral capsule scope because intestines peristalsis are slow(Occurs above-mentioned coloured particle thing in excreta), so as to learn that oneself intestines peristalsis is slow but equally applicable Capsule Endoscopy.
In other embodiments, the indicator 6 also developer including X-ray, such as barium sulfate.Those who are investigated are not observed the color change of urine within 24 hours of the leading piece 1 of oral capsule scope(Urine is in glassy yellow)And/or the color change of excreta(Occurs above-mentioned coloured particle thing in excreta)When, whether can be changed with the position for judging the leading piece 1 of capsule endoscope within a scheduled time by the position of the leading piece 1 of X-ray examination capsule endoscope.The scheduled time is according to clinical setting flexible design, such as any time value in 3 to 4 hours.If the position of the leading piece 1 of capsule endoscope does not change within the scheduled time, judge that the leading piece 1 of capsule endoscope occurs incarceration in small intestine, those who are investigated do not apply to Capsule Endoscopy.Because small intestine digestive juice 8 cannot dissolve site specific DDS for colon dissolved material, so that inner side time control portion 30a cannot dissolve in small intestine, those who are investigated need orally dissolve the material of site specific DDS for colon dissolved material(Such as acetic acid)Come the inner side time control portion 30a that degrades, the color change of urine can be observed(Urine is in glassy yellow)And/or the color change of excreta(Occurs above-mentioned coloured particle thing in excreta).If the position of the leading piece 1 of capsule endoscope changes within the scheduled time, then judge that the leading piece 1 of capsule endoscope does not occur incarceration in small intestine, though those who are investigated's intestines peristalsis are slow but applicable Capsule Endoscopy, those who are investigated slowly cause because of intestines peristalsis its by within 24 hours in addition 48 hours just it is observed that the color change of urine(Urine is in glassy yellow)And/or the color change of excreta(Occurs above-mentioned coloured particle thing in excreta).
The leading piece 1 of capsule endoscope runs into luminal stenosis in small intestine(Including narrow, locking, obstruction)Portion and when there is incarceration, outside time control portion 30b is degraded through small intestine digestive juice 8, and remaining inner side time control portion 30a parcel labels 5 are contacted with small intestine digestive juice 8.Because site specific DDS for colon material cannot dissolve in small intestine digestive juice 8, then those who are investigated cannot observe the color change of urine after 48 hours of the leading piece 1 of oral capsule scope(Urine is in glassy yellow)And/or the color change of excreta(Occurs above-mentioned coloured particle thing in excreta), so as to learn oneself inapplicable Capsule Endoscopy.Because small intestine digestive juice 8 cannot dissolve site specific DDS for colon dissolved material, so that inner side time control portion 30a cannot dissolve in small intestine, those who are investigated need orally dissolve the material of site specific DDS for colon dissolved material(Such as acetic acid)Come the inner side time control portion 30a that degrades, the color change of urine can be observed(Urine is in glassy yellow)And/or the color change of excreta(Occurs above-mentioned coloured particle thing in excreta).
Being shown refering to Fig. 7 carries out the FB(flow block) of the unimpeded status checkout of small intestine using the leading piece of capsule endoscope of the invention.Inspection requirements those who are investigated take food digestible food in the previous day for checking, to carry out INTESTINAL CLEANSING work.Need not be in hospital in checking process or be carried out under physician guidance, checking process is as follows:
Those who are investigated can normal life and work with the leading piece 1 of water swallowable capsule scope, thereafter, it is only necessary to notice whether observation urine and/or excreta color change.
Those who are investigated recognize the color of urine and/or excreta, and judge in Preset Time(48 hours)Inside whether observe that urine and/or excreta color change.
Urine and/or excreta color change are observed in the Preset Time, that is urine has and becomes coloured particle thing occur in glassy yellow and/or excreta, illustrate that the leading piece 1 of capsule endoscope is no in small intestine and incarceration occurs, then judge that those who are investigated are applicable Capsule Endoscopy.
If in preset time(24 hours)The color change of the interior urine for observing those who are investigated(Urine is in glassy yellow)And/or the color change of excreta(There is coloured particle thing)When, then judgement those who are investigated intestines peristalsis are normal, and the leading piece 1 of capsule endoscope no generation incarceration in small intestine, and those who are investigated are applicable Capsule Endoscopy.If be not observed in the preset time those who are investigated urine and/or excreta color change when, and in the developer of indicator 6 including X-ray(Such as barium sulfate), then by the position of the leading piece 1 of X-ray examination capsule endoscope, whether changed with the position for judging the leading piece 1 of capsule endoscope within a scheduled time.The scheduled time is according to clinical setting flexible design, such as any time value in 3 to 4 hours.If the position of the leading piece 1 of capsule endoscope does not change within the scheduled time, judge that the leading piece 1 of capsule endoscope occurs incarceration in small intestine, those who are investigated do not apply to Capsule Endoscopy.If the position of the leading piece 1 of capsule endoscope changes within the scheduled time, then judge that the leading piece 1 of capsule endoscope does not occur incarceration in small intestine, though those who are investigated's intestines peristalsis are slow but applicable Capsule Endoscopy, those who are investigated slowly cause because of intestines peristalsis its by after preset time and in Preset Time just it is observed that the color change of urine(Urine is in glassy yellow)And/or the color change of excreta(Occurs above-mentioned coloured particle thing in excreta).The judgement whether those who are investigated are applicable Capsule Endoscopy can be accelerated by X-ray examination.
When the color change of urine color change and/or excreta being not observed in the Preset Time, i.e. urine did not become coloured particle thing do not occur in glassy yellow and/or excreta, illustrate that the leading piece 1 of capsule endoscope occurs incarceration in small intestine, then there is luminal stenosis portion in prompting those who are investigated's small intestine, and judge that those who are investigated do not apply to Capsule Endoscopy.Using the leading piece 1 of capsule endoscope shown in embodiment one, after Preset Time, those who are investigated are observed that urine color change to those who are investigated(Urine is in glassy yellow)And/or excreta color change(Occurs coloured particle thing in excreta).Using the leading piece 1 of capsule endoscope shown in embodiment two, after Preset Time, those who are investigated need orally dissolve the material of site specific DDS for colon dissolved material those who are investigated(Such as acetic acid)Can observe that urine color changes(Urine is in glassy yellow)And/or excreta color change(Occurs coloured particle thing in excreta).
It should be understood that, although the present specification is described in terms of embodiments, but not each implementation method only includes an independent technical scheme, this narrating mode of specification is only for clarity, those skilled in the art should be using specification an as entirety, technical scheme in each implementation method can also through appropriately combined, formed it will be appreciated by those skilled in the art that other embodiment.
Those listed above is a series of to describe illustrating only for feasibility implementation method of the invention in detail; they simultaneously are not used to limit the scope of the invention, and all equivalent implementations made without departing from skill spirit of the present invention or change should be included within the scope of the present invention.

Claims (14)

1. a kind of leading piece of capsule endoscope, including external packing structure body and label, the label are filled in the sealing cavity of external packing structure body formation, it is characterised in that:The external packing structure body includes time control portion, and the time control portion includes enteric-coated sustained release material and site specific DDS for colon dissolved material, and the label includes making urine and/or excreta change the material of color.
2. the leading piece of capsule endoscope according to claim 1, it is characterised in that:The external packing body also includes adventitia, and the two ends of the adventitia are provided with through hole and are blocked by the time control portion, to form the sealing cavity between control unit between adventitia is timely.
3. the leading piece of capsule endoscope according to claim 2, it is characterised in that:The time control portion is solid utricule, and is substantially the same in outer shape, size with the arc utricule of capsule endoscope.
4. the leading piece of capsule endoscope according to claim 2, it is characterised in that:The top in the time control portion is offered for expanding the window with digestive juice contact area.
5. the leading piece of capsule endoscope according to claim 4, it is characterised in that:By the size of the ratio and window of enteric-coated sustained release material and site specific DDS for colon dissolved material in adjustment time control unit, so that time control portion keeps stabilization in gastric juice, so that dissolution time of the time control portion in small intestine digestive juice is more than human body alimentary canal emptying time, and cause dissolution time of the time control portion in colon digestive juice at the appointed time.
6. the leading piece of capsule endoscope according to claim 1, it is characterised in that:The time control portion includes the inner side time control portion of the capsule shape that site specific DDS for colon dissolved material is formed, and formed identical with above-mentioned inner side time control portion shape of enteric-coated sustained release material and configures outside time control portion on the outside of the inner side time control portion.
7. the leading piece of capsule endoscope according to claim 6, it is characterised in that:The thickness in the outside time control portion should ensure that the leading piece of capsule endoscope reaches the degree for exposing above-mentioned inner side time control portion before colon inside the small intestine, and degradation time under colonic microflora effect of the inner side time portion in large intestine is in setting time.
8. the leading piece of capsule endoscope according to claim 6, it is characterised in that:The label is filled in the sealing cavity that the inner side time control portion is formed, and the inner side time control portion is propped up and the inwall in the outside time control portion is fitted tightly over.
9. the leading piece of capsule endoscope according to claim 1, it is characterised in that:The label is uniformly mixed by core material and indicator and is made, and the indicator is the coloured particle thing that riboflavin and/or human body non-degradable absorb.
10. the leading piece of capsule endoscope according to claim 1, it is characterised in that:The enteric-coated sustained release material is Eudragit E udragit L30D or Eudragit L/S100, and the site specific DDS for colon dissolved material is shitosan, pectin, guar gum or amylose.
The 11. leading pieces of capsule endoscope according to claim 1, it is characterised in that:The indicator also developer including X-ray.
The detection method of the leading piece of 12. a kind of capsule endoscopes as described in any one in claim 1 to 10, it is characterised in that the detection method includes:
S1, makes those who are investigated absorb the leading piece of capsule endoscope;
Whether S2, identification urine and/or excreta color change in Preset Time;
S3, urine and/or excreta color change in the Preset Time, then judge that those who are investigated are applicable Capsule Endoscopy;And
S4, urine and/or excreta color do not change in the Preset Time, then judge that those who are investigated do not apply to Capsule Endoscopy.
The detection method of the 13. leading pieces of capsule endoscope according to claim 12, it is characterised in that the step S3 also includes:
Judge whether urine and/or the change of excreta color occur in preset time, the preset time is less than the Preset Time;
If the change of urine and/or excreta color occurs in the preset time, judge that the intestines peristalsis of those who are investigated are normal;And
If the change of urine and/or excreta color occurs outside the preset time and in the Preset Time, to judge that the intestines peristalsis of those who are investigated are slow.
The detection method of the 14. leading pieces of capsule endoscope according to claim 12, it is characterised in that step S3 also includes:
Be not observed in preset time those who are investigated urine and/or excreta color change when, and during developer of the indicator including X-ray, by the position of the leading piece of X-ray examination capsule endoscope, judge whether the position of the leading piece of capsule endoscope in the given time changes, the preset time is less than the Preset Time;
If the position of the leading piece of capsule endoscope does not change within the scheduled time, judge that the leading piece of capsule endoscope occurs incarceration in small intestine, those who are investigated do not apply to Capsule Endoscopy;And
If the position of the leading piece of capsule endoscope changes within the scheduled time, judge that the leading piece of capsule endoscope does not occur incarceration in small intestine, though the slow applicable Capsule Endoscopy of those who are investigated's intestines peristalsis.
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