CN110123498A - A kind of enteron aisle internal bypass bracket component and its fixing means - Google Patents

Abstract

The invention discloses an intestinal bypass bracket assembly and a fixing method thereof. Specifically, the intestinal bypass bracket assembly includes a bracket and a fixing piece; the bracket has a through hole and a bracket wall, and the bracket wall includes a first protrusion, a second Two protruding parts and a fixed part, the fixed part is located between the first protruding part and the second protruding part; the fixing part is a hard ring structure; the minimum value of the outer diameter of the first protruding part and the outer diameter of the second protruding part is established is d ₁ , the outer diameter of the fixing part is d ₂ , and the inner diameter of the fixing part is d ₃ , then d ₁ > d ₃ > d ₂ ; when in use, the stent is located in the intestinal tract, the fixing part is set outside the intestinal tract and inserted into the stent The corresponding position of the fixing part is used to fix the stent in the intestinal tract. The invention is easy to operate, securely and reliably fixes the protective sheath used to protect the anastomosis of the rectum, and can avoid damage to the intestinal tube during use.

Description

A kind of intestinal bypass stent assembly and fixing method thereof

technical field

The invention relates to the field of medical devices, and more particularly to an intestinal bypass support assembly and a fixing method thereof.

Background technique

Various stents have been used in the digestive tract for a long time, no matter whether the stent is hard, soft, air bag or water bag, covered mesh, memory alloy, or whether the stent is expanded after reaching the position , or have dilated structures at both ends, and can be placed in the esophagus, cardia, biliary tract, and colon with strictures. Although there is a certain probability of displacement, it is generally satisfactory. However, at present, various stents cannot stay in the colon with normal structure and function, which is determined by the special structure and movement mode of the colon.

The intestinal wall muscles of the colon are divided into inner circular muscles and outer longitudinal muscles. The outer longitudinal muscles are shorter than the longitudinal length of the colon serosa, thus forming a "colon bag", which makes the colon more expandable, and it is difficult for ordinary expandable stents to stay. At the same time, there are three types of colonic peristalsis: one is pouch-like reciprocating movement during fasting, which makes it difficult for the stent expanded at one end to stay; The thickening causes pressure on the inner and outer sides of the intestinal wall; the third is the contraction wave with a long movement distance, and the muscles in front of the contraction wave relax, which also makes it difficult for the expandable stent to stay.

At present, there are two difficult problems after the resection of the colon and rectum: one of the problems: the anastomosis after the resection of part of the colon and rectum, due to the existence of E. Therefore, the protection of the anastomosis after the resection of the sigmoid colon and rectum has long been one of the hot spots in the research of colorectal surgery at home and abroad. In the past, gastrointestinal stents were used to treat local stenosis and were rarely used in normal colons. However, since the 1990s, there have been patents and articles explaining a concept called "intestinal bypass device", which means that a soft membrane tube is fixed above the anastomosis in the colon, and the upper end of the membrane tube is connected with a colonic stent Connection, a certain part of the stent is in close contact with the colonic mucosa, so that the intestinal content flows into the soft tube and is directly discharged out of the anus, and E. coli will not contaminate the anastomosis isolated by the soft tube, so as to reduce anastomotic abscess and fistula the goal of. However, this device has not appeared clinically so far, and the reason is that it is difficult to indwell the thin film tube in the colon without damaging the intestinal wall. Question 2: In the clinical treatment of rectal cancer, low and very low anus-preserving operations are becoming more and more mature. However, after removal of the internal anal sphincter, that is, after intersphincteric resection (IRS), the incidence of temporary fecal incontinence is very high. According to comprehensive literature data, the incidence rate within 3 months is 70-80%, but three The recovery rate after 1 month is 90%. This situation caused the patient to be in a state of fecal incontinence for several months after the operation, and even wearing diapers could not prevent odor and local contamination.

In order to solve the above two problems of low rectal resection, most of the current methods are preventive colostomy, but the colostomy itself has complications, and it will take half a year to undergo another operation for resection, which increases the cost. patient pain and burden.

The idea of using a thin-film tube to drain the feces out of the anus can solve the above problems, but how to fix the thin-film tube on a specific colon site for a long time has always been a technical difficulty that has been difficult to overcome. The colon has the following characteristics: soft, long-term pressing will lead to erosion and perforation, large expansion, strong muscle contractility, and the mucosa will detach from a layer every two weeks or so, which makes it difficult to use the existing stents in the normal colon.

Contents of the invention

The object of the present invention is to provide a intestinal bypass support assembly and a fixing method thereof which can fix the thin film pipeline for a long time without damaging the intestine, are safe, reliable, and easy to operate.

In a first aspect of the present invention, an intestinal bypass bracket assembly is provided, specifically, including a bracket and a fixing member; the bracket has a through hole and a bracket wall, and the bracket wall includes a first protrusion, a second a protruding portion and a fixing portion, the fixing portion is located between the first protruding portion and the second protruding portion; the fixing member is a hard ring structure; the outer diameter of the first protruding portion and the The minimum value of the outer diameter of the second protruding part is d ₁ , the outer diameter of the fixing part is d ₂ , and the inner diameter of the fixing part is d ₃ , then d ₁ >d ₃ >d ₂ ; in use, the The stent is located in the intestinal tract, the fixing part is sleeved outside the intestinal tract and inserted into the position corresponding to the fixing part of the stent to fix the stent in the intestinal tract.

In another preferred example, the stent is composed of one body or multiple bodies.

In another preferred example, the hard ring structure is composed of a plurality of ring components, and the connection mode of each ring component is selected from one of snap connection, lock connection, screw connection, hinge connection, and embedded magnet Or multiple combinations; preferably, each ring component is connected by a buckle; more preferably, the buckle has a plurality of grades, and the diameter of the fixing member is adjusted by adjusting the grades.

In another preferred example, the difference between d ₃ and d ₂ is 3-20 mm; preferably, 10-15 mm.

In another preferred example, the difference between d ₃ and d ₂ is 1.0-4.0 times the thickness of the intestinal wall; preferably, 2.0-4.0 times the thickness of the intestinal wall; more preferably, 2.0 times the thickness of the intestinal wall -3.0 times.

In another preferred example, when used in human rectum, the difference between d ₃ and d ₂ is preferably 10-15mm.

In another preferred example, part or all of the structures in the intestinal bypass stent assembly are made of biodegradable materials.

In another preferred example, the degradation period of the biodegradable material is 0.5-6 months.

In another preferred example, the degradation periods of the bracket and the fixing member are similar or the same.

In another preferred example, the assembly is used in a high anastomotic position, there is no fecal incontinence problem, and it is only used to isolate the E. coli contamination of the anastomosis, and the failure time of the fixing member or the bracket in the intestinal tract is 2-3 weeks.

In another preferred example, the assembly is used in occasions where fecal incontinence may be caused by ultra-low anastomosis, and its purpose of use includes isolating E. The failure time of the stent in the intestinal tract is 3-6 months.

In another preferred embodiment, the biodegradable material is a copolymer of one or more materials selected from PLA, PGA, PDMA, PPDO, PCL, PTMC, or a mixture of the above materials.

In another preferred example, the inner surface of the fixing part is a convex structure, and the shape of the convex structure is adapted to the shape of the outer surface of the fixing part.

In another preferred example, the height of the fixing member is 2-40mm; preferably, 3-30mm; more preferably, 4-10mm.

In another preferred example, a plurality of fixing parts are provided between the first protruding part and the second protruding part, and each of the fixing parts is provided with a corresponding fixing part .

In another preferred example, there is a partition structure between adjacent fixed parts, and the outer diameter of the partition structure is larger than the outer diameter of the fixed part.

The second aspect of the present invention provides an intestinal bypass device, comprising the intestinal bypass stent assembly as claimed in claim 1, characterized in that it also includes a thin film pipeline, one end of the thin film pipeline is connected to the The stent is connected and communicated with the through hole of the stent to form a passage for the contents of the large intestine to flow out (isolate the contents of the large intestine from the anastomosis of the intestinal tract).

In another preferred example, the other end of the film conduit extends out of the anus and is connected to the fecal bag.

In another preferred example, the thin film pipe is a rubber sheath; preferably, the rubber sheath is made of the same material as the condom.

In another preferred example, the outer wall of the thin film duct is also coated with antibacterial components.

In a third aspect of the present invention, a method for fixing an intestinal bypass stent assembly is provided, comprising the following steps:

a. Provide intestinal bypass bracket assembly, the intestinal bypass bracket assembly includes a bracket and a fixing piece; the bracket has a through hole and a bracket wall, the bracket wall includes a first protrusion, a second protrusion and a fixing part, the fixing part is located between the first protrusion and the second protrusion; the fixing part is a hard ring structure; the outer diameter of the first protrusion and the second protrusion are set The minimum value of the outer diameter is d ₁ , the outer diameter of the fixing part is d ₂ , and the inner diameter of the hard annular structure is d ₃ , then d ₁ >d ₃ >d ₂ ;

b. placing the stent inside the intestinal tract;

c. Put the fixing part outside the intestinal tract and insert it on the position corresponding to the fixing part of the bracket, so as to fix the bracket in the intestinal tract.

It should be understood that within the scope of the present invention, the above-mentioned technical features of the present invention and the technical features specifically described in the following (such as embodiments) can be combined with each other to form new or preferred technical solutions. Due to space limitations, we will not repeat them here.

Description of drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only These are some embodiments of the present invention, and those skilled in the art can obtain other alternative implementations according to these drawings without creative efforts.

Fig. 1 is a side view of an intestinal bypass stent assembly in an embodiment of the present invention;

Fig. 2 is a cross-sectional view of the A-A section of the intestinal bypass stent assembly shown in Fig. 1;

Fig. 3 is a perspective view of an intestinal bypass stent assembly in an embodiment of the present invention;

Fig. 4 is an exploded view of the fixing part in the intestinal bypass bracket assembly shown in Fig. 3;

Fig. 5 is a perspective view of a fixing member in another embodiment of the present invention;

The left side of Figure 6 is a schematic diagram of the local structure of the intestinal bypass bracket assembly fixed to the intestinal tract in an embodiment of the present invention; the right side of Figure 6 is a cross-sectional view of the E-E section on the left side of Figure 6;

The left side of Fig. 7 is a structural schematic diagram of an intestinal bypass stent assembly with multiple fixing parts and partition structures in an embodiment of the present invention; the right side of Fig. 7 is a cross-sectional view of the F-F section on the left side of Fig. 7;

Figure 8 is a comparison of the damage to the intestinal wall at the position where the bracket is placed by different methods of fixing the bracket after low rectal resection. In figure a, absorbable thread is used for fixation, in figure b, braided band is used for fixation, and in figure c, breast tissue is used for fixation. General surgical mending membrane (commercially available product) is fixed, and figure d is to adopt the intestinal bypass stent assembly in an embodiment of the present invention;

Fig. 9 is three comparison test diagrams of the degree of Escherichia coli contamination of rectal specimens protected by the bypass stent assembly of the present invention at the anastomosis of the intestinal tract of Beagle dogs and without.

In each attached drawing, each mark is as follows:

1-bracket; 11-through hole; 111-through hole outlet; 12-bracket wall; 121-first protrusion; 122-second protrusion; 123-fixing part; 2-fixing part; 21-fixing part inner surface ;3-membrane duct; 4-intestine; 41-intestinal wall; 5-anastomosis; 6-anus; 7-fecal bag; 8-gut content; 9-partition structure; d ₁ -of the first protrusion The minimum value of the outer diameter and the outer diameter of the second protrusion; d ₂ - the outer diameter of the fixing part; d ₃ - the inner diameter of the fixing part; h - the height of the fixing part.

Detailed ways

After extensive and in-depth research and a large number of screenings, the inventor first developed an intestinal bypass bracket assembly and its fixing method. Compared with the prior art, the key point of the present invention is to ensure complete isolation of feces while , put forward the concept of hard external fixation, and set a gap between the internal bracket and the external fixation, so as to achieve the effect of not crushing and damaging the intestinal tube, but also allowing the intestinal peristaltic wave to pass down smoothly. The present invention pioneers a feasible method of isolating a section of intestinal wall in the colon from contamination by intestinal contents, and the method may also be extended to other digestive tracts. As long as the isolation time is long enough, general postoperative anastomotic leakage can be prevented and treated, and the present invention is completed on this basis.

the term

As used herein, the term "rigid annular structure" means that the structure is generally annular and rigid. The ring includes various possible rings such as circular ring, elliptical ring, square ring, and amorphous ring; the hard should be understood as having a certain rigidity so that its structure or shape can be maintained, usually the hardness Greater than 50 degrees of Shore A, preferably above 80 degrees of Shore A. These levels of hardness can be achieved with materials known in the art.

Below in conjunction with specific embodiment, further illustrate the present invention. It should be understood that these examples are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, the drawings are schematic diagrams, so the device and equipment of the present invention are not limited by the size or scale of the schematic diagrams.

It should be noted that in the claims and description of this patent, relative terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or Any such actual relationship or order between such entities or operations is implied. Furthermore, the term "comprises", "comprises" or any other variation thereof is intended to cover a non-exclusive inclusion such that a process, method, article or apparatus comprising a set of elements includes not only those elements, but also includes elements not expressly listed. other elements of or also include elements inherent in such a process, method, article, or apparatus. Without further limitations, an element defined by the statement "comprising a" does not exclude the presence of additional identical elements in the process, method, article or apparatus comprising said element.

Example 1

As shown in FIGS. 1-2 , the intestinal bypass stent assembly of this embodiment includes a stent 1 and a fixing member 2 . The bracket 1 includes a through hole 11 and a bracket wall 12, the bracket wall 12 includes a first protruding portion 121, a second protruding portion 122 and a fixing portion 123, the fixing portion 123 is located between the first protruding portion 121 and the second protruding portion 122, The fixing part is a hollow tube, and the protruding part is a bell mouth structure. The fixing part 2 includes the inner surface 21 of the fixing part. The fixing part 2 is a hard ring structure, and the height of the fixing part is h. The minimum value of the outer diameter of the first protruding portion 121 and the outer diameter of the second protruding portion 122 is d ₁ , the outer diameter of the fixing portion is d ₂ , the inner diameter of the fixing member is d ₃ , Then d ₁ >d ₃ >d ₂ .

The outer diameter of the protrusion refers to the maximum distance between two points located on the outer surface of the protrusion and on the same plane perpendicular to the axis of the through hole 11; The maximum distance between two points on the same plane perpendicular to the axis of the through hole 11; the inner diameter of the fixing part refers to when the fixing part is looped on the bracket fixing part and the upper surface of the fixing part and the axis of the through hole 11 When vertical, the maximum distance between two points on the inner surface of the fixing member and on the same plane perpendicular to the axis of the through hole 11.

The gap between the inner surface of the fixing part 2 and the outer surface of the fixing part 123 is ( _d3 - _d2 )/2, and the gap means that when the fixing part 2 is looped on the fixing part 123 and the fixing part and the fixing part When the centers of the fixing parts coincide, the distance between the inner surface of the fixing part and the outer surface of the fixing part close to the inner surface of the fixing part.

The difference between d ₃ and d ₂ is: 6-20mm; preferably, 10-15mm.

According to the above difference between d ₃ and d ₂ , we estimate that when the bypass stent assembly is used on the human body, the difference between d ₃ and d ₂ is 1.0-4.0 times the thickness of the intestinal wall; preferably, It is 2.0-4.0 times the thickness of the intestinal wall; preferably, it is 2.0-3.0 times the thickness of the intestinal wall. The thickness of the intestinal wall is about 3-7mm, especially the human rectal section is generally about 5mm. In view of this thickness of the intestinal wall, we think through exploration that the difference between d ₃ and d ₂ is set to 10-15mm. The bypass bracket assembly works best.

In another preferred example, the stent is composed of one body or multiple bodies. In another preferred example, part or all of the structure of the intestinal bypass stent assembly is made of biodegradable materials, so that the fixed stent can be degraded and degraded after the anastomotic stoma is healed, and can be excreted from the body. Preferably, all the fixing parts in the intestinal bypass stent assembly are made of biodegradable materials; and the brackets in the intestinal bypass stent assembly can be made of non-biodegradable materials , or the stent may be partially or entirely made of biodegradable materials. In any case, the emphasis of the present invention is that the fixation of the bypass stent assembly in the intestinal tract can be invalidated through biodegradation so as to be excreted from the body.

In another preferred embodiment, the biodegradable material is a copolymer of one or more materials selected from PLA, PGA, PDMA, PPDO, PCL, PTMC, or a mixture of the above materials.

In another preferred example, the degradation period of the biodegradable material is 0.5-6 months.

In another preferred example, the degradation periods of the stent 1 and the fixing member 2 are similar or the same.

It should be noted that the stent of the present invention can not only adopt the structure shown in the drawings, but also can adopt many different types of structures. In a preferred example, the bracket has the characteristics shown in the claims of the present invention (has a through hole and a bracket wall, and the bracket wall includes a first protrusion, a second protrusion and a fixing part, and the fixing part is located at the Between the first protruding portion and the second protruding portion) under the premise, it can be any possible structure, such as ring-shaped stents such as Valtrac anastomotic rings, it can also be a stent structure made of inflatable balloons, or it can be Mesh stand. In optimal cases, the bracket is also of rigid construction.

Example 2

As shown in FIGS. 3-5 , the intestinal bypass stent assembly of this embodiment includes a stent 1 and a fixing member 2 . The bracket 1 includes a through hole 11 and a bracket wall 12, the through hole 11 includes a through hole outlet 111, the bracket wall 12 includes a first protruding portion 121, a second protruding portion 122 and a fixing portion 123, the fixing portion 123 is located at the first protruding portion 121 Between the second protruding part 122 , the fixing part 2 includes a fixing part inner surface 21 and a ring component 22 , and the fixing part 2 is a hard ring structure.

The minimum value of the outer diameter of the first protruding portion 121 and the outer diameter of the second protruding portion 122 is d ₁ , the outer diameter of the fixing portion is d ₂ , the inner diameter of the fixing member is d ₃ , Then d ₁ >d ₃ >d ₂ ;

In another preferred example, the hard ring structure 2 is composed of a plurality of ring components 22, and the connection mode of the plurality of ring components 22 is selected from snap connection, lock connection, screw connection, hinge connection, and embedded magnet. one or a combination of more. Fig. 4 and Fig. 5 show the structure of two different fixing rings according to the present invention, the fixing ring is composed of two semi-circular rings, and the two semi-circular rings are connected by buckling. Preferably, the buckle structure can also have a plurality of steps, and the inner size of the fixing member can be adjusted by adjusting the steps.

In another preferred example, the hard ring structure 2 is a ring structure with an opening, and the size of the opening is as small as the outer diameter of the bracket fixing part.

In another preferred example, the inner surface of the fixing member is a convex structure, and the shape of the convex structure is adapted to the shape of the outer surface of the fixing part, so as to reduce the impact on the intestinal wall. extrusion.

In another preferred example, in order to reduce the extrusion force on the intestinal wall, the contact area between the fixing piece and the intestinal wall can be increased, for example, the fixing piece can be made into a hard ring structure with a certain height to achieve this effect, preferably Specifically, the height h of the fixing member is 2-40mm; more preferably, 3-30mm; more preferably, 4-10mm.

In another preferred example, there are grooves on both sides of the connecting portion of the ring component 22 .

Example 3

As shown in Figure 6, the intestinal bypass stent assembly of embodiment 3 is similar to embodiment 1 or 2, the difference is that the stent assembly of embodiment 3 also includes a thin film duct 3, and one end of the thin film duct 3 is connected to the One end of the stent 1 is connected and connected with the through hole 11 of the stent 1 to form a passage for the contents of the intestinal tract 4 to isolate the contents of the intestinal tract 8 from the anastomotic opening 6 of the intestinal tract.

In another preferred example, the stent assembly is used in a place where the anastomotic position is high, there is no problem of fecal incontinence, and it is only used to isolate the E. coli contamination of the anastomosis. Expiration time is 2-3 weeks.

In another preferred example, the stent 1 is used in occasions where fecal incontinence problems may exist at an ultra-low anastomotic stoma; The end extending out of the anus is connected. The purpose of the bracket assembly in this embodiment includes isolating the E. coli contamination of the anastomosis 6 and introducing the intestinal contents into the fecal bag 7. The failure time of the fixing part 2 in the abdominal cavity is 3-6 months The failure time of the stent 1 in the intestinal tract is also 3-6 months.

In another preferred example, the membrane pipe 3 is a rubber sheath; preferably, the rubber sheath is made of the same material as a condom.

In another preferred example, the outer wall of the thin film pipeline 3 is also coated with antibacterial ingredients, especially preferably coated with slow-release antibacterial drugs, so that the growth of bacteria in the intestinal wall section protected by the thin film pipeline can be effectively inhibited to prevent Anastomotic infection.

Example 4

This embodiment provides a method for fixing the bypass bracket assembly of the present invention, and the method includes the following steps:

a. provide a bypass bracket assembly as described in embodiment 3;

b. Connect one end of the rubber sheath to the stent 1, and then place the stent 1 and the rubber sheath inside the intestinal tract 4 using an insertion tool, and the other end of the rubber sheath covers the anastomosis and extends out of the anus ;

c. Put the rigid annular structural fixing member 2 outside the intestinal tract 4 and clamp it at the position corresponding to the fixing part of the stent 1, so that the stent inserted into the intestinal tract is fixed with the intestinal tract.

In another preferred example, one end of the rubber protective sheath protruding from the anus is connected with the fecal bag.

Example 5

As shown in Figure 7, the intestinal bypass stent assembly of Example 5 is similar to that of Example 1 or 2, the difference is that the stent assembly of Example 5 includes a plurality of fixing parts, wherein the plurality of fixing parts are located at the first There is a partition structure 9 between the first protruding part and the second protruding part, and between adjacent fixed parts. The outer diameter of the partition structure 9 is similar to or the same as the outer diameter of the protruding part, and each fixed part has a corresponding fixing piece 2.

Example 6

In this embodiment, four kinds of bypass devices are tested on Beagle dogs. The four kinds of bypass devices are as follows. ), a bypass device composed of a rubber protective sleeve; the second group: a bypass device composed of a degradable anastomotic ring (Valtrac annular bracket), an absorbable braid, and a rubber protective sleeve; the third group: a biodegradable anastomotic A bypass device composed of a ring (Valtrac ring-shaped bracket), thoracic surgery repair membrane (commercially available product), and a rubber sheath; the fourth group: the bypass device of Embodiment 3 of the present invention, in this embodiment d ₃ - The difference between d and ₂ is 10mm (that is, the gap between the fixing part 2 and the bracket 1 is 5mm).

The test method is as follows:

First select 4 experimental Beagle dogs (labeled as 1, 2, 3, 4), inject Xilixin 2.0g into the 4 Beagle dogs 30 minutes before the experiment to prevent infection, and then inject the Beagle dogs Intravenous injection of 3% pentobarbital sodium 1ml/kg by venipuncture of hind legs. After the 4 dogs were fully anesthetized, the left lower abdomen and back were shaved and the skin was prepared. A high-frequency electric knife negative plate was placed on the back. The left lower abdomen was routinely disinfected and a towel was laid. A midline incision was made on the left lower abdomen, about 8 cm long. The skin, subcutaneous tissue, and fat are opened in sequence, the muscle layer is bluntly separated, and the peritoneum is opened. Locate the lower descending colon in the abdominal cavity.

Then one end of the rubber protective sheath was fixedly connected with the biodegradable anastomotic ring as a channel for the flow of intestinal contents, and the degradable anastomotic ring of the first bypass device was lubricated with paraffin oil from the anus and inserted into the No. 1 Beagle dog In the intestinal tract, the other end of the rubber protective sleeve protrudes from the anus, and a 1-0 Vicryl line is used to loop the outer intestinal wall, paying attention to the tightness, so as to fix the protective ring on the lower colon; the other three experimental methods are the same as above, except that the outer intestinal Fixing methods are different.

Finally, close the peritoneum and rectus sheath with 7# mousse thread, and close the subcutaneous tissue and skin with 4# mousse thread. After the incision was disinfected again, the 4 Beagle dogs were sent back to the animal room to wake up after the operation.

Let the above-mentioned four groups of intestinal bypass devices stay in the Beagle dog for 21 days, and wear a collar during the period to prevent the dog from biting the rubber protective sleeve outside the anus. Four Beagle dogs were euthanized by anesthesia overdose, and the damage of the colon wall was observed. The obtained four groups of colon samples are shown in Figure 8 (a is the colon sample when the first bypass device is fixed and dissected, b is the second group of colon samples when the bypass device is fixed and dissected, and c is the colon sample The third group of colon samples when the bypass device was fixed and dissected, and picture d shows the colon samples when this device was fixed and after dissection): picture a shows that the intestinal wall was cut by Vicryl wire, and there was an obvious crack at the place where the anastomotic ring was placed, The folds of the intestinal mucosa were interrupted; pictures b and c showed local ulcer perforation of the intestinal wall caused by the fixation tape; picture d showed that there was no obvious damage visible to the naked eye at the place where the rigid ring structure was placed.

It has been confirmed by animal experiments that soft bioabsorbable materials such as absorbable threads, absorbable braids, and bio-patch are used to fix colonic stents. Methods Fixation will cause perforation or damage to the intestinal wall at a fixed position; the intestinal bypass stent assembly of the present invention can fix the hollow stent structure (ie, stent 1) in the colorectum without damaging the intestinal wall.

Example 7

The present invention proves that the combination of the outer fixation ring and the inner bracket of the hard structure will not damage and cut the intestinal wall through experiments on Beagle dogs, but whether this device can really protect the anastomotic stoma from pollution What about the role?

For this reason, the inventor has done such a test: observe whether the Escherichia coli on the surface of the mucous membrane is significantly reduced in the protected part of the intestinal tract.

experiment method:

The rectal specimens that were used or not protected by the bypass stent assembly of the present invention were collected from the intestinal anastomosis of Beagle dogs. Similar to the experimental method in Example 6, using the device of the present invention, the difference between d ₃ -d ₂ in this example is 15 mm (that is, the gap between the fixing member 2 and the bracket 1 is 7.5 mm). At the end of the operation, 100ml of type III Amer iodine was injected through the anus outside the rubber protective sheath (between the protective sheath and the rectal mucosa) for a total of three times in the same way as the intestinal disinfection method after rectal resection. After dissecting and observing the condition of the intestinal wall on day 21, firstly use 6 sterile containers to take samples and divide them into three groups for comparison. One sterile container in each group is the rectal specimen protected by the lower part of the device, and the other sterile container is For the unprotected rectal specimen above the device, observe the number of E. coli in 2 sterile containers in each group; each sample is not rinsed, and weighed with an electronic scale. The weight of the mucous membrane in each group of samples must be consistent, and put 5ml of sterile glass Add 1ml of physiological saline to every 10mg of tissue in the homogenizer to prepare the intestinal wall homogenate mother solution for use. Separately prepare sterile agarose E. coli culture medium, add 20ml of culture medium and 1ml of intestinal wall homogenate diluted 100 times to a 9cm petri dish, incubate in an incubator at 37°C for 24 hours, and observe the number of colonies in the petri dish with naked eyes. The three groups of results are shown in Fig. 9 (the left side of the figure is the number of Escherichia coli in the aseptic vessel under the protection situation of the bypass support assembly of the present invention and the Escherichia coli number in the sterile vessel under the protection of the bypass support assembly of the present invention is used on the right side of the figure. coli count).

The results show that the Escherichia coli on the mucosal surface of the protected part of the intestinal tract is reduced to a negligible level by using the intestinal bypass device of the present invention. It has been proved by experiments that in the protected part of the intestinal tract protected by the bypass stent assembly of the present invention, the mucosal surface is no longer contaminated by Escherichia coli.

discuss

Aiming at the problem that the stent in the colon is difficult to fix, the inventors successively fixed the stent in the colon with soft bioabsorbable materials such as absorbable threads, absorbable thread braided fixation belts, and fixation belts with biological patch structures. The tension of the proper bandage has been maintained very carefully in the experiments in the 1990s, and the perforation or injury of the intestinal wall at the fixed position occurred with these methods of fixation. The reasons are as follows: the soft stent in the intestine cannot stay, and a rigid stent in the intestine is required; the colon will constantly push the rigid stent, and strong muscle contraction occurs. Since the external fixation device is a soft structure, the extrusion force of the external fixation device on the intestinal wall is easy to concentrate on one point during muscle contraction, which will cause the intestinal wall to be cut and lost in the long run.

Finally, the inventors proposed a new solution for the first time based on the characteristics of intestinal wall movement: if the film sleeve is to be fixed in the intestine, it must be completed by an external fixation device on the intestinal wall and an intestinal stent. On this basis, the inventors designed an intestinal bypass stent assembly with a specific structure, including a stent and a fixation piece, the fixation piece adopts a hard ring structure, and a specific gap between the fixation piece and the intestinal stent is adopted .

Animal experiments have confirmed that the intestinal bypass stent assembly of the present invention can fix the hollow stent structure (i.e. stent) in the colorectum without damaging the intestinal wall, and at the same time prevent Escherichia coli from leaking from the stent into the lower intestine mucosal surface. The specific mechanism is that the hard external fixation ring can disperse the force to other parts of the ring when the muscle contracts, and it will also move up and down to a certain extent in the narrow part of the internal fixation bracket, allowing peristaltic waves to pass through the external fixation ring and the internal fixation bracket. gap.

In the prior art, one technique is to rely on three ring-shaped inner stents of inflatable or other materials to achieve the function of isolating feces from contaminating the lower intestinal wall. The intestinal wall muscles of the colon are divided into the inner circular muscle and the outer longitudinal muscle. The outer longitudinal muscle is shorter than the colon serosa longitudinally, thus forming a "colon bag", which makes the colon more expandable, and it is difficult for the expandable stent to stay. Therefore, the effect is unsatisfactory. Likewise, internal stents have difficulty in isolating bowel contents from the lower bowel wall when the colonic pouch expands. Therefore, compared with the separation of feces in the present invention, which relies on the clearance fit between the inner bracket and the outer fixing ring, the isolation position and isolation principle of the prior art are different.

Another technique is to use an anastomotic ring as a means of securing the sheath. However, in this technique, the anastomotic ring must be fastened, which is equivalent to doing a second anastomosis of the bowel above the anastomosis. Based on the reported data of bowel anastomosis using anastomotic rings, a large-scale clinical observational study was found in 2000. There were 244 patients with intestinal anastomosis, 119 cases of small bowel-colon anastomosis, and 125 cases of colon-colon end-to-end anastomosis. Anastomosis-related complications occurred in 2 patients: one reoperation for stenosis, 15 cases (6.15%) for anastomotic dehiscence, of which 12 cases were reoperation, the conclusion is that the complication rate of anastomotic ring and stapled stapler quite. The main reason may be that using an anastomotic ring to perform another intestinal anastomosis above the low rectal anastomosis has the same incidence of anastomotic leakage as the tubular stapler, and cannot reduce the overall incidence of anastomotic leakage.

The key point of the present invention is that it is unexpectedly found for the first time that the safe fixed intestinal stent (or corresponding device) adopting the structure of the present invention not only does not damage the intestinal wall, but also can seal and isolate feces extremely effectively.

The inventor's many years of animal experiments have also proved that when using a linear external fixation device, it will cut into the intestine in a very short period of time (7-14 days); ), there is still the possibility of perforation of the bowel wall at some point.

On the contrary, when the intestinal bypass stent assembly of the present invention is adopted, the following technical effects are unexpectedly achieved due to the specific structure, specific material and/or matching specific gap between the outer fixing ring and the inner stent: It does not squeeze and damage the intestinal tube, so that the intestinal peristaltic wave can pass down smoothly, and effectively isolates the feces from entering the lower intestinal wall.

All documents mentioned in this application are incorporated by reference in this application as if each were individually incorporated by reference. In addition, it should be understood that after reading the above teaching content of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the appended claims of the present application.

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.