CN106955420B - 基于形状记忆材料的微创植入端部自展开结构 - Google Patents

基于形状记忆材料的微创植入端部自展开结构 Download PDF

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CN106955420B
CN106955420B CN201710103659.3A CN201710103659A CN106955420B CN 106955420 B CN106955420 B CN 106955420B CN 201710103659 A CN201710103659 A CN 201710103659A CN 106955420 B CN106955420 B CN 106955420B
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implant
shape
wireless energy
energy transmission
cells
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CN106955420A (zh
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李路明
李霖泽
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Tsinghua University
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Priority to US16/463,993 priority patent/US11213411B2/en
Priority to PCT/CN2017/116996 priority patent/WO2018153148A1/zh
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Abstract

本发明涉及一种基于形状记忆材料的微创植入端部自展开结构,以及具有该结构的植入物。本发明的植入物,包括致动部件,所述植入物具有第一形状和第二形状,所述植入物具有中心部和基本对称分布的多个端部,所述第二形状具有比所述第一形状更大的面积,所述致动部件能够使所述端部沿远离植入物中心部的方向运动,从而使所述植入物由第一形状转变成第二形状。本发明可以使植入物在植入前具有较小尺寸的结构,而在植入后展开成较大尺寸的结构。

Description

基于形状记忆材料的微创植入端部自展开结构
技术领域
本发明涉及一种基于形状记忆材料的微创植入端部自展开结构,属于植入式医疗器械技术领域。
背景技术
植入式医疗器械一般是指借助外科手术,部分或全部植入人体或自然腔道中的医疗器械。在手术结束后,长期留在人体内,一般至少为30天。植入医疗器械属于第三类医疗器械的高端产品,是医疗器械产业中重要的产品门类,目前大量应用的有包括心脏起搏器、除颤器、脑起搏器、支架、导管、人工瓣膜、人工耳蜗、人工血管、人工晶体、人工髋关节、人工膝关节、骨板、骨钉等植(介)入类器械等各种有源和无源的植入式器械。
植入式医疗器械在植入过程中,一般不可避免地需要打开部分创口,从而将医疗器械植入到人体中。而过大的手术创口一方面可能在术中给病人带来更大的手术风险,另一方面在术后也有更大的感染风险和疼痛。因此,需要一种结构能够通过微小创口植入体内,而在植入后展开较大的面积,部署到更大的区域,实现其所需的功能。
发明内容
一种基于形状记忆材料的微创植入端部自展开式结构,包括形状记忆端部自展开结构和功能模块。所述的形状记忆端部自展开结构由形状记忆材料组成,在植入人体前,呈现为第一形状。第一形状为基本沿一轴线或多轴线延伸的形状,并且在所述轴线两侧具有两个端部,所述第二形状具有比所述第一形状更大的面积,所述两个端部相互向基本垂直于所述轴线的方向运动,从而使所述植入物由第一形状转变成第二形状。所述的自展开结构,利用形状记忆材料的弹性和/或记忆特性,在植入前为尺度较小的结构,而在植入后通过释放约束、改变温度、光照、电磁、化学感应等方式,使其展开为尺度较大的结构,部署到更大的区域。功能模块可以包括电路、电池、传感器、能量收集装置等各种器件。
具体地,本发明提供一种植入物,包括致动部件,所述植入物具有第一形状和第二形状,所述植入物具有中心部和基本对称分布的多个端部,所述第二形状具有比所述第一形状更大的面积,所述致动部件能够使所述端部沿远离植入物中心部的方向运动,从而使所述植入物由第一形状转变成第二形状。
进一步地所述致动部件包括所述各端部顶点之间的伸缩结构。
进一步地所述致动部件包括各端部与植入物中心部之间的伸缩结构。
进一步地所述致动部件包括各端部之间的伸缩结构。
进一步地所述伸缩结构包括折叠伸缩结构或波浪形伸缩结构。
进一步地所述伸缩结构包括多个片状部。
进一步地所述多个片状部形成的所述第一形状基本为圆柱形,所述第二形状基本为长方形。
进一步地所述伸缩结构包括形状记忆材料。
进一步地所述植入物还包括一功能部。
进一步地所述功能部包括无线能量传输部。
进一步地其特征在于所述无线能量传输部包括可折叠的柔性部。
进一步地所述植入物还包括一约束部,其能够使所述植入物保持在所述第一形状。
进一步地所述约束部采用生物可降解材料制成。
进一步地所述无线能量传输部选自光伏电池阵列、压电发电机、摩擦发电机、热电发电机、电磁发电机、振动发电机。
进一步地所述无线能量传输部具有一层或多层,各层之间有或没有分隔膜。
进一步地无线能量传输部外包覆至少一层生物相容性薄膜。
进一步地致动部件与无线能量传输部至少之一具有一个及以上的通孔。
进一步地包括多个单元,各单元之间用导线连接,所述单元包括致动部件及功能部。
本发明提供一种植入式医疗设备,包括上述的植入物,以及植入主体,所述植入主体与所述植入物之间通过导线连接。
附图说明
图1为本发明实施例一的结构图;
图2为本发明实施例二的结构图;
图3为本发明实施例三的结构图;
图4为本发明实施例四的结构图;
图5为本发明实施例五的结构图;
图6为本发明实施例六的结构图;
图7为本发明实施例七的结构图;
图8为本发明实施例八的结构图;
图9为本发明实施例九的结构图;
图10为本发明实施例十的结构图;
图11为本发明实施例十一的结构图;
具体实施方式
以下将结合附图详细说明本发明提供的基于形状记忆材料的微创植入端部自展开结构。
形状记忆材料具有弹性和记忆特性。通过改变约束、温度、光照、电磁、化学感应等外界条件可以使形状记忆材料实现结构的自动切换。具体使用方法包括但不局限于:
1)弹性自膨胀型
利用形状记忆材料的弹性,先将其约束压缩,植入体内后释放约束,实现自膨胀。
2)记忆效应自膨胀型
利用其记忆效应,首先将形状记忆材料浸泡在消毒冰水中,植入后,靠体温使其受热膨胀。
3)记忆效应加温膨胀型
利用其记忆效应,植入后,加热(或光照、电磁、化学感应)形状记忆材料使其膨胀。加热方法包括:射频、植入后注射热生理盐水、通电发热等。
4)记忆效应加温收缩取出型
植入后,采用球囊扩张;取出前,加热或光照、电磁、化学感应)使其收缩。
本发明提供的基于形状记忆材料的多轴卷曲微创植入自展开结构,可利用形状记忆材料的弹性和记忆效应,设计出不同的自展开结构。将功能模块部署到该结构上,如电路、电池、传感器、能量收集装置等,可以实现更多的功能。
以下将结合具体实施例对本发明提供的基于形状记忆材料的微创植入端部自展开结构进行说明。
实施例一
请参阅图1,本发明实施例提供的基于形状记忆材料的微创植入端部自展开结构10,包括片状形状记忆材料框架110和片间连接120。(a)图为展开前的形态,(b)图为展开后的形态。(a)图中,多层片状形状记忆材料框架110平行叠放,不同层间通过片间连接120交错进行连接。不同的片状形状记忆材料框架可以为相同尺寸、形状,也可以为不同的尺寸、形状,从而使堆叠的片状形状记忆材料框架形成不同的形状。如图1中,整体呈现为圆柱状,利于手术微创切口植入,或者注射、导管植入。(b)图中整体结构展开后的形貌,片状形状记忆材料框架向两个方向平行展开,部署到一个更大的区域范围。在自展开结构10上,可以部署不同的功能模块,如电路、电池、传感器、能量收集装置等,实现不同的功能。
实施例二
请参阅图2,本发明实施例提供的基于形状记忆材料的微创植入端部自展开结构20,包括实施例一中的端部自展开结构10和结构连接210。(a)图为展开前的形态,(b)图为展开后的形态。(a)图中若干个端部自展开结构10通过结构连接210进行连接,形成一个串联结构,整体仍为一个细长的结构。(b)图为展开后的结构,包括展开后的自展开结构11和展开后的结构连接211。展开后的端部自展开结构11部署到更大的区域。在自展开结构20上,可以部署不同的功能模块,如电路、电池、传感器、能量收集装置等,实现不同的功能。
实施例三
请参阅图3,本发明实施例提供的基于形状记忆材料的微创植入端部自展开结构30,包括波浪形的形状记忆材料框架310和功能模块320。功能模块320覆盖在形状记忆材料框架310上,形状记忆材料框架310在植入前呈现波浪折叠状。(a)图为植入人体前的形态,整体尺寸较小,便于微创植入。(b)图为植入后的形态,其中311为展开后的形状记忆材料框架,展开后形成一个较大的平面(可以是各种不同的形状),321为展开后的功能模块,展开后形成一个较大的平面(可以是各种不同的形状),部署到更大的区域。
实施例四
请参阅图4,本发明实施例提供的基于形状记忆材料的微创植入端部自展开结构40,包括形状记忆材料框架410和功能模块420。功能模块420覆盖在形状记忆材料框架410上,形状记忆材料框架410由若干根支架组成,支架可以为不同的几何结构。(a)图为植入人体前的形态前形状记忆材料框架410的形态,(c)图为植入人体前整个功能模块的形态,整体尺寸较小,便于微创植入。(b)、(d)图为植入后的形态,其中411为展开后的形状记忆材料框架,相比于植入前,形状记忆材料框架411延着相反方向展开。421为展开后的功能模块。植入人体后,功能模块展开较大的表面积,部署到更大的区域。
实施例五
请参阅图5,本发明实施例提供的基于形状记忆材料的微创植入端部自展开结构50,包括形状记忆材料框架510和功能模块520。功能模块520覆盖在形状记忆材料框架510上,形状记忆材料框架510由若干根支架组成,支架可以为不同的几何结构。(a)图为植入人体前的形态前形状记忆材料框架510的形态,(c)图为植入人体前整个功能模块的形态,整体尺寸较小,便于微创植入。(b)、(d)图为植入后的形态,其中511为展开后的形状记忆材料框架,相比于植入前,形状记忆材料框架511延着相反方向展开。521为展开后的功能模块。植入人体后,功能模块展开较大的表面积,部署到更大的区域。
实施例六
请参阅图6,本发明实施例提供的基于形状记忆材料的微创植入端部自展开结构60,包括形状记忆材料框架610和功能模块620。功能模块620覆盖在形状记忆材料框架610上,形状记忆材料框架610由若干根支架组成,支架可以为不同的几何结构。(a)图为植入人体前的形态前形状记忆材料框架610的形态,(c)图为植入人体前整个功能模块的形态,整体尺寸较小,便于微创植入。(b)、(d)图为植入后的形态,其中611为展开后的形状记忆材料框架,相比于植入前,形状记忆材料框架611延着六个方向展开(可以为n个方向,n为任意自然数)。621为展开后的功能模块。植入人体后,功能模块展开较大的表面积,部署到更大的区域。
实施例七
请参阅图7,本发明实施例提供的基于形状记忆材料的微创植入端部自展开结构70,包括形状记忆材料框架710、功能模块720。功能模块720覆盖在形状记忆材料框架710上,形状记忆材料框架710由若干根支架组成,支架可以为不同的几何结构。记忆合金框架710上有若干个通孔7101,该通孔7101可用于手术植入后,将形状记忆材料框架用手术缝合线缝合在皮下组织上,防止整个框架移动错位。(a)图为植入人体前整个功能模块的形态,整体尺寸较小,便于微创植入,(b)图为植入后的形态,其中711为展开后的形状记忆材料框架,相比于植入前,形状记忆材料框架711延着六个方向展开(可以为n个方向,n为任意自然数)。721为展开后的功能模块。植入人体后,功能模块展开较大的表面积,部署到更大的区域。
实施例八
请参阅图8,所述基于形状记忆材料的微创植入端部自展开结构80,包括形状记忆材料框架810、生物相容性的柔性材料820、密封柔性薄膜830和功能模块840。其中(a)(b)(c)图分别为展开后的自展开结构11的三维图、俯视图和俯视剖面图。形状记忆材料框架810上部署有功能模块840,在功能模块外部再包裹有密封柔性薄膜830和生物相容性材料820,分别起到密封和提高生物相容性的作用。
实施例九
请参阅图9,所述的基于形状记忆材料的微创植入端部自展开结构90,包括形状记忆材料框架910、功能模块920和通孔930。功能模块920覆盖在形状记忆材料框架910上。其中功能模块920的表面积较大,可能阻挡生物组织的生长。在功能模块上设计若干通孔930,有利于生物组织的生长和血液的流通。
实施例十
请参阅图10,所述的基于形状记忆材料的微创植入端部自展开结构1000包括若干个形状记忆材料框架1010和若干个功能模块1020。功能模块1020部署在形状记忆材料框架1010上。若干个形状记忆材料框架1010和若干个功能模块1020分布在不同的位置,可以通过线路1030进行连接。
实施例十一
请参阅图11,所述的基于形状记忆材料的微创植入端部自展开结构1100,包括形状记忆材料框架1110和功能模块1120。功能模块1120部署在形状记忆材料框架骨架上。所述的基于形状记忆材料的多轴卷曲微创植入自展开结构1100可以植入到不同的皮下位置。1140为不同位置的皮肤(如手部、颈部、头部皮下等),1130为皮肤的切口。另外,若功能部件为光伏电池,为了更多地接收光照,优选的位置为光线不被人体穿戴物(如衣服、鞋、帽子等)所阻挡的皮下位置。

Claims (26)

1.一种植入物,包括致动部件、功能部,功能部部署到致动部件上,所述植入物在植入前呈第一形状,植入后展开呈第二形状,所述植入物具有中心部和基本对称分布的多个端部,所述致动部件能够使所述端部沿远离植入物中心部的方向运动,从而使所述植入物由第一形状转变成第二形状,所述致动部件包括一个以上的伸缩结构;其中:
所述伸缩结构包括折叠伸缩结构,所述折叠伸缩结构包括多个片状部,所述多个片状部形成的所述第一形状基本为圆柱形,所述第二形状基本为长方形,由第一形状转变成第二形状的过程为从所述折叠伸缩结构展开为平整的平面状。
2.如权利要求1所述植入物,其特征在于所述伸缩结构包括形状记忆材料。
3.如权利要求1所述植入物,其特征在于所述功能部包括无线能量传输部。
4.如权利要求3所述植入物,其特征在于所述无线能量传输部包括可折叠的柔性部。
5.如权利要求1-2之一所述的植入物,其特征在于所述植入物还包括一约束部,其能够使所述植入物保持在所述第一形状。
6.如权利要求5所述的植入物,其特征在于所述约束部采用生物可降解材料制成。
7.如权利要求3、4之一所述的植入物,其特征在于所述无线能量传输部选自光伏电池阵列、压电发电机、摩擦发电机、热电发电机、电磁发电机、振动发电机。
8.如权利要求3、4之一所述的植入物,其特征在于所述无线能量传输部具有一层或多层,各层之间有或没有分隔膜。
9.如权利要求3、4之一所述的植入物,其特征在于无线能量传输部外包覆至少一层生物相容性薄膜。
10.如权利要求3、4之一所述的植入物,其特征在于致动部件与无线能量传输部至少之一具有一个及以上的通孔。
11.如权利要求1-4、6之一所述的植入物,其特征在于包括多个单元,各单元之间用导线连接,所述单元包括致动部件及功能部。
12.如权利要求3、4之一所述的植入物,其特征在于所述植入物还包括一约束部,其能够使所述植入物保持在所述第一形状。
13.如权利要求12所述的植入物,其特征在于所述无线能量传输部选自光伏电池阵列、压电发电机、摩擦发电机、热电发电机、电磁发电机、振动发电机。
14.如权利要求12所述的植入物,其特征在于所述无线能量传输部具有一层或多层,各层之间有或没有分隔膜。
15.如权利要求12所述的植入物,其特征在于所述无线能量传输部具有一层或多层,各层之间有或没有分隔膜。
16.如权利要求12所述的植入物,其特征在于无线能量传输部外包覆至少一层生物相容性薄膜。
17.如权利要求13所述的植入物,其特征在于无线能量传输部外包覆至少一层生物相容性薄膜。
18.如权利要求14所述的植入物,其特征在于无线能量传输部外包覆至少一层生物相容性薄膜。
19.如权利要求12所述的植入物,其特征在于致动部件与无线能量传输部至少之一具有一个及以上的通孔。
20.如权利要求5所述的植入物,其特征在于包括多个单元,各单元之间用导线连接,所述单元包括致动部件及功能部。
21.如权利要求7所述的植入物,其特征在于包括多个单元,各单元之间用导线连接,所述单元包括致动部件及功能部。
22.如权利要求8所述的植入物,其特征在于包括多个单元,各单元之间用导线连接,所述单元包括致动部件及功能部。
23.如权利要求9所述的植入物,其特征在于包括多个单元,各单元之间用导线连接,所述单元包括致动部件及功能部。
24.如权利要求10所述的植入物,其特征在于包括多个单元,各单元之间用导线连接,所述单元包括致动部件及功能部。
25.如权利要求12所述的植入物,其特征在于包括多个单元,各单元之间用导线连接,所述单元包括致动部件及功能部。
26.一种植入式医疗设备,包括至少一个如权利要求1-25之一所述的植入物,以及植入主体,所述植入主体与所述植入物之间通过导线连接。
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