CN1325315A - 带有容纳治疗剂空腔的植入体 - Google Patents

带有容纳治疗剂空腔的植入体 Download PDF

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CN1325315A
CN1325315A CN99813037A CN99813037A CN1325315A CN 1325315 A CN1325315 A CN 1325315A CN 99813037 A CN99813037 A CN 99813037A CN 99813037 A CN99813037 A CN 99813037A CN 1325315 A CN1325315 A CN 1325315A
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CN1250299C (zh
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沃尔夫冈·布兰道
阿尔方斯·费希尔
托马斯·沙韦托斯基
冈特·施密德
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ALCOF SURFACE Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/00—Medicinal preparations characterised by special physical form
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    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1002—Intraluminal radiation therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
    • 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time

Abstract

一种植入体和一种用于制造植入体的方法。植入体具有最好由氧化铝制成的覆层,覆层配有相同形状的空腔和朝向覆层表面的独立的开孔用于容纳治疗剂,治疗剂在植入状态根据需要又放出。

Description

带有容纳治疗剂空腔的植入体
本发明涉及权利要求1前序部分的植入体和权利要求25,29以及30前序部分的植入体制造方法。
在这里“植入体”的概念首先在狭义上可以理解为在动物或人类身体里至少暂时使用的、例如可以发挥治疗作用的支撑功能和/或关节功能元件，如暂时的植入体，例如所谓的“籽晶”，或用于肿瘤处理或治疗的移植固定物(Stents)、气管移植固定物和类似物体。但是在广义上也可以理解为以下的来自外部的、尤其是暂时可以与身体接触的元件或类似物体。
移植固定物形式的植入体例如用于支撑扩张的血管。这种管状的部件按照扩径送入缩小的血管并接着径向扩张，使移植固定物支撑在血管壁内侧。
这种移植固定物在大约一至三个月内生长进血管壁。为了防止血管壁向中间过剩的成长，这可能导致再变窄，即继续缩小，局部的血管壁放射性辐射被证明是有效的。对此提供以下的可能性。
首先是使用灌有放射性液体的球形导液管。由于球形导液管在膨胀状态至少部分地封闭血管，使与血管壁的接触以及由此使球形导液管的使用在时间上被强烈地限定。为了能够局部地达到有效剂量，而必须使用很大的活化量，这将导致射线防护技术问题。此外对于患者来说当出现膨胀机械失灵时危险是非常大的。
第二可以通过导液管送入围绕的射线源。在这里由于受限的导液管滞留期因此也必须在血管里使用大活化量，大活化量要求很高的射线防护技术费用。此外在这里存在射线源定心的问题。
第三可以使用放射性移植固定物。由此可以防止上述的问题和危险，所期望的或者说有效的剂量可以通过微少的射线活化量而延长曝露时间来实现。
在最后的情况里，用于移植固定物的放射性结构使用离子植入已经是公知的。在此放射性的磷(32P)通过离子射线植入在已有的移植固定物表面。此外镍-钛-移植固定物在回旋加速器或类似装置中用质子轰击，以便将普通镍/钛合金中含有的钛激活成放射性钒(48V)。
不仅离子植入而且质子激活都要花费很高的技术费用，即移植固定物实际上只能以“个别定制”来制造。此外这两种方法目前都受到较少的制造形式和较少的放射性同位异构体的限制。
用于加工放射性移植固定物的另一种方法是，将放射性铼电化学地离析在移植固定物表面然后用金箔作为保护层。在这里如同所有多层结构一样会出现分裂、即分离的危险，对于移植固定物，由于径向扩张时在血管里面的变形，这种危险恰恰是非常高的。当然如果只是保护层溶解或可能没有完全损耗，则存在大面积裸露的放射性铼部分地溶于血液并可能输送到身体其它位置产生所不期望的后果的危险。
此外使药物尽可能地局部有效是非常有意义的，例如为了防止排斥植入体或者例如进行局部的肿瘤治疗。
由与EP-A-0 875 218相一致的CA-A-2,235,031一种移植固定物已经是公知的，CA-A-2,235,031构成本发明的出发点，移植固定物在一个实施例中具有一个带有可渗透覆层的不可渗透载体。可渗透覆层由烧结的金属颗粒构成。药物或治疗剂容纳在可渗透覆层的空隙里并且当可渗透覆层由例如可溶解或可渗透的保护层覆盖的时候，药物或治疗剂在移植固定物的植入状态又放出。必要时也可以使用放射性物质作为药物。
对于公知的移植固定物存在可渗透覆层的烧结金属颗粒形成极不均匀、不确定空隙的缺陷。在放出药物的情况下只能实现相对不确定的放出比例。
如果放射性物质容纳在覆层空隙里，由于带有不确定开孔的不规则空隙，存在放射性物质不可控且非意愿漏出的危险。有选择配置的覆层涂覆对此没有提供保护。
由烧结在一起的金属颗粒构成的覆层的强度和机械承载性尤其是在移植固定物变形时不是很好。尤其是存在至少个别的金属颗粒从覆层上脱落的危险。此外存在覆层分裂的危险，尤其是当移植固定物扩张的时候。在这里还存在例如血液循环将覆层部件输送到其它产生非期望后果的身体部位的危险。在使用放射性物质作为药物或治疗剂固定保留在可渗透覆层里的时候这种风险特别大。
此外对于金属植入体尤其怀疑镍会促使过度的细胞生长，尤其是在使用植入体周围的部位。来自金属表面的其它金属-如果也仅是微小颗粒-同样可能由体内液体，如血液溶解，此外增加了非期望的后果或至少对于身体里的全部反应是不负责任的。就公知的移植固定物可渗透覆层的金属颗粒可能大面积地与体液或与生长进可渗透覆层里的身体组织接触这一点来说是尤其具有缺陷的。然而例如将陶瓷覆层或涂层涂覆在植入体金属表面例如由DE-A-4311772,DE-A-4040850,DE-A-3241589或EP-A-0520721已经是公知的。
本发明的任务在于，提供一种植入体和一种制造植入体的方法，从而尤其是使构成为移植固定物的植入体可以相对简单地制造，其中特别是可以避免上述现有技术的缺陷或者说将上述现有技术的缺陷减至最小并且可以将治疗剂由植入体所容纳并-如果期望的话-在植入状态局部地又放出，尤其是能够使植入体，尤其是移植固定物，由放射性同位异构体可靠地固定在表面上或表面里面。
上述任务由权利要求1的植入体或权利要求25,29或30的方法而解决。具有优点的其它结构是从属权利要求的内容。
为了容纳至少一种治疗剂，尤其是覆层具有许多带有朝向覆层表面的独立开孔的空腔。在这里“空腔”的概念也可以理解为确定的晶体拼接或类似情况里的位错，这些位错适合于容纳治疗剂。
与现有技术相比通过确定的且尤其是相互分开的覆层里的空腔结构可以非常准确地将治疗剂量填充进空腔，在必要时可固定在空腔里并且-如果期望的话-在植入状态在一定的条件下，如以所期望的放出率，再放出。
“治疗剂”的概念与上述专利申请中的药物相比具有更广泛的意义，必要时也可以理解为放射性物质或其它治疗物质。尤其是所有在EP-A-0875218中所提到的作为“药物”的治疗剂以及受体兴奋剂、受体拮抗药、酶抑制剂、神经传送体、癌细胞抑制剂、抗生素、激素、维生素、代谢酶、抗代谢药物、利尿剂和类似的治疗剂都在考虑范围。
此外按照本发明的植入体具有一载体和一覆层，其中覆层最好至少基本上由金属氧化物和/或陶瓷材料制成。尤其是覆层基本由氧化铝、氧化镁、氧化钽、氧化铁和/或氧化钛构成。这种形式的覆层可以相对简单地制造，例如通过电解地离析和氧化，并形成非常化学稳定且力学稳定的、尤其是非常紧密的载体覆层。这个覆层至少可以防止来自载体的镍或其它金属(电离地)溶解。这样至少可以减少在植入体周围或接触范围里通过金属溶解诱导的过度细胞生长。
覆层里空腔的简单结构最好通过表面层的阳极氧化实现，表面层可以是载体或离析在载体上的覆层的一部分。这样能够以简单的方式形成一定尺寸的相同形状的空腔。一种非常简单的等形空腔的制造最好由此实现，即氧化铝层作为覆层电解地成形于载体表面的平面上。对于这种人为的铝氧化(阳极式)可以根据施加的电压形成一定的空腔。对此除了氧化铝以外所有的所谓单向电解金属都是适合的，如氧化钛和氧化钨。此外也可考虑氧化镁。
通过阳极氧化电压的变化可改变空腔的直径和空腔的面密度，即单位面积上空腔的数量。空腔的长度取决于阳极氧化时间。因此空腔的形状可以在大范围里控制，使得例如根据所期望的放出比例(放出速度，放出量)以简单的方式实现空腔的最佳形状。例如空腔至少基本上管状地构成并且从覆层表面基本垂直地延伸进覆层内部，其中空腔的横截面和/或其开孔在直径上或面积上逐段的减小，以便获得所期望的特性。
根据使用情况和需求也可以在空腔里容纳多种治疗剂，例如治疗剂在植入状态先后和/或以不同的放出速度再被放出。例如不同分子尺寸的治疗剂可以容纳在植入体覆层的不同的、适配尺寸的空腔里。在必要时空腔或其朝向覆层表面的开孔在尺寸上小于通常位于体液，如血液里的组成部分，尤其是蛋白质而构成也是可以的，即不会出现位于空腔里的治疗剂由于大分子组成部分或类似组成部分否则会产生的溶解或生长，因为这些大分子组成部分不能进入空腔。
空腔组合进载体覆层能够以相应微少的分裂倾向实现相对薄的结构，即实现有利机械特性的结构。
空腔在一定位置上以相对于覆层表面膨胀更微小的表面膨胀结构实现这一优点，即覆层的机械特性基本上只取决于覆层的材料而不取决于空腔里的治疗剂或类似物体。相应地一方面能够使用正好与移植固定物中的大机械应力有关的最佳化覆层，另一方面能够采用与治疗最佳适合的治疗剂。
原则上空腔可以在底部相互连接。但是鉴于低矮的结构高度或厚度空腔最好相互分开地构成。
尤其是对于空腔分开结构能够实现一种治疗剂或多种治疗剂以不同的浓度以及剂量或以不同的放出比例设置在空腔里面，以便实现例如所期望的时间上或空间上非均匀的剂量分布，例如在移植固定物终端分布更多的剂量。
将治疗剂和/或络合成分或者说粘接材料装入空腔最好这样实现，即对覆层空腔抽真空然后添加治疗剂或络合成分或粘接材料，治疗剂或络合成分被空腔容纳或者说宛如被吸进空腔。必要时例如在确定的表面部位，尤其是植入体终端重复这一过程，以实现局部增加所容纳的治疗剂剂量。
将治疗剂或粘接材料装入空腔也可以选择或附加地通过超声波到达或支持在空腔中，超声波在植入体浸入要被装入的药物时使空腔里存在的空气或其它气体逸出。
本发明的另一个方面在于，治疗剂或空腔里的治疗剂满足需要的、例如电离地通过氢桥、通过络合成分、通过范德瓦尔斯力(VanderWalds-Krfte)、或类似的措施固定或粘接在空腔里，以便实现所期望的治疗剂的放出或释放。同样化学地或在生物系统中酶促地裂解或破碎的粘接也是可以的并且由此影响释放。所希望的空腔特性较简单地通过空腔壁的化学变化而实现，尤其是通过与各种治疗剂相适合的粘接材料化学地固定在壁表面上。
最后要指出，按照本发明植入体也可以在覆层里面具有向外打开的空腔，其中空腔的大小可以这样选择，使细胞或细胞的一部分可以从其连接植入体的身体组织生长进空腔并且例如可以这样实现非常可靠地将植入体锚在身体里面。
此外存在覆层或空腔开孔通过作为保护层的覆层而覆盖的可能性。这个保护层可以非常薄，因为它基本上只用于实现所期望的表面特性或覆层材料的遮盖。保护层可以根据使用情况例如这样构成，使其在身体里例如通过体温、人为加热、液体或身体自身物质的化学或酶促影响的溶解或者被覆层表面溶解或者保护层对于容纳在空腔里的治疗剂是可渗透的。尤其是保护层可以如在EP-A-0875218里公开的可渗透材料覆层一样的构成。
对于特别规定使用放射性物质作为治疗剂的情况下，本发明的基本方面在于，放射性物质不是大面积设置，而是局部设置在某个位置或设置在载体覆层里面。原则上覆层可以通过载体的表面层，即上面部位构成或者尤其是通过涂覆在载体表面上的层膜或覆层构成。这样是可以的，即空腔或者其朝向覆层表面的开孔在尺寸上小于通常位于血液里的组成部分，尤其是蛋白质，使得对于大面积放射性物质的曝露不会产生通常情况下通过大分子血液组成部分所产生的放射性物质的溶解或损害，因为大分子血液组成部分不能进入空腔。
空腔的另一个优点在于通过空腔壁实现一个非常大的内表面。这个内表面建立起一个比覆层外表面大得多的表面并且相应地形成比通常的多层结构更可靠或更牢固的多放射性物质粘接。
放射性物质安置在空腔里的另一个优点在于根据需要安置不同浓度的放射性物质，以实现所期望的非均匀的空间剂量分布，通过空腔在某些表面部位“灌入”不同量的放射性物质的方法，例如在移植固定物的终端具有更多的剂量。
空腔最好至少基本上呈管状并且从覆层表面基本上垂直地延伸进覆层内部，其中空腔的横截面和/或其开孔最好设计成这样小的尺寸，使至少大多数通常存在于血液里的蛋白质由于其分子尺寸不能进入空腔，尤其是当空腔只部分充满的时候。相应地位于空腔里的放射性物质不能由血液带走。
使用氧化层，尤其是氧化铝构成的氧化层作为覆层具有附加的优点：氧化层在液体中处于膨胀状态，这将使覆层里面的空腔开孔的开孔面积封闭或更加减小，由此使血液中相对较大的蛋白质的进入更加困难或者阻止进入。这种膨胀当然要考虑到，开孔例如在期望的通常的治疗剂放出的情况下恰恰不应该被封闭。
将放射性物质和/或络合成分装入空腔最好可以由此来实现，对空腔抽真空然后添加放射性物质或络合成分，它们被空腔所容纳宛如被吸入空腔一样。根据需要例如可以对空腔在确定的表面部位，尤其是植入体的终端处重复这一过程，以实现局部提高放射性。
本发明另一个独立的方面在于，放射性物质，即给定量的放射性同位异构体或不同的放射性同位异构体最好通过络合成分，如胺、磷、羧化物和/或硫醇类固定在空腔里面。尤其是硫醇类作为络合成分并例如配置锝和铼作为放射性物质，因为锝(V)-和铼(V)-与含硫磺的配位体结合构成络合金属，这种络合金属具有特别高的快速稳定性。而放射性铜作为另一个示例通过羧化物更好地粘接。借助于络合成分尤其能够使放射性阳离子(金属)化学地，尤其是在空腔里或覆层空隙里，非常牢固地粘接。在此络合成分本身最好固定或粘接在空腔壁上，尤其是通过硅烷化，使络合物全部固定在表面上或载体覆层里面。
放射性阴离子(非金属)，例如碘的粘接也可以选择通过络合物粘接配以相应的络合成分或相应的粘接材料，例如固定在空腔里的金属，如惰性金属，尤其是银。
本发明的另一个独立方面在于，具有相应的不同半衰期和辐射能量的不同放射性同位异构体，如186Re(T1/2=90h,Eβmax=1.071MeV)和188Re(T1/2=16.7h,Eβmax=2.116MeV)，以给定量和比例作为混合物或掺杂物一起使用。这样对于各种应用的最佳剂量分布不仅可以在空间上而且可以在时间上实现。不同放射性同位异构体的固定直接通过容纳放射性同位异构体的空腔制备过程实现，因为放射性同位异构体的或以放射性同位异构体构成连接的机械特性在空腔里面由于相对小的空腔膨胀对于覆层的机械特性只起微小的作用，使通常情况下对于大面积覆层不能使用的放射性同位异构体或放射性同位异构体的连接能够容纳和固定在空腔里。
此外存在覆层或空腔开孔通过例如由金箔构成覆层作为保护层覆盖的可能性。这个保护层可以非常薄，因为其只用于实现所期望的表面特性或覆层材料的覆盖，其中与现有技术相反，阻止血液与放射性物质接触是次要的，因为放射性物质在空腔里化学地固定且因此通过空腔本来已经被保护。此外由于材料选择上的自由度可以实现将保护层更好地粘接在覆层上，因为覆层的化学和力学特性基本上不直接受到所使用放射性物质的影响。
下面通过优选实施例的图示来详细解释本发明。图示为：
图1按照本发明的作为移植固定物的植入体在非扩张状态时的简图；
图2图1所示的移植固定物在径向扩张状态时的简图；
图3图2所示的使用在血管中并径向扩张的移植固定物的横截面简图；
图4带有与多个植入体空腔相匹配的覆层的载体的局部放大图；
图5a,b,c图4所示覆层空腔和相匹配的保护层的局部放大图；
图6,7不同放大比例下带有空腔的覆层电子显微照片。
在图1至3中简要地画出了按照本发明的植入体1。在本实施例中植入体1具有移植固定物的形状，即用于血管的基本上管状的部件，如图1和2所示。
植入体1或移植固定物最好具有金属的或金属化的载体2。在这里载体2设计成可变形的，使移植固定物可以径向扩张。移植固定物在图1中处于非扩张状态，而在图2中处于径向扩张状态。
图3画出了移植固定物在血管3中的径向扩张状态，其中移植固定物或植入体1以其外侧顶靠在血管壁内侧并且例如在内部这样支撑膨胀的血管3。血管3由与载体2接触的身体组织构成。此外载体2或者说植入体1与体液，例如通流血管3和移植固定物的血液4接触。
至少一种治疗剂或药物5配属于载体2，治疗剂或药物固定在载体2上或里面，如图4局部放大简图所示的那样，载体2的表面处具有附属的、局部截切去掉的覆层6。关于治疗剂5尤其参照前面的定义。
在这里覆层6最好涂覆在载体2的整个表面7上，例如通过电解离析、氧化作用或等离子涂覆。但是覆层6也可以选择根据载体2的材料和所期望的覆层6的组分和结构通过载体2的表面层构成。
覆层6在其背离载体2的表面8上具有许多散布的、相互间隔距离的开孔9和与开孔相连的空腔10。后面还要详细讲述的治疗剂5容纳在空腔10里面并且在必要时化学地固定，如后面还要根据图5详细解释的那样。
在这里空腔10设计成基本管状并分别在端部封闭。空腔从覆层6的表面8基本上垂直地一直延伸到载体2。
尤其是空腔10既不延伸到载体2的表面7也不进入载体2里面，而是分别终结在覆层6里面并通过覆层6的隔离层11与载体2的表面7分开。由此至少尽可能地实现载体2的整个表面7相对于身体组织和体液而封闭。在此重要的是覆层6在身体里的高化学稳定性。
在这里空腔10基本上为圆柱形。但是它们也可以具有多边形的横截面或不规则的横截面形状。在这里空腔10基本相互平行地延伸并相互分开，空腔10在底部不是相互连通的。但是这不是必须的；必要时在覆层6里面也可以存在空腔10之间底部的相互连通。
覆层6最好由氧化铝构成，氧化铝尤其是电解地离析或成形在载体2的表面7上。在电解氧化条件下开孔9或空腔10的直径可以非常简单地通过相应地调整所施加的电压而变化。在此每1V阳极电压得到大约1.2至1.4nm的直径。
覆层6或非氧化的覆层材料，如铝，可以选择例如通过等离子覆层涂覆在载体2的表面7上并且在必要时接着氧化。这对于只希望外侧涂层时尤其是具有优点的；但是用这种方法也可以附加地内侧涂层。
但是覆层6的制造不局限于上述的示例，例如也可以考虑载体2相应表面层的氧化。此外覆层6的材料不局限于氧化铝，而是例如也可以使用氧化镁和/或氧化钛。此外除了氧化物以外尤其是也可以使用陶瓷材料构成覆层6，重要的是由此而产生的覆层6的机械特性和优选用于容纳治疗剂5的空腔10结构。
按照图5a的空腔10的放大截面简图表示出治疗剂5在覆层6空腔10里面可能的固定。空腔10的壁12例如配有反应材料，如络合成分13，该络合成分例如通过硅烷化粘接在空腔10里面或其壁12上。
在需要时也可以对空腔10的壁12配置其它的、所期望的粘接治疗剂5所需要的粘接材料来代替图5a示例的络合成分13。也可以选择至少一种治疗剂5最好没有粘接或固定地容纳在空腔10里面。特别是在这种情况下，但是必要时也适于通常的情况，最好在覆层6的表面8具有保护层14，保护层也覆盖空腔10或者说其开孔9。
保护层14尤其是用于防止治疗剂5在植入植入体1之前从空腔10里面提前逸出或漏出。但是如果治疗剂5涉及放射性物质时，保护层14也可以用来防止身体组织和/或体液与治疗剂5直接接触。当开孔9的总面积最好小于，尤其是远小于带有保护层14的覆层6表面8的接触面积时，保护层14可以与治疗剂5无关的、根据所选择的覆层6和保护层14的材料非常好地粘接在覆层6上。空腔10的壁12最好形成在比例上远大于覆层6表面8的内部表面，尤其是当所期望的治疗剂5固定在空腔10里的情况下。
重要的是，覆层6和必要时所配备的保护层14这样来设计尺寸和结构，使例如在移植固定物径向扩张时绝不可能分裂。为此覆层6的厚度最好小于1.5μm，最好最大为200nm而尤其为大约30至150nm。但是覆层厚度尤其是为了在空腔10里容纳更大的容积例如也可以直达150μm。
图5b画出了在与图5a相应的局部截面图中带有变化的空腔10的另一实施例。在这里空腔10在垂直于覆层6的主延伸平面截面上大致瓶状地构成或者说在开孔9处具有缩小的截面15、在开孔9对面的一侧连接在截面15上的过渡截面16具有增大的横截面和最终连接在过渡截面上的具有最大横截面或直径的终端截面17。在这种实施例情况下在横截面或直径缩小的截面15上限制放出率或放出速度，以这个放出速度治疗剂5从植入状态的空腔10里在远离或渗透的保护层14上放出。因此根据在电解阳极氧化通过变化电压所确定的空腔10尺寸可以实现所期望的放出率。
在必要时图5b示例画出的截面15至17的排列顺序也可以反过来，使具有最大直径或横截面的截面17朝向表面8打开，以便实现首先剧烈或大量的放出率然后减少的放出率。在各种情况下都可以通过空腔10的形状或尺寸确定所期望的时间上和必要时空间上对于放出或释放治疗剂5的剂量分布。在此重要的是确定的空腔10结构。
在图5b中示例地表示唯一一种治疗剂5容纳在空腔10里面。必要时也可以在空腔10里面例如分层地容纳不同的治疗剂5，以实现不同治疗剂5的依次释放。不同的治疗剂5也可以有选择地或附加地容纳在例如不同结构和/或配有不同粘接材料的覆层6空腔10里面，以便在必要时能够实现不同治疗剂5以所期望的剂量同时放出。
图5c画出了与图5a和5b相应的植入体1的另一个实施例，带有再次变化的空腔10以阐述不同的现实可能性。在这种情况下空腔10分别具有一个朝向覆层6表面8打开的截面18和多个在开孔9对面端连接在截面18上的、在其直径或截面上相对于截面18远为减小的截面19。根状或突起状连接在空腔10截面18上的截面19由于其缩小的直径或截面与截面18的放出或释放相比起到例如相对于截面18慢慢放出或释放所容纳的治疗剂5的作用。必要时空腔10的截面18和截面19也可以配备或注入不同的治疗剂，其中截面18和19的长度，即其垂直于主平面或覆层6表面8的延伸也可以相互间或共同的适配于所期望的放出比例。
为了能够实现足够大的需要被空腔10所容纳的一定量的治疗剂5，覆层6表面8最好每平方厘米配备108至1011个空腔。
图6和7表示不同放大比例情况下氧化铝层表面的电子显微照片。可以明显地看出，明亮显现的管状空腔如何均匀地分布和成形于氧化铝层里面。
按照特别优选的实施例，放射性物质作为治疗剂5容纳在空腔10里面并且尤其是固定在里面。
按照图5a的空腔10局部放大简图表示出放射性物质固定在覆层6空腔10里面。空腔10壁的12配备反应材料或络合成分13，最好是硫醇类或羧化物，这些硫醇类或羧化物例如通过硅烷化粘接在空腔10里或其壁12上，硫醇类或羧化物例如通过硫醇族将放射性物质粘接或固定在空腔10里面。
放射性物质例如包括放射性锝和/或铼，其中锝(V)-和/或铼(V)-形成与含硫磺的配位体结合，这种结合具有特别高的快速稳定性。按照另一个示例88Y,90Y,89Sr,153Sm,64Cu,67Cu和/或105Rh形式的放射性物质通过(络合)羧化物固定在空腔10里面，其中羧化物最好通过硅烷化粘接在空腔10里面。
但是也可以是其它放射性同位异构体，如也可以是阴离子，如碘作为放射性物质固定在空腔10里面且尤其是通过适宜的反应材料，如惰性金属，尤其是银化学地粘接。此外在这里示例的列举出尤其是液体加入的、120I,123I,124I,125I,131I和/或211At形式的放射性物质5的粘接和其通过银粘接在空腔10里面，其中在银这一侧例如通过(络合)羧化物粘接，而在羧化物一侧最好通过硅烷化粘接在空腔10里面。
放射性物质最好以所期望的比例包括不同的放射性同位异构体，使得由于不同的放射性同位异构体的不同特性而达到在空间和/或时间方面最佳的剂量。这对于按照本发明的放射性物质加入空腔10里面来说可以相对简单地实现，因为例如具有不同的半衰期、能量和/或辐射形式(α,β+,β-,γ)的不同放射性同位素和/或不同放射性同位异构体可以例如相互混合或掺杂地加进空腔10里面并且在那里例如通过相应选择的络合成分13而固定。
也可以选择不同的放射性同位异构体先后，即例如分层的加进空腔10并通过相应的或例如择优的络合成分13固定。
可以有选择或附加地实现空腔10不完全以放射性物质充满，而是在部分地填充放射性物质5的情况下添加例如用于稳定和/或封闭开孔9的附加填充物质。
为了改变剂量分布，其它可能的不同的空腔10的放射性物质填充已经提及过了。
尤其是空腔10和/或开孔9的直径这样选择，使血液组成部分或通常在血液4里面存在的相对大的分子由于其分子尺寸而不能通过开孔9进入空腔10。这可以通过大约5至最大100nm的开孔9直径来可靠保证。
为了能够实现足够大的需要被空腔10所容纳的一定量的放射性物质，覆层6表面8最好每平方厘米配备108至1011个空腔。
最后要指出，按照本发明的放射性物质在按照本发明的覆层6空腔10里的安置不受植入体的局限，而是也可以应用于其它的结构部件以及以所期望的放射性特性而进行的放射性辐射。

Claims (35)

1．植入体(1)，带有载体(2)、尤其是由金属制成的载体，为了容纳至少一种治疗剂(5)，载体具有设置在尤其是与身体组织或体液接触部位的、至少逐段构成的覆层(6)，其特征为，为了容纳至少一种治疗剂(5)，覆层(6)具有多个带有朝向覆层(6)表面(8)的独立开孔(9)的空腔(10)，其中开孔(9)和/或空腔(10)至少基本上形状相同。
2．如权利要求1的植入体，其特征为，覆层(6)至少基本上由金属氧化物和/或陶瓷材料构成，尤其是至少基本上由氧化铝、氧化镁、氧化钽、氧化铁和/或氧化钛构成和/或覆层(6)是至少基本上无镍的。
3．如权利要求1或2的植入体，其特征为，载体(2)配有电解涂覆的或氧化的覆层(6)和/或配有在等离子覆层工艺，尤其是汽相等离子覆层工艺中涂覆的覆层(6)和/或覆层(6)通过尤其是氧化的载体(2)表面层构成。
4．如上述权利要求之一的植入体，其特征为，覆层(6)只成形于载体(2)的外侧表面截面或者不仅成形于载体(2)的外侧表面截面而且也成形于载体(2)的内侧表面截面。
5．如上述权利要求之一的植入体，其特征为，覆层(6)以基本上均匀的厚度构成。
6．如上述权利要求之一的植入体，其特征为，覆层(6)的厚度至少基本上最厚为1.5μm，最好最大为200nm而尤其为大约30至150nm。
7．如上述权利要求之一的植入体，其特征为，覆层(6)形成一个尤其是防止体液通过的、最好覆盖整个载体(2)表面(7)的隔离层(11)。
8．如上述权利要求之一的植入体，其特征为，空腔(10)至少基本上均匀地构成和/或空腔(10)至少基本上长形地、尤其是管状地构成和/或各自至少单端封闭。
9．如上述权利要求之一的植入体，其特征为，空腔(10)相互间隔或者说分开地构成和/或空腔(10)至少基本上相互平行和/或至少基本上垂直于覆层(6)和/或载体(2)的表面(7,8)延伸。
10．如上述权利要求之一的植入体，其特征为，覆层(6)具有带有不同横截面和/或容积和/或朝向覆层(6)表面(8)之开孔面的空腔(10)和/或空腔(10)分别具有不同的或者说增大和/或减小的横截面的截面和/或空腔是分叉的。
11．如上述权利要求之一的植入体，其特征为，空腔(10)仅成形在覆层(6)里面。
12．如上述权利要求之一的植入体，其特征为，空腔(10)和/或其开孔(9)在覆层(6)表面(8)的至少一部分上分开地设置和/或空腔(10)以及其开孔(9)以表面密度108至1011/cm2分布在整个覆层(6)表面(8)上。
13．如上述权利要求之一的植入体，其特征为，开孔(9)的横截面积总和最多为覆层(6)表面(8)的50％和/或开孔(9)具有至少基本相等的横截面积和/或至少基本相等的最小、中间和/或最大直径。
14．如上述权利要求之一的植入体，其特征为，空腔(10)和/或其开孔(9)具有平均最大为100nm的最大或中间直径横截面或开孔面积，最好最大为50nm且尤其是为大约25nm或更小。
15．如上述权利要求之一的植入体，其特征为，植入体(1)由移植固定物构成。
16．如上述权利要求之一的植入体，其特征为，植入体(1)包括至少一种容纳在空腔(10)里的治疗剂(5)。
17．如权利要求16的植入体，其特征为，治疗剂(5)至少部分地，尤其是通过络合成分(13)化学地连接在空腔(10)壁(12)上。
18．如权利要求16或17的植入体，其特征为，至少一种治疗剂(5)这样粘接或固定在空腔(10)里面，使得在超过给定温度的情况下和/或通过身体特有的物质、体液、酶或活化物质或通过其它的、尤其是激光或超声波的活化作用将治疗剂从植入状态的植入体(1)中放出。
19．如权利要求16至18之一的植入体，其特征为，植入体(1)具有至少两种这样容纳在空腔(10)里的治疗剂，使在植入状态中治疗剂(5)可以先后和/或以不同的速度和/或以不同的数量放出。
20．如上述权利要求之一的植入体，其特征为，植入体(1)包括作为治疗剂(5)的放射性物质，放射性物质包含特别给定量的至少一种放射性核素且容纳并尤其是固定在空腔(10)里面。
21．如权利要求20的植入体，其特征为，放射性物质尤其是通过络合成分(13)，如硫醇族，化学地粘接在空腔(10)壁(12)上。
22．如权利要求20或21的植入体，其特征为，放射性物质包括放射性的铼和/或锝，放射性的铼或锝尤其通过硫磺族固定在空腔(10)里面。
23．如权利要求20至22之一的植入体，其特征为，放射性物质包括按给定量和比例的不同放射性同位异构体，尤其是具有不同半衰期、辐射特性和/或能量。
24．如上述权利要求之一的植入体，其特征为，覆层(6)或空腔(10)的开孔(9)通过最好由金箔制成的保护层(14)至少暂时地覆盖或封闭。
25．制造如上述权利要求之一构成的植入体的方法，其特征为，为了构成保护层载体表层或涂覆在载体上的覆层阳极地氧化。
26．如权利要求25的方法，其特征为，要被氧化的表层或覆层至少基本由铝、镁、钽、铁和/或钛所组成。
27．如权利要求25或26的方法，其特征为，氧化电压这样选择，以便在覆层里面形成所期望直径的空腔。
28．如权利要求27的方法，其特征为，在氧化期间电压这样变化，使空腔的数量和/或直径根据到覆层表面的距离变化。
29．制造尤其如上述权利要求1至24之一构成的植入体的方法，其中植入体具有载体，载体带有多个向外开口的空腔和至少一种用于容纳在空腔里的治疗剂，其特征为，为了使空腔真空，将植入体置于负压，接着将治疗剂和/或将治疗剂粘接在空腔里的粘接材料送入空腔，尤其是通过将植入体浸入治疗剂或粘接材料然后使压力又恢复正常和/或治疗剂和/或将治疗剂粘接在空腔里的粘接材料通过超声波装进空腔，尤其是当植入体浸入治疗剂或粘接材料的情况下。
30．制造尤其如上述权利要求1至24之一构成的植入体，最好是移植固定物的方法，其中植入体具有尤其是金属制造的载体和与载体相匹配的治疗剂，其特征为，带有覆层的载体配有多个相互间隔的、具有至少基本相同形状的朝向覆层表面开孔的空腔并且治疗剂装进空腔。
31．如权利要求30的方法，其特征为，覆层通过载体表面层的氧化构成和/或氧化层，最好选择由氧化铝、氧化镁和氧化钽族制成的覆层，尤其是电解地或通过等离子覆层离析或成形于载体上。
32．如权利要求30或31的方法，其特征为，空腔或其壁涂覆或配有络合成分或化学地粘接治疗剂的反应材料。
33．如权利要求30至32之一的方法，其特征为，治疗剂通过负压装进空腔。
34．如权利要求30至33之一的方法，其特征为，放射性物质作为治疗剂通过络合成分和/或化学地粘接固定在空腔里。
35．如权利要求30至34之一的方法，其特征为，空腔以及覆层通过例如由金箔制成的保护层覆盖。
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