CN112545711A

CN112545711A - Femoral stem prosthesis and preparation method thereof

Info

Publication number: CN112545711A
Application number: CN202011208119.XA
Authority: CN
Inventors: 韩伟; 贺达
Original assignee: Wuhan United Imaging Zhirong Medical Technology Co Ltd
Current assignee: Wuhan United Imaging Zhirong Medical Technology Co Ltd
Priority date: 2020-11-03
Filing date: 2020-11-03
Publication date: 2021-03-26

Abstract

The invention relates to a femoral stem prosthesis and a preparation method thereof. The femoral stem prosthesis comprises a stem body, a plurality of bulges are arranged on the outer wall of the proximal end of the stem body at intervals, and the outer surfaces of the bulges are provided with roughening structures. The bioactive coating to be used for stimulating or inducing the growth of bone cells is deposited behind the handle body, one part is deposited in a gap between adjacent bulges, the other part is deposited on the outer surface of each bulge far away from the handle body, the outer wall of each bulge is of a roughening structure, the specific surface area of each bulge is increased, the contact area between each bulge and the bioactive coating is increased, the bonding strength between the two bulges can be further increased, and the number of the bulges is multiple and distributed at intervals, so that the bioactive coating deposited on the bulges is also set into a plurality of bulge structures distributed at intervals, the contact area between the bioactive coating and bone tissues can be increased, and the subsidence of the femoral handle prosthesis can be avoided.

Description

Femoral stem prosthesis and preparation method thereof

Technical Field

The invention relates to the technical field of medical devices, in particular to a femoral stem prosthesis and a preparation method thereof.

Background

Along with the continuous improvement of living standard of people, the aging degree of population gradually increases, the patients with hip joint dysfunction increase day by day, and the demand of artificial hip joint replacement also sharply increases. At present, a hydroxyapatite coating layer having excellent biocompatibility and used for stimulating or inducing the growth of bone cells is generally arranged on the surface of a hip joint femoral stem so as to achieve good biological fixation. However, the mechanical properties of the hydroxyapatite coating are poor, so that the bonding strength between the hydroxyapatite coating and the surface of the prosthesis is poor, the hip joint femoral stem and the bone tissue cannot be effectively fixed for a long time, aseptic loosening is caused, and the subsequent complex and expensive revision surgery is still required.

Disclosure of Invention

Accordingly, it is necessary to provide a femoral stem prosthesis and a method for preparing the same, which aim at the technical problem of poor bonding strength between a hydroxyapatite coating and the surface of the prosthesis.

A femoral stem prosthesis, the femoral stem prosthesis comprising: the handle body, be provided with a plurality of archs of interval distribution on the outer wall of the proximal end of handle body, and protruding surface has the structure of increasing rough.

In one embodiment, the protrusions are distributed in an array, the array has rows and columns, and each row of the protrusions and each column of the protrusions respectively have a certain inclination angle with the extending direction of the handle body.

In one embodiment, the protrusions are rectangular parallelepiped structures, and the gaps between the protrusions in each row and the gaps between the protrusions in each column are perpendicular to each other.

In one embodiment, the height H1 of the protrusions is 50 to 200 micrometers, and the distance D between two adjacent protrusions is 200 to 1000 micrometers.

In one embodiment, the roughening of the outer surface of the protrusions is a roughening protrusion and/or a roughening recess.

In one embodiment thereof, the femoral stem prosthesis further comprises: a bioactive coating disposed in a gap between two adjacent of the protrusions and on an outer surface of the protrusions distal from the shank body.

In one embodiment thereof, the bioactive coating comprises: the porous titanium coating and the hydroxyapatite coating are sequentially laminated along the direction far away from the handle body.

In one embodiment, the bioactive coating has a thickness H2 of 150 to 800 microns.

A method of making a femoral stem prosthesis according to any preceding claim, the method comprising:

obtaining a handle body;

processing a plurality of bulges on the outer wall of the near end of the handle body;

and etching the protrusion to form a roughening structure on the outer surface of the protrusion.

In one embodiment, the processing of the plurality of protrusions on the outer wall of the proximal end of the handle body is performed by pulse laser processing or laser engraving, and the etching of the protrusions is performed by at least one of electrochemistry, plasma implantation and laser engraving.

As described above, the femoral stem prosthesis and the method of manufacturing the same, a bioactive coating to be used for stimulating or inducing bone cell growth, such as a hydroxyapatite coating, may be deposited after the stem body, a portion may be deposited in a gap between adjacent two protrusions, and another portion may be deposited on an outer surface of the protrusion, which is away from the stem body, wherein the thickness deposited on the surface of the stem body is the same as the thickness of the bioactive coating. Because the protruding surface has the structure of increasing coarseness, the bellied specific surface area has been increased, the area of contact of arch and bioactive coating has been increased, and then can increase bonding strength between these two, including protruding figure be a plurality of and interval distribution, make that part bioactive coating of deposit on protruding also set to a plurality of protruding structures that are interval distribution, this area of contact that can increase bioactive coating and bone tissue, form good biological nature sealed, and then can avoid femoral stem prosthesis to sink, also can prevent that the abrasive dust from getting into the distal end and arousing osteolysis. In conclusion, the outer wall of the handle body is provided with the plurality of protrusions distributed at intervals, and the outer surfaces of the protrusions are provided with the roughening structures, so that the hip femoral handle prosthesis and bone tissues can be effectively fixed for a long time, aseptic loosening is avoided, and further complicated and expensive revision surgery is avoided.

Drawings

FIG. 1 is a schematic view of a femoral stem prosthesis provided in accordance with an embodiment of the present invention;

FIG. 2 is an enlarged schematic view of a projection on a femoral stem prosthesis provided in accordance with an embodiment of the present invention;

FIG. 3 is an enlarged cross-sectional view of a projection provided in accordance with an embodiment of the present invention;

fig. 4 is a sectional view of a femoral stem prosthesis provided in accordance with an embodiment of the present invention, taken along the line a-a of fig. 1.

Wherein the reference numerals in the drawings are as follows:

100. a handle body; 110a, a longitudinal chute; 110. a proximal end; 120. a distal end; 130. the femoral neck head; 140. a femoral neck; 200. a protrusion; 210. a roughening structure; 300. a bioactive coating.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the invention and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are not to be considered limiting of the invention.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.

In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the present invention, unless otherwise expressly stated or limited, the first feature "on" or "under" the second feature may be directly contacting the first and second features or indirectly contacting the first and second features through an intermediate. Also, a first feature "on," "over," and "above" a second feature may be directly or diagonally above the second feature, or may simply indicate that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature may be directly under or obliquely under the first feature, or may simply mean that the first feature is at a lesser elevation than the second feature.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein are for illustrative purposes only and do not denote a unique embodiment.

One embodiment of the present invention provides a femoral stem prosthesis, which includes a stem body 100, as shown in fig. 1. Referring to fig. 2 and 3, a plurality of protrusions 200 are disposed on the outer wall of the proximal end 110 of the handle 100 at intervals, and the outer surface of the protrusions 200 has a roughening 210. It should be noted that the proximal end 110 of the handle 100 refers to the end of the handle 100 that is closer to the patient's heart, and the distal end 120 of the handle 100 refers to the end of the handle 100 that is further away from the patient's heart.

As an example, as shown in fig. 1, the femoral stem prosthesis further includes: a femoral neck head 130 and a femoral neck 140 connecting the femoral neck head 130 to the proximal end 110 of the handle 100. The material of the femoral neck head 130, the femoral neck 140 and the stem 100 is biocompatible, and may be, for example, titanium alloy or cobalt-chromium alloy.

As an example, as shown in FIG. 4, the cross-section of the shank 100 is wedge-shaped, i.e., the cross-section is relatively sharp at one end and relatively wide at the other end. The stem body 100 and the positive position and the lateral position of the stem body 100 of the structure are also in structures with large top and small bottom, and the three-dimensional space can be tightly embedded when the femoral stem prosthesis sinks.

As an example, the protrusion 200 may be made of the same material as the stem body 100 of the femoral stem prosthesis, and may be made of titanium alloy or cobalt-chromium alloy. The plurality of protrusions 200 may be formed on the proximal end 110 of the shank body 100 by machining, which may be pulsed laser machining or laser engraving. And the machining is adopted, so that the machining precision is high, the controllability is good, and the efficiency is high.

The femoral stem prosthesis as described above, to which a bioactive coating 300 for stimulating or inducing bone cell growth, such as a hydroxyapatite coating, is to be deposited after the stem body 100, a portion may be deposited in a gap between adjacent two protrusions 200, and another portion may be deposited on an outer surface of the protrusions 200 distant from the stem body 100, wherein the thickness deposited on the surface of the stem body 100 is the same as the thickness of the bioactive coating 300. Because the outer surface of the protrusion 200 is provided with the roughening structure 210, the specific surface area of the protrusion 200 is increased, the contact area between the protrusion 200 and the bioactive coating 300 is increased, and further, the bonding strength between the protrusion and the bioactive coating can be increased, and in addition, the number of the protrusions 200 is multiple and distributed at intervals, so that the bioactive coating 300 deposited on the protrusion 200 is also arranged into multiple protrusion structures distributed at intervals, the contact area between the bioactive coating 300 and bone tissue can be increased, a good biological seal is formed, further, the femoral stem prosthesis can be prevented from sinking, and the bone dissolution caused by the grinding dust entering the distal end 120 can also be prevented. In summary, in the embodiment of the present invention, the plurality of protrusions 200 are disposed on the outer wall of the stem body 100 at intervals, and the outer surface of the protrusions 200 has the roughening structure 210, so that the hip stem prosthesis and the bone tissue can be effectively fixed for a long time, aseptic loosening is avoided, and further, a complicated and expensive revision surgery is avoided.

In some embodiments of the present invention, as shown in FIG. 2, the protrusions 200 are distributed in an array. It will be appreciated that, referring to figure 2, the array has rows and columns which are arranged in an inclined manner. The inclination here means an angle having a certain inclination, for example, 45 degrees, with the extending direction of the shank body. Each row of protrusions 200 has a row gap therebetween, each column of protrusions 200 has a column gap therebetween, and the row gap and the column gap intersect at an angle. Wherein, preferably, the row gaps and the column gaps are perpendicular to each other. The fixing of the handle body is facilitated by arranging rows and columns inclined in the extending direction of the handle body. The row gaps and the column gaps are perpendicular to each other, so that machining is facilitated. When the femoral stem prosthesis is implanted into a human body, bone tissue will grow into the bioactive coating 300, forming a biological fixation. Because the elastic modulus of the bioactive coating 300 is different from that of the protrusions 200, when a human body moves, the stress on the proximal end 110 of the femoral stem prosthesis is the largest, and the force is conducted, and the protrusions 200 are uniformly distributed in an inclined array, so that the femoral stem prosthesis can be prevented from sinking, and the long-term fixation of the femoral stem prosthesis can be ensured.

In some embodiments of the present invention, as shown in FIG. 1, the protrusion 200 is a rectangular parallelepiped structure. The rectangular parallelepiped (i.e., quadrangular prism) structured protrusion 200 is easy to process, compared to the protrusion 200 of a cylindrical structure, other polygonal prism (e.g., triangular prism, pentagonal prism, hexagonal prism, heptagonal prism, etc.) structure. Moreover, in one embodiment, the side surfaces of the protrusions 200 of the same row of rectangular parallelepiped structures form a column gap therebetween, the side surfaces of the protrusions 200 of the same column of rectangular parallelepiped structures form a row gap therebetween, and the row gap and the column gap are perpendicular to each other, and can be processed in place once for each row gap and each column gap.

In some embodiments of the present invention, referring to fig. 3, the height H1 of the protrusion 200 is of a small size, specifically, may be 50 microns to 200 microns (illustratively, may be 50 microns, 150 microns, 180 microns, 200 microns, etc.); preferably 50 to 180 microns, more preferably 150 microns. Referring to fig. 2, a distance D (i.e., a width of a row gap or a width of a column gap) between two adjacent protrusions 200 is 200 micrometers to 1000 micrometers (which may be 200 micrometers, 300 micrometers, 400 micrometers, 500 micrometers, 600 micrometers, 700 micrometers, 800 micrometers, 900 micrometers, 1000 micrometers, etc., for example). The height H1 of the protrusion 200 is set to play a role in preventing the pinning from twisting, and also ensure the strength and rigidity of the bioactive coating 300. The height H1 of the protrusions 200 is set relatively small, and in particular, the height H1 of the protrusions 200 is below 200 microns, which can prevent the bioactive coating 300 from falling off due to too large a height. If the height H1 of the protrusion 200 is too large, the bioactive coating 300 will have a large height difference, and the strength and rigidity will be problematic and will easily fall off. The height H1 of the protrusions 200 is greater than 50 microns, which may increase roughness. The height H1 of the protrusion 200 is set to be 50-200 microns, so that the protrusion has good strength and rigidity and certain roughness, can effectively prevent the bioactive coating 300 from falling off and can form stable biological fixation, and the service life is long. The distance D between two adjacent protrusions 200 increases the contact area between the bioactive coating 300 and the handle body 100, thereby improving the bonding strength between the bioactive coating 300 and the handle body 100.

In some embodiments of the present invention, the protrusions 200 are provided with a plurality of roughening structures 210 on the outer surface, and the roughening structures 210 are a plurality of roughening protrusions (see fig. 3) and/or a plurality of roughening grooves. Of course, in other embodiments of the present invention, the outer surface of the protrusion 200 may be coated with a rough roughening layer. It should be noted that the size of the roughening structure 210 is nanometer, that is, the depth of the roughening groove or the height H3 of the roughening protrusion shown in fig. 3 is nanometer, and the height H3 may be an unfixed size according to the processing method. For example, the height H3 of the roughening projections is less than 200 nm, and may be between 50 and 200 nm. According to the application, the roughening structure 210 is arranged on the outer surface of the protrusion 200, so that the roughness of the surface of the protrusion is further improved. The shape of the roughness-increasing structure 210 may be any irregular shape, and the roughness thereof is on the order of nanometers, so long as a finer rough surface is formed on the outer surface of the protrusion 200. The nanoscale roughening structure 210 can further improve the bonding strength between the bioactive coating 300 and the protrusion 200, so that the hip joint femoral stem prosthesis and bone tissues can be effectively fixed for a long time, aseptic loosening is avoided, and further complicated and expensive revision surgery is avoided.

Optionally, the material of the roughening structure 210 is the same as that of the protrusion 200, and may be titanium alloy or cobalt-chromium alloy. The etching may be performed directly on the surface of the protrusion 200, and the etching may be performed by at least one of electrochemical etching, plasma implantation etching, and laser engraving.

In some embodiments of the invention, as shown in fig. 1, the femoral stem prosthesis further comprises: a bioactive coating 300, the bioactive coating 300 is arranged in the gap between two adjacent protrusions 200 and on the outer surface of the protrusion 200 far away from the handle body 100. Thus, the portion of the bioactive coating 300 deposited on the protrusion 200 is also configured as a plurality of protrusion structures distributed at intervals, which can increase the contact area between the bioactive coating 300 and the bone tissue, form a good biological seal, further avoid the subsidence of the femoral stem prosthesis, and prevent the abrasion debris from entering the distal end 120 to cause bone dissolution.

Specifically, in some embodiments of the present invention, bioactive coating 300 comprises: a porous titanium coating and a hydroxyapatite coating which are sequentially laminated along the direction far away from the handle body 100. Considering that a single hydroxyapatite coating layer is generally smaller than 100 micrometers and is easily degraded, and if the thickness of the single hydroxyapatite coating layer is too large, the hydroxyapatite coating layer is easily peeled off, in this embodiment of the present invention, a porous titanium coating layer is added to the bottom layer of the bioactive coating layer 300, which may increase the thickness of the bioactive coating layer 300, and may also set the roughness of the porous titanium coating layer to be greater than that of the hydroxyapatite coating layer, so that bone cells may grow in more easily. Alternatively, as shown in fig. 3, the thickness H2 of bioactive coating 300 is between 150 microns and 800 microns, and illustratively can be 150 microns, 200 microns, 300 microns, 400 microns, 500 microns, 600 microns, 700 microns, 800 microns, and the like. This can improve the excellent effect of inducing bone ingrowth. In one embodiment of the present application, the height H1 of the protrusions is 150 microns and the thickness H2 of the bioactive coating 300 is 200 microns. The bioactive coating with the height of 150 microns and the thickness of 200 microns is adopted, so that better roughness can be achieved, the bioactive coating 300 is prevented from falling off, and better rigidity and strength are achieved.

In some embodiments of the present invention, as shown in fig. 1, at least one longitudinal sliding groove 110a is provided on the outer wall of the distal end 120 of the handle body 100. It should be noted that the longitudinal direction herein refers to a direction in which the proximal end 110 points to the distal end 120 or a direction in which the distal end 120 points to the proximal end 110. The longitudinal sliding grooves 110a can improve the anti-rotation capability of the stem body 100 and enhance the long-term stability of the femoral stem prosthesis.

Optionally, the number of the longitudinal sliding grooves 110a is 1 to 5, for example, 1, 2, 3, 4, or 5.

Alternatively, the width of the longitudinal sliding grooves 110a is 1 mm to 3 mm (for example, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, etc.), the height of the longitudinal sliding grooves 110a decreases gradually along the bending direction of the handle body 100, and the height difference between two adjacent longitudinal sliding grooves 110a is 3 mm to 6 mm (for example, 3 mm, 4 mm, 5 mm, 6 mm, etc.). Thus, the resistance of the stem body 100 against rotation can be further improved, enhancing the long-term stability of the femoral stem prosthesis.

Another embodiment of the present invention further provides a method for preparing the femoral stem prosthesis, which includes:

step S100, obtaining a handle body 100;

step S200, processing and forming a plurality of protrusions 200 on the outer wall of the proximal end 110 of the handle body 100;

step 300, etching the protrusion 200 to form a roughening structure 210 on the outer surface of the protrusion 200.

In the femoral stem prosthesis manufacturing method as described above, a plurality of protrusions 200 may be formed on the outer wall of the proximal end 110 of the stem body 100 and the outer surfaces of the protrusions 200 may be formed into the roughness structure 210, so that a bioactive coating 300 to be used for stimulating or inducing bone cell growth, such as a hydroxyapatite coating, may be deposited after the stem body 100, a portion may be deposited in the gap between adjacent two protrusions 200, and another portion may be deposited on the outer surface of the protrusions 200, which is away from the stem body 100, wherein the thickness deposited on the surface of the stem body 100 is the same as the thickness of the bioactive coating 300. Because the outer surface of the protrusion 200 is the roughening structure 210, the specific surface area of the protrusion 200 is increased, the contact area between the protrusion 200 and the bioactive coating 300 is increased, and further the bonding strength between the protrusion and the bioactive coating can be increased, and in addition, the number of the protrusions 200 is multiple and distributed at intervals, so that the bioactive coating 300 deposited on the protrusion 200 is also set into multiple protrusion structures distributed at intervals, the contact area between the bioactive coating 300 and bone tissues can be increased, good biological sealing is formed, further, the femoral stem prosthesis can be prevented from sinking, and the bone dissolution caused by the grinding chips entering the distal end 120 can also be prevented. In summary, in the embodiment of the present invention, the plurality of protrusions 200 are disposed on the outer wall of the stem body 100 at intervals by etching, and the outer surface of the protrusions 200 forms the roughening structure 210, so that the hip stem prosthesis and the bone tissue can be effectively fixed for a long time, aseptic loosening is avoided, and further, a complicated and expensive revision surgery is avoided.

For step S100, the stem body 100 of the femoral stem prosthesis may be prepared by casting or forging. The joint body 100 is made of a biocompatible material, such as titanium alloy or cobalt-chromium alloy.

For step S200, a protrusion 200 may be provided on the outer wall of the proximal end 110 of the stem body 100 by using a pulsed laser machining or a laser engraving method. For step S300, the roughening structure 210 may be formed on the outer surface of the protrusion 200 by electrochemical etching, plasma implantation, or laser engraving. It is understood that the protrusion 200 is made of a biocompatible material, such as titanium alloy or cobalt-chromium alloy, as the same material as the stem 100.

In particular, in some embodiments, roughened protrusions and/or grooves are etched into the outer surface of protrusion 200 such that the outer surface of protrusion 200 forms roughened structures 210.

In some embodiments of the present invention, the method of preparing a femoral stem prosthesis further comprises:

step S400, depositing the bioactive coating 300 in the gap between two adjacent protrusions 200 and on the wall of the protrusion 200 away from the handle body 100.

Thus, the portion of the bioactive coating 300 deposited on the protrusion 200 is also configured as a plurality of protrusion structures distributed at intervals, which can increase the contact area between the bioactive coating 300 and the bone tissue, form a good biological seal, further avoid the subsidence of the femoral stem prosthesis, and prevent the abrasion debris from entering the distal end 120 to cause bone dissolution.

Specifically, in some embodiments of the present invention, bioactive coating 300 comprises: a porous titanium coating and a hydroxyapatite coating which are sequentially laminated along the direction far away from the handle body 100. Considering that a single hydroxyapatite coating layer is generally less than 100 micrometers and is easily degraded, and if the thickness of the single hydroxyapatite coating layer is too large, the hydroxyapatite coating layer is easily peeled off, in this embodiment of the present invention, a porous titanium coating layer is added to the bottom layer of the bioactive coating layer 300, which may increase the thickness of the bioactive coating layer 300, and may also set the roughness of the porous titanium coating layer to be greater than that of the hydroxyapatite coating layer, so that bone cells may grow in more easily. Alternatively, the thickness H2 of the bioactive coating 300 is between 150 microns and 800 microns, and illustratively can be 150 microns, 200 microns, 300 microns, 400 microns, 500 microns, 600 microns, 700 microns, 800 microns, and the like. Thus, an excellent bone ingrowth inducing effect can be provided.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A femoral stem prosthesis, comprising: the handle comprises a handle body (100), wherein a plurality of protrusions (200) are arranged on the outer wall of the proximal end (110) of the handle body (100) at intervals, and the outer surfaces of the protrusions (200) are provided with roughening structures (210).

2. Femoral stem prosthesis according to claim 1, characterized in that said protrusions (200) are distributed in an array having rows and columns, each row of said protrusions (200) and each column of said protrusions (200) having a respective inclination angle with respect to the extension direction of said stem body (100).

3. The femoral stem prosthesis according to claim 2, wherein said protrusions (200) are of rectangular parallelepiped configuration, the gaps between each row of said protrusions (200) and the gaps between each column of said protrusions (200) being perpendicular to each other.

4. The femoral stem prosthesis according to claim 1, wherein the height H1 of the protrusions (200) is 50-200 microns and the distance D between two adjacent protrusions (200) is 200-1000 microns.

5. Femoral stem prosthesis according to claim 1, characterized in that the roughening (210) of the outer surface of the protrusion (200) is a roughening protrusion and/or roughening recess.

6. The femoral stem prosthesis according to any one of claims 1-5, further comprising: a bioactive coating (300), the bioactive coating (300) being disposed in a gap between two adjacent protrusions (200) and on an outer surface of the protrusions (200) distal from the handle body (100).

7. The femoral stem prosthesis according to claim 6, wherein the bioactive coating (300) comprises: the coating comprises a porous titanium coating and a hydroxyapatite coating which are sequentially laminated along the direction far away from the handle body (100).

8. The femoral stem prosthesis according to claim 6, wherein the thickness H2 of the bioactive coating (300) is between 150 microns and 800 microns.

9. A method of manufacturing a femoral stem prosthesis according to any one of claims 1 to 8, comprising:

-acquiring a shank body (100);

machining a plurality of protrusions (200) on the outer wall of the proximal end of the handle body (100);

the protrusions (200) are etched such that the outer surfaces of the protrusions (200) form roughened structures (210).

10. The femoral stem prosthesis manufacturing method according to claim 9, wherein the processing of the plurality of protrusions (200) on the outer wall of the proximal end of the stem body (100) is performed by pulsed laser processing or laser engraving, and the etching of the protrusions (200) is performed by at least one of electrochemistry, plasma implantation and laser engraving.