CN101534757B - 宫内节育器 - Google Patents

宫内节育器 Download PDF

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CN101534757B
CN101534757B CN2007800349345A CN200780034934A CN101534757B CN 101534757 B CN101534757 B CN 101534757B CN 2007800349345 A CN2007800349345 A CN 2007800349345A CN 200780034934 A CN200780034934 A CN 200780034934A CN 101534757 B CN101534757 B CN 101534757B
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梅琳达·金嘉·卡尔帕蒂
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Abstract

一种包括载体(1)以及活性金属合金(4)的宫内节育器，其特征在于活性金属合金通式为ZnxCuyMnzAuk(I)，或ZnxCuyMnzAgk(II)，其中x+y+z+k＝100％(重量百分比)，x约为18％-30％(重量百分比)，z约为0.5％-3％(重量百分比)，k约为3％-12％(重量百分比)，y为剩余部分。

Description

宫内节育器
技术领域
本发明涉及一种包括载体以及包括锌、铜、锰、金和/或银的活性金属合金的宫内节育器(IUD)。
背景技术
包括铜作为活性金属的宫内节育器的使用自七十年代为人所知。US4198966以及US4353363描述包括一端装备臂相反的一端装备线的支撑体的宫内节育器，以铜作为活性成分。铜制的线螺旋式缠绕支撑体。铜对精子执行杀精功能。同样众所周知铜的使用超过200mm2是获得可靠避孕有效性超过3至5年所必须的。
US4562835公开了一种臂上携带铜套以及铜线制螺旋绕圈的T型宫内节育器，也用于避孕。
一个众所周知的在先技术的宫内节育器的缺点是月经血流经常增加10至35ml且比往常多持续2至4天长。另一个众所周知的缺点是感染风险的增加，特别是上升生殖器感染或传输的细菌导致的感染。
同样众所周知的是锌和铜的结合作为活性成分增加宫内节育器的避孕有效性。Mendel在J.Gynaecol Obstet14，494-498描述具有30mm2铜和47mm2锌的装置提供比仅仅包含至少200mm2铜的装置更高的避孕有效性。装置内，锌和铜线缠绕载体两金属不接触。尽管如此如果在体内使用，这样一种装置的寿命由于15个月的使用后不规则组织学发现物的出现减少至几个月。这样，不能阐明这种装置的实际适用性。此外，Mendel描述说被测装置之间流血以及止疼率没发现有显著差异。
发明内容
本发明的目的是提供一种相比于领域内已知的装置具有提高的避孕有效性的同时引起更短的、低密集的月经期的宫内节育器。本发明另外一个目的是提供一种降低腹部区域感染风险至最小的宫内节育器。
两个问题都通过一种包括载体以及活性金属合金的宫内节育器解决，其中活性金属合金通式为
ZnxCuyMnzAuk(I)，或
ZnxCuyMnzAgk(II)，
其中x+y+z+k＝100％(重量百分比)，x在从约18％至30％(重量百分比)的范围内，z在从约0.5至3％(重量百分比)的范围内，k在从约3％至12％(重量百分比)的范围内，y为剩余部分。
通式(I)和(II)也包括结合中存在金和银的合金。此时金和银重量百分比的总量大约3％至12％(重量百分比)。
在本发明优选的实施例中，活性金属化合物是线型。这使得活性金属合金的方便且无疑问操作成为可能，特别在宫内节育器的完成之中。
活性金属合金可通过形成包括至少锌、铜、锰、金或银或金和银的合金的任何适当的过程制备。优选地，活性金属合金通过熔融、熔融纺丝接着形成线以及利用本领域技术人员已知的技术弯折线制备。这种方法，例如在Sneed-Maynard-Brasted：Comprehensive InorganicChemisty.Copper，Silver and Gold.D.，Van Nostrand Comp.，Inc.，Toronto，New York，London，1945，被描述。
活性金属合金线的平均直径在约0.25-0.4mm的范围内，优选的约0.3-0.4mm，且最优选的约0.3mm。
本发明的活性金属合金中的锰一方面是形成包括18％(重量百分比)或更高的锌含量的合金必须的，另一方面，被认为是月经期增强改善效果必须的。
由于调节生殖器功能的荷尔蒙的重要成分锰的存在，同时锰也是在血液凝结中有重要作用的维他命K的辅助因子、，在本发明的宫内节育器使用期间相比于仅包含铜作为活性成分的宫内节育器月经出血短2-4天且20-60％低密集。
锰的另一个影响是，如果没有锰的存在，在包括铜、锌、金或银或者金和银的合金制造过程中，所制备的合金最多包含17％(重量百分比)的锌。锌含量为17％(重量百分比)或更低的合金不能达到提高避孕有效性的效果，同时不能使月经的持续时间更短、量更少。达到这些效果最少18％(重量百分比)锌是必须的。锰的存在，活性金属合金的锌含量可上升至约30％(重量百分比)。另一方面，锰增加了月经期的改善效果。
不期望被限制在一定理论，据认为活性成分对精子以及月经持续期的杀精功能可解释如下：在本活性金属合金中铜和锌作为避孕有效成分。当该装置被放置在子宫内，金属合金接触到子宫内的液体。结果，众多的带电细胞将增加。这些细胞的阳极包含更多合金的带负电的混合物，铜和锌，而金或银或者金和银成为阴极。由于电流影响，阳极金属通过形成离子溶解。这样，铜和锌产生避孕有效性。尽管如此，阴极基本保持不变。根据本发明阳极金属的电化学溶解，相比于仅仅包括铜作为活性成分的装置中自发的铜溶解，更加剧烈。然而，铜、锌、锰以及金或银，或者金和银的存在导致协同作用的效果，一方面，增强避孕有效性，另一方面引起相比于在先技术中仅仅配备铜作为活性成分的宫内节育器更短的、低密集的月经。
根据本发明的优选的实施例x+y约93％(重量百分比)，更优选的x约24％(重量百分比)y约69％(重量百分比)。
本装置中锌和铜每天的释放在约48-72μg锌离子，约200-280μg铜离子的范围内。在本发明的优选的实施例中锌离子每天的释放约60μg，铜离子约240μg。
由于上述性质，本发明的宫内节育器可靠地防止怀孕的期限延长至5年。
除了上面提到的由本发明中金或银或者金和银的存在导致的协同效果，金和银有杀菌和抑菌性能。金和银的杀菌和抑菌性能基于其少量的微量溶解。名词“微量溶解”意思是金属少量的溶解。例如，金和银的情况，微量溶解是0.04-1μg/ml(见：Die oligodynamischeWirkung der Metalle und Metallsalze，Berlin，Springer，1924；Umschau：55，192(1955)；Sci.Pharm.24，171(1956))。
为了降低感染风险，特别是上升生殖器感染或传输细菌引起的感染，至最低限度，金或银或金和银的组合必须在约3-12％(重量百分比)的范围内，优选的约6％(重量百分比)。
根据本发明另一个优选的实施例，活性金属合金成分如下：
24％(重量百分比)锌
69％(重量百分比)铜
1％(重量百分比)锰
6％(重量百分比)金或银
上面段落描述的宫内节育器的避孕有效性大于99.5％，相当于0.5的Pearl指数。Pearl指数R是避孕有效性公知的量度。它描述在使用年限中每100名妇女的怀孕率，根据Pearl’s公式计算，R＝P×1200/M，其中分子是意外怀孕数乘1200，分母是调查中所有夫妇提供的暴露于怀孕危险的人月数(见Pear R.，Contraception and fertility in 2,000women，Human Biology 1932，4：363-407)。
具体实施方式
本装置的载体的一端装备臂，相反一端装备指标线。根据本发明，活性金属合金设置为绕于载体的臂和指标线之间的一部分。
在一个优选的实施例中，活性金属合金是线型，螺旋式置于载体上。这样的好处是铜和锌离子以稳定、统一的方式释放。螺旋形式易于实施，提供最大的合金表面，此外，这种情况它包含诱捕精子的间隙。
本发明宫内节育器的载体由塑胶制成，优选具有弹性的塑胶。塑胶从由聚乙烯和聚丙烯组成的集合中选择。
在一个优选的实施例中载体由聚乙烯制成。聚乙烯有对子宫内的液体不活泼的优点。此外，聚乙烯体提供作为在此提出的宫内节育器的载体足够的弹性。
本宫内节育器的指标线可为本申请文中任何适当的材料。该材料优选合成材料；更优选从聚酯组成的集合中选出的弹性合成材料。
线可有0.19-0.25mm范围的直径。
在本发明一个优选的实施例中使用单丝聚乙烯线。该单丝聚乙烯线优选具有0.225mm的直径。
一般的，载体的臂可具有任何适当的形式以防止宫内节育器放置在子宫内时的意外遗失，例如T或V型。
根据本发明优选的实施例臂定位朝向输卵管延伸。
载体，各自的臂以及线可为适于本装置的任何尺寸。一般的，本发明宫内节育器的确切尺寸，例如载体，它的臂以及线适于各自子宫的大小。
根据本发明的宫内节育器可在任何插入管以及推动棒的帮助下通过本领域的技术人员已知的任何方法插入子宫内。
图1显示根据本发明宫内节育器的一种可能的实施例。载体1一端装备臂2相对一端装备指标线3。活性金属合金4优选以线的形式螺旋式缠绕在载体1上，位于臂与指标线之间。
下表对比ZnxCuyMnzAuk(I)和/或ZnxCuyMnzAgk(II)-本发明的宫内节育器与本领域现有的铜-宫内节育器的功效。本发明的宫内节育器提供了相比于在先技术中的宫内节育器有益的更低的Pearl指数，也就是提高的避孕有效性结合缩短的月经持续期。
  避孕有效性Pearl指数(36月率)   月经流血持续期(天)
  本发明的宫内节育器   ＜0.5   3-5
  铜-宫内节育器   1-4.8   4-7
本发明的另一个目的是在用于对精子执行杀精功能的宫内节育器中使用下面通式的金属合金
ZnxCuyMnzAuk(I)，或
ZnxCuyMnzAgk(II)，
其中x+y+z+k＝100％(重量百分比)，x约为18％-30％(重量百分比)，z约为0.5％-3％(重量百分比)，k约为3％-12％(重量百分比)，y为剩余部分。

Claims (29)

1.一种宫内节育器，包括载体以及活性金属合金，其特征在于，活性金属合金通式为
ZnxCuyMnzAuk，或
ZnxCuyMnzAgk，
其中
x+y+z+k＝100重量％，
x为18-30重量％，
z为0.5-3重量％，
k为3-12重量％，及
y为剩余部分。
2.权利要求1的宫内节育器，其中，x+y为93重量％。
3.权利要求1至2任一项的宫内节育器，其中，载体一端装备臂，相对的另一端装备指标线。
4.权利要求1至2任一项的宫内节育器，其中，载体由塑胶制成。
5.权利要求3的宫内节育器，其中，载体由塑胶制成。
6.权利要求4的宫内节育器，其中，塑胶为聚乙烯。
7.权利要求5的宫内节育器，其中，塑胶为聚乙烯。
8.权利要求3的宫内节育器，其特征在于指标线为单丝聚酯线。
9.权利要求5的宫内节育器，其特征在于指标线为单丝聚酯线。
10.权利要求7的宫内节育器，其特征在于指标线为单丝聚酯线。
11.权利要求1至2任一项的宫内节育器，其中，活性金属合金为线型。
12.权利要求3的宫内节育器，其中，活性金属合金为线型。
13.权利要求4的宫内节育器，其中，活性金属合金为线型。
14.权利要求5的宫内节育器，其中，活性金属合金为线型。 
15.权利要求6的宫内节育器，其中，活性金属合金为线型。
16.权利要求7的宫内节育器，其中，活性金属合金为线型。
17.权利要求8的宫内节育器，其中，活性金属合金为线型。
18.权利要求9的宫内节育器，其中，活性金属合金为线型。
19.权利要求10的宫内节育器，其中，活性金属合金为线型。
20.权利要求11的宫内节育器，其中，活性金属合金螺旋式置于载体上。
21.权利要求12的宫内节育器，其中，活性金属合金螺旋式置于载体上。
22.权利要求13的宫内节育器，其中，活性金属合金螺旋式置于载体上。
23.权利要求14的宫内节育器，其中，活性金属合金螺旋式置于载体上。
24.权利要求15的宫内节育器，其中，活性金属合金螺旋式置于载体上。
25.权利要求16的宫内节育器，其中，活性金属合金螺旋式置于载体上。
26.权利要求17的宫内节育器，其中，活性金属合金螺旋式置于载体上。
27.权利要求18的宫内节育器，其中，活性金属合金螺旋式置于载体上。
28.权利要求19的宫内节育器，其中，活性金属合金螺旋式置于载体上。
29.具有下面通式的金属合金在用于对精子执行杀精功能的宫内节育器中的应用
ZnxCuyMnzAuk，或
ZnxCuyMnzAgk， 
其中x+y+z+k＝100重量％，x为18-30重量％，z为0.5-3重量％，k为3-12重量％，及y为剩余部分。 
CN2007800349345A 2006-09-20 2007-09-20 宫内节育器 Expired - Fee Related CN101534757B (zh)

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