CN211796677U - Degradable intestinal tract complete diversion bracket - Google Patents

Abstract

A degradable intestinal tract complete diversion bracket comprises an intestinal tract fixing part, wherein the intestinal tract fixing part comprises round tubes forming incision crawling anastomosis sections of intestines on two sides; the two ends of the round tube are respectively connected with a gradually enlarged horn-shaped opening, a convex ring for binding the broken end of the intestine is arranged on the round tube close to the horn-shaped opening, and a barrier membrane sheet for blocking the hollow inner cavity is arranged in the hollow inner cavity of the round tube; the intestinal fixing part and the barrier film sheet are made of degradable materials with biocompatibility. The utility model discloses the cooperation drainage tube is used, can realize that the intestinal changes the class completely, need not to make the secondary operation that mouthful regained, and the risk of infecting does not just can develop in X line or CT inspection.

Description

Degradable intestinal tract complete diversion bracket

Technical Field

The utility model relates to a degradable intestinal turns the flow support completely for supplementary drainage tube accomplishes the intestinal and turns the flow completely.

Technical Field

Anastomotic leakage is a common complication after colorectal surgery, with an incidence of about 2-20%. After the intestinal tract focus is cut off, the broken ends of the intestinal tract need to be anastomosed to restore the continuity of the intestinal tract, if the healing of the intestinal tract anastomotic stoma is poor, anastomotic leakage occurs, the intestinal tract content flows into the abdominal cavity, the abdominal cavity and even the whole body infection can be caused, and in severe cases, the septic shock and even the death can be caused. The incidence of anastomotic leakage after colorectal surgery is reported in the literature to be approximately 2% -20%, with the lower the anastomotic site (closer to the anus), the higher the incidence of anastomotic leakage. Anastomotic leakage not only increases the incidence and mortality of other complications of patients, increases the pain of patients, but also increases the medical burden. Patients with anastomotic leakage have a high probability of suffering from intestinal stenosis, difficulty in defecation, urgency, incontinence and poorer prognosis of tumors, and are likely to receive secondary surgery, permanent stoma and the like. Therefore, after various colorectal surgeries, especially after low rectal cancer, most patients need intestinal tract protection ostomy, and the terminal ileum protection ostomy is commonly used in order to avoid anastomotic leakage and complications caused by anastomotic leakage. The traditional ileum intubation protective stoma operation only inserts the stoma into the ileum, cannot ensure complete blockage of the intestinal cavity, has incomplete diversion excrement, doubts about the protective effect of the stoma, and is limited in application.

The enteron-protective ostomy is a commonly used protective operation after colorectal surgery and can be applied to any situation that a distal anastomotic stoma needs to be protected or a distal intestinal tract needs to be opened. Generally, the terminal ileum is proposed and then a loop type or double-cavity stoma is made, the distal anastomosis opening is arranged in an open manner, and excrement is completely diverted, so that the impact and the pollution of the excrement to the anastomosis opening are avoided, favorable conditions are created for healing the anastomosis opening, and the healing of the anastomosis opening is promoted.

The intestinal tract protective stoma may reduce complications and associated mortality from anastomotic leakage. However, patients who have received a protective stoma, after 1 to 6 months after surgery, need to undergo a second operation, close the temporary stoma, restore intestinal continuity and return to the abdominal cavity. When a patient lives with the ostomy, the patient not only needs to endure the inconvenience of life brought by ostomy nursing, but also needs to pay higher economic cost. The transudate of the ileostomy does not form formed excrement, contains a large amount of digestive juice with strong irritation to the skin, has strong corrosivity to the skin around the stoma, brings great pain to patients if the patients are not nursed, and seriously affects the life quality.

Therefore, a novel intestinal canal diversion device specially designed for patients needing protective intestinal canal diversion is urgently needed in clinical diagnosis and treatment, the secondary operation of the stoma retraction can be avoided on the basis of completely diverting excrement by the artificial stoma, and the skin irritation around the stoma is reduced. The equipment is convenient to use, easy to nurse, safe, effective, economical and practical, and not only reduces the pain of patients, but also saves the medical cost.

Chinese patent 201510840170 discloses a functional intestinal stoma casing, which is composed of a drainage tube for guiding feces out of the body, a plurality of air bags for blocking intestinal juice, and an inflation tube for inflating the air bags. The use of such a sleeve for protective ostomy avoids secondary operations and allows complete diversion of stool. However, after surgery, the air-containing balloon remains in the body and, if broken, the escaping air may cause intestinal infections, endangering the intestinal health. In addition, the mode of blocking the intestinal cavity by pressing the intestinal tract after the air bag is inflated is difficult to master in practical use, the risk is high, and if the inflation pressure is insufficient, the intestinal cavity cannot be completely blocked and the intestinal cavity cannot be completely diverted; if the inflation pressure is too high, the intestinal tract may be compressed excessively, and in severe cases, necrosis of the intestinal wall is caused, and even perforation, intestinal leakage and other serious consequences are caused.

Disclosure of Invention

In order to overcome the defect that the secondary operation is required to return the stoma and the orifice can not completely divert the excrement, the traditional ileum intubation stoma is needed to make the stoma in the prior protective intestinal tract, the utility model provides a degradable intestinal tract diverting bracket which can be used for completely diverting the excrement, automatically closing the stoma and avoiding the secondary operation.

In order to solve the technical problem, the utility model designs a degradable intestinal tract complete diversion bracket which is matched with a common drainage tube, such as a T-shaped drainage tube or a mushroom drainage tube.

The utility model discloses a degradable intestinal turns over a class support completely, including the fixed part of intestinal, its characterized in that: the intestinal canal fixing part comprises round tubes which form incision crawling anastomosis sections of intestines on two sides; the two ends of the round tube are respectively connected with a gradually enlarged horn-shaped opening, a convex ring for binding the broken end of the intestine is arranged on the round tube close to the horn-shaped opening, and a barrier membrane sheet for blocking the hollow inner cavity is arranged in the hollow inner cavity of the round tube; the intestinal fixing part and the barrier film sheet are made of degradable materials with biocompatibility.

Preferably, the barrier film sheet 2 and the trumpet-shaped opening 12 are integrally formed with the round tube 11.

Preferably, the degradable material with biocompatibility is polyglycolic acid (PGA).

Preferably, the degradable material with biocompatibility is also doped with barium sulfate.

The blocking diaphragm 2 can completely prevent the excrement from flowing into the downstream intestinal tract, so that the excrement can completely flow out of the body through the drainage tube 3, and the downstream anastomotic stoma is fully protected. After the critical period of anastomotic leakage has elapsed, the scaffold begins to degrade; when the anastomotic stoma is basically completely anastomosed, the stent is completely disintegrated; thereafter, it is completely degraded into water and carbon dioxide. Therefore, the intestinal tract protective ostomy performed by the bracket matching with the intubation tube can not only completely block the excrement and discharge the excrement out of the body through the drainage tube 3 without the secondary operation of stoma withdrawal, but also has no risk of infecting or damaging the intestinal wall.

The utility model discloses a biocompatibility is good, degradable polyglycolic acid, be 37 + -1 ℃ at the temperature, the pH valve is under 7.4 + -0.2's external environment, this support does not have the damage in 10 days, 28 days degradation and the breakage that disintegrates completely, and the intestinal anastomotic stoma who observes clinically leaks and takes place in postoperative 7 days usually, and the anastomotic stoma has coincide completely usually about 30 days of postoperative, consequently, it can also be in the dangerous phase protection anastomotic stoma that the intestinal anastomotic stoma leaked, avoid taking out the secondary operation of support simultaneously.

The beneficial effects of the utility model reside in that: 1. the bracket is simple and convenient to place in the intestinal cavity, is fixed by a purse, and is obviously quicker than the traditional loop stoma or a double-cavity stoma; 2. the barrier diaphragm arranged in the bracket can completely block intestinal contents, so that the intestinal contents are led out of the body from the diversion drainage tube, the effect of temporarily protecting the far-end anastomotic stoma is achieved, the diversion tube is pulled out after the far-end anastomotic stoma is healed, and secondary operation is avoided; 3. the use process does not need to be assisted by the experience of an operator, and the operation is easy to master, thereby ensuring that the intestinal cavity is completely blocked and avoiding the compression of the intestinal tract; 4. the risk of infection or intestinal wall necrosis and the like which are possibly brought by air bag breakage or intestinal canal compression is overcome by utilizing the support matched with the drainage tube; 5. the material of the bracket also contains barium sulfate developer which can be developed in X-ray or CT examination, so that the degradation condition of the bracket can be observed dynamically; 6. the fistulization tube is connected with the fistulization bag outside the abdominal wall, negative pressure is not needed, a patient can eat slag-free semifluid food, the diversion effect is good, and the skin irritation to the fistulization opening is small; 7. the mushroom tube and the like can be selected as the diversion drainage tube according to different requirements, and the pipeline can be washed.

Drawings

Fig. 1 is a front view of the present invention.

Fig. 2 is a schematic view of the utility model used in cooperation with a drainage tube.

Detailed Description

The technical scheme of the utility model is further explained in the following with the attached drawings.

Degradable intestinal turn a class support completely by degradable material that has biocompatibility make, cooperate drainage tube 3 to use, constitute by intestinal fixed part 1 and barrier membrane piece 2.

The utility model is used for manufacturing the human body acceptable and degradable material adopted by the bracket, such as polyglycolic acid, and a proper amount of barium sulfate is mixed in.

The intestinal fixing part 1 comprises a circular tube 11 which forms a cut crawling anastomosis section of intestines on two sides; two ends of the circular tube 11 are respectively connected with a flared opening 12 which is gradually enlarged, a convex ring 13 for bundling the broken ends of the intestines is arranged on the circular tube 11 near the flared opening 12, and a barrier membrane 2 for separating the hollow inner cavity is arranged in the hollow inner cavity of the circular tube 11.

The barrier diaphragm 2 and the trumpet-shaped opening 12 are integrally formed with the circular tube 11.

The method for performing the diversion operation by using the bracket comprises the steps of measuring the diameter of the intestinal canal after the intestinal canal at the tail end of the ileum is cut off, and selecting the degradable intestinal diversion bracket with a proper specification according to the diameter of the intestinal canal. When in diversion, the stent is placed in the intestinal cavity, the ileum is fixed on the stent by a thread at the position of the convex ring 13, the two sections of the ileum are contacted at the midpoint of the longitudinal axis of the stent, the cutting edges of the two sections of the ileum are completely involuted, and the involution position can be sutured by a suture thread in a full-layer discontinuous way. Then, a small opening is opened at the near end of the small intestine which is 15cm away from the stent, a T-shaped drainage tube or a mushroom drainage tube is implanted, the drainage tube 3 penetrates out of the body surface and is fixed, and the drainage bag is externally connected.

The utility model discloses a degradable for intestinal support degradable support is made by biocompatible polyglycolic acid (PGA) material, and contains barium sulfate. The length of the bracket is about 3-5cm, the diameter range is 15-20mm, the bracket is suitable for intestinal tract sizes of different patients, and a closed degradable barrier diaphragm is arranged in the bracket and is made of the same material as the bracket. The bracket can completely block the intestinal cavity after being placed in the small intestine. The stent contains barium sulfate developer which can be developed in X-ray or CT examination, thereby being convenient for dynamically observing the degradation condition of the stent.

The degradable complete intestinal tract diversion stent takes polyglycolic acid (PGA) as a main material, barium sulfate in a mass ratio of 12.75% is mixed as a developer, and the degradable complete intestinal tract diversion stent is not damaged in 10 days of in vitro experiments and is degraded and completely disintegrated and broken in 28 days. The sample support that this embodiment adopted is the both ends area horn mouth cylindrical, and overall length is about 20mm, internal diameter 18mm, external diameter 23mm, the long 5mm of horn mouth, and wall thickness 1mm, barrier film piece thickness is about 0.75 mm. The design that the support both ends have the horn mouth is convenient for the support to support intestinal, fixed bolster, has in the support to hinder the diaphragm and can block intestinal content completely, realizes changeing the flow completely.

The stent is placed at the tail end of the ileum and fixed by an absorbable thread purse, a stoma drainage tube (such as a mushroom drainage tube and the like) is inserted into the proximal ileum at the place where the stent is placed against the peristalsis direction of the intestinal tract (namely the upstream intestinal tract of the small intestine at the place where the stent is placed), one end of the drainage tube is pulled out of the abdominal wall and fixed on the abdominal skin, and the absorbable thread is used for fixing the serous muscular layer of the small intestine wall and the abdominal wall around the circumference of the intubation tube. Because the barrier film sheet in the degradable stent is closed, the intestinal contents cannot enter the distal intestinal section through the stent, and the impact and the pollution of the intestinal contents to the distal anastomosis stoma are avoided. The degradable stent can be disintegrated in about 30 days and is discharged along with intestinal contents, intestinal anastomotic leakage observed clinically usually occurs within 7 days after operation, and the anastomotic leakage usually is completely healed in about 30 days after operation. The abdominal plain film is shot and the drainage tube radiography is carried out to observe that the bracket is disintegrated and departs from the original position, the drainage tube can be clamped and closed, if no obvious intestinal obstruction, anastomotic leakage and other complications exist, the drainage tube can be pulled out, the abdominal wall incision is sutured, and the secondary operation is avoided.

The utility model is characterized in that:

1. a degradable, biocompatible intestinal diversion stent. The final degradation products are carbon dioxide and water.

2. The bracket is placed in the small intestine in an inner supporting and suturing-free mode, and the operation is convenient and quick.

3. The stent contains a developer and can be developed under X-ray, and the constituent materials of each part of the stent are consistent (polyglycolic acid and barium sulfate).

4. The degradation time of the stent in the human body is about 20 to 30 days. The diversion bracket can be disintegrated by itself and discharged out of the body along with the excrement, and the bracket is taken out without secondary operation.

5. The stent contains a membrane-blocking sheet which can completely block the intestinal cavity. The diversion bracket can completely block the passage of intestinal contents, so that the intestinal contents can only be led out of the body through the diversion drainage tube of the upstream intestinal tract, and the effect of completely diverting the intestinal contents is achieved.

6. The diversion shelf life (protective period) is about 20-28 days. After the effective period of the diversion is finished, the intestinal tract smoothness is automatically recovered without carrying out a second operation to return to the stoma.

The embodiment is provided only for illustrating the technical solution of the present invention, not for limiting the protection scope of the present invention, and those skilled in the art can make various changes without departing from the scope of the present invention, and all equivalent technical solutions also belong to the scope of the present invention, and the protection scope of the present invention should be defined by the claims.

Claims (2)

1. A degradable intestinal tract complete diversion bracket comprises an intestinal tract fixing part (1) and is characterized in that: the intestinal canal fixing part (1) comprises round tubes (11) which form incision crawling anastomosis sections of intestines on two sides; two ends of the round tube (11) are respectively connected with a flared opening (12) which is gradually enlarged, a convex ring (13) for bundling the broken ends of the intestines is arranged on the round tube (11) close to the flared opening (12), and a barrier membrane sheet (2) for separating the hollow inner cavity is arranged in the hollow inner cavity of the round tube (11).

2. The degradable intestinal full diversion stent of claim 1 wherein: the diaphragm (2) and the trumpet-shaped opening (12) are integrally formed with the circular tube (11).

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