CN111513897A - 一种适用于记忆合金骨科内植物的微创植入工具 - Google Patents

一种适用于记忆合金骨科内植物的微创植入工具 Download PDF

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CN111513897A
CN111513897A CN202010383836.XA CN202010383836A CN111513897A CN 111513897 A CN111513897 A CN 111513897A CN 202010383836 A CN202010383836 A CN 202010383836A CN 111513897 A CN111513897 A CN 111513897A
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sleeve
memory alloy
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屠重棋
卢敏勋
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West China Hospital of Sichuan University
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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
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • 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
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4607Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of hip femoral endoprostheses
    • 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
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/30092Properties of materials and coating materials using shape memory or superelastic materials, e.g. nitinol
    • 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
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4653Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor using cooling means
    • 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
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4687Mechanical guides for implantation instruments

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  • Health & Medical Sciences (AREA)
  • Transplantation (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Engineering & Computer Science (AREA)
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Abstract

本发明公开一种适用于记忆合金骨科内植物的微创植入工具,包括套筒,套筒设有用于推动骨科内植物沿套筒轴向移动的推动机构;套筒的侧壁内设有水冷结构,水冷结构的进水口、出水口均位于套筒的下部。本发明能够保证记忆合金材料制作的骨科内植物的顺利植入,避免在植入过程中,由于温度的原因出现骨科内植物未到达预定位置时即开始恢复形态,造成植入位置不准确甚至无法完成植入的情形。

Description

一种适用于记忆合金骨科内植物的微创植入工具
技术领域
本发明涉及医疗器械领域,尤其涉及一适用于记忆合金骨科内植物的微创植入工具。
背景技术
骨头缺血性坏死是骨科常见病、多发病,由各种原因引起的骨头血供破坏,均可造成骨头活性成分死亡,机体在对骨坏死区的修复过程中,早期坏死的骨小梁以被吸收为主,使得塌陷区更脆弱。
目前已有的治疗方法之一为采用支撑装置对其进行支撑。
现有支撑装置有的采用记忆合金材料,如专利申请(申请号:201110161085.8)公开了一种镍钛记忆合金伞-钛笼股骨头内支撑器,由镍钛记忆合金伞、TA2纯钛支撑器体、TA2纯钛尾部紧固螺丝构成,可容纳骨材料或生产因子,植入后可自动增大支撑面积。
再如专利申请(申请号:201020641438.5)公开了一种伞状记忆合金股骨头支撑器,由8个支撑伞骨组成。
对于采用记忆合金材料制作的骨科内植物,在植入过程中,由于温度的原因,会出现骨科内植物未到达预定位置时即开始恢复形态,造成植入位置不准确甚至无法完成植入的情形。
发明内容
本发明旨在提供一种适用于记忆合金骨科内植物的微创植入工具,能够保证记忆合金材料制作的骨科内植物的顺利植入,避免在植入过程中,由于温度的原因出现骨科内植物未到达预定位置时即开始恢复形态,造成植入位置不准确甚至无法完成植入的情形。
为达到上述目的,本发明是采用以下技术方案实现的:
本发明公开的适用于记忆合金骨科内植物的微创植入工具,包括套筒,所述套筒设有用于推动骨科内植物沿套筒轴向移动的推动机构;所述套筒的侧壁内设有水冷结构,所述水冷结构的进水口、出水口均位于套筒的下部。
优选的,所述推动机构包括滑动块、螺杆、帽体,所述滑动块与套筒内壁轴向滑动配合,滑动块的下端设有凹坑,所述螺杆的前端与凹坑适配,所述帽体与套筒的下端螺纹连接,帽体中心设有螺纹通孔A,螺杆与螺纹通孔A螺纹配合。
进一步的,所述套筒内壁设有轴向导槽,所述轴向导槽贯通套筒的下端,轴向导槽不贯通套筒的上端,滑动块的侧壁设有与轴向导槽适配的导向凸愣。
进一步的,所述推动机构还包括导向块,所述导向块套装在套筒内,导向块中心设有螺纹通孔B,螺杆与螺纹通孔B螺纹配合,导向块外壁设有与轴向导槽适配的防转凸愣。
优选的,所述滑动块的上端为弧面。
优选的,所述水冷结构包括位于套筒的侧壁内的夹层,所述夹层内设有轴向隔板,所述轴向隔板将夹层的下部分割为进水区和出水区,所述进水口位于进水区、出水口位于出水区,夹层的顶部连通。
进一步的,所述帽体与套筒之间设有锁紧机构,所述锁紧机构为卡扣。
本发明的有益效果如下:
1、本发明能够保证记忆合金材料制作的骨科内植物的顺利植入,避免在植入过程中,由于温度的原因出现骨科内植物未到达预定位置时即开始恢复形态,造成植入位置不准确甚至无法完成植入的情形。
2、本发明结构简单、可靠,操作方便。
3、本发明设有导向机构、防转机构和锁紧机构,能够进一步的保证植入过程的操作稳定性。
附图说明
图1为本发明的结构示意图;
图2为套筒内壁的局部展开图;
图3为套筒的径向剖视图;
图4为套筒的轴向剖视图;
图中:1-记忆合金骨科内植物、2-套筒、21-套筒外螺纹、22-进水口、23-出水口、24-夹层、25-轴向隔板、26-轴向导槽、3-滑动块、31-弧面、32-凹坑、33-导向凸愣、4-螺杆、41-螺杆外螺纹、42-螺帽、5-导向块、51-螺纹通孔B的内螺纹、52-防转凸愣、6-帽体、61-帽体内螺纹、62-凹槽、63-螺纹通孔A的内螺纹63、7-卡条、71-凸起。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合附图,对本发明进行进一步详细说明。
如图1、图2、图3、图4所示,本发明公开的适用于记忆合金骨科内植物的微创植入工具,包括套筒2,套筒2设有用于推动骨科内植物沿套筒2轴向移动的推动机构;推动机构包括滑动块3、螺杆4、帽体6,滑动块3与套筒2内壁轴向滑动配合,滑动块的上端为弧面31,滑动块3的下端设有凹坑32,螺杆4的前端与凹坑32适配,帽体6与套筒2的下端螺纹连接,具体的,帽体6设有帽体内螺纹61,套筒2的下端设有套筒外螺纹21;帽体6中心设有螺纹通孔A,螺杆4与螺纹通孔A螺纹配合,具体的,螺杆4的螺杆外螺纹41与螺纹通孔A的内螺纹63配合;套筒2内壁设有轴向导槽26,轴向导槽26贯通套筒2的下端,轴向导槽26不贯通套筒2的上端,滑动块3的侧壁设有与轴向导槽26适配的导向凸愣33。
推动机构还包括导向块5,导向块5套装在套筒2内,导向块5中心设有螺纹通孔B,螺杆与螺纹通孔B螺纹配合,具体的,螺杆4的螺杆外螺纹41与螺纹通孔B的内螺纹51配合,导向块5的外壁设有与轴向导槽26适配的防转凸愣52。
当然,轴向导槽26、导向凸愣33、防转凸愣52均可以有多个。
帽体与套筒之间设有锁紧机构,锁紧机构为卡扣;具体的,卡扣包括与套筒2活动连接的卡条7,卡条7上设有凸起71,帽体6设有凹槽62,凸起71与凹槽62卡合。
套筒2的侧壁内设有水冷结构,水冷结构的进水口22、出水口23均位于套筒2的下部,水冷结构还包括位于套筒2的侧壁内的夹层24,夹层24内设有轴向隔板25,轴向隔板25将夹层24的下部分割为进水区和出水区,进水口22位于进水区、出水口23位于出水区,夹层24的顶部连通。
本发明的使用方法如下:套筒2通冷水,将处于压迫状态的记忆合金骨科内植物1、3-滑动块依次放入套筒2中,螺杆4依次穿过帽体6、导向块5后***套筒2中,帽体6拧紧套在套筒2上,然后通过拧动螺杆4的螺帽42,将螺杆4的前端***凹坑32中,将套筒***安装部位,进一步拧动螺帽42,将将记忆合金骨科内植物1推送到安装位置。
为防止帽体6松动,还可以通过卡扣7将帽体6锁紧在套筒2上。
当然,本发明还可有其它多种实施例,在不背离本发明精神及其实质的情况下,熟悉本领域的技术人员可根据本发明作出各种相应的改变和变形,但这些相应的改变和变形都应属于本发明所附的权利要求的保护范围。

Claims (7)

1.一种适用于记忆合金骨科内植物的微创植入工具,其特征在于:包括套筒,所述套筒设有用于推动骨科内植物沿套筒轴向移动的推动机构;所述套筒的侧壁内设有水冷结构,所述水冷结构的进水口、出水口均位于套筒的下部。
2.根据权利要求1所述的微创植入工具,其特征在于:所述推动机构包括滑动块、螺杆、帽体,所述滑动块与套筒内壁轴向滑动配合,滑动块的下端设有凹坑,所述螺杆的前端与凹坑适配,所述帽体与套筒的下端螺纹连接,帽体中心设有螺纹通孔A,螺杆与螺纹通孔A螺纹配合。
3.根据权利要求2所述的适用于记忆合金骨科内植物的微创植入工具,其特征在于:所述套筒内壁设有轴向导槽,所述轴向导槽贯通套筒的下端,轴向导槽不贯通套筒的上端,滑动块的侧壁设有与轴向导槽适配的导向凸愣。
4.根据权利要求3所述的适用于记忆合金骨科内植物的微创植入工具,其特征在于:所述推动机构还包括导向块,所述导向块套装在套筒内,导向块中心设有螺纹通孔B,螺杆与螺纹通孔B螺纹配合,导向块外壁设有与轴向导槽适配的防转凸愣。
5.根据权利要求2所述的适用于记忆合金骨科内植物的微创植入工具,其特征在于:所述滑动块的上端为弧面。
6.根据权利要求1所述的适用于记忆合金骨科内植物的微创植入工具,其特征在于:所述水冷结构包括位于套筒的侧壁内的夹层,所述夹层内设有轴向隔板,所述轴向隔板将夹层的下部分割为进水区和出水区,所述进水口位于进水区、出水口位于出水区,夹层的顶部连通。
7.根据权利要求1-6任一项所述的适用于记忆合金骨科内植物的微创植入工具,其特征在于:所述帽体与套筒之间设有锁紧机构,所述锁紧机构为卡扣。
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Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9714580D0 (en) * 1997-07-10 1997-09-17 Wardlaw Douglas Prosthetic intervertebral disc nucleus
CN1207030A (zh) * 1995-11-15 1999-02-03 奥苏尔公司 制造假肢凹腔的方法和装置及由此制得的假肢凹腔
DE19841252A1 (de) * 1998-09-09 2000-03-30 Aesculap Ag & Co Kg Einsetzinstrument für eine Knochenschraube
CN1709206A (zh) * 2005-07-06 2005-12-21 四川大学华西医院 股骨头内支撑器
US20060074418A1 (en) * 2004-09-24 2006-04-06 Jackson Roger P Spinal fixation tool set and method for rod reduction and fastener insertion
CN102370533A (zh) * 2011-08-22 2012-03-14 王昌惠 带有冷循环***的用于治疗肺减容的输送***
CN203609487U (zh) * 2013-11-15 2014-05-28 山东威高骨科材料有限公司 股骨头支撑器
CN105266928A (zh) * 2015-09-29 2016-01-27 深圳清华大学研究院 颈椎间盘假体、植入器械、颈椎间盘假体与植入器械组合装置及颈椎植入物植入颈椎的方法
CN105559872A (zh) * 2014-10-31 2016-05-11 财团法人金属工业研究发展中心 骨科植入物
CN208851724U (zh) * 2018-02-08 2019-05-14 上海市第一妇婴保健院 一种多功能可调节***模具
CN209661775U (zh) * 2018-12-26 2019-11-22 常州市第二人民医院 一种创伤骨科微创手术中锁定钢板用螺钉植入套筒
CN212973165U (zh) * 2020-05-08 2021-04-16 四川大学华西医院 一种适用于记忆合金骨科内植物的微创植入工具

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1207030A (zh) * 1995-11-15 1999-02-03 奥苏尔公司 制造假肢凹腔的方法和装置及由此制得的假肢凹腔
GB9714580D0 (en) * 1997-07-10 1997-09-17 Wardlaw Douglas Prosthetic intervertebral disc nucleus
DE19841252A1 (de) * 1998-09-09 2000-03-30 Aesculap Ag & Co Kg Einsetzinstrument für eine Knochenschraube
US20060074418A1 (en) * 2004-09-24 2006-04-06 Jackson Roger P Spinal fixation tool set and method for rod reduction and fastener insertion
CN1709206A (zh) * 2005-07-06 2005-12-21 四川大学华西医院 股骨头内支撑器
CN102370533A (zh) * 2011-08-22 2012-03-14 王昌惠 带有冷循环***的用于治疗肺减容的输送***
CN203609487U (zh) * 2013-11-15 2014-05-28 山东威高骨科材料有限公司 股骨头支撑器
CN105559872A (zh) * 2014-10-31 2016-05-11 财团法人金属工业研究发展中心 骨科植入物
CN105266928A (zh) * 2015-09-29 2016-01-27 深圳清华大学研究院 颈椎间盘假体、植入器械、颈椎间盘假体与植入器械组合装置及颈椎植入物植入颈椎的方法
CN208851724U (zh) * 2018-02-08 2019-05-14 上海市第一妇婴保健院 一种多功能可调节***模具
CN209661775U (zh) * 2018-12-26 2019-11-22 常州市第二人民医院 一种创伤骨科微创手术中锁定钢板用螺钉植入套筒
CN212973165U (zh) * 2020-05-08 2021-04-16 四川大学华西医院 一种适用于记忆合金骨科内植物的微创植入工具

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
刘晨旭;宋成利;周宇;毛琳;葛文明;王佩瑶;陈力;: "微创电动吻合器的创新结构设计与功能验证", 医用生物力学, no. 06, 15 December 2019 (2019-12-15) *

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