Disclosure of Invention
The invention aims to provide a hinge type 3D printing artificial ankle joint prosthesis with a simple structure, which can solve the technical problems existing in the prior art and is particularly suitable for treating tibia far-end large-area defect repair and ankle joint replacement prosthesis.
The technical scheme is that the hinged 3D printing artificial ankle joint prosthesis comprises a tibia far-end prosthesis and a talus prosthesis, wherein the lower end of the tibia far-end prosthesis is detachably and movably connected with the talus prosthesis, a containing groove which is concave towards the tibia far-end prosthesis is arranged at the lower end of the tibia far-end prosthesis, an inner lining hole matched with the containing groove is arranged at the upper end of the talus prosthesis, a detachable inner lining is arranged in the inner lining hole, and interference fit is achieved between the inner lining and the inner lining hole.
The tibia far-end prosthesis is formed by 3D printing, the tibia far-end prosthesis comprises a backbone prosthesis and a marrow needle prosthesis, the backbone prosthesis can be customized according to CT data of a patient, the physiological structure of the patient is met, the marrow needle can also be customized according to the length of residual natural bone, the length is 40-120 mm, the marrow needle can be used for customizing bone cement type or biological type according to the requirement of the patient, and the marrow needle plays a role of initially fixing the prosthesis.
The lower extreme of tibia distal end false body is detachable swing joint with talus false body, the both sides of storage tank are connecting portion, two connecting portion are equipped with corresponding round pin shaft hole, round pin axle and round pin shaft hole, inside lining coaxial setting, the inside lining is equipped with the permission the round pin axle is passed through first through-hole, the round pin axle inserts round pin shaft hole and first through-hole, first through-hole with be clearance fit between the round pin axle, guarantee the degree of freedom of ankle joint fore-and-aft direction.
The first through hole and the pin shaft are in clearance fit, namely the inner diameter of the first through hole on the lining is larger than the outer diameter of the pin shaft, so that clearance fit is formed, the clearance fit is different from interference fit, and the pin shaft can shake in the first through hole without representing a clearance.
The utility model provides a novel talar prosthesis, including the talar prosthesis platform, the thickness of talar prosthesis platform is according to the high regulation of talar defect, the inside lining hole is established the upper surface of talar prosthesis platform, be equipped with first screw hole and second screw hole on the talar prosthesis platform, the skirt pendulum is one side boss of talar prosthesis platform lower surface, the skirt pendulum is in order to let the talar prosthesis card on remaining talar prosthesis, the skirt pendulum inboard with the face of remaining talar contact need with remaining talar shape match, be equipped with the third screw hole on the talar prosthesis skirt pendulum, the talar prosthesis is fixed through screw and three screw hole and remaining talar connection. The screw hole adopts solid structure with bone trabecula structure contact department, promptly the screw hole edge increases the intensity of screw hole, prevents screw hole fracture.
The edge profile of the talar prosthesis takes a shape consistent with the remaining talus, avoiding interference with other bones or tissues, while ensuring the positioning of the talar prosthesis.
And a shock pad is arranged on the talus prosthesis platform through an interference fit frustum structure, so that collision with the talus prosthesis platform is prevented when the tibia distal prosthesis rotates around the shaft.
The connecting portion comprises a first connecting portion and a second connecting portion, a first pin hole is formed in the first connecting portion, a second pin hole is formed in the second connecting portion, a pin groove is formed in the pin shaft, a pin hole is formed in the second connecting portion, the axial direction of the pin hole is perpendicular to the axial direction of the second pin hole, the pin hole is communicated with the second pin hole, and the pin is matched with the pin hole of the tibia far-end prosthesis through the pin, so that the functions of preventing withdrawal and preventing axial shaking are achieved.
The lower end of the talus prosthesis is provided with a skirt which is convenient to position and fix during installation, and the lining is designed with a skirt, so that collision and abrasion between the tibia far-end prosthesis and the talus prosthesis can be avoided, and displacement in the axial direction is prevented.
The outer side of the first pin shaft hole is provided with a pin shaft counter bore, the longitudinal section of the pin shaft counter bore is polygonal, and the shape of the pin shaft counter bore is matched with the cap end structure of the pin shaft, so that the positioning of the pin groove is facilitated, and the rotation can be prevented.
The lower ends of the first connecting part and the second connecting part are respectively provided with a first chamfer, and the specific degree of freedom of the ankle joint in the front-back direction can be adjusted by controlling the radius of the first chamfer.
The tibia far-end prosthesis comprises a diaphyseal prosthesis and a intramedullary nail prosthesis, wherein the diaphyseal prosthesis part of the tibia far-end prosthesis is contacted with a bone cutting surface of a residual natural bone, a bone trabecular structure is adopted, bone ingrowth is facilitated, the thickness of the bone trabecular structure is 2-5 mm, the cross section dimension contacted with the natural bone is 1-3 mm larger than the cross section of the residual bone, the bone trabecular structure plays a supporting role to prevent diaphysis from being inserted into the bone, the 3D printing bone trabecular structure is adopted at the contact part of the talus prosthesis and the bone cutting surface of the residual talus, the thickness of the bone trabecular is 2-5 mm, and the bone trabecular structure is designed to facilitate bone ingrowth and promote secondary fixation of the prosthesis and bone tissues.
The invention has the advantages and positive effects that due to the adoption of the technical scheme, the pin shaft hole structure of the tibia far-end prosthesis is matched with the pin shaft to be used, the rotation center and the degree of freedom of the ankle joint prosthesis are ensured, the contact part of the backbone prosthesis part of the tibia far-end prosthesis and the osteotomy surface of the residual natural bone and the contact part of the talus prosthesis and the osteotomy surface of the residual talus are both in a 3D printing bone trabecular structure, the design is favorable for bone ingrowth, the fixation of the prosthesis and bone tissue is promoted, the pin groove structure of the pin shaft can play a role in preventing withdrawal and axial shaking through the pin shaft and the pin hole of the tibia far-end prosthesis, the abrasion of the prosthesis is lightened through the parts such as the skirt edge, the lining, the pin shaft counter bore and the like, and the service life of the prosthesis is improved.
Drawings
FIG. 1 is a schematic view of a tibial distal prosthesis in a hinged 3D printing artificial ankle prosthesis according to embodiment 1 of the present invention;
FIG. 2 is a schematic view of a talus prosthesis constructed of a hinged 3D printed artificial ankle prosthesis according to embodiment 1 of the present invention;
FIG. 3 is a schematic illustration of the lining structure of a hinged 3D printed artificial ankle prosthesis according to embodiment 1 of the present invention;
FIG. 4 is a schematic view of a pin structure of a hinged 3D printed artificial ankle prosthesis according to embodiment 1 of the present invention;
FIG. 5 is a schematic view of the pin structure of a hinged 3D printed artificial ankle prosthesis according to embodiment 1 of the present invention;
FIG. 6 is a schematic top view of the talus prosthesis of the hinged 3D printed artificial ankle prosthesis of embodiment 1 of the invention rotated 180 degrees horizontally;
FIG. 7 is a schematic view of a cross-sectional view of a talus prosthesis A-A of a hinged 3D printed artificial ankle prosthesis according to embodiment 1 of the present invention;
FIG. 8 is a schematic view showing the overall structure of a hinged 3D-printing artificial ankle prosthesis according to embodiment 1 of the present invention;
Fig. 9 is a schematic view showing a cross-sectional structure of a hinge-type 3D printing artificial ankle prosthesis according to embodiment 1 of the present invention.
Fig. 10 is a schematic view of the trabecular structure of a talar prosthesis of a hinged 3D printed artificial ankle prosthesis according to embodiment 1 of the present invention.
In the figure:
1. Tibia distal prosthesis, 2, talus prosthesis, 3, pin, 4, liner, 5, pin, 6, intramedullary prosthesis, 7, diaphyseal prosthesis, 8, pin counterbore, 9, pin hole, 10, pin hole, 11, liner hole, 12, first screw hole, 13, pin cap end, 14, pin slot, 15, skirt, 16, edge profile, 17, first shock pad, 18, frustum, 19, first chamfer, 20, skirt, 21, first connection, 22, second connection, 23, second screw hole, 24, third screw hole, 25, first through hole, 26, second shock pad, 27, bone trabecular structure.
Detailed Description
1-10, The hinged 3D printing artificial ankle joint prosthesis is particularly suitable for treating tibia far-end large-area defect repair and ankle joint replacement prosthesis.
The tibia far-end prosthesis 1 is formed by 3D printing, the tibia far-end prosthesis 1 comprises a backbone prosthesis 7 and a marrow needle prosthesis 6, the backbone prosthesis 7 can be customized according to CT data of a patient, the physiological structure of the patient is met, the length of the backbone prosthesis 7 is 50-100 mm, the length of the marrow needle prosthesis 6 can also be customized according to the length of residual natural bone, the length of the marrow needle prosthesis 6 is 40-120 mm, the bone cement type or biological type can be customized according to the requirement of the patient by the marrow needle prosthesis 6, and the marrow needle plays a role of fixing the prosthesis in the initial stage.
The bone shape of each person is different and the cross section is not regular circular, and the invention aims to reproduce a diaphyseal prosthesis completely consistent with the original natural bone shape or a conical structure approximately similar to the original natural bone shape through CT data of a patient.
The diaphyseal prosthesis 7 part of the tibia far-end prosthesis 1 is contacted with the osteotomy surface of the residual natural bone, a bone trabecula structure 27 is adopted, bone ingrowth is facilitated, the thickness is 2-5 mm, the cross section dimension contacted with the natural bone is 1-3 mm larger than the cross section of the residual bone, and the diaphyseal prosthesis is supported to prevent the diaphyseal prosthesis 7 from being inserted into the residual natural bone.
The diaphyseal prosthesis 7 part of the tibia far-end prosthesis 1 is designed according to CT data of a patient except for the contact surface between the near end and the natural bone, the integral structure of the diaphyseal prosthesis is consistent with the physiological structure of the natural bone, and meanwhile, the physical structure of the diaphyseal prosthesis is reduced by 5% -10% compared with the physical structure of the natural bone in the original size, and the reduced size is favorable for being matched with the original muscle tissue better, so that the prosthesis is prevented from being excessively protruded to cause the overlarge whole.
The talus prosthesis 2 is shaped by 3D printing and fixed to the residual talus by screw connection. The 3D printing bone trabecula structure 27 is adopted at the contact position of the talus prosthesis 2 and the residual talus osteotomy surface, the thickness of the bone trabecula is 2-5 mm, the design is favorable for bone ingrowth, and the secondary fixation of the prosthesis and bone tissues is promoted. The thicker the trabecular structure 27 is, the more beneficial the bone ingrowth, but too thick will affect the strength. The 3D printed bone trabecular structure 27 is adopted at the contact position of the talus prosthesis 2 and the residual talus osteotomy surface, and the thickness of the bone trabecular structure is adjusted according to the space size, so that the thickness can be arbitrary under the premise of ensuring the strength.
As shown in fig. 2, the lower end of the distal tibial prosthesis 1 is detachably and movably connected with the distal tibial prosthesis 2, a containing groove recessed into the distal tibial prosthesis 1 is formed in the lower end of the distal tibial prosthesis 1, an inner lining hole 11 matched with the containing groove is formed in the upper end of the distal tibial prosthesis 2, a detachable inner lining 4 is arranged in the inner lining hole 11, and interference fit is achieved between the inner lining 4 and the inner lining hole 11. The inner liners 4 are fitted into the inner liner holes 11, and two inner liners 4 are inserted from both ends of the inner liner holes 11 of the talar prosthesis 2, respectively, as shown in fig. 8 and 9. The lining 4 is made of wear-resistant PEEK material, and the lining 4 is in interference fit with the talus prosthesis 2, so that relative displacement between the lining 4 and the talus prosthesis 2 is avoided, and abrasion is reduced. The lining 4 is in clearance fit with the pin shaft 3, so that the freedom degree of the ankle joint in the front-rear direction is guaranteed, the range of the freedom degree is (+ -) (15-90 degrees), and the specific angle can be adjusted by controlling the radius R of the first chamfer 19.
As known to those skilled in the art, polyether ether ketone (PEEK) is a polymer composed of a repeating unit containing one ketone bond and two ether bonds in a main chain structure, and belongs to a special polymer material. The material has the physical and chemical properties of high temperature resistance, chemical corrosion resistance and the like, is a semi-crystalline polymer material, can be used as a high temperature resistant structural material and an electric insulating material, and can be compounded with glass fibers or carbon fibers to prepare a reinforcing material. Generally, a polyarylether polymer obtained by condensation with aromatic dihydric phenol is adopted. The material has a great deal of application in the aerospace field, the medical instrument field (serving as artificial bone to repair bone defects) and the industrial field. Has high mechanical strength, high temperature resistance, impact resistance, flame retardance, acid and alkali resistance, hydrolysis resistance, wear resistance, fatigue resistance, irradiation resistance and good electrical property.
The detachable movable connection of the lower end of the tibia far-end prosthesis 1 and the talus prosthesis 2 is that the two sides of the accommodating groove are provided with connecting parts, the two connecting parts are provided with corresponding pin shaft holes 9, the pin shaft 3, the pin shaft holes 9, the lining holes 11 and the lining 4 are coaxially arranged, the lining 4 is provided with a first through hole 25 allowing the pin shaft 3 to pass through, the pin shaft 3 is inserted into the pin shaft holes 9 and the first through hole 25, the first through hole 25 and the pin shaft 3 are in clearance fit, the degree of freedom of the ankle joint in the front-back direction is ensured, the first through hole 25 and the pin shaft 3 are in clearance fit, namely, the inner diameter of the first through hole 25 of the lining 4 is larger than the outer diameter of the pin shaft 3, so that clearance fit is formed, the clearance fit is different from interference fit, the two parts are tightly connected and cannot rotate, the clearance fit can generate rotation between each other, for example, the pin shaft 3 can rotate in the axial direction of the first through hole 25 without shaking, the specific chamfer angle can be adjusted in the specific ankle joint through the specific structure through the circumferential direction of the chamfer angle of 15 DEG, and the radius of the ankle joint can be adjusted by a range of 1 DEG R (19 DEG is controlled). The pin shaft hole 9 structure of the tibia far-end prosthesis 1 is matched with the pin shaft 3 for use, so that the rotation center and the freedom degree of the ankle joint prosthesis are ensured.
The head of the pin shaft 3 is chamfered, so that the pin shaft 3 is convenient to insert, the pin shaft 3 is a rotating shaft of the ankle joint prosthesis, and high strength and hardness are guaranteed by adopting cobalt-chromium-molybdenum materials, so that the wear resistance is better.
The talar prosthesis 2 comprises a talar prosthesis platform, the thickness of the talar prosthesis platform is controllable (4-10 mm), the thickness of the talar prosthesis platform can be adjusted according to the defect height of a talar, so that the talar prosthesis platform is guaranteed to be basically consistent with the rotation center of an original ankle joint, the lining hole 11 is formed in the upper surface of the talar prosthesis platform, a first screw hole 12 and a second screw hole 23 are formed in the talar prosthesis platform, the skirt 15 is a boss on one side of the lower surface of the talar prosthesis platform, a third screw hole 24 is formed in the skirt 15 of the talar prosthesis 2, the thickness of the skirt 15 is larger than that of a screw cap arranged in the third screw hole 24, the fact that a connecting screw is firm is guaranteed, and the talar prosthesis 2 is fixedly connected with a residual talar through the screw holes. The contact between the first screw hole 12 and the second screw hole 23 and the trabecular bone structure 27 adopts a solid structure (as shown in fig. 10), which increases the strength of the screw hole and prevents the screw hole from breaking. According to practical analysis, the mesh around the first screw hole 12 and the second screw hole 23 is made into a solid body because the thickness of the entity except the trabecular bone structure 27 in the skirt 15 is enough, the third screw hole 24 is strong enough not to break screw holes, and the thickness of the talus prosthesis platform is relatively thin to ensure the strength.
The edge profile 16 of the talar prosthesis 2 takes a shape conforming to the residual talus, avoiding interference with other bones or tissues, while ensuring the positioning of the talar prosthesis 2. The edge profile 16 is the outermost circle of the profile line as shown in top view of the talar prosthesis 2 in fig. 6.
As shown in FIG. 7, the shock pad is knocked in by the frustum 18 structure of interference fit on the platform surface of the talus prosthesis, the material is PEEK (or polyethylene material, the material of the polyethylene preferred by another embodiment is selected from high molecular crosslinked polyethylene, high molecular crosslinked polyethylene and wear-resistant property, and meanwhile, the material has the buffering function, in the movement process, the impact between each part is buffered, and the impact is imitated to the buffering function of the ankle joint of a human body), so that the tibia distal prosthesis is prevented from colliding with the talus prosthesis platform when rotating around the shaft. As shown in fig. 2, the shock pads are a first shock pad 17 and a second shock pad 26 on the table top of the talus prosthesis on either side of the liner, respectively.
The connecting part comprises a first connecting part 21 and a second connecting part 22, a first pin shaft hole is formed in the first connecting part 21, a second pin shaft hole is formed in the second connecting part 22, a pin groove 14 is formed in the pin shaft 3, the width of the pin groove 14 is only required to be slightly larger than the diameter of the pin 5, the pin 5 can be conveniently inserted into the pin groove 14, for example, the width of the pin groove 14 is slightly larger than the diameter of the pin 5 by 0.1-0.2 mm, the groove opening direction of the pin groove 14 is perpendicular to the axial direction of the pin shaft 3, a pin hole 10 is formed in the second connecting part 22, the axial direction of the pin hole 10 is perpendicular to the axial direction of the second pin shaft hole, the pin hole 10 is communicated with the second pin shaft hole, and the pin 5 is matched with the pin hole 10 of the tibia far-end prosthesis 1 to play roles of preventing withdrawal and preventing axial shaking.
The lower end of the talus prosthesis 2 is provided with a skirt 15 which is convenient to position and fix during installation, the skirt can be convenient to position and fix during the installation process of the prosthesis, and meanwhile, the bone contact surface is designed into a bone trabecula structure 27, which is beneficial to secondary fixation of the prosthesis, and the rectangular shape on the inner side of the skirt 15 is in contact with the residual talus as well as the lower part of a talus prosthesis platform, is the bone trabecula structure 27 with the same thickness, and is beneficial to bone ingrowth. All pictures this structure has been marked with a honeycomb section line. The talus prosthesis platform is provided with a first screw hole 12 and a second screw hole 23 at the front and back inner ends, the skirt 15 of the talus prosthesis 2 is provided with a third screw hole 24, the talus prosthesis 2 is fixedly connected with the residual talus through screws and screw holes, the number of the screw holes can be designed according to the actual condition of patients, the angle of the screw holes is reasonably arranged on the prosthesis according to the required number of the screws, for fixing, the screw holes are not parallel to each other in space position, but form a crossing angle in space, the specific embodiment is provided with 3 screw holes on the talus prosthesis for fixing, the three screw holes are respectively connected through screws (the first screw hole 12, the second screw hole 23 and the third screw hole 24), for fixing, the three screw holes are not parallel to each other in space position, form a crossing angle in space, the front and back ends of the first screw hole 12 and the second screw hole 23 on the talus prosthesis platform are not perpendicular to the prosthesis platform, but form a crossing angle in space, and the second extending line of the orthographic projection of the third screw hole 24 to the skirt 15 is formed on the talus prosthesis platform.
As shown in fig. 2, a third screw hole 24 is provided at a position located below the center of the skirt 15, and the angle of the third screw hole 24 can be adjusted according to practical situations. The liner 4 is designed with a skirt 20, as shown in fig. 3, one end of the skirt 20 is abutted against one end of the liner hole 11 after being installed, the other side of the skirt 20 is abutted against the inner side of the first pin shaft hole, namely, the skirt 20 is positioned between the liner hole 11 and the pin shaft hole 9, so that collision and abrasion between the tibia far-end prosthesis 1 and the talus prosthesis 2 can be avoided, and displacement in the axial direction is prevented.
The outer side of the first pin shaft hole is provided with a pin shaft counter bore 8, the longitudinal section of the pin shaft counter bore 8 is polygonal, and the shape of the pin shaft counter bore 8 is matched with the structure of the pin shaft cap end 13, so that the positioning of the pin groove 14 is facilitated, and the rotation can be prevented.
In this embodiment, the pin shaft 3 adopts a hexagonal cap structure, the pin shaft counter bore 8 of the tibia far-end prosthesis 1 is a hexagonal pin shaft counter bore, the pin shaft cap end 13 adopts a hexagonal shape to be matched with the hexagonal pin shaft counter bore 8 of the tibia far-end prosthesis 1, when the pin shaft 3 is installed on the tibia far-end prosthesis 1, the pin shaft cap end 13 is completely aligned with the pin shaft counter bore 8, the pin holes 10 of the tibia far-end prosthesis 1 and the notch of the pin groove 14 are aligned, which is beneficial to positioning the pin groove 14, can prevent rotation, and avoid friction collision and abrasion between metal and metal.
All parts of the movable connecting parts are isolated through the lining 4 or the shock pad, so that direct collision between metals is avoided, ion precipitation is caused, and inflammation infection is triggered.
The lower ends of the first connecting part 21 and the second connecting part 22 are respectively provided with a first chamfer 19, and the specific angle of the degree of freedom of the ankle joint in the front-rear direction can be adjusted by controlling the radius of the first chamfer 19.
The prosthesis is suitable for treating the tibia far-end large-area defect repair and ankle joint replacement prosthesis, the tibia far-end of a patient is cut off during operation, then one end of the customized prosthesis is inserted into the tibia near-end of the healthy side, and the other end of the customized prosthesis is fixed with the talus to replace the original ankle joint.
A mounting process of a hinged 3D printing artificial ankle joint prosthesis:
The first step is to insert two liners 4 into the talus prosthesis 2 from either side of the liner hole 11 (this process is reversible, but slightly tight when removed);
secondly, inserting the talus prosthesis 2 into the tibia far-end prosthesis 1 to ensure two coaxiality (attention direction) as much as possible;
thirdly, inserting the pin shaft 3 to the bottom, paying attention to the direction of the pin shaft 3, and aligning the pin hole 10 of the tibia far-end prosthesis 1 with the notch of the pin groove 14;
And fourthly, inserting the pin 5 into the pin hole 10, and forcefully knocking in after vertical and until the upper surface of the pin 5 is coplanar with the front side plane of the tibia far-end prosthesis 1 (the step is interference fit and irreversible, ensuring that all the steps are installed in place before, and resisting the pin cap end 13 when knocking to prevent the pin shaft 3 from withdrawing).
In the third step of the installation process of the hinge type 3D printing artificial ankle joint prosthesis in the embodiment 1, the pin 5 is inserted to the bottom, the direction of the pin shaft 3 is noted, so that the two marking lines are aligned, at the moment, the pin hole 10 of the tibia far-end prosthesis 1 is aligned with the notch of the pin groove 14, and the installation angle and the installation direction can be rapidly and accurately selected by the marking lines on the pin shaft cap end 13 and the first connecting part 21.
Embodiment 3. On the basis of embodiment 2, the side face of the pin 5 is provided with an indication line, and the indication line is provided with an arrow to indicate the installation direction.
It is noted that relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises an element.
The three embodiments of the present invention have been described in detail, but the description is only a preferred embodiment of the present invention and should not be construed as limiting the scope of the present invention. All equivalent changes and modifications within the scope of the present invention are intended to be covered by the present invention.