CN112472369A - Three-dimensional femoral stem and manufacturing method - Google Patents

Three-dimensional femoral stem and manufacturing method Download PDF

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Publication number
CN112472369A
CN112472369A CN202011512157.4A CN202011512157A CN112472369A CN 112472369 A CN112472369 A CN 112472369A CN 202011512157 A CN202011512157 A CN 202011512157A CN 112472369 A CN112472369 A CN 112472369A
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China
Prior art keywords
femoral
stem
shape
femoral stem
dimensional
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CN202011512157.4A
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Chinese (zh)
Inventor
吴栋
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Jingwei Medical Equipment Manufacturing Shenzhen Co ltd
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Jingwei Medical Equipment Manufacturing Shenzhen Co ltd
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Priority to CN202011512157.4A priority Critical patent/CN112472369A/en
Publication of CN112472369A publication Critical patent/CN112472369A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3662Femoral shafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3609Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3662Femoral shafts
    • A61F2/367Proximal or metaphyseal parts of shafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3662Femoral shafts
    • A61F2/3676Distal or diaphyseal parts of shafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30948Designing 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/30985Designing or manufacturing processes using three dimensional printing [3DP]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3609Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/3625Necks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3609Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/3652Connections of necks to shafts

Abstract

The embodiment of the invention provides a three-dimensional femoral stem and a manufacturing method thereof, wherein the stem body is fixedly connected with an outer housing which is sleeved outside the stem body; the handle body comprises a femoral awl, a femoral neck, a femoral handle shoulder and a femoral handle far end; one end of the shoulder part of the femoral stem is connected with the far end of the femoral stem, and the other end of the shoulder part of the femoral stem is connected with the femoral neck; one end of the femoral neck, which is far away from the shoulder part of the femoral stem, is connected with the femoral awl; the outer housing is a hollow annular structure, the inner side shape of the outer housing is matched with the shape of the shoulder of the femoral stem, and the outer side shape of the outer housing is matched with the shape of the femoral side of the patient. Through the outer housing of three-dimensional printing for the outer housing matches with patient's thighbone side, reduces to cut more high-quality bone volume. Prevent the patient from central dislocation caused by long-term looseness caused by excessive bone loss, improve the survival rate of the prosthesis and improve the matching degree.

Description

Three-dimensional femoral stem and manufacturing method
Technical Field
The invention relates to the technical field of medical instruments, in particular to a three-dimensional femoral stem and a manufacturing method thereof.
Background
In recent years, along with the acceleration of the aging process of population, hip joint patients are increased continuously, the annual growth rate reaches 20%, artificial hip joint replacement becomes an effective treatment method for a plurality of final stage hip joint patients, and by replacing hip joints, pain, difficulty in movement and various complications of patients can be solved, such as: deep venous thrombosis, falling pneumonia, bedsore and other high-risk diseases, and can recover various functions of hip joints of patients and effectively improve the quality of life. When the hip joint is created, the cartilage is no longer smooth, the synovial capsule becomes inflamed and atrophy, and the joint can no longer function as usual. In the medical field, artificial hip replacement is widely used as a clinical treatment method. The hip joint prosthesis is used for replacing a hip joint of a human body, and the operation process comprises the following steps: inserting the femoral stem prosthesis into the femoral bone marrow cavity and installing a ball head; and the acetabulum and the lining are matched to realize the function of the hip joint.
The femoral stem prosthesis prepared by the traditional process is a standard femoral stem in a mass production mode, and the size and the shape of the femoral stem are the same.
However, the acetabulum of the human body is personalized and diversified in disease types, which results in that most patients achieve the purposes of initial press fit and later bone ingrowth of the traditional outer cup at the cost of removing more excellent bone mass. So that the long-term looseness of many patients caused by excessive bone loss leads to central dislocation, and the survival rate of the femoral stem is influenced; and if the patient needs to be renovated due to bone absorption, the standard femoral stem can not meet the matching requirement.
Disclosure of Invention
In view of the above, the present invention has been made to provide a three-dimensional femoral stem and a manufacturing method that overcome or at least partially solve the above problems.
The application discloses a three-dimensional femoral stem, which comprises a stem body and an outer housing sleeved outside the stem body, wherein the stem body is fixedly connected with the outer housing; the handle body comprises a femoral awl, a femoral neck, a femoral handle shoulder and a femoral handle far end; one end of the shoulder part of the femoral stem is connected with the far end of the femoral stem, and the other end of the shoulder part of the femoral stem is connected with the femoral neck; one end of the femoral neck, which is far away from the shoulder part of the femoral stem, is connected with the femoral awl;
the outer housing is a hollow annular structure, the inner side shape of the outer housing is matched with the shape of the shoulder of the femoral stem, and the outer side shape of the outer housing is matched with the shape of the femoral side of the patient.
Preferably, the fixed connection is a sintered connection and/or a riveted and/or screwed connection, wherein the sintering temperature is greater than 1000 ℃.
Preferably, the porosity of the outer casing is 20% to 85%; the pore diameter of the pore of the outer cover shell is 50-400 μm.
Preferably, the distal end of the femoral stem is tapered.
Preferably, the top end of the shoulder part of the femoral stem is provided with a fixing hole for connecting a femoral stem driver.
In accordance with the present invention, there is also provided a three-dimensional femoral stem manufacturing method for manufacturing a femoral stem matched with a femoral side of a patient by a three-dimensional printing technique, comprising:
acquiring CT image data of the femoral side part of the patient;
determining the three-dimensional data of the outer casing of the femoral stem according to the CT image data and the preset data of the stem body, wherein the three-dimensional data of the outer casing comprises an outer surface shape and an inner surface shape; the outer surface shape matches the shape of the patient's femoral side and the inner surface shape matches the shape of the pre-set stem;
manufacturing the outer shell according to the outer surface shape and the inner surface shape;
and assembling the outer housing shell and the preset handle body to obtain the femoral handle matched with the femoral side of the patient.
Preferably, the step of determining the three-dimensional data of the outer shell of the femoral stem according to the CT image data and the preset data of the stem body further comprises:
acquiring preset surface shape data of a handle body;
determining an inner surface shape from the surface shape data.
Preferably, the step of manufacturing the outer shell according to the outer surface shape and the inner surface shape includes: determining an outer shell model according to the shape of the outer surface and the shape of the inner surface; partitioning the shell model into at least two plane-level data; manufacturing the outer casing according to the plane level data.
The application has the following advantages:
in the embodiment of the application, the handle body is fixedly connected with the outer cover shell through the handle body and the outer cover shell sleeved outside the handle body; the handle body comprises a femoral awl, a femoral neck, a femoral handle shoulder and a femoral handle far end; one end of the shoulder part of the femoral stem is connected with the far end of the femoral stem, and the other end of the shoulder part of the femoral stem is connected with the femoral neck; one end of the femoral neck, which is far away from the shoulder part of the femoral stem, is connected with the femoral awl; the outer housing is a hollow annular structure, the inner side shape of the outer housing is matched with the shape of the shoulder of the femoral stem, and the outer side shape of the outer housing is matched with the shape of the femoral side of the patient. Through the outer housing of three-dimensional printing for the outer housing matches with patient's thighbone side, reduces to cut more high-quality bone volume. Prevent the patient from central dislocation caused by long-term looseness caused by excessive bone loss, improve the survival rate of the prosthesis and improve the matching degree.
Drawings
In order to more clearly illustrate the technical solutions of the present application, the drawings needed to be used in the description of the present application will be briefly introduced below, and it is apparent that the drawings in the following description are only some embodiments of the present application, and it is obvious for those skilled in the art that other drawings can be obtained according to the drawings without inventive labor.
FIG. 1 is a schematic view of a combination structure of an outer shell and a stem body of a three-dimensional femoral stem according to an embodiment of the present application;
FIG. 2 is a schematic view of a stem body of a three-dimensional femoral stem according to an embodiment of the present application;
FIG. 3 is a schematic structural view of an outer shell of a three-dimensional femoral stem according to an embodiment of the present application;
FIG. 4 is a flowchart illustrating steps of a method for fabricating a three-dimensional femoral stem according to an embodiment of the present application;
1. a handle body; 2. an outer casing.
Detailed Description
In order to make the aforementioned objects, features and advantages of the present application more comprehensible, the present application is described in further detail with reference to the accompanying drawings and the detailed description. It is to be understood that the embodiments described are only a few embodiments of the present application and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
It is noted that in any of the embodiments of the present invention, a three-dimensional femoral stem is used to replace a portion of an implant of a patient's femur during hip replacement surgery.
Referring to fig. 1, a schematic structural diagram of a three-dimensional femoral stem provided in an embodiment of the present application is shown, and specifically includes the following structures: the handle comprises a handle body 1 and an outer housing 2 sleeved outside the handle body 1, wherein the handle body 1 is fixedly connected with the outer housing 2; the handle body 1 comprises a femoral awl, a femoral neck, a femoral handle shoulder and a femoral handle far end; one end of the shoulder part of the femoral stem is connected with the far end of the femoral stem, and the other end of the shoulder part of the femoral stem is connected with the femoral neck; one end of the femoral neck, which is far away from the shoulder part of the femoral stem, is connected with the femoral awl; the outer housing 2 is a hollow annular structure, the inner side shape of the outer housing 2 is matched with the shape of the shoulder of the femoral stem, and the outer side shape of the outer housing 2 is matched with the shape of the femoral side of the patient.
In the embodiment of the application, the handle body 1 is fixedly connected with the outer cover shell 2 through the handle body 1 and the outer cover shell 2 sleeved outside the handle body 1; the handle body 1 comprises a femoral awl, a femoral neck, a femoral handle shoulder and a femoral handle far end; one end of the shoulder part of the femoral stem is connected with the far end of the femoral stem, and the other end of the shoulder part of the femoral stem is connected with the femoral neck; one end of the femoral neck, which is far away from the shoulder part of the femoral stem, is connected with the femoral awl; the outer housing 2 is a hollow annular structure, the inner side shape of the outer housing 2 is matched with the shape of the shoulder of the femoral stem, and the outer side shape of the outer housing 2 is matched with the shape of the femoral side of the patient. Through the three-dimensional printed outer housing 2, the outer housing 2 is matched with the femur of a patient, and the cutting of more high-quality bone mass is reduced. Prevent the patient from central dislocation caused by long-term looseness caused by excessive bone loss, improve the survival rate of the prosthesis and improve the matching degree.
Hereinafter, a three-dimensional femoral stem in the present exemplary embodiment will be further described.
Referring to fig. 2, a schematic structural diagram of a stem body 1 of a three-dimensional femoral stem provided in an embodiment of the present application is shown, specifically, the following structure: the handle body 1 comprises a femoral awl, a femoral neck, a femoral handle shoulder and a femoral handle far end; one end of the shoulder part of the femoral stem is connected with the far end of the femoral stem, and the other end of the shoulder part of the femoral stem is connected with the femoral neck; one end of the femoral neck, which is far away from the shoulder part of the femoral stem, is connected with the femoral awl;
in a specific embodiment, the distal end of the femoral stem is tapered, the taper is used for reducing resistance when the femoral stem is implanted, and the taper is beneficial to the entering of the three-dimensional femoral stem during the three-dimensional femoral stem implantation process.
The outer peripheral wall of the distal end of the femoral stem is provided with a longitudinal groove for increasing the contact area with the bone, wherein the longitudinal groove is used for increasing the contact area with the bone, the longitudinal groove increases the contact area of the three-dimensional femoral stem with the bone in a femoral bone marrow cavity, the bone ingrowth is stimulated, the dislocation problem caused by the axial rotation of the three-dimensional femoral stem relative to the femur in the using process can be effectively improved, and the femoral stem is more stable and durable.
The bottom of the distal end of the femoral stem is spherical, so that the resistance of the three-dimensional femoral stem during implantation can be reduced, and the damage to a medullary cavity is reduced; effectively reducing the stress concentration problem at the bottom when the three-dimensional femoral stem is loaded and relieving the transition stimulation to the bone.
In a specific embodiment, the top end of the shoulder part of the femoral stem is provided with a fixing hole for connecting a femoral stem impactor, wherein the fixing hole is matched with the femoral stem prosthesis impactor.
In a particular embodiment, the shank body 1 is made by casting or forging or by powder metallurgy.
It should be noted that casting is a relatively early metal hot working process, and casting is a method in which liquid metal is cast into a casting cavity adapted to the shape of a part, and after cooling and solidification, a part or a blank is obtained. The casting material is mostly metal which is originally solid but is heated to liquid state, such as copper, iron, aluminum, tin, lead, etc., and the material of the casting mold can be sand, metal or even ceramic.
It should be noted that forging is a processing method that a forging press machine is used to apply pressure to a metal blank to generate plastic deformation to obtain a forging with certain mechanical properties, certain shape and certain size, the defects of as-cast porosity and the like generated in the smelting process of metal can be eliminated through forging, the microstructure is optimized, and meanwhile, because a complete metal streamline is preserved, the mechanical properties of a cast object are generally superior to those of a cast of the same material.
Powder metallurgy is a process technology for manufacturing metal materials, composite materials and various types of products by taking metal powder or a mixture of metal powder and nonmetal powder as raw materials and forming and sintering the raw materials.
Referring to fig. 3, a schematic structural diagram of an outer shell 2 of a three-dimensional femoral stem according to an embodiment of the present application is shown, specifically, the following structure: the outer housing 2 is sleeved outside the handle body 1, and the handle body 1 is fixedly connected with the outer housing 2; the outer housing 2 is a hollow annular structure, the inner side shape of the outer housing 2 is matched with the shape of the shoulder of the femoral stem, and the outer side shape of the outer housing 2 is matched with the shape of the femoral side of the patient.
In a particular embodiment, the outer side of the outer shell 2 is provided with grooves for increasing the contact area with the bone.
In a specific embodiment, the fixed connection is a sintered connection and/or a riveted and/or screwed connection, wherein the sintering temperature is greater than 1000 ℃. Thereby achieving the purpose of reducing the phenomena of micrometastasis and corrosion of the handle body 1 and the outer housing 2 and further bone ingrowth.
In a specific embodiment, the porosity of the outer casing 2 is 20% to 85%, and the pore diameter of the pores of the outer casing 2 is 50 μm to 400 μm. The outer casing 2 is made of metal powder.
It should be noted that, according to the actual size of the patient's femur, the outer casing 2 matching with the patient's femur and the inner surface matching with the bottom casing are formed by an additive three-dimensional printing method. Among them, the porosity is preferably 30% to 70%.
It should be noted that the outer shell is formed to fit the patient's femur and the inner surface is formed to fit the stem 1, depending on the actual size of the patient's femur. The pore diameter refers to the pore diameter of a pore formed by the outer casing 2 printed by the three-dimensional printer; the porosity is the volume of the internal pores of the porous solid block material in percentage of the total volume of the material, and represents the pore size of the material, and the porosity of the outer casing shell 2 formed by the three-dimensional printer is referred to in the application.
Referring to fig. 4, a flowchart illustrating steps of a method for manufacturing a three-dimensional femoral stem according to an embodiment of the present application is shown, and specifically includes the following steps:
s110, acquiring CT image data of the femoral side part of the patient;
s120, determining the outer housing three-dimensional data of the femoral stem according to the CT image data and the preset data of the stem body 1, wherein the three-dimensional data of the outer housing 2 comprises an outer surface shape and an inner surface shape; the external surface shape matches the shape of the patient's femoral side, and the internal surface shape matches the shape of the preset stem 1;
s130, manufacturing the outer shell 2 according to the outer surface shape and the inner surface shape;
s140, assembling the outer casing 2 and the preset handle body 1 to obtain the femoral handle matched with the femoral side of the patient.
In an embodiment of the present application, the image data is obtained by acquiring CT image data of the femoral side part of the patient; determining the three-dimensional data of the outer casing 2 of the femoral stem according to the CT image data and the preset data of the stem body 1, wherein the three-dimensional data of the outer casing 2 comprises an outer surface shape and an inner surface shape; the external surface shape matches the shape of the patient's femoral side, and the internal surface shape matches the shape of the preset stem 1; manufacturing the outer shell 2 according to the outer surface shape and the inner surface shape; and assembling the outer housing 2 and the preset handle body 1 to obtain the femoral handle matched with the femoral side of the patient. By printing the outer housing shell 2 matched with the patient and matching the outer housing shell 2 with the handle body 1, the problems that the traditional processing technology cannot meet the requirement of customization and the mechanical strength of the pure three-dimensional printing technology is not enough can be solved.
Next, a femoral stem manufacturing method based on three-dimensional printing in the present exemplary embodiment will be further described.
As described in step S110, CT image data of the femoral side part of the patient is acquired.
In an embodiment of the present invention, the specific process of "acquiring CT image data of the femoral side part of the patient" in step S110 can be further described with reference to the following description.
It should be noted that CT (Computed Tomography) is performed on the femoral side of the patient to obtain a CT tomographic image of the femoral side; carrying out volume reconstruction on the CT sectional image of the patient by using a CT volume imaging technology; an image of the diseased bone portion is extracted using a tissue isolation technique.
It should be noted that the CT image uses the precisely collimated X-ray beam, gamma ray, ultrasonic wave, etc. to scan the cross section of a certain part of the human body one by one together with the detector with extremely high sensitivity, has the characteristics of fast scanning time, clear image, etc., and can be used for the examination of various diseases.
As described in step S120, determining three-dimensional data of the outer shell 2 of the femoral stem according to the CT image data and the preset data of the stem body 1, wherein the three-dimensional data of the outer shell 2 includes an outer surface shape and an inner surface shape; the outer surface shape matches the shape of the patient's femoral side and the inner surface shape matches the shape of the pre-set stem 1.
In an embodiment of the present invention, the step S120 of "determining three-dimensional data of the outer shell 2 of the femoral stem according to the CT image data and the preset data of the stem body 1" can be further explained in conjunction with the following description, wherein the three-dimensional data of the outer shell 2 includes an outer surface shape and an inner surface shape; the outer surface shape matches the shape of the patient's femoral side and the inner surface shape matches the pre-set shape of the stem 1.
Acquiring preset surface shape data of the handle body 1 as described in the following steps; determining an inner surface shape from the surface shape data.
As described in step S130 above, the outer casing 2 is manufactured according to the outer surface shape and the inner surface shape.
In an embodiment of the present invention, the specific process of "manufacturing the outer casing 2 according to the outer surface shape and the inner surface shape" in step S130 can be further described with reference to the following description.
Determining a model of the outer shell 2 based on the outer surface shape and the inner surface shape as described in the following steps; dividing the housing 2 model into at least two plane level data; the housing shell 2 is manufactured according to the plane level data.
The flat layer data is transmitted to a three-dimensional printer and the outer casing 2 is printed as described in the following steps.
The pore diameter of the outer casing 2 is 50 μm to 400 μm, and the porosity of the outer casing 2 is 20% to 85%, as described in the following steps.
It should be noted that the outer shell 2 is formed to match the acetabulum of the patient and the inner surface is formed to match the stem body 1 according to the actual size of the acetabulum of the patient. The pore diameter refers to the pore diameter of a pore formed by the outer casing 2 printed by the three-dimensional printer; the porosity is the volume of the internal pores of the porous solid block material in percentage of the total volume of the material, and represents the pore size of the material, and the porosity of the outer casing shell 2 formed by the three-dimensional printer is referred to in the application.
The method comprises the following steps that an intercepted main view of a model to be printed is divided into a plurality of plane level data through an upper computer, wherein the number of the plane level data is at least two; defining the number of layers of the plane level data from top to bottom as an Xth layer; and transmitting the plane level data to the three-dimensional printer, defining the number of printing layers of the three-dimensional printer to be consistent with the number of the plane level data, and sequentially printing in layers.
It should be noted that three-dimensional printing, which is a kind of rapid prototyping technology, is also called additive manufacturing, and is a technology for constructing an object by using an adhesive material such as powdered metal or plastic and the like and printing layer by layer on the basis of a digital model file. Three-dimensional printing is typically achieved using digital technology material printers. The method is often used for manufacturing models in the fields of mold manufacturing, industrial design and the like, and is gradually used for directly manufacturing some products, and parts printed by the technology are already available. The technology has applications in jewelry, footwear, industrial design, construction, engineering and construction, automotive, aerospace, dental and medical industries, education, geographic information systems, civil engineering, firearms, and other fields. The three-dimensional printing technology is applied to femoral stem printing, so that the femoral stem is matched with a patient, and the aims of initial press fit and later bone ingrowth of the traditional outer cup are fulfilled without cutting more high-quality bone mass.
As described in step S140, the outer casing 2 and the predetermined stem body 1 are assembled to obtain a femoral stem matching with the femoral side of the patient.
In an embodiment of the present invention, the specific process of "assembling the outer casing 2 and the predetermined stem body 1 to obtain a femoral stem matching the femoral side of the patient" in step S130 can be further described with reference to the following description.
Fixedly connecting the inner surface of the three-dimensional model of the outer casing 2 and the outer surface of the stem body 1 to generate the femoral stem of the patient, wherein the assembly mode is sintering connection and/or riveting connection and/or screw connection, and the temperature of the sintering connection is more than 1000 ℃.
It should be noted that the handle 1 and the outer housing are fixed by sintering, riveting, screwing, etc. to form a stable assembly, so as to reduce the phenomena of interfacial micrometastasis and corrosion, and achieve the purpose of bone ingrowth.
The stem body 1 is formed into a blank by a conventional casting or forging or powder metallurgy method, and then is fixedly connected to form a femoral stem matched with a patient.
It should be noted that casting is a relatively early metal hot working process, and casting is a method in which liquid metal is cast into a casting cavity adapted to the shape of a part, and after cooling and solidification, a part or a blank is obtained. The casting material is mostly metal which is originally solid but is heated to liquid state, such as copper, iron, aluminum, tin, lead, etc., and the material of the casting mold can be sand, metal or even ceramic.
It should be noted that forging is a processing method that a forging press machine is used to apply pressure to a metal blank to generate plastic deformation to obtain a forging with certain mechanical properties, certain shape and certain size, the defects of as-cast porosity and the like generated in the smelting process of metal can be eliminated through forging, the microstructure is optimized, and meanwhile, because a complete metal streamline is preserved, the mechanical properties of a cast object are generally superior to those of a cast of the same material.
Powder metallurgy is a process technology for manufacturing metal materials, composite materials and various types of products by taking metal powder or a mixture of metal powder and nonmetal powder as raw materials and forming and sintering the raw materials.
The embodiments in the present specification are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments are referred to each other.
While preferred embodiments of the present invention have been described, additional variations and modifications of these embodiments may occur to those skilled in the art once they learn of the basic inventive concepts. Therefore, it is intended that the appended claims be interpreted as including preferred embodiments and all such alterations and modifications as fall within the scope of the embodiments of the invention.
Finally, it should also be noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or terminal that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or terminal. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other like elements in a process, method, article, or terminal that comprises the element.
The three-dimensional femoral stem provided by the invention is described in detail, and the principle and the implementation mode of the invention are explained by applying specific examples, and the description of the examples is only used for helping to understand the method and the core idea of the invention; meanwhile, for a person skilled in the art, according to the idea of the present invention, there may be variations in the specific embodiments and the application scope, and in summary, the content of the present specification should not be construed as a limitation to the present invention.

Claims (8)

1. A three-dimensional femoral stem is used for replacing a partial implant of a femur of a patient in hip replacement surgery, and is characterized by comprising a stem body and an outer cover shell sleeved outside the stem body, wherein the stem body is fixedly connected with the outer cover shell;
the handle body comprises a femoral awl, a femoral neck, a femoral handle shoulder and a femoral handle far end; one end of the shoulder part of the femoral stem is connected with the far end of the femoral stem, and the other end of the shoulder part of the femoral stem is connected with the femoral neck; one end of the femoral neck, which is far away from the shoulder part of the femoral stem, is connected with the femoral awl;
the outer housing is a hollow annular structure, the inner side shape of the outer housing is matched with the shape of the shoulder of the femoral stem, and the outer side shape of the outer housing is matched with the shape of the femoral side of the patient.
2. The three-dimensional femoral stem according to claim 1, wherein said fixed connection is a sintered connection and/or a riveted and/or screwed connection, wherein said sintering temperature is greater than 1000 ℃.
3. The three-dimensional femoral stem according to claim 1, wherein the porosity of the outer shell is 20% to 85%;
the pore diameter of the pore of the outer cover shell is 50-400 μm.
4. The three-dimensional femoral stem according to claim 1, wherein the distal end of the femoral stem is tapered.
5. The three-dimensional femoral stem according to claim 1, wherein the top end of the shoulder part of the femoral stem is provided with a fixing hole for connecting a femoral stem driver.
6. A three-dimensional femoral stem fabrication method for fabricating a femoral stem that matches a femoral side of a patient by a three-dimensional printing technique, comprising:
acquiring CT image data of the femoral side part of the patient;
determining the three-dimensional data of the outer casing of the femoral stem according to the CT image data and the preset data of the stem body, wherein the three-dimensional data of the outer casing comprises an outer surface shape and an inner surface shape; the outer surface shape matches the shape of the patient's femoral side and the inner surface shape matches the shape of the pre-set stem;
manufacturing the outer shell according to the outer surface shape and the inner surface shape;
and assembling the outer housing shell and the preset handle body to obtain the femoral handle matched with the femoral side of the patient.
7. The method of claim 6, wherein the step of determining the three-dimensional data of the outer shell of the femoral stem according to the CT image data and the data of the preset stem body further comprises:
acquiring preset surface shape data of a handle body;
determining an inner surface shape from the surface shape data.
8. The method of claim 7, wherein the step of manufacturing the outer shell according to the outer surface shape and the inner surface shape comprises:
determining an outer shell model according to the shape of the outer surface and the shape of the inner surface;
partitioning the shell model into at least two plane-level data;
manufacturing the outer casing according to the plane level data.
CN202011512157.4A 2020-12-19 2020-12-19 Three-dimensional femoral stem and manufacturing method Pending CN112472369A (en)

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN204655196U (en) * 2015-03-17 2015-09-23 刘宏伟 A kind of Modular femoral prosthesis
CN106880424A (en) * 2015-12-16 2017-06-23 重庆润泽医药有限公司 A kind of artificial shoulder joint prosthesis
CN209059542U (en) * 2017-12-13 2019-07-05 西北有色金属研究院 A kind of 3D printing metal bone trabecula surface hip joint prosthese
CN111588519A (en) * 2020-05-28 2020-08-28 常州市第二人民医院 Manufacturing method and evaluation method of metal 3D printed short-stem femoral prosthesis
CN111759548A (en) * 2020-07-22 2020-10-13 张国强 Artificial hip joint femoral stem prosthesis
CN211834874U (en) * 2020-01-10 2020-11-03 北京力达康科技有限公司 Artificial joint femoral stem hip joint prosthesis
CN214632511U (en) * 2020-12-19 2021-11-09 经纬医疗器材制造(深圳)有限公司 Three-dimensional femoral stem

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN204655196U (en) * 2015-03-17 2015-09-23 刘宏伟 A kind of Modular femoral prosthesis
CN106880424A (en) * 2015-12-16 2017-06-23 重庆润泽医药有限公司 A kind of artificial shoulder joint prosthesis
CN209059542U (en) * 2017-12-13 2019-07-05 西北有色金属研究院 A kind of 3D printing metal bone trabecula surface hip joint prosthese
CN211834874U (en) * 2020-01-10 2020-11-03 北京力达康科技有限公司 Artificial joint femoral stem hip joint prosthesis
CN111588519A (en) * 2020-05-28 2020-08-28 常州市第二人民医院 Manufacturing method and evaluation method of metal 3D printed short-stem femoral prosthesis
CN111759548A (en) * 2020-07-22 2020-10-13 张国强 Artificial hip joint femoral stem prosthesis
CN214632511U (en) * 2020-12-19 2021-11-09 经纬医疗器材制造(深圳)有限公司 Three-dimensional femoral stem

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