CN117257529B

CN117257529B - Tantalum coating hip joint prosthesis system

Info

Publication number: CN117257529B
Application number: CN202311556037.8A
Authority: CN
Inventors: 张晓攀; 周海明; 马淑芹
Original assignee: Beijing Lidakang Technology Co Ltd
Current assignee: Beijing Lidakang Technology Co Ltd
Priority date: 2023-11-21
Filing date: 2023-11-21
Publication date: 2024-02-09
Anticipated expiration: 2043-11-21
Also published as: CN117257529A

Abstract

The application discloses a tantalum-coated hip joint prosthesis system. The tantalum coating hip joint prosthesis system comprises a femoral component, wherein the femoral component comprises a femoral stem, the femoral stem comprises a proximal end, a first coating area and an embedding area are arranged on the outer surface of the femoral stem, which is close to the proximal end, the first coating area is provided with a first tantalum coating, and the embedding area is embedded with a tantalum block. The tantalum coating hip joint prosthesis system can solve the problem that the aseptic loosening of the prosthesis is easy to occur due to stress shielding at the proximal femur end after the tantalum coating hip joint prosthesis system in the prior art is implanted.

Description

Tantalum coating hip joint prosthesis system

Technical Field

The application relates to the technical field of medical instruments, in particular to a tantalum coating hip joint prosthesis system.

Background

In recent years, hip joint diseases are increasing and hip joint replacement is becoming mature with various reasons such as continuous deterioration of environment, food safety problems, eating habits, pollution and the like. In actual replacement, the prosthesis is implanted to replace the diseased, necrotic or damaged hip joint so as to achieve the purpose of recovering the joint function.

For a long time, the operation time, the coating technology and the aseptic loosening of the prosthesis caused by stress shielding at the proximal femur after implantation have the factors of poor long-term fixing effect, incapability of meeting the specificity and complexity cases of the standard joint and the like, which always influence the success rate of the hip joint and the satisfaction degree after operation.

Disclosure of Invention

The main object of the present application is to provide a tantalum-coated hip joint prosthesis system, so as to at least solve the problem that the proximal femur end of the hip joint prosthesis after implantation in the prior art is blocked by stress, which easily causes aseptic loosening of the prosthesis.

According to one aspect of the present application, there is provided a tantalum-coated hip prosthesis system comprising:

the femoral component comprises a femoral stem, the femoral stem comprises a proximal end, a first coating area and an embedding area are arranged on the outer surface of the femoral stem, which is close to the proximal end, a first tantalum coating is arranged on the first coating area, and tantalum blocks are embedded in the embedding area.

Further, the femoral stem comprises a first surface and a second surface which are oppositely arranged, and the first surface and the second surface are connected through a third surface;

the third surface is positioned on the side edge of the femoral stem facing the outer side of the human body, the first coating area is formed on one side, at least close to the proximal end, of the first surface and the second surface, and the mosaic area is formed on one side, at least close to the proximal end, of the third surface.

Further, the surface of the first coating area is provided with a step portion, the step portion comprises a plurality of steps, the steps are sequentially connected along the length direction of the femoral stem, a concave hole or a bulge is formed in the step surface of the step, and the step surface with the concave hole and the bulge are alternately arranged along the length direction of the femoral stem.

Further, the recess comprises a hemispherical recess, the protrusion comprises a hemispherical protrusion, and the diameters of the hemispherical recess and the hemispherical protrusion are 2.0mm to 3.0 mm; and/or the number of the groups of groups,

the width of the step surface is 4.0-mm to 6.0mm.

Further, the first coating area and the inlay area are arranged side by side along the same circumference of the femoral stem, a second coating area is further arranged on the surface of the femoral stem, the second coating area is located on one side, away from the proximal end, of the first coating area, a second tantalum coating is arranged on the second coating area, and the density of the second tantalum coating is smaller than that of the first tantalum coating.

Further, the tantalum pellet comprises a microporous structure.

Further, the femoral stem includes a distal end, and the femoral component further includes a soft component coupled to the distal end of the femoral stem.

Further, the software component includes:

a soft core connected to the distal end and extending along the length of the femoral stem;

the isthmus fixing seat is sleeved on the soft core, and the outer side surface of the isthmus fixing seat is provided with teeth;

the ball drill reamer is arranged at one end of the soft core far away from the femoral stem.

Further, the software component further comprises:

the ball drill reamer is positioned in the concave cambered surface of the circular arc-shaped sheet structure.

Further, the isthmus mount is movably disposed along a length of the soft body core, the soft body further comprising:

the elastic element is sleeved on the soft core, and two ends of the elastic element respectively prop against the femur handle and the isthmus fixing seat.

Further, the femoral component further comprises a femoral stem neck detachably connected to the proximal end through a locking member, a first annular positioning rack is arranged on the femoral stem, and a second annular positioning rack meshed with the first annular positioning rack is arranged on the femoral stem neck.

Further, the tantalum coating hip joint prosthesis system further comprises a ball head part, the ball head part comprises a hard ball head and a spherical lining layer, the hard ball head is connected to the femoral stem, the outer surface of the hard ball head is treated by titanium, niobium and nitrogen, and the spherical lining layer is sleeved on the hard ball head and can rotate relative to the hard ball head.

Further, the tantalum-coated hip joint prosthesis system further comprises:

the acetabulum body is provided with a groove, the spherical lining layer is rotatably arranged in the groove, the outer surface of the acetabulum body is provided with an elastic connecting layer, and the elastic connecting layer is provided with a connecting hole;

the acetabular cup layer is sleeved on the acetabular entity, and a through hole for a connecting piece to pass through is formed in the acetabular entity;

the end part of the connecting piece is provided with a ball head structure, an elastic ball sleeve is sleeved on the ball head structure, and the elastic ball sleeve is detachably inserted into the connecting hole.

Further, the acetabular cup layer comprises a 3D printed titanium alloy bone trabecular layer; or,

the acetabular cup layer comprises a titanium alloy layer and a third tantalum coating arranged on the outer surface of the titanium alloy layer.

Further, an internal hydrophobic bore is provided in the femoral stem.

In the application, the metal tantalum in the first tantalum coating and the tantalum block has very excellent corrosion resistance and excellent biocompatibility, and the metal tantalum has high strength, is wear-resistant and has no stimulation effect on a machine body. The first tantalum coating and the tantalum block have strong adhesion effect with cells, and create good conditions for the growth and proliferation of osteoblasts, so that the prosthesis is better combined with bones and soft tissues, the effect of long-time stability is achieved, the service life is prolonged, and the secondary repair operation is avoided or reduced. In addition, after the tantalum coating hip joint prosthesis system is implanted into a human body, the arrangement of the first tantalum coating and the tantalum block can improve the stress distribution of the proximal end of the femoral stem, reduce the rigidity of the distal end of the femoral stem, weaken the shear force transmission load between the tantalum coating hip joint prosthesis system and the contact surface of the human body, and further weaken the condition that the load of the proximal end of the femoral component suddenly becomes smaller. That is, the tantalum coating hip joint prosthesis system in the application can reduce the phenomenon of stress shielding to a certain extent, and further can relieve the problems of aseptic loosening, fracture around the prosthesis, mechanical failure of the prosthesis and the like of the tantalum coating hip joint prosthesis system after operation.

Drawings

The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this application, illustrate embodiments of the application and together with the description serve to explain the application and do not constitute an undue limitation to the application. In the drawings:

FIG. 1 is an exploded view of a tantalum coated hip prosthesis system disclosed in an embodiment of the present application;

FIG. 2 is an exploded view of another tantalum coated hip prosthesis system disclosed in an embodiment of the present application;

FIG. 3 is a schematic diagram of a first tantalum coating, tantalum pellet, and second tantalum coating portion according to an embodiment of the disclosure;

FIG. 4 is a perspective view of a femoral stem in a first view in accordance with an embodiment of the present disclosure;

FIG. 5 is an exploded view of the femoral stem of FIG. 4;

FIG. 6 is a side view of the femoral stem of FIG. 4;

FIG. 7 is a cross-sectional view of the femoral stem of FIG. 4;

FIG. 8 is a partial view of a stepped portion disclosed in an embodiment of the present application;

FIG. 9 is a cross-sectional view of a software component disclosed in an embodiment of the present application;

FIG. 10 is a cross-sectional view of a soft body core disclosed in an embodiment of the present application;

FIG. 11 is a first cross-sectional view of a femoral stem and femoral stem neck portion partially disassembled as disclosed in an embodiment of the present application;

FIG. 12 is a second cross-sectional view of a femoral stem and femoral stem neck portion partially disassembled as disclosed in an embodiment of the present application;

FIG. 13 is a top view of a first annular positioning rack disclosed in an embodiment of the present application;

FIG. 14 is an exploded view of an acetabular component disclosed in an embodiment of the application;

FIG. 15 is a block diagram of an acetabular entity and a connector portion disclosed in an embodiment of the application;

fig. 16 is a schematic view showing a partial structure of a tantalum block according to an embodiment of the present application.

Wherein the above figures include the following reference numerals:

10. a femoral component; 11. a femoral stem; 111. a femoral stem neck; 1111. a second annular positioning rack; 1101. a proximal end; 1102. a distal end; 1103. a first surface; 1104. a second surface; 1105. a third surface; 1106. a step portion; 11061. a step surface; 11062. concave holes; 11063. a protrusion; 1107. a second coating zone; 1108. a first coating zone; 1109. a mosaic region; 1110. a first annular positioning rack; 11111. an inner open hole; 112. a first tantalum coating; 113. a second tantalum coating; 114. a tantalum block; 12. a software component; 121. a soft core; 122. a isthmus holder; 1221. a tooth portion; 123. ball drill reamer; 124. an anchor body; 125. an elastic element; 20. an acetabular component; 21. a ball head portion; 211. a hard ball head; 212. a spherical inner liner; 22. an acetabular component; 221. an acetabular entity; 2211. an elastic connection layer; 2212. a connection hole; 22121. a recessed portion; 2213. a groove; 222. an acetabular cup layer; 2221. a through hole; 23. a connecting piece; 231. a ball head structure; 232. an elastic ball sleeve; 2321. a flange; 30. a locking piece.

Detailed Description

It should be noted that, in the case of no conflict, the embodiments and features in the embodiments may be combined with each other. The present application will be described in detail below with reference to the accompanying drawings in conjunction with embodiments.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments in accordance with the present application. As used herein, the singular is also intended to include the plural unless the context clearly indicates otherwise, and furthermore, it is to be understood that the terms "comprises" and/or "comprising" when used in this specification are taken to specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof.

The relative arrangement of the components and steps, numerical expressions and numerical values set forth in these embodiments do not limit the scope of the present application unless it is specifically stated otherwise. Meanwhile, it should be understood that the sizes of the respective parts shown in the drawings are not drawn in actual scale for convenience of description. Techniques, methods, and apparatus known to one of ordinary skill in the relevant art may not be discussed in detail, but should be considered part of the authorization specification where appropriate. In all examples shown and discussed herein, any specific values should be construed as merely illustrative, and not a limitation. Thus, other examples of the exemplary embodiments may have different values. It should be noted that: like reference numerals and letters denote like items in the following figures, and thus once an item is defined in one figure, no further discussion thereof is necessary in subsequent figures.

According to the prior studies and literature, the stress shielding effect of the proximal femur after Total Hip Arthroplasty (THA) is one of the causes of bone loss around the prosthesis. This phenomenon exists in both bone cement and non-bone cement prostheses. When the femoral stem is implanted with the prosthesis, the load transmission path of the proximal femur can be changed, and the load which is originally directly transmitted through the proximal femur cancellous bone trabecular part is changed into the load which is transmitted through the shearing force between the prosthesis and the contact interface of the femur; in addition, the femoral stem has stronger rigidity than the prosthesis and is not easy to deform, so that the load born by the proximal end of the femur after operation is suddenly reduced, namely stress shielding is generated. The bone tissue growth after operation is a dynamic process which changes along with the load, namely the higher load part promotes the bone growth and the lower load part promotes the bone absorption. The presence of stress shielding causes bone resorption of the bone surrounding the prosthesis due to the lack of sufficient stress stimulus, resulting in failure of the fixation of the prosthesis. Bone loss may cause a series of problems such as mechanical failure of the femoral prosthesis, loosening of the prosthesis, fracture around the prosthesis, increased difficulty in revision surgery, etc. To this end, the present application provides a novel tantalum-coated hip prosthesis system, which will be described in detail below with reference to the specific drawings.

Referring to fig. 2-15, a tantalum-coated hip prosthesis system is provided according to embodiments of the present application. The tantalum-coated hip prosthesis system includes a femoral component 10 and an acetabular component 20.

Wherein the femoral component 10 comprises a femoral stem 11 and a soft component 12, the femoral stem 11 comprising a proximal end 1101 and a distal end 1102, the soft component 12 being connected to the distal end 1102; the acetabular component 20 includes a ball portion 21, an acetabular component 22 and a connector 23, the ball portion 21 being connected at a distal end 1102, the acetabular component 22 being rotatably connected to the ball portion 21, the connector 23 being threaded onto the acetabular component 20 for connection to the pelvic bone.

In the actual operation process, firstly, the diseased hip joint is taken out, the acetabular component 22 is fixed by press fit, and the connecting piece 23 is connected to the pelvic bone, then the distal end 1102 of the femoral component 10 is inserted into the intramedullary canal of the femur of the human body, the femoral component 10 is connected and fixed with the femur of the human body, then the ball head 21 is fixedly connected with the proximal end 1101 of the femoral component 10, and finally the ball head 21 and the acetabular component 22 are assembled. When assembled, the acetabular component 22 may be rotated relative to the ball portion 21 to facilitate the basic kinematics of the hip joint.

In the present application, since the distal end 1102 of the femoral stem 11 of the tantalum-coated hip prosthesis system is connected with the soft component 12, the presence of the soft component 12 can reduce the rigidity of the distal end 1102 of the femoral stem 11, and can reduce the shear force transmission load between the tantalum-coated hip prosthesis system and the human body contact surface, so as to further reduce the sudden load reduction of the proximal end 1101 of the femoral component 10. That is, the tantalum coating hip joint prosthesis system in the embodiment can reduce the phenomenon of stress shielding to a certain extent, so that the problems of aseptic loosening, fracture around the prosthesis, mechanical failure of the prosthesis and the like of the tantalum coating hip joint prosthesis system after operation can be relieved.

As shown in fig. 2, 9-10, the soft body member 12 of the present embodiment includes a soft body core 121, an isthmus anchor 122, and a ball drill reamer 123.

Wherein the soft core 121 is connected to the distal end 1102 and extends along the length of the femoral stem 11; the isthmus fixing seat 122 is sleeved on the soft core 121, and the outer side surface of the isthmus fixing seat 122 is provided with a tooth 1221; the ball drill reamer 123 is disposed at the end of the soft core 121 remote from the femoral stem 11.

In this embodiment, the soft core 121 is generally a cylindrical structure, the cross section of the cylindrical structure is smaller than that of the main body of the femoral stem 11, the soft core 121 is formed by a plurality of wires with certain elasticity (7 wires are shown in fig. 8), and the soft core 121 has certain deformability, is convenient to fit into the femoral marrow cavity of a human body in a homeopathic manner in the operation process, has certain rigidity, can pass through the physiological anterior arch of the bone, and realizes effective protection of bone in the intramedullary cavity. The isthmus fixing seat 122 is a hard block structure, which may be a cylindrical block structure, a prismatic block structure or other special-shaped block structures, a through hole is formed in the block structure, the isthmus fixing seat 122 is sleeved on the soft core 121 through the through hole, and the isthmus fixing seat 122 may be fixedly connected with the isthmus of the femoral marrow cavity of a human body in the actual operation process, specifically, the isthmus fixing seat 122 is fixed through a tooth 1221 arranged on the outer side surface of the isthmus fixing seat 122. The setting of the isthmus fixing base 122 can have the effect of fixing the middle section of the soft body core 121. The ball drill reamer 123 is a flexible reamer arranged in a ball head shape, and in the operation process, when the prosthesis encounters slight resistance in the femoral intramedullary cavity, the ball drill reamer 123 can be rotated to squeeze cortical bone to the outer peripheral side of the femoral component 10 until the femoral component 10 is not sunk any more, that is, the tantalum coating hip joint prosthesis system in the embodiment can be used as an operation tool in the operation, so that the operation time can be reduced to a certain extent.

Further, the soft component 12 of the present embodiment further includes an anchor 124, the anchor 124 is disposed in a circular arc-shaped sheet structure, the ball drill reamer 123 is located in a concave arc surface of the circular arc-shaped sheet structure, and the anchor 124 is disposed to limit and support the femoral component 10.

In actual installation, the isthmus fixing base 122 in this embodiment is movably disposed along the length direction of the soft core 121, so that the soft core 121 is conveniently limited at a proper position. The soft body part 12 further comprises an elastic element 125, the elastic element 125 is sleeved on the soft body core 121, and two ends of the elastic element 125 respectively prop against the femoral stem 11 and the isthmus fixing seat 122. Alternatively, the elastic element 125 may be a spring, an elastic pad, or other elastic structure that may be suitable for use in the femoral marrow cavity. The elastic element 125 can not only protect the soft core 121, but also realize stress buffering with the femoral stem 11, and can further reduce the problem of stress shielding in the use process of the tantalum-coated hip joint prosthesis system. In actual installation, distal end 1102 of femoral stem 11 is provided with a connecting taper hole into which soft core 121 may be inserted by interference fit or the like.

Referring to fig. 2 to 13, the femoral component 10 of the present embodiment further includes a femoral stem neck 111, the femoral stem neck 111 is detachably connected to the proximal end 1101 by a locking member 30, the ball head 21 is connected to an end of the femoral stem neck 111 remote from the femoral stem 11, a first annular positioning rack 1110 is provided on the femoral stem 11, and a second annular positioning rack 1111 engaged with the first annular positioning rack 1110 is provided on the femoral stem neck 111. In this embodiment, by providing the detachable femoral neck 111, in the actual operation process, the femoral neck 111 may be rotated according to the specific situation of the patient to adjust the installation angle of the femoral neck 111, and then locked by the locking member 30, and optionally, the locking member 30 in this embodiment may be a locking screw, a locking pin or a rivet, which is in any other deformation mode under the concept of the present application, and is within the scope of protection of the present application.

In this application, the first annular positioning rack 1110 and the second annular positioning rack 1111 may be planar racks (racks are formed in a plane) or conical racks (racks are formed in a conical surface), and the central angle corresponding to two adjacent convex teeth cannot be too large, which is more suitable for fine adjustment of the rotation angle of the femoral stem neck 111. Alternatively, the central angle a corresponding to two adjacent racks of the first annular set rack 110 and the second annular set rack 1111 in the present embodiment is not more than 10 ° (as shown in fig. 13), for example, 8 °, 6 °, 5 °, 4 °, 2 °, etc. In the actual operation process, the anteversion angle of a proper patient can be found by rotating the femoral stem neck 111, and the femoral stem neck 111 is limited on the femoral stem 11 through the first annular positioning rack 1110 and the second annular positioning rack 1111 after the adjustment is completed, so that the structure is simple, and the operation time can be shortened to a certain extent.

Referring to fig. 2-15, the outer surface of the femoral stem 11 near the proximal end 1101 in this embodiment is provided with a first coating region 1108 and a mosaic region 1109, the first coating region 1108 is provided with a first tantalum coating 112, and the mosaic region 1109 is inlaid with a tantalum block 114, the tantalum block 114 comprising a microporous structure. In this embodiment, by disposing the first tantalum coating 112 and the tantalum block 114 on the outer surface of the femoral stem 11, the first tantalum coating 112 and the tantalum block 114 are both porous structures, and the metal tantalum has very excellent corrosion resistance and excellent biocompatibility, and the metal tantalum has high strength, is wear-resistant, and has no stimulation to the body. The first tantalum coating 112 and the tantalum block 114 have strong adhesion effect with cells, and create good conditions for the growth and proliferation of osteoblasts, so that the prosthesis is better combined with bones and soft tissues, the effect of long-time stability is achieved, the service life is prolonged, and secondary repair operations are avoided or reduced. In addition, when the tantalum-coated hip joint prosthesis system is implanted into a human body, the arrangement of the first tantalum coating 112 and the tantalum block 114 can improve the stress distribution of the proximal end 1101 of the femoral stem 11, reduce the rigidity of the distal end 1102 of the femoral stem 11, reduce the shear force transmission load between the tantalum-coated hip joint prosthesis system and the contact surface of the human body, and further weaken the situation that the load of the proximal end 1101 of the femoral component 10 suddenly becomes smaller. That is, the tantalum coating hip joint prosthesis system in the embodiment can reduce the phenomenon of stress shielding to a certain extent, so that the problems of aseptic loosening, fracture around the prosthesis, mechanical failure of the prosthesis and the like of the tantalum coating hip joint prosthesis system after operation can be relieved.

Further, the femoral stem 11 in this embodiment includes a first surface 1103 and a second surface 1104 that are disposed opposite to each other, where the first surface 1103 and the second surface 1104 are connected by a third surface 1105, and the third surface 1105 is located on a side of the femoral stem 11 facing the outside of the human body, at least one side of the first surface 1103 and the second surface 1104 near the proximal end 1101 forms the first coating area 1108, and at least one side of the third surface 1105 near the proximal end 1101 forms the inlay area 1109. That is, the third surface 1105 in this embodiment is the surface of the femoral stem 11 that faces the outer side of the thigh of the human body. During fabrication of the tantalum coated hip prosthesis system, a first tantalum coating 112 is formed on the first surface 1103 and the second surface 1104, and a tantalum block 114 is inlaid on the third surface 1105, the tantalum block 114 having a better stiffness and strength relative to the first tantalum coating 112. Thus, the proximal end 1101 of the femoral stem 11 can be provided with tantalum blocks 114 of different densities and different strengths, and the end facing away from the inner side of the femur can be provided with tantalum blocks 114 of higher strength, wherein the tantalum blocks 114 are of a porous structure, can simulate the arrangement of a trabecular structure, have an elastic modulus similar to that of the trabecular structure, and are more suitable for being fused with the production of the femur of a human body. The tantalum block 114 can also reduce the overall rigidity of the femoral stem 11, and under the action of bending load, the femoral stem 11 is easy to bend inwards, and can transfer larger load like the inner side of the proximal end 1101 of the femoral stem 11, so that bone absorption of inner bone due to stress shielding is avoided.

Optionally, in some embodiments of the present application, the inlay 1109 is provided with a micro spring (not shown) to maintain a force expanding laterally when the interior of the femoral stem 11 is stressed, enabling load transfer to the proximal 1101 lateral femur, thereby avoiding bone resorption of the lateral bone due to stress shielding.

Illustratively, the tantalum pellet 114 in this embodiment may be a unit lattice structure (see fig. 16) including a plurality of lattice filaments having diameters of 0.3mm to 0.6mm, and pore diameters of 0.8mm to 1.6mm and porosities of 50% -80% on the tantalum pellet 114. The porous structure of human cancellous bone trabecula is simulated by using the 3D printing technology to carry out disordered arrangement.

Further, the surface of the first coating region 1108 is provided with a stepped portion 1106, the stepped portion 1106 including a plurality of steps, the steps being sequentially connected in the length direction of the femoral stem 11, a step surface 11061 of the step being provided with either a concave hole 11062 or a convex protrusion 11063. Wherein the step surface 11061 having the concave hole 11062 and the step surface 11061 having the convex protrusion 11063 are alternately arranged in the longitudinal direction of the femoral stem 11. That is, one step surface 11061 having a concave hole 11062 is provided between two step surfaces 11061 adjacent and each provided with a convex protrusion 11063, or one step surface 11061 having a convex protrusion 11063 is provided between two step surfaces 11061 adjacent and each provided with a concave hole 11062. In this embodiment, the step surface 11061 with the concave hole 11062 and the step surface 11061 with the convex portion 11063 are alternately arranged along the length direction of the femoral stem 11, so that the firmness of the first tantalum coating 112 can be improved, the convex portion 11063 can protect and compact active cancellous bone, and meanwhile, more load can be transmitted to the first tantalum coating 112, and load can be additionally generated to be transmitted to cancellous bone regions to induce bone growth.

Further, the recess 11062 includes a hemispherical recess, the protrusion 11063 includes a hemispherical protrusion, and the diameters of the hemispherical recess and the hemispherical protrusion are each 2.0mm to 3.0mm, for example, 2.0mm, 2.2mm, 2.4mm, 2.6mm, 2.8mm, 3.0mm, etc., when the hemispherical recess and the hemispherical protrusion are more than 3.0mm, the surface roughness of the first coating region 1108 is easily increased, and it is inconvenient to spray the first tantalum coating 112; when the hemispherical concave hole and hemispherical protrusion are smaller than 3.0mm, the first coating area 1108 tends to be planar, which is inconvenient for the first tantalum coating 112 to be firmly attached to the femoral stem 11.

Further, the width of the step surface 11061 in the present embodiment is 4.0mm to 6.0mm, for example, 4.0mm, 4.5mm, 5.0mm, 5.5mm, 6.0mm. When the width of the step surface 11061 is less than 4.0mm, the step surface 11061 is relatively narrow, and it is inconvenient to spray tantalum to the corner position of the step surface 11061; when the width of the step surface 11061 is larger than 6.0mm, the step surface 11061 is relatively wide, the surface roughness of the femoral stem 11 is relatively weak, and the connection between the first tantalum coating 112 and the femoral stem 11 is easily reduced.

Further, the first coating area 1108 and the inlay area 1109 in this embodiment are disposed side by side along the same axial direction of the femoral stem 11, and the surface of the femoral stem 11 is further provided with a second coating area 1107, the second coating area 1107 is located at a side of the first coating area 1108 away from the proximal end 1101, the second coating area 1107 is provided with a second tantalum coating 113, and the density of the second tantalum coating 113 is smaller than that of the first tantalum coating 112. That is, the porosity of the second tantalum coating 113 is smaller than that of the first tantalum coating 112 in this embodiment, and by providing the first tantalum coating 112 and the second tantalum coating 113 with different densities, this embodiment can more fully achieve accurate press-fitting of the proximal end 1101, and transfer the load to the proximal end 1101 area to a great extent, reducing the proximal stress shielding of the tantalum coated hip prosthesis system.

Optionally, the first tantalum coating 112 in this embodiment has a porosity of 30% -80%, an average pore intercept of 30 μm-200 μm, and the second tantalum coating 113 has a porosity and an average pore intercept of 0.5 times that of the first tantalum coating 112.

Further, the femoral stem 11 in this embodiment is provided with the internal dredging hole 11111, and the setting of the internal dredging hole 11111 can reduce the rigidity of the femoral stem 11, promote blood circulation, facilitate the transportation of nutrients and metabolites, promote bone ingrowth, and further improve the long-term stability of the prosthesis.

Referring to fig. 2 and 14-15, the ball head 21 in the present embodiment includes a hard ball head 211 and a spherical lining layer 212, the hard ball head 211 is connected to the distal end 1102 of the femoral stem 11, and specifically connected to the end of the femoral stem neck 111, the outer surface of the hard ball head 211 is treated with titanium, niobium and nitrogen, and the spherical lining layer 212 is sleeved on the hard ball head 211 and can rotate relative to the hard ball head 211. Optionally, the hard ball 211 in this embodiment is made of cobalt chromium molybdenum, and has unique advantages in terms of antiallergic, biocompatible and antiwear properties due to titanium-niobium-nitrogen treatment on the surface, so that a better solution is provided for patients suffering from metal allergy. The spherical liner 212 is a highly crosslinked/VE highly crosslinked material liner that, along with the acetabular component 22, may provide a double active surface.

Optionally, the spherical liner layer 212 in this embodiment is a resilient elastomeric layer (specifically, a highly crosslinked/VE highly crosslinked material), and the acetabular component 22 includes an acetabular solid 221 and an acetabular cup layer 222. The acetabular entity 221 is provided with a groove 2213, the spherical lining layer 212 is rotatably arranged in the groove 2213, the outer surface of the acetabular entity 221 is provided with an elastic connecting layer 2211, and the elastic connecting layer 2211 is provided with a connecting hole 2212; the acetabular cup layer 222 is sleeved on the acetabular entity 221, and a through hole 2221 for the connecting piece 23 to pass through is arranged on the acetabular cup layer 222; the end of the connecting piece 23 is provided with a ball head structure 231, an elastic ball sleeve 232 is sleeved on the ball head structure 231, and the elastic ball sleeve 232 is detachably inserted into the connecting hole 2212.

When an operation is actually performed, firstly, the acetabular cup layer 222 is placed at a corresponding position of the pelvic bone, then, the acetabular cup layer 222 is pre-fixed on the pelvic bone by using the press fit fixing and connecting piece 23, and then, the acetabular entity 221 is installed in the acetabular cup layer 222, at this time, an external force is applied to the acetabular entity 221, so that the ball head structure 231 provided with the elastic ball sleeve 232 can be inserted into the connecting hole 2212 on the elastic connecting layer 2211, and further, the connection between the acetabular entity 221 and the acetabular cup layer 222 can be realized. Thereafter, the ball portion 21 is connected to the acetabular entity 221.

When the acetabulum entity 221 is actually manufactured, firstly, the CoCrMo layer raw material is pretreated for protection, meanwhile, the weight of the layer is reduced, and then the layer is combined with TC by a compound 3D printing method ₄ The entity layers are fused and printed together, and TC is performed after the manufacturing is completed ₄ The physical layer forms the main body structure of the acetabular body 221 and the CoCrMo layer forms the elastic connection layer 2211 described above, which is convenient to connect and fix with the elastic ball sleeve 232.

The arrangement of the connecting piece 23 in this embodiment can fix the tantalum coating hip joint prosthesis system in an initial stage, and at the same time, the end of the connecting piece 23 in this embodiment is positioned by the elastic connecting layer 2211 with a certain elasticity, the connecting piece 23 is not contacted with metal, the problem of metal ion precipitation is not easy to occur, and the possibility of bone dissolution can be reduced. More practical

In this embodiment, the outer surface of the acetabular entity 221 is provided with an elastic connection layer 2211 to better accommodate the ball structure 231 at the end of the connecting member 23. Further, the outer edge of the elastic ball sleeve 232 is provided with a flange 2321, correspondingly, the inner side wall of the connecting hole 2212 is provided with a concave portion 22121, and when the elastic ball sleeve is actually assembled, the flange 2321 is matched with the concave portion 22121, so that the ball head structure 231 can be prevented from rotating relative to the connecting hole 2212, and the connection reliability of the acetabular component 22 can be improved. Alternatively, the connection member 23 in the present embodiment includes a connection screw or a connection pin or the like.

Alternatively, the acetabular cup layer 222 in this embodiment may be a 3D printed titanium alloy bone trabecular layer that facilitates fusion with pelvic bone production. Of course, in other embodiments of the present application, the acetabular cup layer 222 may further include a titanium alloy layer and a third tantalum coating (not shown) disposed on an outer surface of the titanium alloy layer, where by disposing the third tantalum coating on the outer surface of the acetabular cup layer 222, rigidity of the proximal end of the prosthesis may be reduced, and a shear force transmission load between the hip joint prosthesis system and a human body contact surface with the tantalum coating may be reduced, so that a sudden decrease of the load of the proximal end of the prosthesis may be reduced.

Referring to fig. 1, another tantalum-coated hip prosthesis system architecture is provided in accordance with the present embodiment, which is substantially identical to that of fig. 2-15, except that the tantalum-coated hip prosthesis system of the present embodiment is devoid of soft components and the acetabular component 20 is different from that previously described (in particular, a conventional single-action acetabular component, not described in detail herein), the remainder being identical.

According to the description, the invention can effectively improve stress shielding conditions on the inner side, the outer side, the front side and the rear side of the proximal end of the femoral component, reduce the possibility of aseptic loosening of the prosthesis caused by bone resorption, and further improve the middle-term and long-term fixation of the prosthesis.

In addition, the invention can derive the abnormal prosthesis on the basis of keeping the functions of the conventional prosthesis, improves the use effect, the feeling and the satisfaction degree of patients of the product, better recovers the functions of the joint after operation and provides a complete hip joint replacement solution for clinic. The invention breaks the traditional design concept, and applies the fusion of the prosthesis and the tool, namely the prosthesis is the tool, thereby reducing the operation steps, the implantation time and the bleeding amount, and being suitable for patients with special physique. The distal end of the femoral stem is soft, so that the overall rigidity of the femoral stem is reduced, and the stress shielding of the proximal end of the femur is reduced to a certain extent.

In the embodiment, the arrangement of the tantalum coating can realize good biological fixation, the layering and density-dividing tantalum coating process is applied, the tantalum blocks on the outer side of the femoral stem are inlaid, the condition of stress shielding of the proximal femur after hip joint operation is improved in a multi-dimensional manner, cell proliferation is promoted, bone growth is induced, and a good internal environment is created for bone growth. Better long-term fixation is realized.

The femur neck adopts the design of adjustable anteversion angle, so that the patient obtains good biological force line, and prosthesis damage caused by the human body in the process of long-term motion self-correction is properly avoided, and the service life is prolonged. Meanwhile, the tantalum coating hip joint prosthesis system can realize double-acting total hip replacement, a separable bone trabecula layer and a reverse fixed connecting piece are designed, the problem of metal ion precipitation is not easy to occur, and the possibility of bone dissolution can be reduced.

Spatially relative terms, such as "above … …," "above … …," "upper surface at … …," "above," and the like, may be used herein for ease of description to describe one device or feature's spatial location relative to another device or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "above" or "over" other devices or structures would then be oriented "below" or "beneath" the other devices or structures. Thus, the exemplary term "above … …" may include both orientations of "above … …" and "below … …". The device may also be positioned in other different ways (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

In addition, the terms "first", "second", etc. are used to define the components, and are merely for convenience of distinguishing the corresponding components, and unless otherwise stated, the terms have no special meaning, and thus should not be construed as limiting the scope of the present application.

The foregoing is merely a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and variations may be made to the present application by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application should be included in the protection scope of the present application.

Claims

1. A tantalum-coated hip prosthesis system, comprising:

a femoral component (10), the femoral component (10) comprising a femoral stem (11), the femoral stem (11) comprising a proximal end (1101), the femoral stem (11) being provided with a first coating region (1108) and a mosaic region (1109) proximate an outer surface of the proximal end (1101), the first coating region (1108) being provided with a first tantalum coating (112), the mosaic region (1109) being mosaic with tantalum blocks (114);

the surface of first coating district (1108) is provided with step portion (1106), step portion (1106) are including a plurality of steps, and a plurality of steps are followed the length direction of femoral stem (11) is connected gradually, be provided with shrinkage pool (11062) or arch (11063) on step face (11061) of step, have step face (11061) of shrinkage pool (11062) and have step face (11061) of arch (11063) are followed the length direction of femoral stem (11) is set up in turn.

2. The tantalum-coated hip prosthesis system according to claim 1, wherein the femoral stem (11) comprises a first surface (1103) and a second surface (1104) arranged opposite each other, the first surface (1103) and the second surface (1104) being connected by a third surface (1105);

wherein the third surface (1105) is located on a side of the femoral stem (11) facing the outside of the human body, the first surface (1103) and the second surface (1104) form the first coating region (1108) at least on a side near the proximal end (1101), and the third surface (1105) forms the inlay region (1109) at least on a side near the proximal end (1101).

3. The tantalum-coated hip prosthesis system according to claim 1, wherein said recess (11062) comprises a hemispherical recess, said protrusion (11063) comprises a hemispherical protrusion, said hemispherical recess and said hemispherical protrusion each having a diameter of 2.0mm to 3.0 mm; and/or the number of the groups of groups,

the step surface (11061) has a width of 4.0 to mm mm to 6.0mm.

4. The tantalum-coated hip prosthesis system according to claim 1, wherein said first coating zone (1108) and said inlay zone (1109) are arranged side by side along the same circumference of said femoral stem (11), the surface of said femoral stem (11) being further provided with a second coating zone (1107), said second coating zone (1107) being located on a side of said first coating zone (1108) remote from said proximal end (1101), said second coating zone (1107) being provided with a second tantalum coating (113), said second tantalum coating (113) having a density less than the density of said first tantalum coating (112).

5. The tantalum-coated hip prosthesis system according to claim 1, wherein said tantalum mass (114) comprises a microporous structure.

6. The tantalum-coated hip prosthesis system according to claim 1, wherein said femoral stem (11) comprises a distal end (1102), said femoral component (10) further comprising a soft component (12), said soft component (12) being connected to said distal end (1102) of said femoral stem (11).

7. The tantalum-coated hip prosthesis system according to claim 6, wherein said soft component (12) comprises:

a soft core (121), the soft core (121) being connected to the distal end (1102) and extending along the length of the femoral stem (11);

the isthmus fixing seat (122), the isthmus fixing seat (122) is sleeved on the soft core (121), and a tooth part (1221) is arranged on the outer side surface of the isthmus fixing seat (122);

a ball drill reamer (123), the ball drill reamer (123) being disposed at an end of the soft core (121) remote from the femoral stem (11).

8. The tantalum-coated hip prosthesis system according to claim 7, wherein said soft component (12) further comprises:

the ball drill reamer (123) is positioned in the concave cambered surface of the circular arc-shaped sheet structure.

9. The tantalum-coated hip prosthesis system according to claim 7, wherein said isthmus anchor (122) is movably disposed along a length of said soft body core (121), said soft body member (12) further comprising:

the elastic element (125), the elastic element (125) is sleeved on the soft core (121), and two ends of the elastic element (125) are respectively propped against the femur handle (11) and the isthmus fixing seat (122).

10. The tantalum-coated hip prosthesis system according to claim 1, wherein said femoral component (10) further comprises a femoral stem neck (111), said femoral stem neck (111) being detachably connected to said proximal end (1101) by means of a locking member (30), and wherein said femoral stem (11) is provided with a first annular positioning rack (1110), and wherein said femoral stem neck (111) is provided with a second annular positioning rack (1111) which engages said first annular positioning rack (1110).

11. The tantalum-coated hip joint prosthesis system according to any one of claims 1 to 10, further comprising a ball head portion (21), said ball head portion (21) comprising a hard ball head (211) and a spherical lining layer (212), said hard ball head (211) being connected to said femoral stem (11), an outer surface of said hard ball head (211) being treated with titanium niobium nitrogen, said spherical lining layer (212) being sheathed on said hard ball head (211) and being rotatable with respect to said hard ball head (211).

12. The tantalum-coated hip joint prosthesis system of claim 11, further comprising:

the acetabulum body (221), a groove (2213) is arranged on the acetabulum body (221), the spherical lining layer (212) is rotatably arranged in the groove (2213), an elastic connecting layer (2211) is arranged on the outer surface of the acetabulum body (221), and a connecting hole (2212) is arranged on the elastic connecting layer (2211);

the acetabular cup layer (222), the acetabular cup layer (222) is sleeved on the acetabular entity (221), and a through hole (2221) for a connecting piece (23) to pass through is formed in the acetabular entity (221);

the end of the connecting piece (23) is provided with a ball head structure (231), an elastic ball sleeve (232) is sleeved on the ball head structure (231), and the elastic ball sleeve (232) is detachably inserted into the connecting hole (2212).

13. The tantalum-coated hip prosthesis system of claim 12, wherein said acetabular cup layer (222) comprises a 3D printed titanium alloy bone trabecular layer; or,

the acetabular cup layer (222) includes a titanium alloy layer and a third tantalum coating disposed on an outer surface of the titanium alloy layer.

14. The tantalum-coated hip prosthesis system according to any of claims 1 to 10, wherein an internal hydrophobic bore (11111) is provided in the femoral stem (11).