CN108403263A - Patellofemoral joint prosthese and preparation method thereof - Google Patents

Abstract

The invention relates to the field of medical devices, and discloses a patellofemoral joint prosthesis and a manufacturing method thereof. The patellofemoral joint prosthesis includes a femoral trochlear prosthesis and a patella prosthesis. The femoral trochlear prosthesis includes medial and lateral condyles located on both sides of the femoral trochlear prosthesis, and a trochlear groove connecting the medial and lateral condyles. Among them, the medial condyle and the lateral condyle are connected to the trochlear groove in arcs with different radii of curvature, so that the joint surface formed by the medial condyle, the lateral condyle and the trochlear groove constitutes a mating surface for matching with the patella prosthesis. The prosthesis also includes a fixation surface formed on the femoral trochlear prosthesis opposite to the mating surface, on which a fixation component is formed, and the patella prosthesis includes an articular surface that matches the mating surface, and the section of the articular surface is elliptical in a top view The cross-section under the front view state is an asymmetric parabolic shape, and a connecting column is formed on the surface of the patella prosthesis opposite to the articular surface. The patellofemoral joint prosthesis is more suitable for Chinese people.

Description

Patellofemoral prosthesis and method for making the same

technical field

The invention relates to the field of medical devices, in particular to a patellofemoral joint prosthesis and a manufacturing method thereof.

Background technique

Knee arthritis is a common, chronic, and progressive joint disease, accounting for more than 50% of osteoarthritis, of which patellofemoral osteoarthritis accounts for about 67% of knee arthritis. Total knee arthroplasty is an effective method for the treatment of advanced knee osteoarthritis, rheumatoid arthritis and other lesions. According to relevant statistics, nearly 600,000 people in the United States undergo total knee arthroplasty every year. In the past 10 years, with the continuous improvement of the medical insurance system, the number of patients undergoing total knee arthroplasty (TKA) in my country is also increasing year by year. However, TKA has large wounds and extensive tissue damage. For young patients with simple patellofemoral arthritis, patellofemoral arthroplasty (PFA) is more suitable. Compared with TKA, PFA retains the physiological function of the tibiofemoral joint, and only performs patellofemoral joint replacement, with smaller surgical wounds and less tissue damage. Improving PFA prosthesis and technology and avoiding TKA as much as possible is an important direction for the treatment of simple patellofemoral arthritis. The application market prospect of patellofemoral joint prosthesis is broad.

Clinical and experimental studies have shown that the matching of the size of the prosthesis and the original structure of the human joint is very important for the initial stability and subsequent biological fixation after artificial joint replacement, and it is helpful for reducing the fretting of the prosthesis, increasing bone ingrowth, and forming a firm structure. good benefit. However, the patellar thickness and patella length of Chinese are lower than that of Western Caucasians. Due to the differences in race, the design of PFA prosthesis based on the morphological characteristics of patellofemoral joints in Western Caucasians cannot be fully suitable for China. people. At present, the follow-up results of PFA are not satisfactory. The use of imported patellofemoral prosthesis in Chinese is an important reason for postoperative complications such as excessive patellofemoral joint packing and patellar snapping. At present, domestic patellofemoral joint prosthesis is still rare, and the development of high-quality prosthesis and supporting equipment suitable for the characteristics of Chinese people is the key to the treatment of patellofemoral arthritis in Chinese people.

In view of the deficiencies of the existing technology, those skilled in the art are eager to find a patellar joint prosthesis and its manufacturing method suitable for Chinese characteristics, so as to avoid complications such as excessive packing of the patellofemoral joint and patellar snapping after surgery. disease.

Contents of the invention

In order to seek a patellofemoral joint prosthesis suitable for Chinese characteristics, so as to avoid complications such as excessive packing of the patellofemoral joint and patellar snapping, the present invention proposes a patellofemoral joint prosthesis and its manufacturing method.

According to the patellofemoral joint prosthesis of the present invention, it comprises a femoral trochlear prosthesis and a patella prosthesis, and the femoral trochlear prosthesis includes medial condyles and lateral condyles on both sides of the femoral trochlear prosthesis, and a trochlear groove connecting the medial and lateral condyles , wherein the medial condyle and lateral condyle are arc-shaped connected to the trochlear groove with different radii of curvature, so that the joint surface formed by the medial condyle, lateral condyle and trochlear groove constitutes a mating surface for matching with the patella prosthesis, and the femur The trochlear prosthesis also includes a fixation surface formed on the femoral trochlear prosthesis opposite to the mating surface and used to connect with the bone. The fixation component is formed on the fixation surface. The patella prosthesis includes an articular surface that matches the mating surface. The articular surface The cross-section is elliptical in the state of overlooking, and the cross-section in the state of frontal view is asymmetrical parabola. The surface of the patella prosthesis opposite to the articular surface forms a connecting column for connecting with the bone of the human body.

Further, the ratio of width to length of the femoral trochlear prosthesis is between 0.94 and 1.56. Preferably it is 1.195.

Further, the value range of the vertical distance from the lowest point of the trochlear groove to the line connecting the vertices of the medial condyle and the lateral condyle is between 5.1 mm and 8.9 mm. Preferably 6.273mm.

Further, the ratio of the horizontal distance from the lowest point of the trochlear groove to the outermost edge of the medial condyle to the horizontal distance from the lowest point of the trochlear groove to the outermost edge of the lateral condyle is between 0.835 and 1.993. Preferably 1.152.

Further, the fixation surface of the femoral trochlea prosthesis includes a ridge formed by vertically projecting the maximum width line of the femoral trochlea prosthesis on the fixation surface, and the ridge divides the fixation surface into a first surface and a second surface, wherein the first surface The area is greater than the area of the second surface, and an obtuse angle is formed between the first surface and the second surface, the first surface is formed as a plane, the second surface includes the first plane and the second plane, and the clip formed by the first plane and the second plane The angle is greater than 180° and less than or equal to 270°.

Further, the fixing assembly includes three fixing columns and at least two fixing pieces formed on the fixing surface, one of the three fixing columns is arranged on the connecting line between the first plane and the second plane, and the other two are symmetrically arranged on On the first surface, at least two fixing pieces are arranged on the outer edge of the fixing surface.

Further, the line connecting the three fixed columns forms an equilateral triangle.

Further, a titanium-based HA coating is formed on the fixed surface.

Further, the thickness of the outer edge of the femoral pulley prosthesis is smaller than the thickness of other regions of the femoral pulley prosthesis, and the outer edge of the femoral pulley prosthesis is formed into a smooth arc shape.

Further, when the femoral trochlear prosthesis is in use, there is an offset between the line connecting the lowest points of the trochlear groove of the femoral trochlear prosthesis and the line connecting the lowest points of the trochlear groove of the original femoral trochlear of the human body.

Further, in the overlooking state, the angle between the line of the peaks on the articular surface and the long axis of the patella prosthesis is between 8.86° and 11.46°, and the value range of the length of the patella prosthesis is between 34.16mm The value range of the width of the patella prosthesis is between 32.92 mm and 50.32 mm, and the value range of the thickness of the patella prosthesis is between 18.83 mm and 32.34 mm.

According to the manufacturing method of the above-mentioned patellofemoral joint prosthesis of the present invention, comprise the following steps: divide the healthy people of multiple different age groups, make each age group in the healthy people of different age groups all include male group and Female group, each male group and female group also includes different height groups; the shape of the femoral trochlear and patella of each healthy person in different groups is measured respectively, to obtain the average structural parameters of the patellofemoral joint of the healthy person; The corresponding three-dimensional models of the femoral trochlea prosthesis and patella prosthesis were constructed according to the obtained average structural parameters.

Further, measuring the shape of the femoral trochlear of each healthy person includes measuring the following average structural parameters: measuring the width and height of the human femoral trochlear, the lowest point of the trochlear groove to the vertical line connecting the apex of the medial condyle and the lateral condyle. distance, and the horizontal distance from the lowest point of the trochlear groove to the outermost edge of the medial condyle and the horizontal distance from the lowest point of the trochlear groove to the outermost edge of the lateral condyle.

Further, when measuring the width and height of the femoral trochlea, CT scanning and three-dimensional image generation and editing processing software are used to perform simulated osteotomy on the femur of a healthy person. The steps of the simulated osteotomy include: taking the maximum contour line of the distal end of the femur The line between the superior medial condyle and the lateral condyle was used as the condylar axis of the simulated osteotomy; the lowest point of the anterior cortex of the femoral condyle was selected as the simulated osteotomy point; the femur was cut along a straight line parallel to the condyle axis and passing through the simulated osteotomy point. Simulate the cut to obtain the osteotomy surface; measure the width and height of the osteotomy surface to obtain the width and height of the femoral trochlear.

Further, measuring the shape of the patella of each healthy person includes measuring the following parameters: the length, width and thickness of the patella, and the angle between the patella ridge of the patella and the long axis of the patella.

Further, when constructing the three-dimensional model of the femoral trochlear prosthesis, the following steps are included: constructing the matching surface of the femoral trochlear prosthesis according to the corresponding average structural parameters of the obtained femoral trochlear prosthesis, so that the medial condyle and the lateral condyle are respectively connected to the trochlear with different curvatures. Groove arc connection; construct the fixation surface of the femoral trochlear prosthesis, so that the fixation surface is formed to include the first surface, the first plane and the second plane; form a fixation column on the connection line between the first plane and the second plane, and Edge positions of the first plane and the second plane form a fixing piece, and two fixing columns are symmetrically formed on the first surface.

Further, when constructing the fixation surface of the femoral trochlea prosthesis, it also includes: coating the fixation surface of the femoral trochlea prosthesis with a titanium-based HA coating.

Further, when constructing the three-dimensional model of the femoral trochlear prosthesis, it also includes: thinning and smoothing the edge of the femoral trochlear prosthesis.

Further, when constructing the three-dimensional model of the patella prosthesis, it also includes: constructing the articular surface of the patella prosthesis according to the obtained corresponding average structural parameters of the patella, so that the section of the articular surface is elliptical in the state of looking down, and in the state of front view The cross-section of the patella prosthesis is an asymmetric parabola; a connecting column for connecting with the bone of the human body is formed on the surface of the patella prosthesis opposite to the articular surface.

The patellofemoral joint prosthesis of the present invention fully considers the anatomical relationship between the Chinese femoral trochlear prosthesis and the patellar prosthesis, and adapts to the physiological requirements of the Chinese patellofemoral joint movement from the mechanism. , to avoid the collision of the prosthesis when the knee joint is flexed, which can effectively reduce complications such as excessive patellofemoral joint packing and patellar snapping, and increase the range of motion of the knee joint. The patellofemoral joint prosthesis of the present invention can be made into various models according to the size of the femoral trochlear prosthesis and the patella prosthesis that are suitable for Chinese prosthesis, so that the designed prosthesis is suitable for most Chinese patellofemoral joint replacement operations , to provide attending physicians with more and more applicable alternatives.

Description of drawings

In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings that need to be used in the description of the specific embodiments or the prior art. Throughout the drawings, similar elements or parts are generally identified by similar reference numerals. In the drawings, elements or parts are not necessarily drawn in actual scale.

Fig. 1 is the front view according to the structure of femoral trochlear prosthesis of the present invention;

Fig. 2 is the side view according to the structure of femoral trochlear prosthesis of the present invention;

Fig. 3 is the bottom view of the structure of the femoral pulley prosthesis according to the present invention;

Fig. 4 is the top view of the structure of the femoral trochlear prosthesis according to the present invention;

Fig. 5 is the structural representation of the patella prosthesis according to the present invention;

Fig. 6 is the schematic diagram of the measurement of the femur section size of human body;

Fig. 7 is the schematic diagram of the size measurement of the femoral pulley of human body;

Fig. 8 is a schematic diagram of the size measurement structure of the patella of the human body.

Fig. 9 is a schematic diagram of the use state of the femoral trochlear prosthesis of the present invention.

Detailed ways

Embodiments of the technical solutions of the present invention will be described in detail below in conjunction with the accompanying drawings. The following examples are only used to illustrate the technical solutions of the present invention more clearly, and therefore are only examples, rather than limiting the protection scope of the present invention.

1 to 5 show schematic structural views of the patellofemoral joint prosthesis according to the present invention. As shown in conjunction with FIGS. 1 to 5 , the patellofemoral joint prosthesis includes a femoral trochlear prosthesis 1 (shown in FIGS. 1 to 4 ) and a patella prosthesis 2 (shown in FIG. 5 ). As shown in FIG. 1 , the femoral trochlear prosthesis 1 includes a medial condyle 111 and a lateral condyle 112 located on both sides of the femoral trochlear prosthesis 1 , and a trochlear groove 113 connecting the medial condyle 111 and the lateral condyle 112 . Wherein, the medial condyle 111 and the lateral condyle 112 are arc-shapedly connected with the trochlear groove 113 respectively with different radii of curvature, so that the connecting surface formed jointly by the medial condyle 111, the lateral condyle 112 and the trochlear groove 113 constitutes a joint surface for matching with the patella prosthesis 2. Matching curved surface 11 that cooperates, femoral trochlear prosthesis 1 also comprises the fixation surface 12 that is formed on femoral trochlear prosthesis 1 opposite with fitting curved surface 11 and is used for being connected with bone, is formed with fixation assembly (this fixation assembly) on the fixation surface 12 Including a fixed post 13 and a fixed piece 16 as shown in Figure 2). As shown in Figure 5, the patella prosthesis 2 includes an articular surface 21 matched with the mating curved surface 11. The section of the articular surface 21 in a plan view is elliptical, and the section in a frontal view is an asymmetrical parabola. On the surface of the body 2 opposite to the articular surface 21 is formed a connecting column 22 for connecting with the bone of the human body.

When the patellofemoral joint prosthesis of the present invention is in use, at first the femoral trochlear place of the patient's patellofemoral joint is osteotomized and drilled, the femoral trochlea prosthesis 1 is matched with the drilled hole by its fixation assembly, and passed through the bone cement The femoral trochlear prosthesis 1 and the patient's femur are fixed, and then the doctor decides to replace the patella prosthesis 2 according to the condition. If replacement is required, part of the patella is cut off, drilled, and the patella prosthesis 2 is connected to the drilled patella through its connecting column 22. The hole fits, and the patella prosthesis is fixed to the patient's patella by bone cement. In the present invention, the medial condyle 111 and the lateral condyle 112 are arc-shapedly connected to the trochlear groove 113 with different radii of curvature to form a matching curved surface 11, so that the curved surface 11 is closer to the real femoral surface; 21 is arranged so that the cross-section under the state of looking down is elliptical, and the cross-section under the state of frontal view is asymmetrical parabola, that is, the connection line of the peaks on the articular surface 21 of the patella prosthesis 2 (inclined as shown in Figure 5 There is an angle A1 between the long axis of the patella prosthesis 2 (as shown in the horizontal dotted line shown in Figure 5 ), that is to say, the line connecting the peaks of the patella prosthesis 2 in the front view state is opposite There is a certain amount of offset from the long axis of the patella prosthesis 2, so that the patella prosthesis 2 is more similar to the natural patella, so that it can better cooperate with the femoral trochlear prosthesis 1.

The patellofemoral joint prosthesis of the present invention fully considers the anatomical correspondence between the Chinese femoral trochlear prosthesis 1 and the patella prosthesis 2, and adapts to the Chinese patellofemoral joint movement from the mechanism. Physiological requirements, avoiding the collision of the prosthesis when the knee joint is flexed, can effectively reduce complications such as excessive packing of the patellofemoral joint and patellar snapping, and increase the range of motion of the knee joint. The patellofemoral joint prosthesis of the present invention can be made into various models according to the size of the femoral trochlear prosthesis 1 and the patella prosthesis 2, which are suitable for Chinese prosthesis, so that the designed prosthesis is suitable for most Chinese patellofemoral joint replacements During the operation, the attending physician provides more and more suitable options.

It is worth noting that, according to the present invention, the size of the prosthesis suitable for Chinese can be obtained through specific structural parameters (ie the average structural parameters described below), for the femoral trochlea prosthesis 1, in conjunction with Fig. As shown, the specific structural parameters can be, for example, the ratio of the width W1 to the height D1 of the femoral trochlear prosthesis 1, the vertical distance H from the lowest point of the trochlear groove 113 to the apex line between the medial condyle 111 and the lateral condyle 112, and the pulley The ratio of the horizontal distance W3 from the lowest point of the groove to the outermost edge of the medial condyle 111 to the horizontal distance W4 from the lowest point of the trochlear groove to the outermost edge of the lateral condyle 112, etc. Preferably, the ratio of the width W1 to the height D1 of the femoral trochlear prosthesis 1 is between 0.94 and 1.56, preferably 1.195; the vertical distance H from the lowest point of the trochlear groove 113 to the apex of the medial condyle 111 and the lateral condyle 112 The numerical range is between 5.1mm to 8.9mm, preferably 6.273mm; between the horizontal distance from the lowest point of the trochlear groove 113 to the outermost edge of the medial condyle 111 and the horizontal distance from the lowest point of the trochlear groove 113 to the outermost edge of the lateral condyle 112 The ratio is between 0.835 and 1.993, preferably 1.152. And for patella prosthesis 2, as shown in Figure 5, this specific structural parameter can be the length H3 of patella prosthesis 2, width W3, thickness D3 and the connection line of the peak of patella prosthesis 2 and patella prosthesis for example. The angle A1 between the major axes of 2 and so on. Preferably, the numerical range of the length of the patella prosthesis 2 is preferably between 34.16 to 54.83 mm, preferably 41.26 mm; the numerical range of the width of the patella prosthesis 2 is preferably between 32.92 to 50.32 mm, preferably 44.03 mm The numerical range of the thickness of patella prosthesis 2 is preferably between 18.83～32.34mm, preferably 23.23mm; Between 8.86° and 11.46°, preferably 10.58°.

According to the present invention, as shown in FIG. 3 , the fixation surface 12 of the femoral trochlear prosthesis 1 includes a ridge 14 formed by vertically projecting the maximum width line of the femoral trochlear prosthesis 1 on the fixation surface, and the ridge 14 divides the fixation surface 12 into The first surface 121 and the second surface (comprising the first plane 122 and the second plane 123), wherein the area of the first surface 121 is greater than the area of the second surface, and an obtuse angle is formed between the first surface 121 and the second surface, the The obtuse angle is preferably 120° to 150°, more preferably 145°, the first surface 121 is formed as a plane, and the angle formed by the first plane 122 and the second plane 123 is greater than 180° and less than or equal to 270°, preferably 210°. This setting can provide a strong guarantee for the patient to recover the natural shape of the femoral trochlear prosthesis 1 after surgery.

In the embodiment shown in FIG. 3 , the fixing assembly includes three fixing columns 13 and at least two fixing pieces 16 formed on the fixing surface 12, and one of the three fixing columns 13 is arranged between the first plane 122 and the second plane 122. On the connecting line 15 of the two planes 123 , the other two are arranged symmetrically on the first surface 121 , and at least two fixing pieces 16 are arranged on the edge of the fixing surface 12 to realize auxiliary fixation of the femoral trochlear prosthesis 1 . Further preferably, the line connecting the three fixing columns 13 forms an equilateral triangle. This setting can improve the stability of the femoral trochlear prosthesis 1 when it is fixed, thereby effectively improving the medium and long-term treatment effect. Also preferably, the three fixing columns 13 are identical, and the axes of the three fixing columns 13 are parallel to each other, and the diameters of the three fixing columns 13 are all preferably 5 mm, so as to further improve the stability of the femoral trochlear prosthesis 1 during fixation , and the replaceability of the prosthesis.

Further, a titanium-based HA (hydroxyapatite) coating (not shown in the figure) is formed on the fixing surface 12 . The titanium-based HA coating enables the fixation surface 12 of the femoral trochlear prosthesis 1 to have higher toughness, strength and biological activity, thereby accelerating postoperative new bone growth, facilitating the early stability of the implant, and shortening the postoperative healing period .

According to the present invention, as shown in FIG. 2 , the thickness of the outer edge of the femoral trochlear prosthesis 1 is smaller than that of other regions of the femoral trochlear prosthesis 1 , and the outer edge of the femoral trochlear prosthesis 1 is formed into a smooth arc shape. Through this setting, the stress concentration phenomenon that the femoral trochlear prosthesis 1 produces during use can be effectively reduced, so as to increase the stability and reliability of the structure of the femoral trochlear prosthesis 1. It has a good effect on the flexion and extension of the knee joint.

As shown in Figure 9, when the femoral pulley prosthesis 1 of the present invention is in use, that is, when it is installed on the osteotomy surface of the femur 3 of the human body, the connection line S1 of the lowest point of the trochlear groove 113 of the femoral pulley prosthesis 1 is opposite to An offset distance M is formed between the connection line S2 of the lowest point of the trochlear groove of the original femoral trochlear groove of the human body, so as to change the force line of the knee joint, provide mechanical support, and preserve the dynamic mechanism of the knee joint to the greatest extent. Preferably, the offset is 2mm to 5mm, preferably 4mm.

In addition, the present invention also proposes a method for manufacturing the above-mentioned patellofemoral joint prosthesis. Shown in conjunction with Fig. 7 and Fig. 8, this method comprises the following steps: divide the healthy person of a plurality of different age groups, make all include male group and female group in each age group in the healthy person of different age group, each Each of the male group and the female group also includes different height groups; the shape of the femoral trochlear and patella of each healthy person in different groups is measured to obtain the average structural parameters of the patellofemoral joint of the healthy person; The corresponding three-dimensional models of the femoral trochlea prosthesis and patella prosthesis were constructed according to the obtained average structural parameters.

According to the manufacturing method of the patellofemoral joint prosthesis of the present invention, the patellofemoral joint morphology of healthy people of different age groups is grouped and sampled as the basis for making the patellofemoral joint prosthesis, so that it can be made suitable for different groups. The model of patellofemoral prosthesis is suitable for patients of corresponding groups, and its structure is more reasonable and stable. Through the method of the present invention, the anatomical relationship between the femoral trochlear prosthesis 1 and the patella prosthesis 2 can be fully corresponded, the physiological requirements of the patellofemoral joint movement have been adapted from the mechanism, and the collision of the prosthesis when the knee joint is flexed has been avoided. It can reduce complications and increase the range of motion of the knee joint.

In a preferred embodiment, the age group can be specifically divided into four sub-age groups: 20 to 25 years old, 26 to 30 years old, 31 to 35 years old, and 35 to 40 years old, and each age group is further divided into male groups And the female group, for the male group, it is further divided into three sub-male groups of 165cm to 170cm, 171cm to 175cm, and 175cm to 180cm; for the female group, it is further divided into three sub-female groups of 155cm to 160cm, 161cm to 165cm, and 166cm to 170cm group; in each sub-female group and sub-male group, the data of patellofemoral joints of 300 healthy subjects were selected as the basis to obtain the average structural parameters of the patellofemoral joints, which should be understood as the patellofemoral joints of 300 healthy subjects The average value of the corresponding structural parameters of .

According to the present invention, as shown in Figure 7, when measuring the shape of each healthy person's femoral pulley 1 ', include measuring the following average structural parameters: measure the width W1 ' and the height D1 ' of the human femoral pulley 1 ' (that is, Fig. W1 and D1 shown in 4), the vertical distance H1 from the lowest point of the trochlear groove to the apex of the medial condyle and the lateral condyle (that is, H shown in Figure 1), and the level from the lowest point of the trochlear groove to the edge of the medial condyle The distance W3' and the horizontal distance W4' from the lowest point of the trochlear groove to the edge of the lateral condyle (that is, W3 and W4 shown in Figure 1).

Further, when measuring the width W1' and height D1' of the femoral trochlea 1', CT scanning and three-dimensional image generation and editing processing software (such as Mimics) can be used to perform simulated osteotomy on the femur 3 of a healthy person, as shown in Figure 6 As shown, the front view, side view and cross-sectional view of the simulated osteotomy are shown respectively, the step of the simulated osteotomy includes: taking the connection line AB between the inner condyle and the outer condyle on the maximum contour line of the distal end of the femur 3 as Simulate the condylar axis of the osteotomy; select the lowest point O of the anterior cortex of the femoral condyle as the simulated osteotomy point; simulate the femur along a straight line parallel to the condyle axis and pass through the simulated osteotomy point to obtain the osteotomy surface; measure the The width W1' and height D1' of the bone surface can be used to obtain the width W1 and height D1 of the femoral trochlea 1'.

As shown in Figure 8, measuring the shape of the patella 2' of each healthy subject includes measuring the following parameters: the length H2' of the patella 2' (ie the length of the patella prosthesis 2), the width W2' (ie the length of the patella prosthesis 2) and thickness D2' (ie the thickness of the patella prosthesis 2), and the angle α between the patella ridge 212' of the patella 2' and the long axis 211' of the patella 2'.

Further, according to the present invention, when constructing the three-dimensional model of the femoral trochlear prosthesis 1, the following steps may be included: constructing the fitting surface 11 of the femoral trochlear prosthesis 1 according to the corresponding average structural parameters of the obtained femoral trochlear prosthesis 1, so that the medial condyle 111 and lateral condyle 112 are connected with trochlear groove 113 arcs with different curvatures respectively; Construct the fixation surface 12 of femoral trochlear prosthesis 1, make fixation 12 be formed to comprise first surface 121, first plane 122 and second plane 123; One fixing column 13 is formed on the connecting line 15 between the first plane 122 and the second plane 123 , and two fixing columns 13 are symmetrically formed on the first surface 121 . Preferably, the connecting line of the three fixing columns 13 is formed into an equilateral triangle, so as to improve the stability of the femoral trochlear prosthesis 1 during fixation, thereby effectively improving the medium and long-term treatment effect. Also preferably, the height of the fixed column 13 on the connecting line 15 between the first plane 122 and the second plane 123 is constructed to be greater than the height of the two fixed columns 13 located symmetrically on the first surface 121, so as to facilitate further Improve the stability of the femoral trochlear prosthesis 1 during fixation.

In a preferred embodiment, when the fixation surface 12 of the femoral trochlear prosthesis 1 is constructed, the fixation surface 12 of the femoral trochlear prosthesis 1 is coated with a titanium-based HA coating.

In another preferred embodiment, when constructing the three-dimensional model of the femoral trochlear prosthesis 1 , it also includes: thinning and smoothing the edge of the femoral trochlear prosthesis 1 . That is, the thickness of the outer edge of the femoral pulley prosthesis 1 is designed to be smaller than the thickness of other regions of the femoral pulley prosthesis 1, and the outer edge of the femoral pulley prosthesis 1 is formed into a smooth arc shape. Through this setting, the stress concentration phenomenon that the femoral pulley prosthesis 1 produces during use can be effectively avoided, thereby the stability and reliability of the structure of the femoral pulley prosthesis 1 can be increased, and at the same time, it is helpful for restoring the anatomical structure of the human patellofemoral joint surface. It has a good effect on the flexion and extension of the knee joint.

According to the present invention, when constructing the three-dimensional model of the patella prosthesis 2, it includes: constructing the articular surface 21 (as shown in FIG. 5 ) of the patella prosthesis 2 according to the corresponding average structural parameters of the obtained patella 2 ', so that the articular surface 21 is in The cross-section under the overlooking state is elliptical (the ellipse should be understood as roughly elliptical), and the cross-section under the front view state is an asymmetrical parabola; It is connected to the connecting column 22 connected with the bone of the human body. Preferably, the number of the connecting columns 22 may also be three, and the line connecting the three connecting columns 22 forms an isosceles triangle.

The fabrication method of the patellofemoral prosthesis of the present invention can simulate and measure the morphological relationship of the patellofemoral joint of a healthy person by using imaging methods, so as to design the shape and fixation method of the femoral trochlear prosthesis 1 and the shape of the patella prosthesis 2 Provide evidence. Specifically, on the basis of CT scans, Mimics software was used to reconstruct the femur and patella of the patellofemoral joint in healthy people, simulate the surgical osteotomy of the patellofemoral joint and measure the surface parameters, thereby accurately analyzing the normal Chinese patellofemoral joint. For the size of the femoral joint, different types of patellofemoral joint prostheses are designed according to the bone characteristics of Chinese people by taking the normal patellofemoral joint anatomical data of Chinese people of different ages, genders and heights from healthy people.

It should be noted that, unless otherwise specified, the technical terms or scientific terms used in this application shall have the usual meanings understood by those skilled in the art to which the present invention belongs.

In the description of the present application, the terms "first", "second" and so on are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. In the description of the present invention, "plurality" means two or more, unless otherwise specifically defined.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present invention, rather than limiting them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: It is still possible to modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements for some or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the technical solutions of the various embodiments of the present invention. All of them should be covered by the scope of the claims and description of the present invention. In particular, as long as there is no structural conflict, the technical features mentioned in the various embodiments can be combined in any manner. The present invention is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.

Claims (17)

1. a kind of patellofemoral joint prosthese, which is characterized in that including femoral bone pulley prosthese and patellar prosthesis, the femoral bone pulley prosthese Include the entocondyle and external condyle positioned at the both sides of the femoral bone pulley prosthese, and connects the entocondyle and the external condyle Coaster ditch, wherein the entocondyle and the external condyle are connect with different radius of curvature with the coaster ditch arc respectively, So that the joint face that is collectively formed of the entocondyle, external condyle and the coaster ditch constitute for patellar prosthesis is matched matches Curved surface is closed, the femoral bone pulley prosthese further includes being formed in the opposite with the cooperation curved surface of the femoral bone pulley prosthese and being used for The stationary plane being connected with sclerotin is formed with fixation kit on the stationary plane, and the patellar prosthesis includes and the cooperation curved surface Matched joint curved surface, ellipsoidal cross section of the joint curved surface under vertical view state, the section under state of facing is in It is asymmetrical parabola shaped, it is formed for the sclerotin phase with human body on the face opposite with the joint curved surface of the patellar prosthesis Connecting pole even.

2. patellofemoral joint prosthese according to claim 1, which is characterized in that the width of the femoral bone pulley prosthese and height Ratio between 0.94 to 1.56.

3. patellofemoral joint prosthese according to claim 1, which is characterized in that the minimum point of the coaster ditch to the inside The numberical range of the vertical range of the vertex line of condyle and the external condyle is between 5.1mm between 8.9mm.

4. patellofemoral joint prosthese according to claim 1, which is characterized in that the minimum point of the coaster ditch to entocondyle most The minimum point of the horizontal distance at edge and the coaster ditch to the ratio between the horizontal distance at external condyle most edge between 0.835 to Between 1.993.

5. patellofemoral joint prosthese according to claim 1, which is characterized in that the stationary plane of the femoral bone pulley prosthese includes The line of maximum breadth upright projection of femoral bone pulley prosthese is formed by ridge on the stationary plane, the ridge is by the stationary plane It is divided into first surface and second surface, wherein the area of the first surface is more than the area of the second surface, and it is described Form obtuse angle between first surface and the second surface, the first surface is formed as plane, and the second surface includes the One plane and the second plane, first plane are more than 180 ° with the angle that second plane is formed and are less than or equal to 270 °.

6. patellofemoral joint prosthese according to claim 5, which is characterized in that the fixation kit is included into the fixation Three fixed columns on face and at least two fixinig plates, one in three fixed columns is arranged in first plane and institute On the connecting line for stating the second plane, other two is symmetrical arranged on the first surface, at least two fixinig plates setting In the marginal position of the stationary plane.

7. patellofemoral joint prosthese according to claim 1, which is characterized in that be formed with titanium-based HA on the stationary plane and apply Layer.

8. patellofemoral joint prosthese according to claim 1, which is characterized in that the outer peripheral thickness of the femoral bone pulley prosthese Degree is less than the thickness in other regions of the femoral bone pulley prosthese, and the outer edge of the femoral bone pulley prosthese is formed as smooth Arcuation.

9. patellofemoral joint prosthese according to claim 1, which is characterized in that in the use state of the femoral bone pulley prosthese Under, the coaster ditch of the femoral bone pulley of the line of the minimum point of the coaster ditch of the femoral bone pulley prosthese relative to human body script is most It is formed with offset distance between the line of low spot.

10. patellofemoral joint prosthese according to claim 1, which is characterized in that on the joint curved surface of the patellar prosthesis Angle between the line at peak and the long axis of the patellar prosthesis is between 8.86 ° to 11.46 °, the Patellar joint prosthese Length numberical range between 34.16mm between 54.83mm, the numberical range of the width of the Patellar joint prosthese between 32.92mm between 50.32mm, the numberical range of the thickness of the Patellar joint prosthese between 18.83mm to 32.34mm it Between.

11. a kind of production method making patellofemoral joint prosthese according to any one of claim 1 to 10, feature exist In including the following steps：

The healthy person of multiple and different age brackets is divided so that in each age bracket in the healthy person of different age group Including male's group and women group, different height groups is also included in each male's group and the women group；

Different groups of the femoral bone pulley of each healthy person and the form of kneecap are measured respectively, to obtain the healthy person of respective sets Patellofemoral joint average molecular parameters；

The threedimensional model of corresponding femoral bone pulley prosthese and patellar prosthesis is built according to obtained average molecular parameters.

12. production method according to claim 11, which is characterized in that carried out to the form of the femoral bone pulley of each healthy person Include that following average molecular parameters are measured when measurement：

Measure the vertex line of the width and height, the minimum point of coaster ditch to the entocondyle and external condyle of human femur under loading coaster Vertical range and coaster ditch minimum point to the horizontal distance at entocondyle most edge and the minimum point of coaster ditch to external condyle The horizontal distance at most edge.

13. production method according to claim 12, which is characterized in that carried out to the width and height of the femoral bone pulley Simulation osteotomy is carried out to the femur of healthy person using CT scan and 3-D view generation and editing and processing software when measurement, the mould The step of quasi- osteotomy includes：Take condyle of the line as simulation osteotomy on distal femur largest contours line between interior condyle and ectocondyle Axis；The minimum point of cortex on front side of condyle of femur is chosen as simulation osteotomy point；It is cut along being parallel to the condyle axis and passing through the simulation The straight line of bone point carries out simulation interception to obtain osteotomy surface to femur；Measure the width of the osteotomy surface and highly to obtain the stock The width of bone coaster and height.

14. production method according to claim 11, which is characterized in that measured to the form of the kneecap of each healthy person Including being measured to following parameter：

Angle between the kneecap ridge and the long axis of kneecap of the length of kneecap, width and thickness and kneecap.

15. production method according to claim 12, which is characterized in that in the three-dimensional mould for building the femoral bone pulley prosthese When type, include the following steps：

The cooperation curved surface of the femoral bone pulley prosthese is built according to the corresponding average molecular parameters of the femoral bone pulley of gained so that institute Entocondyle and the external condyle is stated to connect with the coaster ditch arc with different curvature respectively；

Build the stationary plane of the femoral bone pulley prosthese so that it includes the first surface that stationary plane, which is formed as, described first flat Face and second plane；

A fixed column is formed on the connecting line of first plane and second plane, first plane with The marginal position of second plane forms the fixinig plate, is symmetrically formed two fixed columns on the first surface.

16. manufacturing method according to claim 15, which is characterized in that in the three-dimensional mould for building the femoral bone pulley prosthese When type, further include：Smoothing processing is thinned to the edge of the femoral bone pulley prosthese.

17. production method according to claim 14, which is characterized in that in the threedimensional model for building the patellar prosthesis When, including：

The joint curved surface of the patellar prosthesis is built according to the corresponding average molecular parameters of the kneecap of gained so that the joint is bent Ellipsoidal cross section of the face under vertical view state, the section under state of facing is in asymmetrical parabola shaped；

The connecting pole being connected for the sclerotin with human body is formed on the face opposite with the joint curved surface of the patellar prosthesis.