Artificial joint handle

Abstract

The artificial joint handle of the present invention comprises: a base extending in the vertical direction with the proximal end side in the human body during use being in the upward direction; and a coating disposed on a portion of the base and comprising a calcium phosphate material and an antibacterial material. Boundaries on the base defined by the presence or absence of the coating include a first boundary line located below the base relative to the coating. The first boundary line is located at a position intersecting the vertical direction. The component of the first boundary line along the vertical direction is smaller than the component along the width direction of the base.

Description

Technical Field

[0001] The invention relates to a handle for an artificial joint. Background Art

[0002] With the increase in the number of athletes and the elderly population, the use of bioimplants in the treatment of bone injuries and diseases is expanding. Among them, bioimplants with coatings are known from the viewpoints of antibacterial properties and bone adhesion.

[0003] For example, Patent Document 1 describes a coating for medical implants, wherein a portion of the coating contains a bone cement and an antibacterial metal agent containing silver.

[0004] Prior art literature

[0005] Patent Literature

[0006] Patent Document 1: Japanese Patent Application No. 2011-512959 Summary of the Invention

[0007] The artificial joint handle of the present invention comprises: a base extending in the vertical direction with the proximal end side in the human body during use being in the upward direction; and a coating disposed on a portion of the base and comprising a calcium phosphate material and an antibacterial material. Boundaries on the base defined by the presence or absence of the coating include a first boundary line located below the base relative to the coating. The first boundary line is located at a position intersecting the vertical direction. The component of the first boundary line along the vertical direction is smaller than the component along the width direction of the base. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 This is a schematic diagram showing an artificial joint handle according to one embodiment.

[0009] Figure 2 This is a schematic diagram showing an artificial joint handle according to one embodiment.

[0010] Figure 3 This is a schematic diagram showing an artificial joint handle according to one embodiment.

[0011] Figure 4 This is a schematic diagram showing a cross section of an artificial joint handle according to one embodiment.

[0012] Figure 5 This is a schematic diagram showing a cross section of an artificial joint handle according to one embodiment.

[0013] Figure 6 This is a schematic diagram showing an artificial joint handle according to one embodiment.

[0014] Figure 7 This is a schematic diagram showing an artificial joint handle according to one embodiment.

[0015] Figure 8 These are process diagrams illustrating a method for manufacturing an artificial joint handle according to one embodiment.

[0016] Figure 9 This is a schematic diagram showing an artificial hip joint according to one embodiment.

[0017] Figure 10 This is a schematic diagram showing an artificial joint handle according to one embodiment.

[0018] Figure 11 This is a schematic diagram showing an artificial joint handle according to one embodiment.

[0019] Figure 12 This is a schematic diagram showing an artificial joint handle according to one embodiment.

[0020] Figure 13 This is a schematic diagram showing a cross section of an artificial joint handle according to one embodiment.

[0021] Figure 14 This is a schematic diagram showing an artificial joint handle according to one embodiment.

[0022] Figure 15 This is a schematic diagram showing an artificial joint handle according to one embodiment.

[0023] Figure 16 This is a schematic diagram showing an artificial joint handle according to one embodiment. DETAILED DESCRIPTION

[0024] Hereinafter, one embodiment will be described in detail. It should be noted that, in this specification, "A to B" indicating a numerical range means "A or more and B or less" unless otherwise specified.

[0025] 〔1.Handle for artificial joint〕

[0026] First, refer to Figure 1 The structure of an artificial joint handle 100 according to one embodiment will be described. The artificial joint handle 100 includes a base 10 extending in the up-down direction with the proximal side in the human body being the upper direction during use, and a coating 20 disposed on a portion of the surface of the base 10. It can also be said that the upper side of the base 10 in the up-down direction corresponds to the proximal side in the human body, and the lower side corresponds to the distal side in the human body. The coating 20 contains a calcium phosphate material and an antibacterial material. In addition, the artificial joint handle 100 has an embedded portion 40 embedded in the bone, and an exposed portion 50 exposed from the bone. Figure 1In the embodiment, the coating 20 is formed in the region of the embedded portion 40 near the exposed portion 50, while the region of the embedded portion 40 away from the exposed portion 50 is exposed from the coating 20. It should be noted that the calcium phosphate-based material has the effect of improving its adhesion to bone. Furthermore, the antibacterial material has the effect of reducing bacterial adhesion and proliferation.

[0027] Here, the coating 20 is arranged on a portion of the surface of the base 10. That is, another portion of the surface of the base 10 is exposed from the coating 20. For example, when the entire surface of the artificial joint handle 100 is covered with a coating containing a bone binder and an antibacterial metal agent, it is difficult to control the adhesion of the artificial joint handle 100 to the bone. In this case, when the artificial joint handle needs to be removed after surgery, it may be difficult to remove it. For example, the embedded portion 40 may be excessively fixed to the bone through the coating. If the base 10 has an area covered by the coating 20 and an area exposed from the coating 20, excessive adhesion to the bone can be reduced. That is, both adhesion to the bone and antibacterial properties can be achieved.

[0028] The boundary lines on the substrate 10 defined by the presence or absence of the coating 20 include a first boundary line 1 located below the substrate 10 relative to the coating 20. First boundary line 1 is located at a position intersecting the vertical direction. That is, the entire first boundary line 1 is not parallel to the vertical direction. Furthermore, the component of first boundary line 1 along the vertical direction is smaller than the component along the width direction of the substrate 10.

[0029] Furthermore, refer to Figure 2 The components of the first boundary line 1 are described. Figure 2 In FIG, the vertical direction of the substrate 10 is represented as the Y-axis direction, and the width direction of the substrate 10 is represented as the X-axis direction. The width direction of the substrate 10 can also be said to be a direction perpendicular to the vertical direction. Figure 2 It can also be said that it is a view viewed from a direction perpendicular to the XY plane, that is, from the Z-axis direction. Figure 2In the embodiment of the present invention, the straight line α connecting the two ends of the first boundary line 1 is studied. When the straight line α is parallel to the X-axis, it can be said that the first boundary line 1 has only a component along the width direction of the substrate 10. When the straight line α is expressed as a straight line with an inclination on the XY coordinates, it can be said that the first boundary line 1 has both a component along the up-down direction of the substrate 10 and a component along the width direction of the substrate 10. In this specification, "the component of the first boundary line 1 along the up-down direction is smaller than the component along the width direction of the substrate 10" means that the absolute value of the inclination of the straight line α is less than 1. In this case, the friction in the shear direction generated on the first boundary line 1 can be reduced, so the peeling of the coating 20 can be reduced. In addition, "the component of the first boundary line 1 along the up-down direction is smaller than the component along the width direction of the substrate 10" also includes the case where the first boundary line 1 has only a component along the width direction of the substrate 10.

[0030] The boundary line may also include a second boundary line 2 located on the upper side of the substrate 10 relative to the coating 20. The second boundary line 2 may also be located at a position intersecting the up-down direction. The second boundary line 2 may also be similar to the first boundary line 1, in that the component along the up-down direction is smaller than the component along the width direction of the substrate 10. Alternatively, the second boundary line 2 may be different from the first boundary line 1, in that the component along the up-down direction is larger than the component along the width direction of the substrate 10. Figure 2 In the example, the straight line connecting the two ends of the second boundary line 2 is referred to as straight line β. "The component of the second boundary line 2 along the vertical direction is smaller than the component along the width direction of the substrate 10" means that the absolute value of the inclination of straight line β is less than 1. On the other hand, "the component of the second boundary line 2 along the vertical direction is larger than the component along the width direction of the substrate 10" means that the absolute value of the inclination of straight line β is greater than 1. Furthermore, the component of the second boundary line 2 along the vertical direction may be larger than the component of the first boundary line 1 along the vertical direction.

[0031] The length of the first boundary line 1 and the length of the second boundary line 2 can be the same, or one of them can be larger. In this specification, "the length of the first boundary line 1" refers to the full length of the first boundary line 1 around the substrate 10. The same applies to "the length of the second boundary line 2". For example, Figure 1 As shown, the length of the first boundary line 1 may also be greater than the length of the second boundary line 2. On the other hand, the length of the first boundary line 1 may also be less than the length of the second boundary line 2.

[0032] When the substrate 10 is viewed from above in a direction perpendicular to the vertical direction, the boundary line may be a straight line or a curved line. For example, when the substrate 10 is viewed from above in a direction perpendicular to the vertical direction, the boundary line may be composed of a single straight line or may include multiple straight lines. "The boundary line includes multiple straight lines" means that, for example, Figure 12 As shown in FIG. 1 , two straight lines (1a) extending in the width direction are connected to a straight line (1b) extending in the vertical direction. Here, the boundary line may include straight lines when viewed from above but may be curved in three dimensions. For example, the first boundary line 1 may be composed of a single straight line or may include multiple straight lines. The second boundary line 2 may also be composed of a single straight line or may include multiple straight lines.

[0033] like Figure 1 As shown, the base 10 may also have a constant width portion 40'a located below the base 10 and having a constant width. In addition, the base 10 may also have a contraction portion 40'b with a width that decreases downward. The constant width portion 40'a may also extend continuously downward from the contraction portion 40'b. The boundary line may be located at the constant width portion 40'a or at the contraction portion 40'b. For example, the first boundary line 1 may be as shown in FIG. Figure 1 It is located at the contraction portion 40'b, or it can be located at the contraction portion 40'b. Figure 3 The same applies to the second boundary line 2.

[0034] In addition, if Figure 11 As shown, the substrate 10 may also have a node. A node is a portion where the length around the substrate 10 is greater than the length around the portion of the substrate 10 located above and below it. In other words, the substrate 10 may also have a node-like protrusion. In addition, the boundary line may also be located at a node.

[0035] The substrate 10 can be made of metal, ceramic or plastic. Examples of metals include stainless steel alloys, cobalt-chromium alloys, titanium and titanium alloys. Examples of titanium alloys include alloys in which at least one of aluminum, tin, zirconium, molybdenum, nickel, palladium, tantalum, niobium, vanadium and platinum is added to titanium. Examples of ceramics include aluminum oxide, zirconium oxide and aluminum oxide-zirconium oxide composite ceramics. Examples of plastics include polyethylene, fluorine-based resins, epoxy resins, polyetheretherketone (PEEK) resins and phenolic resins. It should be noted that in this embodiment, the substrate 10 is formed of a titanium alloy.

[0036] The shape of the base 10 may be, for example, a substantially rod-like shape, but may be appropriately changed according to the shape of the artificial joint to which it is applied.

[0037] The coating 20 includes a calcium phosphate material and an antibacterial material. As the calcium phosphate material, for example, one or a mixture of two or more selected from the group consisting of hydroxyapatite, α-tertiary calcium phosphate, β-tertiary calcium phosphate, quaternary calcium phosphate, octacalcium phosphate and calcium phosphate glass can be used. As the antibacterial material, natural antibacterial agents, organic antibacterial agents and inorganic antibacterial agents can be used. As a natural antibacterial agent, for example, cypress phenol can be used, as an organic antibacterial agent, for example, benzalkonium chloride can be used, as an inorganic antibacterial agent, a metal can be used, and as a metal, for example, silver, copper, zinc, etc. can be used. In addition to the calcium phosphate material and the antibacterial material, the coating 20 may also contain glass ceramics, and may also contain antibacterial drugs such as penicillin and vancomycin.

[0038] The concentration of the antimicrobial material in the coating 20 can be, for example, 0.05% to 3.00% by weight, 0.05% to 2.50% by weight, 0.05% to 1.00% by weight, or 0.1% to 1.00% by weight. A concentration of 0.05% or greater can provide sufficient antimicrobial properties. A concentration of 3.00% or less can reduce the burden on biological tissues.

[0039] A concentration gradient of the antimicrobial material may exist within the coating 20. For example, the concentration of the antimicrobial material at the upper end of the coating 20 may be greater than that at the lower end. This can more effectively reduce bacterial intrusion from the upper end of the coating 20. Alternatively, the antimicrobial material may be contained only at the upper end of the coating 20.

[0040] The ratio of the area of ​​the region on the surface of the substrate 10 where the coating 20 is disposed to the area of ​​the region on the surface of the substrate 10 exposed from the coating 20 can be appropriately determined according to the application, etc. The area of ​​the region on the surface of the substrate 10 where the coating 20 is disposed and the area of ​​the region on the surface of the substrate 10 exposed from the coating 20 may be the same as or one of them may be larger. For example, in Figure 1 In the embodiment, the area where the coating 20 is disposed is smaller than the area of ​​the surface of the base 10 exposed from the coating 20. In this case, the artificial joint handle 100 can be more easily inserted into the bone. On the other hand, if the area where the coating 20 is disposed is larger than the area of ​​the surface of the base 10 exposed from the coating 20, bacterial invasion can be further reduced.

[0041] The area where the coating 20 is arranged and the area exposed from the coating 20 can be identified by elemental analysis of the surface of each area. The method of elemental analysis can be implemented, for example, by mapping the surface elements using an energy dispersive X-ray analysis (EDX) device, which is an accessory of a conventional scanning electron microscope (SEM). In addition, surface analysis methods such as X-ray photoelectron spectroscopy, Auger electron spectroscopy, and secondary ion mass spectrometry can also be used. In addition, the elements can be confirmed by chemical analysis of the sample obtained by mechanically scraping off the surface of each area. For example, phosphorus, calcium, antibacterial components, etc. are detected in the area where the coating 20 is arranged. In the surface of the area exposed from the coating 20, the elements constituting the substrate 10 are over-detected, while phosphorus, calcium, antibacterial components, etc. are not detected, or are below the noise level.

[0042] The substrate 10 may also have a rough surface located on the surface. The boundary line on the substrate 10 defined by the presence or absence of the rough surface may include a third boundary line 3 located on the lower side of the substrate 10 relative to the rough surface. In addition, the boundary line on the substrate 10 defined by the presence or absence of the rough surface may include a fourth boundary line 4 located on the upper side of the substrate 10 relative to the rough surface. The rough surface may be covered by the coating 20 or may be exposed from the coating 20. In addition, only a portion of the rough surface may be covered by the coating 20, or another portion of the rough surface may be exposed from the coating 20. For example, the third boundary line 3 may be located on the upper side of the substrate 10 relative to the first boundary line 1, or may be located on the lower side. In addition, the fourth boundary line 4 may be located on the upper side of the substrate 10 relative to the second boundary line 2, or may be located on the lower side.

[0043] As an indicator of the surface roughness of the rough surface, for example, the arithmetic mean roughness Sa (ISO25178) can be cited. The surface roughness (Sa) of the rough surface can be set to, for example, 10 to 80 μm, 20 to 80 μm, or 30 to 70 μm. It should be noted that the surface roughness (Sa) of the rough surface can be measured, for example, by cutting the artificial joint handle 100 and observing the cut surface using an SEM or the like.

[0044] The surface roughness (Sa) can be measured, for example, using a stylus or optical method. Furthermore, the surface roughness (Sa) can be measured, for example, in accordance with ISO 25178. It should be noted that the measurement of the surface roughness (Sa) is not limited to the above-mentioned method.

[0045] The artificial joint handle 100 may also include a layered member 30. In this specification, a "layered member" refers to a member that is laminated on the base 10 and is different from the coating 20. For example, the surface of the layered member 30 may be roughened. This allows the area that primarily contacts the bone to be roughened. The layered member 30 may also be formed by a spraying method, as described later. Alternatively, the layered member 30 may be formed into a porous structure.

[0046] Figure 4 Shown Figure 1 The AA' section in contains the first boundary line 1. Figure 4 In the embodiment, the layered member 30 is arranged as a rough surface. Thus, the area where the layered member 30 is provided is higher than the area where the layered member 30 is not provided. Therefore, when the artificial joint handle 100 is embedded in the bone, the layered member 30 can mainly contact the bone. Figure 4 In the embodiment, the coating 20 is formed on the layered member 30 .

[0047] exist Figure 4 In the embodiment, the boundary lines defined by the presence or absence of the roughened layer member 30 include a third boundary line 3 located below the substrate 10 relative to the layer member 30. The third boundary line 3 is located above the substrate 10 relative to the first boundary line 1. That is, the coating 20 is formed so as to straddle the third boundary line 3. In this case, the edge of the layer member 30 is covered by the coating 20. In other words, the edge of the layer member 30 is prevented from protruding from the coating 20. This further reduces bacterial growth.

[0048] The third boundary line 3 may have a shape that is consistent with the first boundary line 1, or may have a shape different from the first boundary line 1. The component of the third boundary line 3 along the vertical direction may be greater than the component along the width direction of the substrate 10, or may be smaller than the component along the width direction of the substrate 10. The components of the third boundary line 3 can be considered in the same manner as the first boundary line 1 described above.

[0049] Figure 5 Shown Figure 1 The BB' section in contains the second boundary line 2. Figure 5 In the embodiment, the boundary lines defined by the presence or absence of the layered member 30 as a rough surface include a fourth boundary line 4 located above the substrate 10 relative to the layered member 30. The fourth boundary line 4 is located below the substrate 10 relative to the second boundary line 2. That is, the coating 20 is formed so as to straddle the fourth boundary line 4. In this case, Figure 4 Likewise, since the edge of the layered member 30 is covered with the coating 20 , the proliferation of bacteria can be further reduced.

[0050] The fourth boundary line 4 may have a shape that is along the second boundary line 2 or may have a shape different from the second boundary line 2. The component of the fourth boundary line 4 along the vertical direction may be greater than the component along the width direction of the base 10 or may be smaller than the component along the width direction of the base 10. The components of the fourth boundary line 4 can be considered in the same manner as the first boundary line 1 described above.

[0051] It should be noted that the lower limit of the height of the layered member 30 can be set to, for example, 100 μm or greater, or 300 μm or greater. The upper limit can be set to, for example, 1000 μm or less, or 700 μm or less. Furthermore, the surface roughness of the layered member 30 can be set to, for example, 10 to 80 μm, 20 to 80 μm, or 30 to 70 μm.

[0052] The materials for the layered member 30 can be the materials exemplified as the materials for the base 10. For example, the layered member 30 can also be made of metal. This ensures sufficient strength. The material for the layered member 30 and the base 10 can be the same or different. It should be noted that in this embodiment, the layered member 30 is made of a titanium alloy.

[0053] The height of the layered member 30 may be greater than the thickness of the coating 20. This allows the area where the layered member 30 is formed to be higher than the area where only the coating 20 is formed, allowing the area where the layered member 30 is formed to primarily contact the bone. The thickness of the coating 20 may be, for example, less than 100 μm, or even less than 50 μm. Alternatively, the thickness of the coating 20 may be, for example, 5 μm or greater.

[0054] Furthermore, as described above, the base 10 may include an embedded portion 40 embedded in the bone and an exposed portion 50 exposed from the bone. An example of a bone is the femur. Alternatively, the coating 20 may be formed on a portion of the peripheral wall of the embedded portion 40. This allows the desired fixation and antibacterial properties to be exhibited in the embedded portion 40 that actually contacts the bone.

[0055] For example, Figure 6 As shown, at least a portion of the coating 20 may be disposed in a boundary region 60 encompassing the boundary between the embedded portion 40 and the exposed portion 50. Specifically, the coating 20 may be disposed in a region of the embedded portion 40 that is closer to the exposed portion 50. This can more effectively reduce bacterial intrusion from the exposed portion 50 side.

[0056] The coating 20 disposed in the boundary region 60 may be disposed only in the embedded portion 40. That is, the coating 20 may not be disposed in the exposed portion 50. This can reduce irritation to the soft tissue that the exposed portion 50 contacts.

[0057] The base 10 may also include a main body 40' including the uniform width portion 40'a and the constricted portion 40'b described above, and a neck 50' connected to the upper end of the main body 40'. The main body 40' may be embedded in the femur. The neck 50' may be exposed from the femur. A bone may be placed on the neck 50'. The bone may be embedded in the paired acetabular cups of the artificial joint stem.

[0058] like Figure 6 As shown, the uniform width portion 40'a may also have a central axis C extending in the vertical direction. Furthermore, the constricted portion 40'b may have a shape that extends continuously in the vertical direction from the uniform width portion 40'a and is curved so that its center moves away from the central axis C as it moves upward. Furthermore, the constricted portion 40'b may also have an upper end surface that is offset from the central axis C, with a neck 50' connected to the upper end surface. The width of the neck 50' is smaller than that of the upper end surface of the main body 40'. In other words, the neck 50' can also be said to be a protrusion 50' that protrudes obliquely with respect to the vertical direction of the base 10.

[0059] Furthermore, the base 10 may further include a collar 60' provided at the connection between the main body 40' and the neck 50'. The collar 60' is a protrusion extending from the connection toward the upper end surface. During surgery to insert the artificial joint stem into bone, the collar 60' can prevent the main body 40' from excessively penetrating the bone.

[0060] The coating 20 may satisfy the following formula (1) or the following formula (2).

[0061] L1≤L2 (1)

[0062] L1≥L2 (2)

[0063] In formulas (1) and (2), L1 represents the length of the film 20 along the vertical direction on the side where the neck 50 ′ protrudes, and L2 represents the length of the film 20 along the vertical direction on the side opposite to the side where the neck 50 ′ protrudes.

[0064] Figure 6 The coating 20 shown satisfies formula (2). L1 can also be said to be the maximum value of the length along the Y-axis direction of the side where the neck 50' protrudes in the area where the coating 20 is arranged. That is, L1 represents the difference in Y coordinates between the point where the Y coordinate of the side where the neck 50' protrudes in the area where the coating 20 is arranged becomes the maximum and the point where the Y coordinate becomes the minimum. In addition, L2 can also be said to represent the maximum value of the length along the Y-axis direction of the side opposite to the side where the neck 50' protrudes in the area where the coating 20 is arranged. That is, L2 represents the difference in Y coordinates between the point where the Y coordinate of the side opposite to the side where the neck 50' protrudes in the area where the coating 20 is arranged becomes the maximum and the point where the Y coordinate becomes the minimum. Figure 7 The coating 20 shown satisfies the formula (1).

[0065] Figure 10 The artificial joint handle 101 shown is also included in the artificial joint handle of the present invention. For example, a recess 25 having an opening opening to the surface of the coating 20 may be provided. The opening area of ​​the recess 25 located on the upper end side of the coating 20 may be larger than the opening area of ​​the recess 25 located on the lower end side of the coating 20. Alternatively, the recess 25 may be provided only on the upper end side of the coating 20.

[0066] Figure 11 The artificial joint handle 102 shown is also included in the artificial joint handle of the present invention. For example, the base 10 has a groove, and the groove is arranged so as to span the area where the coating 20 is arranged and the area exposed from the coating 20. The groove may also extend to the upper end of the coating 20. The surface roughness of the groove may be smaller than the surface roughness of the base 10. Alternatively, one end of the groove may be exposed from the coating 20, and the other end may be located at the contraction portion 40′b of the base 10.

[0067] The base 10 may also include a concavely curved inner portion 13 and a convexly curved outer portion 14. Here, the groove may be bent toward either the inner portion 13 or the outer portion 14 at the constricted portion 40'b. For example, the groove may be bent toward the inner portion 13 at the constricted portion 40'b.

[0068] The groove located in the area where the coating 20 is arranged is referred to as the first groove 11, and the groove located in the area where the surface of the substrate 10 is exposed from the coating 20 is referred to as the second groove 12. The first groove 11 may be connected to the second groove 12 or not. That is, the first groove 11 and the second groove 12 may form a continuous and uninterrupted groove. The upper end of the first groove 11 may be located at the curved portion on the inner side. The upper end of the first groove 11 may be bent toward the inner side 13. In other words, the first groove 11 may have a first portion 11a extending in the vertical direction of the substrate 10, and a second portion 11b connected to the first portion 11a and having a component along the width direction of the substrate 10. The depth of the second groove 12 may be smaller than the depth of the first groove 11. The second portion 11b of the first groove 11 has a component along the width direction of the substrate 10. In other words, the second portion 11b of the first groove 11 is not parallel to the vertical direction of the substrate 10. In other words, the second portion 11b of the first groove 11 is not parallel to but inclined relative to the bone insertion direction of the artificial joint handle 102. If the second portion 11b of the first groove 11 has a component along the width direction of the base 10, it can resist sinking.

[0069] The substrate 10 may also include a plurality of grooves. Furthermore, the substrate 10 may include a first groove group 15 in which the first grooves 11 and the second grooves 12 are connected, and a second groove group 16 in which the first grooves 11 and the second grooves 12 are connected and the first grooves 11 extend toward the upper end of the coating 20 beyond the first groove group 15 .

[0070] Furthermore, the base body 10 may include a plurality of first groove groups 15. The plurality of first groove groups 15 may be arranged in the width direction of the base body 10. Among the plurality of first groove groups 15, the first groove group 15 located on the outer portion 14 side may be located above the first groove group 15 located on the inner portion 13 side.

[0071] Figure 12 The artificial joint handle 103 shown is also included in the artificial joint handle of the present invention. For example, the base 10 may have a plurality of grooves, and the grooves located in the upper portion of the base 10 may be wider than the grooves located in the lower portion of the base 10. The grooves may also have a component along the width direction of the base 10. Figure 13 Shown Figure 12 C-C' cross section. Figure 13 As shown, the groove along the width direction of the base 10 (the second portion 11 b of the first groove 11 ) may become shallower toward the upper side.

[0072] The first boundary line 1 may intersect the straight portion of the groove. Here, the first boundary line 1 may intersect the straight portion of the groove at an angle. That is, the first boundary line 1 may not be perpendicular to the straight portion of the groove.

[0073] Alternatively, the first boundary line 1 may include a first portion 1a extending in a direction intersecting the groove, and a second portion 1b extending along the groove. The second portion 1b of the first boundary line 1 may also be disposed separately from the groove. That is, the second portion 1b of the first boundary line 1 may not contact the groove. The same applies to the second boundary line 2.

[0074] Alternatively, the first groove 11 is connected to the second groove 12, and the first groove 11 includes a first portion 11a extending in the vertical direction of the base 10, and a second portion 11b connected to the first portion 11a and having a component along the width direction of the base 10. Figure 12 As shown, the second boundary line 2 may also extend in a direction along the second portion 11 b of the first groove 111 .

[0075] In addition, if Figure 12 As shown in FIG. 1 , the second boundary line 2 may be arranged to be inclined upward from the inner portion 13 toward the outer portion 14. Figure 12As shown, the first boundary line 1 may be located below the apex 13a of the concave portion in the inner portion 13. The first boundary line 2 may be located below the apex 14a of the convex portion in the outer portion 14. Alternatively, the first boundary line 1 may be located above the apex 14a of the convex portion in the outer portion 14.

[0076] Figure 14 The artificial joint handle 104 shown is also included in the artificial joint handle of the present invention. For example, the boundary line determined by the presence or absence of the coating 20 may intersect the groove at an acute angle. Figure 14 In the embodiment, the angle γ formed by the first boundary line 1 and the second groove 12 on the inner portion 13 side is an acute angle.

[0077] Figure 15 The artificial joint handle 105 shown is also included in the artificial joint handle of the present invention. For example, the base 10 includes, from the top, a rough surface region 70, a non-rough surface region 80, and a groove region 90. The rough surface region 70 is provided with a rough surface. The non-rough surface region 80 is a region without a rough surface. The groove region 90 is provided with a groove. For example, the rough surface region 70 may be a region with a rough surface but without a groove, the non-rough surface region 80 may be a region without either a rough surface or a groove, and the groove region 90 may be a region without a rough surface but with a groove. The coating 20 may cover at least one of the rough surface region 70, the non-rough surface region 80, and the groove region 90. The area of ​​the rough surface region 70 may be smaller than the area of ​​the non-rough surface region 80. In the width direction of the base 10, the length of the rough surface region 70 may be greater than the length of the non-rough surface region 80. The boundary line 23 between the rough surface region 70 and the non-rough surface region 80 may also be inclined upward from the inner portion 13 toward the outer portion 14. The length L3 of the inner portion 13 side of the rough surface region 70 may be smaller than the length L4 of the outer portion 14 side of the rough surface region 70. Figure 15 When viewed from above in a direction perpendicular to the XY plane, length L3 represents the difference in Y coordinate between the point where the Y coordinate is maximum and the point where the Y coordinate is minimum on the inner portion 13 side of the rough surface region 70. Length L4 represents the difference in Y coordinate between the point where the Y coordinate is maximum and the point where the Y coordinate is minimum on the outer portion 14 side of the rough surface region 70.

[0078] Figure 16 Artificial joint handles 106, 107, and 108 are also included in the artificial joint handles of the present invention. For example, as in artificial joint handle 106, second boundary line 2 may be a straight line. Alternatively, as in artificial joint handle 107, the apex 14a of the convex portion on the outer portion 14 may be exposed from the coating 20. Alternatively, as in artificial joint handle 108, second boundary line 2 may follow the shape of the outer portion 14 of the base 10.

[0079] [2. Method for manufacturing an artificial joint handle]

[0080] A method for manufacturing an artificial joint handle according to one embodiment includes, for example, a preparation step and a coating forming step. In the preparation step, a substrate 10 having a surface including a first region and a second region is prepared. The coating forming step is a step of forming a coating 20 containing a calcium phosphate material and an antibacterial material on a portion (the first region) of the surface of the substrate 10. Here, the coating 20 is formed as follows: a first boundary line 1 on the lower side of the substrate 10 relative to the coating 20, among the boundary lines on the substrate 10 defined by the presence or absence of the coating 20, intersects with the vertical direction, and the component of the first boundary line 1 along the vertical direction is smaller than the component along the width direction of the substrate 10. Thus, an artificial joint handle 100 as described above can be obtained.

[0081] In the preparation step, the base 10 can be prepared by forming the metal material into a desired shape using a mold, a lamination method, or the like. It should be noted that in the base 10, the second region is located so as to sandwich the first region in the vertical direction. This allows the first and second boundary lines to be formed after the coating 20 is formed. Furthermore, the shape of the first region can be adjusted to the shape of the first and second boundary lines of the coating.

[0082] The coating 20 can be formed, for example, by spraying methods such as flame spraying, high-velocity flame spraying, and plasma spraying; physical vapor deposition methods such as sputtering, ion plating, ion beam deposition, and ion mixing; or wet coating methods such as chemical vapor deposition and sol-gel methods. It should be noted that the material constituting the coating is also referred to as a coating material.

[0083] In order to form the coating 20 only in the first area, a first protective material may be used. In this case, before the coating forming process, a process may be included in which the first protective material is arranged in such a manner that the first area is exposed while protecting the second area so that no coating is formed in the second area. As the first protective material, for example, a masking tape or a partition may be used. Alternatively, as the first protective material, a jig covering the substrate 10 may be used. Examples of materials for these first protective materials include metal, glass, resin, and composite materials thereof. It should be noted that the first protective material may or may not be in contact with the substrate 10. For example, when masking tape is used as the first protective material, it is sufficient to arrange the first protective material into the shape of the second area. When a jig covering the substrate 10 is used, the shape of the jig is not particularly limited, and for example, it may be cylindrical. The cross-section of the cylindrical jig may be polygonal or circular.

[0084] When a partition is provided, the coating 20 can be formed in a specific area by setting the partition at a predetermined position. When a fixture is used, the coating 20 can be formed in a specific area by setting the fixture at a predetermined position. In this case, for example, the coating 20 can be selectively formed only in the desired area by adjusting the positional relationship between the nozzle that sprays the spraying material, the laminated molding material, the chemical etching material, the spraying material or the coating material and the partition. In this case, the front end of the nozzle can be arranged on a straight line with the surface of the desired area without a partition. In addition, hereinafter, the spraying material, the laminated molding material, the chemical etching material, the spraying material or the coating material sprayed from the nozzle will also be referred to as the spraying material. Without being limited to these, the coating 20 can be formed in a state where the substrate 10, the partition and the nozzle are fixed, or the coating 20 can be formed while moving at least one of them. In addition, the angle of the nozzle can be fixed or can be changed while forming the coating 20.

[0085] It should be noted that the coating 20 can also be formed only in the desired area without using a protective material. For example, the coating 20 can be selectively formed only in the desired area by adjusting the shape, angle or position of the nozzle that ejects the ejected material. For example, the ejected material can be ejected in a state where the nozzle is located above the surface of the desired area. In this case, the substrate 10 can be fixed and the coating 20 can be formed while the position and angle of the ejected nozzle are moved, or the ejected nozzle can be fixed and the coating 20 can be formed while the position and angle of the substrate 10 are moved. The ejected nozzle can move at a constant speed or can move while changing the speed. In addition, the ejection direction of the ejected material can form an angle of 90° with a vector extending from the front end of the ejected nozzle toward the surface of the substrate 10 or the rough surface that is at the shortest distance relative to the front end of the ejected nozzle, or can form an angle less than 90°.

[0086] A roughening step may also be performed before the film forming step. The roughening step is a step for forming a rough surface on the substrate 10. Specifically, in the preparation step, a substrate 10 having a surface including a roughened region in addition to the first and second regions is prepared. In the roughening step, a rough surface is formed in the roughened region of the substrate 10.

[0087] In the roughening process, a rough surface can be formed by at least one of a spraying method, a stacking method, a chemical etching method, and a spraying method. Compared with the spraying method, the spraying method, the stacking method, or the chemical etching method can increase the surface roughness. It should be noted that in the spraying method, the material sprayed toward the substrate 10 is called a spraying material. Similarly, in the stacking method, the material sprayed toward the substrate 10 is called a stacking material. In addition, when processing is performed using a chemical etching method, the material sprayed toward the substrate 10 is called a chemical etching material. Similarly, when processing is performed using a spraying method, the material sprayed toward the substrate 10 is called a spraying material. As the spraying material and the stacking material, the materials exemplified as the materials of the substrate 10 can be used. The above-mentioned layered component can also be formed by the spraying method and the stacking method. As the chemical etching method, alkali treatment can be mentioned. As the spraying method, sandblasting can be mentioned.

[0088] In order to form a rough surface only in the desired area, a second protective material can also be used. In this case, before the roughening process, a process can also be included in which the second protective material is configured in a manner that protects other areas while exposing the roughened area so that a rough surface is not formed outside the roughened area. It should be noted that the roughened area can be located inside the first area, or it can be located at a position spanning the first area and the second area. That is, the second protective material only needs to be configured to protect a part of the first area and the second area, or the second area. In addition, for example, depending on the position of the roughened area, the positional relationship between the third boundary line and the fourth boundary line defined according to the presence or absence of the rough surface and the first boundary line and the second boundary line defined according to the presence or absence of the coating can be adjusted.

[0089] As the second protective material, for example, a masking tape or a partition can be used. Alternatively, as the second protective material, a clamp covering the substrate 10 can also be used. Examples of materials for these second protective materials include metals, glass, resins, and composite materials thereof. It should be noted that the second protective material may or may not be in contact with the substrate 10. When a clamp covering the substrate 10 is used as the second protective material, the shape of the clamp is not particularly limited, and for example, it can be cylindrical. The cross-section of the cylindrical clamp can be polygonal or circular.

[0090] When a partition is provided, a rough surface can be formed in a specific area by setting the partition at a predetermined position. When a fixture is used, a rough surface can be formed in a specific area by setting the fixture at a predetermined position. In this case, for example, by adjusting the positional relationship between the nozzle that sprays the spraying material, laminated molding material, chemical etching material, spray material, or coating material and the partition, a rough surface can be selectively formed only in the desired area. In this case, the tip of the nozzle can be arranged in a straight line with the surface of the desired area without a partition in between. In addition, the spraying material, laminated molding material, chemical etching material, spray material, or coating material ejected from the nozzle will also be referred to as the spray material hereinafter. Without being limited to these, the rough surface can be formed with the base 10, partition, and nozzle fixed, or while moving at least one of them. In addition, the angle of the nozzle can be fixed or varied while forming the rough surface. It should be noted that, similar to the coating 20, a rough surface can be formed only in the desired area without using a protective material.

[0091] As described above, when forming a rough surface on an artificial joint handle, for example, during the roughening step, a second protective material may be placed on the base 10 in such a manner as to expose a portion of the surface of the base 10 while protecting another portion of the base 10, and the rough surface may be formed on the surface of the exposed portion. Furthermore, the manufacturing method of the present invention may further include a step of removing the second protective material after the roughening step and before the film forming step.

[0092] Alternatively, after removing the second protective material, a step may be performed to shave the edges of the rough surface, for example, the edge of the layer member 30. This avoids stress concentration at the edge of the layer member 30 and reduces irritation to the living tissue.

[0093] A second masking tape may be used as the second protective material. In this case, the manufacturing method of the present invention may further include a step of attaching the second masking tape to another portion of the substrate 10 while exposing a portion of the surface of the substrate 10 before the roughening step.

[0094] In addition, in the film forming process, a first protective material may be arranged on the substrate 10 in such a manner as to expose a portion of the surface of the substrate 10 while protecting another portion of the substrate 10, and a film 20 may be formed on the surface of the exposed portion. The first protective material may be removed after the film forming process. Here, a first masking tape may also be used as the first protective material. In this case, the manufacturing method of the present invention may also include a step of affixing a second masking tape to another portion of the substrate 10 while exposing a portion of the surface of the substrate 10 before the film forming process.

[0095] The second protective material can be a material with higher heat resistance than the first protective material. For example, a material that does not dissolve or thermally decompose within one minute under spraying conditions at 8000°C can be used as the second protective material, while a material that does not dissolve or thermally decompose within one minute under spraying conditions at 3000°C can be used as the first protective material. Specifically, a composite material of glass and resin can be used as such.

[0096] Furthermore, when the roughening step is performed by blasting, a material that does not dissolve or thermally decompose at room temperature may be used as the second protective material. Specific examples of such a material include resins.

[0097] Furthermore, in the step of forming the rough surface or coating 20 of the manufacturing method of the present invention, in addition to the first protective material and the second protective material described above, a protective material may be provided on a portion or all of the exposed portion 50 during the step of forming the rough surface or coating 20. Thus, the presence or absence of the rough surface or coating 20 in the exposed portion 50 can be appropriately controlled. For example, by providing a protective material in an area of ​​the exposed portion 50 that is away from the embedded portion 40 and forming the coating 20 in the exposed area, the coating 20 can be formed on an area of ​​the exposed portion 50 that is closer to the embedded portion 40.

[0098] To summarize the above matters, for example, Figure 8 Each step is performed in the order shown. Figure 8 This is a process diagram illustrating a method for manufacturing an artificial joint handle 100 according to one embodiment. First, a second protective material may be applied, followed by a roughening step, and then the second protective material may be removed. Next, a first protective material may be applied, followed by a film forming step.

[0099] Furthermore, the manufacturing method of the present invention may or may not include a cleaning step between each step. For example, the manufacturing method of the present invention may further include a step of cleaning the substrate 10, or the substrate 10 and the layered member 30, after the roughening step. The cleaning method is not particularly limited, and may be, for example, a method of immersing the substrate in a liquid such as water or an organic solvent such as alcohol, or a method of spraying the liquid. Alternatively, a method of blowing a gas such as air, nitrogen, or argon may be used. This allows for the removal of excess spraying material and / or cutting residues generated by the roughening step.

[0100] The manufacturing method of the present invention may perform a groove forming step for forming grooves after a roughening step for roughening the surface of the substrate 10, followed by a film forming step for forming a film, or may perform a roughening step after the groove forming step, followed by a film forming step. In the groove forming step, the grooves can be formed by at least one of a cutting method, a rolling method, and a stamping method. For example, a milling process, which is a type of cutting method, may be performed to form the grooves. In addition, when forming a 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.

[0101] Alternatively, the roughening step may include, in sequence, a first roughening step of forming a first rough surface by spraying, and a second roughening step of forming a second rough surface by chemical etching or spraying. Here, the region where the first rough surface is formed by spraying is referred to as the first roughened region, the region where the second rough surface is formed by chemical etching or spraying is referred to as the second roughened region, and the region where no rough surface is formed is referred to as the non-roughened region.

[0102] In the first roughening process, a third protective material (the second protective material described above) may be arranged on the substrate 10 in such a manner as to protect the second roughened region and the non-roughened region while exposing the first roughened region, and a first roughened surface may be formed on the exposed first roughened region. In addition, the manufacturing method of the present invention may further include a process of removing the third protective material after the first roughening process and before the second roughening process. In the second roughening process, a fourth protective material may be arranged on the substrate 10 in such a manner as to protect the non-roughened region while exposing the second roughened region, and a second roughened surface may be formed on the exposed second roughened region. The second roughening process may also be performed in such a manner that the surface roughness of the surface of the second roughened surface formed in the second roughening process is less than the surface roughness of the surface of the first roughened surface in the first roughened region. In addition, the manufacturing method of the present invention may further include a process of removing the fourth protective material after the second roughening process and before the coating formation process. A fourth masking tape may also be used as the fourth protective material. The manufacturing method of the present invention may further include a process of affixing a fourth masking tape on the non-roughened region 3 while exposing the first roughened region 1 and the second roughened region 2 before the second roughening process. The fourth protective material may also be a material with lower heat resistance than the third protective material. For example, a material that does not dissolve or decompose thermally at room temperature may be used as the fourth protective material. Specifically, a resin may be used as the fourth protective material.

[0103] In the second roughening process, the non-roughened area may or may not be covered with a protective material. Alternatively, the first roughened area and the non-roughened area may be protected, with only the second roughened area subjected to at least one of chemical etching and spraying. Alternatively, a fourth protective material may be disposed so as to expose the first roughened area, and at least one of chemical etching and spraying may be performed on the exposed roughened surface of the first roughened area and the second roughened area. This allows for the removal of excess sprayed material and the like remaining on the roughened surface of the first roughened area, while forming a roughened surface in the second roughened area.

[0104] Alternatively, the method of manufacturing the artificial joint handle 100 may initially include a step of preparing the base 10 having a first roughened region, a second roughened region, and a non-roughened region in that order.

[0105] 〔3. Utilization of artificial joint handle〕

[0106] Figure 1 The artificial joint handle 100 shown is primarily shaped as an artificial hip joint handle, but the artificial joint to which the artificial joint handle of the present invention is applied is not limited to an artificial hip joint. Examples of artificial joints include artificial hip joints, artificial knee joints, artificial ankle joints, artificial shoulder joints, artificial elbow joints, and artificial finger joints.

[0107] Below, refer to Figure 9 An example of using the artificial joint handle 100 as a part of the artificial hip joint 1000 will be described. The artificial hip joint 1000 may include a bone 110 and an acetabular cup 120 in addition to the artificial joint handle 100. The bone 110 and the acetabular cup 120 may be formed of the same material as the base 10 of the artificial joint handle 100, or may be formed of different materials. The artificial joint handle 100 is embedded in the femur 91. The bone 110 is arranged in the exposed portion 50 of the artificial joint handle 100. The acetabular cup 120 is fixed to the acetabulum 94 of the hip bone 93. By fitting the bone 110 into the recess of the acetabular cup 120 and causing it to slide, the bone 110 functions as a hip joint.

[0108] The invention of the present disclosure has been described above based on the accompanying drawings and embodiments. However, the invention of the present disclosure is not limited to the above-mentioned embodiments. That is, the invention of the present disclosure can be modified in various ways within the scope shown in the present disclosure, and the embodiments obtained by appropriately combining the technical means disclosed in different embodiments are also included in the technical scope of the invention of the present disclosure. That is, it should be noted that as long as one is skilled in the art, it is easy to make various modifications or corrections based on the present disclosure. In addition, it should be noted that these modifications or corrections are included in the scope of the present disclosure.

[0109] Description of reference numerals:

[0110] 1...first boundary line;

[0111] 2...Second boundary line;

[0112] 3...the third boundary line;

[0113] 4...the fourth boundary line;

[0114] 10...matrix;

[0115] 20...Lamination;

[0116] 40′a...equal width portion;

[0117] 40′b...constriction;

[0118] 50′...Neck;

[0119] 100...Handle for artificial joint.

Claims

1. A handle for an artificial joint, wherein: The artificial joint handle comprises: a base extending in the vertical direction with the proximal end side in the human body during use being set as the upper direction; and A coating is disposed on a portion of the substrate and comprises a calcium phosphate material and an antibacterial material. The boundary line on the substrate defined by the presence or absence of the coating includes a first boundary line located below the substrate relative to the coating and a second boundary line located above the substrate relative to the coating. The first boundary line is located at a position intersecting the up-down direction, The component of the first boundary line along the up-down direction is smaller than the component along the width direction of the substrate. The second boundary line is located at a position intersecting the up-down direction, The component of the second boundary line along the up-down direction is smaller than the component along the width direction. The absolute value of the inclination of the straight line connecting both ends of the second boundary line is less than 1.

2. The artificial joint handle according to claim 1, wherein: The length of the first boundary line is smaller than the length of the second boundary line.

3. The artificial joint handle according to claim 1 or 2, wherein: When the base is viewed from above in a direction perpendicular to the up-down direction, the first boundary line, the second boundary line, or both of them include a plurality of straight lines.

4. The artificial joint handle according to claim 1 or 2, wherein: When the base body is viewed from above in a direction perpendicular to the up-down direction, the first boundary line is formed by a single straight line.

5. The artificial joint handle according to claim 1 or 2, wherein: The base has a contraction portion with a width that decreases downward. The boundary line is located at the constricted portion.

6. The artificial joint handle according to claim 1 or 2, wherein: The base has a constant width portion located below the base and having a constant width. The boundary line is located at the equal-width portion.

7. The artificial joint handle according to claim 1 or 2, wherein: The substrate has a rough surface located on the surface of the substrate, The boundary lines on the substrate defined by the presence or absence of the rough surface include a third boundary line located below the substrate with respect to the rough surface. The third boundary line is located above the base body relative to the first boundary line.

8. The artificial joint handle according to claim 7, wherein: The third boundary line has a shape along the first boundary line.

9. The artificial joint handle according to claim 7, wherein: The third boundary line has a different shape from the first boundary line.

10. The artificial joint handle according to claim 9, wherein: A component of the third boundary line along the up-down direction is greater than a component along the width direction of the base.

11. The artificial joint handle according to claim 7, wherein: The boundary line on the substrate defined by the presence or absence of the coating includes a second boundary line located above the substrate with respect to the coating. The second boundary line is located at a position intersecting the up-down direction, The boundary lines on the substrate defined by the presence or absence of the rough surface include a fourth boundary line located above the substrate with respect to the rough surface. The fourth boundary line is located below the base body relative to the second boundary line.

12. The artificial joint handle according to claim 11, wherein: The fourth boundary line has a shape along the second boundary line.

13. The artificial joint handle according to claim 1 or 2, wherein: The base has a neck portion protruding obliquely with respect to the vertical direction. The coating satisfies the following formula (1): L1≤L2 (1) In formula (1), L1 represents the length of the coating on the side where the neck protrudes along the vertical direction, and L2 represents the length of the coating on the side opposite to the side where the neck protrudes along the vertical direction.

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