CN110893129A - 一种桡骨远端个性化人工假体 - Google Patents

一种桡骨远端个性化人工假体 Download PDF

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CN110893129A
CN110893129A CN201911354935.9A CN201911354935A CN110893129A CN 110893129 A CN110893129 A CN 110893129A CN 201911354935 A CN201911354935 A CN 201911354935A CN 110893129 A CN110893129 A CN 110893129A
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core column
solid part
radius
artificial prosthesis
outer sleeve
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石磊
郭佂
张涌泉
武苏华
付军
李小康
吴智钢
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Fourth Military Medical University FMMU
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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
    • 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
    • A61F2002/2835Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
    • 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
    • A61F2002/2871Radius
    • 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
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/30985Designing or manufacturing processes using three dimensional printing [3DP]
    • 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0041Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels or rivets, e.g. connecting screws
    • 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00179Ceramics or ceramic-like structures

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

一种桡骨远端个性化人工假体。包括由芯柱实体部分和芯柱多孔部分构成的芯柱,所述芯柱实体部分包括芯柱实体部分远端、芯柱实体部分领部和芯柱实体部分髓内针,空心圆锥形的芯柱多孔部分设置在芯柱实体部分髓内针的外侧并被剩余桡骨包裹,芯柱实体部分远端外侧设置有与被截去的桡骨几何形状相同的外套。本发明采用组合式结构设计,外套与被截去的桡骨几何形状相同,保证了其与骨关节面的良好接触,减轻了应力遮挡和骨骼磨损,减少了术后骨折的发生概率。

Description

一种桡骨远端个性化人工假体
技术领域
本发明涉及医疗器械领域,特别涉及一种桡骨远端个性化人工假体。
背景技术
桡骨远端是肿瘤的常见发病部位,其外科治疗目的是为了清除肿瘤,有效地减少局部复发,最大限度地保留腕关节功能。临床上为保留一定的腕关节功能,常用瘤段切除、自体骨或异体半关节置换等治疗方法,但其并发症较多,远期效果不佳。下面分别介绍几种常用的桡骨远端骨缺损外科重建方法:
自体骨移植常采用带血管或不带血管的腓骨小头半关节移植修复桡骨远端骨缺损,其优点是腓骨小头的形态与桡骨远端形态相似,自体骨移植无免疫排异,骨不连的发生率低,然而,术后许多并发症依然存在,如进行性关节退变、植骨塌陷和腕关节半脱位等。
瘤段切除+全腕关节置换可以减小复发率和脱位率,但手术复杂,手术时间长,疗效受手术技术影响,容易失败。半腕关节置换,即桡骨远端人工假体置换治疗减小了手术难度,成功率高,早期疗效较好。目前人工假体采用的材料包括钛合金假体、钴铬钼合金、超高分子聚乙烯等,但由于钛合金材料的高弹性模量引起骨吸收、高分子材料受到运动影响带来的磨损、假体设计本身的缺陷等,单一材料的应用常引发假体松动、下沉、脱位以及假体周围骨折等远期并发症。
发明内容
本发明的目的在于克服上述现有技术的不足,提供了一种桡骨远端个性化人工假体,能够有效减少桡骨远端骨缺损外科重建并发症的发生。
为达到上述目的,本发明采用的技术方案是:包括由芯柱实体部分和芯柱多孔部分构成的芯柱,所述芯柱实体部分包括芯柱实体部分远端、芯柱实体部分领部和芯柱实体部分髓内针,空心圆锥形的芯柱多孔部分设置在芯柱实体部分髓内针的外侧并被剩余桡骨包裹,芯柱实体部分远端外侧设置有与被截去的桡骨几何形状相同的外套。
所述的外套的顶端开设有若干缝合孔。
所述的芯柱实体部分远端侧壁上开设有螺纹孔,外套侧壁上开设有与其相对应的螺纹孔,芯柱实体部分远端与外套通过螺纹孔固定。
所述的芯柱多孔部分的长度为2.5-6cm,最大外径为6mm,芯柱多孔部分的内部为孔径在300μm-800μm的三维网格结构。
所述的芯柱实体部分远端的最大外径为8mm,长度由截骨距离确定。
所述的外套采用聚醚醚酮/陶瓷复合材料制成。
所述的芯柱采用钛合金材料,使用3D打印将芯柱实体部分和芯柱多孔部分一体化制造。
本发明取得的有益效果:
采用组合式结构设计,外套与被截去的桡骨几何形状相同,保证了其与骨关节面的良好接触,减轻了应力遮挡和骨骼磨损,减少了术后骨折的发生概率。
进一步的,本发明的外套采用聚醚醚酮/陶瓷复合材料制成,进一步保证了其与骨关节面的良好接触,减轻了应力遮挡和骨骼磨损,同时采用钛合金芯柱增强了整体强度,减少了术后骨折的发生概率。
进一步的,本发明芯柱多孔部分和芯柱实体部分为一体化制作,保证了力学强度和良好的骨整合效果。
附图说明
图1为本发明的整体结构示意图。
图2为本发明工假体的芯柱实体部分结构示意图。
具体实施方式
下面结合附图和实施例对本发明做进一步详细描述,应当理解,此处所描述的实施案例仅用于说明和解释本发明,但本发明的实施方式不仅限于此。
如图1所示,本发明包括与被截去的桡骨几何形状相同的外套1、芯柱和剩余桡骨5,芯柱采用钛合金材料,在移植物中钛合金材料具有良好的生物相容性,同时具有较强的力学强度和支撑作用。芯柱分为芯柱实体部分3和芯柱多孔部分4;外套采用聚醚醚酮/陶瓷复合材料制成,其弹性模量与人体的自然骨骼更加匹配,减轻了应力遮挡问题,在运动中起到一定缓冲作用,降低了植入物在使用过程中的其他骨骼的磨损,另外,该材料为非金属材料,降低了金属的腐蚀和金属可能引起的过敏、毒性问题,在外套顶端开设有若干个缝合孔2。
本发明外套1的形状设计方法为:在医学图像重建软件和三维建模软件中,通过逆向工程方法,设计出与被截去的桡骨几何形状相同的外套,采用3D打印方法制造,从而达到与患者腕关节最匹配的状态,有利于患者重建后的腕关节功能恢复。
参见图1,2,本发明的芯柱实体部分3包括芯柱实体部分远端7、芯柱实体部分领部8和芯柱实体部分髓内针9,其中芯柱实体部分远端7的最大外径为8mm,长度由截骨距离确定,芯柱多孔部分4设置在芯柱实体部分髓内针9的外侧,芯柱多孔部分4的外形为空心圆锥形,长度为2.5-6cm,最大外径为6mm,芯柱多孔部分的内部为孔径为300μm-800μm的三维网格结构,芯柱使用3D打印方法将芯柱实体部分3和芯柱多孔部分4一体化制造,既保证了芯柱的功能强度,又有利于骨组织与移植材料的整合。芯柱实体部分远端7侧壁上开设有螺纹孔,外套1侧壁上开设有与其相对应的螺纹孔,芯柱实体部分远端7与外套1通过螺纹孔固定。剩余桡骨5则固定在一体化制造的芯柱实体部分3和芯柱多孔部分4外侧。
在使用过程中,芯柱通过与个性化设计的外套1结合,通过螺纹孔及螺栓对芯柱和外套进行固定。

Claims (7)

1.一种桡骨远端个性化人工假体,其特征在于:包括由芯柱实体部分(3)和芯柱多孔部分(4)构成的芯柱,所述芯柱实体部分(3)包括芯柱实体部分远端(7)、芯柱实体部分领部(8)和芯柱实体部分髓内针(9),空心圆锥形的芯柱多孔部分(4)设置在芯柱实体部分髓内针(9)的外侧并被剩余桡骨(5)包裹,芯柱实体部分远端(7)外侧设置有与被截去的桡骨几何形状相同的外套(1)。
2.根据权利要求1所述的桡骨远端个性化人工假体,其特征在于:所述的外套(1)的顶端开设有若干缝合孔(2)。
3.根据权利要求1所述的桡骨远端个性化人工假体,其特征在于:所述的芯柱实体部分远端(7)侧壁上开设有螺纹孔,外套(1)侧壁上开设有与其相对应的螺纹孔,芯柱实体部分远端(7)与外套(1)通过螺纹孔固定。
4.根据权利要求1所述的桡骨远端个性化人工假体,其特征在于:所述的芯柱多孔部分(4)的长度为2.5-6cm,最大外径为6mm,芯柱多孔部分的内部为孔径在300μm-800μm的三维网格结构。
5.根据权利要求1所述的桡骨远端个性化人工假体,其特征在于:所述的芯柱实体部分远端(7)的最大外径为8mm,长度由截骨距离确定。
6.根据权利要求1所述的桡骨远端个性化人工假体,其特征在于:所述的外套(1)采用聚醚醚酮/陶瓷复合材料制成。
7.根据权利要求1所述的桡骨远端个性化人工假体,其特征在于:所述的芯柱采用钛合金材料,使用3D打印将芯柱实体部分(3)和芯柱多孔部分(4)一体化制造。
CN201911354935.9A 2019-12-25 2019-12-25 一种桡骨远端个性化人工假体 Pending CN110893129A (zh)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111358598A (zh) * 2020-03-25 2020-07-03 北京市春立正达医疗器械股份有限公司 一种组配式个性化桡骨假体
CN114028035A (zh) * 2020-06-29 2022-02-11 北京力达康科技有限公司 一种基于3d打印的腓骨假体

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111358598A (zh) * 2020-03-25 2020-07-03 北京市春立正达医疗器械股份有限公司 一种组配式个性化桡骨假体
CN114028035A (zh) * 2020-06-29 2022-02-11 北京力达康科技有限公司 一种基于3d打印的腓骨假体

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