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WO2008001865A1 - EndoProthÈse VASCULAIRE recouverte et procÉdÉ de production d'une endoprothÈse REcouverte - Google Patents

EndoProthÈse VASCULAIRE recouverte et procÉdÉ de production d'une endoprothÈse REcouverte Download PDF

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Publication number
WO2008001865A1
WO2008001865A1 PCT/JP2007/063034 JP2007063034W WO2008001865A1 WO 2008001865 A1 WO2008001865 A1 WO 2008001865A1 JP 2007063034 W JP2007063034 W JP 2007063034W WO 2008001865 A1 WO2008001865 A1 WO 2008001865A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent
covered stent
covered
cover material
diameter
Prior art date
Application number
PCT/JP2007/063034
Other languages
English (en)
Japanese (ja)
Inventor
Kouta Inoue
Yoshihide Toyokawa
Masaru Tanaka
Masatsugu Shimomura
Original Assignee
Zeon Medical Inc.
National University Corporation Hokkaido University
Japan Science And Technology Agency
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
Application filed by Zeon Medical Inc., National University Corporation Hokkaido University, Japan Science And Technology Agency filed Critical Zeon Medical Inc.
Priority to JP2008522632A priority Critical patent/JPWO2008001865A1/ja
Publication of WO2008001865A1 publication Critical patent/WO2008001865A1/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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • 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
    • 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
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • 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
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching

Definitions

  • the present invention is suitably used to expand a stenosis for the purpose of securing a body lumen when a stenosis occurs in a body lumen such as a bile duct, blood vessel, trachea, esophagus and urethra.
  • the present invention relates to a covered stent and a method for manufacturing the covered stent.
  • a stent is generally a cylindrical member in which metal wires are formed in a mesh shape, and can expand and contract in the radial direction.
  • the stent 102 is inserted into a body lumen by a delivery catheter 100 as shown in FIG. 5, for example, with the outer diameter contracted, and placed in a stenosis.
  • the outer diameter of the stent 102 can be expanded at this indwelling position to secure the lumen of the stenosis.
  • 101 indicates an outer tube (sheath) of the delivery catheter
  • 103 indicates an inner tube
  • 104 indicates a tip.
  • a stent is a member in which a metal wire is formed in a mesh shape, it grows so that a tumor tissue or the like enters the inside of the stent from the gap portion of the wire constituting the stent, so that the early stage of stenosis There was a concern about recurrence. For this reason, by providing a cover material made of a resin on the outer periphery of the stent, it is possible to prevent the invasion of tumor tissue, to suppress early recurrence of stenosis, and to suppress the growth of tumor tissue etc. in the body lumen. Coverable stents are also available.
  • Patent Document 1 includes a ring-shaped stent unit configured by a zigzag-shaped wire continuously formed in the circumferential direction and capable of expanding a contracted state force in the radial direction, and configures this stent unit. It is formed by connecting at least one of the zigzag folded ends of the wire and at least one folded end of the zigzag of the wire in another stent unit axially adjacent to the stent unit. Stent, and stent A covered stent is disclosed in which a cover film is wound around the outer periphery! By having this shape, the stent according to Patent Document 1 has excellent flexibility in a contracted state, can be easily inserted into a body lumen, and can easily maintain an expanded state. In addition, the risk of damaging the inner wall of the body lumen and the cover film wound around the outer periphery of the stent can be reduced.
  • Patent Document 2 discloses a stent including a tube-shaped flexible body having a web structure in which a tube wall portion can transfer a non-expanded state force to an expanded state.
  • This web structure has three parts in the pattern where each web is positioned at an angle to each other, thus minimizing its contraction when the stent is expanded and extremely flexible in the unexpanded state. Excellent in properties. Furthermore, it can have a very stable structure in the expanded state.
  • Patent Document 1 International Publication No. WO2006Z001367
  • Patent Document 2 Japanese Translation of Special Publication 2002-524135
  • Such a conventional covered stent cover material includes a method of dipping a bare stent into a resin solution, or a film of a resin coated on a bare stent and bonded with an adhesive or the like. In this way, the stent body and the cover material have not been peeled off.
  • the cover film becomes very thick.
  • the film of the resin is bonded by an adhesive, the part where the adhesive has hardened becomes very hard, so the covered stent cannot be placed without following the movement and bending of the body lumen.
  • the position force deviates, or when the radial stiffness is too high to irritate the living tissue, complications may occur due to the placement of the covered stent.
  • the cover material is covered without reducing the diameter of the stent, and therefore, the remaining cover material when the diameter is reduced in the manufacturing process is folded.
  • the cover material is bulky, and there is a problem that it is difficult to enter a sheath having a small diameter used for stent placement.
  • the cover can be covered without reducing the diameter.
  • the cover material was covered and the diameter of the cover material was reduced, the remaining cover material was folded, so that the folded cover materials were sticking to each other, and the diameter expansion of the covered stent was likely to occur.
  • the covered stent is inserted into the body lumen using a delivery catheter or the like, there is also a problem that the covered stent cannot be easily placed.
  • the object of the present invention is to hold the cover member on the stent body without using an adhesive, and to peel off! /, Which can follow the bending of the body lumen with less irritation to the body lumen wall. It is another object of the present invention to provide a covered stent that can function stably at that position and a manufacturing method thereof.
  • the covered stent (10) of the present invention includes a cylindrical stent (20) and a cover material (30) provided on an outer peripheral portion of the stent, and is used by being placed in a body lumen.
  • the covered stent is a radial stiffness of the stent, Rfs, the bending stiffness of the stent in the long axis direction is Afs, the radial stiffness of the covered stent is Rfc, and the bending stiffness of the covered stent in the long axis direction is Afc.
  • the cover material is 1.2 to 3.0 along the circumferential direction of the stent in the expanded state of the stent.
  • the film is stretched twice.
  • the radial stiffness (Rfs, Rfc) of the stent and the covered stent can be measured using an MSI Radial Expansion Force Gage RX500-01 (manufactured by MSI) in an atmosphere of 37 ° C. According to this, the repulsive force can be measured by uniformly reducing and expanding the entire circumference in the radial direction of the stent and the covered stent.
  • Figure 3 shows how to measure the bending stiffness (A fs, Afc) in the major axis direction.
  • a core rod 133 having an outer diameter substantially equal to the inner diameter of the stent 130 or the covered stent 131 is inserted into the inner lumen of the stent 130 or the covered stent 131 and fixed vertically.
  • the core rod 133 is inserted so that the partial force in which the stent 130 or the covered stent 131 and the core rod 133 do not overlap each other is 20 mm in the lengthwise direction.
  • the end 135 of the core rod 133 on the side inserted into the stent 130 or the covered stent 131 is aligned with the surface position and fixed with a vise.
  • the part that does not overlap with the core rod 133 Push the force gauge 138 at the position where the distance from the end 136 of the core rod 133 on the side of the stent 130 or the covered stent 131 of the minute stent 130 or the covered stent 131 to the major axis direction. Measure the repulsive force when bent so that the angle is 60 °. These are performed using a force gauge 138 in an atmosphere of 37 ° C.
  • the draw ratio Mc of the cover material is the following formula:
  • Mc (the length in the circumferential direction of the covered stent in the expanded state)
  • Z (the length in the circumferential direction of the cover material in the unstretched state)
  • the length of the covered stent in the expanded state in the circumferential direction is measured.
  • the cover material is cut along the long axis direction, and the cover material is peeled off from the stent.
  • the circumferential length of the cover material in an unstretched state from which the stress has been removed is measured. From these measurement results, the draw ratio of the cover material can be specified based on the above formula.
  • the cover material is stretched 1.2 to 3.0 times along the circumferential direction of the stent in the expanded state of the stent, and 1.2 to 2.5 times. Is more preferable.
  • the diameter expansion rate is preferably more than 80% and more than 90%.
  • the “expansion ratio” is a value obtained by (outer diameter of covered stent Z outer diameter of stent) X 100.
  • the diameter expansion rate falls within the above range, the stent body force cover material can be prevented from falling off, and the covered stent can be prevented from deviating from the bile duct.
  • the diameter expansion ratio is in the above range, the narrowed portion can be sufficiently expanded, and the function of the covered stent, that is, the function of ensuring a sufficient lumen. And thus the lumen patency can be lengthened.
  • the structure of the stent used in the covered stent of the present invention is not particularly limited.
  • the stent used in the present invention has a cover material in which the gap formed in the metal wire mesh is narrow to some extent. It is preferable to have a structure that does not enter the inside.
  • the cover material (30) has an initial elastic modulus of 50. It is preferably kPa or less. According to such a configuration, it is possible to keep the value of AfcZAfs small, and thereby it is possible to more easily place in the body lumen, and to place more stably at the position.
  • Initial elastic modulus refers to the value measured first among the elastic modulus of the cover material. The initial elastic modulus is measured by holding the cover material at both ends with a clip and pulling it in the opposite direction.
  • the relational force between the radial rigidity Rfc of the covered stent and the bending rigidity Afc of the long axis of the stent is 30 ⁇ RfcZAfc ⁇ 100.
  • the cover material (30) is made of a hard cam membrane. According to such a configuration, it is possible to reduce the value of the bending rigidity Afc in the major axis direction of the covered stent in which the flexibility of the cover material is high.
  • Her cam membrane refers to a polymer film having a her cam structure, and in the two cam structure, a plurality of holes having a substantially constant hole diameter are regularly arranged. Means a porous structure. In addition, the hole may penetrate through the other surface on the opposite side of the surface force of the honeycomb film, or may not penetrate.
  • the two-cam structure has a hexagonal structure continuously if the polymer film has a structure in which numerous small holes are regularly arranged on the film, such as a honeycomb. It does not have to be a deployed structure.
  • the cover material (30) may be a knitted fabric.
  • Such a configuration has the effect of reducing the value of AfcZAfs.
  • knitted fabric is not particularly limited, but it is preferable because, for example, a knitted fabric force such as stockings is thin and stretchable, and it is difficult to stick to each other even when folded when the stent is contracted.
  • the covered stent (10) of the present invention preferably has a radial rigidity Rfc of 15 N or less and a bending rigidity Afc in the major axis direction of 0.3 N or less. According to such a configuration, there is little effect on the luminal tissue wall in the body, and there is an effect.
  • the method of manufacturing the force bar stent (10) of the present invention used by being placed in a body lumen is a stent diameter reduction process in which the stent is reduced in diameter until the outer diameter becomes 1Z3 to 2Z3. And a cover material coating step of covering the outer peripheral portion of the reduced diameter stent with a cover material.
  • the covered stent of the present invention by placing the bending rigidity in the major axis direction and the rigidity in the radial direction within appropriate ranges, the placement in the body lumen can be facilitated, and the position can be maintained after the placement. It is possible to provide a function of stably securing the body lumen in the position.
  • the diameter of the stent is reduced to a predetermined size, and then the outer peripheral portion of the stent is covered with a cover material without using an adhesive or the like.
  • the cover material can be hugged to the stent. For this reason, indwelling in a body lumen can be facilitated, and the risk of occurrence of complications can be suppressed.
  • FIG. 1 is a perspective view showing a covered stent according to an embodiment of the present invention.
  • FIG. 2 is a schematic view including a method for manufacturing a covered stent according to an embodiment of the present invention.
  • FIG. 3 is a schematic diagram showing a method for measuring bending stiffness Afs and Afc in the major axis direction of a stent and a covered stent.
  • FIG. 5 is a plan view showing a stent delivery catheter with a stent mounted thereon. Explanation of symbols
  • FIG. 1 is a perspective view showing a covered stent according to an embodiment of the present invention.
  • the covered stent 10 according to the embodiment of the present invention includes a cylindrical stent 20 and a cover member 30 provided on the outer peripheral portion of the stent 20.
  • the radial stiffness of the stent 20 is Rfs
  • the bending stiffness in the major axis direction of the stent 20 is Afs
  • the radial stiffness of the covered stent 10 is Rfc
  • the bending stiffness in the major axis direction of the covered stent 10 is When Afc, Rfc / Rfs ⁇ l.5 and AfcZAfs ⁇ 2.0 are satisfied.
  • the cover member 30 is used while being expanded by 1.2 to 3.0 times along the circumferential direction of the stent 20 in the expanded state of the stent 20.
  • the stent used for the covered stent according to the embodiment of the present invention is not particularly limited in its structure. Among them, it is preferable that the stent has a structure in which the cover material narrowed to some extent by the mesh of the metal wire S does not enter the inside of the stent through the mesh space due to compression of the tumor tissue or the like.
  • the stent is configured by a zigzag-shaped wire continuously formed in the circumferential direction, for example, as in the stent described in Patent Document 1, and the contracted state force can be expanded in the radial direction.
  • the stent is preferably formed by connecting two folded ends.
  • the stent includes a tube-like flexible body having a web structure in which the tube wall portion can transfer the non-expanded state force to the expanded state as in the stent described in Patent Document 2.
  • the web structure is preferably a stent such that in its pattern, each web has three parts that are arranged at an angle to each other.
  • the cover material 30 used for the covered stent 10 according to the embodiment of the present invention is stretched 1.2 to 3.0 times along the circumferential direction of the stent in a diameter-expanded state of the stent. 2. It is preferable that the film is stretched 5 times.
  • the initial elastic modulus of the cover material is 20 kPa or less.
  • the initial elastic modulus is If the value is larger than the prescribed value, the diameter expansion of the covered stent 10 is liable to occur, and the bending rigidity Afc in the long axis direction is increased.
  • the initial elastic modulus is the value measured first among the elastic modulus of the cover material. The initial elastic modulus is measured by holding both ends of the cover material with a clip and pulling them in opposite directions on a straight line. Examples of specific methods for measuring the initial elastic modulus will be described in detail in Examples.
  • the material of the cover material 30 is preferably made of a Hercam film!
  • a “her cam membrane” refers to a polymer film having a harm structure.
  • the Hercam structure means a porous structure in which a plurality of holes having a substantially constant hole diameter are regularly arranged (see International Publication No. WO2005 Z051450). Therefore, it is only necessary that the polymer film has a structure in which innumerable small holes are regularly formed on the film like a honeycomb, and the hexagonal structure is continuously developed. There is no need.
  • the average hole diameter of the holes constituting the Hercam structure is preferably 0.1-100 ⁇ m, and 0.1-20 1! 1 is preferably 0. 5 ⁇ : More preferably, LO / zm.
  • the hole diameter refers to the diameter of the maximum inscribed circle with respect to the opening shape of the hole.
  • the aperture shape is circular, it indicates the diameter of the circle, if it is elliptical, it indicates the minor axis of the ellipse, and if it is rectangular, it indicates the length of the short side of the rectangle.
  • the opening shape of the hole is not particularly limited, and may be a round shape, an elliptical shape, a square shape, a rectangular shape, a hexagonal shape or the like!
  • the method for producing the polymer film having the her-cam structure is not particularly limited. To do this, for example, an organic solvent solution of resin is cast on a substrate, and the organic solvent is evaporated and condensation occurs on the cast liquid surface. A method of evaporating the minute water droplets after forming a porous structure is mentioned.
  • the material of the cover member 30 may be a knitted fabric, for example, stockings, in addition to the Herkam film.
  • a knitted fabric such as stockings
  • the thickness is not too thick and can be stretched, so that the bending rigidity in the major axis direction and the rigidity in the radial direction can be suppressed.
  • the covered stent 10 made of knitted fabric can follow the movement and bending of the body lumen. Therefore, the function can be performed stably without deviating from the positional force where the covered stent 10 is placed.
  • the covered stent 10 according to the embodiment of the present invention is manufactured by winding the cover material 30 around the outer peripheral portion of the stent 20. A specific manufacturing method will be described in detail later.
  • the covered stent 10 includes the radial rigidity and the long-axis bending of the covered stent with respect to the radial rigidity and the long-axis bending rigidity of the stent 20, respectively.
  • the stiffness ratio is specified. That is, assuming that the radial stiffness of the stent 20 is Rfs, the bending stiffness in the long axis direction is Afs, the radial stiffness of the covered stent 10 is Rfc, and the bending stiffness in the long axis direction is Afc, Rfc / Rfs ⁇ l 5 and AfcZAfs ⁇ 2.0. Further, the cover material 30 is used by being stretched by 1.2 to 3.0 times along the circumferential direction of the stent 20 in the expanded state of the stent 20.
  • RfcZRfs exceeds 1.5, the rigidity in the radial direction of the covered stent 10 is increased, and stimulation to the body lumen wall is increased, which is not preferable. Also, if the value of AfcZAfs exceeds 2.0, the bending stiffness of the covered stent 10 in the long axis direction becomes high and follows the bending of the body lumen, which is not preferable. Furthermore, when the cover material 30 is stretched by 1.2 to 3.0 times along the circumferential direction of the stent 20 in the expanded state of the stent 20, the cover material 30 is stretched by less than 1.2 times.
  • the cover material 30 does not sufficiently adhere to the stent 20 and the cover material 30 may be peeled off in the body lumen.
  • the cover member 30 is stretched by 3.0 times or more, the cover member 30 is sufficiently tightly attached to the stent 20 and the cover member 30 is stretched to a specified value or more, so that the bending rigidity is increased. Therefore, it is preferable that the covered stent 10 according to the embodiment of the present invention is manufactured with the rigidity defined above, and the cover member 30 is manufactured within the range of the stretching ratio defined above.
  • the covered stent of the present invention can flexibly follow the movement and bending of the body lumen even when it is placed in the body lumen.
  • FIG. 2 (a) is a schematic view showing a method for producing the covered stent 10 of the present invention.
  • the method for manufacturing the covered stent 10 according to the embodiment of the present invention is as follows. First, the stent 20 has a stent diameter-reducing step (first diameter-reducing step) S1 for reducing the diameter of the stent 20 until the outer diameter force becomes 1/3 to 2/3. Next, in this state, there is a cover material coating step S2 for covering the cover material 30 having a size corresponding to one round of the outer diameter in the reduced diameter state.
  • first diameter-reducing step for reducing the diameter of the stent 20 until the outer diameter force becomes 1/3 to 2/3.
  • cover material coating step S2 for covering the cover material 30 having a size corresponding to one round of the outer diameter in the reduced diameter state.
  • the covered stent 10 wound with the cover material 30 is further reduced in diameter so as to be inserted into an inner lumen such as the outer tube (sheath) 101 of the stent delivery force tater shown in FIG. (Second diameter reduction step) S3 is included.
  • the size of the cover material is not limited to the outer diameter of the stent in a reduced diameter state, and a plurality of outer diameters of the stent in a reduced diameter may be included in one circle. You may wind around.
  • the cover material 95 is wound around the stent 99 as shown in FIG. 2 (b).
  • the stent 99 had a step S10 in which the diameter of the stent 99 was not reduced (in the diameter-expanded state), and the cover material 95 having a size corresponding to one circumference was wound around the outer periphery.
  • the covered stent of the present invention is a cover having a size corresponding to one round after the diameter of the stent is reduced until the outer diameter of the stent becomes 1Z3 to 2Z3. Wrap the material.
  • the cover material 30 is stretched by the stent 20 and the stent 20 and the cover material 30 are brought into close contact with each other.
  • the stent 20 and the cover material 30 can be integrated together without using an adhesive. Therefore, the cover material 30 does not cling to the stent 20 due to movement or bending of the body lumen when it is placed in the body lumen.
  • the rigidity of the covered stent can be kept low. Even if the covered stent 10 is placed in the body lumen, the covered stent 10 is placed by the movement or bending of the body lumen. Positional force Deviation can be prevented.
  • the conventional covered stent was covered / covered without being reduced in diameter, so that the remaining cover material was folded when the diameter was reduced in the manufacturing process. This allows the folding force Due to the large amount of the bar material, there is a problem that it becomes bulky and it is difficult to enter a sheath with a small diameter (see FIG. 5) used for stent placement. For this reason, the folded cover materials are sticking to each other, and the diameter of the covered stent tends to be hindered. There was also a problem that could not be done.
  • the cover material when the outer diameter of the stent is reduced and then the cover material is wound, the cover material may be loosened when the diameter is further reduced for insertion into the sheath. And the covered stent can be easily placed in the body lumen.
  • the stent described in Patent Document 1 (hereinafter referred to as “Type A”) was used as the stent.
  • a covered stent test piece was prepared using the above-mentioned Hercam film described in International Publication WO2005Z051450 (hereinafter, simply referred to as “No. 2 cam film”) as the force bar material.
  • the No-Cam membrane was cast in a glass petri dish with a diameter of 20 cm in diameter using a 3 mg / mL chloroform solution of 1,2-polybutadiene (trade name: manufactured by RB820 JSR). It was prepared by volatilizing the black mouth form.
  • the obtained elastic cam film had an initial elastic modulus of 46 kPa.
  • the initial elastic modulus was measured using a RHEO METER (NRM-2002J, manufactured by Fudo Kogyo Co., Ltd.) at a tensile speed of 20 mmZmin with a test piece having a distance of 10 mm between the chuck 150 and 150 (see FIG. 4).
  • the initial elastic modulus is the slope of the approximate curve of the tensile strength curve (horizontal axis: elongation (mm), vertical axis: tensile load (N)) from 0 to 15% elongation, and the cross-sectional area of the tensile specimen. The value divided by.
  • the outer diameter of the stent was first reduced to a size of 5 mm.
  • the cover material was wound eight times with the size of one round of the stent in the reduced state as a single stroke, and further reduced in diameter to produce a cannulated stent.
  • the circumferential dimension in the expanded state was measured.
  • the cover material was cut along the long axis direction, and the length of the cover material in an unstretched state after cutting to remove the stress was measured.
  • the circumferential dimension in the expanded state was 28 mm, and the length in the circumferential direction of the unstretched cover material after cutting was 22 mm. Therefore, the draw ratio was 1.3.
  • the diameter expansion rate of the covered stent was 99%.
  • a knitted fabric, here stockings manufactured by Danze Co., Ltd., rsoft fit No. SM-93SJ (material: nylon, polyurethane), approximately 200 / z m thickness) was used as the cover material.
  • a covered stent was produced in the same manner as in Example 1 except that the number of times of covering of the cover material was one.
  • the initial elastic modulus of the knitted fabric constituting the covered stent was 1.2 kPa.
  • the circumferential dimension in the expanded state was measured. Moreover, in the force bird stent, the cover material was cut along the long axis direction, and the length of the cover material in an unstretched state after cutting to remove the stress was measured. In the covered stent, the circumferential dimension in the expanded state was 27 mm, and the length in the circumferential direction of the unstretched cover material after cutting was 16 mm. Therefore, the draw ratio was 1.7. The diameter expansion rate of the covered stent was 96%.
  • a covered stent was produced in the same manner as in Example 1 except that the stent described in Patent Document 2 (hereinafter referred to as “TypeB ⁇ ”) was used as the stent.
  • the dimension in the circumferential direction in the expanded diameter state was measured.
  • the cover material was cut along the long axis direction, and the length of the cover material in an unstretched state after cutting to remove the stress was measured.
  • the circumferential dimension in the expanded state was 27 mm, and the length in the circumferential direction of the unstretched cover material after cutting was 20 mm. Therefore, the draw ratio was 1.4.
  • the diameter expansion rate of the covered stent was 96%.
  • Cover material knitted fabric, stockings (manufactured by Danze Co., Ltd., rsoft fit No. SM -93SJ (material: nylon, polyurethane), about 200 / zm thick) was used.
  • a covered stent was produced in the same manner as in Example 3 except that the number of times of covering of the cover material was one.
  • the circumferential dimension in the expanded state was measured. Moreover, in the force bird stent, the cover material was cut along the long axis direction, and the length of the cover material in an unstretched state after cutting to remove the stress was measured. In the covered stent, the circumferential dimension in the expanded state was 28 mm, and the length in the circumferential direction of the unstretched cover material after cutting was 16 mm. Therefore, the draw ratio was 1.8 times. The diameter expansion rate of the covered stent was 99%.
  • a covered stent was produced in the same manner as in Example 1 except that the outer diameter of the stent was reduced to 3 mm.
  • the dimension in the circumferential direction in the expanded diameter state was measured.
  • the cover material was cut along the long axis direction, and the length of the cover material in an unstretched state after cutting to remove the stress was measured.
  • the circumferential dimension in the expanded state was 22 mm, and the length in the circumferential direction of the unstretched cover material after cutting was 13 mm. Therefore, the draw ratio was 1.7 times.
  • the diameter expansion rate of the covered stent was 70%.
  • a covered stent was produced in the same manner as in Example 4 except that the outer diameter of the stent was reduced to 3 mm.
  • the circumferential dimension in the expanded state was measured. Moreover, in the force bird stent, the cover material was cut along the long axis direction, and the length of the cover material in an unstretched state after cutting to remove the stress was measured. In the covered stent, the circumferential dimension in the expanded state was 27 mm, and the length in the circumferential direction of the unstretched cover material after cutting was 14 mm. Therefore, the draw ratio was 1.9 times. The diameter expansion rate of the covered stent was 93%.
  • a covered stent was produced in the same manner as in Example 1.
  • the flat membrane constituting this covered stent was cast in a glass petri dish having a diameter of 15 cm with a 7.8 mg ZmL chloroform solution of 1,2-polybutadiene (trade name: manufactured by RB820 JSR). This can be obtained by volatilizing chlorophenol in a draft.
  • the circumferential dimension in the expanded state was measured. Moreover, in the force bird stent, the cover material was cut along the long axis direction, and the length of the cover material in an unstretched state after cutting to remove the stress was measured. In the covered stent, the dimension in the circumferential direction in the expanded state was 24 mm, and the length in the circumferential direction of the unstretched cover material after cutting was 20 mm. Therefore, the draw ratio was 1.2 times. The diameter expansion rate of the covered stent was 83%.
  • Table 1 shows the measurement results in Examples 1 to 6 and Comparative Example 1 described above.
  • Rfc / Rfs which is the ratio of the radial stiffness of the covered stent to the stent
  • AfcZAfs which is the ratio of the rigidity of the covered stent to the stent in the long axis direction, was 2.0 or less, which also satisfied the specified value of the present invention.
  • the Rfc force which is the ratio of the radial stiffness of the covered stent, is 15 N or less
  • the Afc force which is the ratio of the rigidity in the long axis direction of the covered stent, is 0. 3N or less.
  • the wound diameter of the stent was 5 mm, and the draw ratio of the cover material was 1.3 to 1.8 times.
  • the wound diameter of the stent was 3 mm, and the draw ratio of the cover material was 1.7 to 1.9 times.
  • the range of the stretch ratio of the cover material of the present invention is satisfied, so that even if it is placed in the body lumen, it functions stably at a predetermined position without stimulating the body. I was able to demonstrate what I could do.
  • Comparative Example 1 is not suitable as the covered stent of the present invention because Rfc, which is the rigidity in the radial direction of the covered stent, is larger than 15N and does not satisfy the specified value of the present invention.

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Surgery (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne une endoprothèse vasculaire recouverte s'implantant bien dans les tissus vivants du corps, dans laquelle un élément de couverture se presse contre le corps de l'endoprothèse vasculaire sans recours à un agent adhésif et ne s'en détache pas, induit moins d'irritations aux parois de la lumière du corps, suit les courbes de la lumière du corps et même après l'implantation dans le corps, elle remplit sa fonction de façon stable dans la position d'implantation. L'invention concerne aussi un procédé de production de l'endoprothèse vasculaire recouverte. L'endoprothèse vasculaire recouverte (10) présente une endoprothèse vasculaire tubulaire (20) et un élément de recouvrement (30) sur la périphérie externe de l'endoprothèse vasculaire et est utilisée comme implant dans une lumière du corps. L'endoprothèse vasculaire recouverte satisfait les équations Rfc/Rfs £ 1,5 et Afc/Afs £ 2,0, Rfs représentant la rigidité radiale de l'endoprothèse vasculaire (20), Afs la rigidité en flexion dans la direction de l'axe longitudinal de l'endoprothèse vasculaire (20), Rfc la rigidité radiale de l'endoprothèse vasculaire recouverte (10) et Afc la rigidité en flexion dans la direction de l'axe longitudinal de l'endoprothèse vasculaire recouverte (10). De plus, pour utiliser l'élément de recouvrement (30), on l'étend en longueur entre 1,2 et 3,0 fois sa longueur initiale, l'endoprothèse vasculaire (20) étant étendue dans la direction diamétrale, l'extension étant effectuée suivant la circonférence de l'endoprothèse vasculaire (20).
PCT/JP2007/063034 2006-06-30 2007-06-28 EndoProthÈse VASCULAIRE recouverte et procÉdÉ de production d'une endoprothÈse REcouverte WO2008001865A1 (fr)

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Cited By (7)

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JP5575327B2 (ja) * 2011-03-08 2014-08-20 株式会社パイオラックスメディカルデバイス ステント
WO2014171448A1 (fr) 2013-04-18 2014-10-23 国立大学法人 山形大学 Endoprothèse destinée à être placée dans la voie biliaire et son procédé de fabrication
JP2015161576A (ja) * 2014-02-27 2015-09-07 日本ゼオン株式会社 ステントの曲げ方向への変形しやすさを測定する測定方法及び測定装置
US9637722B2 (en) 2013-07-09 2017-05-02 Toyoda Gosei Co., Ltd. Production method of polyurethane porous membrane to be used for at least one of applications of cell culture and cancer cell growth inhibition
JP2018161163A (ja) * 2017-03-24 2018-10-18 ニプロ株式会社 ステント
CN111419470A (zh) * 2020-03-17 2020-07-17 首都医科大学附属北京安贞医院 一种支架覆膜机
CN113367834A (zh) * 2020-03-10 2021-09-10 上海微创医疗器械（集团）有限公司 覆膜支架及其制备方法

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JP2005152004A (ja) * 2003-11-20 2005-06-16 Terumo Corp カバードステント
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JP2006130064A (ja) * 2004-11-05 2006-05-25 National Cardiovascular Center ステントデリバリシステム

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5575327B2 (ja) * 2011-03-08 2014-08-20 株式会社パイオラックスメディカルデバイス ステント
WO2014171448A1 (fr) 2013-04-18 2014-10-23 国立大学法人 山形大学 Endoprothèse destinée à être placée dans la voie biliaire et son procédé de fabrication
US10080640B2 (en) 2013-04-18 2018-09-25 National University Corporation Yamagata University Stent to be placed in bile duct
US9637722B2 (en) 2013-07-09 2017-05-02 Toyoda Gosei Co., Ltd. Production method of polyurethane porous membrane to be used for at least one of applications of cell culture and cancer cell growth inhibition
JP2015161576A (ja) * 2014-02-27 2015-09-07 日本ゼオン株式会社 ステントの曲げ方向への変形しやすさを測定する測定方法及び測定装置
JP2018161163A (ja) * 2017-03-24 2018-10-18 ニプロ株式会社 ステント
CN113367834A (zh) * 2020-03-10 2021-09-10 上海微创医疗器械（集团）有限公司 覆膜支架及其制备方法
CN113367834B (zh) * 2020-03-10 2024-02-27 上海微创医疗器械（集团）有限公司 覆膜支架及其制备方法
CN111419470A (zh) * 2020-03-17 2020-07-17 首都医科大学附属北京安贞医院 一种支架覆膜机
CN111419470B (zh) * 2020-03-17 2022-08-30 首都医科大学附属北京安贞医院 一种支架覆膜机

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