WO2009125576A1 - 3-dimensional surgical guide - Google Patents

3-dimensional surgical guide Download PDF

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Publication number
WO2009125576A1
WO2009125576A1 PCT/JP2009/001597 JP2009001597W WO2009125576A1 WO 2009125576 A1 WO2009125576 A1 WO 2009125576A1 JP 2009001597 W JP2009001597 W JP 2009001597W WO 2009125576 A1 WO2009125576 A1 WO 2009125576A1
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WO
WIPO (PCT)
Prior art keywords
installation tool
alignment
site
bone
femur
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PCT/JP2009/001597
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French (fr)
Japanese (ja)
Inventor
高井信朗
鈴木茂樹
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株式会社ネクスト２１
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Publication of WO2009125576A1 publication Critical patent/WO2009125576A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1742—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the hip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1764—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the knee

Definitions

  • the present invention relates to a method for manufacturing an alignment fixture for a surgical jig, an alignment fixture for a surgical jig, and the like.
  • Patent Document 1 discloses an artificial knee joint installation jig.
  • the condyle at the distal end of the femur is excised flat.
  • This cut surface must be exactly perpendicular to the load center axis of the femur. Therefore, before excision of the distal end of the femur, a reference hole is generally made in the center of the distal end of the femur using a rotary drill, and an alignment guide is attached to the reference hole. Then, with the alignment guide installed, the distal end of the femur is cut flat.
  • Fig. 1 is a photograph showing the situation during artificial joint replacement surgery. As shown in FIG. 1, the distal end of the femur can be viewed during actual surgery. However, it is difficult to accurately grasp the direction of the load center axis of the femur.
  • the femur is curved.
  • the length of the femur and the curvature of the femur vary among individuals. Therefore, it is difficult to accurately grasp the load center axis of the femur even if the distal end of the femur can be visually recognized during surgery. For this reason, the accuracy of alignment largely depended on the experience of the practitioner.
  • An object of the present invention is to provide an alignment installation tool for a surgical jig capable of accurately taking an alignment, and a manufacturing method thereof.
  • the present invention is basically based on the knowledge that accurate alignment can be achieved by using an alignment setting tool of a surgical jig.
  • a resin that hardens at room temperature and softens at a predetermined temperature is used.
  • a bone model including a part where the alignment jig is installed is manufactured.
  • the shape of the alignment installation tool is specified using the bone model. This makes it possible to accurately align the femur and the like that cannot be visually recognized.
  • the first aspect of the present invention relates to a method for manufacturing an alignment fixture for a surgical jig.
  • an installation tool is an installation tool containing the raw material made from resin.
  • This method includes a bone model manufacturing process, a softening process, an installation tool shape adjusting process, and a hardening process.
  • the bone model manufacturing process is a process of manufacturing a bone model including a part where the installation tool is installed.
  • the softening process is a process of softening the installation tool.
  • the installation tool shape adjustment step is a process in which the installation tool is applied to the bone model, and the shape of the installation tool is shaped so as to be a shape suitable for a site where the installation tool is installed.
  • the curing step is a step of curing the installation tool while providing the alignment guide to the installation tool that has a shape suitable for the site where the installation tool is installed.
  • the alignment fixture is manufactured using the bone model in this way, it is possible to manufacture a fixture that can accurately align.
  • a preferable pattern of the first aspect uses a resin that solidifies at room temperature and softens at a predetermined temperature higher than room temperature as the resin contained in the raw material of the alignment fixture.
  • a resin that solidifies at room temperature and softens at a predetermined temperature higher than room temperature as the resin contained in the raw material of the alignment fixture.
  • a resin is sold, for example, under the trade name of free resin. This free resin softens at 60 degrees Celsius.
  • the resin can be warmed and softened to have a predetermined shape, and then cooled to obtain an alignment fixture having a predetermined shape.
  • a preferred pattern on the first side is that the alignment fixture is covered with a film.
  • the film is then removed during surgery. It may take some time to manufacture after the alignment fixture is manufactured.
  • the place where the alignment fixture is manufactured may be different from the place where the treatment is performed. In such a case, if the alignment fixture is contaminated, the procedure cannot be performed properly.
  • the alignment fixture is covered with a film, and a clean alignment fixture can be easily obtained by removing the film during treatment.
  • a preferable pattern on the first side relates to a case where the installation tool has an alignment guide for installing an alignment jig.
  • the alignment guide has a hole for installing an alignment jig or a protrusion for installing an alignment jig. By having such an alignment guide, an alignment jig can be easily installed.
  • the preferred pattern on the first side is that the installation tool has a frame around it. By having the frame, the alignment fixture can be easily removed from the bone model after the fixture is manufactured.
  • the installation tool has an alignment guide for installing an alignment jig, and the alignment guide is made of metal or magnetic. Since the alignment guide is made of metal or magnetized, it can be easily removed from the bone model after the installation tool is manufactured.
  • the site where the installation tool is installed is a bone surface or a cartilage surface.
  • a more preferable pattern is a site
  • the site where the installation tool is installed is the distal end of the femur, and the preferred one is the site where the articular cartilage is not formed in the distal end of the femur.
  • the femur has individual differences in length and degree of curvature. Therefore, accurate alignment is difficult.
  • the alignment installation tool is manufactured based on the bone model, appropriate alignment can be achieved during the treatment.
  • the second aspect of the present invention relates to an alignment fixture for a surgical jig.
  • This installation tool has a shape suitable for the site where the installation tool is installed. Furthermore, this installation tool has an alignment guide for installing an alignment jig. And this installation tool is installed in the predetermined site
  • the preferred pattern on the second side includes a film. And if the site
  • the site where the installation tool is installed is the surface of bone or cartilage, and more preferable is the site of the bone surface where cartilage is not formed.
  • the site where the installation tool is installed is the distal end of the femur, and more preferably the site where the articular cartilage is not formed in the distal end of the femur.
  • FIG. 1 is a photograph showing a state during artificial joint replacement surgery.
  • FIG. 2 is a diagram illustrating an example of a femur model. 2A is a dorsal view of the femur and FIG. 2B is a side view of the femur.
  • FIG. 3 is a view showing a state where an installation tool before molding is applied to the distal end portion of the femur model.
  • FIG. 4 is a view showing a state where the hardened installation tool is removed from the bone model.
  • FIG. 5 is a diagram showing an alignment jig.
  • FIG. 6 is a diagram illustrating a state in which the alignment rod is inserted into the alignment jig.
  • FIG. 7 is a conceptual diagram when the rod is arranged so as to be parallel to the load center axis of the femur.
  • FIG. 8 is a view showing a distal end portion of the femur model when the rod is arranged so as to be parallel to the load center axis of the femur.
  • FIG. 9 is a diagram illustrating a state in which an alignment hole is provided in the installation tool.
  • FIG. 10 is a view showing a state where the hardened installation tool is removed from the bone model.
  • FIG. 11 is a photograph replacing a drawing when the artificial knee joint placement jig is placed on the bone model.
  • FIG. 12 is a photograph replacing a drawing showing the alignment rod installed on the resin.
  • FIG. 13 is a photograph replacing a drawing showing a state where an installation tool is installed on a human femur.
  • FIG. 14 is a photograph replacing a drawing which shows a state where alignment is performed via the installation tool and an artificial knee joint installation jig is installed.
  • the 1st side surface of this invention is related with the manufacturing method of the alignment installation tool of a surgical jig.
  • This method includes a bone model manufacturing process, a raw material softening process, an installation tool shape adjusting process, and a raw material curing process.
  • the bone model manufacturing process is a process of manufacturing a bone model including a part where the installation tool is installed.
  • the process of manufacturing a bone model is known.
  • This bone model is a model of the patient's bone.
  • a site including the treatment part may be imaged by X-ray or MRI to produce a custom-made bone model.
  • bone models are spinal column, vertebrae, cervical vertebrae, atlas vertebrae (first cervical vertebrae), axial vertebrae (second cervical vertebrae), thoracic vertebrae, lumbar vertebrae, sacrum, tailbone, thorax, sternum, rib, clavicle, scapula, free upper limb bone , Humerus, radius, ulna, carpal bone, metacarpal bone, sciatic bone, iliac bone, pubic bone, femur, patella, tibia, rib, tarsal bone, talus, radius, scaphoid bone, cubic bone, metatarsal It is a model of bone, phalanx, etc. Of these, the femur or tibia is preferred.
  • the site where the installation tool is installed is a bone surface or a cartilage surface.
  • a more preferable pattern is a site
  • the site where the installation tool is installed is the distal end of the femur, and more preferably the site of the distal end of the femur where articular cartilage is not formed.
  • the femur has individual differences in length and degree of curvature. Therefore, accurate alignment is difficult.
  • the alignment installation tool is manufactured based on the bone model, appropriate alignment can be achieved during the treatment. Below, it demonstrates centering on the example which installs an alignment guide in a femur. However, in the present invention, the alignment guide may be installed on a bone other than the femur.
  • the femur includes a proximal end, a femoral body, and a distal end.
  • the proximal end of the femur is located on the hip side.
  • the proximal end of the femur includes the femoral head, the femoral neck, the greater trochanter and the lesser trochanter.
  • the femoral head forms a hip joint with the hipbone.
  • protuberances condylar bones
  • medial condyle and a lateral condyle.
  • the two condyles of the femur form a knee joint with the tibia. Between the medial and lateral condyles, there is a depression called the intercondylar fossa.
  • FIG. 2 is a diagram showing an example of a femur model.
  • 2A is a dorsal view of the femur and
  • FIG. 2B is a side view of the femur.
  • the condyle is removed from the distal end of the femur.
  • reference numeral 10 denotes a femur model.
  • the alignment installation tool of the present invention can be suitably used for artificial joint replacement surgery in this osteoarthritis.
  • Softening process is a process of softening the installation tool.
  • a softening process can be performed without performing a special process.
  • a resin that is solidified at room temperature (25 degrees Celsius) and softens at a predetermined temperature higher than room temperature is used as the resin included in the raw material of the alignment fixture.
  • a resin is sold, for example, under the trade name of free resin. This free resin softens at 60 degrees Celsius.
  • the resin can be warmed and softened to have a predetermined shape, and then cooled to obtain an alignment fixture having a predetermined shape.
  • a photocurable resin and a thermosetting resin as a raw material of an installation tool.
  • the resin can be cured by irradiation with light.
  • a thermosetting resin the resin can be cured by heating.
  • the installation tool shape adjustment process is a process in which the installation tool is applied to the bone model so that the shape of the installation tool is suitable for the site where the installation tool is installed.
  • FIG. 3 is a view showing a state where an installation tool before molding is applied to the distal end portion of the femur model.
  • symbol 11 shows a lateral condyle part
  • symbol 12 shows a medial condyle part.
  • Reference numeral 20 in the figure indicates an installation tool.
  • the installation tool is installed at a portion of the distal end of the femur where knee cartilage is not formed. By pressing the softened installation tool against the target site, the shape of the installation tool can be made suitable.
  • the curing step is a step of curing the installation tool while providing an alignment guide to the installation tool that has a shape suitable for the site where the installation tool is installed.
  • FIG. 4 is a view showing a state where the hardened installation tool is removed from the bone model. That is, the installation tool can be obtained by removing the installation tool from the bone model.
  • An alignment guide may be provided before the raw material is cured.
  • an alignment guide may be provided after the installation tool raw material is cured.
  • Examples of alignment guides are holes and hollow protrusions. That is, the preferable pattern of the first side surface relates to a case where the installation tool has an alignment guide for installing an alignment jig.
  • the alignment guide has a hole for installing an alignment jig or a protrusion for installing an alignment jig. By having such an alignment guide, an alignment jig can be easily installed.
  • FIG. 5 is a diagram showing an alignment jig.
  • the alignment jig 30 has a rod hole 31 which is a hole for passing a rod.
  • a plurality of alignment rod insertion holes 32 are provided on the surface where the rod hole 31 is not formed.
  • a plurality of the insertion holes 32 are provided so as to be symmetrical about the rod hole.
  • Reference numeral 33 denotes an alignment bar.
  • FIG. 6 is a diagram illustrating a state in which the alignment rod is inserted into the alignment jig.
  • FIG. 7 is a conceptual diagram when the rod is arranged so as to be parallel to the load center axis of the femur.
  • Reference numeral 34 denotes a rod.
  • Reference numeral 35 denotes an artificial knee joint installation jig. It is preferable that the artificial knee joint installation jig is used at the time of treatment or is the same as that used at the time of treatment.
  • the alignment installation tool is manufactured using the bone model as described above, it is possible to manufacture an installation tool capable of accurately aligning.
  • FIG. 8 is a view showing a distal end portion of the femur model when the rod is arranged so as to be parallel to the load center axis of the femur. In this way, an alignment mark is formed on the installation tool.
  • an alignment guide may be provided by allowing the alignment rod 33 to pass through the hole of the hollow protrusion.
  • an alignment guide may be provided by allowing the alignment rod 33 to pass through the hole.
  • the installation tool has an alignment guide for installing an alignment jig.
  • the alignment guide is made of metal or magnetic. Since the alignment guide is made of metal or magnetized, it can be easily removed from the bone model after the installation tool is manufactured. Further, by using an alignment jig made of magnet or metal, the alignment jig and the installation tool can be firmly fixed.
  • FIG. 9 is a diagram illustrating a state in which an alignment hole is provided in the installation tool. As shown in FIG. 9, an alignment hole can be formed by passing an alignment rod through the installation tool.
  • FIG. 10 is a view showing a state where the hardened installation tool is removed from the bone model. That is, the installation tool can be obtained by removing the installation tool from the bone model.
  • a preferred pattern on the first side is that the alignment fixture is covered with a film.
  • the film is then removed during surgery. It may take some time to manufacture after the alignment fixture is manufactured.
  • the place where the alignment fixture is manufactured may be different from the place where the treatment is performed. In such a case, if the alignment fixture is contaminated, the procedure cannot be performed properly.
  • the alignment fixture is covered with a film, and a clean alignment fixture can be easily obtained by removing the film during treatment.
  • This film is preferably in close contact with the installation tool. And it is preferable that the air in a film is deaerated and is in a so-called vacuum packed state. By doing so, it is possible to prevent the installation tool from being contaminated.
  • the preferred pattern on the first side is that the installation tool has a frame around it. By having the frame, the alignment fixture can be easily removed from the bone model after the fixture is manufactured.
  • the second aspect of the present invention relates to an alignment fixture for a surgical jig.
  • This installation tool has a shape suitable for the site where the installation tool is installed. Furthermore, this installation tool has an alignment guide for installing an alignment jig. And this installation tool is installed in the predetermined site
  • the preferred pattern on the second side includes a film. And if the site
  • the site where the installation tool is installed is the surface of the bone or the surface of the cartilage, and more preferably the site of the bone surface where the cartilage is not formed.
  • the site where the installation tool is installed is the distal end of the femur, and more preferably the site of the distal end of the femur where articular cartilage is not formed.
  • the present invention also provides a surgical operation method and a treatment method using the installation tool described above.
  • the installation tool of the present invention is covered with a film, the film is removed.
  • the installation tool of the present invention is not covered with a film, it is appropriately sterilized.
  • a predetermined part of the patient is incised.
  • tool for alignment is installed through the alignment guide provided in the installation tool.
  • This alignment jig is connected to, for example, an artificial knee joint installation jig. Using this jig, cut out the appropriate part and install an artificial joint. In this way, surgical operations can be performed appropriately.
  • this invention can be used in various surgical operations, such as a femoral neck fracture osteosynthesis operation, for example.
  • FIG. 11 is a photograph replacing a drawing when the artificial knee joint placement jig is placed on the bone model.
  • the resin was then softened by putting it in hot water at 80 degrees Celsius. The softened resin was deformed into an appropriate shape and then brought into close contact with the bone model. Thereafter, the alignment rod was placed on the resin through the alignment jig.
  • FIG. 12 is a photograph replacing a drawing showing the alignment rod installed on the resin.
  • the installation tool obtained in this way had two alignment marks (alignment guide holes).
  • FIG. 13 is a photograph replacing a drawing showing a state where an installation tool is installed on a human femur. As shown in FIG. 13, the manufactured installation tool was installed on the femur.
  • FIG. 14 is a photograph replacing a drawing which shows a state where alignment is performed via the installation tool and an artificial knee joint installation jig is installed. Since the artificial knee joint installation jig was installed through the installation tool in this way, it was possible to achieve proper alignment.
  • the installation tool of the present invention can be suitably used in the field of medical equipment.

Abstract

The objective is to provide an alignment-setting instrument for surgical tools, which can align accurately, and a manufacturing method thereof. The above problem is solved with a method for manufacturing alignment-setting instruments for surgical tools and with a setting instrument. The method is a manufacturing method for surgical tool alignment-setting instruments which comprises a process for manufacturing a bone model, a process for applying the above setting instrument to the bone model before molding and making the shape of the setting instrument a suitable shape and a process wherein an alignment guide is provided on the setting instrument and the setting instrument is hardened.

Description

３次元サージカルガイド3D surgical guide
　本発明は，外科手術用治具のアライメント設置具の製造方法や，外科手術用治具のアライメント設置具などに関する。 The present invention relates to a method for manufacturing an alignment fixture for a surgical jig, an alignment fixture for a surgical jig, and the like.
　外科手術の際に，様々な治具が用いられている。たとえば，特開２００７－７５５１７号公報（下記特許文献１）には，人工膝関節設置用ジグが開示されている。 Various jigs are used during surgery. For example, Japanese Unexamined Patent Publication No. 2007-75517 (Patent Document 1 below) discloses an artificial knee joint installation jig.
　たとえば，人工関節置換手術では，大腿骨遠位端の顆片を平面状に切除する。この切除面は，大腿骨の荷重中心軸に対して正確に直交する必要がある。そのため，一般には，大腿骨遠位端を切除する前に，回転ドリルを用いて大腿骨遠位端の中心に基準孔をあけ，この基準孔にアライメントガイドを装着する。そして，アライメントガイドを設置した状態で，大腿骨遠位端を平坦に切削する。 For example, in artificial joint replacement surgery, the condyle at the distal end of the femur is excised flat. This cut surface must be exactly perpendicular to the load center axis of the femur. Therefore, before excision of the distal end of the femur, a reference hole is generally made in the center of the distal end of the femur using a rotary drill, and an alignment guide is attached to the reference hole. Then, with the alignment guide installed, the distal end of the femur is cut flat.
　図１は，人工関節置換手術の際の様子を示す写真である。図１に示されるように，実際の，外科手術の際，大腿骨遠位端を視認することはできる。しかしながら，大腿骨の荷重中心軸がどの方向であるかを正確に把握することは困難である。 Fig. 1 is a photograph showing the situation during artificial joint replacement surgery. As shown in FIG. 1, the distal end of the femur can be viewed during actual surgery. However, it is difficult to accurately grasp the direction of the load center axis of the femur.
　大腿骨は湾曲している。そして，大腿骨の長さや，大腿骨の湾曲は個人差がある。よって，外科手術の際，大腿骨遠位端を視認できても，大腿骨の荷重中心軸を正確に把握することは困難である。このため，アライメントの正確性は，施術者の経験などに大きく依存していた。 ● The femur is curved. The length of the femur and the curvature of the femur vary among individuals. Therefore, it is difficult to accurately grasp the load center axis of the femur even if the distal end of the femur can be visually recognized during surgery. For this reason, the accuracy of alignment largely depended on the experience of the practitioner.
特開２００７－７５５１７号公報JP 2007-75517 A
　本発明は，アライメントを正確にとることができる外科手術用治具のアライメント設置具，及びその製造方法を提供することを目的とする。 An object of the present invention is to provide an alignment installation tool for a surgical jig capable of accurately taking an alignment, and a manufacturing method thereof.
　本発明は，基本的には，外科手術用治具のアライメント設置具を用いることで，正確なアライメントを取ることができるという知見に基づくものである。また，本発明は，たとえば，室温で硬化し，所定の温度で軟化する樹脂を用いる。そして，アライメント治具を設置する部位を含む骨模型を製造する。そして，その骨模型を用いて，アライメント設置具の形状を特定する。これにより，視認できない大腿骨などのアライメントを正確に取ることができることとなる。 The present invention is basically based on the knowledge that accurate alignment can be achieved by using an alignment setting tool of a surgical jig. In the present invention, for example, a resin that hardens at room temperature and softens at a predetermined temperature is used. Then, a bone model including a part where the alignment jig is installed is manufactured. And the shape of the alignment installation tool is specified using the bone model. This makes it possible to accurately align the femur and the like that cannot be visually recognized.
　本発明の第１の側面は，外科手術用治具のアライメント設置具の製造方法に関する。そして，設置具は，樹脂製の原料を含む設置具である。この方法は，骨模型製造工程，軟化工程，設置具形状調整工程，及び硬化工程を含む。骨模型製造工程は，設置具が設置される部位を含んだ骨模型を製造する工程である。軟化工程は，設置具を軟化する工程である。設置具形状調整工程は，骨模型に設置具をあて，設置具の形状を前記設置具が設置される部位に適した形状となるように成形する工程である。硬化工程は，設置具が設置される部位に適した形状となった設置具にアライメントガイドを設けるとともに，設置具を硬化する工程である。 The first aspect of the present invention relates to a method for manufacturing an alignment fixture for a surgical jig. And an installation tool is an installation tool containing the raw material made from resin. This method includes a bone model manufacturing process, a softening process, an installation tool shape adjusting process, and a hardening process. The bone model manufacturing process is a process of manufacturing a bone model including a part where the installation tool is installed. The softening process is a process of softening the installation tool. The installation tool shape adjustment step is a process in which the installation tool is applied to the bone model, and the shape of the installation tool is shaped so as to be a shape suitable for a site where the installation tool is installed. The curing step is a step of curing the installation tool while providing the alignment guide to the installation tool that has a shape suitable for the site where the installation tool is installed.
　このように骨模型を用いてアライメント設置具を製造するので，正確にアライメントを取ることができる設置具を製造できる。 Since the alignment fixture is manufactured using the bone model in this way, it is possible to manufacture a fixture that can accurately align.
　第１の側面の好ましいパターンは，アライメント設置具の原料に含まれる樹脂として，室温において固化し，かつ室温より高い所定の温度で軟化する樹脂を用いるものである。このような樹脂はたとえば，自由樹脂という商品名で販売されている。この自由樹脂は，摂氏６０度で軟化する。このような樹脂を用いることで，樹脂を暖めて軟化させ，所定の形状とした後，冷ますことで，所定の形状を有するアライメント設置具を得ることができる。 A preferable pattern of the first aspect uses a resin that solidifies at room temperature and softens at a predetermined temperature higher than room temperature as the resin contained in the raw material of the alignment fixture. Such a resin is sold, for example, under the trade name of free resin. This free resin softens at 60 degrees Celsius. By using such a resin, the resin can be warmed and softened to have a predetermined shape, and then cooled to obtain an alignment fixture having a predetermined shape.
　第１の側面の好ましいパターンは，アライメント設置具が，フィルムに覆われたものである。そして，フィルムは，外科手術の際に取り除かれるものである。アライメント設置具を製造した後，施術するまでに時間がかかる場合がある。また，アライメント設置具を製造する場所と，施術を行う場所が異なる場合もある。そのような場合，アライメント設置具が汚染されていると，施術を適切に行うことができない。アライメント設置具がフィルムに覆われており，施術に際してフィルムを取り除くことで，きれいな状態のアライメント設置具を容易に得ることができる。 A preferred pattern on the first side is that the alignment fixture is covered with a film. The film is then removed during surgery. It may take some time to manufacture after the alignment fixture is manufactured. In addition, the place where the alignment fixture is manufactured may be different from the place where the treatment is performed. In such a case, if the alignment fixture is contaminated, the procedure cannot be performed properly. The alignment fixture is covered with a film, and a clean alignment fixture can be easily obtained by removing the film during treatment.
　第１の側面の好ましいパターンは，設置具が，アライメント用の治具を設置するためのアライメントガイドを有するものに関する。そして，アライメントガイドは，アライメント用の治具を設置するための孔又は，アライメント用の治具を設置するための突起を有する。このようなアライメントガイドを有することで，容易にアライメント用の治具を設置できる。 A preferable pattern on the first side relates to a case where the installation tool has an alignment guide for installing an alignment jig. The alignment guide has a hole for installing an alignment jig or a protrusion for installing an alignment jig. By having such an alignment guide, an alignment jig can be easily installed.
　第１の側面の好ましいパターンは，設置具は，その周囲に枠を有するものである。枠を有することで，設置具を製造した後に，骨模型からアライメント設置具を容易に取り外すことができる。 The preferred pattern on the first side is that the installation tool has a frame around it. By having the frame, the alignment fixture can be easily removed from the bone model after the fixture is manufactured.
　第１の側面の好ましいパターンは，設置具は，アライメント用の治具を設置するためのアライメントガイドを有し，アライメントガイドは，金属製又は磁力を帯びたものである。アライメントガイドが金属製又は磁力を帯びたものなので，設置具を製造した後に，骨模型からアライメント設置具を容易に取り外すことができる。 In a preferable pattern of the first side, the installation tool has an alignment guide for installing an alignment jig, and the alignment guide is made of metal or magnetic. Since the alignment guide is made of metal or magnetized, it can be easily removed from the bone model after the installation tool is manufactured.
　第１の側面の好ましいパターンは，設置具が設置される部位は，骨の表面又は軟骨の表面である。また，より好ましいパターンは，設置具が設置される部位が，骨の表面のうち，軟骨が形成されない部位である。軟骨の形状は，変化しやすい。すると，設置具を設置しても，アライメントガイドの方向がずれる場合がある。そこで，本発明の設置具は，軟骨の存在しない部位に設置されることが望ましい。 In a preferred pattern on the first side, the site where the installation tool is installed is a bone surface or a cartilage surface. Moreover, a more preferable pattern is a site | part in which a cartilage is not formed among the surfaces of the bone where the installation tool is installed. The cartilage shape is subject to change. Then, even if an installation tool is installed, the direction of the alignment guide may be shifted. Therefore, it is desirable that the installation tool of the present invention is installed at a site where cartilage does not exist.
　第１の側面の好ましいパターンは，設置具が設置される部位は，大腿骨の遠位端であり，好ましいものは，大腿骨の遠位端のうち関節軟骨が形成されない部位である。大腿骨は，長さや湾曲の程度に個人差がある。よって，正確なアライメントを取ることは難しい。本発明では，骨模型に基づいて，アライメント設置具を製造するので，施術の際に適切なアライメントをとることができることとなる。 In a preferred pattern of the first side, the site where the installation tool is installed is the distal end of the femur, and the preferred one is the site where the articular cartilage is not formed in the distal end of the femur. The femur has individual differences in length and degree of curvature. Therefore, accurate alignment is difficult. In the present invention, since the alignment installation tool is manufactured based on the bone model, appropriate alignment can be achieved during the treatment.
　本発明の第２の側面は，外科手術用治具のアライメント設置具に関する。この設置具は，設置具が設置される部位に適合した形状を有する。さらに，この設置具は，アライメント用の治具を設置するためのアライメントガイドを有する。そして，この設置具は，外科手術の際に，骨の所定の部位に設置され，アライメントガイドを介してアライメント用の治具が設置される。 The second aspect of the present invention relates to an alignment fixture for a surgical jig. This installation tool has a shape suitable for the site where the installation tool is installed. Furthermore, this installation tool has an alignment guide for installing an alignment jig. And this installation tool is installed in the predetermined site | part of a bone in the case of a surgical operation, and the jig | tool for alignment is installed through an alignment guide.
　第２の側面の好ましいパターンは，フィルムを含む。そして，骨の所定の部位に設置される部位を設置具本体とすると，フィルムは，設置具本体を覆うものである。そして，フィルムは，外科手術の際に取り除かれる。 The preferred pattern on the second side includes a film. And if the site | part installed in the predetermined site | part of a bone is made into an installation tool main body, a film will cover an installation tool main body. The film is then removed during surgery.
　第２の側面の好ましいパターンは，設置具が設置される部位は，骨又は軟骨の表面であり，より好ましいものは，骨の表面のうち，軟骨が形成されない部位である。 In a preferable pattern on the second side, the site where the installation tool is installed is the surface of bone or cartilage, and more preferable is the site of the bone surface where cartilage is not formed.
　第２の側面の好ましいパターンは，設置具が設置される部位は，大腿骨の遠位端であり，より好ましくは，大腿骨の遠位端のうち関節軟骨が形成されない部位である。 In a preferred pattern on the second side, the site where the installation tool is installed is the distal end of the femur, and more preferably the site where the articular cartilage is not formed in the distal end of the femur.
　本発明によれば，外科手術用治具のアライメント設置具，及びその製造方法を提供できる。 According to the present invention, it is possible to provide an alignment installation tool for a surgical jig and a manufacturing method thereof.
図１は，人工関節置換手術の際の様子を示す写真である。FIG. 1 is a photograph showing a state during artificial joint replacement surgery. 図２は，大腿骨模型の例を示す図である。図２Ａは，大腿骨の背側図であり，図２Ｂは大腿骨の側面図である。FIG. 2 is a diagram illustrating an example of a femur model. 2A is a dorsal view of the femur and FIG. 2B is a side view of the femur. 図３は，大腿骨の模型の遠位端部分に，成形前の設置具をあてた様子を示す図である。FIG. 3 is a view showing a state where an installation tool before molding is applied to the distal end portion of the femur model. 図４は，骨模型から硬化した設置具を取り外した様子を示す図である。FIG. 4 is a view showing a state where the hardened installation tool is removed from the bone model. 図５は，アライメント用の治具を示す図である。FIG. 5 is a diagram showing an alignment jig. 図６は，アライメント棒をアライメント用治具に挿入した様子を示す図である。FIG. 6 is a diagram illustrating a state in which the alignment rod is inserted into the alignment jig. 図７は，大腿骨の荷重中心軸に平行となるようにロッドを配置した際の概念図である。FIG. 7 is a conceptual diagram when the rod is arranged so as to be parallel to the load center axis of the femur. 図８は，大腿骨の荷重中心軸に平行となるようにロッドを配置した際の大腿骨の模型の遠位端部分を示す図である。FIG. 8 is a view showing a distal end portion of the femur model when the rod is arranged so as to be parallel to the load center axis of the femur. 図９は，設置具にアライメント用の孔が設けられた様子を示す図である。FIG. 9 is a diagram illustrating a state in which an alignment hole is provided in the installation tool. 図１０は，骨模型から硬化した設置具を取り外した様子を示す図である。FIG. 10 is a view showing a state where the hardened installation tool is removed from the bone model. 図１１は，人工膝関節設置治具を骨模型に設置した際の図面に替わる写真である。FIG. 11 is a photograph replacing a drawing when the artificial knee joint placement jig is placed on the bone model. 図１２は，樹脂にアライメント棒を設置した際を示す図面に替わる写真である。FIG. 12 is a photograph replacing a drawing showing the alignment rod installed on the resin. 図１３は，ヒトの大腿骨に設置具を設置した様子を示す図面に替わる写真である。FIG. 13 is a photograph replacing a drawing showing a state where an installation tool is installed on a human femur. 図１４は，設置具を介してアライメントをとり，人工膝関節設置治具を設置した様子を示す図面に替わる写真である。FIG. 14 is a photograph replacing a drawing which shows a state where alignment is performed via the installation tool and an artificial knee joint installation jig is installed.
　以下本発明を詳細に説明する。本発明の第１の側面は，外科手術用治具のアライメント設置具の製造方法に関する。この方法は，骨模型製造工程，原料軟化工程，設置具形状調整工程，及び原料硬化工程を含む。 Hereinafter, the present invention will be described in detail. The 1st side surface of this invention is related with the manufacturing method of the alignment installation tool of a surgical jig. This method includes a bone model manufacturing process, a raw material softening process, an installation tool shape adjusting process, and a raw material curing process.
　骨模型製造工程は，設置具が設置される部位を含んだ骨模型を製造する工程である。骨模型を製造する工程は，公知である。この骨模型は，患者の骨の模型である。具体的には，施術部を含む部位をレントゲンやＭＲＩなどで撮影し，オーダーメイドの骨模型を製造すればよい。 The bone model manufacturing process is a process of manufacturing a bone model including a part where the installation tool is installed. The process of manufacturing a bone model is known. This bone model is a model of the patient's bone. Specifically, a site including the treatment part may be imaged by X-ray or MRI to produce a custom-made bone model.
　骨模型の例は，脊柱，椎骨，頚椎，環椎（第１頚椎），軸椎（第２頚椎），胸椎，腰椎，仙骨，尾骨，胸郭，胸骨，肋骨，鎖骨，肩甲骨，自由上肢骨，上腕骨，橈骨，尺骨，手根骨，中手骨，坐骨，腸骨、恥骨，大腿骨，膝蓋骨，脛骨，腓骨，足根骨，距骨，踵骨，舟状骨，立方骨，中足骨，趾節骨などの模型である。これらの中では，大腿骨又は脛骨が好ましい。 Examples of bone models are spinal column, vertebrae, cervical vertebrae, atlas vertebrae (first cervical vertebrae), axial vertebrae (second cervical vertebrae), thoracic vertebrae, lumbar vertebrae, sacrum, tailbone, thorax, sternum, rib, clavicle, scapula, free upper limb bone , Humerus, radius, ulna, carpal bone, metacarpal bone, sciatic bone, iliac bone, pubic bone, femur, patella, tibia, rib, tarsal bone, talus, radius, scaphoid bone, cubic bone, metatarsal It is a model of bone, phalanx, etc. Of these, the femur or tibia is preferred.
　第１の側面の好ましいパターンは，設置具が設置される部位は，骨の表面又は軟骨の表面である。また，より好ましいパターンは，設置具が設置される部位が，骨の表面のうち，軟骨が形成されない部位である。軟骨の形状は，変化しやすい。すると，設置具を設置しても，アライメントガイドの方向がずれる場合がある。そこで，本発明の設置具は，軟骨の存在しない部位に設置されることが望ましい。 In a preferred pattern on the first side, the site where the installation tool is installed is a bone surface or a cartilage surface. Moreover, a more preferable pattern is a site | part in which a cartilage is not formed among the surfaces of the bone where the installation tool is installed. The cartilage shape is subject to change. Then, even if an installation tool is installed, the direction of the alignment guide may be shifted. Therefore, it is desirable that the installation tool of the present invention is installed at a site where cartilage does not exist.
　第１の側面の好ましいパターンは，設置具が設置される部位は，大腿骨の遠位端であり，より好ましいものは，大腿骨の遠位端のうち関節軟骨が形成されない部位である。大腿骨は，長さや湾曲の程度に個人差がある。よって，正確なアライメントを取ることは難しい。本発明では，骨模型に基づいて，アライメント設置具を製造するので，施術の際に適切なアライメントをとることができることとなる。以下では，大腿骨にアライメントガイドを設置する例を中心に説明する。しかしながら，本発明は，大腿骨以外の骨にアライメントガイドを設置してもよい。 In the preferred pattern of the first side, the site where the installation tool is installed is the distal end of the femur, and more preferably the site of the distal end of the femur where articular cartilage is not formed. The femur has individual differences in length and degree of curvature. Therefore, accurate alignment is difficult. In the present invention, since the alignment installation tool is manufactured based on the bone model, appropriate alignment can be achieved during the treatment. Below, it demonstrates centering on the example which installs an alignment guide in a femur. However, in the present invention, the alignment guide may be installed on a bone other than the femur.
　大腿骨は，近位端，大腿骨体及び遠位端を含む。大腿骨の近位端は，股関節側に位置する。そして，大腿骨の近位端は，大腿骨頭，大腿骨頚，大転子及び小転子を含む。大腿骨頭は，寛骨とともに股関節を形成する。大腿骨の遠位端には，内側顆と外側顆の２つの隆起（顆骨）がある。そして，大腿骨の２つの顆骨は，脛骨とともに膝関節を形成する。内側顆と外側顆の間には，顆間窩とよばれる窪みがある。 The femur includes a proximal end, a femoral body, and a distal end. The proximal end of the femur is located on the hip side. The proximal end of the femur includes the femoral head, the femoral neck, the greater trochanter and the lesser trochanter. The femoral head forms a hip joint with the hipbone. At the distal end of the femur, there are two protuberances (condylar bones), a medial condyle and a lateral condyle. The two condyles of the femur form a knee joint with the tibia. Between the medial and lateral condyles, there is a depression called the intercondylar fossa.
　図２は，大腿骨模型の例を示す図である。図２Ａは，大腿骨の背側図であり，図２Ｂは大腿骨の側面図である。膝の変形性関節症などの治療では，大腿骨の遠位端のうち顆骨を切除する。図中，符号１０は，大腿骨の模型を示す。本発明のアライメント設置具は，この変形性関節症における人工関節置換手術などに好適に用いることができる。 FIG. 2 is a diagram showing an example of a femur model. 2A is a dorsal view of the femur and FIG. 2B is a side view of the femur. For the treatment of osteoarthritis of the knee, the condyle is removed from the distal end of the femur. In the figure, reference numeral 10 denotes a femur model. The alignment installation tool of the present invention can be suitably used for artificial joint replacement surgery in this osteoarthritis.
　軟化工程は，設置具を軟化する工程である。なお，特に処理を施さなくても軟化している樹脂などを用いる場合は，特別な処理を施すことなく軟化工程を行うことができる。第１の側面の好ましいパターンは，アライメント設置具の原料に含まれる樹脂として，室温（摂氏２５度）において固化し，かつ室温より高い所定の温度で軟化する樹脂を用いる。このような樹脂は，たとえば，自由樹脂という商品名で販売されている。この自由樹脂は，摂氏６０度で軟化する。このような樹脂を用いることで，樹脂を暖めて軟化させ，所定の形状とした後，冷ますことで，所定の形状を有するアライメント設置具を得ることができる。なお，設置具の原料として，光硬化性樹脂や，熱硬化性樹脂を用いてもよい。光硬化性樹脂を用いた場合，光を照射して樹脂を硬化させることができる。また，熱硬化性樹脂を用いた場合，加熱することにより樹脂を硬化させることができる。 Softening process is a process of softening the installation tool. In addition, when using the resin etc. which are softening even if it does not perform a process in particular, a softening process can be performed without performing a special process. In a preferred pattern of the first aspect, a resin that is solidified at room temperature (25 degrees Celsius) and softens at a predetermined temperature higher than room temperature is used as the resin included in the raw material of the alignment fixture. Such a resin is sold, for example, under the trade name of free resin. This free resin softens at 60 degrees Celsius. By using such a resin, the resin can be warmed and softened to have a predetermined shape, and then cooled to obtain an alignment fixture having a predetermined shape. In addition, you may use a photocurable resin and a thermosetting resin as a raw material of an installation tool. When a photocurable resin is used, the resin can be cured by irradiation with light. When a thermosetting resin is used, the resin can be cured by heating.
　設置具形状調整工程は，骨模型に，設置具をあて，設置具の形状を設置具が設置される部位に適した形状とする工程である。図３は，大腿骨の模型の遠位端部分に，成形前の設置具をあてた様子を示す図である。図３中，符号１１は外側顆部分を示し，符号１２は内側顆部分を示す。図中符号２０は，設置具を示す。この例では，設置具が，大腿骨の遠位端のうち膝軟骨が形成されない部位に設置される。軟化した設置具を，対象とする部位に押し当てることで，設置具の形状を適した形状とすることができる。 The installation tool shape adjustment process is a process in which the installation tool is applied to the bone model so that the shape of the installation tool is suitable for the site where the installation tool is installed. FIG. 3 is a view showing a state where an installation tool before molding is applied to the distal end portion of the femur model. In FIG. 3, the code | symbol 11 shows a lateral condyle part, and the code | symbol 12 shows a medial condyle part. Reference numeral 20 in the figure indicates an installation tool. In this example, the installation tool is installed at a portion of the distal end of the femur where knee cartilage is not formed. By pressing the softened installation tool against the target site, the shape of the installation tool can be made suitable.
　硬化工程は，設置具が設置される部位に適した形状となった設置具にアライメントガイドを設けるとともに，設置具を硬化する工程である。図４は，骨模型から硬化した設置具を取り外した様子を示す図である。すなわち，骨模型から設置具を取り外すことで，設置具を得ることができる。原料が硬化する前にアライメントガイドを設けてもよい。また，設置具原料を硬化したのち，アライメントガイドを設けてもよい。また，設置原料が軟化している状態でアライメントガイドを設けてもよい。アライメントガイドの例は，孔や，中空の突起である。すなわち，第１の側面の好ましいパターンは，設置具が，アライメント用の治具を設置するためのアライメントガイドを有するものに関する。そして，アライメントガイドは，アライメント用の治具を設置するための孔又は，アライメント用の治具を設置するための突起を有する。このようなアライメントガイドを有することで，容易にアライメント用の治具を設置できる。 The curing step is a step of curing the installation tool while providing an alignment guide to the installation tool that has a shape suitable for the site where the installation tool is installed. FIG. 4 is a view showing a state where the hardened installation tool is removed from the bone model. That is, the installation tool can be obtained by removing the installation tool from the bone model. An alignment guide may be provided before the raw material is cured. In addition, an alignment guide may be provided after the installation tool raw material is cured. Moreover, you may provide an alignment guide in the state which the installation raw material has softened. Examples of alignment guides are holes and hollow protrusions. That is, the preferable pattern of the first side surface relates to a case where the installation tool has an alignment guide for installing an alignment jig. The alignment guide has a hole for installing an alignment jig or a protrusion for installing an alignment jig. By having such an alignment guide, an alignment jig can be easily installed.
　以下，アライメントガイドを形成する例を説明する。図５は，アライメント用の治具を示す図である。このアライメント用治具３０は，ロッドを通すための孔であるロッド孔３１を有している。また，ロッド孔３１が形成されていない面には，複数個のアライメント棒挿入孔３２が設けられている。この挿入孔３２は，ロッド孔を中心として，左右対称となるように複数個ずつ設けられている。符号３３は，アライメント棒を示す。図６は，アライメント棒をアライメント用治具に挿入した様子を示す図である。 Hereinafter, an example of forming an alignment guide will be described. FIG. 5 is a diagram showing an alignment jig. The alignment jig 30 has a rod hole 31 which is a hole for passing a rod. A plurality of alignment rod insertion holes 32 are provided on the surface where the rod hole 31 is not formed. A plurality of the insertion holes 32 are provided so as to be symmetrical about the rod hole. Reference numeral 33 denotes an alignment bar. FIG. 6 is a diagram illustrating a state in which the alignment rod is inserted into the alignment jig.
　図７は，大腿骨の荷重中心軸に平行となるようにロッドを配置した際の概念図である。符号３４はロッドを示す。符号３５は，人工膝関節設置治具を示す。人工膝関節設置治具は，施術の際に用いられるものであるか，施術の際に用いられるものと同じものであることが好ましい。本発明では，このように骨模型を用いてアライメント設置具を製造するので，正確にアライメントを取ることができる設置具を製造できる。図８は，大腿骨の荷重中心軸に平行となるようにロッドを配置した際の大腿骨の模型の遠位端部分を示す図である。このようにして，設置具に，アライメント用の印が形成されることとなる。 FIG. 7 is a conceptual diagram when the rod is arranged so as to be parallel to the load center axis of the femur. Reference numeral 34 denotes a rod. Reference numeral 35 denotes an artificial knee joint installation jig. It is preferable that the artificial knee joint installation jig is used at the time of treatment or is the same as that used at the time of treatment. In the present invention, since the alignment installation tool is manufactured using the bone model as described above, it is possible to manufacture an installation tool capable of accurately aligning. FIG. 8 is a view showing a distal end portion of the femur model when the rod is arranged so as to be parallel to the load center axis of the femur. In this way, an alignment mark is formed on the installation tool.
　なお，設置具が，成形前に中空突起を含んでいる場合は，その中空突起の孔をアライメント棒３３が通るようにすることで，アライメントガイドを設けてもよい。また，設置具が，成形前に孔を有している場合は，その孔をアライメント棒３３が通るようにすることで，アライメントガイドを設けてもよい。 In addition, when the installation tool includes a hollow protrusion before molding, an alignment guide may be provided by allowing the alignment rod 33 to pass through the hole of the hollow protrusion. Moreover, when the installation tool has a hole before molding, an alignment guide may be provided by allowing the alignment rod 33 to pass through the hole.
　第１の側面の好ましいパターンは，設置具は，アライメント用の治具を設置するためのアライメントガイドを有するものである。そして，アライメントガイドは，金属製又は磁力を帯びたものである。アライメントガイドが金属製又は磁力を帯びたものなので，設置具を製造した後に，骨模型からアライメント設置具を容易に取り外すことができる。また，アライメント用の治具を磁石又は金属製のものとすることで，アライメント用の治具と設置具とを強固に固定することができる。 In a preferred pattern on the first side, the installation tool has an alignment guide for installing an alignment jig. The alignment guide is made of metal or magnetic. Since the alignment guide is made of metal or magnetized, it can be easily removed from the bone model after the installation tool is manufactured. Further, by using an alignment jig made of magnet or metal, the alignment jig and the installation tool can be firmly fixed.
　図９は，設置具にアライメント用の孔が設けられた様子を示す図である。図９に示されるように，設置具にアライメント棒を通すことで，アライメント用の孔を形成することができる。図１０は，骨模型から硬化した設置具を取り外した様子を示す図である。すなわち，骨模型から設置具を取り外すことで，設置具を得ることができる。 FIG. 9 is a diagram illustrating a state in which an alignment hole is provided in the installation tool. As shown in FIG. 9, an alignment hole can be formed by passing an alignment rod through the installation tool. FIG. 10 is a view showing a state where the hardened installation tool is removed from the bone model. That is, the installation tool can be obtained by removing the installation tool from the bone model.
第１の側面の好ましいパターンは，アライメント設置具が，フィルムに覆われたものである。そして，フィルムは，外科手術の際に取り除かれるものである。アライメント設置具を製造した後，施術するまでに時間がかかる場合がある。また，アライメント設置具を製造する場所と，施術を行う場所が異なる場合もある。そのような場合，アライメント設置具が汚染されていると，施術を適切に行うことができない。アライメント設置具がフィルムに覆われており，施術に際してフィルムを取り除くことで，きれいな状態のアライメント設置具を容易に得ることができる。このフィルムは，設置具と密着するものが好ましい。そして，フィルム中の空気が脱気され，いわゆる真空パック状態となっていることが好ましい。このようにすることで，設置具が汚染される状態を防止できる。 A preferred pattern on the first side is that the alignment fixture is covered with a film. The film is then removed during surgery. It may take some time to manufacture after the alignment fixture is manufactured. In addition, the place where the alignment fixture is manufactured may be different from the place where the treatment is performed. In such a case, if the alignment fixture is contaminated, the procedure cannot be performed properly. The alignment fixture is covered with a film, and a clean alignment fixture can be easily obtained by removing the film during treatment. This film is preferably in close contact with the installation tool. And it is preferable that the air in a film is deaerated and is in a so-called vacuum packed state. By doing so, it is possible to prevent the installation tool from being contaminated.
　第１の側面の好ましいパターンは，設置具は，その周囲に枠を有するものである。枠を有することで，設置具を製造した後に，骨模型からアライメント設置具を容易に取り外すことができる。 The preferred pattern on the first side is that the installation tool has a frame around it. By having the frame, the alignment fixture can be easily removed from the bone model after the fixture is manufactured.
　本発明の第２の側面は，外科手術用治具のアライメント設置具に関する。この設置具は，設置具が設置される部位に適合した形状を有する。さらに，この設置具は，アライメント用の治具を設置するためのアライメントガイドを有する。そして，この設置具は，外科手術の際に，骨の所定の部位に設置され，アライメントガイドを介してアライメント用の治具が設置される。 The second aspect of the present invention relates to an alignment fixture for a surgical jig. This installation tool has a shape suitable for the site where the installation tool is installed. Furthermore, this installation tool has an alignment guide for installing an alignment jig. And this installation tool is installed in the predetermined site | part of a bone in the case of a surgical operation, and the jig | tool for alignment is installed through an alignment guide.
　第２の側面の好ましいパターンは，フィルムを含む。そして，骨の所定の部位に設置される部位を設置具本体とすると，フィルムは，設置具本体を覆うものである。そして，フィルムは，外科手術の際に取り除かれる。 The preferred pattern on the second side includes a film. And if the site | part installed in the predetermined site | part of a bone is made into an installation tool main body, a film will cover an installation tool main body. The film is then removed during surgery.
　第２の側面の好ましいパターンは，設置具が設置される部位は，骨の表面又は軟骨の表面であり，より好ましいものは，骨の表面のうち，軟骨が形成されない部位である。 In the preferred pattern of the second side, the site where the installation tool is installed is the surface of the bone or the surface of the cartilage, and more preferably the site of the bone surface where the cartilage is not formed.
　第２の側面の好ましいパターンは，設置具が設置される部位は，大腿骨の遠位端であり，より好ましいものは，大腿骨の遠位端のうち関節軟骨が形成されない部位である。 In the preferred pattern of the second side, the site where the installation tool is installed is the distal end of the femur, and more preferably the site of the distal end of the femur where articular cartilage is not formed.
　次に，本発明の設置具の使用方法について説明する。すなわち，本発明は，先に説明した設置具を用いた外科的施術方法や治療方法をも提供する。本発明の設置具が，フィルムで覆われている場合は，そのフィルムを取り外す。また，本発明の設置具が，フィルムで覆われていない場合は，適宜滅菌処理を施す。そして，患者の所定箇所を切開する。その上で，設置具が設置される部位に設置具を設置する。そして，設置具に設けられたアライメントガイドを介してアライメント用の治具を設置する。このアライメント用の治具は，たとえば，人工膝関節設置用の治具と接続されている。この治具を用いて，適切な箇所を切除し，また人工関節を設置する。このようにして，外科的手術を適切に行うことができる。 Next, how to use the installation tool of the present invention will be described. That is, the present invention also provides a surgical operation method and a treatment method using the installation tool described above. When the installation tool of the present invention is covered with a film, the film is removed. In addition, when the installation tool of the present invention is not covered with a film, it is appropriately sterilized. Then, a predetermined part of the patient is incised. Then, install the installation tool at the site where the installation tool is installed. And the jig | tool for alignment is installed through the alignment guide provided in the installation tool. This alignment jig is connected to, for example, an artificial knee joint installation jig. Using this jig, cut out the appropriate part and install an artificial joint. In this way, surgical operations can be performed appropriately.
　なお，本発明は，たとえば，大腿骨頚部骨折骨接合手術など，様々な外科手術において用いることができる。 In addition, this invention can be used in various surgical operations, such as a femoral neck fracture osteosynthesis operation, for example.
　次に，実施例を用いて本発明を具体的に説明する。患者の大腿骨をCTで撮影した。撮影像を基に大腿骨の骨模型を製造した。そして，穿孔具を用いて顆間窩中心から孔を開けた。そして，人工膝関節設置治具を骨模型に設置した。図１１は，人工膝関節設置治具を骨模型に設置した際の図面に替わる写真である。そして，樹脂を摂氏８０度のお湯につけ軟化させた。軟化した樹脂を，適切な形状に変形した後，骨模型に密着させた。その後，アライメント棒を，アライメント治具を通して，樹脂に設置した。図１２は，樹脂にアライメント棒を設置した際を示す図面に替わる写真である。このようにして得られた設置具は，２つのアライメント用の印（アライメントガイド孔）を有していた。 Next, the present invention will be specifically described using examples. The patient's femur was imaged by CT. A femur bone model was manufactured based on the photographed image. Then, a hole was made from the center of the intercondylar fossa using a punch. An artificial knee joint placement jig was placed on the bone model. FIG. 11 is a photograph replacing a drawing when the artificial knee joint placement jig is placed on the bone model. The resin was then softened by putting it in hot water at 80 degrees Celsius. The softened resin was deformed into an appropriate shape and then brought into close contact with the bone model. Thereafter, the alignment rod was placed on the resin through the alignment jig. FIG. 12 is a photograph replacing a drawing showing the alignment rod installed on the resin. The installation tool obtained in this way had two alignment marks (alignment guide holes).
　図１３は，ヒトの大腿骨に設置具を設置した様子を示す図面に替わる写真である。図１３に示されるように，製造された設置具を大腿骨に設置した。図１４は，設置具を介してアライメントをとり，人工膝関節設置治具を設置した様子を示す図面に替わる写真である。このように設置具を介して人工膝関節設置治具を設置したので，適切なアライメントをとることができた。 FIG. 13 is a photograph replacing a drawing showing a state where an installation tool is installed on a human femur. As shown in FIG. 13, the manufactured installation tool was installed on the femur. FIG. 14 is a photograph replacing a drawing which shows a state where alignment is performed via the installation tool and an artificial knee joint installation jig is installed. Since the artificial knee joint installation jig was installed through the installation tool in this way, it was possible to achieve proper alignment.
　本発明の設置具は，医療機器などの分野で好適に利用することができる。 The installation tool of the present invention can be suitably used in the field of medical equipment.
１０　大腿骨の模型
１１　外側顆部分
１２　内側顆部分
２０　設置具
３０　アライメント用治具
３１　ロッド孔
３２　アライメント棒挿入孔
３３　アライメント棒
３４　ロッド
３５　人工膝関節設置治具
  DESCRIPTION OF SYMBOLS 10 Femur model 11 Lateral condyle part 12 Medial condyle part 20 Installation tool 30 Alignment jig | tool 31 Rod hole 32 Alignment rod insertion hole 33 Alignment rod 34 Rod 35 Artificial knee joint installation jig

Claims (16)

  1. 　外科手術用治具のアライメント設置具の製造方法であって，
     
    　前記設置具は，樹脂製の原料を含む設置具であり，
     
    　前記設置具が設置される部位を含んだ骨模型を製造する工程と，
     
    　前記設置具を軟化する工程と，
     
    　前記骨模型に，成形前の前記設置具をあて，設置具の形状を前記設置具が設置される部位に適した形状となるように成形する工程と，
     
    　前記設置具が設置される部位に適した形状となった前記設置具にアライメントガイドを設けるとともに，前記設置具を硬化する工程と，
     
    　を含む，
     
    　外科手術用治具のアライメント設置具の製造方法。     A method of manufacturing an alignment fixture for a surgical jig,

    The installation tool is an installation tool containing a resin raw material,

    Producing a bone model including a site where the installation tool is installed;

    Softening the installation tool;

    Applying the installation tool before molding to the bone model, and shaping the installation tool so as to have a shape suitable for a site where the installation tool is installed;

    Providing an alignment guide to the installation tool that has a shape suitable for a site where the installation tool is installed, and curing the installation tool;

    including,

    A method for manufacturing an alignment fixture for a surgical jig.
  2. 　前記樹脂は，
    　　室温において固化し，かつ
    　　室温より高い所定の温度で軟化する樹脂である，
    　請求項１に記載の方法。     The resin is
    A resin that solidifies at room temperature and softens at a predetermined temperature higher than room temperature.
    The method of claim 1.
  3. 　前記設置具は，フィルムに覆われており，
    　前記フィルムは，
    　　外科手術の際に取り除かれるものである，
    　請求項１に記載の方法。     The installation tool is covered with a film,
    The film is
    Are removed during surgery,
    The method of claim 1.
  4. 　前記アライメントガイドは，
    　　アライメント用の治具を設置するための孔又は，アライメント用の治具を設置するための突起を有するアライメントガイドである，
    　請求項１に記載の方法。     The alignment guide is
    An alignment guide having a hole for installing an alignment jig or a protrusion for installing an alignment jig.
    The method of claim 1.
  5. 　前記設置具は，
    　　その周囲に枠を有する
    　請求項１に記載の方法。     The installation tool is
    The method according to claim 1, further comprising a frame around the periphery.
  6. 　アライメントガイドは，
    　　金属製又は磁力を帯びたものである，
    　請求項１に記載の方法。     The alignment guide
    Made of metal or magnetized,
    The method of claim 1.
  7. 　前記設置具が設置される部位は，骨又は軟骨の表面である，
    　請求項１に記載の方法。     The site where the installation tool is installed is the surface of bone or cartilage,
    The method of claim 1.
  8. 　前記設置具が設置される部位は，骨の表面のうち，軟骨が形成されない部位である，
    　請求項１に記載の方法。     The site where the installation tool is installed is a part of the bone surface where cartilage is not formed.
    The method of claim 1.
  9. 　前記設置具が設置される部位は，
    　大腿骨の遠位骨幹部から顆部端である，
    　請求項１に記載の方法。     The site where the installation tool is installed is
    From the distal diaphysis of the femur to the condylar end,
    The method of claim 1.
  10. 　前記設置具が設置される部位は，
    　大腿骨の遠位骨幹部から顆部端のうち関節軟骨が形成されない部位である，
    　請求項１に記載の方法。     The site where the installation tool is installed is
    Articular cartilage is not formed from the distal diaphysis of the femur to the condylar end.
    The method of claim 1.
  11. 　外科手術用治具のアライメント設置具であって，
    　前記設置具が設置される部位に適合した形状を有し，
    　アライメント用の治具を設置するためのアライメントガイドを有し，
     
    　外科手術の際に，骨の所定の部位に設置され，前記アライメントガイドを介してアライメント用の治具を設置するための，
     
    　外科手術用治具のアライメント設置具。     An alignment fixture for a surgical jig,
    Having a shape suitable for the site where the installation tool is installed;
    It has an alignment guide for installing an alignment jig,

    During the surgical operation, it is installed at a predetermined part of the bone, and an alignment jig is installed through the alignment guide.

    Alignment tool for surgical jigs.
  12. 　請求項１１に記載のアライメント設置具であって，
    　さらに，フィルムを含み，
     
    　骨の所定の部位に設置される部位を設置具本体とすると，
     
    　前記フィルムは，
    　　前記設置具本体を覆い，
    　前記フィルムは，
    　　外科手術の際に取り除かれる
     
    　アライメント設置具。     The alignment installation tool according to claim 11,
    Including film,

    If the part to be installed at a predetermined part of the bone is the main body of the installation tool,

    The film is
    Covering the installation tool body;
    The film is
    Removed during surgery
    Alignment installation tool.
  13. 　前記設置具が設置される部位は，骨の表面又は軟骨の表面である，
    　請求項１１に記載のアライメント設置具。     The site where the installation tool is installed is the surface of bone or the surface of cartilage,
    The alignment installation tool according to claim 11.
  14. 　前記設置具が設置される部位は，骨の表面のうち，軟骨が形成されない部位である，
    　請求項１１に記載のアライメント設置具。     The site where the installation tool is installed is a part of the bone surface where cartilage is not formed.
    The alignment installation tool according to claim 11.
  15. 　前記設置具が設置される部位は，
    　大腿骨の遠位端である，
    　請求項１１に記載のアライメント設置具。     The site where the installation tool is installed is
    The distal end of the femur,
    The alignment installation tool according to claim 11.
  16. 　前記設置具が設置される部位は，
    　大腿骨の遠位端のうち関節軟骨が形成されない部位である，
    　請求項１１に記載のアライメント設置具。
          The site where the installation tool is installed is
    The part of the distal end of the femur where articular cartilage is not formed.
    The alignment installation tool according to claim 11.
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