CN111467091A - Tibial tray prosthesis - Google Patents
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- CN111467091A CN111467091A CN202010436386.6A CN202010436386A CN111467091A CN 111467091 A CN111467091 A CN 111467091A CN 202010436386 A CN202010436386 A CN 202010436386A CN 111467091 A CN111467091 A CN 111467091A
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- 210000000629 knee joint Anatomy 0.000 claims abstract description 29
- 230000003247 decreasing effect Effects 0.000 claims abstract description 15
- 230000007423 decrease Effects 0.000 claims 2
- 210000002303 tibia Anatomy 0.000 abstract description 17
- 208000004550 Postoperative Pain Diseases 0.000 abstract description 13
- 208000037099 Prosthesis Failure Diseases 0.000 abstract description 11
- 238000012827 research and development Methods 0.000 description 6
- 210000000988 bone and bone Anatomy 0.000 description 5
- 238000002513 implantation Methods 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 4
- 238000007619 statistical method Methods 0.000 description 4
- 210000001015 abdomen Anatomy 0.000 description 3
- 238000011160 research Methods 0.000 description 3
- 238000001356 surgical procedure Methods 0.000 description 3
- 210000000838 condylus lateralis tibialis Anatomy 0.000 description 2
- 230000002596 correlated effect Effects 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 210000003127 knee Anatomy 0.000 description 2
- 230000002980 postoperative effect Effects 0.000 description 2
- 210000000689 upper leg Anatomy 0.000 description 2
- 210000001264 anterior cruciate ligament Anatomy 0.000 description 1
- 230000001054 cortical effect Effects 0.000 description 1
- 230000014509 gene expression Effects 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 230000002452 interceptive effect Effects 0.000 description 1
- 238000013150 knee replacement Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 201000008482 osteoarthritis Diseases 0.000 description 1
- 230000001766 physiological effect Effects 0.000 description 1
- 210000002967 posterior cruciate ligament Anatomy 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
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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
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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
- A61F2/28—Bones
- A61F2002/2892—Tibia
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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
- 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
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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)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
本发明涉及一种胫骨托假体,其特征在于,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。上述胫骨托假体能更接近人体膝关节胫骨的解剖形状,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。
The present invention relates to a tibial tray prosthesis, which is characterized in that the tibial tray prosthesis has an anterior-posterior diameter A and a left-right diameter B, and the anterior-posterior diameter A increases as the left-right diameter B increases, The ratio A/B of the front-rear diameter A to the left-right diameter B shows a decreasing trend as the left-right diameter B increases. The tibial tray prosthesis can be closer to the anatomical shape of the human knee joint tibia, thereby improving the coverage of the tibial prosthesis and reducing the prosthesis loosening and the probability of postoperative pain of the patient.
Description
技术领域technical field
本发明涉及医疗器械技术领域,特别是涉及胫骨托假体。The invention relates to the technical field of medical devices, in particular to a tibial tray prosthesis.
背景技术Background technique
单髁置换术采用微创伤切口、同时能保留患者膝关节前后交叉韧带,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。Unicondylar replacement surgery uses a micro-traumatic incision and can preserve the anterior and posterior cruciate ligaments of the knee joint. It has the advantages of less trauma, quick recovery, and good postoperative physiological activity. Therefore, unicondylar replacement surgery is widely used in single-compartment. in the treatment of osteoarthritis. Unicondylar prostheses used in unicondylar replacement can be divided into medial femoral prosthesis and medial tibial prosthesis for replacing the medial compartment, and lateral femoral prosthesis and lateral tibial prosthesis for replacing the lateral compartment.
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,假体覆盖不良即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。Prosthesis loosening and postoperative pain are the main reasons for revision of unicondylar knee replacement, and poor prosthesis coverage is an important cause of prosthesis loosening and postoperative pain. Poor prosthesis coverage means that the prosthesis cannot adequately cover the cortical bone area. , so that the prosthesis cannot be well supported, which may easily lead to the subsidence and loosening of the prosthesis after surgery, the prosthesis overhanging and interfering with the surrounding soft tissue, thereby causing postoperative pain.
发明内容SUMMARY OF THE INVENTION
基于此,有必要针对如何提高胫骨假体覆盖率、降低假体术后松动和术后发生疼痛概率问题,提供一种膝关节系统、胫骨假体以及胫骨托假体。Based on this, it is necessary to provide a knee joint system, a tibial prosthesis and a tibial tray prosthesis in order to improve the coverage of the tibial prosthesis, reduce the postoperative loosening of the prosthesis and the probability of postoperative pain.
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。A tibial tray prosthesis, the tibial tray prosthesis is used to replace the medial compartment of the tibia of a human knee joint, the tibial tray prosthesis has an anterior-posterior diameter A and a left-right diameter B, and the anterior-posterior diameter A follows the left-right diameter A. As the diameter B increases, the ratio A/B of the front-rear diameter A to the left-right diameter B presents a decreasing trend.
上述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,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。By setting the ratio A/B of the anteroposterior diameter A and the left and right diameter B of the tibial tray prosthesis to a decreasing trend with the increase of the left and right diameter B, the tibial tray prosthesis can be closer to the anatomical shape of the inner side of the tibia of the human knee joint. , thereby improving the coverage of the tibial prosthesis, reducing the probability of prosthesis loosening and postoperative pain.
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。In one embodiment, the ratio A/B of the front-rear diameter A to the left-right diameter B ranges from 1.6 to 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。In one embodiment, the ratio A/B of the front-rear diameter A to the left-right diameter B and the left-right diameter B satisfy A/B=-k1×B+x, where 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A/B=-0.019×B+2.32所表示的直线上下0.15的范围内。In one embodiment, the ratio A/B of the front-rear diameter A to the left-right diameter B is within a range of 0.15 above and below the straight line represented by A/B=-0.019×B+2.32.
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。In one embodiment, the ratio A/B of the front-rear diameter A to the left-right diameter B presents a linear decreasing trend with the increase of the left-right diameter B, and the front-rear diameter A and the left-right diameter B The relationship between the ratio A/B of , and the left and right diameter B satisfies A/B=-k1×B+x, where 0.018<k1<0.020 and 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。In one embodiment, the tibial tray prosthesis has a first side surface and a second side surface disposed 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 tangent line is denoted as the first distance C, the ratio C/A of the first distance C to the front and rear diameter A is in the range of 0.45-0.75, and the front tangent line is perpendicular to the second side and A line tangent to the contour of the front end of the tibial tray prosthesis.
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。In one embodiment, the first side surface includes a leading edge curved surface and a trailing edge curved surface, and the ratio R1/A of the curvature radius R1 of the leading edge curved surface to the front and rear diameter A ranges from 0.45 to 0.7; The ratio R2/A of the curvature radius R2 of the edge curved surface to the front and rear diameters A ranges from 0.25 to 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。In one embodiment, the first side surface further includes a straight surface segment, two ends of the straight surface segment are respectively connected to the leading edge curved surface and the trailing edge curved surface, and the length E of the straight surface segment is related to the front and rear diameters. The ratio of A, E/A, is in the range of 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。In one embodiment, the tibial tray prosthesis further includes a straight posterior edge surface, two ends of the straight posterior edge surface are respectively connected to the posterior edge curved surface and the second side surface, and the length of the posterior edge straight surface 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。In one embodiment, the second side surface is a straight surface, and when the tibial tray prosthesis is in the theoretical implantation position, the first side surface is perpendicular to the transcondylar axis of the knee joint.
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。A tibial tray prosthesis, the tibial tray prosthesis is used to replace the lateral compartment of the tibia of a human knee joint, the tibial tray prosthesis has an anterior-posterior diameter a and a left-right diameter b, and the anterior-posterior diameter a follows the left and right diameters. As the diameter b increases, the ratio a/b of the front-rear diameter a and the left-right diameter b presents a decreasing trend with the increase of the left-right diameter b.
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。In one embodiment, the ratio a/b of the front-rear diameter a to the left-right diameter b is in the range of 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。In one embodiment, the relationship between the ratio a/b of the front-rear diameter a and the left-right diameter b and the left-right diameter b satisfies a/b=-k2×b+y, where 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a/b=-0.02×b+2.19所表示的直线上下0.15的范围内。In one embodiment, the ratio a/b of the front-rear diameter a and the left-right diameter b is within a range of 0.15 above and below the straight line represented by a/b=-0.02×b+2.19.
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。In one embodiment, the ratio a/b of the front-rear diameter a to the left-right diameter b shows a linear decreasing trend as the left-right diameter b increases, and the front-rear diameter a and the left-right diameter b The relationship between the ratio a/b of , and the left and right diameter b satisfies a/b=-k2×b+y, where 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。In one embodiment, the tibial tray prosthesis has a first side surface and a second side surface arranged opposite to each other, the second side surface is a straight surface, and the first side surface is farthest from the second side surface to the front end The vertical distance of the tangent is denoted as the second distance c, and the ratio c/a of the second distance c to the front and rear diameter a ranges from 0.45 to 0.6. The tibial tray prosthesis is a straight line tangent to the contour of the front end of the prosthesis.
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。In one embodiment, the first side surface includes a leading edge curved surface and a trailing edge curved surface, and the ratio r1/A of the curvature radius r1 of the leading edge curved surface to the front and rear diameter a ranges from 0.35 to 0.65; The ratio r2/a of the curvature radius r2 of the edge curved surface to the front and rear diameter a ranges from 0.4 to 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。本发明所述的“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。In one embodiment, the first side surface further includes a straight surface segment, two ends of the straight surface segment are respectively connected to the leading edge curved surface and the trailing edge curved surface, and the length e of the straight surface segment is related to the front and rear diameters. The ratio e/a of a ranges from 0.09 to 0.12. The "straight surface" or "straight line" mentioned in the present invention is not a straight surface or a straight line in the mathematical sense, but refers to a straight surface or a straight line in an engineering sense that meets certain error requirements.
上述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,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。By setting the ratio A/B of the anteroposterior diameter A and the left and right diameter B of the tibial tray prosthesis to a decreasing trend with the increase of the left and right diameter B, the tibial tray prosthesis can be closer to the anatomical shape of the inner side of the tibia of the human knee joint. , thereby improving the coverage of the tibial prosthesis, reducing the probability of prosthesis loosening and postoperative pain.
附图说明Description of drawings
构成本申请的一部分的附图用来提供对本发明的进一步理解,本发明的示意性实施例及其说明用于解释本发明,并不构成对本发明的不当限定。The accompanying drawings constituting a part of the present application are used to provide further understanding of the present invention, and the exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention.
为了更清楚地说明本发明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发明的一些实施例,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。In order to illustrate the technical solutions in the embodiments of the present invention more clearly, the following briefly introduces the accompanying drawings used in the description of the embodiments. Obviously, the accompanying drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can also be obtained from these drawings without creative effort.
图1为一实施例的胫骨托假体的结构示意图;1 is a schematic structural diagram of a tibial tray prosthesis according to an embodiment;
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;Fig. 2 is an example table of the anterior-posterior diameter A, the left-right diameter B and the ratio A/B of the tibial tray prosthesis shown in Fig. 1;
图3为另一实施例的胫骨托假体的结构示意图;3 is a schematic structural diagram of a tibial tray prosthesis of another embodiment;
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;Fig. 4 is an example table of the anterior-posterior diameter a, the left-right diameter b and the ratio a/b of the tibial tray prosthesis shown in Fig. 3;
图5为一实施例的胫骨托假体的安装示意图。FIG. 5 is a schematic view of the installation of the tibial tray prosthesis according to an embodiment.
附图标记说明:Description of reference numbers:
100、胫骨托假体;10、前缘曲面;11、直面段;12、后缘曲面;13、后缘直面;14、第二侧面;200、胫骨托假体;20、前缘曲面;21、直面段;22、后缘曲面;23、后缘直面;24、第二侧面。100. Tibial tray prosthesis; 10. Curved surface of anterior edge; 11. Straight surface segment; 12. Curved surface of posterior edge; 13. Straight surface of posterior edge; , straight face segment; 22, trailing edge curved surface; 23, trailing edge straight surface; 24, second side.
具体实施方式Detailed ways
为使本发明的上述目的、特征和优点能够更加明显易懂,下面结合附图对本发明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发明。但是本发明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发明内涵的情况下做类似改进,因此本发明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 invention more clearly understood, the specific embodiments of the present invention 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 invention. However, the present invention 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 invention. Therefore, the present invention is not limited by the specific embodiments disclosed below.
为了更好地阐述本发明的技术方案,首先对各实施例中涉及的方位名称进行解释:In order to better illustrate the technical solutions of the present invention, the orientation names involved in each embodiment are first explained:
矢状面:指从前后方向,将人体或假体分成左、右两部分的纵切面,其中,经过人体或假体正中的矢状面为正中矢状面,该面将人体或假体分成左右相等的两部分。Sagittal plane: refers to the longitudinal section that divides the human body or prosthesis into left and right parts from the anterior and posterior directions. Two equal parts left and right.
冠状面:指从左右方向,将人体或假体分为前后两部分的纵切面,该切面与矢状面垂直。Coronal plane: refers to the longitudinal section that divides the human body or prosthesis into front and rear parts from the left and right directions, and the section is perpendicular to the sagittal plane.
横断面:也称水平面,是与地平面平行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。Transverse plane: also known as the horizontal plane, is a plane parallel to the ground plane that divides the human body or prosthesis into upper and lower parts, and this plane is perpendicular to the coronal and sagittal planes.
内侧:相对接近人体正中矢状面的一侧。Medial: The side relatively close to the midsagittal plane of the human body.
外侧:相对远离人体正中矢状面的一侧。Lateral: The side relatively far from the midsagittal plane of the human body.
前侧:矢状面上相对接近腹部的一侧。Anterior: The side of the sagittal plane that is relatively close to the abdomen.
后侧:矢状面上相对接近背部的一侧。Posterior: The side relatively close to the back in the sagittal plane.
参阅图1,图1示出了本发明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。Referring to FIG. 1, FIG. 1 shows a top view of a
胫骨托假体100包括相对的前端和后端,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。The
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前端轮廓相切(以下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后端轮廓相切(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100的前后径A。In the extending direction of the
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,并且胫骨托假体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。例如图2中所示的,最小号的胫骨托假体100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。Further, referring to FIG. 2 , FIG. 2 shows an example table of the anterior-posterior diameter A, the left-right diameter B and the ratio A/B of a group of
鉴于传统的径骨托假体的覆盖率不足,容易松动等缺点,我司研发人员经过对人体膝关节解剖数据进行研究并对解剖数据的进行统计分析惊讶地发现胫骨内外侧髁骨面率(即股骨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,使得胫骨托假体100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。In view of the shortcomings such as insufficient coverage and easy loosening of the traditional radial bone support prosthesis, our research and development personnel have been surprised to find that the bone surface ratio of the medial and lateral tibial condyle ( That is, the ratio of the anteroposterior diameter of the femur to the left and right diameters) is inversely correlated with the size of the tibia. Therefore, the ratio A/B of the anterior and posterior diameters of the
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,优选k1=0.019,x=2.32。或者,A/B的值在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,优选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在偏差±0.01时,依旧可看作符合上述关系。Further, the relationship between the ratio A/B of the front-rear diameter A and the left-right diameter B and the left-right diameter B satisfies A/B=-k1×B+x, where 0.018<k1<0.020, 2.17<x< 2.47, preferably k1=0.019, x=2.32. Alternatively, the value of A/B is within the range of 0.15 above and below the straight line represented by A/B=-0.019×B+2.32. That is, for the selected B, the value of A/B is in the range of (-0.019×B+2.32)±0.15. Further, in a more ideal situation, the ratio A/B of the front-rear diameter A to the left-right diameter B shows a linear decreasing trend with the increase of the left-right diameter B, and the front-rear diameter A and the The relationship between the ratio A/B of the left and right diameters B and the left and right diameters B satisfies A/B=-k1×B+x, where 0.018<k1<0.020, 2.17<x<2.47, preferably k1=0.019, x=2.32. Understandably, considering that there will be manufacturing errors in the manufacturing process of the product, within the allowable range of errors, for example, when the ratio A/B of the front and rear diameter A and the left and right diameter B is within the deviation of ±0.01, it can still be regarded as meeting the above relationship. .
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。我司研发人员经过对人体膝关节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,使得胫骨托假体100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。Further, the vertical distance from the point farthest from the
进一步地,沿胫骨托假体100的前端到后端方向,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。我司研发人员经过对人体膝关节解剖数据进行研究并对解剖数据的进行统计分析,发现人体膝关节股骨内侧髁为非对称的“D”型结构,即人体膝关节股骨内侧髁的前缘曲面10的曲率半径较大,前缘曲面10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的比值关系使得胫骨托假体100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。Further, along the direction from the front end to the rear end of the
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。Further, the
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。Further, the
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示出了本发明另一实施例中的胫骨托假体200的俯视图,具体地,如图5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的镜像即可用于置换右侧膝关节的胫骨外侧间室。Further, the present application also provides a
胫骨托假体200具有相对前端和后端,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。The
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(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(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。In the extending direction of the
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,并且胫骨托假体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。例如图4中所示的,最小号的胫骨托假体100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。Further, referring to FIG. 4 , FIG. 4 shows an example table of the anterior-posterior diameter a, the left-right diameter b and the ratio a/b of a group of
鉴于传统的径骨托假体的覆盖率不足,容易松动等缺点,我司研发人员经过对人体膝关节解剖数据进行研究并对解剖数据的进行统计分析惊讶地发现胫骨内外侧髁骨面率(即股骨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,使得胫骨托假体200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。In view of the shortcomings such as insufficient coverage and easy loosening of the traditional radial bone support prosthesis, our research and development personnel have been surprised to find that the bone surface ratio of the medial and lateral tibial condyle ( That is, the ratio of the anteroposterior diameter of the femur to the left and right diameters) is inversely correlated with the size of the tibia. Therefore, by setting the ratio a/b of the anterior and posterior diameters a to the left and right diameters of the
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,优选k1=0.020,y=2.19。或者,a/b的值在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,优选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在偏差±0.01时,依旧可看作符合上述关系。Further, the relationship between the ratio a/b of the front-rear diameter a and the left-right diameter b and the left-right diameter b satisfies a/b=-k2×b+y, where 0.019<k2<0.021, 2.04<y< 2.34, preferably k1=0.020, y=2.19. Alternatively, the value of a/b is within a range of 0.15 above and below the straight line represented by a/b=−0.02×b+2.19. That is, for the selected b, the value of a/b is in the range of (−0.02×b+2.19)±0.15. Further, in a more ideal situation, the ratio a/b of the front and rear diameter a to the left and right diameter b presents a linear decreasing trend with the increase of the left and right diameter b, and the front and rear diameter a and the The relationship between the ratio a/b of the left-right diameter b and the left-right diameter b satisfies a/b=-k2×b+y, where 0.019<k2<0.021, 2.04<y<2.34, preferably k1=0.020, y=2.19. Understandably, considering that there will be manufacturing errors in the manufacturing process of the product, within the allowable range of errors, for example, when the ratio a/b of the front and rear diameter a and the left and right diameter b is within a deviation of ±0.01, it can still be regarded as meeting the above relationship. .
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。我司研发人员经过对人体膝关节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。Further, the vertical distance from the point farthest from the
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。我司研发人员经过对人体膝关节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。Further, along the direction from the front end to the rear end of the
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的范围为60°-80°。Further, as shown in FIG. 3 , when the
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发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明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 invention, and the descriptions thereof are specific and detailed, but should not be construed as a limitation on the scope of the invention patent. It should be pointed out that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can also be made, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention should be subject to the appended claims.
在本发明的描述中,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发明和简化描述,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发明的限制。In the description of the present invention, 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 present invention 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 of the invention.
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。在本发明的描述中,“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 invention, "plurality" means at least two, such as two, three, etc., unless otherwise expressly and specifically defined.
在本发明中,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发明中的具体含义。In the present invention, 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 the present invention can be understood according to specific situations.
在本发明中,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 the present invention, unless otherwise expressly specified and limited, a first feature "on" or "under" a second feature may be in direct contact between 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.
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