CN110123498A - A kind of enteron aisle internal bypass bracket component and its fixing means - Google Patents
A kind of enteron aisle internal bypass bracket component and its fixing means Download PDFInfo
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- CN110123498A CN110123498A CN201810134821.2A CN201810134821A CN110123498A CN 110123498 A CN110123498 A CN 110123498A CN 201810134821 A CN201810134821 A CN 201810134821A CN 110123498 A CN110123498 A CN 110123498A
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- bracket
- enteron aisle
- protruding portion
- fixing piece
- internal bypass
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2002/821—Ostial stents
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention discloses a kind of enteron aisle internal bypass bracket component and its fixing means, and specifically, which includes bracket and fixing piece；Bracket has through-hole and cradle wall, and cradle wall includes the first protruding portion, the second protruding portion and fixed part, and fixed position is between the first protruding portion and the second protruding portion；Fixing piece is hard ring structure；If the minimum value in the outer diameter of the outer diameter of the first protruding portion and the second protruding portion is d1, the outer diameter of fixed part is d2, the internal diameter of fixing piece is d3, then d1> d3> d2；In use, bracket is located in enteron aisle, fixing piece is placed on parenterally and is fastened in the corresponding position of fixed part of bracket to fix the bracket in enteron aisle.Operation of the present invention is easy, is safely and reliably fixed for protecting the protective case of rectum previous anastomotic, and can be avoided and cause to damage to intestinal tube in use.
Description
Technical field
The present invention relates to medical instruments field, relate more specifically to a kind of enteron aisle internal bypass bracket component and its fixation side
Method.
Background technique
Various brackets have had the long period in gastral application, and no matter bracket is hard, soft, air bag or water
Capsule, overlay film it is netted, memorial alloy, no matter also bracket is to expand behind in-position or there is dilatancy structure at both ends
, in oesophagus, cardia, biliary tract, there is the colon of Stenotic pathologic change that can be placed in, though there is certain displacement probability, it is overall fine
It is satisfied.But at present various brackets can not but be stopped in the colon of normal configuration function, this is because the special construction of colon and
What motion mode determined.
The intestinal wall muscle of colon is divided into interior circular muscle and outer longitudinal muscle, and China and foreign countries' longitudinal muscle is shorter than tunica serosa coli stringer, thus is formed
" haustrum ", this makes colon have biggish dilatancy, and general dilatancy bracket is difficult to stop.Meanwhile the wriggling of colon point three
Kind: one is bag-shaped back and forth movement on an empty stomach, this bracket that one end is expanded is difficult to stop；Second is that caused more after feed
Bag advancing movement, outer longitudinal muscle has apparent partial thickening at this time, causes the pressure to lateral surface in intestinal wall；Third is that move distance
Longer contraction wave, the muscle diastole in front of contraction wave, this is but also expansionary bracket is difficult to stop.
Face two big difficulties: one of problem: colon and the excision of rectal portion intestinal tube behind colon and rectum resection at present
Since enteral mucous membrane face is with the presence of the Escherichia coli that do not can be removed the probability of previous anastomotic microabscess and fistula occurs for previous anastomotic afterwards
Much larger than other alimentary tract anastomosis mouths, so for the previous anastomotic protection problem after sigmoid colon and rectum resection for a long time one
It is directly one of the hot spot of domestic and international Colon and rectum operations research.Previous alimentary stent be in order to treat lesion part it is narrow,
It is rarely employed in Normal Colon.But just constantly there are patent and article to illustrate that one kind is called " in enteron aisle from the nineties in last century
The concept of shunting device " means and a flexible film pipeline is fixed on above colon previous anastomotic, film pipeline upper end with
One stent in colon connection, is in close contact between a certain position of bracket and colonic mucosa, so that it is soft to flow into intestinal contents
Property pipeline in be expelled directly out anus, Escherichia coli will not pollute the previous anastomotic that soft pipeline is isolated, reach reduce previous anastomotic purulence
Swollen and fistula purpose.But the device does not occur in clinic so far, reason is exactly to be difficult to the film pipeline not damaging intestines
Indwelling is in colon in the case where wall.The two of problem: in carcinoma of the rectum clinical treatment, the operation of low level and extremely low position reservation anus
It is increasingly mature.It is provisional big but after cutting off musculus sphincter ani internus, that is, after having carried out Intersphincteric Resection (IRS)
The incidence of fecal incontinence is very high, and comprehensive literature data are that incidence is 70-80% in 3 months, but recovery rate after three months
It is 90%.The situation causes the state that incontinence of faces is in patient's some months after surgery, even if being also that can not prevent with paper diaper
Only peculiar smell and part are filthy.
In order to solve the problems, such as two of the above low rectal excision, most of current way is to carry out preventative colon to make
Fistula, but the fistulization itself has complication again, but also undergoes primary operation also to be received again after needing half a year, increases patient's
Pain and burden.
The thinking that excrement drains anus can solve the above problem with film pipeline, but how by film pipeline compared with
It is fixed on specific colon site for a long time, is the technological difficulties for being difficult to overcome always.Colon has following characteristics: when soft, long
Between squeezing will lead to that rotten to the corn perforation, dilatancy is big, muscle contractility is strong, mucous membrane controls every two weeks will be detached from one layer, these
Existing bracket is caused to be difficult in Normal Colon.
Summary of the invention
The purpose of the present invention is to provide one kind the long period to fix film pipeline, and does not damage intestinal tube, and pacify
It is complete reliable, easy to operate enteron aisle internal bypass bracket component and its fixing means.
In the first aspect of the present invention, a kind of enteron aisle internal bypass bracket component is provided, specifically, including bracket and fixation
Part；The bracket has through-hole and cradle wall, and the cradle wall includes the first protruding portion, the second protruding portion and fixed part, described
Fixed position is between first protruding portion and second protruding portion；The fixing piece is hard ring structure；If described
Minimum value in the outer diameter of the outer diameter of first protruding portion and second protruding portion is d1, the outer diameter of the fixed part is d2, described
The internal diameter of fixing piece is d3, then d1> d3> d2；In use, the bracket is located in enteron aisle, the fixing piece is placed on parenterally simultaneously
And the corresponding position of fixed part for being fastened in the bracket is to fix the bracket in enteron aisle.
In another preferred example, the bracket is that integrated or more bodies form.
In another preferred example, the hard ring structure is made of multiple ring-shaped components, the connection of each ring-shaped component
Mode is selected from the combination for snapping connection, latching one or more of connection, threaded connection, hinge connection, embedded magnet；
Preferably, each ring-shaped component is connected by a snap；It is highly preferred that the buckle has multiple shelf grades, by adjusting the shelves
Grade adjusts the diameter of the fixing piece.
In another preferred example, d3With d2Between difference be 3-20mm；It preferably, is 10-15mm.
In another preferred example, d3With d2Between difference be 1.0-4.0 times of intestinal wall thickness；It preferably, is intestinal wall thickness
2.0-4.0 times；More preferably, it is 2.0-3.0 times of intestinal wall thickness.
In another preferred example, when being used for people's rectum, d3With d2Between difference be preferably 10-15mm.
In another preferred example, some or all of structure in the enteron aisle internal bypass bracket component can be dropped by biology
It solves made of material.
In another preferred example, the degradation cycle of the biodegradable material is 0.5-6 months.
In another preferred example, the degradation cycle of the bracket and the fixing piece is close or identical.
In another preferred example, the component is used for the higher occasion of anastomotic site, incontinence of faces problem is not present, only
The e. coli contamination of previous anastomotic is isolated, the out-of-service time of the fixing piece or the bracket in enteron aisle is 2-3 weeks.
In another preferred example, the component makes for ultralow anastomosis there may be the occasion of incontinence of faces problem
Isolation previous anastomotic e. coli contamination is contained with purpose and intestinal contents are introduced into colostomy bag, the fixing piece or the branch
Out-of-service time of the frame in enteron aisle is 3-6 months.
In another preferred example, the biodegradable material is in PLA, PGA, PDMA, PPDO, PCL, PTMC
The copolymer of one or more kinds of materials or the mixture of above-mentioned material.
In another preferred example, the inner surface of the fixing piece be outer male structure, and the shape of the outer male structure with
The shape of the outer surface of the fixed part is adaptable.
In another preferred example, the height of the fixing piece is 2-40mm；It preferably, is 3-30mm；It more preferably, is 4-
10mm。
In another preferred example, multiple fixed parts are equipped between first protruding portion and second protruding portion,
And each fixed part is equipped with the matched fixing piece.
In another preferred example, there are partition-type structures, the outer diameter of the partition-type structures is greater than between the adjacent fixed part
The outer diameter of the fixed part.
A kind of enteron aisle internal bypass device is provided in the second aspect of the present invention, includes enteron aisle as described in claim 1
Internal bypass bracket component, which is characterized in that further include film pipeline, one end of the film pipeline connect with the bracket and with
The through-hole of the bracket is formed through the channel (keeping apart big intestinal contents and bowel anastomosis mouth) of big intestinal contents outflow.
In another preferred example, the other end of the film pipeline extends outside anus and connect with colostomy bag.
In another preferred example, the film pipeline is rubber protecting jacket；Preferably, the rubber protecting jacket is used and is kept away
The identical material of pregnant set is made.
In another preferred example, the outer wall of the film pipeline is also coated with antimicrobial component.
A kind of fixing means of enteron aisle internal bypass bracket component, including following step are provided in the third aspect of the present invention
It is rapid:
A. enteron aisle internal bypass bracket component is provided, the enteron aisle internal bypass bracket component includes bracket and fixing piece；It is described
Bracket has through-hole and cradle wall, and the cradle wall includes the first protruding portion, the second protruding portion and fixed part, the fixed part
Between first protruding portion and second protruding portion；The fixing piece is hard ring structure；If described first is prominent
The minimum value in the outer diameter of the outer diameter in portion and second protruding portion is d out1, the outer diameter of the fixed part is d2, the hard ring
The internal diameter of shape structure is d3, then d1> d3> d2；
B. the branch is placed on inside enteron aisle；
C. the fixing piece is placed on parenterally and is fastened in the corresponding position of fixed part of the bracket, to fix intestines
The bracket in road.
It should be understood that above-mentioned each technical characteristic of the invention and having in below (eg embodiment) within the scope of the present invention
It can be combined with each other between each technical characteristic of body description, to form a new or preferred technical solution.As space is limited, exist
This no longer tires out one by one states.
Detailed description of the invention
In order to more clearly explain the embodiment of the invention or the technical proposal in the existing technology, to embodiment or will show below
There is attached drawing needed in technical description to do simply to introduce, it should be apparent that, the accompanying drawings in the following description is only this
Some embodiments of invention for those of ordinary skill in the art without creative efforts, can be with
Other alternative embodiments are obtained according to these attached drawings.
Fig. 1 is the side view of the enteron aisle internal bypass bracket component in one embodiment of the invention；
Fig. 2 is the cross-sectional view of the Section A-A of the bracket component of enteron aisle internal bypass shown in Fig. 1；
Fig. 3 is the perspective view of the enteron aisle internal bypass bracket component in one embodiment of the invention；
Fig. 4 is the exploded view of the fixing piece in the bracket component of enteron aisle internal bypass shown in Fig. 3；
Fig. 5 is the perspective view of the fixing piece in another embodiment of the invention；
The left side Fig. 6 is the partial structurtes signal that enteron aisle internal bypass bracket component in one embodiment of the invention is fixed on enteron aisle
Figure；The right side Fig. 6 is the cross-sectional view in the section E-E on the left side Fig. 6；
The left side Fig. 7 is the enteron aisle internal bypass bracket group with multiple fixed parts and partition-type structures in one embodiment of the invention
The structural schematic diagram of part；The right side Fig. 7 is the cross-sectional view in the section F-F on the left side Fig. 7；
Fig. 8 be after low rectal resection operation the fixed bracket of different modes to the degree of impairment of intestinal wall at bracket placement location
Comparison, in a figure fixed using absorbable thread, in b figure fixed using braid over braid, repaired using chest department of general surgery in c figure
Film (commercial product) is fixed, and d figure is using the enteron aisle internal bypass bracket component in one embodiment of the invention；
Fig. 9 be use and be not used at beasle dog bowel anastomosis mouth the present invention bypass bracket component protection rectum sample by
Three groups of comparative test figures of e. coli contamination degree.
In each attached drawing, each mark is as follows:
1- bracket；11- through-hole；The outlet of 111- through-hole；12- cradle wall；The first protruding portion of 121-；The second protruding portion of 122-；
123- fixed part；2- fixing piece；21- fixing piece inner surface；3- film pipeline；4- enteron aisle；41- intestinal wall；5- previous anastomotic；6- anus
Door；7- colostomy bag；8- intestinal contents；9- partition-type structures；d1In the outer diameter of the outer diameter of-the first protruding portion and second protruding portion
Minimum value；d2The outer diameter of fixed part；d3The internal diameter of fixing piece；The height of h- fixing piece.
Specific embodiment
The present inventor after extensive and in-depth study, by largely screening, develops a kind of enteron aisle internal bypass branch for the first time
Frame component and its fixing means, it is compared with prior art, of the invention it is critical that while guaranteeing completely isolated excrement,
The theory for proposing the outer fixing piece of hard, is arranged gap between internal stent and outer fixing piece, to reach neither squeezing damage intestines
Pipe, the effect for passing intestines peristalsis wave smoothly down.The present invention has been started is isolated one section of intestinal wall not by enteron aisle content in colon
The feasible method of object pollution, this method are also possible to extend to other alimentary canals.It is general postoperative as long as isolation time long enough
Anastomotic leakage can be prevented and treated, and complete the present invention on this basis.
Term
As used herein, term " hard ring structure " refers to that the structure is ring-shaped on the whole and is hard.Institute
The annular stated includes the various possible annulars such as annulus, elliptical ring, Fang Huan, amorphous ring；The hard should be understood as having
There is certain rigidity so that its structure or the available holding of shape, hardness is greater than shore A50 degree under normal conditions, preferably
It is A80 degree of shore or more.The hardness of these grades can be realized with material well known in the art.
Present invention will be further explained below with reference to specific examples.It should be understood that these embodiments are merely to illustrate the present invention
Rather than it limits the scope of the invention.In addition, attached drawing is schematic diagram, therefore apparatus of the present invention and equipment are not shown by described
The size or ratio of intention limit.
It should be noted that in the claim and specification of this patent, such as first and second or the like relationship
Term is only used to distinguish one entity or operation from another entity or operation, without necessarily requiring or implying
There are any actual relationship or orders between these entities or operation.Moreover, the terms "include", "comprise" or its
Any other variant is intended to non-exclusive inclusion so that include the process, methods of a series of elements, article or
Equipment not only includes those elements, but also including other elements that are not explicitly listed, or further include for this process,
Method, article or the intrinsic element of equipment.In the absence of more restrictions, being wanted by what sentence " including one " limited
Element, it is not excluded that there is also other identical elements in the process, method, article or apparatus that includes the element.
Embodiment 1
As shown in Figs. 1-2, the enteron aisle internal bypass bracket component of the present embodiment includes bracket 1 and fixing piece 2.The bracket 1 packet
Through-hole 11 and cradle wall 12 are included, cradle wall 12 includes the first protruding portion 121, the second protruding portion 122 and fixed part 123, fixed part
123 between the first protruding portion 121 and the second protruding portion 122, and fixed part is a hollow tube, and protruding portion is bell-mouth structure of air,
The fixing piece 2 includes fixing piece inner surface 21, and fixing piece 2 is hard ring structure, and the height of fixing piece is h.Described first is prominent
The minimum value in the outer diameter of the outer diameter in portion 121 and second protruding portion 122 is d out1, the outer diameter of the fixed part is d2, described
The internal diameter of fixing piece is d3, then d1> d3> d2。
The outer diameter of the protruding portion refers to being located on protruding portion outer surface and be located at perpendicular to the same of 11 axis of through-hole
The maximum distance between two o'clock in plane；The outer diameter of fixed part refers to being located on fixed part outer surface and be located at perpendicular to logical
The maximum distance between two o'clock on the same plane of 11 axis of hole；The internal diameter of fixing piece is referred to when fixing piece ring set is in bracket
On fixed part and when fixing piece upper surface is vertical with the axis of through-hole 11, it is located on fixing piece inner surface and is located at perpendicular to logical
The maximum distance between two o'clock on the same plane of 11 axis of hole.
Gap is (d between 123 outer surface of inner surface and the fixed part of the fixing piece 23-d2)/2, the gap are
Refer to when 2 ring set of fixing piece is on fixed part 123 and when fixing piece is overlapped with the center of fixed part, the inner surface of fixing piece with lean on
The distance between the outer surface of fixed part of inner surface of the nearly fixing piece.
The d3With d2Between difference are as follows: 6-20mm；Preferably, 10-15mm.
According to above-mentioned d3With d2Between difference, we calculate when this bypass bracket component is used on human body, d3With d2It
Between difference be 1.0-4.0 times of intestinal wall thickness；Preferably, it is 2.0-4.0 times of intestinal wall thickness；Preferably, being intestinal wall thickness
2.0-3.0 times.Intestinal wall thickness is about in 3-7mm, especially people's rectum section generally in 5mm or so, for this intestinal wall thickness,
We are by groping to think d3With d2Between difference be set as present invention bypass bracket component in the case where 10-15mm and can reach
To best effect.
In another preferred example, the bracket is that integrated or more bodies form.In another preferred example, in the enteron aisle
Some or all of structure in bypass bracket component is made of biodegradable material, it is possible thereby to make fixed bracket
By degradation failure after anastomotic healing, and excrete.In preferred situation, in the enteron aisle internal bypass bracket component
Fixing piece is entirely made of biodegradable material；And the bracket in the enteron aisle internal bypass bracket component can be by non-
Made of biodegradable material or the bracket can partially be or be entirely made of biodegradable material.
Anyway, the present invention by biodegrade it is emphasized that can make the fixed function of enteron aisle internal bypass bracket component fail
To excrete.
In another preferred example, the biodegradable material is in PLA, PGA, PDMA, PPDO, PCL, PTMC
The copolymer of one or more kinds of materials or the mixture of above-mentioned material.
In another preferred example, the degradation cycle of the biodegradable material is 0.5-6 months.
In another preferred example, the bracket 1 and the degradation cycle of the fixing piece 2 are close or identical.
It should be noted that bracket of the present invention can only not use structure shown in the drawings, can also use more
The different structure type of kind.In a preferred example the bracket have the characteristics that shown in the claims in the present invention (have through-hole and
Cradle wall, the cradle wall include the first protruding portion, the second protruding portion and fixed part, and the fixed position is prominent in described first
Between portion and second protruding portion) under the premise of, it can be the ring-types such as any possible structure, such as Valtrac anastomosis ring
Bracket, be also possible to the supporting structure being made of inflating balloon, be also possible to network.Optimally, described
Bracket also uses hard structure.
Embodiment 2
As in Figure 3-5, the enteron aisle internal bypass bracket component of the present embodiment includes bracket 1 and fixing piece 2.The bracket 1 packet
Through-hole 11 and cradle wall 12 are included, through-hole 11 includes through-hole outlet 111, and cradle wall 12 includes the first protruding portion 121, the second protruding portion
122 and fixed part 123, fixed part 123 between the first protruding portion 121 and the second protruding portion 122, the fixing piece 2 this fix
Part 2 includes fixing piece inner surface 21, and ring-shaped component 22, fixing piece 2 is hard ring structure.
Minimum value in the outer diameter of the outer diameter of first protruding portion 121 and second protruding portion 122 is d1, described solid
The outer diameter for determining portion is d2, the internal diameter of the fixing piece is d3, then d1> d3> d2；
In another preferred example, the hard ring structure 2 is by multiple ring-shaped components 22, the connection of multiple ring-shaped components 22
Mode is selected from the combination for snapping connection, latching one or more of connection, threaded connection, hinge connection, embedded magnet.
Fig. 4 and Fig. 5 shows that the structure of two different fixed rings according to the present invention, fixed ring are made of two semicircular rings, two
Semicircular ring is connected by a snap.Preferably, which can also have multiple shelf grades, adjust institute by adjusting the shelf grade
State the interior size of fixing piece.
In another preferred example, the hard ring structure 2 is the ring structure with opening, and the size of opening is small and props up
The outer diameter size of frame fixed part.
In another preferred example, the inner surface of the fixing piece be outer male structure, and the shape of the outer male structure with
The shape of the outer surface of the fixed part be it is conformal answer, to reduce extruding to intestinal wall.
In another preferred example, it is reduction to the extruding force of intestinal wall, the contact area of fixing piece and intestinal wall can be increased, such as
The hard ring structure that the fixing piece is formed with certain altitude be can reach into the effect, the height h of the preferably described fixing piece
For 2-40mm；It is highly preferred that being 3-30mm；It more preferably, is 4-10mm.
In another preferred example, the connecting portion two sides of ring-shaped component 22 have groove.
Embodiment 3
As shown in fig. 6, the enteron aisle internal bypass bracket component of embodiment 3 is similar with embodiment 1 or 2, different is real
The bracket component for applying example 3 further includes film pipeline 3, one end of the film pipeline 3 connect with one end of the bracket 1 and with institute
The through-hole 11 for stating bracket 1 is formed through the channel of 4 content of enteron aisle circulation, and intestinal contents 8 are isolated with bowel anastomosis mouth 6
It opens.
In another preferred example, the bracket component is used for the higher occasion of anastomotic site, and incontinence of faces problem is not present,
The e. coli contamination of previous anastomotic is only isolated, the out-of-service time of the fixing piece 2 or the bracket 1 in enteron aisle is 2-3
Week.
In another preferred example, the bracket 1 is that there may be the occasions of incontinence of faces problem for ultralow anastomosis mouth；
Preferably, the bracket component further includes colostomy bag 7, and the one end of the colostomy bag 7 and the film pipeline 3 extended outside anus connects
It connects, the present embodiment bracket component contains isolation 6 e. coli contamination of previous anastomotic using purpose and intestinal contents are introduced excrement
Bag 7, fixing piece 2 are 3-6 months or so in the intraperitoneal out-of-service time, and out-of-service time of the bracket 1 in enteron aisle is also 3-6 months.
In another preferred example, the film pipeline 3 is rubber protecting jacket；Preferably, the rubber protecting jacket use with
The identical material of sheath is made.
In another preferred example, the outer wall of the film pipeline 3 is also coated with antimicrobial component, particularly preferably is to be coated with
Sustained-release antibacterial drug, the intestinal wall section bacteria breed that so can effectively inhibit film pipeline to be protected, to prevent previous anastomotic from infecting.
Embodiment 4
The present embodiment provides a kind of fixing means by present invention bypass bracket component, the described method comprises the following steps:
A. it provides one and bypasses bracket component as described in Example 3；
B. one end of the rubber protecting jacket is connect with the bracket 1, then uses merging tool by 1 He of bracket
Rubber protecting jacket is placed in inside enteron aisle 4, and rubber protecting jacket other end covering previous anastomotic simultaneously stretches out anus；
C. the hard ring structure fixing piece 2 is placed on outside enteron aisle 4 and the fixed part for being fastened in the bracket 1 is corresponding
Position, make be placed in enteron aisle in bracket be fixed together with enteron aisle.
In another preferred example, one end that rubber protecting jacket stretches out anus is connect with colostomy bag.
Embodiment 5
As shown in fig. 7, the enteron aisle internal bypass bracket component of embodiment 5 is similar with embodiment 1 or 2, it is different: real
The bracket component for applying example 5 includes multiple fixed parts, wherein multiple fixed positions between the first protruding portion and the second protruding portion,
And there are partition-type structures 9 between adjacent fixed part, the outer diameter of partition-type structures 9 is close or identical with protruding portion outer diameter, each fixation
There is matched fixing piece 2 in portion.
Embodiment 6
Four kinds of shunting devices have been done comparative test by the present embodiment on beasle dog, and four kinds of shunting devices are as follows, and first group:
The shunting device being made of degradable anastomosis ring (the cricoid bracket of Valtrac), absorbable thread (common vetch Qiao line), rubber protecting jacket；
Second group: being filled by the bypass that degradable anastomosis ring (the cricoid bracket of Valtrac), absorbable braid over braid, rubber protecting jacket are constituted
It sets；Third group: it is protected by degradable anastomosis ring (the cricoid bracket of Valtrac), chest department of general surgery repairing film (commercial product), rubber
Cover the shunting device constituted；4th group: the shunting device of the embodiment of the present invention 3, d in this embodiment3-d2Difference be 10mm (i.e.
The gap of fixing piece 2 and bracket 1 is 5mm).
Test method is as follows:
4 experiments are selected to use beasle dog (marked as 1,2,3,4) first, experiment arrives Xi Lixin 2.0g intravenous in first 30 minutes
In 4 beasle dog bodies, to prevent to infect, then by 3% yellow Jackets 1ml/kg of beasle dog back leg venipuncture intravenous.To 4
In left lower quadrant and back shaving preserved skin after dog holonarcosis, electric knife negative plate is placed at back, conventional to sterilize in left lower quadrant,
Drape；Left lower quadrant paramedian incision, is about 8cm.Skin, subcutaneous tissue, fat are successively opened, blunt separation muscle layer is opened
Peritonaeum.Lower section colon descendens are found in intraperitoneal.
Then one end of rubber protecting jacket is fixedly connected with degradable anastomosis ring, as the logical of intestinal contents circulation
Road is entered the degradable anastomosis ring of the first shunting device in No. 1 beasle dog enteron aisle from anus, rubber with paraffin oil lubrication postposition
The other end of protective case stretches out anus, is ligatured with 1-0 common vetch Qiao line in intestinal wall outer ring, it is elastic suitable to pay attention to, to fix protection ring
In lower colon；Its excess-three group experimental method is same as above, and enteron aisle external fixation is different only.
Silk thread finally is admired with 7# and closes peritonaeum and rectus aabdominis front and back sheath, and silk thread is admired with 4# and closes subcutaneous tissue and skin.It cuts
After mouth sterilizes again, art, which finishes, sends 4 beasle dogs back to animal house revival.
Above-mentioned four groups of enteron aisle internal bypass devices are allowed to stop 21 days in beasle dog body, during which wearing neck circle prevents dog to sting bad anus
Outer rubber protective case.Excessively euthanasia method puts to death 4 beasle dogs to anaesthetic, observes colon wall degree of impairment.The four groups of colons obtained
(a figure is colon sample when the first shunting device is fixed and after dissection to sample, and b figure is second group of shunting device as shown in Figure 8
Colon sample when fixed and after dissection, c figure are colon sample when third group shunting device is fixed and after dissection, and d figure is this
Colon sample when device is fixed and after dissection): a figure shows common vetch Qiao's wire cutting intestinal wall, anastomosis ring place position have it is one apparent
Slight crack, intestinal mucosa fold interruption；B figure and c figure show that fixing belt causes intestinal wall to have topical ulcers perforation；D figure shows hard annular
Structural mount, which places position, does not have macroscopic apparent damage.
Animal experiment proves that the bioabsorbable material that absorbable thread, absorbable braid over braid and biological sticking patch etc. are soft
Stent in colon is fixed, although very finely keeping in test the tensity suitably tied up, uses these
The perforation or damage of fixed position intestinal wall can occur for method fixation；Enteron aisle internal bypass bracket component of the present invention can not damage intestines
In the case where wall, the intrarectal hollow stent structure (i.e. bracket 1) of fixed knot.
Embodiment 7
The present invention with beasle dog by doing experiment, it was demonstrated that the outer fixed ring and inner support of hard structure combine not
Damage dissection can be generated to intestinal wall, but whether this device can really play the role of protecting previous anastomotic not contaminated
?
Inventor has done such test thus: observation enteron aisle protected portion point, whether the Escherichia coli of mucous membrane surface have
It significantly reduces.
Test method:
Collect the rectum sample for using and being not used present invention bypass bracket component protection at beasle dog bowel anastomosis mouth.Such as
With the experimental method of embodiment 6, using apparatus of the present invention, d in this embodiment3-d2Difference be 15mm (i.e. fixing piece 2 and bracket
1 gap is 7.5mm).At the end of operation as human rectum's resection operation rear intestinal sterilization method, per anum is protected in rubber
Sheath III type ANER DIAN 100ml of outer (i.e. between protective case and straight colonic mucosa) injection, altogether three times.To 21 days anatomic observation intestinal walls
After situation, first originally with 6 sterile vessel samplings, it is divided into three groups and compares, be under the present apparatus in every group of sterile vessel
The protected rectum sample of section is unprotected rectum sample above the present apparatus in another sterile vessel, observes every group of 2 nothings
Escherichia coli quantity in bacterium vessel；Each sample does not rinse, and electronic scale weighs, and mucous membrane weight is consistent in every group of sample,
It is put into every 10mg tissue in 5ml sterile glass homogenizer and 1ml physiological saline is added, it is stand-by to be prepared into intestinal wall homogenate mother liquor.Another system
The intestinal wall homogenate of 100 times of 20ml culture medium and dilution is added in standby sterile letheen sugar Escherichia coli culture medium in 9cm culture dish
Liquid 1ml, incubator culture 24 hours, visually observe clump count in culture dish under the conditions of 37 DEG C.Three groups of results are shown in Fig. 9, and (figure is left
While being to be not used on the right of the Escherichia coli quantity in the case that bypass bracket component of the invention is protected in sterile vessel and figure to make
Escherichia coli quantity in the case where being protected with present invention bypass bracket component in sterile vessel).
Enteron aisle internal bypass device of the present invention is applied as the result is shown, and enteron aisle protected portion divides the Escherichia coli of mucous membrane surface to reduce
To negligible degree.It is experimentally verified that: in the enteron aisle protected portion point of present invention bypass bracket component protection, mucous membrane
It is no longer infected with by Escherichia coli on surface.
It discusses
Fixed problem is difficult to for stent in colon, the present inventor successively uses absorbable thread, absorbable thread braiding to fix
Band, biological sticking patch structure the soft bioabsorbable material such as fixing belt stent in colon is fixed, although all
Test in very finely keep the tensity suitably tied up, fixed with these methods and fixed position intestinal wall have occurred
Perforation or damage.Analysis the reason is as follows that: soft bracket cannot stop in intestinal tube, need in intestinal tube rigid bracket；Colon can not
It is disconnected that pushing is generated to rigid bracket, there is stronger contraction of muscle.Since external fixer is flexible structure, when contraction of muscle
External fixer is easy to concentrate on one point to the squeeze force of intestinal wall, has resulted in intestinal wall for a long time and has been lost by cutting.
Finally, the characteristics of the present inventor moves according to intestinal wall has been put forward for the first time new solution: to by membrane casing
It is fixed in the intestine it is necessary to being completed jointly by intestinal wall external fixer and intestinal tube inner support.On this basis, the present inventor devises
Enteron aisle internal bypass bracket component with specific structure, including bracket and fixing piece, fixing piece uses hard ring structure, and adopts
With the gap between specific fixing piece and intestinal tube inner support.
Animal experiment proves that enteron aisle internal bypass bracket component of the present invention can be fixed in the case where not damaging intestinal wall
Hollow stent structure (i.e. bracket) in Colon and rectum, while Escherichia coli being made not leak into lower end intestinal tube mucous membrane outside bracket
Surface.Specific mechanism be hard outer fixed ring can in contraction of muscle by disperses force at other positions of ring, also can be
Inner fixed support narrow positions do it is certain move up and down, allow peristaltic wave transmitted between outer fixed ring and inner fixed support
Gap.
In the prior art, a kind of technology is to reach isolation by the inner support of three annular inflations or other materials
Excrement is not infected with the function of lower section intestinal wall.The intestinal wall muscle of colon is divided into interior circular muscle and outer longitudinal muscle, and China and foreign countries' longitudinal muscle is starched than colon
Film stringer is short, thus forms " haustrum ", this makes colon have biggish dilatancy, and dilatancy bracket is difficult to stop, therefore effect
It is unsatisfactory.Equally, when haustrum is expanded, inner support is also difficult to intestinal contents are isolated and does not enter lower end intestinal wall.Therefore,
What it is with present invention isolation excrement dependence is inner support compared with the clearance fit between outer fixed ring, the isolation part of the prior art
Position is different with separation principle.
Another technology is the tool using anastomosis ring as fixed protective case.However, in the art, anastomosis ring is necessary
It is fastened, is equivalent to secondary the coincideing for having done a previous anastomotic top intestinal tube.Intestines are carried out using anastomosis ring based on reported
The identical data of pipe, large sample clinical observation research are seen 2000, share 244 bowel anastomosis patients, and 119 are small intestine-
Colonic anastomosis, 125 are colon-colon end to end anastomosis, share 16 patients and occur the related complications that coincide: one for it is narrow into
Row re-treatm ent, 15 (6.15%) split for previous anastomotic, wherein 12 re-treatm ents, it was concluded that anastomosis ring and stitching formula are kissed
The complication rate of clutch is suitable.Main cause may be: be carried out again above low rectal previous anastomotic with anastomosis ring primary
The incidence of intestinal canal anastomosis, itself anastomotic leakage is suitable with circular stapler, not can be reduced the generation of Integral-fit mouth fistula
Rate.
Of the invention focuses on, for the first time it was unexpectedly observed that the safety using structure of the present invention fixes enteral bracket
(or related device) will not only damage intestinal wall, but also can extremely efficient close isolation excrement.
The animal experiment of the present inventor's many years also confirms that when using linear external fixer, meeting is in very short time (7-14
It) it is cut into intestinal tube；When using soft external fixer (including absorbable band, bovine pericardium sticking patch), it is possible to a certain
Intestinal wall perforation is formed on point.
When in contrast, using enteron aisle internal bypass bracket component of the invention, due to the specific structure of use, specific materials
And/or the matched specific gap of outer fixed ring and inner support, unexpectedly realize following technical effect: neither squeezing damage
Hurt intestinal tube, pass intestines peristalsis wave smoothly down, and is effectively isolated excrement and does not enter lower section intestinal wall.
All references mentioned in the present invention is incorporated herein by reference, independent just as each document
It is incorporated as with reference to such.In addition, it should also be understood that, after reading the above teachings of the present invention, those skilled in the art can
To make various changes or modifications to the present invention, such equivalent forms equally fall within model defined by the application the appended claims
It encloses.
Claims (10)
1. a kind of enteron aisle internal bypass bracket component, which is characterized in that including bracket and fixing piece；
The bracket has through-hole and cradle wall, and the cradle wall includes the first protruding portion, the second protruding portion and fixed part, described
Fixed position is between first protruding portion and second protruding portion；
The fixing piece is hard ring structure；
If the minimum value in the outer diameter of the outer diameter of first protruding portion and second protruding portion is d1, the fixed part it is outer
Diameter is d2, the internal diameter of the fixing piece is d3, then d1> d3> d2；
In use, the bracket is located in enteron aisle, the fixing piece is placed on parenterally and is fastened in the fixed part of the bracket
Corresponding position is to fix the bracket in enteron aisle.
2. enteron aisle internal bypass bracket component as described in claim 1, which is characterized in that d3With d2Between difference be 3-20mm.
3. enteron aisle internal bypass bracket component as described in claim 1, which is characterized in that in the enteron aisle internal bypass bracket component
Some or all of structure be made of biodegradable material.
4. enteron aisle internal bypass bracket component as claimed in claim 3, the degradation cycle of the biodegradable material are 0.5-6
A month.
5. enteron aisle internal bypass bracket component as claimed in claim 3, which is characterized in that the biodegradable material is selected from
The copolymer of one or more of PLA, PGA, PDMA, PPDO, PCL, PTMC material or the mixture of above-mentioned material.
6. enteron aisle internal bypass bracket component as described in claim 1, which is characterized in that the inner surface of the fixing piece is evagination
Structure, and the shape of the outer surface of the shape of the outer male structure and the fixed part is adaptable.
7. enteron aisle internal bypass bracket component as described in claim 1, which is characterized in that the height of the fixing piece is 2-
40mm。
8. enteron aisle internal bypass bracket component as described in claim 1, which is characterized in that first protruding portion and described second
Multiple fixed parts are equipped between protruding portion, and each fixed part is equipped with the matched fixing piece.
9. a kind of enteron aisle internal bypass device, which is characterized in that including enteron aisle internal bypass bracket component as described in claim 1,
It further include film pipeline, one end of the film pipeline connect with the bracket and is formed through large intestine with the through-hole of the bracket
The channel of content outflow.
10. a kind of fixing means of enteron aisle internal bypass bracket component, which comprises the following steps:
A. enteron aisle internal bypass bracket component is provided, the enteron aisle internal bypass bracket component includes bracket and fixing piece；The bracket
With through-hole and cradle wall, the cradle wall include the first protruding portion, the second protruding portion and fixed part, the fixed position in
Between first protruding portion and second protruding portion；The fixing piece is hard ring structure；If first protruding portion
Outer diameter and second protruding portion outer diameter in minimum value be d1, the outer diameter of the fixed part is d2, the hard ring junction
The internal diameter of structure is d3, then d1> d3> d2；
B. the branch is placed on inside enteron aisle；
C. the fixing piece is placed on parenterally and is fastened in the corresponding position of fixed part of the bracket, to fix in enteron aisle
The bracket.
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|---|---|---|---|
| CN201810134821.2A CN110123498A (en) | 2018-02-09 | 2018-02-09 | A kind of enteron aisle internal bypass bracket component and its fixing means |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810134821.2A CN110123498A (en) | 2018-02-09 | 2018-02-09 | A kind of enteron aisle internal bypass bracket component and its fixing means |
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| CN110123498A true CN110123498A (en) | 2019-08-16 |
Family
ID=67568012
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| CN201810134821.2A Pending CN110123498A (en) | 2018-02-09 | 2018-02-09 | A kind of enteron aisle internal bypass bracket component and its fixing means |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114515176A (en) * | 2020-11-20 | 2022-05-20 | 天臣国际医疗科技股份有限公司 | Anastomotic stoma protection device |
| CN114515178A (en) * | 2020-11-20 | 2022-05-20 | 天臣国际医疗科技股份有限公司 | Anastomotic stoma protection device |
| CN114515177A (en) * | 2020-11-20 | 2022-05-20 | 天臣国际医疗科技股份有限公司 | Anastomotic stoma protection device |
| CN114515200A (en) * | 2020-11-20 | 2022-05-20 | 天臣国际医疗科技股份有限公司 | Anastomotic stoma protection component based on magnetic particles |
| WO2022105854A1 (en) * | 2020-11-20 | 2022-05-27 | 天臣国际医疗科技股份有限公司 | Anastomotic stoma protection device |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101264028A (en) * | 2008-04-14 | 2008-09-17 | 浙江大学 | Intestinal canal inner pass-by device based on Valtrac anastomosis ring |
| CN201216623Y (en) * | 2008-05-09 | 2009-04-08 | 蔡秀军 | Sausage anastomotic stent |
| CN101969881A (en) * | 2007-11-08 | 2011-02-09 | 更新医药股份有限公司 | Fecal incontinence device, system and method |
| CN104382624A (en) * | 2014-07-24 | 2015-03-04 | 西安交通大学医学院第一附属医院 | Novel inner-intestinal-tract bypass device capable of being automatically discharged |
| WO2015084993A1 (en) * | 2013-12-06 | 2015-06-11 | W. L. Gore & Associates, Inc. | Anastomotic connectors |
| US20160058585A1 (en) * | 2014-08-29 | 2016-03-03 | Boston Scientific Scimed, Inc. | Medical devices including covers and methods for making and using same |
| CN105852917A (en) * | 2016-04-19 | 2016-08-17 | 杭州铭众生物科技有限公司 | Side mouth device for enterostomy |
-
2018
- 2018-02-09 CN CN201810134821.2A patent/CN110123498A/en active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101969881A (en) * | 2007-11-08 | 2011-02-09 | 更新医药股份有限公司 | Fecal incontinence device, system and method |
| CN101264028A (en) * | 2008-04-14 | 2008-09-17 | 浙江大学 | Intestinal canal inner pass-by device based on Valtrac anastomosis ring |
| CN201216623Y (en) * | 2008-05-09 | 2009-04-08 | 蔡秀军 | Sausage anastomotic stent |
| WO2015084993A1 (en) * | 2013-12-06 | 2015-06-11 | W. L. Gore & Associates, Inc. | Anastomotic connectors |
| CN104382624A (en) * | 2014-07-24 | 2015-03-04 | 西安交通大学医学院第一附属医院 | Novel inner-intestinal-tract bypass device capable of being automatically discharged |
| US20160058585A1 (en) * | 2014-08-29 | 2016-03-03 | Boston Scientific Scimed, Inc. | Medical devices including covers and methods for making and using same |
| CN105852917A (en) * | 2016-04-19 | 2016-08-17 | 杭州铭众生物科技有限公司 | Side mouth device for enterostomy |
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114515176A (en) * | 2020-11-20 | 2022-05-20 | 天臣国际医疗科技股份有限公司 | Anastomotic stoma protection device |
| CN114515178A (en) * | 2020-11-20 | 2022-05-20 | 天臣国际医疗科技股份有限公司 | Anastomotic stoma protection device |
| CN114515177A (en) * | 2020-11-20 | 2022-05-20 | 天臣国际医疗科技股份有限公司 | Anastomotic stoma protection device |
| CN114515200A (en) * | 2020-11-20 | 2022-05-20 | 天臣国际医疗科技股份有限公司 | Anastomotic stoma protection component based on magnetic particles |
| WO2022105854A1 (en) * | 2020-11-20 | 2022-05-27 | 天臣国际医疗科技股份有限公司 | Anastomotic stoma protection device |
| CN114515177B (en) * | 2020-11-20 | 2024-05-28 | 天臣国际医疗科技股份有限公司 | Anastomotic stoma protection device |
| CN114515178B (en) * | 2020-11-20 | 2024-06-11 | 天臣国际医疗科技股份有限公司 | Anastomotic stoma protection device |
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Application publication date: 20190816 |