WO2023085236A1 - 骨接合材料及び骨接合材料の製造方法 - Google Patents

骨接合材料及び骨接合材料の製造方法 Download PDF

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Publication number
WO2023085236A1
WO2023085236A1 PCT/JP2022/041420 JP2022041420W WO2023085236A1 WO 2023085236 A1 WO2023085236 A1 WO 2023085236A1 JP 2022041420 W JP2022041420 W JP 2022041420W WO 2023085236 A1 WO2023085236 A1 WO 2023085236A1
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WIPO (PCT)
Prior art keywords
osteosynthetic
poly
bending resistance
lactic acid
joint material
Prior art date
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Ceased
Application number
PCT/JP2022/041420
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English (en)
French (fr)
Japanese (ja)
Inventor
英俊 有村
麻衣 塚原
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Gunze Ltd
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Gunze Ltd
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Publication date
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Priority to JP2023559621A priority Critical patent/JPWO2023085236A1/ja
Priority to CN202280040790.9A priority patent/CN117440840A/zh
Priority to US18/708,480 priority patent/US20250001054A1/en
Publication of WO2023085236A1 publication Critical patent/WO2023085236A1/ja
Anticipated expiration legal-status Critical
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Definitions

  • the present invention relates to an osteosynthetic material that has high strength and an appropriate rate of decomposition and that can be bent by hand, and a method for producing the osteosynthetic material.
  • osteosynthetic materials have practically sufficient flexural strength of about 323 N/mm 2 for SUS-316 stainless steel and about 245 to 490 N/mm 2 for ceramic ones, while human bones Since the rigidity is too high compared to , there is a risk that the bone at the application site may be scraped, and continuous stimulation may cause localized bone melting, reduced strength of new bone, and retarded growth of regenerated bone. was there.
  • Patent Literature 1 discloses a biodegradable surgical molded article (osteosynthesis material) comprising a polylactic acid molded article having a specific viscosity-average molecular weight, compressive bending strength and crystallinity.
  • the osteosynthetic material composed of such poly-L-lactic acid has excellent properties such that it can fix the bone with sufficient strength until the bone is regenerated, and is eventually absorbed into the body.
  • the conventional osteosynthesis material made of poly-L-lactic acid has high strength, there is a problem that a special tool is required to change the shape of the osteosynthesis material according to the shape of the application site.
  • the osteosynthetic material can be obtained by using a copolymer of poly-L-lactic acid and other bioabsorbable polymer or a mixture of poly-L-lactic acid and an additive. It has been proposed that the wire can be bent by hand only by immersing it in hot water to heat it without using a special tool.
  • the osteosynthesis material is a copolymer containing poly-L-lactic acid or a mixture with additives, although it can be bent by hand, the rate of decomposition in the body increases, resulting in bone loss. It was sometimes difficult to maintain sufficient strength until regeneration.
  • an object of the present invention is to provide an osteosynthetic material that has high strength and an appropriate rate of decomposition and is bendable by hand, and a method for producing the osteosynthetic material.
  • the present invention provides an osteosynthetic material used to fix bones at a fracture site, the osteosynthetic material comprising only poly-L-lactic acid, having a bending resistance of 10 N or more at 37° C., The osteosynthetic material has a bending resistance of 5 N or less at °C.
  • the present invention will be described in detail below.
  • the osteosynthetic material of the present invention consists only of poly-L-lactic acid. Since the osteosynthetic material of the present invention is composed of poly-L-lactic acid alone (homopolymer) instead of a copolymer or mixture, it can fix the bone with sufficient strength until the bone is regenerated. has a degradation rate that is rapidly absorbed into the body.
  • the weight average molecular weight of the poly-L-lactic acid is preferably 100,000 or more and 500,000 or less. By making the weight average molecular weight equal to or higher than the above lower limit, the strength can be further increased. In addition, by setting the weight average molecular weight to the above upper limit or less, it is absorbed into the body at an early stage after bone regeneration, so that foreign body reaction in the body can be further suppressed.
  • the weight average molecular weight of the poly-L-lactic acid is preferably 100,000 or more, more preferably 150,000 or more, preferably 500,000 or less, and even more preferably 450,000 or less.
  • a weight average molecular weight is a weight average molecular weight of standard polystyrene conversion by GPC(Gel Permeation Chromatography) here. Specifically, it can be determined with a polystyrene standard using chloroform as an eluent at a column temperature of 40° C. and a multipore-dispersed organic solvent column.
  • the poly-L-lactic acid preferably has a crystallinity of 10.0% or more and 25.6% or less.
  • the crystallinity of the poly-L-lactic acid is more preferably 13.4% or more, still more preferably 15.4% or more, and more preferably 23.3% or less. It is more preferably 0% or less.
  • the crystallinity of the poly-L-lactic acid can be adjusted by adjusting the temperature and time of heat treatment after stretching.
  • the crystallinity can be measured by a conventionally known method, for example, X-ray diffraction or differential scanning calorimetry (DSC). preferable.
  • DSC differential scanning calorimetry
  • the osteosynthetic material of the present invention has a bending resistance of 10 N or more at 37°C.
  • the bending resistance at 37° C. of the osteosynthetic material is within the above range, it is possible to obtain sufficient strength to fix the bones until the bones are regenerated.
  • the bending resistance at 37° C. can be adjusted by adjusting the weight-average molecular weight of poly-L-lactic acid and the degree of stretching.
  • the bending resistance at 37° C. can be measured by the following method.
  • FIG. 1 shows a schematic diagram for explaining the method of measuring the bending resistance.
  • a jig 2 having two mutually parallel protrusions with a width of 15 mm is placed in a water bath 1 filled with water so that the protrusions face upward.
  • an osteosynthetic material 3 is placed so as to bridge between the two projections.
  • the osteosynthesis material 3 is arranged so as to be perpendicular to the advancing direction of the projections and so that the center of the osteosynthesis material 3 is positioned on the midline between the projections.
  • the water temperature of the water bath 1 is set to 37° C. After reaching 37° C., the entire osteosynthesis material 3 is allowed to stand still for 2 minutes to equalize the water temperature.
  • an autograph for example, AGS-5KNX manufactured by Shimadzu Corporation
  • the bending resistance at 37° C. is preferably 10 N or more, more preferably 12 N or more. Although the upper limit of the bending resistance at 37° C. is not particularly limited, it is preferably 35 N or less.
  • the osteosynthetic material of the present invention has a bending resistance of 5 N or less at 70°C.
  • the osteosynthetic material of the present invention has a bending resistance of 10 N or more at 37°C and a bending resistance of 5 N or less at 70°C. Since it becomes soft, the osteosynthesis material can be deformed by hand, and the handling during surgery can be enhanced. In addition, while the osteosynthetic material of the present invention can be bent by hand, since the material is poly-L-lactic acid simple substance (homopolymer), the decomposition rate in the body does not increase unlike copolymers and mixtures. , can be fixed with sufficient strength until the bone regenerates.
  • the bending resistance at 70°C can be measured in the same manner as the bending resistance at 37°C except that the water temperature is 70°C.
  • the bending resistance at 70° C. can be adjusted by adjusting the degree of stretching of the poly-L-lactic acid.
  • the bending resistance at 70° C. is preferably 5 N or less, more preferably 3 N or less.
  • the lower limit of the bending resistance at 70° C. is not particularly limited, it is preferably 0.1 N or more from the viewpoint of ease of molding.
  • the shape of the osteosynthetic material of the present invention is not particularly limited, and the shapes of conventional osteosynthetic materials such as dumbbell-shaped and plate-shaped can be used without particular limitations.
  • the method for producing the osteosynthetic material of the present invention is not particularly limited as long as it satisfies the bending resistance at 37°C and the bending resistance at 70°C.
  • a method of forming the shape of the osteosynthetic material afterwards is preferable.
  • the steps of forming a plate consisting only of poly-L-lactic acid and stretching the plate by 1.1 times or more and 2.0 times or less are performed. , and the step of forming the plate after the stretching into the shape of the osteosynthetic material.
  • a step of forming a plate made of only poly-L-lactic acid is performed.
  • the method of forming a plate consisting of only poly-L-lactic acid is not particularly limited, and conventionally known methods such as injection molding, extrusion molding and blow molding can be used.
  • the step of stretching the plate by 1.1 times or more and 2.0 times or less is then performed.
  • a conventional osteosynthesis material made of poly-L-lactic acid stretches the plate four times or more in order to improve the strength.
  • the plate made of poly-L-lactic acid obtained in the above steps is stretched within the above range to satisfy the bending resistance at 37°C and the bending resistance at 70°C. can be made easier.
  • the draw ratio of the plate is preferably 1.1 times or more, and preferably 1.5 times or less.
  • the stretching method is not particularly limited, but rolling is preferable from the viewpoint of productivity.
  • heat treatment is preferably performed after the stretching step.
  • the stretched poly-L-lactic acid By subjecting the stretched poly-L-lactic acid to a heat treatment, the crystallinity of the poly-L-lactic acid can be brought to a more optimal range.
  • the heat treatment is appropriately adjusted on the basis of temperature or time.
  • the step of forming the plate after the drawing into the shape of the osteosynthetic material is then performed.
  • the osteosynthetic material is obtained by molding the stretched plate made of only poly-L-lactic acid into the shape of the osteosynthetic material.
  • the method for forming the plate is not particularly limited, and conventionally known methods such as cutting and punching can be used without particular limitations.
  • the osteosynthetic material of the present invention is used to fix bones at fracture sites.
  • the osteosynthetic material of the present invention retains the excellent properties of poly-L-lactic acid, such as sufficient strength and moderate decomposition rate, and can be deformed by hand by soaking in hot water. very high in nature.
  • Example 1 Production of osteosynthesis material A plate of 90 mm x 90 mm x 2 mm was prepared by injection molding a molten homopolymer of poly-L-lactic acid (weight average molecular weight: 300,000). The resulting plate was stretched 1.1 times by a rolling mill, heat-treated, and then cut to obtain an osteosynthesis material having a total length of 23 mm, a thickness of 1.5 mm, and a width of 5.7 mm.
  • a plate of 45 mm ⁇ 45 mm ⁇ 11.5 mm was prepared by injection molding a molten homopolymer of poly-L-lactic acid (weight average molecular weight: 300,000). The obtained plate was stretched 6.0 times by a rolling mill. After that, by cutting the plate, an osteosynthetic material having a total length of 22 mm, a thickness of 1.5 mm, and a width of 5.1 mm was obtained.
  • Lactosorb 915-2110 (copolymer of L-lactic acid and glycolic acid, length 21.2 mm, width 6.9 mm, thickness 1.4 mm, manufactured by Medical U&A) was used as it was as an osteosynthesis material.
  • the osteosynthetic material was immersed in PBS (phosphate buffered saline) at a bath ratio of 100 and 50°C, and after 1 week, 2 weeks, 3 weeks, 5 weeks, and 7 weeks, GPC was performed. was used to measure the weight average molecular weight, and the ratio of the weight average molecular weight (molecular weight ratio) to the molecular weight before immersion being 100% was calculated to evaluate the degradability of the osteosynthetic material. The results are shown in FIG. For Comparative Example 4, measurements were performed after 2 weeks, 4 weeks, 6 weeks, and 8 weeks.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Epidemiology (AREA)
  • Vascular Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Materials For Medical Uses (AREA)
PCT/JP2022/041420 2021-11-10 2022-11-07 骨接合材料及び骨接合材料の製造方法 Ceased WO2023085236A1 (ja)

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JP2023559621A JPWO2023085236A1 (https=) 2021-11-10 2022-11-07
CN202280040790.9A CN117440840A (zh) 2021-11-10 2022-11-07 骨接合材料及骨接合材料的制造方法
US18/708,480 US20250001054A1 (en) 2021-11-10 2022-11-07 Bone joint material, and method for producing bone joint material

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JP2021183473 2021-11-10
JP2021-183473 2021-11-10

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08196617A (ja) * 1995-09-25 1996-08-06 Takiron Co Ltd 生体内分解吸収性の外科用材料及びその製造法
JPH09173435A (ja) * 1995-12-27 1997-07-08 Takiron Co Ltd インプラント材料及びその製造方法
JP2000084064A (ja) * 1998-09-14 2000-03-28 Takiron Co Ltd 生体内分解吸収性インプラント材とその形状調整方法

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08196617A (ja) * 1995-09-25 1996-08-06 Takiron Co Ltd 生体内分解吸収性の外科用材料及びその製造法
JPH09173435A (ja) * 1995-12-27 1997-07-08 Takiron Co Ltd インプラント材料及びその製造方法
JP2000084064A (ja) * 1998-09-14 2000-03-28 Takiron Co Ltd 生体内分解吸収性インプラント材とその形状調整方法

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
MOCHIZUKI, MASATSUGU: "Crystallization Behaviors of highly LLA-rich PLA", SEN'I GAKKAISHI, vol. 66, no. 2, 1 January 2010 (2010-01-01), pages P_70 (24) - P_77 (31), XP009545642, DOI: 10.2115/fiber.66.P_70 *
SUGIYAMA, YOSHIKI: "Biodegradable osteosynthesis system for maxillofacial surgery ― focusing on high-strength PLLA materials ―", DENTAL JOURNAL OF IWATE MEDICAL UNIVERSITY, vol. 30, no. 2, 16 August 2005 (2005-08-16), pages 121 - 131, XP009545710, ISSN: 0385-1311, DOI: 10.20663/iwateshigakukaishi.30.2_121 *

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US20250001054A1 (en) 2025-01-02
CN117440840A (zh) 2024-01-23
JPWO2023085236A1 (https=) 2023-05-19

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