WO2021233359A1 - 一种移植用支架及移植用支架递送系统 - Google Patents

一种移植用支架及移植用支架递送系统 Download PDF

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WO2021233359A1
WO2021233359A1 PCT/CN2021/094753 CN2021094753W WO2021233359A1 WO 2021233359 A1 WO2021233359 A1 WO 2021233359A1 CN 2021094753 W CN2021094753 W CN 2021094753W WO 2021233359 A1 WO2021233359 A1 WO 2021233359A1
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Prior art keywords
stent
transplantation
stent body
layer
degradable layer
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PCT/CN2021/094753
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English (en)
French (fr)
Inventor
王贵齐
刘勇
李政奇
韦建宇
张宇恒
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中国医学科学院肿瘤医院
南微医学科技股份有限公司
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Publication of WO2021233359A1 publication Critical patent/WO2021233359A1/zh

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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
    • 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
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • 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
    • A61F2002/044—Oesophagi or esophagi or gullets

Definitions

  • the present disclosure relates to a stent for medical transplantation, in particular to a stent for transplantation and a stent delivery system for transplantation.
  • Esophageal cancer is one of the common malignant tumors in my country. The majority of patients with advanced esophageal cancer see a doctor because of dysphagia, and the 5-year survival rate after comprehensive treatment is still less than 20%, while the 5-year survival rate for early-stage esophageal cancer patients can reach 95 after treatment. % Above, so early treatment of esophageal cancer has become an urgent clinical problem to be solved.
  • the main techniques of endoscopic treatment of early esophageal cancer include: endoscopic mucosal resection (EMR), endoscopic multi-ring ligation mucosal resection, endoscopic submucosal dissection (ESD), etc. .
  • ESD treatment has the advantages of less trauma, fewer complications, faster recovery, and lower cost. ESD treatment has become one of the main treatment techniques for early esophageal cancer.
  • the size, depth of invasion and esophageal muscularis basement injury of early esophageal cancer have a greater impact on esophageal stenosis after ESD.
  • the resection range is greater than 3/4 weeks and the muscle layer injury during the operation is an independent risk factor for postoperative stenosis.
  • the incidence of postoperative stenosis of esophageal lesions greater than 3/4 week after ESD is >90%, while esophageal lesions ESD
  • the incidence of postoperative stenosis was 100%. How to prevent and treat esophageal stenosis is very important. At present, there are four main methods to prevent and treat esophageal stenosis:
  • Drugs to prevent esophageal stricture For example, glucocorticoids, 5-fluorouracil, mitomycin C, etc. have been used in the prevention and treatment of esophageal stricture.
  • Polyglycolic acid membrane prevents esophageal stricture.
  • Polyglycolic acid membrane is a biodegradable suture material that can be attached to the fibrin on the wound surface to prevent the formation of esophageal stenosis.
  • the effectiveness of polyglycolic acid film in preventing esophageal stricture is not high, and the incidence of stenosis is higher than that of glucocorticoid therapy. For total resection, the single application of polyglycolic acid film is not effective.
  • Esophageal stent treatment Esophageal stents were originally used for minimally invasive treatment of unresectable malignant esophageal strictures and esophageal fistulas. Its advantage is that it can continuously expand the narrowed esophagus. When there are serious complications or the esophageal stenosis is obviously relieved, the esophageal stent can be removed. In recent years, as recyclable coated metal stents, drug-eluting stents, anti-displacement stents, and biodegradable stents have been used in clinical practice, stent placement has gradually become a new choice for the treatment of benign esophageal strictures.
  • the existing single-layer covered stent does not show a better tissue healing effect in the process of promoting tissue healing, and there are technical problems such as poor epithelial cell regeneration effect and easy re-stenosis.
  • the existing esophageal stent delivery system has a complicated structure, and the operation of the doctor during the operation is relatively complicated. In particular, the release operation of the stent during the release process is complicated, and the release position should not be adjusted.
  • a stent for transplantation including:
  • a stent body is woven from silk threads and has an expanded form and a compressed form, wherein the stent body has a stent middle section located in the middle in the longitudinal direction, and a proximal end and a distal end located at both ends of the stent body
  • the stent body has a longitudinally extending internal passage for passing through the endoscope, the stent body has a membrane structure, and the membrane structure is in the form of a full membrane or a partial membrane,
  • the stent for transplantation further includes: a degradable layer covering the outer surface of the stent body; and a mucosal tissue layer fixedly arranged on the outer surface of the degradable layer.
  • the mucosal tissue layer includes mucosal tissue distributed in any one or more of normal, dislocation, array, linear, and curved shapes, and the mucosal tissue includes autologous mucosa and/or stem cell cultured mucosa, and
  • the distribution mode on the outer surface of the degradable layer includes normal, dislocation, array, linear, curved (such as spiral curve, irregular curve, etc.) and other forms.
  • the primitives of the mucosal tissue are in the shape of dots, sheets or strips.
  • the curve is a spiral curve or an irregular curve.
  • the degradable layer is coated on the outer surface of the stent body by suture and/or adhesion; the mucosal tissue lattice is sutured, glued, and stapled by one or more methods. Fixed to the outer surface of the degradable layer.
  • the degradable layer has a nearly rectangular structure, and the degradable layer is coated on the outer surface of the stent body by one or more of stitching, bonding, and nailing.
  • the degradable layer has a nearly rectangular structure, in which one long side is covered on the outer surface of the stent body by stitching in the longitudinal direction, and the other long side is fixed by bonding in the longitudinal direction, so that the degradable layer is covered On the outer surface of the bracket body.
  • the stent body is woven from silk threads, the diameter of the stent body is 12 mm to 28 mm, and the length of the stent body is 4 cm to 20 cm.
  • the proximal part and the distal part of the two ends of the stent body are flange structures protruding from the middle section of the stent in the radial direction, and the flange structure is spherical, cup-shaped, ellipsoidal or longitudinally extending. Cylindrical structure.
  • a release structure is provided on the edge of the distal end of the stent body
  • the proximal end of the stent body is provided with a recovery line, and the recovery line includes a first recovery line extending outside the body or indwelling in the body, and a second recovery line provided on the edge of the proximal end.
  • the distal end of the first recovery line is connected to the proximal end of the stent body or the proximal end of the second recovery line.
  • the second recovery line includes one or more first line loops.
  • the release structure includes a release ring, one end of the release ring is fixed at the edge of the distal end of the stent body, and the other end of the release ring is in a direction away from the distal end of the stent body extend.
  • the release ring includes one or more second wire loops.
  • the wire is made of an implantable flexible memory alloy.
  • a stent delivery system for transplantation which includes the following structure:
  • the endoscope extending in the internal passage covered by the stent body in the stent for transplantation;
  • a minimally invasive surgical instrument located in the forceps of the endoscope.
  • the stent delivery system for transplantation has a stent structure for transplantation preferably adopted in the present disclosure.
  • the minimally invasive surgical instruments include biopsy forceps, foreign body forceps or clamps and other minimally invasive surgical instruments with a clamping function.
  • the present disclosure has the following technical effects:
  • the embodiments of the present disclosure innovatively integrate the traditional scaffold structure, the degradable layer, and the active tissue mucosa.
  • the degradable layer is provided on the scaffold, and the degradable layer can well induce epithelial regeneration.
  • the active tissue mucosa can help induce the regeneration of epithelial cells in the patient’s digestive tract.
  • the preferred tissue mucosal layer structure in the embodiments of the present disclosure can ensure that the degradable layer is attached to the wound surface to the maximum.
  • the multi-layer structure covering the outer surface of the stent body closely adheres to the wall of the digestive tract through its own expansion force, ensuring the survival of the transplanted mucosa, while reducing the chance of disorderly growth of the mucosa during the growth process, which is effective Avoid narrowing the digestive tract formed along the wound again.
  • the degradable layer automatically degrades and the digestive tract epithelialization is successful, the stent is removed and the entire stent surgical treatment is completed. According to the actual situation of the patient, the optimal length and diameter of the stent can ensure that the multilayer structure on the surface is tightly attached to the wall of the digestive tract to ensure the survival of the transplanted mucosa.
  • the embodiments of the present disclosure adopt a specific stent delivery system to ensure that the entire stent for transplantation in the digestive tract is neither displaced nor excessively compresses the esophagus, and the stent is cleverly placed outside the endoscope, effectively increasing The radial space for accommodating the stent is overcome, thereby overcoming the defect of excessive compression of the mucosal tissue on the stent, avoiding necrosis of the mucosal layer of the tissue fixed on the stent due to compression, and at the same time greatly reducing the displacement of the mucosal tissue.
  • the method of fixing and connecting the degradable layer and the stent body is simpler and more convenient.
  • the stent for transplantation in the embodiment of the present disclosure can be quickly installed according to the actual situation.
  • the present disclosure The stent for transplantation in the embodiment is more flexible and convenient to use, and the firm connection method will not affect the release and recovery process of the stent, and at the same time, it can ensure that the mucosa is completely attached to the entire resection site.
  • the bracket structure is divided into the middle section of the bracket and the flange structure at both ends, which helps to fix the bracket and prevent it from shifting and falling off.
  • FIG. 1 is a schematic diagram of the structure of the stent body in the stent for transplantation provided by an embodiment of the present disclosure
  • Fig. 2 is an exploded physical view of a stent for transplantation provided by an embodiment of the present disclosure
  • Figure 3 is a schematic diagram of the linear distribution of mucosal tissue on the surface of the degradable layer in an embodiment of the present disclosure
  • FIG. 4 is a schematic diagram of the dislocation distribution of mucosal tissue on the surface of the degradable layer in an embodiment of the present disclosure
  • Fig. 5 is a schematic diagram of the array distribution of mucosal tissue on the surface of the degradable layer in an embodiment of the present disclosure
  • Figure 6 is a schematic diagram of the normal distribution of mucosal tissue on the surface of the degradable layer in an embodiment of the present disclosure
  • FIG. 7 is a schematic diagram of the distribution of the mucosal tissue curve on the surface of the degradable layer in an embodiment of the present disclosure
  • Figure 8 is a schematic diagram of the connection between the degradable layer and the stent body in an embodiment of the present disclosure
  • Figure 9 is a schematic diagram of the connection between the degradable layer and the stent body in an embodiment of the present disclosure.
  • Figure 10 is a schematic diagram of the connection between the degradable layer and the stent body in an embodiment of the present disclosure
  • Figure 11 is a perspective view of the stent delivery system for transplantation in an embodiment of the present disclosure before releasing the stent;
  • Fig. 12 is a perspective view of the structure of the stent delivery system for transplantation in the process of releasing the stent in an embodiment of the present disclosure
  • Fig. 13 is a three-dimensional structural view of the stent delivery system for transplantation in an embodiment of the present disclosure after releasing the stent.
  • the proximal end refers to the section close to the operator outside the body, that is, the oral side; the distal end refers to the end in the body, that is, the anal side;
  • the longitudinal direction refers to the longitudinal direction of the stent for transplantation, which can extend non-linearly, usually extending with the human digestive tract The direction corresponds;
  • the radial direction refers to the direction perpendicular to the axial direction;
  • the circumferential direction refers to the circumferential direction around the axial direction.
  • the stent for transplantation includes: a cylindrical stent body 1 with longitudinal extension.
  • the stent body 1 is knitted by silk threads and has expansion
  • the stent body 1 has a stent middle section 2 located in the middle in the longitudinal direction, and a distal end 3 and a proximal end 4 located at both ends of the stent body 1; the stent body 1 has a longitudinal extension inside.
  • the stent for transplantation also includes a degradable layer 8 and a mucosal tissue layer 9. Next, the structure of each part will be explained in detail.
  • the stent body 1 that plays a role of supporting the substrate in this embodiment can be a full-membrane structure of wire mesh, which has good biocompatibility; the wire mesh can optionally be made of implantable flexible memory alloy. It is woven with silk threads.
  • the silk thread material can be any existing implantable material except alloy.
  • the silk mesh structure not only has a good degree of curvature, but also helps the release and recovery of the stent in the outer tube 13, and can also Effectively avoid excessive damage to human tissues by the stent.
  • the embodiment of the present disclosure preferably has a full-membrane structure of the wire mesh, that is, the entire wire mesh is covered with a membrane structure.
  • the membrane structure on the stent body 1 can also adopt an existing membrane structure, such as a full membrane or a partial membrane. In order to achieve the technical effect of effectively preventing the growth of granulation tissue into the stent.
  • the diameter of the middle section 2 of the stent braided by silk threads in the embodiment of the present disclosure can be 12mm to 28mm, so as to ensure that the stent will not be displaced in the esophagus, and at the same time, it will not excessively compress the esophagus A, thereby avoiding insufficient blood supply to the transplanted mucosa , Necrosis.
  • the embodiments of the present disclosure control the length of the stent body 1 within the range of 4 cm to 20 cm, which can make the stent for transplantation suitable for different patients and ensure the successful growth of mucosal transplantation.
  • the stent body 1 has a stent middle section 2 located in the middle in the longitudinal direction, and a distal end 3 and a proximal end 4 located at both ends of the stent body 1.
  • the stent body 1 The distal end 3 and the proximal end 4 are flange structures protruding from the middle section 2 of the stent in the radial direction.
  • the middle section of the stent 2 is in the shape of a long tube, and the tube body can extend along the direction of the human cavity during the treatment.
  • the tube structure of the middle section 1 of the stent can better fit the wall surface of the body tissue; the middle section 1 of the stent has flange structures at both ends
  • the distal part 3 and the proximal part 4 of the stent are determined by the structure of the human tissue.
  • the protruding flange structure is provided at both ends to help the transplantation stent to be more firmly and stably positioned at the wound site in the body cavity and effectively prevent the stent Shift and fall off.
  • the proximal portion 4 has a longitudinally extending cylindrical structure that is easy to drag and is not easily deformed, and the distal portion 3 has an elliptical shape that is less irritating to the human cavity.
  • the flange structure can be any one of spherical, cup-shaped, ellipsoidal, or longitudinally extending cylindrical structure.
  • the distal end 3 and the proximal end 4 of the stent body 1 may be equipped with a first recovery line 7 respectively.
  • the proximal end of the first recovery line 7 can extend outside the body or be indwelled in a body cavity such as the stomach, and a proximal second recovery line 6 arranged on the edge of the proximal end 4, the second recovery line 6 in this embodiment can be a shaft
  • Two symmetrical wire loops, one or more can be set according to the actual situation, which can extend to the proximal end, and can also be wrapped in the wire mesh hole of the proximal edge to be able to drag the stent out.
  • the distal end of the first recovery line 7 is connected to the proximal end of the stent body 1 or the proximal end of the second recovery line 6, when the wound is epithelialized, the degradable layer 8 is automatically degraded (about 2-8 weeks After), the esophagus A is successfully epithelialized, and the stent can be recovered through the first recovery line 7 and the proximal second recovery line 6 to complete the stent treatment process.
  • the present disclosure realizes effective and convenient positioning and recovery of the stent by arranging two first recovery lines 7 with different structures and functions at the proximal end, and improves the safety and success rate of the operation.
  • the distal end 3 of the stent body 1 is provided with a release ring 5, the proximal end of the release ring 5 is connected with a wire mesh hole on the edge of the distal end, and the distal end extends away from the distal end of the stent body 1.
  • the contact point of the minimally invasive surgical instrument 14 (such as biopsy forceps, foreign body forceps, clamps and other minimally invasive instruments with clamping function) that performs the clamping action and the release ring 5 is located at the distal end of the release ring 5, and the contact point is preferably Keep a certain distance from the edge of the distal end of the stent body 1, so as to ensure the stability of the endoscope 12 and the minimally invasive surgical instrument 14 in the forceps to pull the stent.
  • the release ring 5 may be two axially symmetric wire loops, or one or more wire loops may be used according to actual conditions.
  • the surgical instrument that can drag the release ring 5 moves to the distal end from the internal passage of the stent for transplantation, and drags the release ring at the distal end. 5. Drag the stent for transplantation out of the delivery system and realize the release process of the stent.
  • the degradable layer 8 that plays the role of supporting the mucosal tissue layer 9 in the embodiments of the present disclosure is coated on the outer surface of the stent body 1.
  • the degradable layer material can be an existing material that can be used for Made of biodegradable materials with good biocompatibility in the human body.
  • the degradable layer 9 can be coated on the outer surface of the stent body 1 by stitching and/or bonding.
  • the degradable layer 8 and the stent body 1 are sutured and fixed by medical absorbable sutures 10 (as shown in FIG. 8).
  • the approximately rectangular degradable layer 8 is circumferentially wrapped around the outer peripheral surface of the stent body 1, and then fixed by longitudinal sutures with sutures 10.
  • This fixation and connection process can be completed before the mucosal tissue layer 9 is fixed, or it can be in the mucosa.
  • the degradable layer 8 is connected to the stent body 1.
  • the fixed connection method is simple to operate, convenient and flexible.
  • the suture connection method of the embodiment of the present disclosure can ensure that the degradable layer 8 is not easy to fall off during the release process of the stent for transplantation, thereby ensuring the effectiveness of the operation.
  • the degradable layer 8 on the surface of the stent body 1 is used as a carrier for mucosal transplantation, and the mucosal tissue 9 is firmly attached to the wound surface under the tension exerted by the stent body, which is not easy to be displaced and helps to control mucosal growth
  • the rapid connection method of the degradable layer 8 and the stent body 1 is simple and quick to install. At the operation site, medical workers can prepare the required transplantation stent according to the actual operation situation.
  • connection method of the embodiment of the present disclosure is not only firm and not easy to fall off, but also does not affect the release and recovery process of the stent, and at the same time, it can ensure that the mucosa is completely attached to the entire circumference of the resection.
  • the mucosal tissue layer 9 closely adhering to the esophagus A is fixedly arranged on the outer surface of the degradable layer 8, and the mucosal tissue layer 9 includes discrete mucosal tissues.
  • the tissue is linear (as shown in Figure 3), dislocation (as shown in Figure 4), array (as shown in Figure 5), normal (as shown in Figure 6), and curve on the outer surface of the degradable layer 8.
  • the curve refers to the three-dimensional shape after the mucosal layer is coated on the outside of the degradable layer 8, such as a spiral shape or an irregular curve shape
  • the best distribution method can be selected according to the actual wound shape, area size, etc., and the best mucosal tissue element diameter can be selected in order to achieve the best treatment effect.
  • the mucosal tissue in the mucosal tissue layer 9 includes autologous mucosa and/or stem cell cultured mucosa, such as human body, other mammalian organisms, artificially cultured mucosal tissue, etc.
  • the primitives of each mucosal tissue can be in the form of dots, sheets, or strips. And other shapes.
  • the mucosal tissue layer 9 can better help induce the regeneration of epithelial cells of the esophagus A.
  • the biodegradable layer 8 can be attached to the fibrin on the wound surface, and the metal scaffold is tightly attached to the wall of the esophagus A, which can prevent the mucosa from being disordered during the growth process. Growth, causing narrowing again.
  • the mucosal tissue 9 is directly fixed to the outer surface of the degradable layer 8 by one or more of suturing, bonding, and nailing, which is convenient and firm in connection.
  • the mucosal tissue 9 can be placed in the open pocket so that the open pocket carries the mucosal tissue 9, or it can be directly fixed to the outer surface of the degradable layer 8 by one or more of sutures, adhesives, and staples. In this way, the mucosal tissue 9 can be prevented from being detached, lost, deformed during the delivery process, and other situations that are not conducive to subsequent tissue healing.
  • the delivery system of the stent for transplantation shown in the embodiment includes the following structure: the stent for transplantation in this embodiment, the endoscope extending in the internal passage covered by the stent body 1 A mirror 12, a minimally invasive surgical instrument 14 (such as a minimally invasive surgical instrument with a clamping function such as biopsy forceps, foreign body forceps, clips, etc.), and an overtube 13 sheathed on the outside of the transplant stent.
  • the stent for transplantation Before being released, the stent for transplantation is compressed and stored in the overtube 13, the endoscope 12 passes through the internal passage inside the stent, and plays the role of deflection positioning and supporting the stent.
  • the minimally invasive surgical instrument 14 In addition to the surgical function, the minimally invasive surgical instrument 14 also In order to release the stent for transplantation, at least one minimally invasive surgical instrument 14 is used according to actual conditions.
  • the minimally invasive surgical instrument 14 includes a minimally invasive surgical instrument 14 with a clamping function such as a biopsy forceps, a foreign body forceps or a clamp.
  • a clamping function such as a biopsy forceps, a foreign body forceps or a clamp.
  • the specific operation process of the stent delivery system for transplantation in the embodiments of the present disclosure is as follows.
  • the stent body 1 is firmly connected to the degradable layer 8 and the mucosal tissue layer 9 (autologous mucosa and/or stem cell cultivation), and the prepared stent for transplantation is compressed and placed in the outer tube 13 Then, the endoscope 12 is inserted into the internal channel covered by the stent body 1.
  • the endoscope 12 clamp channel sends the minimally invasive surgical instruments 14 (biopsy forceps, foreign body forceps, clamps, etc.) to the distal end of the endoscope.
  • the minimally invasive surgical instruments 14 clamp the distal release ring 5 of the stent body 1 and push the endoscope The endoscope 12 and the minimally invasive surgical instrument 14 drag the stent.
  • the endoscope 12 and the minimally invasive surgical instrument 14 can be used to drag the stent for transplantation in the esophagus A until it reaches the entire esophagus.
  • the peripheral resection is to ensure that the degradable layer 8 and the mucosal tissue layer 9 on the surface of the stent are completely attached to the wound surface in the esophagus A.
  • the proximal end of the first recovery line 7 fixed at the proximal end 4 of the stent for transplantation can be left in the stomach or outside the body for subsequent recovery of the stent for transplantation.
  • the endoscope 12, the minimally invasive surgical instrument 14 and the overtube 13 are withdrawn to complete the stent treatment process.
  • the body stent 1 is recovered. Drag the second recovery line 6 at the proximal end of the stent body 1 through the first recovery line 7 and cooperate with the endoscope 12 and the minimally invasive surgical instrument 14 in the clamp channel; or through the endoscope 12 and minimally invasive surgery in the clamp channel The instrument 14 drags the first recovery line 7 at the proximal end of the stent body 1 to complete the recovery process of the stent for transplantation.
  • the degradable layer 8 and the stent body 1 in the embodiment of the present disclosure can be sutured and fixed instead.
  • the stent body 1 and the degradable layer 8 are fixed by bonding.
  • the degradable layer 8 and the stent body 1 are fixedly connected by an adhesive material 11, and the adhesive material 11 can be a conventional medical adhesive such as glue or double-sided tape that can be used in the human body.
  • the approximately rectangular degradable layer 8 is circumferentially wrapped around the outer peripheral surface of the stent body 1, and then the two-sided symmetrical long sides of the degradable layer 8 are fixed to the stent body 1 longitudinally through the adhesive material 11.
  • This fixing and connection process can be completed before the mucosal tissue layer 9 is fixed, or after the mucosal tissue layer 9 is fixed on the degradable layer 8 and then the degradable layer 8 is connected to the stent body 1.
  • the adhesive and fixed connection The operation is simple, convenient and flexible.
  • the prefabricated adhesive material 11 is used to fix and paste the degradable layer 8 to the stent body 1, which is faster and more convenient to operate, saves the manual sewing process, and improves the preparation efficiency.
  • the degradable layer 8 and the stent body 1 in the embodiment of the present disclosure can be sutured and fixed instead.
  • the degradable layer 8 has a nearly rectangular structure, in which one long side is fixed to the outer surface of the stent body 1 by stitching along the longitudinal direction, and the other long side is fixed by bonding along the longitudinal direction, so that the degradable layer 8 is wrapped on the outer surface of the bracket body 1.
  • the first long side of the degradable layer 8 is longitudinally stitched with the stent body 1, and then the degradable layer 8 is wound circumferentially around the outer peripheral surface of the stent body 1 for one week, and finally the second long side of the degradable layer 8 is passed through
  • the adhesive material 11 is adhesively fixed to the first long side sewn to the stent body 1 before.
  • This fixing and connecting process can be completed before the mucosal tissue layer 9 is fixed, or after the mucosal tissue layer 9 is fixed on the degradable layer 8 and then the degradable layer 8 is connected to the stent body 1.
  • it not only takes into account the fixation strength of suture, but also has the advantages of fast and simple adhesive fixation, which improves the safety and preparation efficiency of the treatment.
  • the embodiments of the present disclosure provide a stent for transplantation and a stent delivery system for transplantation. Since the stent for transplantation of the embodiments of the present disclosure includes a stent body, a degradable layer and a mucosal tissue layer, the degradable layer can well induce epithelial regeneration.
  • the tissue mucosa is transplanted at the patient’s digestive tract resection.
  • the mucosal tissue layer can help induce the regeneration of epithelial cells in the patient’s digestive tract.
  • the structure of the mucosal tissue layer can be configured to ensure that the degradable layer is attached to the fibrin of the wound to the maximum extent and the scaffold body With its own expansion force, the multilayer structure covering its outer surface is tightly attached to the digestive tract wall, ensuring the survival of the transplanted mucosa, while reducing the chance of disorderly growth of the mucosa during the growth process, and effectively avoiding the digestive tract formed along the wound. Narrow again.
  • the fixed connection method between the degradable layer and the stent body is simple and convenient, and the connection method does not affect the release and recovery process of the stent, and at the same time, it can ensure that the mucosa is completely attached to the entire circumference of the resection.

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  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
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Abstract

一种移植用支架及移植用支架递送系统，移植用支架包括：支架本体（1），支架本体（1）由丝线编织而成且具有扩张形态和压缩形态，其中，支架本体（1）在纵向方向上具有位于中部的支架中段（2），以及位于支架本体（1）两端的近端部（4）和远端部（3）；支架本体（1）内部具有纵向延伸的内部通路，移植用支架还包括：可降解层（8），可降解层（8）包覆于支架本体（1）的外表面；黏膜组织层（9），黏膜组织层（9）固定布置于可降解层（8）的外表面。该移植用支架的结构不仅使得递送过程更加简单，同时能够有效促进组织再生、形成上皮化、预防术后再狭窄等并发症的产生。

Description

一种移植用支架及移植用支架递送系统
相关申请的交叉引用
本公开要求于2020年05月20日提交中国专利局的申请号为202010431366.X、名称为“一种移植用支架及移植用支架递送系统”的中国专利申请的优先权，其全部内容通过引用结合在本公开中。
技术领域
本公开涉及医用移植用支架，具体涉及一种移植用支架及移植用支架递送系统。
背景技术
食管癌是我国常见的恶性肿瘤之一，中晚期食管癌患者绝大多数因吞咽困难就诊，综合治疗后5年生存率仍不足20％，而早期食管癌患者治疗后5年生存率可达95％以上，因此食管癌早期治疗成为迫切需要解决的临床问题。内镜治疗早期食管癌的主要技术有：内镜下黏膜切除术(endoscopic mucosal resection，EMR)、内镜下多环套扎黏膜切除术、内镜黏膜下剥离术(endoscopic submucosal dissection，ESD)等。文献报道，传统外科手术以及ESD治疗早期食管癌均可获得良好的临床效果，而相比于传统外科手术，由于ESD治疗具有创伤小、并发症少、恢复快、费用低等优点，目前内镜下ESD治疗，已成为早期食管癌主要治疗技术之一。
而早期食管癌病变的大小、浸润深度及食管固有肌层损伤对食管ESD术后狭窄影响较大。其中，切除范围大于3/4周及操作过程中肌层损伤是发生术后狭窄的独立危险因素，大于3/4周的食管病变ESD术后狭窄发生率>90％，而食管全周病变ESD术后狭窄发生率为100％。如何防治食管狭窄就显得至关重要，目前食管狭窄的预防和治疗手段主要有以下四种：
1)药物预防食管狭窄。例如糖皮质激素、5-氟尿嘧啶、丝裂霉素C等已被用于食管狭窄的预防和治疗过程。
2)聚乙醇酸膜(PGA)预防食管狭窄。聚乙醇酸膜是一种可生物降解的缝合材料，可附着在创面的纤维蛋白上，从而防止食管狭窄形成。然而，聚乙醇酸膜预防食管狭窄的有效性不高，并且狭窄的发生率高于糖皮质激素治疗，对于全周切除，单一应用聚乙醇酸膜是无效的。
3)内镜下自体细胞移植预防食管狭窄。现行具有固定黏膜组织的支架需要压缩在2.8-4.2毫米的内镜通道中实现递送过程，导致在压缩递送过程中黏膜组织受到强挤压而失活，从而大大降低了黏膜组织对创口恢复的促进效果，因此临床中如何实现将自体细胞有效地递送至创口处，以与术后食管组织结合、促进新组织定向生长，仍存在较大的技术困 境。
4)食管支架治疗。食管支架最初用于无法手术切除的食管恶性狭窄和食管瘘的微创治疗。其优势是可以不断地扩张狭窄的食管，当有严重并发症或食管狭窄明显缓解时，食管支架可以被移除。近年来随着可回收覆膜金属支架、药物洗脱支架和防移位支架、生物可降解支架等纷纷应用于临床，使得支架置入逐渐成为治疗食管良性狭窄的新选择。而现有的单层覆膜支架在促进组织愈合过程中并未显示出更优的组织愈合效果，存在上皮细胞再生效果不佳、易再次狭窄等技术问题。此外，现有食管支架递送系统结构复杂，手术过程中医生操作相对复杂，尤其是支架在释放过程中释放操作繁琐，释放位置不宜调整。
发明内容
为了解决本领域已知存在的技术问题，本公开实施例提供一种移植用支架，包括：
支架本体，所述支架本体由丝线编织而成且具有扩张形态和压缩形态，其中，所述支架本体在纵向方向上具有位于中部的支架中段，以及位于支架本体两端的近端部和远端部；所述支架本体内部具有纵向延伸的用于通过内窥镜的内部通路，所述支架本体具有覆膜结构，所述覆膜结构呈全覆膜或部分覆膜形态，
所述移植用支架还包括：可降解层，所述可降解层包覆于所述支架本体的外表面；黏膜组织层，所述黏膜组织层固定布置于所述可降解层的外表面。
可选地，所述黏膜组织层中包括以正态、错位、阵列、线性、曲线中任意一种或多种形态分布的黏膜组织，所述黏膜组织包括自体黏膜和/或干细胞培植黏膜，且在所述可降解层的外表面的分布方式包括正态、错位、阵列、线性、曲线(如螺旋曲线、非规则曲线等)等形态。
可选地，所述黏膜组织的基元呈点状、片状或条状形状。
可选地，所述曲线为螺旋形曲线或不规则曲线。
可选地，所述可降解层通过缝合和/或粘合方式包覆于所述支架本体的外表面；所述黏膜组织点阵通过缝合、粘合、钉合中的一种或多种方式固定至所述可降解层的外表面。
可选地，所述可降解层呈近矩形结构，可降解层通过缝合、粘合、钉合中的一种或多种方式包覆于所述支架本体的外表面。
可选地，可降解层呈近矩形结构，其中一长边沿纵向通过缝合包覆于所述支架本体的外表面，另一长边沿纵向通过粘合方式固定，以使所述可降解层包覆于所述支架本体的外表面。
可选地，支架本体由丝线编织而成，所述支架本体的直径为12mm至28mm，所述支架本体的长度为4cm至20cm。
可选地，所述支架本体两端的近端部和远端部为在径向上凸出所述支架中段的凸缘结 构，所述凸缘结构呈球形、杯形、椭球形或沿纵向延伸的筒形结构。
可选地，所述支架本体的远端部边缘设有释放结构；
所述支架本体的近端部设有回收线，所述回收线包括延伸至体外的或留置在体内的第一回收线，以及设置于近端部边缘的第二回收线。
可选地，所述第一回收线的远端部与所述支架本体的近端部连接或与所述第二回收线的近端部连接。
可选地，所述第二回收线包括一个或更多个第一线环。
可选地，所述释放结构包括释放环，所述释放环的一端固定于所述支架本体的远端部边缘处，所述释放环的另一端沿远离所述支架本体的远端部的方向延伸。
可选地，所述释放环包括一个或更多个第二线环。可选地，所述丝线由可植入式柔性记忆合金制造成。
为了克服现有技术中支架递送过程复杂、支架不易定位这一技术问题，本公开实施例还提供一种移植用支架递送系统，包括如下结构：
移植用支架；
所述移植用支架中支架本体覆盖的内部通路中延伸的内窥镜；
套设于所述移植用支架外侧的外套管；
位于所述内窥镜的钳道内的微创手术器械。
可选地，所述移植用支架递送系统具有本公开优选采用的移植用支架结构。
可选地，所述微创手术器械包括活检钳、异物钳或夹子等具有夹持功能的微创手术器械。
通过上述技术方案，本公开具有如下技术效果：
首先，本公开实施例将传统支架结构、可降解层以及活性组织黏膜创新地融合成一体，通过研究发现在支架上设置可降解层，可降解层能够很好地诱导上皮再生的组织黏膜移植在患者消化道(优选为食道)切除处，活性组织黏膜可以帮助诱导患者消化道上皮细胞再生，同时本公开实施例中优选的组织黏膜层结构的设置方式可以确保可降解层最大限度地附着在创面的纤维蛋白上且支架本体通过自身扩张力使覆盖在其外表面的多层结构均紧贴在消化道壁上，保证移植黏膜成活，同时降低了黏膜在生长过程中无序生长的几率，有效避免沿创口形成的消化道再次狭窄。临床应用过程中，术后消化道创口处上皮化后(约2～8周后)，可降解层自动降解，消化道上皮化成功，将支架取出并完成整个支架手术治疗。根据患者实际情况不同，通过优选的支架长度及支架直径能够保证其表面的多层结构均紧贴在消化道壁上，保证移植黏膜成活。
其次，本公开实施例通过采用特定的支架递送系统，在保证在消化道内移植用支架整 体既不移位，又不过度压迫食道的前提下，通过将支架巧妙地置于内镜外部，有效增加了容置支架的径向空间，从而克服了支架上黏膜组织过度压缩的缺陷，避免造成支架上固定的组织黏膜层因压迫坏死，同时黏膜组织移位的情况也大大降低。
此外，可降解层与支架本体的固定连接方式更为简单便捷，手术中可以根据实际情况快捷地安装形成本公开实施例移植用支架，相对现有技术中常规固定结构的移植用支架，本公开实施例中的移植用支架使用更为灵活，便捷，而且牢固的连接方式不会影响支架的释放与回收过程，同时能够保证黏膜完全贴合在全周切除处。支架结构分为支架中段结构和两端的凸缘结构，有助于支架的固定，防止移位脱落。
附图说明
图1是本公开实施例提供的移植用支架中支架本体结构示意图；
图2是本公开实施例提供的移植用支架分解实物图；
图3是本公开实施例中可降解层表面的黏膜组织线性分布示意图；
图4是本公开实施例中可降解层表面的黏膜组织错位分布示意图；
图5是本公开实施例中可降解层表面的黏膜组织阵列分布示意图；
图6是本公开实施例中可降解层表面的黏膜组织正态分布示意图；
图7是本公开实施例中可降解层表面的黏膜组织曲线分布示意图；
图8是本公开实施例中可降解层与支架本体连接方式示意图；
图9是本公开实施例中可降解层与支架本体连接方式示意图；
图10是本公开实施例中可降解层与支架本体连接方式示意图；
图11是本公开实施例中移植用支架递送系统释放支架前的立体结构视图；
图12是本公开实施例中移植用支架递送系统释放支架过程中立体结构视图；
图13是本公开实施例中移植用支架递送系统释放支架后的立体结构视图。
附图标记说明：
1-支架本体，2-支架中段，3-远端部，4-近端部，5-远端释放环，6-近端第二回收线，7-第一回收线，8-可降解层，9-黏膜组织，10-缝合线，11-粘合材料，12-内窥镜，13-外套管，14-微创手术器械，A-食道。
具体实施方式
结合附图和具体实施例对本公开的技术内容作详细说明。
下面将结合实施例对本公开的实施方案进行详细描述，但是本领域技术人员将会理解，下列实施例仅用于说明本公开，而不应视为限制本公开的范围。
对本公开实施例中涉及的一些名词进行说明。近端是指靠近体外操作者的一段，即口 侧；远端是指位于体内的一端，即肛侧；纵向是指移植用支架纵伸方向，可以为非直线延伸，通常与人体消化道延伸方向相应；径向是指与轴向垂直方向延伸方向；周向是指沿环绕轴向的圆周方向。
如图1-3、8所示的本公开中移植用支架的实施例，该实施例中移植用支架包括：具有纵向延伸的筒形支架本体1，支架本体1由丝线编织而成且具有扩张形态和压缩形态，其中，所述支架本体1在纵向方向上具有位于中部的支架中段2，以及位于支架本体1两端的远端部3和近端部4；所述支架本体1内部具有纵向延伸的内部通路，所述移植用支架还包括可降解层8和黏膜组织层9。接下来对各个部分的结构作详细说明。
如图1所示，本实施例中起到基底支撑作用的支架本体1可以为丝网全覆膜结构，其具备良好的生物相容性；丝网可选地采用可植入类柔性记忆合金丝线编织而成，丝线材质除合金外还可以为任意现有的可植入材质，丝网结构不仅具有很好的弯曲度，而且有助于支架在外套管13中的释放和回收，也能够有效地避免支架对人体组织的过度损伤。本公开实施例优选丝网全覆膜结构，即丝网整体覆有膜结构，支架本体1上的覆膜结构还可以采用现有的覆膜结构，如全覆膜或部分覆膜等形态，以达到有效防止肉芽组织向支架内生长的技术效果。
本公开实施例中由丝线编织而成的所述支架中段2直径可以为12mm至28mm，从而保证支架在食道内既不会移位，同时又不会过度压迫食道A，避免造成移植黏膜供血不足、坏死。此外，通过反复设计，本公开实施例将支架本体1长度控制在4cm至20cm之间的范围内，可以使移植用支架适用不同的患者，并可以确保黏膜移植生长成功。
本公开实施例中，支架本体1在纵向方向上具有位于中部的支架中段2，以及位于支架本体1两端的远端部3和近端部4，本实施例中，所述支架本体1两端的远端部3和近端部4为在径向上凸出所述支架中段2的凸缘结构。其中，支架中段2呈长管形，治疗过程中管体可以沿着人体腔道方向延伸，支架中段1管体结构能够更好地贴合人体内组织壁面；支架中段1两端具有凸缘结构的远端部3和近端部4，由人体组织的结构决定，通过两端设置凸出的凸缘结构，有助于移植用支架更加牢固稳定地定位于人体腔道内创口部位，有效防止支架移位脱落。如图1所示，本实施例中近端部4呈纵向延伸的便于拖拽、不易形变的筒形结构，远端部3呈对于人体腔道刺激较小的椭球形。根据实际治疗部位，凸缘结构可以呈球形、杯形、椭球形或沿纵向延伸的筒形结构中任意一种。
如图1所示，支架本体1远端部3和近端部4可以分别装配有第一回收线7。第一回收线7的近端可以延伸至体外或留置在如胃等体腔内，以及设置于近端部4边缘的近端第二回收线6，本实施例中第二回收线6可以为轴向对称的两个线环，根据实际情况也可以设置1个或更多个，可以向近端延伸，同样也可以缠绕在近端边缘丝网孔内，以能够实现将 支架拖拽出即可；第一回收线7的远端部与支架本体1的近端部连接或与第二回收线6的近端部连接，当创口上皮化后，可降解层8自动降解(约2～8周后)，食道A上皮化成功，通过第一回收线7及近端第二回收线6可以回收支架，完成支架治疗过程。本公开通过在近端设置两种不同结构功能的第一回收线7，实现有效、便捷的支架定位、回收，提高了手术的安全性和成功率。
支架本体1远端部3上设有释放环5，释放环5的近端与远端部边缘丝网孔连接、远端向远离支架本体1的远端的方向延伸，基于这一构想，释放过程中实施夹紧动作的微创手术器械14(如活检钳、异物钳、夹子等具有夹持功能的微创器械)与释放环5的接触点位于释放环5的远端，该接触点优选与支架本体1的远端部边缘保持一定距离，从而保证内窥镜12及钳道内的微创手术器械14对支架拉拽的稳定性。本实施例中，释放环5可以为轴向对称的两个线环，也可以根据实际情况采用1个或更多个线环。在释放移植用支架时，通过内窥镜12及钳道内的微创手术器械14能够实现拖拽释放环5的手术器械由移植用支架内部通路向远端移动，并拖拽远端的释放环5，将移植用支架从递送系统中拖拽出并实现支架的释放过程。
如图2、8所示，本公开实施例中起到支撑黏膜组织层9作用的可降解层8包覆于所述支架本体1的外表面，可降解层材料可以为现有的能够用于人体内具有良好生物相容性的生物可降解材料制成。可降解层9可以通过缝合和/或粘合方式包覆于所述支架本体1的外表面。本实施例中，可降解层8与支架本体1通过医用可吸收缝合线10缝合固定(如图8所示)。制备时，近似矩形的可降解层8周向围绕包覆至支架本体1外周面，随后通过缝合线10纵向缝合固定，这一固定连接过程可以在黏膜组织层9固定前完成，也可以在黏膜组织层9固定在可降解层8上之后再将该可降解层8与支架本体1连接，本公开实施例中固定连接方式操作简单、且方便灵活。本公开实施例的缝合连接方式能够保证可降解层8在移植用支架释放过程中不易脱落，确保手术的有效性。
本公开实施例中支架本体1表面的可降解层8作为黏膜移植的载体，在支架本体施加的张力作用下将黏膜组织9牢固地贴附至创口表面，不易发生位移，有助于控制黏膜生长方向、促进人体组织的吸收；此外，可降解层8与支架本体1的快速连接方式，操作简单、安装快捷，在手术现场，医护工作者完全可以根据实际手术情况制备所需的移植用支架，而且本公开实施例连接方式不仅牢固不易脱落而且连接方式也不会影响支架的释放与回收过程，同时能够保证黏膜完全贴合在全周切除处。
如图3-7所示，本实施例中与食道A紧密贴合的黏膜组织层9固定布置于所述可降解层8的外表面，且黏膜组织层9包括离散的黏膜组织，所述黏膜组织在所述可降解层8的外表面以线性(如图3所示)、错位(如图4所示)、阵列(如图5所示)、正态(如图6所 示)、曲线(如图7所示，曲线是指黏膜层包覆于可降解层8外部后的立体形态，如螺旋形，也可为非规则曲线形态)等形态分布。治疗过程中可以根据实际创面形态、面积大小等，优选最佳的分布方式，并选择最佳的黏膜组织基元的直径，以期达到最优的治疗效果。
黏膜组织层9中的黏膜组织包括自体黏膜和/或干细胞培植黏膜，例如人体、其他哺乳类生物、人工培养的黏膜组织等，每个黏膜组织的基元可以呈点状、片状、条状等形状。黏膜组织层9可以更好地帮助诱导食道A上皮细胞再生，生物可降解层8可附着在创面的纤维蛋白上，且金属支架紧贴在食道A壁上，可以防止黏膜在生长过程中无序生长，造成再次狭窄。
本公开实施例中，所述黏膜组织9通过缝合、粘合、钉合中的一种或多种方式直接固定至所述可降解层8的外表面，这样的连接方式方便、牢固。此外可以将黏膜组织9置于开口袋中以使开口袋承载黏膜组织9，或通过缝合、粘合、钉合中的一种或多种方式直接固定至所述可降解层8的外表面，这种方式可以避免黏膜组织9在递送过程脱离、损失、形变等不利于后续组织愈合的情况发生。
如图11-13所示，作为实施例中所示移植用支架的递送系统，包括如下结构：本实施例中的移植用支架，移植用支架中支架本体1覆盖的内部通路中延伸的内窥镜12、微创手术器械14(如活检钳、异物钳、夹子等具有夹持功能的微创手术器械)，以及套设于所述移植用支架外侧的外套管13。其中，在释放前，移植用支架压缩收纳在外套管13中，内窥镜12穿过支架内部的内部通路，起到偏转定位和支撑支架作用，而微创手术器械14除手术功能外，还起到释放该移植用支架的作用，根据实际情况采用至少一个微创手术器械14，该微创手术器械14包括活检钳、异物钳或夹子等具有夹持功能的微创手术器械14。本公开实施例通过将支架套设在内镜外部，大大增加了支架的径向容置空间，避免了黏膜层受到过度挤压而坏死。通过临床实践，本公开实施例中黏膜层坏死情况有效降低，移植成活率明显提高。
本公开实施例中移植用支架递送系统具体操作过程具体如下。
如图11、12所示，首先将支架本体1与可降解层8、黏膜组织层9(自体黏膜和/或干细胞培植)牢固连接，并将制备好的移植用支架压缩后置于外套管13内，随后将内窥镜12置入支架本体1覆盖的内部通道中。将内窥镜12伸至食道A内观察创面情况，再将外套管13及支架本体1，伸至食管颈部，回撤内窥镜12使其远端位于外套管13远端附近，沿内窥镜12钳道将微创手术器械14(活检钳、异物钳、夹子等)送至内镜远端，微创手术器械14将支架本体1远端释放环5夹紧，并通过推送内窥镜12连同微创手术器械14拖拽支架，当移植用支架完全由外套管13中释放后，可以继续利用内窥镜12和微创手术器械14拖拽移植用支架在食道A中移动直至到达全周切除处，以确保支架表面的可降解层8、 黏膜组织层9完全贴敷在食道A内的创面处。移植用支架近端部4固定的第一回收线7，可将其近端留置于胃内或留置于体外，以便后续回收移植用支架。当完成移植用支架释放后，回撤内窥镜12、微创手术器械14和外套管13，完成支架治疗的过程。
如图1、13所示，约2～8周后，当可降解层8自动降解，且食道A上皮化后，将本体支架1回收。通过第一回收线7，并配合内窥镜12及钳道内的微创手术器械14，拖拽支架本体1近端的第二回收线6；或者通过内窥镜12及钳道内的微创手术器械14，拖拽支架本体1近端的第一回收线7，完成对移植用支架的回收过程。
如图9所示，可以将本公开实施例中可降解层8与支架本体1缝合固定方式进行替换。本实施例中，支架本体1与可降解层8通过粘合方式进行固定。可降解层8与支架本体1通过粘合材料11固定连接，粘合材料11可以为黏胶或双面胶等可用于人体内的常规医用粘合物。制备时，近似矩形的可降解层8周向围绕包覆至支架本体1外周面，随后通过粘合材料11纵向将可降解层8的两侧对称的长边固定至支架本体1。这一固定连接过程可以在黏膜组织层9固定前完成，也可以在黏膜组织层9固定在可降解层8上之后再将可降解层8与支架本体1连接，本实施例中粘合固定连接方式操作简单、且方便灵活。与本实施例中的前述缝合连接方式相比，利用预制的粘合材料11将可降解层8与支架本体1固定粘贴，操作更为快速便捷，省去人工缝制过程，提高制备效率。
如图10所示，可以将本公开实施例中可降解层8与支架本体1缝合固定方式进行替换。本实施例中，可降解层8呈近矩形结构，其中一长边沿纵向通过缝合固定于所述支架本体1的外表面，另一长边沿纵向通过粘合方式固定，以使所述可降解层8包覆于所述支架本体1的外表面。制备时，先将可降解层8的第一长边与支架本体1纵向缝合，然后将可降解层8周向围绕支架本体1外周面缠绕一周，最后将可降解层8的第二长边通过粘合材料11与之前缝合至支架本体1上的第一长边粘合固定。这一固定连接过程可以在黏膜组织层9固定前完成，也可以在黏膜组织层9固定在可降解层8上之后再将可降解层8与支架本体1连接。与本公开实施例中的前述连接方式相比，既兼顾了缝合的固定强度，又具备粘合固定方式的快速简便的优势，提高了治疗的安全性和制备效率。
最后应说明的是：以上实施例仅用以说明本公开的技术方案，而非对其限制；尽管参照前述实施例对本公开进行了详细说明，但本领域的普通技术人员应当理解：其依然可以对前述实施例所记载的技术方案进行修改，或者对其中部分或者全部技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本公开实施例技术方案的范围。
工业实用性
本公开实施例提供了移植用支架及移植用支架递送系统，由于本公开实施例的移植用 支架包含了支架本体、可降解层和黏膜组织层，其中，可降解层能够很好地诱导上皮再生的组织黏膜移植在患者消化道切除处，黏膜组织层可以帮助诱导患者消化道上皮细胞再生，黏膜组织层的结构的设置方式可以确保可降解层最大限度地附着在创面的纤维蛋白上且支架本体通过自身扩张力使覆盖在其外表面的多层结构均紧贴在消化道壁上，保证移植黏膜成活，同时降低了黏膜在生长过程中无序生长的几率，有效避免沿创口形成的消化道再次狭窄。并且可降解层与支架本体的固定连接方式简单便捷，而且连接方式不会影响支架的释放与回收过程，同时能够保证黏膜完全贴合在全周切除处。

Claims (16)

  1. 一种移植用支架，包括：
    支架本体，所述支架本体由丝线编织而成且具有扩张形态和压缩形态，其中，
    所述支架本体在纵向方向上具有位于中部的支架中段，以及位于支架本体两端的近端部和远端部；
    所述支架本体内部具有纵向延伸的内部通路，
    所述支架本体具有覆膜结构，所述覆膜结构呈全覆膜或部分覆膜形态，
    其特征在于，所述移植用支架还包括：
    可降解层，所述可降解层包覆于所述支架本体的外表面；
    黏膜组织层，所述黏膜组织层固定布置于所述可降解层的外表面。
  2. 根据权利要求1所述的移植用支架，其特征在于：
    所述黏膜组织层中包括以正态、错位、阵列、线性、曲线中任意一种或多种形态分布的黏膜组织，所述黏膜组织包括自体黏膜和/或干细胞培植黏膜。
  3. 根据权利要求2所述的移植用支架，其特征在于：
    所述黏膜组织的基元呈点状、片状或条状形状。
  4. 根据权利要求2或3所述的移植用支架，其特征在于：
    所述曲线为螺旋形曲线或不规则曲线。
  5. 根据权利要求1至4任一项所述的移植用支架，其特征在于：
    所述可降解层通过缝合和/或粘合方式包覆于所述支架本体的外表面；
    所述黏膜组织通过缝合、粘合、钉合中的一种或多种方式固定至所述可降解层的外表面。
  6. 根据权利要求1至5任一项所述的移植用支架，其特征在于：
    所述可降解层呈矩形结构，其中一长边沿纵向通过缝合固定于所述支架本体的外表面，另一长边沿纵向通过粘合方式固定，以使所述可降解层包覆于所述支架本体的外表面。
  7. 根据权利要求1至6任一项所述的移植用支架，其特征在于：
    所述支架本体由丝线编织而成，所述支架本体的直径为12mm至28mm，所述支架本体的长度为4cm至20cm。
  8. 根据权利要求1至7任一项所述的移植用支架，其特征在于：
    所述支架本体两端的近端部和远端部为在径向上凸出所述支架中段的凸缘结构，所述凸缘结构呈球形、杯形、椭球形或沿纵向延伸的筒形结构。
  9. 根据权利要求1至8任一项所述的移植用支架，其特征在于：
    所述支架本体的远端部边缘设有释放结构；
    所述支架本体的近端部设有回收线，所述回收线包括延伸至体外的或留置在体内的第一回收线，以及设置于近端部边缘的第二回收线。
  10. 根据权利要求9所述的移植用支架，其特征在于：
    所述第一回收线的远端部与所述支架本体的近端部连接或与所述第二回收线的近端部连接。
  11. 根据权利要求9或10所述的移植用支架，其特征在于：
    所述第二回收线包括一个或更多个第一线环。
  12. 根据权利要求9至11任一项所述的移植用支架，其特征在于：
    所述释放结构包括释放环，所述释放环的一端固定于所述支架本体的远端部边缘处，所述释放环的另一端沿远离所述支架本体的远端部的方向延伸。
  13. 根据权利要求12所述的移植用支架，其特征在于：
    所述释放环包括一个或更多个第二线环。
  14. 根据权利要求1至13任一项所述的移植用支架，其特征在于：
    所述丝线由可植入式柔性记忆合金制造成。
  15. 一种移植用支架递送系统，包括如下结构：
    移植用支架；
    其特征在于，
    所述移植用支架递送系统还包括：
    所述移植用支架中支架本体覆盖的内部通路中延伸的内窥镜；
    套设于所述移植用支架外侧的外套管；
    位于所述内窥镜的钳道内的微创手术器械，
    其中，所述移植用支架具有如权利要求1-14任一项所述的移植用支架结构。
  16. 根据权利要求15所述的移植用支架递送系统，其特征在于：
    所述微创手术器械包括具有夹持功能的微创手术器械。
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