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WO2020171794A1 - Élément de fixation pour l'ostéosynthèse - Google Patents

Élément de fixation pour l'ostéosynthèse Download PDF

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Publication number
WO2020171794A1
WO2020171794A1 PCT/UA2019/000024 UA2019000024W WO2020171794A1 WO 2020171794 A1 WO2020171794 A1 WO 2020171794A1 UA 2019000024 W UA2019000024 W UA 2019000024W WO 2020171794 A1 WO2020171794 A1 WO 2020171794A1
Authority
WO
WIPO (PCT)
Prior art keywords
screw
bone
osteosynthesis
alloy
magnesium
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/UA2019/000024
Other languages
English (en)
Russian (ru)
Inventor
Вадим Николаевич ЧЁРНЫЙ
Роман Александрович МИРОНЕНКО
Сергей Юрьевич ЦОЦОРИН
Дмитрий Игоревич ВИНИЧЕНКО
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.)
"MOTOR SICH JSC"
Original Assignee
"MOTOR SICH JSC"
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 "MOTOR SICH JSC" filed Critical "MOTOR SICH JSC"
Priority to PCT/UA2019/000024 priority Critical patent/WO2020171794A1/fr
Publication of WO2020171794A1 publication Critical patent/WO2020171794A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • 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
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • 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
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • 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
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • 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
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C23/00—Alloys based on magnesium

Definitions

  • the invention relates to medicine, namely to orthopedics, traumatology and medical equipment, and can be used in orthopedic traumatological operations, in particular in osteosynthesis.
  • Fixing structures made of various materials are used for osteosynthesis.
  • One of the elements of fixing structures are bone screws, which are used both as independent fixators and in conjunction with plates.
  • joint endoprostheses and screws are integrated into the musculoskeletal system of the body, they not only themselves are under the influence of constantly occurring static, cyclic and dynamic mechanical loads, but also transfer these loads to the surrounding bone tissue. Therefore, the materials intended for their manufacture must have a high level of biochemical and biomechanical compatibility with body tissues, good functional characteristics, and mechanical properties that ensure their tolerance to bone tissue, i.e. should not destroy it, be non-toxic.
  • the main materials used for the manufacture of immersion implants are stainless steel and titanium alloys.
  • a device for a bone plate including a bone screw as a fixator for insertion into a through hole [1], or, for example, a bone screw with an axially two-component screw head [2] having a base body, which is parallel to the longitudinal axis of the screw, the helical shaft to be fixed concentrically in the bone, and the screw head.
  • fixators of similar structures and materials for osteosynthesis requires repeated surgical interventions aimed at removing metal elements that have fulfilled their function. Often this is no less traumatic process than the osteosynthesis itself.
  • the use of such metal retainers is limited by the possibility of bacterial contamination of these implants. Long-term presence of implants made of these alloys in the human body can lead to the accumulation of toxic elements and metallosis. There are also manifestations of allergic and locally irritating reactions of the body in the form of aseptic inflammation.
  • Bio-soluble polymer materials based on polyglycolic and polylactic acids for example, amorphous polymer PLLA [3], [4], [5], are becoming more widespread.
  • Retainers made from materials of this type dissolve well in the body. Their disadvantages include the fact that after dissolving them in the bone tissue, a void remains, which can further lead to a violation of the supporting ability of the bone.
  • the described conical shape of the screw, when inserted into the bone, can lead to injury to the bone tissue. Osteliasis is often observed around such implants.
  • the implant consists of at least a magnesium alloy.
  • the magnesium alloy contains fractions of rare earth elements and lithium, and optionally also yttrium and aluminum.
  • the magnesium alloy contains lithium in a proportion of 0.01 to 7% by mass, aluminum in a proportion of 0.01 to 16% by mass, optionally yttrium in a proportion of 0.01 to 7% by mass, and rare earth elements in a proportion of 0.01 to 8% by weight.
  • the advantage of devices for osteosynthesis made of magnesium-based alloys is that they are bio-soluble in the body.
  • an essential characteristic of such devices is the degree of their solubility in the human body. So, the disadvantage of the prototype is the insufficient level of solubility (14-15 months), which leads to metalosis and bone destruction.
  • the presence of yttrium significantly increases the cost of the product, in addition, the presence of yttrium and especially lithium leads to complications due to their toxicity.
  • the basis of the invention is the task of improving the fixing elements used in osteosynthesis operations.
  • the technical result is the biodegradation of the fixing elements, such as screws, with a dissolution rate in the body of 6 to 12 months and a decrease in their toxicity.
  • screws made of biodegradable material which make it possible to avoid repeated operations with the removal of the screw, and make it possible to carry out osteosynthesis without complications.
  • the fixing element for osteosynthesis made of a biodegradable casting alloy based on magnesium, according to the invention, contains zirconium, neodymium, zinc, silver in the following ratio of ingredients, wt. %:
  • Magnesium and its biodegradation products have very good biocompatibility, and devices for implantation based on a magnesium alloy of the proposed composition are metabolized by the body and do not have a pathological effect on the surrounding tissues and the body as a whole.
  • Magnesium ions Mg2 + as biodegradation products, interact with phosphate ions contained in the organic body and form layers of magnesium phosphate, which contributes to the formation of bonds between implants and the mineral phase of newly formed bone tissue [7], [8].
  • Excess magnesium ions are easily excreted through the kidneys, and non-toxicity makes it possible to consider it as a material for an implant that can be completely biodegradable in a natural way.
  • microadditives of silver With the introduction of microadditives of silver, the strength and ductility of the alloy increases. Microadditives of silver grind the structure of the alloy, reducing its solubility. Thus, it is possible to regulate the solubility and obtain the required duration of its dissolution in the body.
  • the presence of silver in the magnesium alloy enhances the bactericidal properties of implantable devices.
  • the bactericidal properties of metallic silver and its alloys are associated with the release during bio-dissolution of silver ions Ad + into the space around the fixing element during the interaction of alloys in the electrolytic conditions of the human or animal organism. The amount of silver ions formed during dissolution depends on the composition of the alloy and its structure.
  • the structure of the obtained alloy determines the characteristics of bio-solubility, mechanical and bactericidal properties. It is the combination of the claimed alloy ingredients and their ratio that ensure the achievement of a new technical result - the production of a casting alloy with solubility in the human body within 6-12 months. This is achieved by the fact that with the stated content of ingredients, an additional amount of fine-grained intermetallic compounds (MgZr) i 2 Nd is formed, in which part of the zirconium is replaced by silver. These intermetallic compounds are uniformly distributed over the entire metal cross section and increase the electrochemical potential between the metal matrix and intermetallics with different electrochemical potentials, which leads to an increase in the solubility of such an alloy to the required level when it is in the body. In terms of mechanical properties, the alloy is close to the mechanical properties of bone.
  • MgZr fine-grained intermetallic compounds
  • Table 1 composition of the investigated alloys.
  • Table 2 test results.
  • an intermetallic phase is formed, the volume fraction of which is 0.3 - 0.5 wt%.
  • This amount of intermetallic phase is sufficient for the occurrence of the necessary electrochemical tension between the metal matrix and intermetallic compounds, which ensures the solubility of the alloy within 6 - 12 months (option 3 - 12.0 months, option 4 - 6.0 months, Table 2) ...
  • This rate of dissolution of fixing elements for osteosynthesis is sufficient for reliable bone fusion and excludes the formation of metallosis.
  • the fixing element for osteosynthesis can be made in the form of screws having the following design features, examples of which are shown in the drawings: figure 1 - cancellous screw, figure 2 - cortical screw.
  • the fixing element is made in the form of a cancellous screw (Fig. 1), which is used directly to fasten the fractured bone, and can be used in the treatment of fractures of various localization, for example, the femoral neck, heel bone.
  • Fig. 1 cancellous screw
  • the screw consists of a head 1 and a rod 2 with a thread 3.
  • the special features of the screw are that the rod has a full thread in the distal part, which allows compression of small fragments of bones by increasing the area of screw compression.
  • the threaded part is made with an outer diameter of 6.5 mm, an inner diameter of 3 mm, a thread pitch of 2.75 mm, a special profile of turns with angles of 25 ° and 5 °, passing into the inner diameter of a thread with radii R0.8MM and R1, 2MM, and the head with a diameter of 8 mm has a spherical configuration at the bottom, in contact with the bone.
  • the fixing element is made in the form of a cortical screw (Fig. 2), used for bone osteosynthesis, when fixing various fractures, both independently and together with plates, for example, for fixing plates on the forearm.
  • the screw consists of a head 1 and a rod 2 with a thread 3.
  • the special features of the screw are that the rod has a full thread in the distal part, the threaded part is made with an outer diameter of Q 4 mm, an inner diameter of 3 mm, a thread pitch of 1.5 mm, a special profile turns with angles 35 ° and 10 °, passing into the inner diameter of the thread with radii R 0.6 mm and R 1.0 mm, and the head with a diameter Q 6 mm has a spherical configuration in the lower part in contact with the bone.
  • the proposed sizes of the screw heads and their spherical shape allow them to be immersed into the bone tissue almost completely, i.e. the contact of the screw with soft tissues will be reduced. This reduces the corrosive effect of the electrolyte environment of the body on the screw and ensures the required stay of the screw in the bone.
  • the drill is used to form a channel through the bone fragments that need fixation.
  • a bed for the screw head is formed.
  • the tap is used to prepare the thread in the channel.
  • the screw is screwed into the canal using a screwdriver and additional force is applied to create compression between the bone fragments that are synthesized.
  • the patient is observed on for 3-9 months and control bone consolidation at the fracture site. During this period, resorption of the screw occurs.
  • the cancellous screws made in accordance with the invention have been used for minimally invasive fixation of a calcaneus fracture in patients.
  • the base alloy (Md) has improved adhesion of the implant to the osteocyte and does not retard cell development. Due to the presence of silver microadditions in the alloy, no inflammatory complications were observed in the area of implant insertion. No signs of intoxication were observed in the patient. During the biodegradation of the screw (over approximately 9 months), the bone canal was completely restored. No manifestations of allergic and locally irritating reactions of the body in the form of aseptic inflammation were observed.
  • Patent EP0507162 (A1), publ. 1992-10-07, Bone plate device, IPC: A61 B17 / 56; A61 B17 / 70; A61 B17 / 80;
  • Patent EP1191891 (A1), publ. 2002-04-03, Bone screw with axially two-part screw head, IPC: A61 B17 / 58; A61 B17 / 80; A61 B17 / 86; (IPC1-7):
  • Patent US3739773 (A), publ. 1973-06-19, Polyglycolic acid prosthetic devices, IPC: A61 B17 / 11; A61 F13 / 00; A61L17 / 14; A61L31 / 06;
  • W002100452 (A1), publ. 2002-12-19, Medical implant for the human or animal body, IPC A61 L27 / 04; A61 L27 / 58;

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Epidemiology (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Metallurgy (AREA)
  • Organic Chemistry (AREA)
  • Mechanical Engineering (AREA)
  • Materials Engineering (AREA)
  • Inorganic Chemistry (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Un élément de fixation pour l'ostéosynthèse est réalisé en alliage à base de magnésium contenant du zirconium, du néodyme, du zinc, de l'argent. Le résultat technique consiste en une biodégradation avec un taux de dissolution dans l'organisme de 6 à 12 mois et une toxicité réduite.
PCT/UA2019/000024 2019-02-20 2019-02-20 Élément de fixation pour l'ostéosynthèse Ceased WO2020171794A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/UA2019/000024 WO2020171794A1 (fr) 2019-02-20 2019-02-20 Élément de fixation pour l'ostéosynthèse

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/UA2019/000024 WO2020171794A1 (fr) 2019-02-20 2019-02-20 Élément de fixation pour l'ostéosynthèse

Publications (1)

Publication Number Publication Date
WO2020171794A1 true WO2020171794A1 (fr) 2020-08-27

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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002100452A1 (fr) * 2001-06-11 2002-12-19 Medizinische Hochschule Hannover Implant medical pour le corps humain ou animal
WO2011160533A1 (fr) * 2010-06-22 2011-12-29 上海交通大学 Alliage de magnésium utilisé pour un matériau d'implant dégradable d'os in vivo et son procédé de fabrication
UA66702U (uk) * 2011-07-11 2012-01-10 Публичное акционерное общество "МОТОР СИЧ" Біодеградуючий ливарний сплав на основі магнію для остеосинтезу
UA83676U (uk) * 2013-03-19 2013-09-25 Запорізький Державний Медичний Університет Малеолярний гвинт
UA83675U (uk) * 2013-03-19 2013-09-25 Запорізький Державний Медичний Університет Інтерферентний самокомпресуючий гвинт
UA84170U (en) * 2013-04-22 2013-10-10 Запорожский Государственный Медицинский Университет Bioresorptive anchor screw
UA99916U (uk) * 2015-02-11 2015-06-25 Ливарний сплав на основі магнію для імплантів
CN105154736A (zh) * 2015-10-23 2015-12-16 中国兵器工业第五九研究所 一种耐热铸造镁合金及其制备方法
CN107858575A (zh) * 2017-11-08 2018-03-30 中国兵器科学研究院宁波分院 一种高强耐热铸造镁合金材料及其制备方法

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002100452A1 (fr) * 2001-06-11 2002-12-19 Medizinische Hochschule Hannover Implant medical pour le corps humain ou animal
WO2011160533A1 (fr) * 2010-06-22 2011-12-29 上海交通大学 Alliage de magnésium utilisé pour un matériau d'implant dégradable d'os in vivo et son procédé de fabrication
UA66702U (uk) * 2011-07-11 2012-01-10 Публичное акционерное общество "МОТОР СИЧ" Біодеградуючий ливарний сплав на основі магнію для остеосинтезу
UA83676U (uk) * 2013-03-19 2013-09-25 Запорізький Державний Медичний Університет Малеолярний гвинт
UA83675U (uk) * 2013-03-19 2013-09-25 Запорізький Державний Медичний Університет Інтерферентний самокомпресуючий гвинт
UA84170U (en) * 2013-04-22 2013-10-10 Запорожский Государственный Медицинский Университет Bioresorptive anchor screw
UA99916U (uk) * 2015-02-11 2015-06-25 Ливарний сплав на основі магнію для імплантів
CN105154736A (zh) * 2015-10-23 2015-12-16 中国兵器工业第五九研究所 一种耐热铸造镁合金及其制备方法
CN107858575A (zh) * 2017-11-08 2018-03-30 中国兵器科学研究院宁波分院 一种高强耐热铸造镁合金材料及其制备方法

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