WO2021036198A1 - 一种可降解的肠道完全转流支架 - Google Patents

一种可降解的肠道完全转流支架 Download PDF

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WO2021036198A1
WO2021036198A1 PCT/CN2020/073399 CN2020073399W WO2021036198A1 WO 2021036198 A1 WO2021036198 A1 WO 2021036198A1 CN 2020073399 W CN2020073399 W CN 2020073399W WO 2021036198 A1 WO2021036198 A1 WO 2021036198A1
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intestinal
stent
intestine
degradable
complete diversion
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PCT/CN2020/073399
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English (en)
French (fr)
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蔡秀军
吴仲禺
陈鸣宇
黄迪宇
王一帆
石磊
戴炜建
马艳丽
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浙江大学
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1114—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A61B17/12045—Type of occlusion temporary occlusion double occlusion, e.g. during anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K3/00—Use of inorganic substances as compounding ingredients
    • C08K3/30—Sulfur-, selenium- or tellurium-containing compounds
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L67/00—Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
    • C08L67/02—Polyesters derived from dicarboxylic acids and dihydroxy compounds
    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
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    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00818—Treatment of the gastro-intestinal system
    • A—HUMAN NECESSITIES
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    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1132—End-to-end connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1142—Purse-string sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/045—Stomach, intestines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
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    • A—HUMAN NECESSITIES
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    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0069—Sealing means
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K3/00—Use of inorganic substances as compounding ingredients
    • C08K3/30—Sulfur-, selenium- or tellurium-containing compounds
    • C08K2003/3045—Sulfates
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2201/00—Properties
    • C08L2201/06—Biodegradable
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2203/00—Applications
    • C08L2203/02—Applications for biomedical use

Definitions

  • the invention relates to a degradable intestinal complete diversion stent, which is used to assist a drainage tube to complete the complete intestinal diversion.
  • anastomotic leakage is a common complication, and its incidence is about 2%-20%.
  • the intestinal stump needs to be anastomosed to restore its continuity. If the intestinal anastomosis is not well healed, anastomotic leakage occurs, and the contents of the intestine flow into the abdominal cavity, which may cause abdominal or even systemic infection. Cause septic shock and even death.
  • the incidence of anastomotic leakage after colorectal surgery is about 2%-20%. The lower the anastomotic position (closer to the anus), the higher the incidence of anastomotic leakage.
  • Anastomotic leakage not only increases the incidence of other complications and mortality of patients, increases the suffering of patients, but also increases the medical burden. Patients with anastomotic leakage are likely to endure intestinal stenosis, difficulty defecation, urgency, incontinence, and worse tumor prognosis, and they are likely to undergo secondary surgery, permanent stoma and other treatments. Therefore, after various types of colorectal surgery, especially after low rectal cancer, in order to avoid anastomotic leakage and its complications, most patients need intestinal protective ostomy, and terminal ileal protective ostomy is commonly used. Oral surgery.
  • the intestinal protective stoma is a commonly used protective operation after colorectal surgery in colorectal surgery, and can be applied in any situation where the distal anastomosis needs to be protected or the distal intestine needs to be left open.
  • the terminal ileum is raised and then a loop or double-chamber stoma is made, and the distal anastomotic stoma is left open to completely divert the feces to avoid the impact and pollution of the feces on the anastomotic stoma, create favorable conditions for the anastomotic stoma healing, and promote the anastomotic stoma healing .
  • Intestinal protective stoma can reduce the complications and related mortality caused by anastomotic leakage.
  • patients who have received a protective stoma need to undergo a second operation 1 to 6 months after surgery to close the temporary stoma, restore intestinal continuity, and return to the abdominal cavity.
  • the diversion material of the ileostomy has not yet formed a shaped stool, and contains a large amount of digestive juice that is strong to the skin, and is highly corrosive to the skin around the stoma. Improper care will cause greater pain to the patient and seriously affect the quality of life .
  • Chinese patent 201510840170 discloses a functional intestinal ostomy sleeve, which is composed of a drainage tube for guiding feces to the outside of the body, several balloons for blocking intestinal fluid, and an inflation tube for inflating the balloons.
  • the use of this sleeve for protective ostomy avoids secondary operations and can completely divert feces.
  • the air-containing air sacs remain in the body. If they are damaged, the escaped air may cause intestinal infections and endanger intestinal health.
  • this way of blocking the intestinal lumen by compressing the intestine after the airbag is inflated is difficult to grasp in actual use, and the risk is relatively high.
  • the inflation pressure is not enough, the intestinal lumen cannot be completely blocked and the flow cannot be completely bypassed; If the inflation pressure is too high, it may over-press the intestine, causing necrosis of the intestinal wall in severe cases, and even causing serious consequences such as perforation and intestinal leakage.
  • the present invention provides a method that can be used to completely divert feces and automatically close the stoma.
  • a degradable intestinal bypass stent that does not require a second operation.
  • the present invention designs a degradable intestinal complete diversion stent used in conjunction with ordinary drainage tubes, such as T-shaped drainage tubes or mushroom drainage tubes.
  • the degradable intestinal complete diversion stent of the present invention includes an intestinal fixation part, and is characterized in that: the intestinal fixation part includes a circular tube forming the incision crawling anastomosis section of the intestines on both sides; the two ends of the circular tube are respectively connected A gradually expanding trumpet-shaped opening, a convex ring for binding the broken end of the intestine is arranged on the circular tube near the trumpet-shaped opening, and the hollow inner cavity of the circular tube is provided with a barrier film to block the hollow inner cavity; the intestinal fixed part And the barrier film is made of biocompatible biodegradable materials.
  • the barrier film 2 and the horn-shaped opening 12 are integrally formed with the round tube 11.
  • the biocompatible biodegradable material uses polyglycolic acid (PGA).
  • PGA polyglycolic acid
  • the biocompatible biodegradable material is also doped with barium sulfate.
  • the barrier film 2 can completely prevent the feces from flowing into the downstream intestinal tract, so that the feces can be completely diverted to the outside of the body through the drainage tube 3, thereby fully protecting the downstream anastomosis.
  • the stent begins to degrade; when the anastomosis is almost completely anastomosed, the stent has also completely disintegrated; after that, it is completely degraded into water and carbon dioxide.
  • the intestinal protective ostomy with the use of the stent and the intubation can not only completely block the feces and allow it to be discharged from the body through the drainage tube 3, without the need for a second operation of stoma reinjection, and no infection or damage to the intestines. The risk of the wall.
  • the present invention uses polyglycolic acid with good biocompatibility and degradability.
  • the stent Under an in vitro environment with a temperature of 37 ⁇ 1°C and a pH of 7.4 ⁇ 0.2, the stent has no damage for 10 days, and is completely disintegrated after 28 days of degradation.
  • the clinically observed intestinal anastomotic leakage usually occurs within 7 days after the operation, and the anastomosis is usually completely anastomosed about 30 days after the operation. Therefore, it can also protect the anastomosis during the dangerous period of intestinal anastomotic leakage and avoid The second operation to remove the stent.
  • the beneficial effects of the present invention are: 1.
  • the stent is simple and convenient to insert into the intestinal cavity, and it is fixed with a purse string, which is significantly faster than the traditional loop stoma or double-chamber stoma; 2.
  • the stent with a barrier film can completely block the intestine
  • the contents of the intestine can be drawn out of the body from the diversion drainage tube to temporarily protect the distal anastomosis. After the distal anastomosis is healed, the diversion tube should be removed to avoid secondary operations; 3.
  • the material of the stent also contains barium sulfate imaging agent, which can be visualized in X-ray or CT examination to facilitate the dynamic observation of the degradation of the stent; 6.
  • the fistula tube is connected to the external abdominal wall fistula bag, which does not require negative pressure. You can eat non-slag semi-flow food, with good diverting effect and little irritation to the skin at the stoma; 7. Mushroom tubes can be used as diverting drainage tubes according to different needs, and the pipeline can be flushed.
  • Figure 1 is a front view of the present invention.
  • Figure 2 is a schematic diagram of the present invention used with a drainage tube.
  • the degradable intestinal complete diversion stent of the present invention is made of biocompatible biodegradable materials, used in conjunction with the drainage tube 3, and is composed of an intestinal fixing part 1 and a barrier film 2.
  • the human body acceptable and degradable material used in the present invention for manufacturing the stent such as polyglycolic acid, is mixed with an appropriate amount of barium sulfate.
  • the intestinal fixation part 1 includes a circular tube 11 that forms the incision crawling anastomosis section of the intestines on both sides; the two ends of the circular tube 11 are respectively connected with a flared opening 12 that gradually expands, and the circular tube 11 is arranged near the flared opening 12 There is a convex ring 13 for binding the broken end of the intestine, and the hollow inner cavity of the circular tube 11 is provided with a barrier film 2 that blocks the hollow inner cavity.
  • the barrier film 2 and the horn-shaped opening 12 are integrally formed with the round tube 11.
  • the method of using the above-mentioned stent for diversion operation is to measure the diameter of the intestine after the intestinal tube at the terminal ileum is cut off, and select a degradable intestinal diversion stent of appropriate specifications according to the diameter of the intestine.
  • the stent is placed in the intestinal cavity during the bypass, and the ileum is fixed on the stent 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 stent.
  • the cut edges of the two ends should be completely aligned.
  • Sutures can be used for full-thickness intermittent suture.
  • a small opening was opened in the proximal small intestine about 15 cm away from the stent, and a T-shaped drainage tube or mushroom drainage tube was implanted.
  • the drainage tube 3 penetrates the body surface and is fixed, and the drainage bag is attached.
  • the degradable stent for the degradable intestinal stent of the present invention is made of biocompatible polyglycolic acid (PGA) material and contains barium sulfate.
  • the length of the stent is about 3-5cm, and the diameter ranges from 15-20mm. It is suitable for different patients' intestinal sizes.
  • the stent contains barium sulfate imaging agent, which can be visualized in X-ray or CT inspection, which is convenient for dynamic observation of stent degradation.
  • the degradable complete intestinal bypass stent uses polyglycolic acid (PGA) as the main material and is mixed with 12.75% by mass barium sulfate as the imaging agent.
  • the in vitro experiment has no damage for 10 days, and degrades and completely disintegrates after 28 days.
  • the sample holder used in this embodiment is a cylindrical shape with bell mouths at both ends, with a total length of about 20 mm, an inner diameter of 18 mm, an outer diameter of 23 mm, a bell mouth length of 5 mm, a wall thickness of 1 mm, and a barrier film thickness of about 0.75 mm.
  • the design with bell mouths at both ends of the stent is convenient for the stent to support the intestine and fix the stent.
  • the barrier film inside the stent can completely block the contents of the intestine and achieve complete diversion.
  • the stent Place the stent into the end of the ileum and fix it with an absorbable purse string. Insert the stent into the stoma drainage tube (such as mushroom drainage tube, etc.) in the proximal ileum where the stent is placed against the direction of intestinal peristalsis (that is, the upstream intestine of the small intestine where the stent is placed) ), one end of the drainage tube is pulled out of the abdominal wall and fixed on the abdominal skin, the intubation is around the tube and the intestinal wall of the small intestine is fixed with an absorbable thread to fix the serosamus layer and the abdominal wall.
  • the stoma drainage tube such as mushroom drainage tube, etc.
  • the degradable stent 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.
  • the drainage tube can be clamped by taking a plain radiograph of the abdomen and through the drainage tube angiography. 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. Avoided a second operation.
  • a degradable and biocompatible intestinal bypass stent The final degradation products are carbon dioxide and water.
  • the stent is inserted into the small intestine through internal support and suture-free, which is convenient and quick to operate.
  • the stent contains a developer and can be developed under X-ray.
  • the constituent materials of each part of the stent are the same (polyglycolic acid and barium sulfate).
  • the degradation time of the stent in the human body is about 20-30 days.
  • the bypass stent can disintegrate by itself and be excreted with feces, without the need for a second operation to remove the stent.
  • the stent contains a barrier film that can completely block the intestinal cavity.
  • the diversion stent can completely block the passage of 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.
  • the diverting validity period (protection period) of the diverting stent is about 20-28 days. After the expiration of the bypass period, the intestinal patency is automatically restored, and there is no need for a second operation to return to the stoma.

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Abstract

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）。圆管（11）的中空内腔设置有隔断该中空内腔的阻隔膜片（2）。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。这种可降解的肠道完全转流支架配合引流管使用，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。

Description

一种可降解的肠道完全转流支架 技术领域
本发明涉及一种可降解的肠道完全转流支架，用于辅助引流管完成肠道完全转流。
技术背景
结直肠手术后，吻合口漏是常见的并发症，其发生率约为2％—20％。在切除肠道病灶后，需要将肠道断端吻合以恢复其连续性，若肠道吻合口愈合不佳，出现吻合口漏，肠道内容物流入腹腔，可能引起腹腔甚至全身感染，严重时造成感染性休克甚至导致死亡。据文献报道，结直肠术后吻合口漏的发生率大约为2％-20％，吻合口位置越低(越靠近肛门)，吻合口漏的发生率越高。吻合口漏不仅增加了患者的其他并发症发生率与死亡率，增加了患者的痛苦，也增加了医疗负担。发生吻合口漏的患者有很大几率要忍受肠道狭窄、排便困难、便急、失禁以及更差的肿瘤预后，很可能要接受二次手术、永久造口等治疗。因此，在各类结直肠手术后，尤其是低位直肠癌术后，为了避免吻合口漏及其引起的并发症，多数患者需行肠道保护性造口术，常用的是末端回肠保护性造口术。传统的回肠插管保护性造口手术仅向回肠中插入造瘘管，无法保证完全阻断肠腔，转流粪便不完全，对吻合口的保护效果存疑，因此应用有限。
所述肠道保护性造口术是结直肠外科常用的一种结直肠术后的保护性手术，在任何需要保护远端吻合口或需要旷置远端肠道的情况中均可应用。通常将末端回肠提出后做袢式或双腔造口，将远端吻合口旷置，完全转流粪便，避免粪便对吻合口的冲击与污染，为吻合口愈合创造有利条件，促进吻合口愈合。
肠道保护性造口可以减少吻合口漏带来的并发症及其相关的死亡率。但是，接受了保护性造口的患者，需要在术后1到6个月接受二次手术，将临时造口关闭，恢复肠道连续性并回纳腹腔。患者在携带造口状态生活时，不仅要忍受造口护理带来的生活不便，还要付出较高的经济花费。回肠造口的转流物尚未形成成形粪便，含有大量对皮肤刺激性较强的消化液，对造口周围皮肤腐蚀性较强，若护理不当会给患者带来较大痛苦，严重影响生活质量。
因此，临床诊疗中急需一种专为需行保护性肠道转流术患者设计的新型肠道转流装置，能在起到人工造口完全转流粪便的基础上，避免造口回纳的二次手术，同时减少造口周围皮肤刺激。该设备需使用方便，易于护理，且安全有效，经济实用，不仅减少患者痛苦，也节约医疗费用。
中国专利201510840170公开了一种功能性肠道造口套管，该套管由将粪便导至体外的引流管、数个用于阻隔肠液的气囊以及向气囊充气的充气管构成。利用这种套管进行保护性造口术避免了二次手术，且能完全转流粪便。但是，手术后，含有空气的气囊留在体内，如果出现破损，逸出的空气可能会导致肠道感染，危及肠道健康。另外， 这种依靠气囊充气后压迫肠道来实现阻断肠腔的方式，在实际使用中难以掌握，风险较大，如果充气压力不够，则无法完全阻断肠腔，无法完全转流；如果充气压力过高，则可能过度压迫肠道，严重时引起肠壁坏死，甚至引起穿孔、肠漏等严重后果。
发明内容
为了克服现有保护性肠道造口需要二次手术回纳造口、传统回肠插管造口无法完全转流粪便的缺点，本发明提供一种可用于完全转流粪便、造瘘口自动闭合、无需二次手术的可降解肠道转流支架。
为解决上述技术问题，本发明设计了一种配合普通引流管，如T型引流管或蘑菇引流管，使用的可降解的肠道完全转流支架。
本发明的可降解的肠道完全转流支架，包括肠道固定部分，其特征在于：所述肠道固定部分包括构成两侧的肠的切口爬行吻合段的圆管；圆管两端分别连接一个逐渐扩大的喇叭状开口，圆管上靠近喇叭状开口处设置有用于捆扎肠断端的凸环，圆管的中空内腔设置有隔断该中空内腔的阻隔膜片；所述的肠道固定部分和阻隔膜片采用具有生物相容性的可降解材料制成。
优选地，阻隔膜片2和喇叭状开口12与圆管11一体成型。
优选地，所述的具有生物相容性的可降解材料采用聚乙醇酸(PGA)。
优选地，所述的具有生物相容性的可降解材料还掺有硫酸钡。
阻隔膜片2可以完全阻止粪便流入下游肠道，使得粪便完全通过 引流管3转流到体外，从而充分保护下游吻合口。在渡过吻合口漏的危险期后，所述支架开始降解；吻合口基本完全吻合时，支架也已完全崩解；其后，完全降解成水和二氧化碳。因此，利用所述支架配合插管进行的肠道保护性造口术，不仅可以完全阻隔粪便，使其通过引流管3排出体外，无需造口回纳的二次手术，且无感染或损害肠壁的风险。
本发明采用生物相容性好、可降解的聚乙醇酸，在温度为37±1℃，酸碱度为7.4±0.2的体外环境下，该支架10天无破损，28天降解而完全崩解破碎，而临床上所观察到的肠吻合口漏通常发生在术后7天内，术后30天左右吻合口通常已完全吻合，因此，其还能在肠吻合口漏的危险期保护吻合口，同时避免取出支架的二次手术。
本发明的有益效果在于：1、支架置入肠腔简单方便，使用荷包固定，明显比传统袢式造口或双腔造口更快捷；2、支架内带有阻隔膜片可以完全阻断肠道内容物，使肠道内容物从转流引流管引出体外，起到临时保护远端吻合口的作用，待远端吻合口愈合后拔除转流管，避免二次手术；3、在使用过程中无需借助操作者的经验，容易掌握，既保证完全阻断肠腔，又避免压迫肠道；4、利用该支架配合引流管克服了气囊破损或压迫肠道可能带来的感染或肠壁坏死等风险；5、支架的材料还包含有硫酸钡显影剂，可在X线或CT检查中显影，便于动态观察支架降解情况；6、造瘘管接腹壁外造瘘袋，不需要负压，患者可进食无渣半流食物，转流效果好，对造口处皮肤刺激小；7、可根据不同需要选用蘑菇管等作为转流引流管，可进行管路冲洗。
附图说明
图1是本发明的正视图。
图2是本发明配合引流管使用的示意图。
具体实施方式
下面结合附图进一步说明本发明的技术方案。
本发明所述的可降解的肠道完全转流支架由具有生物相容性的可降解材料制成，配合引流管3使用，由肠道固定部分1和阻隔膜片2构成。
本发明用于制造所述的支架采用的人体可接受且可降解材料,例如聚乙醇酸，并混入适量硫酸钡。
所述肠道固定部分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，圆管11的中空内腔设置有隔断该中空内腔的阻隔膜片2。
阻隔膜片2和喇叭状开口12与圆管11一体成型。
利用上述支架进行转流手术的方法是，离断回肠末端肠管后，测量肠管直径，根据肠管直径选择合适规格的可降解肠道转流支架。转流时支架放置在肠腔中，在凸环13处用线将回肠固定在支架上，回肠两断端在支架纵轴中点接触，两段端切缘应完全对合，对合不良处可用缝合线全层间断缝合。其后，在距离置入支架约15cm的近端小 肠打开一小口，植入T型引流管或蘑菇引流管，引流管3穿出体表并固定，外接引流袋。
本发明的可降解肠道支架用可降解支架由生物相容的聚乙醇酸(PGA)材料制作成，且含有硫酸钡。支架长度约3-5cm，直径范围15-20mm，适合不同患者的肠道尺寸，支架内有封闭的可降解阻隔膜片，其材质与支架一致。支架置入小肠后可完全阻断肠腔。支架中含有硫酸钡显影剂，可在X线或CT检查中显影，便于动态观察支架降解情况。
可降解完全肠道转流支架以聚乙醇酸(PGA)为主要材料，混合有12.75％质量比的硫酸钡作为显影剂，其体外实验10天无破损，28天降解而完全崩解破碎。本实施例采用的样品支架为两端带喇叭口的圆柱形，总长约20mm，内径18mm，外径23mm，喇叭口长5mm，壁厚1mm，阻隔膜片厚度约0.75mm。支架两端带有喇叭口的设计便于支架支撑肠道、固定支架，支架内带有阻隔膜片可以完全阻断肠道内容物，实现完全转流。
将支架置入回肠末端并用可吸收线荷包固定，在支架置入处的近端回肠逆肠道蠕动方向(即支架置入处小肠的上游肠道)插入造口引流管(如蘑菇引流管等)，引流管一端牵出腹壁并固定在腹部皮肤，插管处绕管一周用可吸收线固定小肠肠壁浆肌层与腹壁。由于可降解支架中的阻隔膜片封闭，因此肠道内容物无法通过支架进入远端肠段，避免了肠道内容物对远端吻合口的冲击与污染。可降解支架可在30天左右崩解并随肠道内容物排出，临床上所观察到的肠吻合口漏通常 发生在术后7天内，术后30天左右吻合口通常已完全愈合。通过拍摄腹部平片及经引流管造影观察到支架已崩解并离开原位后，可夹闭引流管，如无明显肠梗阻、吻合口漏等并发症，可拔除引流管，缝合腹壁切口，避免了二次手术。
本发明的特点是：
1、一种可降解的、生物相容的肠道转流支架。其最终降解产物为二氧化碳和水。
2、该支架通过内支撑、免缝合的方式置入小肠内，操作方便快捷。
3、支架含有显影剂，可在X光下显影，支架各部分的构成材料是一致的(聚乙醇酸与硫酸钡)。
4、支架在人体内的降解时间约为20-30天。转流支架可自行崩解并随粪便排出体外，无需二次手术取出支架。
5、支架内含有可以完全阻断肠腔的阻隔膜片。该转流支架可完全阻断肠道内容物通过，使肠道内容物只能通过上游肠道的转流引流管引出体外，起到完全转流肠道内容物的作用。
6、转流支架的转流有效期(保护期)约为20-28天。转流有效期结束后，肠道通畅性自动恢复，无须进行第二次手术回纳造口。
本实施例仅供说明本发明的技术方案，而非对本发明的保护范围的限制，本领域的普通技术人员，在不脱离本发明的构思范围的情况下还可以做出各种变化，所有的等同技术方案也属于本发明的范围， 本发明的保护范围应当由权利要求书限定。

Claims (4)

  1. 一种可降解的肠道完全转流支架，包括肠道固定部分(1)，其特征在于：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)，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。
  2. 如权利要求1所述的可降解的肠道完全转流支架，其特征在于：阻隔膜片(2)和喇叭状开口(12)与圆管(11)一体成型。
  3. 如权利要求1所述的可降解的肠道完全转流支架，其特征在于：所述的具有生物相容性的可降解材料采用聚乙醇酸。
  4. 如权利要求1所述的可降解的肠道完全转流支架，其特征在于：所述的具有生物相容性的可降解材料掺有硫酸钡。
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