Bending guides, surgical guide kits, bit plates, and cutting and drilling guide devices

Abstract

We provide custom-made bending guides, surgical guide kits, bit plates, and cutting and drilling guide devices. [Solution] The present invention relates to a bending guide 70 for forming a fixing device 50 to be fixed to an object, comprising: a first mold 71 formed by reproducing the first three-dimensional shape of the surface of a predetermined region including the fixing position on the object side; and a second mold 72 formed by inverting the first three-dimensional shape into three dimensions.

Description

Technical Field

[0001] The present invention relates to a bending guide, a surgical guide kit, a bite plate, and a cutting and drilling guide device.

Background Art

[0002] When correcting the skull, a surgical operation to cut the bone may be performed. In operations for bone correction (for example, maxillofacial osteotomy such as Le Fort I osteotomy, mandibular osteotomy such as mandibular ramus sagittal split osteotomy), a part of the bone cut from the original bone is positioned and fixed at a preset predetermined position. In recent years, in operations for bone correction, cases using surgical instruments such as screws and plates shaped to the patient's unique shape have become mainstream (for example, see Patent Document 1). In such operations, custom-made surgical instruments tend to be used according to the patient.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] An object of the present invention is to provide a custom-made bending guide, a surgical guide kit, a bite plate, and a cutting and drilling guide device.

Means for Solving the Problems

[0005] (1) One aspect of the present invention is a bending guide for forming a fixing device to be fixed to an object, which is fixed to the object before division and used together with a cutting and drilling guide device for forming a division line and a plurality of fixing holes in the object and a bit plate for temporarily positioning the divided object in a predetermined positional relationship, wherein the fixing device fixes the object, which has been divided into a first object and a second object at the division line, to a predetermined fixing position on the object in a relative predetermined positional relationship, thereby positioning and fixing the first object and the second object in the predetermined positional relationship, wherein the bending guide comprises a first mold formed by reproducing the first three-dimensional shape of the surface of a predetermined region including the fixing position on the object side, and a second mold formed by inverting the first three-dimensional shape in three dimensions, wherein the first mold and the second mold press the fixing device between the first three-dimensional shape and the second three-dimensional shape, thereby fixing the fixing device at the fixing position The bending guide conforms to a three-dimensional shape, the object includes a skull, the dividing line is set on the maxilla side and / or mandible side of the skull, the maxilla and / or mandible is divided into a first object and a second object, and the positional relationship between the maxilla and the mandible is changed to a set position based on the predetermined positional relationship, the cutting and drilling guide device is fixed to the maxilla side and / or mandible side before division, the bite plate temporarily positions the maxilla and the mandible at the set position on the skull where the dividing line has been formed using the cutting and drilling guide device, the bending guide is formed corresponding to the predetermined region which includes a part of the dividing line and a part of the first object and a part of the second object at the set position, and the fixing device is fixed using a plurality of fixing holes at the fixing position which is included in the predetermined region which has been positioned at the set position by the bite plate after being formed by the bending guide.

[0006] (2) In another embodiment of the present invention, the first type is a bending guide according to (1), comprising at least one guide pin protruding from the surface of the first three-dimensional shape at a position corresponding to the positions of a plurality of fixing holes provided in the first object and the second object at the fixed position, wherein the guide pin is inserted into at least one of a plurality of through holes provided in the fixing device corresponding to the positions of the fixing holes, thereby positioning the fixing device to the first type.

[0007] (3) The second type is a bending guide as described in (2), having at least one pin hole corresponding to the position of the guide pin, the pin hole being used to position the first type and the second type and to clamp the fixing device.

[0008] (4) The first type and the second type are bending guides according to any one of (1) to (3), provided in a bending device comprising a first device and a second device that is movable in a direction approaching or moving away from the first device, the first type being fixed to the first device, and the second type being provided on the second device and equipped with a rotation prevention part that prevents it from rotating relative to the second device.

[0009] (5) The fixing device is a bending guide described in any of (1) to (4), which is made of a bioabsorbable material.

[0010] (6) The cutting and drilling guide device is a bending guide according to any one of (1) to (5), comprising a groove-shaped cutting guide for guiding a cutting tool for forming the dividing line, and a plurality of cylindrical parts for guiding a drilling tool for forming a plurality of fixing holes in the first object and the second object.

[0011] (7) The bite plate comprises a first contact portion formed to match the first shape on the maxillary side and a second contact portion formed to match the second shape on the mandibular side, The bending guide according to claim 1, wherein the positional relationship between the first contact portion and the second contact portion is adjusted so that the divided first object and the second object are positioned in the predetermined positional relationship.

[0012] (8) One aspect of the present invention is a surgical guide kit comprising: a bending guide for forming a fixing device for fixing an object divided into a first object and a second object at a dividing line to a predetermined relative positional relationship; a bit plate for temporarily positioning the object divided into the first object and the second object in the predetermined positional relationship; and a cutting and drilling guide device fixed to the object before division, for forming the dividing line and forming a plurality of fixing holes in the first object and the second object, wherein the bending guide is used together with the cutting and drilling guide device and the bit plate, the fixing device is fixed to a preset fixing position of the object temporarily positioned in the predetermined positional relationship by the bit plate, thereby positioning and fixing the first object and the second object in the predetermined positional relationship, the bending guide comprises a first mold formed by reproducing the first three-dimensional shape of the surface of a predetermined region including the fixing position on the object side, and the first three-dimensional shape The first and second types are configured such that a second three-dimensional shape is formed by inverting the first type in three dimensions, and the first and second types are configured such that the fixing device is sandwiched and pressed between the first and second three-dimensional shapes to conform the fixing device to the three-dimensional shape at the fixing position, the object includes a skull, the dividing line is set on the maxilla side and / or mandible side of the skull, the maxilla and / or mandible are divided into a first object and a second object, and the positional relationship between the maxilla and the mandible is changed to a set position based on the predetermined positional relationship. The cutting and drill guide device is fixed to the maxilla and / or mandible side before division, the bite plate temporarily positions the maxilla and mandible at the set position in the skull where the division line has been formed using the cutting and drill guide device, the bending guide is formed in the set position corresponding to a predetermined area including a part of the division line, a part of the first object, and a part of the second object, and the fixing device is formed by the bending guide,This surgical guide kit is fixed using a plurality of fixing holes at the fixed position within the predetermined region positioned at the set position by the bite plate.

[0013] (9) One aspect of the present invention is a bending guide for forming a fixing device to be fixed to an object, wherein the object includes a skull divided by a dividing line, the dividing line is set on the maxilla side and / or mandible side of the skull, divides the maxilla and / or mandible into a first object and a second object, and changes the positional relationship between the maxilla and the mandible, the fixing device is made of a bioabsorbable material, fixes the object divided into a first object and a second object by the dividing line to a predetermined relative positional relationship, and fixes the object to a predetermined fixing position in the predetermined positional relationship, thereby positioning and fixing the first object and the second object in the predetermined positional relationship, the bending guide comprises a first mold formed by reproducing a first three-dimensional shape of the surface of a predetermined region including the fixing position on the object side, and a second mold formed by inverting the first three-dimensional shape in three dimensions, The first and second types are bending guides that, by sandwiching and pressing the fixing device between the first three-dimensional shape and the second three-dimensional shape, align the fixing device with the three-dimensional shape at the fixing position. The first type is provided with at least one guide pin that protrudes from the surface of the first three-dimensional shape at a position corresponding to the positions of a plurality of fixing holes provided in the first object and the second object at the fixing position. The guide pin is inserted into at least one of a plurality of through holes provided in the fixing device corresponding to the positions of the fixing holes, thereby positioning the fixing device to the first type. The first and second types are provided in a bending device that comprises a first device and a second device that is movable in a direction approaching or moving away from the first device. The first type is fixed to the first device, and the second type is provided in the second device and is equipped with a rotation prevention part that prevents it from rotating relative to the second device.

[0014] (10) One aspect of the present invention is a bite plate used together with a bending guide for forming a fixing device for fixing an object divided into a first object and a second object at a dividing line to a predetermined relative positional relationship, and a cutting and drill guide device which is fixed to the object before division and forms the dividing line and a plurality of fixing holes in the first object and the second object, wherein the object includes a skull divided by the dividing line, the dividing line is set on the maxilla side and / or mandible side of the skull, divides the maxilla and / or mandible into a first object and a second object, and changes the positional relationship between the maxilla and the mandible, the bite plate temporarily positions the object divided into a first object and a second object in the predetermined positional relationship, and has a first contact portion formed to match the first shape on the maxilla side, and The first contact portion and the second contact portion are adjusted to position the divided first object and the second object in the predetermined positional relationship, and the fixing device is fixed to a preset fixing position of the object which has been temporarily positioned in the predetermined positional relationship by the bite plate, thereby positioning and fixing the first object and the second object in the predetermined positional relationship, and the bending guide comprises a first type formed to reproduce the first three-dimensional shape of the surface of a predetermined region including the fixing position on the object side, and a second type formed to represent a second three-dimensional shape which is a three-dimensional inversion of the first three-dimensional shape, and the first type and the second type are bite plates which make the fixing device conform to the three-dimensional shape at the fixing position by sandwiching and pressing the fixing device between the first three-dimensional shape and the second three-dimensional shape.

[0015] (11) One aspect of the present invention is a cutting and drilling guide device used together with a bending guide for forming a fixing device for fixing an object divided into a first object and a second object at a dividing line to a predetermined relative positional relationship, wherein the object includes a skull divided by a dividing line, the dividing line is set on the maxilla side and / or mandible side of the skull, and divides the maxilla and / or mandible into a first object and a second object, and changes the positional relationship between the maxilla and the mandible, and the cutting and drilling guide device includes a cutting guide formed in the shape of a groove for guiding a cutting instrument for forming the dividing line, and a bit plate for temporarily positioning the object divided into a first object and a second object in the predetermined positional relationship, wherein the object includes a skull divided by a dividing line, the dividing line is set on the maxilla side and / or mandible side of the skull, and divides the maxilla and / or mandible into a first object and a second object, and changes the positional relationship between the maxilla and the mandible, and the cutting and drilling guide device includes a cutting guide formed in the shape of a groove for guiding a cutting instrument for forming the dividing line, and The bending guide comprises a plurality of cylindrical parts that guide a drilling tool for forming a number of fixed holes, wherein the fixing tool is fixed to a preset fixing position of the object which has been temporarily positioned in the predetermined positional relationship by the bit plate, thereby positioning and fixing the first object and the second object in the predetermined positional relationship, and the bending guide comprises a first type formed by reproducing the first three-dimensional shape of the surface of a predetermined area including the fixing position on the object side, and a second type formed by inverting the first three-dimensional shape in three dimensions, wherein the first type and the second type are used to sandwich and press the fixing tool between the first three-dimensional shape and the second three-dimensional shape, thereby making the fixing tool conform to the three-dimensional shape at the fixing position, and the bending guide is a cutting and drilling guide device.

[0016] (12) One aspect of the present invention is a design apparatus comprising a calculation unit for designing a surgical guide kit used to fix an object divided into a first object and a second object in a predetermined relative positional relationship, wherein the calculation unit acquires measurement data of the three-dimensional shapes of the first object and the second object, acquires division line data indicating the position of the division line that divides the object into the first object and the second object, acquires position setting data of the first object and the second object arranged in a predetermined relative positional relationship, and in the predetermined positional relationship Drilling data indicating the positions of multiple fixing holes drilled in the first object and the second object is acquired; a virtual object that virtually reproduces the object is generated based on the measurement data; a virtual dividing line is generated in the virtual object based on the dividing line data; the virtual object is virtually divided along the virtual dividing line into a virtual first object that virtually reproduces the first object and a virtual second object that virtually reproduces the second object; and the virtual first object and the virtual second object are virtually divided based on the position setting data. The design apparatus generates a virtual object after relocation arranged in an imagined predetermined positional relationship, generates three-dimensional data for a virtual bit plate to temporarily position the virtual first object and the virtual second object in the imagined predetermined positional relationship, forms a virtual dividing line for generating a third three-dimensional data for a virtual fixing device that is virtually fixed to the virtual object after relocation using a plurality of virtual fixing holes, virtually generates a plurality of virtual fixing holes in the virtual first object that virtually reproduces the first object and the virtual second object that virtually reproduces the second object, generates three-dimensional data for a virtual bending guide to form the virtual fixing device based on the three-dimensional shape of the virtual object after relocation and the three-dimensional shapes of the plurality of virtual fixing holes, and generates three-dimensional data for a virtual cutting and drill guide device that is attached to the virtual object when the virtual first object and the virtual second object are returned to their original positions, and divides the virtual object at the position of the virtual dividing line for generating a plurality of virtual fixing holes at the position of the virtual fixing holes.

[0017] (13) A computer program installed in a design device for designing a surgical guide kit used to fix an object divided into a first object and a second object in a predetermined relative positional relationship, the program acquires measurement data of the three-dimensional shapes of the first object and the second object, acquires division line data indicating the position of the division line that divides the object into a first object and a second object, acquires position setting data of the first object and the second object arranged in a predetermined relative positional relationship, and in the predetermined positional relationship the first object and the second object Drilling data indicating the positions of multiple fixing holes drilled in the object is acquired, a virtual object that virtually reproduces the object is generated based on the measurement data, a virtual dividing line is generated in the virtual object based on the dividing line data, the virtual object is virtually divided along the virtual dividing line into a virtual first object that virtually reproduces the first object and a virtual second object that virtually reproduces the second object, and the virtual first object and the virtual second object are placed in the virtual predetermined positional relationship based on the position setting data. This is a computer program that causes a processor in the design apparatus to execute each of the following processes: generating a moved object; generating three-dimensional data for a virtual bit plate to temporarily position the virtual first object and the virtual second object in a virtual predetermined positional relationship; forming a virtual dividing line for generating a third three-dimensional data for a virtual fixing device that is virtually fixed to the virtual moved object using a plurality of virtual fixing holes; virtually generating a plurality of virtual fixing holes in the virtual first object that virtually reproduces the first object and the virtual second object that virtually reproduces the second object; generating three-dimensional data for a virtual bending guide to form the virtual fixing device based on the three-dimensional shape of the virtual moved object and the three-dimensional shapes of the plurality of virtual fixing holes; and generating three-dimensional data for a virtual cutting and drill guide device that is attached to the virtual object when the virtual first object and the virtual second object are returned to their original positions, and that divides the virtual object at the position of the virtual dividing line for generating a plurality of virtual fixing holes at the position of the virtual fixing holes. [Effects of the Invention]

[0018] According to the present invention, for example, it is possible to provide a custom-made bending guide, a surgical guide kit, a bite plate, and a cutting and drilling guide device. Further, for example, surgical instruments such as custom-made screws and plates can be formed by these.

Brief Description of the Drawings

[0019] [Figure 1] It is a diagram schematically explaining a surgery for cutting bone. [Figure 2] It is a block diagram showing the configuration of a surgical guide kit. [Figure 3] It is a diagram showing the configuration of a cutting and drilling guide device. [Figure 4] It is a diagram showing the configuration and usage state of a bite plate. [Figure 5] It is a perspective view showing the configuration of a fixing device. [Figure 6] It is a side view showing the configuration and operation of a bending device. [Figure 7] It is a perspective view showing the configuration of a bending device. [Figure 8] It is a perspective view showing the configuration of a bending guide. [Figure 9] It is a cross-sectional view showing the usage method of a bending device and a bending guide. [Figure 10] It is a diagram showing the fixed state of a fixing device. [Figure 11] It is a block diagram showing the configuration of a design system. [Figure 12] It is a flowchart showing the processing flow of a design method executed in a design device.

Mode for Carrying Out the Invention

[0020] Figure 1 shows an example of a surgery to cut a portion of the skull 1. Surgery to modify a portion of the skull 1 is performed on the maxilla 2 or mandible 3 (for example, maxilloplasty such as Le Fort I osteotomy, mandibular osteoplasty such as sagittal split ramus osteotomy, etc., are examples, but are not limited to these). The object to be surgically treated in this embodiment is the skull 1. The object may include not only the skull 1, but also skeletal models used for practice, etc. The skull 1 is divided by a dividing line D. The dividing line D is made on the maxilla 2 side and / or mandible 3 side of the skull 1. The dividing line D is set to divide the maxilla 2 and / or mandible 3 into at least a first object and a second object, and to change the positional relationship between the maxilla 2 and mandible 3.

[0021] This embodiment illustrates surgical instruments used in surgery to correct the position of the maxilla 2. The surgical instruments according to this embodiment may also be applied to surgery to correct the position of the mandible 3. When correcting the position of the maxilla 2, which is part of the skull 1, surgery to cut the maxilla 2 (for example, Le Fort I osteotomy) is performed. In this surgery, the maxilla 2 is cut along a predetermined division line D. For example, one or more division lines D are set on the left maxilla 2 and one or more on the right maxilla 2.

[0022] The dividing line D set on the left maxilla 2 and the dividing line D set on the right maxilla 2 may be set symmetrically or asymmetrically. The dividing line D set on the left maxilla 2 and the dividing line D set on the right maxilla 2 may differ in position, shape, and number depending on the condition of the maxilla 2. The portion of the maxilla 2 divided at the dividing line D is temporarily fixed in place after its position and angle are corrected.

[0023] Specifically, the dividing line D is set on the maxilla 2 side and / or mandible 3 side of the skull 1. The dividing line D divides the maxilla 2 and / or mandible 3 into a first object and a second object. The dividing line D changes the positional relationship of the first object and the second object to a predetermined position after positional adjustment. The dividing line D is set to change the positional relationship between the maxilla 2 and mandible 3 to a preset position. This surgery improves the skeletal disharmony of the patient. The surgical guide kit according to this embodiment is a surgical instrument used during surgery. The surgical guide kit is custom-made in advance to a shape that corresponds to the patient's surgical site.

[0024] As shown in Figure 2, the surgical guide kit S consists of several surgical instruments used together in surgery. The surgical guide kit S includes a cutting and drilling guide device 10 that is fixed to the maxilla 2 (object). The cutting and drilling guide device 10 functions as a cutting guide for forming a dividing line in the object and as a drilling guide for forming multiple fixation holes in the object. By using the cutting and drilling guide device 10, the object is divided into a first object and a second object at the dividing line D.

[0025] The surgical guide kit S includes a bite plate 30 for temporarily positioning a first object and a second object in a predetermined relative position. The bite plate 30 is a device formed in the shape of a mouthpiece that corresponds to the tooth profiles of the maxilla and mandible in a predetermined position. The surgical guide kit S also includes a fixing device 50 for fixing the first object and the second object, which have been temporarily positioned in a predetermined position by the bite plate 30.

[0026] The fixing device 50 is fixed to the first object and the second object, which are temporarily positioned in a predetermined positional relationship. The fixing device 50 positions and fixes the first object and the second object in a predetermined positional relationship. The fixing device 50 is a standard product that has been formed in advance into a predetermined shape, as described later.

[0027] The surgical guide kit S includes a bending guide 70 for shaping the fixation device 50. The bending guide 70 is a device for deforming the fixation device 50 to match the surface shapes of a first object and a second object that are temporarily positioned in a predetermined relative position. The bending guide 70 is, for example, a device for processing a standard fixation device 50 into a custom-made shape in the surgical field. The bending guide 70 is used together with the cutting and drilling guide device 10 and the bite plate 30.

[0028] In contrast to the surgical guide kit S described above, a typical surgical guide kit is shipped as a product already formed into a custom-made shape. Such a product includes, for example, custom-made titanium surgical instruments (e.g., plates (fixation devices)), cutting and drilling guide devices, and bite plates. This product does not include a bending guide.

[0029] When using standardized fixation devices (so-called catalog products with fixed shapes: for example, bone fixation materials such as Superfixorb®, which is made of bioabsorbable material), it is difficult to include custom-made items in advance at the time of product shipment. Therefore, there is a need for a system that can easily customize such standardized products (for example, by bending them). The Surgical Guide Kit S is configured to easily mold standardized fixation devices and other items into custom-made products on-site. The following describes in detail each device that makes up the Surgical Guide Kit S.

[0030] As shown in Figure 3, the cutting and drilling guide device 10 is a device that is fixed to the maxilla 2 before cutting. The cutting and drilling guide device 10 is made of, for example, resin. The cutting and drilling guide device 10 may also be made of a material other than resin. Examples of such materials other than resin include metals such as titanium. The cutting and drilling guide device 10 is made, for example, by a three-dimensional printer capable of creating three-dimensional objects. The cutting and drilling guide device 10 is made based on three-dimensional data of the skull 1 that has been measured in advance.

[0031] The cutting and drilling guide device 10 includes a base portion 11 that is fixed to the maxilla 2. The base portion 11 is formed in the shape of a plate. One side of the base portion 11 is a contact surface that contacts the surface of the maxilla 2. The contact surface is formed in a shape that is a three-dimensional inversion of the three-dimensional shape of a predetermined area on the surface of the maxilla 2. The base portion 11 is provided with claw portions 12 for positioning on the maxilla 2.

[0032] The claw portion 12 is formed in a shape that conforms to and contacts a characteristic part of the bone. For example, the claw portion 12 is formed in a shape that catches on and contacts the edge of the piriform opening 1A that opens at the nasal position of the skull 1. The claw portion 12 may also be formed to contact, insert into, or grip other characteristic parts of the skull 1, provided that the base portion 11 can be positioned.

[0033] The base portion 11 is provided with a groove-shaped cutting guide 14. The cutting guide 14 is formed to guide a cutting instrument for forming a division line D. The cutting instrument is, for example, a device equipped with a saw blade for cutting bone. The cutting instrument is configured to cut bone by vibrating the saw blade. The saw blade may be included in the surgical guide kit S. In the illustrated example, the base portion 11 is provided with a pair of cutting guides 14. The pair of cutting guides 14 are provided corresponding to one division line D to be set. The base portion 11 may be provided with multiple cutting guides 14 corresponding to one or more division lines D.

[0034] A connecting portion 13 is formed between a pair of cutting guides 14 at a position that interrupts a pre-set dividing line D. The cutting tool is guided by the cutting guides 14 up to the connecting portion 13. Therefore, the portion of the dividing line D corresponding to the connecting portion 13 remains uncut. After the cutting and drilling guide device 10 is removed, the portion of the dividing line D corresponding to the connecting portion 13 is cut by the cutting tool. The connecting portion 13 may also be cut when the cutting tool is guided by the pair of cutting guides 14. When the connecting portion 13 is cut and the dividing line D is formed, the base portion 11 is divided. The formation of the connecting portion 13 allows the base portion 11 to be handled as a single unit during the procedure, improving work efficiency. One or more connecting portions 13 may be formed.

[0035] The cutting guide 14 has a groove 15 formed therein that exposes the position of a predetermined division line D of the maxilla 2 when the base portion 11 is installed in a predetermined position. A pair of guide rails 16 are formed on both sides of the groove 15. The guide rails 16 are formed to protrude from the other side of the base portion 11. The guide rails 16 extend along the groove 15. The pair of guide rails 16 grip the saw blade guided in the groove 15 and hold it at a set angle. The cutting guide 14 allows the saw blade of the cutting tool to be guided along the groove 15, the angle of the saw blade to be maintained, and the division line D to be formed in the maxilla 2 as set.

[0036] The base portion 11 is provided with a plurality of drilling guides 17 protruding from the other side. The drilling guides 17 have cylindrical portions 18 formed thereon. The proximal end of the cylindrical portion 18 is fixed to one side of the base portion 11. The cylindrical portion 18 has guide holes 19 along its axis. The guide holes 19 are formed to penetrate, for example, from the tip of the cylindrical portion 18 to one side of the base portion 11. The guide holes 19 do not necessarily have to penetrate to one side of the base portion 11. The guide holes 19 are formed with different diameters depending on their position. The guide holes 19 are formed to guide drilling instruments for forming a plurality of fixation holes H (see Figure 4) in the maxilla 2.

[0037] The multiple fixation holes H are formed to fix one or more fixation devices 50, as described later. The positional relationship of the multiple fixation holes H does not correspond to the fixation devices 50 when the holes are drilled by the cutting and drilling guide device 10. The positional relationship of the multiple fixation holes H is set to correspond to the fixation devices 50 when the maxilla 2 is cut and the cut bone is positioned in a predetermined location.

[0038] The drilling device is, for example, a device equipped with a drill bit. The drilling device is configured to drill into bone by rotating or vibrating the drill bit at high speed. The drill bit may be included in the surgical guide kit S. The guide hole 19 holds the drill bit at a predetermined angle relative to the maxilla 2 when a drill bit of approximately the same diameter is inserted. As a result, the guide hole 19 causes the drill bit to form a fixed hole H at a predetermined angle at a predetermined position in the maxilla 2.

[0039] The guide hole 19 only needs to be set at a predetermined position and angle in the base portion 11. Therefore, the cylindrical portion 18 does not necessarily have to be formed as a cylindrical shape concentric with the guide hole 19. The cylindrical portion 18 may be formed not only as a cylinder, but also as a polygonal column or an irregularly shaped mass. By adjusting the amount of protrusion of the cylindrical portion 18 relative to a predetermined amount of protrusion of the drill bit, a fixation hole H of a predetermined depth may be formed in the maxilla 2. This makes it possible to set the fixation hole H in a position that avoids nerves and blood vessels present in the maxilla 2.

[0040] The base portion 11 has one or more pilot holes 20 formed therein for fixing itself to the maxilla 2. The pilot holes 20 are formed to screw the base portion 11, which is positioned by the claw portion 12, to the maxilla 2. The pilot holes 20 are provided to form screw holes at predetermined positions in the maxilla 2 and guide the drill bit of the drilling instrument to the predetermined position. The screw holes only need to be able to fix the base portion 11 with screws, and the pilot holes 20 do not need to have a guide such as the cylindrical portion 18.

[0041] The position and number of pilot holes 20 are adjusted according to the object. The base portion 11 may be fixed to the maxilla 2 using screws through one or more guide holes 19. In this case, the pilot holes 20 may be omitted. The pilot holes 20 may also be omitted if the base portion 11 can be temporarily bonded to the maxilla 2.

[0042] With the above configuration, the cutting and drilling guide device 10 is fixed to the maxilla 2 and / or mandible 3 side of the object to be divided. The cutting and drilling guide device 10 is fixed to a predetermined position on the object and is used to form one or more predetermined dividing lines D and one or more fixed holes H on the object at the predetermined position. The cutting and drilling guide device 10 forms the dividing line D, leaving a portion corresponding to the connecting portion 13.

[0043] The cutting and drilling guide device 10 forms multiple fixing holes H for fixing the fixing device 50. After the dividing line D, which leaves a portion corresponding to the connecting portion 13, and the multiple fixing holes H are formed, the cutting and drilling guide device 10 is removed from the maxilla 2. After the cutting and drilling guide device 10 is removed, the maxilla 2 is cut with a cutting instrument in the portion corresponding to the connecting portion 13, so that the dividing line D is completely connected and the maxilla 2 is divided into a first object and a second object. Here, there is no particular limit to the order in which the fixing holes H and the dividing line D are formed; the fixing holes H may be formed first, or the dividing line D may be formed first.

[0044] Figure 4 shows how to use the bite plate 30. The bite plate 30 is made of, for example, resin. The bite plate 30 may be made of a material other than resin. The bite plate 30 is made, for example, by a 3D printer capable of creating three-dimensional objects. The bite plate 30 is made by performing a simulation using pre-measured 3D data of the skull 1.

[0045] The bite plate 30 is configured to temporarily position the maxilla 2 (object), which is divided into a first object 2A and a second object 2B, in a predetermined positional relationship. The upper surface of the bite plate 30 is provided with a first contact portion 31 formed to match, for example, a first shape 2C on the maxilla 2 side. The first shape is, for example, the shape of the occlusal surface of the dentition on the maxilla 2 (second object 2B in the illustrated example) side. The first contact portion 31 is formed in the shape of a tooth, which is a three-dimensional inversion of the first shape. The first contact portion 31 abuts against the first shape 2C.

[0046] The lower surface of the bite plate 30 is provided with a second contact portion 32 formed to match, for example, the second shape 3A on the mandible 3 side. The second shape is, for example, the shape of the occlusal surface of the dentition on the mandible 3 side. The second contact portion 32 is formed in the shape of a tooth, which is a three-dimensional inversion of the second shape. The second contact portion 32 abuts against the second shape 3A. The positional relationship between the first contact portion 31 and the second contact portion 32 is adjusted to position the divided first object 2A and the second object 2B in a predetermined positional relationship. The predetermined positional relationship is set by performing a simulation before surgery, as described later.

[0047] The bite plate 30 is sandwiched between the dentition of the maxilla 2 and the dentition of the mandible 3. The bite plate 30 has its second shape 3A in contact with the second contact portion 32 and its first shape 2C in contact with the first contact portion 31. When the bite plate 30 is fixed, the first object 2A and the second object 2B are temporarily positioned in a predetermined positional relationship. In this state, the multiple fixing holes H formed by the cutting and drilling guide device 10 are arranged in the arrangement relationship of the fixing position F where the fixing device 50 is fixed. The bite plate 30 may be made with different molded colors for the first contact portion 31 and the second contact portion 32 so that the upper and lower directions can be easily distinguished. Text information such as "upper side" and "lower side" may be molded or added to the bite plate 30.

[0048] As shown in Figure 5, the fixing device 50 includes a base plate 51 made of, for example, a bioabsorbable material. Examples of such bioabsorbable materials include at least one selected from the group consisting of hydroxyapatite, tricalcium phosphate, apatite carbonate, and octacalcium phosphate, and polylactic acid or a lactic acid-glycolic acid copolymer. The bioabsorbable material may also be in the form of a lactic acid-glycolic acid copolymer, polylactic acid (including poly-L-lactic acid alone, or a mixture of poly-D-lactic acid / poly-L-lactic acid), etc.

[0049] The fixation device 50 is supplied to the surgical site separately from the other devices that make up the surgical guide kit S for sterilization. The base plate 51 is formed in a plate shape. In the illustrated example, the base plate 51 is formed in an L shape. The base plate 51 may be formed in other shapes such as an I shape, depending on the treatment site. Multiple screw holes 52 are formed in the base plate 51. The multiple screw holes 52 correspond to the positions of multiple fixation holes H formed in the fixation position F (see Figure 4) of the maxilla 2. The position and number of screw holes 52 are adjusted as appropriate according to the variation of the fixation device 50.

[0050] The fixing device 50 is a general-purpose product and needs to be bent to match the three-dimensional shape of the maxilla 2 at the fixing position F. The fixing device 50 is formed by a bending device and bending guide 70, which will be described later. After being formed by the bending guide 70, the fixing device 50 is fixed using multiple fixing holes H at the fixing position F, which has been temporarily positioned at the set position by the bite plate 30. The formed fixing device 50 is screwed into the fixing position F. The fixing device 50 positions and fixes the first object 2A and the second object 2B at the fixing position F in a predetermined positional relationship.

[0051] The screw 55 (see Figure 10) is screwed into the fixation hole H via the screw hole 52, fixing the fixation device 50 to the maxilla 2. The screw is made of, for example, a bioabsorbable material. The fixation device 50 and screw, fixed at the fixation position F, remain in the patient's body and are broken down and absorbed as the maxilla 2 regenerates and fuses over time.

[0052] As shown in Figures 6 and 7, the bending device 80 is a device used in conjunction with the bending guide 70. The bending device 80 is made of, for example, a heat-resistant metal material. The bending device 80 may be made of other materials as long as they are heat-resistant. The bending device 80 may be included in the surgical guide kit S. The bending guide 70 is mounted on the bending device 80.

[0053] The bending device 80 comprises, for example, a first device 80A that is placed on a mounting surface, and a second device 80B that is movable in a direction approaching or moving away from the first device. The first device 80A comprises, for example, a body portion 81 that supports each component. The body portion 81 is configured to stand upright relative to the mounting surface. The body portion 81 is formed, for example, hollow. The body portion 81 has an opening 81A that opens along the upright direction (vertical direction).

[0054] A pair of legs 82 are provided at the lower end of the body 81, which are placed on a mounting surface. The legs 82 are formed to protrude in a direction substantially perpendicular to the upright direction of the body 81. The legs 82 protrude in the direction of the opening 81A. The pair of legs 82 are provided on both sides of the lower end of the body 81.

[0055] A pair of legs 81 are fitted with the first type 71, which constitutes the bending guide 70, as described later. A fixed handle 83 to be gripped is provided at the upper end of the body 81. The fixed handle 83 is formed in a rod shape. The fixed handle 83 is fixed so as to protrude in a direction substantially perpendicular to the upright direction of the body 81. The fixed handle 83 protrudes in the direction of the opening 81A. The body 81 movably supports the second device 80B.

[0056] The second device 80B includes a shaft 84 inserted into the internal space of the body 81 from the upper end of the body 81. The shaft 84 is formed in a rod shape. The shaft 84 is supported so as to be movable along the upright direction of the body 81. The shaft 84 moves between the top dead center and the bottom dead center relative to the body 81. A movable handle 85 to be gripped is provided at the upper end of the shaft 84. The movable handle 85 is formed in a rod shape. The movable handle 85 is fixed so as to protrude in a direction substantially perpendicular to the upright direction of the body 81. The movable handle 85 protrudes in the direction of the opening 81A.

[0057] The movable handle 85 is positioned to face the fixed handle 83 in the vertical direction. When the movable handle 85 is gripped together with the fixed handle 83, it moves in a direction approaching the fixed handle 83 in the vertical direction. When the grip with the fixed handle 83 is released, the movable handle 85 moves in a direction away from the fixed handle 83. An arm portion 86 is provided at the lower end of the shaft 84, which is movable in conjunction with the movable handle 85. The arm portion 86 is formed, for example, in the shape of a rod.

[0058] The arm portion 86 is fixed so as to protrude in a direction substantially perpendicular to the upright direction of the torso portion 81. The arm portion 86 protrudes from the opening 81A. When the moving handle 85 is moved toward the fixed handle 83, the arm portion 86 moves in conjunction with the moving handle 85 toward the leg portion 82 along the opening 81A. The arm portion 86 is positioned opposite the leg portion 82. The arm portion 86 moves toward the leg portion 82 by being gripped together with the moving handle 85 and the fixed handle 83.

[0059] The arm 86 moves away from the leg 82 when the grip between the fixed handle 83 and the movable handle 85 is released. The second type 72, which constitutes the bending guide 70, is attached to the arm 86.

[0060] As shown in Figure 8, the bending guide 70 consists of a first type 71 fixed to the leg portion 82 and a second type 72 fixed to the arm portion 86. The fixing targets of the first type 71 and the second type 72 may be swapped, with the first type 71 being fixed to the arm portion 86 and the second type 72 being fixed to the leg portion 82. The bending guide 70 is created, for example, by a three-dimensional printer capable of creating three-dimensional objects. The bending guide 70 is created based on three-dimensional data of the maxilla 2, including the first object 2A and the second object 2B after their positions have been adjusted to a predetermined positional relationship.

[0061] The bending guide 70 is made for a predetermined area on the left side and a predetermined area on the right side of the maxilla 2. The molding color of the left-side bending guide 70 and the molding color of the right-side bending guide 70 may be different to make them easily distinguishable. Text information such as "left side" and "right side" may be molded or added to the bending guide 70. The molding color of the first type 71 and the second type 72 of the bending guide 70 may be different to make it easily distinguishable in the vertical direction. Text information such as "upper side" and "lower side" may be molded or added to the bending guide 70.

[0062] A stepped portion 71D (positioning portion) is formed on the bottom side of the first type 71, which is clamped and positioned by the leg portion 82. The positioning portion may also include an insertion hole into which the leg portion 82 is inserted, or a guide that clamps the leg portion 82. The positioning portion may be formed in other shapes as long as it is positionable with respect to the leg portion 82. A first three-dimensional shape 71A is formed on the upper side of the first type 71, which is in contact with the second type 72. The first three-dimensional shape 71A is formed to reproduce the surface of a predetermined region on the maxilla 2 (object) side. The first three-dimensional shape 71A reproduces the surface shape of a predetermined region R (see Figure 4) in the predetermined positional relationship between the first object 2A and the second object 2B after position adjustment. The predetermined region R includes a fixing position F (see Figure 4) where the fixing device 50 on the maxilla 2 side is fixed.

[0063] The first type 71 includes at least one guide pin P that protrudes from the surface of the first three-dimensional shape 71A at positions corresponding to the positions of multiple fixing holes H (see Figure 4) provided in the first object 2A and the second object 2B at the fixing position F. The guide pin P is formed, for example, in a cylindrical shape. The guide pin P is provided corresponding to the position of the fixing hole H on the maxilla 2 side. The axis of the guide pin P protrudes so as to coincide with the axis of the fixing hole H. The guide pin P is inserted into at least one of the multiple through holes 52 in the fixing device 50.

[0064] In the illustrated example, two guide pins P are provided on the surface of the first three-dimensional shape 71A for each fixed position F. The guide pins P can position and temporarily fix the fixing device 50 to the first shape 71 before deformation. The two guide pins P at each fixed position F prevent the fixing device 50 from rotating. In the illustrated example, two guide pins P are provided, but the example is not limited to this; there may be one, three or more, or any number of guide pins.

[0065] On the lower surface of the second type 72, a second three-dimensional shape 72A is formed by inverting the first three-dimensional shape 71A in three dimensions. The second three-dimensional shape 72A is formed by inverting a predetermined region on the maxilla 2 (object) side in three dimensions. The second three-dimensional shape 72A reproduces the surface shape of a predetermined region R (see Figure 4) by inverting it in three dimensions. The second type 72 has at least one pin hole Q corresponding to the position of the guide pin P. In the illustrated example, two pin holes Q are formed on the surface of the second three-dimensional shape 72A for one fixed position F.

[0066] The pin hole Q positions the first type 71 and the second type 72 when the guide pin P is inserted into it, and also holds the fixing device 50 between the first type 71 and the second type 72. Since the first type and the second type 72 are elastically deformable when the guide pin P is inserted into the pin hole Q, the axis of the pin hole Q and the axis of the guide pin P do not necessarily coincide with the direction of movement of the second device 80B relative to the first device 80A. The second type 72 has a through hole 72H into which the arm portion 86 is inserted. The second type 72 is provided on the second device 80B when the arm portion 86 is inserted into the through hole 72H. The second type 72 is equipped with a rotation prevention portion 72B that prevents it from rotating relative to the second device 80B.

[0067] On the side of the surface 72C opposite the opening 81A, a pair of anti-rotation parts 72B are provided above and below the through hole 72H. The anti-rotation parts 72B are formed to be slightly narrower in width than the width of the opening 81A. The pair of anti-rotation parts 72B are inserted into the opening 81A. The anti-rotation parts 72B may be realized by forming the cross-section of the arm portion 86 into a cross-sectional shape that can prevent rotation, such as a polygonal cross-sectional shape, a segmental circular shape, a spline shape, a projection, or a groove, and forming the through hole 72H into a shape that matches the cross-sectional shape of the arm portion 86.

[0068] The anti-rotation section 72B may be implemented by screwing the second type 72 to the arm 86. The anti-rotation section 72B may also be implemented by constructing the arm 86 from two or more rods and forming two or more corresponding through holes 72H. The anti-rotation section 72B may be implemented by other configurations as long as it can prevent the rotation of the second type 72.

[0069] As shown in Figure 9, the bending device 80 clamps and presses the fixing device 50 between the first type 71 and the second type 72. With the fixing device 50 clamped between the bending guide 70, the bending device 80 is immersed in hot water T heated to a predetermined temperature in a water tank L for a predetermined time or longer. The fixing device 50 is made of a thermoplastic material, deforms above a predetermined temperature, and maintains its deformed state when cooled to below the predetermined temperature. The bending device 80 may be provided with a stopper mechanism (not shown) to maintain the state in which the fixing device 50 is clamped between the bending guide 70.

[0070] The stopper mechanism only needs to be configured to fix the movable handle 85 to the fixed handle 83, and may be composed of any mechanism. The bending guide 70 conforms the fixing device 50 to the three-dimensional shape at the fixed position F by sandwiching and pressing the fixing device 50 between the three-dimensional shape 71A of the first type 71 and the second three-dimensional shape 72A of the second type 72. The bending guide 70 may be immersed in the hot water T of the water tank L while the fixing device 50 is sandwiched and pressed by restraining the first type 71 and the second type 72 from each other using rubber bands or bands. In this case, the bending device 80 may not be necessary.

[0071] As shown in Figure 10, the fixation device 50, deformed by the bending guide 70, is fixed to the fixation position F of the maxilla 2 by a screw 55. The screw 55 may be included in the surgical guide kit S. The deformed fixation device 50 conforms almost seamlessly to the three-dimensional shape of the maxilla 2 at the fixation position F, securely fixing the first object 2A and the second object 2B.

[0072] The surgical guide kit S described above is designed by performing a computer simulation based on measurement data of the patient's skull 1, and is created by outputting the design data to a 3D printer. Since the simulation and design are performed before surgery, and the surgical guide kit S is provided, the amount of work required at the site can be reduced. The computer simulation used to design the surgical guide kit S is described below.

[0073] As shown in Figure 11, a design system 100 for designing a surgical guide kit S is configured. The design system 100 includes, for example, a measuring device 110 for measuring the three-dimensional shape of a patient's skull 1. The design system 100 includes, for example, a design device 120 for designing the surgical guide kit S based on data acquired from the measuring device 110. The design system 100 includes a three-dimensional printer 130 for outputting the surgical guide kit S in three dimensions based on the data of the surgical guide kit S generated by the design device 120. Each device constituting the design system 100 may be installed in the same facility or may be distributed across different facilities.

[0074] The measuring device 110 is, for example, a computed tomography (CT) scanner or other computed tomography diagnostic device installed in a medical institution. The measuring device 110 includes a measuring unit 112 that measures cross-sectional data of the skull 1. The measuring unit 112 acquires cross-sectional image data of the inside of the patient's head, for example, using X-rays. The measuring unit 112 acquires multiple cross-sectional image data of the patient's head.

[0075] The measuring device 110 includes a storage unit 114 for storing cross-sectional image data. The storage unit 114 is composed of a non-temporary storage medium such as a hard disk drive or solid-state disk capable of storing data. The storage unit 114 may be built into the measuring device 110 or may be composed of an externally connectable storage device. The storage unit 114 may be composed of a server device that can communicate via a network W. The storage unit 114 stores data and programs that can control the measuring unit 112.

[0076] The measuring device 110 is equipped with a communication unit 118 that can communicate with the network W. The communication unit 118 communicates with the design device 120 via the network W. The communication unit 118 is configured with a communication interface that communicates with the network W, for example, by wire or wireless.

[0077] The measuring device 110 includes a control unit 116 that controls the measuring unit 112 based on data and programs stored in the storage unit 114. The control unit 116 is composed of a processor that performs arithmetic processing, such as a CPU (central processing unit). The control unit 116 controls the measuring unit 112 to measure the patient. The control unit 116 stores the multiple cross-sectional image data that have been measured in the storage unit 114. The control unit 116 transmits the multiple cross-sectional image data to the design device 120 via the communication unit 118.

[0078] The design device 120 includes a storage unit 122 that stores multiple cross-sectional image data acquired from the measuring device 110. The storage unit 122 is composed of a non-temporary storage medium such as a hard disk drive or solid-state disk capable of storing data. The storage unit 122 may be built into the design device 120 or may be composed of an externally connectable storage device. The storage unit 122 may be composed of a server device that can communicate via a network W. The storage unit 122 stores data and programs necessary for the design of the surgical guide kit S.

[0079] The design device 120 includes a calculation unit 124 for designing a surgical guide kit S. The calculation unit 124 is composed of a processor such as a CPU that performs calculation processing. The calculation unit 124 performs calculation processing for designing a surgical guide kit S used to fix an object divided into a first object 2A and a second object 2B in a predetermined relative positional relationship. The calculation unit 124 generates three-dimensional data relating to the surgical guide kit S. The design device 120 includes an input / output unit 128 that accepts user operations and displays calculation results. The input / output unit 128 is composed of, for example, a touch panel that integrates a display device and an input device. The input / output unit 128 may also be composed of a separate display device and an input device.

[0080] The design device 120 is equipped with a communication unit 126 that can communicate with the network W. The communication unit 126 communicates with the 3D printer 130 via the network W. The communication unit 126 is configured with a communication interface that connects to the network W, for example, by wire or wireless. The calculation unit 124 transmits 3D data relating to the surgical guide kit S to the 3D printer 130 via the communication unit 126. Next, a method for designing the surgical guide kit S using the design device 120 will be described.

[0081] The calculation unit 124 sequentially interpolates multiple cross-sectional image data (measurement data) acquired from the measuring device 110. Based on the interpolated multiple cross-sectional image data, the calculation unit 124 generates three-dimensional data of a virtual object that virtually reproduces the skull 1 (object). The calculation unit 124 displays the virtual object on the input / output unit 128. The user operates the input / output unit 128 to move the displayed virtual object in three dimensions and sets the position of the virtual dividing line that divides the virtual object into a virtual first object and a virtual second object.

[0082] The virtual first object is a virtual reproduction of the first object 2A. The virtual second object is a virtual reproduction of the second object 2B. The virtual dividing line is a virtual reproduction of the dividing line D.

[0083] The calculation unit 124 acquires division line data indicating the position of the set virtual division line. Based on the division line data, the calculation unit 124 reflects the virtual division line on the virtual object and displays it on the input / output unit 128. The calculation unit 124 divides the virtual object into a virtual first object and a virtual second object at the virtual division line and displays them on the input / output unit 128. The user moves the virtual second object to position the virtual first object and the virtual second object in a predetermined relative positional relationship.

[0084] The calculation unit 124 acquires position setting data that places the virtual first object and the virtual second object in a predetermined relative positional relationship. Based on the position setting data, the calculation unit 124 generates a virtual object after movement in which the virtual first object and the virtual second object are placed in a predetermined virtual positional relationship, and displays it on the input / output unit 128. The user operates the input / output unit 128 to design a virtual byte plate for temporarily positioning the virtual first object and the virtual second object in a predetermined virtual positional relationship. The virtual byte plate is a virtual reproduction of the byte plate 30.

[0085] The calculation unit 124 generates a virtual first contact area on the upper side of the virtual byte plate and a virtual second contact area on the lower side of the virtual byte plate. The virtual first contact area virtually reproduces the first contact area 31. The virtual second contact area virtually reproduces the second contact area 32. The calculation unit 124 generates three-dimensional data of the virtual byte plate and stores it in the storage unit 122.

[0086] The user sets one or more virtual fixed positions on the object after virtual movement. The calculation unit 124 generates setting data for the virtual fixed positions and stores it in the storage unit 122. The user sets multiple virtual fixing holes for fixing virtual fixing devices at the virtual fixed positions. The virtual fixing devices are virtual reproductions of the fixing device 50. The virtual fixing holes are virtual reproductions of the fixing holes H. The user sets the position, angle, and depth of the virtual fixing holes. The calculation unit 124 stores the setting data for the virtual fixing holes in the storage unit 122.

[0087] The user designs a virtual fixing device that is virtually fixed using multiple virtual fixing holes. The user designs a virtual fixing device by bending it at a virtual fixed position to match the surface shape of the object after virtual movement. The calculation unit 124 generates three-dimensional data of the bent virtual fixing device and stores it in the storage unit 122. The user sets a virtual predetermined region that includes one or more virtual fixing positions on the object after virtual movement. The virtual predetermined region virtually reproduces a predetermined region R. The calculation unit 124 stores the setting data of the virtual predetermined region in the storage unit 122.

[0088] The user virtually measures the surface shape of the object after virtual movement in a virtual predetermined area. The calculation unit 124 stores the measurement data in the storage unit 122. Based on the measurement data, the user designs a virtual bending guide. The virtual bending guide virtually reproduces the bending guide 70. The user designs a virtual first type that reproduces the virtual first three-dimensional shape of the surface of the virtual predetermined area. The virtual first type virtually reproduces the first type 71. The user designs one or more virtual guide pins for the virtual first type. The virtual guide pins virtually reproduce the guide pins P.

[0089] The user designs a virtual step in the virtual first type. The virtual step virtually reproduces the step 71D. The calculation unit 124 stores the three-dimensional data of the virtual first type in the storage unit 122. The user designs a virtual second type having a second three-dimensional shape obtained by inverting the virtual first three-dimensional shape of a virtual predetermined region into three dimensions. The virtual second type virtually reproduces the second type 72. The user designs one or more virtual pin holes in the virtual second type.

[0090] The virtual pinhole virtually reproduces pinhole Q. The user designs a virtual through-hole and a virtual anti-rotation section for the virtual Type 2. The virtual through-hole virtually reproduces through-hole 72H. The virtual anti-rotation section virtually reproduces anti-rotation section 72B. The calculation unit 124 stores the three-dimensional data of the virtual Type 2 in the storage unit 122.

[0091] The user performs an operation to return the virtual second object, which was divided in the virtual object after virtual movement, back to its original position. The calculation unit 124 generates three-dimensional data of the virtual object obtained by returning the virtual second object to its original position from the virtual object after virtual movement, and stores it in the storage unit 122. The calculation unit 124 displays the virtual object obtained by returning the divided virtual second object to its original position on the input / output unit 128. The virtual object obtained by returning the divided virtual second object to its original position has multiple virtual fixing holes set, and the positional relationship of the multiple virtual fixing holes is different from the positional relationship at the virtual fixing position.

[0092] The user designs a virtual cutting and drilling guide device on a virtual object that has been returned to its original position. The virtual cutting and drilling guide device virtually reproduces the cutting and drilling guide device 10. The user designs the virtual base, virtual cutting guide, and virtual drilling guide based on the position and angle of the virtual fixing hole, and the position and shape of the virtual dividing line, etc.

[0093] The virtual base section virtually reproduces the base section 11. The virtual cutting guide virtually reproduces the cutting guide 14. The virtual drilling guide virtually reproduces the drilling guide 17. The user designs multiple virtual drilling guides at positions corresponding to the locations of multiple virtual fixing holes set on the virtual object. The user designs a virtual cutting guide at a position corresponding to the location of a virtual dividing line. The calculation unit 124 generates three-dimensional data of the virtual cutting and drilling guide device and stores it in the storage unit 122.

[0094] The user sends the generated three-dimensional data of the virtual cutting guide and virtual drilling guide device to the three-dimensional printer 130 and performs the operation to output the cutting and drilling guide device 10 in three dimensions. The calculation unit 124 sends the three-dimensional data of the virtual cutting guide and virtual drilling guide device to the three-dimensional printer 130.

[0095] In the 3D printer 130, the control unit 132 stores the 3D data of the virtual cutting guide and virtual drilling guide device in the storage unit 134. Based on the 3D data of the virtual cutting guide and virtual drilling guide device, the control unit 132 controls the molding unit 138 to output the cutting and drilling guide device 10 in 3D.

[0096] The user sends the three-dimensional data of the virtual byte plate and the three-dimensional data of the virtual bending guide to the three-dimensional printer 130, in the same manner as described above, and performs the operation to output the byte plate 30 and the bending guide 70 in three dimensions. The calculation unit 124 sends the three-dimensional data of the virtual byte plate and the three-dimensional data of the virtual bending guide to the three-dimensional printer 130.

[0097] In the 3D printer 130, the control unit 132 controls the molding unit 138 based on the 3D data of the virtual bit plate to output the bit plate 30 in 3D. The control unit 132 controls the molding unit 138 based on the 3D data of the virtual bending guide to output the bending guide 70 in 3D.

[0098] Figure 12 shows the processing flow of the design method for the surgical guide kit S executed in the design device 120. The design method for the surgical guide kit S is executed by a computer program installed on the computer mounted in the design device 120. The computer program causes the processor in the design device 120 to execute processing related to computer simulation of the design method.

[0099] The calculation unit 124 acquires three-dimensional measurement data of the skull 1 (object) measured by the measuring device 110 (S100). The calculation unit 124 generates a virtual object that virtually reproduces the object based on the user's operation (S102). The calculation unit 124 generates virtual dividing lines on the virtual object based on the user's operation (S104). The calculation unit 124 divides the virtual object into a virtual first object and a virtual second object based on the user's operation (S106).

[0100] The calculation unit 124 moves the virtual first object and the virtual second object relative to each other so that they are in a predetermined positional relationship based on the user's operation, and generates a virtual object after the virtual movement (step S108). Based on the user's operation, the calculation unit 124 generates a virtual bite plate that matches the shape of the virtual object after the virtual movement (S110). Based on the user's operation, the calculation unit 124 generates a plurality of virtual fixing holes at virtual fixing positions for fixing a virtual fixing device to the virtual object after the virtual movement (S112). Based on the user's operation, the calculation unit 124 generates a virtual fixing device that will be fixed to the virtual object after the virtual movement using the plurality of virtual fixing holes (S114).

[0101] Based on user operations, the calculation unit 124 generates a virtual bending guide based on the three-dimensional shape data of the region including the virtual fixed position of the virtual object after virtual movement (S116). Based on user operations, the calculation unit 124 moves the virtual first object and the virtual second object relative to each other so that they return to their original positional relationship, and generates a virtual object including a plurality of virtual fixed holes whose positional relationship has changed after movement (S118). Based on user operations, the calculation unit 124 generates a virtual cutting and drilling guide device that matches the virtual object including the plurality of virtual fixed holes (S120).

[0102] The calculation unit 124 transmits the three-dimensional data of the virtual bit plate to the three-dimensional printer 130 to output the bit plate 30 in three dimensions (S122). The calculation unit 124 transmits the three-dimensional data of the virtual bending guide to the three-dimensional printer 130 to output the bending guide 70 in three dimensions (S124). The calculation unit 124 transmits the three-dimensional data of the virtual cutting and drilling guide device to the three-dimensional printer 130 to output the cutting and drilling guide device 10 in three dimensions (S126).

[0103] The processes described above may be rearranged as appropriate. The processes described above for generating a virtual bit plate and outputting the bit plate 30 in three dimensions, the processes for generating a virtual bending guide and outputting the bending guide 70 in three dimensions, and the processes for generating a virtual cutting and drilling guide device and outputting the cutting and drilling guide device 10 in three dimensions may be rearranged or processed in parallel.

[0104] As described above, the design system 100 can create a custom-made surgical guide kit S. The design system 100 can divide a virtual object into a virtual first object and a virtual second object by running a simulation, and generate a virtual object after relocation. The design system 100 can generate three-dimensional data of a virtual bending guide and a virtual bit plate based on the virtual object after relocation. The design system 100 can generate three-dimensional data of a virtual cutting and drilling guide device based on a virtual object in which the virtual object after relocation has been placed back to its original position.

[0105] According to the design system 100, a bending guide 70 can be output in three dimensions based on the three-dimensional data of a virtual bending guide. According to the design system 100, a bit plate 30 can be output in three dimensions based on the three-dimensional data of a virtual bit plate. According to the design system 100, a cutting and drilling guide device 10 can be output in three dimensions based on the three-dimensional data of a virtual cutting and drilling guide device. According to the design system 100, a surgical guide kit S including the cutting and drilling guide device 10 can be designed by generating a virtual object after virtual movement and then working backward to generate a virtual object where the virtual object after movement is placed in its original position.

[0106] The Surgical Guide Kit S allows for the provision of various devices, including a custom-made cutting and drilling guide device 10, a bite plate 30, a bending guide 70, and a fixation device 50, tailored to the patient, before surgery. By providing each device in advance before surgery, the Surgical Guide Kit S can improve work efficiency. [Explanation of Symbols]

[0107] 1 Skull, 1A Piriform opening, 2 Maxilla, 2A First object, 2B Second object, 2C First shape, 3 Mandible, 3A Second shape, 10 Drilling guide device, 11 Base part, 12 Claw part, 13 Connecting part, 14 Cutting guide, 15 Groove part, 16 Guide rail, 17 Drilling guide, 18 Cylindrical part, 19 Guide hole, 20 Pilot hole, 30 Bite plate, 31 First contact part, 32 Second contact part, 50 Fixing device, 51 Base plate, 52 Screw hole, 52 Through hole, 55 Screw, 70 Bending guide, 71 First type, 71A First three-dimensional shape, 71A Three-dimensional shape, 71D Stepped part, 72 Second type, 72A Second three-dimensional shape, 72B Rotation prevention part, 72H Through hole, 80 Bending device, 80A First device, 80B Second device, 82 Leg section, 83 Fixing handle, 84 Shaft, 85 Moving handle, 86 Arm section, 100 Design system, 110 Measuring device, 120 Design device, 122 Memory unit, 124 Calculation unit, 126 Communication unit, 128 Input / Output unit, 130 Three-dimensional printer, D Dividing line, F Fixed position, H Fixing hole, P Guide pin, Q Pin hole, R Designated area, S Surgical guide kit, W Network

Claims

1. A bending guide for shaping a fixing device that is fixed to an object, It is used together with a cutting and drilling guide device that is fixed to the object before division and forms division lines and multiple fixing holes in the object, and a bit plate for temporarily positioning the divided object in a predetermined positional relationship. The fixing device fixes the object, which is divided into a first object and a second object along the dividing line, to a predetermined fixing position of the object in a relative predetermined positional relationship, thereby positioning and fixing the first object and the second object in the predetermined positional relationship. The aforementioned bending guide is A first mold is formed by reproducing the first three-dimensional shape of the surface of a predetermined region including the fixed position on the object side, A second mold is formed by inverting the first three-dimensional shape into three dimensions, The first type and the second type are made to conform the fixing device to the three-dimensional shape at the fixing position by sandwiching and pressing the fixing device between the first three-dimensional shape and the second three-dimensional shape. The aforementioned object includes a skull, The dividing line is set on the maxilla side and / or mandible side of the skull, dividing the maxilla and / or mandible into the first object and the second object, and changing the positional relationship between the maxilla and the mandible to the set position based on the predetermined positional relationship. The cutting and drilling guide device is fixed to the maxilla and / or mandible side before division. The bite plate temporarily positions the maxilla and mandible at the set position in the skull where the division line has been formed using the cutting and drilling guide device. The bending guide is formed in a predetermined area at the set position that includes a part of the dividing line, a part of the first object, and a part of the second object. The fixing device is formed by the bending guide and then fixed using a plurality of fixing holes at the fixing position included in the predetermined region positioned at the set position by the bit plate. Bending guide.

2. The first type includes at least one guide pin that protrudes from the surface of the first three-dimensional shape at positions corresponding to the positions of a plurality of fixing holes provided in the first object and the second object at the fixed position, The guide pin is inserted into at least one of the multiple through holes provided in the fixing device corresponding to the position of the fixing hole, thereby positioning the fixing device to the first type. The bending guide according to claim 1.

3. The second type has at least one pin hole corresponding to the position of the guide pin, The aforementioned pin holes, when the guide pins are inserted, position the first type and the second type and clamp the fixing device. The bending guide according to claim 2.

4. The first type and the second type are provided in a bending device comprising a first device and a second device that is movable in a direction approaching or moving away from the first device. The first type is fixed to the first device, The second type is provided on the second device and includes a rotation prevention unit that prevents rotation relative to the second device. The bending guide according to claim 1.

5. The aforementioned fixing device is made of a bioabsorbable material. The bending guide according to claim 1.

6. The cutting and drilling guide device comprises a groove-shaped cutting guide for guiding a cutting tool for forming the dividing line, and a plurality of cylindrical parts for guiding a drilling tool for forming a plurality of fixing holes in the first object and the second object. The bending guide according to claim 1.

7. The bite plate comprises a first contact portion formed to match the first shape on the maxillary bone side, and a second contact portion formed to match the second shape on the mandible side. The bending guide according to claim 1, wherein the positional relationship between the first contact portion and the second contact portion is adjusted so that the divided first object and the second object are positioned in the predetermined positional relationship.

8. A bending guide for forming a fixing device for fixing objects, which are divided into a first object and a second object at a dividing line, in a predetermined relative positional relationship, A bit plate for temporarily positioning the object, which has been divided into the first object and the second object, in the predetermined positional relationship, A cutting and drilling guide device that is fixed to the object before division, forms the dividing line, and forms a plurality of fixing holes in the first object and the second object, A surgical guide kit comprising, The aforementioned bending guide is This device is used together with the aforementioned cutting and drilling guide device and the aforementioned cutting plate. The aforementioned fixing device is The first object and the second object are positioned and fixed in the predetermined positional relationship by the bit plate, which temporarily positions the object in the predetermined positional relationship. The aforementioned bending guide is A first mold is formed by reproducing the first three-dimensional shape of the surface of a predetermined region including the fixed position on the object side, A second mold is formed by inverting the first three-dimensional shape into three dimensions, The first type and the second type are made to conform the fixing device to the three-dimensional shape at the fixing position by sandwiching and pressing the fixing device between the first three-dimensional shape and the second three-dimensional shape. The aforementioned object includes a skull, The dividing line is set on the maxilla side and / or mandible side of the skull, dividing the maxilla and / or mandible into the first object and the second object, and changing the positional relationship between the maxilla and the mandible to the set position based on the predetermined positional relationship. The cutting and drill guide device is fixed to the maxilla and / or mandible side before division. The bite plate temporarily positions the maxilla and mandible at the set position in the skull where the division line has been formed using the cutting and drill guide device. The bending guide is formed in a predetermined area at the set position that includes a part of the dividing line, a part of the first object, and a part of the second object. The fixing device is formed by the bending guide and then fixed using a plurality of fixing holes at the fixing position included in the predetermined region positioned at the set position by the bit plate. Surgical guide kit.

9. A bending guide for shaping a fixing device that is fixed to an object, The aforementioned object includes a skull divided by a dividing line, The dividing line is set on the maxilla side and / or mandible side of the skull, dividing the maxilla and / or mandible into a first object and a second object, and changing the positional relationship between the maxilla and the mandible. The fixing device is made of a bioabsorbable material and fixes the object, which is divided into a first object and a second object at the dividing line, in a predetermined relative positional relationship, and is fixed to a preset fixing position of the object in the predetermined positional relationship, thereby positioning and fixing the first object and the second object in the predetermined positional relationship. The aforementioned bending guide is A first mold is formed by reproducing the first three-dimensional shape of the surface of a predetermined region including the fixed position on the object side, A second mold is formed by inverting the first three-dimensional shape into three dimensions, The first type and the second type are made to conform the fixing device to the three-dimensional shape at the fixing position by sandwiching and pressing the fixing device between the first three-dimensional shape and the second three-dimensional shape. The first type includes at least one guide pin that protrudes from the surface of the first three-dimensional shape at positions corresponding to the positions of a plurality of fixing holes provided in the first object and the second object at the fixed position, The guide pin is inserted into at least one of the multiple through holes provided in the fixing device corresponding to the position of the fixing hole, thereby positioning the fixing device to the first type. The first type and the second type are provided in a bending device comprising a first device and a second device that is movable in a direction approaching or moving away from the first device. The first type is fixed to the first device, The second type is provided on the second device and includes a rotation prevention unit that prevents rotation relative to the second device. Bending guide.

10. A bending guide for forming a fixing device for fixing an object divided into a first object and a second object at a dividing line in a predetermined relative positional relationship, and a cutting and drilling guide device which is fixed to the object before division and forms the dividing line and a plurality of fixing holes in the first object and the second object, and a bit plate used together, The object includes a skull that is divided by the dividing line, The dividing line is set on the maxilla side and / or mandible side of the skull, dividing the maxilla and / or mandible into the first object and the second object, and changing the positional relationship between the maxilla and the mandible. The aforementioned bite plate is The object, which has been divided into the first object and the second object, is temporarily positioned in the predetermined positional relationship. It comprises a first contact portion formed to match the first shape of the maxilla, and a second contact portion formed to match the second shape of the mandible, The positional relationship between the first contact portion and the second contact portion is adjusted so that the divided first object and the second object are in the predetermined positional relationship. The aforementioned fixing device is The first object and the second object are positioned and fixed in the predetermined positional relationship by the bit plate, which temporarily positions the object in the predetermined positional relationship. The aforementioned bending guide is A first mold is formed by reproducing the first three-dimensional shape of the surface of a predetermined region including the fixed position on the object side, A second mold is formed by inverting the first three-dimensional shape into three dimensions, The first type and the second type are configured to align the fixing device with the three-dimensional shape at the fixing position by sandwiching and pressing the fixing device between the first three-dimensional shape and the second three-dimensional shape. Bite plate.

11. A cutting and drilling guide device used together with a bending guide for forming a fixing device for fixing an object divided into a first object and a second object at a dividing line in a predetermined relative positional relationship, and a bit plate for temporarily positioning the object divided into the first object and the second object in the predetermined positional relationship, The aforementioned object includes a skull divided by a dividing line, The dividing line is set on the maxilla side and / or mandible side of the skull, dividing the maxilla and / or mandible into the first object and the second object, and changing the positional relationship between the maxilla and the mandible. The cutting and drill guide device is A cutting guide formed in the shape of a groove for guiding a cutting tool for forming the dividing line, It comprises a plurality of cylindrical parts for guiding a drilling tool for forming a plurality of fixing holes in the first object and the second object, In the bending guide, the fixing device is The first object and the second object are positioned and fixed in the predetermined positional relationship by the bit plate, which temporarily positions the object in the predetermined positional relationship. The aforementioned bending guide is A first mold is formed by reproducing the first three-dimensional shape of the surface of a predetermined region including the fixed position on the object side, A second mold is formed by inverting the first three-dimensional shape into three dimensions, The first type and the second type are configured to align the fixing device with the three-dimensional shape at the fixing position by sandwiching and pressing the fixing device between the first three-dimensional shape and the second three-dimensional shape. Cutting and drilling guide device.

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