WO2010043177A1 - Substitut de tube corporel humain à induction biologique - Google Patents

Substitut de tube corporel humain à induction biologique Download PDF

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Publication number
WO2010043177A1
WO2010043177A1 PCT/CN2009/074441 CN2009074441W WO2010043177A1 WO 2010043177 A1 WO2010043177 A1 WO 2010043177A1 CN 2009074441 W CN2009074441 W CN 2009074441W WO 2010043177 A1 WO2010043177 A1 WO 2010043177A1
Authority
WO
WIPO (PCT)
Prior art keywords
tube
flexible material
human body
support frame
growth factor
Prior art date
Application number
PCT/CN2009/074441
Other languages
English (en)
Chinese (zh)
Inventor
周星
Original Assignee
Zhou Xing
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN200810199151A external-priority patent/CN101721263A/zh
Priority claimed from CN200810199150A external-priority patent/CN101721262A/zh
Application filed by Zhou Xing filed Critical Zhou Xing
Publication of WO2010043177A1 publication Critical patent/WO2010043177A1/fr

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Classifications

    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/227—Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/34—Macromolecular materials
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • 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
    • A61F2/06—Blood vessels
    • 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
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • 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
    • 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
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A61L2300/414—Growth factors
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606—Coatings
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/64—Animal cells

Definitions

  • the present invention relates to a substitute for reconstruction after removal of a human lumen, in particular, an artificial esophagus for esophageal reconstruction after esophagectomy, or an artificial trachea for tracheal reconstruction after tracheal resection, or a urethra after urethral injury Reconstruct the artificial urethra of the sputum.
  • Esophageal cancer is a common disease in China, ranking second among the common incidences of malignant tumors.
  • the incidence rate is 21/100,000, that is, more than 273,000 new patients are added each year, and the current incidence rate is still rising. It is extremely harmful. Esophageal injuries caused by various causes, especially esophageal injuries caused by car accidents, are also on the rise. How to effectively implement esophageal reconstruction is the key to reducing mortality and improving the quality of life of patients.
  • the lesions of esophageal cancer usually have the characteristics of multi-center hopping. So far, the most effective treatment for esophageal cancer is to use surgical resection of the diseased esophagus and the use of alternatives for esophageal recanal esophageal recanalization. Restore the esophageal passage. Since the blood supply blood vessels of the esophagus are small blood vessel networks, the small blood vessels of the esophagus transplant are difficult to match, and the blood supply of the transplanted esophagus is difficult to reconstruct, so that the esophagus is difficult to perform organ transplantation like the heart, liver, kidney and the like.
  • the memory alloy-coated esophageal stent has been successfully applied clinically for 13 years, and patients with advanced esophageal cancer with esophageal stents are placed until they die due to cancer cell proliferation. Can eat normally.
  • Membrane esophageal stents are not only used for dilatation of esophageal stenosis in patients with advanced esophageal cancer, but also for the treatment of esophageal fistula.
  • a wide range of esophageal fistulas are equivalent to local esophageal defects, and the use of memory alloy with esophageal stents has a good effect.
  • the incidence of anastomotic leakage after artificial esophageal implantation is 0%. This is especially important in the early stage after artificial esophageal implantation, and the anastomosis cannot be avoided. You may face surgery failure.
  • the artificial esophagus stays in the body for at least 6 months to effectively relieve the contractile force of the scar tissue of the newborn esophagus and prevent the narrowing of the new esophagus.
  • the ideal support time is 18 months to 30 months. After 18 months to 30 months, the neonatal esophagus can not only be epithelialized but also the scar tissue can be stabilized.
  • the connecting ring is very important for the body of the artificial esophagus.
  • the connecting ring can effectively reduce the influence of esophageal peristalsis on the implanted body, thereby preventing the anastomotic leakage and early decoupling, which directly determines the success or failure of the operation.
  • mucosal epithelium Stabilization and scar tissue provide adequate support for the sac and can be easily removed or removed in a non-invasive or minimally invasive manner after neovascularization of the mucosa and stabilization of the scar tissue, which is not available in the prior art. Instruments, new instruments are needed.
  • the object of the present invention is to provide a bio-inducible human body tube substitute for reconstitution of a human body after resection of the lumen, which can induce a new lumen, and is a growth of the new lumen, mucosa Epithelialization and scar tissue stabilization provide adequate support for the sac and can be easily removed or removed by atraumatic or minimally invasive methods after neovascularization of the mucosal membrane and stabilization of the scar tissue.
  • artificial esophagus for esophageal reconstruction after esophagectomy, or artificial trachea for tracheal reconstruction after tracheal resection, or artificial urethra after reconstruction of the urethra after urethral injury. It can also be used for nasal reconstruction and reconstruction of the external auditory canal.
  • the bio-inducible human body tube substitute of the present invention is a thin-walled tube that can be implanted in a human body for a long time, and includes: A. a support tube, the support tube is a flexible thin-walled tube And comprising: a support frame, a thin-walled mesh support provided as an elastic; a flexible material film disposed such that the flexible material film is wholly or partially covered by the support frame, or attached to the inner wall or the outer wall of the support frame; B. a connecting member, the connecting member is fixed on the supporting tube, and is arranged to fix the supporting tube to the broken end of the human esophagus through the connecting member; C. absorbable coating, the absorbable coating is degradable in the human body The material that absorbs and promotes tissue regeneration is fabricated on the outer wall of the support tube.
  • the absorbable coating comprises at least the following means: containing only biodegradable materials that can be used in humans; containing biodegradable materials and growth factors that can be used in humans; and containing those that can be used in humans. Biodegradable materials and seed cells; and biodegradable materials, growth factors, and seed cells that can be used in humans.
  • the support frame is movably coated between the flexible material films by a film of flexible material.
  • the movably coating refers to coating the support frame with two or more layers of flexible material.
  • the joint between the flexible material films is in the middle of the mesh of the support frame, or is combined with the non-deformable portion of the support frame, and the support frame can move in the space formed between the flexible material films, and the flexible material film is not opposite to the support frame. Movement causes excessive restraint.
  • the flexible material film is fixed on the inner wall or the outer wall of the support frame by an absorbable surgical suture; or the flexible material film is detachably stitched and fixed on the inner wall of the support frame by a non-absorbable surgical suture. Or on the outer wall.
  • the absorbable surgical suture the degradable dilatation of the absorbable surgical suture is generally greater than 6 months, and the scar tissue is not degraded until the growth of the scar tissue of the new lumen is stable.
  • the support frame is a thin-walled tubular body of a mesh material woven by a medical elastic material or a fiber; or a thin-walled tubular body composed of a coil spring wound with a medical elastic material; or Is a bendable elastic medical elastic material mesh structure thin-walled tube body formed by numerical control processing; or a laser-engravable elastic elastic medical elastic material mesh structure thin-walled tube body, Medical elastic material, at least selected from: nickel-titanium shape memory alloy (Nitinol alloy), ⁇ titanium alloy, medical stainless steel, medical zirconium alloy, medical zirconium-niobium alloy, medical titanium zirconium-niobium alloy, nickel-free titanium-based shape memory alloy, high elasticity Molecular material.
  • Nititanium shape memory alloy Niitinol alloy
  • the biodegradable material is at least selected from the group consisting of: polylactic acid, polyglycolic acid, polyhydroxybutyl ester, polyanhydride, polycaprolactone, polyphosphazene, polyphosphazene, polyamino acid, pseudo polyamino acid , polyorthoesters, polyester urethane, polytrimethylene carbonate, polyethylene glycol, polydioxanone, chitosan, collagen, gelatin, hyaluronic acid, chitin, alginate, Calcium alginate gel, acellular matrix, bioglass, and copolymers or mixtures thereof.
  • the growth factor is at least selected from the group consisting of: platelet growth factor (platelet derived growth factor, PDGF; osteosarcoma derived growth factor ODGF), epidermal growth factor (epidermal growth factor, EGF, transforming growth factor, TGF) - ⁇ and TGF- ⁇ ), fibroblast growth factor (FGF, a-FGF, ⁇ -F GF), insulin-like growth factor (IGF-I, IGF- ⁇ ), nerve growth factor (NGF), interleukin Growth factors (IL-1, IL-2, IL-3, etc.), erythrocyte growth factor (EPO), colony stimulating factor (CSF), and mixtures thereof.
  • the seed cells are at least selected from the group consisting of: autologous esophageal mucosal epithelial cells, autologous bone marrow mesenchymal stem cells, allogeneic bone marrow mesenchymal stem cells, embryonic stem cells, and mixtures thereof. Specific seed cells should be selected for specific clinical use.
  • the connecting member is a ring-shaped structure made of woven or knitted with a medical flexible material wire or fiber, and the medical flexible material for the connecting member is at least selected from the group consisting of: polyester (polyethylene terephthalate) Diester fiber), polyethylene, polypropylene, polyurethane, polytetrafluoroethylene.
  • the influence of the peristalsis of the reserved end of the human lumen (such as the esophageal retaining end and the tracheal retaining end) on the implanted tubular body can be effectively reduced, and the peristalsis can be reduced and prevented. Tear, cut, and establish a reliable connection to avoid anastomotic leakage and early tube removal.
  • the flexible material film is a film made of a medical flexible material that can be implanted in a human body for a long time, and is at least selected from the group consisting of: medical silica gel, polyurethane, polytetrafluoroethylene, various fiber-reinforced medical flexible films.
  • the connecting members Preferably, there are two connecting members, and the connecting members have a width of about 3 mm to 15 mm, and are respectively sutured and fixed to the two end portions of the supporting tube, and the distance from the end portion is about 5 mm to 20 mm.
  • the support tube is provided with a film of flexible material, and the flexible material film at the end of the support tube and the flexible material film at the intermediate portion of the support tube are made of different flexible materials.
  • the proximal end of the support tube is provided with a recovery line capable of taking the support tube out of the body.
  • the support tube is provided with an anti-backflow device having a check valve function.
  • the anti-backflow device is a sleeve type one-way valve type structure or a petal type structure.
  • the petal structure is divided into two-petal structure, three-petal structure, four-petal structure, five-petal structure and six-petal structure.
  • the thickness of the absorbable coating layer is between 0. m and 5 mm, preferably between 10 ⁇ and 1 ⁇ .
  • the present invention employs a membrane-reinforced elastic support tube with a connecting member, an absorbent coating is attached to the outer wall of the support tube, and the absorbable coating contains a material which is degradable and absorbable in the human body and can promote tissue regeneration. , can induce or promote the growth of new lumens.
  • the use of the connector's anastomosis can effectively reduce the impact of the patient's retained lumen end (such as esophagus, trachea) peristalsis on the implanted elastic support tube, plus the membrane elastic support tube is good and strong.
  • the support force provides sufficient support for the growth of the neonatal lumen, mucosal epithelialization and scar tissue stabilization, and can easily pass through the atraumatic or minimally invasive manner after the neoplasia mucosal epithelialization and scar tissue stabilization Remove or remove.
  • the bioinducible human body tube substitute of the present invention is used for esophageal reconstruction after esophagectomy, and can be used as an artificial esophagus.
  • the membrane elastic support tube is matched with the retained esophagus broken end, and the connecting piece is connected by a surgical line
  • the suture is fixed on the retained esophageal end, and the absorbable coating applied outside the membrane elastic support tube promotes esophageal regeneration.
  • a biodegradable material capable of inducing or promoting neonatal esophagus, or a biodegradable material and a growth factor; or a biodegradable material and a seed cell; or a biodegradable material, a growth factor, and a seed cell; Accelerate the growth of new esophagus, mucosal epithelialization, and promote the stability of neonatal esophageal scar tissue. After the mucosa of the newborn esophagus is completely covered and the neonatal esophageal scar tissue is stabilized (about 6 months to 30 months), the suture is removed under direct vision of the digestive endoscope.
  • the implanted elastic support tube It is convenient to take out or remove the implanted elastic support tube with the connector. If the esophageal stump and the connector (or the connecting ring, or the reduced connecting ring) are sutured with a special surgical line that degrades the daytime for more than 180 days, there is no need to remove the suture, after the surgical suture is degraded, the support tube Can automatically slip off, fall into the stomach, and take it out under the direct view of the digestive endoscope.
  • the bioinducible human body tube substitute of the present invention is used for tracheal reconstruction and can be used as an artificial trachea.
  • the membrane elastic support tube is anastomosed to the remaining end of the trachea, and the connector is sutured and fixed on the remaining trachea end by a surgical line, and the absorbable coating coated on the membrane elastic support tube can promote tracheal regeneration.
  • the membrane elastic support tube has good flexibility and strong support force, which provides sufficient support for the growth of the new irritated tube, mucosal epithelialization and scar tissue stability, and is convenient after the neoplastic tube mucosa epithelialization and scar tissue stabilization.
  • the ground is removed or removed by a non-invasive or micro-invasive manner.
  • the biologically induced human lumen tube substitute of the present invention is used for urethral reconstruction and can be used as an artificial urethra.
  • the membrane elastic support tube is anastomosed to the retained urethral stump, and the connector is sutured and fixed on the retained urethral stump with a surgical line.
  • the absorbable coating coated on the membrane elastic support tube can promote the urethral biological induction type.
  • Human body tube substitutes are regenerated.
  • the membrane elastic support tube has good flexibility and strong support force, which provides sufficient support for the growth of the new urethra, mucosal epithelialization and scar tissue stability, and is convenient after the epithelialization of the new irritated mucosa and the stabilization of the scar tissue. Remove or remove through a non-invasive or micro-invasive manner
  • the bioinducible human body tube substitute of the present invention can also be used.
  • FIG. 1 is a schematic view showing the structure of a monofilament woven detachable support frame on a support tube of a biologically induced human body tube substitute of the present invention.
  • 2 is a schematic view showing the structure of a biologically induced human body tube substitute of the present invention.
  • FIG. 3 is an enlarged view of a cross-sectional view of D_D of FIG. 2.
  • Fig. 4 is a partially enlarged structural view of the structure of the outer wall of the support frame attached to the outer wall of the support frame by the flexible material film.
  • Fig. 5 is a partially enlarged structural view of a structure in which the flexible material film is attached to the inner wall of the support frame, and Fig. 2 is W.
  • Fig. 6 is a partially enlarged schematic view of the structure of the support frame structure of Fig. 2, which is covered by a two-layer flexible material film.
  • Fig. 7 is a schematic view showing the structure of a partially enlarged crucible at W at Fig. 2, which is covered with a thermal two-layer flexible material film.
  • Figure 8 is a schematic view showing the structure of a partially enlarged W of the support frame of Fig. 2 by fabricating a flexible material film from two different flexible materials.
  • Figure 9 is a schematic view showing the structure of a partially enlarged W at the W of Figure 2, which is directly covered with a flexible material.
  • Figure 10 is a schematic view showing the structure of a cross-grid type biologically induced human body tube substitute of the present invention.
  • Figure 11 is an enlarged view of a cross-sectional view of A_A of Figure 10 .
  • Figure 12 is a schematic view showing the structure of a cross-grid type biologically induced human body tube substitute of the present invention.
  • Figure 13 is an enlarged view of a cross-sectional view taken along line C_C of Figure 12 .
  • Figure 14 is a schematic view showing the structure of a coil spring type biologically induced human body tube substitute of the present invention.
  • Fig. 15 is an enlarged view of a cross-sectional view taken along line E_E of Fig. 14.
  • Figure 16 is a schematic view showing the structure of a laser-engraving bioinductive human body tube substitute of the present invention.
  • Figure 17 is an enlarged view of a cross-sectional view of F_F of Figure 16 .
  • Figure 18 is a schematic view showing the structure of a full-coated bioinducible human body tube substitute of the present invention.
  • FIG. 19 is an enlarged view of a cross-sectional view of G_G of FIG. 18.
  • 20 is a schematic view showing the structure of a growth factor-containing biologically induced human body tube substitute of the present invention.
  • Figure 21 is an enlarged view of a cross-sectional view taken along line B-B of Figure 20 .
  • FIG. 22 is a schematic view showing the structure of a biologically induced human body tube substitute containing seed cells of the present invention.
  • H_H of FIG. 22 is an enlarged view of a cross-sectional view of H_H of FIG. 22.
  • 24 is a schematic view showing the structure of a biologically induced human body tube substitute containing seed cells of the present invention.
  • 25 is an enlarged view of a cross-sectional view of L_L of FIG. 24.
  • Figure 26 is a schematic diagram showing the operation of a freshly implanted esophageal fistula of a bio-inducible human lumen tube containing a growth factor in a single bell mouth of the present invention.
  • Figure 27 is a schematic diagram of the operation of the neonatal esophageal fistula induced by Figure 26.
  • Figure 28 is a schematic view showing the operation of the growth factor-containing bioinducible human body tube substitute of the present invention.
  • Figure 29 is a schematic diagram of the operation of the new angry tube raft of Figure 28.
  • Figure 30 is a schematic diagram showing the working principle of the newly implanted urethral fistula of the biologically induced human lumen tube substitute of the present invention.
  • Figure 31 is a schematic diagram of the operation of Figure 30 for inducing neonatal urethral fistula.
  • 1 is a support tube
  • 2 is a connecting member
  • 3 is an absorbable coating
  • 4 is a biologically induced human body tube substitute of the present invention
  • 5 is a recycling line
  • 6 is an anti-backflow device.
  • 7 is suture
  • 8 is the normal lumen of the human body
  • 9 is the new lumen
  • 11 is the support frame
  • 12 is the flexible material membrane
  • 31 is the biodegradable material
  • 32 is the growth factor
  • 33 is the seed cell
  • 81 is the proximal normal esophageal end
  • 82 is the distal normal esophageal end
  • 83 is the proximal normal tracheal stump
  • 84 is the distal normal trachea stump
  • 85 is the proximal normal urethral stump
  • 86 is the distal normal Urethral stump
  • 90 is the stenosis of the new lumen
  • 91 is the new esophagus
  • 92 is the new irritated tube
  • 93 is the new urethra
  • 111 is the U-section of the support frame
  • 112 is the wire head of the support frame
  • 121 is the heat seal .
  • Example 1 Bioinducible human body tube substitute prepared by monofilament of the present invention
  • Nickel-titanium shape memory alloy (Nitinol alloy) wire with a recovery temperature of 15 ° C and a diameter of 0.25 mm
  • the support frame 11 is formed by a U-shaped section 111 formed by bending a single wire, and one set is connected together to form a detachable bracket, that is, pulling the upper end of the wire head 112, U
  • the U-shaped section 111 can be removed one by one, thereby removing the entire support frame 11 and becoming a monofilament.
  • the detachable support frame 11 which is woven by the monofilament and has the U-shaped section 111 can be freely stretched and contracted in the longitudinal direction to a certain extent, and can be freely bent and swayed in the radial direction, and the radial support force is large, in the tissue. Easy to position, not easy to slip off. It is especially suitable for the reconstruction of the sacral canal for the esophagus and trachea.
  • the above-mentioned support tube 11 is installed in a special mold, and the support frame 11 is coated according to the general process of the medical silica gel to obtain the flexible material film 12, that is, the medical silicone film.
  • the coated mesh stent body of the coated support frame 11, that is, the support tube 1 of the present invention is obtained, with reference to FIG.
  • the connector 2 is sutured to the end of the support tube 1 with a surgical suture 7, and the distance from the end is 10 mm. Wash, sterilize, and wait for the spray to absorb the coating 3 , refer to Figure 2.
  • the liquid containing the biodegradable material 31, such as gelatin solution or collagen solution, is injected into the ultrasonic atomizing spraying device, and while rotating the supporting tube body 1, the liquid containing the biodegradable material 31 is sprayed, and the same is freeze-dried.
  • the absorbent coating 3 can be produced on the outer wall of the support tube 1 by treatment.
  • the absorbable coating 3 is prepared, and after packaging, it is sterilized by gamma irradiation or fumigation with epoxy oxime, and the bio-inducible human body tube substitute of the present invention is obtained 4, referring to Figs. 2 and 3.
  • Fig. 2 and Fig. 3 the basic structure of the biologically induced human body tube substitute of the present invention is shown, and the biologically induced human body tube substitute of the present invention is supported by the support tube 1, the connecting member 2 and the absorbable body.
  • the absorbable coating 3 is coated on the outer wall of the support tube 1, and the connecting member 2 is disposed at both ends of the support tube 1, about 10 mm from the end.
  • the flexible material film 12 is attached to the support frame 11.
  • the above degradable biomaterial 31 at least selected from the group consisting of: lactic acid, polyglycolic acid, polyhydroxybutyl ester, polyanhydride, polycaprolactone, polyphosphazene, polyphosphazene, polyamino acid, pseudopolyamino acid, poly Orthoester, polyester urethane, polytrimethylene carbonate, polyethylene glycol, polydioxanone, chitosan, collagen, gelatin, hyaluronic acid, chitin, alginate, alginic acid Calcium gel, acellular matrix, bioglass, and copolymers or mixtures thereof.
  • the flexible material film 12 may also be at least selected from the group consisting of polyurethane, polytetrafluoroethylene, various fiber-reinforced medical flexible films, and the like.
  • the manufacturing process is different.
  • the flexible material film 12 is made of polytetrafluoroethylene, and the flexible material film 12 of the polytetrafluoroethylene can be fixed to the support frame 11 by sewing, see FIGS. 4 to 6.
  • FIG. 4 a specific manner in which the flexible material film 12 is attached to the support frame 11 is shown, and the gP: flexible material film 12 is attached to the outer wall of the support frame 11.
  • a flexible material film 12 such as a polytetrafluoroethylene film, is placed on the outer wall of the support frame 11, and the flexible material film 12 is detachably sewn to the non-deformable portion of the support frame 11 by the surgical suture 7, such as the metal of the support frame 11.
  • the straight section of the wire, the U-shaped section 111 on the support frame 11 can be freely stretched and contracted to some extent in the longitudinal direction, and can be freely bent and swayed in the radial direction, and the flexible material film 12 is not excessively constrained by the support frame 11.
  • the movable, easy-to-implant support tube 1 accommodates the peristalsis of the esophagus or trachea, preventing anastomotic leakage and detachment.
  • the membrane is external, and the structure inside the stent is more suitable for the induced formation of the trachea, which can avoid the risk of clogging the trachea due to accidental detachment of the membrane, and facilitate the removal of the biologically induced human lumen tube substitute of the present invention under the bronchoscope.
  • the biologically inducible human body tube substitute of the present invention is removed, and only the surgical suture 7 for suturing and fixing the flexible material film 12 is removed under direct vision under the bronchoscope, and the wire of the support frame 11 is clamped by the surgical forceps.
  • the head 112 pulls the wire hard, and the U-shaped section 111 is straightened, so that the support frame 11 can be easily removed, and the connector 2 can be taken out at the same time.
  • FIG. 5 another specific manner in which the flexible material film 12 is attached to the support frame 11 is shown, that is, the flexible material film 12 is attached to the inner wall of the support frame 11.
  • a flexible material film 12, such as a polytetrafluoroethylene film, is placed on the inner wall of the support frame 11, and the flexible material film 12 is sewn to the non-deformable portion of the support frame 11 by the surgical suture 7, such as a straight line of the support frame 11 wire.
  • the U-shaped section 111 on the support frame 11 can be freely extended and contracted to some extent in the longitudinal direction, and can be freely bent and swayed in the radial direction, and the flexible material film 12 is not excessively constrained to support the movement of the support frame 11, which is convenient.
  • the implanted support tube 1 is adapted to the peristalsis of the esophagus or trachea to prevent anastomotic leakage and decoupling.
  • the film is inside, and the structure of the stent is outside, the inner wall is smooth, and the food is slipped, which is more suitable for the induction of esophagus.
  • a new lumen (such as a neonatal esophagus) is induced, and after epithelialization and tissue stabilization, surgery
  • the suture 7 is degraded, and the inner membrane made of the polytetrafluoroethylene film, that is, the flexible material film 12 falls off, falls into the stomach, can be naturally discharged or taken out under the digestive endoscope, and the wire head 112 is pulled out at the same time, and the support can be removed. Shelf 11 retains the induced neonatal lumen (such as the neonatal esophagus) only in vivo.
  • FIG. 6 a third specific manner in which the flexible material film 12 is attached to the support frame 11 is shown, gP:
  • the support frame 11 is covered by two layers of flexible material film 12. ⁇ Use 0.4mm thick PTFE film as soft a film 12 of a material, a layer of flexible material film 12 is placed on the inner wall of the support frame 11 as an inner film; another layer of flexible material film 12 is placed on the outer wall of the support frame 11 as an outer film; 7
  • the inner and outer layers of the flexible material film 12 are sewn together in the non-deformable portion of the support frame 11, such as the straight line segment of the support frame 11 wire.
  • the U-shaped section 111 on the support frame 11 is flexible in two layers.
  • the space formed between the material films 12 can be freely stretched and contracted to some extent in the longitudinal direction, and can be freely bent and swayed in the radial direction, and the flexible material film 12 is not excessively constrained to support the movement of the support frame 11, facilitating implantation.
  • the support tube 1 adapts to the peristalsis of the esophagus or the trachea, preventing anastomotic leakage and decoupling.
  • the flexible material film 12 is made of a polyurethane material
  • the polyurethane flexible film 12 can be fixed to the support frame 11 by a heat sealing process, as shown in Fig. 7.
  • a fourth specific manner in which the flexible material film 12 is attached to the support frame 11 is shown, that is, the support frame 11 is covered by two layers of the flexible material film 12, but between the inner and outer films.
  • the fixing method is different from the embodiment shown in Fig. 6, and thermal law is employed.
  • a 0.5 mm thick polyurethane film is used as the flexible material film 12, and a layer of the flexible material film 12 is placed on the inner wall of the support frame 11 as an inner film; and another layer of the flexible material film 12 is placed on the outer wall of the support frame 11.
  • the outer film; then the inner and outer two layers of flexible material film 12 corresponding to the holes of the support frame 11 are heat-sealed together with reference to FIG.
  • the heat sealing portion is 121, and the U-shaped joint 111 on the support frame 11 is in two
  • the space formed between the layers of the flexible material film 12 can be freely stretched and contracted to some extent in the longitudinal direction, and can be freely bent and swayed in the radial direction, so that the flexible material film 12 does not unduly restrain the movement of the support frame 11, which is convenient.
  • the implanted support tube 1 is adapted to the peristalsis of the esophagus or trachea to prevent anastomotic leakage and decoupling.
  • the flexible material film 12 covering the support frame 11 can use different materials in different parts of the support tube 1, for example, in the middle of the support tube 1, the contraction of the scar tissue of the new esophagus is compared.
  • the flexible material film 12 is required to have relatively good strength, and the inner film of the same support tube 1 is required to be smooth, and it is convenient for the food to slip down and fall into the stomach, so that a polytetrafluoroethylene film with high strength and good corrosion resistance can be selected.
  • the outer part of the support tube 1 is matched with the normal end of the esophagus, and the support force of the wire should be dispersed as much as possible to prevent stress concentration, and excessive stimulation of the esophagus to form the meat tooth tissue, so in the PTFE
  • the vinyl film it can also be coated with medical silica gel to form a later layer of flexible material film 12 to disperse the supporting force of the wire to prevent proliferation of the dental tissue.
  • the manner of attachment of the flexible material film 12 to the multi-material multilayer structure of the support frame 11 is formed, with reference to FIG. [83] In FIG.
  • a schematic view showing the structure of the flexible material film 12 for covering the support frame 11 by using two different flexible materials is shown, that is, the fifth specific manner in which the flexible material film 12 is attached to the support frame 11 is shown.
  • the flexible material film 12 covering the support frame 11 can be made of different materials in different parts of the support tube 1. Taking the induced neonatal esophagus as an example, in the middle of the support tube 1, the contraction of the scar tissue of the new esophagus is serious, and the flexible material membrane 12 requires relatively good strength, and the inner membrane of the same support tube 1 is required to be smooth, and the food is slippery. Dropped into the stomach, you can choose a high strength and corrosion resistance Teflon film.
  • the outer part of the support tube 1 is matched with the normal end of the esophagus, and the support force of the wire should be dispersed as much as possible to prevent stress concentration, and excessive stimulation of the esophagus to form the meat tooth tissue, so in the PTFE
  • the vinyl film it can also be coated with medical silica gel to form a later layer of flexible material film 12 to disperse the supporting force of the wire to prevent proliferation of the dental tissue.
  • the medical silicone coating does not affect the movement of the support frame 11, and the U-shaped section 111 on the support frame 11 can be longitudinally defined in the space formed between the two flexible material films 12.
  • the degree can be freely stretched, and can be freely bent and swayed in the radial direction. Simultaneously, the flexible material film 12 does not unduly restrain the movement of the support frame 11, and the implanted support tube 1 can be adapted to the peristalsis of the esophagus or the trachea to prevent the anastomosis. ⁇ and take off.
  • a technical solution for manufacturing a flexible material film 12 by covering the support frame 11 with a flexible material is shown, i.e., a sixth specific manner in which the flexible material film 12 is attached to the support frame 11 is shown.
  • the high-strength medical silica gel is selected, and the support tube 1 is obtained by directly coating the support frame 11 according to the general process of medical silica gel.
  • the U-shaped section 111 on the support frame 11 is embedded in the middle of the flexible material film 12, and the movement of the support frame 11 is restrained to some extent by the flexible material film 12, which is flexible and adapted to the esophagus or The ability of the trachea to move is not as good as the first five.
  • the material for manufacturing the support frame 11 may also be at least selected from the group consisting of: ⁇ titanium alloy, medical stainless steel, medical zirconium alloy, medical zirconium-niobium alloy, medical titanium zirconium-niobium alloy, nickel-free titanium-based shape memory alloy, elastic polymer material. Elastic materials. The better the elasticity of the material, the better the fit with the human lumen of the human esophagus, or the trachea, and the less likely the anastomotic leakage occurs.
  • the material of the connecting member 2 can also be at least selected from the group consisting of polyethylene, polypropylene, polyurethane, polytetrafluoroethylene, etc., requiring good biocompatibility, high strength and light weight.
  • Example 2 Cross-grid biologically induced human lumen tube substitute of the present invention
  • the manufacturing method of the present embodiment is basically the same as that of the first embodiment, and is characterized in that the knitting method of manufacturing the crucible of the support frame 11 uses a cross-grid weaving method, with reference to FIGS. 10 to 11.
  • the support frame 11 is woven by a cross grid, and the flexible material film 12 is attached to the support frame 11 in a manner similar to that of FIGS. 2 to 9 .
  • Example 3 The cross-grid bioinducing human body tube substitute with a single bell mouth of the present invention
  • the manufacturing method of the embodiment is basically the same as that of the first embodiment, and is characterized in that the knitting method of manufacturing the crucible of the support frame 11 uses a cross-grid weaving method with a single bell mouth; At the same time, a 3-valve anti-backflow device is manufactured at the distal end of the support tube 1, see Figs. 12 to 13.
  • the support frame 11 is woven by a single bell cross-grid, and the flexible material film 12 is attached to the support frame 11 in a similar manner. 2 to various specific modes shown in Fig. 9, in addition, at the lower end of the support tube 1, a three-lobed anti-backflow device 6 is also provided.
  • Example 4 Biologically induced human lumen tube substitute of the spiral structure of the present invention
  • the manufacturing method of this embodiment is basically the same as that of the embodiment 1, and is characterized in that the crucible of the support frame 11 is manufactured by a coil spring structure of a single wire, with reference to Figs. 14 to 15 .
  • the support frame 11 of the present invention is formed by a coil spring structure and is wound by a single wire for easy disassembly.
  • Example 5 Laser-engraved biologically induced human body tube substitute of the present invention
  • the manufacturing method of the present embodiment is basically the same as that of the embodiment 1, and is characterized in that the cymbal of the support frame 11 is manufactured by using a mesh structure bracket formed by laser engraving of a thin-walled tube, with reference to Figs. 16 to 17 .
  • the manufacturing method of the present embodiment is basically the same as that of Embodiment 1, and is characterized in that the outer wall of the support tube 1 is coated with the absorbable coating 3 both at the end portion and the intermediate portion, and further, the support tube 1 is also near The end is provided with a recovery line capable of closing the proximal end opening of the support tube 1, so that the support tube 1 can be taken out of the body if necessary, referring to Figs. 18 to 19.
  • the absorbable coating 3 covers the entire outer wall of the support tube 1, and at the proximal end of the support tube 1, i.e., the upper end, a proximal end opening of the support tube 1 is provided. Recycling line 5, convenient to support The support tube 1 is taken out.
  • Example 7 Growth factor-containing biologically induced human body tube substitute of the present invention
  • the support tube 1 of the present embodiment can be prepared by referring to the method of Example 1.
  • the connector 2 is sutured to the end of the support tube 1 with a surgical suture 7, with a distance of 15 mm from the end. Wash, sterilize, and wait for the spray to absorb the coating 3 .
  • a suitable volatile solvent such as acetone
  • a suspension is formed, and a uniform coating solution having a concentration of 0.01 to 10% is prepared and used.
  • the prepared coating solution is filled in a syringe, the ultrasonic generator power is adjusted to 0.1 to 5w, the injection rate of the coating solution in the syringe is 0.001 to 0.1 ml / min, and the compressed gas pressure is 0.2 to 10 psi. ;
  • clamping the support tube on a particular jig, the bracket is set to 0 in the horizontal moving speed of the software interface 01 ⁇ lcm 7 s, the rotational speed of the support tube 10 ⁇ 350r 7 min, the rotational direction of the support.
  • the number of reciprocating movements of the pipe body is 1 to 200 times, the pressure of the drying gas is 0.2 to lOpsi, and the exhausting speed of the exhaust system is 10 to 1000 CFM.
  • the spraying process is called and started, and the ultrasonic generator generates ultrasonic waves, which are transmitted to the micro atomizing nozzle through the sensor.
  • the coating solution is conveyed by a syringe to the atomizing surface of the nozzle by a syringe pump, and the ultrasonic wave atomizes the liquid into small droplets, and the droplets fly toward the surface of the supporting tube body 1 under the action of the low-speed compressed gas.
  • a thin liquid layer is formed on the surface of the support pipe body 1. After the organic solvent in the liquid layer is volatilized, a thin layer of the surface of the support pipe body 1 is deposited. Growth factor absorbable coating 332, during which the support tube 1 below the nozzle reciprocates.
  • the sprayed support tube 1 is dried to form an absorbable coating 3 on the outer wall of the support tube 1.
  • the absorbable coating 3 is prepared, and after drying and packaging, it is sterilized by ⁇ -ray irradiation or sterilized by epoxy oxime, and the biologically induced human cavity tube substitute of the present invention is obtained.
  • the absorbable coating 3 contains the growth factor 32.
  • the growth factor 32 may be dispersed in the absorbable coating 3, may be distributed in the absorbable coating 3 after being coated with the biodegradable material 31, or may be layered in the absorbable coating 3, or Dip or adsorb in the absorbable coating 3.
  • the growth factor 32 is at least selected from the group consisting of: platelet growth factor (platelet-derived growth factor PDGF; osteosarcoma-derived growth factor ODGF), epidermal growth factor (EGF, EGF, transforming growth factor, TGF- ⁇ , and TGF- ⁇ ) ), fibroblast growth factor (FGF, ⁇ -FGF, ⁇ -FGF), insulin-like growth factor (IGF-I, IGF- ⁇ ), nerve growth factor (NGF), interleukin growth factor (IL-1, IL-2, IL-3, etc.), erythrocyte growth factor (EPO), colony stimulating factor (CSF), and mixtures thereof, see Figure 20, Figure 21.
  • platelet growth factor platelet-derived growth factor PDGF; osteosarcoma-derived growth factor ODGF
  • EGF epidermal growth factor
  • TGF- ⁇ transforming growth factor
  • TGF- ⁇ transforming growth factor
  • TGF- ⁇ transforming growth factor
  • TGF- ⁇ transforming growth factor
  • TGF- ⁇ transforming growth
  • a recovery line 5 is provided on the bell mouth of the embodiment to facilitate the removal of the support tube 1.
  • Example 8 Biologically inducible human body tube substitute for seed-containing cells of the present invention
  • the support tube 1 of the present embodiment can be prepared by referring to the method of Example 1.
  • a braided polyester ring is used as the connecting member 2, and the connecting member 2 is sutured and fixed to the end of the support tube 1 by a surgical suture 7, and the distance from the end portion is 10 mm. Wash, sterilize, and wait for the spray to absorb the coating 3 .
  • a biodegradable material 31 such as a polylactide-ethylene glycol copolymer
  • a bioactive glass in a suitable volatile solvent, such as double distilled water + acetone, dispersed by ultrasonication to form a suspension or
  • a suitable volatile solvent such as double distilled water + acetone
  • a polylactide-ethylene glycol copolymer/bioactive glass solution was injected into an ultrasonic atomizing spray apparatus for spraying. ⁇ Spray while supporting the tube body 1 while rotating. The freeze-drying treatment is carried out to produce an absorbable coating 3 on the outer wall of the support tube 1. Do a good absorption of the coating 3, packaged and sterilized by gamma irradiation or fumigated with epoxy acetonitrile.
  • the seed cell 33 suspension was inoculated into the support tube 1 with the absorbable coating 3 prepared in advance prepared by the PBS buffer solution, and was carried out in a 37 ° C, 5 % C0 2 incubator.
  • the cells are further combined with the absorbable coating 3.
  • the K-SFM medium was carefully added, and the culture was continued at 37 ° C in a 5 % C0 2 incubator.
  • the seed cell 33 in vitro is cultured, and the support tube 1 composite with the absorbable coating 3 is obtained, thereby obtaining the biologically induced human body tube substitute of the present invention, that is, Clinical use.
  • the present embodiment is characterized in that the absorbable coating 3 contains seed cells 33.
  • the seed cells 33 may be dispersedly distributed in the absorbable coating 3, may be distributed in the absorbable coating 3 after being coated with the biodegradable material 31, or may be layered in the absorbable coating 3, or Dip or adsorb in the absorbable coating 3.
  • the seed cells 33 of the present embodiment are at least selected from the group consisting of: autologous esophageal mucosal epithelial cells, autologous mesenchymal stem cells, allogeneic bone marrow stem cells, embryonic stem cells, and mixtures thereof.
  • the specific seed cells should be selected according to the specific II: bed use, refer to Figure 11, Figure 23.
  • Example 9 Bioinducible human body tube substitute containing growth factor and seed cells of the present invention
  • the support tube 1 of the present embodiment can be prepared by referring to the method of Example 1.
  • the woven polyester ring is used as the connecting member 2, and the connecting member 2 is sutured and fixed to the end of the support tube 1 by the surgical suture 7, and the distance from the end portion is 10 mm. Wash, sterilize, and wait for the spray to absorb the coating 3 .
  • the seed cell 33 suspension was inoculated to the support tube 1 with the growth factor 32 prepared with the absorbable coating 3 prepared in advance with PBS buffer solution at 37 ° C, 5 %.
  • the culture was carried out in a 0 2 incubator to further bind the seed cells 33 and the support tube 1 with the absorbable coating 3.
  • the K-SFM medium was carefully added, and the culture was continued in a 37 ° C, 5 % C0 2 incubator.
  • the seed cell 33 in vitro is cultured, and the support tube 1 complex containing the growth factor 32 with the absorbable coating 3 is obtained, thereby obtaining the biologically induced human body tube substitute of the present invention.
  • Figure 24, Figure 25 refers the biologically induced human body tube substitute of the present invention.
  • This embodiment is characterized in that the same layer in the absorbable coating 3 contains seed cells 33 and growth factors 32.
  • the seed cells 33 and the growth factors 32 may be dispersed in the absorbable coating 3, may be distributed in the absorbable coating 3 after being coated with the biodegradable material 31, or may be layered on the absorbable coating. 3, or dip or adsorbed in the absorbable coating 3.
  • the seed cells 33 are at least selected from the group consisting of: autologous esophageal mucosal epithelial cells, autologous bone marrow mesenchymal stem cells, allogeneic bone marrow mesenchymal stem cells, embryonic stem cells, and mixtures thereof. Specific seed cells 33 are selected for specific clinical use.
  • the growth factor 32 is at least selected from the group consisting of: platelet growth factor (platelet derived growth factor, PDGF; osteosarcoma source) Long-factor ODGF), epidermal growth factor (EGF, EGF, transforming growth factor, TGFa and TGFP), fibroblast growth factor (FGF, aFGF, FGF), insulin-like growth factor (IGF-I, IGF- ⁇ ) ), nerve growth factor (NGF), interleukin growth factor (IL-1, IL-2, IL-3, etc.), erythrocyte growth factor (EPO), colony stimulating factor (CSF)
  • platelet growth factor platelet derived growth factor, PDGF; osteosarcoma source
  • Long-factor ODGF long-factor ODGF
  • EGF epidermal growth factor
  • EGF epidermal growth factor
  • TGFa and TGFP transforming growth factor
  • FGF fibroblast growth factor
  • IGF-I insulin-like growth factor
  • IGF-I insulin-like growth factor
  • Example 10 The biologically induced human lumen tube substitute of the present invention is used for esophageal reconstruction
  • FIG. 26 and 27 a method of esophageal reconstruction using a bioinducible human lumen tube surrogate of the present invention is shown.
  • the proximal end that is, the normal esophageal stump 81 near the entrance of the esophagus
  • the mucosa of the normal esophageal end 81 is placed.
  • the connector 2 is intermittently secured to the normal esophageal septum 81 by surgical sutures 7.
  • the proximal end of the biologically induced human lumen tube substitute 4 of the present invention is inserted into the distal normal esophageal end 82, and the distal end, that is, the normal esophageal end 82 adjacent to the stomach, is placed in the present invention.
  • the mucosa of the distal normal esophageal end 82 is placed under the proximal connector 2 of the biologically induced human lumen tube substitute 4 of the present invention, and is surgically sutured.
  • the line 7 intermittently sutures the distal connector 2 of the biologically-inducible human body tube substitute 4 of the present invention and the normal esophageal end 82, thereby completing the implantation of the biologically-inducible human body tube substitute 4 of the present invention. Fixed.
  • the neonatal esophagus will rely on the outer wall of the biologically induced human lumen tube substitute 4 of the present invention to crawl, grow, epithelialize, and scar tissue growth stably.
  • the absorbable coating 3 of the bioinducible human body tube substitute of the present invention contains growth factor 32 and seed cells, it is more effective in promoting the formation of neonatal esophagus, epithelialization, and stabilization of scar tissue.
  • the biologically-inducible human lumen tube substitute of the present invention is formed by one or both ends of fibrous connective tissue surrounding the outer wall of the implanted biologically induced human lumen tube substitute before the formation of the new esophagus.
  • the anastomosis of the normal esophageal tissue is a closed tube that acts as an artificial esophagus to ensure that the food enters the stomach smoothly.
  • the biologically inducible human body tube substitute of the present invention can be excreted under direct vision of the digestive endoscope.
  • the structure of the newborn esophagus in essence It is a scar-conduit that is mainly composed of fibrous connective tissue repair, which can regenerate the stratified mucosal epithelium, submucosal muscle layer and gland, and the muscular layer is filled with scar-repairing fibrous connective tissue and has no contractile function.
  • Example 11 Bioinducible human body tube substitute of the present invention for tracheal reconstruction
  • FIGs 28 and 29 a method of tracheal reconstruction using the bioinducible human lumen tube substitute of the present invention is shown.
  • the proximal end that is, the normal tracheal stump 83 near the oral cavity
  • the mucosa of the proximal normal tracheal stump 83 is placed.
  • the connector 2 is intermittently secured to the normal tracheal stump 83 by surgical sutures 7.
  • the distal end of the biologically induced human lumen tube substitute 4 of the present invention is inserted into the distal normal tracheal end 84, and the mucosa of the distal normal tracheal end 84 is placed in the biologically induced human lumen of the present invention.
  • the distal end connector 2 of the biologically-inducible human body tube substitute 4 of the present invention is intermittently sutured and fixed with the surgical suture 7 to the normal tracheal end 84.
  • the implant of the biologically induced human lumen tube substitute 4 of the present invention is fixed.
  • the biologically induced human body tube substitute of the present invention 4 functions as an artificial air tube to ensure smooth breathing before the new gas tube is formed. In the early stage of the formation of the new gas tube, it plays a role in protecting the new gas tube. During the growth of the new gas tube, it plays a role in promoting the growth of new gas tubes, mucous epithelialization and stabilizing scar tissue, and resisting the narrowness of the new gas tube. After the new eschar tube tissue is completely stabilized, the biologically induced human lumen tube substitute 4 of the present invention can be taken out of the body under direct vision of the bronchoscope.
  • Example 12 Bioinducible human body tube substitute of the present invention is used for urethral reconstruction
  • FIG. 30 and 31 a method of urethral reconstruction using the bioinducible human lumen tube surrogate of the present invention is shown.
  • the proximal end that is, the normal urethral stump 83 close to the urethral opening
  • the proximal end of the bioinducible human lumen tube substitute 4 of the present invention is placed on the proximal end of the bioinducible human lumen tube substitute 4 of the present invention, and the mucosa of the proximal normal urethral stump 83 is placed.
  • the connector 2 is intermittently secured to the normal urethral stump 85 by surgical sutures 7.
  • the distal end of the biologically induced human lumen tube substitute 4 of the present invention is inserted into the distal normal urethral stump 86, and the mucosa of the distal normal urethral stump 86 is placed in the biologically induced human lumen of the present invention.
  • Remote connection of supplies 4 Above the connector 2 the distal end connector 2 of the biologically-inducible human body tube substitute 4 of the present invention is sutured and fixed together with the normal urethral stump 84 by surgical suture 7, thereby completing the biological induction of the present invention.
  • the implant of the human body tube substitute 4 is fixed.
  • the newborn urethra will rely on the outer wall of the bioinducible human body tube substitute 4 of the present invention to be crawled, grown, epithelialized, and scar tissue stable.
  • the biologically induced human lumen tube substitute of the present invention 4 functions as an artificial urethra before the formation of the new urethra to ensure smooth breathing. In the early stage of neonatal urethra formation, it protects the newborn urethra and promotes the growth of new urinary tract, mucosal epithelialization and stable scar tissue during the growth of the new urethra, and resists the narrowing of the new urethra. After the neonatal urethral tissue is completely stabilized, the biologically induced human lumen tube substitute 4 of the present invention can be taken out of the body under direct vision of the urethra.

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Abstract

La présente invention concerne un substitut de tube corporel humain à induction biologique qui fait intervenir un tube support élastique (1) recouvert d’un film (12) et pourvu de pièces de liaison (2). Un revêtement absorbable (3) adhère à la paroi externe du tube support (1) et comprend des facteurs de croissance (32) et/ou des cellules germes (33).
PCT/CN2009/074441 2008-10-15 2009-10-14 Substitut de tube corporel humain à induction biologique WO2010043177A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN200810199151A CN101721263A (zh) 2008-10-15 2008-10-15 生物诱导复合型人工食管
CN200810199150.4 2008-10-15
CN200810199150A CN101721262A (zh) 2008-10-15 2008-10-15 组织工程化组合式人体腔管代用品
CN200810199151.9 2008-10-15

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WO2010043177A1 true WO2010043177A1 (fr) 2010-04-22

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