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CN112972069A - Tibial prosthesis and knee joint prosthesis comprising same - Google Patents

Tibial prosthesis and knee joint prosthesis comprising same Download PDF

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Publication number
CN112972069A
CN112972069A CN201911210889.5A CN201911210889A CN112972069A CN 112972069 A CN112972069 A CN 112972069A CN 201911210889 A CN201911210889 A CN 201911210889A CN 112972069 A CN112972069 A CN 112972069A
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CN
China
Prior art keywords
tibial
distal
proximal
prosthesis
patient
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Granted
Application number
CN201911210889.5A
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Chinese (zh)
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CN112972069B (en
Inventor
李子欣
张文彪
许志勇
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Beijing Montagne Medical Device Co Ltd
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Beijing Montagne Medical Device Co Ltd
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Priority to CN201911210889.5A priority Critical patent/CN112972069B/en
Publication of CN112972069A publication Critical patent/CN112972069A/en
Application granted granted Critical
Publication of CN112972069B publication Critical patent/CN112972069B/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/38Joints for elbows or knees
    • A61F2/389Tibial components
    • 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
    • A61F2/30721Accessories
    • 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
    • A61F2/38Joints for elbows or knees
    • 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
    • A61F2/38Joints for elbows or knees
    • A61F2/3859Femoral components
    • 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
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The 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
    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30448Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (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)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)

Abstract

The invention relates to a tibia prosthesis and a knee joint prosthesis comprising the same, which are built in a modular manner, so that the operation cost can be reduced, the burden of a patient can be lightened, and micromotion can be eliminated, so that failure caused by the micromotion can be avoided, the service life of the tibia prosthesis can be greatly prolonged, and the situation that the patient frequently receives replacement operation can be avoided.

Description

Tibial prosthesis and knee joint prosthesis comprising same
Technical Field
The present invention relates to the field of medical instruments for orthopedic surgery, and more particularly, to a tibial prosthesis implanted in a patient to achieve a knee joint function of the patient in daily life after surgery and a knee joint prosthesis including the same.
Background
An artificial knee joint replacement is an orthopedic surgery for replacing a diseased joint of a human body by using an artificial biomaterial and recovering the normal physiological function of the knee joint. During surgery, the surgeon needs to perform a characterized osteotomy of the patient's knee joint to match the prosthetic joint prosthesis to restore the optimal knee joint stabilization morphology.
After the knee joint focus node is cut, according to preoperative planning and intraoperative cutting data, a doctor implants a knee joint prosthesis tibia component and a femur component which are suitable for specifications into a knee joint so as to replace the knee joint focus and recover the motion function of the joint.
In the process of the artificial knee joint replacement surgery, tibial components with different thicknesses are configured according to the requirements of recovering the stability of the joint according to the focus and the osteotomy degree of a patient, and the cost of the surgery is obviously increased; also, failure of the knee replacement procedure includes the cause that micro-motion between the tibial tray and the tibial insert in the tibial component increases polyethylene wear and may promote aseptic loosening and failure of the prosthesis, which in turn causes the patient to have to undergo replacement once again. Therefore, the knee joint tibial component without micromotion has great significance for the design and clinical application of the knee joint prosthesis.
The tibial components used in the current artificial knee joint replacement are divided into two categories, one category of tibial components is assembled by a mechanical mechanism in a press fit and locking manner, and in order to meet clinical requirements, manufacturers are generally required to produce a plurality of types of tibial components which only have differences in thickness, so that the cost of the replacement operation is high, the burden of the operation cost of a patient is heavy, and the product micromotion cannot be avoided; the other is that the tibial component is a whole body, the whole body material of which is ultra-high molecular weight polyethylene, and in order to meet clinical requirements, manufacturers are also required to produce a plurality of tibial components with differences only in thickness, which also results in higher cost of replacement surgery and heavier burden on the cost of the patient surgery.
It would therefore be desirable to have a modular prosthetic component that is created to reduce the cost of the procedure and to overcome micro-motion of the prosthetic component to reduce the cause of failure of the prosthetic component.
Disclosure of Invention
In order to solve at least one of the above-mentioned problems in the prior art, the present invention proposes a tibial prosthesis and a knee joint prosthesis including the same.
The tibial prosthesis configured for surgically replacing a proximal tibia of a patient and for performing knee joint function as the proximal tibia of the patient in post-operative daily life, the tibial prosthesis comprising:
a tibial tray configured to be secured to a patient's tibia at a distal bone-joining face thereof;
a tibial insert comprising a proximal articular surface for mating with a patient's femur or a femoral prosthesis; and
an intermediate layer disposed between the tibial tray and the tibial insert;
wherein the intermediate layer is bonded to the proximal surface of the tibial tray and the distal surface of the tibial insert by a biocompatible adhesive.
According to a possible embodiment of the invention, the intermediate layer is constituted by the biocompatible adhesive.
According to a possible embodiment of the invention, the tibial tray comprises a first plurality of grooves recessed from its proximal surface for receiving the biocompatible adhesive, and the tibial insert comprises a second plurality of grooves recessed from its distal surface for receiving the biocompatible adhesive.
Optionally, at least some of the first plurality of grooves extend from the proximal surface to the distal bone surface.
Optionally, the geometry of at least some of the plurality of second grooves is arranged such that their width at the distal surface is less than their maximum width; and, the geometry of at least some of the plurality of first grooves is arranged such that their width at the proximal surface is less than their maximum width.
According to a possible embodiment of the invention, the proximal surface comprises at its edges a proximal inclined surface inclined with respect to the proximal-distal direction and the distal surface comprises at its edges a distal inclined surface inclined with respect to the proximal-distal direction, wherein the proximal inclined surface and the distal inclined surface are adapted to conform to each other.
According to a possible embodiment of the invention, the plurality of second grooves comprises at least one second main groove and a plurality of second additional grooves communicating with the second main groove, wherein the width of the second main groove is at least 2 times, preferably at least 4 times, more preferably 6-10 times the width of the second additional groove.
According to a possible embodiment of the invention, at least some of the plurality of second grooves open out onto the exterior of the tibial insert in a direction transverse to the proximal-distal direction.
According to a possible embodiment of the invention, the geometry of at least some of the plurality of second grooves is such that their depth increases progressively as they extend from the centre of the distal surface towards the edge of the distal surface.
According to a possible embodiment of the invention, the intermediate layer comprises at least one spacer, the proximal and distal surfaces of each spacer, opposite to each other, being in contact with the biocompatible adhesive, the spacers being configured in such a way that their number can be adjusted according to the dimensions of the knee joint to be replaced of the patient.
According to a possible embodiment of the invention, each shim comprises: a plurality of third grooves recessed from a proximal surface of the spacer thereof for receiving the biocompatible adhesive; and a plurality of fourth grooves recessed from a shim distal surface thereof for receiving the biocompatible adhesive.
The present invention also relates to a knee joint prosthesis configured for displacing a knee joint of a patient in a surgical operation and implementing a knee joint function as the knee joint of the patient in a post-operative daily life, and comprising: a femoral prosthesis configured to replace a distal femur of a patient and to perform a knee joint function as the distal femur of the patient in post-operative daily life; and the tibia prosthesis matched with the femur prosthesis.
The invention may be embodied in the form of exemplary embodiments shown in the drawings. It is to be noted, however, that the drawings are designed solely for purposes of illustration and that any changes which come within the teachings of the invention are to be considered as included within the scope of the invention, which is defined solely by the appended claims.
Drawings
The drawings illustrate exemplary embodiments of the invention. These drawings should not be construed as necessarily limiting the scope of the invention. Like numbers and/or like reference numerals may refer to like and/or like elements throughout. In the various drawings:
fig. 1 is a schematic perspective view of a tibial prosthesis according to a possible embodiment of the invention;
fig. 2A is a schematic perspective view of a tibial tray of a tibial prosthesis according to one possible embodiment of the invention;
fig. 2B is a schematic top view of a tibial tray of a tibial prosthesis according to one possible embodiment of the invention;
FIG. 2C is a schematic cross-sectional view of the tibial tray taken along line I-I in FIG. 2B;
fig. 3A is a schematic perspective view of a tibial insert of a tibial prosthesis according to one possible embodiment of the present invention;
fig. 3B is a schematic front view of a tibial insert of a tibial prosthesis according to one possible embodiment of the present invention;
fig. 3C is a schematic right side view of a tibial insert of a tibial prosthesis according to one possible embodiment of the present invention;
fig. 3D is a schematic bottom view of a tibial insert of a tibial prosthesis according to one possible embodiment of the present invention;
fig. 4 is a schematic perspective view of a tibial prosthesis according to a possible embodiment of the invention;
FIG. 5A is a schematic top view of a tibial prosthetic insert according to one possible embodiment of the present invention;
FIG. 5B is a schematic bottom view of a shim of a tibial prosthesis according to one possible embodiment of the present invention; and
fig. 5C is a schematic cross-sectional view of the gasket taken along line II-II in fig. 5A.
Detailed Description
The present invention will now be described in more detail with reference to the accompanying drawings, in which exemplary embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as necessarily limited to the exemplary embodiments set forth herein. Rather, these exemplary embodiments are provided merely to illustrate the invention and to convey the concept of the invention to those skilled in the art.
As used herein, with reference to the human body and the components of the systems described herein that are intended to be implanted in the human body, the terms "proximal/proximal end P" and "distal/distal end D" are defined with respect to the position of a limb relative to the torso, wherein the term "proximal/proximal end P" is the end of the limb, bone or prosthesis that is closer to the torso, the term "distal/distal end D" is the end of the limb, bone or prosthesis that is farther from the torso, and the term "proximal/proximal end P" together with the term "distal/distal end D" defines the distal-proximal direction PD. It will be understood by those skilled in the art that the term "proximal/proximal end P" may be equivalent to "upper side/upper end", the term "distal/distal end D" may be equivalent to "lower side/lower end", and the term "distal-proximal direction PD" may be equivalent to the vertical direction in the human body standing state. It is to be noted, however, that the above definitions regarding relative orientations are only given for the purpose of better illustrating the technical solution of the present invention and should not be construed as limiting the scope of protection of the present invention in any way.
The tibial prosthesis according to the present invention is intended to be implanted in a patient to replace the proximal tibia of a resected diseased knee joint of the patient, thereby fulfilling knee joint function as the proximal tibia of the knee joint of the patient in daily life. Referring to fig. 1-3, the size and shape of a tibial prosthesis according to the present invention is determined by the size and shape of the proximal end of a tibia to be resected measured before a knee replacement procedure and/or the proximal end of a resected tibia measured during a replacement procedure of a patient, which includes: a tibial tray 100, said tibial tray 100 being configured to be fixed to the patient's tibia at its distal bone-joining face 110, in particular, said tibial tray 100 comprising a peg 150 extending distally from its distal bone-joining face 110, said peg 150 being intended to be inserted in the patient's tibia (in particular, in the medullary cavity of the tibia) for fixing and supporting the entire tibial prosthesis with respect to the patient's tibia (of course, the proximal tibia end of the patient's tibia has been cut away before inserting the peg 150 in the tibia); a tibial insert 200, the tibial insert 200 including a proximal articular surface 210 for mating with a patient's femur or femoral prosthesis; and an intermediate layer 300 disposed between the tibial tray 100 and the tibial insert 200; wherein the intermediate layer 300 is bonded to the proximal surface 120 of the tibial tray 100 and the distal surface 220 of the tibial insert 200 by a biocompatible adhesive (e.g., bone cement).
According to the above technical solution, since the intermediate layer 300 is bonded to the proximal surface 120 of the tibial tray 100 and the distal surface 220 of the tibial pad 200 by means of a biocompatible adhesive rather than a mechanical locking structure, that is, the tibial tray 100, the tibial pad 200 and the intermediate layer 300 are bonded together by means of adhesion rather than a mechanical locking structure. Therefore, in the daily life after being implanted into the body of a patient, micro-motion does not occur among the tibial tray 100, the tibial gasket 200 and the intermediate layer 300, so that the failure of the prosthesis due to the micro-motion can be avoided, thereby greatly improving the service life of the tibial prosthesis of the present invention and enabling the patient not to suffer from the pain of frequently replacing the tibial prosthesis. Furthermore, because the bonding will be adhesive, neither the proximal surface 120 of the tibial tray 100 nor the distal surface 220 of the tibial insert 200 need to be finished or otherwise roughness required, which enables the cost of machining the tibial prosthesis of the present invention to be saved. In addition, since the thickness of the adhesive is adjustable to some extent, the height of the tibial prosthesis of the present invention in the near-far direction PD (vertical direction in the human body standing state) is adjustable to some extent, and this makes it possible to adapt the tibial prosthesis of the present invention to a greater number of patients to some extent.
According to a possible embodiment of the invention, the intermediate layer 300 is constituted by the biocompatible adhesive (for example, bone cement).
Referring to fig. 2A and 3A, according to one possible embodiment of the present invention, the tibial tray 100 includes a plurality of first grooves 130 recessed from a proximal surface 120 thereof for receiving the biocompatible adhesive, and the tibial pad 200 includes a plurality of second grooves 230 recessed from a distal surface 220 thereof for receiving the biocompatible adhesive.
According to the above technical solution, due to the presence of the first groove 130 and the second groove 230, the contact area of the biocompatible adhesive with the tibial tray 100 and the tibial pad 200 is significantly increased, which enables the adhesive to more firmly combine the tibial tray 100, the tibial pad 200 and the intermediate layer 300 together, thereby more completely eliminating the micromotion and thus improving the service life and reliability of the tibial prosthesis of the present invention.
Referring to fig. 2A-2C, according to one possible embodiment of the invention, at least some of the plurality of first grooves 130 extend from the proximal surface 120 to the distal bone surface 110.
According to the above technical solution, since all or part of the first groove 130 extends from the proximal surface 120 to the distal bone surface 110, i.e., through the tibial tray 100, the biocompatible adhesive may flow from the proximal surface 120 to the distal bone surface 110 through the first groove 130, which allows a locking structure to be formed when the biocompatible adhesive is cured, thereby enabling the tibial tray 100 and the intermediate layer 300 to be more firmly combined together, thereby more completely eliminating the micro-motion and thus improving the lifespan and reliability of the tibial prosthesis of the present invention.
Referring to fig. 3A-3C, according to one possible embodiment of the invention, at least some of the plurality of second grooves 230 have a geometry such that their width Ds at the distal surface 220 is smaller than their maximum width Dmax. Likewise, in a possible embodiment not shown, at least some of the first plurality of grooves 130 have a geometry such that their width at the proximal surface 120 is less than their maximum width. The above-mentioned "width" is understood to mean the dimension of the groove in a direction transverse to its main extension direction.
According to the above technical solution, since the maximum width of all or a part of the groove is greater than the width of the opening thereof at the corresponding surface, the biocompatible adhesive can form a locking structure after entering the groove and curing. In particular, due to the shape of the groove, the width of the biocompatible adhesive entering the groove through the opening of the groove at the respective surface will be larger than the width of said opening, which is such that the biocompatible adhesive will not be able to escape the respective opening after curing. Therefore, by the technical scheme, the tibia tray 100, the tibia pad 200 and the middle layer 300 can be combined together more firmly, so that the micromotion is eliminated more completely, and the service life and the reliability of the tibia prosthesis are prolonged.
Referring to fig. 2A-3C, according to one possible embodiment of the present invention, the proximal end surface 120 includes a proximal inclined surface 121 inclined with respect to a distal-proximal direction PD (human body standing vertical direction) at an edge thereof, and the distal end surface 220 includes a distal inclined surface 221 inclined with respect to a distal-proximal direction PD (human body standing vertical direction) at an edge thereof, wherein the proximal inclined surface 121 and the distal inclined surface 221 are adapted to fit each other.
According to the above technical solution, when assembling the tibial prosthesis of the present invention, since the proximal inclined surface 121 and the distal inclined surface 221 can be fitted to each other, it is possible to more easily position the tibial tray 100 and the tibial pad 200 with respect to each other, and to prevent the biocompatible adhesive between the proximal surface 120 and the distal surface 220 from escaping.
Referring to fig. 3D, according to a possible embodiment of the invention, the plurality of second grooves 230 comprises at least one second main groove 231 and a plurality of second additional grooves 232 communicating with the second main groove 231, wherein the width of the second main groove 231 is at least 2 times, preferably at least 4 times, more preferably 6-10 times the width of the second additional grooves 232.
According to the above technical solution, when assembling the tibial prosthesis of the present invention, some more biocompatible adhesive may be applied at the area of the second main groove 231, and then when the tibial tray 100 and the tibial pad 200 are brought close to each other, the compressed biocompatible adhesive will easily enter the second main groove 231 since the second main groove 231 is wide, and further since the second main groove 231 communicates with the second attaching groove 232, the biocompatible adhesive will flow from the second main groove 231 to the second attaching groove 232, which facilitates filling of the respective grooves with the biocompatible adhesive, thereby enabling the tibial tray 100 and the intermediate layer 300 to be more firmly coupled together.
Referring to fig. 3A-3D, according to a possible embodiment of the invention, at least some of the plurality of second grooves 230 open out of the tibial insert 200 in a direction transverse to the proximal-distal direction PD. Alternatively, according to a possible embodiment of the invention, not shown, at least some of the second grooves 230 have a geometry such that their depth increases progressively as they extend from the centre of the distal surface 220 towards the edge of the distal surface 220.
According to the above technical solution, since at least some of the second grooves 230 open to the outside of the tibial insert 200 in the lateral direction, when the tibial prosthesis of the present invention is assembled, gas (e.g., air) originally present in the grooves can be easily discharged by the biocompatible adhesive, thereby enabling the biocompatible adhesive to more sufficiently fill the grooves so as to obtain a more secure adhesion. Alternatively, as the depth of at least some of the second grooves 230 gradually increases from the center of the distal surface 220 toward the edge of the distal surface 220, the biocompatible adhesive will fill the grooves starting from the shallower depth portion of the grooves and gradually expel air to the deeper depth portion of the grooves, further as the shallower depth portion is located at the center of the distal surface 220 and the deeper depth portion is located at the edge of the distal surface 220, the air will be expelled from the center of the distal surface 220 toward the edge of the distal surface 220 and finally to the outside from the edge of the distal surface 220. This further promotes the discharge of air in the grooves, thereby further ensuring that a firm bond is achieved.
It is to be noted that those skilled in the art will understand that the above definitions regarding various shapes, sizes, arrangements, etc. of the second grooves 230 obviously also apply to the first grooves 130, and therefore it is obviously also included in the scope of the present invention to apply the definitions of various shapes, sizes, arrangements, etc. of the second grooves 230 to the first grooves 130.
Referring to fig. 4 to 5C, according to one possible embodiment of the present invention, the intermediate layer 300 includes at least one spacer 310, a spacer proximal surface 311 and a spacer distal surface 312 of each spacer 310, which are opposite to each other, are in contact with the biocompatible adhesive, and the number of the spacers 310 is configured to be adjustable according to the size of the knee joint to be replaced of the patient. In particular, the thickness of the shim 310 is less than the height of the narrowest point of the first lateral surface 140 of the tibial tray 100, which first lateral surface 140 connects the distal end facet 110 to the proximal end facet 120, and is also less than the height of the narrowest point of the second lateral surface 240 of the tibial insert 200, which second lateral surface 240 connects the distal end facet 220 to the proximal end facet 210.
According to the above technical solution, since the number of the spacers 310, and thus the height of the tibial prosthesis of the present invention, can be adjusted according to the size of the knee joint to be replaced of the patient, the tibial prosthesis of the present invention can be suitably implanted into the patient regardless of the size of the knee joint to be replaced of the patient, or regardless of the degree of osteotomy of the patient during the surgery, thereby helping the patient to restore the knee joint function. In addition, according to the above technical solution, the height of the tibial prosthesis can be adjusted in a stepwise manner (or, quickly adjusted in a wide range) by adjusting the number of the spacers 310, and the height of the tibial prosthesis can be adjusted in a fine manner (or, continuously adjusted) by adjusting the amount of the biocompatible adhesive, so that the height of the tibial prosthesis can be adjusted in a wide range, quickly and continuously by using the spacers 310 in cooperation with the biocompatible adhesive, so that the tibial prosthesis of the present invention can be suitably implanted into a patient to help the patient restore the function of the knee joint for any knee joint size and any osteotomy degree of any patient.
Referring to fig. 5A-5C, according to a possible embodiment of the invention, each shim 310 comprises: a plurality of third grooves 313 recessed from its spacer proximal surface 311 for receiving the biocompatible adhesive; and a plurality of fourth grooves 314 recessed from its spacer distal surface 312 for receiving the biocompatible adhesive.
According to the above technical solution, due to the presence of the third groove 313 and the fourth groove 314, the contact area of the biocompatible adhesive with the shim 310 is significantly increased, which enables the shim 310 to be more firmly bonded in the tibial prosthesis, thereby effectively eliminating micromotion and prolonging the service life of the tibial prosthesis.
Referring to fig. 5C, according to one possible embodiment of the invention, the spacer proximal end surface 311 comprises at its edge a spacer proximal end inclined surface 315 inclined with respect to the distal-proximal direction PD, and the spacer distal end surface 312 comprises at its edge a spacer distal end inclined surface 316 inclined with respect to the distal-proximal direction PD, wherein the spacer proximal end inclined surface 315 is adapted to abut the distal end inclined surface 221 and the spacer distal end inclined surface 316 is adapted to abut the proximal end inclined surface 121.
According to the above technical solution, when assembling the tibial prosthesis of the present invention, since the proximal inclined surface 121, the distal inclined surface 221, and the shim proximal inclined surface 315 and the shim distal inclined surface 316 of each shim 310 can be fitted to each other, it is possible to more easily position the tibial tray 100, each shim 310, and the tibial pad 200 with respect to each other, and to prevent biocompatible adhesives from escaping.
It is to be noted that those skilled in the art will understand that the above definitions regarding various shapes, sizes, arrangements, etc. of the first and second grooves 130 and 230 are obviously also applicable to the third and fourth grooves 313 and 314, and therefore, it is obviously included within the scope of the present invention to apply the definitions regarding various shapes, sizes, arrangements, etc. of the first and second grooves 130 and 230 to the third and fourth grooves 313 and 314.
Furthermore, the present invention relates to a knee joint prosthesis configured for displacing a knee joint of a patient in a surgical operation and for performing a knee joint function as the knee joint of the patient in a post-operative daily life, the knee joint prosthesis comprising: a femoral prosthesis configured to replace a distal femur end of a patient's knee joint and to perform knee joint function as the distal femur end of the patient in post-operative daily life; and the tibia prosthesis matched with the femur prosthesis.
Preferred but non-limiting embodiments of a tibial prosthesis and a knee joint prosthesis comprising the same according to the invention are described in detail above with the aid of the accompanying drawings. Modifications and additions to the techniques and structures may become apparent to those skilled in the art without departing from the scope and spirit of this disclosure as set forth in the following claims. Accordingly, such modifications and additions that may be contemplated under the teachings of the present invention are intended to be part of this disclosure. The scope of the present disclosure is defined by the following appended claims, and includes equivalents known at the time of filing this disclosure and equivalents not yet foreseen.

Claims (10)

1. A tibial prosthesis configured for replacing a proximal tibia of a patient during a surgical procedure and performing a knee joint function as the proximal tibia of the patient in post-operative daily life, the tibial prosthesis comprising:
a tibial tray (100), the tibial tray (100) configured to be secured to a patient's tibia at a distal bone-joining face (110) thereof;
a tibial insert (200), the tibial insert (200) comprising a proximal articular surface (210) for mating with a femur or femoral prosthesis of a patient; and
an intermediate layer (300) disposed between the tibial tray (100) and the tibial insert (200);
wherein the intermediate layer (300) is bonded to the proximal surface (120) of the tibial tray (100) and the distal surface (220) of the tibial insert (200) by a biocompatible adhesive.
2. The tibial prosthesis of claim 1, wherein the intermediate layer (300) is comprised of the biocompatible adhesive.
3. The tibial prosthesis of claim 1 or 2, wherein the tibial tray (100) comprises a first plurality of grooves (130) recessed from a proximal surface (120) thereof for receiving the biocompatible adhesive, the tibial insert (200) comprises a second plurality of grooves (230) recessed from a distal surface (220) thereof for receiving the biocompatible adhesive;
optionally, at least some of the first plurality of grooves (130) extend from the proximal surface (120) to the distal bone surface (110);
optionally, the geometry of at least some of the plurality of second grooves (230) is arranged such that their width at the distal surface (220) is less than their maximum width; and the geometry of at least some of the plurality of first grooves (130) is arranged such that their width at the proximal surface (120) is smaller than their maximum width.
4. Tibial prosthesis according to claim 1 or 2, wherein the proximal surface (120) comprises at its edge a proximal inclined surface (121) inclined with respect to the distal-Proximal Direction (PD), the distal surface (220) comprises at its edge a distal inclined surface (221) inclined with respect to the distal-Proximal Direction (PD), wherein the proximal inclined surface (121) and the distal inclined surface (221) are adapted to fit each other.
5. The tibial prosthesis of claim 3, wherein the plurality of second flutes (230) comprises at least one second primary flute (231) and a plurality of second secondary flutes (232) in communication with the second primary flute (231), wherein the width of the second primary flute (231) is at least 2 times the width of the second secondary flute (232).
6. The tibial prosthesis of claim 3, wherein at least some of the plurality of second flutes (230) open to an exterior of the tibial insert (200) in a direction transverse to the distal-Proximal Direction (PD).
7. The tibial prosthesis of claim 3, wherein the geometry of at least some of the plurality of second grooves (230) is such that their depth gradually increases as they extend from the center of the distal surface (220) towards the edge of the distal surface (220).
8. The tibial prosthesis of claim 1, wherein the intermediate layer (300) comprises at least one shim (310), a shim proximal surface (311) and a shim distal surface (312) of each shim (310) opposite each other being in contact with the biocompatible adhesive, the shims (310) being configured in a number that is adjustable according to a size of a patient's knee joint to be replaced.
9. The tibial prosthesis of claim 8, wherein each shim (310) comprises: a plurality of third grooves (313) recessed from a shim proximal surface (311) thereof for receiving the biocompatible adhesive; and a plurality of fourth grooves (314) recessed from a shim distal surface (312) thereof for receiving the biocompatible adhesive.
10. A knee joint prosthesis configured for surgically replacing a patient's knee joint and for performing knee joint function as the patient's knee joint in post-operative daily life, comprising: a femoral prosthesis configured to replace a distal femur of a patient and to perform a knee joint function as the distal femur of the patient in post-operative daily life; and a tibial component according to any of claims 1 to 9 in cooperation with the femoral component.
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CN203852452U (en) * 2014-05-23 2014-10-01 北京威高亚华人工关节开发有限公司 Stable pad type arthroplasty knee joint
CN107280821A (en) * 2017-08-01 2017-10-24 北京安颂科技有限公司 Rotation platform knee-joint prosthesis
CN211187661U (en) * 2019-12-02 2020-08-07 北京蒙太因医疗器械有限公司 Tibial prosthesis and knee joint prosthesis comprising same

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CN102793594A (en) * 2012-08-18 2012-11-28 深圳清华大学研究院 Artificial knee joint
CN203852452U (en) * 2014-05-23 2014-10-01 北京威高亚华人工关节开发有限公司 Stable pad type arthroplasty knee joint
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