JP7529262B2 - Artificial bone forming method and artificial bone forming kit - Google Patents

Description

The present invention relates to an artificial bone forming method and an artificial bone forming kit.

In neurosurgery, a type of surgery known as craniotomy involves creating an opening in the skull and performing treatments such as draining cerebrospinal fluid through the opening. After the craniotomy, an artificial bone (skull substitute) is embedded in the opening in the skull to close the opening (see, for example, Patent Document 1).

The skull substitute described in Patent Document 1 has a mesh part formed to fit the opening in the skull, and a fixing part that fixes the mesh part to the edge of the opening in the skull. In addition, skull substitutes are generally made of titanium, which is biocompatible and has sufficient strength.

Utility Model Registration No. 3174242

However, the skull replacement described in Patent Document 1 is time-consuming to manufacture and relatively expensive.

The object of the present invention is to provide an artificial bone molding method and an artificial bone molding kit that can easily and relatively inexpensively produce highly aesthetic artificial bones.

Such objectives are achieved by the present invention described below.
(1) A method for forming an artificial bone, which closes an opening formed in a skull by removing a bone fragment that is a part of the skull from the skull, comprising the steps of:
a first adhesion step of adhering a flexible first sheet to the curved convex surface of the bone piece;
a first transfer step of applying a first material, which will become a mold after hardening, to the first sheet adhered to the bone fragment so as to transfer the shape of the curved convex surface to the first material, thereby forming a curved concave surface in the first material;
a second adhesion step of adhering a flexible second sheet to the curved concave surface of the first material after hardening;
a second transfer step of using the first material as a mold to place a second material, which will become the artificial bone after hardening, on the second sheet adhered to the first material, and adhering the second material to the second sheet so as to transfer the shape of the curved concave surface to the second material.

(2) The first sheet is bag-shaped,
The artificial bone molding method according to (1) above, wherein the first adhesion step is carried out by sucking air from within the first sheet.

(3) The artificial bone molding method described in (1) or (2) above, in which, in the first adhesion step, suction is performed with a breathable spacer interposed between the curved concave surface of the bone piece and the first sheet.

(4) The second sheet is bag-shaped,
The method for forming an artificial bone according to any one of (1) to (3) above, wherein the second adhesion step is carried out by sucking air from within the second sheet.

(5) A bag-shaped third sheet is provided to cover the second sheet,
The artificial bone molding method described in (4) above, wherein the first material formed in the first transfer process is contained within the second sheet contained in the third sheet until the second adhesion process.

(6) An artificial bone forming kit for forming an artificial bone for closing an opening formed in a skull by removing a bone fragment that is a part of the skull from the skull, comprising:
A first sheet is used by being in close contact with the curved convex surface of the bone piece;
a second sheet that is used by being closely attached to the curved concave surface of the mold to which the curved convex surface is transferred via the first sheet that is closely attached to the bone piece;
An artificial bone molding kit, characterized in that the second sheet is used to press a second material that will become the artificial bone after hardening in a state of close contact with the curved concave surface of the mold.

(7) The artificial bone molding kit according to (6) above, further comprising a suction device for sucking air between the first sheet and the curved convex surface of the bone piece, and air between the second sheet and the curved concave surface of the mold.

(8) The artificial bone forming kit according to (6) or (7) above, further comprising a spacer that is breathable and is used in a state where it is interposed between the curved concave surface of the bone piece and the first sheet.

The present invention provides an artificial bone molding method and an artificial bone molding kit that can easily and accurately manufacture artificial bones and can also manufacture artificial bones at relatively low cost.

FIG. 1 is a perspective view of an embodiment of an artificial bone forming kit of the present invention. FIG. 2 is a cross-sectional view for explaining an example of the procedure of a method of using the artificial bone forming kit shown in FIG. 1 (the artificial bone forming method of the present invention). FIG. 3 is a cross-sectional view for explaining an example of a procedure for using the artificial bone forming kit shown in FIG. 1 (the artificial bone forming method of the present invention). FIG. 4 is a cross-sectional view for explaining an example of the procedure of a method of using the artificial bone forming kit shown in FIG. 1 (the artificial bone forming method of the present invention). FIG. 5 is a cross-sectional view for explaining an example of a procedure for using the artificial bone forming kit shown in FIG. 1 (the artificial bone forming method of the present invention). FIG. 6 is a cross-sectional view for explaining an example of a procedure for using the artificial bone forming kit shown in FIG. 1 (the artificial bone forming method of the present invention). FIG. 7 is a plan view for explaining an example of the procedure of a method of using the artificial bone forming kit shown in FIG. 1 (the artificial bone forming method of the present invention). FIG. 8 is a cross-sectional view for explaining an example of a procedure for using the artificial bone forming kit shown in FIG. 1 (the artificial bone forming method of the present invention). FIG. 9 is a cross-sectional view for explaining an example of a procedure for using the artificial bone forming kit shown in FIG. 1 (the artificial bone forming method of the present invention). FIG. 10 is a cross-sectional view for explaining an example of the procedure of a method of using the artificial bone forming kit shown in FIG. 1 (the artificial bone forming method of the present invention). FIG. 11 is a cross-sectional view for explaining an example of the procedure of a method of using the artificial bone forming kit shown in FIG. 1 (the artificial bone forming method of the present invention). FIG. 12 is a perspective view showing a schematic diagram of the skull.

Preferred embodiments of the present invention will now be described in detail.
First Embodiment
Fig. 1 is a perspective view of an embodiment of an artificial bone molding kit of the present invention. Figs. 2 to 6 are cross-sectional views for explaining an example of the procedure of a method for using the artificial bone molding kit shown in Fig. 1 (artificial bone molding method of the present invention). Fig. 7 is a plan view for explaining an example of the procedure of a method for using the artificial bone molding kit shown in Fig. 1 (artificial bone molding method of the present invention). Figs. 8 to 11 are cross-sectional views for explaining an example of the procedure of a method for using the artificial bone molding kit shown in Fig. 1 (artificial bone molding method of the present invention). Fig. 12 is a perspective view showing a schematic view of a skull.

In the following explanation, "upper side" and "lower side" respectively refer to the upper side and lower side in the figure, and similarly, "right side" and "left side" respectively refer to the right side and left side in the figure.

As shown in FIG. 1, the artificial bone forming kit 1 is an instrument for forming an artificial bone to fill an opening formed in the skull during craniotomy, for example, and includes a first bag 11, a second bag 12, a third bag 13, a spacer 14, a suction kit 15, a stirring container 16, a mold forming material 10A, a mold forming material 10B, an artificial bone forming material 10C, and an artificial bone forming material 10D. These can be used to carry out the artificial bone forming method of the present invention.

The artificial bone molding method includes a mold molding step of molding a mold for molding an artificial bone, and an artificial bone molding step of molding an artificial bone using the mold molded in the mold molding step. In the mold molding step, a first bag 11, a spacer 14, a suction kit 15, mold forming material 10A, and mold forming material 10B are used. On the other hand, in the artificial bone molding step, a second bag 12, a third bag 13, a suction kit 15, a stirring container 16, artificial bone forming material 10C, and artificial bone forming material 10D are used.

First, each element of the artificial bone forming kit 1 will be described.
(First bag 11)
As shown in Fig. 1, the first bag 11 is a bag into which the bone piece 100 is inserted, and is made of two sheets 11A (first sheets) that are stacked on top of each other and joined at their edges to form a bag shape. The joining method is not particularly limited, and examples thereof include adhesion, fusion, and pressure bonding. The sheet 11A has three sides joined, and the portion corresponding to the unjoined side functions as an insertion opening 111 for inserting the bone piece 100. Note that the first bag 11 is not limited to this configuration, and may be formed, for example, by joining and closing one opening side of the cylindrical sheet 11A.

As shown in Figures 2, 3, and 12, the bone piece 100 is in the shape of a plate with a curved convex surface 100A on one side and a curved concave surface 100B on the other side. This bone piece 100 is, for example, a missing piece of the skull that has been missing when forming an opening in the skull.

The insertion opening 111 is provided with a sealing means 112 that hermetically seals the inside. Examples of the sealing means 112 include Ziploc (registered trademark). This sealing means 112 allows the bone fragments 100 to be inserted into the first bag 11 and to remain stored therein (see FIG. 1).

The sealing means 112 is not particularly limited, and may be, for example, a grip that is clamped and sealed by two elongated bodies, or a fused portion formed by fusing the sheets 11A near the insertion opening 111 together in a re-breakable manner. In the case of a grip, there is no particular limitation as long as it is configured to clamp the sheet 11A near the insertion opening 111 between two elongated bodies and maintain that state, and may be, for example, configured to hold it by a magnet, configured to hold it by fitting, or configured to hold it by crimping.

The first bag 11 is also provided with a suction hole 113. The suction hole 113 is configured as a through hole and is provided with a self-sealing valve (not shown). The suction kit 15 is connected to the suction hole 113. When the suction kit 15 performs suction, air is exhausted from within the first bag 11 through the suction hole 113, and the pressure inside the first bag 11 can be reduced. When the suction kit 15 is removed, the reduced pressure inside the first bag 11 is maintained by the action of the self-sealing valve.

Examples of materials that can be used to form the sheet 11A include polyolefins such as polyethylene, polypropylene, polybutadiene, and ethylene-vinyl acetate copolymer (EVA), polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), various heat-sealable elastomers such as soft polyvinyl chloride, polyvinylidene chloride, silicone, polyurethane, and polyamide elastomers, or any combination of these (blend resins, polymer alloys, etc.).

The sheet 11A is preferably optically transparent. This allows easy and accurate operations such as inserting the bone fragment 100 and aligning the bone fragment 100 with the spacer 14.

(Spacer 14)
The spacer 14 is made of a flexible mesh sheet. The spacer 14 is used by being inserted in the first bag 11 and between the sheet 11A and the curved concave surface 100B of the bone piece 100. When the inside of the first bag 11 is suctioned with the bone piece 100 inserted therein, the spacer 14 prevents the sheet 11A from being excessively deformed, while the spacer 14 itself deforms stably in accordance with the deformation of the sheet 11A. This allows the sheet 11A to be deformed stably and effectively adhered to the curved concave surface 100B of the bone piece 100. Furthermore, as shown in FIG. 3, when suction is performed, the sheet 11A can be adhered to the side surface 100C of the bone piece 100 (the surface between the curved convex surface 100A and the curved concave surface 100B) following the shape of the side surface 100C.

The spacer 14 also has a circular body 141 and a gripping portion 142 that protrudes from the circular body 141 in a plan view. By having the gripping portion 142, the operability of the spacer 14 can be improved when inserting it into the first bag 11. However, the shape of the spacer 14 in a plan view is not particularly limited, and may be any shape, such as a triangle, a rectangle, a polygon with more sides, or an ellipse.

Moreover, it is preferable that main body 141 has a size sufficient to contain bone piece 100 in a plan view. In this way, when first bag 11 is suctioned, sheet 11A can be brought into close contact with side surface 100C of bone piece 100 over the entire circumference thereof in a shape conforming to the shape of side surface 100C.
.

It is also preferable that the spacer 14 is flexible. This allows the spacer 14 to deform more flexibly and effectively follow the curved concave surface 100B when suction is applied inside the first bag 11.

Materials that can be used to make the spacer 14 include natural rubber, silicone rubber, isoprene rubber, butyl rubber, fluororubber, polypropylene, polyamide, polyethylene, etc.

(Second bag 12)
8, the second bag 12 is a bag into which a mold 200 (described later) is inserted, and is composed of a sheet 12A (second sheet). The second bag 12 has an insertion opening 121, a sealing means 122, a suction hole 123, and a cutout portion 124. The configuration of the second bag 12 is substantially the same as that of the first bag 11, and therefore only the differences will be described.

The cut-out portion 124 is a portion that is exposed to the outside from the third bag 13 when the second bag 12 is inserted into the third bag 13. By having the cut-out portion 124, the mold 200 can be inserted into the second bag 12 easily and quickly. Furthermore, it is possible to prevent the mold 200, which is not in a sterile state, from coming into contact with the inside of the third bag 13 or the part of the outside of the second bag 12 that is located inside the third bag 13.

When the insertion of the mold 200 into the second bag 12 is completed, the cut-out portion 124 is detached at the cut-out position 125 shown by the dashed line in FIG. 1 and discarded. It is preferable that the cut-out position 125 has an easily identifiable portion, such as a perforation or a thin portion, formed therein.

In the above, the case where the cut-out portion 124 is part of the second bag 12 has been described, but the cut-out portion 124 may be formed separately in advance.

The constituent material of such a second bag 12 is not particularly limited, and for example, the materials listed as the constituent materials of the first bag 11 can be used. However, the constituent materials of the first bag 11 and the second bag 12 may be the same or different. For example, it is preferable that the first bag 11 is made of a material having elasticity, and the second bag 12 is made of a material having excellent biocompatibility.

(Third bag 13)
1 and 7, the third bag 13 is a bag into which the second bag 12 is inserted, and is composed of a sheet 13A (third sheet). The third bag 13 has an insertion opening 131 and a sealing means 132. That is, the third bag 13 will be described as having substantially the same configuration as the first bag 11, except that the suction hole 113 is omitted and the dimensions are different.

(Suction kit 15)
The suction kit 15 (suction tool) has an aspirator 151 and a flexible tube 152. The aspirator 151 has a suction port 153, to which the tube 152 is connected. The aspirator 151 has a built-in motor (not shown), and can create a reduced pressure state by operating the motor, and can suck air from the suction port 153. The operation of the motor is turned on and off by operating a power switch (not shown).

The suction kit 15 is used in the first and second adhesion processes described below. In the first adhesion process, the air is sucked between the sheet 11A and the curved convex surface 100A of the bone piece 100. In the second adhesion process, the air is sucked between the sheet 12A and the curved concave surface 200B of the mold 200.

In addition, one end of the tube 152 is connected to the suction port 153 of the aspirator 151, and the other end is connected to the suction hole 123 of the second bag 12 in the second adhesion process.

The aspirator 151 is not limited to the above configuration, and may be configured to perform aspirating by manually operating a plunger of a syringe, for example.
Moreover, the tube 152 may be omitted. That is, the tube 152 does not have to be a component of the artificial bone forming kit 1. When the tube 152 is omitted, the suction port 153 of the suction device 151 is directly connected to the suction hole 113 or the suction hole 123.

(Stirring vessel 16)
The stirring vessel 16 is used when mixing the artificial bone forming materials 10C and 10D described below. This stirring vessel 16 is preferably one that has been sterilized.

Sterilization methods are not particularly limited, and examples include steam sterilization using high-temperature, high-pressure steam (high-pressure steam sterilization), sterilization using EOG (ethylene oxide gas) or hydrogen peroxide-based disinfectants, etc.

The stirring container 16 does not have to be a component of the artificial bone forming kit 1. In this case, the user of the artificial bone forming kit 1 prepares a separate container.

(Mold forming material 10A and mold forming material 10B)
The mold-forming material 10A and the mold-forming material 10B are a first material that becomes the mold 200 by mixing and hardening. The mold-forming material 10B functions as a hardening accelerator. As the mold-forming material 10A, various types of silicones can be used, and as the mold-forming material 10B, various types of hardening accelerators can be used. The form of the mold-forming material 10A and the mold-forming material 10B is not particularly limited, and may be any form such as liquid, powder, paste, etc. The mold-forming material 10A and the mold-forming material 10B are not limited to the above, and may be a material that constitutes gypsum or a material that constitutes various resin materials.

(Artificial bone forming material 10C and artificial bone forming material 10D)
The artificial bone forming material 10C and the artificial bone forming material 10D are a second material that become the artificial bone 300 by mixing and hardening. The artificial bone forming material 10C is a powder, and the artificial bone forming material 10D is a liquid. By mixing these, a polymerization reaction occurs to form a resin. Then, after mixing starts, the material gradually starts to harden, and hardening is completed within a few minutes (for example, about 2 to 10 minutes).

The artificial bone forming material 10C is not particularly limited, and for example, a powder containing polymethyl methacrylate as the main component can be used. The artificial bone forming material 10D is not particularly limited, and for example, a liquid containing methyl methacrylate as the main component can be used.

Next, the method for forming an artificial bone of the present invention will be described with reference to FIGS.
First, prior to carrying out the artificial bone forming method of the present invention, a craniotomy is performed. Examples of craniotomy include hematoma removal surgery for traumatic intracranial hematoma (epidural hematoma, subdural hematoma, intracerebral hematoma), hematoma removal surgery for intracerebral hematoma, aneurysmal neck clipping surgery for cerebral aneurysm, bypass surgery for moyamoya disease and major artery occlusion, tumor removal surgery for brain tumors, decompressive craniotomy surgery for cerebral herniation, and microvascular decompression surgery for neurovascular compression syndrome (trigeminal neuralgia, facial spasm). During these craniotomy surgeries, a bone fragment 100 is harvested when an opening is formed by removing a portion of the skull.

The artificial bone molding method of the present invention includes a first adhesion step, a first transfer step, a storage step, a second adhesion step, and a second transfer step.

[First adhesion process]
As shown in FIGS. 2 and 3, the first adhering step is a step of adhering a flexible sheet 11A to the curved convex surface 100A of the bone piece 100.

First, as shown in FIG. 2, the bone fragment 100 and the spacer 14 are inserted into the first bag 11. At this time, the spacer 14 is placed on the curved concave surface 100B side of the bone fragment 100. Then, the suction kit 15 is used to suck out the air from inside the first bag 11. That is, the tube 152 of the suction kit 15 is connected to the suction hole 113 of the first bag 11, and the suction device 151 is activated. This allows the sheet 11A of the first bag 11 to follow the curved shape of the curved convex surface 100A of the bone fragment 100, as shown in FIG. 3, and the sheet 11A can be brought into close contact with the curved convex surface 100A.

At this time, the spacer 14 prevents excessive deformation of the sheet 11A, while the spacer 14 itself deforms stably in accordance with the deformation of the sheet 11A. This allows the sheet 11A to be deformed stably and effectively adhered to the curved concave surface 100B of the bone piece 100. Furthermore, as shown in FIG. 3, when suction is performed, the sheet 11A can be adhered to the side surface 100C of the bone piece 100 (the surface between the curved convex surface 100A and the curved concave surface 100B) by following the shape of the side surface 100C.

[First transfer step]
As shown in Figure 4, the first transfer process is a process of forming a mixture M1 of mold-forming material 10A and mold-forming material 10B, which will become mold 200 after hardening, on a sheet 11A that is in close contact with the curved convex surface 100A of the bone piece 100.

First, the mold-forming material 10A and the mold-forming material 10B are mixed to a desired mixing ratio to obtain a mixture M1. Next, as shown in FIG. 4, the mixture M1 is kneaded, and the mixture M1 is evenly spread and pressed against the sheet 11A that is in close contact with the curved convex surface 100A of the bone piece 100. At this time, the mixture M1 is also evenly pressed against the side surface 100C of the bone piece 100.

The thickness of the mixture M1 is not particularly limited, but is preferably about 5 mm or more and 20 mm or less.

Then, as shown in FIG. 5, the mixture M1 is removed from the sheet 11A and then hardened. This results in a mold 200 onto which the shape of the curved convex surface 100A of the bone piece 100 has been transferred.

More specifically, the obtained mold 200 has a curved concave surface 200B to which the shape of the curved convex surface 100A has been transferred, and a side surface 200C to which the shape of the side surface 100C of the bone piece 100 has been transferred, as shown in FIG. 5.

In addition, the mixture M1 may be cured in the state shown in FIG. 4 before the mold 200 is removed from the sheet 11A.

[Storage process]
Next, as shown in Figures 6 and 7, the mold 200 is inserted into the second bag 12 and stored.
The second bag 12 and the third bag 13 are sterilized before the mold 200 is inserted into the second bag 12. The process for sterilizing the second bag 12 and the third bag 13 is not particularly limited, but may include the methods listed in the sterilization process of the stirring container 16 described above.

The second bag 12 is inserted into the third bag 13, and the cut-out portion 124 of the second bag 12 is exposed from the third bag 13. When inserting the mold 200 into the second bag 12, the second bag 12 has the cut-out portion 124, so that the insertion operation can be performed easily and quickly. Furthermore, during this insertion operation, the user can mainly grasp the cut-out portion 124 to perform the insertion operation, so that the sterility of the second bag 12 and the third bag 13 can be effectively maintained.

The above-mentioned storage state is maintained from the time of craniotomy until the day of the surgery to implant the artificial bone 300. Furthermore, the following steps are performed in a sterile environment.

[Second adhesion process]
The second adhesion step is performed immediately before surgery. First, in the state shown in Fig. 7, the second bag 12 is removed from the third bag 13 to obtain the state shown in Fig. 8. Next, as shown in Fig. 9, the air in the second bag 12 is sucked using the suction kit 15. That is, the tube 152 of the suction kit 15 is connected to the suction hole 123 of the second bag 12, and the aspirator 151 is operated. As a result, as shown in Fig. 9, the sheet 12A of the second bag 12 follows the curved shape of the curved concave surface 200B of the mold 200, and the sheet 12A can be adhered to the curved concave surface 200B.

[Second transfer process]
As shown in Figure 10, the second transfer process is a process in which a mixture M2 of artificial bone forming material 10C and artificial bone forming material 10D, which will become artificial bone 300 after hardening, is formed on a sheet 12A that is in close contact with the curved concave surface 200B of the mold 200 using a mold 200.

First, artificial bone forming material 10C and artificial bone forming material 10D are mixed in a stirring vessel 16 to obtain a mixture M2 at a desired mixing ratio.

Next, the mixture M2 is kneaded, and as shown in FIG. 10, the mixture M2 is evenly spread and pressed against the sheet 12A that is in close contact with the curved concave surface 200B of the mold 200. At this time, the mixture M2 is also evenly pressed against the side surface 200C of the mold 200.

The thickness of the mixture M2 is not particularly limited, but is preferably about 2 mm or more and 10 mm or less.

As shown in FIG. 11, depending on the temperature of the mixture M2 and the constituent materials of the mixture M2, the mixture M2 is cooled to room temperature, and then detached from the sheet 12A and hardened. This makes it possible to obtain an artificial bone 300 onto which the shape of the curved concave surface 200B of the mold 200 has been transferred.

In addition, the artificial bone 300 may be removed from the sheet 12A after the mixture M2 has hardened in the state shown in FIG. 10.

Then, as shown in Figure 12, by performing a procedure in which an artificial bone 300 is embedded in the head so as to close the opening formed in the skull, the skull can be repaired to the extent that the defect is not immediately noticeable.

Thus, the artificial bone molding method of the present invention is a method for molding an artificial bone that closes an opening formed in the skull by removing a bone fragment 100, which is a part of the skull, from the skull, and includes a first adhesion step of adhering a flexible sheet 11A (first sheet) to the curved convex surface 100A of the bone fragment 100, and a second adhesion step of applying a mold-forming material 10A and a mold-forming material 10B (first material), which will become a mold 200 after hardening, to the sheet 11A adhered to the bone fragment 100, so as to transfer the shape of the curved convex surface 100A to the mixture M1 of the mold-forming material 10A and the mold-forming material 10B. The method includes a first transfer step of closely contacting the mold 200 with the curved convex surface 200A of the mixture M1 to form the curved concave surface 200B, a second contact step of closely contacting the mold 200 with the curved convex surface 200B of the mixture M1 after hardening, i.e., the mold 200, and a second transfer step of closely contacting the mold 200 with the sheet 12A that is closely contacted with the mold 200 to form the artificial bone 300 after hardening, the second material (artificial bone-forming material 10C and artificial bone-forming material 10D) that will become the artificial bone 300 after hardening, to the sheet 12A so as to transfer the shape of the curved concave surface 200B to the mixture M2 of the artificial bone-forming material 10C and the artificial bone-forming material 10D. The curved concave surface 200B of the mold 200 has a shape transferred from the curved convex surface 100A of the bone piece 100, so that the artificial bone 300 obtained by this method has a high reproducibility of the shape of the bone piece 100, and the artificial bone 300 can be accurately manufactured. Furthermore, conventional artificial bones made of titanium are relatively expensive, and skilled techniques are required to improve the reproducibility of the artificial bone for the bone fragments. In contrast, in the present invention, the artificial bone 300 can be manufactured by a simple method of evenly spreading the relatively inexpensive mixture M2 over the mold 200. In addition, when spreading the mixture M2, it is easy to shape the outer surface into the desired shape, so that an artificial bone 300 that is aesthetically pleasing can be obtained, that is, an artificial bone 300 with high aesthetic properties can be obtained. As described above, according to the present invention, the artificial bone 300 can be manufactured easily and accurately, and furthermore, an artificial bone 300 with high aesthetic properties can be manufactured relatively inexpensively.

The sheet 11A (first sheet) is bag-shaped, and the first adhesion process is performed by sucking the air out of the sheet 11A. This allows the sheet 11A to be more effectively adhered to the curved convex surface 100A of the bone piece 100 in the first adhesion process.

In the first adhesion step, suction is performed with an air-permeable spacer 14 interposed between the curved concave surface 100B of the bone piece 100 and the sheet 11A (first sheet). This allows the sheet 11A to be stably deformed and effectively adhered to the curved concave surface 100B of the bone piece 100. Furthermore, as shown in FIG. 3, when suction is performed, the sheet 11A can be adhered to the side surface 100C of the bone piece 100 (the surface between the curved convex surface 100A and the curved concave surface 100B) by following the shape of the side surface 100C.

The sheet 12A (second sheet) is bag-shaped, and the second adhesion process is performed by sucking the air out of the sheet 12A. This allows the sheet 12A to be more effectively adhered to the curved concave surface 200B of the mold 200 in the second adhesion process.

The mold 200 formed in the first transfer step is contained within the sheet 12A (second sheet) contained within the sheet 13A (third sheet) until the second contact step. This effectively maintains the sterility of the sheet 12A in contact with the mold 200.

The artificial bone forming kit 1 of the present invention forms an artificial bone to close an opening formed in the skull by removing a bone fragment 100, which is a part of the skull, from the skull, and includes a sheet 11A (first sheet) that is used by adhering to the curved convex surface 100A of the bone fragment 100, and a sheet 12A (second sheet) that is used by adhering to the curved concave surface 200B of the mold 200 to which the curved convex surface 100A is transferred via the sheet 11A that is adhering to the bone fragment 100. The sheet 12A is also used to press a mixture M2 (second material) of the artificial bone forming material 10C and the artificial bone forming material 10D that will become the artificial bone 300 after hardening, while being adhering to the curved concave surface 200B of the mold 200. As a result, as described above, the artificial bone 300 can be easily and accurately manufactured, and furthermore, the artificial bone 300 can be manufactured relatively inexpensively.

As described above, the artificial bone molding kit 1 further includes a suction kit 15, which is a suction tool that sucks in the air between the sheet 11A (first sheet) and the curved convex surface 100A of the bone piece 100, and between the sheet 12A (second sheet) and the curved concave surface 200B of the mold 200. This allows the sheet 11A to be more effectively adhered to the curved convex surface 100A of the bone piece 100 in the first adhesion step, and allows the sheet 12A to be more effectively adhered to the curved concave surface 200B of the mold 200 in the second adhesion step.

As described above, the artificial bone molding kit 1 further includes a spacer 14 that is breathable and is used by being interposed between the curved concave surface 100B of the bone piece 100 and the sheet 11A (first sheet). This allows the sheet 11A to be stably deformed and effectively adhered to the curved concave surface 100B of the bone piece 100. Furthermore, as shown in FIG. 3, when suction is performed, the sheet 11A can be adhered to the side surface 100C of the bone piece 100 (the surface between the curved convex surface 100A and the curved concave surface 100B) by following the shape of the side surface 100C.

The artificial bone molding method and artificial bone molding kit of the present invention have been described above in terms of the illustrated embodiments, but the present invention is not limited to this, and each part and step constituting the artificial bone molding method and artificial bone molding kit can be replaced with any configuration or step that can perform the same function. In addition, any configuration or step may be added.

1 Artificial bone molding kit 10A Mold forming material 10B Mold forming material 10C Artificial bone forming material 10D Artificial bone forming material 11 First bag 11A Sheet 12 Second bag 12A Sheet 13 Third bag 13A Sheet 14 Spacer 15 Suction kit 16 Stirring container 100 Bone fragment 100A Curved convex surface 100B Curved concave surface 100C Side surface 111 Insertion port 112 Sealing means 113 Suction hole 121 Insertion port 122 Sealing means 123 Suction hole 124 Cutout portion 125 Cutout position 131 Insertion port 132 Sealing means 141 Main body 142 Gripping portion 151 Aspirator 152 Tube 153 Suction port 200 Mold 200A Curved convex surface 200B Curved concave surface 200C Side surface 300 Artificial bone M1 Mixture M2 Mixture

Claims (8)

1. A method for forming an artificial bone, which closes an opening formed in a skull by removing a bone fragment that is a part of the skull from the skull, comprising:
a first adhesion step of adhering a flexible first sheet to the curved convex surface of the bone piece;
a first transfer step of applying a first material, which will become a mold after hardening, to the first sheet adhered to the bone fragment so as to transfer the shape of the curved convex surface to the first material, thereby forming a curved concave surface in the first material;
a second adhesion step of adhering a flexible second sheet to the curved concave surface of the first material after hardening;
a second transfer step of using the first material as a mold to adhere a second material, which will become the artificial bone after hardening, to the second sheet, which is adhered to the first material, so as to transfer the shape of the curved concave surface to the second material. The first sheet is bag-shaped,
2. The method for forming an artificial bone according to claim 1, wherein the first adhesion step is performed by sucking air from within the first sheet. The artificial bone molding method according to claim 1 or 2, wherein in the first adhesion step, suction is performed with a breathable spacer interposed between the curved concave surface of the bone piece and the first sheet. The second sheet is bag-shaped,
4. The method for forming an artificial bone according to claim 1, wherein the second adhesion step is performed by sucking air from within the second sheet. a bag-shaped third sheet that covers the second sheet;
5. The method for forming an artificial bone according to claim 4, wherein the first material formed in the first transfer step is contained within the second sheet contained within the third sheet until the second adhesion step. An artificial bone forming kit for forming an artificial bone to close an opening formed in a skull by removing a bone fragment that is a part of the skull from the skull,
A first sheet is used by being in close contact with the curved convex surface of the bone piece;
a second sheet that is used by being closely attached to the curved concave surface of the mold to which the curved convex surface is transferred via the first sheet that is closely attached to the bone piece;
An artificial bone molding kit, characterized in that the second sheet is used in such a way that it is in close contact with the curved concave surface of the mold and is pressed against a second material that will become the artificial bone after hardening. The artificial bone forming kit according to claim 6, further comprising a suction device for sucking air between the first sheet and the curved convex surface of the bone piece, and air between the second sheet and the curved concave surface of the mold. The artificial bone forming kit according to claim 6 or 7, further comprising a spacer that is breathable and is used in a state in which it is interposed between the curved concave surface of the bone piece and the first sheet.

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