WO2021233025A1 - 胫骨托假体 - Google Patents

胫骨托假体 Download PDF

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Publication number
WO2021233025A1
WO2021233025A1 PCT/CN2021/087206 CN2021087206W WO2021233025A1 WO 2021233025 A1 WO2021233025 A1 WO 2021233025A1 CN 2021087206 W CN2021087206 W CN 2021087206W WO 2021233025 A1 WO2021233025 A1 WO 2021233025A1
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WO
WIPO (PCT)
Prior art keywords
diameter
tibial tray
ratio
tray prosthesis
straight
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PCT/CN2021/087206
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English (en)
French (fr)
Inventor
赵开宇
孙延东
史忠兵
鄢正清
Original Assignee
苏州微创关节医疗科技有限公司
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Publication of WO2021233025A1 publication Critical patent/WO2021233025A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A61F2/389—Tibial components
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A61F2002/2892—Tibia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • This application relates to the technical field of medical devices, in particular to tibial tray prostheses.
  • Unicondyle replacement uses a minimally invasive incision, while retaining the anterior and posterior cruciate ligaments of the patient’s knee joint. It has the advantages of less trauma, fast recovery, and good postoperative physiological mobility. Therefore, unicondyle replacement is widely used Treatment of osteoarthritis in a single room. Unicondylar prostheses used in unicondylar replacement can be divided into medial femoral prostheses and medial tibial prostheses used to replace the medial compartment, and lateral femoral prostheses and lateral tibial prostheses used to replace the lateral compartments.
  • Prosthesis loosening and postoperative pain are the main reasons for revision of unicondylar knee replacement. Poor prosthesis coverage is an important reason for prosthesis loosening and postoperative pain. Poor prosthesis coverage means that the prosthesis cannot fully cover the cortical bone area, which makes the prosthesis not well supported. It is easy to cause the prosthesis to sink and loosen after the operation, and the prosthesis can overhang and interfere with the surrounding soft tissues. Pain after surgery.
  • a knee joint system a tibial prosthesis, and a tibial tray prosthesis are provided.
  • a tibial tray prosthesis which is used to replace the medial tibial compartment of a human knee joint
  • the tibial tray prosthesis has an anteroposterior diameter A and a left-right diameter B, and the anterior and posterior
  • the diameter A shows an increasing trend as the left and right diameter B increases
  • the ratio A/B of the front and rear diameter A to the left and right diameter B shows a decreasing trend as the left and right diameter B increases.
  • the above scheme sets the ratio A/B of the anteroposterior diameter A to the left and right diameter B of the tibial tray prosthesis to decrease with the increase of the left and right diameters B, which can make the tibial tray prosthesis closer to the inner tibia of the human knee joint.
  • the anatomical shape improves the coverage of the tibial prosthesis and reduces the probability of loosening of the prosthesis and postoperative pain.
  • the ratio A/B of the front and rear diameter A to the left and right diameter B ranges from 1.6 to 2.0.
  • the ratio A/B of the front and rear diameter A to the left and right diameter B shows a linear decreasing trend as the left and right diameter B increases, and the front and rear diameter A and the left and right diameter B
  • the tibial tray prosthesis has a first side surface and a second side surface opposite to each other, the second side surface is a straight surface, and the point on the first side surface farthest from the second side surface is The vertical distance of the front end tangent is recorded as the first distance C.
  • the ratio C/A of the first distance C to the front and rear diameter A ranges from 0.45 to 0.75, and the front tangent refers to perpendicular to the second side surface and A straight line tangent to the front end contour of the tibial tray prosthesis.
  • the first side surface includes a front edge curved surface and a rear edge curved surface, and the ratio R1/A of the radius of curvature R1 of the front edge curved surface to the front and rear diameter A ranges from 0.45 to 0.7; The ratio R2/A of the radius of curvature R2 of the edge curved surface to the front and rear diameter A ranges from 0.25 to 0.45.
  • the first side surface further includes a straight face section, two ends of the straight face section are respectively connected to the front edge curved surface and the rear edge curved surface, and the length E of the straight face section is related to the front and rear diameters.
  • the range of A ratio E/A is 0.07-0.12.
  • the second side surface is a straight surface, and when the tibial tray prosthesis is in the theoretical implant position, the first side surface is perpendicular to the condyle axis of the knee joint.
  • tibial tray prosthesis is used to replace the lateral tibial compartment of a human knee joint
  • the tibial tray prosthesis has an anteroposterior diameter a and a left and right diameter b
  • the front and rear diameter a increases with the increase of the left and right diameter b
  • the ratio a/b of the front and rear diameter a to the left and right diameter b shows a decreasing trend as the left and right diameter b increases.
  • the ratio a/b of the front and rear diameter a to the left and right diameter b ranges from 1.4 to 1.8.
  • the ratio a/b of the front and rear diameter a to the left and right diameter b shows a linear decreasing trend as the left and right diameter b increases, and the front and rear diameter a and the left and right diameter b
  • the tibial tray prosthesis has a first side surface and a second side surface that are opposed to each other, the second side surface is a straight surface, and the point of the first side surface farthest from the second side surface to the front end
  • the vertical distance of the tangent line is recorded as the second distance c.
  • the ratio c/a of the second distance c to the front and rear diameter a ranges from 0.45 to 0.6.
  • the first side surface includes a front edge curved surface and a rear edge curved surface, and the ratio r1/a of the radius of curvature r1 of the front edge curved surface to the front and rear diameter a ranges from 0.35 to 0.65;
  • the ratio r2/a of the radius of curvature r2 of the edge curved surface to the front and rear diameter a ranges from 0.4 to 0.6.
  • the first side surface further includes a straight face section, two ends of the straight face section are respectively connected to the front edge curved surface and the rear edge curved surface, and the length e of the straight face section is equal to the front and rear diameters.
  • the range of a ratio e/a is 0.09-0.12.
  • the “straight face” or “straight line” mentioned in this application is not a straight face or a straight line in the mathematical sense, but a straight face or a straight line in the engineering sense that meets certain error requirements.
  • the above scheme sets the ratio A/B of the anteroposterior diameter A to the left and right diameter B of the tibial tray prosthesis to decrease with the increase of the left and right diameters B, which can make the tibial tray prosthesis closer to the inner tibia of the human knee joint.
  • the anatomical shape improves the coverage of the tibial prosthesis and reduces the probability of loosening of the prosthesis and postoperative pain.
  • Fig. 1 is a schematic structural diagram of a tibial tray prosthesis according to an embodiment.
  • Fig. 2 is an example table of the anteroposterior diameter A, the left-right diameter B and the ratio A/B of the tibial tray prosthesis shown in Fig. 1.
  • Fig. 3 is a schematic structural diagram of a tibial tray prosthesis according to another embodiment.
  • Fig. 4 is an example table of the anteroposterior diameter a, the left-right diameter b and the ratio a/b of the tibial tray prosthesis shown in Fig. 3.
  • Fig. 5 is a schematic diagram of the installation of the tibial tray prosthesis according to an embodiment.
  • Sagittal plane refers to the first longitudinal section that divides the human body or prosthesis into left and right parts from the front to back direction.
  • the sagittal plane passing through the center of the human body or prosthesis is the median sagittal plane, which The human body or prosthesis is divided into two equal parts.
  • Coronal plane refers to the second longitudinal section that divides the human body or prosthesis into front and rear parts from the left and right directions, and the second longitudinal section is perpendicular to the sagittal plane.
  • Cross section also called horizontal plane, which is a plane that divides the human body or prosthesis into upper and lower parts parallel to the ground plane. This plane is perpendicular to the coronal and sagittal planes.
  • Lateral side The side relatively far away from the mid-sagittal plane of the human body.
  • Anterior side The side relatively close to the abdomen of the human body on the sagittal plane.
  • Posterior side The side relatively close to the back of the human body in the sagittal plane.
  • FIG. 1 shows a top view of a tibial tray prosthesis 100 in an embodiment of the present application.
  • the tibial tray prosthesis 100 is used to replace the medial compartment of the tibia of the left knee. It is worth noting that the mirror image of the tibial tray prosthesis 100 can be used to replace the medial tibial compartment of the right knee joint.
  • the tibial tray prosthesis 100 includes a front end 101 and a back end 102 opposed to each other. From the perspective of its implantation in the human body, the front end 101 is close to the abdomen of the human body, and the rear end 102 is close to the back of the human body. Further, the tibial tray prosthesis 100 further includes a first side surface and a second side surface 14 which are arranged oppositely. From the perspective of its implantation in the human body, the first side surface is close to the median sagittal plane of the human body, which is the inner edge of the tibial tray prosthesis 100, and the second side 14 is away from the median sagittal plane of the human body, and is the outer edge of the tibial tray prosthesis 100 .
  • the first side surface of the tibial tray prosthesis 100 is a curved surface that protrudes away from the second side surface 14, and the second side surface 14 of the tibial tray prosthesis 100 is a straight surface. Therefore, the first side surface of the tibial tray prosthesis 100 has a point farthest from the second side surface 14, and the vertical distance from this point to the second side surface 14 is the left and right diameter B of the tibial tray prosthesis 100.
  • the maximum length of the tibial tray prosthesis 100 is the anteroposterior diameter A of the tibial tray prosthesis 100.
  • a straight line perpendicular to the second side 14 is tangent to the contour of the front end 101 of the tibial tray prosthesis 100 (that is, the straight line is a tangent to the contour of the front end 101, and this tangent is referred to as the front end tangent hereinafter), and is perpendicular to the second
  • the straight line of the side 14 is tangent to the contour of the rear end 102 of the tibial tray prosthesis 100 (that is, the straight line is a tangent to the contour of the rear end 102, and this tangent is hereinafter referred to as the rear tangent), then the front tangent and the rear tangent are The vertical distance between the two is the anteroposterior diameter A of the tibial tray prosthesis 100.
  • Fig. 2 shows an example table of the anterior-posterior diameter A, the left-right diameter B and the ratio A/B of the tibial tray prosthesis 100 whose sizes vary from small to large.
  • the ratio A/B of the anteroposterior diameter A to the left and right diameter B of the tibial tray prosthesis 100 ranges from 1.6 to 2.0.
  • the anteroposterior diameter A of the tibial tray prosthesis 100 increases with the increase of the left and right diameter B, and the ratio A/B of the anteroposterior diameter A to the left and right diameter B of the tibial tray prosthesis 100 increases with the increase of the left and right diameter B. Decreasing trend.
  • the anteroposterior diameter A of the smallest tibial tray prosthesis 100 has a value of 37.1mm
  • the left and right diameter B has a value of 19mm
  • A/B is 1.95
  • the largest tibial tray prosthesis 100 has The value of the front and rear diameter A is 57.5 mm
  • the value of the left and right diameter B is 35.5 mm
  • the value of A/B is 1.62.
  • the inventors studied the anatomical data of the human knee joint and performed statistical analysis of the anatomical data, and were annoyed to find the bony surface of the internal and external condyles of the tibia.
  • the rate ie, the ratio of the anteroposterior diameter to the left and right diameter of the tibia
  • the rate is inversely related to the size of the tibia. Therefore, by setting the ratio A/B of the anteroposterior diameter A to the left-right diameter B of the tibial tray prosthesis 100 to show a decreasing trend as the left-right diameter B increases, the shape of the tibial tray prosthesis 100 can be made closer to the human knee.
  • the anatomical shape of the inner tibia of the joint can increase the coverage of the tibial prosthesis and reduce the probability of prosthesis loosening and postoperative pain.
  • the vertical distance from the point farthest from the second side 14 on the first side surface of the tibial tray prosthesis 100 (hereinafter referred to as the farthest point) to the front end tangent of the tibial tray prosthesis 100 is recorded as the first A distance C, and the range of the ratio C/A of the first distance C to the front and rear diameter A is 0.45-0.75, preferably 0.55-0.62.
  • the inventor found that the position of the farthest point of the medial femoral condyle and the lateral condyle of the human knee joint is not the same, the farthest point of the medial condyle Closer to the posterior end of the medial condyle, the farthest point of the lateral condyle is closer to the middle of the medial condyle.
  • the traditional tibial prosthesis design rarely takes into account the above-mentioned anatomical differences in the shape of the inner and outer sides of the tibia.
  • the shape of the tibial tray prosthesis 100 can be made closer to the inner tibia of the human knee joint.
  • the anatomical shape improves the coverage of the tibial prosthesis and reduces the probability of loosening of the prosthesis and postoperative pain.
  • the first side surface includes a front edge curved surface 10, a straight surface section 11, and a rear edge curved surface 12 that are sequentially connected, and the radius of curvature R1 of the front edge curved surface 10 is equal to
  • the ratio R1/A of the front and rear diameter A is in the range of 0.45-0.7, preferably 0.55-0.63
  • the ratio R2/A of the radius of curvature R2 of the trailing edge curved surface 12 to the front and rear diameter A is in the range of 0.25-0.45, preferably 0.28-0.36.
  • the range of the ratio E/A of the length E of the straight section 11 to the front and rear diameter A is 0.07-0.12.
  • the length E of the straight section 11 refers to the length of the line segment formed after the straight section 11 intersects the horizontal plane.
  • the ratio of the curvature radius R1 of the front edge curved surface 10 of the tibial tray prosthesis 100 to the anteroposterior diameter A and the radius of curvature R2 of the trailing edge curved surface 12 The ratio relationship with the anteroposterior diameter A can make the shape of the tibial tray prosthesis 100 closer to the anatomical shape of the inner tibia of the human knee joint, thereby increasing the coverage of the tibial prosthesis and reducing the prosthesis loosening and the probability of postoperative pain.
  • the tibial tray prosthesis 100 also includes a straight rear edge 13. Two ends of the rear edge straight surface 13 are respectively connected to the rear edge curved surface 12 and the second side surface 14.
  • the length D of the trailing edge straight surface 13 refers to the length of the line segment formed after the trailing edge straight surface 13 intersects the horizontal plane.
  • the second side surface 14 is a straight surface, and when the tibial tray prosthesis 100 is in the theoretical implant position, the second side surface 14 is perpendicular or approximately perpendicular to the transcondylar axis TEA of the knee joint.
  • FIG. 3 shows a top view of a tibial tray prosthesis 200 in another embodiment of the present application.
  • the tibial tray prosthesis 200 is used to replace the lateral compartment of the tibia of the left knee. It is worth noting that the mirror image of the tibial tray prosthesis 200 can be used to replace the lateral tibial compartment of the right knee joint.
  • the tibial tray prosthesis 200 has a front end and a rear end opposite to each other. From the perspective of its implantation in the human body, the front end is close to the abdomen of the human body, and the rear end is close to the back of the human body. Further, the tibial tray prosthesis 200 also includes a first side surface and a second side surface 24 that are arranged oppositely. From the perspective of its implantation in the human body, the first side is away from the median sagittal plane of the human body and is the outer edge of the tibial tray prosthesis 200, and the second side 24 is close to the median sagittal plane of the human body and is the central sagittal plane of the tibial tray prosthesis 200. Inside edge.
  • the first side surface of the tibial tray prosthesis 200 is a curved surface that protrudes away from the second side surface 24, and the second side surface 24 of the tibial tray prosthesis 200 is a straight surface, so the tibial tray prosthesis 200 has a first side surface The point farthest from the second side surface 24 and the vertical distance from the point to the second straight surface is the left and right diameter b of the tibial tray prosthesis 200.
  • the maximum length of the tibial tray prosthesis 200 is the anteroposterior diameter a of the tibial tray prosthesis 200.
  • a straight line perpendicular to the second side surface 24 is tangent to the front end contour of the tibial tray prosthesis 200 (that is, the straight line is a tangent to the front end contour, and the tangent is referred to as the front end tangent below), and a straight line perpendicular to the second side surface 24 is
  • the rear-end contour of the tibial tray prosthesis 200 is tangent (that is, the straight line is the tangent to the front-end contour, and the tangent is referred to as the rear-end tangent below), and the vertical distance between the front-end tangent line and the rear-end tangent line is the tibial tray prosthesis 200
  • the anteroposterior diameter a is assumed that a straight line perpendicular to the second side surface 24 is tangent to the front end contour of the
  • Fig. 4 shows an example table of the anteroposterior diameter a, the left and right diameter b, and the ratio a/b of the tibial tray prosthesis 200 whose sizes vary from small to large. Specifically, the ratio a/b of the anteroposterior diameter a to the left and right diameter b of the tibial tray prosthesis 200 ranges from 1.4 to 1.8.
  • the anteroposterior diameter a of the tibial tray prosthesis 200 increases with the increase of the left and right diameter b, and the ratio a/b of the anteroposterior diameter a to the left and right diameter b of the tibial tray prosthesis 200 increases with the increase of the left and right diameter b.
  • the anteroposterior diameter a of the smallest tibial tray prosthesis 100 has a value of 38.7mm
  • the left and right diameters b has a value of 22mm
  • a/b is 1.76.
  • the largest tibial tray prosthesis 100 has a The value of the front and rear diameter a is 54 mm
  • the value of the left and right diameter b is 37 mm
  • the value of a/b is 1.46.
  • the face ratio (that is, the ratio of the anteroposterior diameter to the left and right diameter of the tibia) is inversely related to the size of the tibia.
  • the shape of the tibial tray prosthesis 200 can be made closer to the human knee.
  • the anatomical shape of the inner tibia of the joint can increase the coverage of the tibial prosthesis and reduce the probability of prosthesis loosening and postoperative pain.
  • the vertical distance from the point on the first side surface of the tibial tray prosthesis 200 farthest from the second side surface 24 (hereinafter referred to as the farthest point) to the tangent to the front end of the tibial tray prosthesis 200 is recorded as the first distance c, and
  • the range of the ratio c/a of a distance c to the front-rear diameter a is 0.45-0.6, preferably 0.48-0.53.
  • the inventor found that the position of the farthest point of the medial femoral condyle and the lateral condyle of the human knee joint is not the same, and the farthest point of the medial condyle is closer The posterior end of the medial condyle, the farthest point of the lateral condyle is closer to the middle of the medial condyle.
  • the traditional tibial prosthesis design rarely takes into account the above-mentioned anatomical differences in the shape of the inner and outer sides of the tibia.
  • the range of the ratio c/a of the first distance c to the anteroposterior diameter a is set to 0.45-0.6, preferably 0.48-0.53, so that the tibial tray prosthesis 200 is closer to the anatomical shape of the outer tibia of the human knee joint.
  • the first side surface includes a front edge curved surface 20, a straight surface section 21, and a rear edge curved surface 22 that are connected in sequence, and the radius of curvature r1 of the front edge curved surface 20 and the anteroposterior diameter a
  • the ratio r1/a ranges from 0.35-0.65, preferably 0.38-0.51
  • the ratio r2/a of the radius of curvature r2 of the trailing edge curved surface 22 to the front and rear diameter a ranges from 0.4 to 0.6, preferably 0.45-0.55.
  • the range of the ratio e/a of the length e of the straight section 21 to the front and rear diameter a is 0.09-0.12.
  • the length e of the straight section 21 refers to the length of the line segment formed by the intersection of the straight section 21 and the horizontal plane.
  • the ratio of the radius of curvature r1 to the anteroposterior diameter a and the ratio of the radius of curvature r2 of the trailing edge curved surface 22 to the anteroposterior diameter a can make the shape of the tibial tray prosthesis 200 closer to the anatomical shape of the outer tibia of the human knee joint, thereby improving The coverage of tibial prosthesis reduces the probability of prosthesis loosening and postoperative pain.
  • the second side surface 24 and the transcondylar axis TEA of the knee joint form an angle ⁇ .
  • the angle ⁇ may range from 60° to 80°.
  • first and second are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of indicated technical features. Therefore, the features defined with “first” and “second” may explicitly or implicitly include at least one of the features. In the description of the present application, "a plurality of” means at least two, such as two, three, etc., unless specifically defined otherwise.
  • the terms “installed”, “connected”, “connected”, “fixed” and other terms should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection , Or integrated; it can be mechanically connected or electrically connected; it can be directly connected or indirectly connected through an intermediary, it can be the internal connection of two components or the interaction relationship between two components, unless otherwise specified The limit.
  • installed can be a fixed connection or a detachable connection , Or integrated; it can be mechanically connected or electrically connected; it can be directly connected or indirectly connected through an intermediary, it can be the internal connection of two components or the interaction relationship between two components, unless otherwise specified The limit.
  • the first feature “on” or “under” the second feature may be in direct contact with the first and second features, or the first and second features may be indirectly through an intermediary. touch.
  • the "above”, “above” and “above” of the first feature on the second feature may mean that the first feature is directly above or diagonally above the second feature, or it simply means that the level of the first feature is higher than that of the second feature.
  • the “below”, “below” and “below” of the second feature of the first feature may mean that the first feature is directly below or obliquely below the second feature, or it simply means that the level of the first feature is smaller than the second feature.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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  • Prostheses (AREA)

Abstract

一种胫骨托假体（100,200），具有前后径A以及左右径B，并且前后径A随左右径B的增大而呈增大趋势，前后径A与左右径B的比值A/B随左右径B的增大而呈递减趋势。可使得胫骨托假体的形状更接近人体膝关节的胫骨解剖形状，提高胫骨假体覆盖率，降低假体松动以及患者术后发生疼痛的概率。

Description

胫骨托假体
相关申请的交叉引用
本申请要求于2020年5月21日提交中国专利局、申请号为2020104363866的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域，特别是涉及胫骨托假体。
背景技术
单髁置换术采用微创伤切口、同时能保留患者膝关节的前、后交叉韧带，具有创伤小、恢复快、患者术后生理活动度好等优点，因此单髁置换术被广泛地运用于单间室的骨关节炎的治疗中。单髁置换术所采用的单髁假体可分为用于置换内侧间室的内侧股骨假体和内侧胫骨假体，以及用于置换外侧间室的外侧股骨假体和外侧胫骨假体。
假体松动、术后疼痛等是单髁膝关节置换的主要翻修原因，而假体覆盖不良是引起假体松动和术后疼痛的重要原因。假体覆盖不良是指假体不能充分覆盖皮质骨区域，使得假体得不到很好的支撑，容易导致术后假体下沉松动，假体外悬凸出，与周围软组织干涉，进而引起术后疼痛。
发明内容
根据本申请公开的各种示例性实施例，提供一种膝关节系统、胫骨假体以及胫骨托假体。
本申请的一方面提供一种胫骨托假体，所述胫骨托假体用于置换人体膝关节的胫骨内侧间室，所述胫骨托假体具有前后径A以及左右径B，并且所述前后径A随所述左右径B的增大而呈增大趋势，所述前后径A与所述左右径B的比值A/B随所述左右径B的增大而呈递减趋势。
上述方案通过将胫骨托假体的前后径A与左右径B的比值A/B设置为随左右径B的增大而呈递减趋势，可使得胫骨托假体能更接近人体膝关节胫骨内侧的解剖形状，从而提高胫骨假体的覆盖率，降低假体松动以及患者术后发生疼痛的概率。
在其中一个实施例中，所述前后径A与所述左右径B的比值A/B的范围为1.6-2.0。
在其中一个实施例中，所述前后径A与所述左右径B的比值A/B与所述左右径B满足A/B＝-k1×B+x，其中0.018＜k1＜0.020，2.17＜x＜2.47。
在其中一个实施例中，所述前后径A与所述左右径B的比值A/B在距A/B＝-0.019×B+2.32所表示的直线上下0.15的范围内。
在其中一个实施例中，所述前后径A与所述左右径B的比值A/B随所述左右径B的增大而呈线性递减趋势，并且所述前后径A与所述左右径B的比值A/B与所述左右径B的关系满足A/B＝-k1×B+x，其中0.018＜k1＜0.020，2.17＜x＜2.47。
在其中一个实施例中，所述胫骨托假体具有相对设置的第一侧面以及第二侧面，所述第二侧面为直面，所述第一侧面上距离所述第二侧面最远的点到前端切线的垂直距离记为第一距离C，所述第一距离C与所述前后径A的比值C/A的范围为0.45-0.75，所述前端切线是指垂直于所述第二侧面且与所述胫骨托假体前端轮廓相切的直线。
在其中一个实施例中，所述第一侧面包括前缘曲面以及后缘曲面，所述前缘曲面的曲率半径R1与所述前后径A的比值R1/A范围为0.45-0.7；所述后缘曲面的曲率半径R2与所述前后径A的比值R2/A范围为0.25-0.45。
在其中一个实施例中，所述第一侧面还包括直面段，所述直面段的两端分别连接所述前缘曲面以及所述后缘曲面，所述直面段的长度E与所述前后径A的比值E/A的范围为0.07-0.12。
在其中一个实施例中，所述胫骨托假体还包括后缘直面，所述后缘直面的两端分别连接所述后缘曲面以及所述第二侧面，所述后缘直面的长度D＝B-R2。
在其中一个实施例中，所述第二侧面为直面，并且所述胫骨托假体在理论植入位置时，所述第一侧面与膝关节的通髁轴相垂直。
本申请的另一方面提供一种胫骨托假体，所述胫骨托假体用于置换人体膝关节的胫骨外侧间室，所述胫骨托假体具有前后径a以及左右径b，并且所述前后径a随所述左右径b的增大而呈增大趋势，所述前后径a与所述左右径b的比值a/b随所述左右径b的增大而呈递减趋势。
在其中一个实施例中，所述前后径a与所述左右径b的比值a/b的范围为1.4-1.8。
在其中一个实施例中，所述前后径a与所述左右径b的比值a/b与所述左右径b的关系满足a/b＝-k2×b+y，其中0.019＜k2＜0.021，2.04＜y＜2.34。
在其中一个实施例中，所述前后径a与所述左右径b的比值a/b在距a/b＝-0.02×b+2.19所表示的直线上下0.15的范围内。
在其中一个实施例中，所述前后径a与所述左右径b的比值a/b随所述左右径b的增大而 呈线性递减趋势，并且所述前后径a与所述左右径b的比值a/b与所述左右径b的关系满足a/b＝-k2×b+y，其中0.019＜k2＜0.021，2.04＜y＜2.34。
在其中一个实施例中，所述胫骨托假体具有相对设置的第一侧面以及第二侧面，所述第二侧面为直面，所述第一侧面距离所述第二侧面最远的点到前端切线的垂直距离记为第二距离c，所述第二距离c与所述前后径a的比值c/a的范围为0.45-0.6，所述前端切线是指垂直于所述第二侧面且与所述胫骨托假体前端轮廓相切的直线。
在其中一个实施例中，所述第一侧面包括前缘曲面以及后缘曲面，所述前缘曲面的曲率半径r1与所述前后径a的比值r1/a范围为0.35-0.65；所述后缘曲面的曲率半径r2与所述前后径a的比值r2/a范围为0.4-0.6。
在其中一个实施例中，所述第一侧面还包括直面段，所述直面段的两端分别连接所述前缘曲面以及所述后缘曲面，所述直面段的长度e与所述前后径a的比值e/a的范围为0.09-0.12。
本申请所述的“直面”或“直线”并非数学意义上的直面或直线，而是指工程意义上的满足一定误差要求的直面或直线。
上述方案通过将胫骨托假体的前后径A与左右径B的比值A/B设置为随左右径B的增大而呈递减趋势，可使得胫骨托假体能更接近人体膝关节胫骨内侧的解剖形状，从而提高胫骨假体的覆盖率，降低假体松动以及患者术后发生疼痛的概率。
附图说明
构成本申请的一部分的附图用来提供对本申请的进一步理解，本申请的示意性实施例及其说明用于解释本申请，并不构成对本申请的不当限定。
为了更清楚地说明本申请实施例中的技术方案，下面将对实施例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的附图。
图1为根据一实施例的胫骨托假体的结构示意图。
图2为图1中所示的胫骨托假体的前后径A、左右径B及其比值A/B的示例表。
图3为根据另一实施例的胫骨托假体的结构示意图。
图4为图3中所示的胫骨托假体的前后径a、左右径b及其比值a/b的示例表。
图5为根据一实施例的胫骨托假体的安装示意图。
具体实施方式
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。
为了更好地阐述本申请的技术方案，首先对各实施例中涉及的方位名称进行解释：
矢状面：指从前后方向，将人体或假体分成左、右两部分的第一纵切面，其中，经过人体或假体正中的矢状面为正中矢状面，该正中矢状面将人体或假体分成左右相等的两部分。
冠状面：指从左右方向，将人体或假体分为前后两部分的第二纵切面，该第二纵切面与矢状面垂直。
横断面：也称水平面，是与地平面平行地将人体或假体分为上、下两部分的平面，该平面与冠状面和矢状面相互垂直。
内侧：相对接近人体的正中矢状面的一侧。
外侧：相对远离人体的正中矢状面的一侧。
前侧：矢状面上相对接近人体的腹部的一侧。
后侧：矢状面上相对接近人体的背部的一侧。
参阅图1，图1示出了本申请一实施例中的胫骨托假体100的俯视图。具体地，如图5所示，胫骨托假体100用于置换左侧膝胫骨的内侧间室。值得说明的是，胫骨托假体100的镜像即可用于置换右侧膝关节的胫骨内侧间室。
胫骨托假体100包括相对的前端101和后端102。以其植入人体的方位来看，前端101靠近人体的腹部，后端102靠近人体的背部。进一步地，胫骨托假体100还包括相对设置的第一侧面以及第二侧面14。以其植入人体的方位来看，第一侧面靠近人体正中矢状面，为胫骨托假体100的内侧边缘，第二侧面14远离人体正中矢状面，为胫骨托假体100的外侧边缘。进一步地，胫骨托假体100的第一侧面为朝远离第二侧面14方向凸出的曲面，胫骨托假体100的第二侧面14为直面。因此，胫骨托假体100的第一侧面上具有离第二侧面14最远的点，该点到第二侧面14的垂直距离即为胫骨托假体100的左右径B。
在第二侧面14的延伸方向上，胫骨托假体100的最大长度即为胫骨托假体100的前后径A。换言之，假设垂直于第二侧面14的直线与胫骨托假体100前端101的轮廓相切(即，该直线为前端101的轮廓的切线，以下将该切线称为前端切线)，垂直于第二侧面14的直线与胫 骨托假体100后端102的轮廓相切(即，该直线为后端102的轮廓的切线，以下将该切线称为后端切线)，则前端切线与后端切线之间的垂直距离即为胫骨托假体100的前后径A。
进一步地，参见图2，图2示出了一组尺寸由小到大变化的胫骨托假体100的前后径A、左右径B以及其比值A/B的示例表。具体地，胫骨托假体100前后径A与左右径B的比值A/B的范围为1.6-2.0。胫骨托假体100的前后径A随左右径B的增大而呈增大趋势，而胫骨托假体100的前后径A与左右径B的比值A/B随左右径B的增大而呈递减趋势。例如，如图2中所示的，最小号的胫骨托假体100的前后径A的数值为37.1mm，左右径B的值19mm，A/B为1.95；最大号的胫骨托假体100的前后径A的值为57.5mm，左右径B的值为35.5mm，A/B的值为1.62。
针对传统的径骨托假体具有覆盖率不足，容易松动等缺点，发明人经过对人体膝关节的解剖数据进行研究并对解剖数据进行统计分析后，惊讶地发现胫骨内、外侧髁的骨面率(即，胫骨的前后径与左右径的比值)跟胫骨的大小成反相关关系。因此，通过将胫骨托假体100的前后径A与左右径B的比值A/B设置为随左右径B的增大而呈递减趋势，可使得胫骨托假体100的形状能更接近人体膝关节的胫骨内侧的解剖形状，从而可提高胫骨假体的覆盖率，降低假体松动以及患者术后发生疼痛的概率。
进一步地，所述前后径A与所述左右径B的比值A/B与所述左右径B的关系满足A/B＝-k1×B+x，其中0.018＜k1＜0.020，2.17＜x＜2.47。在一实施例中，k1＝0.019，x＝2.32。或者，A/B的值在距A/B＝-0.019×B+2.32所表示的直线上下0.15的范围内。即，对于选定的B，A/B的值在(-0.019×B+2.32)±0.15的范围内。进一步地，在更理想的情况下，所述前后径A与所述左右径B的比值A/B随所述左右径B的增大而呈线性递减趋势，并且所述前后径A与所述左右径B的比值A/B与所述左右径B的关系满足A/B＝-k1×B+x，其中0.018＜k1＜0.020，2.17＜x＜2.47。在一实施例中，k1＝0.019，x＝2.32。可理解地，考虑到产品在制造过程中都会存在制造误差，在误差允许范围内，例如前后径A与所述左右径B的比值A/B的偏差为±0.01时，依旧可看作符合上述关系。
进一步地，胫骨托假体100的所述第一侧面上距离所述第二侧面14最远的点(下文称最远点)到所述胫骨托假体100的前端切线的垂直距离记为第一距离C，并且第一距离C与前后径A的比值C/A的范围为0.45-0.75，优选0.55-0.62。发明人经过对人体膝关节的解剖数据进行研究并对解剖数据的进行统计分析之后，发现人体膝关节股骨内侧髁与外侧髁的所述最远点的位置并不相同，内侧髁的最远点更接近内侧髁的后端，外侧髁的最远点更接近内侧髁的中间。 然而，传统的胫骨假体设计很少考虑到上述胫骨内外侧形状的解剖差异。因此，本申请通过将第一距离C与前后径的比值C/A的范围设置为0.45-0.75，优选为0.53-0.63，可使得胫骨托假体100的形状更接近人体膝关节的胫骨内侧的解剖形状，从而提高胫骨假体的覆盖率，降低假体松动以及患者术后发生疼痛的概率。
进一步地，沿胫骨托假体100的前端101到后端102的方向，第一侧面包括依次连接的前缘曲面10、直面段11以及后缘曲面12，并且前缘曲面10的曲率半径R1与前后径A的比值R1/A范围为0.45-0.7，优选0.55-0.63，后缘曲面12的曲率半径R2与前后径A的比值R2/A范围为0.25-0.45，优选0.28-0.36。直面段11的长度E与前后径A的比值E/A的范围为0.07-0.12。此处直面段11的长度E指的是直面段11与水平面相交后所形成的线段的长度。发明人经过对人体膝关节的解剖数据进行研究并对解剖数据的进行统计分析，发现人体膝关节的股骨内侧髁为非对称的“D”型结构，即人体膝关节的股骨内侧髁的前缘曲面10的曲率半径较大，后缘曲面12的曲率半径较小，通过设计胫骨托假体100的前缘曲面10的曲率半径R1与前后径A的比值关系以及后缘曲面12的曲率半径R2与前后径A的比值关系可使得胫骨托假体100的形状更接近人体膝关节的胫骨内侧的解剖形状，从而提高胫骨假体的覆盖率，降低假体松动以及患者术后发生疼痛的概率。
进一步地，胫骨托假体100还包括后缘直面13。后缘直面13的两端分别连接后缘曲面12以及第二侧面14。后缘直面13的长度D等于左右径B与后缘曲面12的曲率半径R2的差值，即D＝B-R2。此处，后缘直面13的长度D指的是后缘直面13与水平面相交后所形成的线段的长度。
进一步地，第二侧面14为直面，并且所述胫骨托假体100在理论植入位置时，所述第二侧面14与膝关节的通髁轴TEA相垂直或近似垂直。
进一步地，本申请还提供另一实施例的胫骨托假体200。参阅图3，图3示出了本申请的另一实施例中的胫骨托假体200的俯视图。具体地，如图5中所示，胫骨托假体200用于置换左侧膝胫骨的外侧间室。值得说明的是，胫骨托假体200的镜像可用于置换右侧膝关节的胫骨外侧间室。
胫骨托假体200具有相对的前端和后端，以其植入人体的方位来看，前端靠近人体的腹部，后端靠近人体的背部。进一步地，胫骨托假体200的还包括相对设置的第一侧面以及第二侧面24。以其植入人体的方位来看，第一侧面远离人体的正中矢状面，为胫骨托假体200的外侧边缘，第二侧面24靠近人体的正中矢状面，为胫骨托假体200的内侧边缘。进一步地，胫骨托 假体200的第一侧面为朝远离第二侧面24方向凸出的曲面，胫骨托假体200的第二侧面24为直面，因此胫骨托假体200的第一侧面上具有离第二侧面24最远的点，该点到第二直面的垂直距离即为胫骨托假体200的左右径b。
在第二侧面24的延伸方向上，胫骨托假体200的最大长度即为胫骨托假体200的前后径a。换言之，假设垂直于第二侧面24的直线与胫骨托假体200前端轮廓相切(即，该直线为前端轮廓的切线，以下该切线称为前端切线)，垂直于第二侧面24的直线与胫骨托假体200后端轮廓相切(即，该直线为前端轮廓的切线，以下该切线称为后端切线)，则前端切线与后端切线之间的垂直距离即为胫骨托假体200的前后径a。
进一步地，参见图4，图4示出了一组尺寸由小到大变化的胫骨托假体200的前后径a、左右径b以及其比值a/b的示例表。具体地，胫骨托假体200前后径a与左右径b的比值a/b的范围为1.4-1.8。胫骨托假体200的前后径a随左右径b的增大而呈增大趋势，而胫骨托假体200的前后径a与左右径b的比值a/b随左右径b的增大而呈递减趋势。例如，如图4中所示的，最小号的胫骨托假体100的前后径a的数值为38.7mm，左右径b的值22mm，a/b为1.76，最大号的胫骨托假体100的前后径a的值为54mm，左右径b的值为37mm，a/b的值为1.46。
针对传统的径骨托假体的覆盖率不足，容易松动等缺点，发明人经过对人体膝关节的解剖数据进行研究并对解剖数据的进行统计分析之后，惊讶地发现胫骨内、外侧髁的骨面率(即，胫骨的前后径与左右径的比值)跟胫骨的大小成反相关关系。因此，通过将胫骨托假体200的前后径a与左右径b的比值a/b设置为随左右径b的增大而呈递减趋势，可使得胫骨托假体200的形状能更接近人体膝关节的胫骨内侧的解剖形状，从而可提高胫骨假体的覆盖率，降低假体松动以及患者术后发生疼痛的概率。
进一步地，所述前后径a与所述左右径b的比值a/b与所述左右径b的关系满足a/b＝-k2×b+y，其中0.019＜k2＜0.021，2.04＜y＜2.34。在一实施例中，k1＝0.020，y＝2.19。或者，a/b的值在距a/b＝-0.02×b+2.19所表示的直线上下0.15的范围内。即，对于选定的b，a/b的值在(-0.02×b+2.19)±0.15的范围内。进一步地，在更理想的情况下，所述前后径a与所述左右径b的比值a/b随所述左右径b的增大而呈线性递减趋势，并且所述前后径a与所述左右径b的比值a/b与所述左右径b的关系满足a/b＝-k2×b+y，其中0.019＜k2＜0.021，2.04＜y＜2.34。在一实施例中，k1＝0.020，y＝2.19。可理解地，考虑到产品在制造过程中都会存在制造误差，在误差允许范围内，例如前后径a与所述左右径b的比值a/b的偏差为±0.01时，依旧可看作符合上述关系。
进一步地，胫骨托假体200的第一侧面上距离第二侧面24最远的点(下文称最远点)到胫骨托假体200的前端切线的垂直距离记为第一距离c，并且第一距离c与前后径a的比值c/a的范围为0.45-0.6，优选为0.48-0.53。发明人经过对人体膝关节的解剖数据进行研究并对解剖数据的进行统计分析之后，发现人体膝关节股骨内侧髁与外侧髁的最远点的位置并不相同，内侧髁的最远点更接近内侧髁的后端，外侧髁的最远点更接近内侧髁的中间。然而，传统的胫骨假体设计很少考虑到上述胫骨内外侧形状的解剖差异。因此，本申请通过将第一距离c与前后径a的比值c/a的范围设置为0.45-0.6，优选为0.48-0.53，使得胫骨托假体200更接近人体膝关节胫骨外侧的解剖形状，从而提高胫骨假体的覆盖率，降低假体松动以及患者术后发生疼痛的概率。
进一步地，沿胫骨托假体200的前端到后端方向，第一侧面包括依次连接的前缘曲面20、直面段21以及后缘曲面22，并且前缘曲面20的曲率半径r1与前后径a的比值r1/a范围为0.35-0.65，优选为0.38-0.51，后缘曲面22的曲率半径r2与前后径a的比值r2/a范围为0.4-0.6，优选为0.45-0.55。直面段21的长度e与前后径a的比值e/a的范围为0.09-0.12。此处，直面段21的长度e指的是直面段21与水平面相交所形成的线段的长度。发明人经过对人体膝关节的解剖数据进行研究并对解剖数据的进行统计分析之后，发现人体膝关节股骨外侧髁为近似对称的半圆形结构，通过设计胫骨托假体200的前缘曲面20的曲率半径r1与前后径a的比值关系以及后缘曲面22的曲率半径r2与前后径a的比值关系可使得胫骨托假体200的形状更接近人体膝关节的胫骨外侧的解剖形状，从而提高胫骨假体的覆盖率，降低假体松动以及患者术后发生疼痛的概率。
进一步的，如图3所示，胫骨托假体200在理论植入位置时，第二侧面24与膝关节的通髁轴TEA呈一夹角β。夹角β的范围可以为60°-80°。
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。
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。
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。
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。
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。
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。
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。

Claims (17)

  1. 一种胫骨托假体，其特征在于，所述胫骨托假体用于置换人体膝关节的胫骨内侧间室，所述胫骨托假体具有前后径A以及左右径B，并且所述前后径A随所述左右径B的增大而呈增大趋势，所述前后径A与所述左右径B的比值A/B随所述左右径B的增大而呈递减趋势。
  2. 根据权利要求1所述的胫骨托假体，其特征在于，所述前后径A与所述左右径B的比值A/B的范围为1.6-2.0。
  3. 根据权利要求1所述的胫骨托假体，其特征在于，所述前后径A与所述左右径B的比值A/B与所述左右径B满足A/B＝-k1×B+x，其中0.018＜k1＜0.020，2.17＜x＜2.47。
  4. 根据权利要求1所述的胫骨托假体，其特征在于，所述前后径A与所述左右径B的比值A/B在距A/B＝-0.019×B+2.32所表示的直线上下0.15的范围内。
  5. 根据权利要求1所述的胫骨托假体，其特征在于，所述前后径A与所述左右径B的比值A/B随所述左右径B的增大而呈线性递减趋势，并且所述前后径A与所述左右径B的比值A/B与所述左右径B的关系满足A/B＝-k1×B+x，其中0.018＜k1＜0.020，2.17＜x＜2.47。
  6. 根据权利要求1所述的胫骨托假体，其特征在于，所述胫骨托假体具有相对设置的第一侧面以及第二侧面，所述第二侧面为直面，所述第一侧面上距离所述第二侧面最远的点到前端切线的垂直距离记为第一距离C，所述第一距离C与所述前后径A的比值C/A的范围为0.45-0.75，所述前端切线是指垂直于所述第二侧面且与所述胫骨托假体前端轮廓相切的直线。
  7. 根据权利要求6所述的胫骨托假体，其特征在于，所述第一侧面包括前缘曲面以及后缘曲面，所述前缘曲面的曲率半径R1与所述前后径A的比值R1/A范围为0.45-0.7；所述后缘曲面的曲率半径R2与所述前后径A的比值R2/A范围为0.25-0.45。
  8. 根据权利要求7所述的胫骨托假体，其特征在于，所述第一侧面还包括直面段，所述直面段的两端分别连接所述前缘曲面以及所述后缘曲面，所述直面段的长度E与所述前后径A的比值E/A的范围为0.07-0.12。
  9. 根据权利要求7所述的胫骨托假体，其特征在于，所述胫骨托假体还包括后缘直面，所述后缘直面的两端分别连接所述后缘曲面以及所述第二侧面，所述后缘直面的长度D＝B-R2。
  10. 一种胫骨托假体，其特征在于，所述胫骨托假体用于置换人体膝关节的胫骨外侧间室，所述胫骨托假体具有前后径a以及左右径b，并且所述前后径a随所述左右径b的增大而呈增大趋势，所述前后径a与所述左右径b的比值a/b随所述左右径b的增大而呈递减趋势。
  11. 根据权利要求10所述的胫骨托假体，其特征在于，所述前后径a与所述左右径b的 比值a/b的范围为1.4-1.8。
  12. 根据权利要求10所述的胫骨托假体，其特征在于，所述前后径a与所述左右径b的比值a/b与所述左右径b的关系满足a/b＝-k2×b+y，其中0.019＜k2＜0.021，2.04＜y＜2.34。
  13. 根据权利要求10所述的胫骨托假体，其特征在于，所述前后径a与所述左右径b的比值a/b在距a/b＝-0.02×b+2.19所表示的直线上下0.15的范围内。
  14. 根据权利要求10所述的胫骨托假体，其特征在于，所述前后径a与所述左右径b的比值a/b随所述左右径b的增大而呈线性递减趋势，并且所述前后径a与所述左右径b的比值a/b与所述左右径b的关系满足a/b＝-k2×b+y，其中0.019＜k2＜0.021，2.04＜y＜2.34。
  15. 根据权利要求10所述的胫骨托假体，其特征在于，所述胫骨托假体具有相对设置的第一侧面以及第二侧面，所述第二侧面为直面，所述第一侧面距离所述第二侧面最远的点到前端切线的垂直距离记为第二距离c，所述第二距离c与所述前后径a的比值c/a的范围为0.45-0.6，所述前端切线是指垂直于所述第二侧面且与所述胫骨托假体前端轮廓相切的直线。
  16. 根据权利要求15所述的胫骨托假体，其特征在于，所述第一侧面包括前缘曲面以及后缘曲面，所述前缘曲面的曲率半径r1与所述前后径a的比值r1/a范围为0.35-0.65；所述后缘曲面的曲率半径r2与所述前后径a的比值r2/a范围为0.4-0.6。
  17. 根据权利要求16所述的胫骨托假体，其特征在于，所述第一侧面还包括直面段，所述直面段的两端分别连接所述前缘曲面以及所述后缘曲面，所述直面段的长度e与所述前后径a的比值e/a的范围为0.09-0.12。
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