CN110840545A - Partially threaded magnesium alloy fixing screw for cancellous bone and preparation process - Google Patents

Partially threaded magnesium alloy fixing screw for cancellous bone and preparation process Download PDF

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Publication number
CN110840545A
CN110840545A CN201911162683.XA CN201911162683A CN110840545A CN 110840545 A CN110840545 A CN 110840545A CN 201911162683 A CN201911162683 A CN 201911162683A CN 110840545 A CN110840545 A CN 110840545A
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magnesium alloy
thread
screw
cancellous bone
nail
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CN201911162683.XA
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Chinese (zh)
Inventor
马国睿
吴锋
张凌风
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Zhuhai Zhongke Advanced Technology Research Institute Co Ltd
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Zhuhai Zhongke Advanced Technology Research Institute Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72Intramedullary pins, nails or other devices
    • A61B17/7233Intramedullary pins, nails or other devices with special means of locking the nail to the bone
    • A61B17/725Intramedullary pins, nails or other devices with special means of locking the nail to the bone with locking pins or screws of special form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72Intramedullary pins, nails or other devices
    • A61B17/7216Intramedullary pins, nails or other devices for bone lengthening or compression
    • CCHEMISTRY; METALLURGY
    • C22METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22CALLOYS
    • C22C1/00Making non-ferrous alloys
    • C22C1/02Making non-ferrous alloys by melting
    • CCHEMISTRY; METALLURGY
    • C22METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22FCHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
    • C22F1/00Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
    • C22F1/06Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of magnesium or alloys based thereon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Neurology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Metallurgy (AREA)
  • Mechanical Engineering (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Materials Engineering (AREA)
  • Animal Behavior & Ethology (AREA)
  • Thermal Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Surgical Instruments (AREA)

Abstract

The embodiment of the invention provides a partial thread magnesium alloy fixing screw for cancellous bone and a preparation process thereof, the partial thread magnesium alloy fixing screw for cancellous bone comprises a screw rod and a screw head integrally formed with the screw rod, a first thread is arranged on the screw rod, the length of the first thread is the same as that of the screw rod, the depth of the first thread is 30-45% of the diameter of the screw rod, and the first thread belongs to a deep thread, so that the magnesium alloy fixing screw can be fully pressurized when being implanted into different types of bone tissues, and the complete restoration and the rapid healing of fracture parts are facilitated. The preparation process provided by the embodiment of the invention has the advantages of simple operation steps, low processing cost and convenient and fast batch production.

Description

Partially threaded magnesium alloy fixing screw for cancellous bone and preparation process
Technical Field
The invention belongs to the technical field of orthopedic instruments, and particularly relates to a partially threaded magnesium alloy fixing screw for cancellous bones and a preparation process thereof.
Background
The currently clinically used bone internal fixation screw is mainly made of inert metal materials such as stainless steel, titanium alloy, cobalt-chromium alloy and the like, and although the inert metal materials have good strength and plasticity and are easy to process and form, the inert metal materials are not degradable after being implanted into a body, and can generate problems such as mechanical friction injury, toxic ion precipitation, local inflammatory reaction, stress shielding effect and the like in the long-term service process, thereby seriously affecting the healing of bone tissues, causing osteoporosis and even causing the risk of secondary fracture.
In view of the above, researchers have developed magnesium alloy set screws with the following significant advantages: (1) good biological safety. Magnesium is an essential nutrient element for human bodies, not only can be used as an important activator of various enzymes in cell metabolic activities, but also participates in various complex physiological activities such as protein synthesis, cell energy storage, nerve signal conduction and the like in human bodies; (2) good mechanical compatibility. The density and the elastic modulus of the magnesium alloy screw are closest to those of human bones, so that the stress shielding effect and the osteoporosis caused by the stress shielding effect can be effectively avoided; (3) good biodegradability and absorbability. The magnesium alloy screw is easy to corrode and degrade in the internal environment and can be completely absorbed by the human body, so that the physiological pain and the economic burden of a patient caused by taking out the magnesium alloy screw in a secondary operation are avoided; (4) good osteoblast inducibility. In recent years, a large number of research results show that magnesium ions released by the magnesium alloy screw in the degradation process can induce osteogenic differentiation and proliferation of stem cells in periosteum, can accelerate the healing of fracture parts, and is an ideal bone tissue repair device.
However, the conventional magnesium alloy fixing screw is a standard screw, as shown in fig. 1 or fig. 2. In fig. 1 and 2, 3 is a standard nail cap and 5 is bone tissue. The head of the standard screw in fig. 1 is of a flat head design, without angular inclination, and the sides of the head are not threaded, so that the fixation to the bone tissue is only achieved by means of the threads. The head of the standard screw in fig. 2 is of round head design, without angular inclination, and the side of the head cannot be provided with threads, so that the fixation with the bone tissue is only achieved by the threads. The design of the standard screw often causes the problems of low fastening strength, insufficient pressurizing effect, easy thread slipping and twisting of the screw in clinical application. These problems not only add additional difficulty to the surgical operator, but also affect the post-operative recovery, thus requiring great care throughout the surgical procedure. The above situation also hinders the clinical application of the magnesium alloy set screw.
Disclosure of Invention
The present invention is directed to solving at least one of the problems of the prior art. Therefore, the invention provides a partially threaded magnesium alloy fixing screw for cancellous bone and a preparation process thereof, the screw has higher fastening strength, sufficient pressurization effect and better mechanical property, and the common problems of lower fastening strength, insufficient pressurization effect and easy thread slipping and twisting of the conventional magnesium alloy screw can be greatly improved.
A partially threaded magnesium alloy fixation screw for cancellous bone in accordance with an embodiment of the first aspect of the present invention includes
A nail rod; and
a nail head integrally formed with the nail stem;
the nail rod is provided with a first thread, and the length of the first thread and the length of the nail rod are in proportion of (0.3-0.5): 1, the depth of the first thread is 30-45% of the diameter of the nail rod;
the top of the nail head is provided with a hole-shaped groove, the side face of the nail head is provided with a second thread, the length of the second thread is 50% of the length of the nail head, and the depth of the second thread is 10-20% of the diameter of the nail head.
The partially threaded magnesium alloy fixing screw for the spongy bone has the following technical effects:
in the partially threaded magnesium alloy fixing screw for cancellous bone, which is provided by the embodiment of the invention, the hole-shaped groove is formed at the top of the screw head, so that when the magnesium alloy screw is implanted into softer bone such as cancellous bone tissue and the like, the sliding wire of the screw can be effectively prevented from being twisted off, and the mechanical property of the magnesium alloy screw can be improved.
In the partially threaded magnesium alloy fixing screw for the cancellous bone, which is provided by the embodiment of the invention, the second threads are arranged on the side surface of the nail head and are self-locking threads, so that when the magnesium alloy screw is implanted into softer bone such as cancellous bone tissue and the like, the loosening and shaking of the screw can be effectively avoided, and the fixing strength of the magnesium alloy screw is improved.
In the partially threaded magnesium alloy fixing screw for cancellous bone, provided by the embodiment of the invention, the first threads are arranged on the screw rod, the depth of the first threads is 30-45% of the diameter of the screw rod, and the partially threaded magnesium alloy fixing screw belongs to deep threads, so that the magnesium alloy fixing screw can be fully pressurized when being implanted into different types of bone tissues, and the complete restoration and the rapid healing of fracture parts are facilitated. The shallow thread is relative to the deep thread, and the shallow thread generally means that the vertical distance between the front end of the thread and the nail shank is 5-10% of the diameter of the nail body. The shallow thread and the deep thread are compared, the application range of the shallow thread and the deep thread is different, the screw with the shallow thread is generally suitable for being implanted into fracture parts of harder sclerotin such as cortical bone, and the screw with the deep thread is generally suitable for being implanted into fracture parts of softer sclerotin such as cancellous bone.
In the magnesium alloy fixing screw for the partial threads of the cancellous bone, which is provided by the embodiment of the invention, the magnesium alloy screw has good biological safety, mechanical compatibility, biodegradation absorptivity and osteoblast inductivity, is beneficial to reducing inflammatory reaction of a fracture part, accelerates tissue healing of the fracture part, and meets the clinical use requirement of the magnesium alloy screw.
According to some embodiments of the invention, the head is spherical in shape, the design of the spherical head providing a head portion with a high fastening strength. The radian of the nail head part of the spherical finger is 0.5-1.0 pi.
According to some embodiments of the invention the angle between the side of the head and the centre line of the stem is 20-40 °.
According to some embodiments of the invention, the profile of the second thread is triangular.
The tooth shape is triangular, so that the nail head part has a better fixing effect.
According to some embodiments of the invention, the hole-type grooves comprise cross-shaped grooves, square grooves, pentagonal grooves and hexagonal grooves.
The hole-shaped groove can enable the nail head part to have better mechanical property.
According to a second aspect embodiment of the invention, the preparation process of the partially threaded magnesium alloy fixing screw for cancellous bone comprises the following steps:
s1: after vacuum melting, the magnesium alloy raw material is cast and molded to obtain a magnesium alloy ingot;
s2: after the magnesium alloy ingot is subjected to solution treatment, turning and skinning to obtain a magnesium alloy round ingot;
s3: preheating the magnesium alloy round ingot, and performing plastic extrusion to obtain a magnesium alloy rod;
s4: and annealing the magnesium alloy rod, and then precisely machining to obtain the partial threaded magnesium alloy fixing screw for the cancellous bone.
The preparation process of the partially threaded magnesium alloy fixing screw for the cancellous bone, provided by the embodiment of the invention, has the following technical effects:
in the preparation process, the magnesium alloy screws with various specifications can be prepared by adopting conventional equipment such as vacuum melting, solution treatment, plastic extrusion, precision machining and the like, and the preparation process has the advantages of simple operation steps, low machining cost and convenient and fast batch production.
According to some embodiments of the invention, the temperature of the vacuum melting is 700-760 ℃.
Stirring is carried out while vacuum melting is carried out, and the stirring time is 1-2 h. And after the vacuum melting is finished, obtaining a magnesium alloy ingot with the diameter phi of 40-80 mm through casting molding.
According to some embodiments of the invention, the temperature of the solution treatment is 400-500 ℃, and the holding time of the solution treatment is 6-8 h.
And after the solid solution treatment is finished, turning and skinning to obtain a magnesium alloy round ingot with the diameter phi of 30-60 mm.
According to some embodiments of the invention, the temperature of the preheating treatment is 300-350 ℃, and the holding time of the preheating treatment is 2-3 h.
After the preheating treatment is finished, a magnesium alloy bar with the diameter of phi 6-12 mm is obtained through plastic extrusion.
According to some embodiments of the invention, the temperature of the annealing treatment is 200-400 ℃, and the holding time of the annealing treatment is 1-2 h.
And after the annealing treatment is finished, performing precision machining to obtain the magnesium alloy screw with the diameter of phi 2-4 mm.
The magnesium alloy raw material used in the preparation process comprises any one of magnesium-zinc alloy, magnesium-calcium alloy, magnesium-strontium alloy, magnesium-manganese alloy, magnesium-silver alloy, magnesium-tin alloy, magnesium-copper alloy, magnesium-lithium alloy, magnesium-zirconium alloy, magnesium-neodymium alloy, magnesium-yttrium alloy and magnesium-gadolinium alloy.
Drawings
Fig. 1 is a schematic view of a standard screw of the prior art with a flat head design.
Fig. 2 is a schematic view of a standard prior art screw with a round head design.
Fig. 3 is a schematic thread depth view of a partially threaded magnesium alloy set screw for cancellous bone.
Fig. 4 is a schematic structural view of a partially threaded magnesium alloy set screw for cancellous bone.
Fig. 5 is a side schematic view of a partially threaded magnesium alloy set screw for use in cancellous bone.
FIG. 6 is a schematic view of a hole-type recess of a partially threaded magnesium alloy set screw for cancellous bone.
FIG. 7 is a partial schematic view of a first thread on a shank of a partially threaded magnesium alloy set screw for use in cancellous bone.
FIG. 8 is a flow chart of a process for preparing a partially threaded magnesium alloy set screw for cancellous bone.
Detailed Description
The following are specific examples of the present invention, and the technical solutions of the present invention will be further described with reference to the examples, but the present invention is not limited to the examples.
To facilitate an accurate understanding of the "depth of the thread" referred to in the embodiments of the present invention, reference will now be made to the drawings. The depth H of the thread refers to the distance as shown in fig. 3.
Example 1
The present embodiment provides a partially threaded magnesium alloy set screw for cancellous bone, as shown in fig. 4 and 5, comprising a shank 2; and
a nail head 1 integrally formed with the nail rod 2;
the nail rod 2 is provided with a first thread 5, and the length ratio of the first thread 5 to the nail rod 2 is (0.3-0.5): 1, the depth of the first thread 5 is 30-45% of the diameter of the nail rod 2;
the top of the nail head 1 is provided with a hole-shaped groove 3, the side surface of the nail head 1 is provided with a second thread 4, the length of the second thread 4 is 50% of the length of the nail head 1, and the depth of the second thread 4 is 10-20% of the diameter of the nail head 1.
The top of the nail head 1 is provided with the hole-shaped groove 3, so that when the magnesium alloy screw is implanted into softer sclerotin such as cancellous bone tissues and the like, the sliding wire of the screw is effectively prevented from being twisted off, and the mechanical property of the magnesium alloy screw is improved. The side of the nail head 1 is provided with the second thread 4, the second thread 4 is a self-locking thread, so that when the magnesium alloy screw is implanted into softer sclerotin such as cancellous bone tissues, loosening and shaking of the screw can be effectively avoided, and the fixing strength of the magnesium alloy screw is improved. The head 1 is spherical in shape and the design of the spherical head 1 allows the head 1 to be partially fastened with a high degree of strength. The included angle between the side surface of the nail head 1 and the center line of the nail rod 2 is 20-40 degrees. The tooth form of the second thread 4 is triangular, and the tooth form is triangular, so that the nail head part has a good fixing effect.
As shown in FIG. 6, the hole-type grooves 3 comprise cross-shaped grooves 31, square grooves 32, pentagonal grooves 33 and hexagonal grooves 34, and the hole-type grooves 3 can enable the nail head 1 part to have better mechanical properties.
As shown in figure 7, the first thread 5 is arranged on the nail rod 2, the depth of the first thread 5 is 30-45% of the diameter of the nail rod 2, and the first thread belongs to deep threads, so that the magnesium alloy screw can be fully pressurized when being implanted into different types of bone tissues, and the complete reduction and the rapid healing of the fracture part are facilitated. The shallow thread is relative to the deep thread, and the shallow thread generally means that the vertical distance between the front end of the thread and the nail shank is 5-10% of the diameter of the nail body. The shallow thread and the deep thread are compared, the application range of the shallow thread and the deep thread is different, the screw with the shallow thread is generally suitable for being implanted into fracture parts of harder sclerotin such as cortical bone, and the screw with the deep thread is generally suitable for being implanted into fracture parts of softer sclerotin such as cancellous bone.
Example 2
The embodiment provides a preparation process of a partially threaded magnesium alloy fixing screw for cancellous bone, the preparation process flow is shown in fig. 8, and the preparation process comprises the following steps:
s1: after vacuum melting of a magnesium alloy raw material 6, casting and forming to obtain a magnesium alloy ingot 7;
s2: after the magnesium alloy ingot 7 is subjected to solution treatment, turning and skinning are carried out to obtain a magnesium alloy round ingot 8;
s3: preheating the magnesium alloy round ingot 8, and performing plastic extrusion to obtain a magnesium alloy rod 9;
s4: after the magnesium alloy rod 9 is annealed, the magnesium alloy rod is precisely machined to obtain the partial thread magnesium alloy fixing screw for the cancellous bone.
Wherein the temperature of vacuum melting is 700-760 ℃. Stirring is carried out while vacuum melting is carried out, and the stirring time is 1-2 h. And after the vacuum melting is finished, obtaining a magnesium alloy ingot 7 with the diameter phi of 40-80 mm through casting molding.
The temperature of the solution treatment is 400-500 ℃, and the heat preservation time of the solution treatment is 6-8 h. And after the solution treatment is finished, turning and skinning to obtain a magnesium alloy round ingot 8 with the diameter phi of 30-60 mm.
The temperature of the preheating treatment is 300-350 ℃, and the heat preservation time of the preheating treatment is 2-3 h. After the preheating treatment is finished, a magnesium alloy rod 9 with the diameter of phi 6-12 mm is obtained through plastic extrusion.
The temperature of the annealing treatment is 200-400 ℃, and the heat preservation time of the annealing treatment is 1-2 h. And after the annealing treatment is finished, the magnesium alloy screw 10 with the diameter of phi 2-4 mm is obtained through precision machining.
The magnesium alloy raw material 6 used in the above preparation process includes any one of magnesium-zinc alloy, magnesium-calcium alloy, magnesium-strontium alloy, magnesium-manganese alloy, magnesium-silver alloy, magnesium-tin alloy, magnesium-copper alloy, magnesium-lithium alloy, magnesium-zirconium alloy, magnesium-neodymium alloy, magnesium-yttrium alloy, and magnesium-gadolinium alloy.
Specific embodiments of the invention have been described above. It is to be understood that the present invention is not limited to the specific embodiments described above, and that various changes or modifications may be made by those skilled in the art within the scope of the appended claims without departing from the spirit of the invention.

Claims (10)

1. A partially threaded magnesium alloy fixation screw for cancellous bone comprising
A nail rod (2); and
a nail head (1) integrally formed with the nail rod (2);
be equipped with first screw thread (5) on nail pole (2), the length of first screw thread (5) with the length ratio of nail pole (2) is (0.3 ~ 0.5): 1, the depth of the first thread (5) is 30-45% of the diameter of the nail rod (2);
the top of the nail head (1) is provided with a hole-shaped groove (3), the side face of the nail head (1) is provided with a second thread (4), the length of the second thread (4) is 50% of the length of the nail head (1), and the depth of the second thread (4) is 10-20% of the diameter of the nail head (1).
2. A partially threaded magnesium alloy fixation screw for cancellous bone according to claim 1 wherein the head (1) is spherical in shape.
3. The partially threaded magnesium alloy fixation screw for cancellous bone according to claim 1, wherein the angle between the side of the head (1) and the centerline of the shank (2) is 20-40 °.
4. A partially threaded magnesium alloy fixation screw for cancellous bone according to claim 1, characterized in that the profile of the second thread (4) is triangular.
5. A partially threaded magnesium alloy fixation screw for cancellous bone according to claim 1 wherein the hole-type recess (3) comprises a cross-shaped recess (31), a square recess (32), a pentagonal recess (33) and a hexagonal recess (34).
6. A preparation process of a partially threaded magnesium alloy fixing screw for cancellous bone is characterized by comprising the following steps of:
s1: after vacuum melting, the magnesium alloy raw material (6) is cast and molded to obtain a magnesium alloy ingot (7);
s2: after the magnesium alloy ingot (7) is subjected to solution treatment, turning and skinning are carried out to obtain a magnesium alloy round ingot (8);
s3: preheating the magnesium alloy round ingot (8), and performing plastic extrusion to obtain a magnesium alloy bar (9);
s4: and annealing the magnesium alloy bar (9), and then precisely machining to obtain the partially threaded magnesium alloy fixing screw (10) for the cancellous bone.
7. The preparation process according to claim 6, wherein the temperature of the vacuum melting is 700-760 ℃.
8. The production process according to claim 6, wherein the temperature of the solution treatment is 400 to 500 ℃ and the holding time of the solution treatment is 6 to 8 hours.
9. The preparation process according to claim 6, wherein the temperature of the preheating treatment is 300 to 350 ℃, and the heat preservation time of the preheating treatment is 2 to 3 hours.
10. The preparation process according to claim 6, wherein the temperature of the annealing treatment is 200-400 ℃, and the heat preservation time of the annealing treatment is 1-2 h.
CN201911162683.XA 2019-11-25 2019-11-25 Partially threaded magnesium alloy fixing screw for cancellous bone and preparation process Pending CN110840545A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117643496A (en) * 2024-01-30 2024-03-05 中国人民解放军西部战区总医院 Thoracolumbar spine individual nail placement device and use method thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117643496A (en) * 2024-01-30 2024-03-05 中国人民解放军西部战区总医院 Thoracolumbar spine individual nail placement device and use method thereof

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