CN102920418A - Self-stable patency capsule of alimentary canal - Google Patents
Self-stable patency capsule of alimentary canal Download PDFInfo
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- CN102920418A CN102920418A CN2012104102700A CN201210410270A CN102920418A CN 102920418 A CN102920418 A CN 102920418A CN 2012104102700 A CN2012104102700 A CN 2012104102700A CN 201210410270 A CN201210410270 A CN 201210410270A CN 102920418 A CN102920418 A CN 102920418A
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Abstract
The invention discloses a self-stable patency capsule of the alimentary canal. The self-stable patency capsule comprises a capsule body, and an enteric-coated shell and an elastic part made of a degradable material, wherein the elastic part is at least arranged at one end of the capsule body; the capsule body and the elastic part are wrapped by the enteric-coated shell, so that the elastic part is in a compressed state; after the enteric-coated shell reaches the small intestine and is dissolved, the elastic part is restored to the original length to increase the length of the entire capsule so as to prevent turning; and the elastic part is preferably a spring. The spring is released in the small intestine, so that the overall length of the capsule is increased, and stable movement towards the same direction in the small intestine can be realized, a self-stable capsule endoscope is also provided with a spring which can be used for increasing the length in the small intestine; both the size and the eight of the self-stable capsule endoscope are similar to those of the patency capsule; and thus, a movement process in the alimentary canal is actually preview of examination of the self-stable capsule endoscope, so that the feasibility for examination of the self-stable capsule endoscope can be accurately evaluated.
Description
Technical field
The present invention relates to technical field of medical instruments, be specifically related to a kind of digestive tract from the capsule of surely exploring the way.
Background technology
From calendar year 2001 capsule endoscope since FDA Food and Drug Administration approval is used for the inspection of disease of intestine, the characteristics such as capsule endoscope is simple, convenient, painless with it, noinvasive, safety obtain doctor, patient's favor.At present, capsule endoscope is mainly used in the sick diagnosis such as Obscure gastrointestinal bleeding, Crohn disease, intestinal tumor.
Yet, owing to a common complication that becomes capsule endoscope in intestinal tumor or the narrow capsule retention body that causes.Because the capsule endoscope non-degradable in the retention body, must take out, otherwise will cause serious consequence.Small intestinal is different from stomach and colon, because its anatomical position and structure is special, in case capsule endoscope generation retention is taken out relatively difficulty with it, sometimes even need the row laparotomy ventrotomy, this has brought great misery to the patient.
Therefore, whether retention is particularly important in vivo to judge in advance capsule endoscope.At present, how the clinician is at first according to medical history Preliminary screening patients undergoing examination of capsule endoscopy, then further goes the clear and definite bowel narrow that whether exists of contrast examination.But this method accuracy rate is not high, and some patient fails to pinpoint a disease in diagnosis, and some patient's radiography result shows bowel narrow, but still can finish Capsule Endoscopy.This explanation, soon differing is decided to be reality, only has personal practice to know actually.Some bowel narrow is false stricture, capsule endoscope by the time still can produce deformation, capsule is passed through.This part patient accepts Capsule Endoscopy often can have positive findings, for its diagnosis provides important evidence.
PiXiTians in 2006 etc. have been invented digestive tract evacuation-detecting slow-release tablet and preparation technology thereof; ElishaRahinovitz in 2010 etc. have invented a kind of degradable capsule, and the assessment intestinal had or not narrow before they can be used for Capsule Endoscopy.Above-mentioned two kinds of capsules all are similar to conventional capsule scope size, but, it moves unpredictable in small intestinal, capsule very easily rolls, because this degradable capsule can't be simulated from steady (being difficult for rolling) capsule endoscope motor process in small intestinal, thus can not accurate evaluation from the feasibility of steady Capsule Endoscopy.
Summary of the invention
The object of the present invention is to provide a kind of can stable motion in digestive tract, can accurate evaluation from the digestive tract of steady Capsule Endoscopy feasibility from the capsule of surely exploring the way.Measurable Capsule Endoscopy feasibility is taken before planning to implement the capsule endoscope patient, and is safe, easy and effective, for the clinician determines whether feasible Capsule Endoscopy provides good foundation for next step.
Purpose of the present invention realizes by following technical measures: a kind of digestive tract is from the capsule of surely exploring the way, comprise the capsule body, it is characterized in that: also comprise enteric shell and the elastic component made by degradable material, described elastic component is arranged on an end of described capsule body at least, described enteric shell wraps the capsule body and elastic component makes described elastic component be in compressive state, after the enteric shell arrived the small intestinal dissolving, elastic component recovered former length and prevents upset with the length that increases whole capsule.
Elastic component of the present invention discharges in small intestinal, increased the entire length of capsule, can realize in small intestinal stably towards same direction motion, from steady capsule endoscope have too can be in small intestinal the elastic component of the length of growth own, all similar to explore the way size and the weight of capsule of the present invention from steady capsule endoscope size and weight, therefore, the motor process of the present invention in digestive tract is actually the preview from steady Capsule Endoscopy, so, but accurate evaluation is from the feasibility of steady Capsule Endoscopy.
After elastic component of the present invention recovered former length, the length range of the whole capsule of exploring the way was 5-7cm.The entire length of the present invention behind retracting spring be greater than the maximum gauge of small intestinal, realized preventing the purpose of overturning, and avoided simultaneously retention at small intestinal normal turn position, and make its can not accurate evaluation from the feasibility of steady Capsule Endoscopy.
As preferred implementation of the present invention, described elastic component adopts spring, and an end of described spring is connected on the described capsule body, and this end is the link of spring, and the other end holds out against on the inwall of described enteric shell.
With spring compression, adopt application of vacuum between enteric shell of the present invention and capsule body, the elastic component for further.
As one embodiment of the present invention, described capsule body mainly reaches the time marker of being made by the enteric-coated sustained release material by soluble supporter in Digestive system, contrast media layer, adventitia and forms, it is peripheral that described contrast media layer is coated on described supporter, and described adventitia then is coated on the surface of contrast media layer and supporter coalition; The link of described spring passes adventitia and stretches between adventitia and the contrast media layer fixing.
Contrast media layer of the present invention is comprised of blanc fixe and the film body that coats blanc fixe, and the link of described spring has fixed disk, and the two sides of described fixed disk is corresponding respectively to be adhesively fixed with film body, adventitia.
Have through hole on the adventitia of the present invention, described time marker closely is inserted in the through hole with the shutoff through hole.
As a kind of improvement of the present invention, being coated with in the peripheral monoblock type of described spring can be with the spring adventitia of the common elongation of spring.The spring adventitia both can prevent Spring Card pressure ileocecal valve, also can increase the contact area between spring and the enteric shell, thereby can protect the enteric shell not damaged, when it is normally moved in intestinal, it is stable that this spring adventitia keeps, and guarantees spring and enteric shell overall appearance and performance; This spring adventitia can also reduce the friction between spring and the intestinal wall.
The present invention has following embodiment:
Described enteric shell adopts the enteric materials such as alginate, Algin to make; Described spring is made by materials such as poly-decanedioic acid witcogum, polylactic acid or gelatin, and this material should have good biocompatibility, suitable elasticity and the characteristic of biodegradability; The spring adventitia is made by the degradation material polylactic acid; Described adventitia can select good biocompatibility, the degradable materials such as polylactic acid, microcrystalline Cellulose, polyvinyl pyrrolidone to make; Described time marker can be selected the making such as enteric-coated sustained release material such as microcrystalline Cellulose, Glyceryl Behenate, polyvinyl pyrrolidone, hydroxypropyl emthylcellulose, lactose, it can keep basicly stable in specifying the 72-96 hours, all dissolvings after the fixed time (96-120 hour); Supporter adopts soluble gelatin, lactose, starch etc. in Digestive system, and its ratio weight is adjustable, and is similar to certainly steady capsule endoscope with the quality that satisfies whole capsule.
Spring of the present invention is for the maximum pressure (P of intestinal wall
Max) be less than or equal to the critical pressure that makes intestinal wall perforation.Computing formula: P
Net=t/R * σ
T(t is intestinal wall thickness, and R is the intestinal wall radius, σ
TBe the small bowel elastic modelling quantity); P
Max=σ
s* x/S; (σ
sBe the elastic modelling quantity of spring, x is the largest deformation amount, and S is the area of fixed disk).
Compared with prior art, the present invention has following significant effect:
⑴ elastic component of the present invention discharges in small intestinal, increased the entire length of capsule, can realize in small intestinal stably towards same direction motion, from steady capsule endoscope have too can be in small intestinal the elastic component of the length of growth own, all similar to explore the way size and the weight of capsule of the present invention from steady capsule endoscope size and weight, therefore the motor process of the present invention in digestive tract is the preview from steady Capsule Endoscopy in fact, but accurate evaluation is from the feasibility of steady Capsule Endoscopy.
⑵ the present invention is noinvasive, safety not only, and reliable, neither allows the patient stand unnecessary inspection, does not also allow the patient lose a kind of chance of good auxiliary diagnosis disease.
⑶ spring adventitia both can prevent Spring Card pressure ileocecal valve; also can increase the contact area between spring and the enteric shell; thereby can protect the enteric shell not damaged; when it is normally moved in intestinal; it is stable that this adventitia keeps; guarantee spring and enteric shell overall appearance and performance, this spring adventitia can also reduce the friction between spring and the intestinal wall.
⑷ the entire length of the present invention behind retracting spring be greater than the maximum gauge of small intestinal, realized preventing the purpose of overturning, and avoided simultaneously being trapped in small intestinal normal turn position, cause its can not accurate evaluation from the feasibility of steady Capsule Endoscopy.
⑸ enteric shell vacuum packet is rolled in the periphery of capsule body and elastic component, can be further with spring compression.
⑹ the present invention is the preview that true capsule endoscope checks in digestive tract, can find the narrow positions that capsule endoscope can't pass through really, for the inspection of capsule endoscope provides safety guarantee and provides the once chance of feasible Capsule Endoscopy for the patient who has Digestive Tract Stenosis.
Description of drawings
The present invention is described in further detail below in conjunction with the drawings and specific embodiments.
Fig. 1 is the overall structure cross-sectional schematic (only enteric shell cut) of the present invention before spring discharges;
Fig. 2 is the cutaway view of the present invention after spring discharges;
Fig. 3 is the local enlarged diagram of A among Fig. 2;
Fig. 4 is the FB(flow block) that uses evaluate capsules endoscopy feasibility of the present invention.
The specific embodiment
Shown in Fig. 1～3, be a kind of digestive tract of the present invention from the capsule 6 of surely exploring the way, all with to have common capsule endoscope now basic identical, it comprises degradable capsule body 1 and enteric shell 2 and the elastic component made by degradable material for its size, quality, outward appearance; Elastic component adopts spring 3, spring 3 is arranged on a wherein end (afterbody of the capsule of namely exploring the way) of capsule body 1, enteric shell 2 vacuum packet wrap capsule body 1 and spring 3 makes spring 3 be in compressive state, one end of spring 3 is connected on the capsule body, this end is the link 31 of spring 3, the other end holds out against on the inwall of enteric shell 2, after the enteric shell arrives the small intestinal dissolving, elastic component recovers former length and prevents upset with the length that increases the whole capsule of exploring the way, and namely the length of whole capsule is greater than human small intestine's maximum gauge.Generally speaking, after elastic component recovered former length, the length range of the whole capsule of exploring the way was 5-7cm.
Capsule body 1 mainly reaches the time marker 14 of being made by the enteric-coated sustained release material by soluble supporter 11 in Digestive system, contrast media layer, adventitia 13 and forms, the contrast media layer is coated on supporter 11 peripheries, and adventitia 13 then is coated on the surface of contrast media layer and supporter 11 coalitions; The link 31 of spring 3 passes adventitia 13 and stretches between adventitia 13 and the contrast media layer fixing; In the present embodiment, the contrast media layer is comprised of blanc fixe 12 and the film body 15 that coats blanc fixe, externally shows the shape of the capsule of exploring the way when the capsule of exploring the way is complete under the x-ray.The link 31 of spring 3 has fixed disk 32, fixed disk 32 is to enter the rear folding circular disk body that forms by the link 31 of spring 3 aperture by the capsule end of exploring the way, the two sides of fixed disk 32 respectively corresponding and film body 15, adventitia 13 connects fixingly so that biogum or UV are gluing, prevents that intestinal juice from entering.Have through hole on adventitia 13 and corresponding to the head of the capsule of exploring the way, time marker 14 closely is inserted in the through hole with the shutoff through hole, does not stay the slit between time marker 14 and the through hole peritreme, prevents that Digestive system from flowing into from the slit.
Being coated with in spring 3 peripheral monoblock types can be with the spring adventitia 4 of spring 3 common elongations.Spring adventitia 4 can prevent Spring Card pressure ileocecal valve, also can increase the contact area between spring and the enteric shell, reduces the friction between spring and the intestinal wall; Spring is for the maximum pressure (P of intestinal wall
Max) be less than or equal to the critical pressure of intestinal wall perforation.Computing formula is as follows: P
Net=t/R * σ
T(t is intestinal wall thickness, and R is the intestinal wall radius, σ
TBe the small bowel elastic modelling quantity); P
Max=σ
s* x/S; (σ
sBe the elastic modelling quantity of spring, x is the largest deformation amount, and S is the area of fixed disk).
In the present embodiment, the enteric shell adopts alginate, Algin or other enteric material to make; Spring is made by materials such as poly-decanedioic acid witcogum, polylactic acid or gelatin, and poly-decanedioic acid witcogum, polylactic acid and gelatin are the degradable biological elastomeric material, and can add disintegrating agent and regulate its biodegradability; The material of spring is selected to need to satisfy: (1) good biocompatibility; (2) degradable (increase safety, such as retention, discharge behind the degradable); (3) suitable to intestinal wall pressure.The fastest approximately 12 hours of normal person's digestive tract evacuation time, average approximately 24 hours.It is stable that the enteric shell keeps under the effect of gastric gastric juice, enter behind the small intestinal because the rapid disintegrate of variation of pH value and intestinal fluid composition, time was less than 10 minutes, discharge compressed spring this moment, spring and capsule body form an integral body and move under the small intestinal peristalsis effect, its increasing that takes up space, whole anteroposterior diameter surpasses the small intestinal maximum gauge, has reached the effect of overturning of preventing; The spring adventitia can be made by degradation material polylactic acid or other enteric-coated sustained release materials, as explores the way capsule not in the retention body, and it can be discharged from anus with capsule; Otherwise this spring adventitia begins degraded after surpassing the given time (approximately 96-120 hour), and Digestive system pours in from the capsule body tail end aperture of exploring the way after the degraded, accelerates to explore the way the capsule disintegrate.
Adventitia can select good biocompatibility, the degradable materials such as polylactic acid, microcrystalline Cellulose, polyvinyl pyrrolidone to make, adventitia keeps the stable of shape and structure at conventional operation in the time, the simulation capsule endoscope is by the human body alimentary canal process, and complete excreting, adventitia is degradable after 96-120 hour, block then incarceration such as bowel narrow, can monitor roughly incarceration position by x-ray, and prolong in time, also can after the above-mentioned fixed time, degrade, finally excrete, can the retention body in; Time marker can be selected enteric-coated sustained release material such as microcrystalline Cellulose, Glyceryl Behenate, polyvinyl pyrrolidone, hydroxypropyl emthylcellulose, the making such as lactose, rate of dissolution is extremely slow at the appointed time for it, only just can dissolve fully exceeding schedule time, namely in the transhipment of normal stool road, this capsule of exploring the way can keep complete, the Reality simulation capsule endoscope is by digestive tract and discharge, be that it can keep basicly stable in specifying the 72-96 hours, all dissolvings after fixed time (96-120 hour), capsule is not discharged yet in case exceed schedule time, then along with the dissolving of time marker, Digestive system enters dissolving supporter in the capsule, and the capsule body subsides thereupon; Supporter adopts soluble gelatin, lactose, starch etc. in Digestive system, and its ratio weight is adjustable, and is similar to certainly steady capsule endoscope with the quality that satisfies whole capsule.
Operation principle of the present invention is summarized as follows: when the capsule of exploring the way is met narrow in digestive tract or locking and can not pass through the time, the temporary transient incarceration of the capsule of exploring the way therewith, after the process stipulated time, adventitia and time indicator are dissolved fully, the spring of afterbody is also degraded, and Digestive system enters dissolving supporter in the capsule body after the past, and whole capsule subsides, the residue amorphous substance can pass through narrow positions, excretes from anus.
As seen, effect of the present invention is: whether (1) assess patient is fit to the row Capsule Endoscopy; (2) monitoring capsule position; (3) find the Digestive Tract Stenosis position.
As shown in Figure 4, use the present invention to estimate from the process of steady Capsule Endoscopy feasibility as follows: at first to select the patient that need to carry out this inspection, played the influent stream food the 1st day noon, can take inferior morning from the capsule of surely exploring the way, advise the patient to observe the defecation situation, as finding to discharge then clean sending back to of capsule; Carry out the first time after 13 hours and detect, excrete as capsule is complete, then patient's digestive tract is unobstructed, can then go Capsule Endoscopy.As lose capsule and excrete, then go the X-ray examination inspection, roughly locate the capsule position; Carrying out the second time after 12 hours detects, excrete as capsule is complete, then patient's digestive tract is unobstructed, can then go Capsule Endoscopy, otherwise, again go the X-ray examination inspection, the location capsule, identical with last time such as the position, capsule incarceration then should not be gone Capsule Endoscopy, different such as the position, then might be digestive tract transhipment time lengthening, can go every 12 hours again and observe, this moment be such as the complete discharge of capsule, then patient's digestive tract is still unobstructed, such as imperfect discharge, then might be in digestive tract incarceration (judging it is to prolong or retention the duration of runs according to the time), the row Capsule Endoscopy is risky.
Embodiments of the present invention are not limited to this, according to foregoing of the present invention, according to ordinary skill knowledge and the customary means of this area, do not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite, spring of the present invention can also be arranged on head or the afterbody of the capsule of exploring the way simultaneously; Supporter, contrast media layer, adventitia, time marker, enteric shell and spring, spring adventitia also can select other satisfactory material to make; therefore the present invention can also make modification, replacement or the change of other various ways, all drops within the rights protection scope of the present invention.
Claims (10)
1. a digestive tract is from the capsule of surely exploring the way, comprise the capsule body, it is characterized in that: also comprise enteric shell and the elastic component made by degradable material, described elastic component is arranged on an end of described capsule body at least, described enteric shell wraps the capsule body and elastic component makes described elastic component be in compressive state, after the enteric shell arrived the small intestinal dissolving, elastic component recovered former length and prevents upset with the length that increases whole capsule.
2. digestive tract according to claim 1 is from the capsule of surely exploring the way, and it is characterized in that: after described elastic component recovered former length, the length range of the whole capsule of exploring the way was 5～7cm.
3. digestive tract according to claim 1 and 2 is from the capsule of surely exploring the way, it is characterized in that: described elastic component adopts spring, one end of described spring is connected on the described capsule body, and this end is the link of spring, and the other end holds out against on the inwall of described enteric shell.
4. digestive tract according to claim 3 is characterized in that: adopt application of vacuum between described enteric shell and capsule body, the elastic component from the capsule of surely exploring the way.
5. digestive tract according to claim 4 is from the capsule of surely exploring the way, it is characterized in that: described capsule body mainly reaches the time marker of being made by the enteric-coated sustained release material by soluble supporter in Digestive system, contrast media layer, adventitia and forms, it is peripheral that described contrast media layer is coated on described supporter, and described adventitia then is coated on the surface of contrast media layer and supporter coalition; The link of described spring passes adventitia and stretches between adventitia and the contrast media layer fixing.
6. digestive tract according to claim 5 is from the capsule of surely exploring the way, it is characterized in that: described contrast media layer is comprised of blanc fixe and the film body that coats blanc fixe, the link of described spring has fixed disk, and the two sides of described fixed disk is corresponding respectively to be adhesively fixed with film body, adventitia.
7. digestive tract according to claim 6 is from the capsule of surely exploring the way, and it is characterized in that: have through hole on the described adventitia, described time marker closely is inserted in the through hole with the shutoff through hole.
8. digestive tract according to claim 7 is characterized in that from the capsule of surely exploring the way: being coated with in the peripheral monoblock type of described spring can be with the spring adventitia of the common elongation of spring.
9. digestive tract according to claim 8 is characterized in that from the capsule of surely exploring the way: described spring is less than or equal to the critical pressure that makes the intestinal wall perforation for the maximum pressure of intestinal wall.
10. digestive tract according to claim 9 is from the capsule of surely exploring the way, and it is characterized in that: described spring is made by poly-decanedioic acid witcogum, polylactic acid or gelatin; Described spring adventitia is made by polylactic acid, microcrystalline Cellulose or polyvinyl pyrrolidone; Described enteric shell adopts alginate or Algin to make; Described time marker is made by microcrystalline Cellulose, Glyceryl Behenate, polyvinyl pyrrolidone, hydroxypropyl emthylcellulose or lactose; Described supporter adopts gelatin, lactose or starch.
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| CN201210410270.0A CN102920418B (en) | 2012-10-24 | 2012-10-24 | Self-stable patency capsule of alimentary canal |
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|---|---|---|---|
| CN201210410270.0A CN102920418B (en) | 2012-10-24 | 2012-10-24 | Self-stable patency capsule of alimentary canal |
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| CN102920418B CN102920418B (en) | 2014-07-30 |
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| CN110694166B (en) * | 2019-10-15 | 2021-09-28 | 马也 | Enteral administration system |
| CN113598689A (en) * | 2021-08-02 | 2021-11-05 | 安徽光阵光电科技有限公司 | Internal endoscope pill capable of being remotely controlled |
| WO2023186155A1 (en) * | 2022-03-31 | 2023-10-05 | 上海安翰医疗技术有限公司 | Digestive tract simulation capsule and preparation method therefor |
| CN115251807A (en) * | 2022-09-26 | 2022-11-01 | 徐州医科大学 | Capsule endoscope system |
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| CN102920418B (en) | 2014-07-30 |
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