3D printed prosthesis for repairing large-section bone defect, manufacturing method thereof and mounting kitTechnical Field
The invention relates to the technical field of orthopedic medical instruments, in particular to a 3D printed prosthesis for repairing a large-section bone defect, a manufacturing method thereof and an installation kit.
Background
Large bone defects, particularly critical bone defects, caused by severe trauma, infection or malignancy, require repair by grafting bone or bone substitute materials for clinical treatment. The bone repair material applied clinically at present mainly comprises bones, biological ceramics, synthetic polymers and medical metal materials. Autologous bone grafting has the defects of pain discomfort in a donor area, secondary bone defect in the donor area, limited available bone quantity, mismatching with the form of the defect position and the like, and still cannot meet the repairing requirement of the defect of a large section of long bone.
In recent years, a degradable metal bone repair material by 3D printing is more and more paid attention to because of its high mechanical strength, degradability and bone bioactivity. For example, the invention patent application publication numbers CN 117752473A and CN 117752472A disclose two 3D printed degradable large-section long bone defect repairing devices and manufacturing methods thereof, and the repairing of bone defect is promoted by utilizing the mechanical support and osteogenic activity of the 3D printed zinc alloy porous scaffold. The invention patent application with publication number CN 118662281A discloses a porous 3D printed femur osteotomy prosthesis and a using method thereof, improves the positioning mode of the prosthesis, promotes the blood discharge during the wound healing period through a drainage hole, and adopts an intramedullary rod to penetrate and fix the fixing mode of the prosthesis.
However, at present, a plurality of large-section bone defect repair brackets or prostheses are manufactured by adopting a 3D printing technology, so that the problems of mechanical support, osteogenesis activity, infection resistance and the like are solved, and the problems of bone growth and contact surface bone fusion are not fundamentally solved, namely the problem of fusion stability between the prostheses and host bones is not solved due to the fact that blood body fluid flow is increased by a prosthetic fixing handle and a porous design.
Disclosure of Invention
Because the prior art has the defects, the invention provides the 3D printed large-section bone defect repair prosthesis, the manufacturing method and the installation kit thereof, solves the problem of connection firmness between the prosthesis and host bone and the problem of poor bone ingrowth and osseointegration of the surface of the prosthesis after the implantation of the prior 3D printed prosthesis, and realizes strong combination and stability of the prosthesis and the host bone.
In order to achieve the above purpose, in a first aspect, the invention provides a 3D printed large-section bone defect repair prosthesis, which comprises a prosthesis body, wherein the upper end and the lower end of the prosthesis body are connected with bone defect positions and are matched with the sizes of the bone defect positions;
the whole prosthesis body is tubular with two open ends, and annular hollow interlayers with the depth of 10-20 mm are respectively arranged at the two end faces, wherein the interlayer wall thickness of the annular hollow interlayer is 2-5 mm, and a plurality of reinforcing ribs are arranged along the radial direction;
The outer surface of the side wall of the middle part of the prosthesis body is provided with a plurality of grooves, and the depth of each groove is 1-3 mm.
In a second aspect, the invention provides a 3D printed large-segment bone defect repair prosthesis mounting kit, which comprises an intramedullary rod, a screw, a bone growth promoting active material, a large-segment bone defect repair prosthesis according to the first aspect, wherein the bone growth promoting active material is filled in an annular cavity interlayer of a prosthesis body, the bone growth promoting active material is filled in a groove, the intramedullary rod penetrates through a pipe hole of the prosthesis body and is inserted into host bones to be connected up and down, and the screw penetrates through the host bones and the intramedullary rod to fixedly connect the upper ends and the lower ends. The intramedullary rod is of a solid or hollow structure and plays roles of positioning the prosthesis body and fixing connecting pieces at the upper end and the lower end. The technical proposal adopts an internal fixation mode to fixedly connect the prosthesis and the host bone.
The prosthesis body formed by the porous printing units provides effective mechanical support and osteogenesis activity, annular hollow interlayers at two ends of the prosthesis body are filled with active materials for promoting bone growth, bone growth is facilitated, firm connection of a prosthesis connecting interface is achieved, grooves in the outer wall of the prosthesis body are filled with active materials for promoting bone growth, bone growth on the surface of the prosthesis is facilitated, new bone formation on the surface of the whole prosthesis is achieved, and the effect of complete fusion of the new bone and the prosthesis is achieved more quickly. The depth of the annular cavity interlayer and the thickness of the groove are designed according to the healing period of bone fusion, so that the technical effects are achieved.
In some embodiments, a first bone plate integrally formed with the prosthesis body in a 3D printing mode is further arranged on one side of the prosthesis body along the axial direction, the top plate surface and the bottom plate surface of the first bone plate respectively exceed the prosthesis body, first screw holes are formed in the exceeding portions, and the first bone plate is of a solid structure. By adopting the technical scheme, the prosthesis main body and the bone fracture plate are integrally formed by a 3D printing technology, and the bone fracture plate is of a solid structure, so that the structural strength of the prosthesis can be effectively improved.
In some embodiments, the outer ring end face of the annular cavity interlayer extends outwards to form a second bone fracture plate integrally formed with the prosthesis body through 3D printing, the thickness of the second bone fracture plate is 2-3 mm, the width of the second bone fracture plate is 10-25 mm, the height of the second bone fracture plate is 30-80 mm, a second screw hole is formed in the plate face of the second bone fracture plate, and the second bone fracture plate is of a solid structure. By adopting the technical scheme, the bone fracture plate is only obtained by extending from the end face of the annular cavity interlayer, so that the quality of the prosthesis can be lightened, and the host bone can be positioned conveniently during bone fracture.
In some embodiments, the cross section of the groove is rectangular, and the proportion of the total cross section of the groove to the surface area of the prosthesis body is 5-25%. By adopting the technical scheme, the shape and the area ratio of the grooves can realize better cortical bone growth effect.
In some embodiments, the annular cavity interlayer of the prosthesis body is filled with bone growth promoting active material, and the groove is filled with bone growth promoting active material.
In some embodiments, the pore distribution of the printing units is uniform, or is dense in the periphery, sparse in the middle, or is distributed by a reinforcing rib partition pore structure, and the pore diameter of the printing units ranges from 0.1mm to 2mm, and the porosity ranges from 50% to 95%.
In some embodiments, the structure of the printing unit is selected from one or more of tetrahedron, octahedron, dodecahedron, spiral icosahedron, extremely small curved surface structure, octagon, three-dimensional Kogome.
The invention provides a 3D printed large-section bone defect repair prosthesis mounting kit, which comprises screws, bone growth promoting active materials and the large-section bone defect repair prosthesis, wherein the bone growth promoting active materials are filled in an annular cavity interlayer of a prosthesis body, the bone growth promoting active materials are filled in grooves, host bones to be connected up and down are respectively arranged on the inner sides of bone plates and are in contact with the prosthesis body, and the screws penetrate through screw holes in the host bones and the bone plates to fixedly connect the upper ends and the lower ends. The technical proposal adopts an external fixation mode to fixedly connect the prosthesis and the host bone.
In a final aspect, the present invention provides a method for manufacturing a 3D printed large-segment bone defect repair prosthesis for manufacturing a large-segment bone defect repair prosthesis as described above, comprising the steps of:
Step S1, scanning a large-section bone defect part by using a high-resolution CT, and determining the length, the diameter and the shape of the large-section bone defect after three-dimensional reconstruction, and establishing the size and the shape of the prosthesis by taking a CT result as a reference modeling;
S2, selecting proper printing metal powder;
And step S3, printing the prosthesis on a metal 3D printer by using the printing metal powder selected in the step S2.
The 3D printing technology for manufacturing the prosthesis has the characteristics of higher technical maturity, satisfied quality, lower manufacturing cost and the like.
Compared with the prior art, the invention has the following beneficial effects:
(1) According to the invention, the pore structures capable of being filled with bone active substances are arranged at the two ends and the surface of the prosthesis, so that the efficient bone ingrowth is realized, and the effects of firm connection and efficient fusion of the prosthesis and host bone are achieved.
(2) The prosthesis supports multiple modes of internal fixation and external fixation, has strong adaptability to the patient's body, and can achieve the effects of light weight, accurate positioning and the like by adjusting the structural design parameters of the prosthesis.
(3) The manufacturing method of the prosthesis is easy to implement and has lower manufacturing cost.
Drawings
The invention and its features, aspects and advantages will become more apparent from the detailed description of non-limiting embodiments with reference to the following drawings. Like numbers refer to like parts throughout. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention.
FIG. 1 is a schematic perspective view of a prosthesis according to embodiment 1 of the present invention;
FIG. 2 is a schematic elevational view of the prosthesis according to example 1 of the present invention;
FIG. 3 is a schematic top view of the prosthesis according to example 1 of the present invention;
FIG. 4 is a schematic view showing the structure of the prosthesis in example 1 of the present invention in axial section;
FIG. 5 is a schematic view showing the installation structure of the prosthesis in embodiment 1 of the present invention;
FIG. 6 is a schematic perspective view of the prosthesis according to embodiment 2 of the present invention;
FIG. 7 is a schematic view showing the installation structure of the prosthesis in embodiment 2 of the present invention;
FIG. 8 is a schematic perspective view of a prosthesis according to example 3 of the present invention;
FIG. 9 is a schematic view showing the structure of the prosthesis in an axial cross section in embodiment 3 of the present invention;
wherein, 1, the prosthesis body; 11, an annular cavity interlayer, 12, reinforcing ribs, 13, grooves, 2, a first bone fracture plate, 21, a first screw hole, 3, a second bone fracture plate, 31, a second screw hole, 4, an intramedullary rod, 5, a host bone, 6 and a screw.
Detailed Description
Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. It is to be understood that all of the described exemplary embodiments are only some, but not all, embodiments and examples of the present invention. Rather, these exemplary embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the technical disclosure to those skilled in the art.
In the description of the present application, it should be understood that the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more of the described features. In the description of the present application, the meaning of "a plurality" is two or more, unless explicitly defined otherwise.
Example 1
Referring to fig. 1 to 5, the embodiment provides a 3D printed large-section bone defect repair prosthesis, which comprises a prosthesis body 1, wherein the upper end and the lower end of the prosthesis body 1 are connected with bone defect positions and are matched with the sizes of the bone defect positions, the prosthesis body 1 is composed of a plurality of porous printing units, the whole prosthesis body 1 is in a tubular shape with two open ends, annular cavity interlayers 11 with the depth of 10-20 mm are respectively arranged at the two end faces, the interlayer wall thickness of the annular cavity interlayers 11 is 2-5 mm, a plurality of reinforcing ribs 12 are arranged along the radial direction, a plurality of grooves 13 are formed in the outer surface of the side wall of the middle part of the prosthesis body 1, and the depth of the grooves 13 is 1-3 mm. More specifically, the depth of the annular cavity interlayer 11 is 15mm, bone ingrowth can be realized within 90 days to achieve bone fusion, the interlayer wall thickness is 2mm, the structural strength of the prosthesis is not affected, and the bone growth promoting active gel/powder can be conveniently filled. The depth of the groove 13 is 1.5mm, and bone ingrowth can be realized in 45 days, so that cortical bone growth can be realized.
In some implementations of this embodiment, the cross-section of the recess 13 is rectangular, and the proportion of the total cross-sectional area of the recess to the surface area of the prosthesis body is 5-25%, preferably 12%. By adopting the technical scheme, the shape and the area ratio of the grooves can realize better cortical bone growth effect.
In some implementations of this example, the annular hollow interlayer 11 of the prosthesis body is filled with bone growth promoting active material, and the grooves 13 are filled with bone growth promoting active material.
In some implementations of this embodiment, the hole distribution of the printing unit is uniform, or dense around, sparse in the middle, or distributed in a rib-divided hole structure, and the pore diameter of the printing unit ranges from 0.1mm to 2mm, and the porosity ranges from 50% to 95%.
In some implementations of this embodiment, the structure of the printing unit is selected from one or more of tetrahedral, octahedral, dodecahedral, spiral icosahedron, extremely small curved surface structure, octagon, three-dimensional Kogome.
The manufacturing method of the prosthesis comprises the following steps:
S1, scanning a large-section bone defect part by using a high-resolution CT, and determining the length, the diameter and the shape of the large-section bone defect after three-dimensional reconstruction, and modeling by taking a CT result as a reference to determine the size and the shape of the large-section bone defect repair prosthesis;
S2, selecting proper printing metal powder;
and S3, printing the printing powder selected in the step S2 on the metal 3D printing to print the large-section bone defect repair prosthesis.
Further, in step S1, the specific steps of modeling are as follows:
Based on CT image technology, three-dimensional reconstruction is carried out on the large-section bone defect part of a patient, the size and the shape of a bone defect area are simulated, according to the range and the shape of the reconstructed bone defect area, the structure, the aperture and the pore design of the implant large-section bone defect repair prosthesis are carried out by utilizing Computer Aided Design (CAD) software, and the designed three-dimensional structure model data is imported into the control software of a metal 3D printer in STL format.
Further, in the step S2, the optional metal powder is selected from pure titanium metal powder, titanium aluminum alloy powder, titanium nickel alloy powder, titanium aluminum alloy powder, titanium magnesium alloy powder, titanium strontium alloy powder, titanium gallium alloy powder, titanium zinc alloy powder, tantalum metal powder, tantalum magnesium alloy powder, tantalum calcium alloy powder, tantalum strontium alloy powder, tantalum aluminum alloy powder, tantalum zinc alloy powder, and stainless steel metal powder. Pure titanium metal powder and titanium aluminum alloy powder are preferred.
Further, in step S3, the 3D printing method includes an L-PBF method. Further, the specific steps of the titanium alloy material printing powder 3D printing large-section bone defect repair prosthesis are as follows:
and using an L-PBF machine to select ytterbium laser with the wavelength of 1000-1100 nm, and printing a prosthesis main body layer by layer under the protection of argon, wherein the prosthesis main body is a porous support with reinforcing ribs and is composed of a plurality of printing units, the aperture range of the printing units is 0.1-2 mm, and the porosity range of the printing units is 50-95%.
Referring to fig. 5, the installation of the above prosthesis using the installation kit comprises the steps of:
s21, filling a bone growth promoting active material in the annular cavity interlayer 11 of the prosthesis body, and filling the bone growth promoting active material in the groove 13;
Step S22, the intramedullary rod 4 penetrates through the pipe hole of the prosthesis body 1 and is inserted into the host bone 5 to be connected up and down, and the screw 6 penetrates through the host bone 5 and the intramedullary rod 4 to fixedly connect the upper end and the lower end. Specifically, the parts of the intramedullary rod 4, which exceed the two ends of the main body of the prosthesis, are provided with a plurality of screw holes, the screw holes penetrate through the intramedullary rod to be connected with the two ends of the host bone large-section bone defect part, and the screw holes and the screw 6 are used for fixing the intramedullary rod in normal marrow cavities at the two ends of the host bone large-section bone defect part. The intramedullary rod 4 is of solid or hollow construction and is formed by conventional machining techniques. The screw is a conventional medical fixing screw purchased in the market.
Example 2
Referring to fig. 1 and 6, the present embodiment provides a 3D-printed prosthesis for repairing a large bone defect, which has a structure similar to that of embodiment 1, and is different from embodiment 1 in that a first bone plate 2 integrally formed with the 3D-printed prosthesis body is further provided on one side of the prosthesis body 1 in the axial direction, the top and bottom plate surfaces of the first bone plate 2 respectively exceed the prosthesis body 1, and the exceeding parts are provided with first screw holes 21, and the first bone plate 2 is in a solid structure. By adopting the technical scheme, the prosthesis main body and the bone fracture plate are integrally formed by a 3D printing technology, and the bone fracture plate is of a solid structure, so that the structural strength of the prosthesis can be effectively improved. The contact between the main body of the prosthesis and the bone plate can be set to be smooth transition, and the bone plate is obtained by extending the reinforcing ribs in the main body of the prosthesis.
The manufacturing method of the prosthesis of this embodiment is similar to that of embodiment 1, except that the printing unit of the first bone plate 2 is of a solid structure as in embodiment 1.
Referring to fig. 7, the installation of the above prosthesis using the installation kit comprises the steps of:
step S31, filling a bone growth promoting active material in the annular cavity interlayer 11 of the prosthesis body, and filling the bone growth promoting active material in the groove 13;
step S32, placing the upper and lower host bones 5 to be connected on the inner sides of the first bone fracture plate 2 respectively to be in contact with the prosthesis body 1, and fixedly connecting the upper and lower ends by penetrating the host bones 5 and the first screw holes 21 on the bone fracture plate through screws 6. The screw is a conventional medical fixing screw purchased in the market.
Example 3
Referring to fig. 1, 8 and 9, the present embodiment provides a 3D-printed prosthesis for repairing a large-section bone defect, which has a structure similar to that of embodiment 1, and is different from embodiment 1 in that the outer ring end surface of the annular cavity interlayer 11 extends outwards to form a second bone fracture plate 3 integrally formed with the 3D-printed prosthesis body, the thickness of the second bone fracture plate 3 is 2-3 mm, the width is 10-25 mm, the height is 30-80 mm, a second screw hole 31 is formed in the plate surface of the second bone fracture plate 3, and the second bone fracture plate 3 is of a solid structure. By adopting the technical scheme, the bone fracture plate is only obtained by extending from the end face of the annular cavity interlayer, so that the quality of the prosthesis can be lightened, and the host bone can be positioned conveniently during bone fracture.
The manufacturing method of the prosthesis of this embodiment is similar to that of embodiment 1, except that the printing unit of the second bone plate 3 is a solid structure as in embodiment 1.
The prosthesis installation procedure of this embodiment is similar to that of embodiment 2.
The structure and the usage of the prosthesis and the installation kit thereof show that the prosthesis body formed by the porous printing units provides effective mechanical support and osteogenesis activity, the annular cavity interlayers at the two ends of the prosthesis body are filled with bone growth promoting active materials, which is beneficial to bone growth and realizing firm connection of a prosthesis connecting interface, the grooves on the outer wall of the prosthesis body are filled with bone growth promoting active materials, which is beneficial to bone growth and realizing bone growth on the surface of the prosthesis and new bone formation on the surface of the whole prosthesis, and the effect of complete fusion of the new bone and the prosthesis is achieved more quickly. The prosthesis supports multiple modes of internal fixation and external fixation, has strong adaptability to the patient's physical signs, and can achieve the effects of light weight, accurate positioning and the like by adjusting the structural design parameters of the prosthesis. The manufacturing method of the prosthesis is easy to implement and has lower manufacturing cost.
The preferred embodiments of the present invention have been described above. It is to be understood that the invention is not limited to the particular embodiments described above, in which the apparatus and structures not described in detail are to be understood as being embodied in a manner commonly understood in the art, and that many possible variations and modifications may be made to the technical solution of the invention by any person skilled in the art using the methods and techniques disclosed above, or modified to equivalent embodiments without departing from the spirit of the invention. Therefore, any simple modification, equivalent variation and modification of the above embodiments according to the technical substance of the present invention still fall within the scope of the technical solution of the present invention.