WO2019007287A1 - 半髁式人工膝关节 - Google Patents

半髁式人工膝关节 Download PDF

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Publication number
WO2019007287A1
WO2019007287A1 PCT/CN2018/093790 CN2018093790W WO2019007287A1 WO 2019007287 A1 WO2019007287 A1 WO 2019007287A1 CN 2018093790 W CN2018093790 W CN 2018093790W WO 2019007287 A1 WO2019007287 A1 WO 2019007287A1
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WO
WIPO (PCT)
Prior art keywords
prosthesis
tibial
knee joint
artificial knee
semi
Prior art date
Application number
PCT/CN2018/093790
Other languages
English (en)
French (fr)
Inventor
朱红文
黄国富
董荣华
朱天谋
Original Assignee
朱红文
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 朱红文 filed Critical 朱红文
Priority to EP18828229.7A priority Critical patent/EP3649989A4/en
Priority to US16/628,033 priority patent/US11129721B2/en
Priority to JP2020522772A priority patent/JP7011057B2/ja
Publication of WO2019007287A1 publication Critical patent/WO2019007287A1/zh

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Definitions

  • the invention relates to a medical artificial joint prosthesis, in particular to a semi-squat artificial knee joint.
  • knee replacement surgery is the most fundamental treatment for knee lesions and injuries in the world.
  • joint prostheses also called artificial knee joints
  • further requirements for artificial knee joints and replacement surgery are getting higher and higher, people want to reduce pain, and hope to improve the service life, and hope that the postoperative recovery effect is better, and even hope to achieve normal health.
  • the two main leg bones of the human body are the femur and tibia, the femur is on the top, the tibia is on the lower side, the femur and the tibia intersect and interact with each other.
  • the knee joint is called the lower end of the femur in the knee joint.
  • the humerus is called the upper end of the humerus; the lower end of the femur and the upper end of the tibia become larger, providing a supporting foundation for the stability of the knee joint;
  • Two lower jaws are formed at the lower end of the femur.
  • the lower surface of the tendon is smooth and covered by articular cartilage.
  • the two isolated tendons are not symmetrical, the medial condyle is larger, and the lateral condyle is smaller to accommodate the medial aspect.
  • Different lateral forces; the upper end of the humerus includes a shallow, concave outer and medial platform covered by articular cartilage, the medial platform is larger than the lateral platform, and the entire tibial plateau is ridged or nodular between the lateral and medial platforms Separated
  • the humerus (knee bone) is buried in the quadriceps tendon.
  • the quadriceps tendon connects the anterior superior thigh muscle quadriceps muscle tissue to the tibia.
  • the patella ligament connects the humerus to the humerus directly below the knee joint;
  • the combination of the tendon, humerus and patella ligament is more like a pulley, transferring the force generated by the quadriceps muscle tissue to the tibia through the flexed knee joint, thereby straightening the leg or slowing the rate of flexion.
  • the tibia also has Other functions to protect the knee joint from impact damage;
  • the role of the cruciate ligament is to position the ankle generally over the humerus during flexion and extension.
  • the tension exerted by the anterior cruciate ligament restricts the posterior displacement of the ankle.
  • the posterior cruciate ligament is constrained. ⁇ forward displacement;
  • the knee meniscus plays a vital role in the normal function of the knee joint.
  • the meniscus is cushioned and differentiated as it passes through the knee joint, weakening the friction and impact between the femur and the tibia;
  • the natural tibial plateau is often directly removed, the artificial tibial plateau is replaced, and a similarly shaped femoral condyle prosthesis is mounted on the femoral surface, thereby making the new femoral condyle prosthesis and
  • the artificial tibial plateau interacts, which results in the absence of a cruciate ligament and meniscus in the knee joint after surgery, and some even have no tibia. Therefore, the current surgical methods and the corresponding characteristics of the artificial knee joint lead to such surgery. It is impossible to have the desired recovery effect. Such surgery destroys the original physiological structure and characteristics of the knee joint, causing permanent irreversible damage to the knee joint, and it is urgent to make adjustments. It is necessary to retain the cruciate ligament and the tibia. New artificial knee joint with meniscus cushioning.
  • the inventors conducted intensive research to design a semi-squat artificial knee joint including a femoral prosthesis and a tibial prosthesis, the tibial prosthesis having a waist-like cross section, the tibia
  • the prosthesis is disposed on one side of the intercondylar ridge of the tibial plateau and is located below the femoral prosthesis.
  • a prosthesis groove is formed on the bottom surface of the tibial prosthesis, and the tibia below the tibial prosthesis is opened.
  • the utility model further comprises a positioning pin insertable into the limiting hole, and the cooperation between the positioning pin and the limiting hole can ensure the relative position and balance between the tibial prosthesis and the intercondylar ridge of the tibial plateau are stable and balanced.
  • the limit holes in the two semi-squat artificial knee joints communicate with each other, sharing a positioning pin to form a complete combined total knee joint;
  • the humeral prosthesis includes Gasket and Spacer, the spacer is provided on the lower elastic member, thereby completing the present invention.
  • the knee joint comprises a femoral prosthesis 1 and a tibial prosthesis 2,
  • the tibial prosthesis 2 is disposed on one side of the tibial plateau intercondylar ridge 31 and below the femoral prosthesis 1.
  • the tibial prosthesis 2 includes an upper spacer 21 and a lower spacer 22,
  • an elastic member 6 is provided on the lower spacer 22, and the impact force transmitted from the femoral prosthesis 1 to the spacer on the tibial prosthesis 2 is buffered by the elastic member 6, so that the upper spacer 21 has a meniscus-like function.
  • the elastic member 6 penetrates the lower gasket 22 and is fixedly mounted on the lower gasket 22, and the upper end protrudes above the lower gasket 22 and is placed on the lower surface of the upper gasket.
  • the elastic member 6 comprises a sleeve 61 and a spring 62, the lower end of the spring 62 is embedded in the sleeve 61, and the upper end of the spring is placed on the lower surface of the upper gasket.
  • the sleeve 61 passes through the lower spacer 22, and the bottom end of the sleeve is mounted in the bore 7 on the tibia.
  • a bolt 63 for adjusting the tension of the spring 62 is provided at the bottom of the sleeve 61.
  • the tibial prosthesis 2 is placed under the posterior aspect of the tibia.
  • the artificial knee joint further comprises a positioning pin 5; the tibial prosthesis 2 is fixed on the tibia by the positioning pin 5.
  • one end of the positioning pin 5 is installed in the upper part of the tibial prosthesis 2, and the other end is embedded in the intercondylar ridge 31 of the tibial plateau.
  • a prosthesis groove 23 is opened at the bottom of the tibial prosthesis 2,
  • a top of the humerus below the humeral prosthesis 2 is provided with a sacral recess 32 corresponding to the sacral recess 32, and together form a limiting hole 4 for receiving the positioning pin 5, and the The limiting hole penetrates into the intercondylar ridge 31 of the tibial plateau.
  • the present invention also provides a method of using a semi-squat artificial knee joint as described above, the method comprising the steps of:
  • Step 1 the femoral prosthesis 1 is mounted on the femoral condyle;
  • Step 2 opening a space for placing the tibial prosthesis 2 on the tibial plateau.
  • Step 3 excavating the humerus groove 32 on the tibia and extending the humerus groove 32 to the tibial plateau intercondylar ridge 31, forming an intercondylar ridge hole 33 on the tibial plate intercondylar ridge 31;
  • Step 4 excavating the cavity 7 on the tibia
  • step 5 the sleeve on the tibial prosthesis 2 is inserted into the cavity 7, and the relative positions of the prosthesis groove 23, the humeral groove 32 and the intercondylar ridge hole 33 are adjusted, so that the prosthesis groove 23 and the humerus
  • the groove 32 and the intercondylar ridge hole 33 together form a limiting hole 4;
  • Step 6 the positioning pin 5 is installed into the limiting hole 4, after the positioning pin 5 is fixed, the tibial prosthesis 2 is fixed by bone cement;
  • the tightening of the spring 62 is adjusted by the rotating bolt 63 before the step 5 is performed.
  • the artificial knee joint according to the present invention has a small tibial prosthesis which can be placed on the side of the intercondylar ridge of the tibial plateau, so that it is not necessary to remove and destroy the tibial plateau intercondylar ridge, so the tibial plateau intercondylar ridge
  • the cruciate ligament can be preserved intact, which greatly enhances the use effect and patient experience;
  • the artificial knee joint provided according to the present invention has a small tibial prosthesis, and only a part of the knee joint can be replaced according to the condition, or the prosthesis transplantation is performed in stages, and the semi-squat artificial labor provided by the present application is replaced first or only one is provided.
  • the knee joint if necessary, can be replaced with a semi-squat artificial knee joint provided by the present application, and the practical application is more flexible and convenient;
  • the artificial knee joint according to the present invention is provided with an elastic member on the tibial prosthesis, which can simulate the function of the meniscus and provide a cushioning and shock absorbing effect, so that the artificial knee joint is more substantially similar to the natural knee joint;
  • the spring elastic/elastic force of the elastic member of the artificial knee joint humeral prosthesis according to the present invention is adjustable, and can be adjusted according to different ages and physical conditions, thereby ensuring that the spring elasticity/elastic force is in an optimal state;
  • the elastic member of the artificial knee joint humeral prosthesis according to the present invention is disposed in a downwardly projecting cylindrical structure that is embedded in a cavity in the tibia, thereby also enabling activation of the humeral prosthesis Limiting fixation
  • the artificial knee joint according to the present invention has a prosthesis groove on the tibial prosthesis, and a positioning pin connecting the tibial prosthesis and the tibial plateau intercondylar ridge to fix the tibial prosthesis completely on the tibia.
  • the fixing method is simple and the effect is good;
  • the artificial knee joint according to the present invention has a prosthesis groove on the tibial prosthesis, and a positioning pin connecting the tibial prosthesis and the tibial plate intercondylar ridge, which allows one and a half to be added when necessary.
  • ⁇ -type artificial knee joint and can extend and penetrate the limit hole, that is, the ridge hole of the day is changed from blind hole to through hole, and the two semi- ⁇ artificial knee joints are fixed by the original positioning pin, and the two joints are fixed in all directions.
  • the relative position between the tibial prostheses makes the artificial knee joints balanced, overall steady state, long service life and good patient experience.
  • FIG. 1 shows an exploded view of a semi-twisted artificial knee joint assembly in accordance with a preferred embodiment of the present invention
  • FIG. 2 is a schematic view showing the structure of a femoral prosthesis in a semi-twisted artificial knee joint according to a preferred embodiment of the present invention
  • FIG. 3 is a schematic cross-sectional view showing a shape of a limiting hole/positioning pin in a semi-twisted artificial knee joint according to a preferred embodiment of the present invention
  • FIG. 4 is a schematic cross-sectional view showing a shape of a limiting hole/positioning pin in a semi-twisted artificial knee joint according to a preferred embodiment of the present invention
  • FIG. 5 is a schematic cross-sectional view showing a shape of a limiting hole/positioning pin in a semi-twisted artificial knee joint according to a preferred embodiment of the present invention
  • FIG. 6 is a schematic view showing the structure of a tibial prosthesis in a semi-ankle artificial knee joint according to a preferred embodiment of the present invention
  • Figure 7 is a cross-sectional view showing an elastic member of a humeral prosthesis in a semi-twisted artificial knee joint in accordance with a preferred embodiment of the present invention
  • Figure 8 is a schematic view showing the structure of a semi-squat artificial knee joint tibia according to a preferred embodiment of the present invention.
  • FIG. 9 is a schematic view showing the structure of a humerus in which two semi-squat artificial knee joints are placed in a semi-squat artificial knee joint according to a preferred embodiment of the present invention.
  • Figure 10 shows an exploded view of the femoral prosthesis and femur assembly in an artificial knee joint in accordance with a preferred embodiment of the present invention
  • Figure 11 is a schematic view showing the structure of a femoral prosthesis and femur assembled in an artificial knee joint in accordance with a preferred embodiment of the present invention.
  • 1-femoral prosthesis 11-front buckle cover; 12-fixed thorn; 13-rear buckle cover; 14-fixed pin; 2-tibia prosthesis; 21-upper gasket; 22-lower gasket; 23-prosthesis Slotted groove; 3- ⁇ bone; 31- ⁇ ⁇ ⁇ ; ;; 32- ⁇ ⁇ ⁇ ;; 33- ⁇ ⁇ ⁇ ; 4-; 4-limit hole; 5--positioning pin; 6-elastic member; 61-sleeve; - spring; 63-bolt; 7-hole cavity; 8-femur;
  • a semi-twisted artificial knee joint as shown in Fig. 1, includes a femoral prosthesis 1 and a tibial prosthesis 2, wherein the femoral prosthesis 1 is placed at the lower end of the femur 8 and replaces the lower end of the femur A part of the bone structure, the tibial prosthesis 2 is disposed at the upper end of the tibia 3, and replaces a part of the bone structure on the tibial plateau at the upper end of the humerus; the tibial plateau in the present application is the surface of the tibia contacting the lower end of the femur, and the humerus in the center of the tibial plateau
  • the intertrochanteric ridge 31, also referred to as a bulge or nodule, has a crisscross ligament attached thereto, and the tibial plateau is mainly composed of an inner platform and an outer platform on both sides of the intercondylar ridge of the tibial
  • the tibial prosthesis 2 is used to replace the medial platform or the lateral platform. After the tibial prosthesis replaces the medial platform or the lateral platform, the height of the unreplaced portion of the tibial plateau (the tibial plateau intercondylar ridge) is substantially the same as the height of the tibial component. After replacing a portion of the tibial structure with the tibial prosthesis, there was no change in the height and shape of the humerus.
  • the femoral prosthesis has only one single cymbal, including a front buckle cover 11, a fixed thorn 12, a rear buckle cover 13 and a fixing pin 14, as shown in Figures 1 and 2;
  • the shape of the femoral prosthesis 1 is identical to the shape of a portion of the femur that is replaced, and the outer portion thereof has a circular arc shape, and a front buckle is respectively disposed at both ends of the femoral prosthesis 1.
  • a concave prosthetic fixation region is first excavated on the femur. After the femoral prosthesis is installed in the region, the region can be filled up, so that the femur recovers to the excavation of the fetus.
  • the previous state of the body fixation region; that is, the femoral prosthesis 1 is fixed to the femur by being embedded in the prosthesis fixation region.
  • a fixed thorn 12 and a fixing pin 14 are also disposed on the inner side of the femoral prosthesis.
  • a blind hole is also dug in the cancellous bone at the corresponding position, and the femoral prosthesis 1 is fastened.
  • the fixing pin 14 is embedded in the blind hole;
  • a tapered groove/conical hole is formed near the anterior cortical bone, wherein the anterior cortical bone refers to the cortical bone in contact with the front buckle cover 11, the tapered groove/cone
  • the specific shape and the number of the shaped holes correspond to the shape and the number of the fixed thorns 12.
  • the aperture size of the blind hole is slightly smaller than the outer diameter of the fixing pin 14; in the process of the fixing pin 14 being embedded in the blind hole, the aperture of the blind hole is forced to expand, pressing the cancellous region of the bone, thereby forming a tight Consolidation
  • the fixing thorn 12 and the fixing pin 14 may be one or more.
  • two fixing thorns are provided, and one fixing pin is provided, and correspondingly, the blind hole and the tapered groove/taper The number of holes matches the number of fixing pins 14 and fixing thorns 12.
  • the area of the femur that is in contact with the front buckle cover 11 and the rear buckle cover 13 is a cortical area with high strength and toughness;
  • the front buckle cover 11 is adjacent to the fixed thorn 12, the front buckle cover 11 is buckled outside the cortical bone, the fixation thorn 12 is inserted into the cancellous bone, and is placed on the cortical bone from the inner side, thereby tightening the bone.
  • the cortex is formed together with the rear buckle cover 13 to form a socket and is fastened to the femur.
  • the front buckle cover 11 and the fixed thorn 12 form a V-shaped groove-like structure, and the bone is ground on the femur.
  • the cortex is placed at the bottom of the trough-like structure; the fixed thorn 12 and the groove-shaped structure having a V-shaped cross section together assist the fixation of the cortical bone by the front buckle cover 11 so that the front buckle cover 11 and the rear buckle cover 13 can be buckled on the femur; scientifically and reasonably, the consolidation between the femoral prosthesis and the femur is firm and reliable, and can withstand long-term tests.
  • the femoral prosthesis has a smaller surface area and therefore a smaller volume and weight.
  • the outer surface of the femoral prosthesis 1 has an area of about half of the femoral medial/femur outer side. 60% or less of the outer surface area of the semi-ankle, preferably about 40% to 55%; preferably about 50% in the present application, which is equivalent to about one quarter of the surface area of the femoral condyle;
  • the femoral prosthesis is located on one side of the femoral trochlear.
  • the replacement of the femoral prosthesis 1 does not affect the normal operation of the femoral trochlear, so replacing the femoral prosthesis 1 has no effect on the normal operation and installation position of the tibia.
  • the tibial prosthesis is located below the femoral prosthesis 1 , and the tibial prosthesis replaces the diseased medial platform or the lateral platform.
  • a certain fixation of the humerus or tibial plate is required. Structural modification, when there is only one of the tibial prostheses, the modified tibial or tibial plateau is as shown in FIG.
  • the other half of the ankle joint is damaged after the one-piece artificial knee joint described in this application has been replaced, it is replaced with another semi-squat artificial knee joint, that is, two humerus are placed on the tibial plateau.
  • the prosthesis, the two tibial prostheses 2 are respectively disposed on both sides of the tibial plateau intercondylar ridge 31, and the tibial prosthesis 2 replaces the medial platform and the lateral platform in the tibial plateau, and supports the femoral prosthesis 1.
  • the modified tibia or tibial plateau is shown in Figure 9.
  • the upper surface of the tibial prosthesis 2 has an inward, downward depression similar to the medial platform and the lateral platform on the natural tibial plateau, as shown in FIG.
  • the tibial prosthesis 2 has a cross-section or a waist-like shape, and its outer contour conforms to the partially excavated tibial plateau, and the cross section is a horizontal cross section.
  • the tibial prosthesis 2 has a cross-sectional dimension that is about one-third the cross-sectional dimension of the tibial plateau.
  • the artificial knee joint further comprises a positioning pin 5 for fixing the tibial prosthesis 2;
  • the positioning pin 5 is mounted on the upper end of the tibial prosthesis 2 at one end, and the other end of the positioning pin 5 is embedded in the intercondylar ridge 31 of the tibial plateau;
  • an intercondylar ridge hole 33 is further disposed on the intercondylar ridge of the tibial plate, and one end of the positioning pin is embedded in the intercondylar ridge hole 33, and the upper end of the other end is installed in the tibial prosthesis 2, and the other end is The lower part is installed in the tibia.
  • a prosthesis groove 23 is opened at the bottom of the tibial prosthesis 2,
  • a tibial recess 32 is formed below the tibial prosthesis 2; that is, a tibial recess 32 is formed in the tibial/tibia platform below the tibial prosthesis, as shown in FIGS. 8 and 9.
  • the prosthesis groove 23 corresponds to the humeral groove 32, and together with the intercondylar ridge hole 33 constitutes a limiting hole 4 for mounting the positioning pin 5, as shown in FIG. 3 and FIG. This is shown in Figure 5.
  • the limiting hole extends into the intercondylar ridge 31 of the tibial plateau, and does not penetrate the intercondylar ridge 31 of the tibial plateau, that is, ⁇
  • the ridge hole is a blind hole.
  • the length of the locating pin is greater than the length of the prosthesis slot 23 of the humeral prosthesis 2, and the length of the locating pin is less than the length of the prosthesis slot 23 and the tibial plateau The sum of the width values of the ridges 31.
  • the positioning pin can satisfy the positioning fixation function, and when the second semi-squat artificial knee joint is installed on the same joint, that is, when the tibial prosthesis is further increased, the limiting hole is
  • the length of the 4 is naturally extended, that is, when the second tibial prosthesis is installed, the original limiting hole is extended and extended, that is, the intercondylar ridge hole is changed from the blind hole to the through hole, wherein, in a preferred embodiment
  • the positioning pin can further move deep into the extended limiting hole, and finally the positioning pin completely penetrates the tibial platform intercondylar ridge 31, and both ends of the positioning pin are embedded in the prosthesis groove 23 to serve as the humeral false Limiting and fixing of the body 2; in another preferred embodiment, the original positioning pin is removed, and a longer length locating pin is inserted into the limiting hole.
  • the original positioning pin can be pushed inward to complete
  • the width value of the tibial plateau intercondylar ridge 31 is less than or equal to the length value of the prosthesis groove 23.
  • the limiting hole penetrates the intercondylar ridge 31 of the tibial plateau, and the two limiting holes corresponding to the two tibial prostheses 2 communicate with each other to form a longer limit.
  • the limiting hole 4 and the positioning pin 5 penetrate the tibial platform intercondylar ridge 31 to connect the two tibial prostheses 2; that is, in the axial direction of the limiting hole 4, the limiting hole is The three parts are spliced, wherein the two parts at the two ends are surrounded by the upper prosthesis groove 23 and the lower tibial recess 32; the third part in the middle is completely open on the tibial plateau.
  • the locating pin it is able to fix the level of the two tibial prostheses 2 located on either side of the intercondylar ridge of the tibial plateau, and also to enable a tibial prosthesis on the side of the intercondylar ridge of the tibial plateau.
  • the intercondylar ridge of the tibial plateau is maintained within a desired level of height such that the physiological height of the replaced femoral femur is substantially consistent with the physiological height of the femur prior to replacement, on which the fixation of the tibial prosthesis 2 is performed, This allows the tibial prosthesis to be in a reasonable position to ensure a good patient experience after surgery.
  • the sectional shape of the limiting hole 4 is identical to the sectional shape of the positioning pin 5; the sectional shape may be elliptical, square, trapezoidal. , diamonds, triangles, pentagons, pentagrams, hexagons, octagons, etc., in the shape of the pin of various cross-section shapes, triangles, squares, trapezoids and polygons are better.
  • the trapezoid is preferably selected in the present invention, and the trapezoidal superior is located in the prosthesis recess 23, the lower base is located in the sacral recess 32, and the upper base length is greater than the lower base length.
  • the cross-sectional dimension of the positioning pin corresponds to the cross-sectional dimension of the limiting hole, and the two are closely matched, preferably an interference fit; thus, the positioning pin is difficult to continue after being embedded in a certain depth. Extending in and being stuck, at this time the positioning pin just stays at the desired position, preferably, the position is a positive center position and does not deviate to both sides;
  • the cross-sectional dimension of the limiting hole corresponds to the cross-sectional dimension of the limiting hole
  • the positioning pin can be embedded in a corresponding depth position of the limiting hole, and can be disposed on the end surface of the positioning pin.
  • the cross-sectional dimension of the positioning pin is uniform, but the cross-sectional dimension of the limiting hole is varied, and an expansion bolt is disposed on the end surface of the positioning pin, and the positioning pin is disposed from the limiting hole.
  • the larger one side protrudes, and the positioning pin is difficult to continue to protrude after being embedded to a certain depth, so that the positioning pin can stay at a desired position, and the expansion bolt is screwed at this time, so that the positioning pin is locked and fixed. In the hole, the fixing of the positioning pin is more stable.
  • the positioning pin has one or more, each positioning pin is matched with a limiting hole.
  • each positioning pin is matched with a limiting hole.
  • there are a plurality of positioning pins there are also a plurality of limiting holes, the number of positioning pins and the limiting hole. The number is consistent.
  • the tibial prosthesis 2 is placed at the anterior superior end surface of the tibia, below the posterior aspect of the tibia.
  • the position of the tibial prosthesis 2 is maintained at a predetermined distance from the lower edge of the tibia.
  • the distance between the natural tibial plateau and the tibia is equal to the predetermined value.
  • Distance value; replacement of the natural tibial plateau by the tibial plateau prosthesis 2 has no substantial effect on the humerus itself, nor does it affect the sliding of the tibia.
  • the natural tibial plateau described in the present application refers to a tibial plateau that naturally grows in the human body, wherein naturally, it means that it exists naturally.
  • the tibial prosthesis 2 includes an upper shim 21 and a lower shim 22, and the upper shim 21 and the lower shim 22 are passed between bolts and pins.
  • the shaft or the like is fixed so that the upper gasket 21 and the lower gasket 22 can have a relative displacement in the vertical direction and cannot move relative to each other in other directions.
  • An elastic member 6 is provided on the lower spacer 22.
  • the impact force transmitted from the femoral prosthesis 1 to the spacer 21 on the tibial prosthesis 2 is buffered by the elastic member 6, so that the upper spacer 21 has a meniscus-like function.
  • the meniscus is a cartilage tissue that functions as a cushioning effect in the human knee joint; specifically, when the femoral prosthesis 1 transmits the impact force to the humeral prosthesis 2, the impact force is first received by the upper spacer 21, and The upper spacer 21 is caused to move downward, thereby pressing the elastic member 6, and as the reaction force of the elastic member 6 is gradually increased, the speed at which the upper spacer 21 moves downward becomes smaller and smaller, and the impact force thereon is also increasingly The smaller the smaller, the upper gasket is pressed against the lower gasket, and the force is transmitted to the tibia. Due to the buffering of the elastic member 6, the force corresponding to the tibia is negligible, so as to achieve a cushioning effect similar to the meniscus. It is called having a meniscus-like function.
  • the elastic member 6 may include a spring, and may also include a flexible member capable of buffering and damping, such as an air bag or a cushioning pad, which is disposed under the upper spacer 21 and can cushion the upper pad.
  • a flexible member capable of buffering and damping such as an air bag or a cushioning pad, which is disposed under the upper spacer 21 and can cushion the upper pad.
  • the impact force transmitted from the sheet 21 can be selected, and a suitable specific placement position can be selected according to the specific structural features.
  • the elastic member 6 is penetrated and fixed to the lower spacer 22, and a part of the elastic member 6 located above the lower spacer 22 is placed on the lower surface of the upper spacer 21, and a part of the elastic member 6 located below the lower spacer 22 has a columnar shape.
  • the elastic member 6 includes a sleeve 61 and a spring 62,
  • the lower end of the spring 62 is embedded in the sleeve 61, and the upper end of the spring is placed on the lower surface of the upper gasket.
  • the prosthesis groove 23 described in the present invention is opened on the lower spacer 22.
  • the sleeve 61 is embedded in a bore 7 formed in the tibia 3.
  • the cross-sectional shape of the cavity is consistent with the cross-sectional shape of the sleeve 61, and the cross-sectional dimensions are also uniform, and the two can be closely fitted, so that the relative position between the tibia and the tibial prosthesis is stable without relative displacement.
  • the cross-sectional shape of the sleeve 61 and the cavity 7 may be various shapes such as a polygon, a quadrangle, a triangular ellipse, a circle, etc., and the cross-sectional shape is preferably circular in the present invention.
  • the sleeve can not only protect the spring, but also limit and fix the humeral prosthesis 2, so that the overall structure of the humeral prosthesis 2 is simple, and the installation process of the humeral prosthesis is simplified.
  • the spring 62 is always in a non-stretched state.
  • a bolt 63 is provided at the bottom of the sleeve 61, and the bolt 63 is movable in a vertical direction with rotation, inside the sleeve 61.
  • the top of the bolt is placed at the bottom of the spring 62 so that the elastic size of the spring 62 can be adjusted by controlling the position of the bolt 63 in the vertical direction; the bolt 63 moves upward in the vertical direction, the spring 62 is pressed, and the spring 62
  • the elasticity is increased, the bolt 63 is moved downward in the vertical direction, the degree of compression of the spring 62 is reduced, and the elasticity of the spring 62 is reduced; thus, the appropriate spring elasticity can be adjusted according to the age and physical condition of the patient, or called a spring.
  • a scale line is drawn at the bottom of the sleeve 61 and/or near the bolt 63 such that the degree of screwing of the bolt 63 can be read directly by the scale line; thereby facilitating the placement of the resilient member 6 Adjusting the spring to tighten;
  • the spring 62 includes a top piece disposed at the top for contact with the upper shim 21.
  • the spring 62 may be made of a material such as metal or various high molecular polymers.
  • the invention provides a method for using a semi-squat artificial knee joint
  • the artificial knee joint is the semi-squat artificial knee joint described above, and the method comprises the following steps:
  • Step 1 Opening a space for placing the tibial prosthesis 2 on the tibial plateau.
  • the space is located on one side of the intercondylar ridge 31 of the tibial plateau, and during the opening of the space, for the intercondylar ridge of the tibial plateau 31 And the cruciate ligament thereon is not damaged; further preferably, the tibia and its quadriceps tendon are not damaged;
  • step 2 the humerus groove 32 is excavated from the tibia and the humerus groove 32 is extended to the tibial plateau intercondylar ridge 31, and the intercondylar ridge hole 33 is formed on the tibial plate intercondylar ridge 31; the cavity 7 is excavated on the tibia 7
  • the number of the tibial recess 32 and the cavity 7 is not fixed, and may be one, two or more, preferably one;
  • step 3 the sleeve on the tibial prosthesis 2 is inserted into the cavity 7, and the relative positions of the prosthesis groove 23, the tibial recess 32 and the intercondylar ridge 33 are adjusted, so that the prosthesis 23 and the humerus
  • the groove 32 and the intercondylar ridge hole 33 together form a limiting hole 4;
  • Step 4 the positioning pin 5 is installed into the limiting hole 4;
  • step 5 the height position of the tibial prosthesis 2 is fixed by the positioning pin 5, and the height of the tibial prosthesis 2 is further fixed by adjusting the amount of bone cement injected.
  • the elasticity of the spring 62 is adjusted by the rotating bolt 63, wherein the elastic/detecting device is also used to detect the tension/strength of the spring to ensure the tension/strength of the spring in the elastic member 6 is uniform;
  • the method further comprises the following steps:
  • step a the upper spacer 21, the lower spacer 22 and the elastic member 6 are assembled into a complete tibial prosthesis 2,
  • Step b the femoral prosthesis 1 is installed, wherein the femoral prosthesis is fixed on the femur and is located above the tibial prosthesis in contact with the tibial prosthesis; preferably, the prosthetic fixation area is first excavated on the femur, and then The femoral prosthesis is inserted into the region, and because the femoral prosthesis has a special curvature and the front and rear flaps 11 and 13, the femoral prosthesis is snapped onto the femur while the fixation thorn 12 on the femoral prosthesis is inserted into the femur In the cancellous bone, the fixation pin 14 on the femoral prosthesis is inserted into the fixation pin 14 dug out of the femur, thereby achieving fixation between the femoral prosthesis and the femur.
  • the prior knee joint replaces the medial platform of the tibial plateau, and the posterior knee joint replaces the lateral platform of the tibial plateau; if the prior knee joint replaces the lateral platform of the tibial plateau, the posterior knee joint replaces the tibial plateau.
  • the positioning pin 5 is a positioning pin in the original semi-squat artificial knee joint, and continues to push the positioning pin to pass through the intercondylar ridge of the tibial plateau, at the center of the knee joint, and the two ends of the positioning pin are respectively embedded into the two In the humeral prosthesis.
  • the invention provides a semi-squat artificial knee joint replacement method
  • the artificial knee joint is the semi-squat artificial knee joint described above, and the method comprises the following steps:
  • Step 1 Opening a space for placing the tibial prosthesis 2 on the tibial plateau.
  • the space is located on one side of the intercondylar ridge 31 of the tibial plateau, and during the opening of the space, for the intercondylar ridge of the tibial plateau 31 And the cruciate ligament thereon is not damaged; further preferably, the tibia and its quadriceps tendon are not damaged;
  • step 2 the humerus groove 32 is excavated from the tibia and the humerus groove 32 is extended to the tibial plateau intercondylar ridge 31, and the intercondylar ridge hole 33 is formed on the tibial plate intercondylar ridge 31; the cavity 7 is excavated on the tibia 7
  • the number of the tibial recess 32 and the cavity 7 is not fixed, and may be one, two or more, preferably one;
  • step 3 the sleeve on the tibial prosthesis 2 is inserted into the cavity 7, and the relative positions of the prosthesis groove 23, the tibial recess 32 and the intercondylar ridge 33 are adjusted, so that the prosthesis 23 and the humerus
  • the groove 32 and the intercondylar ridge hole 33 together form a limiting hole 4;
  • Step 4 the positioning pin 5 is installed into the limiting hole 4;
  • step 5 the height position of the tibial prosthesis 2 is fixed by the positioning pin 5, and the height of the tibial prosthesis 2 is further fixed by adjusting the amount of bone cement injected.
  • the elasticity of the spring 62 is adjusted by the rotating bolt 63, wherein the elastic/detecting device is also used to detect the tension/strength of the spring to ensure the tension/strength of the spring in the elastic member 6 is uniform;
  • the method further comprises the following steps:
  • step a the upper spacer 21, the lower spacer 22 and the elastic member 6 are assembled into a complete tibial prosthesis 2,
  • Step b the femoral prosthesis 1 is installed, wherein the femoral prosthesis is fixed on the femur and is located above the tibial prosthesis in contact with the tibial prosthesis; preferably, the prosthetic fixation area is first excavated on the femur, and then The femoral prosthesis is inserted into the region, and because the femoral prosthesis has a special curvature and the front and rear flaps 11 and 13, the femoral prosthesis is snapped onto the femur while the fixation thorn 12 on the femoral prosthesis is inserted into the femur In the cancellous bone, the fixation pin 14 on the femoral prosthesis is inserted into the fixation pin 14 dug out of the femur, thereby achieving fixation between the femoral prosthesis and the femur.
  • the prior knee joint replaces the medial platform of the tibial plateau, and the posterior knee joint replaces the lateral platform of the tibial plateau; if the prior knee joint replaces the lateral platform of the tibial plateau, the posterior knee joint replaces the tibial plateau.
  • the positioning pin 5 is a positioning pin in the original semi-squat artificial knee joint, and continues to push the positioning pin to pass through the intercondylar ridge of the tibial plateau, at the center of the knee joint, and the two ends of the positioning pin are respectively embedded into the two In the humeral prosthesis.

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Abstract

本发明记载了一种半髁式人工膝关节,该膝关节包括股骨假体和胫骨假体,所述胫骨假体截面呈类腰型,所述胫骨假体设置在胫骨平台髁间脊的一侧,并位于股骨假体的下方,该人工膝关节还包括固定胫骨假体的定位销;在所述胫骨假体的底面上开设有假体豁槽,在所述胫骨假体的下方开设有胫骨豁槽,所述假体豁槽与所述胫骨豁槽相对应,一起构成容纳定位销的限位孔洞;通过该定位销与限位孔洞的配合能够确保胫骨假体与胫骨平台髁间脊之间相对位置稳定、平衡,当两个半髁式(内外侧)人工(半)膝关节同时安装在一个膝关节中时,两个人工(半)膝关节中的限位孔洞联通,共用一个定位销,从而形成一个完整地组合式全膝关节;所述胫骨假体包括上垫片和下垫片,在下垫片上设置有弹性构件。

Description

半髁式人工膝关节 技术领域
本发明涉及一种医用人工关节假体,具体涉及一种半髁式人工膝关节。
背景技术
目前,膝关节替换手术是世界上针对膝关节病变和损伤的最根本性治疗方案,替换手术中将关节假体也称之为人工膝关节植入到人体内,用以替换人体天然的膝关节;随着科技的逐渐进步,对于人工膝关节和替换手术的进一步要求越来越高,人们既希望减少痛苦,还希望提高使用寿命,更希望术后恢复效果更佳,甚至希望能达到正常健康人的水平,为此,各种各样的人工膝关节逐步问世,各种构思设想纷纷提出,然而,目前主流的手术方法及人工膝关节还远远不能满足上述要求;
人体的两个主要腿骨是股骨和胫骨,股骨在上,胫骨在下,股骨和胫骨相交并且相互作用的位置即为膝关节;在膝关节中的一段股骨称之为股骨下端,在膝关节中的一段胫骨称之为胫骨上端;股骨下端和胫骨上端变大,为膝关节的稳定提供支撑基础;
股骨下端形成两个分离的髁,髁的下表面是平滑的圆形并且被关节软骨覆盖,所述两个分离的髁并不是对称的,内侧髁较大,外侧髁较小,以适应内侧和外侧不同的受力情况;胫骨上端包括浅的、凹形的、被关节软骨所覆盖的外侧和内侧平台,内侧平台大于外侧平台,整个胫骨平台被外侧平台和内侧平台之间的隆起或结节所分离;
髌骨(膝盖骨)埋在股四头肌肌腱中,股四头肌肌腱将前上大腿的股四头肌肌肉组织连接到髌骨,髌骨韧带将髌骨连接到位于膝关节正下方的胫骨;股四头肌肌腱、髌骨和髌骨韧带的组合更像一个滑轮,将由股四头肌肌肉组织产生的力经由屈曲的膝关节传递至胫骨,从而使得腿变直或者减慢屈曲的速度,显然,髌骨也具有保护膝关节免受撞击损伤的其他功能;
交叉韧带的作用是在屈曲和伸展期间使髁大致定位在胫骨上,在膝关节的屈曲期间,由前交叉韧带所施加的张力限制髁向后位移,在膝关节的伸展期间,后交叉韧带限制髁向前位移;
膝关节半月板对于膝关节发挥正常功能具有至关重要的作用,除了增加关节对称性外,半月板在使力经过膝关节时得到缓冲和分化,减弱股骨与胫骨之间的摩擦和冲击;
然而,目前流行的膝关节置换手术中,往往是直接切除自然的胫骨平台,换上人工的胫骨平台,并且在股骨表面安装有形状类似的股骨髁假体,从而 使得新的股骨髁假体与人工胫骨平台相互作用,这就导致术后的膝关节中没有了交叉韧带和半月板,有的甚至连髌骨也没有了,所以现行的手术方法及相应的人工膝关节本身特性导致了这样的手术后不可能具有期望的恢复效果,这样的手术破坏了膝关节原有的生理结构和特性,对膝关节造成了永久性的不可逆损坏,急需做出调整,需要一种能够保留交叉韧带、髌骨,并具有半月板缓冲功能的新的人工膝关节。
另外,经过多年临床研究获知,膝关节病变中,内侧髁和外侧髁,内侧平台和外侧平台的损伤程度并不相同,往往受到人的行为习惯、工作习惯等影响,位于内侧的髁或平台先行损坏,再导致另外一侧的髁或平台加速损坏,并且在此过程中病人承受巨大痛苦,如果此过程中进行手术,往往将没有损坏的一侧也一同切除,因为胫骨平台和新的股骨髁都是整体式的;而且,大多数膝关节病变都是由、半月板、股骨髁或者胫骨平台退变、磨损导致的,交叉韧带和髌骨损坏的极少;
为此,有人提出用半髁式膝关节替换已有的整体式膝关节,这种想法虽然值得提倡,但是在实际执行过程中却遇到了极大困难,最终无法实现,或者其真实效果还要低于原本的整体式膝关节;其主要问题在于,当更换了半髁式膝关节,更换部分与完好部分在功能、高度上不匹配,不能有效延缓完好部分的损坏速度,当原本完好的另一部分膝关节也损坏后,仍然需要手术更换人工膝关节,此时如果也使用半髁式膝关节,则两个半髁式膝关节在高度、尺寸、弹性等方面难以协调一致,使用效果不良,如果更换整体式膝关节,原来更换的半髁式膝关节又显得毫无意义,还涉及到胫骨与股骨的二次破损安装。
由于上述问题,本发明人对现有的人工膝关节做了深入研究,设计出一种能够解决上述问题的新的半髁式人工膝关节。
发明内容
为了克服上述问题,本发明人进行了锐意研究,设计出一种半髁式人工膝关节,该膝关节包括股骨假体和胫骨假体,所述胫骨假体截面呈类腰型,所述胫骨假体设置在胫骨平台髁间脊的一侧,并位于股骨假体的下方,在所述胫骨假体的底面上开设有假体豁槽,在所述胫骨假体的下方的胫骨上开设有胫骨豁槽,所述假体豁槽与所述胫骨豁槽相对应,与髁间脊孔洞一起构成限位孔洞;所述限位孔洞穿透/穿入胫骨平台髁间脊,该人工膝关节还包括可嵌入到所述限位孔洞中的定位销,通过该定位销与限位孔洞的配合能够确胫骨假体与胫骨平台髁间脊之间相对位置稳定、平衡,当两个半髁式人工膝关节同时安装在一个膝关节的内外侧时,两个半髁人工膝关节中的限位孔洞 联通,共用一个定位销,形成一个完整地组合式全膝关节;所述胫骨假体包括上垫片和下垫片,在下垫片上设置有弹性构件,从而完成本发明。
具体来说,本发明的目的在于提供一种半髁式人工膝关节,其特征在于,该膝关节包括股骨假体1和胫骨假体2,
所述胫骨假体2设置在胫骨平台髁间脊31的一侧,并位于股骨假体1的下方。
其中,所述胫骨假体2包括上垫片21和下垫片22,
其中,在下垫片22上设置有弹性构件6,通过该弹性构件6来缓冲由股骨假体1传递至胫骨假体2上垫片的冲击力,使得上垫片21具有类半月板功能。
其中,所述弹性构件6贯穿下垫片22,并固定安装在下垫片22上,上端伸出下垫片22上方,顶置于上垫片下表面。
其中,所述弹性构件6包括套筒61和弹簧62,弹簧62下端埋置于套筒61中,弹簧上端顶置于上垫片下表面,
套筒61穿过下垫片22,套筒底端安装于胫骨上的孔腔7中。
其中,在所述套筒61底部设有调节所述弹簧62松紧的螺栓63。
其中,所述胫骨假体2置于髌骨后侧下方。
其中,该人工膝关节还包括定位销5;通过所述定位销5将胫骨假体2固定于胫骨上。
其中,所述定位销5一端上部安装于胫骨假体2中,其另一端嵌入到胫骨平台髁间脊31中。
其中,在所述胫骨假体2的底部开设有假体豁槽23,
在所述胫骨假体2之下的胫骨顶部开设有胫骨豁槽32,所述假体豁槽23与所述胫骨豁槽32相对应,一起形成容纳定位销5的限位孔洞4,且该限位孔洞穿入胫骨平台髁间脊31。
本发明还提供一种如上文所述的半髁式人工膝关节的使用方法,该方法包括如下步骤:
步骤1,将股骨假体1安装在股骨髁上;
步骤2,在胫骨平台上开设出安放胫骨假体2的空间,
步骤3,在胫骨上挖出胫骨豁槽32并延伸该胫骨豁槽32至胫骨平台髁间脊31,在胫骨平台髁间脊31上形成髁间脊孔洞33;
步骤4,在胫骨上挖出孔腔7;
步骤5,将胫骨假体2上的套筒嵌入到孔腔7中,同时调整假体豁槽23、胫骨豁槽32和髁间脊孔洞33的相对位置,使得假体豁槽23与胫骨豁槽32、以及髁间脊孔洞33一起构成限位孔洞4;
步骤6,将定位销5安装到限位孔洞4中,待定位销5固定后通过骨水泥固 定胫骨假体2;
其中,优选地,在执行步骤5以前,通过旋转螺栓63调节弹簧62的松紧。
本发明所具有的有益效果包括:
(1)根据本发明提供的人工膝关节具有较小的胫骨假体,能够放置在胫骨平台髁间脊的侧部,从而使得不必切除、破坏胫骨平台髁间脊,所以胫骨平台髁间脊上的交叉韧带可以完好保留,从而使得使用效果和患者体验极大增强;
(2)根据本发明提供的人工膝关节具有较小的胫骨假体,可以根据病情只更换一部分膝关节,或者分阶段进行假体移植,先更换或者只更换一个本申请提供的半髁式人工膝关节,如有必要,可以后续再更换一个本申请提供的半髁式人工膝关节,实际应用更为灵活方便;
(3)根据本发明提供的人工膝关节的胫骨假体上设置有弹性构件,能够模拟半月板的功能,提供缓冲减震效果,使得人工膝关节与自然膝关节更加实质性相似;
(4)根据本发明提供的人工膝关节胫骨假体的弹性构件中弹簧弹性/弹力可调,可以根据不同年龄和身体状况进行调节,能够确保该弹簧弹性/弹力处于最佳的状态;
(5)根据本发明提供的人工膝关节胫骨假体的弹性构件设置在向下凸出的筒状结构中,该筒状结构嵌入到胫骨上的孔腔内,从而还能够启动对胫骨假体的限位固定作用;
(6)根据本发明提供的人工膝关节的胫骨假体上开设有假体豁槽,还设置有连通胫骨假体与胫骨平台髁间脊的定位销,从而将胫骨假体完全固定在胫骨上,固定方式简单,效果良好;
(7)根据本发明提供的人工膝关节的胫骨假体上开设有假体豁槽,还设置有连通胫骨假体与胫骨平台髁间脊的定位销,能够在必要的时候允许再添加一个半髁式人工膝关节,并且可以通过延长、贯通限位孔洞,即将髁间脊孔洞由盲孔变为通孔,通过原定位销固定两个半髁式人工膝关节,全方位地限制固定了两个胫骨假体之间的相对位置,使得人工膝关节受力均衡,整体稳态,使用寿命长,患者体验良好。
附图说明
图1示出根据本发明一种优选实施方式的半髁式人工膝关节装配爆炸图;
图2示出根据本发明一种优选实施方式的半髁式人工膝关节中股骨假体结构示意图;
图3示出根据本发明一种优选实施方式的半髁式人工膝关节中限位孔洞/定位销截面形状图示意图;
图4示出根据本发明一种优选实施方式的半髁式人工膝关节中限位孔洞/定位销截面形状图示意图;
图5示出根据本发明一种优选实施方式的半髁式人工膝关节中限位孔洞/定位销截面形状图示意图;
图6示出根据本发明一种优选实施方式的半髁式人工膝关节中胫骨假体结构示意图;
图7示出根据本发明一种优选实施方式的半髁式人工膝关节中胫骨假体上弹性构件剖视图;
图8示出根据本发明一种优选实施方式的半髁式人工膝关节胫骨结构示意图;
图9示出根据本发明一种优选实施方式的半髁式人工膝关节中安放两个半髁式人工膝关节的胫骨结构示意图;
图10示出根据本发明一种优选实施方式的人工膝关节中股骨假体与股骨装配爆炸图;
图11示出根据本发明一种优选实施方式的人工膝关节中股骨假体与股骨装配后的结构示意图。
附图标号说明:
1-股骨假体;11-前扣盖;12-固定刺;13-后扣盖;14-固定销;2-胫骨假体;21-上垫片;22-下垫片;23-假体豁槽;3-胫骨;31-胫骨平台髁间脊;32-胫骨豁槽;33-髁间脊孔洞;4-限位孔洞;5-定位销;6-弹性构件;61-套筒;62-弹簧;63-螺栓;7-孔腔;8-股骨;
具体实施方式
下面通过附图和实施例对本发明进一步详细说明。通过这些说明,本发明的特点和优点将变得更为清楚明确。
在这里专用的词“示例性”意为“用作例子、实施例或说明性”。这里作为“示例性”所说明的任何实施例不必解释为优于或好于其它实施例。尽管在附图中示出了实施例的各种方面,但是除非特别指出,不必按比例绘制附图。
根据本发明提供的半髁式人工膝关节,如图1中所示,该人工膝关节包括股骨假体1和胫骨假体2,其中,股骨假体1设置在股骨8下端,并替换股骨下端的一部分骨结构,胫骨假体2设置在胫骨3上端,并替换胫骨上端胫骨平 台上的一部分骨结构;本申请中所述胫骨平台为胫骨上与股骨下端接触的面,胫骨平台的中央有胫骨平台髁间脊31,也称之为隆起或结节,其上附着有十字交叉韧带,胫骨平台主要由所述胫骨平台髁间脊两侧的内侧平台和外侧平台构成。
所述胫骨假体2用以替换内侧平台或外侧平台,所述胫骨假体替换内侧平台或外侧平台后,胫骨平台上未被替换部分(胫骨平台髁间脊)高度与胫骨假体高度基本一致,即经由胫骨假体替换了一部分胫骨结构后,胫骨高度和外形都没有变化。
所述股骨假体只有一个单髁,包括前扣盖11、固定刺12、后扣盖13和固定销14,如图1和图2中所示;
具体来说,如图10和图11中所示,所述股骨假体1的外形与其替换的部分股骨外形一致,其外部呈圆弧面状,在股骨假体1的两端分别设置前扣盖11和后扣盖13,用以使得所述股骨假体固定在股骨上,其中,所述后扣盖13顶端朝向前扣盖方向倾斜;
安装所述股骨假体时,首先在股骨上挖出内凹的假体固定区域,当股骨假体安装在该区域内以后,刚好可以将该区域填满,使得股骨恢复到挖出所述假体固定区域以前的状态;即股骨假体1通过嵌入到假体固定区域来固定在股骨上。
在股骨假体的内侧还设置有固定刺12和固定销14,在股骨上加工假体固定区域时,还要在相应位置,在骨松质中挖出盲孔,股骨假体1扣合在假体固定区域时,固定销14嵌入到所述盲孔内;
同时,在骨松质上,靠近前骨皮质处开设出锥形槽/锥形孔,其中,所述前骨皮质是指与前扣盖11相接触的骨皮质,所述锥形槽/锥形孔的具体形状、数量都与固定刺12的形状、数量相对应,当股骨假体扣合在假体固定区域时,固定刺12上尖锐的插入到该锥形槽/锥形孔内;
优选地,盲孔的孔径尺寸略小于固定销14的外径尺寸;在固定销14嵌入到盲孔内的过程中,必然会迫使盲孔的孔径扩大,压迫该骨松质区域,从而形成紧密的固结;
优选地,所述固定刺12和固定销14都可以是一个或多个,本申请中优选地固定刺有两个,固定销有一个,相应地,所述盲孔和锥形槽/锥形孔的数量与固定销14和固定刺12的数量匹配。
股骨上与所述前扣盖11、后扣盖13相接触的区域为骨皮质区域,具有较高的强度和韧性;
本发明进一步优选地,前扣盖11与所述固定刺12临近,前扣盖11扣在骨皮质外部,固定刺12插入到骨松质中,并且从内侧顶在骨皮质上,从而加紧 骨皮质,与后扣盖13一同形成窝槽进而扣合固定在股骨上;同时,前扣盖11与所述固定刺12一起组成截面呈V型的槽状结构,股骨上经过磨削加工的骨皮质即顶在该槽状结构的底部;通过所述固定刺12和所述截面呈V型的槽状结构共同辅助前扣盖11对骨皮质的固定,从而使得前扣盖11和后扣盖13可以卡扣在股骨上;能够科学合理地使得股骨假体与股骨之间的固结牢固可靠,能够经受长时间的考验。
在一个优选的实施方式中,所述股骨假体的表面积尺寸较小,所以体积和重量都较小,具体来说,所述股骨假体1外表面的面积约占股骨内侧半髁/股骨外侧半髁外表面积的60%以下,优选地可达到40%~55%左右;本申请中优选为50%左右,相当于股骨髁表面积的四分之一左右;
所述股骨假体位于股骨滑车的一侧,股骨假体1的替换不影响股骨滑车的正常工作,所以替换股骨假体1对于髌骨的正常工作及安装位置无影响。
本发明中优选地,所述胫骨假体位于股骨假体1的下方,该胫骨假体替换发生病变的内侧平台或者外侧平台,为了放置固定所述胫骨假体,需要对胫骨或者胫骨平台作出一定结构上的改造,当所述胫骨假体只有一个时,改造后的胫骨或者为胫骨平台如图8中所示。
如果在已经更换了本申请所述的单髁式人工膝关节后,另外半髁关节也发生病变破损后,需用用另一个半髁式人工膝关节进行替换,即胫骨平台上设置两个胫骨假体,所述两个胫骨假体2分别设置在胫骨平台髁间脊31的两侧,胫骨假体2替换胫骨平台中的内侧平台和外侧平台,并承托股骨假体1。当胫骨假体有两个时,改造后的胫骨或者称之为胫骨平台如图9中所示。
所述胫骨假体2的上表面具有向内、向下凹陷,类似于天然胫骨平台上的内侧平台和外侧平台,如图1中所示。
所述胫骨假体2的截面呈腰型或者类腰型,其外轮廓与被挖掉的部分胫骨平台一致,所述截面为水平截面。
所述胫骨假体2的截面尺寸约为胫骨平台截面尺寸的三分之一。
在一个优选的实施方式中,如图1中所示,该人工膝关节还包括固定胫骨假体2的定位销5;
优选地,所述定位销5一端上部安装于胫骨假体2中,其另一端嵌入到胫骨平台髁间脊31中;
具体来说,在所述胫骨平台髁间脊上还开设有髁间脊孔洞33,定位销一端埋置在髁间脊孔洞33中,另一端的上部安装于胫骨假体2中,另一端的下部安装于胫骨中。
在一个优选的实施方式中,如图6中所示,在所述胫骨假体2的底部开设有假体豁槽23,
在所述胫骨假体2的下方开设有胫骨豁槽32;即,在所述胫骨假体下方的胫骨/胫骨平台上开设有胫骨豁槽32,如图8和图9中所示。
所述假体豁槽23与所述胫骨豁槽32相对应,与髁间脊孔洞33一起构成限位孔洞4,该限位孔洞用于安装所述定位销5,如图3、图4和图5中所示。
当所述胫骨假体2只有一个时,即为单髁式人工膝关节,所述限位孔洞延伸至胫骨平台髁间脊31内,并不穿透所述胫骨平台髁间脊31,即髁间脊孔洞是盲孔。
在一个优选的实施方式中,定位销的长度值大于一个胫骨假体2上假体豁槽23的长度值,该定位销的长度值小于一个假体豁槽23的长度值与胫骨平台髁间脊31宽度值之和。从而,当胫骨假体只有一个时,该定位销能够满足定位固定作用,当在同一关节上安装第二个半髁式人工膝关节时,即胫骨假体再增加一个时,所述限位孔洞4的长度自然随之延长,即,在安装第二个胫骨假体时,将原本的限位孔洞延伸、延长,即将髁间脊孔洞由盲孔变为通孔,其中,在一个优选实施方式中,该定位销可以进一步向延长后的限位孔洞内深入移动,最终定位销完全贯穿胫骨平台髁间脊31,定位销的两端都嵌入到假体豁槽23内,起到对胫骨假体2的限位和固定作用;在另外一种优选实施方式中,将原来的定位销取出,更换一个长度更长的定位销,同样插入到所述限位孔洞内;本发明中优选地,不更换定位销,将原本的定位销向内推进即可完成限位固定。
优选地,胫骨平台髁间脊31的宽度值小于或等于假体豁槽23的长度值。
当安装第二个单髁式人工膝关节时,所述限位孔洞穿透胫骨平台髁间脊31,两个胫骨假体2对应的两个限位孔洞互相连通,形成一个更长的限位孔洞;优选地,所述限位孔洞4及定位销5穿透胫骨平台髁间脊31,连通两个胫骨假体2;即在所述限位孔洞4的轴向方向上,限位孔洞是由三部分拼接而成的,其中位于两端的两部分,都是由上方的假体豁槽23和下方的胫骨豁槽32围成的;位于中间的第三部分则完全是开设在胫骨平台髁间脊31上的髁间脊孔洞33。
值得注意的是,由于定位销的存在,其能够固定位于胫骨平台髁间脊两侧的两个胫骨假体2的水平高度,还可以使得位于胫骨平台髁间脊一侧的一个胫骨假体与胫骨平台髁间脊保持在一个期望的水平高度范围内,从而使得替换后的膝关节股骨的生理高度与替换前膝关节股骨生理高度基本一致,在此基础上执行对胫骨假体2的固定,从而使得胫骨假体处于合理位置,确保术后患者体验良好。
在一个优选的实施方式中,如图3、图4和图5中所示,所述限位孔洞4的截面形状与定位销5的截面形状一致;该截面形状可以为椭圆形、正方形、 梯形、菱形、三角形、五边形、五角星形、六边形、八边形等等各种形状,在各种截面形状的定位销中,三角形、正方形、梯形和多边形的使用效果更好一些,本发明中优选地选择梯形,并且该梯形上底位于假体豁槽23中,下底位于胫骨豁槽32中,并且上底长度大于下底长度。
在一个优选的实施方式中,所述定位销的截面尺寸和限位孔洞的截面尺寸相对应,二者之间紧密配合,优选地为过盈配合;从而使得定位销嵌入到一定深度后难以继续伸入,并被卡死,此时定位销刚好停留在期望的位置,优选地,该位置为正中心位置,不会向两侧偏离;
在一个优选的实施方式中,所述限位孔洞的截面尺寸和和限位孔洞的截面尺寸相对应,定位销可以嵌入到限位孔洞的相应深度位置,在所述定位销的端面上可设置有膨胀螺栓,当定位销位于期望的位置,优选为正中心位置时,通过旋拧所述膨胀螺栓,使得定位销卡死固定在限位孔洞中,从而确保定位销的位置稳固,不会向两侧偏移;
在一个优选的实施方式中,所述定位销的截面尺寸均一不变,但是限位孔洞的截面尺寸是变化的,在所述定位销的端面上设置有膨胀螺栓,定位销从限位孔洞上尺寸较大的一侧伸入,定位销嵌入到一定深度后难以继续伸入,从而使得定位销能够停留在期望的位置,并且此时旋拧所述膨胀螺栓,使得定位销卡死固定在限位孔洞中,使得定位销的固定更为稳固。
本发明中,所述定位销有一个或者多个,每个定位销都与一个限位孔洞相配合,当定位销有多个时,限位孔洞也有多个,定位销的数量与限位孔洞的数量保持一致。
所述胫骨假体2置于胫骨前上端面位置,髌骨后侧下方,优选地,胫骨假体2的设置位置与髌骨下缘保持预定距离,自然胫骨平台与髌骨之间的距离值等于该预定距离值;通过胫骨平台假体2替换自然胫骨平台,对于髌骨本身没有实质影响,也不影响髌骨的滑动。本申请中所述的自然胫骨平台是指人体内自然生长的胫骨平台,其中,自然即表示自然存在的。
在一个优选的实施方式中,如图6和图7中所示,所述胫骨假体2包括上垫片21和下垫片22,上垫片21和下垫片22之间通过螺栓、销轴等方式进行固定,使得上垫片21和下垫片22之间可以在竖直方向上有一定的相对位移,在其他方向上不能相对移动。
在下垫片22上设置有弹性构件6。通过该弹性构件6来缓冲由股骨假体1传递至胫骨假体2上垫片21的冲击力,使得上垫片21具有类半月板功能。所述半月板为人体膝关节中起到缓冲减震作用的软骨组织;具体来说,当股骨假体1传递给胫骨假体2冲击力时,首先由上垫片21受到该冲击力,并且致使上垫片21向下移动,从而压迫弹性构件6,并且随着弹性构件6的反作用力的 逐渐增大,上垫片21向下移动的速度越来越小,其上的冲击力也越来越小,最终上垫片抵压在下垫片上,共同将作用力传递给胫骨,由于经过了弹性构件6的缓冲,该作用力对应胫骨的损耗可以忽略,从而达到类似半月板的缓冲作用,即称之为具有类半月板功能。
本申请中,所述弹性构件6可以包括弹簧,也可以包括气囊、缓冲垫片等能起到缓冲减震作用的具有一定弹性的构件,其设置在上垫片21的下方,能够缓冲上垫片21传递来的冲击力即可,可以根据具体结构特征选择适宜的具体安放位置。
下面以包括弹簧的弹性构件为例进行说明;
所述弹性构件6贯穿并固定在下垫片22上,位于下垫片22上方的部分弹性构件6顶在上垫片21的下表面,位于下垫片22下方的部分弹性构件6呈柱状。
优选地,具体来说,如图7中所示,所述弹性构件6包括套筒61和弹簧62,
其中,弹簧62下端埋置于套筒61中,弹簧上端顶置于上垫片下表面。从而使得由股骨假体传递给上垫片21的力经过弹簧62的缓冲后再作用到下垫片22上;
本发明中所述的假体豁槽23开设在所述下垫片22上。
在一个优选的实施方式中,所述套筒61嵌入到开设在胫骨3上的孔腔7中。优选地孔腔的截面形状与套筒61的截面形状一致,截面尺寸也一致,二者可以紧密贴合,从而使得胫骨与胫骨假体之间相对位置稳定,没有相对位移。所述套筒61和孔腔7的截面形状可以为各种形状,如多边形、四边形、三角形椭圆形、圆形等等,本发明中优选地该截面形状为圆形。
所述套筒既能够起到保护安放弹簧的作用,也能够起到限位、固定胫骨假体2的作用,从而使得胫骨假体2整体结构简单,简化胫骨假体的安放固定过程。
本发明中优选地,所述弹簧62始终处于非拉伸状态,
在一个优选的实施方式中,如图7中所示,在所述套筒61的底部设置有螺栓63,该螺栓63可随着旋转而在竖直方向上移动,在所述套筒61内部,所述螺栓的顶部顶在弹簧62的底部,从而可以通过控制螺栓63在竖直方向上的位置来调节弹簧62的弹性大小;螺栓63在竖直方向向上移动,弹簧62被压迫,弹簧62的弹性增大,螺栓63在竖直方向向下移动,弹簧62的压迫程度减小,弹簧62的弹性减小;从而可以根据患者的年龄和身体状况调节适宜的弹簧弹性,或者称之为弹簧松紧,从而使得上垫片21和下垫片22之间的弹性与半月板的弹性一致,使得上垫片21和下垫片22的总高度/厚度与未更换人工膝关节一侧的高度一致,
还可以在安装第二个半髁式人工膝关节时,使得上垫片21和下垫片22的总高度/厚度与在先更换的半髁式人工膝关节的胫骨假体2的高度一致,从而解决了分两次更换的两侧两个胫骨假体2之间高度、弹性不一致的问题,使得分批次手术后的效果良好。
在一个优选的实施方式中,在所述套筒61的底部和/或螺栓63附近刻画刻度线,使得通过该刻度线能够直接读出螺栓63的旋拧程度;从而便于在安放弹性构件6时调节弹簧松紧;
优选地,所述弹簧62包括设置在顶部,用以与上垫片21接触的顶块。
本发明中,所述弹簧62可以由金属、各种高分子聚合物等材料制成。
本发明提供一种半髁式人工膝关节的使用方法,
该人工膝关节为上文中所述的半髁式人工膝关节,该方法包括如下步骤:
步骤1,在胫骨平台上开设出安放胫骨假体2的空间,优选地,该空间开位于胫骨平台髁间脊31的一侧,并且在开设该空间的过程中,对于胫骨平台髁间脊31及其上的十字韧带没有破坏;进一步优选地,还不会对髌骨及其所在的股四头肌肌腱造成损伤;
步骤2,在胫骨上挖出胫骨豁槽32并延伸该胫骨豁槽32至胫骨平台髁间脊31,在胫骨平台髁间脊31上形成髁间脊孔洞33;在胫骨上挖出孔腔7;胫骨豁槽32和孔腔7的数量不固定,可以是一个、两个或者多个,优选地都选择一个;
步骤3,将胫骨假体2上的套筒嵌入到孔腔7中,同时调整假体豁槽23、胫骨豁槽32和髁间脊孔洞33的相对位置,使得假体豁槽23、胫骨豁槽32和髁间脊孔洞33一起构成限位孔洞4;
步骤4,将定位销5安装到限位孔洞4中;
步骤5,通过定位销5固定胫骨假体2的高度位置,通过调节骨水泥的注入量进一步固定胫骨假体2的高度。
优选地,在执行步骤3以前,通过旋转螺栓63调节弹簧62的松紧,其中,还使用弹性检测设备检测弹簧的松紧/强度,以保证弹性构件6中弹簧的松紧/强度一致;
优选地,还包括任选的如下步骤:
步骤a,将上垫片21、下垫片22和弹性构件6组装为完整的胫骨假体2,
步骤b,安装股骨假体1,其中,股骨假体固定在股骨上,并且位于胫骨假体上方,与胫骨假体相接触;优选地,首先在所述股骨上挖出假体固定区域,再将股骨假体嵌入到该区域,并且由于股骨假体具有特殊的弧度及前扣盖11和后扣盖13,股骨假体扣合在股骨上,同时股骨假体上的固定刺12插入 到股骨的骨松质中,股骨假体上的固定销14嵌入到股骨上挖出的固定销14内,从而实现股骨假体与股骨之间的固定。
任选地,完成上述半髁式人工膝关节的安装后,如有必要,可以在该膝关节上继续安装另外一个人工膝关节;
如在先的膝关节替换了胫骨平台的内侧平台,在后的膝关节则替换胫骨平台的外侧平台;如在先的膝关节替换了胫骨平台的外侧平台,在后的膝关节则替换胫骨平台的内侧平台;
安装新的另一个半髁式人工膝关节时重复上述步骤,其中,步骤3中的限位孔洞4与在先的限位孔洞重合,将髁间脊孔洞33由盲孔变为通孔,
步骤4中定位销5为原半髁式人工膝关节中的定位销,继续推动该定位销,使其穿过胫骨平台髁间脊,位于膝关节中心位置,该定位销两端分别嵌入到两个胫骨假体中。
本发明提供一种半髁式人工膝关节置换方法,
该人工膝关节为上文中所述的半髁式人工膝关节,该方法包括如下步骤:
步骤1,在胫骨平台上开设出安放胫骨假体2的空间,优选地,该空间开位于胫骨平台髁间脊31的一侧,并且在开设该空间的过程中,对于胫骨平台髁间脊31及其上的十字韧带没有破坏;进一步优选地,还不会对髌骨及其所在的股四头肌肌腱造成损伤;
步骤2,在胫骨上挖出胫骨豁槽32并延伸该胫骨豁槽32至胫骨平台髁间脊31,在胫骨平台髁间脊31上形成髁间脊孔洞33;在胫骨上挖出孔腔7;胫骨豁槽32和孔腔7的数量不固定,可以是一个、两个或者多个,优选地都选择一个;
步骤3,将胫骨假体2上的套筒嵌入到孔腔7中,同时调整假体豁槽23、胫骨豁槽32和髁间脊孔洞33的相对位置,使得假体豁槽23、胫骨豁槽32和髁间脊孔洞33一起构成限位孔洞4;
步骤4,将定位销5安装到限位孔洞4中;
步骤5,通过定位销5固定胫骨假体2的高度位置,通过调节骨水泥的注入量进一步固定胫骨假体2的高度。
优选地,在执行步骤3以前,通过旋转螺栓63调节弹簧62的松紧,其中,还使用弹性检测设备检测弹簧的松紧/强度,以保证弹性构件6中弹簧的松紧/强度一致;
优选地,还包括任选的如下步骤:
步骤a,将上垫片21、下垫片22和弹性构件6组装为完整的胫骨假体2,
步骤b,安装股骨假体1,其中,股骨假体固定在股骨上,并且位于胫骨 假体上方,与胫骨假体相接触;优选地,首先在所述股骨上挖出假体固定区域,再将股骨假体嵌入到该区域,并且由于股骨假体具有特殊的弧度及前扣盖11和后扣盖13,股骨假体扣合在股骨上,同时股骨假体上的固定刺12插入到股骨的骨松质中,股骨假体上的固定销14嵌入到股骨上挖出的固定销14内,从而实现股骨假体与股骨之间的固定。
任选地,完成上述半髁式人工膝关节的安装后,如有必要,可以在该膝关节上继续安装另外一个人工膝关节;
如在先的膝关节替换了胫骨平台的内侧平台,在后的膝关节则替换胫骨平台的外侧平台;如在先的膝关节替换了胫骨平台的外侧平台,在后的膝关节则替换胫骨平台的内侧平台;
安装新的另一个半髁式人工膝关节时重复上述步骤,其中,步骤3中的限位孔洞4与在先的限位孔洞重合,将髁间脊孔洞33由盲孔变为通孔,
步骤4中定位销5为原半髁式人工膝关节中的定位销,继续推动该定位销,使其穿过胫骨平台髁间脊,位于膝关节中心位置,该定位销两端分别嵌入到两个胫骨假体中。
以上结合了优选的实施方式对本发明进行了说明,不过这些实施方式仅是范例性的,仅起到说明性的作用。在此基础上,可以对本发明进行多种替换和改进,这些均落入本发明的保护范围内。

Claims (10)

  1. 一种半髁式人工膝关节,其特征在于,该膝关节包括股骨假体(1)和胫骨假体(2),
    所述胫骨假体(2)设置在胫骨平台髁间脊(31)的一侧,并位于股骨假体(1)的下方。
  2. 根据权利要求1所述的半髁式人工膝关节,其特征在于,
    所述胫骨假体(2)包括上垫片(21)和下垫片(22),
    其中,在下垫片(22)上设置有弹性构件(6),通过该弹性构件(6)来缓冲由股骨假体(1)传递至胫骨假体(2)上垫片的冲击力,使得上垫片(21)具有类半月板功能。
  3. 根据权利要求2所述的半髁式人工膝关节,其特征在于,
    所述弹性构件(6)贯穿下垫片(22),并固定安装在下垫片(22)上,上端伸出下垫片(22)上方,顶置于上垫片下表面。
  4. 根据权利要求3所述的半髁式人工膝关节,其特征在于,
    所述弹性构件(6)包括套筒(61)和弹簧(62),弹簧(62)下端埋置于套筒(61)中,弹簧上端顶置于上垫片下表面,
    套筒(61)穿过下垫片(22),套筒底端安装于胫骨上的孔腔(7)中。
  5. 根据权利要求4所述的半髁式人工膝关节,其特征在于,
    在所述套筒(61)底部设有调节所述弹簧(62)松紧的螺栓(63)。
  6. 根据权利要求1所述的半髁式人工膝关节,其特征在于,
    所述胫骨假体(2)置于髌骨后侧下方。
  7. 根据权利要求1所述的半髁式人工膝关节,其特征在于,
    该人工膝关节还包括定位销(5);通过所述定位销(5)将胫骨假体(2)固定于胫骨上。
  8. 根据权利要求7所述的半髁式人工膝关节,其特征在于,
    所述定位销(5)一端上部安装于胫骨假体(2)中,其另一端嵌入到胫骨平台髁间脊(31)中。
  9. 根据权利要求1所述的半髁式人工膝关节,其特征在于,
    在所述胫骨假体(2)的底部开设有假体豁槽(23),
    在所述胫骨假体(2)之下的胫骨顶部开设有胫骨豁槽(32),所述假体豁槽(23)与所述胫骨豁槽(32)相对应,一起形成容纳定位销(5)的限位孔洞(4),且该限位孔洞穿入胫骨平台髁间脊(31)。
  10. 一种如权利要求1-9所述的半髁式人工膝关节的使用方法,其特征在于,该方法包括如下步骤:
    步骤1,将股骨假体(1)安装在股骨髁上;
    步骤2,在胫骨平台上开设出安放胫骨假体(2)的空间,
    步骤3,在胫骨上挖出胫骨豁槽(32)并延伸该胫骨豁槽(32)至胫骨平台髁间脊(31),在胫骨平台髁间脊(31)上形成髁间脊孔洞(33);
    步骤4,在胫骨上挖出孔腔(7);
    步骤5,将胫骨假体(2)上的套筒嵌入到孔腔(7)中,同时调整假体豁槽(21)、胫骨豁槽(32)和髁间脊孔洞(33)的相对位置,使得假体豁槽(23)与胫骨豁槽(32)、以及髁间脊孔洞(33)一起构成限位孔洞(4);
    步骤6,将定位销(5)安装到限位孔洞(4)中,待定位销(5)固定后通过骨水泥固定胫骨假体(2);
    其中,优选地,在执行步骤5以前,通过旋转螺栓(63)调节弹簧(62)的松紧。
PCT/CN2018/093790 2017-07-03 2018-06-29 半髁式人工膝关节 WO2019007287A1 (zh)

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