WO2021212580A1 - 解剖型膝关节假体 - Google Patents

解剖型膝关节假体 Download PDF

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Publication number
WO2021212580A1
WO2021212580A1 PCT/CN2020/090638 CN2020090638W WO2021212580A1 WO 2021212580 A1 WO2021212580 A1 WO 2021212580A1 CN 2020090638 W CN2020090638 W CN 2020090638W WO 2021212580 A1 WO2021212580 A1 WO 2021212580A1
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WO
WIPO (PCT)
Prior art keywords
condyle
groove
femoral condyle
tibial
tibial plateau
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PCT/CN2020/090638
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English (en)
French (fr)
Inventor
解凤宝
史春宝
韩川
Original Assignee
北京市春立正达医疗器械股份有限公司
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Application filed by 北京市春立正达医疗器械股份有限公司 filed Critical 北京市春立正达医疗器械股份有限公司
Priority to EP20932333.6A priority Critical patent/EP4140451A4/en
Priority to KR1020227040987A priority patent/KR20230009403A/ko
Publication of WO2021212580A1 publication Critical patent/WO2021212580A1/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
    • A61F2/3859—Femoral 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
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A61F2/3886—Joints for elbows or knees for stabilising knees against anterior or lateral dislocations
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30476—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/305—Snap connection
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3082—Grooves
    • A61F2002/30827—Plurality of grooves
    • A61F2002/30828—Plurality of grooves parallel
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30879—Ribs
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30884—Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity

Definitions

  • the present invention relates to the technical field of medical devices, in particular to an anatomical knee joint prosthesis.
  • a conventional knee joint prosthesis usually includes a femoral condyle fixed to the distal end of the femur, a tibial plateau support fixed to the proximal end of the tibia, and a tibial plateau pad disposed between the femoral condyle and the tibial plateau support.
  • the femoral condyle is a generally C-shaped semi-enclosing structure, including a lateral condyle, a medial condyle, and an open slot between the medial and lateral condyle or a pulley recessed into the femoral condyle.
  • the maximum point of curvature of the longitudinal section of the lateral condyle and the medial condyle is located in the lower half, that is, the part adjacent to the tibial plateau pad.
  • the conventional femoral condyle is set up as: the lateral condyle and the medial condyle are symmetrical with respect to the open groove or the pulley.
  • the tibial plateau pad mated with the femoral condyle is also designed as a symmetrical structure.
  • the above scheme has the following shortcomings: it does not conform to the human anatomical characteristics, and it is easy to cause the soft tissues on both sides of the knee joint to be unbalanced in flexion and extension, which can lead to joint instability, improper force lines, poor postoperative function, and flexion and extension exercises that cannot meet the needs of physiological movements. The occurrence of other problems affects knee proprioception and the survival rate of the prosthesis.
  • one of the objectives of the present invention is to provide an anatomical knee joint prosthesis that is more consistent with human anatomical features.
  • an anatomical knee joint prosthesis including a femoral condyle, a tibial plateau support, and a tibial plateau pad fixed to the tibial plateau support on one side and matched with the femoral condyle on the other side.
  • the femoral condyle includes lateral condyles, Medial condyle, and a pulley located between the medial and lateral condyles.
  • the angle between the line between the point of maximum curvature of the lateral condyle and the point of maximum curvature of the medial condyle and the projection line of the line in the horizontal plane where the point of maximum curvature of the medial condyle is located is about 3°.
  • the structures of the lateral condyle and the medial condyle are asymmetrical with respect to the pulley.
  • the C-shaped vertical sections of the lateral and medial condyles have the same curvature, and the two maximum curvature points are also located in the same vertical plane parallel to the elevation of the human body, but the two maximum curvature points are not at the same vertical height.
  • the anatomical knee joint prosthesis of the present application is more consistent with the anatomical characteristics of the human body.
  • the tibial plateau pad includes a medial platform surface and a lateral platform surface that contact and cooperate with the medial condyle and the lateral condyle, respectively, the medial platform surface and the lateral platform surface are both concave surfaces with a substantially central portion, and the medial platform portion The surface is further recessed downward with respect to the surface of the outer platform portion.
  • the tibial platform pad is provided with an upwardly protruding column at the substantially central part, and the trolley of the femoral condyle is provided with a penetrating intercondylar groove for accommodating the column.
  • the lower end of the femoral condyle and the lowest point of the intercondylar groove on the inner surface of the femoral condyle in the same vertical plane The angle between the line between the points and the horizontal plane is about 15°.
  • the inner wall of the femoral condyle is provided with a plurality of evenly distributed fixing grooves perpendicular to the length direction of the femoral condyle.
  • the inner wall of the femoral condyle is fixedly provided with a groove stand plate surrounding the intercondylar groove, and the groove stand plate and the inner wall of the femoral condyle define a bone cement groove.
  • both ends of the inside of the intercondylar groove are closed for simulating the anterior and posterior cruciate ligaments.
  • the top surface of the column has a smooth inclined curved surface transition on its side wall.
  • the tibial plateau support includes a support body for connecting the tibial plateau pad and a tibial intramedullary column fixed on the bottom surface of the support body.
  • a side wall on the support body is recessed inward to form a groove that matches the hollow on the tibial osteotomy surface, the tibial intramedullary column and the bottom surface of the support body are arranged at an angle of about 93°, and the tibial intramedullary column It extends toward the indentation direction of the side wall of the support body.
  • a plurality of granular convex structures are uniformly distributed on the lower surface of the support body.
  • the top surface of the holder body is provided with a locking groove, at least a part of the locking groove and the side wall of the holder body form a slot-like structure extending toward the inside of the holder body, and the bottom surface of the tibial plateau pad is fixedly provided with a locking groove
  • the locking mechanism, the locking mechanism is locked into the locking groove by means of clamping.
  • the anterior condyle is thinner, which can reduce the compression of the patella, so that the transition between the pulley and the intercondylar groove can be processed more smoothly, reducing the patella snapping and anterior knee pain.
  • the design uses the bionic thickness to achieve 3° Reconstruction of the 3° physiological joint line, so that the soft tissues on both sides are better balanced, which is more in line with the characteristics of human anatomy; the high flexion of the femoral condyle posterior condyle warps 15°, which increases the stable attachment of the femoral prosthesis and reduces the femur
  • the amount of osteotomy of the posterior condyle, a more obvious J-curve, the posterior condyle increases the rollback of the tibial plateau during deep knee flexion, reduces the impact of the femoral condyle and the tibial plateau, and increases the stable attachment of the femoral prosthesis; in addition, the tibial plateau pad
  • the setting of the fixing groove is conducive to the attachment of the bone cement, and the connection strength between the femoral condyle and the bone cement is enhanced, so that the femoral condyle can be more stably connected to the human bone, improving the survival rate of the prosthesis and working stability. sex.
  • the placement of the trough upright plate can protect the intercondylar trough.
  • the leakage of bone cement into the intercondylar trough can be reduced, and it will be consolidated on the post to affect the femoral condyle. It is possible to move smoothly relative to the column.
  • the front end closure of the intercondylar groove can replace the role of the anterior cruciate ligament in straightening and flexion.
  • the front closed end of the intercondylar groove is in contact with the column to achieve the role of reconstructing the anterior cruciate ligament.
  • the posterior closed end of the intercondylar groove is in contact with the posterior side of the column, which plays the role of reconstructing the posterior cruciate ligament, simulating a normal knee joint, and translating backward with the tibial plateau pad to maximize deep flexion .
  • the femoral condyle when the user is bending the knee, the femoral condyle will rotate and shift relative to the tibial plateau pad. Because the front closed end of the intercondylar groove is in contact with the column when the user is standing upright, the column is erected when the knee is bent. There will be friction with the front closed end of the intercondylar groove, and the smooth inclined curved transition of the side wall of the column top surface can reduce the friction between the column and the front closed end of the intercondylar groove, protect the column and the femoral condyle, and reduce A strange noise.
  • the design of the double-wing-shaped reinforced structure can not only increase the mechanical strength, but also improve the anti-rotation stability of the product.
  • the double wing-shaped reinforcement structures are close to each other and set at an included angle to form a structure that conforms to the human anatomy, which can better fit the human bone and tibia section, has good matching, and further improves the product's anti-rotation stability .
  • the tibial intramedullary column extends toward the inverted direction of the sidewall of the support body and is set at an angle of 3° with the bottom surface of the support body, which conforms to the structure of the human anatomy and has a higher degree of matching with the tibial medullary cavity. After implantation in the medullary cavity, the tibial tray is more stable.
  • the granular lower surface increases the fit between the tibial plateau support and the tibial section after adding bone cement, and can make the covered bone receive uniform stress, reduce shear stress and axial load, and improve the tibial plateau Support the stability of the work.
  • the locking groove and the locking structure can make the tibial plateau pad and the tibial plateau support have higher connection strength and connection stability, and greatly reduce the fretting of the pad and back wear.
  • the present invention includes at least one of the following beneficial technical effects:
  • the anterior condyle is thinner, which can reduce the compression of the patella, so that the transition between the pulley and the intercondylar groove can be processed more smoothly, reducing the patella snapping and anterior knee pain.
  • the design is realized by the thickness of the bionic Approximately 3° valgus, reconstruction of the physiological joint line of approximately 3°, so that the soft tissues on both sides are better balanced, which is more in line with the characteristics of the human anatomy; the high flexion femoral condyle posterior condyle warps about 15°, increasing the femoral prosthesis Stable attachment, reducing the amount of osteotomy of the posterior femoral condyle, a more obvious J-curve posterior condyle increases the rollback of the tibial plateau when the knee is deeply flexed, reducing the impact of the femoral condyle and the tibial plateau, increasing the stable attachment of the femoral prosthesis;
  • the design of the double-wing-shaped reinforced structure can increase the mechanical strength and the anti-rotation stability of the product. At the same time, the double-wing-shaped reinforced structure is close to each other and set at an angle. The cross-section of bone and tibia has good matching, which further improves the product's anti-rotation stability
  • Fig. 1 is a schematic structural diagram showing the usage state of the femoral condyle, tibial plateau pad, and tibial plateau support in the embodiment;
  • FIG. 2 is a schematic diagram showing the structure of the femoral condyle in the embodiment
  • Fig. 3 is an enlarged view of part A in Fig. 2 showing the structure of the locking structure and the locking groove;
  • FIG. 4 is a schematic diagram showing the angle between the medial condyle and the lateral condyle in the embodiment
  • Fig. 5 is a schematic diagram showing the concave angle of the posterior condyle toward the inner part of the femoral condyle in the embodiment
  • Fig. 6 is a schematic diagram showing the granular protrusion structure on the bottom surface of the support body in the embodiment.
  • the femoral condyle 1 has a C-shaped semi-enclosed structure.
  • the femoral condyle 1 includes a lateral condyle 141, a medial condyle 142, a pulley 12 extending along its contour, and an intercondylar groove 13 for accommodating a post 21.
  • One end of the pulley 12 is called the anterior condyle 11, and the two sides of the intercondylar groove 13 are called the posterior condyle 14.
  • the intercondylar groove 13 penetrates the femoral condyle 1, and its length is arranged along the contour of the femoral condyle 1.
  • the inner ends of the intercondylar groove 13 are both closed for simulating the anterior and posterior cruciate ligament, and used in conjunction with the tibial platform pad 2.
  • the inner wall of the femoral condyle 1 is fixedly provided with a groove stand plate 15 surrounding the intercondylar groove 13, and the groove stand plate 15 and the inner wall of the femoral condyle 1 define a bone cement groove 17, and the inner wall of the bone cement groove 17 is provided with a plurality of fixing grooves 16.
  • the length direction of the fixing groove 16 is perpendicular to the length direction of the intercondylar groove 13, and the fixing groove 16 is evenly distributed along the contour of the femoral condyle 1.
  • the pulley 12 makes the outer wall of the femoral condyle 1 concave toward the inside thereof, so that the transverse cross-section of the femoral condyle 1 has a V-shaped structure.
  • the two ends of the pulley 12 are one end located in the anterior condyle 11 and the other end located in the intercondylar groove 13 respectively.
  • the thickness of the anterior condyle 11 decreases from one end of the intercondylar groove 13 to the other end.
  • the posterior condyle 14 is divided by the pulley 12 and the intercondylar groove 13 into a lateral condyle 141 and a medial condyle 142.
  • the thickness of the posterior condyle 14 at the lateral condyle 141 is 6-8 mm, and the thickness of the posterior condyle 14 at the medial condyle 142 is 8-10 mm.
  • the maximum curvature point of the lateral condyle 141 and the maximum curvature point of the medial condyle 142 are both located at the vertical lowest point, the maximum curvature point of the lateral condyle 141 and the maximum curvature point of the medial condyle 142
  • the angle between the connecting line and the projection line of the connecting line in the horizontal plane where the point of maximum curvature of the medial condyle is located is about 3° (see FIG. 4).
  • the lower end of the femoral condyle 1 and the intercondyle are in the same vertical plane
  • the angle between the line between the lowest point of the groove 13 on the inner surface of the femoral condyle and the horizontal plane is about 15°, so that the overall posterior condyle 14 has a J-shaped profile (see FIG. 5).
  • a post 21 protruding into the intercondylar groove 13 is fixed at the substantially center of the top surface of the tibial plateau pad 2 so as to cooperate with the intercondylar groove 13 so as to play the role of the anterior and posterior cruciate ligament.
  • the top surface of the upright 21 has a smooth inclined curved surface transition to its side wall (preferably, to one of its side walls), and an inclined surface 22 is formed on the side wall thereof.
  • the tibial plateau pad 2 is divided by a post 21 into a medial platform surface 23 and a lateral platform surface 24 that cooperate with the medial condyle 142 and lateral condyle 141, respectively.
  • the medial platform surface 23 and the lateral platform surface 24 are both internally concave and convex.
  • the inner platform surface 23 is further recessed downward relative to the outer platform surface 24.
  • the tibial plateau support 3 includes a support body 31 for connecting the tibial plateau pad 2 and a tibial intramedullary column 32 fixed on the bottom surface of the support body 31.
  • the tibial intramedullary column 32 is fixedly provided with a double-winged reinforcement structure.
  • the double-winged reinforcement structure in this embodiment includes two radially outwardly extending from the sidewall of the tibial intramedullary column 32 and fixed on the bottom surface of the support body 31.
  • the sidewalls of the wing plates 33 that are at an angle to each other are fixedly connected to the tibial intramedullary column 32 at the same time.
  • a side wall on the support body 31 is recessed inward to form a recess that matches with the hollow on the tibial osteotomy surface. This recess is used to reduce the cost and obtain the maximum coverage of the tibial osteotomy surface, so that the pressure is evenly distributed in the proximal area. End the tibia, and reduce the compression of the tibial tray to the surrounding soft tissues, reduce postoperative pain and facilitate deep flexion and squatting.
  • the tibial intramedullary column 32 and the bottom surface of the support body 31 are arranged at an included angle of about 93°, and the tibial intramedullary column 32 extends toward the invagination direction of the sidewall of the support body 31.
  • the top surface of the support body 31 is provided with a circumferentially extending and downwardly recessed locking groove 34.
  • the bottom surface of the tibial plateau pad 2 is fixedly provided with a locking mechanism 25 that cooperates with the locking groove 34.
  • the locking groove 34 includes a part Formed with the side wall of the holder 31 to form a recessed groove 35 extending into the inside of the holder 31 to form a slot-like structure, and a lower clamping edge 36 located at both ends of the recessed groove 35, between the lower clamping edge 36 and the recessed groove 35 is formed
  • the planar groove-like structure is used for carrying and accommodating the locking mechanism 25;
  • the locking mechanism 25 includes an outer corrugation 26 formed on the bottom surface of the tibial platform pad 2 to cooperate with the recessed groove 35 and an upper clamping edge to cooperate with the lower clamping edge 36 27.
  • a plurality of granular convex structures are uniformly distributed on the lower surface of the holder body 31, and the granular convex structures may be hemispherical or semi-cylindrical.

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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

一种解剖型膝关节假体，包括股骨髁(1)、胫骨平台托(3)、以及一面固定到胫骨平台托(3)而另一面与股骨髁(1)配合的胫骨平台垫(2)，股骨髁(1)包括外侧髁(141)、内侧髁(142)、和位于内侧髁(142)和外侧髁(141)之间的滑车(12)，外侧髁(141)的曲率最大点与内侧髁(142)的曲率最大点之间的连线与连线在内侧髁(142)的曲率最大点所在水平面内的投影线之间的角度为约3°。具有更加符合人体解剖型的特点的效果。

Description

解剖型膝关节假体 技术领域
本发明涉及医疗器械的技术领域，尤其是涉及一种解剖型膝关节假体。
背景技术
在膝关节位置，常规的膝关节假体通常包括固定至股骨远端的股骨髁、固定至胫骨近端的胫骨平台托，以及设置在股骨髁和胫骨平台托之间的胫骨平台垫。股骨髁呈大体C形半包围结构，包括外侧髁、内侧髁、以及位于内侧髁和外侧髁之间的开口槽或向股骨髁的内部凹入的滑车。外侧髁和内侧髁的纵向截面的曲率最大点均位于下半部分，即邻近胫骨平台垫的部分。常规的股骨髁设置为：外侧髁和内侧髁相对于开口槽或滑车为对称结构。相应地，与股骨髁配合的胫骨平台垫也设计为对称的结构。
上述方案存在以下缺点：与人体解剖特征不相符，易导致膝关节两侧软组织在屈伸状态不平衡，会导致关节不稳、力线不正、术后功能差以及屈伸运动达不到生理运动的需要等问题的产生，影响膝关节本体感受和假体的存留率。
发明内容
针对现有技术存在的不足，本发明的目的之一是提供一种与人体解剖特征更加相符的解剖型膝关节假体。
本发明的上述发明目的是通过以下技术方案得以实现的：
根据本申请的一方面，提供一种解剖型膝关节假体，包括股骨髁、胫骨平台托、以及一面固定到胫骨平台托而另一面与股骨髁配合的胫骨平台垫，股骨髁包括外侧髁、内侧髁、和位于内侧髁和外侧髁之间的滑车。外侧髁的曲率最大点与内侧髁的曲率最大点之间的连线与所述连线在内侧髁的曲率最大点所在水平面内的投影线之间的角度为约3°。
通过采用上述技术方案，外侧髁与内侧髁的结构相对于滑车是不对称的。外侧髁与内侧髁的C形的竖向截面具有相同的曲率，两个曲率最大点也位于与人体立面平行的同一竖向平面内，但这两个曲率最大点不处于同一竖向高度处，从而模仿人体膝关节的股骨髁结构。因而本申请的解剖型膝关节假体与人体解剖特征更加相符。
优选地，胫骨平台垫包括分别与内侧髁以及外侧髁接触配合的内侧平台部表面和外侧平台部表面，内侧平台部表面与外侧平台部表面均为大体中部向下凹的凹面，且内侧平台部表面相对于外侧平台部表面进一步向下凹陷。
优选地，所述胫骨平台垫在大体中央部设有向上凸起的立柱，股骨髁的滑车设有用于容纳立柱的贯穿的髁间槽。
优选地，外侧髁的曲率最大点与内侧髁的曲率最大点均处于竖直方向最低点的情况下， 在同一竖向平面内股骨髁的下端与髁间槽的位于股骨髁内表面上的最低点之间的连线与水平面的角度为约15°。
优选地，股骨髁在内壁上设置有均匀分布的垂直于股骨髁的长度方向的多个固定槽。
优选地，股骨髁在内壁上固设有将髁间槽包围的槽立板，槽立板与股骨髁的内壁限定骨水泥槽。
优选地，髁间槽内部两端均封闭，用于模拟前后交叉韧带。
优选地，所述立柱的顶面向其侧壁呈平滑的倾斜曲面状过渡。
优选地，所述胫骨平台托包括用于连接胫骨平台垫的托体以及固设于托体底面上的胫骨髓内柱。
优选地，托体上的一处侧壁向内凹陷形成与胫骨截骨面上空陷处配合槽体，胫骨髓内柱与托体底面之间呈约93°夹角设置，且胫骨髓内柱朝向托体侧壁内陷方向延伸。
优选地，所述托体下表面均匀的分布有多个颗粒状凸起结构。
优选地，托体顶面开设有锁合槽，锁合槽至少有一部分与托体侧壁形成向托体内部延伸的卡槽状结构，胫骨平台垫的底面固设有与锁合槽配合的锁合机构，锁合机构通过卡接的方式卡入锁合槽内部。
前髁更薄，能够减少对髌骨的挤压，使得滑车与髁间槽之间的过渡能够加工的更滑顺，减少髌骨弹响和膝前痛，同时在设计上利用仿生的厚度实现3°的外翻，重建3°生理关节线，使两侧软组织更好地平衡，更加符合人体解剖型的特点；高屈曲的股骨髁后髁后翘15°，增加股骨假体的稳定附着，减少股骨后髁截骨量，更明显的J型曲线后髁增加了深屈膝时于胫骨平台的后滚，减少股骨髁与胫骨平台的撞击，增大增加股骨假体的稳定附着；另外胫骨平台垫的仿生设计，内凹外凸，重现膝关节半月板生理状态，符合人体运动特征，胫骨平台前凹，以恢复自然膝关节的正常起始AP位，防止反常运动，模拟正常膝关节运动，使深度屈曲最大化。
通过采用上述技术方案，固定槽的设置利于骨水泥的附着，增强了股骨髁与骨水泥之间的连接强度，使得股骨髁能够更加稳定的与人体骨质连接，提高假体生存率和工作稳定性。
通过采用上述技术方案，槽立板的设置能够保护髁间槽，在向骨水泥槽内部填充骨水泥时，能够减小骨水泥向髁间槽内部泄露，并在立柱上固结进而影响股骨髁相对于立柱顺畅移动的可能。
通过采用上述技术方案，髁间槽的前端封闭能够替代伸直与屈曲中前交叉韧带的作用，在0°-20°时髁间槽前封闭端和立柱接触，达到重建前交叉韧带的作用，在60°-150°时，髁间槽后封闭端和立柱后侧接触，起到重建后交叉韧带的作用，模拟正常膝关节，随着胫骨 平台垫双侧向后平移，使深度屈曲最大化。
通过采用上述技术方案，在使用者进行屈膝动作时，股骨髁会相对于胫骨平台垫发生转动和位移，由于使用者竖直站立状态时髁间槽前封闭端与立柱接触，所以在屈膝时立柱会与髁间槽前封闭端产生摩擦，而立柱顶面向其侧壁呈平滑的倾斜曲面状过渡能够减小立柱与髁间槽前封闭端之间的摩擦，保护了立柱和股骨髁，减小了异响。
通过采用上述技术方案，双翼型增强结构的设计既可以增加机械强度，又能提高产品抗旋转稳定性。
通过采用上述技术方案，双翼型增强结构互相靠拢互呈夹角设置符合人体解剖型态的结构，能够更好的贴合人体骨骼和胫骨截面，具有良好的匹配性，进一步提高产品抗旋转稳定性。
通过采用上述技术方案，胫骨髓内柱朝向托体侧壁内陷方向延伸并与托体底面之间呈3°夹角设置，符合人体解剖型态的结构，与胫骨髓腔匹配度更高，植入髓腔后使胫骨托更加稳定。
通过采用上述技术方案，颗粒状下表面在添加骨水泥后增加胫骨平台托与胫骨截面契合度，并可以使覆盖的骨质受到均匀的应力，减少剪切应力及轴向负荷，提高了胫骨平台托的工作稳定性。
通过采用上述技术方案，锁合槽和锁合结构可以使得胫骨平台垫与胫骨平台托之间具有更高的连接强度和连接稳定性，大幅度降低垫片微动及背部磨损。
综上所述，本发明包括以下至少一种有益技术效果：
1.前髁更薄，能够减少对髌骨的挤压，使得滑车与髁间槽之间的过渡能够加工的更滑顺，减少髌骨弹响和膝前痛，同时在设计上利用仿生的厚度实现约3°的外翻，重建约3°生理关节线，使两侧软组织更好地平衡，更加符合人体解剖型的特点；高屈曲的股骨髁后髁后翘约15°，增加股骨假体的稳定附着，减少股骨后髁截骨量，更明显的J型曲线后髁增加了深屈膝时于胫骨平台的后滚，减少股骨髁与胫骨平台的撞击，增大增加股骨假体的稳定附着；另外胫骨平台托的仿生设计，内凹外凸，重现膝关节半月板生理状态，符合人体运动特征，胫骨平台前凹，以恢复自然膝关节的正常起始AP位，防止反常运动，模拟正常膝关节运动，使深度屈曲最大化；
2.双翼型增强结构的设计既可以增加机械强度，又能提高产品抗旋转稳定性，同时双翼型增强结构互相靠拢互呈夹角设置符合人体解剖型态的结构，能够更好的贴合人体骨骼和胫骨截面，具有良好的匹配性，进一步提高产品抗旋转稳定性
附图说明
图1是实施例中为表示股骨髁、胫骨平台垫以及胫骨平台托使用状态的结构示意图；
图2是实施例中为表示股骨髁结构的示意图；
图3是图2中为表示锁合结构与锁合槽的结构的A部放大图；
图4是实施例中为表示内侧髁与外侧髁之间夹角的示意图；
图5是实施例中为表示后髁向股骨髁内部凹陷角度的示意图；
图6是实施例中为表示托体底面颗粒状凸起结构的示意图。
图中，1、股骨髁；11、前髁；12、滑车；13、髁间槽；14、后髁；141、外侧髁；142、内侧髁；15、槽立板；16、固定槽；17、骨水泥槽；2、胫骨平台垫；21、立柱；22、斜面部；23、内侧平台部；24、外侧平台部；25、锁合机构；26、外凸楞；27、上卡边；3、胫骨平台托；31、托体；32、胫骨髓内柱；33、翼板；34、锁合槽；35、内陷槽；36、下卡边。
具体实施方式
以下结合附图对本发明作进一步详细说明。本申请中，表示方向的措辞“前”、“后”、“上”、“下”与膝关节假体植入人体后在人直立状态下的前、后、上、下的方向相一致，并且本申请以左腿膝关节假体为例进行描述。
图1和图2为本发明公开的一种解剖型膝关节假体，包括股骨髁1、胫骨平台垫2以及胫骨平台托3。优选地，胫骨平台垫与胫骨平台托之间通过卡合的方式固定连接。股骨髁1呈C形半包围结构，股骨髁1包括外侧髁141、内侧髁142、延其轮廓开设的滑车12、以及用于容纳立柱21的髁间槽13。位于滑车12的一端称为前髁11，以及位于髁间槽13两侧称为后髁14。
髁间槽13将股骨髁1贯穿，其长度方向沿股骨髁1的轮廓设置，髁间槽13内部两端均封闭，用于模拟前后交叉韧带，用于与胫骨平台垫2配合使用。股骨髁1内壁上固设有将髁间槽13包围的槽立板15，槽立板15与股骨髁1的内壁限定骨水泥槽17，骨水泥槽17内部侧壁上开设有多个固定槽16，固定槽16的长度方向垂直于髁间槽13的长度方向，且固定槽16沿股骨髁1的轮廓均匀分布。
滑车12使得股骨髁1的外壁向其内部凹陷，从而使股骨髁1横向截面成V形结构。滑车12的两端分别为位于前髁11的一端和位于髁间槽13的另一端，前髁11的厚度由髁间槽13一端向另一端减小。
后髁14被滑车12与髁间槽13分为外侧髁141以内侧髁142，外侧髁141处的后髁14厚度为6-8mm，内侧髁142处的后髁14厚度为8-10mm。在本申请的膝关节假体工作期间，当外侧髁141的曲率最大点与内侧髁142的曲率最大点均位于竖向最低点时，外侧髁141的曲率最大点与内侧髁142的曲率最大点之间连线与与所述连线在内侧髁的曲率最大点所在水 平面内的投影线之间的角度为约3°(参见图4)。
在本申请的膝关节假体工作期间，当外侧髁141的曲率最大点与内侧髁142的曲率最大点均处于竖直方向最低点时，在同一竖向平面内股骨髁1的下端与髁间槽13的位于股骨髁内表面上的最低点之间的连线与水平面的角度为约15°，使整体后髁14轮廓呈J型(参见图5)。
胫骨平台垫2顶面的大体中央处固设有向髁间槽13内部凸起的立柱21，以便与髁间槽13配合，从而起到前后交叉韧带的作用。优选地，立柱21顶面向其侧壁(优选地，向其一个侧壁)呈平滑的倾斜曲面状过渡，并在其侧壁上形成斜面部22。胫骨平台垫2被立柱21分隔为分别与内侧髁142以及外侧髁141配合的内侧平台部表面23和外侧平台部表面24，内侧平台部表面23与外侧平台部表面24均呈内部凹陷、边缘凸起的曲面状，且内侧平台部表面23相对于外侧平台部表面24进一步向下凹陷。
参见图2和图3，胫骨平台托3包括用于连接胫骨平台垫2的托体31以及固设于托体31底面上的胫骨髓内柱32。胫骨髓内柱32上固设有双翼型增强结构，本实施例中的双翼型增强结构包括从胫骨髓内柱32的侧壁径向向外延伸且固设于托体31底面上的两个互呈夹角的翼板33，两个翼板33的侧壁同时与胫骨髓内柱32固定连接。托体31上的一处侧壁向内凹陷形成与胫骨截骨面上空陷处配合的凹部，该凹部用于减少成本的同时获得对胫骨截骨面的最大覆盖，使压力均匀地分布在近端胫骨，并减少胫骨托对周围软组织的挤压，减少术后疼痛和利于深屈和下蹲。胫骨髓内柱32与托体31底面之间呈约93°夹角设置，且胫骨髓内柱32朝向托体31侧壁内陷方向延伸。
托体31顶面开设有周向延伸的、向下凹入形成的锁合槽34，胫骨平台垫2的底面固设有与锁合槽34配合的锁合机构25，锁合槽34包括一部分与托体31侧壁形成向托体31内部延伸形成卡槽状结构的内陷槽35以及位于内陷槽35两端处的下卡边36，下卡边36与内陷槽35之间形成平面槽体状结构，用于承载容纳锁合机构25；锁合机构25包括成型于胫骨平台垫2底面上与内陷槽35配合的外凸楞26以及与下卡边36配合的上卡边27，外凸楞26插接在内陷槽35内部时，上卡边27与下卡边36抵接。
参见图6，托体31下表面均匀的分布有多个颗粒状凸起结构，颗粒状凸起结构可以是半球状也可以是半圆柱状。
本具体实施方式的实施例均为本发明的较佳实施例，并非依此限制本发明的保护范围，故：凡依本发明的结构、形状、原理所做的等效变化，均应涵盖于本发明的保护范围之内。

Claims (12)

  1. 一种解剖型膝关节假体，包括股骨髁(1)、胫骨平台托(3)、以及一面固定到胫骨平台托(3)而另一面与股骨髁(1)接触配合的胫骨平台垫(2)，股骨髁(1)包括外侧髁、内侧髁、和位于内侧髁和外侧髁之间的滑车，其特征在于：外侧髁(141)的曲率最大点与内侧髁(142)的曲率最大点之间的连线与所述连线在内侧髁的曲率最大点所在水平面内的投影线之间的角度为约3°。
  2. 根据权利要求1所述的解剖型膝关节假体，其特征在于：胫骨平台垫(2)包括分别与内侧髁(142)以及外侧髁(141)接触配合的内侧平台部表面(23)和外侧平台部表面(24)，内侧平台部表面(23)与外侧平台部表面(24)均为大体中部向下凹的凹面，且内侧平台部表面(23)相对于外侧平台部表面(24)进一步向下凹陷。
  3. 根据权利要求1所述的解剖型膝关节假体，其特征在于：所述胫骨平台垫(2)在大体中央部设有向上凸起的立柱(21)，股骨髁(1)的滑车(12)设有用于容纳立柱(21)的贯穿的髁间槽(13)。
  4. 根据权利要求1所述的解剖型膝关节假体，其特征在于：外侧髁(141)的曲率最大点与内侧髁(142)的曲率最大点均处于竖直方向最低点的情况下，在同一竖向平面内股骨髁(1)的下端与髁间槽(13)的位于股骨髁内表面上的最低点之间的连线与水平面的角度为约15°。
  5. 根据权利要求1所述的解剖型膝关节假体，其特征在于：股骨髁(1)在内壁上设置有均匀分布的垂直于股骨髁的长度方向的多个固定槽(16)。
  6. 根据权利要求1所述的解剖型膝关节假体，其特征在于：股骨髁(1)在内壁上固设有将髁间槽(13)包围的槽立板(15)，槽立板(15)与股骨髁(1)的内壁限定骨水泥槽(17)。
  7. 根据权利要求1所述的解剖型膝关节假体，其特征在于：髁间槽(13)内部两端均封闭，用于模拟前后交叉韧带。
  8. 根据权利要求1所述的解剖型膝关节假体，其特征在于：所述立柱(21)的顶面向其侧壁呈平滑的倾斜曲面状过渡。
  9. 根据权利要求1所述的解剖型膝关节假体，其特征在于：所述胫骨平台托(3)包括用于连接胫骨平台垫(2)的托体(31)以及固设于托体(31)底面上的胫骨髓内柱(32)。
  10. 根据权利要求9所述的解剖型膝关节假体，其特征在于：托体(31)上的一处侧壁向内凹陷形成与胫骨截骨面上空陷处配合槽体，胫骨髓内柱(32)与托体(31)底面之间呈约93°夹角设置，且胫骨髓内柱(32)朝向托体(31)侧壁内陷方向延伸。
  11. 根据权利要求1所述的解剖型膝关节假体，其特征在于：所述托体(31)下表面均 匀的分布有多个颗粒状凸起结构。
  12. 根据权利要求1所述的解剖型膝关节假体，其特征在于：托体(31)顶面开设有锁合槽(34)，锁合槽(34)至少有一部分与托体(31)侧壁形成向托体(31)内部延伸的卡槽状结构，胫骨平台垫(2)的底面固设有与锁合槽(34)配合的锁合机构(25)，锁合机构(25)通过卡接的方式卡入锁合槽(34)内部。
PCT/CN2020/090638 2020-04-23 2020-05-15 解剖型膝关节假体 WO2021212580A1 (zh)

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