WO2020155378A1 - 关节垫片假体及具有其的关节假体 - Google Patents

关节垫片假体及具有其的关节假体 Download PDF

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Publication number
WO2020155378A1
WO2020155378A1 PCT/CN2019/081498 CN2019081498W WO2020155378A1 WO 2020155378 A1 WO2020155378 A1 WO 2020155378A1 CN 2019081498 W CN2019081498 W CN 2019081498W WO 2020155378 A1 WO2020155378 A1 WO 2020155378A1
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WIPO (PCT)
Prior art keywords
joint
gasket
prosthesis
elastic
contact surface
Prior art date
Application number
PCT/CN2019/081498
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English (en)
French (fr)
Inventor
张卫平
Original Assignee
北京爱康宜诚医疗器材有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 北京爱康宜诚医疗器材有限公司 filed Critical 北京爱康宜诚医疗器材有限公司
Priority to EP19914127.6A priority Critical patent/EP3868340A4/en
Priority to JP2019533653A priority patent/JP7015309B2/ja
Priority to US17/042,962 priority patent/US11331195B2/en
Publication of WO2020155378A1 publication Critical patent/WO2020155378A1/zh

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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3082—Grooves
    • A61F2002/30822—Circumferential grooves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3082—Grooves
    • A61F2002/30827—Plurality of grooves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3082—Grooves
    • A61F2002/30827—Plurality of grooves
    • A61F2002/30831—Plurality of grooves perpendicular with respect to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/30934—Special articulating surfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A61F2/3859—Femoral components
    • A61F2002/3863—Condyles fitted on an anchored base
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A61F2/3877—Patellae or trochleae
    • A61F2002/3881—Patellae or trochleae with moving parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A61F2002/3895—Joints for elbows or knees unicompartimental

Definitions

  • the present invention relates to the field of artificial prosthesis replacement, in particular to a joint gasket prosthesis and a joint prosthesis having the same.
  • the knee joint prosthesis used in artificial knee replacement surgery is usually made of medical metal on the femur side to make the femoral condyle prosthesis, such as stainless steel or cobalt alloy, and the tibia side is made of ultra-high molecular weight polyethylene as a gasket.
  • the metal articular surface of the femoral condyle prosthesis is generally designed as a complex continuous spatial surface, but the UHMWPE articular gasket on the tibial side can only be designed according to a specific position ( For example, in the upright position, the articular surface of the femur has a curved surface with a higher degree of anastomosis to ensure the stability when upright.
  • the contact area between the femoral condyle prosthesis and the articular surface pad may be much smaller than the ideal value, which causes the pressure between the femoral condyle prosthesis and the articular surface pad to be too high and accelerates the articular surface pad. Wear of tablets.
  • the knee joint since the post-operative joint ligaments and soft tissues cannot establish a close connection similar to the original joint biological tissues between the implanted artificial joint prosthesis, the knee joint, a mechanical system that relies heavily on soft tissues to maintain balance, is stable. Greatly dropped.
  • the present invention aims to provide a joint gasket prosthesis and a joint prosthesis with the same, so as to solve the problem that the contact area between the femoral condyle prosthesis and the joint gasket prosthesis cannot be guaranteed in the prior art.
  • the gasket prosthesis is severely worn, leading to the problem of short service life of the patient's joint prosthesis.
  • it can establish an effective connection between the artificial joint prosthesis and the soft tissue around the human joint to enhance joint stability.
  • a joint gasket prosthesis comprising: an elastic gasket arranged between a first bone and a second bone forming a joint, the first bone refers to the The joint gasket prosthesis of the invention forms a bone with a significant sliding friction relationship.
  • the second bone refers to the bone on which the joint gasket prosthesis of the present invention is fixed;
  • the elastic gasket includes: an elastic matrix having a first contact surface facing the first bone And the second contact surface facing the second bone; multiple synovial fluid channels are distributed in the elastic matrix and communicate with the first contact surface and the second contact surface, and the multiple synovial fluid channels are arranged in a predetermined manner to make the elastic matrix rigid It gradually increases from the center to the edge and the elasticity of the elastic base gradually decreases from the center to the edge.
  • the plurality of synovial fluid channels includes a plurality of accommodating cavity layers and a plurality of flow passages, the plurality of accommodating cavity layers are arranged along the direction from the first contact surface to the second contact surface, and each accommodating cavity layer includes a plurality of accommodating cavity layers. Cavity, each flow channel is connected between two adjacent accommodating cavity layers.
  • the volumes of the multiple containing cavity layers gradually decrease from the first contact surface to the second contact surface.
  • the plurality of accommodating cavities gradually decrease from the first contact surface to the second contact surface.
  • the volumes of the multiple accommodating cavities located in the same accommodating cavity layer gradually decrease from the center to the edges.
  • synovial fluid channel further includes an inflow channel, which communicates with at least one accommodating cavity and/or at least one overflow channel, and a one-way valve is provided in the inflow channel.
  • the joint gasket prosthesis further includes a gasket base, the gasket base is arranged between the first bone and the second bone, the gasket base has a containing groove, the elastic gasket is arranged in the containing groove, and the hardness of the gasket base is Larger than elastic gaskets.
  • a positioning protrusion is provided on the circumferential side wall of the elastic base, and a positioning groove is provided at a position corresponding to the accommodating groove and the positioning protrusion.
  • the bottom surface of the gasket base is provided with an overflow groove
  • the bottom of the containing groove is provided with a communicating hole and communicates with the overflow groove, so that the joint fluid can enter the containing groove through the overflow groove and the communicating hole.
  • the gasket base further includes a communication channel, the inlet of the communication channel extends to the top surface of the gasket base, and the outlet of the communication channel communicates with the liquid inlet channel.
  • the joint gasket prosthesis further includes a reinforcing ring, which is arranged on the circumferential outer side of the gasket base.
  • the reinforcement ring infiltration layer and the integration layer are both porous structures, the infiltration layer can contact and fuse with the gasket matrix, the soft tissue around the joint can grow into the integration layer, and the isolation layer is arranged between the infiltration layer and the integration layer.
  • the reinforcing ring infiltration layer and the integration layer are both porous structures
  • the pore size of the porous structure of the infiltration layer is between 500 ⁇ m and 3000 ⁇ m
  • the pore size of the porous structure of the integration layer is between 400 ⁇ m and 2000 ⁇ m.
  • the elastic gasket is made of a transparent polymer material or composite material with elasticity.
  • a joint prosthesis including a joint gasket prosthesis, the joint gasket prosthesis being the above-mentioned joint gasket prosthesis.
  • the joint prosthesis is a knee joint prosthesis, and the knee joint prosthesis also includes a tibial plateau prosthesis and a femoral condyle prosthesis.
  • the joint fluid channel is arranged in a predetermined manner in the elastic gasket, and the elastic matrix is made by adjusting the cross-sectional shape, aperture, length, volume, position, arrangement direction, and density of the joint fluid channel.
  • the hardness gradually increases from the center to the edge, and the elasticity gradually decreases from the center to the edge, so that different elasticity and hardness indexes can be obtained at different predetermined parts of the elastic gasket, so that the elastic gasket can be as close as possible to the human joints
  • the mechanical characteristics of the joint can make the elastic gasket fully contact the joint bone when the joint is moving, and then keep the pressure between the contact surfaces within the ideal range, ensuring the use effect and life of the joint gasket prosthesis.
  • porous structure design of the reinforced ring integration layer with a pore size between 400 ⁇ m and 2000 ⁇ m enables the joint capsule and the original ligament residues that are wrapped around the joint gasket prosthesis after the operation to grow into the porous structure pores of the integration part.
  • the formation of biological tissue integration During the postoperative healing process, soft tissues such as ligaments can grow into the voids of the porous structure, thereby making the postoperative knee joint system more stable.
  • Fig. 1 shows an exploded structural diagram of the first embodiment of the joint gasket prosthesis according to the present invention
  • Fig. 2 shows a schematic sectional view of the joint gasket prosthesis of Fig. 1 in a combined state
  • Fig. 3 shows a schematic diagram of a partial enlarged structure at C of the joint gasket prosthesis of Fig. 2;
  • Fig. 4 shows a schematic view of the A-direction structure of the reinforcing ring of the joint gasket prosthesis of Fig. 1;
  • Fig. 5 shows a schematic diagram of a partial enlarged structure at B of the joint gasket prosthesis of Fig. 1;
  • FIGS 6 and 7 show schematic diagrams of the fluid delivery principle of the joint gasket prosthesis of Figure 1;
  • Fig. 8 shows an exploded structural schematic diagram of the second embodiment of the joint gasket prosthesis according to the present invention.
  • FIG. 9 to 11 show schematic structural diagrams of the joint gasket prosthesis of FIG. 8 in different postures
  • Fig. 12 shows a schematic sectional view of the elastic gasket of the joint gasket prosthesis of Fig. 8;
  • FIGS 13 and 14 show schematic diagrams of the fluid delivery principle of the joint gasket prosthesis of Figure 8;
  • Fig. 15 shows a schematic diagram of the bottom structure of the gasket base of the joint gasket prosthesis of Fig. 8;
  • Fig. 16 shows an exploded structural diagram of the third embodiment of the joint gasket prosthesis according to the present invention.
  • Fig. 17 shows an exploded structural diagram of the fourth embodiment of the joint gasket prosthesis according to the present invention.
  • the joint gasket prosthesis of the present application is suitable for artificial joint replacement surgery to absorb the impact generated when the joint moves and reduce the friction damage between the joint bones.
  • the femur swings and rotates relative to the tibia to achieve bending and turning movements.
  • the cartilage on the lower end of the femur (femoral condyle) and the upper end of the tibia (tibial plateau) and the meniscus structure rise between the femur and the tibia. To the role of gaskets.
  • the upper and lower surfaces of the meniscus structure have similar bending trends to the lower surface of the femur and the upper surface of the tibia, respectively, which increases the contact area of the joint, increases the stability of the joint, and reduces the pressure.
  • the meniscus structure also has good elasticity, can moderate topographical changes to absorb impact and shock, and adapt to the anatomical shape of the lower end of the femur when the knee joint is moving, ensuring the coordination of the knee joint geometry, thereby maintaining the coordination of knee joint movement.
  • the knee joint prosthesis used in artificial knee replacement surgery is usually made of medical metal on the femur side to make the femoral condyle prosthesis, and the tibia side is made of ultra-high molecular weight polyethylene as the gasket.
  • the gasket material is single and the structure is single. It has a certain degree of elasticity, but it is far from restoring the deformation amplitude of the original meniscus structure and cartilage, as well as the cushioning and anti-wear effects.
  • the gasket made of ultra-high molecular weight polyethylene lacks sufficient elasticity, when the knee joint starts to flex, the effective contact area between the femoral condyle prosthesis and the gasket may change as the position and angle between the femur and the tibia change. It is very small, and it can only meet line contact or point contact in certain positions, and local high pressure at these positions causes the joint surface to wear faster, which affects the life of the entire knee joint and affects the life of the patient after surgery; The original close connection between the ligaments and soft tissues around the joint and the implanted artificial joint prosthesis is lost, so the stability of the knee joint, a mechanical system that relies heavily on soft tissue to maintain balance, is greatly reduced.
  • This application proposes an improvement to the structure of the gasket in response to the above problems.
  • the joint gasket prosthesis of the first embodiment and the joint gasket prosthesis of the second embodiment both include an elastic gasket 10, which is arranged between the femoral structure and the tibial structure
  • the elastic gasket 10 includes an elastic base and a plurality of joint fluid channels distributed in the elastic base.
  • the elastic base has a first contact surface facing the femoral structure and a second contact surface facing the tibial structure.
  • a plurality of synovial fluid channels connect the first contact surface and the second contact surface so that the synovial fluid can pass through the elastic base and flow in the elastic base .
  • the plurality of synovial fluid channels are arranged in a predetermined manner such that the hardness of the elastic base gradually increases from the center to the edge and the elasticity of the elastic base gradually decreases from the center to the edge.
  • the joint gasket prosthesis 2 is set on the tibial plateau prosthesis 3.
  • the upper surface of the elastic gasket 10 and the femoral condyle in the joint gasket prosthesis 2 The prosthesis 1 fits; as shown in Figure 10, the weight and impact force of the human body is applied to the elastic gasket 10 of the joint gasket prosthesis 2.
  • the compression deformation of the elastic gasket 10 serves as a buffer.
  • the gasket matrix 20 and the elastic pad 10 share the mechanical load transmitted by the femoral condyle prosthesis; as shown in Figure 11, when the knee joint is flexed, the elastic pad 10 is locally compressed and deformed, and the outer side is relatively high in hardness and low in elasticity.
  • the internal high elasticity and low hardness characteristics enable the elastic gasket to ensure a relatively sufficient contact area with the femoral condyle under uneven loads and share the mechanical load transmitted by the femoral condyle prosthesis with the base body 20.
  • the joint fluid channel is arranged in the elastic gasket 10 in a predetermined manner, and the cross-sectional shape, aperture, length, volume, position, arrangement direction and density of the joint fluid channel are adjusted to make
  • the hardness of the elastic matrix gradually increases from the center to the edge, while the elasticity gradually decreases from the center to the edge. In this way, different elasticity and hardness indexes can be obtained at different predetermined positions of the elastic gasket 10, so that the elastic gasket 10 can be as good as possible.
  • the elastic gasket 10 can fully contact the femoral condyle when the knee joint is active, thereby keeping the pressure between the contact surfaces within the ideal range, ensuring the use effect and life of the joint gasket prosthesis .
  • the elastic gasket 10 of this embodiment is made of a transparent polymer material or composite material with elasticity.
  • the joint fluid channel includes a plurality of containing cavity layers (T1, T2, T3, T4) and a plurality of flow channels 12, and the containing cavity layer T1
  • the accommodating cavity layer T4 is arranged along the direction from the first contact surface to the second contact surface, each accommodating cavity layer includes a plurality of accommodating cavities 11, and the flow channel 12 is connected between the accommodating cavities of two adjacent accommodating cavity layers. between.
  • the overflow channel 12b communicates with the containing cavity 11a of the containing cavity layer T1 and the containing cavity 11b of the containing cavity layer T2
  • the overflow channel 12c communicates with the containing cavity 11b and the containing cavity 11c of the containing cavity layer T3
  • the overflow channel 12d communicates with the containing cavity 11c.
  • the plurality of accommodating cavities 11 in this embodiment gradually decrease from the accommodating cavity layer T1 to the accommodating cavity layer T4, and the overall volume of each accommodating cavity layer is made to extend from the first contact surface to the first contact surface.
  • the direction of the two contact surfaces gradually decreases.
  • the joint fluid channel arranged in this way can make the side of the elastic substrate close to the first contact surface relatively high in elasticity, and the side close to the second contact surface is relatively low in elasticity, which facilitates the contact between the first contact surface and the femoral condyle.
  • the synovial fluid channel of this embodiment further includes an inflow channel 13, which communicates with the accommodating cavity 11, so that the inflow channel 13 and each accommodating cavity in each accommodating cavity layer 11 and the overflow channel 12 connected between the containing cavity layers are connected.
  • a one-way valve 14 is provided in the inlet channel 13. As shown in FIG. 7, when the elastic gasket 10 is squeezed and deformed under a load, the one-way valve 14 reacts to the joint fluid.
  • the synovial fluid When closed under pressure, the synovial fluid can only drain upward through the containing cavity 11 and the overflow channel 12 to the first contact surface, reducing the friction between the first contact surface and the femoral condyle;
  • the elastic matrix recovers and a negative pressure is formed in the joint fluid channel, the one-way valve 14 is opened, and the joint fluid can enter the receiving cavity 11 and the overflow channel 12 through the inflow channel 13. In this way, the cycle of synovial fluid replenishment and injection into the friction surface can be completed when the knee joint is moving.
  • the joint gasket prosthesis of this embodiment further includes a gasket base 20, which is arranged between the femoral structure and the tibial structure.
  • the gasket base 20 has a receiving groove 21, and an elastic pad
  • the sheet 10 is arranged in the receiving groove 21, and the hardness of the gasket base 20 is greater than that of the elastic gasket 10.
  • An optional material compatibility method is that the elastic gasket 10 is made of polyurethane material, and the gasket base 20 can be made of ultra-high molecular weight polyethylene.
  • the annular edge of the containing groove 21 can be similar to a physiological meniscus. Function to enhance the support effect and wear resistance of the elastic gasket 10.
  • the joint fluid channel and other structures in the elastic gasket 10 can be formed by engraving and ablating the interior of the transparent polyurethane material by laser femtosecond technology.
  • the gasket base 20 of this embodiment further includes a communication channel 28, the inlet of the communication channel 28 extends to the top surface of the gasket base 20, and the outlet of the communication channel 28 communicates with the inlet channel 13 to connect Synovial fluid is introduced into the synovial fluid channel.
  • a positioning protrusion 15 is provided on the circumferential side wall of the elastic base of this embodiment, and a positioning protrusion 15 is provided at the position corresponding to the receiving groove 21 and the positioning protrusion 15. ⁇ 25 ⁇ Slot 25. After the elastic gasket 10 is placed in the containing groove 21, the positioning protrusion 15 can extend into the positioning groove 25 to prevent the elastic gasket 10 from falling out.
  • the spacer base 20 also includes a patella groove 29 that is matched with the patella and its ligaments.
  • the joint gasket prosthesis of this embodiment further includes a reinforcement ring 30, which is disposed in the reinforcement ring receiving groove 23 on the circumferential outer side of the gasket base 20, and is preferably made of medical metal material .
  • the reinforcing ring 30 is embedded on the circumferential outer side of the gasket base 20 to improve the joint strength of the joint gasket prosthesis.
  • the reinforcing ring 30 of this embodiment includes an infiltration layer 33, an isolation layer 32, and an integrated layer 31, and the infiltration layer 33 and the integrated layer 31 adopt a porous structure.
  • the pore size of the infiltration layer 33 of the reinforcing ring 30 of this embodiment is between 500 ⁇ m and 3000 ⁇ m, and the pore size of the integration layer 31 is between 400 ⁇ m and 2000 ⁇ m.
  • the UHMWPE material forming the gasket base 20 can penetrate into the porous structure of the infiltration layer 33 and contact and fuse with the gasket base 20 to realize the connection and fixation between the reinforcing ring 30 and the gasket base 20 .
  • the integrated layer 31 is exposed. After the operation, the ligament and soft tissue cells of the knee joint covering the corresponding parts of the joint gasket prosthesis will grow into the pores of the integrated layer 31 to form biological tissue integration.
  • the isolation layer 32 is a solid structure and is arranged between the infiltration layer 33 and the integration layer 31 to prevent the molten polyethylene from penetrating into the outer integration layer 31 during the manufacturing process.
  • soft tissues such as ligaments can grow into the pores of the porous structure, thereby making the postoperative knee joint system more stable.
  • the elastic pad 10 in this embodiment can also be separately arranged between the two bones forming the joint to have a certain buffering and wear-reducing function, and it can also increase the contact area with the bones.
  • the joint gasket prosthesis of the second embodiment mainly changes the arrangement mode and inflow mode of the joint fluid channel.
  • the lower surface of the elastic base is provided with a joint fluid containing groove
  • the opening of the inflow channel 13 is provided at the bottom of the joint fluid containing groove, as shown in the figure
  • the elastic gasket 10 when the elastic gasket 10 is squeezed by a load, a closed space is formed between the joint fluid containing groove and the gasket base 20, and the joint fluid can be discharged upward through the containing cavity 11 and the overflow channel 12 to the first contact surface. Reduce the friction between the first contact surface and the femoral condyle; as shown in FIG.
  • the bottom surface of the gasket base 20 of this embodiment is provided with an overflow groove 26, and the bottom of the containing groove 21 is provided with a communicating hole 27 and communicates with the overflow groove 26, so that the joint fluid can pass through The flow groove 26 and the communication hole 27 enter the receiving groove 21.
  • the volume of the plurality of accommodating cavities 11 located in the same accommodating cavity layer gradually decreases from the center to the edge, so that the elasticity and hardness distribution of the elastic pad 10 is closer to the human native cartilage tissue.
  • the joint gasket prosthesis of Embodiment 1 and Embodiment 2 is suitable for dual-condylar knee joint replacement surgery, and the joint gasket prosthesis of Embodiment 3 is suitable for uni-condylar knee joint replacement surgery. Its overall structure is the same as that of Embodiment 1 and Embodiment The two joint gasket prostheses are similar, so I won’t repeat them here.
  • the joint gasket prosthesis of the fourth embodiment is a femoral condyle substitute, which is suitable for uni-condylar knee replacement surgery.
  • the gasket base 20 is provided on the femoral condyle 4, and the elastic gasket 10 is provided on the gasket base 20.
  • the joint prosthesis of this embodiment is a knee joint prosthesis, including a joint gasket prosthesis 2, a tibial plateau prosthesis 3 and a femoral condyle prosthesis Body 1.
  • the joint gasket prosthesis 2 is a joint gasket prosthesis that includes some or all of the above technical features.
  • the joint prosthesis of this embodiment has the advantages of low pressure between contact surfaces and long service life.
  • the joint fluid channel in the elastic gasket Arrange the joint fluid channel in the elastic gasket in a predetermined way, and adjust the cross-sectional shape, aperture, length, volume, position, arrangement direction and density of the joint fluid channel to make the hardness of the elastic matrix gradually from the center to the edge As it rises, the elasticity gradually decreases from the center to the edge. In this way, different elasticity and hardness indexes can be obtained at different predetermined positions of the elastic gasket, so that the elastic gasket can be as close as possible to the mechanical characteristics of the human joints.
  • the elastic gasket can be fully contacted with the joint bones, thereby keeping the pressure between the contact surfaces within an ideal range, and ensuring the use effect and life of the joint gasket prosthesis.

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

Abstract

一种关节垫片假体（2）及具有其的关节假体。关节垫片假体（2）包括：设置在形成关节的第一骨骼和第二骨骼之间的弹性垫片（10），弹性垫片（10）包括：弹性基体（20），具有朝向第一骨骼的第一接触面和朝向第二骨骼的第二接触面；多个关节液通道（12），分布在弹性基体（20）中并连通第一接触面和第二接触面，多个关节液通道（12）按照预定方式布置以使弹性基体（20）的硬度从中心向边缘逐渐升高并且弹性基体（20）的弹性从中心向边缘逐渐降低。该关节垫片假体（2）有效地解决了现有技术中关节骨骼与关节垫片假体之间接触面积无法保证，可能出现局部压强过大、关节垫片假体磨损严重，导致患者关节假体使用寿命短的问题。

Description

关节垫片假体及具有其的关节假体 技术领域
本发明涉及人工假体置换领域，具体而言，涉及一种关节垫片假体及具有其的关节假体。
背景技术
目前在人工膝关节置换手术中所使用的膝关节假体在股骨一侧通常采用医用金属制作股骨髁假体，例如不锈钢或钴合金，胫骨侧则采用超高分子量聚乙烯制作垫片。出于膝关节运动学的需要股骨髁假体金属关节面一般会被设计成复杂的连续空间曲面，但是胫骨侧的超高分子量聚乙烯关节面垫片则只能设计成按照某一特定位置(例如直立位)时股骨侧关节面有较高吻合度的曲面以保证直立时的稳定。但是随着膝关节的活动，股骨髁假体与关节面垫片之间的接触面积可能远小于理想值，导致股骨髁假体与关节面垫片之间的压强过高，加速了关节面垫片的磨损。另外由于术后关节周围韧带及软组织与植入的人工关节假体之间不能建立类似于原有关节生物组织间的紧密联系，因此膝关节这一严重依靠软组织来维持平衡的力学系统的稳定性大为下降。
发明内容
本发明旨在提供一种关节垫片假体及具有其的关节假体，以解决现有技术中股骨髁假体与关节垫片假体之间接触面积无法保证，可能出现局部压强多大、关节垫片假体磨损严重，导致患者关节假体使用寿命短的问题，同时可建立人工关节假体与人体关节周围软组织之间的有效联系以增强关节稳定。
为了实现上述目的，根据本发明的一个方面，提供了一种关节垫片假体，包括：设置在形成关节的第一骨骼和第二骨骼之间的弹性垫片，第一骨骼是指与本发明关节垫片假体形成显著滑动摩擦关系的骨骼，第二骨骼是指本发明关节垫片假体固定其上的骨骼；弹性垫片包括：弹性基体，具有朝向第一骨骼的第一接触面和朝向第二骨骼的第二接触面；多个关节液通道，分布在弹性基体中并连通第一接触面和第二接触面，多个关节液通道的按照预定方式布置以使弹性基体的硬度从中心向边缘逐渐升高并且弹性基体的弹性从中心向边缘逐渐降低。
进一步地，多个关节液通道包括多个容纳腔层和多个过流通道，多个容纳腔层沿第一接触面至第二接触面的方向布置，每个容纳腔层均包括多个容纳腔，每个过流通道连接在相邻的两个容纳腔层之间。
进一步地，多个容纳腔层的容积沿第一接触面至第二接触面的方向上逐渐减小。
进一步地，多个容纳腔从第一接触面向第二接触面的方向上逐渐减小。
进一步地，位于同一容纳腔层中的多个容纳腔的容积由中心向边缘逐渐减小。
进一步地，关节液通道还包括进流通道，进流通道与至少一个容纳腔和/或至少一个过流通道相连通，进流通道中设置有单向阀。
进一步地，关节垫片假体还包括垫片基体，垫片基体设置在第一骨骼和第二骨骼之间，垫片基体具有容纳槽，弹性垫片设置在容纳槽中，垫片基体的硬度大于弹性垫片。
进一步地，弹性基体的周向侧壁上设置有定位凸部，容纳槽与定位凸部对应的位置上设置有定位凹槽。
进一步地，垫片基体的底面设置有过流凹槽，容纳槽的底部设置有连通孔并与过流凹槽连通，以使关节液能够通过过流凹槽和连通孔进入容纳槽。
进一步地，垫片基体还包括连通通道，连通通道的进口延伸至垫片基体的顶面上，连通通道的出口与进液通道连通。
进一步地，关节垫片假体还包括加强环，加强环设置在垫片基体的周向外侧。
进一步地，加强环渗入层与整合层均为多孔结构，渗入层能够与垫片基体接触融合，关节周围的软组织能够长入整合层，隔离层设置在渗入层和整合层之间。
进一步地，加强环渗入层和整合层均为多孔结构，渗入层多孔结构的孔径在500μm至3000μm之间，整合层的多孔结构的孔径在400μm至2000μm之间。
进一步地，弹性垫片由具有弹性的透明的高分子材料或复合材料制成。
根据本发明的另一方面，提供了一种关节假体，包括关节垫片假体，关节垫片假体为上述的关节垫片假体。
进一步地，关节假体为膝关节假体，膝关节假体还包括胫骨平台假体和股骨髁假体。
应用本发明的技术方案，在弹性垫片中按照预定方式布置关节液通道，并通过调整关节液通道的截面形状、孔径、长度、容积、位置以及排布方向及疏密程度等参数使弹性基体的硬度从中心向边缘逐渐升高，同时弹性亦从中心向边缘逐渐降低，这样可以在弹性垫片各个不同的预定部位得到不同的弹性和硬度指标，以使弹性垫片能够尽可能接近人体关节的力学特征，在关节活动时能够使弹性垫片与关节骨骼充分接触，进而使接触面之间的压强保持在理想范围内，保证关节垫片假体的使用效果和寿命。此外加强环整合层孔径在400μm至2000μm之间的多孔结构设计使得术后包覆在关节垫片假体周围的关节囊及原有的韧带残留等软组织能够长入整合部的多孔结构孔隙中以形成生物型组织整合，在术后愈合过程中，韧带等软组织能够长入多孔结构的空隙中，由此可使术后的膝关节系统更为稳定。
附图说明
构成本申请的一部分的说明书附图用来提供对本发明的进一步理解，本发明的示意性实施例及其说明用于解释本发明，并不构成对本发明的不当限定。在附图中：
图1示出了根据本发明的关节垫片假体的实施例一的分解结构示意图；
图2示出了图1的关节垫片假体在组合状态下的剖视结构示意图；
图3示出了图2的关节垫片假体的C处局部放大结构示意图；
图4示出了图1的关节垫片假体的加强环的A向结构示意图；
图5示出了图1的关节垫片假体的B处局部放大结构示意图；
图6和图7示出了图1的关节垫片假体的送液原理示意图；
图8示出了根据本发明的关节垫片假体的实施例二的分解结构示意图；
图9至图11示出了图8的关节垫片假体在不同姿态下的结构示意图；
图12示出了图8的关节垫片假体的弹性垫片的剖视结构示意图；
图13和图14出了图8的关节垫片假体的送液原理示意图；
图15示出了图8的关节垫片假体的垫片基体的底部结构示意图；
图16示出了根据本发明的关节垫片假体的实施例三的分解结构示意图；以及
图17示出了根据本发明的关节垫片假体的实施例四的分解结构示意图。
其中，上述附图包括以下附图标记：
1、股骨髁假体；2、关节垫片假体；3、胫骨平台假体；4、股骨髁；5、髌骨结构；10、弹性垫片；11、容纳腔；11a、容纳腔；11b、容纳腔；11c、容纳腔；12、过流通道；12b、过流通道；12c、过流通道；12d、过流通道；13、进流通道；14、单向阀；15、定位凸部；20、垫片基体；21、容纳槽；23、加强环容纳槽；25、定位凹槽；26、过流凹槽；27、连通孔；28、连通通道；29、髌骨槽；30、加强环；31、整合层；32、隔离层；33、渗入层。
具体实施方式
本申请的关节垫片假体适用于人工关节的置换手术中，用以吸收关节活动时产生的冲击、降低关节骨骼之间的摩擦损伤。例如在人体膝关节中，股骨相对胫骨摆动、转动以实现曲腿和转体的动作，股骨下端(股骨髁)和胫骨上端(胫骨平台)上的软骨以及半月板结构在股骨和胫骨之间起到垫片的作用。半月板结构的上下表面分别与股骨下端曲面和胫骨上端曲面的弯曲趋势相近，增大了关节的接触面积，增加了关节的稳定性、降低了压强。同时半月板结构还具有良好的弹性，能够适度地形变以吸收冲击与震荡并在膝关节运动时适应股骨下端的解剖形态，保证膝关节几何形态的协调，从而维持膝关节运动协调。
目前人工膝关节置换手术中所使用的膝关节假体在股骨一侧通常采用医用金属制作股骨髁假体，胫骨侧则采用超高分子量聚乙烯制作垫片，垫片材料单一、结构单一，虽然具备一定弹性，但远无法还原原生半月板结构和软骨的形变幅度以及缓冲和减磨效果。并且由于超高分子量聚乙烯制作的垫片缺乏足够的弹性，在膝关节开始屈曲运动时，随着股骨与胫骨之 间位置、角度的变化股骨髁假体与垫片之间的有效接触面积可能很小，甚至在某些位置只能满足线接触或者点接触，并在这些位置产生局部高压导致关节面磨损加快，进而影响整个膝关节的使用寿命，影响患者术后生活；另外由于术后原关节周围韧带及软组织与植入的人工关节假体之间失去原有的紧密联系，因此膝关节这一严重依靠软组织来维持平衡的力学系统的稳定性大为下降。本申请针对上述问题对垫片的结构提出了改进。
需要说明的是，在不冲突的情况下，本申请中的实施例及实施例中的特征可以相互组合。下面将以膝关节为例参考附图并结合实施例来详细说明本发明。
如图1、图2以及图8所示，实施例一的关节垫片假体和实施例二的关节垫片假体均包括弹性垫片10，弹性垫片10设置在股骨结构和胫骨结构之间，弹性垫片10包括弹性基体和分布在弹性基体中的多个关节液通道。弹性基体具有朝向股骨结构的第一接触面和朝向胫骨结构的第二接触面，多个关节液通道连通第一接触面和第二接触面使关节液能够穿过弹性基体并在弹性基体中流动。多个关节液通道的按照预定方式布置以使弹性基体的硬度从中心向边缘逐渐升高并且弹性基体的弹性从中心向边缘逐渐降低。
如图9所示，在膝部非负重自然伸直的状态下，关节垫片假体2设置在胫骨平台假体3上，关节垫片假体2中弹性垫片10的上表面与股骨髁假体1贴合；如图10所示，人体的重量和冲击力施加在关节垫片假体2的弹性垫片10上，弹性垫片10压缩变形起到缓冲的作用，此时垫片基体20与弹性垫片10共同承担由股骨髁假体传递来的力学载荷；如图11所示，在膝关节屈曲的状态下，弹性垫片10局部受压变形，此时外侧相对高硬度低弹性、内部高弹性低硬度特性使弹性垫片在不均匀的荷载下也能与股骨髁保证相对足够的接触面积并与基体20共同承担由股骨髁假体传递来的力学载荷。
应用本实施例的技术方案，在弹性垫片10中按照预定方式布置关节液通道，并通过调整关节液通道的截面形状、孔径、长度、容积、位置以及排布方向及疏密程度等参数使弹性基体的硬度从中心向边缘逐渐升高，同时弹性从中心向边缘逐渐降低，这样可以在弹性垫片10各个不同的预定部位得到不同的弹性和硬度指标，以使弹性垫片10能够尽可能接近人体膝关节的力学特征，在膝关节活动时能够使弹性垫片10与股骨髁充分接触，进而使接触面之间的压强保持在理想范围内，保证关节垫片假体的使用效果和寿命。
优选地，本实施例的弹性垫片10由具有弹性的透明的高分子材料或复合材料制成。如图2和图3所示，在实施例一的弹性垫片10中，关节液通道包括多个容纳腔层(T1、T2、T3、T4)和多个过流通道12，容纳腔层T1至容纳腔层T4沿第一接触面至第二接触面的方向布置，每个容纳腔层均包括多个容纳腔11，过流通道12连接在相邻的两个容纳腔层的容纳腔之间。例如过流通道12b连通容纳腔层T1的容纳腔11a和容纳腔层T2的容纳腔11b，过流通道12c连通容纳腔11b和容纳腔层T3的容纳腔11c，过流通道12d连通容纳腔11c和容纳腔层T4的容纳腔。
具体地，如图3所示，本实施例中的多个容纳腔11从容纳腔层T1至容纳腔层T4上逐渐减小，并使各容纳腔层的整体容积沿第一接触面至第二接触面的方向上逐渐减小。这样布置的关节液通道能够使弹性基体靠近第一接触面的一侧弹性相对较高，靠近第二接触面的一侧弹性相对较低，有利于第一接触面与股骨髁接触。
如图3至图7所示，本实施例的关节液通道还包括进流通道13，进流通道13与容纳腔11相连通，以使进流通道13与各容纳腔层中的各个容纳腔11以及连接在各容纳腔层之间的过流通道12相连通。进一步地，如图6和图7所示，进流通道13中设置有单向阀14，如图7所示，在弹性垫片10受到载荷挤压变形时，单向阀14在关节液反向压力下被关闭，此时关节液仅能够向上通过容纳腔11和过流通道12排至第一接触面，降低第一接触面与股骨髁之间的摩擦；如图6所示，在弹性垫片10受到的载荷消失时，弹性基体复原并在关节液通道中形成负压，单向阀14打开，关节液能够通过进流通道13进入容纳腔11和过流通道12。这样在膝关节活动时就能够完成关节液补充和向摩擦面注入的循环。
如图1至图3所示，本实施例的关节垫片假体还包括垫片基体20，垫片基体20设置在股骨结构和胫骨结构之间，垫片基体20具有容纳槽21，弹性垫片10设置在容纳槽21中，垫片基体20的硬度大于弹性垫片10。可选的一种材料配伍方式为弹性垫片10选用聚氨酯材料制作，垫片基体20可以采用超高分子量聚乙烯制作而成，其在容纳槽21的环形边缘可以起到近似于生理半月板的功能，加强弹性垫片10的支撑效果和耐磨能力。弹性垫片10中的关节液通道等结构可以通过激光飞秒技术在透明的聚氨酯材料内部雕刻烧蚀形成。
如图3所示，本实施例的垫片基体20还包括连通通道28，连通通道28的进口延伸至垫片基体20的顶面上，连通通道28的出口与进流通道13连通，以将关节液引入关节液通道中。
为固定弹性垫片10，如图1和图5所示，本实施例的弹性基体的周向侧壁上设置有定位凸部15，容纳槽21与定位凸部15对应的位置上设置有定位凹槽25。在弹性垫片10置入容纳槽21后，定位凸部15能够伸入定位凹槽25中防止弹性垫片10脱出。
如图1所示，垫片基体20还包括与髌骨及其韧带相适配的髌骨槽29。
如图1和图4所示，本实施例的关节垫片假体还包括加强环30，加强环30设置在垫片基体20周向外侧的加强环容纳槽23中，并优选采用医用金属材料。加强环30嵌设在垫片基体20的周向外侧，用以提高关节垫片假体的结合强度。具体地，本实施例的加强环30包括渗入层33、隔离层32和整合层31，渗入层33和整合层31采用多孔结构。优选地，本实施例的加强环30的渗入层33的孔径在500μm至3000μm之间，整合层31的孔径在400μm至2000μm之间。在模塑过程中，形成垫片基体20的超高分子量聚乙烯材料能够渗入渗入层33的多孔结构中并与垫片基体20接触融合，实现加强环30与垫片基体20之间的连接固定。整合层31暴露在外，术后膝关节包覆在关节垫片假体周围相应部位的韧带和软组织细胞将生长进入到整合层31的孔隙内形成生物性组织整合，这种生物性整合使得胫骨平台垫片与关节周围的软组织形成类似于人体正常生理膝关节的软组织稳定系统从而加强了植入的膝关节假体的稳定性。隔离层32为实体结构并设置在渗入层33和整合层31之间，用以阻挡制作过程中熔融的聚乙烯渗透到外侧整合层31中。在术后愈合过程中，韧带等软组织能够长入多孔结构的孔隙中，由此可使术后的膝关节系统更为稳定。
本实施例中的弹性垫片10也可以单独设置在形成关节的两个骨骼之间，起到一定的缓冲减磨功能，并且也能够起到增大与骨骼之间接触面积的效果。
实施例二的关节垫片假体相比于实施例一主要改变了关节液通道的布置方式和进流方 式。如图8至图15所示，在实施例二的弹性垫片10中，弹性基体的下表面设置有关节液容纳槽，进流通道13的开口设置在关节液容纳槽的槽底，如图14所示，在弹性垫片10受到载荷挤压时，关节液容纳槽与垫片基体20之间形成封闭空间，关节液能够向上通过容纳腔11和过流通道12排至第一接触面，降低第一接触面与股骨髁之间的摩擦；如图13所示，在弹性垫片10受到的载荷消失时，弹性基体复原，关节液容纳槽与垫片基体20分离并在关节液通道中形成负压，关节液能够通过进流通道13进入容纳腔11和过流通道12。这样在膝关节活动时就能够完成关节液补充和向摩擦面注入的循环。
如图15所示，本实施例的垫片基体20的底面设置有过流凹槽26，容纳槽21的底部设置有连通孔27并与过流凹槽26连通，以使关节液能够通过过流凹槽26和连通孔27进入容纳槽21。
优选地，在本实施例中，位于同一容纳腔层中的多个容纳腔11的容积由中心向边缘逐渐减小，使弹性垫片10的弹性、硬度分布更贴近于人体原生软骨组织。
实施例一和实施例二的关节垫片假体适用于双髁膝关节置换手术，实施例三的关节垫片假体适用于单髁膝关节置换手术，其整体结构与实施例一和实施例二的关节垫片假体相近，在此不再赘述。
实施例四的关节垫片假体为股骨髁替代物，适用于单髁膝关节置换手术，垫片基体20设置在股骨髁4上，弹性垫片10设置在垫片基体20。
本申请还提供了一种关节假体，如图9至图11所示，本实施例的关节假体为膝关节假体，包括关节垫片假体2，胫骨平台假体3和股骨髁假体1。其中，关节垫片假体2为包含上述部分或全部技术特征的关节垫片假体，本实施例的关节假体具有接触面之间压强较小，使用寿命长的优点。
可以理解的是，本实施例的技术构思也可以应用在肩关节、髋关节等其他关节结构中。
从以上的描述中，可以看出，本发明上述的实施例实现了如下技术效果：
在弹性垫片中按照预定方式布置关节液通道，并通过调整关节液通道的截面形状、孔径、长度、容积、位置以及排布方向及疏密程度等参数使弹性基体的硬度从中心向边缘逐渐升高，同时弹性从中心向边缘逐渐降低，这样可以在弹性垫片各个不同的预定部位得到不同的弹性和硬度指标，以使弹性垫片能够尽可能接近人体关节的力学特征，在关节活动时能够使弹性垫片与关节骨骼充分接触，进而使接触面之间的压强保持在理想范围内，保证关节垫片假体的使用效果和寿命。
以上所述仅为本发明的优选实施例而已，并不用于限制本发明，对于本领域的技术人员来说，本发明可以有各种更改和变化。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (16)

  1. 一种关节垫片假体，其特征在于，包括：设置在形成关节的第一骨骼和第二骨骼之间的弹性垫片(10)，所述弹性垫片(10)包括：
    弹性基体，具有朝向所述第一骨骼的第一接触面和朝向所述第二骨骼的第二接触面；
    多个关节液通道，分布在所述弹性基体中并连通所述第一接触面和所述第二接触面，多个所述关节液通道的按照预定方式布置以使所述弹性基体的硬度从中心向边缘逐渐升高并且所述弹性基体的弹性从中心向边缘逐渐降低。
  2. 根据权利要求1所述的关节垫片假体，其特征在于，所述多个关节液通道包括多个容纳腔层和多个过流通道(12)，多个所述容纳腔层沿所述第一接触面至所述第二接触面的方向布置，每个所述容纳腔层均包括多个容纳腔(11)，每个所述过流通道(12)连接在相邻的两个所述容纳腔层之间。
  3. 根据权利要求2所述的关节垫片假体，其特征在于，多个所述容纳腔层的容积沿所述第一接触面至所述第二接触面的方向上逐渐减小。
  4. 根据权利要求3所述的关节垫片假体，其特征在于，多个所述容纳腔(11)从所述第一接触面向所述第二接触面的方向上逐渐减小。
  5. 根据权利要求2所述的关节垫片假体，其特征在于，位于同一所述容纳腔层中的多个所述容纳腔(11)的容积由中心向边缘逐渐减小。
  6. 根据权利要求2所述的关节垫片假体，其特征在于，所述关节液通道还包括进流通道(13)，所述进流通道(13)与至少一个所述容纳腔(11)和/或至少一个所述过流通道(12)相连通，所述进流通道(13)中设置有单向阀(14)。
  7. 根据权利要求1至6中任一项所述的关节垫片假体，其特征在于，所述关节垫片假体还包括垫片基体(20)，所述垫片基体(20)设置在所述第一骨骼和所述第二骨骼之间，所述垫片基体(20)具有容纳槽(21)，所述弹性垫片(10)设置在所述容纳槽(21)中，所述垫片基体(20)的硬度大于所述弹性垫片(10)。
  8. 根据权利要求7所述的关节垫片假体，其特征在于，所述弹性基体的周向侧壁上设置有定位凸部(15)，所述容纳槽(21)与所述定位凸部(15)对应的位置上设置有定位凹槽(25)。
  9. 根据权利要求7所述的关节垫片假体，其特征在于，所述垫片基体(20)的底面设置有过流凹槽(26)，所述容纳槽(21)的底部设置有连通孔(27)并与所述过流凹槽(26)连通，以使关节液能够通过所述过流凹槽(26)和所述连通孔(27)进入所述容纳槽(21)。
  10. 根据权利要求7所述的关节垫片假体，其特征在于，所述关节垫片假体为权利要求6的关节垫片假体，所述垫片基体(20)还包括连通通道(28)，所述连通通道(28)的进口延伸至所述垫片基体(20)的顶面上，连通通道(28)的出口与进液通道连通。
  11. 根据权利要求7所述的关节垫片假体，其特征在于，所述关节垫片假体还包括加强环(30)，所述加强环(30)设置在所述垫片基体(20)的周向外侧。
  12. 根据权利要求11所述的关节垫片假体，其特征在于，所述加强环(30)包括渗入层(33)、隔离层(32)和整合层(31)，所述渗入层(33)能够与所述垫片基体(20)接触融合，所述关节周围的软组织能够长入所述整合层(31)，所述隔离层(32)设置在所述渗入层(33)和所述整合层(31)之间。
  13. 根据权利要求12所述的关节垫片假体，其特征在于，所述渗入层(33)和所述整合层(31)均为多孔结构，所述渗入层(33)的多孔结构的孔径在500μm至3000μm之间，所述整合层(31)的多孔结构的孔径在400μm至2000μm之间。
  14. 根据权利要求1所述的关节垫片假体，其特征在于，所述弹性垫片(10)由具有弹性的透明的高分子材料或复合材料制成。
  15. 一种关节假体，包括关节垫片假体，其特征在于，所述关节垫片假体为权利要求1至14中任一项所述的关节垫片假体。
  16. 根据权利要求14所述的关节假体，其特征在于，所述关节假体为膝关节假体，所述膝关节假体还包括胫骨平台假体和股骨髁假体。
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