CN111631843A - Hip joint femoral stem prosthesis and manufacturing method thereof - Google Patents
Hip joint femoral stem prosthesis and manufacturing method thereof Download PDFInfo
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- CN111631843A CN111631843A CN202010506702.2A CN202010506702A CN111631843A CN 111631843 A CN111631843 A CN 111631843A CN 202010506702 A CN202010506702 A CN 202010506702A CN 111631843 A CN111631843 A CN 111631843A
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- femoral stem
- stem prosthesis
- mesh structure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
- A61F2/3662—Femoral shafts
- A61F2/367—Proximal or metaphyseal parts of shafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30907—Nets or sleeves applied to surface of prostheses or in cement
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30772—Apertures or holes, e.g. of circular cross section
- A61F2002/30784—Plurality of holes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30907—Nets or sleeves applied to surface of prostheses or in cement
- A61F2002/30909—Nets
- A61F2002/30912—Nets made of expanded metal, e.g. diamond mesh or metal nets having lozenge-shaped apertures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2002/3093—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
- A61F2310/00419—Other metals
- A61F2310/00544—Coating made of tantalum or Ta-based alloys
Abstract
The invention relates to the technical field of medical instruments, and provides a hip joint femoral stem prosthesis and a manufacturing method thereof. The method comprises the following steps: the femoral stem prosthesis comprises a femoral stem prosthesis body, wherein a bone trabecular structure is arranged on the outer surface of the femoral stem prosthesis body and matched with the outer surface of the femoral stem prosthesis body; the bone trabecula structure is a 3D printed tantalum mesh structure, the pore diameters of the inner surfaces of the 3D printed tantalum mesh structure are respectively 200-400 mu m, the thickness of the porous structure of the inner surface is 1mm, the pore diameters of the outer surfaces of the 3D printed tantalum mesh structure are 600-800 mu m, and the thickness of the porous structure of the outer surface is 1 mm. The invention has the beneficial effects that: the high-porosity structure of the tantalum mesh structure is beneficial to the occurrence of osteoinduction, and soft tissues can be quickly and widely infiltrated and firmly attached; the femoral stem prosthesis has simple preparation method and low cost, is beneficial to implementation and clinical application and is suitable for the requirements of patients.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a hip joint femoral stem prosthesis and a manufacturing method thereof.
Background
The hip joint femoral stem prosthesis is a surgical implant used for replacing a hip joint femoral part of a human body. At present, cement type and biological type hip joint femoral stems exist, the cement type needs to be fixed by filling bone cement, and the biological type needs to be fixed by processes of spraying titanium powder or sintering titanium beads on the surface. The hip joint femoral stem is combined with a full acetabulum, a lining and a ball head for use in hip joint total hip replacement surgery. The existing hip joint femoral stem prosthesis structure has the defects of inconvenient processing, long development period and the like.
Although the hip joint femoral stem prosthesis can replace the hip joint femoral part, the hip joint femoral stem prosthesis has a plurality of defects in actual use, so that the hip joint femoral stem prosthesis cannot achieve the optimal use effect in actual application. The disadvantages can be summarized as follows:
(1) the prior hip joint biological femoral stem is prepared by processes of spraying emery, titanium, HA, titanium bead sintering and the like on the surface. Although the surface of the titanium bead reaches a certain roughness, the problems of absorption and falling of the coating, micromotion of the titanium bead and the bone and the like exist, so that the problems of unsatisfactory bone growth or infection, operative revision and the like caused by the falling of the titanium bead are caused.
(2) In the titanium alloy 3D printing hip joint femoral stem trabecular structure, titanium and titanium alloy have good mechanical strength and biocompatibility, are preferred materials of orthopedic implants and dental implants, can carry out surface biological modification on titanium, and obviously enhance the integration capability of titanium and host bones, but titanium has the defects of poor mechanical property, easy physiological corrosion and the like, and the clinical success rate of titanium is influenced.
(3) Both in the spraying technique and in the metal sintering technique, the distribution of the coating and the technical parameters (such as pore diameter, porosity, thickness and the like) thereof cannot be precisely controlled, and the combination of the coating and the bone cannot be optimized.
With the increasing medical requirements, new requirements are made on the ability of joint components to promote bone ingrowth.
Disclosure of Invention
The invention aims to provide a hip joint femoral stem prosthesis and a manufacturing method thereof, and aims to solve the technical problems in the prior art.
In order to achieve the purpose, the invention adopts the technical scheme that: a hip femoral stem prosthesis comprising: the femoral stem prosthesis comprises a femoral stem prosthesis body, wherein a bone trabecular structure is arranged on the outer surface of the femoral stem prosthesis body and matched with the outer surface of the femoral stem prosthesis body; the bone trabecula structure is a 3D printed tantalum mesh structure, the pore diameters of the inner surfaces of the 3D printed tantalum mesh structure are respectively 200-400 mu m, the thickness of the porous structure of the inner surface is 1mm, the pore diameters of the outer surfaces of the 3D printed tantalum mesh structure are 600-800 mu m, and the thickness of the porous structure of the outer surface is 1 mm.
In an optional embodiment, the compressive strength of the tantalum mesh structure for 3D printing is 120-180 MPa, the elastic modulus is 10-20 GPa, and the porosity is 75-85%.
In an optional embodiment, the tantalum mesh structure is formed by a 3D printing brazing process.
In another aspect, the present invention further provides a method for manufacturing the hip femoral stem prosthesis, which comprises: and importing the obtained format file into a 3D printer for 3D printing to obtain the tantalum mesh structure.
In an optional embodiment, the 3D printing material is 15-45 μm spherical tantalum powder, the purity of the spherical tantalum powder is greater than 99.9%, the oxygen content is less than 500ppm, the sphericity is greater than 90, and the Hall flow rate is less than 10s/50 g.
In an alternative embodiment, the laser straight defocused spot for 3D printing is 135 μm, the speed is 150mm/s, the line spacing is 0.5mm, and the power is 250W.
In an alternative embodiment, the temperature of the 3D printed substrate is 100 ℃.
The invention has the beneficial effects that:
(1) the trabecular bone metal with the cellular structure of the 3D printed tantalum mesh structure is similar to a cancellous bone structure and is closer to a bone than any other prosthesis metal in terms of physical properties and mechanical properties.
(2) The high-porosity structure of the 3D printed tantalum mesh structure is beneficial to the occurrence of bone induction, can quickly and widely infiltrate and firmly attach soft tissues, and has high load strength and low elastic modulus, so that stress shielding is minimized under physiological load conditions, and the surface of the tantalum material has excellent biocompatibility.
(3) The 3D printed tantalum mesh structure is a three-dimensional communicated pore structure, the porosity is 75-85%, and the pore diameter is 400-600 mu m; the high porosity of the tantalum mesh structure is determined by the high porosity of the CoCr sintered body (30-50%) and the titanium fiber mesh (40-50%) which are superior in mechanical properties.
(4) The femoral stem prosthesis has simple preparation method and low cost, is beneficial to implementation and clinical application and is suitable for the requirements of patients.
Drawings
In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed for the embodiments or the prior art descriptions will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings without creative efforts.
Fig. 1 is a front view of a hip stem prosthesis according to an embodiment of the present invention.
Fig. 2 is a side view of a hip femoral stem prosthesis according to an embodiment of the present invention.
Wherein, the reference numbers in the figures are: 1. tantalum mesh structure, 2, silver braze metal.
Detailed Description
In order to make the technical problems, technical solutions and advantageous effects to be solved by the present invention more clearly apparent, the present invention is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly or indirectly secured to the other element. When an element is referred to as being "connected to" another element, it can be directly or indirectly connected to the other element. The terms "upper", "lower", "left", "right", "front", "rear", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like indicate orientations or positions based on the orientations or positions shown in the drawings, and are for convenience of description only and not to be construed as limiting the technical solution. The terms "first", "second" and "first" are used merely for descriptive purposes and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features. The meaning of "plurality" is two or more unless specifically limited otherwise.
Example one
Referring to fig. 1-2, the present embodiment provides a hip stem prosthesis, including: the method comprises the following steps: the femoral stem prosthesis comprises a femoral stem prosthesis body, wherein a bone trabecular structure is arranged on the outer surface of the femoral stem prosthesis body and matched with the outer surface of the femoral stem prosthesis body; the trabecular bone structure is a 3D printed tantalum mesh structure 1, the pore diameters of the inner surfaces of the 3D printed tantalum mesh structure 1 are respectively 200-400 mu m, the thickness of the porous structure of the inner surface is 1mm, the pore diameters of the outer surfaces of the 3D printed tantalum mesh structure 1 are 600-800 mu m, and the thickness of the porous structure of the outer surface is 1 mm. It is worth mentioning that the trabecular metal of the cellular structure of the tantalum mesh structure 1 resembles cancellous bone structure and is closer to bone in physical and mechanical properties than any other prosthetic metal. In addition, the high porosity structure of the tantalum mesh structure 1 is beneficial to the occurrence of osteoinduction, can rapidly and widely infiltrate and firmly attach soft tissues, has high load bearing strength and low elastic modulus, thereby allowing the stress shielding to be minimized under physiological load bearing conditions, and has excellent biocompatibility on the surface of the tantalum material.
Specifically, the compressive strength of the 3D printed tantalum mesh structure 1 is 120-180 MPa, the elastic modulus is 10-20 GPa, and the porosity is 75-85%. It should be noted that the tantalum mesh structure 1 adopts a 3D printing brazing process, and the silver brazing metal 2 is a main auxiliary material in the 3D printing brazing process. The high porosity of the tantalum mesh structure 1 is determined by its superior mechanical properties through the high porosity structure of the CoCr sintered body (30-50%) and the titanium fiber mesh (40-50%). The maximum bending strength of the tantalum mesh structure 1 reaches 110MPa, and sufficient physiological support can be provided for new bone tissues. The coefficient of friction purlin of tantalum net structure 1 and bone group is 40 ~ 80% higher than traditional metal implant material, helps the combination with the host bone, although increase initial stage stability. The elastic modulus of the tantalum mesh structure 1 is about 3GPa, is between that of cortical bone (12-I8GPa) and that of cancellous bone (0.2-0.5GPa), is obviously lower than that of titanium alloy and chromium alloy, and the elastic modulus matched with human bone tissue can effectively reduce stress shielding effect and is beneficial to bone tissue remodeling.
Example two
The invention also provides a manufacturing method of the hip joint femoral stem prosthesis, which comprises the following steps: and importing the obtained format file into a 3D printer for 3D printing to obtain the tantalum mesh structure 1.
Specifically, the 3D printing material is 15-45 mu m spherical tantalum powder, the purity of the spherical tantalum powder is more than 99.9%, the oxygen content is less than 500ppm, the sphericity is more than 90, and the Hall flow rate is less than 10s/50 g. The laser positive defocusing spot of 3D printing is 135 μm, the speed is 150mm/s, the line spacing is 0.5mm, and the power is 250W. The temperature of the 3D printed substrate was 100 ℃. GB/T1964-1996 is adopted to test the mechanical property of the tantalum mesh structure 1, and the result shows that the compressive strength reaches more than 180MPa and the elastic modulus reaches more than 15 GPa. The porosity of the tantalum mesh structure 1 is measured by GB/T5163-2006, and reaches over 75%. The hip joint femoral stem process has the advantages of simple preparation method, low cost, and contribution to implementation and clinical application, and is suitable for the requirements of patients
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included within the scope of the present invention.
Claims (7)
1. A hip femoral stem prosthesis comprising: the femoral stem prosthesis comprises a femoral stem prosthesis body, wherein a bone trabecular structure is arranged on the outer surface of the femoral stem prosthesis body and matched with the outer surface of the femoral stem prosthesis body;
the method is characterized in that: the bone trabecula structure is a 3D printed tantalum mesh structure, the pore diameters of the inner surfaces of the 3D printed tantalum mesh structure are respectively 200-400 mu m, the thickness of the porous structure of the inner surface is 1mm, the pore diameters of the outer surfaces of the 3D printed tantalum mesh structure are 600-800 mu m, and the thickness of the porous structure of the outer surface is 1 mm.
2. The hip femoral stem prosthesis according to claim 1, wherein the tantalum mesh structure printed in 3D has a compressive strength of 120 to 180MPa, an elastic modulus of 10 to 20GPa, and a porosity of 75 to 85%.
3. The hip femoral stem prosthesis according to claim 2, wherein the tantalum mesh structure is applied by a 3D printing brazing process.
4. The method for manufacturing a hip-femoral stem prosthesis according to any one of claims 1 to 3, wherein the obtained format file is introduced into a 3D printer for 3D printing to obtain the tantalum mesh structure.
5. The method for manufacturing a hip femoral stem prosthesis according to claim 4, wherein the 3D printed material is 15-45 μm spherical tantalum powder, the purity of the spherical tantalum powder is more than 99.9%, the oxygen content is less than 500ppm, the sphericity is more than 90, and the Hall flow rate is less than 10s/50 g.
6. The method of claim 5, wherein the 3D printed laser beam has a positive defocus spot of 135 μm, a velocity of 150mm/s, a line spacing of 0.5mm, and a power of 250W.
7. The method of manufacturing a hip femoral stem prosthesis according to claim 6, wherein the temperature of the 3D printed substrate is 100 ℃.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202010506702.2A CN111631843A (en) | 2020-06-05 | 2020-06-05 | Hip joint femoral stem prosthesis and manufacturing method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010506702.2A CN111631843A (en) | 2020-06-05 | 2020-06-05 | Hip joint femoral stem prosthesis and manufacturing method thereof |
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| CN111631843A true CN111631843A (en) | 2020-09-08 |
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| CN202010506702.2A Pending CN111631843A (en) | 2020-06-05 | 2020-06-05 | Hip joint femoral stem prosthesis and manufacturing method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112336477B (en) * | 2020-11-06 | 2022-03-25 | 北京市春立正达医疗器械股份有限公司 | Dental implant with bone induction structure |
| CN117257529A (en) * | 2023-11-21 | 2023-12-22 | 北京力达康科技有限公司 | Tantalum coating hip joint prosthesis system |
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| CN107260369A (en) * | 2017-06-15 | 2017-10-20 | 西安交通大学 | It is a kind of to be used for the personalized biological type cushion block of Cranial defect in total knee arthroplasty |
| CN209075034U (en) * | 2018-01-15 | 2019-07-09 | 北京力达康科技有限公司 | A kind of artificial dog hip prosthesis of porous metals |
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