CN113730000A - 一种锌基合金可降解牵张成骨器 - Google Patents

一种锌基合金可降解牵张成骨器 Download PDF

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CN113730000A
CN113730000A CN202111147481.5A CN202111147481A CN113730000A CN 113730000 A CN113730000 A CN 113730000A CN 202111147481 A CN202111147481 A CN 202111147481A CN 113730000 A CN113730000 A CN 113730000A
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adjusting screw
jaw
distractor
bone
zinc
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周永胜
夏丹丹
刘云松
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Peking University School of Stomatology
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0089Implanting tools or instruments
    • AHUMAN NECESSITIES
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    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C19/00Dental auxiliary appliances
    • A61C19/06Implements for therapeutic treatment
    • 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02Inorganic materials
    • A61L31/022Metals or alloys
    • 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148Materials at least partially resorbable by the body
    • AHUMAN NECESSITIES
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    • 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/102Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
    • 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
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Abstract

一种内置式锌合金颌骨牵张器,采用锌基可降解材料制作颌骨牵张器。牵张期结束后,体内的牵张器逐渐降解,无需二次手术取出。同时,在牵张过程中,牵张器可缓慢释放锌离子,不仅可以为细胞提供更好的成骨环境,还可加快新生骨的形成速度。锌合金牵张成骨器不仅减少了二次手术创伤,而且通过缓释锌离子促进成骨,提高了牵张成骨的质量和效果。

Description

一种锌基合金可降解牵张成骨器
技术领域
本发明涉及口腔颌面外科器械领域,具体为一种锌基合金颌骨牵张器。
背景技术
近年来,种植修复因其优异的修复效果已成为修复缺失牙的首选治疗方法。然而,缺牙区往往存在骨量不足的问题,导致无法种植或种植手术的失败。在骨量不足无法种植时,需要进行骨增量。目前用于骨增量的方法主要有:骨移植技术、引导骨再生术以及牙槽骨牵张成骨。牵张成骨无需取患者的自体骨,避免了对患者额外的创伤,同时还能同步增高软组织和硬组织,在大面积骨缺损的治疗中具有优势。
牵张成骨术通过使用牵张器对骨的断端间提供持久缓慢的作用力,促进骨组织和骨周围软组织的再生,从而起到骨增量的治疗效果。传统的牵张器分为内置式牵张器和外置式牵张器。传统的外置式牵张器存在一些不足:需要使用伸出体外的调节杆,增加了感染的风险,并给患者的正常生活和美观带来不利;中心螺丝在长期受力过程容易损伤或折断;需要医生调节牵张距离,调节杆旋精确度较差,患者难以自行调节,复诊次数多;牵张成骨周期较长;牵张器由不可降解材料制作,牵张完成后,需要二次手术拆除牵张器。内置式牵张器的手术难度、手术创伤和手术时间。而现在还没有能同时适用于成型与牵张成骨的装置。
发明内容
针对现有技术中存在的上述不足之处,本发明要解决的技术问题是提供一种内置式锌合金颌骨牵张器的设计方法及应用,旨在解决传统牵张器需要二次手术取出及成骨速度慢的问题。
为了解决上述技术问题,本申请采用如下技术方案予以实现:
一种内置式锌合金颌骨牵张器,该牵张器包括两大部分,固定装置和牵张装置,固定装置包括固定板和固定钉,固定板通过固定钉与劈开后的颌骨断端侧壁固定,牵张装置包括牵张轴、调节螺帽和调节螺杆,牵张轴在体内与固定板相连,牵张轴与调节螺杆连接,通过调节螺杆的旋进使得颌骨产生牵张力,所述固定装置包括至少两组锌合金固定板和锌合金骨钉,分别固定于颌骨的两个断端。
优选地,所述牵张装置,调节螺杆与调节螺帽内部为螺丝固定。
优选地,所述固定装置、牵张轴、调节螺杆及辅助装置均由锌基可降解合金组成。所述调节螺帽的材料为锌合金,所述固定调节螺杆与螺帽的螺丝的材料为锌合金。
优选地,所述牵张装置的表面涂布了超声响应型水凝胶,增加了锌合金牵张器的早期稳定性。
优选地,所述牵张装置,其特征在于牵张轴与调节螺杆之间为螺旋轨道,按照特定的速度旋转调节螺杆,可以使与调节螺杆固定的骨段沿螺旋轨道移动。
进一步优选地,所述锌基可降解牵张成骨器,其特征在于:在牵张治疗完成,通过超声装置引发锌合金牵张器的降解,牵张器快速发生降解。本装置无需二次手术取出。
本发明提供的锌基可降解牵张器,通过合金化提高了材料的机械强度,可以满足体内牵引器的强度要求,植入3~6个月可以维持结构和力学的完整性,在牵张过程中降解产生锌离子,调节多种骨代谢相关酶活性,可以促进碱性磷酸酶的表达并促进胶原合成,也可以促进骨矿化过程,并且在抑制成骨细胞终末凋亡的同时抑制破骨细胞分化及骨吸收,为成骨过程创造更有利的微环境,通过牵张力和锌离子协同促进牵张成骨的效果;可以避免二次手术的创伤。
附图说明
图1.锌基可降解牵张成骨装置示意图
图2.调节螺杆与调节螺帽的螺丝内连接示意图
具体实施方式
实施例1
一种内置式锌合金颌骨牵张器,该牵张器包括两大部分,固定装置和牵张装置,固定装置包括固定板5和固定钉4,固定板5通过固定钉4与劈开后的颌骨断端侧壁固定,牵张装置包括牵张轴3、调节螺帽1和调节螺杆2,牵张轴3在体内与固定板5相连,牵张轴3与调节螺杆2连接,通过调节螺杆2的旋进使得颌骨产生牵张力,所述固定装置包括至少两组锌合金固定板5和锌合金骨钉4,分别固定于颌骨的两个断端。
调节螺杆与调节螺帽内部通过螺丝7固定,调节螺杆上具有螺纹。
所述固定装置、牵张轴、调节螺杆及辅助装置均由锌基可降解材料组成,牵张器表面涂布超声响应型水凝胶。
所述调节螺帽可在口外无创拆除,通过超声波的刺激来引发锌合金降解,使得牵张器快速启动降解,快速在体内降解。
牵张轴与调节螺杆之间为螺旋轨道,按照特定的速度旋转调节螺杆,可以使与调节螺杆固定的骨段沿螺旋轨道移动。
实施例2
以下颌骨大面积缺损为例,一种锌基颌骨牵张器的实施包括以下步骤:
(1)首先针对患者的下颌骨缺损,CT重建缺损区骨形态,虚拟设计截骨段及牵张距离;
(2)选择匹配截骨断面长度及拟牵张距离的固定装置、锌钉数量及牵引装置;
(3)实施骨牵张手术。骨劈开后,安放牵张器;
(4)牵张进入稳定期后,根据上下颌血运、成骨环境和影像学判断,4~6个月后,牵张结束。
(5)在牵张成骨结束后,通过超声装置引发锌合金牵张器的降解,牵张器快速发生降解。

Claims (6)

1.一种内置式锌合金颌骨牵张器,其特征在于:该牵张器包括两大部分,固定装置和牵张装置,固定装置包括固定板和固定钉,固定板通过固定钉与劈开后的颌骨断端侧壁固定,牵张装置包括牵张轴、调节螺帽和调节螺杆,牵张轴在体内与固定板相连,牵张轴与调节螺杆连接,通过调节螺杆的旋进使得颌骨产生牵张力,所述固定装置包括至少两组锌合金固定板和锌合金骨钉,分别固定于颌骨的两个断端。
2.根据权利要求1所述的颌骨牵张器,其特征在于:调节螺杆与调节螺帽内部通过螺丝固定,调节螺杆上具有螺纹。
3.根据权利要求1所述的颌骨牵张器,其特征在于:所述固定装置、牵张轴、调节螺杆及辅助装置均由锌基可降解材料组成,牵张器表面涂布超声响应型水凝胶。
4.根据权利要求1或2所述的颌骨牵张器,其特征在于:所述调节螺帽可在口外无创拆除,通过超声波的刺激来引发锌合金降解,使得牵张器快速启动降解,快速在体内降解。
5.根据权利要求1所述的颌骨牵张器,其特征在于:牵张轴与调节螺杆之间为螺旋轨道,按照特定的速度旋转调节螺杆,可以使与调节螺杆固定的骨段沿螺旋轨道移动。
6.权利要求1所述的内置式锌合金颌骨牵张器的使用方法,其特征在于,包括以下步骤:
1)劈开后的颌骨断端侧壁分别用固定钉将固定板固定;
2)颌骨下侧的固定板上具有牵张轴;
3)颌骨下侧的固定板上具有调节螺杆;
4)按照特定的速度旋转调节螺杆使与调节螺杆固定的骨段沿螺旋轨道移。
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Application publication date: 20211203