阅读说明：本技术 一种可降解的肠道完全转流支架 (A kind of complete turn of tidal stream bracket of degradable enteron aisle ) 是由 蔡秀军 吴仲禺 陈鸣宇 黄迪宇 王一帆 石磊 戴炜建 马艳丽 于 2019-08-27 设计创作，主要内容包括：一种可降解的肠道完全转流支架,包括肠道固定部分1,肠道固定部分1包括构成两侧的肠的切口爬行吻合段的圆管11；圆管11两端分别连接一个逐渐扩大的喇叭状开口12,圆管11上靠近喇叭状开口12处设置有用于捆扎肠断端的凸环13,其特征在于：圆管11的中空内腔设置有隔断该中空内腔的阻隔膜片2；所述的肠道固定部分1和阻隔膜片2采用具有生物相容性的可降解材料制成。本发明配合引流管使用,可实现肠道完全转流,无需造口回纳的二次手术,无感染风险,且可在X线或CT检查中显影。(A kind of complete turn of tidal stream bracket of degradable enteron aisle, including enteron aisle fixed part 1, enteron aisle fixed part 1 include constituting the notch of the intestines of two sides to creep the round tube 11 of identical section；11 both ends of round tube are separately connected the flare openings being gradually expanded 12, are provided with the bulge loop 13 for tying up broken-hearted end on round tube 11 at flare openings 12, it is characterised in that: the hollow cavity of round tube 11 is provided with the barrier diaphragm 2 for separating the hollow cavity；The enteron aisle fixed part 1 and barrier diaphragm 2 is made of the degradation material with biocompatibility.The present invention cooperates drainage tube to use, it can be achieved that the complete turn of tidal stream of enteron aisle, without the second operation of stoma Hui Na, no infection risk, and can develop in x-ray or CT examination.)

1. a kind of degradable complete turn of tidal stream bracket of enteron aisle, including enteron aisle fixed part (1), it is characterised in that: enteron aisle fixed part Point (1) includes constituting the notch of the intestines of two sides to creep the round tube (11) of identical section；Round tube (11) both ends are separately connected one gradually Widened flare openings (12) are provided with the bulge loop for tying up broken-hearted end on round tube (11) at flare openings (12) (13), the hollow cavity of round tube (11) is provided with the barrier diaphragm (2) for separating the hollow cavity；The enteron aisle fixed part (1) it is made with barrier diaphragm (2) of the degradation material with biocompatibility.

2. the degradable complete turn of tidal stream bracket of enteron aisle as described in claim 1, it is characterised in that: barrier diaphragm (2) and loudspeaker Shaped opening (12) and round tube (11) are integrally formed.

3. the degradable complete turn of tidal stream bracket of enteron aisle as described in claim 1, it is characterised in that: described has bio-compatible Property degradation material use polyglycolic acid.

4. the degradable complete turn of tidal stream bracket of enteron aisle as described in claim 1, it is characterised in that: described has bio-compatible The degradation material of property is mixed with barium sulfate.

Technical field

The present invention relates to a kind of degradable complete turn of tidal stream brackets of enteron aisle, complete enteron aisle for Assist drainage pipe and turn completely Stream.

Technical background

After Colon and rectum operation, anastomotic leakage is common complication, and incidence is about 2% -20%.In excision enteron aisle It after lesion, needs by enteron aisle end-to-end anastomosis to restore its continuity, if the healing of bowel anastomosis mouth is bad, anastomotic leakage, intestines occurs Road content flows into abdominal cavity, may cause abdominal cavity even general infection, causes infectious shock to even result in death when serious.According to Document report, the incidence of Colon and rectum anastomotic fistula are about 2%-20%, and previous anastomotic position is lower (closer to anus), The incidence of anastomotic leakage is higher.Anastomotic leakage not only increases other complication rates and the death rate of patient, increases The pain of patient, also increases medical burden.It is tired that the patient of generation anastomotic leakage has very big probability to endure bowel narrow, defecation Difficult, just anxious, incontinence and worse tumor prognosis, it is likely that receive the treatment such as second operation, permanent stoma.Therefore, each After the operation of class Colon and rectum, especially Low Rectal is postoperative, in order to avoid anastomotic leakage and its caused complication, most of patients Row gut protective neostomy is needed, the most commonly used is terminal ileum protectiveness neostomy.Traditional ileum is intubated protectiveness stoma hand Art is only inserted into stoma into ileum, not can guarantee and blocks enteric cavity completely, turn of tidal stream excrement is incomplete, to the protecting effect of previous anastomotic Leave a question open, therefore application is limited.

The gut protective neostomy is a kind of commonly protectiveness that Colon and rectum the is postoperative operation of Colon and rectum surgery, in office What is the need for distal anastomosis mouth to be protected or need it is spacious set distal gut in the case where can apply.It is done after usually terminal ileum is proposed Loop formula or Double-cavity stoma are set distal anastomosis mouth is spacious, complete turn of tidal stream excrement, avoid the excrement from being to the impact and pollution of previous anastomotic Anastomotic healing creates favorable conditions, and promotes anastomotic healing.

Gut protective stoma can reduce anastomotic leakage bring complication and its relevant death rate.But receive The patient of protectiveness stoma, needs receive second operation within 1 to 6 months after surgery, interim stoma is closed, and it is continuous to restore enteron aisle Property and the abdominal cavity Hui Na.Patient will not only endure the life inconvenience of enterostomal nursing bring, also to pay when carrying the life of stoma state Higher economic costs out.The turn of tidal stream object of ileal stoma not yet forms forming excrement, containing largely stronger to skin irritation Digestive juice, it is stronger to stoma skin corrosivity, if nursing is improper to bring larger pain to patient, seriously affect life matter Amount.

Therefore, it is badly in need of a kind of novel enteron aisle turn of tidal stream for aiming at and row protectiveness enteron aisle shunt patient being needed to design in clinic diagnosis Device can avoid the second operation of stoma Hui Na, while reducing stoma on the basis of playing artificial ostomy complete turn of tidal stream excrement Surrounding skin stimulation.The equipment need to be easy to use, is easy to nurse, and safely and effectively, economical and practical, not only reduces patient suffering, Also Economy type medicine expense.

Chinese patent 201510840170 discloses a kind of functional bowel stoma casing, and the casing is by being directed at body for excrement Outer drainage tube, several air bags for obstructing intestinal juice and the gas tube composition to air bag inflation.It is carried out using this casing Protectiveness neostomy avoids second operation, and can complete turn of tidal stream excrement.But after operation, the air bag containing air stays in body Interior, if there is breakage, the air of evolution may result in enteric infection, jeopardize intestinal health.In addition, this fill by air bag Enteron aisle is oppressed after gas to realize the mode for blocking enteric cavity, is difficult to grasp in actual use, risk is larger, if the blowing pressure is not It is enough, then enteric cavity can not be blocked completely, it can not complete turn of tidal stream；If the blowing pressure is excessively high, enteron aisle may be excessively oppressed, when serious It is downright bad to cause intestinal wall, or even causes the serious consequences such as perforation, intestines leakage.

Summary of the invention

It can not be complete in order to overcome existing protectiveness enteron aisle stoma that second operation time is needed to receive stoma, traditional ileum intubation stoma The shortcomings that full turn of tidal stream excrement, the present invention provide that one kind can be used for complete turn of tidal stream excrement, fistulization oral be closed automatically, be not necessarily to second operation Degradable enteron aisle turn of tidal stream bracket.

In order to solve the above technical problems, the present invention devises a kind of cooperation general drainage pipe, as T-type drainage tube or mushroom draw Flow tube, the complete turn of tidal stream bracket of the degradable enteron aisle used.

The complete turn of tidal stream bracket of degradable enteron aisle of the invention, including enteron aisle fixed part, it is characterised in that: the enteron aisle Fixed part includes constituting the notch of the intestines of two sides to creep the round tube of identical section；Tube ends are separately connected one and are gradually expanded Flare openings, the bulge loop for tying up broken-hearted end is provided on round tube at flare openings, and the hollow cavity of round tube is set It is equipped with the barrier diaphragm for separating the hollow cavity；The enteron aisle fixed part and barrier diaphragm is used with biocompatibility Degradation material is made.

Preferably, diaphragm 2 and flare openings 12 are obstructed and round tube 11 is integrally formed.

Preferably, the degradation material with biocompatibility uses polyglycolic acid (PGA).

Preferably, the degradation material with biocompatibility is also mixed with barium sulfate.

Barrier diaphragm 2 can prevent completely excrement to flow into downstream enteron aisle, so that excrement passes through 3 turn of tidal stream of drainage tube to body completely Outside, thus the downstream previous anastomotic that adequately protects.After tiding over the critical days of anastomotic leakage, the bracket starts to degrade；Previous anastomotic base When originally fitting like a glove, bracket has also been disintegrated completely；Thereafter, degradable Cheng Shui and carbon dioxide.Therefore, matched using the bracket The gut protective neostomy that intubation carries out is closed, excrement can be not only obstructed completely, make it through drainage tube 3 and excrete, nothing The second operation of stoma Hui Na is needed, and without the risk for infecting or damaging intestinal wall.

The present invention use good biocompatibility, degradable polyglycolic acid, temperature be 37 ± 1 DEG C, pH value be 7.4 ± Under 0.2 vitro, the bracket 10 days without breakage, degradation in 28 days and be disintegrated completely it is broken, and clinically observed by intestines Anastomotic leakage usually occurs in 7 days after surgery, and previous anastomotic has usually fitted like a glove within postoperative 30 days or so, therefore, can also be in intestines The critical days of anastomotic leakage protects previous anastomotic, while avoiding taking out the second operation of bracket.

The beneficial effects of the present invention are: 1, bracket merging enteric cavity simple and convenient, is fixed using pocket, hence it is evident that than traditional loop Formula stoma or Double-cavity stoma are faster；2, intestinal contents can be blocked completely with barrier diaphragm in bracket, make enteron aisle content Object plays the role of temporarily protecting distal anastomosis mouth outside turn of tidal stream drainage tube lead body, pulls out and turns after the healing of distal anastomosis mouth Flow tube avoids second operation；3, it is easily mastered in use without the experience of operator, has both guaranteed to block completely Enteric cavity, and avoid compressing enteron aisle；4, air bag breakage is overcome using the support assorted drainage tube or compressing enteron aisle is possible The risks such as infection or intestinal wall necrosis；5, the material of bracket also includes barium sulfate developer, can be developed in x-ray or CT examination, Convenient for dynamic observation scaffold degradation situation；6, stoma connects the outer ostomy bag of stomach wall, does not need negative pressure, patient can feed no slag semi-fluid Food, turn of tidal stream effect is good, small to making-port skin irritatin；7, it according to different can need that mushroom pipe etc. is selected to drain as turn of tidal stream Pipe, can carry out flushing of pipeline.

Detailed description of the invention

Fig. 1 is front view of the invention.

Fig. 2 is the schematic diagram that present invention cooperation drainage tube uses.

Specific embodiment

Technical solution of the present invention is further illustrated with reference to the accompanying drawing.

The complete turn of tidal stream bracket of degradable enteron aisle of the present invention is made of the degradation material with biocompatibility, Cooperate drainage tube 3 to use, is made of enteron aisle fixed part 1 and barrier diaphragm 2.

The human body that the present invention is used to manufacture the bracket use is subjected to and degradation material, such as polyglycolic acid, and It is mixed into moderate amount of sulfuric acid barium.

The enteron aisle fixed part 1 includes constituting the notch of the intestines of two sides to creep the round tube 11 of identical section；11 both ends of round tube The flare openings being gradually expanded 12 are separately connected, are provided at flare openings 12 for tying up intestines on round tube 11 The bulge loop 13 of the broken ends of fractured bone, the hollow cavity of round tube 11 are provided with the barrier diaphragm 2 for separating the hollow cavity.

It obstructs diaphragm 2 and flare openings 12 and round tube 11 is integrally formed.

It is after detachment terminal ileum intestinal tube, to measure intestinal tube diameter using the method that above-mentioned bracket carries out turn of tidal stream operation, according to The degradable enteron aisle turn of tidal stream bracket of intestinal tube diameter selection appropriate size.Bracket is placed in enteric cavity when turn of tidal stream, is used at bulge loop 13 Ileum is fixed on bracket by line, two broken ends of fractured bone of ileum point contact in longitudinal stent axis, and two sections of end incisxal edges answer complete pairing, and pairing is not Good place can use suture holostrome interrupted suture.Thereafter, an osculum, implantation are opened in the proximal small bowel apart from Stent Implantation about 15cm T-type drainage tube or mushroom drainage tube, drainage tube 3 are pierced by body surface and fixation, external drainage bag.

Degradable intestinal stent biodegradable stent of the invention is made by biocompatible polyglycolic acid (PGA) material At, and contain barium sulfate.Stent length about 3-5cm, diameter range 15-20mm, are suitble to the enteron aisle size of different patients, in bracket There is closed degradable barrier diaphragm, material is consistent with bracket.Enteric cavity can be blocked completely after bracket merging small intestine.Contain in bracket There is barium sulfate developer, can develop in x-ray or CT examination, is convenient for dynamic observation scaffold degradation situation.

Degradable complete enteron aisle turn of tidal stream bracket for main material, is mixed with 12.75% mass ratio with polyglycolic acid (PGA) Barium sulfate without breakage, is degraded and is disintegrated completely broken as developer for experiment in vitro 10 days for 28 days.The sample that the present embodiment uses Product bracket is the bell-mouthed cylinder of both ends band, is always about 20mm, internal diameter 18mm, outer diameter 23mm, the long 5mm of horn mouth, wall thickness 1mm obstructs diaphragm thickness about 0.75mm.Bracket both ends are with bell-mouthed design convenient for bracket support enteron aisle, fixed bracket, branch Intestinal contents can be blocked completely with barrier diaphragm in frame, realize complete turn of tidal stream.

Bracket is placed in terminal ileum and is fixed with absorbable thread pocket, the proximal ileum at bracket merging is compacted against enteron aisle Dynamic direction (i.e. the upstream enteron aisle of small intestine at bracket merging) insertion stoma drainage tube (such as mushroom drainage tube), drainage tube one end is led Stomach wall and it is fixed on skin of abdomen out, fixes small intestine intestinal wall seromuscular layer and stomach wall with absorbable thread around Guan Yizhou at intubation.Due to Barrier diaphragm closing in biodegradable stent, therefore intestinal contents can not enter distal end intestinal segment by bracket, avoid enteron aisle Impact and pollution of the content to distal anastomosis mouth.Biodegradable stent can be disintegrated at 30 days or so and be discharged with intestinal contents, Intestinal anastomotic stoma leakage observed by clinically usually occurs in 7 days after surgery, and previous anastomotic has usually been cured completely within postoperative 30 days or so It closes.By shooting plain abdominal radiograph and after drainage tube radiography observes that bracket has been disintegrated and has left original position, it can press from both sides and close drainage tube, such as Without complication such as obvious intestinal obstruction, anastomotic leakages, drainage tube can be pulled out, suturing them notch avoids second operation.

The invention has the characteristics that

1, a kind of degradable, biocompatible enteron aisle turn of tidal stream bracket.Its final catabolite is carbon dioxide and water.

2, the bracket inner support, exempt from suture by way of be placed in small enteral, it is easy to operate.

3, bracket contains developer, can develop under X-ray, the constituent material of bracket each section is consistent (polyglycolic acid With barium sulfate).

4, bracket is about 20-30 days in the intracorporal degradation time of people.Turn of tidal stream bracket can voluntarily be disintegrated and body is discharged with excrement Outside, bracket is taken out without second operation.

5, contain the barrier diaphragm that can block enteric cavity completely in bracket.The turn of tidal stream bracket can block intestinal contents completely Pass through, make intestinal contents can only be by the turn of tidal stream drainage tube lead body of upstream enteron aisle outside, play complete turn of tidal stream intestinal contents Effect.

6, the turn of tidal stream validity period (protection period) of turn of tidal stream bracket is about 20-28 days.After turn of tidal stream validity period, enteron aisle patency It is automatic to restore, stoma is received without perform the operation back for second.

The present embodiment is only for illustrating technical solution of the present invention, rather than the limitation to protection scope of the present invention, this field Those of ordinary skill, can also be made a variety of changes in the case where not departing from conception range of the invention, all is equal Technical solution also belongs to the scope of the present invention, and protection scope of the present invention should be defined by the claims.