CN105751500A - Porous bone scaffold manufacturing device and method - Google Patents

Porous bone scaffold manufacturing device and method Download PDF

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Publication number
CN105751500A
CN105751500A CN 201610101063 CN201610101063A CN105751500A CN 105751500 A CN105751500 A CN 105751500A CN 201610101063 CN201610101063 CN 201610101063 CN 201610101063 A CN201610101063 A CN 201610101063A CN 105751500 A CN105751500 A CN 105751500A
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extruding
unit
bone
device
structure
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CN 201610101063
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Chinese (zh)
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贺永
邵惠锋
傅建中
苟中入
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浙江大学
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L27/446Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L27/46Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with phosphorus-containing inorganic fillers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56Porous materials, e.g. foams or sponges
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B33ADDITIVE MANUFACTURING TECHNOLOGY
    • B33YADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y10/00Processes of additive manufacturing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B33ADDITIVE MANUFACTURING TECHNOLOGY
    • B33YADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y30/00Apparatus for additive manufacturing; Details thereof or accessories therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/02Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Abstract

The invention discloses a porous bone scaffold manufacturing device and method. The method comprises a three-dimensional movement framework structure, an extruding unit, an extruding mechanism, a working surface and a temperature control unit mounted on the working surface, wherein the extruding unit comprises a liquid storage device and a linear unit; the extruding mechanism comprises a fixing clamp for fixing the extruding unit, a push rod for pushing a bone material in the liquid storage device to be extruded, and a driving mechanism for driving the push rod to do reciprocating motion; the extruding unit does the reciprocating motion in X-axis and Y-axis directions in the three-dimensional movement framework structure; the working surface does the reciprocating motion in a Z-axis direction in the three-dimensional movement framework structure. The porous bone scaffold manufacturing device disclosed by the invention is simple in structure, convenient to operate and low in manufacturing cost; a solution can be stably extruded; porous bone scaffold structures of different pore diameters, different pore structures, different sizes and different strip shapes can be manufactured through extruding high-viscosity biological ink.

Description

一种多孔骨支架制造装置及制造方法 An apparatus and a method for producing a porous bone scaffold manufactured

技术领域 FIELD

[0001]本发明涉及组织工程技术领域,尤其是涉及一种多孔骨支架制造装置及制造方法。 [0001] The present invention relates to the field of tissue engineering, particularly to a porous bone scaffold manufacturing apparatus and manufacturing method.

背景技术 Background technique

[0002]各种创伤、骨肿瘤、骨坏死等原因引起的骨缺损的修复一直是骨科领域的棘手问题。 [0002] bone defect repair all kinds of trauma, bone tumors, bone necrosis and other causes has been a thorny issue in the field of orthopedics. 当前,面对已有的传统骨缺损治疗方法包括自身骨移植、自体松质骨移植等,虽然自体骨移植提供了好的骨传导、骨诱导以及骨生成作用,但是存在供体不足、手术耗费周期长等问题,异体骨移植又极易引起排斥反应,治疗效果差。 Currently, the face of the existing traditional method of treating bone defects comprising bone graft itself, autogenous bone transplantation, although the autogenous bone graft provides good osteoconductive, osteoinductive bone formation and action, but there donor shortage, surgical consuming long cycle and so on, and can easily cause allograft rejection, treatment is poor.

[0003]利用骨组织工程技术制备人工骨支架替代骨缺损是目前再生医学领域的一个热门课题,多孔性骨支架的结构设计对于骨修复有着至关重要的作用,多孔性骨支架中的孔道能够作为细胞生长时所需要的营养物质的输送管道,同时也是代谢物的排出通道,而且孔道的大小和形状对骨组织的生长也起着至关重要的作用,如果孔道尺寸过大,则不利于细胞的依附,反之,如果孔道尺寸太小,则不利于细胞的生长、繁殖和分化,因此,如果可以制备出孔道尺寸可控,孔道结构贯通的多孔性骨支架,这能够为骨组织细胞的生长提供一个有力的环境。 [0003] was prepared using the artificial bone scaffold for bone tissue engineering technology to replace bone defects in the field of regenerative medicine is currently a hot topic, the structural design porous bone scaffold for bone repair has a vital role, porous bone scaffold tunnel can as a conduit when the nutrients required for cell growth, but also the discharge passage metabolite thereof, and the pore size and shape of the bone tissue growth also plays a vital role, if the pore size is too large, is not conducive to cell attachment, whereas, if the pore size is too small, is not conducive to cell growth, proliferation and differentiation, therefore, can be prepared if a controllable pore size, porous bone through the scaffold pore structure, which can of bone tissue cells growth provides a powerful environment.

[0004]目前,常用的制造多孔骨支架的方法主要有静电纺丝技术,造孔剂法,泡沫复制法,粒子析出法,选择激光烧结等。 [0004] At present, the common method for producing porous bone scaffold mainly electrospinning, the pore former method, a replication bubble, particle deposition, selective laser sintering. 以上方法都存在着不同的缺陷,如静电纺丝技术制造支架效率低,而且制造的支架力学性能较低;造孔剂法制造的多孔支架孔道结构的互通性不好,而且孔尺寸不统一;泡沫复制法制造的多孔支架内部的孔尺寸不可控,而且也存在孔道结构不互通的缺点;粒子析出法存在支架内部孔尺寸过小,尺寸不可控,孔道不规则等缺点;选择激光烧结存在设备投入成本高,对制造骨支架的粉体要求高等。 The above methods have different drawbacks, such as low efficiency electrospinning technique of fabricating a stent, stent mechanical properties and low manufacturing; good interoperability pore structure of a porous scaffold manufactured pore former method, and the pore size is not uniform; pore size of the porous interior of the foam scaffold produced uncontrolled replication method, but there are also disadvantages not intercommunicating pore structure; the presence of internal stent pore size is too small, uncontrolled size, pore irregular particles disadvantages precipitation method; selected laser sintering device is present high investment cost, the powder for manufacturing the high requirement of the bone scaffold.

发明内容 SUMMARY

[0005]本发明基于已有的制造骨支架的方法和设备遇到的问题,本发明提供了一种多孔的骨支架制造装置,通过该装置,能够制造出孔形状可控,孔尺寸可控,线条形状多样,线条尺寸可变,孔道结构规则而又互通的多孔的骨支架结构;同时,本装置结构简单,制造成本低。 [0005] The present invention is based on the problems of the prior manufacturing method and apparatus of the bone scaffold encountered, the present invention provides an apparatus for producing a porous bone scaffold by the apparatus can be manufactured controllable pore shape, pore size controllable , various shapes lines, lines of variable size, pore structure of the porous structure of the bone scaffold but interworking rules; while the present apparatus is simple structure and low manufacturing cost.

[0006]本发明同时提供了一种多孔的骨支架制造方法,通过本发明方法,能够实现在能够制造出孔形状可控,孔尺寸可控,线条形状多样,线条尺寸可变,孔道结构规则而又互通的多孔的骨支架结构。 [0006] The present invention also provides a method for producing a porous bone scaffold, by the process of the present invention can be realized in a controllable pore shape can be manufactured, a controllable pore size, shape and diverse lines, lines of variable size, pore structure rules but interworking porous bone scaffold.

[0007] 一种多孔骨支架制造装置,包括三维运动框架结构、安装在三维运动框架结构上的挤出单元、控制挤出单元挤出骨材料的挤出机构、支撑多孔骨支架的工作面以及安装在工作面上的温控单元; [0007] A porous bone scaffold manufacturing apparatus, comprising a frame structure three-dimensional motion, the extrusion unit is mounted on the frame structure of the three-dimensional motion, the extruded units extruded The extrusion mechanism bone material, porous bone support face of the holder and temperature control unit mounted on a surface;

[0008]所述挤出单元包括储存骨材料溶液的储液器以及固定在储液器出料端的用于控制挤出骨材料形状的线型单元; [0008] The bone material extrusion unit comprises a storage reservoir solution and a unit for controlling a linear extruded shape is fixed to the bone material reservoir discharge end;

[0009]所述的挤出机构包括: [0009] The extrusion mechanism comprises:

[0010]用于固定所述挤出单元的固定夹具; [0010] fixing jig for fixing said extrusion unit;

[0011]用于推动储液器中的骨材料挤出的推杆; [0011] for promoting bone material in the reservoir of the ram extrusion;

[0012]驱动推杆往复运动的驱动机构; [0012] The drive mechanism reciprocates the ram;

[0013]所述挤出单元在三维运动框架结构内做X轴和Y轴方向的往复移动,所述工作面在三维运动框架结构内做Z轴方向的往复移动。 [0013] The extrusion unit to make the X-axis and Y-axis direction in the three-dimensional motion to reciprocate the frame structure, the Z-axis direction to make the face of the frame structure in the three-dimensional motion to reciprocate.

[0014I 所述的三维运动框架结构主要包括X运动单元,Y运动单元和Z运动单元,其中所述的X运动单元安装在Y运动单元上,跟随Y运动单元在Y方向上往复运动,通过X运动单元的往复运动,实现安装在X运动单元上的挤出单元在XY平面内的运动,再通过与安装在所述Z运动单元上的工作面的Z方向相对运动,实现所述的挤出单元在三维空间内的运动。 [Three-dimensional movement of the frame structure of the X moving unit comprises a primary 0014I, Y and Z moving unit moving unit, wherein said X-Y moving unit mounted on the moving unit, follows the Y moving unit reciprocates in the Y direction, the X reciprocation motion unit, effect movement of the extrusion unit mounted on the X moving unit in the XY plane, the Z direction and then mounted on the face of the Z moving unit relative movement to achieve the extrusion cell movement within the three-dimensional space.

[0015]作为优选,所述的线型单元包括针头底座和针头端部,针头端部通过螺纹方式与针头底座固定,方便拆卸和更换针头端部。 [0015] Advantageously, the linear unit includes a needle and a base end portion of the needle, the needle end portion threadably secured to the base of the needle, to facilitate removal and replacement of the needle end portion. 所述的针头端部内部通道的横截面形状为三角形,正方形,五边形,六边形,圆形等,溶液经针头端部被所述的活塞挤出,针头端部内部的形状直接决定挤出的线条的形状,而且针头端部内部的孔径尺寸可调,以满足支架不同孔隙率的需求。 The cross-sectional shape of the needle end of the inner channel is triangular, square, pentagonal, hexagonal, circular, etc., the solution was needle end portion of the piston extrusion, the shape of the inner needle end portion directly determine extruded line shape, and pore size of the interior of the needle end portion is adjustable, to meet the needs of different porosity of the stent.

[0016]作为优选,所述固定夹具包括: [0016] Advantageously, said fixture comprising:

[0017]与三维运动框架结构固定连接的夹具底座; [0017] The three-dimensional motion of the clip seat fixedly connected to the frame structure;

[0018]与夹具底座可拆卸固定的夹具端盖,该夹具端盖将挤出单元可拆卸固定在所述夹具底座上。 [0018] with the clip seat cover detachably fixed clamp, the clamp is removably fixed to the end cap extrusion unit on the clamp base.

[0019]采用上述技术方案,挤出单元中的储液器嵌在夹具底座的凹槽内,起到对储液器进行定位和固定的作用,同时夹具端盖盖住储液器,使安装在储液器下端的线型单元的针头端部经夹具端盖的通孔暴露在空气中,夹具端盖卡住线型单元的针头底座,防止挤出单元中的线型单元因自重、长时间的工作、或者溶液堵塞线型单元等原因而脱落,影响之前已经制造好的支架结构。 [0019] With the above technical solution, the reservoir is embedded in the extrusion unit in the recess of the clamp base, to play a reservoir for positioning and fixing effect while the clamp reservoir cap covering the installation the needle end portion of the lower end of the linear section through a reservoir cap of the clamp through holes exposed to air, the needle header clip end cap stuck linear unit, to prevent extrusion unit in linear units own weight, length working hours, a solution or clogging reasons like linear unit off, the support structure has been fabricated prior to impact.

[0020]挤出单元优选的方案有以下两种: [0020] Scheme extrusion unit preferably has the following two:

[0021]作为优选,所述夹具底座两侧设有卡台;所述夹具端盖包括设置在顶部用于与卡台卡合的卡合部,以及设置在底部用于固定线型单元的定位部。 [0021] Advantageously, the clip base is provided on both sides of the card table; the clamp provided at the top end cap includes engagement portions for engagement with the card table, and a fixing is provided for positioning at the bottom of the unit linear unit. 该技术方案中,挤出单元整体结构简单。 In this technical solution, a simple extruded unitary structure unit.

[0022]作为优选,所述夹具底座两侧设有卡槽;所述夹具端盖顶部设有用于与夹具底座卡合的卡合部,底部设有用于固定针头底座的定位部;所述卡合部两侧设有与所述卡槽卡合的凸起,底部设有向内弯折折用于卡住线型单元底部边缘的卡舌。 [0022] Advantageously, the clamp is provided with slots on both sides of the base; a top end cap provided with the clamp engaging portion for engaging the jig base, a bottom provided with a positioning portion for fixing the needle base; said card engagement projection portion is provided on both sides of the slot engaged with a tab fold line inwardly folded bottom edge of the bottom unit jammed. 该技术方案中,夹具端盖固定力度较强,适于对工艺要求较高的场合。 In this technical solution, the end cap clamp strong fixing strength, is suitable for the process requires high.

[0023]本发明中,所述的固定夹具可以随意更换,方便安装不同尺寸的储液器,满足不同体积溶液的需要,实现不同尺寸的支架的制造。 [0023] In the invention, the fixture can easily replace, easy to install different sized reservoirs, to meet the needs of different volume of the solution to achieve different sizes of manufacturing the stent.

[0024]本发明中,所述驱动机构可选择丝杆和直线电机机构,所述的挤出机构通过直线电机驱动安装在直线电机上的丝杆运动,丝杆上端由于与滑块固定,跟随滑块沿着均匀对称分布的2根光杆上下运动,光杆和滑块结构构成了挤出机构的导向机构。 [0024] In the present invention, the drive mechanism selectively screw and linear motor means, said extruding means driven by a linear motor mounted on the screw movement linear motor, since the fixing screw and the upper end of the slider, to follow 2 along the slide bar up and down symmetrical light distribution, and structure of the slider rod guide means constitute means of extrusion. 保证了丝杆下端的移动夹具能够稳定的上下运动,丝杆下端通过螺母与移动夹具固定,通过移动夹具的运动,从而实现推杆的运动,达到溶液挤出的目的。 The lower end of the screw to ensure jig can be stably moved up and down movement, the lower end of the screw clamp secured by a nut and moving, by moving the clamp movement, enabling movement of the push rod, the extruded solution to achieve the purpose.

[0025]所述的储液器包括储液桶,推动液体运动的活塞,固定安装在活塞上的推杆,所述的推杆固定在上述移动夹具上,通过移动夹具的往复运动,带动安装在移动夹具上的推杆的运动,从而带动与推杆相连的活塞的运动,实现储液桶内的液体的挤出与回吸,所述的活塞需要与所述的储液桶有好的配合,防止储液桶内的溶液从活塞端漏出。 The reservoir according to [0025] a reservoir comprising a tub, to promote movement of the liquid piston, the piston is fixedly mounted on the push rod, the push rod is fixed on the movable clamp, by reciprocation movement of the clamp carrying the mounting movement of the push rod in the moving clamp, so as to drive the movement of the piston and the push rod connected to, and extruded to achieve suck back the liquid reservoir of the barrel, the piston needs to have a tub with good reservoir cooperate to prevent the end of the reservoir solution from leaking out of the tub of the piston.

[0026]作为优选,所述储液器为注射器,注射器内的活塞与所述推杆固定,注射器的外壳固定在固定夹具上。 [0026] Advantageously, the reservoir is a syringe piston and the push rod fixed in the syringe, the syringe is fixed to the fixture housing. 所述的储液器可以是现有的商用注射器,便于更换和购买,如Iml注射器,2ml注射器,5ml注射器,1ml注射器等。 The reservoir may be a conventional commercial syringes, easy to replace and purchase, such as a syringe Iml, 2ml syringes, syringes 5ml, 1ml syringe or the like.

[0027]作为优选,所述的温控单元包括安装在工作面上的工作底板、设置在工作底板上的加热膜和温度传感器以及连接加热膜和温度传感器的温控仪,利用温控仪调节加热膜的开和关,再通过温度传感器对工作底板上的温度的检测,实现对工作底部上温度的精确实时控制。 [0027] Advantageously, said temperature control unit comprises a base plate mounted on a work surface, the base plate is provided on the working film and the heating temperature sensor, and temperature controller connected to the temperature sensor and heating the film, using a temperature controller adjusting heating the film on and off, and then by detecting the temperature of the temperature sensor on the working floor, accurate real-time control of the temperature of the bottom of the work. 在制造支架过程中,工作底板上的热量传递到已经制造的支架内部,加速支架内部水分的蒸发,使得支架能够在短时间内固化,在支撑自身重量的同时,也能够支撑后面即将在其上方制造的支架结构。 In the manufacturing process of the stent, the amount of heat transmitted to the inner working plate holder has been made to accelerate the evaporation of moisture inside the stent, so the stent can be cured in a short time, to support its own weight at the same time, it is possible to support the coming back thereover manufacturing a stent structure.

[0028]作为优选,所述工作底板与工作面之间通过螺栓连接,每个螺栓上套有弹簧,弹簧的两端分别与工作底板与工作面相抵。 [0028] Advantageously, between the base plate and the working face is connected by bolts, each bolt spring sleeve, the ends of the spring plate are working against the work surface. 本技术方案中,所述的工作底板与工作面之间通过螺栓连接,螺栓均匀的分布在工作底板的四个角落上,每个螺栓上套有弹簧,在正常情况下,弹簧处于被压缩的状态,通过调节螺栓,利用弹簧的回复力实现工作底板的运动,从而调节工作底板的水平度,保证支架的顺利制造。 In this aspect, the base plate is between the working face and is connected by bolts, evenly distributed in the four corners of the work floor bolts, each bolt spring sleeve, under normal circumstances, the spring is compressed state, by adjusting the bolts, using the restoring force of the spring effect movement of the work floor, so as to adjust the level of the work floor, to ensure smooth manufacturing the stent.

[0029] —种多孔骨支架制造方法,其特征在于,采用权利要求1〜8任一权利要求所述的多孔骨支架制造装置,包括如下步骤: [0029] - A method for producing seed porous bone scaffold, which is characterized in that a porous bone scaffold as claimed in claim manufacturing apparatus according to any one of claims 1~8, comprising the steps of:

[0030] (I)将待制造的骨支架结构三维模型转化成STL格式文件,输入骨支架制造装置中,设置温控单元的工作温度; [0030] (I) a bone scaffold three-dimensional model to be produced is converted into STL format, an input apparatus for manufacturing bone scaffold, provided the operating temperature of the temperature control unit;

[0031 ] (2)配置骨材料溶液,并将配置好的骨材料溶液置入挤出单元中; [0031] (2) Configuration of bone material solution, a solution of bone material and configured into an extrusion unit;

[0032] (3)挤出机构工作,挤出单元挤出骨材料,骨材料沉积在工作台,直至完成整个骨支架的沉积; [0032] (3) extruding the working mechanism, the extrusion unit extruding bone material, bone material is deposited on the table until the deposition is completed the entire bone scaffold;

[0033] (4)冷却,将得到的骨支架结构在80〜120°C烘箱中干燥20〜48小时,然后放到高温炉内高温1000〜1500°C保温2〜4小时,最后冷却得到骨支架结构。 [0033] (4) cooling the resulting bone structure of the stent at 80~120 ° C oven for 20~48 hours, and then placed in a high temperature furnace insulation temperature 1000~1500 ° C ~ 4 hours, and finally cooled to give a bone support structure.

[0034]作为优选,所述骨材料溶液为水凝胶溶液和粉体的混合物; [0034] Advantageously, the material solution for bone hydrogel solution and the powder mixture;

[0035] 所述水凝胶溶液为PVA水凝胶溶液、CMC水凝胶溶液、PEG水凝胶溶液中的一种或几种混合; [0035] The aqueous solution of a PVA hydrogel hydrogel solution, the CMC hydrogel solution, or a mixture of several PEG hydrogel in a solution;

[0036]所述粉体可以是硅酸盐、磷酸盐、生物玻璃中的一种或几种的混合,其粒径在I到1微米之间。 [0036] The powder may be a silicate, phosphate, bioglass several mixing of one or a particle size between 1 micron in I.

[0037]本发明的装置能够完成挤出单元的直线,圆弧,三维空间曲线等运动,可实现二维或三维的空间制造,可挤出水凝胶,海藻酸盐等高粘度的液体,利用把液体和粉末混合的生物墨水挤出后,水分的蒸发加速线条的固化,形成一定的自我支撑的能力,维持整个制造的三维结构的稳定性和孔道结构的规则性和结构的完整性,最后通过烧结工艺形成一定强度的多孔的骨支架结构。 [0037] The present invention can be accomplished motion linear, circular, three-dimensional curves of the extrusion unit, may be two or three dimensional space to achieve manufacturing extrudable hydrogels, alginate high viscosity liquid, after use of the liquid and the powder mixture is extruded bio-ink, accelerate the evaporation of moisture curing lines, a certain self-supporting ability to maintain structural integrity rules and pore structure and stability of the entire three-dimensional structure produced, Finally, the porous support structure is formed of a certain bone strength by a sintering process.

[0038]与现有技术相比,本发明具有如下优点: [0038] Compared with the prior art, the present invention has the following advantages:

[0039] —、本发明的多孔骨支架制造装置结构简单,操作方便,装置制造成本低,将生物墨水通过挤出机构沉积到工作底板上,利用高粘度生物墨水自支撑的特性,再加上加热膜对工作底板温度的精确控制,通过三维运动框架结构的运动,实现不同尺寸,不同形状的多孔骨支架结构的制造。 [0039] -, porous bone scaffold manufacturing apparatus simple structure, convenient operation, low cost device manufacturing, biological deposit ink onto the plate by extrusion working mechanism, the use of high viscosity ink from the biological characteristics of the present invention, the support, plus precise control of the heating temperature of the film on the work floor by the movement of the three-dimensional movement of the frame structure to achieve different sizes, for producing the porous structure of the bone scaffold different shapes.

[0040] 二、本发明的制造装置采用了直线步进电机驱动丝杆挤出生物墨水,丝杆运动匀速平稳,挤出力大,挤出量精确可控。 [0040] Second, the manufacturing apparatus of the present invention employs a linear stepper motor driven screw extruder bio-ink, uniform smooth screw movement, a large force is extruded, the extrusion amount precisely controllable.

[0041]三、本发明的制造装置可以制造不同孔形状,孔尺寸,不同侧孔高度的骨支架结构,只需要简单的设置制造的参数。 [0041] Third, the manufacturing apparatus of the present invention may be manufactured of different hole shapes, hole size, the height of the side hole structurally different bone scaffold, simply setting parameters produced.

[0042]四、本发明的制造装置通过更换不同形状的针头端部结构,可以制造不同线条形状的骨支架结构,同时通过针头端部与针头底座的分开设计,可以方便的更换针头端部。 [0042] Fourth, the manufacturing apparatus of the present invention through the needle end structure to replace a different shape, may be manufactured of different line shapes of the bone scaffold, through designed separately from the needle end of the needle base can easily replace the needle end portion.

[0043]五、本发明的制造装置可以按需要更换储液器,方便制造不同尺寸的骨支架结构。 [0043] Fifth, the manufacturing apparatus of the present invention can be replaced by a reservoir, ease of manufacture of a bone scaffold structures of different sizes.

附图说明 BRIEF DESCRIPTION

[0044]图1是本发明的多孔骨支架制造装置的结构示意图; [0044] FIG. 1 is a schematic diagram of the apparatus for manufacturing a porous structure of the bone scaffold according to the present invention;

[0045]图2是本发明的多孔骨支架的挤出机构的结构示意图; [0045] FIG. 2 is a schematic view of an extrusion mechanism porous bone scaffold of the present invention;

[0046]图3a是本发明的固定夹具和挤出单元结构示意图; [0046] FIG 3a is a fixture of the present invention and a schematic structure of the extrusion unit;

[0047]图3b是本发明采用另一种结构的固定夹具和挤出单元结构示意图; [0047] Figure 3b is a fixing jig of the present invention adopts another configuration of the cell structure and a schematic view of an extrusion;

[0048]图4是本发明的温控单元的结构示意图; [0048] FIG. 4 is a schematic diagram of the temperature control unit according to the present invention;

[0049]图5是本发明的针头端部的孔截面形状示意图; [0049] FIG. 5 is an end portion of the needle hole of the present invention is a schematic cross-sectional shape;

[0050]图6是本发明的装置在制造第一层的结构示意图; [0050] FIG. 6 is a configuration apparatus of the invention in a schematic view the manufacturing of the first layer;

[0051]图7是本发明的装置逐层制造中的结构示意图; [0051] FIG. 7 is a schematic structural diagram of layer by layer manufacturing apparatus according to the present invention;

[0052]图8是本发明的制造装置制造的支架表面结构的SEM图; [0052] FIG. 8 is a SEM view of the surface structure of the stent manufacturing apparatus according to the present invention is manufactured;

[0053]图9是本发明的制造装置制造的支架断面结构的SEM图; [0053] FIG. 9 is a SEM cross-sectional structure of the stent of FIG manufacturing apparatus according to the present invention is manufactured;

[0054] 图中:I为X运动单元,2为Y运动单元,3为Z运动单元,4为挤出机构,5为温控单元,6为挤出单元,7为工作面,8为上端面,9为滑块,10为光杆,11为丝杆,12为下端面,13为直线电机,14为移动夹具,15为底板,16为固定夹具,17为线型单元,18为储液器,19为针头底座,20为针头端部,21为夹具端盖,21a、卡合部,21b、定位部,21c、卡合部,21d、卡舌,22为夹具底座,22a、卡台,22b、卡槽,23为温度传感器,24为螺栓,25为弹簧,26为加热膜,27为工作底板,28为储液桶,29为活塞,30为推杆。 [0054] FIG: I is the X moving unit, moving unit 2 is Y, a Z moving unit 3, an extrusion mechanism 4, 5 is a temperature control unit, an extrusion unit 6, 7 is a face, 8 end surface 9 of the slider rod 10, lead screw 11, the lower end face 12, a linear motor 13, the clamp 14 is moved, the bottom plate 15, a fixed jig 16, a linear unit 17, the reservoir 18 is , a base 19 of the needle, the needle end portion 20, a clamp cover 21, 21a, the engaging portion, 21b, the positioning portion, 21c, the engaging portion, 21d, the tabs 22 of the clip seat, 22a, card sets , 22b, slot, a temperature sensor 23, a bolt 24, a spring 25, the film 26 is heated, the working plate 27, a reservoir 28 for the barrel, a piston 29, the push rod 30.

具体实施方式 detailed description

[0055]下面结合附图和实施过程对本发明作进一步的说明。 [0055] The present invention will be further explained in conjunction with the accompanying drawings and the implementation process.

[0056]如图1所示,一种多孔骨支架制造装置,包括:三维运动框架结构、安装在三维运动框架结构上的挤出单元6、控制挤出单元6挤出溶液的挤出机构4、工作面7以及安装在工作面7上的温控单元5。 [0056] As shown, a porous bone scaffold manufacturing apparatus 1, comprising: a frame structure three-dimensional motion, the extrusion unit is mounted on the three-dimensional movement of the frame structure 6, 6 Extrusion The extrusion unit extruding mechanism 4 solution 7 and a temperature control unit 5 is mounted on the face of the face 7.

[0057] 三维运动框架结构包括固定框架、估计在固定框架上的X运动单元I,Y运动单元2和Z运动单元3,Y运动单元2。 [0057] The three-dimensional movement of the frame structure includes a fixing frame, motion estimation X on the stationary frame unit I, Y moving unit moving unit 2 and Z 3, Y moving unit 2. 其中Y运动单元2包括安装在固定框架顶部的Y轴轨道以及滑动设置在Y轴轨道上的Y轴滑块。 Wherein Y moving unit 2 comprises a fixed frame mounted on the top of the Y-axis rail and a Y-axis slider is moved in the Y-axis rail. X运动单元I则包括X轴轨道以及滑动设置在X轴轨道上的X轴滑块。 I the X moving unit comprises an X-axis slider and X-axis rails slidably disposed in the X-axis rails. Z运动单元3包括安装在定框架一侧的Z轴轨道以及滑动设置在Z轴轨道上的Z轴滑块。 Z Z-axis moving unit 3 includes a slider slidably disposed and a Z-axis rail mounted on the side of the fixed frame in the Z-axis rail.

[0058] X运动单元I的X轴轨道安装在Y运动单元2的Y轴滑块上,跟随Y运动单元2在Y方向上往复运动。 [0058] X-axis rails I X moving unit mounted on the Y slider Y-axis moving unit 2, the Y moving unit 2 to follow the reciprocating motion in the Y direction. 挤出机构4通过挤出机构4与X轴滑块相对固定,通过X运动单元I的往复运动,实现安装在X运动单元I上的挤出单元6在XY平面内的运动。 Extruded through an extrusion mechanism 4 and the X-axis slide mechanism 4 is relatively fixed, reciprocates the X moving unit I, to achieve movement of the extrusion unit 6 mounted on the X moving unit I in the XY plane. 工作面7与Z轴滑块相对固定,通过Z运动单元3,实现工作面的Z方向相对运动,实现挤出单元相对工作面在三维空间内的运动。 7 and Z axis slide relative to the fixed face, the Z moving unit 3, to achieve a relative movement in the Z direction face, the face opposite effect movement of the extrusion unit in the three-dimensional space.

[0059] 挤出单元6安装在挤出机构4上,固定夹具16,直线电机13,上端面8和下端面12都固定在底板15上,底板15安装在三维运动框架结构的X运动单元I上,工作面7安装在三维运动框架结构的Z运动单元3上。 [0059] The extrusion unit 6 is mounted on the extrusion means 4, the fixing jig 16, the linear motor 13, the end surface 8 and the lower end face 12 are fixed to the base 15, the base plate 15 is mounted on a three-dimensional X moving unit moving frame structure of I on the face 7 is mounted on the Z moving unit three-dimensional structure of the moving frame 3.

[0060]如图2所示,挤出机构4包括:底板15,用于固定挤出单元6的固定夹具16,用于推动储液器18中的液体挤出的移动夹具14,驱动移动夹具14往复运动的丝杆11,驱动丝杆11往复运动的直线电机13,固定安装在丝杆11上的滑块9,配合丝杆11运动并起导向作用的光杆10,固定光杆10两端的上端面8和下端面12。 [0060] 2, 4 out mechanism comprising: a base plate 15 for fixing the fixing jig 6 extrusion unit 16 for moving the liquid in the reservoir 18 pushing extruded clamp 14, the clamp moves the drive 10, the fixed rod 10 on both ends of the linear motor slider rod 14 reciprocating screw 11, screw 11 driven to reciprocate 13, 11 fixedly mounted on the spindle 9, with the screw 11 and serves as a guide of movement 8 and the lower end surface of the end face 12. 底板15与X轴滑块相对固定。 Base plate 15 is fixed relative to the X-axis slider. 固定夹具16固定在底板15上。 Fixing jig 16 fixed to the base 15. 移动夹具14 一端与丝杆11固定连接,另一端与推杆30通过设置在固定夹具内的卡合螺母固定连接。 Moving the clamp screw 11 with one end 14 fixedly connected to the other end of the push rod 30 is provided by the card in the fixed clamp nut is fixedly connected. 上端面8和下端面12限制了滑块9两个方向的移动极限位置。 Upper end surface 8 and the lower end surface 12 limits the movement limit position of the slider 9 in both directions. 挤出机构4通过直线电机13驱动安装在直线电机13上的丝杆11上下运动,丝杆11上端由于与滑块9固定,跟随滑块9沿着均匀对称分布的2根光杆11上下运动,保证了丝杆11下端的移动夹具14能够稳定的上下运动,丝杆11下端通过螺母与移动夹具14固定,通过移动夹具14的运动,从而实现推杆30的运动,达到溶液挤出的目的。 Vertical movement mechanism 11 screw extruder 4 driven by a linear motor 13 mounted on a linear motor 13, since the upper end of the screw 11 fixed to the slider 9, the slider 9 follows the symmetrical distribution along the two rod 11 up and down movement, ensuring the movement of the clamp screw 11 the lower end 14 of vertical movement can be stabilized, the lower end of the clamp screw 11 is fixed by a nut 14 and a mobile, the movement by moving the jig 14, such that motion of the push rod 30, the purpose of the solution extruded.

[0061]如图2所示,挤出单元6包括储存溶液的储液器18和控制挤出溶液形状的线型单元17,线型单元17安装在所述的储液器18上。 [0061] 2, the extrusion unit 6 comprises a storage reservoir 18 and a control solution is a solution of a linear extruded shape unit 17, line unit 17 is mounted in the reservoir 18.

[0062] 如图6和图7所示,储液器18包括储液桶28,推动液体运动的活塞29,固定安装在活塞29上的推杆30,推杆30固定在上述的移动夹具14上,通过移动夹具14的往复运动,带动安装在移动夹具14上的推杆30的运动,从而带动与推杆30相连的活塞29的运动,实现储液桶28内的液体的挤出与回吸,活塞29需要与储液桶28有好的配合,防止储液桶28内的溶液从活塞29处漏出。 [0062] FIG. 6 and FIG. 7, the reservoir 18 comprises a reservoir tub 28, to promote movement of the liquid piston 29, the push rod 30 is fixedly mounted on the piston 29, the push rod 30 fixed to the moving jig 14 on, by moving the clamp 14 reciprocates to drive the movement of push rod 30 is mounted on the moving clamp 14, so as to drive the movement of the piston 29 and the rod 30 is connected, the liquid in the reservoir to achieve the tub 28 and is extruded back withdrawing the piston 29 and the reservoir tub 28 needs to have a good fit, to prevent the solution in the reservoir tub 28 from leaking from the piston 29.

[0063] 储液器18可以是现有的商用注射器,便于更换和购买,如Iml注射器,2ml注射器,5ml注射器,1ml注射器等。 [0063] The reservoir 18 may be a conventional commercial syringes, easy to replace and purchase, such as a syringe Iml, 2ml syringes, syringes 5ml, 1ml syringe or the like.

[0064] 如图3a和图3b所示,线型单元17包括针头底座19和针头端部20,针头底座19与储液器18上的储液桶28的底部固定,针头端部20通过螺纹方式与针头底座19固定,方便拆卸和更换针头〗而部。 [0064] Figures 3a and 3b, the linear unit 17 includes a needle 19 and a base 20, with the bottom of the reservoir on the tub 18, the accumulator 28 is fixed, the needle end of the needle base 19 by a threaded needle end portion 20 with the needle base 19 is fixed manner, to facilitate removal and replacement of the needle〗 portion.

[0065]如图5所示,针头端部20内部孔道横截面的形状可以是三角形(图5中(a)所示),正方形(图5中(b)所示),五边形(图5中(c)所示),六边形(图5中(d)所示),圆形(图5中(e)所示)等,溶液经针头端部20被活塞29挤出,针头端部20内部的形状直接决定挤出的线条的形状。 [0065] FIG. 5, the inner end 20 of the needle bore cross-sectional shape may be a triangle (FIG. 5 (a) as shown), square (FIG. 5 (b) below), pentagons (FIG. 5 (c),), hexagonal (in FIG. 5 (d) below), circular (in FIG. 5 (e) as shown) or the like, the end portion of the needle solution was 20 extruded by the piston 29, the needle shape of the inner end portion 20 will determine the shape of the extruded line. 针头端部20内部的孔径尺寸可调,可以方便的拆卸和更换不同孔径的针头端部,以满足支架结构不同孔隙率的需求。 Needle end portion 20 of the inner aperture of adjustable size, can easily remove and replace the needle end portion of different pore sizes, to meet the needs of different porosity stent structure.

[0066]如图3a和图3b所示,为两种结构的固定夹具。 [0066] shown in FIGS. 3a and 3b, the fixture of the two structures. 两种结构的固定夹具16均包括用来固定挤出单元6的夹具底座22和安装在夹具底座22上的夹具端盖21,挤出单元6中的储液器18嵌在夹具底座22的凹槽内,起到对储液器18进行定位和固定的作用,同时夹具端盖21盖住储液器18,使安装在储液器18下端的线型单元17的针头端部20经夹具端盖21的通孔暴露在空气中,夹具端盖21卡住线型单元17的针头底座19,防止挤出单元6中的线型单元17因自重、长时间的工作、或者溶液堵塞线型单元等原因而脱落,影响之前已经制造好的支架结构。 Fixing jig 16 includes two structures for fixing the base 6 of the extrusion unit 22 and the gripper clamp is mounted on the jig base 22 of cap 21, out of the reservoir unit 618 in the recess is embedded in the clamp base 22 tank, functions of accumulator 18 for positioning and fixing effect while the jig 21 covering the reservoir cap 18, so that the linear unit is mounted on the lower end of the reservoir 18 through the needle end portion 20 of the clip end 17 the cover through hole 21 is exposed to air, the jammed cap 21 clamps the base 17 of the linear section of the needle 19, 17 to prevent its own weight, linear long work unit 6 extrusion unit, linear unit or plugging solution other reasons to fall off, the support structure has been fabricated before impact.

[0067]图3a中,夹具底座22两侧设有两个卡台22a,用于防止夹具端盖21向下脱落;夹具端盖21包括设置在顶部用于与卡台22a卡合的卡合部21a,以及设置在底部用于固定针头底座19的定位部21b;实际安装时,将夹具端盖21与针头底座19定位后,推进夹具端盖21,当卡合部21a与卡台22a卡合到位即可完成夹具端盖21的安装。 In [0067] FIG. 3a, 22 on both sides of the clamp base is provided with two sets of card 22a, the end cap 21 for preventing the falling-down clamp; jig 21 includes a cap provided at the top of the card and the card table 22a for engaging the engagement portion 21a, and is provided for positioning the bottom portion 21b of the fixing base 19 of the needle; the actual installation, end cap clamp 21 is positioned with the needle base 19, cover 21 clamps advance, when the engagement portion 21a of the card table card 22a into place to complete installation jig 21 of the end cap.

[0068]图3b中,夹具底座22两侧设有两个卡槽22b;夹具端盖21包括设置在顶部用于与夹具底座22卡合的卡合部21c,以及设置在底部用于固定针头底座19的定位部21b。 [0068] FIG. 3b, the base 22 is provided with two slots on both sides of the jig 22b; jig provided at the top end cap 21 includes a seat 22 for engagement with the clamp engagement portion 21c, and is provided at the bottom for fixing the needle positioning the base portion 21b 19. 卡合部21c内侧设有与卡槽22b卡合的凸起,用于防止夹具端盖21向一侧偏移;卡合部21c底部设有内折的卡舌21d,用于与夹具底座22底端边缘卡合,方防止夹具端盖21脱落。 The inner engaging portion 21c is provided with a projection engaging slot 22b for preventing the clamp 21 is shifted to the side of the end cap; bottom of the engagement portion 21c is provided inside the folded tabs 21 d, for the jig base 22 engaging the bottom edge of the square to prevent the end cap 21 off the jig.

[0069]本发明中,固定夹具16可以随意更换,方便安装不同尺寸的储液器18,满足不同体积溶液的需要,实现不同尺寸的支架的制造。 [0069] In the present invention, the fixing jig 16 can freely change, easy to install different sized accumulator 18, to meet the needs of different volume of the solution to achieve different sizes of manufacturing the stent.

[0070]如图4所示,温控单元5包括工作底板27,安装在工作底板27背面(底面)上的加热膜26,安装在工作底板27上的温度传感器23,连接加热膜26和温度传感器23的温控仪,利用温控仪调节加热膜26的开和关,再通过温度传感器23对工作底板27上的温度的检测,实现对工作底部27上温度的精确实时控制。 [0070] 4, the temperature control unit 5 includes a working plate 27, heating the film 27 is mounted on the back surface (bottom surface) of the work plate 26, the temperature sensor 27 is mounted onto a base plate 23, and a film 26 connecting the heating temperature sensor temperature controller 23 by adjusting the heating temperature controller 26 on and off membrane, and then the temperature detected by the temperature sensor 27 on the bottom plate 23 of the work, the precise real-time control of the temperature of the bottom 27 of the work. 在制造支架过程中,工作底板27上的热量传递到已经制造的支架内部,加速支架内部水分的蒸发,使得支架能够在短时间内固化,在支撑自身重量的同时,也能够支撑后面即将在其上方制造的支架结构。 In the manufacturing process of the stent, the amount of heat transmitted to the bottom plate 27 inside the work holder has been made to accelerate the evaporation of moisture inside the stent, so the stent can be cured in a short time, to support its own weight at the same time, can be supported at its rear is about manufacturing a stent structure above.

[0071]如图4所示,工作底板27与工作面7之间通过螺栓24连接,螺栓24均匀的分布在工作底板27的四个角落上,每个螺栓24上套有弹簧25,在正常情况下,弹簧25处于被压缩的状态,通过调节螺栓24,利用弹簧25的回复力实现工作底板27的运动,从而调节工作底板27的水平度,保证支架的顺利制造。 [0071] 4, the working face 27 and the bottom plate 7 is connected by bolts 24 between the bolt 24 evenly distributed in the four corners of the work floor 27, each bolt 24 on a spring sleeve 25, in the normal case, the spring 25 in a compressed state, by the adjusting bolt 24 by the restoring force of the spring 25 to achieve movement of the working plate 27, thereby adjusting the working level of the bottom plate 27 to ensure the smooth fabricating a stent.

[0072]实施例 [0072] Example

[0073]如图8和图9所示,是利用本发明的多孔骨支架制造装置制造的多孔骨支架的表面电镜图和断面电镜图,以硅酸盐粉体的骨支架结构为例,来说明本发明装置的工作过程: [0073] FIGS. 8 and 9, a porous bone scaffold is porous bone scaffold manufacturing apparatus of the present invention and a cross-sectional electron micrograph of the surface electron micrographs, bone scaffold silicate powder, for example, to Description of the working process of the present invention apparatus:

[0074] I)通过化学合成方法制备硅酸盐粉体,或者直接采用市购产品,通过球磨处理得至IJ5到10微米大小的粉体,配置浓度在5 %到8 %之间的PVA水溶液,然后把粉体和溶液按重量比1.4〜1.6:1的比例混合均匀,得到可挤出的高粘度的生物墨水; [0074] I) preparing a silicate powder synthesized by chemical methods, using the commercially available products or directly, to the powder obtained by the ball mill treatment IJ5 to 10 micron size, arranged in a concentration of between 5% aqueous solution of PVA to 8% and then a solution of the powder and 1.4~1.6 weight ratio: 1 ratio mixed to obtain a biological extrudable high viscosity ink;

[0075] 2)将上述方法得到的生物墨水装入储液桶28,去掉储液桶28内的生物墨水中的气泡,在储液桶28的底部装上内部孔结构为圆形的线型单元17,如图5(e),然后将挤出单元6安装到固定夹具16的夹具底座22上,将推杆30装到移动夹具14上,盖上夹具端盖21; [0075] 2) The ink obtained as described above was charged biological reservoir barrel 28, to remove air bubbles in the ink reservoir biological bucket 28, the bucket 28 at the bottom of the reservoir is mounted on the internal pore structure of the circular line unit 17, FIG. 5 (e), and then the extrusion unit 6 is mounted to the fixing jig 22 on the jig base 16, the push rod 30 is attached to the mobile jig 14, the jig cover cap 21;

[0076] 3)将温控单元5打开,设置工作底板27的温度为40°C,等待工作底板27到达设定的温度。 [0076] 3) a temperature control unit 5 to open, set the operating temperature of the base plate 27 is 40 ° C, waiting for work plate 27 reaches the set temperature.

[0077] 4)开始调节初始高度,使针头端部20的下表面与工作底板27平齐,记下此时的高度。 [0077] 4) adjust the initial start height, so that the lower surface of the needle end portion 20 of the base plate 27 flush with the work, note the height at that time.

[0078] 5)在计算机内将骨支架结构三维模型转化成STL格式文件,输入骨支架制造装置,再将步骤4中得到的高度输入骨支架制造装置,进行高度补偿,通过CAM软件将其转化为骨支架制造装置可以识别的G代码。 [0078] 5) In three-dimensional computer model of the bone scaffold transformed into STL format, input means for producing bone scaffold, a bone scaffold height input apparatus manufacturing step 4 then obtained, for height compensation, which was converted by CAM software bone is a G code stent manufacturing apparatus can recognize.

[0079] 6)开始制造支架:骨支架制造装置回零。 [0079] 6) Start stent manufactured: zero back bone scaffold manufacturing apparatus.

[0080] 7)挤出单元6运动到所需的位置,针头端部20距离工作底板27的高度为第一层的高度。 Position [0080] 7) the extrusion unit 6 is moved to the desired height of the needle end portion 20 of the base plate 27 from the working height of the first layer.

[0081] 8)Z运动单元3保持高度不变,X、Y运动单元按照程序运动,同时直线电机13也开始运动,带动丝杆11和活塞29向下运动,挤压储液桶28内的生物墨水,使其从针头端部20挤出。 [0081] 8) Z moving unit 3 remains constant height, X, Y motion unit according to a program movement, while the linear motor 13 also starts to move, driven by the screw 11 and the piston 29 moves downward, squeezing the reservoir barrel 28 bio-ink, it is extruded from the needle end portion 20. 如图6所示。 As shown in Figure 6.

[0082] 9)随着挤出单元6在XY平面内的运动和储液桶28内的生物墨水的挤出、回吸或停止,挤出材料按需沉积在工作底板27上,直到这一层制造完为止。 [0082] 9) with an extrusion unit and the reservoir 6 is moved in the XY plane of the tub extruded bio-ink within 28 suck back or stop, as needed extruded material is deposited on the working plate 27, until the Ends layer manufactured so far.

[0083] 10)直线电机13停止工作,Z运动单元3下降一个层高,Χ、Υ运动单元运动到第二层开始的坐标,开始新一层的制造,重复步骤9。 [0083] 10) the linear motor 13 is stopped, Z moving unit 3 descends a storey, Χ, Υ moving unit is moved to the coordinate of the start of the second layer begins manufacturing a new layer, repeat step 9. 如图7所示。 As shown in FIG.

[0084] 11)待所有层都制造完成,直线电机13停止工作,三维运动框架结构带动挤出单元6回到原点。 [0084] 11) to be manufactured complete all layers, the linear motor 13 is stopped, the three-dimensional movement of the frame structure to drive the extrusion unit 6 back to the origin.

[0085] 12)等待一段时间后,取出制造完成的支架结构,把得到的支架结构在100°C烘箱中干燥24小时。 [0085] 12) after a specified time, remove the support structure completely manufactured, the scaffold was dried in an oven at 100 ° C for 24 hours.

[0086] 13)从烘箱中取出支架,放到高温炉内高温1150 °C保温3小时,最后炉内室温冷却得到多孔骨支架结构。 [0086] 13) the holder removed from the oven, placed in a high temperature furnace temperature 1150 ° C for 3 hours, and finally furnace cooled to room temperature to obtain porous bone scaffold. 如图8和图9所示。 8 and 9.

Claims (10)

  1. 1.一种多孔骨支架制造装置,包括三维运动框架结构、安装在三维运动框架结构上的挤出单元、控制挤出单元挤出骨材料的挤出机构、支撑多孔骨支架的工作面以及安装在工作面上的温控单元;其特征在于: 所述挤出单元包括储存骨材料溶液的储液器以及固定在储液器出料端的用于控制挤出骨材料形状的线型单元; 所述的挤出机构包括: 用于固定所述挤出单元的固定夹具; 用于推动储液器中的骨材料挤出的推杆; 驱动推杆往复运动的驱动机构; 所述挤出单元在三维运动框架结构内做X轴和Y轴方向的往复移动,所述工作面在三维运动框架结构内做Z轴方向的往复移动。 An apparatus for producing porous bone scaffold, three-dimensional movement comprising a frame structure, the extrusion unit is mounted on the three-dimensional movement of the frame structure, an extrusion unit extruding a control mechanism of bone material, porous bone support face and a mounting bracket in the temperature control unit of the work surface; wherein: said extrusion unit comprises a unit linear extruded material shape of the bone the bone material solution storage reservoir, and a fixed discharge end of the reservoir for controlling; the said extrusion mechanism comprises: fixing jig for fixing said extrusion unit; means for promoting bone material in the reservoir of the ram extrusion; ram driving mechanism to reciprocate; in the extrusion unit do X axis and Y axis direction in the three-dimensional movement of the frame structure of the reciprocating movement, Z-axis direction to make the face of the frame structure in the three-dimensional motion to reciprocate.
  2. 2.根据权利要求1所述的多孔骨支架制造装置,其特征在于,所述固定夹具包括: 与三维运动框架结构固定连接的夹具底座; 与夹具底座可拆卸固定的夹具端盖,该夹具端盖将挤出单元可拆卸固定在所述夹具底座上。 The porous bone scaffold manufacturing apparatus according to claim 1, characterized in that, said fixture comprising: a fixture base and three-dimensional motion of the frame structure is fixedly connected; detachable fixing jig and the jig base end cap, the end jig the extrusion unit cover removably secured to said base clamp.
  3. 3.根据权利要求2所述的多孔骨支架制造装置,其特征在于,所述夹具底座两侧设有卡台;所述夹具端盖包括设置在顶部用于与卡台卡合的卡合部,以及设置在底部用于固定线型单元的定位部。 3. The porous bone scaffold manufacturing apparatus according to claim 2, characterized in that, on both sides of the clip base is provided with the card table; said clamp comprises a cap engaging portion provided at the top of the table to engage with the card , and a positioning portion provided at the bottom for fixing the linear unit.
  4. 4.根据权利要求2所述的多孔骨支架制造装置,其特征在于,所述夹具底座两侧设有卡槽;所述夹具端盖顶部设有用于与夹具底座卡合的卡合部,底部设有用于固定针头底座的定位部;所述卡合部两侧设有与所述卡槽卡合的凸起,底部设有向内弯折用于卡住线型单元底部边缘的卡舌。 4. The porous bone scaffold manufacturing apparatus according to claim 2, wherein said clamp is provided with slots on both sides of the base; a top end cap provided with the clamp engaging portion for engaging with the clip seat bottom a positioning portion for fixing the needle base; said card engagement portion is provided on both sides of the projection engaging slot, inwardly bent tabs provided for the bottom line of the bottom edge of the jammed unit.
  5. 5.根据权利要求1所述的多孔骨支架制造装置,其特征在于,所述储液器为注射器,注射器内的活塞与所述推杆固定,注射器的外壳固定在固定夹具上。 The porous bone scaffold manufacturing apparatus according to claim 1, wherein the reservoir is a syringe piston and the push rod fixed in the syringe, the syringe is fixed to the fixture housing.
  6. 6.根据权利要求1所述的多孔骨支架制造装置,其特征在于,所述的线型单元包括针头底座和针头端部,针头端部通过螺纹方式与针头底座固定;所述的针头端部内部通道的横截面形状为三角形,正方形,五边形,六边形,圆形中的一种。 6. A porous bone scaffold manufacturing apparatus according to claim 1, wherein said linear element includes a needle and a base end portion of the needle, the needle end portion threadably secured by the needle header; needle end portion of the the internal cross-sectional shape of the channel is triangular, square, pentagonal, hexagonal, in a round.
  7. 7.根据权利要求1所述的多孔骨支架制造装置,其特征在于,所述的温控单元包括安装在工作面上的工作底板、设置在工作底板上的加热膜和温度传感器以及连接加热膜和温度传感器的温控仪。 The porous bone scaffold manufacturing apparatus according to claim 1, wherein said temperature control unit comprises a base plate mounted on a working surface, is provided on the working floor heating the film and heating the film temperature sensor and the connection temperature controller and a temperature sensor.
  8. 8.根据权利要求7所述的多孔骨支架制造装置,其特征在于,所述工作底板与工作面之间通过螺栓连接,每个螺栓上套有弹簧,弹簧的两端分别与工作底板与工作面相抵。 8. porous bone scaffold manufacturing apparatus according to claim 7, characterized in that the working face between the base plate and connected by bolts, each bolt spring sleeve, the ends of the spring respectively the work floor and work surface even.
  9. 9.一种多孔骨支架制造方法,其特征在于,采用权利要求1〜8任一权利要求所述的多孔骨支架制造装置,包括如下步骤: (1)将待制造的骨支架结构三维模型转化成STL格式文件,输入骨支架制造装置中,设置温控单元的工作温度; (2)配置骨材料溶液,并将配置好的骨材料溶液置入挤出单元中; (3)挤出机构工作,挤出单元挤出骨材料,骨材料沉积在工作台,直至完成整个骨支架的沉积; (4)冷却,将得到的骨支架结构在80〜120 0C烘箱中干燥20〜48小时,然后放到高温炉内高温1000〜1500°C保温2〜4小时,最后冷却得到骨支架结构。 A method of manufacturing a porous bone scaffold, which is characterized in that a porous bone scaffold as claimed in claim manufacturing apparatus according to any one of claims 1~8, comprising the steps of: (1) bone scaffold structure to be fabricated three-dimensional model conversion into the STL format, an input apparatus for manufacturing bone scaffold, provided the operating temperature of the temperature control unit; (2) configuration of bone material solution, a solution of bone material and configured into the extrusion unit; and (3) extruding mechanism work , extrusion unit extruding bone material, bone material is deposited on the table until the entire bone scaffold deposition is completed; bone support structure (4) is cooled, the resultant was dried in an oven 80~120 0C 20~48 hours, then put temperature to a high temperature furnace insulation 1000~1500 ° C ~ 4 hours, and finally cooled to give a bone scaffold.
  10. 10.根据权利要求9所述的多孔骨支架制造方法,其特征在于,所述骨材料溶液为水凝胶溶液和粉体的混合物; 所述水凝胶溶液为PVA水凝胶溶液、CMC水凝胶溶液、PEG水凝胶溶液中的一种或几种混合; 所述粉体可以是硅酸盐、磷酸盐、生物玻璃中的一种或几种的混合,其粒径在I到10微米之间。 10. A method of manufacturing a porous bone scaffold according to claim 9, wherein said bone material solution is a solution of a mixture of water and gel powder; the hydrogel solution is a solution of PVA hydrogels, the CMC water gel solution, mixed with one or more PEG hydrogel solution; the powder may be mixed silicate, phosphate, bioglass of one or more of a particle size in the 10 to I between microns.
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