CN101647734B - Flexible implant - Google Patents

Abstract

Implant for temporary or permanent introduction into a human or animal body of at least one biocompatible material with a shape that is oriented to fulfill one or more first functions, characterized by the fact that the shape has one or more areas (1, 18) in which, as second function, elasticity or mobility is provided, with the implant having material recesses (7, 19) in the area or areas which serve to locally reduce rigidity and are provided in addition to the shape caused by the first functions.

Description

Flexible implant

The application is the divisional application of Chinese patent application CN200480030525.4 (international application no: PCT/EP2004/011782).

technical field

The present invention relates to the method for the manufacture implant that implant that claim 1 or claim 3 preamble are corresponding and claim 19 preamble are corresponding.

background technology

In modern medicine, use implant can make up or at utmost reduce the impact of human body or animal body defect.For example, the interval eyelid retractor of vertebra or intervertebral disc can be used for substituting vertebral body or intervertebral disc.And for example, spinal column is strengthened or stabilisation systems can be by pedicle screw being fixed on to vertebra and interconnecting by connecting rod, so that mutual distance, the arrangement of vertebra can be adjusted and fix.

Concerning all implants, implant material can compatiblely with human or animal's body be very important, that is to say, does not cause rejection or can be because its decomposing phenomenon causes body burden.Therefore, the selection of the material of implant is in fact restricted.

In addition, preferably as far as possible simply particularly to make implant in the mode of fewer parts, because the combination of parts need to increase the surgery cost that packs implant into, on the other hand, thereby more easily make mistakes and more may break down in the interconnective place of various parts.Therefore, integrated implant is made in special recommendation.

But in contrast, implant must realize several functions, this wishes again to use different materials and/or forms implant by different parts.Such as, for sept, wish that they all not only realize packing space and keep the function of the certain distance between vertebrae adjacent, and they also help mutual motion certain between each vertebra, in certain narrow range, play a part similar joint.For this reason, can adopt such as according to the interval eyelid retractor described in DE 10056977 C2, wherein between the support member adjacent with vertebral body, be furnished with by woven fabric or fabric material closely, made, implant longitudinally on the pipe fitting of stretchable bellow-shaped.But this has brought foregoing shortcoming: need to use several different materials that must interconnect, and this has just increased the probability of makeing mistakes.And, although there be i.e. tensility, compressibility and the flexible specifically of certain elasticity, be the implant of its advantage, due to recited above, about the problem of interconnection technique or material selection, be not up to the present still put into limit of consideration.

From EP0669109 B1, can know a kind of like this securing device of stabilize adjacent vertebrae: it comprises 2 single shaft pedicle screws and a bands, this ribbon is fixed on respectively the reception position of pedicle screw by a trip bolt, described in this, device also comprises several support components, for being enclosed within the withstand voltage body on ribbon.But except a lot of shortcoming of various parts, this securing device also has a problem, when putting support component, it just no longer includes elasticity.Use single shaft pedicle screw further to limit the application of this securing device.From EP 1188416A1, can know another kind of similarly securing device, wherein use multiaxis pedicle screw rather than single shaft pedicle screw.

From US2003/0109880A1, can know the dynamic vertebra securing device of such one: this device comprises the first screw and the second screw that are anchored on vertebra, each screw is useful on the reception position and the such spring that insert a spring that screw is coupled together.Spring self is done as a wholely with extension spring form, to be formed as closely adjacent helical spring shape be fixed on and received position by trip bolt of coil.But also there is risk in this device, due to the elastic buckling of spring to trip bolt pressure, thereby fixing the relaxing between bone screw and spring.

Therefore the object of this invention is to provide such implant, it is comprised of simple as far as possible parts, particularly one or several of easily connecting, consists of; And wherein except other functions, guarantee that implant or its some regions have certain elasticity and activeness.In addition, this device should be easy to manufacture, implant, and uses safety, durable in use and be widely used.

Above-mentioned purpose is by having the interval eyelid retractor of following feature and the manufacture method of this interval eyelid retractor realizes.

The invention provides a kind of for vertebra and/or intervertebral disc, having interval supports and weight forwarding function, interval eyelid retractor (10) temporarily or in Permanent implantation human or animal body, by at least one biocompatible materials, formed, described interval eyelid retractor has tubular body (1) and is used in the end of this tubular body the device (2) being connected with adjacent body part, on described tubular body, be useful on the material recess (7) that reduces local stiffness, wherein, for the device (2) that described tubular body portion is connected with adjacent body part, be formed as the extension of described tubular body portion, and be integrally formed with described tubular body portion, wherein at the superficies of described device, there are depression and opening growing into for tissue, and wherein for the described device that described tubular body portion is connected with adjacent body part, be included in the outthrust that has serration form in the axial direction of described tubular body portion, described serration is formed by triangular shaped recess or trapezoidal serration, with with body part tabling as adjacent in bone etc.

The present invention also provides a kind of and produces for vertebra and/or intervertebral disc, having interval supports and weight forwarding function, the method of the interval eyelid retractor (10) temporarily or in Permanent implantation human or animal body, described interval eyelid retractor consists of at least one biocompatible materials, there is tubular body (1) and be used in the end of this tubular body the device (2) being connected with adjacent body part, on described tubular body, be useful on the material recess (7) that reduces local stiffness, wherein, for the device (2) that described tubular body portion is connected with adjacent body part, be formed as the extension of described tubular body portion, and be integrally formed with described tubular body portion, wherein at the superficies of described device, there are depression and opening growing into for tissue, and wherein for the described device that described tubular body portion is connected with adjacent body part, be included in the outthrust that has serration form in the axial direction of described tubular body portion, described serration is formed by triangular shaped recess or trapezoidal serration, with with body part tabling as adjacent in bone etc., described method comprises: the object having around the wall of axle is provided, and along around the described wall of axle, by machinery, chemical method or process the material recess of at least one groove shape or slit-shaped by laser treatment.

The present invention builds on following understanding: about the implant for human body and animal body, shape be substantially according to its to implant body realize one or multiple function select.These functions may also comprise that implant has activeness or elasticity to a certain degree.And in some other situation, the activeness in implant or elasticity are substantially dispensable, 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 material.This invention has adopted another approach, wherein activeness or elasticity are not to realize by other material or additional separate part, but in the implant forming as one or implant component, by the design of material recess being stipulated to realize the region with elasticity or activeness.

In second group of situation, activeness or elasticity are not indispensable functions, according to the present invention, by the additional respective material depression arranging in respective regions in shape in required function regulation, realize this additional function yet.

In this way, just can avoid adopting additional elastomeric material and corresponding link or additional individual components, and in simple mode, obtain elasticity and the activeness of implant or its parts.About this respect, elasticity or activeness function can be additional settings outside implant necessary function, or as the ingredient of necessary function.Particularly, so just can, in simple and reliable mode, particularly, in shape all-in-one-piece implant or its parts, produce compression and/or drawing zone and in certain restriction, form bending joint or torsion element etc.

Correspondingly, for the implant that is preferably formed as one, can use stable, hard, particularly under application-specific condition, use rigidity, preferably resilient rigid material is as titanium, titanium alloy, plastics etc.In general, allly can not cause rejection or occur that to body, to bring the biocompatible materials of the decomposing phenomenon of burden can be candidate material.

Recessed groove depression or perforate that material recess preferably forms on the wall of implant or implant component.Shape, quantity and the arrangement of material recess can meet load request according to concrete condition adjustment.

As a kind of common shape that meets multiple requirement, material recess is particularly suitable for forming the helical form of extending around implant main body, thereby form especially the shape of helical spring type, and be particularly suitable between the adjacent spiral bar in helical spring element, forming free space by material recess.Except easy production, associated materials select face wider, it is also beneficial to the elasticity that realization is larger.

Particularly advantageously, two material recess can be formed as the spiral type of parallel or round trip flight in pairs.Like this, can form especially mutual embedding containing two helical springs arranging.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 be especially obviously suitable for using together as a system, the interval eyelid retractor of vertebra and/or intervertebral disc and the connecting rod of pedicle of vertebral arch screw spike devices, so that patient's spinal column has again appropriate activeness when keeing relative stability.

Interval is supported and weight transfer function is the premiere feature of vertebra and/or intervertebral disc space eyelid retractor, and damping effect and activeness are the additional functions as the second function.

Support and linkage function are its premiere features for connecting rod.

For implant or interval eyelid retractor or connecting rod, confirmed the tubular body that preferably makes it be formed as thering is intermediate tubular body and have Connection Element in end, and for obtaining elastic material recess, be preferably formed as the form into one or two spiral-shaped orifices of tubular body, thereby make these parts substantially form one or two mutual embedding containing the helical spring shape of arranging.The Connection Element of interval eyelid retractor preferably have connect adjacent body area as the device of vertebra, as the hamulus in end and/or at outer depression in the surface, groove and opening so that interval eyelid retractor can be grown into tissue and with its weave in.But in this, not in the hole of this Connection Element or depression and tubular body for obtaining the elasticity of interval eyelid retractor and the material recess of activeness is obscured mutually.Due to Connection Element completely with adjacent body area such as vertebra weave in, the elasticity to vertebra or activeness are not made contributions for they.

The device that tubular body is connected to adjacent body area can be arranged to, or forms one particularly by the mode of extending in tubular body end with tubular body, or end is separable for example can be screwed into the end plate on tubular body end.

Adopt this separable end plate or link into an integrated entity with tubular body end plate time, be preferably in the tubular body of material recess and sleeve that an elastomeric material makes be at least set to realize elasticity or activeness around; Or an elastomeric core is at least set in tubular body.This elastomeric core of preferably being made by artificial rubber or resilient sleeve have can accurately regulate tubular body or the elasticity of interval eyelid retractor or the benefit of rigidity.Module shape by the tubular body with respective recesses and core and/or sleeve is arranged, and uses the different assemblies of different-stiffness just can obtain the implant that accurately limits rigidity with damping meaning in simple mode.Here, with obtaining the implant component of elastic material recess, be the very basic object of the present invention with the combination of the implant component being formed by the elastomeric material of an energy adjustment restriction rigidity.For obtaining the rigidity changing, as long as change the combination of parts, such as long as reinstate with another core of different-stiffness or another sleeve and elastic tubular body one.Although can expect that sleeve can be used with core simultaneously together with elastic tubular body, for simplicity, conventionally only use the one combination of tubular body and core or tubular body and sleeve.Here, sleeve also has advantages of that protection is not subject to external action with the tubular body that preferably spiral type caves in, but in contrast, when using core, core is subject to the protection of tubular body.

Core and sleeve preferably can be by arranging that in tubular body end end plate fixes, and in the situation that using sleeve, therefore end plate preferably forms larger diameter than tubular body from tubular body is outstanding.End plate at least can partly be connected with tubular body in a side, 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 end plate, also can be located on tubular body.

Preferably, this implant or can stretch or compress 0.5% to 20% along interval eyelid retractor longitudinal axis in a longitudinal direction with the tubular body of the material recess that is used for obtaining elasticity and activeness, 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 region between pedicle of vertebral arch screw spike devices between single shaft or multiaxis pedicle of vertebral arch screw spike devices can be by arranging that corresponding material recess has certain elasticity and activeness, 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, by the plain mode that changes rod-shaped elements size, obtain these characteristics.

Such as, so a kind of implant can be made by an object by the simple mode of one, makes one or more material recess by machinery or chemical process, electric 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 wall setting.

At object, be solid during such as solid cylinder, can in additional step or below, form particularly coaxial with material recess thorax hole above, thereby preferably at Hookean region, form coil spring shape.When using tube material, with regard to unnecessary brill core.

Comparatively ideal, by the laser treatment of tubular body, make material recess, because in that case, two depressions can form in same treatment step.By laser, for example, by boring tubular body (, can be also rectangular tube), can in both sides, form thorax hole simultaneously.Rotate simultaneously and advance tubulose body to form round trip flight spiral.

On the other hand, the present invention relates to a kind of rod-shaped elements, this element is for connecting at least two bone anchoring elements (bone-anchoring element), each bone anchoring element is useful on and anchors into the anchoring section of bone and receiving portion for being connected with rod-shaped elements, and this rod-shaped elements is surrounded by least one the rigidity section and the elastic segments that are formed by a material, and elastic segments is particularly formed as helical spring, and/or wherein on the other end of elastic segments and rigidity section adjacency, there are the second rigidity section and elastic segments adjacency, and/or wherein the overall diameter of elastic segments is at least different from the overall diameter of rigidity section a position, and/or wherein this elastic segments at least certain part with perpendicular certain direction of this rod axis on little than on 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 be wherein provided with a coaxial thorax hole and run 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 as described above for connecting the rod-shaped elements of bone anchoring element, each bone anchoring element is useful on and anchors into the bone anchoring section of bone and accept 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 manufacturing rod-shaped elements, comprises following steps:

Prepare a rigid rod;

Preferably by the method for removing material forming helical spring section at least one longitudinal section in the free-ended preset distance of this bar, and its core can axially get out or reserve, and/or elastic segments longitudinally on remove a restriction material area with at least one region in elastic segments, produce non-circular cross sections, and/or rigidity segment diameters arranges littlely with respect to elastic segments.

This invention is particularly related to the flexible member for bone or vertebra securing device, it is roughly a cylinder that contains first end and second end contrary with it, described cylindrical contrary each end all contains in a coaxial aperture and these ends at least one end and contains female thread for being connected to nut and/or the screw rod of bone screw or for being connected to bar section or plate, wherein particularly every end at two ends has female thread.

This invention also relates to the flexible member for bone and vertebra securing device, it is roughly a cylinder that contains first end and second end contrary with it, and described cylinder first end contains with externally threaded cylindrical outthrust for being connected to the nut of bone screw or screw rod, for being connected to bar section or for being connected to plate.

Described cylinder the second end contain one with externally threaded cylindrical outthrust for being connected to the nut of bone screw or screw rod, for being connected to bar section or for being connected to plate.

According to another preferred embodiment, described flexible member includes adjacent with a second end coaxial thorax hole and/or at least in coaxial thorax hole, the section place adjacent with the second end includes female thread for being connected to the nut of bone screw or screw rod, for being connected to bar section or for being connected to plate.

According to another preferred embodiment, the feature of described flexible member is that total length is run through in thorax hole, and/or described cylinder is with the tubulose in the coaxial thorax of seriality hole and has the wall sunken inside extending with spiral form in cylinder axis direction, wherein said depression terminates in place, thorax hole diametrically.

According to another preferred embodiment, the feature of described flexible member is in thorax hole, to be provided with core and/or flexible member is formed as 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 with flexible member as previously described, the preferably nut of dististyle that has comprised the bone screw being connected with the screw rod of bone thread with the flexible member other end being connected with flexible member one end.

This invention is particularly related to the rod-shaped elements for connecting two bone anchoring elements, and this rod-shaped elements, with a flexible member and the first rigid rod section being connected with flexible member one end, wherein particularly has the second rigid rod section to be connected with the flexible member other end.

This invention is particularly related to a kind of plate, and it at least has one with externally threaded cylindrical outthrust or has a thorax hole with female thread shape in its one end, for connecting flexibility recited above or flexible member.

This invention is particularly related to a kind of securing device of the dynamic stability for bone, osteogenic section or spinal column, with passing through 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 tubular body or

(b) prepare a columniform object;

(c) by the method for removing material along the coaxial spiral type of bearing of trend and the main shaft of cylinder or tubular body in metal cutting mode from outside, form spiral type depression;

(d) along cylindrical main shaft, form a thorax hole;

(e) in two end section in tubular body or thorax hole, form female thread;

Wherein the interior diameter in thorax hole is chosen to make to utilize in step (c) the spiral type depression on the cylinder lateral wall that metal cutting forms to terminate in diametrically thorax hole in step (d), particularly in the another one end section in thorax hole, forms female thread.

This invention is particularly related to a kind of manufacture method of flexible member, comprises following step:

(a) prepare a cylinder;

(b) by the method for metal rotation cutting, in every one end at cylinder two ends, form with externally threaded cylindrical outthrust;

(c) by the method for removing material along the coaxial spiral type of bearing of trend and cylinder main shaft in metal cutting mode from outside, form spiral type depression;

(d) along cylinder major axes orientation, form a thorax hole, particularly further comprising the steps of:

(f) forming behind thorax hole by the afterbody of grinding polish spiral type depression, to remove the sharp edges on inner side, 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 with the first and second ends;

(b) prepare a cylinder with the first and second ends and form the thorax hole coaxial with cylindrical main shaft, described thorax hole at least should be adjacent with cylinder first end;

(c) along bearing of trend and cylinder main shaft, with axial screw, adopt the processing of line discharge cutting, laser treatment or water cutter processing cutting to go out depression;

(d) or cylindrical first end adopt metal rotation cutting form a diameter be 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, or in the thorax hole of contiguous cylinder or tubular body first end section, form female thread, wherein particularly the middle thorax hole forming of step (b) extends to the second end from cylindrical first end.

According to another preferred embodiment, the method is also included in the step that forms female thread in the thorax hole of contiguous cylinder the second end section.

According to another preferred embodiment, said method also comprises step below: at the second end of cylinder or tubular body, by metal rotation, cut and form the second cylindrical outthrust that diameter is less than cylinder or the predetermined overall diameter of tubular body, and form external screw thread on this second cylindrical outthrust surface.

This invention is particularly related to a kind of manufacture method of flexible member, comprises following step:

(a) prepare cylinder or a tubular body with first end and the second end;

(b) first end on cylinder and the second end, by metal rotation, cut and form the cylindrical outthrust that a diameter is less than the predetermined overall diameter of the middle cylinder of step (a) or tubular body, and form external screw thread on this cylindrical outthrust surface; And

(c) along bearing of trend and the same axial screw of this cylinder main shaft, by the processing of line discharge cutting, laser treatment or water cutter processing cutting, go out depression, wherein particularly two afterbodys of spiral type depression are the form of 1/4 circle.

Accompanying drawing explanation

By the detailed description to two specific embodiments below in conjunction with accompanying drawing, the further advantage of the present invention, characteristic and feature will become more obvious.The demonstration of accompanying drawing is schematic purely.

The 3-D view of the interval eyelid retractor of Fig. 1 vertebra or intervertebral disc;

The side view of the interval eyelid retractor in Fig. 2 Fig. 1;

The detailed side view of the interval eyelid retractor in Fig. 3 Fig. 1 and Fig. 2;

Fig. 4 a)-c) view of another kind of interval eyelid retractor;

Fig. 5 a)-c) view of the third interval eyelid retractor;

Fig. 6 a)-c) fabrication stage of object of the present invention;

Fig. 7 is with two pedicle of vertebral arch screw spike devices of a connecting rod and the 3-D view of interval eyelid retractor;

Fig. 8 is furnished with interval eyelid retractor therebetween and by the pedicle of vertebral arch screw spike devices with flexible connecting rod, carries out the 3-D view of side fixed adjacent vertebrae;

In Fig. 9 the present invention with the schematic three dimensional views of the securing device of rod-like members;

The graphics of rod-like members in Figure 10 Fig. 9;

The side view of rod-like members in Figure 11 a Fig. 9;

The cutaway view of rod-like members in Figure 11 b Fig. 9;

The 3-D view connecting between Figure 12 a rod-like members and bone anchor part;

The cutaway view connecting between Figure 12 b rod-like members and bone anchor part;

The side view of the rod-like members in the another kind of embodiment of Figure 13;

The side view of the rod-like members in another embodiment of Figure 14;

Side view in Figure 15 Figure 14 after rod-shaped elements 90-degree rotation;

The 3-D view of the rod-shaped elements in another embodiment of Figure 16;

The side view of rod-like members in Figure 17 Figure 16;

Figure 18 is the cutaway view of the rod-like members in a kind of embodiment also;

In Figure 19 the present invention with the use of the securing device of a rod-like members;

The side view of rod-like members in Figure 20 Figure 19;

In Figure 21 Figure 19 with the 3-D view of the another kind of using state of the securing device of a rod-like members;

The side view of rod-like members in Figure 22 Figure 21;

The another kind application of Figure 23 securing device;

Another application example of Figure 24 securing device;

The side view of another embodiment of Figure 25 a elasticity rod-like members;

The cutaway view of Figure 25 b Figure 25 a Elastic rod-like members;

The first application example of Figure 26 a elasticity rod-like members;

The modification of rod-like members in Figure 26 b Figure 26 a;

Figure 27 is with the bone anchor part of Figure 25 a and 25b Elastic rod-like members;

Mono-of Figure 28 is by two three-member type bone anchor parts and a securing device that rod-like members forms, and wherein each parts comprise an elastomeric element;

The side view of another embodiment of Figure 29 elasticity rod-like members;

The side view of another embodiment of Figure 30 elasticity rod-like members;

The also side view of a kind of embodiment of Figure 31 a elasticity rod-like members;

Side view after Figure 31 b Figure 31 a Elastic rod-like members 90-degree rotation;

The cutaway view of Figure 32 elasticity rod-like members;

Elasticity rod-like members in Figure 33 further embodiment of this invention;

Elasticity rod-like members in Figure 34 yet another embodiment of the invention;

The exploded view of the bonded block that Figure 35 a comprises elastomeric element in a rod-like members, a present invention and a plate;

Plate in Figure 35 b Figure 35 a is along the cutaway view of A-A line;

The application example of plate in Figure 36 Figure 35 a and Figure 35 b, wherein said plate and the rod-like members that is connected to this plate by elastomeric element are anchored on vertebra by bone anchor part.

Figure 37 a elasticity rod-like members of the present invention is in the application of the dynamic securing device for hipbone;

Figure 37 b is applied in the cutaway view of the bone anchor part on the securing device in Figure 37 a;

The spring members made from the processing of line discharge cutting, laser treatment or the processing of water cutter in Figure 38 the present invention.

The specific embodiment

Figure 1 shows that the three-dimensional representation of implant the first embodiment of the present invention, this implant is as an interval eyelid retractor, for vertebra or intervertebral disc.Interval eyelid retractor 10 has a cylinder 1 and two and is positioned at the link 2 of this cylinder 1 end, and this link is for being connected to its adjacent body area interval eyelid retractor 10, for example, at the bone such as in 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, and this projection can be at implantation position and adjacent body tissue tabling.

The serration 3 at interval eyelid retractor 10 two ends forms by triangular shaped recess 5, thereby makes chimeric being fixed in adjacent body tissue of trapezoidal serration 3 energy.

In addition, link 2 has rhombus hollow out 4 (seeing Fig. 2), 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 trapezoidal serration 3.

In illustrated embodiment, the tubular body 1 between the link 2 of the each end of cylinder has spiral type material recess 7, so wall 11 (seeing Fig. 3) itself is formed as spiral type.Because interval eyelid retractor 10 is formed as hollow circular cylinder on the whole, even if so interval eyelid retractor 10 self is to consist of such as titanium or titanium alloy original firm material, become a Hookean region or zone of action with the tubular body 1 of material recess 7 between link 2.Interval eyelid retractor 10 has just obtained a kind of relevant elasticity that designs in tubular body 1 region by material recess 7, so just may obtain independent elasticity or activeness without use independent elastomeric material in this region.Particularly, this can be avoided the parts of having to combine with multiple needs to manufacture interval eyelid retractor.

By spiral type material recess 7, obtained easily tubular body 1 interval eyelid retractor 10 longitudinally the ductility on axis 9 and compressibility and around such as (Fig. 2) shown in 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 elasticity or the activeness of steady even weighing apparatus in the many directions of most probable.But nature can be expected and solution or the possible loading condition that also can adopt according to case adopt the material recess of other shapes and this class material recess of varying number and arrangement.

The subgraph of Fig. 4 is a) to being c) that three different figure with the second embodiment of the 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 and is linked to be overall end plate 125 with tubular body 101 and seals at downside, thereby forms a beaker shape.

Tubular body 101 has and according to the present invention, brings this tubular body 101 certain elastic helical form depression 107 on its wall 111.

In order accurately to adjust the rigidity of interval eyelid retractor 100, a kind of interchangeable core components 130 of being made by elastomeric material is provided in the inside of tubular body 101, this core components by end plate 125 from bottom, end plate 126 is fixed on tubular body 101 from top.

The end plate 126 of interval eyelid retractor upside has external screw thread 127, and by this external screw thread, it can be screwed into the female thread 128 of tubular body 101 inner top side place tubular bodies 101, 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 adjacent tissue tabling, to interval eyelid retractor can be fixedly positioning at that.

On end plate 126, there is connecting hole 129, to end plate 126 can be screwed in tubular body 101.

Fig. 5 is a) the third embodiment of interval eyelid retractor at subgraph shown in c); Wherein subgraph is a) and c) three-dimensional, exploded view, and subgraph b) is 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 a shape all-in-one-piece end plate 225 at downside place, has formed so again the tubular body 201 of beaker dress.Really, the external diameter of end plate 225 does than tubular body 201 large that is wherein provided with helical form material recess 207.Therefore formed a shoulder, made the tubular sleeve 230 of being made by elastomeric material have an end seat.Resilient sleeve 230 be enclosed within on tubular body 201 and Perfect Ring around it.In upper end, end plate 226 is threaded connection and is screwed on tubular body 201.Here, the external screw thread 227 of end plate 226 engages with the female thread 228 of tubular body 201, thereby sleeve 230 is tightly fixed between end plate 225 and end plate 226.Sleeve 230, also for adjusting overall rigidity, is wherein changed the mode of core 130 (seeing Fig. 4) and is changed simply sleeve 230 by being similar to, change simply the rigidity of implant 100 and 200 entirety.

End plate 225 and end plate 226 are provided with PYR serration 203 and are used for and surrounding tissue tabling firm grappling interval eyelid retractor.

Lid 226 equally also has connecting hole 229, is used for end plate 226 to be screwed on tubular body 201.

Figure 6 shows that how laser beam 331 can form by laser treatment the example of material recess 307 and 337 simply on pipe fitting 301.

From the subgraph of Fig. 6 a), and from plane graph, see obviously especially, first with laser beam 331, drill pipe fitting 301 to form 332 and 333 two openings; Then, as Fig. 6 b) as shown in, in rotary tube piece 301, along the direction of arrow, advance, just can form the depression 307 starting from opening 332 and the depression 337 starting from opening 333.Result has formed the parallel material recess of twice, thus formed be arranged to mutual embedding containing, in pairs parallel, double pitch spiral spring or helical spring region.

Figure 7 shows that the another embodiment of Elastic implant of the present invention.In Fig. 7 with graphics shown by connecting rod 20 interconnect, with two pedicle of vertebral arch screw spike devices 12 and 14 of corresponding pedicle screw 13,15.Connecting rod 20, says elasticity or 18 positions, zone of action between fixed area 16,17 in place more accurately, is designed to flexible implant, and wherein connecting rod supports by pedicle of vertebral arch screw spike devices.

In the Hookean region 18 of connecting rod 20, be provided with spiral type material recess 19, 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 formed as titanium alloy by biocompatible materials or shaft-like.Primary step is by machining or chemical etching or form material recess 19 in this solid hopkinson bar by laser treatment in specific region is Hookean region 18.This connecting rod will have larger elasticity and can use like this at Hookean region 18.

By machinery or chemical method, on the longitudinal axis 21 of connecting rod 20, form thorax hole and make connecting rod 20 form hollow circular cylinder shape or tubulose, can further improve elasticity or the activeness in region 18.

If the diameter in thorax hole is hanked, make the thickness of connecting rod wall that bar stays be less than the degree of depth of the material recess 19 of original formation, be not just groove depression but perforate so in Hookean region 18, and this is in fact also with regard to spirality.Although last-mentioned this shape is preferred embodiment, previously mentioned only with the shape of material recess be the groove depression of ducted body or other structure be also can be used as alternative.

Figure 8 shows that the application of these two embodiment examples, at arrangement interval eyelid retractor 10 between two vertebras 22,23 and between the pedicle of vertebral arch screw spike devices 12,14 on human spine, flexible connecting rod 20 is set.From this figure, can easily see, particularly, the in the situation that of use in conjunction, the elastic construction of implant makes spinal column respective regions have certain activeness, and this will obviously increase patient's comfort.

Figure 19 to 38 has shown flexible implant, particularly more embodiment and the range of application of the connecting rod in spinal column securing device.

As can be seen from Fig. 9, this securing device shown in application 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 406 therebetween.

Rod-like members 401 in the present invention forms as one.According to first embodiment as shown in Figure 10,11a and 11b, it comprises from rod-like members first end, have the first rigidity section 407 of predetermined length, from the second end of rod-like members, there is the second rigidity section 408 of predetermined length, and between rigidity section 407,408, have the elastic segments 409 of predetermined length, and the overall diameter of all sections is identical.In addition rod-like members is run through in the coaxial thorax hole 410 that, has a predetermined diameter.Elastic segments 409 is formed as a helical spring with the screw thread 411 of pre-constant pitch.The screw thread 411 of elastic segments 409 is chosen to make rod-like members 411 to having required rigidity being subject to axial force, bending force, torsional forces along the height of rod-like members longitudinal axis A direction, coaxial thorax hole 410 diameters that determine screw thread 411 radial thickness and pitch.

From Fig. 9,12a and 12b, the pedicle screw 402,403 of securing device has a screw rod 412 with bone thread and one as known with being used for inserting the U-shaped depression 415 of rod-like members, cylindrical end seat 413 substantially.The built-in screw 414 of energy screw terminal seat is set as known rigidity section 407,408 is fixed on 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 and make can be connected on pedicle screw 402,403 with the rod-like members 401 of rigidity section 407,408.So the length of rigidity section 407,408 is at least roughly suitable with the diameter of 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 to insert from top but laterally push opening 421, so the length of rigidity section is also at least roughly suitable with the diameter of the built-in screw 414 at end seat 413 place's fixing shaft parts.

In the example of the securing device shown in Fig. 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, but this class material does not have or only have a little elasticity.

In operation process, 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.Determining the relative position of vertebra 404,405 and adjusting after the relative position of pedicle screw 402,403,420 and rod-like members, by rigidity section 407,408 be fixed on end 413,413 ' in.The elastic segments 409 that the Relative position determination of vertebra 404,405 becomes rod-like members 401 under intervertebral disc 406 no-load conditions in relaxed state.When having load, stressed via acting on intervertebral disc 406 after vertebra and intervertebral disc device.Rod-like members 401 has limited vertebra multiaxial motion each other by elastic segments 409, has avoided thus the excessive stressed of intervertebral disc.So just can prevent being worse off of slight or moderate defects intervertebral disc.As another kind, select, can under spinal column no-load condition, by securing device, carry out default vertebra traction as required, to alleviate by this method intervertebral disc load.As another, select, also can directly bone screw be anchored into vertebra from side direction as required.

In the embodiment shown in fig. 13, as the previous embodiment, a rod-like members 500 comprises rigidity section 507,508 and an elastic segments 590 that be connected with them, helical spring form, and wherein elastic segments 590 is between rigidity section 507,508.It is different from first embodiment, and the diameter of the diameter specific rigidity section 507,508 of elastic segments 590 is large.So, the rigidity of acquisition is also large than the rigidity of rod-like members in first embodiment.Operation process is described in first embodiment.

Figure 14 and 15 is depicted as the rod-like members 501 in another embodiment.Different from the rod-like members 401,500 in embodiment above, the elastic segments 591 being arranged between rigidity section 507,508 has two regions 592, and 180 degree recessed to rod axis are departed from mutually in these two 592 regions.The length L of region 592 in 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.This structure of result make elastic segments 591 with the perpendicular direction of principal axis B of rod axis A on form narrower waist thereby upwards rigidity be less the party.Result just obtains and applies for some is favourable directed rigidity.

Operation process is as described in previous embodiment situation, and unique rod-like members 501 that is not both can be connected in pedicle screw in directed in a circumferential direction mode.By the size of selecting elastic segments, can select exactly, set required rigidity.

In 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 behind thorax hole 510, can block rightly and fix pushing.Core preferably adopts the material identical with rod-like members, but also can adopt elastoplast.

In a kind of design variable, core 511 with to rigidity section 507,508 and elastic segments 593 helical spring, be threaded integral.

Compared with embodiment above, core 511 makes rod-like members 502 have larger bending stiffness.So, in this embodiment, can obtain and the similar rigidity of rod-like members 500 with larger elastic segments diameter.By the diameter of core and/or the selection of material, can further adjust bending stiffness.

Operation process carries out as in embodiment situation above.But from embodiment is different above, compression in the axial direction of elastic segments 593 or extension and moment of torsion all diminish dimensionally.Particularly only allow curvature movement, this applies for some is favourable.

In the another kind of embodiment shown in Figure 18, the same embodiment above of rod-like members 503 equally has rigidity section 507,508 and an elastic segments 590.In coaxial thorax hole 510, be provided with one by fixed part as pinching screw 513 with tension, be fixed on rigidity section 507,508 can for example tinsel of tensile part 512.In operation, this can add prestressing force in 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 the given shape section of directed rigidity.In a design variable of embodiment 502, elastic segments forms evenly narrower waist or the uniform several sunk areas in interval is set on circumference a position, to obtain certain rigidity in the direction limiting.

In another embodiment, if if rod-like members have with in individual elastic segments corresponding in individual rigidity section, and each elastic segments is between rigidity section, and many pedicle screws can partially rigid part be flexibly connected to each other.

In an embodiment also, the surrounding of elastic segments arranges cover layer or the protectiveness overcoat by biocompatible materials, made, causes damage injured or rod-like members function to prevent tissue, blood vessel or other organism materials from sandwiching in screw thread.

And in another embodiment, adopt uni-axial screws to replace multi-axial screws, or in securing device, use a uni-axial screws and the combination of a multi-axial screws or the combination of multiple these screws.Can expect equally replacing bone screw with hook.In another embodiment, rigidity section and/or elastic segments are bending.

Figure 19 to 24 is depicted as several advantageous applications modes with the securing device of rod-like members.In the securing device of Figure 19 to 22, use the rod-like members 502 with core 511.When this securing device needs to support for the intervertebral disc 506 such as slight or moderate defects and need to avoid illeffects masterpiece to be used on intervertebral disc by the activity of restriction vertebra.Rod-like members 502 is rigidity in the axial direction, neither allows in the axial direction to elongate or also do not allow compression.But be α angle such as the curvature movement that are 8 degree to the maximum are fine with bar axle.

Figure 23 is depicted as with the securing device of rod-like members taking away after primary intervertebral disc with rigid element 450 such as the application in the situation of two vertebras of titanium cylinder connection 404,405.Here, bar need to have larger rigidity to can obtain enough movement limits.But be connected and compare with perfect rigidity, interpyramidal slight relative motion is good; Because increasing the partial load of circulation can stimulate bone tissue growth and accelerate ossific process.

The application of the elastic ends that to be dynamic securing device connect as expansion showing in Figure 24, wherein several in illustrative example, be 3 vertebras 405,405 ', 405 " by rigid element 450, interconnect and with rigid rod 460, connect subsequently.Here, having born disproportionate load with the last vertebra 405 of connection chain and the adjacent primary intervertebral disc 406 of 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 for constrained motion.In the embodiment exemplifying at this, 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 adjacent for linking 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 body compatibility material such as titanium forms, has the rigid rod of required diameter.Then in the section between the each end of rod-like members, be processed into the elastic segments 409 of helical spring form.If needed, bore the core 410 that goes to run through in spring members, thereby form rod-like members 401.

While manufacturing rod-like members 502, core 511 leaves or inserts subsequently another independent core.

Manufacture during rod-like members 500, prepare bar that what a diameter meets elastic segments 590 diameter requirements as raw material, then adopt the method for for example miller to make helical spring, then rigid end section 507,508 cars are become to required diameter.

For manufacturing rod-like members 501, in elastic segments, along the circumferential direction depart from mutually in the region of position of 180 degree and remove material to form thus directed waist.

Elastomeric element 601 shown in Figure 25 a and 25b has comprised a cylindrical tube, this cylindrical tube with a continuous coaxial thorax hole 602 and with the spiral form with pre-constant pitch along cylinder axis direction on wall definite length extended, radially terminating in the depression 603 in hole 602.Just formed thus a helical spring.The diameter in the pitch of the length that in cylinder axis direction, spiral type caves in, the height of depression, spiral and coaxial thorax hole is chosen to make helical spring and has 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, have the female thread 604 and 604 of predetermined length '.According to the external diameter of corresponding application choice elastomeric element.

In first example application shown in Figure 26, spring members 601 is one ingredients for 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 ', on these two outthrust, have respectively can with the external screw thread 633,633 of female thread 604,604 on elastomeric element 601 ' coordinate '.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 length separately according to required application.For example, rod-like members is used for connecting epispinal pedicle screw.Due to the elasticity of spring members 601, the rod-like members 630 of making according to this absorbs compression stress, tension force, bending force and twisting resistance to predetermined degree.

Elasticity rod-like members shown in Figure 26 b 680 is with the difference of elasticity rod-like members 630, the overall diameter of its first rigid rod section 681 than the large of elastomeric element 601 and second rigid rod section 681 ' little than elastomeric element 601 of overall diameter.As another kind, select, the diameter of two bar sections can all be greater than or all be less than spring members.

Shown in Figure 27 is second application example of elastomeric element 601.From scheming, can find out, elastomeric element 601 is one ingredients being arranged to the bone anchor part 610 of multiaxis bone screw form.This multiaxis bone screw comprises one by elastomeric element 601, with the screw rod 612 at unshowned tip and the screw component 611 that nut 613 forms here.

On screw rod 612, have bone thread 624 and cylindrical outthrust 625, wherein bone thread 624, for screwing in bone, has external screw thread to coordinate with the female thread 604 on elastomeric element 601 on cylindrical outthrust 625.

The cylindrical outthrust 626 that nut 613 comprises cylindrical outthrust 627 and is adjacent, to similar in screw rod 612, cylindrical outthrust 626 with elastomeric element 601 on the external screw thread of female thread 604 ' be used in conjunction with.

Screw component 611 is nested in acceptor site 614 and can under no-load condition, rotates.Acceptor site 614 profiles are roughly columniform, and have a first thorax hole 615 arranging with axisymmetric direction at its end, little than the large of screw rod 612 but than nut 613 of the diameter in this thorax hole.In addition, acceptor site 614 also has a coaxial second thorax hole 616 that is located at the end contrary 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 until nut 613, with the edge in the first thorax hole 615 near.Acceptor site 614 have T shape depression 614 ', two free lower limbs 617,618 are extended and formed to this depression by its free end along the first thorax hole 615 directions.At their free end near zone, on lower limb 617,618, there is the female thread can be in order to fixed bar 620 together with the external screw thread of built-in screw 619.

In addition, in acceptor site 614, also has a press member 621 for hold-doun nut 613, this press member 621 is designed to there is being a bulb-shaped recess 622 towards a side of nut 613, 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 acceptor site 614 in nut 613 directions.In addition, on press member 621, also have a coaxial thorax hole 623, to screw-in instrument can be stretched into, engage with the depression (not drawing on figure) on nut 613.

In operation process, screw rod 612 screws in the female thread 604 of elastomeric element 601 by the cylindrical outthrust 625 on it, and nut 613 by its cylindrical outthrust 626 screw in female thread 604 ', so just formed screw component 611.Screw rod 612 forward, the screw component of making according to this 611 is inserted to acceptor site 614 by second perforate until the edge in 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 to bone or vertebra.Finally, bar 620 is placed in to the acceptor site 614 between two lower limbs 617,618, adjusts acceptor site with respect to the angle position of screw component fixing with built-in screw 619.Elastic segments allows near limited activity relaxed position.

Multi-axial screws is not limited to embodiment described above, and can be any other band multi-axial screws of described syllogic screw component above.Correspondingly, if first nut 613 was entered to acceptor site 614 by the second thorax hole 616 forward with cylindrical outthrust 626 in operation before elastomeric element 601 and screw rod 612 screw in nut 613, what the diameter in the first thorax hole 615 in the embodiment shown in Figure 27 can be than screw rod 612 is little.In such cases, as long as greatly just much of that than cylindrical outthrust 626 and cylindrical sector 627 of the first thorax hole 615 diameters.As another kind, select, 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 pass through.

But acceptor site also can be designed to insert from below screw component and by a press member, screw component is clipped in the middle of acceptor site.In this case, the diameter in the thorax hole 615 shown in Figure 27 should be larger than the diameter of nut 613.

Bar be fixedly not limited to the built-in screw shown in Figure 27, and can use additional external nut or the bar fixing means of other any known types.

If elastomeric element 601 at least can partly protrude from bone surface, elastomeric element 601 just can absorb bending force and tension force and pressure so.When spring members does not protrude from 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 with screw component 693 ' with elasticity rod-like members 692 for being 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 only with the combination of some basic elements of character, to obtain the securing device 690 with various characteristics.This securing device also not necessarily must comprise bone anchor part with elastomeric element and the bar type parts with elastomeric element.According to the field of application, also can only comprise with the bar type parts of spring members with the bone anchor part of rigidity screw component.

Shown in Figure 29 is elastomeric element 640, elastomeric element 640 and the difference of elastomeric element 601 be only female thread 641 that length has run through 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 from aforesaid embodiment is ' and compared with embodiment above the less spiral number of turns.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, different from aforesaid embodiment, and it comprises two regions 661, and 180 degree all recessed to central shaft are departed from these two regions mutually.Region 661 is in the length L of central axis direction ' be not more than the length L of spiral, and the radius of curvature in region 661 is arranged to be unlikely to make helical spring bung flange to interrupt.Due to this design, this spring members with the perpendicular direction of central shaft on have a narrower lumbar shape, therefore the party, upwards rigidity is less.This makes the rigidity of elastomeric element have directivity, to be applicable to the needs of some application.

Elastomeric element 672 shown in Figure 32 includes the shaft-like core 671 in a 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 in its one end, comprise one with externally threaded cylindrical outthrust 761 rather than as in the previous examples be with female thorax hole.Accordingly, the parts that are connected with this end of this spring members have the thorax hole with corresponding female thread.At the other end of this spring members, be a bag-shaped thorax hole 762 as in above-described embodiment, it has female thread 763 near this end of this spring members.

Shown in Figure 34, be spring members 770, its each end has respectively one with externally threaded cylindrical outthrust 771,772.

As a kind of modification of previous embodiment, elastomeric element does not comprise continuous thorax hole.

As another example application of elastomeric element 601 of the present invention, shown in Figure 35 a in exploded view is link 700, and this link contains rod-shaped member 631, elastomeric element 601 and plate 701.In rod-shaped member 631, have a column type outthrust 632 with external screw thread 633, this external screw thread is for screwing near the female thread 604 elastomeric element 601 one end.Plate 701 also includes the column type outthrust 702 with external screw thread 703, this external screw thread for screw near be positioned at other one end of elastomeric element 601 female thread 604 '.This plate comprise two sections 704 and 704 ', this two section in top view rounded and by fin 705 be mutually connected.The width B of fin 705 be less than circular section 704,704 ' diameter D.For placing two of counter-sunk screw thorax holes 706,706 through plate ' be arranged to circular section coaxial.As shown in Figure 35 b, the first surface 707 of plate has a protruding bending and second 708 of plate has the bending of depression, and the bending of this depression is for making 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 space.As shown in Figure 35 b, thorax hole 706,706 ' respectively comprise hole 706a, taper the first section 706b and the second section 706c; Second 708 of its mesopore 706a adjoining plate, contiguous this hole of taper the first section 706b, the first surface 707 of contiguous the first section of the second section 706c and plate.Their shape makes thorax hole 706 and 706 ' be applicable to accepting counter-sunk screw.Thorax hole 706 and 706 ' shape can with above-described difference, as long as they are applicable to accepting counter-sunk screw.

Shown in Figure 36 is an application example of the link in Figure 35 a.Wherein plate 701 is fixed on two vertebras 711 that are positioned at cervical spine from rear side by two bone screw 710, 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 in the present invention is used in another application example in dynamic pelvis securing device 730.This dynamic pelvis securing device comprise by rod-shaped member 631,631 ' and 631 " and spring members 601 and 601 " interconnective bone anchor part 728,728 ' and 728 ".

" the same; bone anchor part 728 comprises two half- unit 725 and 731; this two half-unit is connected with each other by a screw 727, the screw thread 735 in screw 727 and screw thread 734 in the first half portions 725 and the second half portions 731 engages with other two bone anchor parts 728 ' with 728.Half portion 725 above top view in Figure 37 a only shows.Rod-shaped member 631 is clipped between two half-unit 725,731 noted earlier, and in the depression 733 in the depression 732 in the first half portions 725 and in the second half portions 731, so just bone anchor part 728 is connected in rod-shaped member 631 securely.In addition, two half-unit 725,731 has respectively thorax hole 736,737, these two thorax hole arranged in co-axial alignment under the state of assembling.Near bulb-shaped recess 739 near bulb-shaped recess 738 thorax hole 736 and thorax hole 737 is for hold bone screw 726.Bone screw 726 comprises the nut section 753 of a rod section 751 and a billiard table shape, and on its king-rod type section 751, band is useful on the external screw thread 752 that screws in bone, and the radius of billiard table shape nut 753 equates substantially with the radius of bulb-shaped recess 738 and 739.

Similar with bone anchor part, link 724 also has two half-unit 722, can only see one in the top view of Figure 37 a.By entering depression, rod-shaped member 631 is clipped in foregoing two half-unit 722, thereby link 724 is firmly received in 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 be connected with two half-unit 722 by the depression between unshowned, two half-unit 722 and makes it be fixed in a pivot location.At another end contrary with head 721b, be rod-like members 721a, it comprises that one with externally threaded column type outthrust (not shown), wherein external screw thread can screw in elastomeric element 601 ' in female thread (not shown).

The method of the available miller of making of elastomeric element, its raw material used be by the material with biocompatibility as titanium forms, has the cylinder of predetermined overall diameter, then use thin slice milling cutter to mill out depression along its main shaft and the collinear helix of cylindrical main shaft.Subsequently, along cylindrical main shaft, form thorax hole, cylinder total length is run through in this hole, and spiral type depression is terminated on thorax hole.In order to guarantee the stability of elastomeric element, between the distolateral section of spiral part and elastomeric element, the spiral afterbody of transition is very important.Therefore be necessary at the both ends of spiral, to use slotting cutter finishing spiral afterbody, to remove the sharp keen edge of inside, thorax hole.In order to reach this object, spiral afterbody is used slotting cutter to carry out milling along the tangential direction of spiral profile.Subsequently, by the interior outside burr removing of whole assembly.Finally, in two end section in thorax hole, produce respectively female thread.

Except using milling technology, elastomeric element 800 also can be used the processing of line discharge cutting, laser treatment or water cutter to process and be processed by cylinder.As shown in figure 38, processing also can, since a cylinder that has a predetermined overall diameter D ', form a thorax hole 801 of running through cylinder total length along cylindrical main shaft A in step subsequently.According to the thickness of wall, select above-mentioned a kind of processing method subsequently, along spiral 802, cut the hollow circuit cylinder body wall of making according to this.The afterbody 803 of spiral 802 is formed as the shape of one 1/4 circle, thereby makes to become unnecessary with respect to completing afterbody 803 by extra operation in milling operation.And, in these operations also without deburr.The shape of afterbody needn't be also 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.

Finally, as adopted the processing technology of miller, in thorax hole, two end section form female thread separately.

In a kind of improved form, said method can be changed at lathe, to get on the bus and replace at least one female thread with externally threaded cylindrical outthrust when operation starts.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 continuous thorax hole.

Claims (14)

1. One kind for vertebra and/or intervertebral disc, have that interval is supported and interval eyelid retractor (10) weight forwarding function, in temporary transient or Permanent implantation human or animal body, by at least one biocompatible materials, formed, described interval supporter has tubular body (1) and is used in the end of described tubular body the device (2) being connected with adjacent body part, on described tubular body, be useful on the material recess (7) that reduces local stiffness, wherein

   For the device (2) that described tubular body is connected with adjacent body part, be formed as the extension of described tubular body, and be integrally formed with described tubular body, wherein at the superficies of described device, there are depression and opening growing into for tissue, and wherein for the described device that described tubular body is connected with adjacent body part, be included in the outthrust that has serration form in the axial direction of described tubular body, described serration is formed by triangular shaped recess or trapezoidal serration, with adjacent body part tabling.
2. 2. interval according to claim 1 eyelid retractor, is characterized in that, described biocompatible materials is the material under application-specific condition with flexural rigidity.
3. 3. interval according to claim 1 eyelid retractor, is characterized in that, described biocompatible materials is selected from the group of titanium and alloy and plastics composition.
4. 4. interval according to claim 1 eyelid retractor, is characterized in that, described adjacent body part is bone.
5. 5. interval according to claim 1 eyelid retractor, is characterized in that, described material recess (7) is formed as perforate and/or the recessed groove depression in the wall of described tubular body.
6. 6. interval according to claim 1 eyelid retractor, is characterized in that, two material recess are formed as recessed groove depression and/or the perforate that a kind of mutual embedding contains, paired parallel helical form is arranged.
7. 7. interval according to claim 1 eyelid retractor, it is characterized in that, described interval eyelid retractor comprises the part of being made by elastomeric material, the part that should be made by elastomeric material is used for obtaining elasticity together with the described tubular body with material recess, and whole interval eyelid retractor last rigidity or activeness are determined.
8. 8. interval according to claim 1 eyelid retractor, it is characterized in that, described interval eyelid retractor is compressible in the axial direction can and can be reversed around longitudinal axis (9) around rotating shaft (8) bending with stretching and for the described device (2) for being connected with adjacent body part that is located at end.
9. 9. interval according to claim 8 eyelid retractor, is characterized in that, described tubular body (1) is used the sleeve consisting of biocompatible flexible material to encase and/or had the core consisting of biocompatible flexible material.
10. 10. interval according to claim 9 eyelid retractor, is characterized in that, described elastomeric material is elastomer.
11. 11. interval according to claim 1 eyelid retractors, is characterized in that, described tubular body, and with regard to it is longitudinal, can elastic stretching or elastic compression 0.5% to 20%.
12. 12. interval according to claim 1 eyelid retractors, it is characterized in that, described tubular body (1) can be in the upper elastic bending of rotating shaft (8), and the described device (2) for being connected with adjacent body part that makes to be located at end can be with respect to 0.5 ° to 10 ° of the longitudinal axis of tubular body (9) deflection.
13. 13. interval according to claim 1 eyelid retractors, is characterized in that, described tubular body can reverse 0.5 ° to 10 ° around its longitudinal axis (9).
14. 14. interval according to claim 5 eyelid retractors, is characterized in that, the perforate of described wall and/or recessed groove depression form with helical form.

Images