CN107349030B - 多孔金属棒 - Google Patents

多孔金属棒 Download PDF

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CN107349030B
CN107349030B CN201610299664.1A CN201610299664A CN107349030B CN 107349030 B CN107349030 B CN 107349030B CN 201610299664 A CN201610299664 A CN 201610299664A CN 107349030 B CN107349030 B CN 107349030B
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porous metal
hole
metal rod
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shaft
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CN107349030A (zh
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叶雷
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Chongqing Runze Pharmaceutical Co Ltd
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Chongqing Runze Pharmaceutical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
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    • 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
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    • 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
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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
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    • 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
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30433Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
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    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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    • A61F2310/00017Iron- or Fe-based alloys, e.g. stainless steel
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    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys
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    • A61F2310/00005The prosthesis being constructed from a particular material
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    • A61F2310/00035Other metals or alloys
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    • A61F2310/00035Other metals or alloys
    • A61F2310/00131Tantalum or Ta-based alloys

Abstract

一种多孔金属棒,包括多孔金属材料构成的本体,本体为圆棒状,分大端、小端,大端内部有盲孔,盲孔中靠近大端外端的部分为螺纹孔,另一部分为直壁孔,在盲孔内装有推进轴,推进轴包括螺纹部分和锥形轴部分,锥形轴部分轴向外侧面的直径由靠近螺纹部分的大端向外线性逐渐减小;在盲孔内装有侧向块,侧向块内侧面与锥形轴的轴向外侧面相匹配,外侧面与大端的直壁孔配合,直壁孔壁上分布有通孔,通孔内装有凸针,凸针包括圆柱部和带尖锥形部,尖指向外,凸针长度l大于大端直壁孔壁厚b,锥形轴锥度角α与凸针长度l、大端直壁孔壁厚b、锥形轴部分长度z满足α≥2arctg((l‑b)/z),该多孔金属棒避免了在骨内攻丝,减少了手术时间,使固定效果更好。

Description

多孔金属棒
技术领域
本发明涉及假体领域,具体涉及一种用于治疗早、中期股骨头坏死的医用植入的多孔金属棒。
背景技术
股骨头坏死是由多种原因引起的股骨头血供破坏、骨细胞变性导致骨的活性成分死亡的病理过程。早期的临床症状是患侧髋关节的慢性疼痛、活动功能障碍及进行性跛行为,如果进一步发展,将发展为髋关节骨性关节炎,直至导致关节僵硬,并可引起持续性的关节疼痛,是临床常见的疾病之一。我国的股骨头坏死人群数量非常庞大,常发于30-50岁青壮年,致残率极高,治疗困难,其中约80%的患者会发生股骨头塌陷,5%-12%的患者需行人工全髋关节置换术,会给个人生活和工作造成严重的影响。
随着临床检查技术的不断进步,越来越多的早期股骨头坏死患者得以发现,对于早期发现股骨头坏死并且股骨头尚保持良好形态的的患者来说,及时进行有意义的保髋手术治疗,不仅能都在一定程度上减轻病痛,大大提高生活质量,延缓病情的进一步发展,延迟进行全髋关节置换的时间,甚至还可以避免患者进行全髋关节置换手术。
髓芯减压加自体骨移植术作为一种改良保髋手术,主要针对早期股骨头缺血坏死,手术操作相对简单,在临床易广泛开展,但减压后的股骨头内的结构支持不足,有时甚至会加快股骨头的塌陷。
植入金属棒如多孔金属棒是一种新的保髋手术,通过在股骨头坏死早期行髓芯减压时的减压通道进行植入,靠周围骨组织生长包裹及长入等方式进行固定,对减压后的股骨头起到了良好的结构性支撑作用,而且棒的多孔结构还可以刺激骨组织修复以及成骨细胞的牢固生长,并使坏死区域再血管化,它为早期的股骨头坏死患者提供了一种新的保髋手术治疗选择,创伤相对较小,手术操作相对简单,能延缓病情的进一步发展,延迟进行全髋关节置换的时间,甚至还可以避免患者进行全髋关节置换手术,从而易为医生及患者所接受。目前国外的多孔金属棒已在国内临床应用于治疗早、中期股骨头坏死,如多孔钽金属棒。
发明专利CN 103462730 B 一种多孔钽棒及其应用介绍了一种多孔钽棒,用于治疗早、中期股骨头坏死。该多孔钽棒包括本体,本体由化学气相沉积方法制备的多孔钽制成,本体的一端设置有凹槽,可负载骨髓基质干细胞或骨髓基质干细胞联合生物膜复合体等,有利于新生骨的生成,另一端为螺纹结构,所述螺纹结构末端端面上设置有槽口。
由于现有的多孔金属棒有螺纹结构,在植入时,需要专用攻丝工具,且花费一定的攻丝时间,延长了手术时间,有的病人在骨内攻丝效果不佳,影响了固定效果。
发明内容
本发明的目的在于提供一种用于治疗早期股骨头坏死的避免在骨内攻丝的医用植入的多孔金属棒。
发明人认为,螺纹结构仅是多孔金属棒的一种固定方式,如果利用松质骨具有孔隙结构的特点,在多孔金属棒上有尖状物插入孔隙,也可以实现固定的效果。由此,本发明提出了如下技术方案:
一种多孔金属棒,包括多孔金属材料构成的本体,本体的一端为圆棒状,为小端,本体的另一端为大端,外形为圆棒状,与小端同轴,圆棒状外径大于小端外径,大端内部有盲孔,盲孔沿轴向分为两部分,靠近大端外端的部分为螺纹孔,另一部分为直壁孔,在盲孔内装有致密材料制备的推进轴,推进轴包括两部分,一部分为螺纹部分,该部分的外螺纹与螺纹孔的内螺纹相配,另一部分为锥形轴部分,锥形轴部分与螺纹部分同轴,锥形轴部分轴向外侧面的直径由靠近螺纹部分的大端向外线性逐渐减小,推进轴螺纹部分端部有槽口;在盲孔内装有侧向块,侧向块内侧面与锥形轴的轴向外侧面相匹配,外侧面与大端的直壁孔配合,直壁孔壁上分布有通孔,通孔内装有凸针,凸针包括圆柱部和带尖锥形部,尖指向外,凸针长度l大于大端直壁孔壁厚b,锥形轴锥度角α与凸针长度l、大端直壁孔壁厚b、锥形轴部分长度z满足以下关系式: α≥2arctg((l-b)/z)。
通过上述结构,可以实现植入后凸针被插入植入的松质骨孔隙中,起到固定多孔金属棒的作用。
进一步说,所述的多孔金属棒,所述的盲孔的最小壁厚不小于3mm,既保证了多孔金属棒的强度,又保证了骨组织长入有一定的深度,使多孔金属棒与骨组织固定牢靠。
进一步说,所述的多孔金属棒,所述的凸针直径为1mm-2mm,便于尖部与松质骨匹配。
进一步说,所述的多孔金属棒,所述的本体大端到小端通过直径逐渐减小过渡,以避免大端与小端的交界处产生较大的应力。
进一步说,所述的多孔金属棒,所述的直壁孔底部圆角、本体小端与大端交界处的圆角不小于1.5mm,以避免此处尖角产生较大的应力。
进一步说,所述的多孔金属棒,所述的螺纹孔螺纹、推进轴螺纹为圆形螺纹,根部圆角半径大于0.5mm,以降低应力。
进一步说,所述的多孔金属棒,所述的多孔金属棒本体的孔隙率为50%-85%,孔径为350µm-600µm,以便于骨组织长入。
进一步说,所述的多孔金属棒,所述的多孔金属棒本体、推进轴、侧向块、凸针由医用钛及合金、医用铌及合金、医用钽及合金、医用不锈钢、医用钴基合金制备。
本发明的有益效果:
(1)本发明通过在多孔金属棒的大端的外侧伸出凸针插入植入的松质骨孔隙中,起到固定多孔金属棒的作用,避免了在骨内攻丝,减少了手术时间,使固定效果更好,且安装方便、快捷。
(2)盲孔最小壁厚的设定既保证了多孔金属棒的强度,又保证了骨组织长入有一定的深度,使多孔金属棒与骨组织固定牢靠。
(3)凸针直径尺寸设计既使多孔金属棒固定牢靠,又不会破坏松质骨。
(4)多孔金属棒的大端到小端通过直径逐渐减小过渡,避免了大端与小端的交界处产生较大的应力。
(5)多孔金属棒的直壁孔底部圆角、本体小端与大端交界处的圆角不小于1.5mm,避免了此处尖角产生较大的应力。
(6)多孔金属棒的螺纹孔螺纹、推进轴螺纹为圆形螺纹,根部圆角半径大于0.5mm,降低了螺纹部分的应力。
(7)使多孔金属棒的多孔金属材料的孔隙率为50%-85%,孔径为350µm-600µm,有利于骨组织长入。
附图说明
下面将结合附图与实施例对本发明作进一步阐述。
图1为本发明多孔金属棒结构示意图,图2为图1的俯视图,图3为图1的A-A剖视图,图4为多孔金属棒本体结构示意图,图5为推进轴结构示意图,图6为凸针结构示意图,图7为螺纹部分牙型结构示意图,图8为实施例2 多孔金属棒本体结构示意图。
具体实施方式
下面结合附图对本发明的具体实施方式作说明,实施方式以本发明技术方案为前提,给出了详细的实施方式和具体的操作过程,但本发明的保护范围不仅限于下述的实施方式。
如图所示,一种多孔金属棒,包括多孔金属材料构成的本体1,本体1的一端为圆棒状,为小端1-1,本体的另一端为大端1-2,外形为圆棒状,与小端1-1同轴,圆棒状外径大于小端1-1外径,大端1-2内部有盲孔1-3,盲孔1-3沿轴向分为两部分,靠近大端1-2外端的部分为螺纹孔1-3-1,另一部分为直壁孔1-3-2,在盲孔1-3内装有致密材料制备的推进轴2,推进轴2包括两部分,一部分为螺纹部分2-1,该部分的外螺纹与螺纹孔1-3-1的内螺纹相配,另一部分为锥形轴部分2-2,锥形轴部分2-2与螺纹部分2-1同轴,锥形轴部分2-2轴向外侧面的直径由靠近螺纹部分2-1的大端向外线性逐渐减小,推进轴2螺纹部分2-1端部有槽口2-3;在盲孔1-3内装有侧向块3,侧向块3内侧面与锥形轴部分2-2的轴向外侧面相匹配,侧向块3外侧面与大端1-2的直壁孔1-3-2配合,侧向块图中为4个,还可以设计为3个、5个、6个或更多;直壁孔1-3-2壁上分布有通孔1-3-3,通孔1-3-3内装有凸针4,凸针4包括圆柱部4-1和带尖锥形部4-2,其直径为d,总长度为l,尖指向外,凸针4长度l大于大端1-2直壁孔1-3-2壁厚b,锥形轴部分2-2锥度角α与凸针4长度l、大端1-2直壁孔1-3-2壁厚b、锥形轴部分2-2长度z满足以下关系式:α≥2arctg((l-b)/z)。
以下详细给出本发明的实施例。
实施例1
本实施例的多孔金属棒结构如图1所示,多孔金属棒本体1用金属钽制备,多孔金属钽材料用泡沫浸渍法制备,所制备的多孔钽孔隙率为50%,孔径为350µm-500µm,推进轴2、侧向块3、凸针4用致密金属钽制备,盲孔的最小壁厚为3mm,直壁孔1-3-2底部圆角r1、本体1小端1-1与大端1-2交界处的圆角r2为1.7mm,大端1-2内部的盲孔1-3的螺纹孔1-3-1、推进轴螺纹部分2-1的螺纹为圆形螺纹,根部圆角半径r3为0.6mm,凸针4的直径d为1mm。
按照本实施例的设计,2arctg((l-b)/z)=15.8°,α为16.5°,满足α≥2arctg((l-b)/z)的要求,使得凸针4在多孔金属棒推入骨安装孔时能在直壁孔1-3-2壁上的通孔1-3-3内不冒出本体1大端1-2外侧,多孔金属棒推入安装孔后通过用螺丝刀插入槽口2-3旋转推进轴2又能通过锥形轴部分2-2的大端向外线性逐渐减小的轴向外侧面即锥面将侧向块3推向直壁孔1-3-2孔壁,将凸针4向外推,插入松质骨孔隙内,使多孔金属棒固定。
实施例2
本实施例参见图8,与实施例1相似,不同之处为多孔金属棒本体1大端1-2通过过渡部分1-4直径逐渐减小过渡到小端1-1,所用材料为金属铌,凸针4的直径d为2mm,所制备的多孔铌孔隙率为85%,孔径为450µm-600µm。

Claims (11)

1. 一种多孔金属棒,包括多孔金属材料构成的本体,本体的一端为圆棒状,为小端,其特征在于:本体的另一端为大端,外形为圆棒状,与小端同轴,圆棒状外径大于小端外径,大端内部有盲孔,盲孔沿轴向分为两部分,靠近大端外端的部分为螺纹孔,另一部分为直壁孔,在盲孔内装有致密材料制备的推进轴,推进轴包括两部分,一部分为螺纹部分,该部分的外螺纹与螺纹孔的内螺纹相配,另一部分为锥形轴部分,锥形轴部分与螺纹部分同轴,锥形轴部分轴向外侧面的直径由靠近螺纹部分的大端向外线性逐渐减小,推进轴螺纹部分端部有槽口;在盲孔内装有侧向块,侧向块内侧面与锥形轴的轴向外侧面相匹配,外侧面与大端的直壁孔配合,直壁孔壁上分布有通孔,通孔内装有凸针,凸针包括圆柱部和带尖锥形部,尖指向外,凸针长度l大于大端直壁孔壁厚b,锥形轴锥度角α与凸针长度l、大端直壁孔壁厚b、锥形轴部分长度z满足以下关系式:α≥2arctg((l-b)/z)。
2.如权利要求1所述的多孔金属棒,其特征在于:所述的盲孔的最小壁厚不小于3mm。
3.如权利要求1或2所述的多孔金属棒,其特征在于:所述的凸针直径为1mm-2mm。
4.如权利要求1或2所述的多孔金属棒,其特征在于:所述的本体大端到小端通过直径逐渐减小过渡。
5.如权利要求3所述的多孔金属棒,其特征在于:所述的本体大端到小端通过直径逐渐减小过渡。
6. 如权利要求1或2所述的多孔金属棒,其特征在于:所述的直壁孔底部圆角、本体小端 与大端交界处的圆角不小于1.5mm。
7.如权利要求3所述的多孔金属棒,其特征在于:所述的直壁孔底部圆角、本体小端与大端交界处的圆角不小于1.5mm。
8.如权利要求4所述的多孔金属棒,其特征在于:所述的直壁孔底部圆角、本体小端与大端交界处的圆角不小于1.5mm。
9.如权利要求1所述的多孔金属棒,其特征在于:所述的螺纹孔螺纹、推进轴螺纹为圆形螺纹,根部圆角半径大于0.5mm。
10.如权利要求1所述的多孔金属棒,其特征在于:所述的多孔金属棒本体的孔隙率为50%-85%,孔径为350µm-600µm。
11.如权利要求1所述的多孔金属棒,其特征在于:所述的多孔金属棒本体、推进轴、侧向块或/和凸针由医用钛及合金、医用铌及合金、医用钽及合金、医用不锈钢或/和医用钴基合金制备。
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