WO2021100877A1 - Feuille de traitement osseux et procédé de traitement d'os d'animal - Google Patents

Feuille de traitement osseux et procédé de traitement d'os d'animal Download PDF

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Publication number
WO2021100877A1
WO2021100877A1 PCT/JP2020/043521 JP2020043521W WO2021100877A1 WO 2021100877 A1 WO2021100877 A1 WO 2021100877A1 JP 2020043521 W JP2020043521 W JP 2020043521W WO 2021100877 A1 WO2021100877 A1 WO 2021100877A1
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Prior art keywords
bone
treatment sheet
bone treatment
damaged
sheet
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PCT/JP2020/043521
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English (en)
Japanese (ja)
Inventor
橋元　伸晃
水野　潤
関　康弘
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公立大学法人公立諏訪東京理科大学
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Priority to JP2021558482A priority Critical patent/JP7541749B2/ja
Publication of WO2021100877A1 publication Critical patent/WO2021100877A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • 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
    • A61F2/28—Bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body

Definitions

  • the present invention relates to a bone treatment sheet and a method for treating animal bone.
  • Patent Document 1 As a treatment method when a long bone is damaged, a method of covering the damaged part with a sheet is known (see, for example, Patent Document 1).
  • a sheet made of a medical metal material for example, titanium or titanium alloy
  • a filler for example, a bone filling material composed of autologous bone granules and allogeneic bone granules
  • the sheet itself does not have the effect of actively promoting bone healing.
  • the present invention has been made in view of the above-mentioned problems, and is a bone treatment sheet capable of promoting bone healing as compared with a conventional sheet (a sheet in which a nanoscale structure is not formed) and the present invention. It is an object of the present invention to provide a bone treatment method using the bone treatment sheet of.
  • the bone treatment sheet of the present invention is a bone treatment sheet for use in bone treatment by arranging it so as to cover the damaged portion of the damaged bone, and a nanoscale uneven structure is formed at least in a part thereof. It is characterized by being done.
  • the nanoscale uneven structure affects the proliferation and differentiation of cells, so that the bone healing is promoted as compared with the conventional sheet (sheet in which the nanoscale structure is not formed). It becomes a possible bone treatment sheet.
  • the bone treatment sheet of the present invention has a holding portion for holding the bone healing promoting substance, and the holding portion has a porous structure capable of accommodating the bone healing promoting substance, and the porous structure is formed. It is preferable that the nanoscale uneven structure is formed on at least a part of the wall surface of the constituent pores.
  • the bone treatment sheet of [2] above since it has a holding portion that holds a bone healing promoting substance that is a physiologically active substance that promotes bone healing, the bone healing promoting substance held by the holding portion is a damaged portion of the bone.
  • the bone treatment sheet of the above [2] When used to contact or invade bone, it is possible to promote the proliferation and differentiation of cells (particularly, cells that are the source of bone and blood vessels around bone). Therefore, according to the bone treatment sheet of the above [2], it is possible to enhance the healing power of the bone itself. Further, according to the bone treatment sheet of the above [2], it is possible to firmly fix the bone treatment sheet and the bone at an early stage through cell proliferation and differentiation, and as a result, the bone is damaged during the healing period. It is possible to suppress the displacement and expansion of the damaged part of the bone. Therefore, the bone treatment sheet of the above [2] is a bone treatment sheet capable of promoting bone healing as compared with the conventional sheet.
  • the bone treatment sheet of the above [2] by appropriately setting the structure and physical properties of the holding portion, it is possible to adjust the release condition of the bone healing promoting substance and appropriately promote the bone healing. It will be possible.
  • the bone healing promoting substance can be continuously released (exuded) continuously for a long period of time, and the bone healing promoting substance is rapidly released. It can also be done.
  • the "easiness of detachment of the bone healing promoting substance” can also be referred to as "retaining power to the bone healing promoting substance” or "affinity between the holding portion and the bone healing promoting substance”.
  • the holding portion since the holding portion has a porous structure capable of accommodating the bone healing promoting substance, it is possible to stably hold the bone healing promoting substance. Further, by adopting the configuration as described in [2] above, when the bone healing promoting substance is liquid, the holding portion and the bone healing promoting substance are brought into contact with each other so that the holding portion absorbs the bone healing promoting substance. By a simple method, the bone healing promoting substance can be retained in the holding portion.
  • nanoscale uneven structure does not need to have periodicity as described later.
  • uneven structure having no periodicity for example, a structure composed of random point-shaped unevenness can be mentioned.
  • bone includes the bones of animals such as dogs, cats, and birds, and the bones of humans.
  • the holding portion is arranged at a portion corresponding to the damaged portion of the damaged bone (bone assuming treatment), that is, a portion to be brought into contact with the damaged portion.
  • the "bone healing promoting substance” in the present specification means a physiologically active substance related to promoting bone healing.
  • the bone healing promoting substance may be a pure substance or a mixture.
  • Bone healing-promoting substances may also be used in combination with other substances such as substances for dissolving or dispersing bone healing-promoting substances, substances for assisting the promotion of bone healing, and substances for suppressing alteration of bone healing-promoting substances. Good.
  • the "retaining portion" in the present specification refers to a part of a bone treatment sheet having a structure that easily retains a bone healing promoting substance from some viewpoint (for example, from the viewpoint of surface structure and affinity).
  • the holding portion may be one that holds the bone healing promoting substance inside, or may be one that holds the bone healing promoting substance on the surface.
  • porous structure capable of accommodating a bone healing promoting substance examples include a sponge-like structure and a structure containing a large amount of inorganic substances having pores.
  • the bone treatment sheet according to the present invention may be left in the body even after the bone is healed, or may be removed from the body after the bone is healed.
  • the holding portion contains a scaffolding material that serves as a scaffold for bone healing.
  • the holding portion serves as a scaffold for reconstructing the surface structure of the bone as it is, and it is possible to achieve early healing and strength improvement of the bone.
  • the bone treatment sheet of the present invention it is preferable to further have a scaffolding material-containing portion containing a scaffolding material that serves as a scaffolding for bone healing.
  • the scaffolding material-containing portion serves as a scaffold for reconstructing the surface structure of the bone, and it is possible to achieve early healing and strength improvement of the bone.
  • the scaffolding material-containing portion can be particularly preferably used when the holding portion does not contain the scaffolding material.
  • the scaffolding material-containing portion may or may not have the ability to retain the bone healing promoting substance.
  • the holding portion is configured to be able to penetrate the inside of the damaged portion when placed on the damaged bone.
  • the holding portion has a protruding portion corresponding to the damaged portion.
  • the "protruding portion in the holding portion” in the present specification means a portion of the holding portion that protrudes in the thickness direction of the bone treatment sheet.
  • the holding portion holds the bone healing promoting substance.
  • the bone treatment sheet in which the bone healing promoting substance is held in the holding portion is preferably stored in an environment (for example, a low temperature environment) in which deterioration of the bone healing promoting substance can be suppressed. Further, although it depends on the constituent materials of the bone treatment sheet and the type of the bone healing promoting substance, the bone treatment sheet is dried or frozen in a state where the bone healing promoting substance is held in the holding portion. May be possible for long-term storage.
  • the holding portion holds at least one of bone formation factors, platelet-rich plasmas and blood vessel increasing factors as a bone healing promoting substance.
  • bone formation factors, platelet-rich plasmas, and blood vessel-increasing factors are substances that are highly related to bone healing, it is possible to further promote bone healing by adopting the above configuration. ..
  • the "bone-forming factors” in the present specification refer to proteins and polypeptides used for signal transduction in the living body, which can promote bone formation.
  • platelet-rich plasma refers to a blood-derived substance that is obtained by centrifugation of blood and is rich in growth factors and the like.
  • blood vessel increasing factor refers to a protein or polypeptide used for signal transduction in a living body that can promote the formation of blood vessels or granulation tissue. Since bone healing in the living body proceeds integrally with healing of living tissue in the vicinity of the injured site, promotion of angioplasty and the like by angiogenic factors is considered to indirectly promote bone healing.
  • the holding portion holds platelet-rich plasma (Platelet-Rich Plasma) as the bone healing promoting substance.
  • the "platelet-rich plasma” in the present specification is obtained by centrifuging blood and collecting plasma having a specific gravity within a predetermined range, and is plasma containing a large amount of platelets.
  • the bone treatment sheet of the present invention preferably has biodegradability.
  • the bone treatment sheet can be absorbed without performing surgery for taking out the bone treatment sheet. Is possible.
  • biodegradable refers to the property that at least a part of the substance is decomposed in the living body so that it can be absorbed by the living body and the structure is different from the original structure when left in the living body. In the bone treatment sheet of the present invention, only a part thereof may be decomposed in the living body. Further, in the present specification, “biodegradability” is a concept including the property of forming biological tissues (for example, bones and blood vessels) based on the shape of the original structure, so-called “absorption-replacement property”. Use.
  • the bone treatment sheet of the present invention is a bone treatment sheet for use in bone treatment by arranging the bone treatment sheet on the outer surface of the damaged portion, and at least a portion corresponding to the damaged portion. It is characterized in that a nano-periodic structure composed of a nano-scale concavo-convex structure having periodicity is partially formed.
  • the bone treatment sheet of [8] above since the nano-periodic structure is formed in at least a part of the portion corresponding to the damaged portion, the nano-periodic structure is brought into contact with the damaged portion of the bone or a portion in the vicinity thereof. By using this, it becomes possible to promote the proliferation and differentiation of bone cells (particularly osteoblasts). Therefore, according to the bone treatment sheet of the above [8], it is possible to increase the strength of the bone by firmly fixing the bone treatment sheet and the bone at an early stage. Further, according to the bone treatment sheet of the above [8], it is possible to enhance the healing power of the bone itself because it promotes the proliferation and differentiation of cells. Therefore, the bone treatment sheet of the above [8] is a bone treatment sheet capable of promoting bone healing as compared with the conventional sheet.
  • nano-periodic structure in the bone treatment sheet of the present invention will be described.
  • the inventors of the present invention have focused on a nanoscale structure in which the same structure repeats at regular intervals, that is, a “nanoperiodic structure which is a nanoscale uneven structure having periodicity”. I came.
  • the bone marrow stromal cells when bone marrow stromal cells are cultured on the surface of the substrate by forming a normalized nanostructure (nano-periodic structure) on the surface of the substrate, the bone marrow stromal cells can be proliferated along the direction in which the grooves are continuous. It has been confirmed by experiments conducted by the inventors of the present invention that it is possible.
  • the "location corresponding to the damaged portion” means a portion that should be brought into contact with the damaged portion of the damaged bone (bone that is supposed to be treated) when the bone treatment sheet is used.
  • the “nanoscale” means a size (a size of about 1 nm to 1000 nm) that is appropriate to be expressed in nanometer units.
  • the “nanoscale concavo-convex structure” means that any of the basic units of the structure, such as the width, height, and diameter of the concavo-convex, is within the range of 1 nm to 1000 nm. Therefore, the “nano-periodic structure” in the present specification means a nano-scale periodic structure in which the period of the unevenness of the nano-scale uneven structure is in the range of 1 nm to 1000 nm.
  • the nanoperiodic structure preferably has an uneven width, height, and diameter in the range of 20 nm to 600 nm, and a period in the range of 20 nm to 600 nm. Further, it is more preferable that the width, height and diameter of the unevenness are in the range of 50 nm to 500 nm and the period is in the range of 50 nm to 500 nm. Further, it is more preferable that the width, height and diameter of the unevenness are in the range of 80 nm to 300 nm and the period is in the range of 80 nm to 300 nm. Further, it is more preferable that the width, height and diameter of the unevenness are in the range of 100 nm to 200 nm and the period is in the range of 100 nm to 200 nm.
  • the bone treatment sheet of the present invention may have nano-periodic structures at a plurality of independent locations.
  • the bone treatment sheet of the present invention may have a plurality of types of nanoperiodic structures.
  • the bone treatment sheet of the present invention may have a nano-scale uneven structure having no periodicity in addition to the nano-periodic structure.
  • a randomly arranged dot-shaped uneven structure can be mentioned.
  • the nanoperiodic structure is composed of a plurality of band-shaped recesses or a plurality of band-shaped protrusions that do not come into contact with each other.
  • the "belt-shaped recess” means a recess that is continuous without branching when viewed in a plan view.
  • the band-shaped recess can also be expressed as a groove-shaped structure.
  • the "belt-shaped convex portion” means a continuous convex portion without branching when viewed in a plan view.
  • the band-shaped convex portion can also be expressed as a ridge-shaped structure. Whether a certain structure is composed of concave portions or convex portions is mainly a matter of how to set the reference height. Therefore, in reality, it can be said that the nanoperiodic structure is composed of a plurality of band-shaped concave portions and at the same time is composed of a plurality of band-shaped convex portions (see the eleventh embodiment described later).
  • not in contact with each other means that the band-shaped concave portions do not intersect or merge with each other with respect to the plurality of band-shaped concave portions, and the band-shaped convex portions intersect with each other with respect to the plurality of band-shaped convex portions. It means not to join.
  • the nanoperiodic structure often looks like a stripe when viewed in a plan view (see FIG. 16C described later).
  • the bone treatment sheet of the present invention is provided with a caution indication indicating the position where the nanoperiodic structure is formed.
  • the caution display for displaying the position it is possible to clarify the position where the nanoperiodic structure is formed by colors, patterns, figures, characters, three-dimensional shapes, and the like.
  • the caution indication may be attached to the place where the nano-periodic structure is formed, or may be attached to the place where the nano-periodic structure is not formed. Further, the caution indication may be attached to all the places where the nano-periodic structure is formed or the places where the nano-periodic structure is not formed, or may be attached only to a part of the place.
  • the main structure constituting the main shape of the bone treatment sheet is made of stainless steel.
  • Such a bone treatment sheet has an excellent balance between strength and cost as compared with a bone treatment sheet made of other materials that can be used in vivo, and can actively promote bone healing. It becomes a treatment sheet.
  • the "main structure” in the present specification refers to a structure that constitutes the main shape (sheet-like shape) of the bone treatment sheet.
  • the "main structure constituting the main shape” means the main structure constituting the main shape. It can be said that the main structure of the bone treatment sheet is a structure that bears the mechanical strength of the bone treatment sheet.
  • stainless steel include medical (low nickel) SUS316 series stainless steel.
  • the main structure constituting the main shape of the bone treatment sheet is made of magnesium or a magnesium alloy.
  • Some magnesium and magnesium alloys have the property of being easily decomposed and absorbed in the human body. Therefore, the above-mentioned bone treatment sheet has sufficient initial strength, can be expected to be decomposed and absorbed by the living body, and can positively promote bone healing. It becomes.
  • Magnesium alloy is an alloy of magnesium and elements other than magnesium.
  • Examples of magnesium alloys that can be suitably used in the present invention include Mg—Ca—Zn-based alloys.
  • the main structure constituting the main shape of the bone treatment sheet is made of titanium or a titanium alloy.
  • Such a bone treatment sheet is a bone treatment sheet that has high strength and low toxicity, and can actively promote bone healing.
  • the main structure constituting the main shape of the bone treatment sheet is made of a non-metallic material containing collagen as a main component.
  • Such a bone treatment sheet is a bone treatment sheet that can be expected to be rapidly decomposed and absorbed by the living body and can actively promote bone healing.
  • the "main component" in the constituent material means the component having the largest mass ratio among the components constituting the constituent material. However, when determining which component is the main component of the constituent material, water is excluded from the components of the constituent material for evaluation.
  • non-metallic material means a material that does not contain a substance having metallic properties as a main component. Therefore, the non-metallic material may contain a component containing a metallic element.
  • type I collagen molecule and type II collagen molecule can be used.
  • V-type, XI-type, IX-type, XII-type, and XIV-type collagen molecules can also be used.
  • the non-metal material according to the above [20] does not contain unintended impurities (heavy metals and the like) as much as possible.
  • the non-metallic material may contain a component or the like that contributes to promotion of bone healing or the like.
  • the main structure of the bone treatment sheet is made of a non-metallic material containing collagen as a main component, it is sufficient that a nanoperiodic structure is formed on the surface of the bone treatment sheet when it is brought into contact with the bone.
  • the main structure constituting the main shape of the bone treatment sheet is made of a non-metallic material containing agarose or cellulose as a main component.
  • the non-metal materials described above do not contain unintended impurities (heavy metals and the like) as much as possible.
  • the non-metallic material may contain a component or the like that contributes to promotion of bone healing or the like.
  • the main structure of the bone treatment sheet is made of a non-metallic material containing agarose or cellulose as a main component, it is sufficient that a nanoperiodic structure is formed on the surface of the bone treatment sheet when it is brought into contact with bone.
  • the bone treatment sheet of the present invention it is preferable to further include a coating film covering at least a part of the main structure.
  • the nanoperiodic structure may be formed only on the surface of the main structure or only the surface of the coating film, or the main structure and the coating film. It may be formed on both surfaces of and.
  • the coating film is made of a material that rapidly separates from the main structure in the living body, such as when the coating film is made of a liquid or gel-like substance or is made of a highly water-soluble or biodegradable substance.
  • the nanoperiodic structure may be embedded under the coating film.
  • Examples of materials constituting the coating film include metals, non-metallic inorganic substances (ceramics, etc., particularly those composed of hydroxyapatite and tricalcium phosphate), collagen, agarose, cellulose and synthetic polymer substances, and these. Can be mentioned as a composite material in which the above is combined.
  • a cellulose lactic acid polymer, a lactic acid-glycolic acid polymer, a lactone polymer, a dioxanone polymer and a polyethylene glycol polymer can be preferably used.
  • lactic acid polymers, lactic acid-glycolic acid polymers, lactone-based polymers, dioxanone-based polymers, and polyethylene glycol-based polymers have high biodegradability, and therefore, they are particularly preferably used when it is desired to increase the biodegradability of bone treatment sheets. Can be done.
  • the thickness is preferably in the range of 0.05 ⁇ m to 500 ⁇ m.
  • the thickness of the bone treatment sheet is more preferably in the range of 0.08 ⁇ m to 100 ⁇ m, and even more preferably in the range of 0.1 ⁇ m to 50 ⁇ m.
  • the nano-periodic structure includes a concave portion or a convex portion that intersects the damaged portion when it is arranged on the outer surface of the damaged portion.
  • intersecting the damaged part with respect to the concave portion or the convex portion means that the concave portion or the convex portion straddles the damaged portion of the bone.
  • the "concave or convex portion that intersects the damaged portion when placed on the outer surface of the damaged portion” may include a band-shaped concave portion and a band-shaped convex portion.
  • recesses and protrusions that intersect the damaged area when placed on the outer surface of the damaged area may intersect or merge with each other if they intersect the damaged area of the bone when placed on the outer surface of the damaged area. You may be.
  • body fluids and the like containing substances useful for bone healing can easily reach the damaged part of the bone, so that the healing of the bone can be further promoted.
  • the shape, size, formation position, and number of formations of the "opening that is a through hole” can be appropriately determined according to the shape of the bone to be used for the bone treatment sheet, the state of damage, and the like. For example, when a filler containing a granular bone filling material is used for the damaged part of the bone, the opening having a shape and size that can prevent the bone filling material from spilling out from the opening is formed. It is preferable to use the formed bone treatment sheet.
  • the bone treatment sheet of the present invention preferably has a fixing structure for fixing the bone treatment sheet to the damaged bone.
  • the fixation structure has a structure including an extension portion extending from any part of the bone treatment sheet and a fixing hole through which the extension portion can pass. It is preferable to have.
  • the bone treatment sheet is wrapped around the bone with a simple structure that can be integrally molded with the important part (the part where the nano-periodic structure is formed) of the bone treatment sheet. It is possible to construct a fixed structure that can be used when arranging in this way.
  • a plurality of the fixing holes are formed along the extending direction of the extending portion.
  • the method for treating an animal bone of the present invention includes a preparatory step for preparing the bone treatment sheet according to any one of the above, and the bone treatment sheet so as to cover at least a part of the damaged portion in the damaged bone. Including a placement step of placing on the surface of the damaged bone.
  • animal bone treatment method in this specification does not include the "human bone treatment method”.
  • animal bone treatment method of the present invention is essentially a bone treatment method, substantially the same method as the animal bone treatment method of the present invention is applied to the human bone treatment method. It is also possible.
  • the bone treatment sheet according to any one of the above [2] to [6] is prepared in the preparation step, and bone healing is performed in the placement step. It is preferable that the bone treatment sheet holding the accelerator is placed on the surface of the damaged bone so as to cover at least a part of the damaged part in the damaged bone.
  • the bone treatment method for animals according to [12] uses the bone treatment sheet according to any one of [2] to [6] above, as compared with the conventional method for treating animal bones using a sheet, It is a method of treating bone in animals that can promote bone healing.
  • any method can be used as a method of invading at least a part of the holding portion inside the damaged portion as long as the effect of the invention is not impaired.
  • the bone treatment sheet itself is flexible, simply placing (for example, wrapping) the bone treatment sheet on the bone with appropriate tension will cause the holding part to penetrate inside the damaged area. be able to.
  • an external force for example, pressing or winding a wire or thread
  • the damage is caused. It is possible to reliably penetrate the holding portion into the inside of the portion.
  • a bone treatment sheet having a structure (for example, a protruding portion) corresponding to the damaged part as described in the above [5] is used, the inside of the damaged part is simply placed at an appropriate position. Can invade the holding part.
  • bone fixtures used by attaching to the bone for the treatment of fractures and the like can be widely used.
  • Specific examples of the fixture include screws, pins, wires, staples and plates.
  • the fixture in the present invention may be left in the body after the bone has healed, or may be removed from the body after the bone has healed. Further, after the bone is healed, the bone treatment sheet may be left in the body and the fixture may be removed from the body.
  • the bone treatment sheet according to any one of the above [11] to [13] is prepared in the preparation step, and the bone is prepared in the placement step. It is preferred that the bone treatment sheet be placed on the surface of the damaged bone so that the nanoperiodic structure of the treatment sheet is in contact with the damaged bone.
  • the bone treatment method for animals according to [15] uses the bone treatment sheet according to any one of [11] to [13] above, bone healing is performed as compared with conventional animal bone treatment methods. It is a method of treating animal bone that can be promoted.
  • the damaged bone is a bone with a defect
  • a filler is used in the portion where the defect has occurred between the preparation step and the placement step.
  • the placement step it is preferable to arrange the bone treatment sheet so as to cover at least a part of the portion filled with the filler.
  • the figure shown for demonstrating the bone to be treated (damaged bone B1).
  • FIG. 5 is a cross-sectional view of the bone treatment sheets 7, 8 and 7a according to the tenth embodiment.
  • FIG. 1 is a diagram shown for explaining the bone treatment sheet 1 according to the first embodiment.
  • 1 (a) is a plan view of the bone treatment sheet 1
  • FIG. 1 (b) is a cross-sectional view of A1-A1 of FIG. 1 (a)
  • FIG. 1 (c) is M1 of FIG. 1 (a).
  • FIG. 1 (d) is an enlarged figure which shows the part shown by M2 of FIG. 1 (b).
  • a code is displayed for only one pore P1 and the code is omitted for the other pores P1.
  • FIG. 1 (c) a code is displayed for only one pore P1 and the code is omitted for the other pores P1.
  • FIG. 1D the reference numerals are displayed only for one pore P2, and the reference numerals are omitted for the other pores P2.
  • FIG. 1C and FIG. 1D in order to make the drawing easy to understand, the pores in which the nanoscale uneven structure is formed on the wall surface are designated by P1 and the nanoscale uneven structure is attached. The illustration of itself is omitted.
  • FIG. 2 is a diagram shown for explaining the bone to be treated (damaged bone B1).
  • FIG. 2A is a plan view of the damaged bone B1
  • FIG. 2B is a cross-sectional view taken along the line A2-A2 of FIG. 2A.
  • FIG. 3 is a diagram shown for explaining a bone treatment method according to the first embodiment.
  • FIG. 3 is a diagram shown for explaining a bone treatment method according to the first embodiment.
  • FIG. 3A is a plan view showing a state after performing the arrangement step (described later), and FIG. 3B is a cross-sectional view of FIG. 3A (cross-sectional view corresponding to FIG. 2A).
  • FIG. 3A the cross section of the bone treatment sheet 1, the contour of the bone B1, and the damaged portion D1 are indicated by broken lines in order to make it easy to understand the position of the damaged portion D1 and the like.
  • the bone treatment sheet, the contour of the bone, and the damaged part are indicated by broken lines as necessary.
  • the bone treatment sheet 1 is a bone treatment sheet for use in the treatment of bone B1 by arranging it so as to cover the damaged portion D1 of the damaged bone B1 (see FIG. 3).
  • the bone treatment sheet 1 has a main structure 10 having a sheet-like shape and a holding portion 11 that holds a bone healing promoting substance (see FIG. 1).
  • the holding portion 11 exists at a position corresponding to the damaged portion D1 of the damaged bone B1.
  • the holding portion 11 in the bone treatment sheet 1 is arranged on the entire surface of one side of the main structure 10 (see FIG. 1 (b)).
  • the bone treatment sheet 1 is preferably biodegradable.
  • the “damaged bone” and the “bone to be treated” in the description of one bone treatment sheet are the same, and these bones have the same reference numerals (if the first embodiment).
  • the description and illustration will be given with a reference numeral (B1).
  • the shapes of the bones and injuries described in the drawings are schematic views, and these do not limit the bones and injuries to which the bone treatment sheet and the treatment method of the present invention are applied.
  • the damaged bone B1 bone to be treated
  • the bone treatment sheet 1 according to the first embodiment is a method for treating human bone. It can also be used as a method for treating animal bones. The same applies to each bone treatment sheet described in each embodiment described later.
  • the holding portion 11 has a porous structure capable of accommodating a bone healing promoting substance.
  • a holding portion 11 for example, one having a sponge-like structure can be preferably used.
  • a biodegradable material containing collagen or a composite material of collagen and a non-metallic inorganic substance (ceramic having biocompatibility) as a main component can be preferably used.
  • the holding portion 11 is preferably made of sponge-like collagen or a collagen-non-metallic inorganic substance complex having a porous structure.
  • the collagen constituting the holding portion 11 for example, one containing a type I collagen molecule or a type II collagen molecule as a main component can be used. Further, for example, V-type, XI-type, IX-type, XII-type, and XIV-type collagen molecules can also be used. In addition, when collagen can be used as a material for components other than the holding portion described later, basically, the above collagen can be preferably used.
  • biocompatible non-metallic inorganic substance examples include hydroxyapatite and calcium phosphates (salts of calcium ions such as tricalcium phosphate and octacalcium phosphate and phosphate ions or diphosphate ions). It can.
  • hydroxyapatite and calcium phosphates salts of calcium ions such as tricalcium phosphate and octacalcium phosphate and phosphate ions or diphosphate ions.
  • the above-mentioned hydroxyapatite and calcium phosphates can be preferably used.
  • the holding portion 11 preferably contains a scaffolding material that serves as a scaffolding for bone healing.
  • the holding portion 11 may be entirely composed of a material that also serves as a scaffolding material, or may be composed of a mixture of an essential material as the holding portion and the scaffolding material.
  • the scaffold material particles, powders, and porous bodies made of a biocompatible non-metallic inorganic substance (for example, hydroxyapatite or calcium phosphate) or a composite material of the non-metallic inorganic substance and an organic substance such as collagen are preferable. Can be used for.
  • the holding portion 11 may contain a bone healing promoting substance on its surface by something like a mere uneven structure.
  • Such an uneven structure can be formed not only by surface processing such as cutting, but also by, for example, surface etching (for example, plasma etching).
  • the holding portion 11 holds the bone healing promoting substance.
  • the holding portion 11 does not hold the bone healing promoting substance, it is necessary to have the holding portion 11 hold the bone healing promoting substance before use.
  • the holding portion 11 holds at least one of bone-forming factors, platelet-rich plasmas, and blood vessel-increasing factors as a bone healing promoting substance. It is more preferable that the holding unit 11 holds platelet-rich plasma (Platelet-Rich Plasma). In this case, it is preferable to use platelet-rich plasma obtained from the blood of the subject to be treated.
  • the holding portion 11 may also hold components (solvents, additives, etc.) other than the bone healing promoting substance.
  • bone morphogenetic factors include bone morphogenetic protein-2 (BMP-2), bone morphogenetic protein-4 (BMP-4), bone morphogenetic protein-6 (BMP-6), and bone morphogenetic protein-7 (BMP).
  • BMP-2 bone morphogenetic protein-2
  • BMP-4 bone morphogenetic protein-4
  • BMP-6 bone morphogenetic protein-6
  • BMP-7 bone morphogenetic protein-7
  • TGF- ⁇ transforming growth factor beta
  • FGF fibroblast growth factor
  • IGF-1 insulin-like growth factor
  • osteocalcin can be mentioned.
  • platelet-rich plasmas include platelet-rich plasma (Platelet-Rich Plasma, PRP), PRGF (Plasma Rich in Growth Factors), PRF (Platelet-Rich Fiber), and A-PRF (Advanced Plate). CGF (Concentrated Growth Factors) can be mentioned.
  • the holding portion 11 holds platelet-rich plasma (platelet-rich plasma).
  • BafA Bartonella angular factor A
  • BafA is an angiogenic factor (angiogenic factor) found in pathogens (Bartonella Hensere and Bartonella quintana) classified in the genus Bartonella.
  • a nanoscale uneven structure is formed on at least a part of the wall surface of the pore P1 in the holding portion 11.
  • the pores P1 in which the nanoscale uneven structure is formed on the wall surface are pores that are open on the surface of the holding portion 11. Since these pores are exposed on the surface, it is relatively easy to later form a nanoscale concavo-convex structure on the wall surface. It is preferable that a nanoscale uneven structure is formed on the wall surface even in the pores that are not directly opened on the surface of the holding portion 11 as shown by the reference numeral P2 in FIG. 1 (d).
  • the nanoscale uneven structure on the wall surface of the pore P1 can be formed by, for example, an appropriate surface treatment (for example, plasma etching). Further, it is considered that the nanoscale uneven structure can be formed depending on the conditions for forming the holding portion (for example, the type of solvent used and the heat treatment conditions). For example, by processing by an isotropic etching processing method including plasma etching, not only the depth direction of the pores (in the case of plasma etching, the irradiation direction of plasma) but also the side of the pores (other than the irradiation direction). (Direction) can also be etched, and a nanoscale concavo-convex structure can be easily formed on the side wall surface of the pores.
  • an appropriate surface treatment for example, plasma etching
  • the nanoscale uneven structure can be formed depending on the conditions for forming the holding portion (for example, the type of solvent used and the heat treatment conditions). For example, by processing by an isotropic etching processing method including plasma etching, not only the depth direction of
  • the main structure 10 may be capable of retaining a bone healing promoting substance.
  • the main structure 10 in the bone treatment sheet 1 may be entirely made of a single material or may be made of a plurality of materials.
  • a structure made of a single-layer thin film can be exemplified.
  • the main structure composed of a plurality of materials include a multi-layer structure and a structure in which a plurality of types of powdery substances are fixed in a mixed state (for example, a powder solidified with a binder). ..
  • any material can be used as long as it is made of a material that can be used in a living body, depending on the intended use.
  • a material containing a biocompatible polymer substance or a non-metallic inorganic substance as a main component can be used.
  • the main structure 10 has biodegradability.
  • the biocompatible polymer substance include collagen, polylactic acid, agarose and cellulose.
  • a composite material of a polymer substance and a non-metallic inorganic substance for example, an artificial bone material composed of a composite of hydroxyapatite and collagen
  • an artificial bone material composed of a composite of hydroxyapatite and collagen can also be used.
  • a material containing a metal as a main component can also be used.
  • a metal for example, magnesium, magnesium alloy, titanium, titanium alloy and stainless steel for medical use can be preferably used.
  • the biodegradability of the bone treatment sheet 1 can be enhanced by making the main structure 10 made of magnesium or a magnesium alloy.
  • magnesium alloys that can be suitably used in the present invention include Mg—Ca—Zn-based alloys.
  • Titanium and titanium alloys are characterized by high strength and low toxicity, and stainless steel is characterized by high strength and low cost.
  • stainless steels that can be suitably used in the present invention include low nickel SUS316 series stainless steels.
  • a coating film may be formed on the surface of the main structure 10. With such a configuration, it has excellent properties (for example, excellent strength, high biocompatibility, ease of production, low production cost, etc.) that are difficult to obtain only with the main structure 10 at a high level. It is possible to obtain the property). Further, by using the coating film, there is a possibility that even a metal having low biocompatibility can be used as a constituent material of the main structure of the bone treatment sheet. Examples of the material of the coating film include metals, non-metallic inorganic substances (particularly hydroxyapatite and calcium phosphates), collagen, agarose, cellulose and synthetic polymer substances, and composite materials combining these.
  • a cellulose lactic acid polymer, a lactic acid-glycolic acid polymer, a lactone polymer, a dioxanone polymer and a polyethylene glycol polymer can be preferably used.
  • lactic acid polymer, lactic acid-glycolic acid polymer, lactone polymer, dioxanone polymer and polyethylene glycol polymer have high biodegradability, they are particularly preferably used when it is desired to increase the biodegradability of the bone treatment sheet 1. be able to.
  • the bone treatment sheet 1 is provided with a caution display indicating the position of the holding portion 11.
  • the caution indication on the bone treatment sheet 1 is made by color (for example, color coding with paint), and specifically, the color is different between the position where the holding portion 11 is present and the position where the holding portion 11 is not present.
  • the front and back sides have different colors.
  • the caution display may be a pattern, a figure, a character, a three-dimensional shape, or the like, in addition to the color.
  • the caution indicator may be attached at a position where the holding portion exists, or conversely, may be attached at a position where the holding portion does not exist. Further, the caution indication may be attached to all the positions where the holding portion exists or the positions where the holding portion does not exist, or may be attached only to a part of the positions.
  • the thickness of the bone treatment sheet 1 depends on the size of the treatment target, but can be, for example, in the range of 0.05 ⁇ m to 50 mm.
  • the thickness of the bone treatment sheet 1 is more preferably in the range of 0.08 ⁇ m to 5 mm, and even more preferably in the range of 0.1 ⁇ m to 3 mm.
  • the thickness of the bone treatment sheet 1 is preferably 100 ⁇ m or less.
  • the animal bone treatment method according to the first embodiment includes a preparatory step for preparing the bone treatment sheet 1 (see FIG. 1) according to the first embodiment and a bone treatment sheet 1 holding a bone healing promoting substance. It includes a placement step (see FIG. 3) of placing on the surface of the injured bone B1 so as to cover at least a portion of the injured site D1 in the injured bone B1.
  • the bone treatment sheet 1 already described is prepared (for example, the purchased or manufactured one is ready to be used (for example, the bone healing promoting substance is held in the holding portion and can be used immediately). Since it is a process of keeping it at hand as a state), detailed explanation and illustration will be omitted.
  • the damaged bone B1 in the first embodiment is a fractured bone, and the damaged portion D1 is a fractured portion due to the fracture (see FIG. 2).
  • Bone B1 has cortical bone Ba and cancellous bone Bb (see FIG. 2B).
  • the bone treatment sheet 1 is wrapped around the surface of the damaged bone B1.
  • an inclusion tool (described later) or an inclusion such as a bioadhesive may be used, if necessary.
  • the bone treatment sheet 1 since the nanoscale uneven structure affects the proliferation and differentiation of cells, the bone is compared with the conventional sheet (sheet in which the nanoscale structure is not formed). It is possible to promote the healing of bones.
  • the bone healing promoting substance held by the holding portion 11 is bone.
  • the bone treatment sheet 1 according to the first embodiment it is possible to enhance the healing power of the bone itself.
  • the bone treatment sheet 1 according to the first embodiment it is possible to firmly fix the bone treatment sheet 1 and the bone B1 at an early stage through cell proliferation and differentiation, and as a result, during the healing period. It is possible to suppress the displacement and expansion of the damaged part of the damaged bone in. Therefore, the bone treatment sheet 1 according to the first embodiment is a bone treatment sheet capable of promoting bone healing as compared with the conventional sheet.
  • the degree of release of the bone healing promoting substance is adjusted to appropriately promote the bone healing. It becomes possible.
  • the holding portion 11 since the holding portion 11 has a porous structure capable of accommodating the bone healing promoting substance, the bone healing promoting substance can be stably held. .. Further, according to the bone treatment sheet 1 according to the first embodiment, when the bone healing promoting substance is in a liquid state, the holding portion 11 and the bone healing promoting substance are brought into contact with each other and the holding portion 11 absorbs the bone healing promoting substance. By a simple method of causing the bone to heal, the bone healing promoting substance can be retained in the holding portion 11.
  • the nanoscale uneven structure formed in the porous structure makes it possible to activate the proliferation and differentiation of cells inside and outside the holding portion 11.
  • the holding portion 11 is biodegradable, a combination of a porous structure and a nanoscale uneven structure is used. Is considered to promote decomposition and replacement of the holding portion 11.
  • the holding portion 11 when the holding portion 11 contains a scaffolding material that serves as a scaffold for bone healing, the holding portion 11 directly serves as a scaffold for reconstructing the surface structure of the bone, and the bone It is possible to achieve early healing and improvement of strength.
  • the bone treatment sheet 1 when the bone healing promoting substance is held in the holding portion 11, it takes time and effort to prepare the bone healing promoting substance separately from the bone treatment sheet 1. It becomes possible to use without.
  • the holding portion 11 is at least one of bone formation factors, platelet-rich plasmas and blood vessel-increasing factors as a bone healing promoting substance, for example, polyplatelets.
  • a bone healing promoting substance for example, polyplatelets.
  • the bone treatment sheet 1 according to the first embodiment since it has biodegradability, even if it is inconvenient to leave the bone treatment sheet 1 in the living body even after healing, it can be taken out. It is possible to absorb the bone treatment sheet 1 without performing surgery or the like.
  • the method for treating an animal bone according to the first embodiment is such that the preparatory step for preparing the bone treatment sheet 1 according to the first embodiment and the bone treatment sheet 1 cover at least a part of the damaged portion D1 in the damaged bone B1. Including a placement step of arranging the damaged bone B1 on the surface (because the bone treatment sheet 1 according to the first embodiment is used), the bone healing is promoted as compared with the conventional animal bone treatment method. It is a possible method of treating animal bones.
  • the animal bone treatment method according to the first embodiment uses the bone treatment sheet 1 according to the first embodiment, it is possible to promote bone healing as compared with the animal bone treatment method using the conventional sheet. It is a possible method of treating animal bones.
  • the bone treatment sheet of the present invention can also be used for a human bone treatment method, substantially the same method as the animal bone treatment method according to the first embodiment is applied to the human bone treatment method. It is also possible to do. This also applies to each embodiment described later.
  • FIG. 4 is a diagram shown for explaining the bone treatment sheet 1a and the bone treatment method according to the second embodiment.
  • FIG. 4A is a plan view showing a state after the arrangement step is performed
  • FIG. 4B is a cross-sectional view of FIG. 4A (cross-sectional view corresponding to FIG. 3B).
  • the bone treatment sheet 1a according to the second embodiment basically has the same configuration as the bone treatment sheet 1 according to the first embodiment, but is smaller than the bone treatment sheet 1 according to the first embodiment. Therefore, in the animal bone treatment method according to the second embodiment, the bone treatment sheet 1a is arranged so as to be placed on the bone B1 instead of being wrapped around the bone B1 in the arrangement step (see FIG. 4).
  • the bone treatment sheet 1a may be originally smaller than the bone treatment sheet 1, but may be a bone treatment sheet 1 cut to an appropriate size.
  • the bone treatment sheet 1a according to the second embodiment is different from that of the bone treatment sheet 1 according to the first embodiment, since it has a holding portion 11, the bone treatment sheet 1a according to the first embodiment is the same as the conventional bone treatment sheet 1 according to the first embodiment. It is a bone treatment sheet that can promote bone healing compared to the sheet. Further, the bone treatment sheet 1a according to the second embodiment has a corresponding effect among the effects of the bone treatment sheet 1 according to the first embodiment.
  • the method for arranging the bone treatment sheet 1a in the placement step is different from the method for treating the bones for animals according to the first embodiment, but the bone treatment sheet 1a according to the second embodiment is used. Therefore, it is an animal bone treatment method capable of promoting bone healing as compared with an animal bone treatment method using a conventional sheet.
  • the embodiment described in the first embodiment can be applied as it is in the second embodiment.
  • FIG. 5 is a diagram shown for explaining a bone treatment method according to the third embodiment.
  • FIG. 5A is a plan view showing a state after the fixing step is performed
  • FIG. 5B is a sectional view taken along line A3-A3 of FIG. 5A.
  • the bone treatment sheet 1a is displayed in a large size while ignoring the pressure and the like caused by the fixture 100. Therefore, in FIG. 5B, a gap is formed between the fixture 100 and the bone B1.
  • the bone treatment sheet 1a and the fixture 100 may be arranged so that a gap is not formed between the fixture 100 and the bone B1.
  • the method for treating animal bones according to the third embodiment is basically the same as the method for treating animal bones according to the second embodiment, but the second embodiment further includes a fixing step after the placement step. It is different from the animal bone treatment method according to the above. Since the preparation step and the placement step in the animal bone treatment method according to the third embodiment are the same steps as the preparation step and the placement step in the animal bone treatment method according to the second embodiment, the description thereof will be omitted. ..
  • the fixing step according to the third embodiment is a step of fixing the bone treatment sheet 1a to the damaged bone B1 by using the fixture 100 (see FIG. 5).
  • the fixture 100 is a plate for bone fixation.
  • a mounting hole (not shown) is formed in the plate-shaped main body 110, and by passing the fastener 120 (for example, a screw for fixing the bone) through the mounting hole, the bone is formed. It can be fixed to B1.
  • the fixture 100 fixes the bone treatment sheet 1a to the bone B1 by applying pressure to the bone treatment sheet 1a.
  • the position where the bone treatment sheet 1a is fixed by the fixture 100 is merely an example.
  • the bone treatment sheet 1a is hidden under the fixture 100, but the bone treatment sheet 1a may be exposed on the outside of the fixture 100.
  • a bone treatment sheet larger than the bone treatment sheet 1a for example, a bone treatment sheet 1 according to the first embodiment, can be used together with the fixture 100.
  • the animal bone treatment method according to the third embodiment is different from the animal bone treatment method according to the second embodiment in that the fixation step is further included after the placement step, but the animal bone treatment method according to the second embodiment. Since the bone treatment sheet 1a is used in the same manner as the method, it is an animal bone treatment method capable of promoting bone healing as compared with the animal bone treatment method using the conventional sheet.
  • the bone treatment sheet 1a is further fixed to the damaged bone B1 by using the fixture 100 after the placement step, the bone treatment sheet It is possible to increase the adhesion between 1a and the bone B1. Further, according to the animal bone treatment method according to the third embodiment, it is possible to suppress the misalignment and peeling of the bone treatment sheet 1a. Furthermore, according to the method for treating animal bones according to the third embodiment, it is possible to increase the strength of bone B1 during healing.
  • the embodiment described in the first or second embodiment can be applied as it is in the third embodiment.
  • FIG. 6 is a view (plan view) shown for explaining the bone to be treated (damaged bone B2).
  • FIG. 7 is a diagram shown for explaining the bone treatment method according to the fourth embodiment.
  • FIG. 7A is a plan view showing a state after the arrangement step is performed
  • FIG. 7B is a sectional view taken along the line A4-A4 of FIG. 7A.
  • the filler S is indicated by a broken line in addition to the contour of the bone B2 and the damaged portion D2. In each drawing described later, the filler is also indicated by a broken line as necessary.
  • the animal bone treatment method according to the fourth embodiment is basically the same as the animal bone treatment method according to the first embodiment, but the animal bone according to the first embodiment is used in that a filler is used. It is different from the case of the treatment method of.
  • the damaged bone B2 in the fourth embodiment is a bone having a defect at the damaged portion D2 (see FIG. 6).
  • the method for treating an animal bone according to the fourth embodiment includes a filling step of filling the inside of the damaged portion D2 with the filler S between the preparation step and the placement step. Further, in the arrangement step in the fourth embodiment, the bone treatment sheet 1 is arranged so as to cover at least a part (all in the fourth embodiment) of the portion filled with the filler S (see FIG. 7).
  • the filler S contains, for example, a granular or block-shaped bone filling material (aggregate).
  • Materials constituting the bone filling material include autologous bone, allogeneic bone, non-metallic inorganic substances (for example, hydroxyapatite and calcium phosphates), polymer substances (for example, collagen), and polymer substances and non-metallic inorganic substances.
  • the filler may contain an additive or the like (for example, a bone healing promoting substance) in addition to the bone filling material.
  • a nanoscale uneven structure or a nanoperiodic structure may be formed on the surface of the bone filling material.
  • the bone treatment sheet 1 may be partially wound around the damaged portion D2 (for example, wound about half a circumference), and then the filling material S may be filled. In this case, in the subsequent placement step, the bone treatment sheet 1 is completely wrapped around the bone B2.
  • the animal bone treatment method according to the fourth embodiment is different from the animal bone treatment method according to the first embodiment in that a filler is used, but is the same as the animal bone treatment method according to the first embodiment. Since the bone treatment sheet 1 is used for the bone treatment sheet 1, it is an animal bone treatment method capable of promoting bone healing as compared with the conventional animal bone treatment method.
  • the animal bone treatment method according to the fourth embodiment it is possible to suppress the spillage of the filler S. Further, according to the animal bone treatment method according to the fourth embodiment, it is possible to promote bone healing from the outside of the defect.
  • the embodiment described in the first or second embodiment can be applied as it is in the fourth embodiment.
  • FIG. 8 is a diagram shown for explaining the bone treatment sheet 2 and the bone treatment method according to the fifth embodiment.
  • FIG. 8 (a) is a cross-sectional view of the bone treatment sheet 2 (cross-sectional view corresponding to FIG. 1 (b))
  • FIG. 8 (b) is a plan view showing a state after performing the arrangement step.
  • 8 (c) is a cross-sectional view of FIG. 8 (b) (a cross-sectional view corresponding to FIG. 7 (b)).
  • the bone treatment sheet 2 according to the fifth embodiment basically has the same configuration as the bone treatment sheet 1 according to the first embodiment, but the bone treatment sheet 1 according to the first embodiment further has a scaffolding material-containing portion. Is different.
  • the bone treatment sheet 2 has a scaffolding material-containing portion 20 containing a scaffolding material that serves as a scaffolding for bone healing (see FIG. 8).
  • the scaffolding material-containing portion 20 is arranged in layers on the surface of the bone treatment sheet 2. Further, the scaffolding material-containing portion 20 is arranged outside the holding portion 11 (the side closer to the center of the bone B2 during use) (see FIGS. 8 (b) and 8 (c)).
  • the scaffolding material-containing portion 20 preferably has a structure that allows the bone healing promoting substance to pass directly or indirectly.
  • the scaffold material particles, powders, and porous bodies made of a biocompatible non-metallic inorganic substance (for example, hydroxyapatite or calcium phosphate) or a composite material of the non-metallic inorganic substance and an organic substance such as collagen are preferable. Can be used for.
  • the bone treatment sheet 2 according to the fifth embodiment is different from the bone treatment sheet 1 according to the first embodiment in that it further has a scaffolding material-containing portion, but since it has a holding portion 11, the bone treatment sheet 1 according to the first embodiment has. Similarly, it becomes a bone treatment sheet capable of promoting bone healing. Further, the bone treatment sheet 2 according to the fifth embodiment has a corresponding effect among the effects of the bone treatment sheet 1 according to the first embodiment.
  • the scaffold material-containing portion 20 containing the scaffold material serving as a scaffold for bone healing is further provided, the scaffold material-containing portion 20 is a scaffold for reconstructing the surface structure of the bone B2. Therefore, it becomes possible to achieve early healing and strength improvement of bone B2.
  • the embodiments described in the first, second, and fourth embodiments can be applied as they are in the fifth embodiment.
  • FIG. 9 is a diagram shown for explaining the bone treatment method according to the sixth embodiment. It can be said that FIG. 9 is a plan view showing a state after the arrangement process is performed.
  • the animal bone treatment method according to the sixth embodiment is basically the same as the animal bone treatment method according to the fourth embodiment, but the holding portion in the bone treatment sheet is inside the damaged portion in the placement step. It differs from the animal bone treatment method according to the fourth embodiment in that at least a part of the above is invaded.
  • the bone treatment sheet 1 according to the sixth embodiment is the same as the bone treatment sheet 1 according to the first embodiment.
  • the bone treatment sheet 1 needs to have a structure that can withstand the placement step (described later) in the sixth embodiment. That is, the holding portion 11 in the first embodiment is configured so that at least a part of the holding portion 11 can enter the inside of the damaged portion D2 when placed on the damaged bone B2. Therefore, in order to avoid breakage during arrangement, the holding portion 11 in the sixth embodiment is preferably made of a material having sufficient flexibility or fluidity. From the above viewpoint, it is preferable that the holding portion 11 is made of sponge-like collagen or a collagen-non-metallic inorganic substance complex having a porous structure.
  • the portion of the bone treatment sheet 1 covering the damaged portion D2 is pressed from the outside.
  • the holding portion can be penetrated into the damaged portion.
  • inward pressure such as by wrapping a wire or thread (not shown) around the portion where the bone treatment sheet 1 covers the damaged portion D2, the holding portion penetrates into the damaged portion. Can be made to.
  • the bone treatment sheet 1 according to the sixth embodiment Since the bone treatment sheet 1 according to the sixth embodiment has the holding portion 11, it is a bone treatment sheet capable of promoting bone healing like the bone treatment sheet 1 according to the first embodiment. Further, the bone treatment sheet 1 according to the sixth embodiment has a corresponding effect among the effects of the bone treatment sheet 1 according to the first embodiment.
  • the holding portion 11 since at least a part of the holding portion 11 is configured to be able to enter the inside of the damaged portion D2 when placed on the damaged bone B2, the holding portion 11 is held.
  • the bone healing promoting substance held in the portion 11 can be introduced into the damaged portion D2.
  • the animal bone treatment method according to the sixth embodiment is different from the animal bone treatment method according to the fourth embodiment in that at least a part of the holding portion of the bone treatment sheet is invaded inside the damaged portion in the placement step.
  • the bone treatment sheet 1 is used in the same manner as the animal bone treatment method according to the fourth embodiment, the animal can promote bone healing as compared with the conventional animal bone treatment method. It is a bone treatment method.
  • a part of the holding portion 11 in the bone treatment sheet 1 is allowed to penetrate into the damaged portion D2, so that the holding portion 11 is held. It becomes possible to introduce the bone healing promoting substance in the state of being in the damaged part D2.
  • the embodiments described in the first, second, and fourth embodiments can be applied as they are in the sixth embodiment.
  • FIG. 10 is a diagram shown for explaining the bone treatment sheet 3 and the bone treatment method according to the seventh embodiment.
  • 10 (a) is a plan view of the bone treatment sheet 3
  • FIG. 10 (b) is a sectional view taken along the line A5-A5 of FIG. 10 (a)
  • FIG. It is a top view which shows.
  • the bone treatment sheet 3 according to the seventh embodiment basically has the same configuration as the bone treatment sheet 1 according to the first embodiment, but the bone treatment sheet 1 according to the first embodiment has a holding portion having a protruding portion. Is different.
  • the holding portion 31 in the bone treatment sheet 3 has a protruding portion 32 corresponding to the damaged portion D2 (see FIGS. 10 (a) and 10 (b)).
  • the protruding portion 32 can also be said to be a portion where the holding portion 31 is locally thickened.
  • the holding portion 31 has the same configuration as the holding portion 11 in the first embodiment except that it has a protruding portion 32.
  • the animal bone treatment method according to the seventh embodiment is basically the same as the animal bone treatment method according to the fourth embodiment, but in the placement step, the bone treatment sheet is placed inside the damaged portion. It differs from the animal bone treatment method according to the fourth embodiment in that at least a part of the holding portion is invaded.
  • the bone treatment sheet 3 is wrapped around the bone B2 so that the protruding portion 32 of the bone treatment sheet 3 enters the damaged portion D2. Since the bone treatment sheet 3 has a protruding portion 32, pressing or winding a wire or the like is not essential in the arrangement step in the seventh embodiment.
  • the bone treatment sheet 3 according to the seventh embodiment is different from the bone treatment sheet 1 according to the first embodiment in that the holding portion has a protruding portion, but since it has the holding portion 31, the bone treatment sheet 1 according to the first embodiment. Similarly, it becomes a bone treatment sheet capable of promoting bone healing. Further, the bone treatment sheet 1 according to the seventh embodiment has a corresponding effect among the effects of the bone treatment sheet 1 according to the first embodiment.
  • the holding portion 31 since at least a part of the holding portion 31 is configured to be able to enter the inside of the damaged portion D2 when placed on the damaged bone B2, the holding portion 31 is held.
  • the bone healing promoting substance held in the portion 31 can be introduced into the damaged portion D2.
  • the holding portion 31 since the holding portion 31 has a protruding portion 32 corresponding to the damaged portion D2, the bone healing promoting substance in the state of being held by the holding portion 31 is transferred to the damaged portion D2. It is possible to make it easier to introduce inside.
  • the animal bone treatment method according to the seventh embodiment is different from the animal bone treatment method according to the fourth embodiment in that at least a part of the holding portion of the bone treatment sheet is invaded inside the damaged portion in the placement step.
  • the bone treatment sheet 4 since the bone treatment sheet 4 is used, it is an animal bone treatment method capable of promoting bone healing as compared with the conventional animal bone treatment method.
  • a part of the holding portion 31 in the bone treatment sheet 1 is invaded inside the damaged portion D2, so that the holding portion 31 heals the bone. It is possible to introduce the bone healing promoting substance into the damaged part D2 while retaining the promoting substance.
  • the embodiments described in the first, second, and fourth embodiments can be applied as they are in the seventh embodiment.
  • FIG. 11 is a diagram shown for explaining the bone treatment sheet 4 according to the eighth embodiment.
  • 11 (a) is a plan view of the bone treatment sheet 4
  • FIG. 11 (b) is a cross-sectional view taken along the line A6-A6 of FIG. 11 (a).
  • FIG. 11 and FIG. 12 which will be described later, the reference numerals are displayed only in one opening 40, and the reference numerals are omitted for the other openings 40.
  • FIG. 12 is a diagram shown for explaining a method of treating bone according to the eighth embodiment. 12 (a) is a plan view showing a state after carrying out the arrangement step, and FIG. 12 (b) is a sectional view taken along the line A7-A7 of FIG. 12 (a).
  • the bone treatment sheet 4 according to the eighth embodiment basically has the same configuration as the bone treatment sheet 1 according to the first embodiment, but the first embodiment is in that an opening 40 which is a through hole is formed. It is different from the bone treatment sheet 1 (see FIGS. 11 and 12).
  • the opening 40 in the bone treatment sheet 4 has a square shape (square shape) when viewed in a plan view.
  • the number, size and shape of the openings 40 can be arbitrarily determined according to various circumstances.
  • the size of the opening 40 can be determined according to the size and shape of the bone filling material contained in the filler S.
  • the maximum width of the opening 40 can be set to about 0.5 mm in order to suppress the outflow of the bone filling material.
  • the distance between the openings 40 in this case can be, for example, about 1 mm to 1.25 mm.
  • the bone treatment sheet 4 according to the eighth embodiment is different from the bone treatment sheet 1 according to the first embodiment in that an opening 40 is formed, but has a holding portion 11, so that the bone treatment sheet 4 according to the first embodiment has a holding portion 11. Similar to No. 1, it becomes a bone treatment sheet capable of promoting bone healing. Further, the bone treatment sheet 4 according to the eighth embodiment has a corresponding effect among the effects of the bone treatment sheet 1 according to the first embodiment.
  • the bone treatment sheet 4 according to the eighth embodiment it is possible to make it easier for a body fluid or the like containing a substance useful for bone healing to reach the damaged portion D2 of the bone B2.
  • the embodiments described in the first, second, and fourth embodiments can be applied as they are in the eighth embodiment.
  • FIG. 13 is a diagram shown for explaining the bone treatment sheet 5 according to the ninth embodiment.
  • 13 (a) is a plan view of the bone treatment sheet 5
  • FIG. 13 (b) is a cross-sectional view taken along the line A8-A8 of FIG. 13 (a).
  • the reference numerals are displayed only in one fixing hole 52 per group (one row), and the reference numerals are omitted for the other fixing holes 52.
  • FIG. 14 is a diagram shown for explaining a method of treating bone according to the ninth embodiment.
  • 14 (a) is a plan view showing a state after carrying out the arrangement step
  • FIG. 14 (b) is a cross-sectional view taken along the line A9-A9 of FIG. 14 (a).
  • the bone treatment sheet 5 according to the ninth embodiment basically has the same configuration as the bone treatment sheet 1 according to the first embodiment, but has a fixing structure for fixing the bone treatment sheet 5 to the damaged bone B2. It differs from the bone treatment sheet 1 according to the first embodiment in that it (see FIG. 14).
  • the fixation structure in the ninth embodiment includes an extension portion 50 extending from any part of the bone treatment sheet 5 and a fixing hole 52 through which the extension portion 50 can pass.
  • the extending portion 50 extends from the end of the holding portion 11, and the fixing hole 52 is formed near the end opposite to the end on which the extending portion 50 extends.
  • the holding portion 11 is not arranged in the extending portion 50.
  • the holding portion 11 may also be arranged on the extending portion 50.
  • a plurality of fixing holes 52 are formed so as to line up along the extending direction of the corresponding extending portion 50.
  • the extension portion 50 is pulled out from the fixing hole 52 and passed through, and then the extension portion 50 is folded back to form the bone B2.
  • the bone treatment sheet 5 can be fixed.
  • the extending portion 50 may be cut so as to have an appropriate length after being folded back.
  • the bone treatment sheet 5 according to the ninth embodiment is different from the bone treatment sheet 1 according to the first embodiment in that it has a fixed structure, but since it has a holding portion 11, it is similar to the bone treatment sheet 1 according to the first embodiment. , It becomes a bone treatment sheet that can promote bone healing. Further, the bone treatment sheet 5 according to the ninth embodiment has a corresponding effect among the effects of the bone treatment sheet 1 according to the first embodiment.
  • the bone treatment sheet 5 since the bone treatment sheet 5 has a fixing structure for fixing the bone treatment sheet 5 to the damaged bone B2, a member (fixing tool or the like) for fixing the bone treatment sheet 5 is provided. It is not necessary to separately prepare the bone treatment sheet 5, and it is possible to reduce the time and effort required to fix the bone treatment sheet 5 to the bone B2.
  • the embodiments described in the first, second, and fourth embodiments can be applied as they are in the ninth embodiment.
  • FIG. 15 is a cross-sectional view of the bone treatment sheets 7, 8 and 7a according to the tenth embodiment.
  • 15 (a) is a cross-sectional view of the bone treatment sheet 7
  • FIG. 15 (b) is a cross-sectional view of the bone treatment sheet 8
  • FIG. 15 (c) is a cross-sectional view of the bone treatment sheet 7a.
  • 15 (a) to 15 (c) are cross-sectional views corresponding to FIG. 1 (b).
  • the bone treatment sheets 7 and 8 according to the tenth embodiment basically have the same configuration as the bone treatment sheet 1 according to the first embodiment, but the holding portion also serves as the main structure at least in part (from only the holding portion). It is different from the bone treatment sheet 1 according to the first embodiment in that (there is a portion).
  • the entire bone treatment sheet 7 is composed of the holding portion 81 (see FIG. 15A).
  • the holding portion 91 also serves as the main structure near the center of the bone treatment sheet 8, and the main structure 90 (having the same structure as the main structure 10 in the first embodiment) is the holding portion 91. It is arranged on the outside (see FIG. 15B).
  • the holding portions 81 and 91 are required to have higher strength than the holding portions 11 in the first embodiment.
  • the bone treatment sheet 7a according to the tenth embodiment has the scaffolding material-containing portion 20 like the bone treatment sheet 2 according to the fifth embodiment (see FIG. 15C).
  • the bone treatment sheets 7 and 8 according to the eleventh embodiment may have the same additional features as the bone treatment sheets having the holding portion and the main structure described above.
  • the bone treatment sheets 7, 8 and 7a according to the tenth embodiment are different from the bone treatment sheet 1 according to the first embodiment in that the holding portion also serves as the main structure in at least a part, but have the holding portions 81 and 91. Similar to the bone treatment sheet 1 according to the first embodiment, the bone treatment sheet is capable of promoting bone healing. Further, the bone treatment sheets 7, 8 and 7a according to the tenth embodiment also have the corresponding effects among the effects of the bone treatment sheet 1 according to the first embodiment.
  • the embodiment described in the first or fifth embodiment can be applied as it is in the tenth embodiment.
  • FIG. 16 is a diagram shown for explaining the bone treatment sheet 201 according to the eleventh embodiment.
  • 16 (a) is a plan view of the bone treatment sheet 201
  • FIG. 16 (b) is a sectional view taken along line A15-A15 of FIG. 16 (a)
  • FIG. 16 (c) is A14 of FIG. 16 (a).
  • FIG. 16 (d) is an enlarged figure which shows the part shown by A16 of FIG. 16 (b).
  • the double-headed arrow in FIG. 16A indicates the direction in which the plurality of strip-shaped concave portions S1 or the plurality of strip-shaped convex portions S2 in the nanoperiodic structure are continuous.
  • the double-headed arrow in the figure described later is the same as the double-headed arrow in FIG. 16A.
  • FIG. 17 is a diagram shown for explaining a bone treatment method according to the eleventh embodiment.
  • FIG. 17A is a plan view showing a state after the arrangement step is performed
  • FIG. 17B is a cross-sectional view taken along the line A17-A17 of FIG. 17A.
  • the bone treatment sheet 201 is a bone treatment sheet for use in bone treatment by arranging it on the outer surface of the damaged portion D1 of the damaged bone B1.
  • the bone treatment sheet 201 has a nano-periodic structure having a periodic nano-scale uneven structure formed at a portion corresponding to the damaged portion D1.
  • a nanoperiodic structure is formed on one surface 212 of the main structure 210 that constitutes the main shape of the bone treatment sheet 201. Further, no nanoperiodic structure is formed on the other surface 214 of the bone treatment sheet 201.
  • the nanoperiodic structure of the bone treatment sheet 201 is composed of a plurality of band-shaped recesses S1 that do not come into contact with each other. It can also be said that the nanoperiodic structure is composed of a plurality of strip-shaped convex portions S2 that do not come into contact with each other.
  • the width of the band-shaped concave portion S1 and the band-shaped convex portion S2 and the depth of the band-shaped concave portion S1 are arbitrary values as long as they are nanoscale, depending on the application of the bone treatment sheet 201 and the like. be able to.
  • the nanoperiodic structure in the bone treatment sheet 201 includes a concave portion or a convex portion that intersects the damaged portion D1 when arranged on the outer surface of the damaged portion D1.
  • the strip-shaped concave portion S1 and the strip-shaped convex portion S2 are concave portions and convex portions that intersect with the damaged portion D1 when arranged on the outer surface of the damaged portion D1.
  • the nano-periodic structure can be formed by any method that can form a nano-scale structure. Examples of methods capable of forming a nanoperiodic structure include cutting with a cutting tool or laser, pressing with a die (for example, press molding), and etching with ions or a chemical solution.
  • a caution indication is attached to indicate the position where the nanoperiodic structure is formed.
  • the caution indication on the bone treatment sheet 201 is made by color, and specifically, the color is different between the portion where the nanoperiodic structure is formed (surface 212) and the portion where the nanoperiodic structure is not formed. Note that the caution indication by color can be attached by using, for example, a paint.
  • the nanoperiodic structure is formed on the entire surface 212, the entire surface 212 has a different color from other parts (for example, the surface 214).
  • the thickness of the bone treatment sheet 201 is, for example, in the range of 0.05 ⁇ m to 500 ⁇ m.
  • the main structure 210 constituting the main shape of the bone treatment sheet 201 any material can be used as long as it is made of a material that can be used in vivo.
  • the main structure 210 is preferably made of, for example, stainless steel. It is also preferable that the main structure 210 is made of, for example, magnesium or a magnesium alloy. It is also preferable that the main structure 210 is made of, for example, titanium or a titanium alloy. It is also preferable that the main structure 210 is made of a non-metallic material containing collagen as a main component. Further, it is also preferable that the main structure 210 is made of a non-metallic material containing agarose or cellulose as a main component.
  • the bone treatment method according to the eleventh embodiment is an animal bone treatment method, the same method can be applied to a human bone treatment method.
  • the method for treating bone according to the eleventh embodiment includes a preparatory step for preparing the bone treatment sheet 201 according to the eleventh embodiment and the bone treatment sheet 201 so that the nanoperiodic structure of the bone treatment sheet 201 comes into contact with the bone B1 to be treated. Includes a placement step (see FIG. 17) of placing the bone B1 to be treated.
  • the bone treatment sheet 201 is placed on the surface of the bone B1 to be treated so that the nanoperiodic structure of the bone treatment sheet 201 is in contact with the bone B1 to be treated. Since the nanoperiodic structure of the bone treatment sheet 201 is formed on the surface 212, the surface 212 is brought into contact with the bone B1 to be treated.
  • the size may be just right by cutting the bone treatment sheet 201 or the like.
  • the bone treatment sheet 201 is arranged so as to wrap around the bone B1 exactly once, but the present invention is not limited to this.
  • the bone treatment sheet 201 may be placed so as to cover only a part of the periphery of the bone B1.
  • the bone treatment sheet 201 can be fixed to the bone by any means.
  • the fixing may be performed by using a fixture such as a screw or a wire, or may be performed by using an inclusion such as an adhesive. Further, when a sufficient fixing force can be obtained only by arranging the bone treatment sheet 201, it is not necessary to use a fixture or inclusions.
  • the bone treatment sheet 201 according to the eleventh embodiment since the nanoscale uneven structure affects the proliferation and differentiation of cells, the bone is compared with the conventional sheet (the sheet on which the nanoscale structure is not formed). It is possible to promote the healing of bones.
  • the bone treatment sheet 201 according to the eleventh embodiment since the nano-periodic structure is formed at the portion corresponding to the damaged portion D1, the nano-periodic structure is brought into contact with the damaged portion D1 of the bone B1 or a portion in the vicinity thereof. By using this, it becomes possible to promote the proliferation and differentiation of bone cells (particularly osteoblasts). Therefore, according to the bone treatment sheet 201 according to the eleventh embodiment, the strength of the bone B1 can be increased by firmly fixing the bone treatment sheet 201 and the bone B1 at an early stage. Further, according to the bone treatment sheet 201 according to the eleventh embodiment, it is possible to enhance the healing power of the bone B1 itself because it promotes the proliferation and differentiation of cells. Therefore, the bone treatment sheet 201 according to the twelfth embodiment is a bone treatment sheet capable of promoting healing of bone B1 as compared with the conventional sheet.
  • the nanoperiodic structure is composed of a plurality of band-shaped recesses S1 or a plurality of band-shaped protrusions S2 that do not contact each other, cell proliferation and differentiation occur in the band-shaped recesses S1 and the band-shaped recesses S1. It becomes possible to control so that it occurs along the convex portion S2, and it becomes possible to control the direction of healing.
  • the bone treatment sheet 201 according to the eleventh embodiment since the caution indication indicating the position where the nano-periodic structure is formed is attached, it becomes easy to grasp the position where the nano-periodic structure is formed. , It is possible to suppress placement mistakes during use.
  • the bone treatment sheet 201 When the main structure of the bone treatment sheet 201 according to the eleventh embodiment is made of stainless steel, the bone treatment sheet 201 has a balance between strength and cost as compared with the bone treatment sheet made of other materials that can be used in vivo. It is an excellent bone treatment sheet that can positively promote the healing of bone B1.
  • the bone treatment sheet 201 When the main structure of the bone treatment sheet 201 according to the eleventh embodiment is made of magnesium or a magnesium alloy, the bone treatment sheet 201 has sufficient initial strength and can be expected to be decomposed and absorbed by a living body. , It becomes a bone treatment sheet capable of positively promoting the healing of bone B1.
  • the bone treatment sheet 201 When the main structure of the bone treatment sheet 201 according to the eleventh embodiment is made of titanium or a titanium alloy, the bone treatment sheet 201 has high strength and low toxicity, and can heal bone B1. It is a bone treatment sheet that can be actively promoted.
  • the bone treatment sheet 201 can be expected to be rapidly decomposed and absorbed by the living body, and can be expected to be rapidly decomposed and absorbed. It is a bone treatment sheet that can positively promote the healing of bone B1.
  • the main structure of the bone treatment sheet 201 according to the eleventh embodiment is made of a non-metallic material containing agarose or cellulose as a main component, it is made of a naturally occurring material that is not harmful to the living body and can heal bone B1. It is a bone treatment sheet that can be actively promoted.
  • the thickness is in the range of 0.05 ⁇ m to 500 ⁇ m, it is possible to sufficiently secure the strength and sufficiently secure the bendability. It is also possible to do.
  • the nanoperiodic structure includes a concave portion or a convex portion that intersects the damaged portion D1 when arranged on the outer surface of the damaged portion D1, the damaged portion of the bone B1 is included. It is considered that it becomes possible to promote the proliferation and differentiation of cells so as to fill D1, and as a result, it becomes possible to quickly heal the damage of bone B1.
  • the method for treating an animal bone according to the eleventh embodiment includes a preparatory step for preparing the bone treatment sheet 201 and a treatment target for the bone treatment sheet 201 so that the nanoperiodic structure of the bone treatment sheet 201 is in contact with the bone to be treated. Since it includes an arrangement step of arranging the bone B1 on the surface, it is an animal bone treatment method capable of promoting bone healing as compared with a conventional animal bone treatment method.
  • the bone treatment method according to the eleventh embodiment can also be applied to a human bone treatment method.
  • FIG. 18 is a diagram shown for explaining a method of treating bone according to the twelfth embodiment.
  • FIG. 18A is a plan view showing a state after performing the arrangement step
  • FIG. 18B is a cross-sectional view taken along the line A18-A18 of FIG. 18A.
  • the bone treatment method according to the twelfth embodiment is basically the same as the bone treatment method according to the eleventh embodiment, but the damage to the bone to be treated is different from the case of the bone treatment method according to the embodiment. ..
  • the bone B2 to be treated is a defective bone
  • the defective portion is the damaged portion D2.
  • the bone treatment method according to the twelfth embodiment further includes a filling step of filling the defective portion (damaged portion D2) with the filler S between the preparation step and the placement step, and the placement step includes a filling step.
  • the bone treatment sheet 201 is arranged so as to be in contact with the bone B2 to be treated and to cover the portion filled with the filler S.
  • the filler S the same filler as that described in the fourth embodiment can be used.
  • the bone treatment sheet 201 may be arranged so as to be partially wound (for example, wound about half a circumference) in the vicinity of the portion where the bone B1 is defective, and then the filling material S may be filled. In this case, the bone treatment sheet 201 is completely wrapped around the bone B in the placement step so as to be in the state shown in FIG.
  • the bone treatment method according to the twelfth embodiment is different from the case where the bone to be treated is the bone treatment method according to the eleventh embodiment, but the bone treatment method according to the twelfth embodiment prepares the bone treatment sheet 201.
  • the bone according to embodiment 12 includes a preparatory step and an arrangement step of arranging the bone treatment sheet 201 on the surface of the bone B2 to be treated so that the nanoperiodic structure of the bone treatment sheet 201 is in contact with the bone B2 to be treated. Similar to the treatment method of the above, it is a bone treatment method capable of promoting bone healing as compared with the conventional bone treatment method.
  • the bone treatment method according to the twelfth embodiment can also be applied to both the animal bone treatment method and the human bone treatment method.
  • the bone B2 to be treated is a bone having a defect, and the portion where the defect has occurred (damaged portion D2) between the preparation step and the placement step.
  • the bone treatment sheet 201 is placed so as to be in contact with the bone B2 to be treated and to cover the portion filled with the filling material S. It is possible to suppress the spillage of the substance constituting the material S, particularly the granular bone filling material.
  • FIG. 19 is a diagram shown for explaining the bone treatment sheet 202 according to the thirteenth embodiment.
  • 19 (a) is a plan view of the bone treatment sheet 202
  • FIG. 19 (b) is a cross-sectional view taken along the line A19-A19 of FIG. 19 (a).
  • the reference numerals are displayed only in one opening 226, and the reference numerals for the other openings 226 are omitted. Further, the number and size of the openings 226 shown in FIGS. 19 and 20 do not necessarily reflect the actual configuration of the bone treatment sheet of the present invention.
  • FIG. 20 is a diagram showing a state in which the bone treatment sheet 202 according to the thirteenth embodiment is fixed to the bone B2.
  • FIG. 20 (a) is a plan view showing a state after performing a step corresponding to the arrangement step in the bone treatment method according to the thirteenth embodiment
  • FIG. 20 (b) is a plan view showing the state after performing the step corresponding to the arrangement step
  • FIG. It is a sectional view.
  • the bone treatment sheet 202 according to the thirteenth embodiment basically has the same configuration as the bone treatment sheet 201 according to the eleventh embodiment, but the eleventh embodiment has an opening 226 which is a through hole. It is different from the bone treatment sheet 201.
  • a nanoperiodic structure is formed on one surface 222 of the main structure 220 that constitutes the main shape of the bone treatment sheet 202. Further, no nanoperiodic structure is formed on the other surface 224 of the bone treatment sheet 202.
  • the main structure 220, one surface 222 and the other surface 224 in the thirteenth embodiment have substantially the same configurations as the main structure 210, one surface 212 and the other surface 214 in the eleventh embodiment, respectively.
  • the opening 226 in the bone treatment sheet 202 has a quadrangular shape when viewed in a plan view.
  • the size of the opening 226 can be arbitrarily determined according to various circumstances, and for example, the size can be set according to the size and shape of the bone filling material contained in the filler S. For example, when the bone filling material has a particle size of 0.5 mm or more, the maximum width of the opening 226 can be set to about 0.5 mm. Further, in this case, the distance between the openings 226 can be, for example, about 1 mm to 1.25 mm.
  • the bone treatment sheet 202 according to the thirteenth embodiment is different from the bone treatment sheet 201 according to the twelfth embodiment in that an opening 226 which is a through hole is formed, but at the damaged portion D2 (the portion where the defect occurs). A nanoperiodic structure is formed at the corresponding location. Therefore, the bone treatment sheet 202 according to the thirteenth embodiment is a bone treatment sheet capable of promoting the healing of the bone B2, similarly to the bone treatment sheet 201 according to the eleventh embodiment.
  • the body fluid or the like containing a substance useful for healing the bone B2 easily reaches the damaged portion D2 of the bone B2, so that the healing of the bone B2 is further promoted. It becomes possible.
  • the bone treatment sheet 202 according to the thirteenth embodiment has substantially the same configuration as the bone treatment sheet 201 according to the eleventh embodiment except that the opening 226 which is a through hole is formed. , Among the effects of the bone treatment sheet 201 according to the eleventh embodiment, it also has a corresponding effect.
  • FIG. 21 is a diagram shown for explaining the bone treatment sheet 203 according to the fourteenth embodiment.
  • 21 (a) is a plan view of the bone treatment sheet 203
  • FIG. 21 (b) is a cross-sectional view taken along the line A21-A21 of FIG. 21 (a).
  • the reference numeral is displayed only in one opening 236, and the indication of the reference numeral for the other opening 236 is omitted.
  • the number and size of the openings 236 shown in FIGS. 21 and 22 do not necessarily reflect the actual configuration of the bone treatment sheet of the present invention.
  • FIG. 22 is a diagram showing a state in which the bone treatment sheet 203 according to the 14th embodiment is fixed to the bone B2.
  • FIG. 22 is a plan view showing a state after performing a step corresponding to the arrangement step in the bone treatment method according to the fourteenth embodiment
  • FIG. 22 (b) is a cross-sectional view taken along the line A22-A22 of FIG. 22 (a). is there.
  • the bone treatment sheet 203 according to the 14th embodiment basically has the same configuration as the bone treatment sheet 202 according to the 13th embodiment, but the shape of the opening is different from the bone treatment sheet 202 according to the 13th embodiment.
  • a nanoperiodic structure is formed on one surface 232 of the main structure 230 that constitutes the main shape of the bone treatment sheet 203. Further, no nanoperiodic structure is formed on the other surface 234 of the bone treatment sheet 203.
  • the main structure 230, one surface 232 and the other surface 234 in embodiment 14 have substantially the same configurations as the main structure 220, one surface 222 and the other surface 224 in embodiment 14, respectively.
  • the opening 236 of the bone treatment sheet 203 has a quadrangular shape when viewed in a plan view, but has a longer and narrower shape than the opening 226 of the bone treatment sheet 202 according to the thirteenth embodiment. It can also be said that the opening 236 has a so-called slit-like shape.
  • the size of the opening 236 can also be arbitrarily determined according to various circumstances, as in the case of the opening 226.
  • the bone treatment sheet 203 according to the 14th embodiment has a different opening shape from the bone treatment sheet 202 according to the 13th embodiment, but a nanoperiodic structure is formed at a portion corresponding to the damaged portion D2 (the portion where the defect has occurred). Has been done. Therefore, the bone treatment sheet 203 according to the 14th embodiment is a bone treatment sheet capable of promoting the healing of the bone B2, similarly to the bone treatment sheet 202 according to the 13th embodiment.
  • the bone treatment sheet 203 according to the 14th embodiment has substantially the same configuration as the bone treatment sheet 202 according to the 13th embodiment except for the shape of the opening, the bone treatment sheet 202 according to the 13th embodiment has. It also has the corresponding effect among the effects.
  • FIG. 23 is a diagram shown for explaining the bone treatment sheet 201a according to the fifteenth embodiment.
  • the code is displayed only in one fixing hole 218 per group, and the display of the code for the other fixing holes 218 is omitted.
  • the number and size of the extending portion 216 and the fixing hole 218 shown in FIGS. 23 and 24 do not necessarily reflect the actual configuration of the bone treatment sheet of the present invention.
  • FIG. 24 is a diagram showing a state in which the bone treatment sheet 201a according to the fifteenth embodiment is fixed to the bone B2.
  • FIG. 24 (a) is a plan view showing a state after performing a step corresponding to the placement step in the bone treatment method according to the fifteenth embodiment
  • FIG. 24 (b) is a plan view showing the state after performing the step corresponding to the arrangement step
  • FIG. It is a sectional view.
  • the bone treatment sheet 201a according to the 15th embodiment basically has the same configuration as the bone treatment sheet 201 according to the 11th embodiment, but the bone treatment sheet 201a is fixed to the damaged bone (bone assuming treatment) B2. It differs from the bone treatment sheet 201 according to the eleventh embodiment in that it has a fixed structure for the treatment.
  • the fixation structure in the fifteenth embodiment is a structure including an extension portion 216 extending from any portion of the bone treatment sheet 201a and a fixing hole 218 through which the extension portion 216 can pass.
  • the extension portion 216 extends from the end portion of the bone treatment sheet 201a, and the fixing hole 218 is formed near the end portion on the side opposite to the side where the extension portion 216 exists.
  • the nano-periodic structure is not formed in the extension portion 216 in the fifteenth embodiment, the nano-periodic structure may also be formed in the extension portion 216. As shown in FIG. 23, a plurality of fixing holes 218 are formed along the extending direction of the extending portion 216.
  • the fixation structure in the fifteenth embodiment is such that the bone treatment sheet 201a is wound around the bone B2 and then passed by pulling out the extension portion 216 from the fixation hole 218, and then the extension portion 216 is passed therethrough.
  • the bone treatment sheet 201a can be fixed to the damaged bone B2 by folding back.
  • the extension portion 216 may be cut so as to have an appropriate length after being folded back.
  • the bone treatment sheet 201a according to the 15th embodiment is different from the bone treatment sheet 201 according to the 12th embodiment in that it has the above-mentioned fixed structure, but the nanocycle is located at a portion corresponding to the damaged portion D2 (the portion where the defect has occurred).
  • the structure is formed. Therefore, the bone treatment sheet 201a according to the 15th embodiment is a bone treatment sheet capable of promoting the healing of the bone B2, similarly to the bone treatment sheet 201 according to the 12th embodiment.
  • the bone treatment sheet 201a since the bone treatment sheet 201a has a fixing structure for fixing the bone treatment sheet 201a to the damaged bone B2, it is necessary to separately prepare a member for fixing the bone treatment sheet 201a. It becomes possible to reduce the labor when fixing the bone treatment sheet 201a to the bone B2.
  • the fixation structure is for fixing that can pass the extension portion 216 extending from any part of the bone treatment sheet 201a and the extension portion 216. Since it has a structure including holes 218, it has a simple structure that can be integrally molded when forming the bone treatment sheet 201a, and is used when the bone treatment sheet 201a is wound around the bone B2. It is possible to construct a fixed structure that can be formed.
  • the bone treatment sheet 201a since a plurality of fixing holes 218 are formed along the extending direction of the extending portion 216, it is possible to correspond to bones of various thicknesses. It will be possible.
  • the bone treatment sheet 201a according to the fifteenth embodiment has substantially the same configuration as the bone treatment sheet 201 according to the eleventh embodiment except that it has a fixed structure
  • the bone treatment sheet 201 according to the eleventh embodiment has a substantially similar structure.
  • the effects of the sheet 201 it also has the corresponding effect.
  • FIG. 25 is a diagram showing a main structure 210 and a coating film 211 in the bone treatment sheet (not shown as a whole) according to the 16th embodiment.
  • FIG. 25 is a diagram corresponding to FIG. 16 (d) (a diagram showing an enlarged portion corresponding to the portion shown by A16 in FIG. 16 (a)).
  • the bone treatment sheet according to the 16th embodiment has basically the same configuration as the bone treatment sheet 201 according to the 11th embodiment, but includes a covering film 211 that covers at least a part of the main structure 210. It is different from the case of the bone treatment sheet 201 according to the above.
  • the covering film 211 may be arranged on the entire bone treatment sheet, or may be arranged only on a part of the bone treatment sheet.
  • the coating film 211 those made of various materials and thicknesses can be used depending on the use of the bone treatment sheet and the like.
  • the bone treatment sheet according to the 16th embodiment is different from the bone treatment sheet 201 according to the 11th embodiment in that it includes a covering film 211, but a nanoperiodic structure is formed at a portion corresponding to the damaged portion. Therefore, the bone treatment sheet according to the 16th embodiment is a bone treatment sheet capable of promoting bone healing, similarly to the bone treatment sheet 201 according to the 11th embodiment.
  • the bone treatment sheet according to the 16th embodiment further includes a covering film 211 that covers at least a part of the main structure 210, it is possible to obtain a bone treatment sheet having properties that are difficult to obtain from the main structure alone. Become.
  • the bone treatment sheet according to the 16th embodiment has substantially the same configuration as the bone treatment sheet 201 according to the 11th embodiment except that the covering film 211 is provided, the bone according to the 11th embodiment.
  • the effects of the treatment sheet 201 it also has the corresponding effect.
  • FIG. 26 is a diagram shown for explaining the bone treatment sheet 6 according to the seventeenth embodiment.
  • 26 (a) is a plan view of the bone treatment sheet 6
  • FIG. 26 (b) is a cross-sectional view of FIG. 26 (a) (a cross-sectional view corresponding to FIG. 1 (b))
  • FIG. 26 (c) Is an enlarged view showing a portion shown by A10 in FIG. 26 (a)
  • FIG. 26 (d) is an enlarged view showing a portion shown by A11 in FIG. 26 (b).
  • the bone treatment sheet 6 according to the 17th embodiment basically has the same structure as the bone treatment sheet 1 according to the 1st embodiment, but a nano-periodic structure having a periodic nanoscale uneven structure is formed. This is different from the bone treatment sheet 1 according to the first embodiment (see FIG. 26).
  • a nanoperiodic structure is formed on the surface of the holding portion 61. No nanoperiodic structure is formed on the surface of the main structure 10. A nanoperiodic structure may be formed on the surface of the main structure 10.
  • the nanoperiodic structure in the bone treatment sheet 6 can be formed by any method capable of forming a nanoscale structure. Examples of methods capable of forming a nanoperiodic structure include cutting with a cutting tool or laser, pressing with a die (for example, press molding), and etching with gas, ions, chemicals, or the like (including plasma etching).
  • the bone treatment sheet 6 according to the 17th embodiment is different from the bone treatment sheet 1 according to the first embodiment in that a nano-periodic structure is formed, but has a holding portion 61, so that the bone treatment sheet 6 according to the first embodiment has a holding portion 61. Similar to No. 1, it becomes a bone treatment sheet capable of promoting bone healing. Further, the bone treatment sheet 6 according to the 17th embodiment has a corresponding effect among the effects of the bone treatment sheet 1 according to the 1st embodiment.
  • bone cells particularly osteoblasts are also used in terms of surface shape. It becomes possible to promote the proliferation and differentiation of.
  • the embodiment described in the 1st embodiment can be applied as it is in the 17th embodiment.
  • FIG. 27 is a plan view of the bone treatment sheet 202a according to the first modification.
  • the opening may have a shape that looks circular when viewed in a plan view. Further, the shape may be other than a quadrangle or a circle. Further, the arrangement of the openings is not limited to the matrix-like arrangement, and may be, for example, a staggered arrangement.
  • FIG. 28 is a plan view of the bone treatment sheets 4a and 4b according to the modified example 2.
  • the opening may have a shape that looks circular when viewed in a plan view. Further, the shape may be other than a quadrangle or a circle.
  • the arrangement of the openings is not limited to the matrix-like arrangement, and may be, for example, a staggered arrangement. Further, even in a bone treatment sheet having a holding portion 11 as in the opening 40b shown in FIG. 28 (b), the opening may have a so-called slit-like shape.
  • the nanoperiodic structure in the present invention is not limited to the one composed of the band-shaped concave portion S1 or the band-shaped convex portion S2 described above.
  • the direction in which the band-shaped concave portion and the band-shaped convex portion are continuous may be different from the direction in the case of the band-shaped concave portion S1 or the band-shaped convex portion S2 described above.
  • the band-shaped concave portion and the band-shaped convex portion may have a structure having a bent shape or a meandering shape.
  • the nanoperiodic structure may be a structure including a lattice-shaped concave or convex portion or a structure including a circular unevenness.
  • the bone treatment sheet as described in the 13th to 15th embodiments can be applied to the bone treatment method according to the 11th embodiment. That is, the bone treatment sheet and the bone treatment method described by showing only one of the bone B1 and the bone B2 as the damaged bone in the above embodiment are basically applied to both the bone B1 and the bone B2. It is possible to do.
  • the bone treatment sheet 201a described in the 15th embodiment does not have an opening, but the present invention is not limited thereto.
  • An opening may be formed in a bone treatment sheet having a fixed structure such as the bone treatment sheet 201a.
  • the opening 40 in the eighth embodiment or the openings 40a and 40b in the modified example are formed.
  • the present invention is not limited thereto.
  • An opening may be formed in the bone treatment sheet having the holding portion.
  • the configuration including the coating film described in the 16th embodiment can also be applied to the bone treatment sheet as described in the other 16th embodiment.
  • the fixture 100 in the third embodiment is a plate for bone fixation, but the present invention is not limited thereto. Fixtures other than plates (eg, screws, pins, wires and staples) can also be used alone or in combination.
  • Bone healing in the present specification includes “fracture healing”.
  • the "bone treatment method” in the present specification includes a “fracture treatment method”.
  • the fractured bone B1 is the treatment target (the target using the bone treatment sheet) as in the first embodiment
  • the “bone healing” is the “fracture healing” and the “bone treatment”.
  • Method is "a method for treating bone fractures”.
  • a nanoscale uneven structure having no periodicity may be formed instead of the nanoperiodic structure.
  • Bone treatment sheet 10,90,210,220,230 ... Main structure , 11, 31, 61, 71, 81, 91 ... Holding part, 20 ... Scaffolding material containing part, 32 ... Protruding part, 40, 40a, 40b, 226, 226a, 236 ... Opening, 50, 216 ... Extension part , 52, 218 ... Fixing hole, 100 ... Fixing tool, 110 ... Main body, 120 ... Fastener, 211 ... Coating film, 212, 214, 222, 224, 232, 234 ... Surface, B1, B2 ...

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
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  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Medicinal Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Molecular Biology (AREA)
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  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
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Abstract

L'invention concerne une feuille de traitement osseux (1) destinée à être utilisée pour traiter les os en étant placée de manière à recouvrir une partie endommagée (D1) d'un os endommagé (B1), et comportant une structure de saillie-renfoncement à l'échelle nanométrique formée dans au moins une partie de celle-ci.　Les feuilles classiques qui ont été employées dans le domaine de la thérapie osseuse sont utilisées dans le simple but de retenir un produit de remplissage disposé sur une partie endommagée d'un os long, alors que les feuilles elles-mêmes n'ont aucun effet actif pour favoriser la guérison osseuse. La présente invention concerne : une feuille de traitement osseux capable de favoriser la guérison des os ; et un procédé de traitement osseux utilisant ladite feuille de traitement osseux.
PCT/JP2020/043521 2019-11-20 2020-11-20 Feuille de traitement osseux et procédé de traitement d'os d'animal WO2021100877A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100168771A1 (en) * 2008-11-24 2010-07-01 Georgia Tech Research Corporation Systems and methods to affect anatomical structures
US20110159070A1 (en) * 2008-07-03 2011-06-30 The Regents Of The University Of California Biomaterials and implants for enhanced cartilage formation, and methods for making and using them
US20140248585A1 (en) * 2013-03-01 2014-09-04 Shih-Liang Stanley Yang Medical barrier with micro pores
JP2016010690A (ja) * 2015-07-31 2016-01-21 京セラメディカル株式会社 骨誘導再生用支持体
US20170100508A1 (en) * 2015-10-09 2017-04-13 Huazhong University Of Science And Technology Bio-artificial periosteum based on micropatterning of biomimetic mineralized calcium-phosphorus nanoparticles and method for manufacturing the same

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110159070A1 (en) * 2008-07-03 2011-06-30 The Regents Of The University Of California Biomaterials and implants for enhanced cartilage formation, and methods for making and using them
US20100168771A1 (en) * 2008-11-24 2010-07-01 Georgia Tech Research Corporation Systems and methods to affect anatomical structures
US20140248585A1 (en) * 2013-03-01 2014-09-04 Shih-Liang Stanley Yang Medical barrier with micro pores
JP2016010690A (ja) * 2015-07-31 2016-01-21 京セラメディカル株式会社 骨誘導再生用支持体
US20170100508A1 (en) * 2015-10-09 2017-04-13 Huazhong University Of Science And Technology Bio-artificial periosteum based on micropatterning of biomimetic mineralized calcium-phosphorus nanoparticles and method for manufacturing the same

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