A kind of POROUS TITANIUM Invasive lumbar fusion device
Technical field
The implant for vertebrae is the utility model is related to, belongs to fixed network in intervertebral fusion, and in particular to is a kind of
POROUS TITANIUM Invasive lumbar fusion device and preparation method thereof.
Background technology
The degenerative disc disease of the symptom such as protrusion of lumber intervertebral disc and cervical spondylosis is a kind of common disease in modern society
And frequently-occurring disease, seriously affect the quality of life of patient.Spinal fusion is one of most widely used technology of spinal surgery, main logical
Cross and establish that backbone is stablized at once and implant ostosis effect, bone inductive effect, bone conduction effect promote backbone Bony union.
At present, intervertebral fusion has become treatment lumbar instability, lumbar spinal stenosis, degenerated centrum olisthe, degenerated spine lateral bending, false pass
The main means of the illness such as section and degenerative disc disease.Fusion device of the prior art is according to the mode of postoperative bone tissue growth
Difference be broadly divided into two types, the first kind is provided with the fusion device of bone graft area, and the second class is not set the fusion device of bone graft area.
Chinese patent literature CN204683846U(Application number 201520112316.X)Disclose a kind of arc anterior lateral cervical approach
Fusion device between spinal vertebral.The fusion device generally ellipsoidal structure, top and bottom are equipped with gradual wave rib tooth;Fusion device is also
The symmetrical through hole for being provided with two approximate half-circulars set along the vertical direction, and two through holes can conveniently be implanted into autologous bone.
The device is designed using super-large diameter, it is possible to increase stability between centrum, can also improve the mechanical strength for bearing compression.The practicality
Although new disclosed fusion device possesses relatively stable supporting structure, the effect to regrow of sclerotin is not ideal enough.
Fusion device disclosed in the document belongs to first kind fusion device.
Chinese patent literature CN201529176U(Application number 200920247060.8)Disclose one kind and be used for vertebral fusion
When the embedded bone trabecula intervertebral fusion device that is implanted into, it has by titanium alloy powder through the molding reticulated porous structures of electron beam melting, shape
Shape can be wedge-shaped, square, semicircle or triangle, or be designed according to the concrete condition of patient's diseased region.The bone trabecula
There is a through hole in the centre of Invasive lumbar fusion device, and the aperture of net structure is 50-900 microns, porosity 40-90%, and surface is also
There can be hydroxyapatite coating layer.Although fusion device disclosed in the utility model can reduce stress shielding band to a certain extent
The adverse effect come, and single reticulated porous structures are used, but the effect to regrow of sclerotin is still not ideal enough.This article
Offer disclosed fusion device and belong to first kind fusion device.
204581605 U of Chinese patent literature CN(Application number 201520265012.7)A kind of Invasive lumbar fusion device is disclosed,
Fusion device body including approximate cuboid, is provided with the bone grafting hole penetrated through vertically, fusion device body in the fusion device body
Upper and lower surface be evenly arranged with teeth;The front end face of fusion device body is gradually slipped over to contract by rounding marginal ray
Cross, the rear end face of fusion device body is provided with implantation location hole and implantation locating slot;The two sides hollow out of fusion device body runs through,
Hollow part is provided with growth net.But since the surrounding of the upper side and lower side of its body occupies certain space, for Postoperative Bone
The growth of matter adversely affects.104706446 A of Chinese patent literature CN(Application number 201510129242.5)It is disclosed
Fusion device it is also similar with the fusion device.Fusion device disclosed in two documents belongs to first kind fusion device.
Chinese patent literature CN102293693 A(Application number 201110146497.4)Disclosing one kind has bioactivity
Porous titanium alloy people's neck Invasive lumbar fusion device and preparation method thereof.The standby Invasive lumbar fusion device of the invention patent system has and natural bone group
Similar elasticity modulus is knitted, loose structure and its Internal biological active factors slow-released system can induce freshman bone tissue and grow into.Should
Although patent solves the problems, such as that fusion device elasticity modulus matches and Bone Ingrowth with natural bone tissue, but this single more
Pore structure lacks anti-fatigue ability, is easily broken off under the action of dynamic circulation stress, it is impossible to meet the needs of Long-Term Clinical.Should
Fusion device disclosed in document belongs to the second class fusion device.
Utility model content
The purpose of this utility model is that solve the above problems, there is provided a kind of intensity preferably and the life to sclerotin etc. after surgery
The long preferable POROUS TITANIUM Invasive lumbar fusion device of effect.
Technical solution is used by the utility model solves its technical problem:The Invasive lumbar fusion device of the utility model is logical
3D printer is crossed by the structural member of titanium alloy material one printing shaping, including supporting structure portion and gap structure portion;Described
Supporting structure portion is mutually fixed together with gap structure portion in integrated;Supporting structure portion is used to undertake external load,
Gap structure portion is used to guide new Bone Ingrowth;The volume in the supporting structure portion accounts for the 5% to 20% of fusion device cumulative volume;
To exposing outside, and merged on the upside of fusion device, downside, front side, rear side and right side in the gap structure portion
Front side, rear side and the right side of device are in openly to exposing outside.
The supporting structure portion includes mounting portion, left socle, connecting portion and the right support being sequentially connected;Mounting portion is equipped with
The front and rear slot device set of a pair point and an instrument hole among a pair of of slot device along left and right to setting;It is left
Stent is with right support using a pair of of the cross harden structure and the structure being connected by corresponding column that distribution is set up and down, left branch
It is connected between frame and right support by connecting portion.
The connecting portion in the supporting structure portion includes front column, rear column, upper beam and bottom end rail;Front column is stood with rear
It is connected between column by upper beam with bottom end rail;
The left socle has upper left frame, lower-left frame and left column;Left column is connected to upper left frame and lower-left frame
Between;Upper left frame and lower-left frame be in cross harden structure, and at the same time in from left front to behind the right side and from the left back intersection to before the right side
Structure setting, and left column is located at upper left frame and the respective crossover sites of lower-left frame;Front and rear the two of the left side of upper left frame
End is connected with the right side on the top of mounting portion, and the rear and front end in the left side of lower-left frame is connected with the right side of the lower part of mounting portion;It is left
The right side front of restocking is connected with the upper left-hand of front column, and the right side rear end of upper left frame is connected with the upper left-hand of rear column;
The front end on the right side of lower-left frame is connected with the lower left side of front column, the rear end on the right side of lower-left frame and the lower left side of rear column
It is connected;So that the front and rear sides of left socle are respectively provided with the open space of triangle cylindricality;
The right support has upper right frame, bottom right frame and right central post,;Right central post is connected to upper right frame and bottom right frame
Between 14-2;Upper right frame and bottom right frame be in cross harden structure, and at the same time in from left front to behind the right side and from left back to before the right side
Chi structure is set, and right central post is located at upper right frame and the respective crossover sites of bottom right frame;Before the left side of upper right frame
End is connected with the upper right of front column, and the rear end in the left side of upper right frame is connected with the upper right of rear column;A left side for bottom right frame
The front end of side on the right side of the lower part of front column with being connected, and the rear end in the left side of bottom right frame on the right side of the lower part of rear column with being connected;So as to
So that the front and rear sides and right side of right support are respectively provided with the open space of triangle cylindricality.
The supporting structure portion is additionally provided with right front column and right rear column;Right front column is connected to the right front ends of upper right frame
Between the right front ends of bottom right frame, right rear column is connected between the right rear end of upper right frame and the right rear end of bottom right frame.
The length L in the supporting structure portion is 22mm to 36mm, and wide W is 8mm to 14mm, and height H is 3mm to 18mm.
The gap structure portion is formed to be combined by the cell voids in positive tetrahedron structure;Wherein, construction unit is equal
Connected and composed by the titanium column of the identical cuboid columnar of 4 root long degree, and the mutual angle of each titanium column is 109 degree 28 and divides.
The length l of every titanium column in the gap structure portion is 0.3mm to 0.6mm, and width w is identical with thickness h, is
0.1mm to 0.3mm;The porosity in gap structure portion is 70% to 90%.
The good effect that the utility model has:
(1)POROUS TITANIUM Invasive lumbar fusion device provided by the utility model has supporting structure portion and gap structure portion, it is supported
Structural portion is used for the mechanical support that fusion device is implanted into initial stage, has excellent antifatigue mechanical property;And gap structure portion is like people
The effect of body interverbebral disc, has good elasticity and toughness, and the micropore in gap structure portion is adapted to growing into for new bone, promotes up and down
Centrum and the Bony union of POROUS TITANIUM fusion device.Phase after the implantation, with regeneration of the bone tissue in microscopic void and reconstruction
Complete, form preferable bone-POROUS TITANIUM embedded structure, the physiological loads with mechanical support structure shared backbone position, this
The Invasive lumbar fusion device of kind structure can be effectively used for the treatment of clinically degenerative disc disease.
(2)The overall structure of the fusion device of the utility model is that supporting structure portion is centrally located, and gap structure portion
Then be arranged on most of region on the periphery at supporting structure position, and gap structure portion in the up-down direction expose the external world
Position accounts for the major part of the upper and lower side of fusion device, when being used as the master in supporting structure portion preferably using the left and right stent of cross harden structure
During body structure, structural strength is not only ensured, and forms front and rear and rear side open space up and down, gap structure portion is then
In the open space, it can not only effectively ensure that Invasive lumbar fusion device enters internal mechanical support early period, and
And after fusion device is implanted into human body, open growing space is provided for effective growth of sclerotin etc., is more beneficial to merge
Device incorporates intervertebral.
(3)Why the gap structure portion of the fusion device of the utility model can have good elasticity and toughness, be because
Employ and formed in the cell voids combination of positive tetrahedron structure, according to the connection of carbon atom in diamond structures between cell voids
The similar connection mode design of mode, so that the POROUS TITANIUM is assigned with certain elasticity, it is enough by conventional titanium alloy fusion device
Osseointegration character(Refer to the bone of titanium and patient being combined together, the compatible performance of both osteocyte and titanium)And PEEK materials
The low elastic modulus of material fusion device is integrated in one, and compensate for conventional titanium alloy alloy fusion device and PEEK material fusions device each
Deficiency.
Brief description of the drawings
Fig. 1 is a kind of schematic perspective view of the Invasive lumbar fusion device of the utility model.
Fig. 2 is the schematic perspective view in the supporting structure portion in Fig. 1.
Fig. 3 is the schematic top plan view of Fig. 2.
Fig. 4 be from the forward observation of Fig. 2 when schematic diagram.
Fig. 5 is the schematic perspective view in the gap structure portion in Fig. 1.
Fig. 6 is the schematic diagram of the positive tetrahedron construction unit sub-assembly in the gap structure portion in Fig. 5.
Reference numeral in above-mentioned attached drawing is as follows:
Supporting structure portion 1, gap structure portion 2, mounting portion 11, slot device 11-1, instrument hole 11-2, left socle 12, upper left
Frame 12-1, lower-left frame 12-2, left column 12-3, connecting portion 13, front column 13-1, rear column 13-2 right supports 14, upper right frame
14-1, bottom right frame 14-2, right central post 14-3, right front column 15, right rear column 16, long L, wide W, high H, titanium column 21, long l are wide
W, high h.
Embodiment
Elaborate below in conjunction with the accompanying drawings to the embodiment of the utility model:Following embodiments are with the utility model skill
Implemented under premised on art scheme, give detailed embodiment and specific operating process, but the guarantor of the utility model
Shield scope is not limited to following embodiments.
(Embodiment 1)
As shown in Figure 1, the Invasive lumbar fusion device of the present embodiment is by titanium alloy material one printing shaping by 3D printer
Structural member.The fusion device is divided into supporting structure portion 1 and gap structure portion 2 according to the difference of role.Supporting structure portion 1 with
Gap structure portion 2 is mutually fixed together in integrated.Supporting structure portion 1 is used to undertake external load, gap structure portion 2
For guiding new Bone Ingrowth;The volume in supporting structure portion 1 accounts for the 10% of fusion device cumulative volume.
As described in Figure 2, the supporting structure portion 1 includes mounting portion 11, left socle 12,13 and of connecting portion being sequentially connected
Right support 14.Mounting portion 11 is equipped with a pair of slot device 11-1 for dividing front and rear setting and one is located at a pair of of device along left and right to setting
Instrument hole 11-2 among tool groove.
Left socle 12 and right support 14 using a pair of of cross harden structure that distribution is set up and down and pass through corresponding column
(Left column 12-3 and right central post 14-3)It is connected, is connected between left socle 12 and right support 14 by connecting portion 13, support
The connecting portion 13 of structural portion 1 includes front column 13-1, rear column 13-2, upper beam 13-3 and bottom end rail 13-4;Front column 13-1
It is connected between rear column 13-2 by upper beam 13-3 with bottom end rail 13-4.
Left socle 12 has upper left frame 12-1, lower-left frame 12-2 and left column 12-3.Left column 12-3 is connected to a left side
Between restocking 12-1 and lower-left frame 12-2.Upper left frame 12-1 and lower-left frame 12-2 is in cross harden structure, and is in from left front at the same time
Set after to the right side and from the left back chi structure to before the right side, and left column 12-3 is connected to upper left frame 12-1 and lower-left frame
Between the respective crossover sites of 12-2.
The rear and front end in the left side of upper left frame 12-1 is connected with the right side on the top of mounting portion 11, the left side of lower-left frame 12-2
Rear and front end be connected with the right side of the lower part of mounting portion 11.
The rear and front end on the right side of upper left frame 12-1 is connected with the left side on the top of connecting portion 13, namely upper left frame 12-1
Right side front is connected with the upper left-hand of front column 13-1, the right side rear end of upper left frame 12-1 and the upper left-hand of rear column 13-2
It is connected.The front end on the right side of lower-left frame 12-2 is connected with the lower left side of front column 13-1, the rear end on the right side of lower-left frame 12-2
It is connected with the lower left side of rear column 13-2;So that the front and rear sides of left socle 12 are respectively provided with the open space of triangle cylindricality
Right support 14 has upper right frame 14-1, bottom right frame 14-2 and right central post 14-3.Right central post 14-3 is connected to the right side
Between restocking 14-1 and bottom right frame 14-2.Upper right frame 14-1 and bottom right frame 14-2 is in cross harden structure, and is in from left front at the same time
Set after to the right side and from the left back chi structure to before the right side, and right central post 14-3 is connected to upper right frame 14-1 and bottom right frame
Between the respective crossover sites of 14-2
The rear and front end in the left side of upper right frame 14-1 is connected with the right side on the top of connecting portion 13, namely upper right frame 14-1
The front end in left side is connected with the upper right of front column 13-1, the rear end in the left side of upper right frame 14-1 and the top of rear column 13-2
Right side is connected.The rear and front end in the left side of bottom right frame 14-2 is connected with the right side of the lower part of connecting portion 13, namely bottom right frame 14-2
Left side front end and front column 13-1 lower part on the right side of be connected, under the rear end in the left side of bottom right frame 14-2 and rear column 13-2
It is connected on the right side of portion.So that the front and rear sides and right side of right support 14 are respectively provided with the open space of triangle cylindricality.
Supporting structure portion 1 is additionally provided with right front column 15 and right rear column 16, and right front column 15 is connected to upper right frame 14-1's
Between right front ends and the right front ends of bottom right frame 14-2, right rear column 16 is connected to the right rear end and bottom right frame 14-2 of upper right frame 14-1
Right rear end between.
The front and rear side of the left socle 12 in the supporting structure portion 1, the front and rear side and right side of right support 14 are in open
Set, the design of this supporting structure, can either effectively ensure that Invasive lumbar fusion device enters internal mechanical support early period, at the same time
The design of four-bladed vane support provides open structure design while supporting structure surface maximum mechanical strength is ensured
Space, ensure that after fusion device is implanted into human body, possibility that sclerotin is grown according to open mode is more beneficial to melt
Clutch incorporates intervertebral.
See Fig. 3, the length L of the mechanical support structural portion 1 in the present embodiment is 28mm, and wide W is 11mm.
See Fig. 4, the height H of the mechanical support structural portion 1 in the present embodiment is 4mm, the appearance of the upside in supporting structure portion 1
The middle part in face is higher, left and right sides position is relatively low, and arc-shaped curved surface is set, and belongs to and meets the outer of physiology curved surface between cone
Surface.Corresponding, the middle part of the outer surface of the downside in supporting structure portion 1 is downwardly projecting more, left and right sides position
Protrude less, and also arc-shaped curved surface is set, and belongs to the outer surface for meeting the physiology curved surface between cone.
See Fig. 5 and Fig. 6, the gap structure portion 2 in the present embodiment is by being in the diamond lattic structure of positive tetrahedron structure substantially
Cell voids combination form, be connected according to the connection mode of carbon atom in diamond structures between cell voids.Wherein, structure list
The titanium column 21 of the cuboid columnar identical by 4 root long degree of member is connected and composed according in the structure of positive tetrahedron, namely each titanium
The mutual angle of column 21 is 109 degree 28 and divides.The length of every titanium column 21 is 0.5mm, and width and thickness are 0.2mm.It is empty
The porosity in gap structure portion 2 is 80%.Connection mode so between cell voids according to carbon atom in diamond structures is similar
Connection mode designs, so as to assign the POROUS TITANIUM with certain elasticity, enough osseointegration characters by conventional titanium alloy fusion device(It is
The bone of titanium and patient are combined together by finger, the compatible performance of both osteocyte and titanium)And PEEK material fusion devices is low
Elasticity modulus is integrated in one, and compensate for conventional titanium alloy alloy fusion device and the respective deficiency of PEEK material fusion devices
The specific implementation step for preparing above-mentioned fusion device is as follows:
1. utilize CAD(CAD)Software carries out the configuration design of Invasive lumbar fusion device, can be with people's vertebra
The anatomical contours of body match;The CAD software is Unigraphics, Pro/E, Solidworks etc.;
2. matching mechanical support structure is designed in fusion device appearance profile, 1 supporting structure volume of the present embodiment
The 10% of fusion device cumulative volume is accounted for, mechanical support structure CAD data are stored with independent STL data formats;
3. designing micropore structure in the remaining space for removing mechanical support structure, pore-size is 200 μm, microcosmic
Pore structure CAD data is stored with independent STL data formats;
4. it is soft that the STL data of mechanical support structure and micropore structure STL data are directed respectively into hierarchy slicing processing
Part, and mechanics supporting structure and relative tertiary location during micropore structure design are kept, then, handled using hierarchy slicing
Software carries out hierarchy slicing processing to mechanical support structure and micropore structure STL data, be converted into respectively two it is independent
2-D data message file;
5. the independent 2-D data message file of mechanical support structure and micropore structure two is imported 3D printing to set
Standby control software, keeps relative tertiary location when mechanics supporting structure and micropore structure design, sets corresponding 3D to beat
Print technological parameter,
6. using titanium alloy powder as raw material, carry out integrated 3D printing and make, obtain POROUS TITANIUM Invasive lumbar fusion device.
Wherein, it is corresponding to the 3D printing manufacture craft parameter of mechanical support structure:The power of laser is 160W, scanning speed
Spend for 1000mm/s, powdering thickness is 0.02mm, sweep span:80μm.Corresponding to micropore structure 3D printing manufacture craft
Parameter is:The power of laser is 100W;Sweep speed is 200mm/s;Powdering thickness is 0.02mm;Sweep span:160μm.Adopt
With this process design parameter, two kinds of structures can be made not only to be individually present but also cooperate, form the more of complete composite construction
Hole titanium Invasive lumbar fusion device.