Artificial lumbar intervertebral discTechnical field
The present invention relates to a kind of orthopaedics implantation instrument, particularly a kind of artificial prosthesis of lumbar intervertebral disc of alternative degeneration.
Background technology
Human body lumbar vertebra structural defence intraspinal spinal cord and nerve root, gives trunk stability and motility simultaneously, is the load-carrying members that body weight for humans is wanted, and the stress conduction of lumbar vertebra is by “San joint association " carry out, comprise the articular process that intervertebral disc and rear are paired.Intervertebral disc is comprised of fibrous ring, vertebral pulp, terminal plate of vertebral body, is the depletion of blood fortune tissue of human body maximum, and tissue regeneration and repair ability are limited, causing intervertebral disc degeneration to be difficult to self reverses, when the water content minimizing of vertebral pulp, elasticity and anti-load-bearing capacity go down greatly, just easily develop into the intervertebral disc of degeneration.Epidemiological study discovery, incidence rate and age from adolescence to geratic period intervertebral disc degeneration are in linear relation, and old degeneration of intervertebral disc almost reaches " saturated " state.
For Symptomatic degenerative disc regression patient, as invalid through strict expectant treatment, just should take operative treatment.Traditional therapeutic method of surgery is lumbar spinal fusion, the conventional fusion method that has the decompression operation based on vertebral plate and adopt pedicle screw.The method has been alleviated lumbar intervertebral disc source property pain, within several years after surgery, occur recurrence, then operability is higher yet long-term results shows many patients.In addition, fusion make the to perform the operation activeness permanent loss of sections, adjacent segment mobility strengthens and causes regression to be accelerated, and has changed the original biomechanics environment of spinal column.
Now, another selection scheme for the treatment of intervertebral disk retrogression disease is implantable artificial intervertebral disk prosthesis, the method has some potential advantages with respect to fusion, comprise effective alleviating pain, avoided adjacent segment to get involved, can also multi-segmental displacement, a kind of method that in theory can the original biomechanics state of preservation spinal is provided.Current artificial lumbar disc prostheses both domestic and external has multiple design, can be divided into two kinds of multi-part and integral type prostheses, below introduces respectively.
Existing artificial lumbar disc prostheses is mostly multi-part prosthese, be the motor function of utilizing engineering means to reach intervertebral disc, be mainly by ball-and-socket joint imitate intervertebral disc anteflexion, after stretch, the motion of left and right lateral bending and left rotation and right rotation six-freedom degree, generally by metal soleplate and upper and lower vertebral body, fix, between two metal soleplates, directly form ball-and-socket joint (as Maverick) or in the middle of two metals, place polyethylene vertebral pulp formation " sandwich structure " (as ProDisc, SB Charit é, Mobidisc).Structure and the material technology of the design of this multi-part are more ripe, however this design cannot imitate the coupled motions of intervertebral disc complexity, can not complete the compression and separated/turgor movement of similar physiology intervertebral disc.
The replacement operation that multi-part prosthese is carried out adopts the place ahead to expose vertebral body through peritoneum approach or peritoneum posterior approach mostly, the method wound is large, both increased patient's misery, extended again the postoperative rehabilitation time, what is more important, as need carry out revision procedure, the risk that massive hemorrhage or thromboembolism complication occur in art is approximately 6 times of first operation.Therefore, realizing lateral approach or front lateral approach implanting prosthetic, or carry out minimal invasive operation, is one of the main points of studying now the artificial lumbar disc of new construction.And the integrated design of prosthese, also can simplified apparatus inventory, and doctor is tended towards stability to the learning curve of lumbar intervertebral disc implant surgery, reduces the technical error while implanting.
Existing integrated prosthese mainly contains FlexiCore prosthese, the design of employing all-metal, two soleplates connect by central ball-and-socket joint and set up axial-rotation and other motor functions, prosthese ball-and-socket joint before passing doctor has assembled simultaneously, tension load structure can prevent the surperficial separated and dislocation of loading, and prosthese can carry out multi-angle operation and insert according to doctor's custom.But the design of the all-metal of this prosthese makes the elastic modelling quantity of prosthese larger, easily produce stress-shielding effect, after inserting human body because this prosthese lacks load absorbability, load outside the necessary commitment of adjacent intervertebral disc, even cause the too early degeneration of adjacent disc, the unit area loading that metal brings is larger, has the prosthese of generation to be absorbed in the risk of vertebra after inserting, and the Follow-up After of this prosthese has no extensive report.
Existing prosthetic designs is mostly multicomponent structure, adopts front road approach outside peritoneum or peritoneum, and wound is large, and operation risk is large.Adopt the prosthese of integrated design as FlexiCore, owing to adopting all-metal construction, elastic modelling quantity is far longer than the elastic modelling quantity of cortical bone, exists stress shielding and prosthese to subside risk.
Summary of the invention
The object of the invention is to overcome above-mentioned weak point of the prior art, a kind of integrated prosthese made from metal material and macromolecular material combination is provided, except allowing spinal surgery doctor according to being accustomed to implanting prosthetic from different perspectives, the artificial lumbar intervertebral disc of also can effectively avoid that the load that cause of prosthese in human body is excessive, stress shielding, prosthese being subside equivalent risk.
Technical solution of the present invention is described artificial lumbar intervertebral disc, and its special character is: by top panel, in panel, rotating shaft ball, damping damping, lower panel form; Between top panel, middle panel and lower panel, in the containing cavity of molding, be provided with the rotating shaft ball being connected with articulated manner; The bulb of this rotating shaft ball is installed with in the ball-and-socket of plate and middle panel forming in the above slidably, and the axial region of rotating shaft ball is screwed onto in the screw that lower panel offers, thus make top panel relatively lower panel rotate; Between middle panel and damping damping and be provided with gap and the arcuate gap that makes the relative lower panel of top panel make banking motion between the convex surface of middle panel and the concave surface of damping damping.
As preferably: the surface that top panel, lower panel contact with vertebral body arranges respectively central dome-shaped projection; Top panel is all bolted or selects being connected of other member with lower panel with middle panel and damping damping: groove and spring connecting mechanism, protruding tail and corresponding recessed bindiny mechanism, snap fastener, bonding agent, ultrasonic bonding, screw, joinery and its construction lead.
As preferably: the molding mode of central dome-shaped projection and panel is selected following a kind of:
(1) the dome-shaped projection of these central authorities and panel are one-body molded;
(2) the wire mesh grid that the dome-shaped projection of these central authorities and panel are combined as a whole, described wire mesh grid is made deformation process when implant into body, to be applicable to the concave surface of upper vertebral body, hypocentrum;
(3) the porous convex surface metallic object that the dome-shaped projection of these central authorities and panel are combined as a whole, to promote osseous tissue to grow into.
As preferably: be provided with the top panel of central dome-shaped projection and the surface of lower panel and be provided with the initial fixing tooth of the label that sees through for ray and several and vertebral body and dash forward; Be provided with the top panel surface and lower panel surface spraying biological activity or bone induction material of central dome-shaped projection.
As preferably: described biological activity or bone induction material are selected: the coating that titanium coating, hydroxyapatite coating layer, titanium and calcium phosphate are made, calcium silicates coating, tantalum coating a kind of; Or, the relative sliding of employing embossed surface, the corrugated surface prevention surface of top panel and the surface of lower panel and upper vertebral body, hypocentrum soleplate.
As preferably: the arcuate section between joint, middle panel convex surface and damping damping concave surface that ball-and-socket forms, the position of the set angle of being separated by is equipped with the detent mechanism that restriction artificial lumbar intervertebral disc excessively rotates; That is: the ball-and-socket place of the bulb of rotating shaft ball and top panel, middle panel arranges relative projection and recessed, or, adopt embossing, groove, acid etching, sintering at surperficial globule, be etched in surperficial texture, can not continue rotation after making panel rotate to this position; Joint, middle panel convex surface that ball-and-socket forms contact the surface of arcuate section with damping damping, be provided with and import tissue fluid to lubricate prosthetic surface, guarantee the groove of fluidity of motion.
As preferably: the concave surface of the convex surface of described middle panel and damping damping diminishes gradually in side direction, for the rotation of artificial lumbar intervertebral disc with tilt to produce more " play "; The marginal portion that middle panel is relative with damping damping is provided with angular aperture, and this angular aperture is that the relative damping damping of middle panel convex surface concave surface tilts and/or the edge of horizontal slip forms; This angular aperture is arranged in middle panel or damping damping, or the two all has; So, can when artificial lumbar intervertebral disc completes side direction rotation, increase the anglec of rotation, in the terminal contact process of middle panel convex surface and damping damping concave surface, occur gap-closing, stop rotation.
As preferably: top panel, middle panel, lower panel and rotating shaft ball are selected respectively following a kind of material:
Metal species material: titanium alloy, zircaloy, tantalum alloy; Preferred: vitallium;
Ceramic-like materials: aluminium oxide, zirconium oxide;
Following a kind of material is selected in damping damping:
Ultra-high molecular weight polyethylene (UHMWPE), polymethyl methacrylate (PMMA), polyethers, ether ketone (PEEK); Preferred: polyurethane.
As preferably: adapt to cartilage endplate by kidney shape develop gradually ovalisation state top panel, in panel, lower panel, select following a kind of shape: ellipse, oval, kidney shape, round rectangle, D shape.
Another technical solution of the present invention is described artificial lumbar intervertebral disc, and its special character is: by top panel, in panel, rotating shaft ball, damping damping, lower panel form; Between top panel, middle panel and lower panel, in the containing cavity of molding, be provided with the rotating shaft ball being connected with articulated manner; The bulb of this rotating shaft ball is installed with in the ball-and-socket of plate and middle panel forming in the above slidably, and the axial region of rotating shaft ball is screwed onto in the screw that lower panel offers, thus make top panel relatively lower panel rotate; Between middle panel and damping damping and be provided with gap and the arcuate gap that makes the relative lower panel of top panel make banking motion between the convex surface of middle panel and the concave surface of damping damping; The surface that top panel, lower panel contact with vertebral body arranges respectively central dome-shaped projection; Top panel and middle panel and damping damping and lower panel are all bolted or select removably mode connected mode: groove and spring connecting mechanism, protruding tail and corresponding recessed bindiny mechanism, snap fastener, bonding agent, ultrasonic bonding, screw, joinery and its construction lead; The molding mode of the dome-shaped projection of central authorities and panel is selected following a kind of:
(1) the dome-shaped projection of these central authorities and panel are one-body molded;
(2) the wire mesh grid that the dome-shaped projection of these central authorities and panel are combined as a whole, described wire mesh grid is made deformation process when implant into body, to be applicable to the concave surface of upper vertebral body, hypocentrum;
(3) the porous convex surface metallic object that the dome-shaped projection of these central authorities and panel are combined as a whole, to promote osseous tissue to grow into;
Being provided with the top panel of central dome-shaped projection and the surface of lower panel is provided with the initial fixing tooth of the label that sees through for ray and several and vertebral body and dashes forward; Be provided with the top panel surface and lower panel surface spraying biological activity or bone induction material of central dome-shaped projection; Described biological activity or bone induction material are selected: the coating that titanium coating, hydroxyapatite coating layer, titanium and calcium phosphate are made, calcium silicates coating, tantalum coating a kind of; Or, the relative sliding of employing embossed surface, the corrugated surface prevention surface of top panel and the surface of lower panel and upper vertebral body, hypocentrum soleplate;
Arcuate section between joint, middle panel convex surface and damping damping concave surface that ball-and-socket forms, the position of the set angle of being separated by is equipped with the excessively detent mechanism of rotation of restriction artificial lumbar intervertebral disc transition; That is: the ball-and-socket place of the bulb of rotating shaft ball and top panel, middle panel arranges relative projection and recessed, or, adopt embossing, groove, acid etching, sintering at surperficial globule, be etched in surperficial texture, can not continue rotation after making panel rotate to this position; Joint, middle panel convex surface that ball-and-socket forms contact the surface of arcuate section with damping damping, be provided with and import tissue fluid to lubricate prosthetic surface, guarantee the groove of fluidity of motion;
The concave surface of the convex surface of described middle panel and damping damping diminishes gradually in side direction, for the rotation of artificial lumbar intervertebral disc and the generation more " play " of tilting; The marginal portion that middle panel is relative with damping damping is provided with angular aperture, and this angular aperture is that the relative damping damping of middle panel convex surface concave surface tilts and/or the edge of horizontal slip forms; This angular aperture is arranged in middle panel or damping damping, or the two all has; So, can when artificial lumbar intervertebral disc completes side direction rotation, increase the anglec of rotation, in the terminal contact process of middle panel convex surface and damping damping concave surface, occur gap-closing, stop rotation;
Top panel, middle panel, lower panel and rotating shaft ball are selected respectively following a kind of material:
Metal species material: titanium alloy, zircaloy, tantalum alloy; Preferred: vitallium;
Ceramic-like materials: aluminium oxide, zirconium oxide;
Following a kind of material is selected in described damping damping;
Ultra-high molecular weight polyethylene (UHMWPE), polymethyl methacrylate (PMMA), polyethers, ether ketone (PEEK); Preferred: polyurethane;
Adapt to cartilage endplate by kidney shape develop gradually ovalisation state top panel, in panel, lower panel, select following a kind of shape: ellipse, oval, kidney shape, round rectangle, D shape.
Compared with prior art, the present invention has good effect as described below:
Artificial lumbar intervertebral disc of the present invention is integral type prosthese, can maximize and reduce implantation instrument inventory, makes doctor easy and simple to handle, and learning curve slows down greatly, also can be accustomed to implanting prosthetic from different perspectives according to doctor.Because this artificial lumbar intervertebral disc has adopted the mode of metal material and macromolecular material combination; this artificial lumbar intervertebral disc material has overcome the deficiency that elastic modelling quantity is large and quality is large of all-metal prosthese; avoided stress shielding; reduced the sagging danger of artificial lumbar intervertebral disc; in addition; macromolecular material can absorption portion load, and adjacent segment intervertebral disc is played a protective role.
Accompanying drawing explanation
Fig. 1 is the STRUCTURE DECOMPOSITION schematic diagram of artificial lumbar intervertebral disc of the present invention.
Fig. 2 is the Standard profile of artificial lumbar intervertebral disc of the present invention.
Fig. 3 is the Facad structure axonometric chart of artificial lumbar intervertebral disc top panel of the present invention.
Fig. 4 is the reverse side structural perspective of artificial lumbar intervertebral disc top panel of the present invention.
Fig. 5 is the Facad structure axonometric chart of panel in artificial lumbar intervertebral disc of the present invention.
Fig. 6 is the reverse side structural perspective of panel in artificial lumbar intervertebral disc of the present invention.
Fig. 7 is the Facad structure axonometric chart of artificial lumbar intervertebral disc damping damping of the present invention.
Fig. 8 is the reverse side structural perspective of artificial lumbar intervertebral disc damping damping of the present invention.
Fig. 9 is the Facad structure axonometric chart of artificial lumbar intervertebral disc lower panel of the present invention.
Figure 10 is the reverse side structural perspective of artificial lumbar intervertebral disc lower panel of the present invention.
The specific embodiment
The present invention is further detailed in conjunction with the accompanying drawings below:
Refer to shown in Fig. 1, described artificial lumbar intervertebral disc bytop panel 1, inpanel 2, rotatingshaft ball 3,damping damping 4,lower panel 5 form; Symmetrically on the plate face that short two screw ofscrew 13, spacing that the dome-shaped projection 12 of central authorities that the surface thattop panel 1 is contacted with vertebral body by the top ofellipse 11,ellipse 11 is convexly equipped with, the periphery that is positioned at central dome-shaped projection 12 are all laid is 13 be convexly equipped with the ball-and-socket 15 that the tooth initial fixing with vertebral body is prominent 14, the bottom ofellipse 11 is arranged with and form; The central authorities of theconvex surface 22 thatmiddle panel 2 is convexly equipped with by the bottom of ellipse 21, ellipse 21,screw 23 that the periphery that is positioned atconvex surface 22 is all laid, ellipse 21 connect the ball-and-socket 24 of offering and form; Theconcave surface 42 that at the bottom of the central vault that dampingdamping 4 is arranged with by the top ofellipse 41,ellipse 41, shape connects, be positioned at thescrew 44 that the periphery of the bottom perforated 43 ofellipse 41 all lays and form; On the plate face that short two screw ofscrew 53, spacing that the dome-shaped projection 52 of central authorities that the surface thatlower panel 5 is contacted with vertebral body by the bottom of ellipse 51, ellipse 51 is convexly equipped with, the periphery that is positioned at central dome-shaped projection 52 are all laid is 53, the symmetrical tooth being convexly equipped withscrew 55 prominent 54, that the top of ellipse 51 is arranged with forms.
Betweentop panel 1,middle panel 2 andlower panel 5, in the ball-and-socket 15,24 of molding, be provided with the rotatingshaft ball 3 being connected with articulated manner; Thebulb 31 of this rotatingshaft ball 3 is installed with in the ball-and-socket 15,24 of plate in the above 1 andmiddle panel 2 molding slidably, and theaxial region 32 of rotatingshaft ball 3 is screwed onto in thescrew 55 thatlower panel 5 offers, thereby, maketop panel 1 relativelylower panel 5 rotate; Betweenmiddle panel 2 and dampingdamping 4 and be provided withgap 25 and the arcuate gap 26 that makes the relativelower panel 5 oftop panel 1 make banking motion between theconvex surface 22 ofmiddle panel 2 and theconcave surface 42 ofdamping damping 4, wherein;Top panel 1 is connected bybolt 6 withmiddle panel 2;Damping damping 4 is connected bybolt 8 with lower panel 5.Top panel 1 andmiddle panel 2 anddamping damping 4 andlower panel 5 be optional use connected mode removably below also: groove and spring connecting mechanism, protruding tail and corresponding recessed bindiny mechanism, snap fastener, bonding agent, ultrasonic bonding, screw, joinery and its construction lead.Ball-and-socket joint 15,24 betweentop panel 1 andmiddle panel 2 can be arranged on the centre of artificial lumbar intervertebral disc, also can be arranged on the position of inclined to one side human body veutro or human body dorsal part, betweentop panel 1 andmiddle panel 2 part of ball-and-socket joint 15,24, the part thatmiddle panel 2 contacts with damping damping 4 enlarge active surface of should trying one's best, so that load is delivered inlower panel 5 and lower vertebra uniformly.
In the present embodiment, the molding mode of the dome-shaped projection 12,52 of described central authorities andtop panel 1,lower panel 5 is selected following a kind of:
(1) the dome-shaped projection 12,52 of these central authorities andtop panel 1,lower panel 5 are one-body molded;
(2) the wire mesh grid (not shown) that the dome-shaped projection 12,52 of these central authorities andtop panel 1,lower panel 5 are combined as a whole, described wire mesh grid is made deformation process when implant into body, to be applicable to the concave surface of upper vertebral body, hypocentrum;
(3) the porous convex surface metallic object (not shown) that the dome-shaped projection 12,52 of these central authorities andtop panel 1,lower panel 5 are combined as a whole, promotes osseous tissue to grow into.
In the present embodiment, arcuate section between joint, middle panel convexsurface 22 and damping dampingconcave surface 42 that ball-and-socket 15,24 forms, as the position at be separated by 180 ° or 90 °, 60 ° is equipped with the detent mechanism (not shown) that restriction artificial lumbar intervertebral disc excessively rotates; That is: ball-and-socket 15,24 places of thebulb 31 of rotatingshaft ball 3 andtop panel 1,middle panel 2 arrange relative projection and recessed (not shown), or, adopt embossing, groove, acid etching, sintering at surperficial globule, be etched in surperficial texture, can not continue rotation or rotation difficulty after making panel rotate to this position; The surface of the joint that ball-and-socket 15,24 forms, middle panel convexsurface 22 and damping dampingengagement concavity face 2, is provided with importing tissue fluid, lubricated prosthetic surface, the groove (not shown) of assurance fluidity of motion.
In the present embodiment, be provided with thetop panel 1 of central dome-shaped projection 12,52 and the surface oflower panel 5 is provided with the label (not shown) seeing through for ray.Because lumbar vertebra soleplate compressive resistance periphery is greater than central authorities, rear portion is greater than front portion, so artificial lumbar intervertebraldisc top panel 1,lower panel 5 are used for being arranged on outside or rear portion with the initial fixing member of vertebral body, spinal disc prosthesis surface is completed with the initial of vertebral body and is fixed by six teeth prominent 14,54, every group of three distributions, are distributed in left and right side, also tooth prominent 14,54 can be fixed on to proceeds posterolateral, tooth prominent 14,54 can be continuously arranged, can be also spaced.Except tooth prominent 14,54, preferred alternative structure comprises the (not shown) such as Os Draconis, spike, hook, screw, hook.Be provided with the surface oftop panel 1 and surface spraying biological activity or the bone induction material oflower panel 5 of central dome-shaped projection 12,52, select: the coating that titanium coating, hydroxyapatite coating layer, titanium and calcium phosphate are made, calcium silicates coating, tantalum coating a kind of; Or, the relative sliding of employing embossed surface, the corrugated surface prevention surface oftop panel 1 and the surface oflower panel 5 and upper vertebral body, hypocentrum soleplate.
In the present embodiment, the ventrad and dorsad radius of curvature of theconvex surface 22 ofmiddle panel 2 and theconcave surface 42 of damping damping 4 keeps being derived from the constant distance of same circle, also can be for having different radii but have two circles of identical mid point.
In the present embodiment, two arc curved surfaces can not keep constant distance mutually yet, and arrange in opposite directions or it has the distance of increase between side direction in side direction.Theconvex surface 22 ofmiddle panel 2 and corresponding damping dampingconcave surface 42 can diminish gradually in side direction, to give the rotation of panel and to tilt to produce more " play ".Theconvex surface 22 ofmiddle panel 2 also can increase with the contact area of theconcave surface 42 of damping damping 4, and this can improve the materials ' durability in articulation region.The marginal portion thatmiddle panel 2 is relative with damping damping 4 is provided with angular aperture (not shown), and described angular aperture is to form by the relative damping damping of middle panelconvex surface 22concave surface 42 inclinations with adjacent and/or the edge of horizontal slip; This angular aperture is arranged inmiddle panel 2 or damping damping 4, or the two all has; So, can when artificial lumbar intervertebral disc completes side direction rotation, increase the anglec of rotation, in the terminal contact process of middle panelconvex surface 22 and damping dampingconcave surface 42, occur gap-closing, could stop rotation.
In the present embodiment, describedtop panel 1,middle panel 2,lower panel 5 androtating shaft ball 3 are from selecting one group of material below:
Metal species material: titanium alloy, zircaloy, tantalum alloy, preferably vitallium;
Ceramic-like materials: aluminium oxide, zirconium oxide;
Described damping damping is from selecting one group of material below:
Ultra-high molecular weight polyethylene (UHMWPE), polymethyl methacrylate (PMMA), polyethers, ether ketone (PEEK), optimization polyurethane.
In the present embodiment, describedtop panel 1,middle panel 2,lower panel 5, adapt to cartilage endplate and develop into gradually oval form by kidney shape, selects following a kind of shape: ellipse, oval, kidney shape, round rectangle, D shape.
In the present embodiment, the range scale of this artificial lumbar intervertebral disc is, width (transverse diameter) 28~45mm, length (radius vector) 24~35mm, height 7~17mm.This artificial lumbar intervertebral disc needs substantially to occupy the interbody space of removing after physiology intervertebral disc after inserting human body, and " substantially occupying " means, described dish occupies the surface area at least about 50%, perhaps at least about 80% surface area or more.
The motion function of artificial lumbar intervertebral disc of the present invention is determined by following factor:
(1) themiddle panel 2 of relative sliding and the back of the body between damping damping 4 tilting procedure ventrad, depends on ventrad and dorsad around height and the radius of curvature of the respective edges in ball-and-socket 15,24 articulation regions and middle panel convex surface, damping damping 4 concave surfaces.
(2) betweenmiddle panel 2 and damping damping 4, be provided with gap and angular aperture, for themiddle panel 2 by with relative sliding and the edge of damping damping 4 inclinations and/or level form, wherein in themiddle panel 2 of relative sliding and the terminal contact process of damping damping 4, there is gap-closing in angular aperture.
(3) themiddle panel 2 of relative sliding and the rotation of damping damping 4 with respect to rotatingshaft 32 axle center, depend on respectively the bow action of middle panelconvex surface 22 and corresponding damping dampingconcave surface 42 and the tolerance between this bow action degree, middle panelconvex surface 22 and damping dampingconcave surface 42.
The foregoing is only preferred embodiment of the present invention, all equalizations of doing according to the claims in the present invention scope change and modify, and all should belong to the covering scope of the claims in the present invention.