Artificial joint handle
By covering the surface of the artificial joint with a shank substrate, the coating of calcium phosphate-based material and antibacterial material, and optimizing the groove design, the problem of difficulty in taking into account both fixability and antibacterial properties in the coating is solved, and good bone fixability and antibacterial effects are achieved.
Patent Information
- Application Number
- CN202080101363.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2020-05-29
- Publication Date
- 2025-08-19
- Estimated Expiration
- 2040-05-29
AI Technical Summary
The existing artificial joint stems are difficult to take into account the fixation and antibacterial properties of the bones in the coating, resulting in the problem of difficulty in removing after surgery or the bacteria are prone to adhesion and proliferation.
A shank for artificial joints is designed, and the surface of the base is partially covered with a coating of calcium phosphate-based material and antibacterial material. The groove design is divided into a first groove in the coated area and a second groove in the uncovered area. The sum of the lengths of the first groove is smaller than the sum of the lengths of the second groove. The shape and distribution of the groove are optimized to improve insertion and antibacterial properties.
It achieves good fixation and antibacteriality between the stems of artificial joints and bones, reduces bacterial invasion, and improves the convenience of removal and biocompatibility after surgery.
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Figure CN115697252B_ABST
Abstract
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 present invention provides an artificial joint handle comprising: a base having one or more grooves disposed on a surface; and a coating disposed on a portion of the surface of the base and comprising a calcium phosphate material and an antibacterial material. When the grooves of the one or more grooves located in an area where the coating is disposed are designated as first grooves, and the grooves located in an area exposed on the surface of the base are designated as second grooves, the total length of the first grooves is less than the total length of the second grooves.
[0008] Alternatively, the artificial joint handle of the present invention comprises: a base having one or more recesses disposed on a surface; and a coating disposed on a portion of the surface of the base and comprising a calcium phosphate material and an antibacterial material. When the recesses located in the region where the coating is disposed are defined as first recesses, and the grooves located in the region where the surface of the base is exposed are defined as second recesses, the total opening area of the first recesses is smaller than the total opening area of the second recesses. BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Figure 1 This is a schematic diagram showing an artificial joint handle according to one embodiment.
[0010] Figure 2 This is a schematic diagram showing an artificial joint handle according to one embodiment.
[0011] Figure 3 This is a schematic diagram showing a cross section of an artificial joint handle according to one embodiment.
[0012] Figure 4This is a schematic diagram showing a cross section of an artificial joint handle according to one embodiment.
[0013] Figure 5 This is a schematic diagram showing an artificial joint handle according to one embodiment.
[0014] Figure 6 This is a schematic diagram showing an artificial joint handle according to one embodiment.
[0015] Figure 7 This is a schematic diagram showing an artificial joint handle according to one embodiment.
[0016] Figure 8 This is a schematic diagram showing a cross section of an artificial joint handle according to one embodiment.
[0017] Figure 9 This is a schematic diagram showing an artificial joint handle according to one embodiment.
[0018] Figure 10 These are process diagrams illustrating a method for manufacturing an artificial joint handle according to one embodiment.
[0019] Figure 11 This is a schematic diagram showing an artificial hip joint according to one embodiment.
[0020] Figure 12 This is a schematic diagram showing an artificial joint handle according to one embodiment.
[0021] Figure 13 This is a schematic diagram showing an artificial joint handle according to one embodiment.
[0022] Figure 14 This is a schematic diagram showing a cross section of an artificial joint handle according to one embodiment.
[0023] Figure 15 This is a schematic diagram showing an artificial joint handle according to one embodiment.
[0024] Figure 16 This is a schematic diagram showing an artificial joint handle according to one embodiment.
[0025] Figure 17 This is a schematic diagram showing an artificial joint handle according to one embodiment. DETAILED DESCRIPTION
[0026] 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.
[0027] 〔1.Handle for artificial joint〕
[0028] 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 and a coating 20 disposed on a portion of the surface of the base 10. 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 1 In 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.
[0029] 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 taken into account.
[0030] Furthermore, one or more grooves are provided on the surface of the base 10. These grooves facilitate insertion of the artificial joint handle 100 into the bone. Here, when the grooves located in the area where the coating 20 is provided are designated as first grooves 1, and the grooves located in the area of the base 10 surface exposed from the coating 20 are designated as second grooves 2, the total length of the first grooves 1 is less than the total length of the second grooves 2.
[0031] In this specification, "the sum of the lengths of the first grooves 1" does not necessarily mean that there are multiple first grooves 1. The groove may include one first groove 1, or may include multiple first grooves 1. It should be noted that when the first groove 1 is a curved groove, the length along the curve is measured. When the first groove 1 has a branch, the length of the groove after the branch is also summed. The above situation is the same for "the sum of the lengths of the second grooves 2". In addition, "the sum of the lengths of the first grooves 1 is less than the sum of the lengths of the second grooves 2" also includes the case where the sum of the lengths of the first grooves 1 is 0. That is, the groove may include the first groove 1 or may not include the first groove 1. The groove only needs to include the second groove 2, or may only include the second groove 2. As a result, it is possible to adjust the fixation of the artificial joint handle 100 to the bone, etc.
[0032] exist Figure 1In the artificial joint handle 100 shown in FIG. 1 , the base 10 has both the first groove 1 and the second groove 2. Figure 1 In the embodiment, the base body 10 has a plurality of first grooves 1. Figure 1 In the embodiment, the base body 10 has one second groove 2. As a result, the artificial joint handle 100 can be easily inserted into the bone. Figure 2 Shown with Figure 1 A different example. Figure 2 In the artificial joint handle 100 shown, the base 10 does not have the first groove 1 but has only the second groove 2. When the base 10 does not have the first groove 1, the invasion of bacteria from the region where the coating 20 is disposed can be further reduced.
[0033] In other words, in the artificial joint handle 100, the grooves may include a first groove 1 located in the region where the coating 20 is disposed, and a second groove 2 located in the region where the surface of the base 10 is exposed from the coating 20, and the total length of the first grooves 1 may be less than the total length of the second grooves 2. Alternatively, the grooves may include only the second grooves 2 located in the region where the surface of the base 10 is exposed from the coating 20, with no grooves formed in the region where the coating 20 is disposed.
[0034] The first groove 1 may be connected to the second groove 2 or not. That is, the first groove 1 and the second groove 2 may be formed as continuous grooves. In other words, the groove may be configured to span the area where the coating 20 is configured and the area exposed from the coating 20. The groove may also extend to the upper end of the coating 20. In addition, as Figure 1 As shown, only a portion of the plurality of first grooves 1 may be connected to the second groove 2. The same applies even when there are multiple second grooves 2. If the first groove 1 is connected to the second groove 2, the artificial joint handle 100 can be more easily inserted into the bone. On the other hand, if the first groove 1 is not connected to the second groove 2, the intrusion of bacteria from the first groove 1 side can be further reduced.
[0035] The depth D1 of the first groove 1 and the depth D2 of the second groove 2 can be the same, or one of them can be larger. The same applies to the relationship between the width W1 of the first groove 1 and the width W2 of the second groove 2. Here, the depth D1 of the first groove 1 can be calculated as the average of the depths at several arbitrary locations within the first groove 1. The width W1 of the first groove 1 can also be calculated using the same method. The same applies to the depth D2 and width W2 of the second groove 2. It should be noted that the depth D1 and width W2 of the first groove 1 represent the depth and width on the coating 20. Figure 3 Shown Figure 1 The AA' section including the first groove 1 and the BB' section including the second groove 2. Figure 3 In the embodiment, the depth D1 of the first groove 1 is smaller than the depth D2 of the second groove 2. Figure 3In the embodiment, the width W1 of the first groove 1 is smaller than the width W2 of the second groove 2. When the depth D1 of the first groove 1 is smaller than the depth D2 of the second groove 2 and / or the width W1 of the first groove 1 is smaller than the width W2 of the second groove 2, the intrusion of bacteria from the side of the first groove 1 can be further reduced.
[0036] Furthermore, the depths of the groove at both ends in the groove width direction may be the same, or the depth of one end may be smaller than the depth of the other end. Figure 4 is included Figure 1 The AA' section of the first groove 1 shows the Figure 3 Different examples. Figure 4 In the width direction of the first groove 1 , the depth D1 a of one end portion of the first groove 1 is smaller than the depth D1 b of the other end portion.
[0037] The groove can also be decomposed into a component along the width direction of the substrate 10 and a component along a direction perpendicular to the width direction. Figure 5 , the components of the slot are described. Figure 5 The base 10 shown has a shape extending in the up-down direction. It can also be said that the upper side of the base 10 in the up-down direction corresponds to the proximal side of the human body, and the lower side corresponds to the distal side of the human body. The width direction of the base 10 can also be said to be a direction perpendicular to the up-down direction. That is, the direction perpendicular to the width direction can also be the up-down direction of the base 10. Figure 5 In FIG. 1 , the width direction of the substrate 10 is represented as the X-axis direction, and the direction perpendicular to the width direction is represented as the Y-axis direction.
[0038] Here, we will examine the straight line α connecting the ends of the first groove 1 that are the largest in distance. When the straight line α is parallel to the X-axis, the first groove 1 can be said to have only a component along the width direction of the substrate 10. When the straight line α is parallel to the Y-axis, the first groove 1 can be said to have only a component along the direction perpendicular to the width direction of the substrate 10. When the straight line α is represented as a straight line with an inclination on the XY coordinate system, the first groove 1 can be said to have both a component along the width direction of the substrate 10 and a component along the direction perpendicular to the width direction.
[0039] Figure 5The first groove 1 shown has both a component along the width direction of the base 10 and a component along a direction perpendicular to the width direction, but may have only one of them. It can also be said that the first groove 1 has at least one of a component along the width direction of the base 10 and a component along a direction perpendicular to the width direction. In other words, the first groove 1 having a component along the width direction of the base 10 means that the first groove 1 is not parallel to the up and down direction. In other words, it means that the first groove 1 is not parallel to the insertion direction of the artificial joint handle 100 into the bone, but is inclined. If the first groove 1 has a component along the width direction of the base 10, it can resist the occurrence of the phenomenon of sinking downward after the artificial joint handle is inserted. It should be noted that the second groove 2 may also have both a component along the width direction of the base 10 and a component along the direction perpendicular to the width direction.
[0040] The magnitude of the component along the width direction of the substrate 10 and the component along the direction perpendicular to the width direction may be the same, or one of them may be larger. Figure 5 As shown, the component of the first groove 1 along the width direction of the base 10 can be smaller than the component along the direction perpendicular to the width direction. Here, "the component along the width direction of the base 10 is smaller than the component along the direction perpendicular to the width direction" means that the absolute value of the inclination of the straight line α is greater than 1. In this case, the artificial joint handle 100 can be more easily inserted into the bone. Similarly, the component of the second groove 2 along the width direction of the base 10 can be smaller than the component along the direction perpendicular to the width direction.
[0041] The groove may have either a straight portion or a curved portion. For example, the first groove 1 may have multiple straight portions. Furthermore, the multiple straight portions may be parallel to each other, intersect each other perpendicularly, or be randomly arranged. Figure 6 The artificial joint handle 100 is shown in which the first groove 1 has a plurality of straight portions, and the plurality of straight portions intersect each other perpendicularly.
[0042] 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 or one of them may be larger. For example, Figure 1 In the embodiment, the area of the region where the coating 20 is disposed is smaller than the area of the region where the surface of the base 10 is exposed from the coating 20. In this case, the artificial joint handle 100 can be more easily inserted into the bone. Figure 7 The artificial joint handle 100 is shown in which 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. In this case, the antibacterial property can be improved.
[0043] The ratio of the length L1 of the area on the surface of the substrate 10 where the coating 20 is disposed, along the direction perpendicular to the width direction of the substrate 10, to the length L2 of the area on the surface of the substrate 10 exposed from the coating 20, along the direction perpendicular to the width direction of the substrate 10, can also be appropriately determined according to the application, etc. The length L1 and the length L2 can be the same, or one of them can be larger. For example, Figure 5 , the length L1 is smaller than the length L2. In this case, the artificial joint handle 100 can be inserted into the bone more easily. Here, the length L1 represents the maximum value of the length of the region where the coating 20 is provided along the Y-axis direction. That is, the length L1 represents the difference in Y coordinate between the point with the maximum Y coordinate and the point with the minimum Y coordinate in the region where the coating 20 is provided. In addition, the length L2 also represents the maximum value of the length of the region where the surface of the base 10 is exposed from the coating 20 along the Y-axis direction. That is, the length L2 represents the difference in Y coordinate between the point with the maximum Y coordinate and the point with the minimum Y coordinate in the region where the surface of the base 10 is exposed from the coating 20.
[0044] 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. Titanium alloys can be made of titanium with at least one of aluminum, tin, zirconium, molybdenum, nickel, palladium, tantalum, niobium, vanadium, and platinum added thereto. Examples of ceramics include aluminum oxide, zirconium oxide, and aluminum oxide-zirconia 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 made of a titanium alloy.
[0045] 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.
[0046] 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.
[0047] 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.
[0048] 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.
[0049] A boundary line defined by the presence or absence of the coating 20 may exist on the substrate 10. The length of the boundary line around the substrate 10 may be greater than the length around the portion of the substrate 10 located above and below the boundary line. For example, the portion where the boundary line exists may be a nodular protrusion on the substrate 10.
[0050] 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 elemental analysis method can be implemented, for example, by mapping the surface elements using an energy dispersive X-ray analyzer (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 samples 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, elements constituting the substrate 10 are detected, while phosphorus, calcium, antibacterial components, etc. are not detected, or are below the noise level.
[0051] The substrate 10 may also have a rough surface. The rough surface may be covered by the coating 20 or may be exposed from the coating 20. Alternatively, only a portion of the rough surface may be covered by the coating 20, with the remaining portion of the rough surface exposed from the coating 20. The grooves may or may not be located on the rough surface. For example, only the first groove 1 may be located on the rough surface. The surface roughness of the inner surface of the groove located on the rough surface may also be less than the surface roughness of the rough surface of the substrate 10.
[0052] An example of an indicator of the surface roughness of a rough surface is the arithmetic mean roughness Sa (ISO 25178). The surface roughness (Sa) of a rough surface can be set, for example, to 10 to 80 μm, 20 to 80 μm, or 30 to 70 μm. The surface roughness (Sa) of a rough surface can be measured, for example, by cutting the artificial joint handle 100 and observing the cut surface using a SEM or the like.
[0053] The surface roughness (Sa) can be measured, for example, using a stylus or optical method. Alternatively, the surface roughness (Sa) can be measured, for example, in accordance with ISO 25178. The measurement of the surface roughness (Sa) is not limited to the above-mentioned method.
[0054] 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.
[0055] Figure 8 The AA' section includes the first groove 1 and shows the Figure 3 and Figure 4 Different examples. Figure 8 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 8 In the embodiment, the coating 20 is formed on the layered member 30 , and only the first groove 1 is arranged as the groove.
[0056] It should be noted that the height of the layered member 30 can be set to, for example, a lower limit of 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. 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.
[0057] 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.
[0058] The height of the layered member 30 can 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 can be set to, for example, less than 100 μm, or even less than 50 μm. Alternatively, the thickness of the coating 20 can be set to, for example, 5 μm or greater.
[0059] The above describes the artificial joint handle 100 having the groove, but the shape of the groove is not particularly limited. For example, a circular, polygonal or amorphous depression may be formed instead of the groove. The artificial joint handle 100 formed with such a depression is also included in the present invention. For example, the artificial joint handle 100 of the present invention comprises: a base 10 having one or more depressions arranged on the surface, and a coating 20 comprising a calcium phosphate material and an antibacterial material arranged on a portion of the surface of the base 10. When the depression located in the area where the coating 20 is arranged is set as the first depression and the depression located in the area where the surface of the base 10 is exposed from the coating 20 is set as the second depression, the sum of the opening areas of the first depressions may be smaller than the sum of the opening areas of the second depressions. The relationship between the first depression and the second depression may be the same as the relationship between the first groove 1 and the second groove 2 described above. In addition, the opening areas of the first depression and the second depression can be calculated using image analysis software, etc.
[0060] 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 embedded portion 40, which is in actual contact with the bone, to exhibit the desired adhesion and antibacterial properties.
[0061] For example, Figure 9 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.
[0062] 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 may contact.
[0063] It should be noted that the first groove 1 may not reach the boundary between the embedded portion 40 and the exposed portion 50. In other words, the end of the first groove 1 may be located at the embedded portion 40. In this case, the invasion of bacteria can be further reduced.
[0064] In addition, if Figure 9 As shown, the base 10 may also include a main body 40' 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.
[0065] The main body 40' has a lower portion 40'a with a central axis C extending in the vertical direction, and an upper portion 40'b extending continuously in the vertical direction from the lower portion 40'a and having a curved shape with its center moving away from the central axis C as it moves upward. Furthermore, the upper portion 40'b has an upper end surface offset from the central axis C, to which a neck 50' is connected. 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 be described as a protrusion 50' that protrudes in a direction inclined from the central axis C of the main body 40'.
[0066] The base 10 may also 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. The collar 60' can prevent the main body 40' from excessively penetrating the bone during surgery to insert the artificial joint stem into the bone.
[0067] Figure 12 The artificial joint handle 101 shown is also included in the artificial joint handle of the present invention. For example, the base 10 may also have an inner portion 13 curved into a concave shape and an outer portion 14 curved into a convex shape. The upper end portion of the first groove 1 may also be located at the curved portion on the inner side. Here, the upper end portion of the first groove 1 may also be bent toward the inner side 13. In other words, the first groove 1 may also have a first portion 1a extending in the vertical direction of the base 10, and a second portion 1b connected to the first portion 1a and having a component along the width direction of the base 10. The depth of the second groove 2 may also be smaller than the depth of the first groove 1.
[0068] The base body 10 may also include a first groove group 15 in which the first grooves 1 and the second grooves 2 are connected, and a second groove group 16 in which the first grooves 1 and the second grooves 2 are connected and the first grooves 1 extend toward the upper end of the coating 20 rather than the first groove group 15 .
[0069] 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.
[0070] Figure 13The artificial joint handle 102 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 width of the grooves located in the upper portion of the base 10 may be greater than the width of 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 14 Shown Figure 13 The C-C' section. Figure 14 As shown, the groove along the width direction of the base 10 (the second portion 1 b of the first groove 1 ) may become shallower toward the upper side.
[0071] The boundary line defined by the presence or absence of the coating 20 may include a first boundary line 21 located below the substrate 10 relative to the coating 20. Furthermore, the boundary line may include a second boundary line 22 located above the substrate 10 relative to the coating 20. The first boundary line 21 may intersect the straight portion of the groove. Here, the first boundary line 21 may intersect the straight portion of the groove at an angle. That is, the first boundary line 21 may not be perpendicular to the straight portion of the groove.
[0072] The component of the boundary line along the vertical direction may also be greater than the component along the width direction of the substrate 10. Figure 13 When viewed from above in a direction perpendicular to the XY plane, the inclination of the straight line connecting the two ends of the boundary line on the XY coordinates may also exceed 1. Figure 13 In the embodiment, the inclination of the straight line β connecting the two ends of the first boundary line 21 on the XY coordinates exceeds 1.
[0073] Alternatively, the first boundary line 21 may include a first portion 21a extending in a direction intersecting the groove, and a second portion 21b extending along the groove. The second portion 21b of the first boundary line 21 may also be disposed separately from the groove. That is, the second portion 21b of the first boundary line 21 may not contact the groove. The same applies to the second boundary line 22.
[0074] The first groove 1 is connected to the second groove 2, and the first groove 1 may also include a first portion 1a extending in the vertical direction of the base 10, and a second portion 1b connected to the first portion 1a and having a component along the width direction of the base 10. Figure 13 As shown, the second boundary line 22 may also extend in a direction along the second portion 1 b of the first groove 1 .
[0075] In addition, if Figure 13 As shown in FIG. 1 , the second boundary line 22 may also be arranged to be inclined upward from the inner portion 13 toward the outer portion 14. Figure 13As shown, the first boundary line 21 may be located below the apex 13a of the concave portion in the inner portion 13. The first boundary line 21 may be located below the apex 14a of the convex portion in the outer portion 14. Alternatively, the first boundary line 21 may be located above the apex 14a of the convex portion in the outer portion 14.
[0076] Figure 15 The artificial joint handle 103 shown is also included in the artificial joint handle of the present invention. For example, the boundary line and the groove may intersect at an acute angle. Figure 15 In the embodiment, the angle γ between the first boundary line 21 and the second groove 2 on the inner portion 13 side is an acute angle.
[0077] Figure 16 The artificial joint handle 104 shown is also included in the artificial joint handle of the present invention. For example, the base 10 includes a rough surface region 70, a non-rough surface region 80, and a groove region 90, in order from the top. 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 no 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 16 When viewed from above in a direction perpendicular to the XY plane, length L3 represents the difference in Y coordinate between the point with the maximum Y coordinate and the point with the minimum Y coordinate on the inner portion 13 side of the rough surface region 70. Length L4 represents the difference in Y coordinate between the point with the maximum Y coordinate and the point with the minimum Y coordinate on the outer portion 14 side of the rough surface region 70.
[0078] Figure 17 The artificial joint handles 105, 106, and 107 shown are also included in the artificial joint handle of the present invention. For example, as in the artificial joint handle 105, only the second groove 2 may be along a portion of the first boundary line 21. As in the artificial joint handle 106, a plurality of second grooves 2 may be arranged circumferentially at the front end portion of the base 10. In addition, the coating 20 may not be in contact with the second groove 2. As in the artificial joint handle 107, the groove may be close to either the inner portion 13 or the outer portion 14. Figure 17 In the embodiment, the first groove 1 and the second groove 2 of the artificial joint handle 107 are close to the outer portion 14 .
[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, a groove forming step, and a coating forming step. In the preparation step, a base 10 having a surface including a first region and a second region is prepared. The groove forming step forms one or more grooves on the surface of the base 10. The coating forming step forms a coating 20 containing a calcium phosphate material and an antibacterial material on a portion of the surface (the first region) of the base 10.
[0081] In the artificial joint handle of the present invention, the groove located in the area where the coating 20 is arranged is the first groove 1, and the groove located in the area where the surface of the base 10 is exposed from the coating 20 is the second groove 2. That is, in the groove forming process, the groove formed in the first area becomes the first groove 1, and the groove formed in the second area becomes the second groove. In the groove forming process, the grooves are formed in such a manner that the sum of the lengths of the first grooves 1 is less than the sum of the lengths of the second grooves 2. In the coating forming process, the coating 20 is formed in the first area of the surface of the base 10 where the first groove 1 is formed. In this way, the above-mentioned artificial joint handle 100 can be obtained.
[0082] In the preparation step, the base body 10 can be prepared by forming a metal material into a desired shape using a mold, a lamination molding method, or the like.
[0083] In the groove forming step, the groove can be formed by at least one of a cutting process, a rolling process, and a stamping process. It should be noted that in this embodiment, the groove is formed by, for example, milling, which is a type of cutting process. Furthermore, if the artificial joint handle has the aforementioned recess, a recess forming step can be provided in place of the groove forming step using the same method as the groove forming step.
[0084] The film forming step can be performed after the groove forming step. The film 20 can be formed, for example, by a spraying method such as flame spraying, high-velocity flame spraying, and plasma spraying; a physical vapor deposition method such as sputtering, ion plating, ion beam evaporation, and ion mixing; or a wet coating method such as chemical vapor deposition or sol-gel method. It should be noted that the material constituting the film is also referred to as a coating material.
[0085] 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.
[0086] 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.
[0087] It should be noted that the coating 20 can 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 from which the ejected material is ejected. For example, the ejected material can be ejected while 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°.
[0088] A roughening step may also be performed before the groove 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.
[0089] In the roughening process, a rough surface can be formed by at least one of a spraying method, a stacking molding method, a chemical etching method, and a spraying method. Compared with the spraying method, the spraying method, the stacking molding 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 molding method, the material sprayed toward the substrate 10 is called a stacking molding material. In addition, when the chemical etching method is used for processing, the material sprayed toward the substrate 10 is called a chemical etching material. Similarly, when the spraying method is used for processing, the material sprayed toward the substrate 10 is called a spraying material. As the spraying material and the stacking molding 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 molding method. As the chemical etching method, alkali treatment can be mentioned. As the spraying method, sandblasting can be mentioned.
[0090] A second protective material can also be used to create a rough surface only in the desired area. In this case, before the roughening process, a step can be included in which the second protective material is arranged in a manner that exposes the roughened area while protecting other areas, so that the 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 at a position that straddles the first and second areas. In other words, the second protective material can be arranged to protect a portion of the first area and the second area, or the second area.
[0091] 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 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.
[0092] 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 sprayed 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 can be 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.
[0093] As described above, when the artificial joint handle of the present invention has a rough surface, for example, during the roughening step, a second protective material may be disposed relative to 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, thereby forming a rough surface on 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 groove forming step.
[0094] Alternatively, after removing the second protective material, a step may be performed to shave the edges of the rough surface, for example, the edges of the layer member 30. This avoids stress concentration at the edges of the layer member 30 and reduces irritation to the living tissue.
[0095] 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.
[0096] In addition, in the film forming step, 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, thereby forming a film 20 on the surface of the exposed portion. The first protective material may be removed after the film forming step. 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 first masking tape to another portion of the substrate 10 while exposing a portion of the surface of the substrate 10 before the film forming step.
[0097] 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.
[0098] 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.
[0099] 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.
[0100] To summarize the above matters, for example, Figure 10 Each step is performed in the order shown. Figure 10 This is a process diagram illustrating a method for manufacturing an artificial joint handle 100 according to one embodiment. First, a second protective material can be applied, followed by a roughening step, after which the second protective material is removed. Next, a groove forming step can be performed. Finally, a first protective material can be applied, followed by a coating forming step.
[0101] 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 makes it possible to remove excess spraying material and / or cutting residues generated by the roughening step.
[0102] While the above description describes a method for manufacturing an artificial joint handle 100 having the aforementioned grooves, the present invention is not particularly limited to the aforementioned steps. For example, the aforementioned manufacturing method describes an example in which a groove forming step is performed after a roughening step for roughening the surface of the base 10, followed by a film forming step for forming a film. However, the roughening step may be performed after the groove forming step, followed by the film forming step.
[0103] 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.
[0104] During the first roughening step, a third protective material (the aforementioned second protective material) may be placed on the substrate 10 to expose the first roughened region while protecting the second roughened region and the non-roughened region, thereby forming a first roughened surface in the exposed first roughened region. Furthermore, the manufacturing method of the present invention may include a step of removing the third protective material after the first roughening step and before the second roughening step. During the second roughening step, a fourth protective material may be placed on the substrate 10 to expose the second roughened region while protecting the non-roughened region, thereby forming a second roughened surface in the exposed second roughened region. The second roughening step may be performed such that the surface roughness of the second roughened surface formed in the second roughening step is less than the surface roughness of the first roughened surface in the first roughened region. Furthermore, the manufacturing method of the present invention may include a step of removing the fourth protective material after the second roughening step and before the coating formation step. For example, a fourth masking tape may be used as the fourth protective material. In this case, the manufacturing method of the present invention may include a step of applying the fourth masking tape to the non-roughened region while exposing the first and second roughened regions before the second roughening step. 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.
[0105] 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.
[0106] 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.
[0107] 〔3. Utilization of artificial joint handle〕
[0108] 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.
[0109] Below, refer to Figure 11 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.
[0110] 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.
[0111] Description of reference numerals:
[0112] 1...first slot;
[0113] 2...Second slot;
[0114] 10...matrix;
[0115] 20...Lamination;
[0116] 100...Handle for artificial joint;
[0117] 1000...artificial hip joint.
Claims
1. A handle for an artificial joint, wherein: The artificial joint handle comprises: a substrate having one or more grooves disposed on a surface thereof; and a coating disposed on a portion of the surface of the substrate and comprising a calcium phosphate material and an antibacterial material; When the grooves located in the region where the coating is disposed among the one or more grooves are defined as first grooves and the grooves located in the region where the surface of the substrate is exposed from the coating are defined as second grooves, the total length of the first grooves is smaller than the total length of the second grooves. The depth of the first groove is smaller than the depth of the second groove.
2. The artificial joint handle according to claim 1, wherein: The first groove is connected to the second groove.
3. The artificial joint handle according to claim 1 or 2, wherein: The width of the first groove is smaller than the width of the second groove.
4. The artificial joint handle according to claim 1 or 2, wherein: The grooves include a plurality of first grooves.
5. The artificial joint handle according to claim 1 or 2, wherein: The first groove has a component along the width direction of the base body.
6. The artificial joint handle according to claim 1 or 2, wherein: A component of the first groove along the width direction of the base body is smaller than a component along a direction perpendicular to the width direction.
7. The artificial joint handle according to claim 1 or 2, wherein: The first groove has a plurality of straight portions.
8. The artificial joint handle according to claim 7, wherein: The plurality of straight line portions intersect each other perpendicularly.
9. The artificial joint handle according to claim 1 or 2, wherein: A component of the second groove along the width direction of the base body is smaller than a component along a direction perpendicular to the width direction.
10. The artificial joint handle according to claim 1 or 2, wherein: The depth of the groove at one end portion in the width direction of the groove is smaller than the depth of the other end portion.
11. The artificial joint handle according to claim 1 or 2, wherein: An area of a region of the surface of the base body where the coating is disposed is larger than an area of a region of the surface of the base body exposed from the coating.
12. The artificial joint handle according to claim 1 or 2, wherein: A length of a region of the surface of the substrate where the coating is disposed, along a direction perpendicular to the width direction of the substrate, is shorter than a length of a region of the surface of the substrate exposed from the coating, along the perpendicular direction.
13. The artificial joint handle according to claim 1 or 2, wherein: The substrate has a rough surface located on the surface of the substrate, Of the first and second grooves, only the first grooves are located on the rough surface.
14. The artificial joint handle according to claim 13, wherein: The surface roughness of the inner surface of the first groove located on the rough surface is smaller than the surface roughness of the rough surface of the base.
15. The artificial joint handle according to claim 1 or 2, wherein: The artificial joint handle includes a layered member located between the base and the coating and different from the coating.
16. The artificial joint handle according to claim 15, wherein: In the base body, of the first groove and the second groove, only the first groove is located in a region where the layered member is located.
17. A handle for an artificial joint, wherein: The artificial joint handle comprises: a substrate having one or more depressions disposed on a surface thereof; and a coating disposed on a portion of the surface of the substrate and comprising a calcium phosphate material and an antibacterial material; When the depression located in the region where the coating is disposed is defined as a first depression and the depression located in the region where the surface of the substrate is exposed from the coating is defined as a second depression, the total opening area of the first depression is smaller than the total opening area of the second depression. The depth of the first recess is smaller than the depth of the second recess.
Citation Information
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