WO2009125576A1 - Guide chirurgical en 3 dimensions - Google Patents

Guide chirurgical en 3 dimensions 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
Prior art date
Application number
PCT/JP2009/001597
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English (en)
Japanese (ja)
Inventor
高井信朗
鈴木茂樹
Original Assignee
株式会社ネクスト２１
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社ネクスト２１ filed Critical 株式会社ネクスト２１
Publication of WO2009125576A1 publication Critical patent/WO2009125576A1/fr

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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.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Dentistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L’objectif de la présente invention consiste à fournir un instrument de réglage d’alignement pour outils chirurgicaux, qui permet un alignement précis, et un procédé de fabrication de cet instrument. La présente invention concerne en conséquence un procédé de fabrication d’instruments de réglage d’alignement pour outils chirurgicaux avec un instrument de réglage. Le procédé est un procédé de fabrication d’instruments de réglage d’alignement pour outils chirurgicaux qui comprend un procédé de fabrication d’un modèle osseux, un procédé d’application de l’instrument de réglage ci-dessus au modèle osseux avant le moulage et la formation de l’instrument de réglage en une forme adaptée, ainsi qu’un procédé dans lequel un guide d’alignement est fourni sur l’instrument de réglage et l’instrument de réglage est durci.
PCT/JP2009/001597 2008-04-08 2009-04-07 Guide chirurgical en 3 dimensions WO2009125576A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2008099842 2008-04-08
JP2008-099842 2008-04-08

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WO2009125576A1 true WO2009125576A1 (fr) 2009-10-15

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014018437A (ja) * 2012-07-18 2014-02-03 Biomet Japan Inc 手術用ジグ

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4893619A (en) * 1988-02-04 1990-01-16 Intermedics Orthopedics, Inc. Humeral osteotomy guide
JPH0858851A (ja) * 1994-08-08 1996-03-05 Ethicon Inc 取付け用の両面テープを有する滅菌包装
JP2002500061A (ja) * 1998-01-12 2002-01-08 モルソエ，クラウス 注射器
JP2002248107A (ja) * 2000-11-13 2002-09-03 Benoist Girard Sas 義肢を移植する手術における大腿骨の切開に用いられる位置決め装置
JP2004000533A (ja) * 2002-03-29 2004-01-08 Depuy Products Inc 人工器官の移植に備えて尺骨から骨を切除する方法および装置

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4893619A (en) * 1988-02-04 1990-01-16 Intermedics Orthopedics, Inc. Humeral osteotomy guide
JPH0858851A (ja) * 1994-08-08 1996-03-05 Ethicon Inc 取付け用の両面テープを有する滅菌包装
JP2002500061A (ja) * 1998-01-12 2002-01-08 モルソエ，クラウス 注射器
JP2002248107A (ja) * 2000-11-13 2002-09-03 Benoist Girard Sas 義肢を移植する手術における大腿骨の切開に用いられる位置決め装置
JP2004000533A (ja) * 2002-03-29 2004-01-08 Depuy Products Inc 人工器官の移植に備えて尺骨から骨を切除する方法および装置

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014018437A (ja) * 2012-07-18 2014-02-03 Biomet Japan Inc 手術用ジグ

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