CN110051456B - Modularized flexion-extension clearance measurer/tibia prosthesis test mould - Google Patents

Modularized flexion-extension clearance measurer/tibia prosthesis test mould Download PDF

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Publication number
CN110051456B
CN110051456B CN201810054256.9A CN201810054256A CN110051456B CN 110051456 B CN110051456 B CN 110051456B CN 201810054256 A CN201810054256 A CN 201810054256A CN 110051456 B CN110051456 B CN 110051456B
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face
flexion
extension gap
tibial
test
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CN110051456A (en
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赵开宇
孙延东
张娟
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Suzhou Microport Orthorecon Co Ltd
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Suzhou Microport Orthorecon Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/468Testing instruments for artificial joints
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4684Trial or dummy prostheses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/061Measuring instruments not otherwise provided for for measuring dimensions, e.g. length

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Cardiology (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)

Abstract

The invention discloses a modularized flexion and extension clearance measurer/tibial prosthesis test mould, which comprises a tibial tray test mould, a flexion and extension clearance cushion block, a gasket test mould and a thickness adjusting module; the proximal end face of the tibia support test die and the distal end face of the flexion and extension gap cushion block are in interference fit to form a flexion and extension gap measurer, and the thickness adjusting module is positioned between the flexion and extension gap cushion block and the tibia support test die; the proximal end face of the tibial tray test die and the distal end face of the gasket test die are in interference fit to form a tibial prosthesis test die; the thickness adjustment module is positioned between the gasket test die and the tibia support test die. The modularized flexion and extension clearance measurer and the tibial prosthesis test mould provided by the invention can realize modularized and generalized design, reduce the number of instruments and reduce the cost; improving the operation efficiency of doctors and reducing the operation time.

Description

Modularized flexion-extension clearance measurer/tibia prosthesis test mould
Technical Field
The invention relates to a flexion and extension clearance measurer and a tibial prosthesis test model, in particular to a modularized flexion and extension clearance measurer/tibial prosthesis test model which is used for primary replacement of an artificial full knee joint and revision of the artificial full knee joint.
Background
In total knee replacement, a doctor needs to use a flexion-extension clearance measurer to measure flexion-extension clearance after knee osteotomy so as to evaluate whether the osteotomy amount and the osteotomy direction are accurate and whether soft tissues are balanced; prior to implantation of a true tibial prosthesis, a physician needs to use a tibial prosthesis trial to select the appropriate tibial prosthesis size, evaluate whether the lower limb force lines are accurate, whether soft tissue balance, stability and mobility are warranted. Generally, a knee prosthesis provider will provide a flexion-extension gap measurer and a tibial prosthesis trial corresponding to a knee tibial prosthesis.
The existing flexion and extension clearance measurer and the tibial prosthesis test model have the following defects or shortcomings: the number of the instruments is large, and the cost of manufacturers is increased; the space for placing the instruments in the operating room of the hospital is required to be larger, and the cost of the hospital is increased; the instrument box is heavy and inconvenient to carry. Such as the modular tibial insert trial disclosed in U.S. patent publication No. 5702464-Modular trial tibial insert, suffer from the following disadvantages:
1) The device is not universal with a flexion and extension clearance measurer, and the number of the devices is more;
2) The thickness adjusting module and the tibial gasket test die interface are not good enough, the technical scheme utilizes the convex characteristic of the gasket test die to be matched with the concave characteristic of the thickness adjusting module, and simultaneously also utilizes the cylindrical characteristic of the thickness adjusting module to be matched with the characteristic of the tibial gasket test die hole, the two types of matching are rigidly connected, the tight fit is adopted, the assembly and the disassembly are inconvenient, and the loose fit is adopted, so that the stability of the fit is not ensured. Therefore, the technical proposal can not well balance the stability and the assembly and disassembly convenience during the operation.
Disclosure of Invention
The invention aims to solve the technical problem of providing a modularized flexion-extension clearance measurer/tibial prosthesis test mold which can realize modularization and universalization design, reduce the number of instruments and reduce the cost; improving the operation efficiency of doctors and reducing the operation time.
The invention provides a modularized flexion and extension clearance measurer/tibial prosthesis test mould which comprises a tibial tray test mould, a flexion and extension clearance cushion block, a gasket test mould and a thickness adjusting module; the proximal end face of the tibia support test die and the distal end face of the flexion and extension gap cushion block are in interference fit to form a flexion and extension gap measurer, and the thickness adjusting modules are positioned between the flexion and extension gap cushion block and the tibia support test die, wherein the number of the thickness adjusting modules is 0, 1 or more; the proximal end face of the tibial tray test die and the distal end face of the gasket test die are in interference fit to form a tibial prosthesis test die; the thickness adjustment modules are positioned between the gasket test die and the tibia support test die, and the number of the thickness adjustment modules is 0, 1 or more.
The modularized flexion and extension clearance measurer/tibial prosthesis test mold comprises a proximal end face of a tibial tray test mold, a distal end face of a flexion and extension clearance cushion block, a locking column provided with a rectangular groove and a positioning pin hole are in interference fit, the proximal end face of the tibial tray test mold and the distal end face of a gasket test mold are in interference fit with the locking column provided with the rectangular groove and the positioning pin hole, and the same locking column and the same positioning pin hole are arranged on a thickness adjusting module.
The modularized flexion-extension clearance measurer/tibial prosthesis test mold comprises a tibial tray test mold, wherein the tibial tray test mold is provided with a first proximal end surface, and the first proximal end surface is provided with a first positioning pin hole; the flexion-extension gap cushion block is provided with a first distal end surface, and the first distal end surface is provided with a first locking column; the first locking column is in interference connection with the first positioning pin hole, and is provided with a first rectangular groove; the gasket test die is provided with a second proximal joint surface and a second distal end surface, the second distal end surface is provided with a second locking column, the second locking column is provided with a second rectangular groove, the second locking column and the first locking column have the same structural characteristics, and the second rectangular groove and the first rectangular groove have the same structural characteristics; the thickness adjustment module is provided with a third proximal end face and a third distal end face, the second proximal end face is provided with a second positioning pin hole, and the diameter of the second positioning pin hole is the same as that of the first positioning pin hole; the third distal end face is provided with a third locking column, the third locking column is provided with a third rectangular groove, the third locking column and the second locking column have the same structural characteristics, and the third rectangular groove and the second rectangular groove have the same structural characteristics.
The modular flexion-extension gap measurer/tibial prosthesis test mold described above, wherein the first locking post diameter is 0.05-0.1mm greater than the first locating pin hole diameter.
The modular flexion-extension gap measurer/tibial prosthesis trial described above, wherein the ratio of the width of the first rectangular slot to the diameter of the first locking post is between 0.66-0.74.
The modularized flexion and extension clearance measurer/tibial prosthesis test mold comprises a proximal end face of a tibial tray test mold, a distal end face of a flexion and extension clearance cushion block, a locking post O-shaped ring and a positioning pin hole are adopted for interference fit, the proximal end face of the tibial tray test mold and the distal end face of a gasket test mold are adopted for interference fit, the locking post O-shaped ring and the positioning pin hole are adopted for interference fit, and the same locking post and positioning pin hole are arranged on a thickness adjusting module.
The modularized flexion-extension clearance measurer/tibial prosthesis test mold comprises a tibial tray test mold, wherein the tibial tray test mold is provided with a first proximal end surface, and the first proximal end surface is provided with a first positioning pin hole; the flexion-extension gap cushion block is provided with a first distal end surface, and the first distal end surface is provided with a first locking column; the first locking column is in interference connection with the first positioning pin hole, and a first O-shaped ring is arranged on the first locking column; the gasket test die is provided with a second proximal joint surface and a second distal end surface, the second distal end surface is provided with a second locking column, a second O-shaped ring is arranged on the second locking column, the second locking column and the first locking column have the same structural characteristics, and the second O-shaped ring and the first O-shaped ring have the same structural characteristics; the thickness adjustment module is provided with a third proximal end face and a third distal end face, the second proximal end face is provided with a second positioning pin hole, and the diameter of the second positioning pin hole is the same as that of the first positioning pin hole; the third distal end face is provided with a third locking column, a third O-shaped ring is arranged on the third locking column, the third locking column and the second locking column have the same structural characteristics, and the third O-shaped ring and the second O-shaped ring have the same structural characteristics.
The modularized flexion and extension clearance measurer/tibial prosthesis test mold is characterized in that the diameter of the first locking column is 0.05-0.1mm smaller than that of the first positioning pin hole, and the diameter of the first O-shaped ring is 0.1-0.2mm larger than that of the first positioning pin hole.
The modularized flexion-extension clearance measurer/tibial prosthesis test mold comprises a proximal end face of a tibial tray test mold, a distal end face of a flexion-extension clearance cushion block, a thickness adjusting module and a thickness adjusting module, wherein the proximal end face of the tibial tray test mold and the distal end face of the tibial tray test mold are in interference fit through a concave face and a convex face, the proximal end face of the tibial tray test mold and the distal end face of the gasket test mold are in interference fit through the concave face and the convex face, and the thickness adjusting module is provided with the same concave face and convex face.
The modularized flexion and extension clearance measurer/tibial prosthesis test mold comprises a tibial tray test mold, a first cavity and a second cavity, wherein the tibial tray test mold is provided with a first proximal end surface, the first proximal end surface is provided with a first concave surface, and the first concave surface is provided with a first conical surface, a first straight surface, a front groove and a rear step; the bending and stretching gap cushion block is provided with a first distal end face, the first distal end face is provided with a first convex face, and the first convex face is provided with a second conical face, a second straight face and a front step; the pad test die has a second proximal joint face and a second distal face, the second distal face having a second convex face, the second convex face and the first convex face having the same structural features; the thickness adjustment module is provided with a third proximal end face and a third distal end face, the second proximal end face is provided with a third concave face, the third concave face and the first concave face on the tibia support test die are provided with the same structural characteristics, the third distal end face is provided with a third convex face, and the third convex face and the second convex face on the gasket test die are provided with the same structural characteristics.
The modularized flexion and extension clearance measurer/tibial prosthesis test die is characterized in that the width of the large end of the first conical surface is 10mm-50mm, the cone angle is 0-45 degrees, the length is 5mm-15mm, the width of the front groove is 2mm-8mm, and the height of the rear step is 0.5mm-6.5mm.
The modularized flexion and extension clearance measurer/tibial prosthesis test die comprises a first conical surface, a second conical surface, a front step and a back step, wherein the width of the large end of the second conical surface is 0-0.5mm different from the width of the large end of the first conical surface, the taper angle of the second conical surface is 0-3 degrees different from the taper angle of the first conical surface, the length of the second conical surface is 0.2-0.5mm shorter than that of the first conical surface, the front step is smaller than the height of the front groove, and the height of the front step is smaller than the height difference between the top surface of the front groove and the top surface of the back step.
The modular flexion and extension gap measurer/tibial prosthesis test mold described above, wherein the taper angle of the second taper surface and the first taper surface is 10 ° -15 °.
The modular flexion-extension clearance measurer/tibial prosthesis test mold, wherein the first distal end face is provided with a first upper inclined plane, the second distal end face is provided with a second upper inclined plane, the third distal end face is provided with a third upper inclined plane, and the inclination angles of the first upper inclined plane, the second upper inclined plane and the third upper inclined plane are 10 degrees to 60 degrees.
Compared with the prior art, the invention has the following beneficial effects: the modularized flexion-extension clearance measurer/tibial prosthesis test mould provided by the invention adopts modularized and generalized design, so that the number of instruments is reduced, the weight of the whole instrument box is reduced, and the cost is reduced; meanwhile, through the elastic deformation design (locking column with groove/locking column with O-shaped ring/taper locking) of the instrument matching interface, the stability and the mounting and dismounting convenience of the instrument during use are improved, the operation efficiency of doctors is improved, and the operation time is shortened.
Drawings
Fig. 1 is a schematic view of a tibial tray trial model according to a first embodiment of the present invention;
FIG. 2 is a schematic diagram of a cushion block with a flexion-extension gap according to a first embodiment of the present invention;
FIG. 3 is a schematic diagram of a test structure of a gasket according to a first embodiment of the present invention;
FIG. 4 is a schematic view of a thickness adjustment module according to a first embodiment of the present invention;
FIG. 5 is a schematic diagram of a first embodiment of the invention assembled into a modular flexion-extension gap measurer;
FIG. 6 is a schematic view of a first embodiment of the present invention assembled into a tibial prosthesis;
FIG. 7 is a schematic diagram of a thickness-adjustable flexion-extension gap measurer according to a first embodiment of the present invention;
FIG. 8 is a schematic illustration of a tibial prosthesis trial formed to an adjustable thickness in accordance with a first embodiment of the present invention;
fig. 9 is a schematic view of a tibial tray trial structure in a second embodiment of the invention;
FIG. 10 is a schematic diagram of a cushion block with a flexion-extension gap according to a second embodiment of the present invention;
FIG. 11 is a schematic view of a thickness adjustment module according to a second embodiment of the present invention;
FIG. 12 is a schematic diagram of a second embodiment of the invention assembled into a modular flexion-extension gap measurer;
FIG. 13 is a schematic view of a second embodiment of the present invention assembled into a tibial prosthesis;
FIG. 14 is a schematic view of a thickness-adjustable flexion-extension gap measurer according to a second embodiment of the present invention;
FIG. 15 is a schematic view of a tibial prosthesis trial formed to an adjustable thickness in accordance with a second embodiment of the present invention;
fig. 16 is a schematic view of a tibial tray trial design in accordance with a third embodiment of the present invention;
FIG. 17 is a schematic view of a cushion block with a flexion-extension gap according to a third embodiment of the present invention;
FIG. 18 is a schematic diagram of a test pattern of a gasket in a third embodiment of the invention;
FIG. 19 is a schematic view of a thickness adjustment module according to a third embodiment of the present invention;
FIG. 20 is a schematic view of a third embodiment of the invention assembled into a modular flexion-extension gap measurer;
FIG. 21 is a schematic view of a third embodiment of the present invention assembled into a tibial prosthesis;
FIG. 22 is a schematic view of a thickness-adjustable flexion-extension gap measurer according to a third embodiment of the present invention;
fig. 23 is a schematic view of a third embodiment of the present invention formed with an adjustable thickness tibial prosthesis.
Detailed Description
The invention is further described below with reference to the drawings and examples.
Fig. 1-8 illustrate a modular flexion-extension gap measurer and tibial prosthesis trial according to a first embodiment of the present invention. The modularized flexion-extension clearance measurer/tibial prosthesis test comprises a tibial tray test 100, a flexion-extension clearance cushion block 101, a gasket test 102 and a thickness adjustment module 103. The distal end herein refers to an end far from the head, and the proximal end refers to an end near to the head.
As shown in fig. 1, the tibial tray trial 100 has a first proximal surface 10, the first proximal surface 10 having staple holes 11a,11b, first alignment pin holes 12a,12b, a keel forming slot 13, a stepped hole 14, and quick connect handles (not shown) and handle alignment holes 16a-16d.
As shown in fig. 2, the flexion-extension gap pad 101 has a first distal end surface 20, and the first distal end surface 20 has first locking posts 18a,18b and a first upper incline surface 21. The diameters of the first locking columns 18a and 18b are about 0.05-0.1mm larger than those of the first positioning pin holes 12a and 12b on the tibia support test mould 100, the first locking columns 18a and 18b are provided with first rectangular grooves 17a and 17b, and the ratio of the widths of the first rectangular grooves 17a and 17b to the diameters of the first locking columns 18a and 18b is 0.66-0.74; the first upper inclined surface 21 has an inclination angle of 10 DEG to 60 deg. The locking posts 18a,18b have a certain elasticity in the radial direction due to the provision of the rectangular grooves 17a,17b, can be easily inserted into or withdrawn from the first positioning pin holes 12a,12b, and are more firmly fitted. When the diameters of the first locking posts 18a,18b and the widths of the first rectangular grooves 17a,17b are within the above-mentioned numerical ranges, the easy assembling and disassembling of the locking posts and the positioning pin holes, the fitting stability and the firmness of the locking posts themselves can be better considered.
As shown in fig. 3, the shim trial 102 has a second proximal articular surface 30 and a second distal end surface 40, the second proximal articular surface 30 mating with the femoral condyle prosthesis or the femoral condyle prosthesis trial distal articular surface (not shown); the second distal end surface 40 has second locking posts 22a,22b, first countersunk grooves 23a,23b, and second upper inclined surfaces 24, the second locking posts 22a,22b are provided with second rectangular grooves 25a,25b, and the second locking posts 22a,22b and the second rectangular grooves 25a,25b have the same structural characteristics as the first locking posts 18a,18b and the first rectangular grooves 17a,17b on the flexion-extension gap pad 101; the second upper inclined surface 24 has an inclination angle of 10 deg. -60 deg.. The first countersinks 23a,23b are adapted to receive a staple (not shown) for securing the tibial tray trial 100.
As shown in fig. 4, the thickness adjustment module 103 has a third proximal end surface 50 and a third distal end surface 60, the third proximal end surface 50 has second registration pin holes 26a,26b, and the second registration pin holes 26a,26b have the same diameter as the first registration pin holes 12a,12b on the tibial tray trial 100; the third distal end face 60 has third locking posts 27a,27b, second countersunk grooves 28a,28b, and third upper inclined surfaces 29, the third locking posts 27a,27b are provided with third rectangular grooves 31a,31b, the third locking posts 27a,27b and the third rectangular grooves 31a,31b have the same structural characteristics as the second locking posts 22a,22b and the second rectangular grooves 25a,25b on the gasket test mold, and the third upper inclined surfaces 29 have an inclination angle of 10 ° to 60 °. The second countersinks 28a,28b are adapted to receive fasteners (not shown) that secure the tibial tray trial 100.
As shown in fig. 5 and 7, during the surgical operation, the flexion and extension measurer is formed by the cooperation of the first proximal end surface 10 on the tibial tray test mold 100 and the first distal end surface 20 on the flexion and extension gap pad 101, and the cooperation is realized by the cooperation of the first positioning pin holes 12a and 12b on the tibial tray test mold 100 and the first locking posts 18a and 18b on the flexion and extension gap pad 101. The locking of the flexion and extension gap pad 101 and the tibial tray test mold 100 is achieved by the deformation of the first rectangular grooves 17a,17b on the first locking posts 18a,18b on the flexion and extension gap pad 101, and the finite element analysis shows that when the ratio of the widths of the first rectangular grooves 17a,17b to the diameters of the first locking posts 18a,18b is between 0.66 and 0.74, and the diameters of the first locking posts 18a,18b are 0.05 to 0.1mm larger than the diameters of the first positioning pin holes 12a,12b on the tibial tray test mold 100, the insertion or extraction friction force between the flexion and extension gap pad 101 and the tibial tray test mold 100 is between 20N and 30N, which is convenient for the doctor to assemble and disassemble. Meanwhile, the first upper inclined surface 21 on the bending and stretching gap cushion block 101 is convenient for taking the bending and stretching gap cushion block 101, and the convenience for disassembling the bending and stretching gap cushion block 101 is further improved. As shown in fig. 7, a single thickness adjustment module 103 or a plurality of thickness adjustment modules 103 can be inserted between the flexion and extension gap pad 101 and the tibial tray jig 100 to combine flexion and extension gap measuring devices with different thicknesses required for the operation. The combination is achieved by the second registration pin holes 26a,26b and third locking posts 27a,27b on the thickness adjustment module 103 respectively mating with the first locking posts 18a,18b on the first distal surface 20 of the flexion and extension gap pad 101 and the first registration pin holes 12a,12b on the tibial tray trial 100. The third upper inclined surface 29 of the thickness adjustment module 103 facilitates the disassembly of the thickness adjustment module 103 after the operation is completed.
As shown in fig. 6 and 8, during the operation, the first proximal end surface 10 of the tibial tray test mold 100 is matched with the second distal end surface 40 of the gasket test mold 102 to form a tibial prosthesis test mold, the matching is realized through the matching of the first positioning pin holes 12a and 12b on the tibial tray test mold 100 and the second locking columns 22a and 22b on the gasket test mold 102, and the locking of the gasket test mold 102 and the tibial tray test mold 100 is realized through the deformation of the second rectangular grooves 25a and 25b on the second locking columns 22a and 22b on the gasket test mold 102, so that the stability of the tibial prosthesis test mold is ensured; the second upper inclined surface 24 of the shim stock 102 facilitates disassembly of the shim stock 102 upon completion of the procedure. As shown in fig. 8, a single thickness adjustment module 103 or a plurality of thickness adjustment modules 103 may be inserted between the shim and tibial tray molds 102, 100, combined into a tibial prosthesis mold of different thickness required for the surgical procedure by the second and third locking posts 26a,26b, 27b of the thickness adjustment module 103 cooperating with the second and first locking posts 22a,22b, respectively, of the shim mold 102 and the first locking posts 12a,12b of the tibial tray mold 100.
Figures 1, 9-16 illustrate further modifications to the modular flexion-extension gap measurer and tibial prosthesis trial illustrated in figures 1-8. As shown in fig. 1 and 9-16, the modular flexion-extension gap measurer and tibial prosthesis trial includes a tibial tray trial 100, a flexion-extension gap pad 2.101, a pad trial 2.102, and a thickness adjustment module 2.103. As shown in FIG. 1, the tibial tray trial 100 has a first proximal face 10, the first proximal face 10 having staple holes 11a,11b, first alignment pin holes 12a,12b, a keel forming slot 13, a stepped hole 14, a quick connect handle (not shown), and mounting hole features (handle alignment holes 16a-16 d).
As shown in fig. 9, the flexion-extension gap pad 2.101 has a first distal end surface 2.20, the first distal end surface 2.20 has a first locking post 2.18a,2.18b and a first upper inclined surface 2.21, the diameter of the first locking post 2.18a,2.18b is slightly smaller than the diameter of the first positioning pin hole 12a,12b of the first proximal end surface 10 of the tibial tray test mold 100 by 0.1-0.5mm, the first locking post 2.18a,2.18b is provided with a first O-ring 2.17a,2.17b, the outer diameter of the first O-ring 2.17a,2.17b is about 0.1-0.2mm larger than the diameter of the first positioning pin hole 12a,12b of the tibial tray test mold 100, and the material of the first O-ring 2.17a,2.17b may be plastic (such as polytetrafluoroethylene) with certain elasticity; the angle of the first upper inclined plane 2.21 is 10-60 degrees. Because the diameter of the locking column is slightly smaller than that of the positioning pin hole, and the O-shaped ring with certain elasticity is arranged on the locking column, the locking column can be conveniently inserted or withdrawn, and the matching is firmer. When the diameters of the first locking columns 2.18a and 2.18b and the outer diameters of the first O-rings 2.17a and 2.17b are in the numerical ranges, the easy assembly and disassembly of the locking columns and the positioning pin holes, the matching stability and the like can be better considered.
As shown in fig. 10, the shim trial 2.102 has a second proximal articular surface 2.30 and a second distal articular surface 2.40, the second proximal articular surface 2.30 being articular surface-mated with a femoral condyle prosthesis or femoral condyle prosthesis trial (not shown); the second distal end surface 2.40 is provided with second locking posts 2.22a,2.22b, first countersink 2.23a,2.23b and second upper inclined surfaces 2.24, the second locking posts 2.22a,2.22b are provided with second O-shaped rings 2.25a,2.25b, and the second locking posts 2.22a,2.22b and the second O-shaped rings 2.25a,2.25b have the same structural characteristics as the first locking posts 2.18a,2.18b and the first O-shaped rings 2.17a,2.17b on the flexion and extension gap pads 2.102; the second upper inclined plane is 2.24 degrees 10-60 degrees. The first countersink 2.23a,2.23b is adapted to receive a staple (not shown) for securing the tibial tray trial 100.
As shown in fig. 11, the thickness adjustment module 2.103 has a third proximal surface 2.50 and a third distal surface 2.60, the third proximal surface 2.50 has second registration pin holes 2.26a,2.26b, the second registration pin holes 2.26a,2.26b having the same diameter as the first registration pin holes 12a,12b on the tibial tray mold 100; the third distal end surface 2.60 is provided with third locking columns 2.27a,2.27b, second countersink 2.28a,2.28b and third upper inclined surfaces 2.29, the third locking columns 2.27a,2.27b have the same structural characteristics as the second locking columns 2.22a,2.22b on the gasket test die 2.102, the third locking columns 2.27a,2.27b are provided with third O-rings 2.31a,2.31b, and the third O-rings 2.31a,2.31b have the same structural characteristics as the second O-rings 2.25a,2.25b on the gasket test die 2.102; the angle of the third upper inclined plane 2.29 is 10-60 degrees. The second countersinks 2.28a,2.28b are adapted to receive a staple (not shown) for securing the tibial tray trial 100.
As shown in FIG. 12, during operation, the flexion and extension gap measurer is formed by the cooperation of the first proximal end surface 10 of the tibial tray test mold 100 and the first distal end surface 2.20 on the flexion and extension gap pad 2.101, the cooperation being achieved by the cooperation of the first positioning pin holes 12a,12b on the tibial tray test mold 100 and the first locking posts 2.18a,2.18b on the flexion and extension gap pad 2.101, by the deformation of the first O-rings 2.17a,2.17b on the first locking posts 2.18a,2.18b on the flexion and extension gap pad 2.101, the locking of the flexion and extension gap cushion block 2.101 and the tibia support test mould 100 is realized, and finite element analysis shows that when the diameters of the first locking posts 2.18a and 2.18b are slightly smaller than the diameters of the first positioning pin holes 12a and 12b on the tibia support test mould 100 by 0.1-0.5mm, and the diameters of the first O-shaped rings 2.17a and 2.17b are slightly larger than the diameters of the first positioning pin holes 12a and 12b on the tibia support test mould 100 by 0.1-0.2mm, the friction force for inserting or extracting the flexion and extension gap cushion block 2.101 and the tibia support test mould 100 is between 15N and 30N, so that the assembly and disassembly operations of doctors are convenient; the first upper inclined surface 2.21 of the flexion and extension gap cushion 2.101 further increases the convenience of disassembly of the flexion and extension gap cushion 2.101. As shown in fig. 14, a single thickness adjustment module 2.103 or a plurality of thickness adjustment modules 2.103 can be inserted between the flexion and extension gap pad 2.101 and the tibial tray test mold 100 to form a flexion and extension gap measurer with different thickness required by an operation, wherein the combination is realized by matching the second positioning pin holes 2.26a,2.26b and the third O-rings 2.31a,2.31b of the thickness adjustment modules 2.103 with the first O-rings 2.17a,2.17b of the flexion and extension gap pad 2.102 and the first positioning pin holes 12a,12b on the tibial tray test mold 100 respectively.
As shown in fig. 13, during the operation, the tibial prosthesis test mold is formed by matching the first proximal end surface 10 of the tibial tray test mold 100 with the second distal end surface 2.40 of the gasket test mold 2.102, wherein the matching is realized by matching the first positioning pin holes 12a and 12b on the tibial tray test mold 100 with the second O-rings 2.25a and 2.25b on the gasket test mold 2.102, and the locking of the gasket test mold 2.102 and the tibial tray test mold 100 is realized by the deformation of the second O-rings 2.25a and 2.25b on the gasket test mold 2.102, so that the stability of the tibial prosthesis test mold is ensured.
As shown in fig. 15, a single thickness adjustment module 2.103 or a plurality of thickness adjustment modules 2.103 may be inserted between the insert trial 2.102 and the tibial tray trial 100 to form a tibial prosthesis trial of different thickness required for the procedure, the combination being achieved by the second registration pin holes 2.26a,2.26b on the third proximal face 2.50 and the third O-rings 2.31a,2.31b on the third distal face 2.60 of the thickness adjustment module 2.103 respectively cooperating with the second O-rings 2.25a,2.25b on the insert trial 2.102 and the first registration pin holes 12a,12b on the tibial tray trial 100, the third upper chamfer 2.29 of the thickness adjustment module 2.103 facilitating removal of the thickness adjustment module 2.103 upon completion of the procedure.
Figures 16-23 illustrate a further modification of the modular flexion-extension gap measurer and tibial prosthesis trial illustrated in figures 1 and 9-15. As shown in fig. 16-23, the modular flexion-extension gap measurer and tibial prosthesis test comprises a tibial tray test 2.100, a flexion-extension gap pad 3.101, a pad test 3.102, and a thickness adjustment module 3.103. As shown in fig. 20, the tibial tray trial 2.100 has a first proximal surface 2.10, as shown in fig. 16, the first proximal surface 2.10 has a peg hole 2.12a,2.12b, a keel shaped slot 2.13, a stepped hole 2.14, a quick-connect handle (not shown), an installation locating feature 2.16, and a first concave surface 41, the first concave surface 41 has a first tapered surface 32, the first tapered surface 32 ranges from 32a to 32b (i.e., the non-parallel portions of the opposite sides of the first concave surface 41), a first straight surface 33 (i.e., the parallel portions of the opposite sides of the first concave surface 41), a front groove 34, a rear step 35a,35b, the first tapered surface 32 has a major end 36 width of 10mm-50mm, the tapered angle 37 of 0-45 degrees, the first tapered surface 32 has a length 38 of 5mm-15mm, the front groove 34 has a depth 39 of 2mm-8mm, and the rear step 35a,35b has a height of 0.5mm-6.5mm. When the size and the angle are in the numerical range, the installation of the matched instrument can be facilitated, and the matched effect is ensured.
As shown in fig. 17, the flexion-extension gap pad 3.101 has a first distal surface 3.20, the first distal surface 3.20 has a first convex surface 51 and a first upper inclined surface 3.21, the first convex surface 51 has a second tapered surface 43, the second tapered surface 43 ranges from 43a to 43b (i.e., a portion of the first convex surface 51 where two opposite sides are not parallel), a second straight surface 44 (i.e., a portion of the first convex surface 51 where two opposite sides are parallel) and an anterior step 49, and the width of the large end 45 of the second tapered surface 43 is different from the width of the large end 36 of the first tapered surface 32 of the tibial tray mold 2.100 by 0-0.5mm, where the difference may be greater than or less, i.e., the value of the former is within ±0.5mm of the value of the latter. The taper angle 46 of the second taper surface 43 is 0-3 degrees different from the taper angle 37 of the first taper surface 32 of the tibial tray trial 2.100, and the difference may be greater or less, i.e., the former is within + -3 degrees of the latter. The cone angle 46 of the second conical surface 43 of the flexion and extension gap cushion block 3.101 and the cone angle 37 of the first conical surface 32 of the tibia support test mold 2.100 are preferably 10 degrees to 15 degrees, so that the stability in use and the convenience in disassembly are facilitated; the length 47 of the second conical surface 43 is 0.2-0.5mm shorter than the length 38 of the first conical surface 32 of the tibia support test mould 2.100, the height 48 of the front step 49 is smaller than the height 39 of the front groove 34 of the tibia support test mould 2.100, and the height 48 of the front step 49 is smaller than the height difference 42 between the top surface of the front groove 34 and the top surfaces of the rear steps 35a and 35b of the tibia support test mould 2.100, so that the flexion and extension gap cushion block 3.101 can be conveniently and horizontally inserted (horizontally sliding inserted) from the rear steps 35a and 35b of the tibia support test mould 2.100 to the front groove 34, and the installation and the disassembly are simpler and more convenient; the first upper inclined surface 3.21 of the bending and stretching gap cushion block 3.101 is 10-60 degrees.
As shown in fig. 18, the shim trial 3.102 has a second proximal articular surface 3.30 and a second distal articular surface 3.40, the second proximal articular surface 3.30 mating with a distal articular surface of a femoral condyle prosthesis or femoral condyle prosthesis trial (not shown); the second distal end surface 3.40 has a second convex surface 59, a first countersink 3.23a,3.23b, and a second upper inclined surface 3.24, and the second convex surface 59 has the same structural characteristics as the first convex surface 51 of the flexion-extension gap pad 3.101. The first countersinks 3.23a,3.23b are adapted to receive a fixing peg (not shown) for fixing the tibial tray trial 2.100.
As shown in fig. 19, the thickness adjustment module 3.103 has a third proximal end face 3.50 and a third distal end face 3.60, the third proximal end face 3.50 having a third concave face 75, the third concave face 75 having the same structural features as the first concave face 41 of the tibial tray trial 2.100; the third distal end surface 3.60 has a third convex surface 61, second countersink 3.28a,3.28b, and third upper inclined surface 3.29, and the third convex surface 61 has the same structural characteristics as the second convex surface 59 on the shim test mold 3.102. The second countersinks 3.28a,3.28b are adapted to receive a staple (not shown) for securing the tibial tray trial 2.100.
As shown in fig. 20, during operation, the flexion and extension clearance measurer is formed by matching a first proximal end face 2.10 of the tibial tray test mold 2.100 with a first distal end face 3.20 of the flexion and extension clearance cushion block 3.101, wherein the matching is realized by matching a first concave face 41 on the tibial tray test mold 2.100 with a first convex face 51 on the flexion and extension clearance cushion block 3.101, and the front-back and left-right locking of the flexion and extension clearance cushion block 3.101 and the tibial tray test mold 2.100 is realized by taper matching a second conical face 43 on the flexion and extension clearance cushion block 3.101 with a first conical face 32 on the tibial tray test mold 2.100; the upper and lower limiting of the flexion and extension gap cushion block 3.101 and the tibia support test die 2.100 is realized through the matching of the front step 49 on the flexion and extension gap cushion block 3.101 and the front groove 34 on the tibia support test die 2.100; the first upper inclined surface 3.21 on the flexion and extension gap cushion block 3.101 facilitates the taking out of the flexion and extension gap cushion block 3.101.
As shown in fig. 22, a single thickness adjustment module 3.103 or a plurality of thickness adjustment modules 3.103 may be inserted between the flexion and extension gap pad 3.101 and the tibial tray trial mold 2.100 to form a flexion and extension gap measurer with different thicknesses required for the operation, and the combination is implemented by respectively matching the second concave surface 75 and the third convex surface 61 of the thickness adjustment module 3.103 with the first convex surface 51 of the flexion and extension gap pad 3.101 and the first concave surface 41 of the tibial tray trial mold 2.100. As shown in fig. 21, in the operation, the tibial prosthesis test mold is formed by matching the first proximal end surface 2.10 of the tibial tray test mold 2.100 with the second distal end surface 3.40 of the tibial tray test mold 3.102, wherein the matching is realized by matching the first concave surface 41 on the first proximal end surface 2.10 of the tibial tray test mold 2.100 with the second convex surface 59 on the second distal end surface 3.40 of the tibial tray test mold, and the front-back and left-right locking of the tibial tray test mold 3.102 and the tibial tray test mold 2.100 is realized by the taper matching of the third conical surface 52 on the tibial tray test mold 3.102 and the first conical surface 32 on the tibial tray test mold 2.100; the upper and lower limit of the flexion and extension gap cushion block 3.102 and the tibia support test die 2.100 is realized through the matching of the front step 57 on the gasket test die 3.102 and the front groove 34 of the tibia support test die 2.100.
As shown in fig. 21, during the operation, the tibial prosthesis test mold is formed by matching the first proximal end surface 2.10 of the tibial tray test mold 2.100 with the second distal end surface 3.40 of the gasket test mold 3.102, and the matching is realized by matching the first concave surface 41 on the tibial tray test mold 2.100 with the first convex surface 59 of the gasket test mold 3.102, and the matching manner of the first concave surface 41 on the tibial tray test mold 2.100 and the first convex surface 51 on the flexion and extension gap cushion block 3.101 is the same.
As shown in fig. 23, a single thickness adjustment module 3.103 or a plurality of thickness adjustment modules 3.103 may be inserted between the shim and tibial tray molds 3.102, 2.100 to combine tibial prosthesis molds of different thicknesses as required for the surgical procedure by the second concave surface 75 on the third proximal surface 3.50 and the third convex surface 61 on the third distal surface 3.60 of the thickness adjustment module 3.103 respectively cooperating with the second convex surface 59 on the second distal surface 3.40 of the shim mold 3.102 and the first concave surface 41 on the first proximal surface 2.10 of the tibial tray mold 2.100.
While the invention has been described with reference to the preferred embodiments, it is not intended to limit the invention thereto, and it is to be understood that other modifications and improvements may be made by those skilled in the art without departing from the spirit and scope of the invention, which is therefore defined by the appended claims.

Claims (14)

1. A modularized flexion-extension clearance measurer/tibial prosthesis test model comprises a tibial tray test model (100, 2.100), a flexion-extension clearance cushion block (101, 2.101, 3.101), a gasket test model (102, 2.102, 3.102) and a thickness adjusting module (103, 2.103, 3.103);
the tibia support test die is characterized in that the proximal end face of the tibia support test die (100, 2.100) and the distal end face of the flexion and extension gap cushion blocks (101, 2.101, 3.10) are in interference fit to form a flexion and extension gap measurer, and the thickness adjusting modules (103, 2.103, 3.103) are arranged between the flexion and extension gap cushion blocks (101, 2.101, 3.101) and the tibia support test die (100, 2.100) and are 0 in number, 1 in number or more;
the proximal end surface of the tibial tray test mold (100, 2.100) and the distal end surface of the gasket test mold (102, 2.102, 3.102) are in interference fit to form a tibial prosthesis test mold; the thickness adjustment modules (103, 2.103, 3.103) are positioned between the shim test molds (102, 2.102, 3.102) and the tibial tray test molds (100, 2.100) in an amount of 0, 1 or more.
2. The modular flexion and extension gap measurer/tibial prosthesis test of claim 1, wherein the proximal face of the tibial tray test (100) is in interference fit with the locating pin hole by using a locking post with a rectangular slot with the distal face of the flexion and extension gap pad (101), the proximal face of the tibial tray test (100) is in interference fit with the locating pin hole by using a locking post with a rectangular slot with the distal face of the pad test (102), and the thickness adjustment module (103) is provided with the same locking post and locating pin hole.
3. The modular flexion-extension gap measurer/tibial prosthesis trial of claim 2, wherein the tibial tray trial (100) has a first proximal face (10), the first proximal face (10) having a first locating pin hole (12 a,12 b);
the flexion-extension gap pad (101) has a first distal end surface (20), the first distal end surface (20) having a first locking post (18 a,18 b); the first locking columns (18 a,18 b) are in interference connection with the first positioning pin holes (12 a,12 b), and the first locking columns (18 a,18 b) are provided with first rectangular grooves (17 a,17 b);
the gasket test mould (102) is provided with a second proximal joint surface (30) and a second distal end surface (40), the second distal end surface (40) is provided with second locking columns (22 a,22 b), the second locking columns (22 a,22 b) are provided with second rectangular grooves (25 a,25 b), the second locking columns (22 a,22 b) and the first locking columns (18 a,18 b) have the same structural characteristics, and the second rectangular grooves (25 a,25 b) and the first rectangular grooves (17 a,17 b) have the same structural characteristics;
the thickness adjustment module (103) has a third proximal face (50) and a third distal face (60), the second proximal face (60) having second dowel holes (26 a,26 b), the second dowel holes (26 a,26 b) having the same diameter as the first dowel holes (12 a,12 b); the third distal end face (60) has a third locking post (27 a,27 b), the third locking post (27 a,27 b) is provided with a third rectangular groove (31 a,31 b), the third locking post (27 a,27 b) and the second locking post (22 a,22 b) have the same structural characteristics, and the third rectangular groove (31 a,31 b) and the second rectangular groove (25 a,25 b) have the same structural characteristics.
4. A modular flexion-extension gap measurer/tibial prosthetic trial as claimed in claim 3, wherein the first locking post (18 a,18 b) has a diameter that is 0.05-0.1mm greater than the diameter of the first locating pin hole (12 a,12 b).
5. A modular flexion-extension gap measurer/tibial prosthetic trial as claimed in claim 3, wherein the ratio of the width of the first rectangular slot (17 a,17 b) to the diameter of the first locking post (18 a,18 b) is between 0.66-0.74.
6. The modular flexion and extension gap measurer/tibial prosthesis jig of claim 1, wherein the proximal face of the tibial tray jig (100) is in interference fit with the distal face of the flexion and extension gap pad (2.101) using a locking post O-ring and dowel pin hole, the proximal face of the tibial tray jig (100) is in interference fit with the distal face of the pad jig (2.102) using a locking post O-ring and dowel pin hole, and the thickness adjustment module (2.103) is provided with the same locking post and dowel pin hole.
7. The modular flexion-extension gap measurer/tibial prosthetic trial of claim 6, wherein the tibial tray trial (100) has a first proximal face (10), the first proximal face (10) having a first locating pin hole (12 a,12 b);
the flexion-extension gap pad (2.101) has a first distal end face (2.20), the first distal end face (2.20) having a first locking post (2.18 a,2.18 b); the first locking columns (2.18 a,2.18 b) are in interference connection with the first positioning pin holes (12 a,12 b), and the first O-shaped rings (2.17 a,2.17 b) are arranged on the first locking columns (2.18 a,2.18 b);
the gasket test die (2.102) is provided with a second proximal joint surface (2.30) and a second distal end surface (2.40), the second distal end surface (2.40) is provided with a second locking post (2.22 a,2.22 b), the second locking post (2.22 a,2.22 b) is provided with a second O-shaped ring (2.25 a,2.25 b), the second locking post (2.22 a,2.22 b) and the first locking post (2.18 a,2.18 b) have the same structural characteristics, and the second O-shaped ring (2.25 a,2.25 b) and the first O-shaped ring (2.17 a,2.17 b) have the same structural characteristics;
the thickness adjustment module (2.103) has a third proximal face (2.50) and a third distal face (2.60), the second proximal face (2.60) having second dowel holes (2.26 a,2.26 b), the second dowel holes (2.26 a,2.26 b) having the same diameter as the first dowel holes (12 a,12 b); the third distal end face (2.60) is provided with a third locking column (2.27 a,2.27 b), the third locking column (2.27 a,2.27 b) is provided with a third O-shaped ring (2.31 a,2.31 b), the third locking column (2.27 a,2.27 b) and the second locking column (2.22 a,2.22 b) have the same structural characteristics, and the third O-shaped ring (2.31 a,2.31 b) and the second O-shaped ring (2.25 a,2.25 b) have the same structural characteristics.
8. The modular flexion-extension gap measurer/tibial prosthesis trial of claim 6, wherein the first locking post (2.18 a,2.18 b) has a diameter that is 0.05-0.1mm smaller than the first locating pin hole (12 a,12 b) and the first O-ring (2.17 a,2.17 b) has a diameter that is 0.1-0.2mm larger than the first locating pin hole (12 a,12 b).
9. The modular flexion and extension gap measurer/tibial prosthesis jig of claim 1, wherein the proximal surface of the tibial tray jig (2.100) is in interference fit with the distal surface of the flexion and extension gap pad (3.101) using a concave surface and a convex surface, the proximal surface of the tibial tray jig (2.100) is in interference fit with the distal surface of the pad jig (3.102) using a concave surface and a convex surface, and the thickness adjustment module (3.103) is provided with the same concave surface and convex surface.
10. The modular flexion-extension gap measurer/tibial prosthetic trial of claim 9, wherein the tibial tray trial (2.100) has a first proximal face (2.10), the first proximal face (2.10) having a first concave face (41), the first concave face (41) having a first conical face (32), a first straight face (33), an anterior slot (34), a posterior step (35 a,35 b);
the flexion-extension gap cushion block (3.101) is provided with a first distal end surface (3.20), the first distal end surface (3.20) is provided with a first convex surface (51), and the first convex surface (51) is provided with a second conical surface (43), a second straight surface (44) and a front step (49);
the shim test mould (3.102) has a second proximal joint face (3.30) and a second distal face (3.40), the second distal face (3.40) having a second convex face (59), the second convex face (59) and the first convex face (51) having the same structural features;
the thickness adjustment module (3.103) has a third proximal face (3.50) and a third distal face (3.60), the second proximal face (2.60) has a third concave face (75), the third concave face (75) has the same structural features as the first concave face (41) on the tibial tray trial (2.100), the third distal face (3.60) has a third convex face (61), and the third convex face (61) has the same structural features as the second convex face (59) on the shim trial (3.102).
11. The modular flexion-extension gap measurer/tibial prosthetic trial of claim 10, wherein the first taper surface (32) has a major end width of 10mm-50mm, a taper angle of 0-45 degrees, a length of 5mm-15mm, the anterior slot (34) has a width of 2mm-8mm, and the posterior step (35) has a height of 0.5mm-6.5mm.
12. The modular flexion-extension gap measurer/tibial prosthesis trial of claim 11, wherein the width of the large end of the second taper surface (43) is 0-0.5mm different from the width of the large end of the first taper surface (32), the taper angle of the second taper surface (43) is 0-3 degrees different from the taper angle of the first taper surface (32), the length of the second taper surface (43) is 0.2-0.5mm shorter than the length of the first taper surface (32), the height of the anterior step (49) is less than the height of the anterior slot (34), and the height of the anterior step (49) is less than the height difference between the top surface of the anterior slot (34) and the top surface of the posterior step (35).
13. The modular flexion and extension gap measurer/tibial prosthetic trial of claim 12, wherein the taper angle of the second taper surface (43) and the first taper surface (32) is 10 ° -15 °.
14. The modular flexion-extension gap measurer/tibial prosthesis trial of claim 3, 7 or 10, wherein the first distal end face (20, 2.20, 3.20) has a first upper slope (21, 2.21, 3.21), the second distal end face (40, 2.40, 3.40) has a second upper slope (24, 2.24, 3.24), the third distal end face (60, 2.60, 3.60) has a third upper slope (29, 2.29, 3.29), and the first upper slope (21, 2.21, 3.21), second upper slope (24, 2.24, 3.24) and third upper slope (29, 2.29, 3.29) have an inclination angle of 10-60 °.
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