CN102920418B - Self-stable patency capsule of alimentary canal - Google Patents
Self-stable patency capsule of alimentary canal Download PDFInfo
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- CN102920418B CN102920418B CN201210410270.0A CN201210410270A CN102920418B CN 102920418 B CN102920418 B CN 102920418B CN 201210410270 A CN201210410270 A CN 201210410270A CN 102920418 B CN102920418 B CN 102920418B
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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 through FDA Food and Drug Administration approval for since the inspection of disease of intestine, the features 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 becoming a common complication of capsule endoscope in intestinal tumor or the narrow capsule retention body causing.Because capsule endoscope non-degradable, in retention body, must take out, otherwise will cause serious consequence.Small intestinal is different from stomach and colon, because its anatomical position and structure are special, once capsule endoscope generation retention is taken out more difficultly, sometimes even needs row laparotomy ventrotomy, and this has brought great misery to patient.
Therefore whether retention is particularly important in vivo, to judge in advance capsule endoscope.At present, how clinician is first according to medical history Preliminary screening patients undergoing examination of capsule endoscopy, then the further clear and definite bowel narrow that whether exists of row contrast examination.But this method accuracy rate is not high, some patient fails to pinpoint a disease in diagnosis, and some patient's radiography result shows bowel narrow, but still can complete Capsule Endoscopy.This explanation, soon differs and is decided to be reality, only has personal practice to know actually.Some bowel narrow is false stricture, capsule endoscope by 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 they can have or not narrow for assessing intestinal before Capsule Endoscopy.Above-mentioned two kinds of capsules are all similar to conventional capsule scope size, but, it moves unpredictable in small intestinal, capsule very easily rolls, because this degradable capsule cannot 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 capsule endoscope patient, safe, easy and effective, for clinician determines next step whether feasible Capsule Endoscopy, provides good foundation.
Object of the present invention realizes by following technical measures: a kind of digestive tract is from the capsule of surely exploring the way, comprise capsule body, it is characterized in that: also comprise enteric shell and the elastic component by degradable material, made, described elastic component is at least arranged on one end of described capsule body, described enteric shell wraps capsule body and elastic component makes described elastic component in compressive state, enteric shell arrives after small intestinal dissolving, and elastic component recovers former length and to increase the length of whole capsule, prevents upset.
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, can accurate evaluation from the feasibility of steady Capsule Endoscopy.
Elastic component of the present invention recovers after former length, and the length range of the whole capsule of exploring the way is 5-7cm.The entire length of the present invention after retracting spring is greater than the maximum gauge of small intestinal, realized the object that prevents upset, avoided retention at small intestinal normal turn position simultaneously, and make its can not accurate evaluation from the feasibility of steady Capsule Endoscopy.
As the preferred embodiment of the present invention, described elastic component adopts spring, and one end of described spring is connected on described capsule body, the link that this end is spring, and the other end holds out against on the inwall of described enteric shell.
For further, by spring compression, between enteric shell of the present invention and capsule body, elastic component, adopt application of vacuum.
As one embodiment of the present invention, described capsule body is mainly comprised of soluble supporter in Digestive system, contrast media layer, adventitia and the time marker made by enteric-coated sustained release material, it is peripheral that described contrast media layer is coated on described supporter, and described adventitia is coated on the surface of contrast media layer and supporter coalition; The link of described spring stretches between adventitia and contrast media layer fixing through adventitia.
Contrast media layer of the present invention is comprised of the film body of blanc fixe and coated blanc fixe, and the link of described spring has fixed disk, and the two sides of described fixed disk is corresponding to be respectively adhesively fixed with film body, adventitia.
On adventitia of the present invention, have through hole, described time marker is closely inserted in through hole with shutoff through hole.
As a modification of the present invention, in the peripheral monoblock type of described spring, being coated with can be with the common spring adventitia extending of spring.Spring adventitia both can prevent Spring Card pressure ileocecal valve, also can increase the contact area between spring and enteric shell, thereby can protect 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 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 gathering decanedioic acid witcogum, polylactic acid or gelatin, and this material should have good biocompatibility, suitable elasticity and the characteristic of biodegradability; Spring adventitia is made by 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 select enteric-coated sustained release material as making such as microcrystalline Cellulose, Glyceryl Behenate, polyvinyl pyrrolidone, hydroxypropyl emthylcellulose, lactose, it can keep basicly stable in specifying 72-96 hours, after the fixed time (96-120 hour), all dissolves; Supporter adopts soluble gelatin, lactose, starch etc. in Digestive system, and its ratio weight is adjustable, and to meet the quality of whole capsule, surely capsule endoscope is similar to oneself.
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 intestinal wall radius, σ
tfor small bowel elastic modelling quantity); P
max=σ
s* x/S; (σ
sfor the elastic modelling quantity of spring, x is largest deformation amount, the area that S is fixed disk).
Compared with prior art, the present invention has following significant effect:
(1) 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, can accurate evaluation from the feasibility of steady Capsule Endoscopy.
(2) not only noinvasive, safety of the present invention, and reliable, neither allow patient stand unnecessary inspection, do not allow patient lose a kind of chance of good auxiliary diagnosis disease yet.
(3) spring adventitia both can prevent Spring Card pressure ileocecal valve; also can increase the contact area between spring and enteric shell; thereby can protect 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 intestinal wall.
(4) the entire length of the present invention after retracting spring is greater than the maximum gauge of small intestinal, realized the object that prevents upset, avoided being trapped in small intestinal normal turn position simultaneously, cause its can not accurate evaluation from the feasibility of steady Capsule Endoscopy.
(5) enteric shell vacuum packet is rolled in the periphery of capsule body and elastic component, can be further by spring compression.
(6) the present invention is the preview that true capsule endoscope checks in digestive tract, can find the narrow positions that capsule endoscope cannot pass through really, for the inspection of capsule endoscope provides safety guarantee and for existing the patient of Digestive Tract Stenosis that the once chance of feasible Capsule Endoscopy is provided.
Accompanying drawing explanation
Below in conjunction with the drawings and specific embodiments, the present invention is described in further detail.
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 in Fig. 2;
Fig. 4 is the FB(flow block) that uses evaluate capsules endoscopy feasibility of the present invention.
The specific embodiment
As shown in Figures 1 to 3, be a kind of digestive tract of the present invention from the capsule 6 of surely exploring the way, its size, quality, outward appearance are all basic identical with existing common capsule endoscope, and it comprises degradable capsule body 1 and enteric shell 2 and the elastic component by degradable material, made; Elastic component adopts spring 3, spring 3 is arranged on wherein one end (afterbody of the capsule of exploring the way) of capsule body 1, enteric shell 2 vacuum packet wrap capsule body 1 and spring 3 makes spring 3 in compressive state, one end of spring 3 is connected on capsule body, this end is the link 31 of spring 3, the other end holds out against on the inwall of enteric shell 2, enteric shell arrives after small intestinal dissolving, elastic component recovers former length and prevents upset to increase the length of the whole capsule of exploring the way, and the length of whole capsule is greater than human small intestine's maximum gauge.Generally speaking, at elastic component, recover after former length, the length range of the whole capsule of exploring the way is 5-7cm.
Capsule body 1 is mainly comprised of soluble supporter 11, contrast media layer, adventitia 13 in Digestive system and the time marker 14 made by enteric-coated sustained release material, contrast media layer is coated on supporter 11 peripheries, and adventitia 13 is coated on the surface of contrast media layer and supporter 11 coalitions; The link 31 of spring 3 stretches between adventitia 13 and contrast media layer fixing through adventitia 13; In the present embodiment, contrast media layer is comprised of blanc fixe 12 and the film body 15 of coated blanc fixe, externally shows the shape of the capsule of exploring the way when the capsule of exploring the way is complete under x-ray.The link 31 of spring 3 has fixed disk 32, fixed disk 32 is that the aperture by the capsule end of exploring the way enters the rear folding circular disk body forming by the link 31 of spring 3, the two sides of fixed disk 32 is corresponding to be respectively adhesively fixed with biogum or UV glue with film body 15, adventitia 13, prevents that intestinal juice from entering.On adventitia 13 and corresponding to the head of the capsule of exploring the way, have through hole, time marker 14 is closely inserted in through hole with shutoff through hole, between time marker 14 and through hole peritreme, does not stay gap, prevents that Digestive system from flowing into from gap.
In the peripheral monoblock type of spring 3, being coated with can be with the common spring adventitia 4 extending of spring 3.Spring adventitia 4 can prevent Spring Card pressure ileocecal valve, also can increase the contact area between spring and enteric shell, reduces the friction between spring and 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 intestinal wall radius, σ
tfor small bowel elastic modelling quantity); P
max=σ
s* x/S; (σ
sfor the elastic modelling quantity of spring, x is largest deformation amount, the area that S is fixed disk).
In the present embodiment, enteric shell adopts alginate, Algin or other enteric material to make; Spring is made by materials such as gathering decanedioic acid witcogum, polylactic acid or gelatin, and poly-decanedioic acid witcogum, polylactic acid and gelatin are degradable biological elastomeric material, and can add disintegrating agent to regulate its biodegradability; The material of spring is selected to need to meet: (1) good biocompatibility; (2) degradable (increase safety, as retention, discharge after degradable); (3) suitable to intestinal wall pressure.Approximately 12 hours normal person's digestive tract evacuation time, average approximately 24 hours.It is stable that enteric shell keeps under the effect of gastric gastric juice, enter after small intestinal the rapid disintegrate of variation due to pH value and intestinal fluid composition, time is less than 10 minutes, now discharge compressed spring, spring and capsule body form an integral body and move under small intestinal peristalsis effect, its increasing that takes up space, whole anteroposterior diameter surpasses small intestinal maximum gauge, has reached the effect that prevents upset; Spring adventitia can be made by degradation material polylactic acid or other enteric-coated sustained release materials, as explores the way capsule not in retention body, and it can be discharged from anus with capsule; Otherwise this spring adventitia starts degraded after surpassing the given time (about 96-120 hour), after degraded, Digestive system pours in from the capsule body tail end aperture of exploring the way, and accelerates to explore the way 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, simulation capsule endoscope is by human body alimentary canal process, and complete excreting, adventitia is degradable after 96-120 hour, in case of bowel narrow blocks incarceration, can monitor roughly incarceration position by x-ray, and extend in time, also can after the above-mentioned fixed time, degrade, finally excrete, can retention body in, time marker can select enteric-coated sustained release material 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 completely exceeding schedule time, in the transhipment of normal stool road, this capsule of exploring the way can keep complete, Reality simulation capsule endoscope is by digestive tract discharge, be that it can keep basicly stable in specifying 72-96 hours, after fixed time (96-120 hour), all dissolve, once exceed schedule time, capsule is not discharged yet, along with the dissolving of time marker, Digestive system enters dissolving supporter in capsule, capsule body subsides thereupon, supporter adopts soluble gelatin, lactose, starch etc. in Digestive system, and its ratio weight is adjustable, and to meet the quality of whole capsule, surely capsule endoscope is similar to oneself.
Operation principle of the present invention is summarized as follows: when the capsule of exploring the way is met narrow or locking and can not be passed through in digestive tract, the temporary transient incarceration of the capsule of exploring the way therewith, when after the stipulated time, adventitia and time marker dissolve completely, the spring of afterbody is also degraded, and Digestive system enters after the past in capsule body and dissolves supporter, and whole capsule subsides, residue amorphous substance can pass through narrow positions, from anus, excretes.
Visible, effect of the present invention is: whether (1) assess patient is applicable to row Capsule Endoscopy; (2) monitoring capsule position; (3) find Digestive Tract Stenosis position.
As shown in Figure 4, use the present invention to evaluate from the process of steady Capsule Endoscopy feasibility as follows: the patient that first selection need to be carried out this inspection, the 1st day noon, played influent stream food, can take inferior morning from the capsule of surely exploring the way, advise patient to observe defecation situation, as found, discharge capsule and clean and send back to; After 13 hours, detect for the first time, as capsule is complete, excrete, patient's digestive tract is unobstructed, then row Capsule Endoscopy.As lose capsule and excrete, row X-ray examination checks, roughly locates capsule position, after 12 hours, detect for the second time, as capsule is complete, excrete, patient's digestive tract is unobstructed, then row Capsule Endoscopy, otherwise, row X-ray examination checks again, location capsule, as identical with last time in position, capsule incarceration, should not row Capsule Endoscopy, as different in position, it is likely digestive tract transhipment time lengthening, can go and observe again every 12 hours, now discharge as complete in capsule, patient's digestive tract is still unobstructed, as imperfect discharge, incarceration (being to extend or retention the duration of runs according to time judgement) in digestive tract likely, 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 departing 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, within all dropping on rights protection scope of the present invention.
Claims (10)
1. a digestive tract is from the capsule of surely exploring the way, comprise capsule body, it is characterized in that: also comprise enteric shell and the elastic component by degradable material, made, described elastic component is at least arranged on one end of described capsule body, described enteric shell wraps capsule body and elastic component makes described elastic component in compressive state, enteric shell arrives after small intestinal dissolving, and elastic component recovers former length and to increase the length of whole capsule, prevents upset.
2. digestive tract according to claim 1, from the capsule of surely exploring the way, is characterized in that: described elastic component recovers after former length, and the length range of the whole capsule of exploring the way is 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 described capsule body, the link that this end is spring, and the other end holds out against on the inwall of described enteric shell.
4. digestive tract according to claim 3, from the capsule of surely exploring the way, is characterized in that: between described enteric shell and capsule body, elastic component, adopt application of vacuum.
5. digestive tract according to claim 4 is from the capsule of surely exploring the way, it is characterized in that: described capsule body is mainly comprised of soluble supporter in Digestive system, contrast media layer, adventitia and the time marker made by enteric-coated sustained release material, it is peripheral that described contrast media layer is coated on described supporter, and described adventitia is coated on the surface of contrast media layer and supporter coalition; The link of described spring stretches between adventitia and contrast media layer fixing through adventitia.
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 the film body of blanc fixe and coated blanc fixe, the link of described spring has fixed disk, and the two sides of described fixed disk is corresponding to be respectively adhesively fixed with film body, adventitia.
7. digestive tract according to claim 6, from the capsule of surely exploring the way, is characterized in that: on described adventitia, have through hole, described time marker is closely inserted in through hole with shutoff through hole.
8. digestive tract according to claim 7, from the capsule of surely exploring the way, is characterized in that: in the peripheral monoblock type of described spring, being coated with can be with the common spring adventitia extending of spring.
9. digestive tract according to claim 8, from the capsule of surely exploring the way, is characterized in that: described spring is less than or equal to for the maximum pressure of intestinal wall the critical pressure that makes intestinal wall perforation.
10. digestive tract according to claim 9, from the capsule of surely exploring the way, is characterized in that: described spring is made by gathering 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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210410270.0A CN102920418B (en) | 2012-10-24 | 2012-10-24 | Self-stable patency capsule of alimentary canal |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210410270.0A CN102920418B (en) | 2012-10-24 | 2012-10-24 | Self-stable patency capsule of alimentary canal |
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| Publication Number | Publication Date |
|---|---|
| CN102920418A CN102920418A (en) | 2013-02-13 |
| CN102920418B true CN102920418B (en) | 2014-07-30 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201210410270.0A Expired - Fee Related CN102920418B (en) | 2012-10-24 | 2012-10-24 | Self-stable patency capsule of alimentary canal |
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Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN203539304U (en) * | 2013-07-08 | 2014-04-16 | 南方医科大学南方医院 | Digestive tract patency capsule |
| CN105030183B (en) * | 2015-09-09 | 2016-11-16 | 京东方科技集团股份有限公司 | A kind of endoscope and medical detection system |
| CN106923787B (en) * | 2015-12-29 | 2023-11-24 | 上海安翰医疗技术有限公司 | Capsule endoscope advanced lens and detection method thereof |
| CN106725634B (en) * | 2017-01-23 | 2024-01-16 | 天津医科大学总医院 | Intestinal microorganism collection capsule |
| IL301683A (en) | 2017-05-17 | 2023-05-01 | Massachusetts Inst Technology | Self-righting systems and related components and methods |
| US11541015B2 (en) | 2017-05-17 | 2023-01-03 | Massachusetts Institute Of Technology | Self-righting systems, methods, and related components |
| 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 |
| CN114712527B (en) * | 2022-03-31 | 2024-01-09 | 上海安翰医疗技术有限公司 | Digestive tract simulation capsule and preparation method thereof |
| CN115251807B (en) * | 2022-09-26 | 2022-12-06 | 徐州医科大学 | Capsule endoscope system |
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| JPS58194809A (en) * | 1982-05-07 | 1983-11-12 | Matsushita Electric Ind Co Ltd | Capsule for applying drug into digestive tract |
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