Summary of the invention
Therefore the purpose of this invention is to provide such implant, it is made up of simple as far as possible parts, particularly by one or easily several of connection form; And wherein except other functions, guarantee that implant or its some zones have certain elasticity and activeness.In addition, this device should be easy to make, implant, and is safe in utilization, durable in use and be widely used.
Above-mentioned purpose realizes by implant with claim 1 or claim 3 technical characterictic and the implant manufacture method with claim 19 technical characterictic.Preferred embodiment as described in the dependent claims.
The present invention builds on following understanding: about being used for the implant of human body and animal body, shape is to select according to its that implant is realized at body or multinomial function basically.These functions may comprise also that implant has activeness or elasticity to a certain degree.And under some other situation, activeness or elasticity in the implant are dispensable basically, but may be preferably can have or had can be more favourable.About this point, in the following description, activeness and spring function will be called as secondary function, and all the other functions are called premiere feature.
In first group of situation, prior art is to obtain activeness or elastic by optional feature and/or dissimilar materials.Another approach has been adopted in this invention, wherein activeness or elasticity are not to realize by other material or additional separate part, but in implant that forms as one or implant component, the zone by the design of material recess being stipulated realize to have elasticity or activeness.
In second group of situation, activeness or elasticity are not indispensable functions, according to the present invention, realize this additional function by the additional in shape respective material depression that is provided with in the respective regions in the required function regulation yet.
In this way, just can avoid adopting additional elastomeric material and corresponding link or additional individual components, and obtain the elasticity and the activeness of implant or its parts in simple mode.About this respect, elasticity or activeness function can be additional settings the outside the necessary function of implant, perhaps as the ingredient of necessary function.Particularly, so just can particularly in the implant or its parts that form one, produce compression and/or drawing zone and in certain restriction, form bending joint or torsion element etc. in the better way mode.
Correspondingly, can use stablely, hard for the implant that is preferably formed as one, particularly under the application-specific condition, use inflexible, preferably resilient rigid material such as titanium, titanium alloy, plastics or the like.In general, all can not cause rejection or occur bringing the biocompatible materials of the decomposing phenomenon of burden to body can be candidate material.
Groove shape depression or perforate that material recess preferably forms on the wall of implant or implant component.The shape of material recess, quantity and arrangement can be adjusted to meet load request according to concrete condition.
As a kind of common shape that satisfies multiple requirement, material recess is particularly suitable for forming the helical form around the implant Subject Extension, thereby form the shape of helical spring type especially, and be particularly suitable for by material recess forming free space between the adjacent spiral bar in helical spring element.Except easy production, associated materials select face wider, it also is beneficial to the bigger elasticity of realization.
Particularly advantageous is that two material recess can form the spiral type of parallel in pairs or round trip flight.Like this, can form two helical springs that mutual embedding contains layout especially.If the height of this helical form sunk area is identical, so double pitch Double helix shape depression can replace the single-screw shape depression of low pitch.
Elastic implant is particularly suitable for, also especially obviously be suitable for using together as a system, the interval eyelid retractor of vertebra and/or intervertebral disc and the connecting rod of pedicle screw device are so that patient's spinal column has the activeness of appropriateness when keeing relative stability again.
Support and weight transfer function are the premiere features of vertebra and/or intervertebral disc space eyelid retractor at interval, and damping effect and activeness are the additional functions as second function.
Support and linkage function are its premiere features for connecting rod.
For implant or interval eyelid retractor or connecting rod, confirmed preferably to make it to form the tubular body that has the intermediate tubular body and Connection Element is arranged in the end, and be used for obtaining elastic material recess and be preferably formed as form, thereby make these parts form the helical spring shape that one or two mutual embedding contains layout basically into one or two spiral-shaped orifices of tubular body.At interval the Connection Element of eyelid retractor preferably has the device that connects adjacent body area such as vertebra, as at the hamulus of end and/or at depression, groove and the opening of superficies so that at interval eyelid retractor can grow into tissue and with its weave in.But in this, the elasticity of eyelid retractor and the material recess of activeness are not obscured mutually at interval being used to obtain in the hole of this Connection Element or depression and the tubular body.Since Connection Element fully with adjacent body area such as the vertebra weave in, they are not made contributions to the elasticity or the activeness of vertebra.
The device that tubular body is connected to adjacent body area can be arranged to, or forms the particularly mode by extending in the tubular body end of one with tubular body, or the separable end plate that for example can be screwed on the tubular body end in end.
During the end plate that adopts this separable end plate or link into an integrated entity with tubular body, be preferably in and sleeve that an elastomeric material makes be set at least around the tubular body that has material recess to realize elasticity or activeness; Or an elastomeric core is set at least in tubular body.This elastomeric core or the resilient sleeve of preferably being made by artificial rubber has elasticity or the inflexible benefit that can accurately regulate tubular body or interval eyelid retractor.By tubular body and the core and/or the arrangement of telescopic module shape of band respective recesses, the different assemblies of use different-stiffness just can obtain accurately to limit with the damping meaning implant of rigidity in simple mode.Here, having implant component that can obtain elastic material recess and the combining of being made up of the elastomeric material of an energy adjustment qualification rigidity of implant component is the very basic purpose of the present invention.Be to obtain the rigidity of change, as long as change the combination of parts, promptly such as long as reinstate with another core of different-stiffness or another sleeve and elastic tubular body one.Can use with the elastic tubular body simultaneously though can expect sleeve and core, for simplicity, only use tubular body and core or tubular body and telescopic a kind of combination usually.Here, sleeve also has the advantage that tubular body that protection has a depression of spiral type preferably is not subjected to external action, yet in contrast, when using core, core is subjected to the protection of tubular body.
Core and sleeve preferably can both use under the telescopic situation by arranging that in the tubular body end end plate fixes, and therefore end plate preferably forms bigger diameter than tubular body from tubular body is outstanding.End plate can partly promptly fuse in a side and tubular body at least, thereby forms beaker shape at this.In addition, end plate can also be at one end or two ends be connected separably with tubular body, such as by screw or be threaded.Here, external screw thread can be located on the end plate, also can be located on the tubular body.
Preferably, the tubular body that this implant or have is used for obtaining the material recess of elasticity and activeness can stretch or compress 0.5% to 20% along interval eyelid retractor longitudinal axis in a longitudinal direction, particularly 1% to 15%, and can be about making the contiguous body area can be with respect to longitudinal axis deflection about 0.5 to 10 degree, particularly 1 to 6 degree with the perpendicular radial axle bending of the longitudinal axis of interval eyelid retractor.In addition, in a preferred embodiment, can twist 0.5 to 2.5 degree around the longitudinal axis.
In another favourable application of flexible implant, connecting rod in the zone between the pedicle screw device between single shaft or the multiaxis pedicle screw device can have certain elasticity and activeness by arranging corresponding material recess, and this elasticity and activeness can be that ducted body is enhanced by the part-structure of connecting rod at least especially.Rod-shaped elements is specially adapted to the firm and activeness restriction of adjacent vertebrae in the intervertebral disc defect situation of various degree.In manufacture process, obtain these characteristics by the plain mode that changes the rod-shaped elements size.
Such as, a kind of like this implant can be made by an object with a kind of simple mode, makes one or more material recess by machinery or chemical process, discharge processing (EDM), and laser treatment or any alternate manner are formed on the wall of object.Particularly one or preferably two material recess can spiral type around object or along the wall setting.
At object is solid during such as solid cylinder, can in front or form in the additional step of back particularly and the co-axial thorax of material recess hole, thereby preferably form coil spring shape at Hookean region.When using tube material, with regard to unnecessary brill core.
Comparatively ideally be, make material recess by the laser treatment of tubular body, because under the sort of situation, two depressions can form in same treatment step.By laser, can form the thorax hole simultaneously in both sides by boring tubular body (for example, also can be rectangular tube).Rotate simultaneously and advance the tubulose body to form the round trip flight spiral.
On the other hand, the present invention relates to a kind of rod-shaped elements, this element is used for connecting at least two bone anchoring elements (bone-anchoring element), each bone anchoring element is useful on anchoring section that anchors into bone and the part of accepting that is used for being connected with rod-shaped elements, and this rod-shaped elements is surrounded by at least one rigidity section and elastic segments that is formed by a material, and elastic segments particularly forms helical spring, and/or wherein on the other end of elastic segments and rigidity section adjacency, the second rigidity section and elastic segments adjacency are arranged, and/or wherein the overall diameter of elastic segments is different with the overall diameter of rigidity section a position at least, and/or wherein this elastic segments at least certain part with perpendicular certain direction of this rod axis on little than on the other direction of the overall diameter that has, and/or wherein the overall diameter of elastic segments is vicissitudinous, and/or wherein elastic segments has a core, and/or wherein is provided with a coaxial thorax hole and runs through this rod-shaped elements.
And, on the other hand, this invention relates to a kind of bone securing device, contain at least two bone anchoring elements and the rod-shaped elements that is used to connect bone anchoring element as described above, each bone anchoring element all is useful on the bone anchoring section that anchors into bone and accepts the bone screw that section, particularly bone anchoring element can be single shaft or multiaxis.
In addition, this invention relates to a kind of method of making rod-shaped elements, comprises following steps:
Prepare a rigid rod;
Preferably at least one vertical section in the free-ended preset distance of this bar, form the helical spring section with the method for removing material, and its core can axially get out or reserve, and/or elastic segments vertically on remove a material area that limits and produce non-circular cross sections with at least one zone in elastic segments, and/or the rigidity segment diameters is provided with lessly with respect to elastic segments.
This invention is particularly related to the flexible member that is used for bone or vertebra securing device, it roughly is one and contains the cylinder that first end reaches second end opposite with it, described cylindrical opposite each end all contains in a coaxial aperture and these ends at least one end and contains female thread and be used to be connected to the nut and/or the screw rod of bone screw or be used to be connected to bar section or plate, and wherein particularly every end at two ends all has female thread.
This invention also relates to the flexible member that is used for bone and vertebra securing device, it roughly is a cylinder that contains first end and second end opposite with it, and described cylinder first end contains the nut or the screw rod that have externally threaded cylindrical outthrust and be used to be connected to bone screw, is used to be connected to the bar section or is used to be connected to plate.
Described cylinder second end contains one and has nut or screw rod that externally threaded cylindrical outthrust is used to be connected to bone screw, is used to be connected to the bar section or is used to be connected to plate.
According to another preferred embodiment, described flexible member includes adjacent with second an end coaxial thorax hole and/or the section place adjacent with second end includes nut or screw rod that female thread is used to be connected to bone screw, is used to be connected to the bar section or is used to be connected to plate in coaxial thorax hole at least.
According to another preferred embodiment, the feature of described flexible member is that total length is run through in the thorax hole, and/or described cylinder is to have the tubulose in the coaxial thorax of seriality hole and have on the cylinder axis direction wall sunken inside that extends with spiral form, and wherein said depression terminates in place, thorax hole diametrically.
According to another preferred embodiment, the feature of described flexible member is to be provided with core in the thorax hole and/or flexible member forms coil spring.
According to another preferred embodiment, described flexible member with biocompatible materials particularly titanium make.
This invention is particularly related to the bone anchoring element that has flexible member as previously described, and the dististyle that has comprised screw rod that has bone thread that is connected with flexible member one end and the bone screw that is connected with the flexible member other end is nut preferably.
This invention is particularly related to the rod-shaped elements that is used to connect two bone anchoring elements, and this rod-shaped elements has a flexible member and the first rigid rod section that links to each other with flexible member one end, wherein particularly has the second rigid rod section to link to each other with the flexible member other end.
This invention is particularly related to a kind of plate, and it has one to have externally threaded cylindrical outthrust or a thorax hole that has the female thread shape is arranged at the one end at least, is used to connect flexibility recited above or flexible member.
This invention is particularly related to a kind of securing device that is used for the dynamic stability of bone, osteogenic section or spinal column, has by interconnected at least two bone anchoring elements of foregoing rod-shaped elements.
This invention is particularly related to a kind of manufacture method of flexible member, comprises following step:
(a) prepare a tubular body or
(b) prepare a columniform object;
(c) form the spiral type depression by the method for removing material along the co-axial spiral type of main shaft of bearing of trend and cylinder or tubular body in the metal cutting mode from the outside;
(d) form a thorax hole along cylindrical main shaft;
(e) form female thread in two end section in tubular body or thorax hole;
Wherein the interior diameter in thorax hole is chosen to make the spiral type depression on the cylinder lateral wall that utilizes metal cutting formation in the step (c) to terminate in the thorax hole diametrically in the step (d), particularly forms female thread in the another one end section in thorax hole.
This invention is particularly related to a kind of manufacture method of flexible member, comprises following step:
(a) prepare a cylinder;
(b) method each end formation at the cylinder two ends with the metal rotary cutting has externally threaded cylindrical outthrust;
(c) form the spiral type depression by the method for removing material along bearing of trend and the co-axial spiral type of cylinder main shaft in the metal cutting mode from the outside;
(d) form a thorax hole along the cylinder major axes orientation, particularly further comprising the steps of:
(f) afterbody that caves in by grinding polish spiral type after forming the thorax hole is to remove the sharp edges on inboard, thorax hole; With
(g) the flexible member deburr for making like this.
This invention is particularly related to a kind of manufacture method of flexible member, comprises following step:
(a) prepare a tubular body that has first and second ends;
(b) prepare cylinder and a formation and the co-axial thorax of cylindrical main shaft hole that has first and second ends, described thorax hole at least should be adjacent with cylinder first end;
(c) adopt line cutting discharge processing, laser treatment or water cutter processing cutting to go out depression along bearing of trend and the co-axial spiral of cylinder main shaft;
(d) or cylindrical first end adopt the metal rotary cutting form a diameter less than step (a) in tubular body or (b) in the cylindrical outthrust of cylindrical predetermined outer diameter, and form external screw thread on this cylindrical outthrust surface, perhaps form female thread in the thorax hole of contiguous cylinder or tubular body first end section, wherein particularly the middle thorax hole that forms of step (b) extends to second end from cylindrical first end.
According to another preferred embodiment, this method also is included in the step that forms female thread in the thorax hole of contiguous cylinder second end section.
According to another preferred embodiment, said method also comprises following step: at second end of cylinder or tubular body, form the second cylindrical outthrust of diameter by the metal rotary cutting, and form external screw thread on this second cylindrical outthrust surface less than cylinder or the predetermined overall diameter of tubular body.
This invention is particularly related to a kind of manufacture method of flexible member, comprises following step:
(a) prepare a cylinder or a tubular body that has first end and second end;
(b) first end on cylinder and second end form the cylindrical outthrust of a diameter less than the predetermined overall diameter of cylinder in the step (a) or tubular body by the metal rotary cutting, and form external screw thread on this cylindrical outthrust surface; And
(c) along bearing of trend and the co-axial spiral of this cylinder main shaft, go out depression by line cutting discharge processing, laser treatment or water cutter processing cutting, wherein particularly two afterbodys of spiral type depression are the form of 1/4 circle.
The specific embodiment
Figure 1 shows that the three-dimensional representation of first kind of embodiment of an implant of the present invention, this implant is used for vertebra or intervertebral disc as an interval eyelid retractor.At interval eyelid retractor 10 has a cylinder 1 and two links 2 that are positioned at this cylinder 1 end, and this link is used for an eyelid retractor 10 at interval is connected to its adjacent body area, for example such as bone in the human body or cartilage.
The link 2 that is arranged in cylinder 1 each end in illustrated illustrative example has same shape, but also can be different shapes.Link 2 has serration 3 on each free end of end, this projection can be at implantation position and adjacent body tissue tabling.
The serration 3 at eyelid retractor 10 two ends forms by triangular shaped recess 5 at interval, thereby makes chimeric being fixed in the adjacent body tissue of trapezoid serration 3 energy.
In addition, link 2 has rhombus hollow out 4 (see figure 2)s, and is arranged to make them adjacent one another are at the whole cylinder outer surface of link 2.As a result, each link self forms by many rhombus interconnection moulding 6 again, and the rhombus end that forms of moulding 6 cuts away and formed trapezoid serration 3.
In illustrated embodiment, the tubular body 1 between the link 2 of each end of cylinder has spiral type material recess 7, so wall 11 (see figure 3)s itself form spiral type.Because eyelid retractor 10 forms hollow circular cylinder on the whole at interval, even if so eyelid retractor 10 self is to be made of original firm material such as titanium or titanium alloy at interval, the tubular body 1 that has material recess 7 between the link 2 becomes a Hookean region or zone of action.At interval eyelid retractor 10 has just obtained a kind of relevant elasticity that designs by material recess 7 in tubular body 1 zone, so just may need not to use independent elastomeric material in this zone and obtains independent elasticity or activeness.Particularly, this can be avoided having to making eyelid retractor at interval with the parts that a plurality of needs are combined.
By spiral type material recess 7, obtained easily tubular body 1 interval eyelid retractor 10 longitudinally ductility and the compressibility on the axis 9 and wind such as (Fig. 2) shown in the axis 8, perpendicular to the flexible on the rotating shaft of major axis 9.Here, particularly material recess 7 spiral-shaped brought into play effect, and it is convenient to obtain the steadily elasticity or the activeness of even weighing apparatus on the many directions of most probable.Yet nature can be expected and the material recess that also can adopt other shapes according to solution that case adopted or possible loading condition and this class material recess of varying number and arrangement.
The subgraph of Fig. 4 is a) to c) be that three the different figure of second kind of embodiment that have an interval eyelid retractor 100 of tubular body 101 are three-dimensional, exploded view (a), (c) and three-dimensional cross-sectional figure (b), this tubular body 101 is used at downside and is linked to be whole end plate 125 with tubular body 101 and seals, thereby forms a beaker shape.
Tubular body 101 has on its wall 111 and brings this tubular body 101 certain elastic helical forms depressions 107 according to the present invention.
In order accurately to adjust the at interval rigidity of eyelid retractor 100, a kind of interchangeable core components of being made by elastomeric material 130 is provided in the inside of tubular body 101, this core components by end plate 125 from the bottom, end plate 126 is fixed on the tubular body 101 from top.
The end plate 126 of eyelid retractor upside has external screw thread 127 at interval, and it can be screwed into the female thread 128 of tubular body 101 inner top side place tubular bodies 101 by this external screw thread, and end plate 126 also has a shoulder that it is tightly covered on wall 111.Thereby serration 103 be arranged on the whole circumference of wall 111 ends and extend through end plate 125 and end plate 126 can with the adjacent tissue tabling eyelid retractor can fixedly positioning at that so that make at interval.
Connecting hole 129 is arranged, so that can be screwed into end plate 126 in the tubular body 101 on the end plate 126.
Fig. 5 at subgraph a) to c) shown in be the third embodiment of interval eyelid retractor; Wherein subgraph a) and c) be three-dimensional, exploded view, and subgraph b) be depicted as three-dimensional cutaway view.In the embodiment of Fig. 5, tubular body 201 also has spiral type depression 207 on wall 211.
Tubular body 201 is also sealed by an end plate 225 that forms one at the downside place, has formed the tubular body 201 of beaker dress so again.What really, the external diameter of end plate 225 was done than the tubular body 201 that wherein is provided with helical form material recess 207 is big.Therefore formed a shoulder, made the tubular sleeve of making by elastomeric material 230 that an end seat arranged.Resilient sleeve 230 is enclosed within on the tubular body 201 also fully around it.In the upper end, end plate 226 is screwed on the tubular body 201 by being threaded.Here, the external screw thread 227 of end plate 226 and 228 engagements of the female thread of tubular body 201, thus sleeve 230 tightly is fixed between end plate 225 and the end plate 226.Sleeve 230 also is used to adjust whole rigidity, wherein changes sleeve 230 simply by being similar to the mode of changing core 130 (see figure 4)s, changes implant 100 and 200 whole rigidity simply.
End plate 225 and end plate 226 are provided with PYR serration 203 and are used for and surrounding tissue tabling and firm grappling interval eyelid retractor.
Lid 226 equally also has connecting hole 229, is used for end plate 226 is screwed on the tubular body 201.
Figure 6 shows that how laser beam 331 can form the example of material recess 307 and 337 simply by laser treatment on pipe fitting 301.
From the subgraph of Fig. 6 a) as seen, and from plane graph, see obviously especially, at first drill pipe fitting 301 to form 332 and 333 two openings with laser beam 331; Then, as Fig. 6 b) shown in, in rotary tube piece 301, advance along the direction of arrow, just can form from the depression 307 of opening 332 beginnings and the depression 337 that begins from opening 333.The result has formed the parallel material recess of twice, is arranged to that mutual embedding contains, parallel, double pitch spiral spring or helical spring zone in pairs thereby formed.
Figure 7 shows that the another embodiment of flexible implant among the present invention.Two the pedicle screw devices 12 and 14 that interconnect, have corresponding pedicle screw 13,15 by connecting rod 20 have been shown with graphics among Fig. 7.Connecting rod 20, elasticity or 18 positions, zone of action between fixed area 16,17 on the throne of saying so more accurately are designed to flexible implant, and wherein connecting rod supports by the pedicle screw device.
Be provided with spiral type material recess 19 in the Hookean region 18 of connecting rod 20, this depression is extended around the longitudinal axis 21 of connecting rod 20.
Because connecting rod 20 is designed to hollow circular cylinder, Hookean region 18 is in fact also with regard to spirality.
In order to produce connecting rod of the present invention as shown in Figure 7, can use the solid cylindrical that constitutes by biocompatible materials such as titanium alloy or shaft-like.Primary step is to form material recess 19 by machining or chemical etching or by laser treatment in this solid hopkinson bar in the specific region is Hookean region 18.This connecting rod will have bigger elasticity also can use like this at Hookean region 18.
On the longitudinal axis 21 of connecting rod 20, form the thorax hole and make connecting rod 20 form hollow circular cylinder shape or tubulose by machinery or chemical method, can further improve the elasticity or the activeness in zone 18.
The thickness that makes connecting rod wall that bar stays is less than the degree of depth of original material recess 19 that forms if the diameter in thorax hole is hanked, and just is not groove depression but perforate in Hookean region 18 so, and this is in fact also with regard to spirality.Though last-mentioned this shape is a preferred embodiment, the groove depression that the previously mentioned shape that only has material recess is a ducted body or other structure also be can be used as alternative.
Figure 8 shows that the application of these two embodiment examples, promptly at arrangement interval eyelid retractor 10 between two vertebras 22,23 and between the pedicle screw device on the human spine 12,14, flexible connecting rod 20 is being set.Can see easily that from this figure particularly under the situation of use in conjunction, the elastic construction of implant makes the spinal column respective regions have certain activeness, this will obviously increase patient's comfort.
Figure 19 to 38 has shown flexible implant, particularly the more embodiment and the range of application of the connecting rod in the spinal column securing device.
As can be seen from Fig. 9, this securing device in using shown in comprises a rod-like members 401 and passes through interconnective two pedicle screws 402,403 of this rod-like members.Pedicle screw 402,403 is anchored in the pedicle of vertebral arch of impaired two adjacent vertebraes 404,405 of intervertebral disc therebetween 406.
Rod-like members 401 among the present invention forms as one.According to first embodiment shown in Figure 10,11a and 11b, it comprises from rod-like members first end, has the first rigidity section 407 of predetermined length, from second end of rod-like members, have the second rigidity section 408 of predetermined length, and the elastic segments 409 that has predetermined length between rigidity section 407,408, and the overall diameter of all sections is identical.In addition, rod-like members is run through in the coaxial thorax hole 410 with predetermined diameter.Elastic segments 409 forms a helical spring that has the screw thread 411 of pre-constant pitch.The screw thread 411 of elastic segments 409 is chosen to make 411 pairs of rod-like members to have required rigidity being subjected to axial force, bending force, torsional forces along coaxial thorax hole 410 diameters of the height of rod-like members longitudinal axis A direction, decision screw thread 411 radial thickness and pitch.
As seen, the pedicle screw 402,403 of securing device has a screw rod 412 that has a bone thread and one to have to be used for inserting the U-shaped depression 415 of rod-like members, cylindrical end seat 413 basically as known from Fig. 9,12a and 12b.The built-in screw 414 that energy screw terminal seat is set as known is to be fixed on rigidity section 407,408 on the end seat 413.Pedicle screw is preferably made multi-axial screws.The axial length of rod-like members 401 rigidity sections 407,408 and diameter are sized to the rod-like members 401 that has rigidity section 407,408 can be connected on the pedicle screw 402,403.So the length of rigidity section 407,408 is at least roughly suitable with the diameter of the built-in screw 414 that is used for fixing rod-like members.For the end seat 413 of pedicle screw 420 ', because rod-like members is not from the top insertion but laterally pushes at opening 421, the length of rigidity section also will be with at least roughly suitable at the diameter of the built-in screw 414 of holding seat 413 place's fixing shaft parts.
In the example of securing device shown in Figure 9, it is roughly suitable with the spacing of pedicle screw 402,403 under intervertebral disc 406 no-load conditions that the length of the elastic segments 409 of rod-like members 401 is chosen to, but but elastic segments 409 is also longer or shorter.
Rod-like members 401 is made by biocompatible materials, and such as titanium or biocompatible plastic, yet this class material does not have or only have a little elasticity.
In operation process, at first pedicle screw 402,403,420 is screwed in the vertebra adjacent with pedicle of vertebral arch, then rod-like members 401 and rigidity section 407,408 thereof insert respectively the end seat (receiving-member) 413,413 of pedicle screw 402,403,420 ' one of in.At the relative position of determining vertebra 404,405 and after adjusting the relative position of pedicle screw 402,403,420 and rod-like members, with rigidity section 407,408 be fixed on end 413,413 ' in.The elastic segments 409 that the relative position of vertebra 404,405 is specified to rod-like members 401 is in relaxed state under intervertebral disc 406 no-load conditions.When load, stressed via acting on the intervertebral disc 406 behind vertebra and the intervertebral disc device.Rod-like members 401 has limited vertebra multiaxial motion each other by elastic segments 409, has avoided the excessive stressed of intervertebral disc thus.So just can prevent being worse off of slight or moderate defects intervertebral disc.Select as another kind, can under the spinal column no-load condition, carry out default vertebra traction as required, to alleviate the intervertebral disc load by this method by securing device.As another selection, also can directly anchor into bone screw the vertebra from side direction as required.
In the embodiment shown in fig. 13, as the previous embodiment, a rod-like members 500 comprises 507,508 and elastic segments 590 that fuse with them, the helical spring form of rigidity section, and wherein elastic segments 590 is between rigidity section 507,508.What it was different with first embodiment is that the diameter of the diameter specific rigidity section 507,508 of elastic segments 590 is big.So, also the rigidity than rod-like members among first embodiment is big for the rigidity of acquisition.Described in operation process such as first embodiment.
Figure 14 and 15 is depicted as the rod-like members 501 among another embodiment.Different with rod-like members 401,500 among the embodiment of front is, the elastic segments 591 that is arranged between the rigidity section 507,508 has two zones 592, and 180 degree and recessed to rod axis are departed from these two 592 zones mutually.The length L of zone 592 on the rod axis direction is the length of elastic segments 592 to the maximum, and radius of curvature is arranged to make helical spring screw thread to be unlikely to be interrupted.Thereby this structure of result make elastic segments 591 with the perpendicular direction of principal axis B of rod axis A on to form narrower waist rigidity on this direction less.It is favourable directed rigidity that the result just obtains to use for some.
The embodiment situation is described as described above for operation process, and unique rod-like members 501 that is not both can be connected in the pedicle screw in directed in a circumferential direction mode.Can select, set required rigidity exactly by the size of selecting elastic segments.
Among the another embodiment shown in Figure 16,17, rod-like members 502 has a concentric cylinder core 511 that runs through its elastic segments 593, and described core has certain elasticity of flexure.The diameter of core 511 is arranged to make core can block rightly after pushing thorax hole 510 and is fixed.Core preferably adopts and the rod-like members identical materials, but also can adopt elastoplast.
In a kind of design variable, core 511 is integral with helical spring being threaded to rigidity section 507,508 and elastic segments 593.
Compare with the embodiment of front, core 511 makes rod-like members 502 have bigger bending stiffness.So, in this embodiment, can obtain and have rod-like members 500 similar rigidity of bigger elastic segments diameter.Can further adjust bending stiffness by the diameter of core and/or the selection of material.
Operation process carries out as under the embodiment situation of front.But different with front embodiment is, elastic segments 593 compression or extension and moment of torsion in the axial direction all diminishes dimensionally.Particularly only allow curvature movement, this uses for some is favourable.
In another kind of embodiment shown in Figure 180, rod-like members 503 equally has 507,508 and elastic segments 590 of rigidity section with front embodiment.But in coaxial thorax hole 510, be provided with one and be fixed on tensile part 512 tinsel for example on the rigidity section 507,508 with tension by fixed part such as pinching screw 513.In operation, this can add prestressing force on elastic segments 590.
The technical characterictic of described each embodiment can mutually combine.Such as, rod-like members 501 also can have core and/or be used for obtaining directed inflexible given shape section.In the design variable of embodiment 502, elastic segments forms evenly narrower waist or uniform several sunk areas at interval is set on circumference a position, to obtain certain rigid on the direction that limits.
In another embodiment, rod-like members have with if in individual elastic segments corresponding if in individual rigidity section, and each elastic segments is all between the rigidity section, makes many pedicle screws can both the partially rigid part flexibly interconnection.
In embodiment also, cover layer or the protectiveness overcoat of being made by biocompatible materials is set around the elastic segments, with prevent to organize, blood vessel or other organism materials sandwich in the screw thread and cause damage injured or the rod-like members function.
And among another embodiment, adopt uni-axial screws to replace multi-axial screws, perhaps in securing device, use a uni-axial screws and the combination of a multi-axial screws or the combination of a plurality of these screws.Can expect equally replacing bone screw with hook.In another embodiment, rigidity section and/or elastic segments are crooked.
Figure 19 to 24 is depicted as several advantageous applications modes of the securing device that has rod-like members.In the securing device of Figure 19 to 22, use the rod-like members 502 that has core 511.This securing device is used for supporting and need avoid the illeffects masterpiece to be used on the intervertebral disc by the activity of restriction vertebra the time such as intervertebral disc 506 needs of slight or moderate defects.Rod-like members 502 is inflexible in the axial direction, neither allows to elongate or also do not allow compression in the axial direction.But being the α angle with the bar axle is fine such as the curvature movement that are 8 degree to the maximum.
Shown in Figure 23 is that the securing device that has rod-like members uses rigid element 450 such as the application in the situation of two vertebras 404,405 of titanium cylinder connection after taking primary intervertebral disc away.Here, bar needs bigger rigidity so that can obtain enough motion restrictions.But be connected with perfect rigidity and compare, interpyramidal slight relative motion is good; Because increasing the circulation partial load can stimulate bone tissue growth and quicken ossific process.
The application of the elastic ends that to be dynamic securing device connect as expansion that shows among Figure 24, wherein several in illustrative example be 3 vertebras 405,405 ', 405 " interconnect and connect with rigid rod 460 subsequently by rigid element 450.Here, having born disproportionate load with the adjacent primary intervertebral disc 406 of the last vertebra 405 of connection chain and next piece vertebra 404 causes intervertebral disc 406 wearing and tearing to increase.For the load of protecting this adjacent part to avoid improper motion and increase thus, securing device is used for constrained motion.In the embodiment that this exemplifies, rod-like members 460 have be dimensioned to make three pedicle screws 402,402 ', 402 " the rigidity sections 458 that can be attached thereto.Elastic segments 459 is arranged to be adjacent and is connect, and it is adjacent to be used to link the rigidity section 457 of pedicle screw 403 end and one again.
In the manufacture method of rod-like members of the present invention, be ready to constitute, have such as titanium the rigid rod of required diameter with the body compatibility material.Be processed into the elastic segments 409 of helical spring form then in the section between each end of rod-like members.If desired, bore the core 410 that goes to run through in the spring members, thereby form rod-like members 401.
When making rod-like members 502, core 511 stays or inserts subsequently another independent core.
When making rod-like members 500, prepare bar that what a diameter meets elastic segments 590 diameter requirements, adopt the method for for example miller to make helical spring then, again rigid end section 507,508 cars are become required diameter as raw material.
Be to make rod-like members 501, on elastic segments, along the circumferential direction depart from mutually in the zone of positions of 180 degree and remove material so that form directed waist thus.
Elastomeric element 601 shown in Figure 25 a and the 25b has comprised a cylindrical tube, this cylindrical tube have a successive coaxial thorax hole 602 and with spiral form with pre-constant pitch along cylinder axis direction definite length extended, depression 603 of radially terminating in hole 602 on wall.Just formed a helical spring thus.The pitch of the length that spiral type caves on the cylinder axis direction, the height of depression, spiral and the diameter in coaxial thorax hole are chosen to make helical spring and have required intensity with respect to the axial force, bending force and the twisting resistance that act on this spring members.Elastomeric element 601 near its each free end, all have the female thread 604 and 604 of predetermined length '.Select the external diameter of elastomeric element according to application corresponding.
In first example application shown in Figure 26, spring members 601 is one ingredients of elasticity rod-like members 630.Elasticity rod-like members 630 comprise an elastomeric element 601 and two cylindrical bar sections 631,631 ', each bar section 631 and 631 ' end respectively have a cylindrical outthrust 632,632 ', have respectively on these two outthrust can with the external screw thread 633,633 of female thread 604,604 on the elastomeric element 601 ' cooperate '.In this embodiment, rod-like members and elastomeric element have essentially identical diameter.Rod-like members 631,631 ' and spring members 601 can independently select separately length according to required application.For example, rod-like members is used to connect epispinal pedicle screw.Because the elasticity of spring members 601, the rod-like members of making according to this 630 absorbs compression stress, tension force, bending force and twisting resistance to predetermined degree.
Elasticity rod-like members 680 shown in Figure 26 b is with the difference of elasticity rod-like members 630, the overall diameter of its first rigid rod section 681 than the big of elastomeric element 601 and second rigid rod section 681 ' overall diameter little than elastomeric element 601.Select as another kind, the diameter of two bar sections can be all greater than or all less than spring members.
Shown in Figure 27 is second application example of elastomeric element 601.As can be seen, elastomeric element 601 is one ingredients being arranged to the bone anchor part 610 of multiaxis bone screw form from the figure.This multiaxis bone screw comprise one by elastomeric element 601, have the screw rod 612 at unshowned tip and the screw component 611 that nut 613 is formed here.
Bone thread 624 and cylindrical outthrust 625 are arranged on the screw rod 612, and wherein bone thread 624 is used to screw in bone, has external screw thread to cooperate with female thread 604 on the elastomeric element 601 on the cylindrical outthrust 625.
The cylindrical outthrust 626 that nut 613 comprises cylindrical outthrust 627 and is adjacent, to similar in the screw rod 612, cylindrical outthrust 626 have with elastomeric element 601 on the external screw thread of female thread 604 ' be used.
Screw component 611 is nested in the acceptor site 614 and can rotates under no-load condition.Acceptor site 614 profiles roughly are columniform, and at its end first a thorax hole 615 that is provided with axisymmetric direction are arranged, the diameter in this thorax hole little than the big of screw rod 612 but than nut 613.In addition, acceptor site 614 also has coaxial second a thorax hole 616 that is located at the end opposite with the first thorax hole 615, the diameter in this thorax hole be designed so that screw component can by opening and together with its screw rod by the first thorax hole 615 up to nut 613, with the edge in the first thorax hole 615 near.Acceptor site 614 have T shape depression 614 ', this depression by its free end along the extension of the first thorax hole, 615 directions and form two free lower limbs 617,618.At their free end near zone, have on the lower limb 617,618 female thread can with the external screw thread of built-in screw 619 together in order to fixed bar 620.
In addition, in acceptor site 614, also have a press member 621 to be used for fixing nut 613, this press member 621 is designed in the side towards nut 613 bulb-shaped recess 622 is arranged, and the radius of this bulb-shaped recess 622 is substantially equal to the radius of the billiard table shape section of nut 613.The overall diameter of press member 621 is chosen to make press member 621 to insert in the acceptor site 614 in nut 613 directions.In addition, also have a coaxial thorax hole 623 on the press member 621, engage with depression (not drawing on the figure) on the nut 613 so that the screw-in instrument can be stretched into.
In operation process, screw rod 612 screws in the female thread 604 of elastomeric elements 601 by the cylindrical outthrust on it 625, and nut 613 by its cylindrical outthrust 626 screw in female threads 604 ', so just formed screw component 611.Screw rod 612 forward, with the screw component made according to this 611 by second perforate insert acceptor site 614 up to the edge in the nut 613 and the first thorax hole 615 near.Then, press member 621 enters acceptor site 614 by the second thorax hole 616 forward with bulb-shaped recess.Then screw component 611 is screwed in bone or vertebra.At last, bar 620 is placed acceptor site 614 between two lower limbs 617,618, adjust acceptor site and fix with respect to the angle position of screw component and with built-in screw 619.Elastic segments allows near the limited activity relaxed position.
Multi-axial screws is not limited to embodiment described above, and can be the multi-axial screws of any other described syllogic screw component above band.Correspondingly, if earlier nut 613 was entered acceptor site 614 by the second thorax hole 616 forward with cylindrical outthrust 626 in the operation before elastomeric element 601 and screw rod 612 screws in nuts 613, what the diameter in the first thorax hole 615 among the embodiment then shown in Figure 27 can be than screw rod 612 is little.In such cases, as long as the first thorax hole, 615 diameters greatly just much of that than cylindrical outthrust 626 and cylindrical sector 627.Select as another kind, nut 613 can not have cylindrical sector 627 yet.In the case, the diameter in the first thorax hole only need be enough to allow outthrust 626 by getting final product.
But acceptor site also can be designed to from following insertion screw component and by a press member screw component is clipped in the middle of the acceptor site.In this case, the diameter in thorax hole 615 shown in Figure 27 should be bigger than the diameter of nut 613.
Bar fixedly be not limited to built-in screw shown in Figure 27, and can use the bar fixing means of additional external nut or other any known types.
If elastomeric element 601 can partly protrude in bone surface at least, elastomeric element 601 just can absorb bending force and tension force and pressure so.When spring members did not protrude in bone surperficial, screw component 611 still can be reacted in a certain way to the motion of bone or vertebra.This has stoped the development of disadvantageous tense situation.
Shown in Figure 28 is the securing device 690 of spinal column, comprising two bone anchor parts 691,691 that have a screw component 693 ' with the elasticity rod-like members 692 that is used to be connected two bone anchor parts, these elasticity rod-like members 692 have elastomeric element 601 of the present invention.This multi-piece type design of elasticity rod-like members and screw component allows a securing device 690 that obtains to have various characteristics with the combination of some basic elements of character.This securing device also not necessarily must comprise the bone anchor part of being with elastomeric element and have the bar type parts of elastomeric element.According to the field of using, also can only comprise bar type parts that have spring members and the bone anchor part that has the rigidity screw component.
Shown in Figure 29 is elastomeric element 640, the difference of elastomeric element 640 and elastomeric element 601 only be female thread 641 that length has run through the elastomeric element total length replaced two female threads 604,604 '.
Shown in Figure 30 is elastomeric element 650.These parts comprise rigid tip part 651 and 651 that different with aforesaid embodiment is ' and compare the less spiral number of turns with the embodiment of front.This can make the elastic design of spring members be independent of the length of spring members.
Figure 31 a and 31b are depicted as spring members 660, and be different with aforesaid embodiment, and it comprises two zones 661, and 180 degree and all recessed to central shaft are departed from these two zones mutually.Zone 661 length L ' be not more than the length L of spiral at central axis direction, and the radius of curvature in zone 661 is arranged to be unlikely to make helical spring bung flange to interrupt.Because this design, this spring members with the perpendicular direction of central shaft on a narrower lumbar shape is arranged, therefore rigidity is less on this direction.This makes the rigidity of elastomeric element that directivity be arranged, to be fit to the needs of some application.
Elastomeric element 672 shown in Figure 32 includes the shaft-like core 671 in the patchhole.On the one hand, this core can play the effect of retainer when elastomeric element 672 is under pressure.On the other hand, core 671 can strengthen the rigidity of elastomeric element 672 for bending force.
Spring members 760 shown in Figure 33 comprises one at the one end and has externally threaded cylindrical outthrust 761 rather than the thorax hole that has female thread as in the previous examples.Accordingly, the parts that link to each other with this end of this spring members have the thorax hole with corresponding female thread.The other end at this spring members is a bag shape thorax hole 762 as among the above-mentioned embodiment, and it has female thread 763 near this end of this spring members.
Shown in Figure 34 is spring members 770, and its each end has one to have externally threaded cylindrical outthrust 771,772 respectively.
As a kind of modification of previous embodiment, elastomeric element does not comprise successive thorax hole.
As another example application of elastomeric element 601 of the present invention, shown in Figure 35 a in the exploded view is link 700, and this link contains rod-shaped member 631, elastomeric element 601 and plate 701.A column type outthrust 632 that has external screw thread 633 is arranged on the rod-shaped member 631, and this external screw thread is used to screw near the female thread 604 of elastomeric element 601 1 ends.Plate 701 also includes the column type outthrust 702 that has external screw thread 703, this external screw thread be used to screw in be positioned at elastomeric element 601 an other end near female thread 604 '.This plate comprise two sections 704 and 704 ', this two section is rounded and link to each other mutually by fin 705 in vertical view.The width B of fin 705 less than circular section 704,704 ' diameter D.Be used to place the thorax hole 706,706 that two of counter-sunk screw pass plate ' be arranged to circular section coaxial.Shown in Figure 35 b, first 707 of plate has the bending of a projection and second 708 bending that depression is arranged of plate, and the bending of this depression is to be used to make this face near bone.The different curvature radius of two faces 707,708 of plate 701 causes plate 701 towards the attenuation gradually of side 709 directions.This makes plate not only stable but also save the space.As shown in Figure 35 b, thorax hole 706,706 ' respectively comprises hole 706a, the taper first section 706b and the second section 706c; Second 708 of its mesopore 706a adjoining plate, contiguous this hole of the taper first section 706b, contiguous first section of the second section 706c and plate first 707.Their shape makes thorax hole 706 and 706 ' be fit to accept counter-sunk screw.Thorax hole 706 and 706 ' shape can be with above-described different, as long as they are fit to accept counter-sunk screw.
Shown in Figure 36 is an application example of the link among Figure 35 a.Wherein plate 701 is fixed in two vertebras 711 that are positioned at the cervical part of esophagus spinal column by two bone screw 710 from rear side, and the rod-shaped member 631 of linking this plate 701 by elastomeric element 601 is anchored on the vertebra 712 of breast section spinal column by three bone anchoring screw parts 715.
Shown in Figure 37 a is that spring members 601 among the present invention is used in another application example in the dynamic pelvis securing device 730.This dynamic pelvis securing device comprise by rod-shaped member 631,631 ' and interconnective bone anchor part 728,728 of 631 " and spring members 601 and 601 " ' and 728 ".
With other two bone anchor parts 728 ' with 728 " the same; that bone anchor part 728 comprises two and half ones 725 and 731; that this two and half one is connected with each other by a screw 727, screw thread 735 engagements in screw thread 734 in screw 727 and the first half ones 725 and the second half ones 731.Half one 725 above vertical view in Figure 37 a only shows.Rod-shaped member 631 is clipped between two and half ones 725,731 noted earlier, and in the depression 732 in the first half ones 725 and in the depression 733 in the second half ones 731, so just bone anchor part 728 is connected on the rod-shaped member 631 securely.In addition, two and half ones 725,731 have thorax hole 736,737 respectively, these two thorax hole arranged in co-axial alignment under the state of assembling.Near near the thorax hole 736 bulb-shaped recess 738 and the thorax hole 737 bulb-shaped recess 739 is used for hold bone screw 726.Bone screw 726 comprises the nut section 753 of a rod section 751 and a billiard table shape, has the external screw thread 752 that is used to screw in bone on its king-rod type section 751, and the radius of billiard table shape nut 753 equates substantially with the radius of bulb-shaped recess 738 and 739.
Similar with the bone anchor part, link 724 also has two and half ones 722, can only see one in the vertical view of Figure 37 a.By entering depression, rod-shaped member 631 is clipped in foregoing two and half ones 722, thereby link 724 is firmly received on the rod-shaped member 631 mutually.
Rod unit 721 comprises a ballhead section 721b and a bar section 721a.Thereby head sections 721b is clamped to link to each other with two and half ones 722 by the depression between unshowned, two and half ones 722 and makes it be fixed in a pivot location.At another end opposite with head 721b is rod-like members 721a, and it comprises that has an externally threaded column type outthrust (not shown), wherein external screw thread can screw in elastomeric element 601 ' in the female thread (not shown).
The method of the available miller of making of elastomeric element, its used raw material is the cylinder that is constituted, had predetermined overall diameter by material with biocompatibility such as titanium, uses the thin slice milling cutter to mill out depression along its main shaft and the collinear helix of cylindrical main shaft then.Subsequently, form the thorax hole along cylindrical main shaft, the cylinder total length is run through in this hole, and the spiral type depression is terminated on the thorax hole.In order to guarantee the stability of elastomeric element, the spiral afterbody of transition is very important between the distolateral section of spiral part and elastomeric element.Therefore be necessary to use slotting cutter finishing spiral afterbody, to remove the sharp keen edge of inside, thorax hole at the both ends of spiral.In order to reach this purpose, the spiral afterbody uses slotting cutter to carry out milling along the tangential direction of spiral profile.Subsequently, with the interior outside burr removing of whole assembly.At last, produce female thread respectively in two end section in thorax hole.
Except using the milling technology, elastomeric element 800 also can use line cutting discharge processing, laser treatment or water cutter to handle and be processed by cylinder.As shown in figure 38, processing also can form a thorax hole 801 of running through the cylinder total length along cylindrical main shaft A since a cylinder that predetermined overall diameter D ' is arranged in step subsequently.Select above-mentioned a kind of processing method according to the thickness of wall subsequently, cut the hollow circuit cylinder body wall of making according to this along spiral 802.The afterbody 803 of spiral 802 forms the shape of one 1/4 circle, becomes unnecessary thereby make with respect to finishing afterbody 803 by extra operation in the milling operation.And, also need not deburr in these operations.The shape of afterbody also needn't be 1/4 circle, can be the shape of any other shape such as another section of circle, as long as make material maximum load in use can remain on low level by these shapes.
At last, as the processing technology that adopts miller, two end section form female thread separately in the thorax hole.
In a kind of improved form, said method can be changed into to get on the bus at lathe when operation begins and has externally threaded cylindrical outthrust and replace at least one female thread.In this situation, the diameter in thorax hole must be less than the diameter of cylindrical outthrust.
In the improvement manufacturing process of another, spring members is made into does not have successive thorax hole.