Patent Description:
Prior art which is related to this field is disclosed in <CIT> showing implant and method for coating an implant, and in <CIT> showing metal implants.

The use of a biological implant for the treatment of both bone injuries and diseases is constantly expanding with the growth of the active population and aging population. In such a situation, a known biological implant is provided with a coating from the viewpoint of antimicrobial properties, adherence to bone, and the like.

For example, Patent Document <NUM> describes a coating for a medical implant, in which a part of the coating contains a bone-binding agent and an antimicrobial metal agent containing silver.

The present disclosure provides an artificial joint stem according to claim <NUM>.

Hereinafter, one embodiment will be described in detail. Note that, unless otherwise specified in the present specification, "A to B", which represents a numerical range, means "A or more and B or less".

First, in an embodiment, the configuration of an artificial joint stem <NUM> will be described with reference to <FIG>. The artificial joint stem <NUM> includes a base <NUM> extending in the vertical direction when the proximal side of a human body in use is defined as an upward direction, and a coating film <NUM> disposed on a part of the surface of the base <NUM>. For the vertical direction of the base <NUM>, the upward direction corresponds to the proximal direction and the downward direction corresponds to the distal direction of a human body. The coating film <NUM> includes a calcium phosphate-based material and an antimicrobial material. The artificial joint stem <NUM> includes an embedded portion <NUM> embedded in the bone and an exposed portion <NUM> exposed from the bone. In <FIG>, of the embedded portion <NUM>, the coating film <NUM> is formed in a region close to the exposed portion <NUM>, and a region far from the exposed portion <NUM> is exposed from the coating film <NUM>. Note that the calcium phosphate-based material has an effect of improving adherence to bone. The antimicrobial material is also effective in reducing bacterial adhesion and growth.

The coating film <NUM> is disposed on a part of the surface of the base <NUM>. That is, the other part of the surface of the base <NUM> is exposed from the coating film <NUM>. For example, it is difficult to control the adherence of the artificial joint stem <NUM> to bone when all of the surface of the artificial joint stem <NUM> is covered with a coating containing a bone-binding agent and an antimicrobial metal agent. In this case, removal of the artificial joint stem may become difficult when removal of the artificial joint stem is required after surgery. For example, the embedded portion <NUM> may become excessively adhered to the bone through the coating. When the base <NUM> includes a region covered by the coating film <NUM> and a region exposed from the coating film <NUM>, excessive adhesion to the bone can be reduced. That is, the adherence to bone and the antimicrobial properties can be compatible.

The base <NUM> includes one or more boundary lines on the base defined by the presence or absence of the coating film <NUM>. The one or more boundary lines include a first boundary line <NUM> located on the lower side of the base <NUM> with respect to the coating film <NUM>. The first boundary line <NUM> is located so as to intersect the vertical direction. That is, all of the first boundary line <NUM> is not parallel to the vertical direction. A component along the vertical direction of the first boundary line <NUM> is smaller than a component along the width direction of the base <NUM>.

Further, the components of the first boundary line <NUM> will be described with reference to <FIG>. In <FIG>, the vertical direction of the base <NUM> is represented as a Y-axis direction, and the width direction of the base <NUM> is represented as an X-axis direction. The width direction of the base <NUM> may be a direction orthogonal to the vertical direction. <FIG> may also be a plan view from the direction perpendicular to the XY plane, that is, the Z-axis direction. In <FIG>, a straight line α connecting both ends of the first boundary line <NUM> is examined. When the straight line α is parallel to the X-axis, the first boundary line <NUM> may contain only a component along the width direction of the base <NUM>. When the straight line α is represented as a straight line having an inclination in the XY coordinates, the first boundary line <NUM> may contain both of a component along the vertical direction of the base <NUM> and a component along the width direction of the base <NUM>. As used herein, "a component along the vertical direction of the first boundary line <NUM> is smaller than a component along the width direction of the base <NUM>" means that the absolute value of the inclination of the straight line α is less than <NUM>. In this case, since the friction in the shear direction occurring in the first boundary line <NUM> can be reduced, the peeling of the coating film <NUM> can be reduced. The expression "a component along the vertical direction of the first boundary line <NUM> is smaller than a component along the width direction of the base <NUM>" also includes a case where the first boundary line <NUM> contains only a component along the width direction of the base <NUM>.

The one or more boundary lines may include a second boundary line <NUM> located on the upper side of the base <NUM> with respect to the coating film <NUM>. The second boundary line <NUM> may also be located so as to intersect the vertical direction. The second boundary line <NUM> may contain a component along the vertical direction smaller than a component along the width direction of the base <NUM>, similar to the first boundary line <NUM>. Alternatively, unlike the first boundary line <NUM>, the component along the vertical direction of the second boundary line <NUM> may be greater than the component along the width direction of the base <NUM>. In <FIG>, a straight line connecting both ends of the second boundary line <NUM> is defined as a straight line β. The expression "a component along the vertical direction of the second boundary line <NUM> is smaller than a component along the width direction of the base <NUM>" means that the absolute value of the inclination of the straight line β is less than <NUM>. On the other hand, "a component along the vertical direction of the second boundary line <NUM> is greater than a component along the width direction of the base <NUM>" means that the absolute value of the inclination of the straight line β is greater than <NUM>. The component along the vertical direction of the second boundary line <NUM> may be greater than the component along the vertical direction of the first boundary line <NUM>.

The length of the first boundary line <NUM> and the length of the second boundary line <NUM> may be the same, or one of them may be larger than the other. As used herein, the "length of the first boundary line <NUM> " means the total length of the first boundary line <NUM> that circles around the base <NUM>. The same is true for "the length of the second boundary line <NUM>". For example, as illustrated in <FIG>, the length of the first boundary line <NUM> may be greater than the length of the second boundary line <NUM>. On the other hand, the length of the first boundary line <NUM> may be smaller than the length of the second boundary line <NUM>.

Each of the one or more boundary lines may be a straight line or a curve when the base <NUM> is viewed in a plan view from a direction perpendicular to the vertical direction. For example, each of the one or more boundary lines may consist of one straight line or a plurality of straight lines when the base <NUM> is viewed in a plan view from a direction perpendicular to the vertical direction. The expression "each of the one or more boundary lines includes a plurality of straight lines" refers to, for example, a state in which two straight lines (1a) extending in the width direction and one straight line (1b) extending in the vertical direction are connected, as illustrated in <FIG>. Each of the one or more boundary lines may be a curve in three dimensions while including a straight line in a plan view. For example, the first boundary line <NUM> may consist of one straight line or may include a plurality of straight lines. The second boundary line <NUM> may also consist of one straight line or may include a plurality of straight lines.

As illustrated in <FIG>, the base <NUM> may include a constant width portion <NUM>'a that is located lower in the base <NUM> and is constant in width. The base <NUM> may also include a contraction portion <NUM>'b that decreases in width downward. The constant width portion <NUM>'a may extend continuously downward from the contraction portion <NUM>'b. The one or more boundary lines may be located at the constant width portion <NUM>'a or the contraction portion <NUM>'b. For example, the first boundary line <NUM> may be located at the contraction portion <NUM>'b as illustrated in <FIG>, or may be located at the constant width portion <NUM>'a as illustrated in <FIG>. The same is true for the second boundary line <NUM>.

As illustrated in <FIG>, the base <NUM> may include a node. The node is a portion of the base <NUM> where the circumference is greater than the circumference of a portion of the base <NUM> located above and below the node. In other words, the base <NUM> may be nodular. Any of the one or more boundary lines may be located at the node.

As the base <NUM>, a metal, ceramic or plastic may be used. Examples of the metal include stainless steel alloy, cobalt-chromium alloy, titanium, and titanium alloy. The titanium alloy can be made by adding at least one selected from the group consisting of aluminum, tin, zirconium, molybdenum, nickel, palladium, tantalum, niobium, vanadium, and platinum to titanium. Examples of the ceramic include alumina, zirconia and alumina-zirconia composite ceramic. Examples of the plastic include polyethylene, fluorine-based resin, epoxy resin, polyetheretherketone (PEEK) resin, and bakelite. Note that, in the present embodiment, the base <NUM> is made of a titanium alloy.

The shape of the base <NUM> may be substantially rod-shaped, for example, but may be appropriately changed according to the shape of the artificial joint to be applied.

The coating film <NUM> includes a calcium phosphate-based material and an antimicrobial material. Examples of the calcium phosphate-based material include one or more types of mixtures selected from the group consisting of hydroxyapatite, α-tertiary calcium phosphate, β-tertiary calcium phosphate, quaternary calcium phosphate, octacalcium phosphate, and calcium phosphate-based glass. As the antimicrobial material, a natural antimicrobial agent, an organic antimicrobial agent, or an inorganic antimicrobial agent can be used. For example, hinokitiol can be used as a natural antimicrobial agent, benzalkonium chloride can be used as an organic antimicrobial agent, and a metal can be used as an inorganic antimicrobial agent. Examples of the metal include silver, copper, and zinc. In addition to the calcium phosphate-based material and the antimicrobial material, the coating film <NUM> may contain a glass ceramic, and may further contain an antimicrobial agent such as penicillin and vancomycin.

The concentration of the antimicrobial material in the coating film <NUM> may be, for example, from <NUM> wt% to <NUM> wt%, from <NUM> wt% to <NUM> wt%, from <NUM> wt% to <NUM> wt%, or from <NUM> wt% to <NUM> wt%. When the concentration of the antimicrobial material is <NUM> wt% or more, sufficient antimicrobial properties can be achieved. When the concentration of the antimicrobial material is <NUM> wt% or less, the impact on living tissue can be reduced.

There may be a concentration gradient of antimicrobial material in the coating film <NUM>. For example, the concentration of the antimicrobial material contained in an upper end portion of the coating film <NUM> may be greater than the concentration of the antimicrobial material contained in a lower end portion of the coating film. Thus, invasion of bacteria from the upper end portion side of the coating film <NUM> can be more effectively reduced. The antimicrobial material may be contained only at the upper end portion of the coating film <NUM>.

Of the surface of the base <NUM>, the ratio between the area of a region where the coating film <NUM> is disposed and the area of a region where the surface of the base <NUM> is exposed from the coating film <NUM> may be appropriately determined depending on the application, or the like. The area of the region where the coating film <NUM> is disposed may be the same as the area of the region where the surface of the base <NUM> is exposed from the coating film <NUM>, or one of the regions may be larger than the other. For example, in <FIG>, the area of the region where the coating film <NUM> is disposed is smaller than the region where the surface of the base <NUM> is exposed from the coating film <NUM>. In this case, the artificial joint stem <NUM> can be more easily inserted into the bone. On the other hand, when the area of the region where the coating film <NUM> is disposed is greater than the area of the region where the surface of the base <NUM> is exposed from the coating film <NUM>, the invasion of bacteria can be further reduced.

The regions where the coating film <NUM> is disposed and the regions exposed from the coating film <NUM> can be distinguished by elemental analysis of the surface of each region. The method of elemental analysis can be performed, for example, by mapping the surface elements with an energy dispersive X-ray spectrometry (EDX) apparatus, which is an accessory for a general scanning electron microscope (SEM). Surface analysis methods such as X-ray photoelectron spectroscopy, Auger electron spectroscopy, and secondary ion mass spectrometry may also be used. The element may be confirmed by chemical analysis of a sample obtained by mechanically scraping off the surface of each region. For example, in the region where the coating film <NUM> is disposed, phosphorus, calcium, antimicrobial components, or the like are detected. On the surface of the region exposed from the coating film <NUM>, elements constituting the base <NUM> are detected, and phosphorus, calcium, antimicrobial components or the like are not detected, or the detected level is below the noise level.

The base <NUM> may have a rough surface located on the surface. One or more boundary lines on the base <NUM> defined by the presence or absence of the rough surface may include a third boundary line <NUM> located on the lower side of the base <NUM> with respect to the rough surface. The one or more boundary lines on the base <NUM> defined by the presence or absence of the rough surface may include a fourth boundary line <NUM> located on the upper side of the base <NUM> with respect to the rough surface. The rough surface may be covered with the coating film <NUM> or exposed from the coating film <NUM>. Only a part of the rough surface may be covered with the coating film <NUM>, and the other part of the rough surface may be exposed from the coating film <NUM>. For example, the third boundary line <NUM> may be located farther on the upper or lower side of the base <NUM> than the first boundary line <NUM>. The fourth boundary line <NUM> may be located farther on the upper or lower side of the base <NUM> than the second boundary line <NUM>.

An example of index of the surface roughness of the rough surface includes an arithmetic mean roughness Sa (ISO <NUM>). The surface roughness (Sa) of the rough surface may be set to, for example, from <NUM> to <NUM>, from <NUM> to <NUM>, or from <NUM> to <NUM>. Note that the surface roughness (Sa) of the rough surface can be measured, for example, by cutting the artificial joint stem <NUM> and observing the cut surface by SEM or the like.

The surface roughness (Sa) is only required to be measured, for example, by a stylus method or an optical method. The surface roughness (Sa) is only required to be measured in accordance with "ISO <NUM>", for example. Note that the measurement of the surface roughness (Sa) is not limited to the above-described method.

The artificial joint stem <NUM> further includes the layer member <NUM>. As used herein, "layer member" means a member different from the coating film <NUM> that is layered on the base <NUM>. For example, the surface of the layer member <NUM> is a rough surface. Thus, the region primarily in contact with the bone can have a rough surface. The layer member <NUM> may be formed by a thermal spraying method as described below. Alternatively, the layer member <NUM> may be formed as a porous structure.

<FIG> illustrates a cross section A-A' including the first boundary line <NUM> in <FIG>. In <FIG>, a layer member <NUM> is disposed as a rough surface. Thus, the region where the layer member <NUM> is provided is higher than the region where the layer member <NUM> is not provided. Accordingly, when the artificial joint stem <NUM> is embedded in the bone, the layer member <NUM> can mainly be brought into contact with the bone. Note that in <FIG>, the coating film <NUM> is formed on the layer member <NUM>.

In <FIG>, one or more boundary lines defined by the presence or absence of the layer member <NUM> as a rough surface, includes the third boundary line <NUM> located on the lower side of the base <NUM> with respect to the layer member <NUM>. The third boundary line <NUM> is located farther on the upper side of the base <NUM> than the first boundary line <NUM>. That is, the coating film <NUM> is formed so as to straddle the third boundary line <NUM>. In this case, the edge of the layer member <NUM> is covered with the coating film <NUM>. That is, the edge of the layer member <NUM> is covered so as not to be exposed from the coating film <NUM>. This further reduces bacterial growth.

The third boundary line <NUM> may have a shape along the first boundary line <NUM> or may have a shape different from that of the first boundary line <NUM>. A component along the vertical direction of the third boundary line <NUM> may be larger or smaller than a component along the width direction of the base <NUM>. The components of the third boundary line <NUM> can be considered in the same manner as the first boundary line <NUM> described above.

<FIG> illustrates a B-B' cross section including the second boundary line <NUM> in <FIG>. In <FIG>, the one or more boundary lines defined by the presence or absence of the layer member <NUM> as a rough surface, includes the fourth boundary line <NUM> located on the upper side of the base <NUM> with respect to the layer member <NUM>. The fourth boundary line <NUM> is located farther on the lower side of the base <NUM> than the second boundary line <NUM>. That is, the coating film <NUM> is formed so as to straddle the fourth boundary line <NUM>. In this case, as in <FIG>, since the edge of the layer member <NUM> is covered with the coating film <NUM>, the growth of bacteria can be further reduced.

The fourth boundary line <NUM> may have a shape along the second boundary line <NUM> or may have a shape different from that of the second boundary line <NUM>. A component along the vertical direction of the fourth boundary line <NUM> may be larger or smaller than a component along the width direction of the base <NUM>. The components of the fourth boundary line <NUM> can be considered in the same manner as the first boundary line <NUM> described above.

Note that the lower limit of the height of the layer member <NUM> may be only required to be set to, for example, <NUM> or more, and may be set to <NUM> or more. The upper limit may be only required to be set to, for example, <NUM> or less, and may be set to <NUM> or less. The surface roughness of the layer member <NUM> may be set to, for example, <NUM> to <NUM>, <NUM> to <NUM>, or <NUM> to <NUM>.

As the material of the layer member <NUM>, the material exemplified as the material of the base <NUM> can be used. For example, the layer member <NUM> may be made of a metal. Thus, sufficient strength can be secured. The material of the layer member <NUM> and the material of the base member <NUM> may be the same or different. Note that in the present embodiment, the layer member <NUM> is made of a titanium alloy.

The height of the layer member <NUM> may be greater than the thickness of the coating film <NUM>. Thus, since the region where the layer member <NUM> is formed is higher than the region where only the coating film <NUM> is formed, the region where the layer member <NUM> is formed can mainly be brought into contact with the bone. The thickness of the coating film <NUM> may be only required to be set to, for example, less than <NUM>, and may be set to less than <NUM>. The coating film <NUM> may be only required to be, for example, set to be <NUM> or more.

Also, as described above, the base <NUM> may include the embedded portion <NUM> embedded in the bone and the exposed portion <NUM> exposed from the bone. The femur is an example of the bone. A coating film <NUM> may be formed on a part of the peripheral wall of the embedded portion <NUM>. Thus, the embedded portion <NUM>, which can actually come into contact with the bone, can exhibit desirable adherence and antimicrobial properties.

For example, as illustrated in <FIG>, at least a part of the coating film <NUM> may be disposed in a boundary region <NUM> including a boundary between the embedded portion <NUM> and the exposed portion <NUM>. That is, the coating film <NUM> may be disposed in a region of the embedded portion <NUM> near the exposed portion <NUM>. Thus, invasion of bacteria from the exposed portion <NUM> side can be more effectively reduced.

The coating film <NUM> disposed in the boundary region <NUM> may be disposed only in the embedded portion <NUM>. That is, the coating film <NUM> need not be disposed in the exposed portion <NUM>. Thus, irritation to the soft tissue that may come in contact with the exposed portion <NUM> can be reduced.

The base <NUM> may include a body portion <NUM>' including the constant width portion <NUM>'a and the contraction portion <NUM>'b described above, and a neck portion <NUM>' connected to the upper end portion of the body portion <NUM>'. The body portion <NUM>' may be embedded in the femur. The neck portion <NUM>' may be exposed from the femur. The neck portion <NUM>' may be provided with a bone head. The bone head may be fitted into an acetabular cup that constitutes a pair with the artificial joint stem.

As illustrated in <FIG>, the constant width portion <NUM>'a may have a center axis C extending in the vertical direction. The contraction portion <NUM>'b may extend continuously from the constant width portion <NUM>'a in the vertical direction, and may have a shape curved such that the center of the contraction portion <NUM>'b is separated from the center axis C as advancing upward. The contraction portion <NUM>'b has an upper end face disposed away from the center axis C, and the neck portion <NUM>' may be connected to the upper end face. The neck portion <NUM>' is smaller in width than the upper end face of the body portion <NUM>'. In other words, the neck portion <NUM>' may be also referred to as a protruding portion <NUM>' protruding obliquely with respect to the vertical direction of the base <NUM>.

The base <NUM> may further include a collar <NUM>' provided at a connecting portion between the body portion <NUM>' and the neck portion <NUM>'. The collar <NUM>' is a protruding portion protruding from the connecting portion toward the surface direction of the upper end face. The collar <NUM>' can reduce excessive penetration of the body portion <NUM>' into the bone during surgery to insert the artificial joint stem into the bone.

The coating film <NUM> may satisfy the following relationship (<NUM>) or (<NUM>). <MAT> <MAT>L1 ≥ L2 In the relationships (<NUM>) and (<NUM>), L1 represents the length of the coating film <NUM> along the vertical direction on the side where the neck portion <NUM>' protrudes, and L2 represents the length of the coating film <NUM> along the vertical direction on a side opposite to the side where the neck portion <NUM>' protrudes.

The coating film <NUM> illustrated in <FIG> satisfies the relationship (<NUM>). L1 can be also referred to as a maximum value of a length along the Y-axis direction on the side where the neck portion <NUM>' protrudes in the region in which the coating film <NUM> is located. In other words, L1 represents a difference in the Y coordinate between a point where the Y coordinate of the side where the neck portion <NUM>' protrudes in the region in which the coating film <NUM> is located is maximum and a point where the Y coordinate is minimum. L2 can also be referred to as a maximum value of a length along the Y-axis direction on the side opposite to the side where the neck portion <NUM>' protrudes in the region in which the coating film <NUM> is located. In other words, L2 represents a difference in the Y coordinate between a point where the Y coordinate on a side opposite to the side where the neck portion <NUM>' protrudes in the region in which the coating film <NUM> is located is maximum and a point where the Y coordinate is minimum. The coating film <NUM> illustrated in <FIG> satisfies the relationship (<NUM>).

In the present disclosure, the artificial joint stem includes an artificial joint stem <NUM> illustrated in <FIG>. For example, a recessed portion <NUM> including an opening in the surface of the coating film <NUM> may be provided. The opening area of the recessed portion <NUM> located on the upper end portion side of the coating film <NUM> may be greater than the opening area of the recessed portion <NUM> located on the lower end portion side of the coating film <NUM>. The recessed portion <NUM> may be provided only at the upper end portion of the coating film <NUM>.

In the present disclosure, the artificial joint stem also includes an artificial joint stem <NUM> illustrated in <FIG>. For example, the base <NUM> may include a groove. The groove may straddle the region where the coating film <NUM> is disposed and the region exposed from the coating film <NUM>. The groove may extend to the upper end portion of the coating film <NUM>. The surface roughness in the groove may be smaller than that of the base <NUM>. One end of the groove may be exposed from the coating film <NUM> and the other end may be located at the contraction portion <NUM>'b of the base <NUM>.

The base <NUM> may include an inner side portion <NUM> that curves concavely and an outer side portion <NUM> that curves convexly. Here, the groove may be bent at the contraction portion <NUM>'b to either the inner side portion <NUM> or the outer side portion <NUM>. For example, the groove may be bent at the contraction portion <NUM>'b to the inner side portion <NUM>.

The groove located in the region where the coating film <NUM> is disposed is defined as a first groove <NUM>, and the groove located in the region where the surface of the base <NUM> is exposed from the coating film <NUM> is defined as a second groove <NUM>. The first groove <NUM> may or may not be connected to the second groove <NUM>. That is, the first groove <NUM> and the second groove <NUM> may be formed as a single continuous groove. The upper end portion of the first groove <NUM> may be located at a bend on the inner side portion side. The upper end portion of the first groove <NUM> may be bent to the inner side portion <NUM>. In other words, the first groove <NUM> may include a first portion 11a extending in the vertical direction of the base <NUM> and a second portion 11b connected to the first portion 11a and having a component along the width direction of the base <NUM>. The depth of the second groove <NUM> may be smaller than the depth of the first groove <NUM>. The fact that the second portion 11b of the first groove <NUM> has a component along the width direction of the base <NUM> indicates that the second portion 11b of the first groove <NUM> is not parallel to the vertical direction of the base <NUM>. In other words, the second portion 11b of the first groove <NUM> is not parallel to, but is inclined with respect to the bone insertion direction of the artificial joint stem <NUM>. When the second portion 11b of the first groove <NUM> has a component along the width direction of the base <NUM>, sinking can be avoided.

The base <NUM> may include a plurality of grooves. The base <NUM> may also include a first groove set <NUM> and a second groove set <NUM>. The first groove set <NUM> includes the first groove <NUM> and the second groove <NUM> connected to each other. The second groove set <NUM> includes the first groove <NUM> and the second groove <NUM> connected to each other, and the first groove <NUM> extends to the upper end portion of the coating film <NUM> further than the first groove set <NUM>.

In addition, the base <NUM> may include a plurality of first groove sets <NUM>. The plurality of the first groove sets <NUM> may be arranged in the width direction of the base <NUM>. Of the plurality of the first groove sets <NUM>, the first groove set <NUM> located on the outer side portion <NUM> side may be located above the first groove set <NUM> located on the inner side portion <NUM> side.

In the present disclosure, the artificial joint stem also includes an artificial joint stem <NUM> illustrated in <FIG>. For example, the base <NUM> may include a plurality of grooves, and a groove located on the upper portion of the base <NUM> may be wider than a groove located on the lower portion of the base <NUM>. The grooves may have a component along the width direction of the base <NUM>. <FIG> illustrates a C-C ' cross section of <FIG>. As illustrated in <FIG>, a groove (the second portion 11b of the first groove <NUM>) along the width direction of the base <NUM> may be shallower upward.

The first boundary line <NUM> may intersect a linear portion of the groove. Here, the first boundary line <NUM> may diagonally intersect the linear portion of the groove. That is, the first boundary line <NUM> need not be orthogonal to the linear portion of the groove.

The first boundary line <NUM> may include a first portion 1a extending in a direction intersecting the groove and a second portion 1b extending in a direction along the groove. The second portion 1b of the first boundary line <NUM> may be separated from the groove. That is, the second portion 1b of the first boundary line <NUM> need not be in contact with the groove. The same is true for the second boundary line <NUM>.

The first groove <NUM> and the second groove <NUM> are connected. The first groove <NUM> may include the first portion 11a extending in the vertical direction of the base <NUM> and the second portion 11b connected to the first portion 11a and having a component along the width direction of the base <NUM>. As illustrated in <FIG>, the second boundary line <NUM> may extend in a direction along the second portion 11b of a first groove <NUM>.

As illustrated in <FIG>, the second boundary line <NUM> may be disposed so as to incline upward from the inner side portion <NUM> toward the outer side portion <NUM>. As illustrated in <FIG>, the first boundary line <NUM> may be located below an apex 13a of the recessed portion at the inner side portion <NUM>. A first boundary line <NUM> may be located below an apex 14a of the protruding portion at the outer side portion <NUM>. Alternatively, the first boundary line <NUM> may be located above the apex 14a of the protruding portion at the outer side portion <NUM>.

In the present disclosure, the artificial joint stem also includes an artificial joint stem <NUM> illustrated in <FIG>. For example, each of the one or more boundary lines defined by the presence or absence of the coating film <NUM> may intersect the groove with an acute angle. In <FIG>, an angle γ on the inner side portion <NUM> side of the angle formed by the first boundary line <NUM> and the second groove <NUM> is an acute angle.

In the present disclosure, the artificial joint stem also includes an artificial joint stem <NUM> illustrated in <FIG>. For example, the base <NUM> includes, from top to bottom, a rough surface region <NUM>, a non-rough-surface region <NUM>, and a groove region <NUM>. A rough surface is disposed in the rough-surface region <NUM>. The non-rough-surface region <NUM> is a region without a rough surface. The grooves are disposed in the groove region <NUM>. For example, the rough-surface region <NUM> may be a region in which rough surfaces are disposed but no grooves are disposed. The non-rough-surface region <NUM> may be a region in which neither a rough surface nor a groove is disposed. The groove region <NUM> may be a region in which a rough surface is not disposed but a groove is disposed. The coating film <NUM> may cover at least one selected from the group consisting of the rough-surface region <NUM>, the non-rough-surface region <NUM> and the groove region <NUM>. The area of the rough-surface region <NUM> may be smaller than that of the non-rough-surface region <NUM>. In the width direction of the base <NUM>, the length of the rough-surface region <NUM> may be greater than the length of the non-rough-surface region <NUM>. One or more boundary lines <NUM> between the rough-surface region <NUM> and the non-rough-surface region <NUM> may be inclined upward from the inner side portion <NUM> toward the outer side portion <NUM>. A length L3 on the inner side portion <NUM> side of the rough-surface region <NUM> may be less than the length L4 on the outer side portion <NUM> side of the rough-surface region <NUM>. Here, when viewed in a plan view from a direction perpendicular to the XY plane of <FIG>, the length L3 represents a difference in the Y coordinate between a point where the Y coordinate is maximum and a point where the Y coordinate is minimum, on the inner side portion <NUM> side of the rough-surface region <NUM>. A length L4 represents a difference in the Y coordinate between a point where the Y coordinate is maximum and a point where the Y coordinate is minimum, on the outer side portion <NUM> side of the rough-surface region <NUM>.

In the present disclosure, the artificial joint stem also includes artificial joint stems <NUM>, <NUM>, and <NUM> illustrated in <FIG>. For example, the second boundary line <NUM> may be a straight line, such as the artificial joint stem <NUM>. As in the artificial joint stem <NUM>, the apex 14a of the protruding portion may be exposed from the coating film <NUM> at the outer side portion <NUM>. As in the artificial joint stem <NUM>, the second boundary line <NUM> may follow the shape of the outer side portion <NUM> of the base <NUM>.

In an embodiment, a method of manufacturing an artificial joint stem includes, for example, a preparation step and a coating film forming step. In the preparation step, a base <NUM> having a surface including a first region and a second region is prepared. The coating film forming step is a step of forming the coating film <NUM> containing a calcium phosphate-based material and an antimicrobial material on a part (the first region) of the surface of the base <NUM>. Here, the base <NUM> includes thereon one or more boundary lines defined by the presence or absence of the coating film <NUM>. Of the one or more boundary lines, the first boundary line <NUM> is located on the lower side of the base <NUM> with respect to the coating film <NUM>. The coating film <NUM> is formed such that the first boundary line <NUM> intersects the vertical direction and a component along a vertical direction of a first boundary line <NUM> becomes smaller than a component along a width direction of the base <NUM>. Thus, the artificial joint stem <NUM> described above can be obtained.

In the preparation step, the base <NUM> can be prepared by molding the metal material into a desired shape by using a metal mold, or an additive manufacturing method, or the like. Note that since the second region is located so as to sandwich the first region vertically in the base <NUM>, the first boundary line and the second boundary line can be formed after the coating film <NUM> is formed. The shapes of the first boundary line and the second boundary line of the coating film can be adjusted according to the shape of the first region.

The coating film <NUM> can be formed by: a thermal spraying method such as flame spraying, high-speed flame spraying, and plasma spraying; a physical vapor deposition method or chemical vapor deposition method such as sputtering, ion plating, ion beam deposition, and an ion mixing method; or a wet coating method such as a sol-gel method. Note that the material constituting the coating film is also referred to as a coating material.

A first protective material may be used to form the coating film <NUM> only in the first region. In this case, the coating film forming step may further include a step of disposing the first protective material so as to protect the second region while exposing the first region so that the coating film is not formed in the second region. For example, a masking tape or a screen may be used as the first protective material. Alternatively, a jig covering the base <NUM> may be used as the first protective material. Examples of the first protective material include metals, glasses, resins, and composite materials thereof. Note that the first protective material may or may not be in contact with the base <NUM>. When, for example, a masking tape is used as the first protective material, the first protective material may be disposed on the second region. When a jig covering the base <NUM> is used, the shape of the jig is not particularly limited, but may be, for example, tubular. The cross section of the tubular jig may be polygonal or circular.

When a screen is to be disposed, the coating film <NUM> can be formed in a specific region by placing the screen in a predetermined location. When a jig is used, the coating film <NUM> can be formed in a specific region by placing the jig in a predetermined location. In this case, for example, the coating film <NUM> can be selectively formed only in a desired region by adjusting the positional relationship between the screen and a discharge nozzle configured to discharge the thermal spraying material, the additive manufacturing material, the chemical etching material, the blasting material, or the coating material. In this case, a tip of the discharge nozzle is only required to be disposed, for example, in a straight line with the surface of the desired region without being separated by the screen. Hereinafter, a thermal spraying material, an additive manufacturing material, a chemical etching material, a blasting material, or a coating material discharged from the discharge nozzle is also referred to as a discharge material. Without being limited to the above, the coating film <NUM> may be formed while the base <NUM>, the screen, and the discharge nozzle are fixed, or the coating film <NUM> may be formed while moving at least one selected from the group consisting of the aforementioned. The angle of the discharge nozzle may be fixed or the coating film <NUM> may be formed while changing the angle.

Note that the coating film <NUM> can be formed only in a desired region without using a protective material. For example, the coating film <NUM> can be selectively formed only in a desired region by adjusting the shape, angle degree, or position, of the discharge nozzle configured to discharge the discharge material. For example, the discharge material may be discharged with the discharge nozzle located above the surface of the desired region. In this case, the coating film <NUM> may be formed by fixing the base <NUM> and moving the position and angle of the discharge nozzle, or the coating film <NUM> may be formed by fixing the discharge nozzle and moving the position and angle of the base <NUM>. The discharge nozzle may be moved at a constant speed or at a variable speed. The discharge direction of the discharge material may be an angle of <NUM> ° or an angle of less than <NUM> ° with the vector extending from the tip of the discharge nozzle toward the base <NUM> or the surface of the rough surface, which are located at the shortest distance from the tip of the discharge nozzle.

A roughening step may be performed before the coating film forming step. The roughening step is a step of forming a rough surface on the base <NUM>. Specifically, in the preparation step, the base <NUM> having a surface further including a roughening region in addition to the first region and the second region is prepared. Then, in the roughening step, a rough surface is formed in the roughening region of the base <NUM>.

In the roughening step, a rough surface can be formed by at least one selected from the group consisting of a thermal spraying method, an additive manufacturing method, a chemical etching method, and a blasting method. Compared with the blasting method, the thermal spraying method, the additive manufacturing method or the chemical etching method can increase the surface roughness. Note that the material discharged toward the base <NUM> in the thermal spraying method is referred to as a thermal spraying material. Similarly, a material discharged toward the base <NUM> in the additive manufacturing method is referred to as an additive manufacturing material. A material discharged toward the base <NUM> when processing by the chemical etching method is referred to as a chemical etching material. Similarly, a material discharged toward the base <NUM> when processing by the blasting method is referred to as a blasting material. As the thermal spraying material and the additive manufacturing material, the material exemplified as the material for the base <NUM> can be used. The layer member described above may be formed by a thermal spraying method or an additive manufacturing method. Examples of the chemical etching method include alkali treatment. Examples of the blasting method include sandblasting.

A second protective material may be used to form a rough surface only in a desired region. In this case, the roughening step may further include a step of disposing the second protective material so as to protect other regions while exposing the roughening region so that no rough surface is formed in other than the roughening region. Note that the roughening region may be located inside the first region or may straddle across the first region and the second region. That is, the second protective material may be disposed to protect a part of the first region and the second region, or the second region. For example, the positional relationship between the third boundary line and the fourth boundary line defined by the presence or absence of the rough surface, and between the first boundary line and the second boundary line defined by the presence or absence of the coating film, can be adjusted according to the location of the roughening region.

For example, a masking tape or a screen may be used as the second protective material. Alternatively, a jig covering the base <NUM> may be used as the second protective material. Examples of the second protective material include metals, glasses, resins, and composite materials thereof. Note that the second protective material may or may not be in contact with the base <NUM>. When a jig covering the base <NUM> is used as the second protective material, the shape of the jig is not particularly limited, but may be, for example, tubular. The cross section of the tubular jig may be polygonal or circular.

When a screen is to be placed, a rough surface can be formed in a specific region by placing the screen in a predetermined position. When a jig is to be used, a rough surface can be formed in a specific region by placing the jig in a predetermined position. In this case, for example, the rough surface can be selectively formed only in a desired region by adjusting the positional relationship between the screen and a discharge nozzle for discharging the thermal spraying material, the additive manufacturing material, the chemical etching material, the blasting material, or the coating material. In this case, a tip of the discharge nozzle is only required to be disposed, for example, in a straight line with the surface of the desired region without being separated by the screen. Hereinafter, a thermal spraying material, an additive manufacturing material, a chemical etching material, a blasting material, or a coating material discharged from the discharge nozzle is also referred to as a discharge material. Without being limited to the above, the rough surface may be formed while the base <NUM>, the screen, and the discharge nozzle are fixed, or the rough surface may be formed while moving at least one selected from the group consisting of the aforementioned. The angle of the discharge nozzle may be fixed or the rough surface may be formed while changing the angle. Note that similarly to the coating film <NUM>, a rough surface may be formed only in a desired region without using a protective material.

As described above, when forming a rough surface on the artificial joint stem, for example, in the roughening step, while exposing a part of the surface of the base <NUM>, the second protective material may be disposed on the base <NUM> so as to protect another part of the base <NUM>, so that a rough surface may be formed on the exposed part of the surface. In the present disclosure, the manufacturing method may further include a step of removing the second protective material after the roughening step and before the coating film forming step.

After the second protective material is removed, a step of scraping the edge of the rough surface, for example, the edge of the layer member <NUM>, may be performed. Thus, the concentration of stress at the edge of the layer member <NUM> can be avoided, and irritation to the biotissue can be reduced.

A second masking tape may be used as the second protective material. In this case, in the present disclosure, the manufacturing method may further include a step of, while exposing a part of the base <NUM>, sticking the second masking tape to another part of the base <NUM>, before the roughening step.

In the coating film forming step, while exposing a part of the surface of the base <NUM>, the first protective material may be disposed on the base <NUM> so as to protect another part of the base <NUM>, so that the coating film <NUM> may be formed on the exposed part of the surface. The first protective material can be removed after the coating film forming step. A first masking tape may be used as the first protective material. In this case, in the present disclosure, the manufacturing method may further include a step of, while exposing a part of the base <NUM>, attaching a second masking tape to another part of the base <NUM>, before the coating film forming step.

As the second protective material, one having higher thermal resistance than that of the first protective material can be used. For example, a material which is not melted or pyrolyzed for <NUM> minute under a thermal spraying condition of <NUM> may be used as the second protective material, and a material which is not melted or pyrolyzed for <NUM> minute under a thermal spraying condition of <NUM> may be used as the first protective material. A specific example of such a material includes a composite material of glass and resin.

When processing by the blasting method in the roughening step, a material which is not dissolved or pyrolyzed at room temperature may be used as the second protective material. A specific example of such a material includes a resin.

In the present disclosure, in the step of forming the rough surface or the coating film <NUM> in the manufacturing method, a protective material may be disposed in addition to the first protective material and the second protective material. For example, in the step of forming the rough surface or the coating film <NUM>, a protective material may be disposed on a part or all of the exposed portion <NUM>. Thus, the presence or absence of the formation of the rough surface or the coating film <NUM> in the exposed portion <NUM> can be appropriately controlled. For example, by disposing a protective material in a region of the exposed portion <NUM> far from the embedded portion <NUM> and forming the coating film <NUM> in the exposed region, the coating film <NUM> can be formed in a region of the exposed portion <NUM> near the embedded portion <NUM>.

In summary, each step can be performed in the order illustrated in <FIG>, for example. <FIG> is a flowchart illustrating a method of manufacturing an artificial joint stem <NUM> according to an embodiment. First, the second protective material is disposed, and after a roughening step is performed, the second protective material can be removed. Thereafter, the first protective material may be disposed, followed by a coating film forming step.

In the present disclosure, the manufacturing method may or may not include a cleaning step between each step. For example, in the present disclosure, the manufacturing method includes a step of cleaning the base <NUM>, or the base <NUM> and the layer member <NUM> after the roughening step. The cleaning method is not particularly limited, but may be, for example, a method of immersing in a liquid such as water or an organic solvent such as alcohol, or a method of showering using the liquid. Alternatively, a method of blowing a gas such as air, nitrogen or argon may be employed. Thus, the excess thermal spraying material or the like and/or scrapes or the like generated by the roughening step can be removed.

In the manufacturing method according to the present disclosure, after the roughening step for roughening the surface of the base <NUM>, a groove forming step for forming a groove may be performed, and then the coating film forming step for forming a coating film may be performed. Alternatively, after the groove forming step, the roughening step may be performed, and then the coating film forming step may be performed. In the groove forming step, the groove can be formed by at least one selected from the group consisting of a cutting method, a rolling processing method and a pressing method. For example, the groove may be formed by milling as one of the cutting methods. When forming the recessed portion, the recessed portion forming step may be performed in place of the groove forming step by the same method as the groove forming step.

The roughening step may include, in order, a first roughening step of forming a first rough surface by a thermal spraying method and a second roughening step of forming a second rough surface by a chemical etching method or a blasting method. Herein, a region where the first rough surface is formed by thermal spraying method is referred to as a first roughening region, a region where the second rough surface is formed by chemical etching method or blasting method is referred to as a second roughening region, and a region where no rough surface is formed is referred to as a non-roughening region.

In the first roughening step, a third protective material (the second protective material described above) may be disposed to protect the second roughening region and the non-roughening region with respect to the base <NUM> while exposing the first roughening region, thereby forming the first rough surface in the exposed first roughening region. In the present disclosure, the manufacturing method may further include a step of removing the third protective material after the first roughening step and before the second roughening step. In the second roughening step, a fourth protective material may be disposed to protect the non-roughening region while exposing the second roughening region with respect to the base <NUM> to form the second rough surface on the exposed second roughening region. The second roughening step may be performed such that the surface of the second rough surface formed in the second roughening step has a surface roughness smaller than that of the first rough surface in the first roughening region. In the present disclosure, the manufacturing method may include a step of removing the fourth protective material after the second roughening step and before the coating film forming step. A fourth masking tape may be used as the fourth protective material. In the present disclosure, the manufacturing method may further include a step of attaching a fourth masking tape to a non-roughening region <NUM> while exposing a first roughening region <NUM> and a second roughening region <NUM> before the second roughening step. As the fourth protective material, a material having lower thermal resistance than the above-described third protective material may be used. For example, a material which is not dissolved or pyrolyzed at room temperature may be used as the fourth protective material. Specifically, a resin may be used as the fourth protective material.

In the second roughening step, the non-roughening region may or may not be covered with a protective material. The first roughening region and the non-roughening region may be protected, and only the second roughening region may be processed by at least one selected from the group consisting of chemical etching method and blasting method. Alternatively, a fourth protective material may be disposed so as to expose the first roughening region, and the rough surface of the exposed first roughening region and the second roughening region may be processed by at least one selected from the group consisting of a chemical etching method and a blasting method. Thus, an excess thermal spraying material or the like remaining on the rough surface of the first roughening region can be removed, and a rough surface can be also formed on the second roughening region.

The method of manufacturing the artificial joint stem <NUM> may initially include a step of preparing a base <NUM> in which the first roughening region, the second roughening region, and the non-roughening region are located in this order.

Although the artificial joint stem <NUM> illustrated in <FIG> has a shape mainly assuming a stem for an artificial hip joint, artificial joints to which the artificial joint stem according to the present disclosure is applied, are not limited to artificial hip joints. Examples of the artificial joint include an artificial hip joint, an artificial knee joint, an artificial ankle joint, an artificial shoulder joint, an artificial elbow joint and an artificial finger joint.

Referring now to <FIG>, an example in which the artificial joint stem <NUM> is used as a part of an artificial hip joint <NUM> will be described below. The artificial hip joint <NUM> may include a bone head <NUM> and an acetabular cup <NUM> in addition to the artificial joint stem <NUM>. The bone head <NUM> and the acetabular cup <NUM> may be formed of the same or different materials as the base <NUM> of the artificial joint stem <NUM>. The artificial joint stem <NUM> is embedded in a femur <NUM>. The bone head <NUM> is disposed at the exposed portion <NUM> of the artificial joint stem <NUM>. The acetabular cup <NUM> is fixed to an acetabular <NUM> of a hip bone <NUM>. The acetabular cup functions as a hip joint by fitting and sliding the bone head <NUM> into the depression of the acetabular cup <NUM>.

Claim 1:
An artificial joint stem (<NUM>) comprising:
a base (<NUM>) extending in a vertical direction when a proximal side of a human body in use is defined as an upward direction;
a coating film (<NUM>) on a part of the base (<NUM>), containing a calcium phosphate-based material and an antimicrobial material; and
one or more boundary lines (<NUM>, <NUM>) on the base (<NUM>) defined by a presence or absence of the coating film (<NUM>), and comprising a first boundary line (<NUM>) located on a lower side of the base (<NUM>) with respect to the coating film (<NUM>), and that intersects the vertical direction, wherein
a component along the vertical direction of the first boundary line (<NUM>) is smaller than a component along a width direction of the base (<NUM>),
characterized in that
the artificial joint stem (<NUM>) further comprising:
a layer member (<NUM>) having a rough surface located on a surface of the base (<NUM>):
one or more boundary lines (<NUM>, <NUM>) on the base (<NUM>) defined by a presence or absence of the rough surface, and comprising a third boundary line (<NUM>) that is located on a lower side of the base (<NUM>) with respect to the rough surface,
wherein the third boundary line (<NUM>) is located farther on an upper side of the base (<NUM>) than the first boundary line (<NUM>), and
the coating film (<NUM>) is formed as to straddle the third boundary line (<NUM>) such that an edge of the layer member (<NUM>) is covered with the coating film (<NUM>).