CN110585490B - Micro-motion pressurizing steel plate - Google Patents

Micro-motion pressurizing steel plate Download PDF

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Publication number
CN110585490B
CN110585490B CN201910871153.6A CN201910871153A CN110585490B CN 110585490 B CN110585490 B CN 110585490B CN 201910871153 A CN201910871153 A CN 201910871153A CN 110585490 B CN110585490 B CN 110585490B
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bone
steel plate
micro
coating
motion
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CN201910871153.6A
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CN110585490A (en
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姚天平
徐竹
周凯华
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Shangli International Standards Co ltd
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Shangli International Standards 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
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/08Materials for coatings
    • A61L31/10Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/146Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148Materials at least partially resorbable by the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412Tissue-regenerating or healing or proliferative agents

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a micro-motion pressurizing steel plate which is provided with a bone-knitting surface in contact with a wound bone and a non-bone-knitting surface in non-contact with the wound bone, wherein a degradable coating is coated on the bone-knitting surface. According to the micro-motion compression steel plate, the degradable coating is coated on the bone-knitting surface contacted with the wounded bone, rigid fixation can be formed in the initial stage of fracture fixation, and micro-motion of the wounded bone is formed due to degradation of the degradable coating 2-3 weeks after fracture operation, so that healing of the fracture part is facilitated.

Description

Micro-motion pressurizing steel plate
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a micro-motion pressurizing steel plate.
Background
The limb trauma fracture is the fracture of bones caused by violence or accidents, and the fracture is often accompanied by the injuries of other parts such as blood vessels, tendons, nerves and the like, and the limb mobility is large, so that effective fixation is required in time to avoid continuous secondary damage. With the development of medical level and technology, most limb fractures can be effectively reduced, and the functions of limbs can be recovered as much as possible, but researches show that more than 5% of limb fracture patients in clinic have nonunion and need to be treated again, so that not only is the physical pain of the patients increased, but also the psychological pressure and the economic expenditure of the patients are increased.
The main reason is that the traditional built-in steel plate is designed into a whole, the steel plate is fixed on the skeleton through screws, so that the steel plate and the skeleton are integrated, the micromotion in all directions is small, the longitudinal stress required in the fracture healing process is blocked, the fracture end face (especially comminuted fracture) cannot be subjected to micromotion, the healing time is prolonged, even the fracture is not healed, and the phenomenon of bone nonunion occurs.
With the summary of clinical experience and the exploration of animal experiments, people gradually and deeply know the related problems of fracture treatment interrupted end fixation, and most of the scholars think that the broken ends have axial micromotion to a certain degree to promote the healing of fracture and effectively reduce the occurrence of bone nonunion phenomenon.
Chinese patent CN105520775A discloses a fracture fixation device capable of longitudinally and dynamically sliding, which is characterized in that a slide rail is arranged on a strip steel plate, a slide groove is arranged on a block steel plate, the block steel plate is sleeved on the slide rail of the strip steel plate through the slide groove, and the block steel plate can longitudinally and dynamically slide on the strip steel plate; the block steel plate is provided with a screw hole, the thread of the screw hole is matched with the thread at the tail of the screw, and the block steel plate and the screw are combined into a whole; the steel bar plate is provided with a groove, and the screw penetrates through the screw hole of the steel bar plate and the groove of the steel bar plate in sequence and then is screwed into the bone and can slide in the groove of the steel bar plate. By adopting the fixing technology of limiting sliding, the fracture end can be continuously pressurized in the healing process of the fracture without generating stress shielding, the longitudinal mechanical stress and micromotion can be transmitted to the fracture end to promote the healing of the fracture, and the difficulties of limited bone development, slow fracture healing and the like in the traditional static fixing mode are overcome.
Chinese patent CN 105193489 a dynamic compression locking bone screw and its using method, which comprises screw sleeve and screw core, the screw core comprises top cap, polish rod, nail head, the screw sleeve is set on the periphery of polish rod and nail head, there is gap between screw sleeve and polish rod, the screw sleeve is connected with nail head, the dynamic compression locking bone screw which can fix the opposite side cortex to make the fracture part nearly parallel to the fracture part, it can avoid the stress concentration of screw root to prevent screw fracture, at the same time, it can provide micro friction for fracture broken end to promote the formation of callus, thus providing faster and more stable healing process.
In actual clinical medicine, the fracture healing period is divided into a hematoma organization period and an original callus period, the hematoma organization period approximately needs 2-4 weeks, the fracture part needs to be firmly fixed, and a patient can exercise early, the original callus period needs 4-8 weeks, the fracture part needs to generate micro motion to promote the formation of callus, therefore, the micro motion of 1-4mm generated in 2-3 weeks after the fracture operation is optimal, and the micro motion is not generated in the first two weeks after the operation, however, the existing dynamic compression fixing system has certain micro motion from the beginning of fixing to the fracture healing, and the structure is not beneficial to the healing and the recovery of the fracture part in the early stage.
Disclosure of Invention
In order to solve the problem that the prior dynamic compression fixing system has a certain micromotion after the fixation is finished, the invention discloses a micromotion compression steel plate, which can form rigid fixation at the initial stage of fracture fixation by coating a degradable coating on the fracture surface contacted with a wound bone, and can form the micromotion of the wound bone part due to the degradation of the degradable coating 2-3 weeks after the fracture operation, thereby being beneficial to the healing of the fracture part.
In order to achieve the purpose, the invention adopts the following technical scheme:
a micro-motion compression steel plate is provided with a bone-knitting surface which is in contact with a wounded bone and a non-bone-knitting surface which is not in contact with the wounded bone, wherein the bone-knitting surface is coated with a degradable coating.
Preferably, the non-bone-setting surface is coated with a degradable coating.
Preferably, the thickness of the degradable coating is 0.2-1 mm.
Preferably, the degradable coating degrades for 3 to 5 weeks.
Preferably, the degradable coating is a protein coating.
Preferably, the protein coating is a fibroin coating.
Preferably, the injured bone is an extremity injured bone, preferably a lower limb injured bone.
Preferably, the limb injured bone is tibia, fibula, femur, ulna, radius or humerus.
The invention has the following beneficial effects:
(1) according to the micro-motion compression steel plate, the degradable coating is coated on the bone-knitting surface contacted with the wounded bone, rigid fixation can be formed in the initial stage of fracture fixation, and micro-motion of the wounded bone is formed due to degradation of the degradable coating 2-3 weeks after fracture operation, so that healing of the fracture part is facilitated.
(2) The thickness of the degradable coating of the micromotion compression steel plate is 0.2-1mm, coatings with different thicknesses can be selected according to people with different physiques, teenagers with good physical quality have faster healing of fracture wounds, coatings with high degradation speed, such as high-porosity coatings, or thinner coatings can be selected to adapt to healing of the fracture wounds of the teenagers, and middle-aged and old patients with older age can be selected, coatings with lower degradation speed, such as low-porosity coatings, or thicker coatings can be selected to adapt to healing of the fracture wounds of the middle-aged and old patients.
(3) According to the micro-motion compression steel plate, the degradable coating is coated on the bone-knitting surface contacted with the wounded bone, so that the tiny blood vessels of the periosteum can be protected, and the defect that the traditional steel plate is completely contacted, the tiny blood vessels on the periosteum can be abraded or damaged, and the fracture part is not easy to heal is overcome.
(4) According to the micro-motion compression steel plate, the degradable coating is coated on the bone-knitting surface contacted with the wounded bone, and the protein coating is selected as the coating, so that the growth of the bone at the fracture part is promoted.
Detailed Description
The present invention will now be described in further detail with reference to examples.
A micro-motion compression steel plate has a bone-knitting surface which is in contact with a wounded bone and a non-bone-knitting surface which is not in contact with the wounded bone, wherein the bone-knitting surface is coated with a degradable coating.
In one embodiment, the non-bone-engaging surface is coated with a degradable coating. To facilitate coating, the entire steel sheet may be optionally coated with a degradable coating.
In one embodiment, the thickness of the degradable coating is 0.2 to 1 mm. The coating with different thicknesses can be selected according to people with different physiques, teenagers with better physique can have faster fracture wound healing, the coating with high degradation speed, such as a high-porosity coating, or a thinner coating can be selected to adapt to fracture wound healing of the teenagers, and the coating with lower degradation speed, such as a low-porosity coating, or a thicker coating can be selected to adapt to fracture wound healing of the middle-aged and old-aged patients.
In one embodiment, the degradable coating degrades for a period of 3 to 5 weeks. In actual clinical medicine, the micro-motion of 1-4mm is generated in 2-3 weeks after the fracture operation as the best, the micro-motion is not generated in the first two weeks after the fracture operation as the best, in order to ensure the fixation stability of the previous stage, the degradation time of the degradable coating is adjusted to 3-5 weeks as the best, and the slight degradation of the previous stage can not influence the fracture part of a patient.
In one embodiment, the degradable coating is a protein coating. Because there are many degradable materials on the market, there are few materials that can be degraded in vivo within 3-5 weeks, in this particular embodiment, a protein coating is selected.
Wherein the protein coating can be prepared according to the following method:
(1) dissolving protein in water or organic solvent, preparing protein solution with concentration of 5-20wt%, and stirring to obtain protein solution;
(2) and (3) spraying the protein solution on the bone-knitting surface of the micromotion compression steel plate, or dip-coating the protein solution on the outer surface of the micromotion compression steel plate, and drying to obtain the micromotion compression steel plate.
Wherein the thickness of the degradable coating can be controlled by the concentration of the protein.
In order to better control the degradation time of the protein, when the protein solution is prepared in the step (1), some water-soluble polymers (such as PVP, PEO, sodium alginate) and the like can be added, after the micro-motion pressurizing steel plate is obtained, the temperature is raised to denature the protein, and then the micro-motion pressurizing steel plate is immersed in water to dissolve the water-soluble polymers in the water, so that a microporous structure with a certain porosity is formed in the coating of the micro-motion pressurizing steel plate, and the degradation of the degradable coating is facilitated; the porosity of the microporous structure can be controlled by changing the concentration of the water-soluble macromolecules, and finally the degradation time of the degradable coating can be controlled.
In a specific embodiment, the protein coating is a fibroin coating.
In a specific embodiment, the injured bone is an extremity injured bone, preferably a lower extremity injured bone.
In one embodiment, the limb injury bone is a tibia, fibula, femur, ulna, radius, or humerus.
In light of the foregoing description of the preferred embodiment of the present invention, many modifications and variations will be apparent to those skilled in the art without departing from the spirit and scope of the invention. The technical scope of the present invention is not limited to the content of the specification, and must be determined according to the scope of the claims.

Claims (7)

1. A micro-motion compression steel plate, which has a bone-knitting surface contacting with a wounded bone and a non-bone-knitting surface not contacting with the wounded bone, is characterized in that: the bone-knitting surface is coated with a degradable coating which is a protein coating; the protein coating is prepared according to the following method:
(1) dissolving protein in an organic solvent, preparing a protein solution with the concentration of 5-20wt%, and uniformly stirring to obtain a protein solution;
(2) spraying the protein solution on the bone-knitting surface of the micromotion compression steel plate, or dip-coating the protein solution on the outer surface of the micromotion compression steel plate, and drying to obtain the micromotion compression steel plate;
when the protein solution is prepared in the step (1), adding a water-soluble polymer;
after the micro-motion pressing steel plate is obtained, the temperature is raised to denature protein, and then the micro-motion pressing steel plate is immersed in water to dissolve water-soluble polymers in the water, so that a micro-pore structure is formed in a coating of the micro-motion pressing steel plate.
2. The micro-motion compression steel plate as set forth in claim 1, wherein: the non-bone-knitting surface is coated with a degradable coating.
3. The micromotion press steel plate according to claim 1 or 2, wherein: the thickness of the degradable coating is 0.2-1 mm.
4. The micromotion press steel plate according to claim 1 or 2, wherein: the degradable coating has a degradation time of 3-5 weeks.
5. The micro-motion compression steel plate as set forth in claim 1, wherein: the protein coating is a fibroin coating.
6. The micromotion press steel plate according to claim 1 or 2, wherein: the injured bone is injured bone of limbs.
7. The micro-motion compression steel plate as set forth in claim 6, wherein: the limb injured bone is tibia, fibula, femur, ulna, radius or humerus.
CN201910871153.6A 2019-09-16 2019-09-16 Micro-motion pressurizing steel plate Active CN110585490B (en)

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CN112617995B (en) * 2020-12-11 2022-03-25 中国人民解放军总医院 Fracture repair device for realizing transition from mechanical fixation (AO) to biological fixation (BO)

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