CN116869709A - In-vivo functionalized bone repair member and preparation method thereof - Google Patents
In-vivo functionalized bone repair member and preparation method thereof Download PDFInfo
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- CN116869709A CN116869709A CN202310081935.6A CN202310081935A CN116869709A CN 116869709 A CN116869709 A CN 116869709A CN 202310081935 A CN202310081935 A CN 202310081935A CN 116869709 A CN116869709 A CN 116869709A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
-
- 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
- A61L27/54—Biologically active materials, e.g. therapeutic substances
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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
- 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
- A61L27/56—Porous materials, e.g. foams or sponges
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2002/2817—Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2002/2825—Femur
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00179—Ceramics or ceramic-like structures
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Dispersion Chemistry (AREA)
- Cardiology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Inorganic Chemistry (AREA)
- Molecular Biology (AREA)
- Prostheses (AREA)
Abstract
The invention relates to the technical field of bone repair medical equipment, in particular to an in-vivo functional bone repair component, which comprises a metal framework body, porous contents, an outer pipeline and a nutrition conveying device, wherein a plurality of mounting holes are respectively formed at two ends of the metal framework body; the preparation method comprises the steps of preparing a metal framework body, preparing an outer pipeline and an inner pipeline, preparing a porous content, preparing a nutrition conveying device, assembling all parts, implanting a host and operating the nutrition conveying device.
Description
Technical Field
The invention relates to the technical field of bone repair medical equipment, in particular to an in-vivo functionalized bone repair member and a preparation method thereof.
Background
Bones are the mechanical support part of the overall structure of the human body and have self-repairing ability for minor injuries, and when the defect is larger than 2cm, the bone repair members must be used for treatment, otherwise, life-long disability is caused. In addition to being biocompatible and morphologically compatible, this bone repair member is more important for tissue regeneration and adaptation of mechanical properties, in particular limiting bone defects (> 6 cm). To break through the world problem of long segment mechanical structure reconstruction and tissue regeneration matching, a great deal of research and invention creation has emerged, for example:
chinese patent publication No. CN1268583C discloses porous bioceramics of controllable microstructure, preparation method and application thereof, chinese patent ZL200710047210.6 discloses preparation method of porous ceramics, both patents improve material regeneration capability by regulating and controlling microstructure of the material;
the Chinese patent with publication number CN1542120 discloses a cell reactor which is used for tissue reconstruction engineering and can be used for inoculating biological cells to a biological bracket in a single environment, and the Chinese patent with publication number CN1257971C discloses a dynamic three-dimensional input type tissue reaction device, and both patents use an in-vitro reaction device to improve the material regeneration capacity;
the Chinese patent with publication number of CN100540071 discloses a medical enhanced porous biological ceramic, a preparation method and application thereof, and mechanical properties are improved by a material enhancement technology;
chinese patent publication No. CN104188738B discloses a multifunctional in vivo bone generator, chinese patent publication No. CN110882417a discloses a metal prosthesis of composite porous bioceramic and a preparation method thereof, chinese patent publication No. CN114569799a discloses a metal prosthesis of bearing modular ceramic and a preparation method thereof, and the above-mentioned patents improve repair capability and mechanical matching degree by combining inorganic and metal materials.
Cells and bioactive substances are often required to be loaded on a large-section bone repair member to improve the repair capability, but when the member is implanted into a body, the blood circulation reconstruction cannot be completed quickly, so that a plurality of problems such as apoptosis, active substance loss, mechanical property reduction and the like are caused. Therefore, the invention aims to solve the difficult problem of cell and tissue nutrition in the large-section bone repair component and lays a foundation for repairing bone tissue and organ defects.
Disclosure of Invention
The invention aims to overcome the technical defects and provide an in-vivo functionalized bone repair member and a preparation method thereof.
The utility model provides an internal functional bone repair component, includes metal framework, porous content, outer pipeline and nutrition conveyor, the both ends of metal framework are equipped with a plurality of mounting holes respectively, be equipped with the holding chamber of placing porous content in the metal framework, outer pipeline one end and the intercommunication that holds the chamber, the other end is at external nutrition conveyor of connecting, nutrition conveyor passes through outer pipeline and carries nutrition to holding the porous content in the intracavity.
Further, the porous content is the granule of porous structure, be equipped with built-in pipe in the metal framework body, be equipped with a plurality of side openings on the pipe wall of built-in pipe, the one end and the outer pipeline intercommunication of built-in pipe, the other end stretches into in the porous content, nutrition conveyor passes through outer pipeline, built-in pipe and carries the nutrient substance to holding the intracavity, and the nutrient substance flows on porous structure of porous content, the built-in pipe forms the inner pipeline that carries the nutrient substance in the metal framework body with the porous on the porous content.
Further, the porous contents are module bodies, each porous content is provided with a plurality of mutually communicated nutrient solution flow holes, the plurality of porous contents are mutually communicated through the nutrient solution flow holes to form an inner pipeline, one end of the outer pipeline is communicated with the nutrient solution flow hole on one of the porous contents, and the nutrient conveying device conveys nutrient substances to the porous contents through the outer pipeline.
Further, the metal frame body is provided with a plurality of through holes for communicating the accommodating cavity with the outside.
Further, the nutrition conveying device comprises a storage tank for storing the nutrition liquid and a power device, wherein the storage tank is connected with the outer pipeline, and the power device is arranged on the pipeline between the storage tank and the outer pipeline.
Further, the capacity of the storage tank is 500 milliliters, but is not limited to the capacity.
A method of preparing an in vivo functionalized bone repair member comprising the steps of:
step S1, preparing a metal framework body, an outer pipeline and an inner pipeline: according to the imaging data of the affected part of the patient, a finite element analysis model is established, and the mechanical structure and material selection of the metal framework body, the outer pipeline and the inner pipeline are designed according to the topology mathematical principle, so that the metal framework body, the outer pipeline and the inner pipeline are manufactured;
step S2, preparation of porous content: designing porous contents and material selection according to the shape, size and structure of the metal framework in the step S1 and the requirements of the surface and the internal structure of the porous contents, and manufacturing the porous contents;
step S3, preparing a nutrition conveying device: the nutrition conveying device consists of a storage tank, a pipeline and an intelligent power device, and is connected with an external conduit to provide conditions for storing, conveying and regulating and controlling the nutrition.
Step S4, assembling all the components and implanting the components into a host: after the porous content is arranged in the metal framework body and is communicated with the outer pipeline and the inner pipeline, the metal framework body is implanted into a host through a surgical operation, one end of the metal framework body is connected with a proximal host bone through a fixing nail, and the other end of the metal framework body is also connected with a distal host bone through a fixing nail and is connected with a nutrition conveying device through the outer pipeline; the host tissue covered outside the through holes on the metal framework can absorb excessive liquid and metabolites or directly discharge the excessive liquid and metabolites outside the body through the drainage tube.
Step S5, operating the nutrition conveying device: starting a power device after the storage tank is filled with nutrient solution, performing functional construction in a bone repair member body, enabling cells and tissues to continuously obtain nutrition and oxygen supply to grow and differentiate, gradually reducing the nutrient solution supply after the expected target is achieved, promoting self vascularization, finally removing the nutrition conveying device, retaining the metal framework and the porous content at a treatment position, gradually replacing the porous content by new tissues, and embedding the metal framework by the regenerated tissues to form the clinical curative effect of the reinforced concrete bone.
The invention has the advantages that: the bone repair member provided by the invention has the advantages that through reasonable structural design and manufacture, the blood circulation establishment, tissue regeneration, structural reconstruction and information transmission of the bone repair member are effectively adapted, the life of the bone repair member is endowed, and a reliable solution is provided for huge bone defects. The metal framework body provides powerful mechanical support for the bone defect part, the porous content provides a carrier for compounding cells and bioactive substances, provides a repairing environment for blood vessel and tissue regeneration, and adopts the nutrition conveying device to provide necessary living substances for cells and tissues in a bone repairing member in vivo, and the shearing force formed by nutrient solution promotes cell differentiation, so that the aim of treating huge bone defect is finally fulfilled.
Drawings
FIG. 1 is a schematic view of an in vivo functionalized bone repair member of the present invention;
FIG. 2 is a schematic view of an in vivo functionalized bone repair member with porous contents in granular form according to the invention;
FIG. 3 is a schematic illustration of a particulate porous content of the present invention;
FIG. 4 is a schematic illustration of an in vivo functionalized bone repair member with the porous contents of the body of the present invention being a module body;
FIG. 5 is a flow chart of the preparation and use of an internal functionalized bone repair member of the present invention;
FIG. 6 is a graph of glucose consumption in static and dynamic culture of porous content-loaded stem cells of the body of the present invention;
FIG. 7 is a graph of histological quantitative analysis in static and dynamic culture of porous content-loaded stem cells of the body of the present invention.
As shown in the figure: 1. a metal frame body; 2. porous content; 3. an outer pipe; 4. a built-in tube; 5. a mounting hole; 6. a receiving chamber; 7. a nutrient delivery device; 8. a side hole; 9. a through hole; 10. a nutrient fluid flow aperture; 13. distal host bone; 14. proximal host bone; 15. fixing nails; 701. a storage tank; 702. a power device; 7011. a liquid adding port; 7012. one-way pressure regulating valve; 7013. a unidirectional outlet.
Detailed Description
The present invention will be described in further detail with reference to the accompanying drawings.
Component example 1, porous content was granular
As shown in fig. 1, 2 and 3, the in-vivo functional bone repair member comprises a metal framework body 1, a porous content 2, an outer pipeline 3 and a nutrition conveying device 7, wherein a plurality of mounting holes 5 are respectively formed in two ends of the metal framework body 1, a containing cavity 6 for containing the porous content 2 is formed in the metal framework body 1, one end of the outer pipeline 3 is communicated with the containing cavity 6, the other end of the outer pipeline 3 is externally connected with the nutrition conveying device 7, the nutrition conveying device 7 conveys nutrition to the porous content 2 in the containing cavity 6 through the outer pipeline 3, the porous content 2 is in a particle shape of a porous structure, a built-in pipe 4 is arranged in the metal framework body 1, a plurality of side holes 8 are formed in the pipe wall of the built-in pipe 4, one end of the built-in pipe 4 is communicated with the outer pipeline 3, the other end of the built-in pipe 4 stretches into the porous content 2, the nutrition conveying device 7 conveys nutrition substances into the containing cavity 6 through the outer pipeline 3 and the built-in pipe 4, the nutrition substances flow in the porous structure of the porous content 2, the built-in pipe 4 and the porous content 2 convey nutrition substances in the porous content 2 in the metal framework body 1, and the metal framework body is communicated with the through holes 9.
Component example 2 porous content is a Module body
As shown in fig. 1 and 4, the nutrition storage device comprises a metal framework body 1, porous contents 2, an outer pipeline 3 and a nutrition conveying device 7, wherein a plurality of mounting holes 5 are respectively formed in two ends of the metal framework body 1, a containing cavity 6 for containing the porous contents 2 is formed in the metal framework body 1, one end of the outer pipeline 3 is communicated with the containing cavity 6, the other end of the outer pipeline is externally connected with the nutrition conveying device 7, the nutrition conveying device 7 conveys nutrition to the porous contents 2 in the containing cavity 6 through the outer pipeline 3, the porous contents 2 are module bodies, a plurality of mutually communicated nutrition liquid flow holes 10 are formed in each porous content 2, an inner pipeline is formed between each porous content 2 through the corresponding nutrition liquid flow holes 10, one end of the outer pipeline 3 is communicated with the nutrition liquid flow hole 10 in one porous content 2, and the nutrition conveying device 7 conveys nutrition substances to the porous contents 2 through the outer pipeline 3.
In the two embodiments, the porous content 2 is granular, the grain diameter is controlled to be 3-5mm, the porous content 2 is of a porous structure and is provided with nutrient solution flow holes 10, the pore diameter of the porous content 2 is 500-600 μm, and the porosity is 63%;
at least one accommodating cavity 6 is arranged in the metal framework body 1, and is provided with a through hole 9 communicated with the outside, and in the whole nutrient solution input process, excessive liquid and metabolites are eliminated through self absorption of host tissues, and can also be inserted into a drainage tube to be discharged out of the body, for example, the through hole 9 on the metal framework body 1 in the figure is realized, namely, the excessive liquid and the metabolites enter the host tissues through the through hole 9 to be eliminated through self absorption, or the through hole 9 is connected with the drainage tube to be discharged out of the body;
the nutrition conveying device 7 comprises a storage tank 701 for storing a nutrition liquid and a power device 702, wherein the storage tank 701 is connected with an outer pipeline 702 through a pipeline, the power device 702 is arranged on a pipeline between the storage tank 701 and the outer pipeline 3, and the capacity of the storage tank 701 is 500 milliliters;
metal structure 1: the metal frame body may be manufactured by at least one of 3D printing, casting, forging, and machining, but is not limited to the method; the metal framework adopts at least one of gold and alloy thereof, silver and alloy thereof, copper and alloy thereof, iron and alloy thereof, titanium and alloy thereof, tantalum and alloy thereof, aluminum and alloy thereof, magnesium and alloy thereof, but is not limited to the material; when the metal frame body is connected with the host bone, the fixing nails 9 can be used for connection as shown in fig. 2, but the connection method is not limited to the above.
Porous content 2: the porous content is made of at least one of hydroxyapatite and its adulterants, tricalcium phosphate and its adulterants, alumina and its adulterants, zirconia and its adulterants, titania and its adulterants, silica and its adulterants, aluminum magnesium spinel and its adulterants, but not limited to the material, and plays a role in guiding blood vessels and tissue regeneration; the porous content adopts at least one of 3D printing, mould pressing, grouting and extrusion forming to prepare an intercommunicating porous structure, thereby providing conditions for cell and tissue ingrowth and nutrient exchange; the porous content is in a three-dimensional geometric form, including at least one of a cylinder, a quadrilateral column, a hexagonal column and an anatomical form, but is not limited to the form;
the porous content 2 can be added with at least one of a bioactive substance such as bone morphogenetic protein, nerve growth factor, vascular endothelial growth factor, etc., cells such as osteoblast, chondrocyte, mesenchymal stem cell, green stem cell, etc., tissues such as autologous bone and cartilage tissue, allogenic bone and cartilage tissue, etc., but is not limited to the substance, improving the tissue regeneration ability of the bone repair member;
outer pipe 3: at least 1 porous content 2 with the diameter larger than or equal to 0.5 mm is communicated with the nutrition conveying device and the metal framework body, so as to provide a channel for nutrition conveying in the bone repairing structure device;
an inner pipeline: including two forms:
first internal pipe form: the porous content is granular, at least one built-in pipe 4 is arranged in the metal framework body 1, the built-in pipe 4 and the porous holes on the porous content 2 form an inner pipeline for conveying nutrient substances in the metal framework body 1, the diameter of the built-in pipe 4 is larger than or equal to 0.5 millimeter, the pipe wall of the built-in pipe is provided with at least one side hole 8 which is communicated with the porous structure of the porous content 2, and the aperture of the side hole 8 can ensure that the nutrient solution flows without limitation;
second innerduct form: the porous contents are module bodies, a plurality of mutually communicated nutrient solution flow holes 10 are formed in each porous content 2, each porous content 2 is mutually communicated through the nutrient solution flow holes 10 to form an inner pipeline, one end of the outer pipeline 3 is communicated with the nutrient solution flow hole 10 in one porous content 2, and the nutrient conveying device 7 conveys nutrient substances to the porous content 2 through the outer pipeline 3.
Nutrition delivery device 7: comprises a storage tank 701, a power device 702 and a plurality of pipelines;
storage tank 701: the nutrient solution storage device is used for storing nutrient solution and is communicated with the power device 702 and the porous content 2 through a pipeline, the capacity of the nutrient solution storage device is more than or equal to 50 milliliters, and the nutrient solution storage device can be made of materials such as silicone rubber, methyl vinyl silicone rubber, phenyl silicone rubber, fluorosilicone rubber and the like, wherein the silicone rubber comprises methyl silicone rubber, methyl vinyl silicone rubber, phenyl silicone rubber, fluorosilicone rubber and the like, the plastics such as polystyrene, polyethylene, polypropylene, polyvinyl chloride, polyamide, polyurethane, polymethyl methacrylate and the like, and the metals comprise gold, silver, alloys thereof, copper, alloys thereof, iron, alloys thereof, titanium, alloys thereof, tantalum, alloys thereof, aluminum, alloys thereof, magnesium, alloys thereof and the like.
The power device 702 is an intelligent power device and comprises a micro pump, a pressure sensor, a pH value sensor and a regulating and controlling device, so that the functions of timely and quantitatively conveying nutrition to the bone repair component and intelligent regulation and control are realized.
The micropump provides power for nutrient delivery, enabling uniform distribution and exchange of the nutrient solution within the bone repair member, ensuring survival and proliferation differentiation of cells and tissues, with an output of not less than 1 ml/hr, but not limited to only said output.
The intelligent power device is provided with at least one pressure sensor, can dynamically observe the tissue pressure in the bone repair component and at the implantation position, know the unobstructed condition of the pipeline system and intelligently adjust the output quantity of the micropump through the regulating and controlling device.
The intelligent power device is provided with at least one pH value sensor, can dynamically observe the pH value of tissues in the bone repair member and the implantation site, obtain the cell and tissue supply condition in the bone repair member, and intelligently adjust the output quantity of the micropump through the adjusting and controlling device.
The preparation of the in vivo functionalized bone repair member of the invention, as shown in fig. 5, comprises the steps of:
step S1, preparing a metal framework 1, an outer pipeline 3 and an inner pipeline: according to the imaging data of the affected part of the patient, a finite element analysis model is established, and the mechanical structure and material selection of the metal framework body, the outer pipeline and the inner pipeline are designed according to the topology mathematical principle, so that the metal framework body, the outer pipeline and the inner pipeline are manufactured;
step S2, preparation of porous content 2: designing porous contents and material selection according to the shape, size and structure of the metal framework in the step S1 and the requirements of the surface and the internal structure of the porous contents, and manufacturing the porous contents;
step S3, preparing a nutrition conveying device 7: the nutrition conveying device 7 consists of a storage tank 701, a pipeline and an intelligent power device 702, and is connected with an external conduit to provide conditions for storing, conveying and regulating the nutrition.
Step S4, assembling all the components and implanting the components into a host: the porous content 2 is arranged in the metal framework 1, the outer pipeline 3 and the inner pipeline 4 are implanted into a host through a surgical operation, the inner pipeline 4 is arranged in the metal framework 1, one end of the metal framework 1 is connected with a proximal host bone 14 through a fixing nail 15, the other end is also connected with a distal host bone 13 through a fixing nail 15, and the other end is connected with the nutrition conveying device 7 through the outer pipeline 3.
Step S5, operating the nutrition conveying device 7: after the storage tank 701 is filled with the nutrient solution, the power device 702 is started to perform in-vivo functional construction on the bone repair member, so that cells and tissues continuously obtain nutrition and oxygen supply to grow and differentiate, the supply amount of the nutrient solution is gradually reduced after the expected target is reached, the self-vascularization is promoted, finally the nutrient delivery device is removed, the metal framework and the porous content are reserved at the treatment position, the porous content is gradually replaced by new tissues, and the metal framework is embedded by the regenerated tissues, so that the clinical curative effect of the reinforced concrete bone is formed. Verification 1, verifying feasibility and practicality of the preparation method of the in-vivo functionalized bone repair member
The method for preparing the large-section bone repair component with the shape consistent with the shape of the lower 2/3 of the tibia and the length of 210 mm comprises the following steps:
step S1, preparing a metal framework body;
step S2, preparing porous content;
step S3, preparing a nutrition conveying device;
s4, assembling and implanting all parts;
and S5, operating the nutrition conveying device.
According to said step S1:
CT imaging data of a lesion part and contralateral healthy limbs of a patient are collected, a finite element analysis model is established, a main stress of the metal framework 1 is designed to be a compact structure by using a topology mathematical principle, and a non-bearing or secondary bearing area is designed to be a porous structure;
the metal framework 1 is prepared by adopting titanium alloy 3D printing, the shape and the size of the metal framework are consistent with those of the bone defect to be repaired, and 3 and 2 transverse opposite nailing holes, namely mounting holes 5 of the fixing nails 15, are respectively formed at the upper end and the lower end of the metal framework 1, so that the metal framework 1 and the host bone are connected and fixed through the fixing nails 15.
According to the step S2, the shape, the size and the structure of the metal framework body 1 are selected to meet the requirements of the surface and the internal structure of the porous content 2, the porous content 2 adopts degradable tricalcium phosphate powder as a raw material, tricalcium phosphate porous biological ceramic particles are prepared through a grouting forming method, the particle size is 3 mm to 5mm, the pore diameter is 500 micrometers to 600 micrometers, the porosity is 63%, the internal connecting diameter is 100 micrometers to 120 micrometers, and the ceramic particles are filled in the accommodating cavity of the metal framework body to form the granular porous content. And a silica gel pipeline with a pipe diameter of 5mm and a plurality of side holes is inserted into the center of the porous content to form an inner pipeline.
According to said step S3: the nutrition conveying device 7 is composed of a storage tank 701, a pipeline system and a power device 702, and provides conditions for storage, conveying and regulation of the nutrients, the storage tank 701 is used for storing the nutrient solution, the storage tank 701 is made of polymethyl methacrylate and comprises a liquid adding port 7011, a one-way pressure regulating valve 7012 and a one-way outlet 7013, the capacity of the storage tank is 500 milliliters, and the pipeline system comprises a conveying pipeline between the storage tank 701 and the power device 702, an inner pipeline and an outer pipeline, and lays a foundation for conveying the nutrition inside the bone repair member.
The power device 702 is an intelligent power device and comprises a micro pump, a pressure sensor, a pH value sensor and a regulating and controlling device, so that the functions of timely and quantitatively conveying nutrition to the bone prosthesis and intelligent regulation and control are realized;
the micropump provides power for nutrient delivery, so that the nutrient solution can be uniformly distributed and exchanged in the bone repair member, cell and tissue survival and proliferation differentiation are ensured, and the output quantity is 10 milliliters/hour;
at least one pH value sensor is arranged in the intelligent power device, the pH value of tissues in the bone repair member and the implantation position is dynamically observed, the cell and tissue supply condition in the bone repair member is known, and the output quantity of the micropump is intelligently regulated through the regulating and controlling device; throughout the nutrient input process, excess fluids and metabolites may be eliminated by self-absorption by the host tissue.
According to said step S4: after the porous content 2 is inserted into the metal frame body 1, it is surgically implanted into the treatment site of the patient, and then the nutrition delivery device 7 is installed so as to complete the corresponding conditions of the in-vivo functionalized bone repair member.
According to said step S5: after the storage tank 701 is filled with the nutrient solution, the micropump and the regulating device are started to perform in-vivo functional construction on the bone repair member, so that cells and tissues continuously obtain nutrition and oxygen supply to grow and differentiate, after the expected target is reached, the nutrient solution supply is gradually reduced to promote self vascularization, finally the nutrient delivery device 7 is removed, the metal framework 1 and the porous content 2 are reserved at the treatment part, and the metal framework 1 is filled with regenerated tissues to form the clinical curative effect of the reinforced concrete bone.
Verification 2: verification of the Effect of nutrient solution input on cell growth of the porous Contents of the invention
Preparing porous tricalcium phosphate bioceramics of hollow cylinder by adopting an organic template grouting sintering technology, namely preparing a porous content of a module, wherein the hollow cylinder is a nutrient solution flow hole, the component of the bioceramics is tricalcium phosphate with purity of 99%, the porosity is 75%, the pore diameter is 400-500 micrometers, the internal connection diameter is 100-150 micrometers, a plurality of nutrient solution flow holes are completely communicated and are opened to the outer surface of the porous content of the module, and a carrier for preparing the porous content is sterilized and disinfected at 220 ℃ for 120 minutes;
compounding sheep bone marrow stem cells into a carrier for preparing a porous content entirely through the hollow tube, and carrying out dynamic culture and static culture on the sheep bone marrow stem cells, wherein the dynamic culture group comprises 6 samples, and the porous content which is a compound cell is connected with the nutrition conveying device for continuous cell nutrient solution input; the static culture group is 6 samples, and the porous content of the composite cells is directly soaked in the same cell nutrient solution for culture, as shown in fig. 6 and 7;
observing daily consumption of glucose and cell activity, namely MTT colorimetric detection, and detecting expansion of stem cells in a carrier by using hard tissue sections after 2 and 4 weeks of culture;
the results show that: glucose daily consumption increases with prolonged culture time, and increases more rapidly 2 weeks before and 2 weeks after culture, with dynamic culture groups significantly larger than static culture groups (P < 05);
the cell activity is increased along with the extension of the culture time, the dynamic culture group is obviously higher than that of the static culture group, the cell activity is higher than that of the static culture group for 4 weeks (P < 05), the cell activity is not obviously changed (P > 05) in the static culture for 2 weeks and 4 weeks, under the dynamic perfusion culture, bone marrow stem cells can survive and proliferate in the center and the periphery of a large section of carrier, under the static culture, bone marrow stem cells can survive and proliferate only in the periphery of the carrier, the cell quantity is obviously less than that of the dynamic culture group, the cell occupation rate of the dynamic culture group for 4 weeks is obviously higher than that of the static culture group for 2 weeks (P < 05), and the cell occupation rate of the static culture group for 4 weeks and 2 weeks is not obviously changed (P > 05).
The above-mentioned research proves that the in vivo functionalized bone repair member technique of the invention can obviously increase the survival and proliferation of cells in the member and improve the repair capability of tissues and organs.
Verification 3, verifying the clinical application value and significance of the in-vivo functionalized bone repair member:
malignant osteosarcoma of the middle lower femur of a 9 year old boy must undergo tumor resection or amputation, otherwise the patient will be life threatening;
the tumor and the prevention area bone are resected through surgery, a large-section bone defect of 210 mm of the middle lower section of the left femur is formed, and the host bone and the joint surface are reserved at the two ends;
the prepared in-vivo functional bone repair component is embedded into a bone defect area; the mounting holes of the 3 fixing nails at the upper end of the metal framework body are transversely penetrated and fixed with the host bone reserved at the proximal end of the tibia, the mounting holes of the 2 fixing nails at the lower end of the metal framework body are transversely penetrated and fixed with the host bone reserved at the distal end of the tibia, so that the continuous reconstruction of an instant anatomical structure is realized, the mechanical support function is recovered, and the patient moves downwards after the operation for 1 week;
in order to ensure that tissue nutrition and rapid growth in the in-vivo functionalized bone repair member are ensured, 480 milliliters of cell culture solution with autologous serum is filled in the storage tank, the nutrition delivery device is started, the output of the culture solution is 10 milliliters/hour, the culture solution is maintained for 14 days, 480 milliliters of the culture solution is added every two days, 2 milliliters of the output is reduced every three days after 15 days after operation until the 30 th day is stopped to input the nutrition solution, the nutrition delivery device is removed, an X-ray film after 2 months shows that interfaces of host bones at two ends of a tibia and the bone repair member are completely integrated, new bone formation is visible in the porous content, and a patient completely resumes normal life after 6 months, and no complications occur in follow-up 3.5 years.
Through the three groups of verification, the in-vivo functional bone repair component can be completely used for treating large-section bone defects, and the feasibility and clinical effect are obvious.
The invention and its embodiments have been described above with no limitation, and the actual construction is not limited to the embodiments of the invention as shown in the drawings. In summary, if one of ordinary skill in the art is informed by this disclosure, a structural manner and an embodiment similar to the technical solution should not be creatively devised without departing from the gist of the present invention.
Claims (7)
1. An in vivo functionalized bone repair member, characterized by: including metal framework body, porous content, outer pipeline and nutrition conveyor, the both ends of metal framework body are equipped with a plurality of mounting holes respectively, be equipped with the holding chamber of placing porous content in the metal framework body, outer pipeline one end and holding the chamber intercommunication, the other end is at the external nutrition conveyor of connecting, nutrition conveyor passes through outer pipeline to holding the porous content in the intracavity and carry nutrition.
2. An in vivo functionalized bone repair member according to claim 1 wherein: the porous content is granular with a porous structure;
the nutrition conveying device conveys nutrition substances into the accommodating cavity through the outer pipeline and the built-in pipe, the nutrition substances flow in the porous structure of the porous content, and the built-in pipe and the porous on the porous content form an inner pipeline for conveying the nutrition substances in the metal framework.
3. An in vivo functionalized bone repair member according to claim 1 wherein: the nutrient solution conveying device comprises a plurality of porous contents, wherein each porous content is a module body, a plurality of mutually communicated nutrient solution flow holes are formed in each porous content, the porous contents are mutually communicated through the nutrient solution flow holes to form an inner pipeline, one end of each outer pipeline is communicated with one of the nutrient solution flow holes in the porous contents, and the nutrient conveying device conveys nutrient substances to the porous contents through the outer pipeline.
4. An in vivo functionalized bone repair member according to claim 1 wherein: the metal framework body is provided with a plurality of through holes for communicating the accommodating cavity with the outside.
5. An in vivo functionalized bone repair member according to claim 1 wherein: the nutrition conveying device comprises a storage tank for storing the nutrition liquid and a power device, wherein the storage tank is connected with the outer pipeline, and the power device is arranged on the pipeline between the storage tank and the outer pipeline.
6. An in vivo functionalized bone repair member according to claim 5 wherein: the storage tank has a capacity of 500 ml.
7. A method of preparing an in vivo functionalized bone repair member according to any one of claims 1-7 comprising the steps of:
step S1, preparing a metal framework body, an outer pipeline and an inner pipeline: according to the imaging data of the affected part of the patient, a finite element analysis model is established, and the mechanical structure and material selection of the metal framework body, the outer pipeline and the inner pipeline are designed according to the topology mathematical principle, so that the metal framework body, the outer pipeline and the inner pipeline are manufactured;
step S2, preparation of porous content: designing porous contents and material selection according to the shape, size and structure of the metal framework in the step S1 and the requirements of the surface and the internal structure of the porous contents, and manufacturing the porous contents;
step S3, preparing a nutrition conveying device: the nutrition conveying device consists of a storage tank, a pipeline and an intelligent power device, and is connected with the outer pipeline to provide conditions for storing, conveying and regulating and controlling the nutrition.
Step S4, assembling all the components and implanting the components into a host: the method comprises the steps that porous contents are arranged in a metal framework, the metal framework, an outer pipeline and an inner pipeline are implanted into a host through surgical operation, the inner pipeline is arranged in the metal framework, one end of the metal framework is fixedly connected with a proximal host bone through a fixing nail, the other end of the metal framework is also fixedly connected with a distal host bone through a fixing nail, the metal framework is connected with a nutrition conveying device through the outer pipeline, and host tissues covered outside through holes in the metal framework can absorb excessive liquid and metabolites or can be directly discharged out of the body through a drainage tube;
step S5, operating the nutrition conveying device: the storage tank is filled with nutrient solution, the power device is started, the bone repair member is constructed in an in-vivo functional way, so that cells and tissues continuously obtain nutrition and oxygen supply to grow and differentiate, the nutrient solution supply is gradually reduced after the expected target is reached, the self vascularization is promoted, finally the nutrient delivery device is removed, the metal framework and the porous content are reserved at the treatment position, the porous content is gradually replaced by new tissues, and the metal framework is embedded by the regenerated tissues, so that the reinforced concrete bone clinical curative effect is formed.
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