WO2022127330A1 - Wrist joint radial prosthesis - Google Patents

Wrist joint radial prosthesis Download PDF

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Publication number
WO2022127330A1
WO2022127330A1 PCT/CN2021/124120 CN2021124120W WO2022127330A1 WO 2022127330 A1 WO2022127330 A1 WO 2022127330A1 CN 2021124120 W CN2021124120 W CN 2021124120W WO 2022127330 A1 WO2022127330 A1 WO 2022127330A1
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WO
WIPO (PCT)
Prior art keywords
radial
wrist
arc segment
prosthesis
convex arc
Prior art date
Application number
PCT/CN2021/124120
Other languages
French (fr)
Chinese (zh)
Inventor
孙延东
周思远
黄有军
Original Assignee
苏州感动赋能医疗科技有限公司
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Application filed by 苏州感动赋能医疗科技有限公司 filed Critical 苏州感动赋能医疗科技有限公司
Publication of WO2022127330A1 publication Critical patent/WO2022127330A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/42Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • A61F2/4261Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for wrists
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • A61F2002/2871Radius
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/42Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • A61F2/4261Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for wrists
    • A61F2002/4264Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for wrists for radio-carpal joints
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008Fixation appliances for connecting prostheses to the body

Definitions

  • the present application relates to the technical field of medical devices, and in particular, to a wrist radial prosthesis.
  • the wrist joint is one of the most flexible and important joints in the human body.
  • most of the wrist joint fusions were used before.
  • total wrist arthroplasty is more and more used in the treatment of wrist joints.
  • the current wrist radial prosthesis has poor installation stability and is prone to dislocation.
  • a wrist joint radial prosthesis is provided, which effectively solves the technical problems of poor stability and easy dislocation.
  • the present application provides a radial prosthesis for a wrist joint, comprising: a handle part, which is tapered and has opposite big head ends and small head ends; and a platform part, the platform part has a bottom surface.
  • the handle portion extends in a direction perpendicular to the bottom surface.
  • the big end is connected with the bottom surface.
  • a first boundary line parallel to the bottom surface is set between the large end and the small end.
  • the width of the first boundary line is LA
  • the width of the junction between the large end and the bottom surface is LB
  • the vertical distance from the first boundary line to the bottom surface of the platform portion is HC
  • the maximum vertical distance from the small end to the bottom surface is HD, where 0.4 ⁇ LA/LB ⁇ 0.6 and 0.5 ⁇ HC/HD ⁇ 0.7 are satisfied.
  • the outer surface of the portion of the handle portion between the large end and the first boundary line is provided with a porous coating.
  • the diameter of the small head end is greater than or equal to 2 mm.
  • a side of the platform portion facing away from the bottom surface is formed with an ellipsoidal joint surface.
  • the short-axis length of the plan projection of the ellipsoid articular surface is W
  • the long-axis length of the plan projection of the ellipsoid articular surface is L
  • 0.5 ⁇ W/L ⁇ 0.8 is satisfied.
  • the angle A between the long axis of the top-view projection of the ellipsoid articular surface and the bottom surface ranges from 10° to 25°, and/or the top-view projection of the ellipsoid articular surface
  • the value range of the included angle B between the short axis of and the bottom surface is 0° to 10°.
  • the angle A1 between the lower section of the ellipsoid articular surface and the bottom surface ranges from 10° to 25°, and/or in the lateral projection, the The value range of the included angle B1 between the lower section of the ellipsoid joint surface and the bottom surface is 0° ⁇ 10°.
  • the peripheral surface of the platform portion and the lateral projection surface intersect the first edge line and the second edge line.
  • the value range of the included angle C between the first edge line and the second edge line is 5° ⁇ 15°.
  • the included angle D between the first edge line and the normal line of the bottom surface ranges from 15° to 25°.
  • a portion of the platform portion that is close to the bottom surface extends to form a flange relative to the large end in the radial direction of the handle portion.
  • the two points with the largest distance are the first point and the second point.
  • the distance between the first take point and the second take point defines the length ML of the flange.
  • the distance between the two outermost points on the outline of the flange in the vertical direction defines the width AP of the flange , where 0.5 ⁇ AP/ML ⁇ 0.7 and 28mm ⁇ ML ⁇ 45mm are satisfied.
  • the contour of the flange includes a first convex arc segment, a second convex arc segment, a third convex arc segment, a fourth convex arc segment and a fifth concave arc segment that are smoothly adjacent in sequence.
  • the value range of the curvature radius R1 of the first convex arc segment is 7mm ⁇ 15mm
  • the value range of the curvature radius R2 of the second convex arc segment is 15mm ⁇ 30mm
  • the fifth concave arc segment has a value range of 15mm ⁇ 30mm.
  • the value range of the radius of curvature R5 is -30mm to -20mm.
  • a straight line segment is connected between the third convex arc segment and the fourth convex arc segment. Both the third convex arc segment and the fourth convex arc segment are tangent to the straight line segment.
  • the bottom surface of the platform portion is provided with a porous structure layer.
  • the porous structure layer is connected to the porous coating.
  • the platform portion and the handle portion are detachably connected.
  • the platform portion and the handle portion are integrally formed.
  • the wrist radial prosthesis provided by the present application includes a handle portion and a platform portion.
  • the handle portion extends in a direction perpendicular to the bottom surface, wherein the handle portion is tapered and has opposite large head ends and small head ends, and the large head end is connected to the bottom surface. , there is a first boundary line parallel to the bottom surface between the big end and the small end.
  • the width of the first boundary line is LA
  • the width of the junction between the big end and the bottom surface is LB
  • the first boundary line The vertical distance to the bottom of the platform is HC
  • the vertical distance from the small end of the handle to the bottom of the platform is HD, where 0.4 ⁇ LA/LB ⁇ 0.6, 0.5 ⁇ HC/HD ⁇ 0.7, so that the handle It has good adherence to the radial medullary cavity, which can effectively improve the connection stability of the wrist radial prosthesis and the radius, and reduce the occurrence of dislocation.
  • FIG. 1 is a schematic structural diagram of a wrist radial prosthesis according to an embodiment
  • FIG. 2 is a schematic structural diagram of a wrist radial prosthesis according to another embodiment
  • FIG. 3 is a schematic structural diagram of a wrist radial prosthesis according to another embodiment
  • Fig. 4(a) is a schematic diagram of the state of the wrist radial prosthesis implanted into the radius according to one embodiment
  • Figure 4(b) is a schematic diagram of the state of the wrist radial prosthesis of another embodiment when implanted into the radius;
  • FIG. 5 is a schematic view of an embodiment of the wrist radial prosthesis after implantation of the radius from the direction of the osteotomy surface;
  • Fig. 6 is a schematic view from the direction of the osteotomy surface after various sizes of wrist radial prostheses are implanted into the radius, wherein the peripheral contours of the flanges of the wrist radial prostheses of various sizes are schematically shown on the same radius osteotomy surface;
  • FIG. 7 is a schematic diagram of an edge profile of an ellipsoid articular surface of a wrist radial prosthesis according to an embodiment
  • FIG. 8 is a schematic diagram of the structure and morphology of a wrist radial prosthesis in an orthotopic wrist film according to an embodiment
  • FIG. 9 is a schematic diagram of the structure of the radial prosthesis of the wrist joint in the lateral view of the wrist joint according to an embodiment.
  • first and second are only used for descriptive purposes, and should not be construed as indicating or implying relative importance or implying the number of indicated technical features. Thus, a feature delimited with “first”, “second” may expressly or implicitly include at least one of that feature.
  • plurality means at least two, such as two, three, etc., unless expressly and specifically defined otherwise.
  • the terms “installed”, “connected”, “connected”, “fixed” and other terms should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection , or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between the two elements, unless otherwise specified limit.
  • installed may be a fixed connection or a detachable connection , or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between the two elements, unless otherwise specified limit.
  • a first feature "on” or “under” a second feature may be in direct contact with the first and second features, or the first and second features indirectly through an intermediary touch.
  • the first feature being “above”, “over” and “above” the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is level higher than the second feature.
  • the first feature being “below”, “below” and “below” the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature has a lower level than the second feature.
  • a wrist joint radial prosthesis provided by the present application includes a handle portion 10 and a platform portion 20 .
  • the platform part 20 is detachably connected with the handle part 10 , so that the handle part 10 and the platform part 20 can flexibly cooperate with different models of the platform part 20 and the handle part 10 respectively.
  • the two can be detachably connected by snap fit, which is convenient for disassembly and assembly, and is beneficial to improve the matching efficiency between the platform portion 20 and the handle portion 10 .
  • the handle portion 10 is provided with a sliding protrusion
  • the platform portion 20 is provided with a sliding groove slidably matched with the sliding protrusion.
  • the platform portion 20 is limited to the handle portion 10 in the direction perpendicular to the bottom surface 20a of the platform portion 20 (ie, the extending direction of the normal line of the bottom surface 20a ) by the cooperation between the sliding protrusion and the sliding groove.
  • the platform portion 20 can be quickly assembled to the handle portion 10 by pushing the platform portion 20 relative to the handle portion 10 in a direction parallel to the bottom surface 20a.
  • it is only necessary to push the platform portion 20 away from the handle portion 10 along the sliding protrusion.
  • the platform portion 20 and the handle portion 10 are integrally formed.
  • This integrated structure reduces the number of components, thereby facilitating implantation into the radius, and has better stability.
  • the platform portion 20 and the handle portion 10 are integrally formed, there is a large space for process selection.
  • the wrist radial prosthesis can be obtained by cutting and grinding the material, or it can be processed by 3D printing.
  • the material of the wrist radial prosthesis can be made of cobalt-chromium-molybdenum material, which not only has good wear resistance and corrosion resistance, but also has good biocompatibility.
  • the handle 10 of the wrist radial prosthesis can be made of titanium alloy material, so as to facilitate processing by 3D printing.
  • Figure 3 shows a frontal projection of a wrist radial prosthesis.
  • the so-called upright position for the human wrist, is the front of the wrist, that is, the position looking down on the palm when the palm is placed flat on the table; for the radial prosthesis, it is the position with the largest projected area, that is, parallel to the bottom surface 20a and The orientation where the width of the prosthesis is widest is observed.
  • the orientation perpendicular to the orthotopic in the direction parallel to the bottom surface 20a is the lateral orientation, that is, the orientation of the surface where the width of the prosthesis is the narrowest.
  • the shank 10 is tapered (ie, in an orthographic projection, gradually widening or narrowing from one end to the other), with opposing large and small ends 10a and 10b.
  • the platform portion 20 has a bottom surface 20a, and the bottom surface 20a is substantially perpendicular to the handle portion 10 and is connected to the large end 10a.
  • the width of the first boundary line 11a is LA
  • the width of the junction between the large end 10a of the handle portion 10 and the bottom surface 20a is LB
  • the vertical distance from the first boundary line 11a to the bottom surface 20a of the platform portion 20 is HC
  • the vertical distance from the end point of the small end 10b of the handle portion 10 to the bottom surface 20a of the platform portion 20 is HD
  • 0.4 ⁇ LA/LB ⁇ 0.6 and 0.5 ⁇ HC/HD ⁇ 0.7 are satisfied
  • the handle 10 and The radial medullary cavity has good adherence, which can effectively improve the connection stability of the wrist radial prosthesis and the radius to reduce the occurrence of dislocation.
  • the length of the LB is in the range of 10mm-30mm and the length of the HD is in the range of 35mm-60mm.
  • the first boundary line 11a is a virtual line (auxiliary line) provided for the convenience of describing the shape of the handle portion 10 , and the real first boundary line 11a may not necessarily be visible on the handle portion 10 .
  • the outer surface of the portion of the shank 10 between the large end 10a and the first boundary line 11a is provided with a porous coating 11 .
  • the porous coating 11 on the surface of the handle 10 can be closely attached to the radial medullary cavity, thereby improving the position of the handle 10 in the radial bone. installation stability.
  • the small head end 10 of the stem 10 will not cross the radial isthmus after implantation, that is, the length HD of the stem 10 does not exceed the osteotomy surface of the radius (the bottom surface 20a will fit on the radial isthmus). Osteotomy surface) to the length of the radial isthmus, to prevent the stem 10 from being inserted too deep to damage the radius.
  • the porous coating 11 can be located anywhere between the big end 10a and the first boundary line 11a, for example, it can be covered between the junction of the big head 10a and the bottom surface 20a and the first boundary line 11a, or not.
  • the porous coating 11 may or may not cross the first boundary line 11a, which is not limited here.
  • the porous coating 11 is provided to facilitate the growth of the radial bone tissue into the porous coating 11, which further enhances the installation stability of the handle 10 in the radial medullary cavity.
  • the porosity of the porous coating 11 is comparable to the porosity of the radial bone tissue, so that with the growth of the radial bone tissue, the radial bone tissue can better grow into the porous coating 11, so as to achieve the same.
  • the stable connection of the porous coating 11 improves the stability of the handle 10 in the radial medullary cavity.
  • the porous coating 11 can be formed by sintering metal particles or ceramic particles, and the process is simple, easy to manufacture, and has high structural strength and good wear resistance, which effectively improves the service life of the wrist radial prosthesis.
  • the bottom surface 20 a of the platform portion 20 is provided with a porous structure layer 22 .
  • the porous structure layer 22 is connected to the porous coating layer 11 .
  • the structure of the porous structure layer 22 can be the same as the structure of the porous coating 11, so as to improve the overall covering effect of the radial prosthesis of the wrist joint, so that after the radial prosthesis of the wrist joint is installed on the radius, the positions in contact with the radius are porous.
  • the structure facilitates the growth of radial tissue into the wrist radial prosthesis and improves the overall structural stability.
  • the structure of the porous structure layer 22 may also adopt a structure or material different from that of the porous coating layer 11 , which is not limited herein.
  • the stems 10 of samples 1 to 5 all meet the conditions of 0.4 ⁇ LA/LB ⁇ 0.6, 0.5 ⁇ HC/HD ⁇ 0.7, so that after the stem 10 is inserted into the radial medullary cavity, the porous coating 11 on its surface is in contact with the radial cavity.
  • the bone marrow cavity has better adherence (see Figure 4a), so that the connection between the handle 10 and the radius is stable, which improves the stability of the wrist radial prosthesis and reduces the instability of the wrist joint radial prosthesis. Dislocation of the joint occurs.
  • the LA/LB value is 0.3
  • the HC/HD value is 0.4, which is beyond the range constrained by the conditions of 0.4 ⁇ LA/LB ⁇ 0.6 and 0.5 ⁇ HC/HD ⁇ 0.7.
  • the porous coating 11 on its surface has poor adherence to the radial medullary cavity, and there is a clear gap between the outer surface of the handle 10 and the inner wall of the radial medullary cavity. Therefore, the handle 10 is prone to loosening, which may easily lead to dislocation at the wrist joint.
  • wrist radial prosthesis can be used for total wrist replacement or half wrist replacement.
  • the radial medullary canal is ripped with a tool such as a radial medullary canal rasp, and then the handle 10 is inserted into the reamed radial medullary medullary canal, so that the Under the fixation of the handle portion 10, the platform portion 20 remains in contact with the osteotomy surface of the radius, thereby completing the implantation operation of the radial prosthesis of the wrist joint.
  • the operation of implanting the carpal prosthesis is performed on the carpal side, and finally the articular surface of the carpal prosthesis is matched with the articular surface formed on the platform portion 20, and the implantation of the wrist prosthesis is completed.
  • the platform portion 20 may be a polyethylene material or a cobalt chromium molybdenum material.
  • the wrist radial prosthesis can be used for hemi-carpal replacement, so that a good wrist can be achieved by contacting the carpal bone with the articular surface formed on the platform part 20 under the condition of retaining the carpal bone. joint function.
  • the radial medullary canal is ripped with a tool such as a radial medullary canal file, and then the handle 10 is inserted into the reamed radial medullary canal Therefore, under the fixation of the handle portion 10, the platform portion 20 remains in contact with the osteotomy surface of the radius, thereby completing the implantation operation of the radial prosthesis of the wrist joint. Then, the carpal bone is brought into contact with the articular surface formed on the platform portion 20 to complete the implantation of the hemi-carpal joint prosthesis.
  • the diameter of the small tip 10b is greater than or equal to 2 mm, which can prevent the small tip 10b from being too sharp to scratch the inner wall of the radial medullary cavity.
  • a portion of the platform portion 20 close to the bottom surface 20 a extends along the radial direction of the handle portion 10 to form a flange 21 relative to the big end 10 a.
  • the flange 21 is in the shape of a flat sheet. After the handle 10 is inserted into the radial medullary cavity, the flange 21 abuts on the osteotomy surface of the radius, thereby improving the connection stability between the handle 10 and the radius.
  • the top projection of the flange 21 can be in an irregular shape, so as to be closer to the anatomical shape to a greater extent, so that the flange 21 fits with the osteotomy surface of the radius in a larger area and improves the wrist joint. Installation stability of radial prosthesis.
  • two points on the contour of the flange 21 that form the largest distance are selected to define the length of the flange 21
  • the corresponding maximum vertical dimension corresponding to the length of the flange 21 is selected to define the width of the flange 21 .
  • the two points with the maximum distance are the first point and the second point, and the distance between the first point and the second point defines the flange.
  • Length ML of 21 ie width of flange 21 in orthographic projection).
  • the distance between the two outermost points on the outline of the flange 21 in the vertical direction defines the width AP of the flange 21 (that is, the lateral projection width of the middle flange 21 ), wherein 0.5 ⁇ AP/ML ⁇ 0.7, 28mm ⁇ ML ⁇ 45mm is satisfied.
  • the size ratio of the flange 21 is adapted to the aspect ratio of the osteotomy surface of the radius, so that the flange 21 can cover the osteotomy of the radius as much as possible while maintaining the total area of the flange 21 unchanged.
  • the coverage ratio of the flange 21 to the osteotomy surface of the radius (the ratio of the effective area of the flange 21 covering the osteotomy surface to the total area of the osteotomy surface) is increased, so as to enhance the connection stability with the radius.
  • the wrist radial prosthesis can maximize the installation stability with the radius while maintaining the overall size miniaturization.
  • the outline of the flange 21 includes the first convex arc segment 21a and the second convex arc segment 21b which are smoothly adjacent to each other in sequence , a third convex arc segment 21c, a fourth convex arc segment 21e and a fifth concave arc segment 21f.
  • the radius of curvature R1 of the first convex arc segment 21a (corresponding to the dorsal lateral edge of the radius and close to the ulna) ranges from 7mm to 15mm, such as 7mm, 10mm, 12mm, 13mm or 15mm.
  • the radius of curvature R2 of the second convex arc segment 21b ranges from 15mm to 30mm, such as 15mm, 17mm, 20mm, 23mm, 26mm or 30mm.
  • the value range of the curvature radius R5 of the fifth concave arc segment 21f is -30mm to -20mm, for example, -30mm, -29.5mm, -25mm or -20mm.
  • the contour of the flange 21 of this structure is similar to the contour of the osteotomy surface of the radius, so that it can cover the osteotomy surface of the radius to a greater extent and improve the connection stability between the radial prosthesis of the wrist and the radius.
  • the curvature radius R5 of the fifth concave arc segment 21f takes a negative value, indicating that the part of the contour of the flange 21 corresponding to the fifth concave arc segment 21f is a concave arc, and the actual value of its radius is the curvature radius The absolute value of R5.
  • the value of the radius of the fifth concave arc segment 21f is 25mm, and its bending direction is opposite to that of the fourth convex arc segment 21e.
  • a straight line segment 21d is connected between the third convex arc segment 21c and the fourth convex arc segment 21e. Both the third convex arc segment 21c and the fourth convex arc segment 21e are tangent to the straight line segment 21d.
  • the value range of the length H of the straight section 21d is 0mm-10mm, preferably 0mm ⁇ 5mm, for example, the length H of the straight section 21d is 1mm, 2mm, 3mm, 4mm and 5mm.
  • the overall shape of the flange 21 can be similar to the shape of the osteotomy surface of the radius, so as to increase the contact area between the flange 21 and the osteotomy surface of the radius, thereby improving the radius of the wrist joint The installation firmness of the prosthesis.
  • the first convex arc segment 21a, the second convex arc segment 21b and the fifth concave arc When the segments 21f are selected with different curvature radii within their respective ranges, the coverage of the contour of the flange 21 will be different.
  • the contour of the flange 21 always has a high degree of fit with the shape of the osteotomy surface of the radius, and for the patient, the shape of the osteotomy surface of the radius is similar, only the size Therefore, within the range of the above parameters, a plurality of flanges 21 with similar contours can be formed to adapt to the osteotomy surfaces of different sizes of the radius.
  • the outline of the flange 21 configured according to the above parameter range will not change greatly on the whole, the similarity is very high, and only the size changes.
  • the flange 21 can meet the replacement needs of radial prostheses with different osteotomy surfaces.
  • an ellipsoidal joint surface 20b is formed on the side of the platform portion 20 that is away from the bottom surface 20a.
  • the short-axis length of the ellipse O of the top-view projection of the ellipsoid joint surface 20b (the projection of the direction with the largest ellipse area in the projection) is W, and the long-axis length is L, and satisfies 0.5 ⁇ W/L ⁇ 0.8, so that
  • the shape of the ellipsoid articular surface 20b is close to that of the normal radial articular surface, so that after the replacement of the radial prosthesis, the wrist joint function can be recovered well.
  • the angle A between the long axis and the bottom surface 20a of the platform portion 20 ranges from 10° to 25°, for example, the angle A is 10°, 15°, 20° or 25°.
  • the opening plane of the ellipsoid articular surface 20b (the plane where the edge contour of the ellipse O is located) will be inclined relative to the platform portion 20 as a whole, so as to be close to the radial and ulnar declination, so as to better realize the wrist joint. Function.
  • the radius-ulnar declination refers to the angle between the vertical line of the longitudinal axis of the radius and the line connecting the farthest point on the distal ulnar side of the radius, specifically in the wrist anteroposterior radiograph , the angle between the distal articular surface of the radius and the perpendicular to the longitudinal axis of the radius.
  • the value range of the angle A1 between the lower section of the ellipsoid joint surface 20b and the bottom surface 20a of the platform portion 20 is 10° ⁇ 25°.
  • the lower cut plane refers to a cut plane that is parallel to the long axis of the ellipsoid where the ellipsoid joint surface 20b is located and has the lowest tangent point. This ensures that the ellipsoid articular surface 20b is inclined as a whole while maintaining a sufficient depth of the acetabular joint.
  • the value range of the included angle B between the short axis of the ellipse O and the bottom surface 20a of the platform portion 20 is 0° ⁇ 15°, for example, the included angle B is 5°, 7°, 10° or 15°.
  • the inclination of the ellipsoid articular surface 20b relative to the bottom surface 20a of the platform portion 20 is close to the inclination of the radial palm, so that the wrist joint function can be better achieved.
  • the radial palmar inclination angle refers to the angle between the distal articular surface of the radius and the vertical line of the longitudinal axis of the radius in the lateral radiograph of the wrist joint.
  • the angle B1 between the lower section of the ellipsoid joint surface 20b and the bottom surface 20a of the platform portion 20 ranges from 0° to 15°, for example, the angle B is 5°, 7°, 10° ° or 15°. Within this value range, the ellipsoid articular surface 20b can be tilted as a whole while maintaining a sufficient depth of the acetabular joint.
  • the peripheral surface of the platform portion 20 and the lateral projection surface intersect the first edge line 20c and the second edge line 20d.
  • the value range of the included angle C between the first side line 20c and the second side line 20d is 5° ⁇ 15°, for example, the value of the included angle C is 5°, 8°, 10° or 15°.
  • the platform portion 20 has a bell mouth shape, the side of the platform portion 20 close to the handle portion 10 is the small mouth side, and the side away from the handle portion 10 is the large mouth side. In the direction of the handle portion 10, the opening gradually expands, so as to better support the articular surface of the carpal bone side of the wrist joint to be matched with it, thereby improving the stability of the function of the wrist joint.
  • the value range of the included angle D between the first edge line 20c and the normal line of the bottom surface 20a of the platform portion 20 is 15° ⁇ 25°, for example, the value of the included angle D may be 15°, 20° ° or 25°.
  • the wrist joint radial prosthesis according to various embodiments of the present application can effectively solve the technical problems of poor stability and easy dislocation.

Abstract

The wrist joint radial prosthesis provided in the present application comprises a handle part and a platform part. The platform part has a bottom surface. The handle part extends in a direction perpendicular to the bottom surface. The handle part is conical and has a large end and a small end which are opposite to each other. The large end is connected to the bottom surface. A first boundary line parallel to the bottom surface is provided between the large end and the small end. In a frontal projection, the width of the first boundary line is LA, the width of a junction of the large end and the bottom surface is LB, a vertical distance from the first boundary line to the bottom surface of the platform part is HC, a vertical distance from the small end of the handle part to the bottom surface of the platform part is HD, wherein 0.4≤LA/LB≤0.6 and 0.5≤HC/HD≤0.7.

Description

腕关节桡骨假体wrist radial prosthesis
相关申请的交叉引用CROSS-REFERENCE TO RELATED APPLICATIONS
本申请要求于2020年12月16日提交中国专利局、申请号为2020114852430的中国专利申请的优先权,所述专利申请的全部内容通过引用结合在本申请中。This application claims the priority of the Chinese patent application with application number 2020114852430 filed with the China Patent Office on December 16, 2020, the entire contents of which are incorporated herein by reference.
技术领域technical field
本申请涉及医疗器械技术领域,特别是涉及一种腕关节桡骨假体。The present application relates to the technical field of medical devices, and in particular, to a wrist radial prosthesis.
背景技术Background technique
腕关节是人体最灵活、最重要的关节之一,对于创伤性、退行性腕关节炎、类风湿性腕关节炎等严重受损类疾症的治疗,之前大多数以腕关节融合为主,随着医学和科技的发展以及患者迫切希望能够在解决疼痛的同时保留其腕关节的活动功能,全腕关节置换术越来越多应用到腕关节治疗中。The wrist joint is one of the most flexible and important joints in the human body. For the treatment of traumatic, degenerative wrist arthritis, rheumatoid wrist arthritis and other severely damaged diseases, most of the wrist joint fusions were used before. With the development of medicine and technology and the urgent desire of patients to relieve pain while preserving the mobility of their wrist joints, total wrist arthroplasty is more and more used in the treatment of wrist joints.
然而,目前的腕关节桡骨假体安装稳定性差,容易出现脱位。However, the current wrist radial prosthesis has poor installation stability and is prone to dislocation.
发明内容SUMMARY OF THE INVENTION
根据本申请的各种实施例,提供一种腕关节桡骨假体,有效解决稳定性差、易脱位的技术问题。According to various embodiments of the present application, a wrist joint radial prosthesis is provided, which effectively solves the technical problems of poor stability and easy dislocation.
本申请提供的一种腕关节桡骨假体,包括:柄部,其呈锥状,并具有相对的大头端和小头端;和平台部,所述平台部具有底面。所述柄部沿垂直于所述底面的方向延伸。所述大头端与所述底面相连接。所述大头端与所述小头端之间设有与所述底面平行的第一边界线。在正位投影中,所述第一边界线的宽度为LA,所述大头端与所述底面交界处的宽度为LB,所述第一边界线到所述平台部的底面的垂直距离为HC,所述小头端到所述底面的最大垂直距离为HD,其中,满足0.4≤LA/LB≤0.6,0.5≤HC/HD≤0.7。The present application provides a radial prosthesis for a wrist joint, comprising: a handle part, which is tapered and has opposite big head ends and small head ends; and a platform part, the platform part has a bottom surface. The handle portion extends in a direction perpendicular to the bottom surface. The big end is connected with the bottom surface. A first boundary line parallel to the bottom surface is set between the large end and the small end. In the orthographic projection, the width of the first boundary line is LA, the width of the junction between the large end and the bottom surface is LB, and the vertical distance from the first boundary line to the bottom surface of the platform portion is HC , the maximum vertical distance from the small end to the bottom surface is HD, where 0.4≤LA/LB≤0.6 and 0.5≤HC/HD≤0.7 are satisfied.
在其中一个实施例中,所述柄部的在所述大头端与所述第一边界线之间的部分的外表面设有多孔涂层。In one of the embodiments, the outer surface of the portion of the handle portion between the large end and the first boundary line is provided with a porous coating.
在其中一个实施例中,所述小头端的直径大于或等于2mm。In one of the embodiments, the diameter of the small head end is greater than or equal to 2 mm.
在其中一个实施例中,所述平台部的背向所述底面的一侧形成有椭球形关节面。所述椭球 形关节面的俯视投影的短轴长度为W,所述椭球形关节面的俯视投影的长轴长度为L,且满足0.5≤W/L≤0.8。In one of the embodiments, a side of the platform portion facing away from the bottom surface is formed with an ellipsoidal joint surface. The short-axis length of the plan projection of the ellipsoid articular surface is W, and the long-axis length of the plan projection of the ellipsoid articular surface is L, and 0.5≤W/L≤0.8 is satisfied.
在其中一个实施例中,所述椭球形关节面的俯视投影的长轴与所述底面的夹角A的取值范围为10°~25°,且/或所述椭球形关节面的俯视投影的短轴与所述底面的夹角B的取值范围为0°~10°。In one embodiment, the angle A between the long axis of the top-view projection of the ellipsoid articular surface and the bottom surface ranges from 10° to 25°, and/or the top-view projection of the ellipsoid articular surface The value range of the included angle B between the short axis of and the bottom surface is 0° to 10°.
在其中一个实施例中,正位投影中,所述椭球形关节面的下切面与所述底面的夹角A1的取值范围为10°~25°,且/或侧位投影中,所述椭球形关节面的下切面与所述底面的夹角B1的取值范围为0°~10°。In one embodiment, in the frontal projection, the angle A1 between the lower section of the ellipsoid articular surface and the bottom surface ranges from 10° to 25°, and/or in the lateral projection, the The value range of the included angle B1 between the lower section of the ellipsoid joint surface and the bottom surface is 0°˜10°.
在其中一个实施例中,所述平台部的周面与侧位投影面相交于第一边线和第二边线。所述第一边线和所述第二边线之间的夹角C的取值范围为5°~15°。In one embodiment, the peripheral surface of the platform portion and the lateral projection surface intersect the first edge line and the second edge line. The value range of the included angle C between the first edge line and the second edge line is 5°˜15°.
在其中一个实施例中,所述第一边线与所述底面的法线之间的夹角D的取值范围为15°~25°。In one embodiment, the included angle D between the first edge line and the normal line of the bottom surface ranges from 15° to 25°.
在其中一个实施例中,所述平台部的靠近所述底面的部分相对所述大头端沿所述柄部的径向延伸形成凸缘。在所述凸缘的轮廓上的任意两点中,最大距离的两点为第一取点和第二取点。所述第一取点和第二取点之间的距离界定所述凸缘的长度ML。在与所述第一取点和第二取点的连线的垂直方向上,所述凸缘的轮廓上的位于最外侧的两点在该垂直方向上的距离界定所述凸缘的宽度AP,其中,满足0.5≤AP/ML≤0.7,28mm≤ML≤45mm。In one of the embodiments, a portion of the platform portion that is close to the bottom surface extends to form a flange relative to the large end in the radial direction of the handle portion. Among any two points on the contour of the flange, the two points with the largest distance are the first point and the second point. The distance between the first take point and the second take point defines the length ML of the flange. In the vertical direction of the line connecting the first and second points, the distance between the two outermost points on the outline of the flange in the vertical direction defines the width AP of the flange , where 0.5≤AP/ML≤0.7 and 28mm≤ML≤45mm are satisfied.
在其中一个实施例中,所述凸缘的轮廓包括依次平滑邻接的第一凸弧段、第二凸弧段、第三凸弧段、第四凸弧段和第五凹弧段。其中,所述第一凸弧段的曲率半径R1的取值范围为7mm~15mm,所述第二凸弧段的曲率半径R2的取值范围为15mm~30mm,所述第五凹弧段的曲率半径R5的取值范围为-30mm~-20mm。In one embodiment, the contour of the flange includes a first convex arc segment, a second convex arc segment, a third convex arc segment, a fourth convex arc segment and a fifth concave arc segment that are smoothly adjacent in sequence. Wherein, the value range of the curvature radius R1 of the first convex arc segment is 7mm~15mm, the value range of the curvature radius R2 of the second convex arc segment is 15mm~30mm, and the fifth concave arc segment has a value range of 15mm~30mm. The value range of the radius of curvature R5 is -30mm to -20mm.
在其中一个实施例中,所述第三凸弧段与所述第四凸弧段之间连接有直线段。所述第三凸弧段和所述第四凸弧段均与所述直线段相切。In one embodiment, a straight line segment is connected between the third convex arc segment and the fourth convex arc segment. Both the third convex arc segment and the fourth convex arc segment are tangent to the straight line segment.
在其中一个实施例中,所述平台部的底面设置有多孔结构层。In one of the embodiments, the bottom surface of the platform portion is provided with a porous structure layer.
在其中一个实施例中,所述多孔结构层与所述多孔涂层相连接。In one embodiment, the porous structure layer is connected to the porous coating.
在其中一个实施例中,所述平台部和所述柄部可拆卸地连接。In one of the embodiments, the platform portion and the handle portion are detachably connected.
在其中一个实施例中,所述平台部和所述柄部一体成型。In one embodiment, the platform portion and the handle portion are integrally formed.
本申请提供的腕关节桡骨假体包括柄部和平台部,柄部沿垂直于底面的方向延伸,其中,柄部呈锥状,具有相对的大头端和小头端,大头端与底面相连接,大头端与小头端之间设有与 底面平行的第一边界线,在正位投影中,第一边界线的宽度为LA,大头端与底面交界处的宽度为LB,第一边界线到平台部的底面的垂直距离为HC,柄部的小头端到平台部的底面的垂直距离为HD,其中,0.4≤LA/LB≤0.6,0.5≤HC/HD≤0.7,可使得柄部与桡骨髓腔的贴壁性好,可有效提高腕关节桡骨假体与桡骨的连接稳定性,减少脱位现象的发生。The wrist radial prosthesis provided by the present application includes a handle portion and a platform portion. The handle portion extends in a direction perpendicular to the bottom surface, wherein the handle portion is tapered and has opposite large head ends and small head ends, and the large head end is connected to the bottom surface. , there is a first boundary line parallel to the bottom surface between the big end and the small end. In the orthographic projection, the width of the first boundary line is LA, the width of the junction between the big end and the bottom surface is LB, and the first boundary line The vertical distance to the bottom of the platform is HC, and the vertical distance from the small end of the handle to the bottom of the platform is HD, where 0.4≤LA/LB≤0.6, 0.5≤HC/HD≤0.7, so that the handle It has good adherence to the radial medullary cavity, which can effectively improve the connection stability of the wrist radial prosthesis and the radius, and reduce the occurrence of dislocation.
附图说明Description of drawings
为了更清楚地说明本申请实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本申请的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他实施例的附图。In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the accompanying drawings that are used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments of the present application. For those of ordinary skill in the art, the drawings of other embodiments can also be obtained according to these drawings without creative efforts.
图1为一实施方式的腕关节桡骨假体的结构示意图;1 is a schematic structural diagram of a wrist radial prosthesis according to an embodiment;
图2为另一实施方式的腕关节桡骨假体的结构示意图;2 is a schematic structural diagram of a wrist radial prosthesis according to another embodiment;
图3为再一实施方式的腕关节桡骨假体的结构示意图;3 is a schematic structural diagram of a wrist radial prosthesis according to another embodiment;
图4(a)为一实施方式的腕关节桡骨假体植入桡骨时的状态示意图;Fig. 4(a) is a schematic diagram of the state of the wrist radial prosthesis implanted into the radius according to one embodiment;
图4(b)为另一实施方式的腕关节桡骨假体植入桡骨时的状态示意图;Figure 4(b) is a schematic diagram of the state of the wrist radial prosthesis of another embodiment when implanted into the radius;
图5为一实施方式的腕关节桡骨假体植入桡骨后从截骨面方向观察示意图;5 is a schematic view of an embodiment of the wrist radial prosthesis after implantation of the radius from the direction of the osteotomy surface;
图6为多种不同规格的腕关节桡骨假体植入桡骨后从截骨面方向观察示意图,其中,各规格的腕关节桡骨假体的凸缘的外围轮廓示意性地表示于同一个桡骨的截骨面;Fig. 6 is a schematic view from the direction of the osteotomy surface after various sizes of wrist radial prostheses are implanted into the radius, wherein the peripheral contours of the flanges of the wrist radial prostheses of various sizes are schematically shown on the same radius osteotomy surface;
图7为一实施方式的腕关节桡骨假体的椭球形关节面的边缘轮廓示意图;7 is a schematic diagram of an edge profile of an ellipsoid articular surface of a wrist radial prosthesis according to an embodiment;
图8为一实施方式的腕关节桡骨假体在腕关节正位片中的结构形态示意图;8 is a schematic diagram of the structure and morphology of a wrist radial prosthesis in an orthotopic wrist film according to an embodiment;
图9为一实施方式的腕关节桡骨假体在腕关节侧位片中的结构形态示意图。FIG. 9 is a schematic diagram of the structure of the radial prosthesis of the wrist joint in the lateral view of the wrist joint according to an embodiment.
具体实施方式Detailed ways
为使本申请的上述目的、特征和优点能够更加明显易懂,下面结合附图对本申请的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本申请。但是本申请能够以很多不同于在此描述的其它方式来实施,本领域技术人员可以在不违背本申请内涵的情况下做类似改进,因此本申请不受下面公开的具体实施例的限制。In order to make the above objects, features and advantages of the present application more clearly understood, the specific embodiments of the present application will be described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present application. Therefore, the present application is not limited by the specific embodiments disclosed below.
在本申请的描述中,需要理解的是,术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺 时针”、“逆时针”、“轴向”、“径向”、“周向”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本申请和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本申请的限制。In the description of this application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", " Back, Left, Right, Vertical, Horizontal, Top, Bottom, Inner, Outer, Clockwise, Counterclockwise, Axial , "radial", "circumferential" and other indicated orientations or positional relationships are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the application and simplifying the description, rather than indicating or implying the indicated device or Elements must have a particular orientation, be constructed and operate in a particular orientation and are therefore not to be construed as limitations on this application.
此外,术语“第一”、“第二”仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。在本申请的描述中,“多个”的含义是至少两个,例如两个,三个等,除非另有明确具体的限定。In addition, the terms "first" and "second" are only used for descriptive purposes, and should not be construed as indicating or implying relative importance or implying the number of indicated technical features. Thus, a feature delimited with "first", "second" may expressly or implicitly include at least one of that feature. In the description of the present application, "plurality" means at least two, such as two, three, etc., unless expressly and specifically defined otherwise.
在本申请中,除非另有明确的规定和限定,术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或成一体;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通或两个元件的相互作用关系,除非另有明确的限定。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本申请中的具体含义。In this application, unless otherwise expressly specified and limited, the terms "installed", "connected", "connected", "fixed" and other terms should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection , or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between the two elements, unless otherwise specified limit. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific situations.
在本申请中,除非另有明确的规定和限定,第一特征在第二特征“上”或“下”可以是第一和第二特征直接接触,或第一和第二特征通过中间媒介间接接触。而且,第一特征在第二特征“之上”、“上方”和“上面”可是第一特征在第二特征正上方或斜上方,或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”可以是第一特征在第二特征正下方或斜下方,或仅仅表示第一特征水平高度小于第二特征。In this application, unless otherwise expressly stated and defined, a first feature "on" or "under" a second feature may be in direct contact with the first and second features, or the first and second features indirectly through an intermediary touch. Also, the first feature being "above", "over" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is level higher than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature has a lower level than the second feature.
需要说明的是,当元件被称为“固定于”或“设置于”另一个元件,它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件,它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“上”、“下”、“左”、“右”以及类似的表述只是为了说明的目的,并不表示是唯一的实施方式。It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or an intervening element may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used herein are for the purpose of illustration only and do not represent the only embodiment.
参阅图1所示,本申请提供的一种腕关节桡骨假体,包括柄部10和平台部20。Referring to FIG. 1 , a wrist joint radial prosthesis provided by the present application includes a handle portion 10 and a platform portion 20 .
在一实施例中,平台部20与柄部10可拆卸地连接,从而柄部10和平台部20可以分别灵活地配合不同型号的平台部20和柄部10。两者之间可以采取卡扣配合的方式实现可拆卸连接,这种方式拆装方便,有利于提高平台部20与柄部10的匹配效率。例如,柄部10设置有滑凸,平台部20设置与滑凸滑动配合的滑槽。利用滑凸与滑槽的配合,使得平台部20在垂直于平台部20的底面20a的方向上(即底面20a的法线的延伸方向)限位于柄部10。这种结构形式下,将滑凸与滑槽滑动配合后,沿平行于底面20a的方向相对柄部10推动平台部20,便能快捷地将平台部20装配至柄部10。相应地,在需要从柄部10取下时,只需要将平台部20沿滑凸推 离柄部10即可。In one embodiment, the platform part 20 is detachably connected with the handle part 10 , so that the handle part 10 and the platform part 20 can flexibly cooperate with different models of the platform part 20 and the handle part 10 respectively. The two can be detachably connected by snap fit, which is convenient for disassembly and assembly, and is beneficial to improve the matching efficiency between the platform portion 20 and the handle portion 10 . For example, the handle portion 10 is provided with a sliding protrusion, and the platform portion 20 is provided with a sliding groove slidably matched with the sliding protrusion. The platform portion 20 is limited to the handle portion 10 in the direction perpendicular to the bottom surface 20a of the platform portion 20 (ie, the extending direction of the normal line of the bottom surface 20a ) by the cooperation between the sliding protrusion and the sliding groove. In this structure, after the sliding protrusion and the sliding groove are slidably matched, the platform portion 20 can be quickly assembled to the handle portion 10 by pushing the platform portion 20 relative to the handle portion 10 in a direction parallel to the bottom surface 20a. Correspondingly, when it needs to be removed from the handle portion 10, it is only necessary to push the platform portion 20 away from the handle portion 10 along the sliding protrusion.
在一实施例中,结合图2所示,平台部20与柄部10一体成型,这种一体结构设置减小了组件数量,继而便于植入至桡骨,且稳定性较好。在平台部20与柄部10采取一体成型的结构时,工艺的选择空间大,可以采取对材料进行切割、打磨的方式获得腕关节桡骨假体,也可以利用3D打印的方式来加工。In one embodiment, as shown in FIG. 2 , the platform portion 20 and the handle portion 10 are integrally formed. This integrated structure reduces the number of components, thereby facilitating implantation into the radius, and has better stability. When the platform portion 20 and the handle portion 10 are integrally formed, there is a large space for process selection. The wrist radial prosthesis can be obtained by cutting and grinding the material, or it can be processed by 3D printing.
在一些实施方式中,腕关节桡骨假体的材料可以采用钴铬钼材料,这种材料不仅具有良好的耐磨性、耐腐蚀性,同时,也具有良好的生物相容性。In some embodiments, the material of the wrist radial prosthesis can be made of cobalt-chromium-molybdenum material, which not only has good wear resistance and corrosion resistance, but also has good biocompatibility.
在另一些实施方式中,腕关节桡骨假体的柄部10可以采取钛合金材料,从而便于通过3D打印的方式加工。In other embodiments, the handle 10 of the wrist radial prosthesis can be made of titanium alloy material, so as to facilitate processing by 3D printing.
图3显示的是一种腕关节桡骨假体的正位投影。所谓正位,对于人的手腕来说,是手腕的正面,即将手掌平放于桌面时俯视手掌的方位;对于桡骨假体来说,是其投影面积最大的方位,也就是平行于底面20a且观察到假体宽度最宽的方位。在平行于底面20a的方向上与正位垂直的方位为侧位,即观察到假体宽度最窄的面的方位。Figure 3 shows a frontal projection of a wrist radial prosthesis. The so-called upright position, for the human wrist, is the front of the wrist, that is, the position looking down on the palm when the palm is placed flat on the table; for the radial prosthesis, it is the position with the largest projected area, that is, parallel to the bottom surface 20a and The orientation where the width of the prosthesis is widest is observed. The orientation perpendicular to the orthotopic in the direction parallel to the bottom surface 20a is the lateral orientation, that is, the orientation of the surface where the width of the prosthesis is the narrowest.
柄部10呈锥状(即在正位投影中,从一端到另一端逐渐变宽或逐渐变窄),具有相对的大头端10a和小头端10b。平台部20具有底面20a,底面20a与柄部10大致垂直并与大头端10a相连接。大头端10a和小头端10b之间有第一边界线11a,第一边界线11a与底面20a相平行。在正位投影中,第一边界线11a的宽度为LA,柄部10的大头端10a与底面20a交界处的宽度为LB,第一边界线11a到平台部20的底面20a的垂直距离为HC,柄部10的小头端10b的端点到平台部20的底面20a的垂直距离为HD,其中,满足0.4≤LA/LB≤0.6,0.5≤HC/HD≤0.7的情况下,柄部10与桡骨髓腔的贴壁性好,可有效提高腕关节桡骨假体与桡骨的连接稳定性,以减少脱位现象的发生。The shank 10 is tapered (ie, in an orthographic projection, gradually widening or narrowing from one end to the other), with opposing large and small ends 10a and 10b. The platform portion 20 has a bottom surface 20a, and the bottom surface 20a is substantially perpendicular to the handle portion 10 and is connected to the large end 10a. There is a first boundary line 11a between the large end 10a and the small end 10b, and the first boundary line 11a is parallel to the bottom surface 20a. In the orthographic projection, the width of the first boundary line 11a is LA, the width of the junction between the large end 10a of the handle portion 10 and the bottom surface 20a is LB, and the vertical distance from the first boundary line 11a to the bottom surface 20a of the platform portion 20 is HC , the vertical distance from the end point of the small end 10b of the handle portion 10 to the bottom surface 20a of the platform portion 20 is HD, where 0.4≤LA/LB≤0.6 and 0.5≤HC/HD≤0.7 are satisfied, the handle 10 and The radial medullary cavity has good adherence, which can effectively improve the connection stability of the wrist radial prosthesis and the radius to reduce the occurrence of dislocation.
在一些实施例中,LB的长度范围为10mm-30mm,HD的长度范围为35mm-60mm。需要说明的是,第一边界线11a是为了方便描述柄部10的形态而设置的虚拟的线(辅助线),柄部10上并不一定可以看到实体的第一边界线11a。In some embodiments, the length of the LB is in the range of 10mm-30mm and the length of the HD is in the range of 35mm-60mm. It should be noted that the first boundary line 11a is a virtual line (auxiliary line) provided for the convenience of describing the shape of the handle portion 10 , and the real first boundary line 11a may not necessarily be visible on the handle portion 10 .
柄部10的在大头端10a与第一边界线11a之间的部分的外表面设有多孔涂层11。通过限定柄部10的形态满足0.4≤LA/LB≤0.6,0.5≤HC/HD≤0.7,可使得柄部10表面的多孔涂层11能够与桡骨髓腔紧密相贴,提高柄部10在桡骨上的安装稳定性。同时,如图4(a)所示,植入后柄部10的小头端10不会越过桡骨峡部,即柄部10的长度HD不超过桡骨的截骨面(底面20a将贴合于该截骨面)到桡骨峡部的长度,避免柄部10插入过深而损坏桡骨。The outer surface of the portion of the shank 10 between the large end 10a and the first boundary line 11a is provided with a porous coating 11 . By defining the shape of the handle 10 to satisfy 0.4≤LA/LB≤0.6 and 0.5≤HC/HD≤0.7, the porous coating 11 on the surface of the handle 10 can be closely attached to the radial medullary cavity, thereby improving the position of the handle 10 in the radial bone. installation stability. At the same time, as shown in FIG. 4(a), the small head end 10 of the stem 10 will not cross the radial isthmus after implantation, that is, the length HD of the stem 10 does not exceed the osteotomy surface of the radius (the bottom surface 20a will fit on the radial isthmus). Osteotomy surface) to the length of the radial isthmus, to prevent the stem 10 from being inserted too deep to damage the radius.
多孔涂层11可以位于大头端10a与第一边界线11a之间的任何位置,例如,可布满大头端10a与底面20a交界处和第一边界线11a之间,也可以不布满。多孔涂层11可以越过第一边界线11a,也可以不越过,此处不做限制。The porous coating 11 can be located anywhere between the big end 10a and the first boundary line 11a, for example, it can be covered between the junction of the big head 10a and the bottom surface 20a and the first boundary line 11a, or not. The porous coating 11 may or may not cross the first boundary line 11a, which is not limited here.
设置多孔涂层11,便于桡骨组织生长嵌入到多孔涂层11,进一步加强柄部10在桡骨髓腔内的安装稳定性。具体地,在其中一个实施例中,多孔涂层11的孔隙率与桡骨组织的孔隙率相当,从而随着桡骨组织的生长,桡骨组织能够更好地长入多孔涂层11内,从而实现与多孔涂层11的稳定连接,从而提升柄部10在桡骨髓腔内的稳定性。The porous coating 11 is provided to facilitate the growth of the radial bone tissue into the porous coating 11, which further enhances the installation stability of the handle 10 in the radial medullary cavity. Specifically, in one of the embodiments, the porosity of the porous coating 11 is comparable to the porosity of the radial bone tissue, so that with the growth of the radial bone tissue, the radial bone tissue can better grow into the porous coating 11, so as to achieve the same The stable connection of the porous coating 11 improves the stability of the handle 10 in the radial medullary cavity.
多孔涂层11可以是金属颗粒或陶瓷颗粒烧结而成,其工艺简单,便于制作,且结构强度高,耐磨性好,有效提高腕关节桡骨假体的使用寿命。The porous coating 11 can be formed by sintering metal particles or ceramic particles, and the process is simple, easy to manufacture, and has high structural strength and good wear resistance, which effectively improves the service life of the wrist radial prosthesis.
平台部20的底面20a设置有多孔结构层22。在其中一个实施例中,多孔结构层22与多孔涂层11相连接。由于腕关节桡骨假体安装于桡骨后,平台部20的底面20a与桡骨的截骨面相贴合,从而桡骨组织生长嵌入位于平台部20的底面20a上的多孔结构层22,以提高腕关节桡骨假体在桡骨上的安装稳定性,降低腕关节处出现脱位的几率。The bottom surface 20 a of the platform portion 20 is provided with a porous structure layer 22 . In one of the embodiments, the porous structure layer 22 is connected to the porous coating layer 11 . After the wrist radial prosthesis is installed on the radius, the bottom surface 20a of the platform portion 20 is in contact with the osteotomy surface of the radius, so that the radial bone tissue grows and embeds the porous structure layer 22 on the bottom surface 20a of the platform portion 20, so as to improve the radial bone of the wrist joint. The installation stability of the prosthesis on the radius reduces the chance of dislocation at the wrist joint.
多孔结构层22的结构可以与多孔涂层11的结构相同,从而提高其对腕关节桡骨假体的整体覆盖效果,以便腕关节桡骨假体安装于桡骨后,与桡骨接触的位置均具有多孔的结构来方便桡骨组织生长至腕关节桡骨假体中,提高整体结构稳固性。在其它实施方式中,多孔结构层22的结构也可以采取与多孔涂层11不同的结构或材料,在此不做限定。The structure of the porous structure layer 22 can be the same as the structure of the porous coating 11, so as to improve the overall covering effect of the radial prosthesis of the wrist joint, so that after the radial prosthesis of the wrist joint is installed on the radius, the positions in contact with the radius are porous. The structure facilitates the growth of radial tissue into the wrist radial prosthesis and improves the overall structural stability. In other embodiments, the structure of the porous structure layer 22 may also adopt a structure or material different from that of the porous coating layer 11 , which is not limited herein.
用软件模拟不同柄部10植入桡骨髓腔后的填充状态,结果如表1所示。The filling state of different stems 10 after being implanted into the radial medullary cavity was simulated by software, and the results are shown in Table 1.
表1不同柄部的LA/LB、HC/HD参数Table 1 LA/LB, HC/HD parameters of different shanks
   LA/LBLA/LB HC/HDHC/HD
样本1Sample 1 0.420.42 0.60.6
样本2Sample 2 0.580.58 0.530.53
样本3Sample 3 0.520.52 0.70.7
样本4Sample 4 0.60.6 0.620.62
样本5Sample 5 0.40.4 0.50.5
样本6Sample 6 0.30.3 0.40.4
样本1至样本5的柄部10,均符合0.4≤LA/LB≤0.6,0.5≤HC/HD≤0.7这一条件,从而柄部10插入桡骨髓腔后,其表面的多孔涂层11与桡骨髓腔的贴壁性较好(参阅图4a所示),从而柄部10与桡骨之间连接稳固,提高了腕关节桡骨假体稳定性,减少了因腕关节桡骨假体不稳 而导致腕关节处产生脱位的现象发生。The stems 10 of samples 1 to 5 all meet the conditions of 0.4≤LA/LB≤0.6, 0.5≤HC/HD≤0.7, so that after the stem 10 is inserted into the radial medullary cavity, the porous coating 11 on its surface is in contact with the radial cavity. The bone marrow cavity has better adherence (see Figure 4a), so that the connection between the handle 10 and the radius is stable, which improves the stability of the wrist radial prosthesis and reduces the instability of the wrist joint radial prosthesis. Dislocation of the joint occurs.
样本6的柄部10,其LA/LB取值为0.3,HC/HD取值为0.4,超出0.4≤LA/LB≤0.6,0.5≤HC/HD≤0.7这一条件所约束的范围。结合图4(b)所示,柄部10插入桡骨髓腔后,其表面的多孔涂层11与桡骨髓腔的贴壁性差,柄部10的外表面与桡骨髓腔的内壁之间存在明显的空隙,导致柄部10容易出现松动,容易导致腕关节处产生脱位。For the handle 10 of the sample 6, the LA/LB value is 0.3, and the HC/HD value is 0.4, which is beyond the range constrained by the conditions of 0.4≤LA/LB≤0.6 and 0.5≤HC/HD≤0.7. As shown in Figure 4(b), after the handle 10 is inserted into the radial medullary cavity, the porous coating 11 on its surface has poor adherence to the radial medullary cavity, and there is a clear gap between the outer surface of the handle 10 and the inner wall of the radial medullary cavity. Therefore, the handle 10 is prone to loosening, which may easily lead to dislocation at the wrist joint.
需要说明的是,腕关节桡骨假体可以用于全腕置换,也可以用于半腕置换。It should be noted that the wrist radial prosthesis can be used for total wrist replacement or half wrist replacement.
例如,在全腕置换中,在完成桡骨侧截骨形成相应的截骨面后,使用桡骨髓腔锉等工具锉桡骨髓腔,然后将柄部10插入锉好的桡骨髓腔中,从而在柄部10的固定下,平台部20保持与桡骨的截骨面相贴合,从而完成腕关节桡骨假体的植入操作。相应地,对腕骨侧进行植入腕骨假体的操作,最终使得腕骨假体的关节面与平台部20上所形成的关节面相匹配,完成腕关节假体植入。For example, in total wrist replacement, after the radial side osteotomy is completed to form the corresponding osteotomy surface, the radial medullary canal is ripped with a tool such as a radial medullary canal rasp, and then the handle 10 is inserted into the reamed radial medullary medullary canal, so that the Under the fixation of the handle portion 10, the platform portion 20 remains in contact with the osteotomy surface of the radius, thereby completing the implantation operation of the radial prosthesis of the wrist joint. Correspondingly, the operation of implanting the carpal prosthesis is performed on the carpal side, and finally the articular surface of the carpal prosthesis is matched with the articular surface formed on the platform portion 20, and the implantation of the wrist prosthesis is completed.
在平台部20与柄部10可拆卸地连接的实施方式中,平台部20可以是为聚乙烯材料或者钴铬钼材料。In the embodiment in which the platform portion 20 is detachably connected to the handle portion 10, the platform portion 20 may be a polyethylene material or a cobalt chromium molybdenum material.
其中,采取聚乙烯材质的平台部20时,腕关节桡骨假体可用于半腕置换,从而在保留腕骨的情况下,将腕骨与平台部20上所形成的关节面相接触即可实现良好的腕关节功能。Among them, when the platform part 20 made of polyethylene material is used, the wrist radial prosthesis can be used for hemi-carpal replacement, so that a good wrist can be achieved by contacting the carpal bone with the articular surface formed on the platform part 20 under the condition of retaining the carpal bone. joint function.
该实施方式中,在半腕置换术中,在完成桡骨侧截骨形成相应的截骨面后,使用桡骨髓腔锉等工具锉桡骨髓腔,然后将柄部10插入锉好的桡骨髓腔中,从而在柄部10的固定下,平台部20保持与桡骨的截骨面相贴合,从而完成腕关节桡骨假体的植入操作。然后将腕骨与平台部20上所形成的关节面相接触,便完成半腕关节假体植入。In this embodiment, in the hemicarpal arthroplasty, after the radial side osteotomy is completed to form the corresponding osteotomy surface, the radial medullary canal is ripped with a tool such as a radial medullary canal file, and then the handle 10 is inserted into the reamed radial medullary canal Therefore, under the fixation of the handle portion 10, the platform portion 20 remains in contact with the osteotomy surface of the radius, thereby completing the implantation operation of the radial prosthesis of the wrist joint. Then, the carpal bone is brought into contact with the articular surface formed on the platform portion 20 to complete the implantation of the hemi-carpal joint prosthesis.
在一些实施方式中,小头端10b的直径大于或等于2mm,这可避免小头端10b过于尖锐而刮伤桡骨髓腔的内壁。In some embodiments, the diameter of the small tip 10b is greater than or equal to 2 mm, which can prevent the small tip 10b from being too sharp to scratch the inner wall of the radial medullary cavity.
再次参阅图1所示,平台部20的靠近底面20a的部分相对大头端10a沿柄部10的径向延伸形成凸缘21。结合图4a所示,凸缘21呈平面的片状,在柄部10插入桡骨髓腔后,凸缘21抵靠在桡骨的截骨面上,从而提高柄部10与桡骨连接稳固性。Referring again to FIG. 1 , a portion of the platform portion 20 close to the bottom surface 20 a extends along the radial direction of the handle portion 10 to form a flange 21 relative to the big end 10 a. 4a, the flange 21 is in the shape of a flat sheet. After the handle 10 is inserted into the radial medullary cavity, the flange 21 abuts on the osteotomy surface of the radius, thereby improving the connection stability between the handle 10 and the radius.
如图5、图6所示,凸缘21的俯视投影可呈不规则形态,以更大限度地接近解剖形态,以便凸缘21更大面积地与桡骨的截骨面贴合,提高腕关节桡骨假体的安装稳定性。As shown in FIGS. 5 and 6 , the top projection of the flange 21 can be in an irregular shape, so as to be closer to the anatomical shape to a greater extent, so that the flange 21 fits with the osteotomy surface of the radius in a larger area and improves the wrist joint. Installation stability of radial prosthesis.
为了便于理解,选取凸缘21的轮廓上的形成最大距离的两点来界定凸缘21的长度,选取相应的对应该凸缘21的长度的最大垂直尺寸来界定凸缘21的宽度。结合图5所示,凸缘21的轮廓上的任意两点中,最大距离的两点为第一取点和第二取点,第一取点和第二取点之间的 距离界定凸缘21的长度ML(即正位投影中凸缘21的宽度)。在与第一取点和第二取点的连线的垂直方向上,凸缘21的轮廓上位于最外侧的两点在该垂直方向上的距离界定凸缘21的宽度AP(即侧位投影中凸缘21的宽度),其中,满足0.5≤AP/ML≤0.7,28mm≤ML≤45mm。这种凸缘21的尺寸比例,与桡骨的截骨面的长宽比相适应,从而在维持凸缘21的总面积不变的情况下,使凸缘21尽可能多地覆盖桡骨的截骨面,从而提高凸缘21对桡骨的截骨面的覆盖率(凸缘21覆盖截骨面的有效面积占截骨面总面积的比率),以增强与桡骨的连接稳定性。通过这种结构设置,腕关节桡骨假体能够在维持整体尺寸小型化的同时,最大程度地提升其与桡骨的安装稳固性。For ease of understanding, two points on the contour of the flange 21 that form the largest distance are selected to define the length of the flange 21 , and the corresponding maximum vertical dimension corresponding to the length of the flange 21 is selected to define the width of the flange 21 . 5, in any two points on the outline of the flange 21, the two points with the maximum distance are the first point and the second point, and the distance between the first point and the second point defines the flange. Length ML of 21 (ie width of flange 21 in orthographic projection). In the vertical direction of the line connecting the first and second points, the distance between the two outermost points on the outline of the flange 21 in the vertical direction defines the width AP of the flange 21 (that is, the lateral projection width of the middle flange 21 ), wherein 0.5≤AP/ML≤0.7, 28mm≤ML≤45mm is satisfied. The size ratio of the flange 21 is adapted to the aspect ratio of the osteotomy surface of the radius, so that the flange 21 can cover the osteotomy of the radius as much as possible while maintaining the total area of the flange 21 unchanged. Therefore, the coverage ratio of the flange 21 to the osteotomy surface of the radius (the ratio of the effective area of the flange 21 covering the osteotomy surface to the total area of the osteotomy surface) is increased, so as to enhance the connection stability with the radius. Through this structural arrangement, the wrist radial prosthesis can maximize the installation stability with the radius while maintaining the overall size miniaturization.
继续参阅图5所示,在满足0.5≤AP/ML≤0.7,28mm≤ML≤45mm这一条件下,凸缘21的轮廓包括依次平滑邻接的第一凸弧段21a、第二凸弧段21b、第三凸弧段21c、第四凸弧段21e和第五凹弧段21f。其中,第一凸弧段21a(对应于桡骨背侧外侧缘并靠近尺骨)的曲率半径R1的取值范围为7mm~15mm,比如为7mm、10mm、12mm、13mm或15mm。第二凸弧段21b(对应于桡骨背侧缘)的曲率半径R2的取值范围为15mm~30mm,比如为15mm、17mm、20mm、23mm、26mm或30mm。第五凹弧段21f(对应于桡骨掌侧轮廓内凹曲线)的曲率半径R5的取值范围为-30mm~-20mm,比如为-30mm、-29.5mm、-25mm或-20mm。这种结构的凸缘21的外形轮廓与桡骨的截骨面的轮廓相近似,从而可更大程度地覆盖桡骨的截骨面,提高腕关节桡骨假体与桡骨的连接稳定性。Continuing to refer to FIG. 5 , under the conditions of 0.5≤AP/ML≤0.7, 28mm≤ML≤45mm, the outline of the flange 21 includes the first convex arc segment 21a and the second convex arc segment 21b which are smoothly adjacent to each other in sequence , a third convex arc segment 21c, a fourth convex arc segment 21e and a fifth concave arc segment 21f. The radius of curvature R1 of the first convex arc segment 21a (corresponding to the dorsal lateral edge of the radius and close to the ulna) ranges from 7mm to 15mm, such as 7mm, 10mm, 12mm, 13mm or 15mm. The radius of curvature R2 of the second convex arc segment 21b (corresponding to the dorsal edge of the radius) ranges from 15mm to 30mm, such as 15mm, 17mm, 20mm, 23mm, 26mm or 30mm. The value range of the curvature radius R5 of the fifth concave arc segment 21f (corresponding to the concave curve of the volar radial contour) is -30mm to -20mm, for example, -30mm, -29.5mm, -25mm or -20mm. The contour of the flange 21 of this structure is similar to the contour of the osteotomy surface of the radius, so that it can cover the osteotomy surface of the radius to a greater extent and improve the connection stability between the radial prosthesis of the wrist and the radius.
需要特别指出的是,第五凹弧段21f的曲率半径R5取负值,表明凸缘21的轮廓对应该第五凹弧段21f的部分为凹弧,实际其半径的数值大小为该曲率半径R5的绝对值。例如,曲率半径R5取值-25mm时,该第五凹弧段21f的半径的数值大小为25mm,且其弯曲方向与第四凸弧段21e相反。It should be pointed out that the curvature radius R5 of the fifth concave arc segment 21f takes a negative value, indicating that the part of the contour of the flange 21 corresponding to the fifth concave arc segment 21f is a concave arc, and the actual value of its radius is the curvature radius The absolute value of R5. For example, when the radius of curvature R5 is -25mm, the value of the radius of the fifth concave arc segment 21f is 25mm, and its bending direction is opposite to that of the fourth convex arc segment 21e.
在一些实施方式中,第三凸弧段21c与第四凸弧段21e之间连接有直线段21d。第三凸弧段21c和第四凸弧段21e均与直线段21d相切。直线段21d的长度H的取值范围为0mm-10mm,优选0mm~5mm,例如,直线段21d的长度H为1mm、2mm、3mm、4mm和5mm。通过将直线段21d控制在合适的长度下,能够使得凸缘21的整体形状与桡骨的截骨面形状相近似,以提高凸缘21与桡骨的截骨面的接触面积,进而改善腕关节桡骨假体的安装牢固性。In some embodiments, a straight line segment 21d is connected between the third convex arc segment 21c and the fourth convex arc segment 21e. Both the third convex arc segment 21c and the fourth convex arc segment 21e are tangent to the straight line segment 21d. The value range of the length H of the straight section 21d is 0mm-10mm, preferably 0mm˜5mm, for example, the length H of the straight section 21d is 1mm, 2mm, 3mm, 4mm and 5mm. By controlling the straight segment 21d to an appropriate length, the overall shape of the flange 21 can be similar to the shape of the osteotomy surface of the radius, so as to increase the contact area between the flange 21 and the osteotomy surface of the radius, thereby improving the radius of the wrist joint The installation firmness of the prosthesis.
需要说明的是,上述的凸缘21在其轮廓满足0.5≤AP/ML≤0.7,28mm≤ML≤45mm这一条件下,第一凸弧段21a、第二凸弧段21b和第五凹弧段21f在各自范围内选取不同的曲率半径时,凸缘21的轮廓的覆盖面将有所不同。确切的说,在上述的参数范围下,凸缘21的轮廓与 桡骨的截骨面的形状始终具有较高贴合度,而且对于患者而言,桡骨的截骨面形状是相似的,仅尺寸上有所不同,从而在上述参数范围内可以形成多个轮廓相似的凸缘21,以与不同大小的桡骨的截骨面相适应。例如,结合图6所示,根据上述参数范围所配置的凸缘21,其轮廓整体上不会出现较大变化,相似度很高,仅尺寸有所变化,这种结构设置下的多种规格的凸缘21能够满足截骨面大小不同的桡骨假体的置换需要。It should be noted that, under the condition that the profile of the above-mentioned flange 21 satisfies the conditions of 0.5≤AP/ML≤0.7 and 28mm≤ML≤45mm, the first convex arc segment 21a, the second convex arc segment 21b and the fifth concave arc When the segments 21f are selected with different curvature radii within their respective ranges, the coverage of the contour of the flange 21 will be different. To be precise, under the above parameter range, the contour of the flange 21 always has a high degree of fit with the shape of the osteotomy surface of the radius, and for the patient, the shape of the osteotomy surface of the radius is similar, only the size Therefore, within the range of the above parameters, a plurality of flanges 21 with similar contours can be formed to adapt to the osteotomy surfaces of different sizes of the radius. For example, as shown in FIG. 6 , the outline of the flange 21 configured according to the above parameter range will not change greatly on the whole, the similarity is very high, and only the size changes. Various specifications under this structure are set. The flange 21 can meet the replacement needs of radial prostheses with different osteotomy surfaces.
结合图7所示,平台部20的背向底面20a的一侧形成有椭球形关节面20b。椭球形关节面20b的俯视投影(投影中的椭圆形面积最大的方向的投影)的椭圆形O的短轴长度为W,长轴长度为L,并满足0.5≤W/L≤0.8,从而使得椭球形关节面20b与正常桡骨关节面的形态很接近,以使得在置换桡骨假体之后,腕关节功能恢复效果良好。As shown in FIG. 7 , an ellipsoidal joint surface 20b is formed on the side of the platform portion 20 that is away from the bottom surface 20a. The short-axis length of the ellipse O of the top-view projection of the ellipsoid joint surface 20b (the projection of the direction with the largest ellipse area in the projection) is W, and the long-axis length is L, and satisfies 0.5≤W/L≤0.8, so that The shape of the ellipsoid articular surface 20b is close to that of the normal radial articular surface, so that after the replacement of the radial prosthesis, the wrist joint function can be recovered well.
结合图8所示,长轴与平台部20的底面20a的夹角A的取值范围为10°~25°,比如夹角A取值为10°、15°、20°或25°。这种结构设置下,椭球形关节面20b的开口平面(椭圆形O的边缘轮廓所在平面)整体上会相对平台部20倾斜,以与桡骨尺偏角相接近,从而能够更好的实现腕关节功能。其中,在骨科临床中,桡骨尺偏角是指桡骨的纵轴线的垂线与桡骨的远端尺桡侧的最远点的连线之间的夹角,具体为在腕关节正位片中,桡骨的远端关节面与桡骨纵轴的垂线的夹角。8 , the angle A between the long axis and the bottom surface 20a of the platform portion 20 ranges from 10° to 25°, for example, the angle A is 10°, 15°, 20° or 25°. Under this structural arrangement, the opening plane of the ellipsoid articular surface 20b (the plane where the edge contour of the ellipse O is located) will be inclined relative to the platform portion 20 as a whole, so as to be close to the radial and ulnar declination, so as to better realize the wrist joint. Function. Among them, in orthopaedic clinics, the radius-ulnar declination refers to the angle between the vertical line of the longitudinal axis of the radius and the line connecting the farthest point on the distal ulnar side of the radius, specifically in the wrist anteroposterior radiograph , the angle between the distal articular surface of the radius and the perpendicular to the longitudinal axis of the radius.
在正位投影中,椭球形关节面20b的下切面与平台部20的底面20a的夹角A1的取值范围为10°~25°。该下切面是指,与椭球形关节面20b所在的椭球的长轴相平行且切点最低的切面。从而确保椭球形关节面20b整体倾斜的同时,维持足够的臼关节深度。In the orthographic projection, the value range of the angle A1 between the lower section of the ellipsoid joint surface 20b and the bottom surface 20a of the platform portion 20 is 10°˜25°. The lower cut plane refers to a cut plane that is parallel to the long axis of the ellipsoid where the ellipsoid joint surface 20b is located and has the lowest tangent point. This ensures that the ellipsoid articular surface 20b is inclined as a whole while maintaining a sufficient depth of the acetabular joint.
结合图9所示,椭圆形O的短轴与平台部20的底面20a的夹角B的取值范围为0°~15°,比如夹角B取值为5°、7°、10°或15°。在该角度范围内,椭球形关节面20b相对平台部20的底面20a的倾角形态与桡骨掌倾角相接近,从而能够更好的实现腕关节功能。其中,在骨科临床中,桡骨掌倾角指在腕关节侧位片中,桡骨的远端关节面与桡骨纵轴的垂线的夹角。9, the value range of the included angle B between the short axis of the ellipse O and the bottom surface 20a of the platform portion 20 is 0°~15°, for example, the included angle B is 5°, 7°, 10° or 15°. Within this angle range, the inclination of the ellipsoid articular surface 20b relative to the bottom surface 20a of the platform portion 20 is close to the inclination of the radial palm, so that the wrist joint function can be better achieved. Among them, in the orthopedic clinic, the radial palmar inclination angle refers to the angle between the distal articular surface of the radius and the vertical line of the longitudinal axis of the radius in the lateral radiograph of the wrist joint.
在侧位投影中,椭球形关节面20b的下切面与平台部20的底面20a的夹角B1的取值范围为0°~15°,比如夹角B取值为5°、7°、10°或15°。在该取值范围下,椭球形关节面20b整体倾斜的同时,能够维持足够的臼关节深度。In the lateral projection, the angle B1 between the lower section of the ellipsoid joint surface 20b and the bottom surface 20a of the platform portion 20 ranges from 0° to 15°, for example, the angle B is 5°, 7°, 10° ° or 15°. Within this value range, the ellipsoid articular surface 20b can be tilted as a whole while maintaining a sufficient depth of the acetabular joint.
在一些实施方式中,平台部20的周面与侧位投影面相交于第一边线20c和第二边线20d。第一边线20c和第二边线20d之间的夹角C的取值范围为5°~15°,比如夹角C的取值为5°、8°、10°或15°。通过这种结构设置,使得平台部20上呈喇叭口状,平台部20的靠近柄部10的一侧为小口侧,远离柄部10的一侧为大口侧,继而使得在平台部20朝远离柄部10的方向上, 开口逐渐扩张,以更好地承托与其配合的腕关节的腕骨侧的关节面,从而提高腕关节功能的稳定性。In some embodiments, the peripheral surface of the platform portion 20 and the lateral projection surface intersect the first edge line 20c and the second edge line 20d. The value range of the included angle C between the first side line 20c and the second side line 20d is 5°˜15°, for example, the value of the included angle C is 5°, 8°, 10° or 15°. Through this structural arrangement, the platform portion 20 has a bell mouth shape, the side of the platform portion 20 close to the handle portion 10 is the small mouth side, and the side away from the handle portion 10 is the large mouth side. In the direction of the handle portion 10, the opening gradually expands, so as to better support the articular surface of the carpal bone side of the wrist joint to be matched with it, thereby improving the stability of the function of the wrist joint.
在一些实施方式中,第一边线20c与平台部20的底面20a的法线之间的夹角D的取值范围为15°~25°,比如夹角D取值可以为15°、20°或25°。In some embodiments, the value range of the included angle D between the first edge line 20c and the normal line of the bottom surface 20a of the platform portion 20 is 15°˜25°, for example, the value of the included angle D may be 15°, 20° ° or 25°.
根据本申请的各种实施例的腕关节桡骨假体可有效解决稳定性差、易脱位的技术问题。The wrist joint radial prosthesis according to various embodiments of the present application can effectively solve the technical problems of poor stability and easy dislocation.
以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity, all possible combinations of the technical features in the above-described embodiments are not described. However, as long as there is no contradiction between the combinations of these technical features, All should be regarded as the scope described in this specification.
以上所述实施例仅表达了本申请的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对申请专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本申请构思的前提下,还可以做出若干变形和改进,这些都属于本申请的保护范围。因此,本申请专利的保护范围应以所附权利要求为准。The above-mentioned embodiments only represent several embodiments of the present application, and the descriptions thereof are relatively specific and detailed, but should not be construed as a limitation on the scope of the patent application. It should be pointed out that for those skilled in the art, without departing from the concept of the present application, several modifications and improvements can be made, which all belong to the protection scope of the present application. Therefore, the scope of protection of the patent of the present application shall be subject to the appended claims.

Claims (15)

  1. 一种腕关节桡骨假体,其特征在于,包括:A wrist radial prosthesis, comprising:
    柄部;其呈锥状,并具有相对的大头端和小头端;和a shank; it is tapered and has opposing large and small ends; and
    平台部,其具有底面,a platform portion, which has a bottom surface,
    其中,所述柄部沿垂直于所述底面的方向延伸,所述大头端与所述底面相连接,所述大头端与所述小头端之间设有与所述底面平行的第一边界线,在正位投影中,所述第一边界线的宽度为LA,所述大头端与所述底面交界处的宽度为LB,所述第一边界线到所述平台部的底面的垂直距离为HC,所述小头端到所述底面的最大垂直距离为HD,其中,满足0.4≤LA/LB≤0.6,0.5≤HC/HD≤0.7。The handle portion extends in a direction perpendicular to the bottom surface, the large end is connected to the bottom surface, and a first edge parallel to the bottom surface is arranged between the large end and the small end. The boundary line, in the orthographic projection, the width of the first boundary line is LA, the width of the junction between the large end and the bottom surface is LB, and the vertical distance from the first boundary line to the bottom surface of the platform portion is HC, and the maximum vertical distance from the small end to the bottom surface is HD, where 0.4≤LA/LB≤0.6 and 0.5≤HC/HD≤0.7 are satisfied.
  2. 根据权利要求1所述的腕关节桡骨假体,其特征在于,所述柄部的在所述大头端与所述第一边界线之间的部分的外表面设有多孔涂层。The radial prosthesis of the wrist joint according to claim 1, wherein a porous coating is provided on the outer surface of the portion of the handle between the large head end and the first boundary line.
  3. 根据权利要求1所述的腕关节桡骨假体,其特征在于,所述小头端的直径大于或等于2mm。The radial prosthesis of the wrist joint according to claim 1, wherein the diameter of the small head end is greater than or equal to 2 mm.
  4. 根据权利要求1所述的腕关节桡骨假体,其特征在于,所述平台部的背向所述底面的一侧形成有椭球形关节面,所述椭球形关节面的俯视投影的短轴长度为W,所述椭球形关节面的俯视投影的长轴长度为L,且满足0.5≤W/L≤0.8。The wrist radial prosthesis according to claim 1, wherein an ellipsoid articular surface is formed on a side of the platform portion facing away from the bottom surface, and a short axis length of a plan projection of the ellipsoid articular surface is is W, and the length of the long axis of the top-view projection of the ellipsoid articular surface is L, and satisfies 0.5≤W/L≤0.8.
  5. 根据权利要求4所述的腕关节桡骨假体,其特征在于,所述椭球形关节面的俯视投影的长轴与所述底面的夹角A的取值范围为10°~25°,且/或所述椭球形关节面的俯视投影的短轴与所述底面的夹角B的取值范围为0°~10°。The radial prosthesis for wrist joint according to claim 4, wherein the angle A between the long axis of the top-view projection of the ellipsoid articular surface and the bottom surface ranges from 10° to 25°, and/ Or the value range of the included angle B between the short axis of the top-view projection of the ellipsoid joint surface and the bottom surface is 0° to 10°.
  6. 根据权利要求4所述的腕关节桡骨假体,其特征在于,正位投影中,所述椭球形关节面的下切面与所述底面的夹角A1的取值范围为10°~25°,且/或侧位投影中,所述椭球形关节面的下切面与所述底面的夹角B1的取值范围为0°~10°。The wrist radial prosthesis according to claim 4, wherein, in the frontal projection, the angle A1 between the lower section of the ellipsoid articular surface and the bottom surface ranges from 10° to 25°, And/or in the lateral projection, the value range of the included angle B1 between the lower section of the ellipsoid articular surface and the bottom surface is 0° to 10°.
  7. 根据权利要求1所述的腕关节桡骨假体,其特征在于,所述平台部的周面与侧位投影面相交于第一边线和第二边线,所述第一边线和所述第二边线之间的夹角C的取值范围为5°~15°。The radial prosthesis for wrist joint according to claim 1, wherein the peripheral surface of the platform portion and the lateral projection surface intersect with a first edge line and a second edge line, and the first edge line and the first edge line The value range of the included angle C between the two sides is 5° to 15°.
  8. 根据权利要求7所述的腕关节桡骨假体,其特征在于,所述第一边线与所述底面的法线之间的夹角D的取值范围为15°~25°。The radial prosthesis for wrist joint according to claim 7, wherein the included angle D between the first edge line and the normal line of the bottom surface ranges from 15° to 25°.
  9. 根据权利要求1所述的腕关节桡骨假体,其特征在于,所述平台部的靠近所述底面的部分相对所述大头端沿所述柄部的径向延伸形成凸缘,在所述凸缘的轮廓上的任意两点中,最大距离的两点为第一取点和第二取点,所述第一取点和第二取点之间的距离界定所述凸缘 的长度ML,在与所述第一取点和第二取点的连线的垂直方向上,所述凸缘的轮廓上的位于最外侧的两点在所述垂直方向上的距离界定所述凸缘的宽度AP,其中,满足0.5≤AP/ML≤0.7,28mm≤ML≤45mm。The radial prosthesis for wrist joint according to claim 1, wherein a portion of the platform portion close to the bottom surface forms a flange extending in the radial direction of the stem portion relative to the big head end, and a flange is formed on the convex portion. In any two points on the outline of the edge, the two points with the largest distance are the first and second points, and the distance between the first and second points defines the length ML of the flange, In the vertical direction to the line connecting the first and second points, the distance in the vertical direction between the two outermost points on the outline of the flange defines the width of the flange AP, wherein, 0.5≤AP/ML≤0.7, and 28mm≤ML≤45mm.
  10. 根据权利要求9所述的腕关节桡骨假体,其特征在于,所述凸缘的轮廓包括依次平滑邻接的第一凸弧段、第二凸弧段、第三凸弧段、第四凸弧段和第五凹弧段,其中,所述第一凸弧段的曲率半径R1的取值范围为7mm~15mm,所述第二凸弧段的曲率半径R2的取值范围为15mm~30mm,所述第五凹弧段的曲率半径R5的取值范围为-30mm~-20mm。The radial prosthesis for wrist joint according to claim 9, wherein the outline of the flange comprises a first convex arc segment, a second convex arc segment, a third convex arc segment, and a fourth convex arc segment that are smoothly adjacent to each other in sequence segment and the fifth concave arc segment, wherein the value range of the curvature radius R1 of the first convex arc segment is 7mm~15mm, and the value range of the curvature radius R2 of the second convex arc segment is 15mm~30mm, The value range of the curvature radius R5 of the fifth concave arc segment is -30mm~-20mm.
  11. 根据权利要求10所述的腕关节桡骨假体,其特征在于,所述第三凸弧段与所述第四凸弧段之间连接有直线段,所述第三凸弧段和所述第四凸弧段均与所述直线段相切。The radial prosthesis for wrist joint according to claim 10, wherein a straight line segment is connected between the third convex arc segment and the fourth convex arc segment, and the third convex arc segment and the fourth convex arc segment are connected with a straight line segment. The four convex arc segments are all tangent to the straight line segment.
  12. 根据权利要求2所述的腕关节桡骨假体,其特征在于,所述平台部的所述底面设置有多孔结构层。The radial prosthesis for wrist joint according to claim 2, wherein the bottom surface of the platform portion is provided with a porous structure layer.
  13. 根据权利要求12所述的腕关节桡骨假体,其特征在于,所述多孔结构层与所述多孔涂层相连接。The radial wrist prosthesis of claim 12, wherein the porous structure layer is connected to the porous coating.
  14. 根据权利要求1所述的腕关节桡骨假体,其特征在于,所述平台部和所述柄部可拆卸地连接。The wrist radial prosthesis according to claim 1, wherein the platform portion and the handle portion are detachably connected.
  15. 根据权利要求1所述的腕关节桡骨假体,其特征在于,所述平台部和所述柄部一体成型。The wrist radial prosthesis according to claim 1, wherein the platform portion and the handle portion are integrally formed.
PCT/CN2021/124120 2020-12-16 2021-10-15 Wrist joint radial prosthesis WO2022127330A1 (en)

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US4784661A (en) * 1985-11-22 1988-11-15 Robert Beckenbaugh Total wrist prosthesis
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US20140277524A1 (en) * 2013-03-14 2014-09-18 Mayo Foundation for Medical Education and Research Radial head implant
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