DEGRADABLE INTESTINAL DIVERSION DEVICE

Abstract

A degradable intestinal complete diversion device, made of biocompatible degradable materials, includes a circular tube constituting the bridge for the intestinal incisions on both sides to crawl towards each other and anastomosed; the end of the circular tube is connected with a gradually expanding flared opening, and a convex ring for binding the broken end of the intestine is arranged on the circular tube near each flared opening, and the hollow inner cavity of the circular tube is provided with a barrier film for blocking the hollow inner cavity. The invention used with a drainage tube realizes complete intestinal diversion without secondary operations of stoma reintroduction.

Claims

1. A degradable intestinal diversion device, comprising an intestinal fixation part (1), wherein the intestinal fixation part (1) includes a circular tube (11) constituting the bridge for the intestinal incisions on both sides to crawl towards each other and anastomose; the two ends of the circular tube (11) are respectively connected a gradually expanding flared opening (12), and a convex ring (13) for binding the broken end of the intestine is arranged on the circular tube (11) near each flared opening (12), and the hollow inner cavity of the circular tube (11) is provided with a barrier film (2) for blocking the hollow inner cavity; the intestinal fixed part (1) and the barrier film (2) is made of biocompatible degradable materials.

2. The degradable intestinal diversion device according to claim 1, wherein the barrier film (2) and the flared opening (12) are integrally formed with the circular tube (11).

3. The degradable intestinal diversion device according to claim 1, wherein the biocompatible degradable material is polyglycolic acid.

4. The degradable intestinal diversion device according to claim 1, wherein the biocompatible degradable material is doped with barium sulfate.

Description

DESCRIPTION OF THE DRAWINGS

[0016] FIG. 1 is a front view of the present invention.

[0017] FIG. 2 is a schematic diagram of the present invention used with a drainage tube.

EMBODIMENTS

[0018] The technical scheme of the present invention will be further explained below in conjunction with the drawings.

[0019] The degradable intestinal diversion device of the present invention made of biocompatible degradable materials and used with the drainage tube 3 is composed of an intestinal fixing part 1 and a barrier film 2.

[0020] The human body biocompatible and degradable material used in the present invention for manufacturing the device, such as polyglycolic acid (PGA), is mixed with an appropriate amount of barium sulfate.

[0021] The intestinal fixation part 1 includes a circular tube 11 constituting the bridge for the intestinal incisions on both sides to crawl towards each other and anastomosed; the two ends of the circular tube 11 are respectively connected with a gradually expanding flared opening 12, and a convex ring 13 for binding the broken end of the intestine is arranged on the circular tube 11 near each flared opening, and the hollow inner cavity of the circular tube 11 is provided with a barrier film 2 that blocks the hollow inner cavity.

[0022] Preferably, the barrier film 2 and the flared opening 12 are integrally formed with the circular tube 11.

[0023] The barrier film 2 and the flared opening 12 are integrally formed with the circular tube 11.

[0024] The method of using the above-mentioned device for diversion operation is that after cutting off the terminal ileum intestine, measure the diameter of the intestine, and then select a degradable intestinal diversion device of appropriate specifications according to the diameter of the intestine. When diverting, the device is placed in the intestinal cavity, and the ileum is fixed on the device with a thread at the convex ring 13. The two broken ends of the ileum are in contact at the midpoint of the longitudinal axis of the device. The incision edges of the two ends should be completely aligned. Sutures can be used for full-thickness intermittent suture. After that, a small opening is opened in the proximal small intestine about 15 cm away from the device, and a T-shaped drainage tube or mushroom drainage tube is implanted. The drainage tube 3 penetrates the body surface and is fixed, and the drainage bag is connected.

[0025] The degradable device for the degradable intestinal device of the present invention is made of biocompatible polyglycolic acid (PGA) material and contains barium sulfate. The length of the device is about 3-5 cm, and the diameter range is 15-20 mm. It is suitable for different patient's intestinal size. There is a degradable barrier film inside the device, the material of which is the same as that of the device. After the device is placed in the small intestine, the intestinal lumen can be completely blocked. The device contains barium sulfate imaging agent, which can be visualized in X-ray or CT inspection, which is convenient for dynamic observation of device degradation.

[0026] The degradable complete intestinal diversion device is made of polyglycolic acid (PGA) as the main material, mixed with 12.75% by weight of barium sulfate as the imaging agent. In vitro experiment it keeps intact for 10 days, and it degrades and completely disintegrates after 28 days. The sample used in this embodiment is a circular tube with flared opening at each of the both ends, with a total length of about 20 mm, an inner diameter of 18 mm, an outer diameter of 23 mm, a flared opening length of 5 mm, a wall thickness of 1 mm, and a barrier film thickness of about 0.75 mm. The design with a flared opening at each of the both ends of the device is convenient for the device to support the intestine and fix the device. The barrier film inside the device can completely block the contents of the intestine and accomplish complete diversion.

[0027] Place the device into the end of the ileum and fix it with an absorbable purse string. Insert the stoma drainage tube (such as mushroom drainage tube) in the proximal ileum where the device is placed against the direction of intestinal peristalsis (that is, the upstream intestine of the small intestine where the device is placed). One end of the drainage tube is pulled out of the abdominal wall and fixed on the abdominal skin. The intubation and the intestinal wall of the small intestine is fixed with an absorbable thread around the tube. Since the barrier film in the degradable device blocks the the hollow inner cavity of the device, the intestinal contents cannot enter the distal intestinal segment through the device, thereby avoiding the impact and contamination of the intestinal contents on the distal anastomosis. The degradable device can disintegrate in about 30 days and be discharged with the contents of the intestine. Clinically observed intestinal anastomotic leakage usually occurs within 7 days after the operation, and the anastomosis is usually completely healed about 30 days after the operation. After it is observed that the device has collapsed and left the original position by taking a plain radiograph of the abdomen and an angiography through the drainage tube, the drainage tube can be clamped. If there is no obvious intestinal obstruction, anastomotic leakage and other complications, the drainage tube can be removed and the abdominal wall incision can be sutured. A second operation is avoided.

[0028] The features of the present invention are:

[0029] 1. It is a degradable and biocompatible intestinal diversion device. The final degradation products are carbon dioxide and water.

[0030] 2. The device is inserted into the small intestine by the way of internal support and suture-free, which is convenient and quick to operate.

[0031] 3. The device contains a developer and can be developed under X-ray. The constituent materials of each part of the device are the same (a mixture of polyglycolic acid and barium sulfate).

[0032] 4. The degradation time of the device in the human body is about 20-30 days. The diversion device can disintegrate by itself and be excreted with feces, without the need for a second operation to remove the device.

[0033] 5. The device contains a barrier film that can completely block the intestinal cavity. The diversion device can completely block the intestinal contents, so that the intestinal contents can only be drawn out of the body through the diversion drainage tube of the upstream intestine, and play the role of completely diverting the intestinal contents.

[0034] 6. The validity period (protection period) of the diversion device is about 20-28 days. After the expiration of the diversion period, the intestinal patency is automatically restored, without the need for a second operation to return to the stoma.

[0035] This embodiment is only to illustrate the technical solution of the present invention, not to limit the protection scope of the present invention. Those of ordinary skill in the art can make various changes without departing from the scope of the present invention. The 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.