WO2008018412A1 - Câble creux de fixation osseuse - Google Patents

Câble creux de fixation osseuse Download PDF

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Publication number
WO2008018412A1
WO2008018412A1 PCT/JP2007/065371 JP2007065371W WO2008018412A1 WO 2008018412 A1 WO2008018412 A1 WO 2008018412A1 JP 2007065371 W JP2007065371 W JP 2007065371W WO 2008018412 A1 WO2008018412 A1 WO 2008018412A1
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WO
WIPO (PCT)
Prior art keywords
fastening
bone
cable
fibers
hollow cable
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2007/065371
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English (en)
Japanese (ja)
Inventor
Masashi Nagae
Noritoshi Yamaguchi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alfresa Pharma Corp
Original Assignee
Alfresa Pharma Corp
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 Alfresa Pharma Corp filed Critical Alfresa Pharma Corp
Publication of WO2008018412A1 publication Critical patent/WO2008018412A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/82—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage

Definitions

  • the present invention relates to a cable for fastening bones used in various bone operations, and more specifically, bone transplantation for fixing and fixing a plurality of adjacent vertebrae in damaged bones, particularly in spinal surgery.
  • This is related to the cable used to fasten the vertebrae in the body directly or with a metal fixation device in order to acquire the immobility of the spinal column.
  • bone fixation referring to uniting bones by fusion
  • bone fixation for example, for fixing broken bone parts, and for fixing damaged bone and bone graft fragments in bone grafting
  • These bones must be firmly attached to each other in the correct positional relationship, and must be held firmly to each other so that the bones do not shift until the fusion is completed.
  • bones are typically fastened with a metal wire (wire) such as stainless steel or titanium, and various metal rods, hooks, bolts (pedicles) are used depending on the situation. Screw or pedicle screw) and other instruments.
  • the wire due to its rigidity, the wire is inadvertently pressed against the spinal cord when it is passed under the vertebral arch (where the spinal cord passes), for example, during spinal surgery, causing serious damage.
  • the surgeon needs to be very careful not to give it.
  • Even after surgery, the wire may be severed if a large force is repeatedly applied to the bone, and there is a risk that the resulting stump may seriously damage the spinal cord.
  • synthetic fibers such as ultra-high molecular weight polyethylene (also called “ultra-high-strength polyethylene”). High-strength synthetic fibers) and cables made of metal fibers have become widely known.
  • a bone fastening cable made of synthetic fiber As a bone fastening cable made of synthetic fiber, a Nespron (registered trademark) cable system (non-woven) made of braided ultrahigh molecular weight polyethylene fiber and having a thin tape shape with a width of 3 mm or 5 mm Patent Document 1) is widely used in clinical practice.
  • a cable for bone fastening made of fiber a cross section made of braided fiber is generally used.
  • a solid cable having a substantially circular shape, that is, a non-directional cross section is known (see Patent Document 1).
  • the spinal column is composed of vertebrae (consisting of vertebral bodies and vertebral vertebrae) connected in series via a cartilage disc (intervertebral disc). providing.
  • a cable was wrapped around the vertebra underneath the vertebra to hold it, and the cable tension was maintained with the vertebra adjacent to it or with a metal fixation device placed adjacent to it. By tightening in a state, the technique of holding the vertebra in question in place is frequently performed.
  • the spinal cord runs under the vertebral arch, and the cable is passed through the gap between the vertebral arch and the spinal cord.
  • a solid cable with a circular cross-section can be made narrower than a tape-shaped cable, so it is easy to pass through the gap between the vertebral arch and spinal cord. Therefore, there is an advantage that it is easy to avoid the cable coming into contact with the spinal cord!
  • solid cables with a circular cross section are prone to bone depressions and cuts when fastened. This is because a solid cable with a circular cross-section has a narrow width and force, but the entire surface is round (ie, not flat), so that the contact area between the bone and the cable is small, and pressure is concentrated on the contact area when fastened. This is because the bones can not withstand the burden and are cut.
  • the tape-shaped cable makes contact with the bone surface across the flat surface that is wider than the circular cross-section cable when the bone is fastened. Since the pressure drops per unit area when dispersed, it has the great advantage of being less prone to recesses and cuts.
  • this type of cable is wider than a solid cable with a circular cross-section, so that when the cable is passed through the gap between the spinal cord and the vertebral arch, the edge tends to come into contact with the spinal cord. Requires appropriate skills.
  • a tape-shaped cable is wound around a bone, it is likely to be inadvertently twisted at the site behind the bone that is not visible to the operator (that is, the front and back are reversed halfway).
  • Twisted part is tape-shaped
  • the cable was folded and overlapped in part, and the thickness doubled and the width locally decreased in the overlapped part. Therefore, if it is not noticed to be twisted and fastened without untwisting it, the bone surface in contact with the twisted part is undesirably subjected to pressure, and the stress distribution in the cable is disturbed at the twisted part. Adversely affects the strength of the cable.
  • both types of cables have conflicting advantages and disadvantages.
  • spinal surgery the use of cable fastening alone or in combination with metal fixation devices such as bolts and hooks is becoming more widespread and is used by more physicians.
  • metal fixation devices such as bolts and hooks
  • Patent Document 1 Japanese Patent Laid-Open No. 7-163583
  • Non-Patent Document 1 "Nespron Cable System” pamphlet, Alfresa Pharma Corporation, October 2004
  • the present invention is a bone fastening cable capable of fastening a bone with a sufficient width to eliminate the fear of bone depression or cutting. It is an object of the present invention to provide an improved cable for bone fastening, which can be prevented, and has the advantage of being easily passed through the gap between the vertebral arch and spinal cord in spinal surgery.
  • the present inventor has obtained a cylindrical shape, which is produced by braiding fibers and has a substantially circular cross section and a lumen having a sufficient inner diameter compared to the outer diameter.
  • This hollow cape is easy to pass through the gap between the vertebral arch and spinal cord, so it has the same advantages as a conventional cable, and twisting occurs, and it is pressed against the bone surface during fastening and collapses. Since it has a tape shape, it has been found that the advantages of the conventional tape that it is less likely to cause dents and cuts in the bone are obtained, and based on this, the present invention has been completed.
  • a hollow cable for fastening bones which can be crushed and deformed into a belt by fastening the fastening object, and is formed by braiding fibers into a tubular shape with a roughly circular cross section.
  • the hollow cable for fastening bone according to 1 or 2 above, which has an inner diameter of 1.0 to 10. Omm.
  • the hollow cable for fastening bone according to any one of 1 to 3 above, wherein the fiber is an organic fiber and / or an inorganic fiber.
  • the organic fiber is one or more fibers selected from the group consisting of polyolefin, polyamide, polyacrylonitrile and silk, and the inorganic fibers are selected from the group consisting of titanium, titanium alloy and stainless steel.
  • the bone fastening hollow cable according to any one of 1 to 5 above, which is formed by plain weaving or oblique weaving of fibers.
  • the present invention configured as described above is in the form of a cylindrical cable before the bone is fastened, the operation of passing through the gap between the vertebral arch and the spinal cord is easy.
  • it since it has a circular cross-section, it is extremely unlikely to be twisted in the middle like a tape-shaped cable, so that it can be prevented from being tightened without noticing the fact that it is twisted behind the bone.
  • it is strongly pressed against the bone surface by the tensile force applied to the cable during fastening, and it collapses and deforms into a flat tape shape.
  • the contact surface with the bone is wide, and the bone
  • it has the advantage that it is less prone to bone depressions and cuts than conventional cables with a circular cross section.
  • FIG. 1 is a schematic diagram of fastening by a double loop.
  • Fig. 2 is a schematic diagram of plain weave.
  • Fig. 3 is a schematic diagram of twill weave.
  • FIG. 4 is an enlarged photograph of the vicinity of the stump of the hollow cable of Example lb.
  • the cable of the present invention is a hollow cable having a substantially circular cross section, and the cross-sectional state is maintained until it is wrapped around a hard fastening object such as a bone and tightened, that is, until used for fastening the fastening object. It is produced so as to have a hardness as high as possible. This can be easily achieved simply by using, for example, a resin-made long wire or tube with a circular cross section as the core material and braiding the fibers closely around it. In other words, the hollow cable produced in this way is still strongly pressed against the bone surface when it is wound around the bone, for example, inside the vertebral arch and passed through the gap with the spinal cord after the core material is removed.
  • the braiding method is not particularly limited, and for example, plain weaving (Fig. 2), oblique weaving (Twill weaving) (Fig. 3), etc. may be used as appropriate.
  • the fibers constituting the cable of the present invention it is possible to use both organic fibers and inorganic fibers.
  • Organic fibers are preferable to metal fibers because of their excellent flexibility.
  • organic fibers include polyolefins such as polyethylene and polypropylene, polyethylene terephthalate, polylactic acid, polydarlicolic acid, polydaricholic acid 'lactic acid, polyesters such as polydioxanone, polyamides such as nylon 6, nylon 66, and other polyacrylonitriles. Natural fibers such as synthetic fibers and silk can be used.
  • biodegradable fibers such as polylactic acid, polydaricholic acid, polydalicholic acid 'lactic acid, polydioxanone, etc. are not long enough to fasten bones, it is preferable that they are decomposed, absorbed and disappear after that. Can be used.
  • these fibers are highly compatible with living organisms, so that they can be used in addition to other fibers (for example, by twisting) to increase the biocompatibility of cables mainly composed of other fibers. It can also be used.
  • organic fibers may be used alone or in combination of two or more.
  • high-strength fibers for obtaining high strength and fastening strength are mainly used, and other fibers may be braided together.
  • organic fibers are X-ray transparent, X-ray diagnosis cannot be performed on the condition of the cable after bone fastening, but X-ray opaque material (for example, a barium compound) is mixed with the raw resin.
  • a spun fiber can also be used in the present invention.
  • a cable made using such X-ray-impermeable fibers in at least one part can be captured as an X-ray image.
  • an ultra-high molecular weight polyethylene fiber (molecular weight of 400,000 or more), which is a kind of polyethylene fiber, is particularly suitable as a fiber used in the present invention because of its high tensile strength and tensile modulus. Yes.
  • inorganic fibers materials conventionally used as bone fastening cables, such as titanium, titanium alloys and alloys thereof, and stainless steel, can be used.
  • a cable can also be produced using a combination of organic fibers and inorganic fibers.
  • a hollow cable made by incorporating a part of inorganic fiber into an X-ray permeable organic fiber can be captured in the X-ray image, enabling X-ray inspection of the cable in the patient.
  • the hollow cable for bone fastening of the present invention has an inner diameter (that is, a diameter of the lumen) that is sufficiently large compared to the outer diameter so as to become a flat tape shape when the fastening object is crushed by fastening. ) Is preferable.
  • the ratio of the outer diameter to the inner diameter is preferably 1.;! ⁇ 2.0, and more preferably 1.;! ⁇ 1.5.
  • the preferred inner diameter of the bone fastening hollow cable of the present invention varies depending on the part to be fastened and the fastening force required, but is usually preferably 1.0 to 10 mm, more preferably 1. 5 ⁇ lOmm "C3 ⁇ 4.
  • the bone fastening hollow cable of the present invention can be used particularly advantageously in conventional spinal surgery compared to conventional cables, but is also handled when fastening bones in other parts of the body. It can be used for an IJ because it is easy to prevent, prevents bone depressions and cuts, and avoids twisting.
  • the bone fastening hollow cable of the present invention is supplied while including the core material at the time of manufacture, and the operating room.
  • the core material may be pulled out at the same time, and when it is supplied in a box or the like so that it is not subject to inadvertent pressure during transportation and storage, it may be supplied with only the hollow cable with the core material pulled out. Good.
  • Hollow fibers were made by plain weaving with 24 spindles using two layers of 100 denier yarn made of ultra high molecular weight polyethylene fibers (denier: mass per 9000m (g)).
  • a polytetrafluoroethylene resin tube with an outer diameter of 2 mm is used as the core material, and the gear ratio between the winding side gear and the spindle side gear is set around it using a No. 101 (medium) round string machine manufactured by KOKUBUN LIMITED.
  • KOKUBUN LIMITED No. 101 (medium) round string machine manufactured by KOKUBUN LIMITED.
  • Example 1 Each of the la and lc hollow cables, a loop formed by doubling as shown schematically in Fig. 1 is formed and wound around two round pipes of a tensile tester.
  • the maximum traction force (hereinafter referred to as “maximum fixing strength”) was also measured by pulling the directional force and maintaining the loop fixed. The results are shown in Table 2.
  • each of the lb and lc hollow cables in Example 1 was formed by wrapping and fastening two round pipes in a double loop.
  • width and thickness of the cable part in contact with the round pipe referred to as “width at fastening” and “thickness at fastening”, respectively.
  • Example 2a, 2b, and 2c Three types of hollow cables were produced in the same manner as in Example 1 using a single thread without overlapping them (Examples 2a, 2b, and 2c, respectively).
  • the fabricated hollow cable maintained a circular cross-section until it was compressed by fastening the object to be fastened, even if the core material was pulled out.
  • the inner diameter of these hollow cables was 2 mm. Table 1 shows the outer diameter of these hollow cables and the number of yarn windings per unit length.
  • Example 2 Two hollow cables were produced in the same manner as in Example 1 (with gear ratios of 100/45 and 100/40) using two 250 denier yarns used in Example 2 in a stack. (Examples 3a and 3b, respectively).
  • the fabricated hollow cable maintained a circular cross-section until it was compressed by fastening the object to be fastened, even if the core material was pulled out.
  • the inner diameter of these hollow cables was 2 mm.
  • Table 1 shows the number of yarns wound per unit length of these hollow cables and the outer diameter of the cables.
  • the hollow cable for bone fastening according to the present invention is easy to handle in bone fastening, has a low risk of causing bone depression or cutting, can be prevented from twisting, is easy to prevent contact with the spinal cord during spinal surgery, and is excellent. It can be used as a bone fastening cable.

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

Abstract

La présente invention concerne un câble de fixation osseuse capable de maintenir l'os avec une ampleur suffisante pour éliminer la crainte d'un affaissement ou d'une séparation de l'os, lequel câble creux de fixation osseuse est perfectionné de manière à être capable de prévenir toute torsion au moment de la fixation et d'être aisément introduit au travers de l'interstice présent entre l'arc vertébral et la moelle épinière au cours d'une intervention chirurgicale rachidienne. Le câble est constitué d'un câble creux de fixation osseuse maintenu dans une configuration tubulaire de section transversale à peu près circulaire par un maillage de fibres, qui peut être écrasée par la fermeture d'un objet de fixation afin de passer dans une configuration de bande.
PCT/JP2007/065371 2006-08-11 2007-08-06 Câble creux de fixation osseuse Ceased WO2008018412A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2006220113A JP2008043431A (ja) 2006-08-11 2006-08-11 骨締結用中空ケーブル
JP2006-220113 2006-08-11

Publications (1)

Publication Number Publication Date
WO2008018412A1 true WO2008018412A1 (fr) 2008-02-14

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PCT/JP2007/065371 Ceased WO2008018412A1 (fr) 2006-08-11 2007-08-06 Câble creux de fixation osseuse

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JP (1) JP2008043431A (fr)
WO (1) WO2008018412A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011049139A1 (fr) * 2009-10-22 2011-04-28 アルフレッサファーマ株式会社 Câble plat tressé constitué de fibres de polyéthylène d'ultra-haute masse moléculaire
WO2016013123A1 (fr) * 2014-07-25 2016-01-28 大阪コートロープ株式会社 Tresse de ligature osseuse et procédé de fabrication de tresse de ligature osseuse
CN105561401A (zh) * 2015-12-29 2016-05-11 深圳市昌华生物医学工程有限公司 一种复合纤维、制作方法及骨科捆扎线

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997011654A1 (fr) * 1995-09-27 1997-04-03 Pioneer Laboratories Inc. Systeme de sertissage de cable
WO2002087415A2 (fr) * 2001-04-26 2002-11-07 Poly-4 Medical, Inc. Procede d'application d'une force active de compression en continu a travers une fracture
WO2006060911A1 (fr) * 2004-12-06 2006-06-15 Socovar Societe En Commandite Composant de liaison

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997011654A1 (fr) * 1995-09-27 1997-04-03 Pioneer Laboratories Inc. Systeme de sertissage de cable
WO2002087415A2 (fr) * 2001-04-26 2002-11-07 Poly-4 Medical, Inc. Procede d'application d'une force active de compression en continu a travers une fracture
WO2006060911A1 (fr) * 2004-12-06 2006-06-15 Socovar Societe En Commandite Composant de liaison

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011049139A1 (fr) * 2009-10-22 2011-04-28 アルフレッサファーマ株式会社 Câble plat tressé constitué de fibres de polyéthylène d'ultra-haute masse moléculaire
CN102665581A (zh) * 2009-10-22 2012-09-12 爱芙乐赛制药株式会社 超高分子量聚乙烯纤维制编织扁平线缆
CN102665581B (zh) * 2009-10-22 2015-04-22 爱芙乐赛制药株式会社 超高分子量聚乙烯纤维制编织扁平线缆
JP5943606B2 (ja) * 2009-10-22 2016-07-05 アルフレッサファーマ株式会社 超高分子量ポリエチレン繊維製編組扁平ケーブル
WO2016013123A1 (fr) * 2014-07-25 2016-01-28 大阪コートロープ株式会社 Tresse de ligature osseuse et procédé de fabrication de tresse de ligature osseuse
CN105561401A (zh) * 2015-12-29 2016-05-11 深圳市昌华生物医学工程有限公司 一种复合纤维、制作方法及骨科捆扎线
CN105561401B (zh) * 2015-12-29 2020-06-02 深圳市昌华生物医学工程有限公司 一种复合纤维、制作方法及骨科捆扎线

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Publication number Publication date
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