CN109223248B - Skull prosthesis for inducing bone tissue regeneration and preparation method thereof - Google Patents
Skull prosthesis for inducing bone tissue regeneration and preparation method thereof Download PDFInfo
- Publication number
- CN109223248B CN109223248B CN201811443770.8A CN201811443770A CN109223248B CN 109223248 B CN109223248 B CN 109223248B CN 201811443770 A CN201811443770 A CN 201811443770A CN 109223248 B CN109223248 B CN 109223248B
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- skull
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- prosthesis
- supporting layer
- curved surface
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- 230000017423 tissue regeneration Effects 0.000 title claims abstract description 21
- 238000002360 preparation method Methods 0.000 title claims abstract description 12
- 230000008093 supporting effect Effects 0.000 claims abstract description 99
- 230000006698 induction Effects 0.000 claims abstract description 76
- 239000000463 material Substances 0.000 claims abstract description 44
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- 230000008439 repair process Effects 0.000 claims description 31
- 238000004088 simulation Methods 0.000 claims description 24
- 238000000034 method Methods 0.000 claims description 14
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- 239000001506 calcium phosphate Substances 0.000 claims description 3
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- 238000001035 drying Methods 0.000 claims description 3
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- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 claims description 3
- 229920001652 poly(etherketoneketone) Polymers 0.000 claims description 3
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- 239000004626 polylactic acid Substances 0.000 claims description 3
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims description 3
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- GRYLNZFGIOXLOG-UHFFFAOYSA-N Nitric acid Chemical compound O[N+]([O-])=O GRYLNZFGIOXLOG-UHFFFAOYSA-N 0.000 description 1
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- JUPQTSLXMOCDHR-UHFFFAOYSA-N benzene-1,4-diol;bis(4-fluorophenyl)methanone Chemical compound OC1=CC=C(O)C=C1.C1=CC(F)=CC=C1C(=O)C1=CC=C(F)C=C1 JUPQTSLXMOCDHR-UHFFFAOYSA-N 0.000 description 1
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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
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- 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
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- 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
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
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- 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
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- 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
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
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- A61F2002/30948—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
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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
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
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Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Veterinary Medicine (AREA)
- Biomedical Technology (AREA)
- Public Health (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Cardiology (AREA)
- General Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Neurosurgery (AREA)
- Physics & Mathematics (AREA)
- Geometry (AREA)
- Manufacturing & Machinery (AREA)
- Prostheses (AREA)
Abstract
The invention relates to the technical field of medical equipment, in particular to a skull restoration body for inducing bone tissue regeneration and a preparation method thereof, wherein the skull restoration body has bioactivity and sequentially comprises an inner induction layer, a support layer and an outer induction layer from inside to outside; the supporting layer is made of polyaryletherketone materials with the intensity, hardness and weight equivalent to those of the human bone, and plays a role in supporting; the inner induction layer and the outer induction layer are made of bioactive materials and are respectively arranged on the inner surface and the outer surface of the supporting layer, so that the composite material has good bioactivity and osteoinductive property and can induce bone tissue regeneration; the supporting layer is provided with a plurality of grid holes, and bioactive materials are filled in each grid hole, so that the exchange of internal and external nutrient substances of the skull restoration can be promoted, and the growth of tissues is facilitated. The preparation method of the skull prosthesis establishes a digital model according to skull data of a patient, so that the skull prosthesis has higher matching degree with the skull defect part, and the operation difficulty during operation is reduced.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a skull prosthesis for inducing bone tissue regeneration and a preparation method thereof.
Background
When a patient performs craniotomy due to brain trauma or intracranial diseases, skull defects are usually caused, the brain tissues lose protective barriers due to the skull defects, the brain tissues are easy to be injured, symptoms such as dizziness, headache, depression, irritability, dysphoria and the like are more accompanied when the defects are larger, the appearance is influenced, and the psychological damage of the patient is caused. The skull defect area can be repaired by means of skull repair operation and skull repair body, thereby realizing the purposes of protecting brain tissue, reducing complications and restoring the appearance of a patient.
At present, materials used for manufacturing the skull prosthesis mainly comprise two main types of natural biological materials and artificial synthetic materials. Natural biological materials mainly originate from autologous bones, allogeneic bones and xenogeneic bones, have limited materials, and have the risks of immune rejection, infection and the like, so that the natural biological materials are limited to filling type implantation of skull small-area defects. Synthetic materials can be classified into metallic materials and nonmetallic materials. Metallic materials include tantalum, titanium alloys, or stainless steel, etc., which are repaired as permanent implants, and long term foreign body irritation can cause complications and can easily lead to malformed growth of new bone. The nonmetallic materials comprise organic glass, bone cement, composite materials thereof and the like, the bone cement stimulates brain tissues, the bone cement is easy to deform and loose after operation, and the organic glass has the advantages of small strength, fragility, easy aging and poor tissue compatibility. Chinese patent CN102490350a discloses a solution using PEEK as a skull repair material, which has good biocompatibility and excellent mechanical properties, but is a bio-inert material, which is unfavorable for the adhesion growth of cell tissues, affecting wound healing.
Disclosure of Invention
The invention aims to provide a skull prosthesis with high mechanical strength and biocompatibility and favorable for inducing bone tissue regeneration in a defect area and a preparation method thereof.
In order to achieve the above object, the present invention provides a skull prosthesis for inducing bone tissue regeneration, comprising an inner induction layer, a support layer and an outer induction layer in this order from inside to outside;
the supporting layer is made of polyaryletherketone materials, is in a grid-shaped structure, is provided with a plurality of grid holes, and each grid hole is communicated with the inner surface and the outer surface of the supporting layer and is filled with bioactive materials;
the inner induction layer and the outer induction layer are made of bioactive materials and are respectively arranged on the inner surface and the outer surface of the supporting layer.
Preferably, at the edge of the skull prosthesis, the inner inducing layer and the outer inducing layer both extend outwardly beyond the support layer.
Preferably, the distance of the inner inducing layer beyond the supporting layer is not more than 2mm; the distance of the outer induction layer beyond the supporting layer is not less than 5mm.
Preferably, the thickness of the skull prosthesis ranges from 3mm to 12mm, the thickness of the supporting layer ranges from 1mm to 4mm, and the thickness of the inner induction layer and the thickness of the outer induction layer range from 1mm to 4mm.
Preferably, the grid holes are uniformly distributed, the width of each grid hole ranges from 0.5 mm to 2mm, and the distance between two adjacent grid holes ranges from 2mm to 3mm.
Preferably, the polyaryletherketone material is any one or a mixture of at least two of polyetheretherketone, polyetherketoneketone and polyetheretherketone.
Preferably, the bioactive material is any one or a mixture of at least two of mineralized collagen, hydroxyapatite, calcium phosphate, collagen, polylactic acid, polycaprolactone or polylactide.
The invention also provides a preparation method of the skull prosthesis according to the first aspect, which comprises the following steps:
s1, acquiring skull data of a patient;
s2, performing three-dimensional reconstruction by using the obtained skull data, and extracting a digital model of the skull prosthesis and the supporting layer according to the skull defect part;
s3, printing the supporting layer of the skull prosthesis by taking polyaryletherketone powder as a raw material by adopting a selective laser sintering 3D printing technology according to a digital model of the supporting layer;
s4, manufacturing an upper die and a lower die of the skull prosthesis according to the digital model of the skull prosthesis;
s5, preparing colloid or emulsion bioactive materials;
s6, embedding the support layer printed in the step S3 into the bioactive material prepared in the step S5 by using the upper die and the lower die prepared in the step S4, so as to prepare the skull prosthesis.
Preferably, the step S2 includes:
s2-1, importing the skull data obtained in the step S1 into medical reverse software, segmenting bones and soft tissues by using threshold values, extracting bone regions of the skull, removing bone tissues which are not connected with the skull of the main body through region growing operation, and completing three-dimensional model reconstruction of the skull;
s2-2, importing a three-dimensional model of the skull into reverse engineering software, extracting a contour line in the middle of the bone edge of the damaged part of the skull as a contour line of the supporting layer, repairing to obtain an upper curved surface and a lower curved surface of the supporting layer, and stitching to obtain a simulation image of the supporting layer;
s2-3, drawing a plurality of grid holes communicated with the upper curved surface and the lower curved surface of the supporting layer in the simulated image of the supporting layer to obtain a preliminary simulation body of the supporting layer with a grid structure;
s2-4, extracting a three-dimensional image of the repaired damaged part as a skull simulated repair body image according to the three-dimensional model of the skull;
s2-5, introducing the support layer preliminary simulation body obtained in the step S2-3 into the skull simulation prosthesis image obtained in the step S2-4, overlapping the support layer preliminary simulation body and the skull simulation prosthesis image, and storing a curved surface model of the support layer and the skull prosthesis;
s2-6, importing the curved surface model obtained in the step S2-5 into digital model engraving software, and referring to the skull shape of the mirror image position of the damaged part, adjusting the internal repair curved surface and the external repair curved surface of the skull prosthesis to enable the skull shape of the damaged part and the mirror image position of the damaged part to be consistent;
adjusting the curvature of the supporting layer to be consistent with the curvature of the skull restoration, so that the supporting layer is positioned at the middle position of the skull restoration;
stitching the upper and lower curved surfaces of the support layer into a closed entity to obtain a digital model of the support layer; and sewing the inner repairing curved surface and the outer repairing curved surface of the skull repairing body into a closed entity to obtain a digital model of the skull repairing body.
Preferably, the method further comprises:
s7, trimming the step S6 to obtain the skull prosthesis, so that the outline of the supporting layer of the skull prosthesis is matched with the bone edge of the damaged area of the skull, and the inner induction layer and the outer induction layer both exceed the supporting layer.
The technical scheme of the invention has the following advantages: the invention provides a skull restoration body with a bone tissue regeneration induction function, which has a three-layer structure, comprises an inner induction layer, a support layer and an outer induction layer, has higher bioactivity and good biocompatibility with the inner induction layer and the outer induction layer of the contact part of the dura mater and the skin of a patient, and can promote and induce the regeneration of bone tissue. With the gradual degradation of the inner and outer induction layers, raw materials and creeping structures can be provided for the regeneration of bone tissues, and new bones grow along the inner and outer induction layers and gradually replace the inner and outer induction layers. The supporting layer in the middle of the skull restoration is made of polyaryletherketone materials, has the same strength, hardness and weight as those of human bones, has good biocompatibility, and can provide mechanical supporting effect for the skull restoration all the time while the bioactive materials induce the regeneration of new bones, so as to continuously maintain the mechanical strength and protect brain tissues from being damaged by external force. The supporting layer is of a grid structure, a plurality of grid holes are formed in the supporting layer, bone induction layer substances are filled in the grid holes, exchange of nutrient substances inside and outside the supporting layer can be promoted, and tissue ingrowth is facilitated.
The invention also provides a preparation method of the skull prosthesis for inducing bone tissue regeneration, which comprises the steps of establishing a digital model according to skull data of a patient, taking polyaryletherketone powder as a raw material, printing to obtain a supporting layer of the skull prosthesis, manufacturing a mould, embedding the supporting layer in a bioactive material, and performing mould filling and compression moulding to obtain the skull prosthesis, wherein the obtained skull prosthesis has higher matching degree with the bone edge of the skull defect part of the patient, and reduces operation difficulty during operation.
Drawings
FIG. 1 is a schematic longitudinal section of a skull prosthesis for inducing bone tissue regeneration according to the first embodiment of the present invention;
FIG. 2 is a schematic diagram of a grid-like structure of a supporting layer according to an embodiment of the present invention;
FIG. 3 is a flowchart showing a method for preparing a skull prosthesis for inducing bone tissue regeneration in the second embodiment of the present invention.
In the figure: 1: an inner induction layer; 11: repairing the curved surface internally; 2: a support layer; 21: grid holes; 3: an outer induction layer; 31: and (5) externally repairing the curved surface.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments of the present invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Example 1
As shown in fig. 1, a first embodiment of the present invention provides a skull prosthesis for inducing bone tissue regeneration, comprising a three-layer structure, which comprises an inner induction layer 1, a support layer 2 and an outer induction layer 3 from inside to outside. Wherein, the supporting layer 2 is made of polyaryletherketone material with mechanical strength equivalent to skull, as shown in fig. 2, the supporting layer 2 is in a grid structure and has a plurality of grid holes 21. Each mesh hole 21 is communicated with the inner surface and the outer surface of the supporting layer, and each mesh hole 21 is filled with a bioactive material capable of inducing bone tissue growth. The inner induction layer 1 and the outer induction layer 3 are made of bioactive materials capable of inducing bone tissue growth, and are respectively arranged on the inner surface and the outer surface of the support layer 2.
The skull prosthesis for the skull prosthesis in the prior art generally has the problems of insufficient mechanical strength, poor biocompatibility or adverse cell tissue adhesion growth. The invention provides a skull repairing body for inducing bone tissue regeneration, which adopts a three-layer structure, wherein the inner induction layer 1 and the outer induction layer 3 at the contact part of the skull and the skin of a patient are both bioactive materials with higher bioactivity and good biocompatibility, and can promote and induce the bone tissue regeneration. The supporting layer 2 with the mechanical supporting function in the middle is made of polyaryletherketone material, and is equivalent to the strength, the hardness and the weight of human bones. After the skull prosthesis is put into the defect part of the skull of a patient, the inner induction layer 1 and the outer induction layer 3 are gradually degraded and promote the growth of human tissues, the bioactive materials are replaced, the supporting layer 2 does not participate in degradation, the mechanical strength of the skull of the patient is continuously maintained all the time in the replacement process, and the brain tissues are protected from being damaged by external force. Meanwhile, the supporting layer 2 is provided with a plurality of grid holes 21, and bone induction layer substances are filled in each grid hole 21, so that the exchange of nutrient substances inside and outside the supporting layer 2 can be promoted, the growth of tissues is facilitated, and the wound healing of a patient is promoted.
Preferably, at the edges of the cranial prosthesis, both the inner and outer guiding layers 1, 3 extend outwards beyond the supporting layer 2, where "outwards" means away from the centre of each surface of each layer structure itself. As shown in fig. 1, the inner induction layer 1 and the outer induction layer 3 are both larger than the support layer 2, the upper surface of the inner induction layer 1 is larger than the lower surface of the support layer 2, the lower surface of the outer induction layer 3 is larger than the upper surface of the support layer 2, and expands outwards along the curved surface where the lower surface of the support layer 2 is located. The projection of the circumferential edges of the inner induction layer 1 and the outer induction layer 3 on the curved surface where the circumferential edges of the support layer 2 are located falls outside the circumferential edges of the support layer 2, that is, the upper surface contour line of the inner induction layer 1 surrounds outside the lower surface contour line of the support layer 2, and the lower surface contour line of the outer induction layer 3 surrounds outside the upper surface contour line of the support layer 2.
As can be seen from fig. 1, the edge of the skull prosthesis for inducing bone tissue regeneration is a U-shaped groove, which can be clamped at the bone edge of the damaged portion, thereby helping to fix the skull prosthesis, avoiding the movement and dislocation of the skull prosthesis, and enabling the supporting layer 2 to be in close contact with the bone edge of the damaged portion of the skull so as to better support the skull.
Further preferably, the distance between the inner induction layer 1 and the supporting layer 2 is not more than 2mm, i.e. the length of the part of the inner induction layer 1 larger than the supporting layer 2 is not more than 2mm, i.e. the distance between the upper surface contour line of the inner induction layer 1 and the lower surface contour line of the supporting layer 2 is not more than 2mm, so that the skull repairing body is prevented from being incapable of being smoothly clamped into a damaged part; the distance between the outer induction layer 3 and the supporting layer 2 is not less than 5mm, namely, the distance between the lower surface contour line of the outer induction layer 3 and the upper surface contour line of the supporting layer 2 is not less than 5mm, so that holes can be formed in the part of the outer induction layer 3, which exceeds the supporting layer 2, during installation, fixing nails are installed, penetrate through the outer induction layer 3 and are fixed on the bone edge of the skull of a patient, the position of the skull prosthesis is further fixed, and relative movement between the skull prosthesis and the skull of the patient is avoided, so that friction damage is caused to tissues.
Preferably, in order to obtain a better repairing effect and to ensure sufficient mechanical strength of the skull restoration, the thickness of the skull restoration ranges from 3mm to 12mm, the thickness of the supporting layer 2 ranges from 1mm to 4mm, and the thickness of the inner inducing layer 1 and the outer inducing layer 3 respectively arranged inside and outside the supporting layer 2 ranges from 1mm to 4mm.
Preferably, the individual mesh holes 21 provided on the support layer 2 are uniformly distributed in an array, the width of a single mesh hole ranges from 0.5 to 2mm, the spacing between two adjacent mesh holes 21 ranges from 2 to 3mm, and the spacing refers to the minimum distance between two adjacent mesh holes 21, i.e. the distance between two adjacent sides. Each mesh hole 21 is preferably square, and promotes the exchange of nutrients inside and outside the support layer 2 uniformly while securing the mechanical strength of the skull restoration.
Preferably, the polyaryletherketone material of the support layer 2 is any one or a mixture of at least two of polyetheretherketone, polyetherketoneketone and polyetheretherketone.
Preferably, the inner and outer induction layers 1 and 3 are made, and the bioactive material filled in each mesh hole 21 is any one or a mixture of at least two of mineralized collagen, hydroxyapatite, calcium phosphate, collagen, polylactic acid, polycaprolactone, or polylactide.
Preferably, the skull repairing body is manufactured according to the skull defect part of a patient, the upper surface of the outer induction layer 3 is an external repairing curved surface 31, the lower surface of the inner induction layer 1 is an internal repairing curved surface 11, and the whole skull repairing body is matched with the skull defect part of the patient.
Example two
As shown in fig. 3, the second embodiment of the present invention provides a method for preparing a skull prosthesis for inducing bone tissue regeneration, which is used for preparing the skull prosthesis for inducing bone tissue regeneration described in the above embodiment, and includes the following steps:
s1, acquiring skull data of a patient;
s2, performing three-dimensional reconstruction by using the obtained skull data, and extracting a skull prosthesis and a digital model of the supporting layer 2 according to the skull defect part; the skull-prosthesis digital model here is a skull-prosthesis whole digital model comprising a support layer 2;
s3, printing the supporting layer 2 of the skull prosthesis by taking polyaryletherketone powder as a raw material by adopting a selective laser sintering 3D printing technology according to a digital model of the supporting layer 2;
s4, manufacturing an upper die and a lower die of the skull prosthesis according to the digital model of the skull prosthesis;
s5, preparing colloid or emulsion bioactive materials;
s6, embedding the support layer 2 printed in the step S3 into the bioactive material prepared in the step S5 by using the upper die and the lower die prepared in the step S4 to prepare the skull restoration.
The preparation method of the skull restoration for inducing bone tissue regeneration provided by the invention acquires the skull data of a patient, so that a digital model is built, and the skull restoration which is matched with the skull defect of the patient is further obtained, and the prepared skull restoration is not only beneficial to inducing bone tissue regeneration, but also has higher matching degree with the bone edge of the skull defect part, and reduces the operation difficulty of skull restoration operation.
Preferably, the method for acquiring skull data of the patient in step S1 is one or more of computed tomography, magnetic resonance imaging, X-ray imaging, B-ultrasonic imaging, and electronic imaging. The acquired data may be recorded on an optical disc or other storable device in DICOM format.
Preferably, in step S2, when extracting the digital model of the skull prosthesis and the supporting layer 2 according to the skull defect site, the method specifically comprises the following steps:
s2-1, importing the skull data obtained in the step S1 into medical reverse software, segmenting bones and soft tissues by using threshold values, extracting bone regions of the skull, removing bone tissues which are not connected with the skull of the main body through region growing operation, and completing three-dimensional model reconstruction of the skull.
Preferably, the medical inverse software used in this step may be a chemicals software or other type of software, such as 3D-sector, 3D-Med or 3D Slicer.
Taking the Mimics software as an example, importing the skull data in the DICOM format by using the Mimics software, and dividing bones and soft tissues into bright and dark two types by using a threshold value T to realize the binarization segmentation of images so as to extract bone parts; and (3) obtaining a gradient threshold G according to gradient information of the image, extracting the outline of the tissue, selecting a required skull bone region as a seed region at a determined level, clicking an automatic region growth command, automatically completing three-dimensional model reconstruction of the skull, and outputting a data file in an STL format.
S2-2, importing the three-dimensional model of the skull into reverse engineering software, extracting the contour line of the middle part of the bone edge of the damaged part of the skull as the contour line of the supporting layer 2, repairing to obtain the upper and lower curved surfaces of the supporting layer 2, and stitching to obtain the simulation image of the supporting layer 2.
Preferably, the reverse engineering software applied in this step includes one or more of Imageware, geomatic Studio, copyCAD and RapidForm.
Taking Imageware as an example, importing the three-dimensional model of the skull (STL format data) obtained in the step S2-1 into Imageware software, extracting the contour line in the middle of the bone edge of the damaged skull by a method of commanding point cloud intersection, B-spline and fitting point cloud, namely, the contour line of the supporting layer 2, and storing the contour line as an IMW format.
And importing the obtained IMW format data into UG, repairing the upper and lower curved surfaces of the support layer 2 by using functions such as a grid curve and the like through designing an arc line, and sewing the repaired curved surfaces to obtain a simulation image of the support layer 2.
S2-3, drawing a plurality of grid holes 21 communicated with the upper curved surface and the lower curved surface of the support layer in the simulation image of the support layer 2, and obtaining a preliminary simulation body of the support layer 2 with a grid structure.
In this step, the supporting layer 2 is edited into a grid structure, preferably, squares or rectangles with the width range of 0.5-2mm are drawn on the projection plane of the supporting layer 2, the spacing range of a plurality of squares or rectangles is 2-3mm through a line array, grid holes 21 are formed on the supporting layer 2 through stretching, boolean subtracting and other operations, the grid holes 21 are uniformly distributed in an array form, the width range of a single grid hole 21 is 0.5-2mm, the spacing range of two adjacent grid holes is 2-3mm, a preliminary simulation body of the supporting layer 2 is obtained, and the preliminary simulation body is stored into an STL format.
S2-4, extracting a three-dimensional image of the repaired damaged part according to the three-dimensional model of the skull to serve as a skull simulation repair body image.
Preferably, the three-dimensional model of the skull obtained in the step S2-1 (STL format data) is used for removing noise points, the outline of the skull at the damaged part is extracted by removing point clouds or boundary curves, the hole is repaired by selecting a curvature repairing method through a hole repairing function, and a three-dimensional image of the repaired part is extracted, so that a simulated skull repairing body image, namely a whole skull repairing body image, can be obtained.
S2-5, introducing the preliminary simulation body of the support layer 2 obtained in the step S2-3 into the skull simulation repair body image obtained in the step S2-4 so that the preliminary simulation body and the skull simulation repair body are overlapped, and storing the curved surface models of the support layer 2 and the skull repair body.
Preferably, the (STL format data) support layer 2 preliminary simulator file obtained in step S2-3 is imported into the skull simulated repair image obtained in step S2-4, the support layer 2 preliminary simulator is made to coincide with the skull simulated repair image by operations such as feature points, alignment, etc., other images in the support layer 2 preliminary simulator file except for the support layer 2 preliminary simulator are deleted, the support layer 2 image (upper and lower curved surfaces of the support layer 2), the skull simulated repair image (outer repair curved surface 31 and inner repair curved surface 11 of the skull prosthesis, i.e., upper and lower curved surfaces of the skull prosthesis), and the original skull defect image are saved together into OBJ format, so that the detail adjustment of the next step is facilitated.
S2-6, importing the curved surface model obtained in the step S2-5 into digital model engraving software, and referring to the skull shape of the mirror image position of the damaged part, adjusting the internal repair curved surface 11 and the external repair curved surface 31 of the skull prosthesis to enable the skull shape of the damaged part and the mirror image position thereof to be consistent; the curvature of the supporting layer 2 is adjusted to be consistent with the curvature of the skull restoration, namely, the curvature of the upper (lower) curved surface of the supporting layer is adjusted to be consistent with the curvature of the external (internal) restoration curved surface of the skull restoration, so that the supporting layer 2 is positioned at the middle position of the skull restoration. And sewing the curved surface of the support layer 2 into a closed entity to obtain the digital model of the support layer 2. The inner repair surface 11 and the outer repair surface 31 of the skull prosthesis are stitched into a closed entity, thus obtaining a digital model of the skull prosthesis.
Preferably, the digital model engraving software in this step is ZBrush software, and refers to the skull form of the mirror image position in the original skull defect image in the surface model file in OBJ format, and the external repair surface 31 and the internal repair surface 11 of the skull prosthesis are adjusted by different operation brushes, so that the surfaces of the external repair surface 31 and the internal repair surface 11 are smoothly transited and are consistent with the skull form of the mirror image position.
The curvature of the supporting layer 2 is consistent with the curvature of the skull restoration through the commands of protruding pulling or recessing, and the supporting layer 2 is positioned at the middle position of the skull restoration. The new data size is exported to the STL format by modifying the size unit command to change the unit inch to mm, refreshing the data size ratio.
And importing the derived STL format into Geomagic Studio software, selecting the skull prosthesis and the supporting layer 2, and deleting other images. Selecting the image of the supporting layer 2, deleting the image of the skull prosthesis, sewing the upper and lower curved surfaces of the supporting layer 2 into a closed entity, and exporting the closed entity into an STL format to obtain a digital model of the supporting layer 2.
Selecting the skull restoration, deleting the supporting layer 2, and repairing the internal restoration curved surface 11 and the external restoration curved surface 31 of the skull restoration into a whole through the hole repairing function to obtain a digital model of the skull restoration.
Preferably, in the step S3, the STL format support layer 2 digital model obtained in the step S2-6 is led into a selective laser sintering 3D printer, and the support layer 2 in the skull restoration is obtained by printing the implantation-level polyaryletherketone powder serving as a raw material.
Preferably, in step S4, when the upper mold and the lower mold of the skull prosthesis are manufactured according to the digital model of the skull prosthesis, the digital model of the skull prosthesis obtained in step S2-6 is subjected to mold turning operations such as segmentation, whole deviation, extension, boolean subtraction, accurate curved surface and the like to obtain the upper mold data and the lower mold data of the whole skull prosthesis, and the IGS format is derived.
And according to the obtained IGS format data, manufacturing the upper die and the lower die of the solid skull prosthesis by one or more of machining, casting, die stamping, chemical method, electrolytic machining or model comparison and bench work knocking. Preferably, the upper surface of the upper mold is planar and the lower surface is identical to the outer prosthetic curve 31 of the cranial prosthesis. The upper surface of the lower die is the same as the inner repair curved surface 11 of the skull prosthesis, the lower surface is a plane and is parallel to the upper surface of the lower die, so that the compression die is convenient. And the contact surfaces of the upper die and the lower die are required to be completely matched, so that a closed cavity is formed after pressurization without flash.
Preferably, in the preparation of the colloid or emulsion bioactive material in step S5, the mineralized collagen colloid may be prepared by the following method:
s5-1, dissolving collagen in any one of hydrochloric acid, nitric acid or acetic acid to prepare collagen acid solution with collagen concentration of 5.0X10 -5 -5.0×10 -3 g/ml。
S5-2, adding the solution containing calcium ions into the collagen acid solution obtained in the step 4.1, wherein the addition amount of the calcium ions is 0.01-0.16mol of calcium ions corresponding to each gram of collagen.
S5-3, continuously stirring the solution obtained in the step S5-2, slowly adding the solution containing phosphate ions, wherein the molar ratio of the adding amount of the phosphate ions to the adding amount of the calcium ions in the step S5-2 is Ca/P=1/1-2/1.
S5-4, continuously stirring the solution obtained in the step S5-3, and slowly dropwise adding NaOH solution until the pH value of the solution is=6-8, so as to form a white suspension mixed system.
S5-5, standing the mixed system obtained in the step S5-4 for 24-120h, separating precipitate, washing impurity ions, and concentrating the mixed system to obtain mineralized collagen colloid.
Preferably, step S6 includes: pouring 1-3mm high colloid or emulsion bioactive materials into the lower mould prepared in the step S4, putting the lower mould into a freeze dryer, freezing for 0.5h at-20 ℃, taking out the frozen lower mould, putting the support layer 2 printed in the step S3 into the lower mould, adjusting the position, adding the same colloid or emulsion bioactive materials again, filling the same colloid or emulsion bioactive materials into the grid holes 21 of the support layer 2, covering the upper mould, putting the covered upper and lower moulds into the freeze dryer, freezing for 5h at-20 ℃ integrally, taking out the upper mould, vacuumizing, freeze drying until the weight is not changed any more, and removing the lower mould after drying to obtain the skull prosthesis.
Preferably, the skull repair preparation method further comprises: s7, trimming the step S6 to obtain the skull restoration, so that the outline of the supporting layer 2 of the skull restoration is matched with the bone edge of the damaged area of the skull, and the inner induction layer 1 and the outer induction layer 3 both exceed the supporting layer 2, namely, the circumferential edge of the skull restoration is a U-shaped groove. It is further preferable that the distance of the inner induction layer 1 beyond the support layer 2 is not more than 2mm, and the distance of the outer induction layer 3 beyond the support layer 2 is not less than 5mm.
In the embodiment, firstly, a skull restoration with the peripheral edge exceeding the damaged part of the skull is obtained by demoulding through a mould, and then the skull restoration which is matched with the damaged part of the skull of a patient is obtained by trimming in the step S7. The in-vivo induction layer 1 and the in-vitro induction layer 3 of the trimmed skull restoration exceed the support layer 2, the outline of the support layer 2 of the skull restoration is matched with the bone edge of the damaged area of the skull, as shown in figure 1, the skull restoration is circumferentially provided with U-shaped grooves, and the U-shaped grooves can be clamped into the defects of the skull when in use, so that the skull restoration is not easy to move, the tissues are prevented from being scratched, meanwhile, the outline of the support layer 2 of the skull restoration is matched with the bone edge of the damaged area of the skull, the skull can be better supported, the mechanical strength is maintained in the process of inducing the growth of the bone tissues, and the effect of protecting the brain tissues is achieved.
In order to obtain a skull prosthesis with a circumferential edge beyond the extent of the fracture of the skull of the patient before the trimming in step S7, a preferred embodiment is: when the upper die and the lower die of the skull restoration are manufactured in the step S4, the peripheral edge of the whole skull restoration is expanded outwards according to the digital model of the skull restoration, so that the peripheral outline of the skull restoration manufactured by the upper die and the lower die of the skull restoration is larger than the actual requirement. At the time of the modification in step S7, the inner and outer induction layers 1 and 3 may be modified along the circumferential direction of the skull restoration, and the support layer 2 embedded in the bioactive material may be exposed.
Another preferred embodiment is: when the digital model of the skull prosthesis is extracted in the step S2, preferably, after the supporting layer 2 is adjusted in the step S2-6, the corresponding areas of the internal induction layer 1 and the external induction layer 3 of the skull prosthesis are expanded outwards, so as to obtain the digital model of the skull prosthesis with the internal induction layer 1 and the external induction layer 3 exceeding the supporting layer 2. When the corresponding upper mold and lower mold are obtained in step S4, the thickness of the lower mold preferably exceeds the thickness of the inner induction layer 1. In step S6, when demoulding, the areas corresponding to the outlines of the inner induction layer 1 and the supporting layer 2 in the lower mould have step change, and the bioactive materials are filled according to the outline change condition of the skull restoration in the lower mould, so that the skull restoration with the inner induction layer 1 and the outer induction layer 3 exceeding the supporting layer 2 is directly manufactured. During the correction in the step S7, polishing and small-range trimming adjustment can be performed along the circumferential direction of the skull restoration to obtain the final skull restoration.
Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present invention, and are not limiting; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit and scope of the technical solutions of the embodiments of the present invention.
Claims (3)
1. A method for preparing a skull repair body for inducing bone tissue regeneration, which is characterized by comprising the following steps:
the skull prosthesis is used for preparing a skull prosthesis for inducing bone tissue regeneration, and comprises an inner induction layer, a support layer and an outer induction layer from inside to outside in sequence;
the supporting layer is made of polyaryletherketone materials, is in a grid-shaped structure, is provided with a plurality of grid holes, and each grid hole is communicated with the inner surface and the outer surface of the supporting layer and is filled with bioactive materials;
the inner induction layer and the outer induction layer are made of bioactive materials and are respectively arranged on the inner surface and the outer surface of the supporting layer; at the edge of the skull prosthesis, the inner inducing layer and the outer inducing layer both extend outwards beyond the supporting layer; the distance between the inner induction layer and the supporting layer is not more than 2mm; the distance between the outer induction layer and the supporting layer is not less than 5mm;
the thickness range of the skull prosthesis is 3mm-12mm, the thickness range of the supporting layer is 1mm-4mm, and the thickness ranges of the inner induction layer and the outer induction layer are 1mm-4mm;
the grid holes are uniformly distributed, the width range of each grid hole is 0.5-2mm, and the distance range of two adjacent grid holes is 2-3mm; each grid hole is square;
the preparation method comprises the following steps:
s1, acquiring skull data of a patient;
s2, performing three-dimensional reconstruction by using the obtained skull data, and extracting a digital model of the skull prosthesis and the supporting layer according to the skull defect part;
s3, printing the supporting layer of the skull prosthesis by taking polyaryletherketone powder as a raw material by adopting a selective laser sintering 3D printing technology according to a digital model of the supporting layer;
s4, manufacturing an upper die and a lower die of the skull prosthesis according to the digital model of the skull prosthesis;
s5, preparing colloid or emulsion bioactive materials;
s6, embedding the support layer printed in the step S3 into the bioactive material prepared in the step S5 by using the upper die and the lower die prepared in the step S4 to prepare the skull restoration;
s7, trimming the step S6 to obtain a skull prosthesis, so that the outline of a supporting layer of the skull prosthesis is matched with the bone edge of the damaged area of the skull, and the inner induction layer and the outer induction layer both exceed the supporting layer;
the step S2 comprises the following steps:
s2-1, importing the skull data obtained in the step S1 into medical reverse software, segmenting bones and soft tissues by using threshold values, extracting bone regions of the skull, removing bone tissues which are not connected with the skull of the main body through region growing operation, and completing three-dimensional model reconstruction of the skull;
s2-2, importing a three-dimensional model of the skull into reverse engineering software, extracting a contour line of the middle part of the bone edge of the damaged part of the skull as a contour line of the supporting layer, repairing to obtain an upper curved surface and a lower curved surface of the supporting layer, and splicing to obtain a simulation image of the supporting layer;
s2-3, drawing a plurality of grid holes communicated with an upper curved surface and a lower curved surface of the supporting layer in a simulation image of the supporting layer to obtain a preliminary simulation body of the supporting layer with a grid structure;
s2-4, extracting a three-dimensional image of the repaired damaged part as a skull simulated repair body image according to the three-dimensional model of the skull;
s2-5, introducing the support layer preliminary simulation body obtained in the step S2-3 into the skull simulation prosthesis image obtained in the step S2-4, overlapping the support layer preliminary simulation body and the skull simulation prosthesis image, and storing a curved surface model of the support layer and the skull prosthesis;
s2-6, importing the curved surface model obtained in the step S2-5 into digital model engraving software, and referring to the skull shape of the mirror image position of the damaged part, adjusting the internal repair curved surface and the external repair curved surface of the skull prosthesis to enable the skull shape of the damaged part and the mirror image position of the damaged part to be consistent;
adjusting the curvature of the supporting layer to be consistent with the curvature of the skull restoration, so that the supporting layer is positioned at the middle position of the skull restoration;
splicing the upper curved surface and the lower curved surface of the supporting layer into a closed entity to obtain a digital model of the supporting layer; splicing the internal repair curved surface and the external repair curved surface of the skull prosthesis into a closed entity to obtain a digital model of the skull prosthesis;
the step S6 comprises the following steps:
pouring the colloid or emulsion bioactive material with the height of 1-3mm into the lower die prepared in the step S4, putting the lower die into a freeze dryer, freezing for 0.5h at the temperature of minus 20 ℃, taking out the frozen lower die, putting the support layer printed in the step S3 into the lower die, adjusting the position, adding the same colloid or emulsion bioactive material again, filling the same into grid holes of the support layer, covering the upper die, putting the covered upper die and the covered lower die into the freeze dryer as a whole, freezing for 5h at the temperature of minus 20 ℃, removing the upper die, vacuumizing, freezing and drying until the weight is not changed, and removing the lower die after drying to obtain the skull restoration.
2. A method of preparing a cranial prosthesis according to claim 1, wherein: in the skull prosthesis, the polyaryletherketone material is any one or a mixture of at least two of polyetheretherketone, polyetherketoneketone and polyetheretherketone.
3. A method of preparing a cranial prosthesis according to claim 1, wherein: in the skull prosthesis, the bioactive material is any one or a mixture of at least two of mineralized collagen, hydroxyapatite, calcium phosphate, collagen, polylactic acid, polycaprolactone and polylactide.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811443770.8A CN109223248B (en) | 2018-11-29 | 2018-11-29 | Skull prosthesis for inducing bone tissue regeneration and preparation method thereof |
Applications Claiming Priority (1)
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| CN110292466B (en) * | 2019-07-19 | 2021-06-22 | 深圳市艾科赛龙科技股份有限公司 | Three-dimensional model construction method of anatomical structure and prosthesis thereof |
| CN110496246B (en) * | 2019-09-09 | 2021-12-14 | 广州飞胜智能科技股份有限公司 | A kind of bone repair material constructed by 3D printing and preparation method |
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| CN101559240A (en) * | 2008-04-17 | 2009-10-21 | 杨立群 | Skull repairing material and preparation method thereof |
| CN104667345B (en) * | 2015-01-30 | 2017-02-22 | 深圳迈普再生医学科技有限公司 | Cranioplasty prosthesis with biological activity and preparation method of cranioplasty prosthesis |
| CN204971712U (en) * | 2015-07-03 | 2016-01-20 | 天津市赛宁生物工程技术有限公司 | Body is implanted in damaged restoration of skull with blood drainage hole |
| CN106620846B (en) * | 2016-09-13 | 2019-11-29 | 北京奥精医药科技有限公司 | Mineralized collagen base repair of cranial defects body and preparation method based on digital reconstruction |
| CN106923935B (en) * | 2017-03-15 | 2018-06-19 | 马驰原 | A kind of Anatomical Reconstruction skull patch fast method for preparing |
| CN209916294U (en) * | 2018-11-29 | 2020-01-10 | 北京奥精医药科技有限公司 | Skull prosthesis for inducing bone tissue regeneration |
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