WO2012115103A1 - Osteosynthesis plate former and method for forming osteosynthesis plate - Google Patents
Osteosynthesis plate former and method for forming osteosynthesis plate Download PDFInfo
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- WO2012115103A1 WO2012115103A1 PCT/JP2012/054123 JP2012054123W WO2012115103A1 WO 2012115103 A1 WO2012115103 A1 WO 2012115103A1 JP 2012054123 W JP2012054123 W JP 2012054123W WO 2012115103 A1 WO2012115103 A1 WO 2012115103A1
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- osteosynthesis plate
- mold
- rod
- osteosynthesis
- female
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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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00526—Methods of manufacturing
-
- 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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
Definitions
- the present invention relates to a molding tool and a molding method for an osteosynthesis plate, and more particularly to a simple molding tool and a molding method for molding an osteosynthesis plate made of a thermoplastic polymer into a three-dimensional curved surface shape.
- osteosynthesis plates made of biodegradable and absorbable thermoplastic polymers have led to the fixation of fracture sites and osteotomy sites.
- osteosynthesis plate should match the contoured shape of the bone and other anatomical shapes at that site. It is desired to form the material into a three-dimensional curved surface shape or bend it.
- a bifurcated jaw portion 102a and a bifurcated jaw portion 102a are provided at the tip side of the pivots 101 of the two arms 100a and 100b.
- a “yatsuko-type” tool 103 provided with a rod-like jaw 102b that meshes with the jaw 102a (Patent Document 1).
- the tool 103 holds the rod portion 104a of the osteosynthesis plate 104 between the bifurcated jaw portion 102a and the rod-like jaw portion 102b while fixing one end portion of the osteosynthesis plate 104 with another tool 105.
- the rod portion 104a of the osteosynthesis plate 104 is bent.
- the present applicant as a processing tool for bending an osteosynthesis plate made of a thermoplastic polymer into a step shape, rotates the left and right arms provided with a clamping portion at the tip for clamping the osteosynthesis plate at the intersection.
- a forceps-type processing instrument that is pivotally attached, and the opposing surfaces of the clamping part are divided into a plurality of clamping surfaces having different lateral widths by gradually reducing the lateral width toward the tip, and facing each other.
- a processing tool having stepped portions on both side surfaces of the sandwiching portion corresponding to the stepwise reduction of the lateral width of the surface has already been proposed (Patent Document 2).
- This forceps-type processing instrument selects a clamping surface having a desired lateral width of the clamping part, clamps the osteosynthesis plate softened by heating with the selective clamping surface of the clamping part, Convenient processing tool that can accurately bend a flat osteosynthesis plate into a step-shaped osteosynthesis plate having a desired step size by folding the other end along the side of the clamping part in opposite directions. It is.
- the bioabsorbable mesh when the bioabsorbable mesh is transplanted to the implant receiving site on the bone, the bioabsorbable mesh is heated to a temperature exceeding its glass transition temperature and directly placed on the implant receiving site on the bone.
- a method for forming a bioabsorbable mesh into a three-dimensional shape by contouring the anatomical three-dimensional shape of the implant receiving site and then cooling and solidifying to a temperature lower than the glass transition temperature is known (Patent Literature). 3).
- the tool of Patent Document 1 can bend the osteosynthesis plate
- the osteosynthesis plate is three-dimensionally arranged so as to substantially match the anatomical shape of the bone at the fracture site or osteotomy site.
- this tool has a problem in that the bending angle of the osteosynthesis plate varies depending on the operator, and even the same operator has a problem that the bending angle is slightly different at each processing.
- the processing tool disclosed in Patent Document 2 is an excellent tool that can accurately bend a flat osteosynthesis plate into a step-shaped osteosynthesis plate having a desired step size, no matter who bends it.
- this processing tool is also incapable of forming the osteosynthesis plate into a three-dimensional curved surface shape so as to substantially match the anatomical shape of the bone at the fracture site or osteotomy site.
- the bioabsorbable mesh forming method of Patent Document 3 can form a bioabsorbable mesh into a three-dimensional curved surface shape that substantially matches the anatomical three-dimensional shape of the implant receiving site. Since the bioabsorbable mesh heated to a temperature higher than the temperature is directly placed on the implant receiving site and molded, the implant receiving site may be adversely affected by heat, and it is difficult to say that it is a safe molding method. Although this molding method can be applied to bioabsorbable meshes with a large area, it is difficult to say that it is practical and difficult to apply as an osteosynthesis plate that is smaller and has a large number of used. there were.
- the present invention has been made under the above circumstances, and the problem to be solved is an osteosynthesis plate molding tool capable of molding an osteosynthesis plate made of a thermoplastic polymer into a three-dimensional curved surface shape with good reproducibility, and this molding.
- An object of the present invention is to provide a simple and safe molding method using a tool.
- an osteosynthesis plate forming tool is an osteosynthesis plate made of a thermoplastic polymer on two members that can move relatively along a common axis or two parallel axes.
- a male mold and a female mold each having a molding surface having a three-dimensional curved surface that is molded with a sandwiched therebetween are attached to face each other in the axial direction.
- the male mold and the female mold it is preferable to attach the male mold and the female mold to the two members in a replaceable manner. It is preferable that at least one of the male mold and the female mold has a molding surface having a width that covers the entire surface of the osteosynthesis plate when the osteosynthesis plate is molded.
- the two members are preferably provided with grips, respectively, and further preferably provided with urging means for urging the two members in directions away from each other along the axis.
- two members can be moved relative to each other along a common longitudinal axis, and are slidably inserted into the tubular member.
- the female die protrudes to one side of the lower end portion of the cylindrical member and is replaceably attached, and the male die protrudes from the lower end of the rod-like member to one side through the longitudinal groove portion of the cylindrical member. It is attached to the rod so as to be replaceable, and is opposed to the female die in the direction of the vertical axis.
- a grip part is provided in the upper end of a rod-shaped member, and the upper end of a cylindrical member, respectively, and the compression coil spring is arrange
- it is preferably stretched between a spring receiving portion formed on the outer peripheral surface of the rod-shaped member and a spring receiving portion formed on the inner peripheral surface of the cylindrical member.
- the osteosynthesis plate forming method according to the present invention includes a step of sandwiching an osteosynthesis plate made of a thermoplastic polymer between the male mold and the female mold of the osteosynthesis plate molding tool according to the present invention, and the osteosynthesis plate as a male mold.
- the process of heating and softening above the softening temperature while sandwiched between the female mold and the female mold, and the process of cooling and solidifying the softened osteosynthesis plate below the softening temperature while sandwiched between the male mold and the female mold It is characterized by including these.
- the osteosynthesis plate molding tool of the present invention is used to mold an osteosynthesis plate made of a thermoplastic polymer according to the molding method of the present invention
- the two members are placed on a common axis or two parallel axes.
- the osteosynthesis plate made of a thermoplastic polymer is sandwiched while being elastically deformed between the molding surfaces of the male mold and the female mold by relatively moving along the surface.
- the osteosynthesis plate is heated and softened above its softening temperature, so that the osteosynthesis plate is in accordance with the three-dimensional curved shape of the molding surface of the male mold and the female mold. Plastically deform.
- the plastically deformed osteosynthesis plate is sandwiched between the male mold and the female mold, and cooled to a temperature lower than the softening temperature to be solidified, so that the molding surface of the male mold and the female mold has a three-dimensional curved surface shape.
- the shape of the osteosynthesis plate is fixed to the street and molded into a three-dimensional curved surface with good reproducibility.
- the molding method using the osteosynthesis plate molding tool of the present invention is a method of cooling after heating and softening the osteosynthesis plate between the male mold and the female mold having a molding surface having a three-dimensional curved shape.
- the osteosynthesis plate can be molded with good reproducibility according to the three-dimensional curved surface shape of the male and female molding surfaces, Since the mesh softened by heating is not placed directly on the implant receiving site of the living bone and molded into a three-dimensional curved surface shape as in Patent Document 3, it is safe.
- a male mold and a female mold are attached to two members in a replaceable manner.
- the male mold and the female mold are provided with a male surface having a molding surface having a desired three-dimensional curved shape.
- the osteosynthesis plate can be formed into a desired three-dimensional curved surface shape.
- at least one of the male mold and the female mold is provided with a molding surface having a width that covers the entire surface of the osteosynthesis plate when molding the osteosynthesis plate, even when the osteosynthesis plate is partially molded, The entire surface of the osteosynthesis plate can be stably supported by the molding surface, and the osteosynthesis plate can be partially molded with high accuracy.
- the two members each provided with the grip portion can easily move the two members by gripping the grip portion by hand, so that the male mold and the female mold This makes it easier to sandwich the osteosynthesis plate.
- biases the two members in the direction which separates along an axis line only moves the two members by the urging
- the osteosynthesis plate forming tool of the preferred specific form described above is simple in structure and can be manufactured at low cost, and has good operability, and relatively moves the cylindrical member and the rod-shaped member along the vertical axis.
- a three-dimensional curved surface shape can be formed with good reproducibility by sandwiching an osteosynthesis plate between the male mold and the female mold.
- molding tool is shown, (a) is the top view, (b) is the back view, (c) is the sectional drawing.
- molding tool is shown, (a) is the front view, (b) is the top view, (c) is the sectional drawing.
- mold is shown, (a) is the front view, (b) is the side view, (c) is the back view, (d) is the bottom view.
- mold is shown, (a) is the front view, (b) is the top view, (c) is the back view, (d) is the sectional drawing.
- A) is a plan view of the material plate of the osteosynthesis plate, (b) is a plan view showing an example of the osteosynthesis plate cut out from the material plate, (c) is the osteosynthesis shaped into a three-dimensional curved surface shape It is a perspective view of a plate.
- FIG. 4 shows still another example of a male mold, wherein (a) is a front view thereof, (b) is a plan view thereof, (c) is a bottom view thereof, (d) is a side view thereof, and (e) is a rear view thereof.
- FIG. 4 shows still another example of a male mold, wherein (a) is a front view thereof, (b) is a plan view thereof, (c) is a bottom view thereof, (d) is a side view thereof, and (e) is a rear view thereof.
- FIG. 4 shows still another example of a male mold, wherein (a) is a front view thereof, (b) is a plan view thereof, (c) is a bottom view thereof, (d) is a side view thereof, and (e) is a rear view thereof.
- FIG. 4 shows still another example of a male mold, wherein (a) is a front view thereof, (b) is a plan view thereof, (c) is a bottom view thereof, (d) is a side view thereof, and (e) is a rear view thereof.
- mold is shown, (a) is the front view, (b) is the top view, (c) is the bottom view, (d) is the side view.
- a rod-like member 1 is slidably inserted into a cylindrical member 2, and these two members 1 and 2 are vertically moved along a common longitudinal axis C1. It is comprised so that it can move relatively.
- the rod-shaped member 1 is configured as a rod-shaped member having a different diameter with a cylindrical body 1 a fitted on the upper half thereof, and the lower end of the cylindrical body 1 a is the upper end of the compression coil spring 4. It becomes the spring receiving part 1b which receives.
- the grip part 3A is attached to the upper end of the rod-shaped member 1 in the T shape with the screw 3c with a knurled knob.
- the cylindrical member 2 is formed by integrally connecting and fixing a square cylindrical portion 2 b to the lower end of the cylindrical portion 2 a, and the upper end of the cylindrical portion 2 a of the cylindrical member 2 is A grip portion 3B that is paired with the grip portion 3A is fixed in a T-shape by welding.
- a spring receiving portion 2 c is formed on the inner peripheral surface of the connecting portion between the cylindrical portion 2 a and the rectangular tube portion 2 b of the cylindrical member 2, and the spring receiving portion on the outer peripheral surface of the spring receiving portion 2 c and the rod-shaped member 1.
- a compression coil spring 4 is stretched between the portions 1b as urging means for urging the rod-like member 1 and the cylindrical member 2 in directions away from each other along a common longitudinal axis C1.
- the rectangular tube portion 2b of the cylindrical member 2 is a rectangular tube portion having a substantially square cross-sectional shape in which the length of one side is larger than the outer diameter of the cylindrical portion 2a, as shown in FIGS.
- a vertical groove 2d is formed on one side surface (front side surface) of the rectangular tube portion 2b.
- substrate 5 is provided in the right-and-left both sides and rear side of the lower end of this square cylinder part 2b, and the horizontal board
- a rod 7 is connected to the lower end of the rod-shaped member 1 at a right angle through a connecting member 6, and this rod 7 passes through the vertical dividing groove 2 d of the rectangular tube portion 2 b of the cylindrical member 2 and is on one side (front). Sticks out.
- the male mold 8 is attached so as to be detachable and replaceable by fitting the through hole 8a of the male mold 8 into the rod 7.
- two pins 9, 9 projecting to one side (front) are implanted at the lower end portions of the left and right side wall portions of the rectangular tube portion 2 b of the tubular member 2.
- the female mold 10 can be attached to and detached from the male mold 8 in the direction of the vertical axis C1 (vertical direction). Installed on.
- the male mold 8 has a substantially circular planar shape as shown in FIG. 5 (a). As shown in FIGS. 5 (b) and 5 (c), the through-hole 8a penetrating in the front-rear direction (the rod 7 is inserted). The lower surface of the male mold 8 is a convex spherical surface 8b as shown in FIGS. 5B and 5C.
- the female die 10 has a substantially square planar shape as shown in FIG. 6 (b). As shown in FIG. 6 (a), the female die 10 has two through holes 10a and 10a (through the front and rear direction).
- a through hole into which the pins 9 and 9 are inserted is formed, and the upper surface of the female die 10 is a concave spherical shaped molding surface 10b (convex spherical surface of the male die 8) as shown in FIG. A concave spherical shaped molding surface corresponding to the shaped molding surface 8b).
- the molding surfaces 8b and 10b of the male mold 8 and the female mold 10 are not limited to the convex spherical shape and the concave spherical shape as in this embodiment, but have an anatomical shape of a fracture site or an osteotomy site. Needless to say, various three-dimensional curved surface shapes that substantially match each other can be obtained.
- the male mold 8 and the female mold 10 of this embodiment are provided with molding surfaces 8b and 10b that are wide enough to cover both surfaces of the osteosynthesis plate, but at least one molding surface of the male mold 8 and the female mold 10 is provided. If the molding surface is wide enough to cover the entire surface of the osteosynthesis plate, the molding surface can stably support at least the entire surface of the osteosynthesis plate, and the osteosynthesis plate can be partially molded with high accuracy. It is.
- the osteosynthesis plate is cut out from a material plate made of a thermoplastic polymer in advance.
- the material plate is not particularly limited as long as it is made of a thermoplastic polymer, and there are no particular limitations on the polymer type, thickness, presence or absence of pores, etc., but poly-L-lactic acid, poly-D, L-lactic acid or their Biodegradable and absorbable thermoplastic polymers such as copolymers and lactic acid-polyglycolic acid copolymers, and a plate with an infinite number of holes and a thickness of about 1 mm, and the above biodegradable and absorbable thermoplastic polymers
- a plate having a thickness of about 1 mm having a myriad of holes made of a composite material containing bioceramic powder particles such as hydroxyapatite (HA) or tricalcium phosphate (TCP) is preferably used.
- the rod-like member 1 and the cylindrical member 2 are moved along the vertical axis C1 while gripping the grip portions 3A, 3B of the osteosynthesis plate forming tool by hand.
- the osteosynthesis plate P is not displaced from both the molds 8 and 10 between the molding surface 8 b of the male mold 8 and the molding surface 10 b of the female mold 10. Is slightly elastically deformed and sandwiched.
- the osteosynthesis plate P made of poly-L-lactic acid or poly-D, L-lactic acid has a certain degree of flexibility, so there is no fear of cracking.
- the osteosynthesis plate P is sandwiched between the male mold 8 and the female mold 10, and the osteosynthesis plate P is heated and softened to the softening temperature or higher in the next process as it is, and the gripping portion 3A of the osteosynthesis plate forming tool is While further tightening 3B by hand, the rod-shaped member 1 and the cylindrical member 2 are relatively moved in the vertical direction along the longitudinal axis C1, and the osteosynthesis plate P is formed on the molding surfaces 8b and 10b of the male mold 8 and the female mold 10. Plastic deformation is performed as in the convex spherical shape and the concave spherical shape.
- a means such as immersion in warm water or application of warm air is suitable, but depending on the case, heating such as a heater built in the male mold 8 and / or the female mold 10 or a hot water flow path is possible. You may make it heat by a means.
- the heating temperature is not particularly limited as long as it is equal to or higher than the softening temperature of the osteosynthesis plate P, but it is preferable to heat at a temperature about 1 to 50 ° C. higher than the softening temperature, for example, poly-L-lactic acid or poly-D described above. In the case of the osteosynthesis plate P made of, L-lactic acid and having a softening temperature of 65 ° C., it is appropriate to heat to about 66 to 115 ° C.
- the osteosynthesis plate P is solidified by cooling to a temperature lower than the softening temperature. And the shape of the osteosynthesis plate P is fixed according to the convex curved surface shape and the concave curved surface shape of the molding surfaces 8b and 10b of the female mold 10, and the molding is completed.
- a cooling means means such as natural cooling at room temperature may be adopted, but it is preferable to immerse in cold water or apply cold air.
- the osteosynthesis plate P may be taken out by moving the male mold 8 and the female mold 10.
- a round plate-shaped osteosynthesis plate P formed by the male mold 8 shown in FIG. 5 and the female mold 10 shown in FIG. 6 is used for joining fractured parts such as patella and craniofacial bone and bone fragments after osteotomy. Is suitable. It is also useful as a scaffold to make up for the missing part of the hip acetabulum.
- the grip portion 3A of the rod-shaped member 1 and the cylindrical member 3B are temporarily fixed by means such as a lock belt. Temporary fixing is preferable because the male mold 8 and the female mold 10 do not open even if the hand is released from the grip portions 3A and 3B, and the osteosynthesis plate P can be securely held.
- the forming method using this osteosynthesis plate forming tool is performed by using a male die 8 and a female die 10 having three-dimensional curved surface shapes (convex spherical shape and concave spherical shape). Since it is formed by heating and softening with the joining plate P sandwiched between cooling and solidification, no matter who performs the molding operation, the molding surfaces 8b and 10b of the male mold 8 and the female mold 10 are three-dimensional.
- the osteosynthesis plate can be molded with good reproducibility according to the curved shape, and the osteosynthesis plate P softened by heating is directly applied to the fracture site or osteotomy site to form a three-dimensional curved shape. Since it is not, it can be said that it is also excellent in terms of safety.
- the male mold 8 and the female mold 10 are formed from a trowel-shaped osteosynthesis plate P shown in FIG. 9B cut out from the material plate MP shown in FIG. With complex three-dimensional curved surface 8b, 10b for forming a curved surface (a shape in which the entire trowel-shaped plate is curved and bent in a step shape at the base of the leg piece) is there.
- the male mold 8 and the female mold 10 also project forward from the through hole 8a inserted into the rod 7 projecting forward from the lower end of the rod-shaped member 1 and the lower end portion of the rectangular tube portion 2b of the cylindrical member 2.
- the osteosynthesis plate P of FIG. 9 (c) formed by the male mold 8 and the female mold 10 is, for example, the distal portion of the radius, the proximal portion of the radius (radial head), the distal portion of the ulna, and the proximal portion of the humerus. It is suitable for joining fracture sites and bone fragments such as the distal part and the proximal part of the tibia.
- the male mold 8 and the female mold 10 show still other examples of the male mold 8 and the female mold 10 having different shapes of the molding surfaces 8b and 10b.
- the male mold 8 and the female mold 10 are obtained by converting a rectangular osteosynthesis plate cut out from the material plate MP shown in FIG. 9A into a three-dimensional curved osteosynthesis as shown in FIGS. 12A and 12B.
- Three-dimensional curved surface 8b, 10b for forming a plate P (a U-shaped groove-shaped osteosynthesis plate P having a U-shaped cross section and warped in the length direction) It is provided.
- the male mold 8 and the female mold 10 also project forward from the through hole 8a inserted into the rod 7 projecting forward from the lower end of the rod-shaped member 1 and the lower end portion of the rectangular tube portion 2b of the cylindrical member 2.
- the osteosynthesis plate P of FIG. 12 formed by the male mold 8 and the female mold 10 is, for example, bones such as the finger bone, metatarsal bone, humerus, forearm bone (radius, ulna), femur, tibia, and ribs. It is suitable for joining a fracture site or a bone fragment at a site where the diameter is reduced from the proximal part of the bone and the distal part of the bone to the diaphyseal part like the trunk.
- FIGS. 13 and 14 show still other examples of the male mold 8 and the female mold 10 having different shapes of the molding surfaces 8b and 10b.
- the male mold 8 and the female mold 10 are shown in FIG. 9 (a).
- a trowel-shaped osteosynthesis plate P shown in FIG. 9B cut out from the material plate MP is replaced with a three-dimensional curved osteosynthesis plate P as shown in FIG.
- the female die 10 is provided with a plurality of (three) small pins 10c for positioning, and when these small pins 10c are inserted into the holes of the trowel-shaped plate P, the trowel-shaped plate P is accurately placed.
- the male mold 8 and the female mold 10 also project forward from the through hole 8a inserted into the rod 7 projecting forward from the lower end of the rod-shaped member 1 and the lower end portion of the rectangular tube portion 2b of the cylindrical member 2.
- Two through-holes 10a and 10a fitted into the two pins 9 and 9 are perforated, and both are attached so as to be detachable and replaceable.
- the osteosynthesis plate P shown in FIG. 15 formed by the male mold 8 and the female mold 10 is used for bone joints such as nasal bones, ribs, ulna, tibias, ribs, etc. It is suitable for joining fracture sites when it is desired to implant a part of the plate in the bone while avoiding interference with the tendon.
- FIGS. 16 and 17 show still another example of the male mold 8 and the female mold 10 having different shapes of the molding surfaces 8b and 10b.
- the male mold 8 and the female mold 10 are shown in FIG.
- a rectangular osteosynthesis plate cut out from the material plate MP is converted into a three-dimensional curved osteosynthesis plate P (a U-shaped groove having a U-shaped cross section and concavely curved in the length direction as shown in FIG. It is provided with molding surfaces 8b and 10b having a three-dimensional curved surface for molding into a shape osteosynthesis plate P).
- the male mold 8 and the female mold 10 also project forward from the through hole 8a inserted into the rod 7 projecting forward from the lower end of the rod-shaped member 1 and the lower end portion of the rectangular tube portion 2b of the cylindrical member 2.
- the osteosynthesis plate P of FIG. 18 formed by the male mold 8 and the female mold 10 is, for example, a bone like a diaphysis such as a first metacarpal bone (a thumb metacarpal bone) or a first metatarsal bone. It is suitable for joining fracture sites and bone fragments that are curved outward from the proximal and distal bones to the diaphysis.
- 5, 7, 10, 13, and 16 all have a key groove (not shown) formed in the inner peripheral surface of the rear end of the through hole 8a.
- a key (not shown) formed at the root portion of the rod 7 engages with the key groove, so that the male mold 8 is attached in a non-rotatable manner.
- FIG. 19 shows another embodiment of the osteosynthesis plate forming tool of the present invention.
- one rod-like member 1 is slidably inserted into the ring portion 11 a of the other rod-like member 11, and the other rod-like member 11 is attached to the upper end of one rod-like member 1.
- both the rod-shaped members 1 and 11 are configured to be relatively movable in the vertical direction along two parallel longitudinal axes C2 and C3.
- a grip portion 3B that is paired with the grip portion 3A is provided in an intermediate portion of the other rod-shaped member 11, and both the rod-shaped members 1 and 11 are urged away from each other along the vertical axes C2 and C3.
- a compression coil spring 4 that surrounds one rod-like member 1 is stretched between the grip portion 3A and the ring portion 11a.
- a rod 7 is connected and fixed at a right angle to the lower end of one rod-like member 1 via a connecting member 6 and protrudes forward.
- the rod 7 is formed into a three-dimensional curved surface shape (convex spherical shape).
- a male mold 8 having a surface 8b is attached to be removable and replaceable.
- Two pins 9 protruding forward are planted at the lower end portion of the other rod-shaped member 11, and the three-dimensional curved surface shape (concave shape) corresponding to the molding surface 8 b of the male mold 8 is provided on this pin 9.
- a female die 10 having a (spherical) molding surface 10b is attached to the male die 8 so as to be detachable and replaceable.
- 5 is a board
- 3c is a screw with a knurled knob for fixing the grip portion 3A to the upper end of the one rod-shaped member 1
- 3d is secured to the upper end of the other rod-shaped member 11. It is a screw with a knurled knob for fixing the member 3e.
- Such an osteosynthesis plate forming tool is also provided by moving both rod-shaped members 1 and 11 relatively in the vertical direction along parallel longitudinal axes C2 and C3 while grasping the grip portions 3A and 3B by hand.
- An osteosynthesis plate is sandwiched between the molding surface 8b of the mold 8 and the molding surface 10b of the female mold 10, and the male mold 8 and female are heated and softened while the osteosynthesis plate is sandwiched between the male mold 8 and the female mold 10.
- the osteosynthesis plate is three-dimensional curved surface shape with good reproducibility. Can be molded.
- the osteosynthesis plate molding tool and osteosynthesis plate molding method of the present invention form a thermoplastic resin plate into a desired three-dimensional curved surface shape by variously changing the shapes of the molding surfaces of the male mold and the female mold. It can be widely used for applications.
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Abstract
Provided is an osteosynthesis plate former in which an osteosynthesis plate (P) composed of thermoplastic polymer is heated to above a softening temperature and softened while being sandwiched between a male mold (8) and a female mold (10) provided with molding surfaces (8b, 10b) having a three dimensionally curved shape, and the softened osteosynthesis plate (P) is cooled to a temperature below the softening temperature and solidified while being sandwiched.
Description
本発明は骨接合プレートの成形具と成形方法に関し、更に詳しくは、熱可塑性ポリマーからなる骨接合プレートを三次元的曲面形状に成形するための簡便な成形具と成形方法に関する。
The present invention relates to a molding tool and a molding method for an osteosynthesis plate, and more particularly to a simple molding tool and a molding method for molding an osteosynthesis plate made of a thermoplastic polymer into a three-dimensional curved surface shape.
近年、生体内分解吸収性の熱可塑性ポリマーからなる骨接合プレートを用いて、骨折部位や骨切り部位の接合固定が行われるようになってきた。このように骨接合プレートを用いて骨折部位や骨切り部位を接合固定する場合は、当然のことながら、その部位の骨の起伏形状その他の解剖学的形状にほぼ合致するように、骨接合プレートを三次元的曲面形状に成形したり、折曲げ加工することが望まれる。
In recent years, the use of osteosynthesis plates made of biodegradable and absorbable thermoplastic polymers has led to the fixation of fracture sites and osteotomy sites. When bone fractures and osteotomy sites are joined and fixed using an osteosynthesis plate in this way, it is a matter of course that the osteosynthesis plate should match the contoured shape of the bone and other anatomical shapes at that site. It is desired to form the material into a three-dimensional curved surface shape or bend it.
ところで、金属製の骨接合プレートを折曲げ加工する工具として、図20に示すように、2本のアーム100a,100bの枢軸101より先端側に、二股状の顎部102aと、この二股状の顎部102aに噛み合う棒状の顎部102bを設けた「やっとこ型」の工具103が知られている(特許文献1)。この工具103は、図示のように骨接合プレート104の一端部を他の工具105で固定しながら、骨接合プレート104のロッド部104aを二股状の顎部102aと棒状の顎部102bで挟むことにより、骨接合プレート104のロッド部104aを折曲げ加工するものである。
By the way, as a tool for bending a metal osteosynthesis plate, as shown in FIG. 20, a bifurcated jaw portion 102a and a bifurcated jaw portion 102a are provided at the tip side of the pivots 101 of the two arms 100a and 100b. There has been known a “yatsuko-type” tool 103 provided with a rod-like jaw 102b that meshes with the jaw 102a (Patent Document 1). As shown in the figure, the tool 103 holds the rod portion 104a of the osteosynthesis plate 104 between the bifurcated jaw portion 102a and the rod-like jaw portion 102b while fixing one end portion of the osteosynthesis plate 104 with another tool 105. Thus, the rod portion 104a of the osteosynthesis plate 104 is bent.
また、本出願人も、熱可塑性ポリマーからなる骨接合プレートを段形状に折曲げ加工する加工器具として、骨接合プレートを挟持する挟持部を先端に設けた左右のアームをその交叉部で回動可能に枢着した鉗子型の加工器具であって、挟持部の相対向する面を、先端に近づくほど横幅を段階的に縮小して横幅の異なる複数の挟持面に区分し、この相対向する面の横幅の段階的な縮小に対応して挟持部の両側面に段部を設けた加工器具を既に提案した(特許文献2)。この鉗子型の加工器具は、挟持部の所望の横幅を有する挟持面を選択して、加熱により軟化させた骨接合プレートを挟持部の該選択挟持面で挟持し、骨接合プレートの一端側と他端側を挟持部の側面に沿わせて互いに反対方向に折曲げることにより、平らな骨接合プレートを所望の段差寸法を有する段形状の骨接合プレートに正確に折曲げ加工できる便利な加工器具である。
In addition, the present applicant, as a processing tool for bending an osteosynthesis plate made of a thermoplastic polymer into a step shape, rotates the left and right arms provided with a clamping portion at the tip for clamping the osteosynthesis plate at the intersection. A forceps-type processing instrument that is pivotally attached, and the opposing surfaces of the clamping part are divided into a plurality of clamping surfaces having different lateral widths by gradually reducing the lateral width toward the tip, and facing each other. A processing tool having stepped portions on both side surfaces of the sandwiching portion corresponding to the stepwise reduction of the lateral width of the surface has already been proposed (Patent Document 2). This forceps-type processing instrument selects a clamping surface having a desired lateral width of the clamping part, clamps the osteosynthesis plate softened by heating with the selective clamping surface of the clamping part, Convenient processing tool that can accurately bend a flat osteosynthesis plate into a step-shaped osteosynthesis plate having a desired step size by folding the other end along the side of the clamping part in opposite directions. It is.
一方、生体吸収性メッシュを骨上のインプラント受容部位に移植する際に、生体吸収性メッシュをそのガラス転移温度を越える温度に加熱して骨上のインプラント受容部位に直接載せ、生体吸収性メッシュをインプラント受容部位の解剖学的三次元形状に輪郭合わせをした後、ガラス転移温度より低い温度に冷却、固化して、生体吸収性メッシュを三次元形状に成形する方法が知られている(特許文献3)。
On the other hand, when the bioabsorbable mesh is transplanted to the implant receiving site on the bone, the bioabsorbable mesh is heated to a temperature exceeding its glass transition temperature and directly placed on the implant receiving site on the bone. A method for forming a bioabsorbable mesh into a three-dimensional shape by contouring the anatomical three-dimensional shape of the implant receiving site and then cooling and solidifying to a temperature lower than the glass transition temperature is known (Patent Literature). 3).
しかしながら、前記特許文献1の工具は、骨接合プレートを折曲げ加工することはできても、骨折部位や骨切り部位の骨の解剖学的形状にほぼ合致するように骨接合プレートを三次元的曲面形状に成形できないという問題があった。しかも、この工具は作業者によって骨接合プレートの折曲げ角度にバラツキが生じ、同じ作業者でも、加工の度に折曲げ角度が多少異なるという問題があった。
However, although the tool of Patent Document 1 can bend the osteosynthesis plate, the osteosynthesis plate is three-dimensionally arranged so as to substantially match the anatomical shape of the bone at the fracture site or osteotomy site. There was a problem that it could not be formed into a curved shape. In addition, this tool has a problem in that the bending angle of the osteosynthesis plate varies depending on the operator, and even the same operator has a problem that the bending angle is slightly different at each processing.
これに対し、前記特許文献2の加工器具は、誰が折曲げ加工しても、平らな骨接合プレートを、所望の段差寸法を有する段形状の骨接合プレートに正確に折曲げ加工できる優れた器具であるが、この加工器具も、骨折部位や骨切り部位の骨の解剖学的形状にほぼ合致するように骨接合プレートを三次元的曲面形状に成形できないものであった。
On the other hand, the processing tool disclosed in Patent Document 2 is an excellent tool that can accurately bend a flat osteosynthesis plate into a step-shaped osteosynthesis plate having a desired step size, no matter who bends it. However, this processing tool is also incapable of forming the osteosynthesis plate into a three-dimensional curved surface shape so as to substantially match the anatomical shape of the bone at the fracture site or osteotomy site.
一方、前記特許文献3の生体吸収性メッシュの成形方法は、生体吸収性メッシュをインプラント受容部位の解剖学的三次元形状にほぼ合致する三次元的曲面形状に成形することはできるが、ガラス転移温度より高い温度に加熱した生体吸収性メッシュをインプラント受容部位に直接載せて成形するため、インプラント受容部位に熱による悪影響を及ぼす恐れがあり、安全な成形方法とは言い難いものであった。また、この成形方法は、面積が大きい生体吸収性メッシュなどには適用できるとしても、それより小さくて使用個数が多い骨接合プレートの成形方法としては実用的と言い難く、適用が困難なものであった。
On the other hand, the bioabsorbable mesh forming method of Patent Document 3 can form a bioabsorbable mesh into a three-dimensional curved surface shape that substantially matches the anatomical three-dimensional shape of the implant receiving site. Since the bioabsorbable mesh heated to a temperature higher than the temperature is directly placed on the implant receiving site and molded, the implant receiving site may be adversely affected by heat, and it is difficult to say that it is a safe molding method. Although this molding method can be applied to bioabsorbable meshes with a large area, it is difficult to say that it is practical and difficult to apply as an osteosynthesis plate that is smaller and has a large number of used. there were.
本発明は上記事情の下になされたもので、その解決しようとする課題は、熱可塑性ポリマーからなる骨接合プレートを三次元的曲面形状に再現性良く成形できる骨接合プレート成形具と、この成形具を用いた簡便で安全な成形方法を提供することにある。
The present invention has been made under the above circumstances, and the problem to be solved is an osteosynthesis plate molding tool capable of molding an osteosynthesis plate made of a thermoplastic polymer into a three-dimensional curved surface shape with good reproducibility, and this molding. An object of the present invention is to provide a simple and safe molding method using a tool.
上記課題を解決するため、本発明に係る骨接合プレート成形具は、共通の軸線又は平行な二本の軸線に沿って相対的に移動し得る二つの部材に、熱可塑性ポリマーからなる骨接合プレートを挟んで成形する三次元的曲面形状の成形面を備えた雄型と雌型を、軸線方向に対向させて取付けたことを特徴とするものである。
In order to solve the above-described problems, an osteosynthesis plate forming tool according to the present invention is an osteosynthesis plate made of a thermoplastic polymer on two members that can move relatively along a common axis or two parallel axes. A male mold and a female mold each having a molding surface having a three-dimensional curved surface that is molded with a sandwiched therebetween are attached to face each other in the axial direction.
本発明の骨接合プレート成形具においては、二つの部材に雄型と雌型をそれぞれ取替え可能に取付けることが好ましい。そして、雄型と雌型の少なくとも一方が、骨接合プレートの成形時に骨接合プレートの片面全体を覆う広さの成形面を備えていることが好ましい。
また、二つの部材には握り部をそれぞれ設けることが好ましく、更に、二つの部材を軸線に沿って離反させる方向に付勢する付勢手段を備えていることが好ましい。 In the osteosynthesis plate forming tool of the present invention, it is preferable to attach the male mold and the female mold to the two members in a replaceable manner. It is preferable that at least one of the male mold and the female mold has a molding surface having a width that covers the entire surface of the osteosynthesis plate when the osteosynthesis plate is molded.
The two members are preferably provided with grips, respectively, and further preferably provided with urging means for urging the two members in directions away from each other along the axis.
また、二つの部材には握り部をそれぞれ設けることが好ましく、更に、二つの部材を軸線に沿って離反させる方向に付勢する付勢手段を備えていることが好ましい。 In the osteosynthesis plate forming tool of the present invention, it is preferable to attach the male mold and the female mold to the two members in a replaceable manner. It is preferable that at least one of the male mold and the female mold has a molding surface having a width that covers the entire surface of the osteosynthesis plate when the osteosynthesis plate is molded.
The two members are preferably provided with grips, respectively, and further preferably provided with urging means for urging the two members in directions away from each other along the axis.
本発明に係る骨接合プレート成形具の好ましい具体的形態は、二つの部材が、共通の縦軸線に沿って相対的に移動し得る、筒状部材とこの筒状部材に摺動可能に挿入された棒状部材であり、雌型が筒状部材の下端部の片側に突き出して取替え可能に取付けられており、雄型が、棒状部材の下端から筒状部材の縦割溝部を貫いて片側へ突き出すロッドに取替え可能に取付けられて、雌型と縦軸線の方向に対向しているものである。
そして、この具体的形態においては、棒状部材の上端と筒状部材の上端に握り部がそれぞれ設けられ、棒状部材の外周面と筒状部材の内周面との隙間に圧縮コイルスプリングが配置されて、棒状部材の外周面に形成されたバネ受け部と筒状部材の内周面に形成されたバネ受け部との間に張設されていることが好ましい。 In a preferred specific form of the osteosynthesis plate forming tool according to the present invention, two members can be moved relative to each other along a common longitudinal axis, and are slidably inserted into the tubular member. The female die protrudes to one side of the lower end portion of the cylindrical member and is replaceably attached, and the male die protrudes from the lower end of the rod-like member to one side through the longitudinal groove portion of the cylindrical member. It is attached to the rod so as to be replaceable, and is opposed to the female die in the direction of the vertical axis.
And in this specific form, a grip part is provided in the upper end of a rod-shaped member, and the upper end of a cylindrical member, respectively, and the compression coil spring is arrange | positioned in the clearance gap between the outer peripheral surface of a rod-shaped member, and the inner peripheral surface of a cylindrical member. Thus, it is preferably stretched between a spring receiving portion formed on the outer peripheral surface of the rod-shaped member and a spring receiving portion formed on the inner peripheral surface of the cylindrical member.
そして、この具体的形態においては、棒状部材の上端と筒状部材の上端に握り部がそれぞれ設けられ、棒状部材の外周面と筒状部材の内周面との隙間に圧縮コイルスプリングが配置されて、棒状部材の外周面に形成されたバネ受け部と筒状部材の内周面に形成されたバネ受け部との間に張設されていることが好ましい。 In a preferred specific form of the osteosynthesis plate forming tool according to the present invention, two members can be moved relative to each other along a common longitudinal axis, and are slidably inserted into the tubular member. The female die protrudes to one side of the lower end portion of the cylindrical member and is replaceably attached, and the male die protrudes from the lower end of the rod-like member to one side through the longitudinal groove portion of the cylindrical member. It is attached to the rod so as to be replaceable, and is opposed to the female die in the direction of the vertical axis.
And in this specific form, a grip part is provided in the upper end of a rod-shaped member, and the upper end of a cylindrical member, respectively, and the compression coil spring is arrange | positioned in the clearance gap between the outer peripheral surface of a rod-shaped member, and the inner peripheral surface of a cylindrical member. Thus, it is preferably stretched between a spring receiving portion formed on the outer peripheral surface of the rod-shaped member and a spring receiving portion formed on the inner peripheral surface of the cylindrical member.
また、本発明に係る骨接合プレート成形方法は、熱可塑性ポリマーからなる骨接合プレートを、本発明に係る上記骨接合プレート成形具の雄型と雌型で挟む工程と、骨接合プレートを雄型と雌型で挟んだまま、その軟化温度以上に加熱して軟化させる工程と、軟化させた骨接合プレートを雄型と雌型で挟んだまま、その軟化温度より低温に冷却して固化させる工程とを含むことを特徴とするものである。
Further, the osteosynthesis plate forming method according to the present invention includes a step of sandwiching an osteosynthesis plate made of a thermoplastic polymer between the male mold and the female mold of the osteosynthesis plate molding tool according to the present invention, and the osteosynthesis plate as a male mold. The process of heating and softening above the softening temperature while sandwiched between the female mold and the female mold, and the process of cooling and solidifying the softened osteosynthesis plate below the softening temperature while sandwiched between the male mold and the female mold It is characterized by including these.
本発明の骨接合プレート成形具を使用し、本発明の成形方法に従って、熱可塑性ポリマーからなる骨接合プレートを成形するときは、まず、二つの部材を共通の軸線又は平行な二本の軸線に沿って相対的に移動させることにより、雄型と雌型の成形面の間に熱可塑性ポリマーからなる骨接合プレートを弾性変形させながら挟み込む。次いで、骨接合プレートを雄型と雌型で挟んだまま、その軟化温度以上に加熱して軟化させることにより、骨接合プレートを雄型と雌型の成形面の三次元的曲面形状の通りに塑性変形させる。そして、この塑性変形させた骨接合プレートを雄型と雌型で挟んだまま、軟化温度より低い温度に冷却して固化させることにより、雄型と雌型の成形面の三次元的曲面形状の通りに骨接合プレートの形状を固定して、再現性良く三次元的曲面形状に成形する。
このように、本発明の骨接合プレート成形具を用いた成形方法は、三次元的曲面形状の成形面を備えた雄型と雌型で骨接合プレートを挟んで加熱、軟化させた後、冷却、固化して成形するものであるから、誰が成形作業を行っても、雄型と雌型の成形面の三次元的曲面形状の通りに骨接合プレートを再現性良く成形することができ、また、前記特許文献3のように加熱により軟化させたメッシュを生体骨のインプラント受容部位に直接載せて三次元的曲面形状に成形するものではないので、安全である。 When the osteosynthesis plate molding tool of the present invention is used to mold an osteosynthesis plate made of a thermoplastic polymer according to the molding method of the present invention, first, the two members are placed on a common axis or two parallel axes. The osteosynthesis plate made of a thermoplastic polymer is sandwiched while being elastically deformed between the molding surfaces of the male mold and the female mold by relatively moving along the surface. Next, while the osteosynthesis plate is sandwiched between the male mold and the female mold, the osteosynthesis plate is heated and softened above its softening temperature, so that the osteosynthesis plate is in accordance with the three-dimensional curved shape of the molding surface of the male mold and the female mold. Plastically deform. Then, the plastically deformed osteosynthesis plate is sandwiched between the male mold and the female mold, and cooled to a temperature lower than the softening temperature to be solidified, so that the molding surface of the male mold and the female mold has a three-dimensional curved surface shape. The shape of the osteosynthesis plate is fixed to the street and molded into a three-dimensional curved surface with good reproducibility.
As described above, the molding method using the osteosynthesis plate molding tool of the present invention is a method of cooling after heating and softening the osteosynthesis plate between the male mold and the female mold having a molding surface having a three-dimensional curved shape. Because it is solidified and molded, anyone can perform the molding work, and the osteosynthesis plate can be molded with good reproducibility according to the three-dimensional curved surface shape of the male and female molding surfaces, Since the mesh softened by heating is not placed directly on the implant receiving site of the living bone and molded into a three-dimensional curved surface shape as in Patent Document 3, it is safe.
このように、本発明の骨接合プレート成形具を用いた成形方法は、三次元的曲面形状の成形面を備えた雄型と雌型で骨接合プレートを挟んで加熱、軟化させた後、冷却、固化して成形するものであるから、誰が成形作業を行っても、雄型と雌型の成形面の三次元的曲面形状の通りに骨接合プレートを再現性良く成形することができ、また、前記特許文献3のように加熱により軟化させたメッシュを生体骨のインプラント受容部位に直接載せて三次元的曲面形状に成形するものではないので、安全である。 When the osteosynthesis plate molding tool of the present invention is used to mold an osteosynthesis plate made of a thermoplastic polymer according to the molding method of the present invention, first, the two members are placed on a common axis or two parallel axes. The osteosynthesis plate made of a thermoplastic polymer is sandwiched while being elastically deformed between the molding surfaces of the male mold and the female mold by relatively moving along the surface. Next, while the osteosynthesis plate is sandwiched between the male mold and the female mold, the osteosynthesis plate is heated and softened above its softening temperature, so that the osteosynthesis plate is in accordance with the three-dimensional curved shape of the molding surface of the male mold and the female mold. Plastically deform. Then, the plastically deformed osteosynthesis plate is sandwiched between the male mold and the female mold, and cooled to a temperature lower than the softening temperature to be solidified, so that the molding surface of the male mold and the female mold has a three-dimensional curved surface shape. The shape of the osteosynthesis plate is fixed to the street and molded into a three-dimensional curved surface with good reproducibility.
As described above, the molding method using the osteosynthesis plate molding tool of the present invention is a method of cooling after heating and softening the osteosynthesis plate between the male mold and the female mold having a molding surface having a three-dimensional curved shape. Because it is solidified and molded, anyone can perform the molding work, and the osteosynthesis plate can be molded with good reproducibility according to the three-dimensional curved surface shape of the male and female molding surfaces, Since the mesh softened by heating is not placed directly on the implant receiving site of the living bone and molded into a three-dimensional curved surface shape as in Patent Document 3, it is safe.
本発明の骨接合プレート成形具において、二つの部材に雄型と雌型をそれぞれ取替え可能に取付けたものは、雄型と雌型を、所望の三次元的曲面形状の成形面を備えた雄型と雌型にそれぞれ取り替えることによって、骨接合プレートを所望の三次元的曲面形状に成形することができる。
そして、雄型と雌型の少なくとも一方が、骨接合プレートの成形時に骨接合プレートの片面全体を覆う広さの成形面を備えていると、骨接合プレートを部分的に成形する場合でも、当該成形面により骨接合プレートの片面全体を安定良く支持して高精度で骨接合プレートを部分的に成形することができる。 In the osteosynthesis plate molding tool of the present invention, a male mold and a female mold are attached to two members in a replaceable manner. The male mold and the female mold are provided with a male surface having a molding surface having a desired three-dimensional curved shape. By replacing the mold and the female mold respectively, the osteosynthesis plate can be formed into a desired three-dimensional curved surface shape.
And, when at least one of the male mold and the female mold is provided with a molding surface having a width that covers the entire surface of the osteosynthesis plate when molding the osteosynthesis plate, even when the osteosynthesis plate is partially molded, The entire surface of the osteosynthesis plate can be stably supported by the molding surface, and the osteosynthesis plate can be partially molded with high accuracy.
そして、雄型と雌型の少なくとも一方が、骨接合プレートの成形時に骨接合プレートの片面全体を覆う広さの成形面を備えていると、骨接合プレートを部分的に成形する場合でも、当該成形面により骨接合プレートの片面全体を安定良く支持して高精度で骨接合プレートを部分的に成形することができる。 In the osteosynthesis plate molding tool of the present invention, a male mold and a female mold are attached to two members in a replaceable manner. The male mold and the female mold are provided with a male surface having a molding surface having a desired three-dimensional curved shape. By replacing the mold and the female mold respectively, the osteosynthesis plate can be formed into a desired three-dimensional curved surface shape.
And, when at least one of the male mold and the female mold is provided with a molding surface having a width that covers the entire surface of the osteosynthesis plate when molding the osteosynthesis plate, even when the osteosynthesis plate is partially molded, The entire surface of the osteosynthesis plate can be stably supported by the molding surface, and the osteosynthesis plate can be partially molded with high accuracy.
また、本発明の骨接合プレート成形具において、二つの部材に握り部をそれぞれ設けたものは、握り部を手で握って二つの部材を容易に移動させることができるので、雄型と雌型で骨接合プレートを挟む作業がし易くなる。
そして、二つの部材を軸線に沿って離反させる方向に付勢する付勢手段を備えたものは、握り部から手を離すだけで、付勢手段により二つの部材が離反方向に移動して雄型と雌型が開くため、成形された骨接合プレートの取出しが容易になる。 Further, in the osteosynthesis plate forming tool of the present invention, the two members each provided with the grip portion can easily move the two members by gripping the grip portion by hand, so that the male mold and the female mold This makes it easier to sandwich the osteosynthesis plate.
And the thing provided with the urging means which urges | biases the two members in the direction which separates along an axis line only moves the two members by the urging | biasing means to a separation direction, and only removes a hand from a grip part. Since the mold and the female mold are opened, the molded osteosynthesis plate can be easily taken out.
そして、二つの部材を軸線に沿って離反させる方向に付勢する付勢手段を備えたものは、握り部から手を離すだけで、付勢手段により二つの部材が離反方向に移動して雄型と雌型が開くため、成形された骨接合プレートの取出しが容易になる。 Further, in the osteosynthesis plate forming tool of the present invention, the two members each provided with the grip portion can easily move the two members by gripping the grip portion by hand, so that the male mold and the female mold This makes it easier to sandwich the osteosynthesis plate.
And the thing provided with the urging means which urges | biases the two members in the direction which separates along an axis line only moves the two members by the urging | biasing means to a separation direction, and only removes a hand from a grip part. Since the mold and the female mold are opened, the molded osteosynthesis plate can be easily taken out.
更に、前述した好ましい具体的形態の骨接合プレート成形具は、構造が簡単で安価に製造でき、しかも、操作性が良好で、筒状部材と棒状部材を縦軸線に沿って相対的に移動させることにより、雄型と雌型との間に骨接合プレート挟んで三次元的曲面形状に再現性良く成形することができる。
Furthermore, the osteosynthesis plate forming tool of the preferred specific form described above is simple in structure and can be manufactured at low cost, and has good operability, and relatively moves the cylindrical member and the rod-shaped member along the vertical axis. Thus, a three-dimensional curved surface shape can be formed with good reproducibility by sandwiching an osteosynthesis plate between the male mold and the female mold.
以下、図面を参照して、本発明に係る骨接合プレート成形具の代表的な実施形態を詳細に説明する。
Hereinafter, with reference to the drawings, representative embodiments of the osteosynthesis plate forming tool according to the present invention will be described in detail.
図1~図4に示す骨接合プレート成形具は、棒状部材1が筒状部材2に摺動可能に挿入されており、これら二つの部材1,2が共通の縦軸線C1に沿って上下方向に相対的に移動できるように構成されている。棒状部材1は、図3に示すように、その上半部に筒体1aが外嵌着されて異径の棒状部材に構成されており、この筒体1aの下端が圧縮コイルスプリング4の上端を受けるバネ受け部1bとなっている。そして、棒状部材1の上端には、握り部3Aがローレットノブ付きのネジ3cでT字形に取付けられている。
In the osteosynthesis plate forming tool shown in FIGS. 1 to 4, a rod-like member 1 is slidably inserted into a cylindrical member 2, and these two members 1 and 2 are vertically moved along a common longitudinal axis C1. It is comprised so that it can move relatively. As shown in FIG. 3, the rod-shaped member 1 is configured as a rod-shaped member having a different diameter with a cylindrical body 1 a fitted on the upper half thereof, and the lower end of the cylindrical body 1 a is the upper end of the compression coil spring 4. It becomes the spring receiving part 1b which receives. And the grip part 3A is attached to the upper end of the rod-shaped member 1 in the T shape with the screw 3c with a knurled knob.
上記筒状部材2は、図3に示すように、円筒部2aの下端に角筒部2bを一体に連結固定したものであって、この筒状部材2の円筒部2aの上端には、上記握り部3Aと対をなす握り部3Bが溶接でT字形に固定されている。この筒状部材2の円筒部2aと角筒部2bとの連結部分の内周面にはバネ受け部2cが形成されており、このバネ受け部2cと棒状部材1の外周面の前記バネ受け部1bとの間には、棒状部材1と筒状部材2を共通の縦軸線C1に沿って互いに離反させる方向に付勢する付勢手段として、圧縮コイルスプリング4が張設されている。
As shown in FIG. 3, the cylindrical member 2 is formed by integrally connecting and fixing a square cylindrical portion 2 b to the lower end of the cylindrical portion 2 a, and the upper end of the cylindrical portion 2 a of the cylindrical member 2 is A grip portion 3B that is paired with the grip portion 3A is fixed in a T-shape by welding. A spring receiving portion 2 c is formed on the inner peripheral surface of the connecting portion between the cylindrical portion 2 a and the rectangular tube portion 2 b of the cylindrical member 2, and the spring receiving portion on the outer peripheral surface of the spring receiving portion 2 c and the rod-shaped member 1. A compression coil spring 4 is stretched between the portions 1b as urging means for urging the rod-like member 1 and the cylindrical member 2 in directions away from each other along a common longitudinal axis C1.
上記筒状部材2の角筒部2bは、一辺の長さが円筒部2aの外径よりも大きいほぼ正方形の横断面形状を有する角筒部であって、図1,図3に示すように、この角筒部2bの一側面(前側面)には縦割溝部2dが形成されている。そして、この角筒部2bの下端の左右両側と後側には水平基板5が設けられており、左右両側の水平基板5は前方へ延びている。従って、この骨接合プレート成形具は、これらの水平基板5によって安定良く縦置きできるようになっている。
The rectangular tube portion 2b of the cylindrical member 2 is a rectangular tube portion having a substantially square cross-sectional shape in which the length of one side is larger than the outer diameter of the cylindrical portion 2a, as shown in FIGS. A vertical groove 2d is formed on one side surface (front side surface) of the rectangular tube portion 2b. And the horizontal board | substrate 5 is provided in the right-and-left both sides and rear side of the lower end of this square cylinder part 2b, and the horizontal board | substrates 5 on the left and right both sides are extended ahead. Therefore, the osteosynthesis plate forming tool can be placed vertically with good stability by these horizontal substrates 5.
前記棒状部材1の下端には、連結部材6を介してロッド7が直角に連結されており、このロッド7は筒状部材2の角筒部2bの縦割溝部2dを貫いて片側(前方)へ突き出している。そして、このロッド7に雄型8の貫通孔8aを嵌挿することにより、雄型8が脱着、取替え可能に取付けられている。
A rod 7 is connected to the lower end of the rod-shaped member 1 at a right angle through a connecting member 6, and this rod 7 passes through the vertical dividing groove 2 d of the rectangular tube portion 2 b of the cylindrical member 2 and is on one side (front). Sticks out. The male mold 8 is attached so as to be detachable and replaceable by fitting the through hole 8a of the male mold 8 into the rod 7.
また、図1,図2に示すように、筒状部材2の角筒部2bの左右側壁部の下端部には、片側(前方)へ突き出す2本のピン9,9が植設されており、これらのピン9,9に雌型10の貫通孔10a,10aを嵌挿することによって、雌型10が上記雄型8と縦軸線C1の方向(上下方向)に対向して脱着、取替え可能に取付けられている。
As shown in FIGS. 1 and 2, two pins 9, 9 projecting to one side (front) are implanted at the lower end portions of the left and right side wall portions of the rectangular tube portion 2 b of the tubular member 2. By inserting the through- holes 10a and 10a of the female mold 10 into these pins 9 and 9, the female mold 10 can be attached to and detached from the male mold 8 in the direction of the vertical axis C1 (vertical direction). Installed on.
雄型8は、図5(a)に示すように略円形の平面形状を有するもので、図5(b)(c)に示すように前後方向に貫通する貫通孔8a(前記ロッド7が挿入される貫通孔)が穿設されており、この雄型8の下面は、図5(b)(c)に示すような凸球面形状の成形面8bとなっている。
これに対し、雌型10は、図6(b)に示すように略正方形の平面形状を有するもので、図6(a)に示すように前後方向に貫通する二つの貫通孔10a,10a(前記ピン9,9が挿入される貫通孔)が穿設されており、この雌型10の上面は、図6(c)に示すような凹球面形状の成形面10b(雄型8の凸球面形状の成形面8bに対応する凹球面形状の成形面)となっている。 Themale mold 8 has a substantially circular planar shape as shown in FIG. 5 (a). As shown in FIGS. 5 (b) and 5 (c), the through-hole 8a penetrating in the front-rear direction (the rod 7 is inserted). The lower surface of the male mold 8 is a convex spherical surface 8b as shown in FIGS. 5B and 5C.
On the other hand, the female die 10 has a substantially square planar shape as shown in FIG. 6 (b). As shown in FIG. 6 (a), the female die 10 has two through holes 10a and 10a (through the front and rear direction). A through hole into which the pins 9 and 9 are inserted is formed, and the upper surface of the female die 10 is a concave spherical shaped molding surface 10b (convex spherical surface of the male die 8) as shown in FIG. A concave spherical shaped molding surface corresponding to the shaped molding surface 8b).
これに対し、雌型10は、図6(b)に示すように略正方形の平面形状を有するもので、図6(a)に示すように前後方向に貫通する二つの貫通孔10a,10a(前記ピン9,9が挿入される貫通孔)が穿設されており、この雌型10の上面は、図6(c)に示すような凹球面形状の成形面10b(雄型8の凸球面形状の成形面8bに対応する凹球面形状の成形面)となっている。 The
On the other hand, the female die 10 has a substantially square planar shape as shown in FIG. 6 (b). As shown in FIG. 6 (a), the female die 10 has two through
なお、雄型8と雌型10の成形面8b,10bは、この実施形態のような凸球面形状と凹球面形状に限定されるものではなく、骨折部位や骨切り部位の解剖学的形状にほぼ合致するような種々の三次元的曲面形状となし得ることは言うまでもない。
また、この実施形態の雄型8と雌型10は、骨接合プレートの両面全体を覆う広さの成形面8b,10bを備えているが、雄型8と雌型10の少なくとも一方の成形面が骨接合プレートの片面全体を覆う広さの成形面であれば、当該成形面により骨接合プレートの少なくとも片面全体を安定良く支持して高精度で骨接合プレートを部分的に成形することが可能である。 The molding surfaces 8b and 10b of themale mold 8 and the female mold 10 are not limited to the convex spherical shape and the concave spherical shape as in this embodiment, but have an anatomical shape of a fracture site or an osteotomy site. Needless to say, various three-dimensional curved surface shapes that substantially match each other can be obtained.
In addition, themale mold 8 and the female mold 10 of this embodiment are provided with molding surfaces 8b and 10b that are wide enough to cover both surfaces of the osteosynthesis plate, but at least one molding surface of the male mold 8 and the female mold 10 is provided. If the molding surface is wide enough to cover the entire surface of the osteosynthesis plate, the molding surface can stably support at least the entire surface of the osteosynthesis plate, and the osteosynthesis plate can be partially molded with high accuracy. It is.
また、この実施形態の雄型8と雌型10は、骨接合プレートの両面全体を覆う広さの成形面8b,10bを備えているが、雄型8と雌型10の少なくとも一方の成形面が骨接合プレートの片面全体を覆う広さの成形面であれば、当該成形面により骨接合プレートの少なくとも片面全体を安定良く支持して高精度で骨接合プレートを部分的に成形することが可能である。 The molding surfaces 8b and 10b of the
In addition, the
以上のような構成の骨接合プレート成形具を使用し、本発明の成形方法に従って骨接合プレートを成形するときは、予め、熱可塑性ポリマーからなる材料プレートから骨接合プレートを切り出す。材料プレートとしては、熱可塑性ポリマーからなるものであればポリマー種、厚さ及び孔の有無等が特に限定されるものではないが、ポリ-L-乳酸やポリ-D,L-乳酸あるいはそれらの共重合体や乳酸-ポリグリコール酸共重合体などの生体内分解吸収性の熱可塑性ポリマーからなる、無数の孔があいた厚さ1mm程度のプレートや、上記の生体内分解吸収性の熱可塑性ポリマーにハイドロキシアパタイト(HA)あるいはトリカルシウムフォスフェート(TCP)などのバイオセラミックス粉粒を含んだ複合材料からなる、無数の孔があいた厚さ1mm程度のプレートが好ましく使用される。
When the osteosynthesis plate molding tool having the above-described configuration is used and the osteosynthesis plate is molded according to the molding method of the present invention, the osteosynthesis plate is cut out from a material plate made of a thermoplastic polymer in advance. The material plate is not particularly limited as long as it is made of a thermoplastic polymer, and there are no particular limitations on the polymer type, thickness, presence or absence of pores, etc., but poly-L-lactic acid, poly-D, L-lactic acid or their Biodegradable and absorbable thermoplastic polymers such as copolymers and lactic acid-polyglycolic acid copolymers, and a plate with an infinite number of holes and a thickness of about 1 mm, and the above biodegradable and absorbable thermoplastic polymers In addition, a plate having a thickness of about 1 mm having a myriad of holes made of a composite material containing bioceramic powder particles such as hydroxyapatite (HA) or tricalcium phosphate (TCP) is preferably used.
材料プレートからの骨接合プレートの切り出しが終わると、最初の工程において、骨接合プレート成形具の握り部3A,3Bを手で握り締めながら、棒状部材1と筒状部材2を縦軸線C1に沿って上下方向に相対的に移動させ、図4に示すように、雄型8の成形面8bと雌型10の成形面10bとの間に骨接合プレートPを双方の型8,10からずれないように僅かに弾性変形させて挟み込む。このとき、前記のポリ-L-乳酸やポリ-D,L-乳酸からなる骨接合プレートPは、ある程度の柔軟性があるので、割れる心配はない。
When the cutting of the osteosynthesis plate from the material plate is finished, in the first step, the rod-like member 1 and the cylindrical member 2 are moved along the vertical axis C1 while gripping the grip portions 3A, 3B of the osteosynthesis plate forming tool by hand. As shown in FIG. 4, the osteosynthesis plate P is not displaced from both the molds 8 and 10 between the molding surface 8 b of the male mold 8 and the molding surface 10 b of the female mold 10. Is slightly elastically deformed and sandwiched. At this time, the osteosynthesis plate P made of poly-L-lactic acid or poly-D, L-lactic acid has a certain degree of flexibility, so there is no fear of cracking.
上記のように骨接合プレートPを雄型8と雌型10で挟み、そのまま次の工程で骨接合プレートPをその軟化温度以上に加熱して軟化させ、骨接合プレート成形具の握り部3A,3Bを手でさらに握り締めながら、棒状部材1と筒状部材2を縦軸線C1に沿って上下方向に相対的に移動させ、骨接合プレートPを雄型8と雌型10の成形面8b,10bの凸球面形状及び凹球面形状の通りに塑性変形させる。加熱手段としては、温水に浸漬するか、或いは、温風を当てるなどの手段が好適であるが、場合によっては、雄型8又は/及び雌型10に内蔵したヒーターや温水流路等の加熱手段で加熱するようにしてもよい。加熱温度は骨接合プレートPの軟化温度以上であれば特に制限されないが、軟化温度よりも1~50℃程度高い温度で加熱することが好ましく、例えば、上記のポリ-L-乳酸やポリ-D,L-乳酸からなる軟化温度65℃の骨接合プレートPの場合は、66~115℃程度に加熱するのが適当である。
As described above, the osteosynthesis plate P is sandwiched between the male mold 8 and the female mold 10, and the osteosynthesis plate P is heated and softened to the softening temperature or higher in the next process as it is, and the gripping portion 3A of the osteosynthesis plate forming tool is While further tightening 3B by hand, the rod-shaped member 1 and the cylindrical member 2 are relatively moved in the vertical direction along the longitudinal axis C1, and the osteosynthesis plate P is formed on the molding surfaces 8b and 10b of the male mold 8 and the female mold 10. Plastic deformation is performed as in the convex spherical shape and the concave spherical shape. As a heating means, a means such as immersion in warm water or application of warm air is suitable, but depending on the case, heating such as a heater built in the male mold 8 and / or the female mold 10 or a hot water flow path is possible. You may make it heat by a means. The heating temperature is not particularly limited as long as it is equal to or higher than the softening temperature of the osteosynthesis plate P, but it is preferable to heat at a temperature about 1 to 50 ° C. higher than the softening temperature, for example, poly-L-lactic acid or poly-D described above. In the case of the osteosynthesis plate P made of, L-lactic acid and having a softening temperature of 65 ° C., it is appropriate to heat to about 66 to 115 ° C.
加熱が完了すると、次の工程で、塑性変形した骨接合プレートPを雄型8と雌型10で挟んだまま、軟化温度より低い温度に冷却して骨接合プレートPを固化させ、雄型8と雌型10の成形面8b,10bの凸曲面形状及び凹曲面形状の通りに骨接合プレートPの形状を固定して成形を完了する。冷却手段としては、室温で自然放冷するなどの手段を採用してもよいが、冷水に浸漬したり、冷風を当てるのが好適である。
When the heating is completed, in the next step, while the plastically deformed osteosynthesis plate P is sandwiched between the male mold 8 and the female mold 10, the osteosynthesis plate P is solidified by cooling to a temperature lower than the softening temperature. And the shape of the osteosynthesis plate P is fixed according to the convex curved surface shape and the concave curved surface shape of the molding surfaces 8b and 10b of the female mold 10, and the molding is completed. As a cooling means, means such as natural cooling at room temperature may be adopted, but it is preferable to immerse in cold water or apply cold air.
骨接合プレートPの成形が完了すると、握り部3A,3Bから手を放し、圧縮コイルスプリング4の復元弾発力で、棒状部材1と筒状部材2を縦軸線C1に沿って離反する方向に移動させ、雄型8と雌型10を開いて骨接合プレートPを取り出せばよい。
図5に示す雄型8と図6に示す雌型10で成形される丸皿形の骨接合プレートPは、例えば膝蓋骨、頭蓋顎顔面骨等の骨折部位や骨切り後の骨片の接合に適している。また、股関節寛骨臼底の欠損部分を補う足場としても有用である。 When the formation of the osteosynthesis plate P is completed, the hand is released from the grip portions 3A and 3B, and the rod member 1 and the cylindrical member 2 are separated from each other along the vertical axis C1 by the restoring elastic force of the compression coil spring 4. The osteosynthesis plate P may be taken out by moving the male mold 8 and the female mold 10.
A round plate-shaped osteosynthesis plate P formed by themale mold 8 shown in FIG. 5 and the female mold 10 shown in FIG. 6 is used for joining fractured parts such as patella and craniofacial bone and bone fragments after osteotomy. Is suitable. It is also useful as a scaffold to make up for the missing part of the hip acetabulum.
図5に示す雄型8と図6に示す雌型10で成形される丸皿形の骨接合プレートPは、例えば膝蓋骨、頭蓋顎顔面骨等の骨折部位や骨切り後の骨片の接合に適している。また、股関節寛骨臼底の欠損部分を補う足場としても有用である。 When the formation of the osteosynthesis plate P is completed, the hand is released from the
A round plate-shaped osteosynthesis plate P formed by the
尚、図示はしていないが、雄型8と雌型10の間に骨接合プレートPを挟んだ状態で、棒状部材1の握り部3Aと筒状部材3Bをロックベルトなどの仮固定手段で仮固定すると、握り部3A,3Bから手を放しても雄型8と雌型10が開くことがなく、確実に骨接合プレートPを挟み続けることができるので好ましい。
Although not shown in the figure, with the osteosynthesis plate P sandwiched between the male mold 8 and the female mold 10, the grip portion 3A of the rod-shaped member 1 and the cylindrical member 3B are temporarily fixed by means such as a lock belt. Temporary fixing is preferable because the male mold 8 and the female mold 10 do not open even if the hand is released from the grip portions 3A and 3B, and the osteosynthesis plate P can be securely held.
上記のように、この骨接合プレート成形具を用いた成形方法は、三次元的曲面形状(凸球面形状及び凹球面形状)の成形面8b,10bを備えた雄型8と雌型10で骨接合プレートPを挟んで加熱、軟化させた後、冷却、固化して成形するものであるから、誰が成形作業を行っても、雄型8と雌型10の成形面8b,10bの三次元的曲面形状の通りに骨接合プレートを再現性良く成形することができ、また、加熱により軟化させた骨接合プレートPを骨折部位や骨切り部位に直接当てて三次元的曲面形状に成形するものではないので、安全性の面でも優れたものと言える。
As described above, the forming method using this osteosynthesis plate forming tool is performed by using a male die 8 and a female die 10 having three-dimensional curved surface shapes (convex spherical shape and concave spherical shape). Since it is formed by heating and softening with the joining plate P sandwiched between cooling and solidification, no matter who performs the molding operation, the molding surfaces 8b and 10b of the male mold 8 and the female mold 10 are three-dimensional. The osteosynthesis plate can be molded with good reproducibility according to the curved shape, and the osteosynthesis plate P softened by heating is directly applied to the fracture site or osteotomy site to form a three-dimensional curved shape. Since it is not, it can be said that it is also excellent in terms of safety.
図7,図8は、成形面8a,10bの形状が異なる雄型8と雌型10の他の例を示したものである。この雄型8と雌型10は、図9(a)に示す材料プレートMPから切り出した図9(b)に示すコテ形の骨接合プレートPを、図9(c)に示すような三次元的曲面形状(コテ形のプレート全体が湾曲し且つ脚片の付根部分で段形状に屈曲した形状)に成形するための、複雑な三次元的曲面形状の成形面8b,10bを備えたものである。この雄型8と雌型10も、前記棒状部材1の下端から前方に突き出したロッド7に嵌挿される貫通孔8aと、前記筒状部材2の角筒部2bの下端部から前方に突き出した2本のピン9,9に嵌挿される二つの貫通孔10a,10aが穿孔されており、いずれも脱着、取替え可能に取付られるようになっている。
これらの雄型8と雌型10で成形される図9(c)の骨接合プレートPは、例えば橈骨遠位部、橈骨近位部(橈骨頭)、尺骨遠位部、上腕骨近位部および遠位部、脛骨近位部等の骨折部位や骨片の接合に適している。
7 and 8 show other examples of themale die 8 and the female die 10 having different shapes of the molding surfaces 8a and 10b. The male mold 8 and the female mold 10 are formed from a trowel-shaped osteosynthesis plate P shown in FIG. 9B cut out from the material plate MP shown in FIG. With complex three-dimensional curved surface 8b, 10b for forming a curved surface (a shape in which the entire trowel-shaped plate is curved and bent in a step shape at the base of the leg piece) is there. The male mold 8 and the female mold 10 also project forward from the through hole 8a inserted into the rod 7 projecting forward from the lower end of the rod-shaped member 1 and the lower end portion of the rectangular tube portion 2b of the cylindrical member 2. Two through- holes 10a and 10a fitted into the two pins 9 and 9 are perforated, and both are attached so as to be detachable and replaceable.
The osteosynthesis plate P of FIG. 9 (c) formed by themale mold 8 and the female mold 10 is, for example, the distal portion of the radius, the proximal portion of the radius (radial head), the distal portion of the ulna, and the proximal portion of the humerus. It is suitable for joining fracture sites and bone fragments such as the distal part and the proximal part of the tibia.
これらの雄型8と雌型10で成形される図9(c)の骨接合プレートPは、例えば橈骨遠位部、橈骨近位部(橈骨頭)、尺骨遠位部、上腕骨近位部および遠位部、脛骨近位部等の骨折部位や骨片の接合に適している。
7 and 8 show other examples of the
The osteosynthesis plate P of FIG. 9 (c) formed by the
図10,図11は、成形面8b,10bの形状が異なる雄型8と雌型10の更に他の例を示したものである。この雄型8と雌型10は、図9(a)に示す材料プレートMPから切り出した方形の骨接合プレートを、図12(a)(b)に示すような三次元的曲面形状の骨接合プレートP(U字状の横断面を有し、長さ方向に弓なりに反り上がったU字溝形状の骨接合プレートP)に成形するための、三次元的曲面形状の成形面8b,10bを備えたものである。この雄型8と雌型10も、前記棒状部材1の下端から前方に突き出したロッド7に嵌挿される貫通孔8aと、前記筒状部材2の角筒部2bの下端部から前方に突き出した2本のピン9,9に嵌挿される二つの貫通孔10a,10aが穿孔されており、いずれも脱着、取替え可能に取付られるようになっている。
これらの雄型8と雌型10で成形される図12の骨接合プレートPは、例えば手指骨、中足骨、上腕骨、前腕骨(橈骨、尺骨)、大腿骨、脛骨、腓骨等の骨幹部のように骨近位部および骨遠位部から骨幹部にかけて縮径している部位の骨折部位や骨片の接合に適している。 10 and 11 show still other examples of themale mold 8 and the female mold 10 having different shapes of the molding surfaces 8b and 10b. The male mold 8 and the female mold 10 are obtained by converting a rectangular osteosynthesis plate cut out from the material plate MP shown in FIG. 9A into a three-dimensional curved osteosynthesis as shown in FIGS. 12A and 12B. Three-dimensional curved surface 8b, 10b for forming a plate P (a U-shaped groove-shaped osteosynthesis plate P having a U-shaped cross section and warped in the length direction) It is provided. The male mold 8 and the female mold 10 also project forward from the through hole 8a inserted into the rod 7 projecting forward from the lower end of the rod-shaped member 1 and the lower end portion of the rectangular tube portion 2b of the cylindrical member 2. Two through- holes 10a and 10a fitted into the two pins 9 and 9 are perforated, and both are attached so as to be detachable and replaceable.
The osteosynthesis plate P of FIG. 12 formed by themale mold 8 and the female mold 10 is, for example, bones such as the finger bone, metatarsal bone, humerus, forearm bone (radius, ulna), femur, tibia, and ribs. It is suitable for joining a fracture site or a bone fragment at a site where the diameter is reduced from the proximal part of the bone and the distal part of the bone to the diaphyseal part like the trunk.
これらの雄型8と雌型10で成形される図12の骨接合プレートPは、例えば手指骨、中足骨、上腕骨、前腕骨(橈骨、尺骨)、大腿骨、脛骨、腓骨等の骨幹部のように骨近位部および骨遠位部から骨幹部にかけて縮径している部位の骨折部位や骨片の接合に適している。 10 and 11 show still other examples of the
The osteosynthesis plate P of FIG. 12 formed by the
図13,図14は、成形面8b,10bの形状が異なる雄型8と雌型10の更に他の例を示したもので、この雄型8と雌型10は、図9(a)の材料プレートMPから切り出した図9(b)に示すコテ形の骨接合プレートPを、図15に示すような三次元的曲面形状の骨接合プレートP(コテ形のプレートの脚片がその付根部分でV字状に屈曲した形状の骨接合プレートP)に成形するための、三次元的曲面形状の成形面8b,10bを備えている。この雌型10には位置決め用の複数(3本)の小ピン10cが突設されており、これらの小ピン10cをコテ形のプレートPの孔に挿入すると、コテ形のプレートPを正確に位置決めして成形できるようになっている。この雄型8と雌型10も、前記棒状部材1の下端から前方に突き出したロッド7に嵌挿される貫通孔8aと、前記筒状部材2の角筒部2bの下端部から前方に突き出した2本のピン9,9に嵌挿される二つの貫通孔10a,10aが穿孔されており、いずれも脱着、取替え可能に取付られるようになっている。
これらの雄型8と雌型10によって成形される図15の骨接合プレートPは、生体骨の鋭角に曲がっている部位、例えば、鼻骨、橈骨、尺骨、脛骨、腓骨等の骨接合や、関節や腱への干渉を避けて骨中にプレートの一部を埋植したい場合の骨折部位の接合に適している。 FIGS. 13 and 14 show still other examples of themale mold 8 and the female mold 10 having different shapes of the molding surfaces 8b and 10b. The male mold 8 and the female mold 10 are shown in FIG. 9 (a). A trowel-shaped osteosynthesis plate P shown in FIG. 9B cut out from the material plate MP is replaced with a three-dimensional curved osteosynthesis plate P as shown in FIG. Are provided with molding surfaces 8b and 10b having a three-dimensional curved shape for molding into an osteosynthesis plate P) bent in a V shape. The female die 10 is provided with a plurality of (three) small pins 10c for positioning, and when these small pins 10c are inserted into the holes of the trowel-shaped plate P, the trowel-shaped plate P is accurately placed. It can be positioned and molded. The male mold 8 and the female mold 10 also project forward from the through hole 8a inserted into the rod 7 projecting forward from the lower end of the rod-shaped member 1 and the lower end portion of the rectangular tube portion 2b of the cylindrical member 2. Two through- holes 10a and 10a fitted into the two pins 9 and 9 are perforated, and both are attached so as to be detachable and replaceable.
The osteosynthesis plate P shown in FIG. 15 formed by themale mold 8 and the female mold 10 is used for bone joints such as nasal bones, ribs, ulna, tibias, ribs, etc. It is suitable for joining fracture sites when it is desired to implant a part of the plate in the bone while avoiding interference with the tendon.
これらの雄型8と雌型10によって成形される図15の骨接合プレートPは、生体骨の鋭角に曲がっている部位、例えば、鼻骨、橈骨、尺骨、脛骨、腓骨等の骨接合や、関節や腱への干渉を避けて骨中にプレートの一部を埋植したい場合の骨折部位の接合に適している。 FIGS. 13 and 14 show still other examples of the
The osteosynthesis plate P shown in FIG. 15 formed by the
図16,図17は、成形面8b,10bの形状が異なる雄型8と雌型10の更に他の例を示したもので、この雄型8と雌型10は、図9(a)の材料プレートMPから切り出した方形の骨接合プレートを、図18に示すような三次元的曲面形状の骨接合プレートP(U字状の横断面を有し、長さ方向に凹湾曲したU字溝形状の骨接合プレートP)に成形するための、三次元的曲面形状の成形面8b,10bを備えている。この雄型8と雌型10も、前記棒状部材1の下端から前方に突き出したロッド7に嵌挿される貫通孔8aと、前記筒状部材2の角筒部2bの下端部から前方に突き出した2本のピン9,9に嵌挿される二つの貫通孔10a,10aが穿孔されており、いずれも脱着、取替え可能に取付られるようになっている。
これらの雄型8と雌型10によって成形される図18の骨接合プレートPは、例えば、第一中手骨(親指の中手骨)、第一中足骨等の骨幹部のように骨近位部および骨遠位部から骨幹部にかけて外側に湾曲している部位の骨折部位、骨片の接合に適している。 FIGS. 16 and 17 show still another example of themale mold 8 and the female mold 10 having different shapes of the molding surfaces 8b and 10b. The male mold 8 and the female mold 10 are shown in FIG. A rectangular osteosynthesis plate cut out from the material plate MP is converted into a three-dimensional curved osteosynthesis plate P (a U-shaped groove having a U-shaped cross section and concavely curved in the length direction as shown in FIG. It is provided with molding surfaces 8b and 10b having a three-dimensional curved surface for molding into a shape osteosynthesis plate P). The male mold 8 and the female mold 10 also project forward from the through hole 8a inserted into the rod 7 projecting forward from the lower end of the rod-shaped member 1 and the lower end portion of the rectangular tube portion 2b of the cylindrical member 2. Two through- holes 10a and 10a fitted into the two pins 9 and 9 are perforated, and both are attached so as to be detachable and replaceable.
The osteosynthesis plate P of FIG. 18 formed by themale mold 8 and the female mold 10 is, for example, a bone like a diaphysis such as a first metacarpal bone (a thumb metacarpal bone) or a first metatarsal bone. It is suitable for joining fracture sites and bone fragments that are curved outward from the proximal and distal bones to the diaphysis.
これらの雄型8と雌型10によって成形される図18の骨接合プレートPは、例えば、第一中手骨(親指の中手骨)、第一中足骨等の骨幹部のように骨近位部および骨遠位部から骨幹部にかけて外側に湾曲している部位の骨折部位、骨片の接合に適している。 FIGS. 16 and 17 show still another example of the
The osteosynthesis plate P of FIG. 18 formed by the
なお、図5、図7、図10、図13、図16に示す雄型8はいずれも、貫通孔8aの後端部内周面にキー溝(不図示)が形成されており、この貫通孔8aに前記ロッド7を嵌挿すると、ロッド7の付根部分に形成されたキー(不図示)が上記キー溝に係合して、雄型8が回転不能に取付けられるようになっている。
5, 7, 10, 13, and 16 all have a key groove (not shown) formed in the inner peripheral surface of the rear end of the through hole 8a. When the rod 7 is inserted into 8a, a key (not shown) formed at the root portion of the rod 7 engages with the key groove, so that the male mold 8 is attached in a non-rotatable manner.
図19は本発明の骨接合プレート成形具の他の実施形態を示したものである。この骨接合プレート成形具は、一方の棒状部材1を他方の棒状部材11のリング部11aに摺動可能に挿通すると共に、他方の棒状部材11を一方の棒状部材1の上端に取付けられた握り部3Aの孔に摺動可能に挿通することによって、双方の棒状部材1,11が平行な二本の縦軸線C2,C3に沿って上下方向に相対的に移動できるように構成されている。そして、他方の棒状部材11の中間部には、上記握り部3Aと対をなす握り部3Bが設けられ、双方の棒状部材1,11を縦軸線C2,C3に沿って離反する方向に付勢する圧縮コイルスプリング4が、一方の棒状部材1を取り巻いて握り部3Aと上記リング部11aとの間に張設されている。
FIG. 19 shows another embodiment of the osteosynthesis plate forming tool of the present invention. In this osteosynthesis plate forming tool, one rod-like member 1 is slidably inserted into the ring portion 11 a of the other rod-like member 11, and the other rod-like member 11 is attached to the upper end of one rod-like member 1. By being slidably inserted into the hole of the part 3A, both the rod-shaped members 1 and 11 are configured to be relatively movable in the vertical direction along two parallel longitudinal axes C2 and C3. A grip portion 3B that is paired with the grip portion 3A is provided in an intermediate portion of the other rod-shaped member 11, and both the rod-shaped members 1 and 11 are urged away from each other along the vertical axes C2 and C3. A compression coil spring 4 that surrounds one rod-like member 1 is stretched between the grip portion 3A and the ring portion 11a.
更に、一方の棒状部材1の下端には、連結部材6を介してロッド7が直角に連結固定されて前方に突き出しており、このロッド7には三次元的曲面形状(凸球面形状)の成形面8bを備えた雄型8が脱着、取替え可能に取付けられている。そして、他方の棒状部材11の下端部には、前方へ突き出す2本のピン9が植設されており、このピン9には雄型8の成形面8bに対応する三次元的曲面形状(凹球面形状)の成形面10bを備えた雌型10が、雄型8と対向して、脱着、取替え可能に取付けられている。なお、5は他方の棒状部材の下端に設けられた基板、3cは握り部3Aを一方の棒状部材1の上端に固定するローレットノブ付きのネジ、3dは他方の棒状部材11の上端に抜止め部材3eを固定するローレットノブ付のネジである。
Further, a rod 7 is connected and fixed at a right angle to the lower end of one rod-like member 1 via a connecting member 6 and protrudes forward. The rod 7 is formed into a three-dimensional curved surface shape (convex spherical shape). A male mold 8 having a surface 8b is attached to be removable and replaceable. Two pins 9 protruding forward are planted at the lower end portion of the other rod-shaped member 11, and the three-dimensional curved surface shape (concave shape) corresponding to the molding surface 8 b of the male mold 8 is provided on this pin 9. A female die 10 having a (spherical) molding surface 10b is attached to the male die 8 so as to be detachable and replaceable. In addition, 5 is a board | substrate provided in the lower end of the other rod-shaped member, 3c is a screw with a knurled knob for fixing the grip portion 3A to the upper end of the one rod-shaped member 1, and 3d is secured to the upper end of the other rod-shaped member 11. It is a screw with a knurled knob for fixing the member 3e.
このような骨接合プレート成形具も、握り部3A,3Bを手で握り締めながら双方の棒状部材1,11を平行な縦軸線C2,C3に沿って上下方向に相対的に移動させることにより、雄型8の成形面8bと雌型10の成形面10bとの間に骨接合プレートを挟み込み、骨接合プレートを雄型8と雌型10で挟んだまま加熱、軟化させて雄型形8と雌型10の成形面8b,10bの三次元的曲面形状の通りに可塑変形させ、さらに冷却、固化させて骨接合プレートの形状を固定することにより、骨接合プレートを再現性良く三次元的曲面形状に成形することができる。
Such an osteosynthesis plate forming tool is also provided by moving both rod-shaped members 1 and 11 relatively in the vertical direction along parallel longitudinal axes C2 and C3 while grasping the grip portions 3A and 3B by hand. An osteosynthesis plate is sandwiched between the molding surface 8b of the mold 8 and the molding surface 10b of the female mold 10, and the male mold 8 and female are heated and softened while the osteosynthesis plate is sandwiched between the male mold 8 and the female mold 10. By plastically deforming according to the three-dimensional curved surface shape of the molding surfaces 8b and 10b of the mold 10, and further cooling and solidifying to fix the shape of the osteosynthesis plate, the osteosynthesis plate is three-dimensional curved surface shape with good reproducibility. Can be molded.
本発明の骨接合プレート成形具及び骨接合プレート成形方法は、雄型と雌型のそれぞれの成形面の形状を種々変更することによって、熱可塑性樹脂プレートを所望の三次元的曲面形状に成形する用途に広く利用することができる。
The osteosynthesis plate molding tool and osteosynthesis plate molding method of the present invention form a thermoplastic resin plate into a desired three-dimensional curved surface shape by variously changing the shapes of the molding surfaces of the male mold and the female mold. It can be widely used for applications.
1 棒状部材
1b バネ受け部
2 筒状部材
2a 筒状部材の円筒部
2b 筒状部材の角筒部
2c バネ受け部
2d 縦割溝部
3A,3B 握り部
4 圧縮コイルスプリング(付勢手段)
7 ロッド
8 雄型
8a 貫通孔
8b 雄型の成形面
9 ピン
10 雌型
10a 貫通孔
10b 雌型の成形面
11 他方の棒状部材
P 骨接合プレート DESCRIPTION OFSYMBOLS 1 Bar-shaped member 1b Spring receiving part 2 Cylindrical member 2a Cylindrical part of cylindrical member 2b Square cylindrical part of cylindrical member 2c Spring receiving part 2d Vertical split groove part 3A, 3B Grip part 4 Compression coil spring (biasing means)
7Rod 8 Male 8a Through-hole 8b Male molding surface 9 Pin 10 Female 10a Through-hole 10b Female molding 11 Other rod-shaped member P Osteosynthesis plate
1b バネ受け部
2 筒状部材
2a 筒状部材の円筒部
2b 筒状部材の角筒部
2c バネ受け部
2d 縦割溝部
3A,3B 握り部
4 圧縮コイルスプリング(付勢手段)
7 ロッド
8 雄型
8a 貫通孔
8b 雄型の成形面
9 ピン
10 雌型
10a 貫通孔
10b 雌型の成形面
11 他方の棒状部材
P 骨接合プレート DESCRIPTION OF
7
Claims (8)
- 共通の軸線又は平行な二本の軸線に沿って相対的に移動し得る二つの部材に、熱可塑性ポリマーからなる骨接合プレートを挟んで成形する三次元的曲面形状の成形面を備えた雄型と雌型を、軸線方向に対向させて取付けたことを特徴とする骨接合プレート成形具。 A male mold having a three-dimensional curved surface that is formed by sandwiching an osteosynthesis plate made of a thermoplastic polymer on two members that can move relatively along a common axis or two parallel axes. An osteosynthesis plate forming tool, wherein a female die and a female die are attached to face each other in the axial direction.
- 二つの部材に雄型と雌型をそれぞれ取替え可能に取付けたことを特徴とする請求項1に記載の骨接合プレート成形具。 2. The osteosynthesis plate forming tool according to claim 1, wherein a male mold and a female mold are attached to the two members in a replaceable manner.
- 雄型と雌型の少なくとも一方が、骨接合プレートの成形時に骨接合プレートの片面全体を覆う広さの成形面を備えていることを特徴とする請求項1又は請求項2に記載の骨接合プレート成形具。 The osteosynthesis according to claim 1 or 2, wherein at least one of the male mold and the female mold has a molding surface having a width that covers the entire surface of the osteosynthesis plate when the osteosynthesis plate is molded. Plate forming tool.
- 二つの部材に握り部をそれぞれ設けたことを特徴とする請求項1ないし請求項3のいずれかに記載の骨接合プレート成形具。 The osteosynthesis plate forming tool according to any one of claims 1 to 3, wherein a grip portion is provided on each of the two members.
- 二つの部材を軸線に沿って離反させる方向に付勢する付勢手段を備えていることを特徴とする請求項1ないし請求項4のいずれかに記載の骨接合プレート成形具。 The osteosynthesis plate forming tool according to any one of claims 1 to 4, further comprising an urging means for urging the two members in a direction to separate them along the axis.
- 二つの部材が、共通の縦軸線に沿って相対的に移動し得る、筒状部材とこの筒状部材に摺動可能に挿入された棒状部材であり、
雌型が筒状部材の下端部の片側に突き出して取替え可能に取付けられており、
雄型が、棒状部材の下端から筒状部材の縦割溝部を貫いて片側へ突き出すロッドに取替え可能に取付けられて、雌型と縦軸線の方向に対向している、
ことを特徴とする請求項1に記載の骨接合プレート成形具。 Two members are a cylindrical member that can move relatively along a common longitudinal axis and a rod-like member that is slidably inserted into the cylindrical member,
The female mold is attached so that it can be replaced by protruding to one side of the lower end of the cylindrical member,
The male mold is removably attached to the rod protruding from the lower end of the rod-shaped member to the one side through the longitudinal groove portion of the cylindrical member, and is opposed to the female mold in the direction of the vertical axis.
The osteosynthesis plate forming tool according to claim 1. - 棒状部材の上端と筒状部材の上端に握り部がそれぞれ設けられ、棒状部材の外周面と筒状部材の内周面との隙間に圧縮コイルスプリングが配置されて、棒状部材の外周面に形成されたバネ受け部と筒状部材の内周面に形成されたバネ受け部との間に張設されていることを特徴とする請求項6に記載の骨接合プレート成形具。 A grip portion is provided at each of the upper end of the rod-shaped member and the upper end of the cylindrical member, and a compression coil spring is disposed in a gap between the outer peripheral surface of the rod-shaped member and the inner peripheral surface of the cylindrical member, and formed on the outer peripheral surface of the rod-shaped member. The osteosynthesis plate forming tool according to claim 6, wherein the osteosynthesis plate forming tool is stretched between the spring receiving portion formed and the spring receiving portion formed on the inner peripheral surface of the tubular member.
- 熱可塑性ポリマーからなる骨接合プレートを、請求項1ないし請求項7のいずれかに記載さた骨接合プレート成形具の雄型と雌型で挟む工程と、骨接合プレートを雄型と雌型で挟んだまま、その軟化温度以上に加熱して軟化させる工程と、軟化させた骨接合プレートを雄型と雌型で挟んだまま、その軟化温度より低温に冷却して固化させる工程とを含むことを特徴とする骨接合プレート成形方法。
A step of sandwiching an osteosynthesis plate made of a thermoplastic polymer between the male mold and the female mold of the osteosynthesis plate forming tool according to any one of claims 1 to 7, and the osteosynthesis plate between a male mold and a female mold. Heating and softening above the softening temperature while sandwiched, and cooling and solidifying the softened osteosynthesis plate below the softening temperature while sandwiched between the male and female molds An osteosynthesis plate molding method characterized by the above.
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2017524434A (en) * | 2014-06-30 | 2017-08-31 | デピュイ・シンセス・プロダクツ・インコーポレイテッド | Locking the first metacarpal plate |
JP2021129851A (en) * | 2020-02-21 | 2021-09-09 | オリンパステルモバイオマテリアル株式会社 | Bender for bone plate and bender system |
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JPS6374631A (en) * | 1986-09-17 | 1988-04-05 | Naruto Plast Kogyo Kk | Formation of synthetic resin container |
JPH04305436A (en) * | 1991-04-03 | 1992-10-28 | Nitta Ind Corp | Mold for mutually welding and parts of thermoplastic resin strips |
JP2002505142A (en) * | 1998-03-06 | 2002-02-19 | ビオンクス インプランツ オサケユイチア | Biocompatible deformable fixation plate |
WO2006121079A1 (en) * | 2005-05-10 | 2006-11-16 | Dainippon Ink And Chemicals, Inc. | Process for forming thermoformable sheet and forming machine |
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JP4037437B2 (en) * | 2005-05-10 | 2008-01-23 | 大日本インキ化学工業株式会社 | Thermoforming sheet forming method and forming apparatus |
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JPS6374631A (en) * | 1986-09-17 | 1988-04-05 | Naruto Plast Kogyo Kk | Formation of synthetic resin container |
JPH04305436A (en) * | 1991-04-03 | 1992-10-28 | Nitta Ind Corp | Mold for mutually welding and parts of thermoplastic resin strips |
JP2002505142A (en) * | 1998-03-06 | 2002-02-19 | ビオンクス インプランツ オサケユイチア | Biocompatible deformable fixation plate |
WO2006121079A1 (en) * | 2005-05-10 | 2006-11-16 | Dainippon Ink And Chemicals, Inc. | Process for forming thermoformable sheet and forming machine |
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JP2017524434A (en) * | 2014-06-30 | 2017-08-31 | デピュイ・シンセス・プロダクツ・インコーポレイテッド | Locking the first metacarpal plate |
JP2021129851A (en) * | 2020-02-21 | 2021-09-09 | オリンパステルモバイオマテリアル株式会社 | Bender for bone plate and bender system |
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JP5689166B2 (en) | 2015-03-25 |
JPWO2012115103A1 (en) | 2014-07-07 |
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