WO2016136913A1 - 医療用デバイス、歯科用、頭頸部外科用及び整形外科用デバイス構造、並びに骨への医療用デバイスの接合方法 - Google Patents
医療用デバイス、歯科用、頭頸部外科用及び整形外科用デバイス構造、並びに骨への医療用デバイスの接合方法 Download PDFInfo
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- WO2016136913A1 WO2016136913A1 PCT/JP2016/055713 JP2016055713W WO2016136913A1 WO 2016136913 A1 WO2016136913 A1 WO 2016136913A1 JP 2016055713 W JP2016055713 W JP 2016055713W WO 2016136913 A1 WO2016136913 A1 WO 2016136913A1
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- bone
- shaft portion
- medical device
- exposed
- cortical bone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/864—Pins or screws or threaded wires; nuts therefor hollow, e.g. with socket or cannulated
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
- A61C7/00—Orthodontics, i.e. obtaining or maintaining the desired position of teeth, e.g. by straightening, evening, regulating, separating, or by correcting malocclusions
-
- 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
- A61C8/0012—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy
-
- 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
- A61C8/0018—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the shape
- A61C8/0022—Self-screwing
-
- 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
- A61C8/0018—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the shape
- A61C8/0037—Details of the shape
- A61C8/0039—Details of the shape in the form of hollow cylinder with an open bottom
-
- 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
- A61C8/0093—Features of implants not otherwise provided for
- A61C8/0096—Implants for use in orthodontic treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/686—Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B2017/8655—Pins or screws or threaded wires; nuts therefor with special features for locking in the bone
-
- 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
- A61C8/0003—Not used, see subgroups
- A61C8/0004—Consolidating natural teeth
- A61C8/0006—Periodontal tissue or bone regeneration
Definitions
- the present invention relates to medical devices, dental, head and neck surgical and orthopedic device structures, and a method for joining medical devices to bone.
- Japanese Patent Application Laid-Open No. 2004-57729 discloses a tooth including an implant body having a thread formed on the outer periphery and an anchor head fixed by screwing a screw to an axial end portion of the implant body.
- An orthodontic implant (implant device) is disclosed.
- a groove is provided between the end face of the implant body and the anchor head, two small screws are screwed into the screw holes of the anchor head, and the tip of the small screw is in the groove. It protrudes.
- the wire is pressed with the tip of the machine screw and fixed between the end surface of the implant body .
- the length of the orthodontic implant in the axial direction is set longer, more specifically, the length of the screw (10.9 mm). It has long dimensions. For this reason, for example, when the orthodontic implant is screwed into the bone and fixed, there is a possibility that the tooth root and the tooth germ may be damaged, and there is room for improvement.
- the present invention has been made in view of the above problems, and is a medical device, dental, head and neck surgery, and orthopedic surgery that is capable of realizing a strong joint with a bone with little invasiveness to a patient. It is an object to provide a device structure and a method for joining a medical device to bone.
- the medical device is a hollow shaft that is inserted into the cortical bone constituting the bone, or penetrates through the cortical bone to reach the cancellous bone on the back side of the cortical bone. And a bent portion that is bent radially outward from one axial end portion of the shaft portion and exposed on the surface of the cortical bone.
- the medical device is provided with the hollow shaft portion, and the shaft portion is inserted into the cortical bone constituting the bone, or the shaft portion is the cortical bone. It penetrates to the position where it reaches the cancellous bone on the back side of the cortical bone.
- the medical device is provided with a bent portion that is bent radially outward from one axial end portion of the shaft portion, and the shaft portion penetrates into the cortical bone or penetrates the cortical bone into the cancellous bone. The bent part is exposed on the surface of the cortical bone in a state where it is inserted to the position where it reaches.
- the invention according to the second aspect is the medical device according to the first aspect, wherein the shaft portion is provided with one or more slits along the axial direction.
- the shaft portion of the medical device is provided with one or more slits along the axial direction, the outer diameter of the shaft portion is increased or decreased. It becomes easy to deform
- the invention according to a third aspect is the medical device according to the first aspect or the second aspect, wherein a plurality of the bent portions are provided in the circumferential direction of the shaft portion.
- the shaft portion since a plurality of bent portions are provided in the circumferential direction of the shaft portion, at least a part of the bent portion contacts the surface of the cortical bone, so that the shaft portion is in the bone. It can suppress more reliably that it falls into.
- the invention according to a fourth aspect is the medical device according to the second aspect or the third aspect, wherein an opening continuous with the slit is provided at a position adjacent to the shaft portion in the bent portion. .
- the opening continuous with the slit is provided at a position adjacent to the shaft portion in the bent portion, it is easily deformed in a direction in which the outer diameter of the shaft portion expands or contracts.
- the shaft portion can be more reliably fixed to the bone.
- cells having the ability to form bone migrate from the inside of the bone to the surface of the cortical bone through the opening, it is possible to quickly form new bone in the bent portion in addition to the inner surface side of the shaft portion. Become.
- the invention according to the fifth aspect includes a hollow shaft portion inserted into a cortical bone constituting a bone or penetrating through the cortical bone and reaching a cancellous bone on the back side of the cortical bone; And an exposed portion that has a portion extending radially outward from one axial end portion of the shaft portion and is exposed on the surface of the cortical bone.
- the medical device is provided with the hollow shaft portion, and the shaft portion is inserted into the cortical bone constituting the bone, or the shaft portion is the cortical bone. It penetrates to the position where it reaches the cancellous bone on the back side of the cortical bone.
- the medical device is provided with an exposed portion having a portion extending radially outward from one axial end portion of the shaft portion, and the shaft portion penetrates the cortical bone or penetrates the cortical bone.
- the exposed part is exposed on the surface of the cortical bone in the state where it is inserted to reach the cancellous bone. For this reason, when an exposed part contacts the surface of a cortical bone, it is suppressed that a shaft part falls in bone.
- the invention according to a sixth aspect is the medical device according to the fifth aspect, wherein one end portion of the shaft portion is closed by a part of the exposed portion, and the shaft portion in the exposed portion is At least a part of the opposite surface is exposed from the epithelium covering the cortical bone.
- the one end portion of the shaft portion is closed by the exposed portion.
- the area of the surface on the opposite side to the shaft portion in the exposed portion can be increased.
- at least a part of the surface of the exposed portion opposite to the shaft portion covers the cortical bone. Exposed from. Thereby, another medical device etc. can be joined to the part exposed from the epithelium in the surface on the opposite side to the axial part in the exposed part.
- the invention according to a seventh aspect is the medical device according to the fifth aspect or the sixth aspect, wherein the shaft portion is provided with one or more slits along the axial direction.
- the shaft portion of the medical device is provided with one or more slits along the axial direction, the outer diameter of the shaft portion is expanded or reduced. It becomes easy to deform
- the invention according to an eighth aspect is the medical device according to the sixth aspect or the seventh aspect, wherein the slit is connected to the position adjacent to the shaft portion on the bottom surface of the exposed portion or the inner surface of the shaft portion A groove is provided in the opening.
- the groove that is connected to the slit or opened to the inner surface of the shaft portion is provided at a position adjacent to the shaft portion on the bottom surface of the exposed portion, the bone forming ability from the inside of the bone. Since the cells having sigmoid migrate to the surface of the cortical bone through the groove, the new bone is quickly formed on the bottom surface and the periphery of the exposed portion in addition to the inner surface side of the shaft portion, and the medical device and the bone are joined. become stronger. This makes it possible to firmly join the medical device to the bone even with a short shaft portion.
- the invention according to a ninth aspect is the medical device according to any one of the first to eighth aspects, wherein a through hole is formed in the shaft portion.
- the through hole is formed in the shaft portion. Therefore, when cells having the ability to form bone migrate through this through-hole, new bone is also formed at the periphery of the through-hole, and the bonding between the medical device and the bone becomes stronger and the medical device rotates. Can be suppressed.
- the invention according to a tenth aspect is the medical device according to any one of the first aspect to the ninth aspect, wherein the shaft portion is located in the cortical bone at 70% or more of the axial length.
- the shaft portion is set such that 70% or more of the axial length is located in the cortical bone, the shaft portion is inserted deeper into the cancellous bone.
- bone damage can be suppressed.
- the root or tooth germ is damaged as compared to a conventional orthodontic implant in which about 5 mm or more of a shaft portion having a length of about 10 mm is inserted into cancellous bone. This can be suppressed more effectively.
- the invention according to an eleventh aspect is the medical device according to any one of the first aspect to the tenth aspect, wherein a male screw portion is provided on the outer peripheral surface of the shaft portion.
- the external thread portion is provided on the outer peripheral surface of the shaft portion, and the shaft portion is fixed to the bone by screwing the male screw portion of the shaft portion into the bone. For this reason, a shaft part can be more reliably fixed to a bone.
- the invention according to a twelfth aspect is the medical device according to any one of the first aspect to the eleventh aspect, wherein the shaft portion and the bent portion or the exposed portion are formed of titanium or a titanium alloy. ing.
- the shaft portion and the bent portion or the exposed portion are formed of titanium or a titanium alloy, the biocompatibility is excellent.
- the invention according to a thirteenth aspect is the medical device according to any one of the first to twelfth aspects, wherein at least a part of the surface of the shaft portion and the bent portion or the exposed portion is a living body. Coated with functional material.
- the surface of the shaft portion and at least a part of the bent portion or the exposed portion are coated with the biofunctional material, the bonding between the medical device and the bone is promoted.
- the dental, head and neck surgical or orthopedic device structure of the present invention comprises the medical device according to any one of the first to thirteenth aspects, and uses the medical device for fixation to bone. To do.
- the inner surface of the hollow shaft portion passes through the slit in the shaft portion and the groove provided in the opening portion of the bending portion or the bottom surface of the exposed portion. Since cells having the ability to form bone rapidly migrate to the side and the bent part exposed to the cortical bone surface or the exposed part, the cell causes the bent part or the bottom surface and the periphery of the exposed part in addition to the inner surface side of the shaft part. Also, new bone is quickly formed, and the joint between the medical device and the bone becomes stronger. As a result, the medical device can be firmly joined to the bone even with a short shaft portion, and the invasion to the patient is small, and the medical device can be firmly joined to the bone.
- the medical device joining method of the present invention is a joining method for joining the medical device according to any one of the first to thirteenth aspects to a bone, inside the cortical bone constituting the bone. Inserting the shaft portion or penetrating the cortical bone, inserting the shaft portion to a position reaching the cancellous bone on the back side of the cortical bone, and exposing the bent portion or the exposed portion to the surface of the cortical bone
- the shaft portion By fixing the shaft portion to the bone, the cells having bone forming ability migrate from the inside of the bone through the hollow shape of the shaft portion and the slit, and are regenerated on the inner surface side of the shaft portion by the cells.
- On the bottom of A cell having bone forming ability is migrated from the inside of the bone to the surface of the cortical bone by a groove connected to the slit provided at a position adjacent to the shaft portion or opened to the inner surface of the shaft portion, and the cell causes the A function of promoting the joining of the medical device to the cortical bone surface by forming new bone on the bottom surface and the periphery of the bent portion or the exposed portion.
- the shaft portion of the medical device is inserted into the bone, and the shaft portion is fixed in a state where the bent portion or the exposed portion of the medical device is exposed on the surface of the cortical bone. Further, through the slits in the shaft part and the grooves provided in the opening part of the bent part or the bottom surface of the exposed part, the bone forming ability to the inner surface side of the hollow shaft part and the bent part or exposed part exposed on the cortical bone surface.
- the cells having the above structure are caused to migrate, and the new bone is formed around the inner surface side of the shaft portion and the bent portion or the exposed portion of the surface of the cortical bone by the cells, thereby joining the medical device to the bone.
- the medical device can be firmly joined to the bone even with a short shaft portion, and the invasion to the patient is small, and the medical device can be firmly joined to the bone.
- the medical device of the present invention can be manufactured, for example, by subjecting a tubular metal substrate to plastic processing or cutting.
- the medical device of the present invention can be manufactured by casting into a finished product.
- the medical device of the present invention can be manufactured into a finished product by additive manufacturing using a 3D printer.
- the metal constituting the medical device of the present invention is not particularly limited, and a known metal material may be appropriately selected according to the use. From the viewpoint of biocompatibility, titanium or a titanium alloy is preferable.
- the titanium alloy Ti-6Al-4V, Ti-6Al-4V ELI, Ti-6Al-7Nb, Ti-3Al-2.5V, Ti-5Al-2.5Fe, or the like can be used.
- the medical device of the present invention may have a surface subjected to processing such as etching, sandblasting, and particle baking.
- the surface of the medical device of the present invention may be coated with a biofunctional material for the purpose of promoting bonding with bone.
- a biofunctional material for coating the medical device of the present invention include hydroxyapatite (HAp), collagen (Col), and HAp / Col composite containing HAp and Col.
- HAp hydroxyapatite
- Col collagen
- HAp / Col composite containing HAp and Col.
- the medical device of the present invention may include a sponge-like composition made of a biofunctional material (for example, Col, HAp / Col composite) on the inner surface side of the shaft portion.
- a sponge-like composition made of a biofunctional material for example, Col, HAp / Col composite
- tissue fluid or blood soaks into the sponge-like composition, and cells having the ability to form bone (osteogenic cells) are likely to migrate.
- osteogenic cells are proliferated and differentiated using a sponge-like composition as a scaffold to promote bone formation. Therefore, the joint between the medical device of the present invention and the bone becomes stronger.
- the sponge-like composition made of the biofunctional material can be provided on the inner surface side of the shaft portion of the present invention by adjusting the conditions of the metal surface coating method.
- the method for joining a medical device to a bone comprises a step of placing a sponge-like composition comprising a biofunctional material (eg, Col, HAp / Col composite) after the medical device of the present invention is placed on a bone.
- a biofunctional material eg, Col, HAp / Col composite
- a cell having the ability to form a bone is allowed to migrate, and the medical device is joined to the bone by forming new bone around the bent portion or exposed portion of the cortical bone surface in addition to the inner surface side of the shaft portion.
- the medical device can be firmly joined to the bone, the invasion to the patient is small, and the medical device can be firmly joined to the bone.
- FIG. 2 is a cross-sectional view showing a state before a hole is made in a bone in the method of joining a device to a bone for joining the device shown in FIG. 1 to a bone.
- FIG. 2 is a cross-sectional view showing a step of fixing the device to a hole in a bone in the method of joining a device to a bone for joining the device shown in FIG. FIG.
- FIG. 2 is a cross-sectional view showing a state in which cells having osteogenic potential (osteogenic cells) migrate through the hollow shaft portion of the device in the method of joining the device shown in FIG. 1 to the bone to join the device to the bone.
- FIG. 1 is a cross-sectional view showing a state in which a new bone is formed at a shaft portion and a bent portion of a device by cells having osteogenic ability (osteogenic cells) in the method of joining a device to bone, which joins the device shown in FIG.
- FIG. It is a perspective view which shows the device as a medical device which concerns on 2nd Embodiment of this invention.
- FIG. 12B is a bottom view of the device shown in FIG. 12A.
- FIG. 12B is a cross-sectional view showing a state where the device shown in FIG. 12A is joined to bone.
- FIG. 13B is a bottom view of the device shown in FIG. 13A.
- FIG. 13B is a cross-sectional view showing a state where the device shown in FIG. 13A is joined to bone.
- FIG. 1 is a perspective view of a medical device (hereinafter referred to as “device”) according to a first embodiment of the present invention.
- 2A is a plan view (top view) of the device shown in FIG. 1
- FIG. 2B is a bottom view (bottom view) of the device shown in FIG.
- the device 10 includes a hollow shaft portion 10A and a wing-shaped bent portion (outer side) as an exposed portion bent radially outward from one axial end portion of the shaft portion 10A. Wings) 10B and 10C. That is, the device 10 is a pin-shaped device (hereinafter sometimes referred to as “pin device”) including a shaft portion 10A and a plurality of bent portions 10B and 10C.
- pin device pin-shaped device
- the shaft portion 10A is formed in a substantially cylindrical shape, and a through hole 12 penetrating the center portion is provided inside.
- the shaft portion 10A is provided with a plurality of slits 14 along the axial direction.
- the slit 14 is formed over substantially the entire length of the shaft portion 10A in the axial direction, and one end in the longitudinal direction of the slit 14 opens at the tip of the shaft portion 10A.
- the slits 14 are arranged at substantially equal intervals in the circumferential direction of the shaft portion 10A.
- four slits 14 are provided at a position of about 90 ° in the circumferential direction of the shaft portion 10A.
- the shaft portion 10A can be deformed in a direction in which the outer diameter of the shaft portion 10A is enlarged or reduced by providing four slits 14 along the axial direction.
- the shaft portion 10A is disposed at a position of about 180 ° in the circumferential direction of the shaft portion 10A and extends in the opposite direction between the pair of bent portions 10B and the pair of bent portions 10B.
- Another pair of bent portions 10C that are disposed and extend in opposite directions are provided. That is, a total of four bent portions 10B and 10C are provided, and the bent portions 10B and the bent portions 10C are alternately arranged at a position of about 90 ° in the circumferential direction of the shaft portion 10A.
- the width of the bent portion 10B (the width in the circumferential direction of the shaft portion 10A) is set larger than the width of the bent portion 10C (the width in the circumferential direction of the shaft portion 10A).
- An opening 16 continuous with the slit 14 is provided at a position adjacent to the shaft portion 10A in the bent portion 10B.
- the opening 16 has a shape including a rectangular portion continuous with a substantially circular portion in plan view, and the rectangular portion is connected to one end in the longitudinal direction of the slit 14.
- the length of the opening 16 in the radial direction is set to be longer than half the length of the bent portion 10B in the radial direction.
- the opening part 16 is provided only in the two bending parts 10B, and is not provided in the other two bending parts 10C.
- the axial length of the shaft portion 10A is the length inserted into the cortical bone 22 (see FIG. 3B) constituting the bone 20, which will be described later, or the cancellous bone 24 penetrating through the cortical bone 22 ( The length is set to be inserted up to the position reaching (see FIG. 3B).
- the bent portion 10B and the bent portion 10C protrude outward in the radial direction from the shaft portion 10A, and the shaft portion 10A penetrates the cortical bone 22 with the shaft portion 10A inserted into the cortical bone 22, or the sponge.
- the bending portion 10B and the bending portion 10C are configured to be exposed on the surface of the cortical bone 22 in a state where the bone 24 is inserted to the position reaching the bone 24 (see FIG. 3C).
- the axial length of the shaft portion 10A is set to about 2.0 mm.
- the outer diameter of the shaft portion 10A of the device 10 is set to about 2.4 mm
- the thickness (wall thickness) of the shaft portion 10A and the bent portion 10B is set to about 0.25 mm
- the inner diameter of the shaft portion 10A. Is set to about 1.9 mm.
- said dimension of the device 10 is not limited to the dimension of this embodiment, A change is possible.
- the axial length of the shaft portion 10A is set to about 1.5 mm, which is substantially the same thickness as the cortical bone 22. Also good.
- the number of slits 14 of the shaft portion 10A of the device 10 is not limited to the number of the present embodiment, and can be changed.
- the number of the slits 14 in the shaft portion 10A may be one, or two or more.
- the number of the bent portions 10B and the bent portions 10C and the positions of the bent portions 10B and 10C in the circumferential direction of the shaft portion 10A are not limited to the present embodiment, and can be changed.
- the device 10 (the shaft portion 10A and the bent portions 10B and 10C) is made of titanium or a titanium alloy.
- the titanium alloy Ti-6Al-4V, Ti-6Al-4V ELI, Ti-6Al-7Nb, Ti-3Al-2.5V, Ti-5Al-2.5Fe, or the like can be used.
- the metal constituting the device 10 is not limited to titanium or a titanium alloy, and other metal materials may be selected as appropriate.
- the surface of the device 10 may be subjected to processing such as etching, sandblasting, and particle baking.
- the surface of the device 10 may be coated with a biofunctional material for the purpose of promoting the bonding with the bone.
- a biofunctional material for coating the device 10 include hydroxyapatite (HAp), collagen (Col), and HAp / Col composite containing HAp and Col.
- the device 10 of the present embodiment may include a sponge-like composition made of a biofunctional material (for example, Col, HAp / Col composite) on the inner surface side of the shaft portion 10A.
- a sponge-like composition made of a biofunctional material (for example, Col, HAp / Col composite) on the inner surface side of the shaft portion 10A.
- tissue fluid or blood soaks into the sponge-like composition, and cells having the ability to form bone (osteogenic cells) are likely to migrate.
- osteogenic cells are proliferated and differentiated using a sponge-like composition as a scaffold to promote bone formation.
- the device 10 of the present embodiment can be manufactured, for example, by subjecting a tubular metal base material to plastic working or cutting. Further, the device 10 of the present embodiment can be manufactured by casting into a finished product. Moreover, the device 10 of this embodiment can be manufactured in the form of a finished product by additive manufacturing using a 3D printer.
- the bone 20 includes a cortical bone 22 on the surface side and a cancellous bone 24 on the back side of the cortical bone 22.
- the surface of the cortical bone 22 is covered with the mucosa 26.
- illustration is omitted, when the device 10 is fixed to the bone 20, the mucous membrane 26 is incised. Then, with the incised mucosa 26 lifted, as shown in FIG. 3A, the bone 20 is cut using a drill 42 to penetrate the cortical bone 22 into the bone 20 and slightly reach the cancellous bone 24. A long hole (prepared hole) 28 is drilled (formed) (see FIG. 3B).
- the inner diameter of the hole portion 28 is slightly smaller than the outer diameter of the shaft portion 10 ⁇ / b> A of the device 10.
- the hole 28 is good also as a structure provided only in the cortical bone 22 (it does not reach the cancellous bone 24). Even in this case, cells (osteogenic cells) 30 having the ability to form bone can be migrated from the inside of the bone 20.
- the shaft portion 10A of the device 10 is inserted into the hole portion 28 of the bone 20.
- the four slits 14 are provided along the axial direction of the shaft portion 10 ⁇ / b> A, so that the shaft portion 10 ⁇ / b> A is deformed in a direction in which the outer diameter decreases and is inserted into the hole portion 28.
- the shaft portion 10A is pushed into the hole portion 28 until the bent portion 10B and the bent portion 10C (see FIG. 1) of the device 10 come into contact with the surface of the cortical bone 22.
- the shaft portion 10A is fixed to the hole portion 28 of the bone 20 in a state where the bent portion 10B and the bent portion 10C are exposed on the surface of the cortical bone 22.
- the bending portion 10 ⁇ / b> B and the bending portion 10 ⁇ / b> C contact the surface of the cortical bone 22, so that the shaft portion 10 ⁇ / b> A can be prevented from falling into the bone 20.
- 70% or more of the axial length of the shaft portion 10A is located in the cortical bone 22, preferably 80% or more is located in the cortical bone 22, and more preferably 85% or more is located in the cortical bone 22. It is desirable that Since 70% or more of the axial length of the shaft portion 10A is located in the cortical bone 22, the insertion amount of the shaft portion 10A into the bone 20 is reduced, and the invasion to the patient can be further reduced. . In addition, in the device 10, in one example, 100% of the axial length of the shaft portion 10A is located in the cortical bone 22, and in another example, 100% or less or 95% of the axial length of the shaft portion 10A. The following is located in the cortical bone 22.
- the axial length of the shaft portion 10A is set to about 2.0 mm, and the axial length of the shaft portion 10A is shorter than that of a conventional orthodontic implant or the like.
- 10A penetrates the cortical bone 22 until it reaches the cancellous bone 24 slightly (see FIG. 3C). For this reason, when the device 10 is used for orthodontic treatment, for example, a tooth root and a tooth germ are compared with a conventional orthodontic implant in which about 5 mm or more of a shaft portion having a length of about 10 mm is inserted into cancellous bone. It is possible to more effectively suppress damage.
- the shaft portion 10A is inserted to a position that penetrates the cortical bone 22 and slightly reaches the cancellous bone 24, but is not limited to this configuration, and the shaft portion 10A. May be inserted only into the cortical bone 22.
- the mucosa 26 is returned to the position before the incision to cover the device 10.
- the bone forming ability is obtained from the inside of the bone 20 through the hollow shaft portion 10A, the slit 14, and the opening portion 16 (see FIG. 1) of the device 10.
- Cells 30 (osteogenic cells) possessed migrate in the blood 32 toward the bent portions 10B and 10C of the shaft portion 10A indicated by arrows.
- new bone 34 is formed on the inner surface side of the shaft portion 10A and the surfaces of the bent portions 10B and 10C by the migrated (mobilized) cells 30.
- the bent portions 10 ⁇ / b> B and 10 ⁇ / b> C of the device 10 serve as a foothold for forming the new bone 34 on the migrated cell 30 and fixing it to the bone 20. Thereby, the device 10 can be firmly joined to the bone 20. At that time, the new bone 34 is also formed in the opening 16 (see FIG. 1) of the bent portion 10B of the device 10, whereby the rotation of the device 10 can be suppressed.
- a hole 28 having a length that penetrates the cortical bone 22 and slightly reaches the cancellous bone 24 is formed in the bone 20, and the shaft portion 10 ⁇ / b> A of the device 10 is inserted into the hole 28. Invasion of the device 10 is small, and the device 10 and the bone 20 can be firmly joined.
- the shaft portion 10A of the device 10 is provided with a plurality of slits 14 along the axial direction, and the bent portion 10B is provided with an opening 16 continuous with the slits 14, so that the outer diameter of the shaft portion 10A is increased. Is easily deformed in the direction of enlargement or reduction. For this reason, 10 A of axial parts can be fixed to the bone 20 more reliably. Furthermore, since the cells 30 having the ability to form bone from the inside of the bone 20 migrate through the slit 14 of the shaft portion 10A and the opening 16 of the bent portion 10B, the inner surface side of the shaft portion 10A and the bent portion 10B are moved by the migrated cells 30. New bone 34 can be rapidly formed on the surface of 10C.
- the inner diameter of the hole portion 28 of the bone 20 is formed to be slightly smaller than the outer diameter of the shaft portion 10A of the device 10, and the shaft portion 10A is deformed in a direction in which the outer diameter is reduced to thereby form a hole.
- the configuration is not limited to this.
- the shaft portion 10A is deformed in the direction in which the outer diameter expands and is fixed to the hole portion 28. It may be.
- the hole portion may be formed to a length that remains only in the cortical bone 22 (a length that does not reach the cancellous bone 24), and the shaft portion 10A of the device 10 may be inserted into the hole portion.
- the shaft portion 10A of the device 10 is inserted only into the cortical bone 22, the invasion to the patient is further reduced.
- cells (osteogenic cells) 30 having the ability to form bone migrate from the inside of the bone 20, and the migrated cells 30 form new bone on the inner surface side of the shaft portion 10A and the surfaces of the bent portions 10B and 10C. 34 can be formed.
- the device (medical device) 50 includes a hollow shaft portion 10A, and a male screw portion 52 is provided on the outer peripheral surface of the shaft portion 10A.
- Other configurations of the device 50 are the same as those of the device 10 of the first embodiment.
- four slits 14 are provided along the longitudinal direction of the shaft portion 10A. For example, after the male screw portion 52 is formed on the outer peripheral surface of the cylindrical shaft portion 10A, the slit 14 is formed. By doing so, the device 50 can be manufactured.
- the method for manufacturing the device 50 is not limited to this method, and other methods may be used.
- the male screw portion 52 of the shaft portion 10A is attached to the bone 20 Screw into the hole 28.
- a thread groove is cut in the peripheral portion of the hole portion 28 of the bone 20, and the shaft portion 10 ⁇ / b> A is fixed to the bone 20.
- the cells 30 having bone forming ability migrate from the inside of the bone 20 through the hollow shaft portion 10A, the slit 14, and the opening portion 16 of the device 50, and the shaft portion 10A and the bent portion 10B are moved by the migrated cells 30.
- a new bone 34 is formed on the surface of 10C (see FIG. 3D).
- Such a device 50 is less invasive to the patient and can realize a strong initial fixation between the device 50 and the bone 20 (see FIG. 3D). Further, since the shaft portion 10A is fixed to the bone 20 by screwing the male screw portion 52 of the shaft portion 10A into the hole portion 28 of the bone 20, the shaft portion 10A can be more securely fixed to the bone 20.
- FIG. 5 shows a dental device structure 60 which is an example in which the device 10 shown in FIG. 1 is applied for orthodontic treatment.
- the shaft portion 10 ⁇ / b> A (see FIG. 1) of the device 10 is inserted into the bone 20 inside the alveolar mucosa 62 (see FIG. 3C, in this embodiment, between the teeth). It is.
- the shaft portion 10A of the device 10 is inserted into the cortical bone 22 of the bone 20 or inserted to a position that penetrates the cortical bone 22 of the bone 20 and reaches the cancellous bone 24 (see FIG. 3D and the like). ).
- the main body of the device 10 is covered with the alveolar mucosa 62, and one bent portion 10 ⁇ / b> B is extended so as to protrude outward at the boundary between the alveolar mucosa 62 and the attached gingiva 63.
- a hole 40 independent of the opening 16 is provided at the end of the extended bent portion 10B, and various devices developed for orthodontic treatment can be installed in the hole 40.
- the device 10 is used as a fixed source for moving teeth by connecting the device 10 and the hook 66 connected to the orthodontic archwire 64 with a spring 68.
- the axial length of the shaft portion 10A of the device 10 is set to about 2.0 mm, and the axial length of a conventional orthodontic implant or the like (for example, about 10 mm or more). Therefore, in the dental device structure 60, by using the device 10 as a fixing source for moving teeth, the root of the tooth is compared with a conventional orthodontic implant or the like in which about 5 mm or more of the shaft portion is inserted into the cancellous bone. And damage to the tooth germ can be more effectively suppressed. Therefore, the dental device structure 60 is less invasive to the patient.
- the dental device structure 60 cells having bone forming ability migrate from the inside of the bone through the hollow shaft portion 10A of the device 10, and new bone is formed on the inner surface side of the shaft portion 10A by the cells. . Thereby, the firm joining of the device 10 and the bone 20 can be realized.
- the position where the shaft portion 10A of the device 10 is inserted into the bone 20 is not limited to the position shown in FIG. 5 and can be changed.
- the devices of the first embodiment and the second embodiment are not limited to orthodontic applications.
- various devices for orthopedics and otolaryngology or epithesis for maxillofacial surgery are used.
- Epithesis refers to an artificial object that is attached to the surface of the body as a medical device.
- the thickness of the cortical bone constituting the bone is larger than that of orthodontic treatment. It is preferable to increase the axial length of the shaft portion of the device.
- the dental device structure 60 which applied the device for orthodontic treatment is shown, this invention is not limited to this.
- the present invention can be applied to device structures that utilize the device for fixation to bone in other dental, head and neck and orthopedic areas.
- a pure titanium tube was used as a metal substrate. Specifically, a pure titanium tube having an outer diameter of 2.4 mm and a wall thickness of 0.25 mm was cut into a length of 10 mm and used.
- the titanium tube was molded into a device (pin device) 10 shown in FIG. 1 using a diamond wheel saw, a round bar, and pliers.
- the device 10 includes a hollow shaft portion 10A and a plurality of bent portions (outer wings) 10B and 10C that are bent radially outward from one axial end portion of the shaft portion 10A. It has.
- Four slits 14 are formed in the shaft portion 10A along the axial direction.
- An opening 16 is provided in the pair of bent portions 10B, and no opening is provided in the other pair of bent portions 10C.
- This device pin device
- the device was collected with the tibia and subjected to tissue observation and mechanical tests.
- micro CT imaging was performed using SMX100CT manufactured by Shimadzu Corporation, and the image was reconstructed using 3D-BON image analysis software manufactured by Ratok.
- the mechanical test for confirming the osteosynthesis strength of the device was performed using a universal testing machine AG-X manufactured by Shimadzu Corporation.
- the device was sampled in one piece with the tibia and then stored in 4 ° C. physiological saline and tested within 1 hour.
- a tensile force was applied to the opening 16 (see FIG. 1) of the bending portion 10B of the device on the knee joint side of the tibia in parallel to the longitudinal direction of the tibia through a wire.
- the bone around the bent portion 10B (see FIG. 1) of the device to which the wire was applied was removed with a round bar (FIG. 7).
- the orthodontic anchor screw 100 includes a solid shaft portion 100A having a thread on the outer peripheral surface, and an outer diameter at one end portion in the axial direction of the shaft portion 100A. And a head 100B formed larger than the diameter.
- An orthodontic anchor screw having a diameter of 2.0 mm and a length of 8.0 mm was used. The orthodontic anchor screw was placed in the same position as the device with reference to the position of the knee joint.
- FIGS. 10A and 10B show images of bone tissue around the device (reconstructed images of micro CT).
- formation of the new bone was confirmed by the inner surface side of the axial part of a device (arrowhead).
- the formation of new bone was not observed on the entire inner surface of the shaft portion of the device, but only in the same extent as the surrounding cortical bone in the depth direction.
- the center image corresponds to a cross section of the horizontal line portion of the left image.
- formation of new bone was confirmed at the opening of the bent portion (arrow in the center image).
- the right image corresponds to a cross section of a portion of the diagonal line of the left image.
- formation of new bone was confirmed between the bent portion (arrowhead in the right image).
- Fig. 11 shows the results of the mechanical test.
- the maximum strength (arrow position in the figure) determined by the mechanical test was 48.7N for the device and 37.8N for the orthodontic anchor screw.
- the device is mono-cortical and the orthodontic anchor screw is bi-cortical. It was.
- FIGS. 12A to 12C a fourth embodiment of the medical device according to the present invention will be described with reference to FIGS. 12A to 12C. Note that in the fourth embodiment, the same components and members as those in the first and second embodiments are denoted by the same reference numerals and detailed description thereof may be omitted.
- the device 70 (medical device) includes a hollow shaft portion 10A, and the outer peripheral surface of the shaft portion 10A is formed in a cylindrical surface shape. Moreover, two slits 14 are formed in the shaft portion 10A, and the two slits 14 are arranged at intervals of 180 ° along the circumferential direction of the shaft portion 10A.
- a head portion 70A as an exposed portion formed in a hexagonal shape when viewed in the axial direction of the shaft portion 10A is provided at one end portion of the shaft portion 10A in the axial direction.
- the head portion 70A includes a closing portion 70A1 that closes the open end of the shaft portion 10A, and an outer peripheral side extending portion 70A2 that extends outward from the closing portion 70A1 in the radial direction of the shaft portion 10A.
- the surface of the closing portion 70A1 and the outer peripheral side extending portion 70A2 on the side of the closing portion 70A1 opposite to the shaft portion 10A is a flat surface S1 extending in the radial direction of the shaft portion 10A.
- the flat surface S1 is adjusted so that the surface roughness of the flat surface S1 becomes a predetermined roughness by machining or the like. More specifically, the surface roughness of the flat surface S1 is adjusted so that the adhesiveness of the adhesive to the flat surface S1 is good.
- the surface roughness of the flat surface S1 may be adjusted by performing file processing, shot blast processing, or the like.
- the surface of the outer peripheral side extending portion 70A2 opposite to the shaft portion 10A is an inclined surface S2 that is inclined toward the shaft portion 10A side toward the outer side in the radial direction of the shaft portion 10A.
- a concave groove portion 70A3 in which the shaft portion 10A side is opened is formed at the end portion of the head portion 70A on the shaft portion 10A side.
- the recessed groove portion 70A3 passes through the head portion 70A and is connected to the two slits 14 formed in the shaft portion 10A.
- the device 70 is similar to the device 10 according to the first embodiment (see FIG. 3B), and after forming the hole 28 in the bone 20 smaller than the outer diameter of the shaft portion 10A, The shaft portion 10A is inserted into the hole portion 28 of the bone 20. At this time, in this embodiment, the shaft portion 10A can be inserted into the hole 28 of the bone 20 by engaging a tool corresponding to the shape (hexagonal shape) of the head portion 70A with the head portion 70A. . Thereby, the shaft portion 10 ⁇ / b> A is fixed to the bone 20.
- the flat surface S1 of the head 70A of the device 70 is the mucosa 26 that is the epithelium covering the bone 20 (cortical bone 22 (see FIG. 3C)).
- the thickness and the like of the head 70A are set so as to be exposed from the head.
- another medical device or the like can be joined to the flat surface S1 of the head 70A via an adhesive or the like.
- the other medical device is, for example, the spring 68 or the hook 66 (see FIG. 5) described in the third embodiment.
- cells having the ability to form bone migrate from the inside of the hollow shaft portion 10A of the device 70 to the groove portion 70A3, and new bone is also formed inside the groove portion 70A3.
- joining of device 70 and bone 20 can be strengthened more.
- the device 70 can be firmly joined to the bone 20 even with the short shaft portion 10A.
- FIGS. 13A to 13C a fifth embodiment of the medical device according to the present invention will be described with reference to FIGS. 13A to 13C.
- the same components and members as those in the first to third embodiments are denoted by the same reference numerals, and detailed description thereof may be omitted.
- the device 72 (medical device) of this embodiment is replaced with the slit 14 (see FIG. 12A) formed in the shaft portion 10A of the device 70 of the fourth embodiment.
- a circular through hole 72A penetrating in a direction orthogonal to the axial direction of the shaft portion 10A is formed in the shaft portion 10A, and a concave groove portion 70A3 communicating with a space radially inward of the shaft portion 10A is formed.
- FIG. 13C according to this device 72, cells having the ability to form bone can be migrated through the through hole 72A and the recessed groove portion 70A3.
- the present invention is not limited to this.
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Abstract
Description
図1には、本発明の第1実施形態の医療用デバイス(以下、「デバイス」という)が斜視図にて示されている。図2Aには、図1に示すデバイスが平面図(上面図)にて示されており、図2Bには、図1に示すデバイスが底面図(下面図)にて示されている。図1~図2Bに示されるように、デバイス10は、中空形状の軸部10Aと、軸部10Aの軸方向の一端部から半径方向外側に屈曲された露出部としての翼状の屈曲部(外翼)10B、10Cと、を備えている。すなわち、デバイス10は、軸部10Aと複数の屈曲部10B、10Cとを備えたピン形状のデバイス(以下、「ピンデバイス」と称する場合がある)とされている。
次に、図4を用いて、本発明に係る医療用デバイスの第2実施形態について説明する。なお、第2実施形態において、第1実施形態と同一の構成要素、部材等については同一符号を付して、詳細な説明を省略する。
次に、図5を用いて、本発明に係る医療用デバイスの第3実施形態である歯科用デバイス構造について説明する。なお、第3実施形態において、第1及び第2実施形態と同一の構成要素、部材等については同一符号を付して、詳細な説明を省略する。
また、第3実施形態では、デバイスを歯科矯正治療用に応用した歯科用デバイス構造60が示されているが、本発明はこれに限定されるものではない。例えば、本発明は、デバイスを、その他の歯科、頭頸部外科、整形外科の各領域で骨への固定に利用するデバイス構造に適用することができる。
金属基材として純チタン製の管を使用した。具体的には外径2.4mm、肉厚0.25mmの純チタン製の管を長さ10mmに切断し用いた。チタン管はダイヤモンドホイールソー、ラウンドバー及びペンチを用いて図1に示すデバイス(ピンデバイス)10に成型した。図1に示されるように、デバイス10は、中空形状の軸部10Aと、軸部10Aの軸方向の一端部から半径方向外側に屈曲された複数の屈曲部(外翼)10B、10Cと、を備えている。軸部10Aには、軸方向に沿って4つのスリット14が形成されている。一対の屈曲部10Bには、開口部16が設けられており、他の一対の屈曲部10Cには、開口部は設けられていない。このデバイス(ピンデバイス)を中性洗剤、純水、アセトン、エタノール、純水の順に、各30分間超音波洗浄し、オートクレーブで滅菌して動物実験に用いた。
12週齢SD系雄ラットの脛骨膝関節部内側にラウンドバーにて径2.2mm~2.3mm、深さ3mmの下穴をあけ、デバイスを設置した。その際、開口部16のある一対の屈曲部10Bが脛骨の長軸方向になるようにした(図6)。デバイスは、皮質骨を貫通し先端が海綿骨に達する設置とした(mono-corticalな固定とした)。
デバイス周囲の骨組織の画像(マイクロCTの再構築画像)を図10A、図10Bに示す。図10Aに示すように、デバイスの軸部の内面側に新生骨の形成が確認された(矢頭)。新生骨の形成はデバイスの軸部の内面側全体で認められたわけではなく、深さ方向において周囲の皮質骨と同程度の範囲にのみ認められた。図10Bでは、中央の画像は、左の画像の横線の部位の断面に相当する。中央の画像に示すように、屈曲部の開口部に新生骨の形成が確認された(中央の画像の矢印)。右の画像は、左の画像の斜め線の部位の断面に相当する。右の画像に示すように、屈曲部と屈曲部との間に新生骨の形成が確認された(右の画像の矢頭)。
次に、図12Aから図12Cを用いて、本発明に係る医療用デバイスの第4実施形態について説明する。なお、第4実施形態において、第1及び第2実施形態と同一の構成要素、部材等については同一符号を付して、詳細な説明を省略することがある。
次に、図13A~図13Cを用いて、本発明に係る医療用デバイスの第5実施形態について説明する。なお、第5実施形態において、第1~第3実施形態と同一の構成要素、部材等については同一符号を付して、詳細な説明を省略することがある。
Claims (15)
- 骨を構成する皮質骨の内部に差し込まれる、又は前記皮質骨を貫通し、前記皮質骨の奥側の海綿骨に達する位置まで差し込まれる中空形状の軸部と、
前記軸部の軸方向の一端部から半径方向外側に屈曲され、前記皮質骨の表面に露出する屈曲部と、
を有する医療用デバイス。 - 前記軸部には、軸方向に沿って1又は2以上のスリットが設けられている請求項1に記載の医療用デバイス。
- 前記屈曲部は、前記軸部の周方向に複数設けられている請求項1又は請求項2に記載の医療用デバイス。
- 前記屈曲部における前記軸部と隣接する位置に、前記スリットと連続する開口部が設けられている請求項2又は請求項3に記載の医療用デバイス。
- 骨を構成する皮質骨の内部に差し込まれる、又は前記皮質骨を貫通し、前記皮質骨の奥側の海綿骨に達する位置まで差し込まれる中空形状の軸部と、
前記軸部の軸方向の一端部から半径方向外側に延在される部分を有し、前記皮質骨の表面に露出する露出部と、
を有する医療用デバイス。 - 前記軸部の一端部は、前記露出部の一部によって閉止されており、
前記露出部における前記軸部とは反対側の面の少なくとも一部は、前記皮質骨を覆う上皮から露出される請求項5記載の医療用デバイス。 - 前記軸部には、軸方向に沿って1又は2以上のスリットが設けられている請求項5又は請求項6に記載の医療用デバイス。
- 前記露出部の底面における前記軸部と隣接する位置に、前記スリットとつながる又は前記軸部の内面に開口する溝が設けられている請求項6又は請求項7に記載の医療用デバイス。
- 前記軸部には、貫通孔が形成されている請求項1から請求項8までのいずれか1項に記載の医療用デバイス。
- 前記軸部は、軸方向の長さの70%以上が前記皮質骨に位置する長さに設定されている請求項1から請求項9までのいずれか1項に記載の医療用デバイス。
- 前記軸部の外周面には、雄ねじ部が設けられている請求項1から請求項10までのいずれか1項に記載の医療用デバイス。
- 前記軸部及び前記屈曲部が、チタン又はチタン合金により形成されている請求項1から請求項11までのいずれか1項に記載の医療用デバイス。
- 前記軸部の表面及び前記屈曲部又は前記露出部の少なくとも一部が、生体機能材料でコーティングされている請求項1から請求項12までのいずれか1項に記載の医療用デバイス。
- 請求項1から請求項13までのいずれか1項に記載の医療用デバイスを備え、前記医療用デバイスを骨への固定に利用する、歯科用、頭頸部外科用又は整形外科用デバイス構造。
- 請求項1から請求項13までのいずれか1項に記載の医療用デバイスを骨に接合する接合方法であって、
骨を構成する皮質骨の内部に前記軸部を差し込み、又は前記皮質骨を貫通し、前記皮質骨の奥側の海綿骨に達する位置まで前記軸部を差し込み、前記屈曲部又は前記露出部を前記皮質骨の表面に露出した状態で前記軸部を前記骨に固定する工程と、
前記軸部の中空形状及び前記スリットを通じて、前記骨の内部から骨形成能を有する細胞を遊走させ、前記細胞により前記軸部の内面側に新生骨を形成させて前記医療用デバイスの前記骨への接合を促進する機能と、
前記屈曲部における前記軸部と隣接する位置に設けられた前記スリットと連続する開口部、又は、前記露出部の底面における前記軸部と隣接する位置に設けられた前記スリットとつながる又は前記軸部の内面に開口する溝、によって前記骨の内部から骨形成能を有する細胞を皮質骨表面に遊走させ、前記細胞により前記屈曲部又は前記露出部の底面及び周囲に新生骨を形成させて前記医療用デバイスの前記皮質骨表面への接合を促進する機能と、
を有する骨への医療用デバイスの接合方法。
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CN201680011553.4A CN107405179B (zh) | 2015-02-25 | 2016-02-25 | 医疗用器件、牙科用、头颈部外科用和整形外科用器件结构以及医疗用器件对骨的接合方法 |
EP16755657.0A EP3263064B1 (en) | 2015-02-25 | 2016-02-25 | Medical orthodontic device and device structure for dental use |
US15/553,269 US11234747B2 (en) | 2015-02-25 | 2016-02-25 | Medical device, device structures for dentistry, for head and neck surgery and for orthopedic surgery, and method for bonding medical device to bone |
JP2017502490A JP6762034B2 (ja) | 2015-02-25 | 2016-02-25 | 医療用デバイス、歯科用、頭頸部外科用、整形外科用のうちのいずれか1つの用途のデバイス構造 |
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US (1) | US11234747B2 (ja) |
EP (1) | EP3263064B1 (ja) |
JP (3) | JP6762034B2 (ja) |
CN (1) | CN107405179B (ja) |
WO (1) | WO2016136913A1 (ja) |
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JP7472416B1 (ja) | 2022-10-12 | 2024-04-23 | イーワイヤーライナー カンパニー リミテッド | 骨の表面の癒着型歯科スクリュー |
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CN115177414B (zh) * | 2022-09-14 | 2022-11-18 | 山东百多安医疗器械股份有限公司 | 一种可促进骨组织再生的颅骨修复板及其制备方法 |
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JP6917090B2 (ja) | 2021-08-11 |
JP6732276B2 (ja) | 2020-07-29 |
JP2020096986A (ja) | 2020-06-25 |
EP3263064A4 (en) | 2018-11-14 |
EP3263064B1 (en) | 2022-12-07 |
JPWO2016136913A1 (ja) | 2017-11-30 |
CN107405179A (zh) | 2017-11-28 |
JP6762034B2 (ja) | 2020-09-30 |
JP2020168429A (ja) | 2020-10-15 |
EP3263064A1 (en) | 2018-01-03 |
US20180235682A1 (en) | 2018-08-23 |
CN107405179B (zh) | 2020-06-26 |
US11234747B2 (en) | 2022-02-01 |
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