WO2017100977A1 - Stent en polymère individualisé et procédé de fabrication de celui-ci et utilisation de celui-ci - Google Patents

Stent en polymère individualisé et procédé de fabrication de celui-ci et utilisation de celui-ci Download PDF

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Publication number
WO2017100977A1
WO2017100977A1 PCT/CN2015/097260 CN2015097260W WO2017100977A1 WO 2017100977 A1 WO2017100977 A1 WO 2017100977A1 CN 2015097260 W CN2015097260 W CN 2015097260W WO 2017100977 A1 WO2017100977 A1 WO 2017100977A1
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Prior art keywords
stent
axis
polymer
personalized
lumen
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PCT/CN2015/097260
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English (en)
Chinese (zh)
Inventor
赵庆洪
石桂欣
刘青
赵清华
崔淑君
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北京阿迈特医疗器械有限公司
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Priority to CN201580083108.4A priority Critical patent/CN108025108B/zh
Priority to PCT/CN2015/097260 priority patent/WO2017100977A1/fr
Publication of WO2017100977A1 publication Critical patent/WO2017100977A1/fr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials

Definitions

  • the invention belongs to the field of medical instruments, and in particular relates to a personalized polymer stent and a preparation method and use thereof.
  • the stent is a mesh tubular instrument that is placed in an organ having a luminal structure in the human body for treating intraluminal stenosis due to a lesion.
  • the stent can support the lumen and keep the lumen open. Some stents also have the effect of preventing restenosis of the lumen.
  • the stent is usually placed in the lesion by percutaneous puncture or through the original pipeline of the human body under the guidance of imaging equipment (such as angiography machine, fluoroscopy machine, CT, MR, B-ultrasound).
  • imaging equipment such as angiography machine, fluoroscopy machine, CT, MR, B-ultrasound.
  • the process is called Interventional stent medicine. Due to its minimal invasiveness and high efficiency, since the United States in 1964, Dotter has used coaxial catheter technology for angioplasty of patients, and has been rapidly developed and applied.
  • the sites that need to be implanted include: blood vessels, biliary tract, urinary tract, trachea, esophagus, pancreatic duct, stomach, intestine, etc., wherein the amount of blood vessels is the largest. Since these different parts to be used themselves have different shapes, lumen diameters, lesion lengths, etc., it is necessary to provide a variety of stents that can be better matched to the shape and size of the lumen or extraluminal contour of the site to be used. .
  • cardiovascular stents and peripheral vascular stents are almost straight-line tubular in shape.
  • Cardiovascular stents are usually 2.5, 3.0, and 4.0 mm in diameter. Common lengths are 13, 18, 23, 29, 33, and 38 mm.
  • the common length is 7, 10, 13, 16mm
  • the outer stent diameter is usually 5 ⁇ 10mm, 12 ⁇ 18mm, 24 ⁇ 42mm
  • the common length is 20 ⁇ 80mm, 60 ⁇ 100mm, 140 ⁇ 160mm, compared with the thickness of the human blood vessels and the length of the diseased blood vessels, the length of the stenosis varies from person to person, etc.
  • the stent model is relatively simple. The stent is fixed in size and cannot meet the needs of changes in the length and diameter of the lesion in clinical patients.
  • interventional stenting is currently the most effective treatment for vascular disease, intravascular restenosis and stent thrombosis after stent implantation limit the application of this technique.
  • the shape of the stent is one of the main causes of restenosis and thrombosis. It is clinically shown that the straight tubular stent will cause different stresses on the different conforming parts of the vessel wall during the expansion process after implantation, resulting in different degrees of tearing of the vessel wall.
  • the above-mentioned blood vessel stents are all made of medical metal or alloy material, and the processing methods generally adopt knitting, laser engraving, etching, micro-charge processing, electroforming and die-casting, etc.
  • laser engraving is often used, and the main defects of such stent systems are: Laser engraving method to prepare traditional straight cylindrical stent products, the process is long, the engraving pipe needs to be prepared first, and then 70-80% of the material is wasted by cutting; 2.
  • the variable diameter bracket is prepared by laser engraving, and the straight cylindrical shape is also required to be prepared first.
  • the tube, cutting, post-expansion balloon expansion or heat treatment on a conical mold, the process is more complicated; 3, laser engraving can not prepare irregular shape or more complex stent products, still can not meet the clinical pathology and physiology Need.
  • the interventional stent technique is in non-vascular body lumens, such as biliary tract, urethra, trachea, and food. Tubes, pancreatic ducts, stomach, intestines and other parts of the stenosis, opening drainage channels and occlusion abnormal pathways are also an effective treatment.
  • stents and vascular stents are basically the same.
  • CN 2424786 Y discloses a high-intensity biliary stent prepared using a wire material
  • CN 203852712 U discloses a single-female biliary stent of polyurethane or polyethylene material
  • CN 2220875 Y discloses a nickel-titanium wire preparation.
  • Urinary tract stent CN 101480506 A discloses a degradable tracheal stent prepared from polydioxanone or polyglycolide monofilament
  • CN 103607975 A discloses a nickel-titanium alloy laser-cut esophageal stent
  • CN 102202605 A discloses a scaffold for preventing pancreatic disorders, which is prepared using a high molecular polymer. None of these methods address the need for individualized stents for patients.
  • the current clinical vascular stent products are still standardized products.
  • the structure of the stent is mostly straight-line tubular, and some stents, such as the carotid artery stent, the radial artery stent, and the thoracic aorta stent have a tapered external form, but the diversity of the lesion vessel is still relatively simple. Therefore, it still cannot meet the individual needs of clinical patients.
  • non-vascular stent products are also becoming more and more extensive, but due to the high rate of restenosis caused by the permanent existence and single shape of traditional stents, there is an urgent need for a new type of personalized stent for the patient's lesion. .
  • Chinese invention patent application (application number: 201080002569.1) discloses a four-axis rapid prototyping system and a method for preparing a three-dimensional porous tubular stent
  • the Chinese invention patent application (CN 104274867 A) discloses a degradable polymer stent and rapid molding with four axes A method of preparing a polymeric stent.
  • the above patent application still does not solve the single defect of the external shape of the stent, and does not satisfactorily meet the special requirements of the site to be used.
  • the present invention has been further studied and developed in view of the above-mentioned drawbacks in the prior art, and a new personalized polymer stent has been obtained.
  • the present invention to provide a personalized polymeric stent.
  • the shape and size of the inner cavity or the outer contour of the stent to be used are more closely matched to meet the special requirements of the site to be used. At the same time, it can also solve the subsequent complications of the stent and improve the safety and effectiveness of the stent.
  • Another object of the invention is to provide a method of making the personalized polymeric stent.
  • Yet another object of the invention is to provide the use of the personalized polymeric stent.
  • solid or hollow personalized stent mold refers to a part that has an outer contour that matches the lumen or extraluminal contour of the patient's lesion, when the stent is fabricated using a four-axis rapid prototyping system.
  • the processing of the stent profile is achieved on the fourth axis or directly as the fourth axis for receiving the polymer.
  • the article has a particular hollow cavity shape.
  • the personalized stent mold is prepared based on the 3D size information of the patient's lesion. Personalized molds can be prepared by CNC machine tool processing, or individual molds can be prepared by 3D printing methods.
  • zigzag and/or woven structure refers to a form of stent structure formed using a "Z" shaped wire routing and/or a "latitude and longitude” braided wire routing.
  • arc-shaped structure refers to the internal structure of the stent formed by a “smooth” curved wire routing.
  • arc double-chamfer structure refers to a curve-traversing route with “peak-valley” similar to “sine and cosine", with a peak or valley separated by an average of two parts.
  • the peak or valley like a double chamfer, forms the internal structure of the scaffold with double arc chamfers.
  • woven and bridge structure refers to two filaments that are “parallel” between the filaments, similar to two adjacent “bridges” in the river, and the individual filaments are designed to be woven. Forming the internal structure of the bracket of the braided bridge.
  • the present invention provides a personalized polymeric stent having a shape and size that matches the shape and size of the lumen or cavity contour of the site to be used, and having a pre-designed pattern of polymer filaments
  • the site to be used is a blood vessel or a body cavity, such as cardiovascular and cerebrovascular, peripheral blood vessels, biliary tract, urinary tract, trachea, esophagus, pancreatic duct, stomach, intestine, and the like.
  • a blood vessel or a body cavity such as cardiovascular and cerebrovascular, peripheral blood vessels, biliary tract, urinary tract, trachea, esophagus, pancreatic duct, stomach, intestine, and the like.
  • the shape of the bracket is a regular or irregular shape, including but not limited to a tapered cone, a dumbbell shape, an irregular curved shape, and the like.
  • the bracket structure is a zigzag and/or a braided structure, a circular arc structure, a circular double chamfered structure, and/or a braided and bridged structure.
  • the polymer is a degradable polymer, wherein the degradable polymer is selected from one or more of the following: polylactic acid (PLA), L-polylactic acid (PLLA), right-handed polylactic acid (PDLA), polyethylene glycol-polyglycolic acid (PGA), polycaprolactone (PCL), polyethylene glycol (PEG), polyanhydride, polyhydroxyalkanoate (PHA), polydioxane Hexone, polyiminocarbonate, polyfumaric acid, degradable polyurethane, copolymer or mixture of the above materials, and mixtures of one or more of the above materials with other polymeric materials that are degradable.
  • PLA polylactic acid
  • PLLA L-polylactic acid
  • PDLA right-handed polylactic acid
  • PGA polyethylene glycol-polyglycolic acid
  • PCL polycaprolactone
  • PEG polyethylene glycol
  • PEG polyanhydride
  • PHA polyhydroxyalkanoate
  • PHA poly
  • the polymer is a non-biodegradable polymer, wherein the non-biodegradable polymer is selected from one or more of the following: polyester, including but not limited to, polyethylene terephthalate, poly Butylene terephthalate; nylon, including but not limited to, nylon 6, nylon 66; polyethylene, polytetrafluoroethylene, polypropylene, polyurethane, silicone rubber, and copolymers or mixtures of the foregoing.
  • polyester including but not limited to, polyethylene terephthalate, poly Butylene terephthalate
  • nylon including but not limited to, nylon 6, nylon 66
  • the stent is a vascular stent or a body lumen stent, such as a cardiovascular vascular stent, a peripheral vascular stent, a biliary stent, a urinary stent, a tracheal stent, an esophageal stent, a pancreatic stent, a gastric stent, or an intestinal stent; preferably,
  • the stent surface is sprayed with a drug that inhibits cell growth.
  • the present invention provides a method of preparing a stent of the present invention, wherein the method is carried out using a four-axis rapid prototyping system as a manufacturing apparatus, the four-axis rapid prototyping system comprising:
  • a fourth shaft system coupled to the base, comprising a rotating rod coupled to the base below the nozzle, wherein the rotating rod is rotatable about a central axis thereof in a forward or reverse direction;
  • the central axis of the rotating rod is parallel to the Y axis;
  • the method includes the following steps:
  • the bracket processing program is generated by automatic or manual method
  • the preparation of the personalized stent mold in step 1) is based on a medical imaging technique (such as CT, MRI, angiography data or OCT data) of the lesion site of the patient, and a 3D model of the patient's lesion is obtained after 3D reconstruction in vitro. Then, it is prepared by 3D printing technology or CNC machine tool processing method.
  • a medical imaging technique such as CT, MRI, angiography data or OCT data
  • the method further comprises the step of removing the fabricated stent from the fourth shaft.
  • the fixing is carried out using a clamp in step 5) or by sleeving a hollow individualized stent mold onto a rotating rod of the fourth shaft system.
  • the personalized support bracket mold is used to replace the rotary shaft of the fourth shaft system to receive the polymer, fix it on the fourth shaft system, and enable it to be positive under the control of the computer control system. Rotate in the opposite direction.
  • the four-axis rapid prototyping system disclosed in the Chinese Patent Application No. 201080002569.1, which is incorporated herein by reference.
  • the four-axis rapid prototyping system includes: (i) a susceptor; (ii) a three-axis XYZ positioning system coupled to the pedestal, wherein the XYZ positioning system defines X, Y, and Z directions, respectively; (iii) mounting a distribution system on the XYZ positioning system and moving by the XYZ positioning system, the dispensing system comprising a nozzle; (iv) a fourth shaft system coupled to the base, included under the nozzle a rotating rod coupled to the base, wherein the rotating rod is rotatable about a central axis thereof in a forward or reverse direction; a center axis of the rotating rod is parallel to the Y axis; and (v) a computer control system, which may
  • the XYZ positioning system is precisely controlled according to a set program to precisely control the movement of the nozzles of
  • the invention adopts a new personalized stent processing technology and provides a method for individually producing a stent in vivo.
  • the preparation of the stent requires a personalized stent model to achieve a personalized stent external morphology.
  • the stent model can be obtained by scanning the structure of the site to be used by 3D medical imaging technology, and the 3D model of the site to be used is obtained after 3D reconstruction in vitro, and then 3D printing method or number
  • a conventional technique such as a controlled machine tool manufacturing method prepares a solid or hollow personalized stent mold that matches the shape and size of the lumen or cavity contour of the portion to be used, and fixes it to the four-axis rapid prototyping system.
  • the individualized stent mould is fixed directly to the rotating rod of the fourth shaft system, for example by means of a clamp or by placing a hollow individualized stent mould on the rotating shaft of the fourth shaft system
  • Fixing, or the personalized support bracket mold can be used instead of the rotary shaft of the fourth axle system to receive the polymer, fix it on the fourth axle system, and enable it to be positive under the control of the computer control system Or turn in the opposite direction.
  • the computer is input, and the X, Y, Z axis and the rotating rod are synchronously controlled by the computer control system, and the reasonable X, Y and Z are designed according to the ideal structure of the bracket.
  • the shaft routing path after the material is fed into the dispensing system of the extrusion equipment, the material distribution system accurately extrudes the filaments according to the set pattern and deposits them on a specific position on the individual mold, thereby A bracket of the required shape, size and structure.
  • the four-axis rapid prototyping system employed in the present invention can include a material extrusion or conveying apparatus and a set of operating systems for controlling material delivery conditions. More specifically, the forming system can include a feed system and an extrusion system, a four-axis positioning system, and a temperature control system.
  • the material delivery system is a polymeric melt extrusion system that directly extrudes the thermal fuse of the polymeric material.
  • the four-axis positioning system refers to a space controlled by a computer X, Y, Z axis and a rotating fourth axis rotating rod, which is driven by a stepping motor or a servo motor, which can be accurately rotated at a certain speed according to needs. Stop, rotate forward or backward.
  • the rotating rod can be equipped with a heater or operated in a temperature-controlled environment to control the softness and viscosity of the material being received to maximize the material's performance.
  • a heater or operated in a temperature-controlled environment to control the softness and viscosity of the material being received to maximize the material's performance.
  • the thermal fuse can adhere to the pre-extrusion wire that meets it, thereby eliminating the glue. usage of.
  • an ideal combination of parameters is needed to ensure adequate adhesion between the emerging polymer extrudates.
  • the set of parameters includes extrusion rate, material extrusion system moving rate, and melting chamber temperature.
  • the XYZ axis and the rotating rod are simultaneously controlled by a program edited by the computer control system, thereby simultaneously preparing a bracket for setting the internal structure and the external shape.
  • the system is also suitable for preparing a polymer stent of a hybrid material.
  • different polymer materials are sequentially extruded on a rotating rod or a mold on a rotating rod.
  • the stent body profile has at least one varying diameter along the length, including but It is not limited to shapes such as tapered cones, dumbbells, and irregular surfaces.
  • the present invention provides the use of the personalized polymer stent as a vascular stent or a body cavity stent, such as a cardio-cerebral stent, a peripheral vascular stent, a biliary stent, a urinary stent, a tracheal stent, an esophageal stent, and a pancreatic duct.
  • a vascular stent or a body cavity stent such as a cardio-cerebral stent, a peripheral vascular stent, a biliary stent, a urinary stent, a tracheal stent, an esophageal stent, and a pancreatic duct.
  • a stent, gastric stent, or intestinal stent such as a vascular stent or a body cavity stent.
  • the present invention provides a method of treating a stenosis caused by a lesion in a subject, comprising:
  • the subject is a human or an animal.
  • the invention provides a more diverse variety of stents, and the specialized stent products for different physiological and pathological parts of the patient are prepared by using the rapid prototyping system and the polymer material by specially designing the parts to be used, so that the parts to be used are most matched.
  • the bracket, the length, angle and curvature of the bracket are more adapted to the configuration of the part to be used, and can meet the special requirements of the part to be used, and the adhering performance and the therapeutic effect can be improved.
  • the biodegradable material is used to prepare the stent, and the stent gradually disappears after the healing site is used, and no subsequent complications are generated; the biodegradable stent is prepared by the stent rapid prototyping system, and the material, the external shape of the stent, and the internal structure of the stent can be formed in one step.
  • the procedure is quick and easy, and improves the fit of the stent to the lesion.
  • the personalized polymer stent provided by the invention can meet the requirements of transportability, support and compliance.
  • the invention realizes the personalized bracket design and preparation method, improves the adaptability of the stent to be used, and solves the problem that the traditional bracket has poor passing ability for distorting the to-be-used part; and the method is simple in operation, easy to control, and program change It is convenient and fast, and it is easier to produce the ideal bracket, which has wider application range. It also provides a new technical research direction for the personalized design of the bracket.
  • FIG. 1 is a schematic plan view showing a planar structure of a radial artery stent prepared in the longitudinal direction of the stent (ie, the longitudinal direction of the stent);
  • FIG. 2 is a schematic plan view showing the planar structure of another radial artery stent prepared in the first embodiment of the present invention
  • FIG. 3 is a schematic plan view showing another radial artery stent prepared in the longitudinal direction of the first embodiment of the present invention
  • FIG. 4 is a schematic plan view showing a planar structure of an extratracheal stent prepared in the longitudinal direction according to Embodiment 2 of the present invention
  • FIG. 5 is a schematic plan view showing the planar structure of another tracheal outer stent prepared in the second embodiment of the present invention.
  • Figure 6 is a perspective view of the tracheal outer bracket shown in Figure 4.
  • Figure 7 is a perspective view of the tracheal outer stent shown in Figure 5;
  • Figure 8 is a view showing the internal structure of an esophageal stent prepared in Example 3 of the present invention.
  • Figure 9 shows a perspective side view of the esophageal stent shown in Figure 8.
  • the degradable polymer stent suitable for the radial artery uses polylactic acid as the raw material and adopts the same zigzag processing route.
  • the specific processing steps are as follows:
  • the hollow personalized stent mold is placed on the rotating rod of the fourth axis system of the four-axis rapid prototyping system, and is fixed so that it can be rotated with the fourth axis rotating rod under the control of the computer control system. Rotating in the opposite direction; adding the polylactic acid pellets to the dispensing system of the apparatus, the dispensing system sequentially extruding the individual filaments of the filaments on the fourth axis according to the routing path set in the control system, thereby Preparing the radial artery degradable polymer scaffold;
  • the extruded stent is removed from the personalized mold and used for subsequent operations, such as pressing onto the balloon.
  • the schematic diagrams of the three radial artery stents are shown in Figure 1, Figure 2 and Figure 3.
  • the body is composed of a connected mesh ring unit and a connecting unit, and the outer shape is tapered in the longitudinal direction.
  • the diameter of the mesh along the axial direction may be the same or different, and the density of the mesh ring along the axial direction is the same, in the radial direction.
  • the density of the supporting unit is also the same, and the prepared bracket has a uniform radial supporting force under the condition of the variable diameter.
  • Degradable polymer stent for tracheal lumen formation using polylactic acid as raw material, adopts "back" shape processing route, the specific processing steps are as follows:
  • the two tracheal stents prepared in the longitudinal direction are shown in Fig. 4 and Fig. 5.
  • the main body is composed of a connected "back" unit.
  • the diameter of the filaments in the "back” unit can be the same or different.
  • the filament density may be the same or different, and the blank portion of the "back" shaped unit may be sized to realize a tracheal stent having different radial supporting forces; the corresponding three-dimensional structures are respectively shown in FIG. 6 and FIG.
  • the shape structure when used, is buckled from the outside of the trachea to the trachea, and the stent is sutured on the trachea through surgical sutures.
  • the preparation material has a certain elasticity, so the inner diameter of the "C" shape is variable, and the flexibility of the stent is improved. .
  • Degradable polymer stent for esophageal stenosis using polylactic acid as a raw material, using a braided processing route, the specific processing steps are as follows:
  • the hollow personalized stent mold is placed on the rotating rod of the fourth axis system of the four-axis rapid prototyping system, and is fixed so that it can be rotated with the fourth axis rotating rod under the control of the computer control system. Rotating in the opposite direction; adding the polylactic acid pellets to the dispensing system of the apparatus, the dispensing system sequentially extruding the individual filaments of the filaments on the fourth axis according to the routing path set in the control system, thereby Preparing the degradable polymer esophageal stent;
  • the internal structure of the prepared esophageal stent is shown in Fig. 8.
  • the main body is composed of a connected diamond-shaped unit.
  • the overall figure is shown in Fig. 9.
  • the diamond-shaped unit design and the curved contour can make the stent produce a gentle and gentle radial expansion. Obeying the peristalsis of the esophagus, thereby keeping the esophagus unobstructed and reducing the patient's foreign body sensation.
  • One end of the stent is conical and the other end is a cup-shaped design, which avoids the cutting effect of the stent on the esophageal mucosa.
  • the inner wall of the esophagus is damaged or even bleeding. Therefore, the stent prepared by the design has good adhesion to the esophageal wall and improves the stent implantation effect.

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Abstract

La présente invention concerne un stent en polymère individualisé et un procédé de fabrication et une utilisation de celui-ci. Le stent présente une forme une taille correspondant à la forme et à la taille d'une cavité interne ou d'un profil externe de cavité d'une partie où le stent doit être utilisé, et présente une structure de stent formée par dépôt de filaments de polymère conformément à un motif prédéterminé, et le stent présente au moins un diamètre variable le long de la direction longitudinale du stent. L'invention concerne la fabrication, conformément aux données de la cavité interne ou du profil externe de cavité balayé par l'image médicale de la partie où le stent doit être utilisé, d'un moule de stent individualisé creux ou plein correspondant à la forme et à la taille de la cavité interne ou du profil externe de cavité de la partie où le stent doit être utilisé ; et l'emboîtement du moule sur une quatrième tige d'un système de prototypage rapide à quatre tiges ou l'utilisation directe du moule en tant que quatrième tige afin de recevoir le polymère, de manière à fabriquer le produit de stent individualisé. La forme et la taille du stent correspondent à la partie où le stent doit être utilisé, la longueur, l'angle et la courbure du stent sont plus adaptés à la forme de construction de la partie où le stent doit être utilisé, de manière à permettre de satisfaire aux exigences spéciales de la partie où le stent doit être utilisé, de sorte que les performances d'adhérence aux parois et l'effet de traitement du stent soient améliorés.
PCT/CN2015/097260 2015-12-14 2015-12-14 Stent en polymère individualisé et procédé de fabrication de celui-ci et utilisation de celui-ci WO2017100977A1 (fr)

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CN201580083108.4A CN108025108B (zh) 2015-12-14 2015-12-14 一种个性化聚合物支架及其制备方法和用途
PCT/CN2015/097260 WO2017100977A1 (fr) 2015-12-14 2015-12-14 Stent en polymère individualisé et procédé de fabrication de celui-ci et utilisation de celui-ci

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110314024A (zh) * 2019-06-26 2019-10-11 北京工业大学 一种适形贴壁血管内支架
WO2020132704A1 (fr) * 2018-12-21 2020-06-25 Matheny Enterprises, Llc Systèmes et procédés pour former un support thérapeutique personnalisé
CN112040906A (zh) * 2018-04-30 2020-12-04 加利福尼亚大学董事会 用于捕获毒素和释放剂的三维印刷的支架
WO2021086104A1 (fr) * 2019-10-31 2021-05-06 주식회사 삼양바이오팜 Stent non-vasculaire
CN115317664A (zh) * 2022-06-09 2022-11-11 北京大学口腔医学院 哑铃型或米字型电活性钛支架增强复合膜及其制备方法
CN115464882A (zh) * 2022-10-09 2022-12-13 上海交通大学医学院附属新华医院 一种3d打印滑扣婴幼儿生物可吸收血管支架的制备方法

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998053759A2 (fr) * 1997-05-28 1998-12-03 Yadav Jay S Stent carotidien
US20010010013A1 (en) * 1999-07-22 2001-07-26 Cox Daniel L. Tapered self-expanding stent
WO2002013727A1 (fr) * 2000-08-16 2002-02-21 Edwards Lifesciences Corporation Stent destine a etre implante dans l'artere carotide forme au moyen d'un procede utilisant le mappage intraluminal et d'autres produits obtenus au moyen dudit procede
CN202637199U (zh) * 2012-05-07 2013-01-02 同济大学 一种螺旋形可降解食管支架
CN102973340A (zh) * 2011-09-05 2013-03-20 上海市第十人民医院 一种可生物降解贲门支架
CN202875544U (zh) * 2012-07-12 2013-04-17 辽宁生物医学材料研发中心有限公司 一种适应肺动脉血管生理特点的变径支架
CN203169358U (zh) * 2013-04-08 2013-09-04 上海市同济医院 用于食管破裂及吻合口漏封堵的食管内支架
CN204500833U (zh) * 2014-12-18 2015-07-29 蔡秀军 金属蛋白酶抑制剂涂层可降解肠道支架
CN102149859B (zh) * 2009-06-25 2015-08-26 北京阿迈特医疗器械有限公司 用于制备三维多孔管状支架的方法及设备
US20150265438A1 (en) * 2014-03-18 2015-09-24 Abbott Cardiovascular Systems Inc. Tapered scaffolds

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9043190B2 (en) * 2013-08-16 2015-05-26 Heartflow, Inc. Systems and methods for identifying personalized vascular implants from patient-specific anatomic data

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998053759A2 (fr) * 1997-05-28 1998-12-03 Yadav Jay S Stent carotidien
US20010010013A1 (en) * 1999-07-22 2001-07-26 Cox Daniel L. Tapered self-expanding stent
WO2002013727A1 (fr) * 2000-08-16 2002-02-21 Edwards Lifesciences Corporation Stent destine a etre implante dans l'artere carotide forme au moyen d'un procede utilisant le mappage intraluminal et d'autres produits obtenus au moyen dudit procede
CN102149859B (zh) * 2009-06-25 2015-08-26 北京阿迈特医疗器械有限公司 用于制备三维多孔管状支架的方法及设备
CN102973340A (zh) * 2011-09-05 2013-03-20 上海市第十人民医院 一种可生物降解贲门支架
CN202637199U (zh) * 2012-05-07 2013-01-02 同济大学 一种螺旋形可降解食管支架
CN202875544U (zh) * 2012-07-12 2013-04-17 辽宁生物医学材料研发中心有限公司 一种适应肺动脉血管生理特点的变径支架
CN203169358U (zh) * 2013-04-08 2013-09-04 上海市同济医院 用于食管破裂及吻合口漏封堵的食管内支架
US20150265438A1 (en) * 2014-03-18 2015-09-24 Abbott Cardiovascular Systems Inc. Tapered scaffolds
CN204500833U (zh) * 2014-12-18 2015-07-29 蔡秀军 金属蛋白酶抑制剂涂层可降解肠道支架

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112040906A (zh) * 2018-04-30 2020-12-04 加利福尼亚大学董事会 用于捕获毒素和释放剂的三维印刷的支架
WO2020132704A1 (fr) * 2018-12-21 2020-06-25 Matheny Enterprises, Llc Systèmes et procédés pour former un support thérapeutique personnalisé
US20220072798A1 (en) * 2018-12-21 2022-03-10 Matheny Enterprises, Llc Systems And Methods For Forming A Customized Therapeutic Support
EP3897806A4 (fr) * 2018-12-21 2022-08-10 Matheny Enterprises, LLC Systèmes et procédés pour former un support thérapeutique personnalisé
CN110314024A (zh) * 2019-06-26 2019-10-11 北京工业大学 一种适形贴壁血管内支架
CN110314024B (zh) * 2019-06-26 2021-11-05 北京工业大学 一种适形贴壁血管内支架
WO2021086104A1 (fr) * 2019-10-31 2021-05-06 주식회사 삼양바이오팜 Stent non-vasculaire
CN115317664A (zh) * 2022-06-09 2022-11-11 北京大学口腔医学院 哑铃型或米字型电活性钛支架增强复合膜及其制备方法
CN115464882A (zh) * 2022-10-09 2022-12-13 上海交通大学医学院附属新华医院 一种3d打印滑扣婴幼儿生物可吸收血管支架的制备方法

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