WO2017208318A1 - 骨プレートおよび骨プレートシステム - Google Patents
骨プレートおよび骨プレートシステム Download PDFInfo
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- WO2017208318A1 WO2017208318A1 PCT/JP2016/065960 JP2016065960W WO2017208318A1 WO 2017208318 A1 WO2017208318 A1 WO 2017208318A1 JP 2016065960 W JP2016065960 W JP 2016065960W WO 2017208318 A1 WO2017208318 A1 WO 2017208318A1
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- WIPO (PCT)
- Prior art keywords
- tibia
- bone plate
- screw
- screw holes
- bone
- Prior art date
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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
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
-
- 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
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
-
- 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
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8095—Wedge osteotomy devices
-
- 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
-
- 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
- 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
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8897—Guide wires or guide pins
-
- 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
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
-
- 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
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8052—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded
- A61B17/8057—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded the interlocking form comprising a thread
-
- 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
- A61F2002/2892—Tibia
Definitions
- the present invention relates to a bone plate and a bone plate system.
- a bone plate system having a bone plate and a screw for fixing the bone plate to a bone has been used in order to fix a fracture or an osteotomy portion and promote bone healing or osteosynthesis (for example, Patent Literature 1).
- Such a bone plate system is used, for example, for high tibial osteotomy (HTO) of osteoarthritis of the knee.
- the high tibial osteotomy is an operation in which the direction of the load biased inward due to deformation of the O-leg is corrected by cutting its own bone and changing the angle slightly to adjust the alignment and move it outward.
- high tibial osteotomy open wedge that corrects the angle by cutting the bone from the inside to the outside of the tibia, expanding the cut and inserting a trapezoidal or wedge-shaped artificial bone, etc.
- An Open Wedge (HTO) method a closed wedge HTO method in which a bone is cut into a wedge shape from the outside of the tibia and shortened to correct the angle are known.
- hybrid HTO Hybrid HTO
- Patent Document 1 discloses a bone plate system used in the open wedge method.
- Patent Document 2 discloses a bone plate system that is used to repair and fix each fractured part when a long bone such as a femur or tibia is fractured.
- the bone plate system of Patent Document 2 when the bone plate is fixed to the bone end portion with a screw, the axial direction of the screw can be rotated and changed.
- the hybrid HTO method is a new method that incorporates the advantages of both the open wedge method and the closed wedge method, and can be used for patients with more advanced knee osteoarthritis.
- the procedure is difficult and there is no bone plate dedicated to hybrid HTO.
- a complex bone plate for example, Patent Document 2 in which the screw fixing direction can be selected is used as a bone plate for a hybrid HTO.
- the screw fixing direction can be appropriately selected in order to fix the bone plate to the tibia according to the corrected tibia shape.
- the fixing strength of the bone plate is reduced, and it cannot withstand tibial fixation during a long correction period of one to two years, and the correction position is It may be lost or the bone plate or screw may break.
- the present invention has been made in view of the above-described circumstances, and provides a bone plate and a bone plate system having an optimized structure in consideration of adaptability to a tibial shape after correction performed by hybrid HTO.
- the purpose is to do.
- One aspect of the present invention is a band plate-like main body fixed along the longitudinal direction of the tibia to the outer surface of the tibia lower than the osteotomy surface formed on the outer surface of the tibia, and the main body A wide portion that is formed wider than the cut surface and is fixed along an outer peripheral surface of the tibia head of the tibia higher than the osteotomy surface, a connecting portion that connects the main body portion and the wide portion, and the wide portion A plurality of screw holes arranged in the body portion and the connecting portion at intervals and penetrating in the plate thickness direction, and an inner surface facing the tibia from the wide portion to the connecting portion,
- the curved portion has a curved shape that is continuously aligned according to a three-dimensional contour of the tibia so as to be twisted around an axis along the longitudinal direction of the tibia, and the wide portion is directed outward in the thickness direction with respect to the main body portion.
- Cormorants curvature of the side surface of the connecting portion is a bone plate configured to be greater than the curvature of the side surface of the connecting portion along the front of the tibia.
- the inner surface of the bone plate facing the tibia has a curved shape that substantially matches the three-dimensional contour of the tibia after the hybrid HTO operation, so that it follows the side shape of the tibia after the operation.
- a bone plate can be placed. Since it is a bone plate designed for hybrid HTO, it is not necessary to bend or sterilize the bone plate formed for fracture fixation before the operation, and the pre-operative preparation can be performed easily.
- the curvature of the side surface of the connecting portion along the back surface of the tibia is made larger than the curvature of the side surface of the connecting portion along the front surface of the tibia, thereby making it closer to the direction orthogonal to the screw direction.
- the tip of the screw inserted into the screw hole of the connecting portion can surely reach the bone behind the tibia where the bone density of the tibia is high. Thereby, the part which cannot obtain the support from an osteotomy surface can also be fixed firmly.
- the plurality of screw holes are provided with a plurality of first screw holes provided at intervals in the wide portion, and a plurality of second screw holes provided at intervals in the connecting portion.
- a first screw hole axis provided at a position on the back side of the tibia when attached to the tibia among the plurality of first screw holes.
- An axis and a second axis which is an axis of one second screw hole provided at a position on the front side of the tibia when attached to the tibia among the plurality of second screw holes. It is good also as arrange
- regulates the sequence direction of these 1st screw holes, and the axial direction of the said 1st screw hole are included.
- the angle formed by the first plane may be 80 ° or more and 90 ° or less. In this way, regardless of the difference in tibia length or the amount of correction due to differences in the patient's physique, the bone plate should be placed exactly along the outer surface of the tibia after correction. Can do. Further, the screw can be inserted in an optimum range that does not break through the joint surface and does not interfere with the artificial bone or the bone defect portion.
- a bone plate can be arrange
- the fitting property with respect to the tibia of a bone plate can be improved, preventing that the front-end
- the full length of a longitudinal direction being 100 mm or more and 120 mm or less, desirably 95 mm or more and 105 mm or less.
- Another aspect of the present invention is a bone plate system comprising: any one of the bone plates; and a plurality of screws fastened to the plurality of screw holes of the bone plate and fixing the bone plate to the tibia. It is.
- the bone plate facing the tibia since the inner surface of the bone plate facing the tibia has a curved shape that substantially matches the three-dimensional contour of the tibia after the hybrid HTO operation, the bone plate is arranged so as to follow the lateral shape of the tibia after the operation. Can be arranged.
- the tips of the screws inserted into the screw holes of the bone plate are fastened so as to be below the tibial joint surface, the portion with high bone density is prevented from breaking through the tibial joint surface.
- a screw can be fastened.
- the bone plate since the bone plate is designed not to project outward from the tibial head, it is possible to prevent the occurrence of pain due to skin irritation caused by the projection of the bone plate.
- the bone plate has a thickness of 3 ⁇ 1 mm, and when the bone plate is fastened by the plurality of screws, the bone when the vertical load is applied in the longitudinal axis direction of the bone plate
- the amount of bending of the plate may be 0.5 mm ⁇ 0.3 mm / kgf.
- the bone plate and the screw may include a material having high biocompatibility. By doing in this way, it can be set as the implant of the material with sufficient biocompatibility provided with sufficient intensity
- the said screw is a hollow screw which has a through-hole which can penetrate a guide pin
- the thickness of the mountain diameter of the said screw is ⁇ 5.0 mm or more and 5.8 mm or less, and the thickness of a valley diameter is ⁇ 4. It is good also as 5 mm or more and 5.3 mm or less, and the hollow shaft diameter of the said hollow screw being (phi) 1.8mm or more and 2.8mm or less.
- the bone By setting in such a range, for example, in the bone end portion, the bone can enter the distal end portion of the hollow hole, so that the fixability can be improved.
- adverse effects due to screw holes generated in the tibial cancellous bone after removal of the bone plate can be minimized.
- the inner surface from the wide part of the bone plate to the connecting part has a curved shape that is continuous so as to be twisted, the fastening direction of the screw is not uniform, and the fixing direction of the screw is likely to be wrong.
- the screw Since the screw has a through-hole that can penetrate the guide pin, the screw can be fastened using the through-hole provided in the screw with the guide pin as a guide. For this reason, workability
- the present invention it is possible to provide a bone plate and a bone plate system dedicated to the hybrid HTO that have improved compatibility and fixation to the tibia shape after correction that has been performed by the hybrid HTO.
- FIG. 1 is an overall view showing a bone plate system according to an embodiment of the present invention. It is a top view which shows the bone plate of FIG. It is a top view at the time of inserting a screw in the bone plate of FIG. It is a side view which shows the bone plate of FIG. It is a side view which shows the bone plate of FIG. It is a front view which shows the bone plate of FIG. 2A. It is a side view which shows the angle which the axial direction of the screw inserted in the wide part and the straight line which connects the longitudinal direction upper end part and lower end part in a bone plate make. It is a figure which shows the case where a guide pin is inserted in the screw used for the bone plate system of FIG.
- FIG. 6B is an enlarged view of the screw head of FIG. 6A.
- the bone plate system 2 includes a bone plate 1 and a plurality of screws 3 for fixing the bone plate 1 to the higher outer surface of the tibia X.
- the bone plate 1 is an open wedge method and a closed type, which are performed when the correction angle is large due to highly medial osteoarthritis, or when osteoarthritis is also observed in the patella and femoral joint. It is used in a so-called hybrid HTO that incorporates the advantages of the wedge method, and is an elongated strip-like member that is fixed to the high lateral surface of the tibia X after osteotomy.
- the bone plate 1 used in the hybrid HTO includes an elongated strip-like body portion 1a, a wide portion 1b formed wider than the body portion 1a, and a body portion 1a. And a connecting portion 1c that connects the wide portion 1b. Further, as shown in FIG. 2A, the bone plate 1 includes a plurality of screw holes 4 that are arranged in the wide portion 1b, the main body portion 1a, and the connecting portion 1c with a space therebetween and penetrate in the plate thickness direction. Yes.
- the plurality of screw holes 4 includes a plurality of screw holes 4a provided in the main body portion 1a, a plurality of first screw holes 4b provided in the wide portion 1b, and a plurality of second holes provided in the connecting portion 1c.
- Screw holes 4c. 2A shows an example in which four screw holes 4a are provided in the main body 1a, two screw holes 4b are provided in the wide portion 1b, and two screw holes 4c are provided in the connecting portion 1c.
- the number of screw holes is not limited to this and may be increased or decreased.
- the main body 1a is formed in a strip shape so as to follow the lower outer surface of the tibia X. Further, the inner surface facing the tibia X from the wide portion 1b to the connecting portion 1c has a continuously curved shape so as to be twisted around an axis along the longitudinal direction of the tibia X as shown in FIG.
- the torsion angle of the bone plate is, for example, 13 ⁇ 5 ° so as to be substantially aligned according to the three-dimensional contour when attached to the tibia X, and the portion where the torsion is maximum is the screw hole 4c. If it is in the vicinity, both the fixing strength of the screw and the shape compatibility of the plate can be achieved.
- the wide portion 1b is offset outward in the plate thickness direction with respect to the main body portion 1a.
- This offset amount is 15 mm or more and 25 mm or less in this embodiment.
- the bone plate 1 according to the present embodiment is formed so that the curvature of the side surface of the connecting portion 1c when viewed from both side surfaces is different, as shown in FIGS. 3A and 3B.
- the curvature of the side surface of the connecting portion 1c along the back surface of the tibia X (FIG. 3B) is the tibia when the bone plate 1 is attached to the tibia X.
- the curvature radius on the side along the back surface of the tibia X is 12.5 ⁇ 7.5 mm
- the curvature radius on the side along the front surface is 90 ⁇ 30 mm.
- the screw 3 is inserted into the screw hole 4 in the thickness direction from one side to the other side.
- the screw 3a is inserted into the screw hole 4a provided in the main body 1a
- the screw 3c is inserted into the screw hole 4c provided in the connecting portion 1c.
- a screw 3b is inserted into the screw hole 4b of the wide portion 1b.
- each screw hole 4c A and the axial line B of the screw 3c fastened to the screw hole 4c (the right side in FIG. 2A) of the screw hole 4c provided in the connecting portion 1c that has a large curvature on the side surface are substantially flush with each other.
- the threading angle of each screw hole is set so as to be arranged along ⁇ .
- a first incision surface is formed by forming an incision in an inclined direction, and further, an incision is formed inward from the outer surface of the tibia X that is spaced from the osteotomy surface in the longitudinal axis direction.
- the wedge-shaped bone fragment between the first osteotomy surface and the second osteotomy surface is removed using a predetermined instrument.
- the bone is placed on the outer surface of the tibia X at a position where it moves from the diaphysis to the end.
- the screws 3 are passed through the screw holes 4 provided in the bone plate 1 from the outside toward the inside in the thickness direction and fastened to the tibia X.
- the tibia X after osteotomy correction can support a vertical load by the bone plate 1 fixed by the screw 3 across the incision.
- the screw 3b inserted into the screw hole 4b of the wide portion 1b is fastened so as to be disposed on a plane substantially parallel to the tibial joint surface. For this reason, the bone plate can be fixed so that the tip of the screw 3b does not face the tibial joint surface direction.
- the tip of the screw 3b can be directed in the direction where the bone density of the tibia X is thick, the bone quality is not good due to osteoporosis or the like, and the cancellous bone is in a healthy state even when the fixation condition is bad. It is possible to improve the fixing property while maintaining the same.
- the curvature of the side surface of the connecting portion 1c on the side along the back surface of the tibia X is such that the bone plate 1 is attached to the tibia X. Since it is formed to be larger than the curvature of the side surface of the connecting portion 1c on the side along the front surface of the tibia X (FIG. 3A), the bone plate 1 is substantially aligned according to the three-dimensional contour of the tibia X after the hybrid HTO operation. Can be arranged.
- the threading angle of each screw hole is set so that the axis B of the screw 3c fastened to the screw hole 4c on the side having a large curvature on the side surface is arranged along substantially the same plane. Therefore, it can be brought close to the direction orthogonal to the direction of the screw 3, and the number of screwed threads can be increased to achieve more reliable fixing.
- the tip of the screw 3 can be accurately reached behind the tibia X where the bone density of the tibia X is high. Fixability can be improved.
- the bone plate 1 has an offset amount of the wide portion 1b with respect to the main body portion 1a of 15 mm or more and 25 mm or less, so that the bone on the outer surface of the corrected tibia X
- the plate 1 can be placed along the snug. Further, the bone plate 1 fits to the tibia X while preventing the tip of the screw 3c inserted into the screw hole 4c of the connecting portion 1c from interfering with the tip of the screw 3b inserted into the screw hole 4b of the wide portion 1b. Can increase the sex.
- the straight line connecting the upper end and the lower end in the longitudinal direction of the bone plate 1, the straight line defining the arrangement direction of the screw holes 4b, and the axial direction of the screw holes 4b are included.
- the angle formed by the plane is 80 ° or more and 90 ° or less
- the tip of the screw 3c inserted into the screw hole 4c of the connecting portion 1c is exactly the same as that of the screw 3b inserted into the screw hole 4b of the wide portion 1b.
- the tip of the screw 3c inserted into the screw hole 4c of the connecting portion 1c can be prevented from interfering with the tip of the screw 3b inserted into the screw hole 4b of the wide portion 1b. be able to.
- tip of the screw 3c inserted in the screw hole 4c of the connection part 1c can be fastened so that it may reach
- the bone plate 1 by setting the total length in the longitudinal direction of the bone plate 1 to 100 mm to 120 mm, preferably 95 mm to 105 mm, regardless of the difference in the length of the tibia X and the correction amount due to the difference in the patient's physique.
- the bone plate 1 can be placed closely along the outer surface of the tibia X.
- the vertical load W in the longitudinal axis direction of the bone plate 1 (the bone axis direction of the tibia X)
- the amount of bending of the bone plate 1 when applied is designed to be within the range of 0.5 mm ⁇ 0.3 mm / kgf, thereby correcting the bone plate 1 attached. It is possible to suppress stress shielding for the inner tibia X (a phenomenon in which a load is hardly applied to the bone).
- the bone plate 1 and the screw 3 are formed from a metal material having high biocompatibility. Even when such a material is disposed on the human body, safety to the human body is relatively high.
- a biocompatible material used for the bone plate 1 and the screw 3 a titanium alloy that can ensure sufficient strength and elasticity over a long period of time is optimal.
- the biocompatible material is not limited to the titanium alloy, and other materials such as a cobalt chromium alloy and stainless steel can also be used.
- Screw 3 of the present embodiment as shown in FIGS. 6A and 6B, a hollow screw 3 having a through hole 6 which can penetrate the guide pin 5, the thickness d 1 of the crest diameter of the screw 3 .phi.5 .0mm above 5.8mm or less, more ⁇ 4.5mm the thickness d 2 of the root diameter 5.3mm or less, the hollow shaft diameter d 3 of the screw 3 may be less 2.8mm or more Fai1.8Mm.
- the screw 3 of the present embodiment is designed to have a thickness that does not break due to sufficient absorption of the load in the vertical direction even when fastened and fixed to the tibia X for a long period of time.
- the bone can enter the distal end portion of the hollow hole, so that the fixability can be improved.
- the thickness of the screw 3 does not become too thick, the bad influence by the screw hole which arises in the cancellous bone of the tibia X after extraction of the bone plate 1 can be suppressed to the minimum.
- the screw 3 according to the present embodiment has the through hole 6 that can penetrate the guide pin 5, the screw 3 is fastened with the guide pin 5 as a guide by using the through hole 6 provided in the screw 3. Therefore, the workability of the fastening work can be improved.
Abstract
Description
高位脛骨骨切り術にはいくつかの種類があり、脛骨の内側から外側に向かって骨を切り、切込みを開大して台形または楔型の人工骨等を挿入することで角度を矯正するオープンウエッジ(Open Wedge HTO)法、脛骨の外側から骨を楔型に切り取り、短縮させて角度を矯正するクローズドウエッジ法(Closed Wedge HTO)等が知られている。
また、特許文献2には、大腿骨や脛骨等の長骨が骨折した際に、骨折した各部分を修復固定するのに用いられる骨プレートシステムが開示されている。特許文献2の骨プレートシステムでは、骨プレートをスクリュにより骨端部に固定する際に、スクリュの軸線方向を回転して変更できるようになっている。
ハイブリッドHTO用に設計された骨プレートであるので、術前に骨折固定用に形成された骨プレートの曲げ加工や滅菌処理等をする必要が無く、簡便に術前準備を行うことができる。
また、脛骨に取り付けたときに脛骨の背面に沿う連結部の側面の曲率を、脛骨の正面に沿う連結部の側面の曲率よりも大きくしたことで、スクリュの方向に直交する方向に近づけることができ、噛み合うねじ山数を増やしてより確実な固定を図ることができる。また、連結部のネジ孔に挿入されるスクリュの先端を、脛骨の骨密度が高い脛骨後方の骨に、確実に到達させることができる。これにより、骨切面からの支持を得られない部分も強固に固定することが出来る。
このようにすることで、患者の体格の違いに起因する脛骨の長さの違いや、矯正量の違いにかかわらず、骨プレートを矯正後の脛骨の外側面にぴったりと沿わせて配置することができる。
また、関節面を突き破ることがなく、かつ、人工骨や骨欠損部と干渉することがない最適な範囲にスクリュを挿入することができる。
このようにすることで、矯正後の脛骨の外側面に骨プレートをぴったりと沿わせて配置することができる。
また、連結部に挿入されたスクリュの先端と、幅広部に挿入されたスクリュの先端が干渉することを防ぎながら、骨プレートの脛骨に対するフィット性を高めることができる。
このようにすることで、患者の体格の違いに起因する脛骨の長さの違いや、矯正量の違いにかかわらず、ハイブリッドHTOを施術した後の脛骨の外側面に骨プレートを適切にフィットさせて配置することができる。また、骨プレートがこのような寸法範囲に設定されているため、スクリュを適切な方向・位置に締結することができる。
また、骨プレートが脛骨頭に対して外側に張り出すことが無いデザインとされているので、骨プレートの張り出しによる皮膚への刺激に起因する痛みの発生を防ぐことができる。
このように骨プレートの撓み量を調整したことで、骨プレート装着中の脛骨に対するストレスシールディング(骨に荷重が加わりにくくなる現象)を抑制することができる。
このようにすることで、十分な強度及び弾性を備えた生体適合性の高い材質のインプラントとすることができる。
上記態様によれば、年単位にわたる長期間の間、骨プレートがスクリュにより脛骨にネジ止め固定された場合であっても、鉛直方向の荷重を十分に吸収してスクリュが折れることがない太さに設計されている。このような範囲に設定することで、例えば骨端部においては、中空穴の先端部に骨が入り込むことにより、固定性を向上させることができる。
また、骨プレート抜去後の脛骨海綿骨内に生じるスクリューホールによる悪影響を最小限に留めることができる。
骨プレートの幅広部から連結部にかけての内面は、ねじれるように連続した曲面形状とされているので、スクリュの締結方向も一様では無く、スクリュの固定方向を誤りやすいが、上記態様においては、スクリュは、ガイドピンを貫通可能な貫通孔を有するので、スクリュに設けた貫通孔を利用して、ガイドピンをガイドとしてスクリュを締結していくことができる。このため、締結作業の作業性を向上することができる。
本実施形態に係る骨プレートシステム2は、図1に示されるように、骨プレート1と、該骨プレート1を脛骨Xの高位外側面に固定するための複数のスクリュ3とを備えている。
図2Bに示されるように、本体部1aに設けられたネジ孔4aには、スクリュ3aが挿入され、連結部1cに設けられたネジ孔4cには、スクリュ3cが挿入される。また、幅広部1bのネジ孔4bには、スクリュ3bが挿入される。
また、図2Bに示されるように、幅広部1bに設けたネジ孔4bのうち、側面の曲率が大きく形成されている側のネジ孔4b(図2Aにおいて左側)に締結されたスクリュ3bの軸線Aと、連結部1cに設けたネジ孔4cのうち、側面の曲率が大きく形成されている側のネジ孔4c(図2Aにおいて右側)に締結されたスクリュ3cの軸線Bとが、略同一平面αに沿って配置されるようにそれぞれのネジ孔のネジ切り角度が設定されている。
本実施形態に係る骨プレートシステム2を用いてハイブリッドHTO法により変形膝関節症の高位脛骨骨切り術を行うには、脛骨Xの高位外側面から内側に向かって、脛骨Xの長手軸に対して傾斜する方向に切り込みを形成して第1の骨切面を形成し、さらに、この骨切り面よりも長手軸方向に離間した脛骨Xの外側面から内側に向かって切込みを形成して第2の骨切面を形成し、第1の骨切面と第2の骨切面の間の楔形の骨片を、所定の器具を用いて除去する。そして、第1の骨切面と第2の骨切面をあわせて閉鎖することで脛骨の軸線方向を外反させた後、脛骨Xの骨幹部から端部に向かって移行する位置の外側面に骨プレート1を沿わせて固定する。具体的には、図1に示されるように、脛骨Xの外側面における、第1の骨切面と第2の骨切面をあわせて閉鎖した閉鎖面Pの長手方向下方に骨プレート1の本体部1aがあてがわれ、閉鎖面の長手方向上方に幅広部1bおよび連結部1cがあてがわれる。
また、連結部1cのネジ孔4cに挿入されたスクリュ3cの先端と、幅広部1bのネジ孔4bに挿入されたスクリュ3bの先端が干渉することを防ぎながら、骨プレート1の脛骨Xに対するフィット性を高めることができる。
骨プレート1およびスクリュ3に使用される生体適合材料としては、長期間にわたる十分な強度や弾性を確保できるチタン系合金が最適である。もちろん、生体適合材料としてはチタン合金に限るものではなく、これ以外にも、コバルトクロム合金、ステンレス等、その他の材料を用いることもできる。
また、スクリュ3の太さが太くなりすぎることが無いので、骨プレート1抜去後の脛骨Xの海綿骨内に生じるスクリューホールによる悪影響を最低限に留めることができる。
1a 本体部
1b 幅広部
1c 連結部
2 骨プレートシステム
3,3a,3b,3c スクリュ
4,4a,4b,4c ネジ孔
5 ガイドピン
6 貫通孔
X 脛骨
第1の軸線 A
第2の軸線 B
Claims (9)
- 脛骨の外側面に形成された骨切面よりも低位の前記脛骨の外側面に、該脛骨の長手方向に沿って固定される帯板状の本体部と、
該本体部よりも幅広に形成され、前記骨切面よりも高位の前記脛骨の脛骨頭の外周面に沿って固定される幅広部と、
前記本体部と前記幅広部とを連結する連結部と、
前記幅広部、前記本体部および前記連結部に相互に間隔をあけて配列され、板厚方向に貫通する複数のネジ孔と、を備え、
前記幅広部から前記連結部までの前記脛骨に面する内面が、前記脛骨の長手方向に沿う軸線回りにねじれるように連続して前記脛骨の三次元輪郭に従って略整合する曲面形状を有し、
前記幅広部が、前記本体部に対して板厚方向外方に向けてオフセットされ、
前記脛骨に取り付けたときに前記脛骨の背面に沿う前記連結部の側面の曲率が、前記脛骨の正面に沿う前記連結部の側面の曲率よりも大きくなるよう構成されている骨プレート。 - 前記複数のネジ孔が、
前記幅広部に間隔をあけて設けられた複数の第1のネジ孔と、
前記連結部に間隔をあけて設けられた複数の第2のネジ孔と、を有し、
前記複数の第1のネジ孔のうち、前記脛骨に取り付けたときに前記脛骨の背面側となる位置に設けられた一の第1のネジ孔の軸線である第1の軸線と、前記複数の第2のネジ孔のうち、前記脛骨に取り付けたときに前記脛骨の正面側となる位置に設けられた一の第2のネジ孔の軸線である第2の軸線とが、略同一平面に沿って配置されている請求項1に記載の骨プレート。 - 前記骨プレートにおける長手方向上端部と下端部とを結ぶ直線と、前記複数の第1のネジ孔の配列方向を規定する直線と前記第1のネジ孔の軸線方向とを含む第1の平面とがなす角度が、80°以上90°以下である請求項1に記載の骨プレート。
- 前記オフセットのオフセット量が15mm以上25mm以下である請求項1に記載の骨プレート。
- 長手方向の全長が100mm以上120mm以下、望ましくは95mm以上105mm以下である請求項1に記載の骨プレート。
- 請求項1から請求項5のいずれかに記載の骨プレートと、
該骨プレートの前記複数のネジ孔のそれぞれに締結され、前記骨プレートを前記脛骨に固定する複数のスクリュと、を備える骨プレートシステム。 - 前記骨プレートの板厚が3±1mmであり、
前記複数のスクリュにより前記骨プレートを締結した状態において、前記骨プレートの長手軸方向に鉛直荷重が加えられたときの前記骨プレートの撓み量が、0.5mm±0.3mm/kgfとなるよう構成されている請求項6に記載の骨プレートシステム。 - 前記骨プレートおよび前記スクリュが、生体適合性の高い材料を含む請求項7に記載の骨プレートシステム。
- 前記スクリュが、ガイドピンを貫通可能な貫通孔を有する中空スクリュであり、
前記スクリュの山径の太さがφ5.0mm以上5.8mm以下、谷径の太さがφ4.5mm以上5.3mm以下であり、
前記中空スクリュの中空軸径がφ1.8mm以上2.8mm以下である、請求項7に記載の骨プレートシステム。
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EP16903946.8A EP3466358B1 (en) | 2016-05-31 | 2016-05-31 | Bone plate and bone plate system |
KR1020187032965A KR20180134396A (ko) | 2016-05-31 | 2016-05-31 | 뼈 플레이트 및 뼈 플레이트 시스템 |
PCT/JP2016/065960 WO2017208318A1 (ja) | 2016-05-31 | 2016-05-31 | 骨プレートおよび骨プレートシステム |
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PH12018502485A PH12018502485A1 (en) | 2016-05-31 | 2018-11-26 | Bone plate and bone plate system |
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JP2020175197A (ja) * | 2019-04-18 | 2020-10-29 | 国立大学法人福井大学 | 骨を固定するためのプレート |
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EP3466358A1 (en) | 2019-04-10 |
PH12018502485A1 (en) | 2019-09-23 |
KR20180134396A (ko) | 2018-12-18 |
SG11201809487PA (en) | 2018-11-29 |
EP3466358A4 (en) | 2020-01-01 |
CN109310457B (zh) | 2022-05-06 |
JPWO2017208318A1 (ja) | 2019-03-22 |
EP3466358B1 (en) | 2022-08-03 |
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