CN1168640A - 植入体、植入方法和施放装置 - Google Patents

植入体、植入方法和施放装置 Download PDF

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CN1168640A
CN1168640A CN95195132A CN95195132A CN1168640A CN 1168640 A CN1168640 A CN 1168640A CN 95195132 A CN95195132 A CN 95195132A CN 95195132 A CN95195132 A CN 95195132A CN 1168640 A CN1168640 A CN 1168640A
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P·路斯施
E·威特马尼艾尔
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/12186—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices liquid materials adapted to be injected
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A61B2017/00495—Surgical glue applicators for two-component glue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices

Abstract

在本发明中，线状植入体材料(13)借助于流体流(24)从线圈(10)拉出并通过导管(19)注射入机体(22)中。在注射导器的远端开口(20)前植入体材料形成线团(25)形式的开放细孔聚结结构。注射导管(19)可以是套管针、导管或内腔镜导管。从而可用最小的创伤性手术施放植入体(25)。植入体的尺寸和形状可变并可在手术中确定。可使用不同的植入体材料和线形式。植入体的可能应用是填充机体内空腔，用于连续释放系统作用物质或化疗剂的药物释放系统，组织诱导，细胞移植物和治疗栓塞术的诱导。

Description

植入体、植入方法和施放装置
本发明涉及一个植入体、该植入体的应用、以及施放一个植入体的装置和方法
已知在医学上植入体适于各种用途和有无数实施方法。它们通常是作为一个整体被植入，这意味着一个比较大的手术过程和对病人相应较高的负荷。
本发明的任务是：创造出一种植入体，其植入对病人而言具有较小的负荷并且其特征为具有较宽广的适用范围。本发明的另一任务是：创造出施放一个植入体的装置以及施放一个植入体的方法。
本发明的植入体的特征为一个三维的具有开放细孔的结构形式的线团。这样一个线团可以原位通过一个较小的进针和在对病人负荷微小的手术性显微技术下以任意量被植入。尤其是因为植入体的大小和形式具有很大的可变性并且可以在手术中确定，所以具有很宽广的可应用范围。例如植入体的孔径和材料特性可以通过变更尤其是线的材料特性而具有可变性。该线可以是生物活化物的载体并且尤其适于监控下的药物释放或者诱导机体组织。也可广泛应用于牙科医学和兽医学。
施放植入体的本发明装置其特征为：一个导管和工具，可将植入体以线状的形式通过导管远端的开口释出。由于本发明的装置可释出线状植入体并可通过导管引导释出，因此可以在手术性显微技术下施放并且可以最小的创伤性植入手术。
本发明装置的另一组成部分是用所提及的工具在导管中产生流体流，以使线随之通过导管被传送。该流体可以与线一起通过导管远端的开口被释出，也可以例如作为生物活化物的载体或者作为粘体以在组织内局部固定被释放的线。然而可以考虑的还有一种操作方法，即该流体通过一个回引管被导出。该流体可为液体或混悬液尤其是自体血或电解质溶液，也可以是气体。
本发明方法的特征为：植入体以线状的形式被引导至施放局部并在局部呈三维线团被释出。本方法可以通过一个现存的或者做成的小的机体开口导入植入体。本方法因而可使病人的负荷最小。尽管如此，所构造形式的植入体可有较大的体积，例如在骨科学的应用中，线团可以充填相对较大的组织间隙尤其是骨缺损区。线的长度可由临床医师准确确定并且因此可以很准确地定量给药。
按照本发明方法的进一步组成部分是：导入线时将线的一端由进针部位也即机体开口处突出。这样一个植入体可以随时很简单地植入，即握住线的突出端并从进针部位拉出。
其它的特征和优点出自于相关的权利要求、说明书和附图。本发明的实施例以下借助于附图予于更详细的说明：图1表示本发明装置的一个部分剖面图，图2和3表示本发明植入体的施放，图4表示被导入组织内的植入体，图5表示本发明装置的一个变异体的部分剖面观，图6表示植入体及与之相连接的注射器，图7表示放大尺寸下的一段线。
本发明装置1按图1具有一个罩管9，该罩管具备一个内空腔8，该内空腔开口于空针17的导管19内并与管道7相连接，通过该管道将流体3尤其是液体由容器2导入内空腔8。将流体3借助于吸管4和泵5引入管道7，其内装入有一个阀门6以定量流体流。
内空腔8内装有线圈10，它可以在罩管固定的轴11上按箭头12的方向旋转。设置的线圈10应能使缠卷其上的线13可以按箭头15的方向放出至空针17的导管19内。线13在此被导入导管19的近端开口14内并通过远端开口20而离开导管19。还可以考虑的实施方法是，将线圈10装在罩管9之外。尚可考虑的实施方法还有，用其它合适的装置代替线圈10。最后还可以考虑的实施方法有，线13较短或不明显长于导管19则不需要线圈10或者类似件。导管19的构造要求是：线13在其内的导放基本上没有磨擦，流体由内空腔8按照箭头16的方向流入近端开口14和导管19内并且为了传送线13而在导管19内流动。导管19内传送线13的速度可以通过提高内管腔8的液压而得以提高。线的传送可以通过中断阀门6处的流体流而中断。最后还可以将整段线通过远端开口20放出至外。
空针17的导管19的构造要求是：将其远端开口20按照图2通过进针开口23推至组织22内所希望的位置或者待治疗机体的某一位置。如果这样所定位的装置1通过调节阀门6在流体3的压力下被导入内空腔8，那么该流体按照箭头24的方向(图3)流向导管19的近端开口14进入导管19而传送线13由线圈10放出向远端开口20并且最后向外。由开口20出来的线13的终端21在组织22内遇到阻力，使随后的线段弯曲而最后成为一个线团25，如图3所示。这里重要的是：将线13引至导管19内的开口20附近且能被冲向外。
线13在此为一个相关的结构，其横断面主要为圆形并且与其长度相比较很小。该线也可为一个空腔线和/或带有多孔，也即由里向外相通且可以含有药物。尤其适合的制作原料为：无机的凝胶，例如以氧化硅或磷酸钙的为基质的凝胶；或者合成的或天然聚合物的凝胶，例如聚交酯凝胶或海藻酸钙凝胶。合成聚合物同样合适，例如聚原酸酯；或者天然的聚合物，例如胶原蛋白或肝素。还可考虑其它的应用原料：其中尤其适合的有：来自自体的血液成分的线，例如纤维蛋白-血小板线；可吸收陶瓷纤维的线，例如磷酸钙纤维的线；金属线或多种制作原料的复合线。
线13的构造要求为，如上所述可弯曲或可折叠成线团25。优选整段长度的线具备相同的直径。还可以考虑的实施方法有：该直径沿着线的长度均一或不均一地改变着。
优选流体3与线13一起在远端开口20被释放出，以使线团25被注入的流体所包围。在这样构成的线团25时，线13和流体3可以是生物活化物质或微粒的载体，例如细胞。但流体3也可以是粘体，例如纤维蛋白粘体，以固定线团25的结构。通过合适地选择线和流体可使线团25的特性有很大的变化。此外线团25的大小和构型因线的长度和施放技术不同而有所变化。因此线团25的形状和大小可以在手术中确定。同样地，孔径大小和线团25的结构特性也可以在很大的范围内被影响着。尤其是通过选择线13和流体3的材料特性以及施放技术使其可能。
流体3可为液状或气体状。如果选择流体3为气体，则应相应地将容器2构造成气体容器。在此情况下一般不需要泵5。流体3的选择以所规定的应用为准。尤其合适的流体3为自体血、自体血清或血分馏液以及电解质溶液。如果流体3应固定线团25，则由血液制备的纤维蛋白粘体尤为合适。适于诱导组织的流体3为混悬液例如骨粉或微球体的混悬液，或者细胞混悬液例如骨髓细胞的混悬液。如果流体3为气体，则氮在此尤其合适。
由以上叙述应明了：本发明的植入体可以很广泛地应用于医学以及兽医学。以下将说明几个具有优点的应用可能性。
本发明植入体25的主要应用是在所谓的组织工程中诱导机体组织。线13和/或流体3可以为细胞载体或细胞混悬液，它们在形成线团25后构成新的组织或者诱导组织形成。设定尤其是骨缺损时骨组织的形成或者内假体与骨之间的空腔内的骨组织的形成。同样地在脊椎或关节融合时以及在牙医学中可以通过植入线团25而诱导骨组织。诱导组织的其它应用有：骨折时诱导骨痂以及成形手术时的组织诱导例如结缔组织、软骨组织或内皮细胞的诱导。
除以上所列诱导组织的应用之外，还可以是释放系统性作用的药物或局部作用的物质。局部作用的药物尤其是用于癌症治疗的抗生素或细胞毒素。在此本发明植入体的特征尤其是较好的作用物质可定量性。即使很小的物质剂量也可以通过选择线13的长度而很准确地测定。对此可以通过选择线团25的密度而测定释放动力学。较致密的线团25比较松的线团25能更缓慢地释放作用物质。对此可能为多阶段地释放作用物质。
线13也可以为细胞载体，例如形成包囊的异体细胞的载体，例如朗汉斯氏细胞、神经细胞或者遗传变化的细胞。
本发明植入体的另一应用为治疗性的栓塞例如血管瘤的栓塞。这里将线引入到血管瘤的一个中央血管内。之后很强的血栓性线团25阻塞血管瘤的血液供应。
本发明植入体的另一应用为在监控下施用作用物质至粘膜上。将可粘附在粘膜上的线用按照本发明的装置引至粘膜上而释放其内含有的作用物质至粘膜内。
本发明植入体因此在主要的应用中无负荷并可代谢性诱导。
线13可以释放入组织23内并完全位于组织内。相反地如果打算植出线团25或注射入或浸注入药物，则应按照图4引导线13的后端26，使其突出于进针部位23之外，这样才能达到目的。终端26例如可以用一个未在此标示的胶带固定在组织外侧22a上。植出时将线13在终端26由组织22抽出。在此没必要施行对病人有损伤的手术操作。
按照图5导出时，应将装置构造成针30以施放植入体。尤其是单道针并且在罩管31内有带有密封环38的活塞32。活塞32以常用的方式靠柄39被推入罩管31内并在前端有一个支架33用于线圈10，由它放出线13。在应用针30前优选将线13事先与其前端13a至少部分地引入空针17的导管19内。空针17可以构造成常见的注射针也可以如已知的方法装上一个套插35。针30的空腔37内有以上所述的流体。如果活塞32按照图5在安装时被移向左，则流体在相应的压力下流入导管19内并随带由可自由旋转的线圈10放出并被导入导管19的线13。在空腔17的远端如上所述在组织内构成一个植入体。
还可以考虑的实施方法有：传送导管19内的线13时不使用流体。例如药物可以对传送具有在此未图示的起动作用，它被置于空针7的远端并推动线。
如果将植入体25在组织22内植入，则按照图6借助于一个调节器42将注射器40连接在线13的突出端。注射器40具有盛装作用物质46的存储器41、吸管45、泵44以及引管43。泵44作功时由存储器41引出作用物质46，尤其是药物，至线13。若此时线13按照图7为带通道开口47的空针或为多孔性可由里向外流通，则到达线13的空腔49(图7)内的作用物质46通过壁13b沿着箭头48的方向释放入组织22内或机体开口内。因此可以较好定量地有目的地释出作用物质。该情况下还可在治疗后去除植入体。

Claims (35)

1.植入体，其特征为：一个三维的具有开放细孔的结构形式的线团(25)。
2.按照权利要求1的植入体，其特征为：线团(25)至少部分被注入的流体包围。
3.按照权利要求1或2的植入体，其特征为：线团(25)的线(13)和/或流体(3)为生物活化物的或微粒的尤其是细胞载体。
4.按照权利要求1-3之一的植入体，其特征为：流体(3)的组成应能固定线团(25)的结构或形状。
5.按照权利要求4的植入体，其特征为：流体(3)为粘体。
6.按照权利要求1-5之一的植入体，其特征为：能代谢性诱导。
7.按照权利要求1-6之一的植入体，其特征为：线团(25)的线(13)由无机凝胶制成。
8.按照权利要求7的植入体，其特征为：该凝胶以氧化硅为基质制成。
9.按照权利要求7的植入体，其特征为：该凝胶以磷酸钙为基质制成。
10.按照权利要求1-6之一的植入体，其特征为：线(13)由一个聚合物或聚合物凝胶制成。
11.按照权利要求10的植入体，其特征为：聚合物为胶原蛋白、聚糖或明胶。
12.按照权利要求1-6之一的植入体，其特征为：线(13)由自体血液成分的制作原料为基础制成。
13.按照权利要求1-5之一的植入体，其特征为：线(13)为陶瓷线。
14.按照权利要求1-13之一的植入体，其特征为：线(13)为空腔的或多孔的，尤其是构成为空腔线。
15.按照权利要求1-14之一的植入体，其特征为：制成的线作为药剂或药物的载体或者细胞或细胞混悬液的载体。
16.按照权利要求1-15之一的植入体，其特征为：线(13)由可生物分解的制作原料所制成。
17.按照权利要求2-16之一的植入体，其特征为：流体(3)为自体血、自体血清或血分馏液或电解质溶液。
18.按照权利要求2-16之一的植入体，其特征为：流体为气体尤其是氮。
19.按照权利要求1-17之一的植入体，其特征为：流体为生物粘体。
20.按照权利要求2-16之一的植入体，其特征为：流体为混悬液尤其是细胞混悬液。
21.施放植入体的装置，其特征为：一个导管(19)和一种工具(10，3)，用以使植入体以线状的形式通过导管(19)的远端(20)释放。
22.按照权利要求21的装置，其特征为：用导管(19)内的工具(10，3)可产生流动的流体流，方法为：使引入导管(19)内的线(13)通过朝向导管(19)远端的流体流并由之向外移动。
23.按照权利要求21或22的装置，其特征为：工具(10，3)为线圈(10)，由此可放出线(13)。
24.按照权利要求22-23之一的装置，其特征为：流体(3)为液体，优选自体血、自体血清或血分馏液或电解质溶液。
25.按照权利要求22-23之一的装置，其特征为：流体(3)为气体或气体混合体且尤其是氮。
26.按照权利要求22-23之一的装置，其特征为：流体(3)为混悬液并且尤其是细胞混悬液或粘体。
27.按照权利要求21的装置，其特征为：工具(10，3)为机械性传送仪器，用它可以移动引入导管(19)内的线(13)。
28.施放植入体的方法，其特征为：植入体以线样的形式被带至施放局部并形成线团(25)。
29.按照权利要求28的方法，其特征为：线(13)被传送通过导管(19)并且直接放置在导管(19)的远端开口(20)前。
30.按照权利要求28或29的方法，其特征为：放置线(13)时使其终端(26)的一端或两端突出于进针部位(23)或机体开口处。
31.按照权利要求28至30之一的方法，其特征为：线(13)用于牙科治疗尤其是牙根治疗。
32.按照权利要求28-30之一的方法，其特征为：线(13)用于骨缺损内的骨组织形成。
33.按照权利要求28-30之一的方法，其特征为：线(13)用以诱导骨折范围内的骨痂。
34.按照权利要求28-30之一的方法，其特征为：线(13)用以血管内的治疗性栓塞，尤其是血管瘤的栓塞。
35.按照权利要求28-30之一的方法，其特征为：线(13)用以成形手术中的组织诱导。
CN95195132A 1994-08-17 1995-08-16 植入体、植入方法和施放装置 Pending CN1168640A (zh)

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KR970704489A (ko) 1997-09-06
CA2197679A1 (en) 1996-02-22
US6296632B1 (en) 2001-10-02
JPH10504210A (ja) 1998-04-28
US6258055B1 (en) 2001-07-10
EP0776230B1 (de) 2001-10-24
US6299590B1 (en) 2001-10-09
CA2197679C (en) 2007-09-11
BR9508723A (pt) 1998-01-06
WO1996004954A1 (de) 1996-02-22
ATE207374T1 (de) 2001-11-15
AU3108395A (en) 1996-03-07
EP0776230A1 (de) 1997-06-04
US6139520A (en) 2000-10-31
KR100341192B1 (ko) 2002-08-22
DE59509755D1 (de) 2001-11-29
DE19580865D2 (de) 1998-03-19
AU689622B2 (en) 1998-04-02

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