WO2013017007A1 - 一种节育器的支架 - Google Patents

一种节育器的支架 Download PDF

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Publication number
WO2013017007A1
WO2013017007A1 PCT/CN2012/078429 CN2012078429W WO2013017007A1 WO 2013017007 A1 WO2013017007 A1 WO 2013017007A1 CN 2012078429 W CN2012078429 W CN 2012078429W WO 2013017007 A1 WO2013017007 A1 WO 2013017007A1
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WO
WIPO (PCT)
Prior art keywords
stent
shape
memory alloy
shape memory
bracket
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Application number
PCT/CN2012/078429
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English (en)
French (fr)
Inventor
武小锋
史凤阳
Original Assignee
辽宁爱母医疗科技有限公司
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Publication date
Application filed by 辽宁爱母医疗科技有限公司 filed Critical 辽宁爱母医疗科技有限公司
Publication of WO2013017007A1 publication Critical patent/WO2013017007A1/zh

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Classifications

    • 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
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/14—Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
    • A61F6/142—Wirelike structures, e.g. loops, rings, spirals
    • A61F6/144—Wirelike structures, e.g. loops, rings, spirals with T-configuration

Definitions

  • the present invention relates to a female intrauterine contraceptive, and more particularly to a stent for an intrauterine device. Background technique
  • the intrauterine device (referred to as "the IUD") is a contraceptive device placed in the uterine cavity of a woman. It is a reversible, long-lasting contraceptive device and is a widely used contraceptive method for women of childbearing age in China.
  • the device has less interference with the whole body and basically acts on the part. It does not affect fertility after removal, and has the advantages of safety and convenience.
  • intrauterine devices Most of the IUDs currently in use are stented intrauterine devices, and intrauterine devices can be divided into three types: polyethylene, stainless steel, and shape memory alloys.
  • polyethylene and stainless steel brackets are mainly plastically deformed by external force, and the shape retention ability is poor. After the product is used, the product often falls off due to deformation, resulting in unintended pregnancy.
  • the deformation of the shape memory alloy is mainly elastic deformation and strong conformal ability.
  • the stainless steel bracket has poor conformal capability, it has an additional advantage.
  • the bracket is made into a spiral spring, and the copper is built into the coil spring to avoid direct contact with the uterus, which can reduce the copper's stimulation of the uterus.
  • the shape memory alloy coil spring bracket has the shape retaining ability and can be built into the coil spring
  • the shape memory alloy coil spring of the size suitable for the uterine cavity has a smaller supporting force than the conventional stainless steel spring of the intrauterine device. Many, can not play alone to support the role of the IUD in the uterus does not fall off.
  • a method of increasing the wire diameter and increasing the outer diameter of the coil spring may be employed, but increasing the wire diameter means that the device is heavier and the risk of falling off is increased.
  • Increasing the outer diameter of the coil spring means that the overall size of the device is increased, which increases the difficulty of placement and removal, and increases the incompatibility with the uterine cavity. Summary of the invention
  • the present invention provides a stent for an IUD, including an inner bracket and an outer bracket.
  • the inner bracket is a planar structure made of a medically acceptable wire
  • the outer bracket is a coil spring made of a shape memory alloy wire.
  • the stent of the device wherein the inner stent is a TiNi shape memory alloy.
  • planar structure is a uterine cavity, a triangle, a 7 shape, a serpentine shape, a T shape, a Y shape, a ⁇ shape, a 0 shape, a ⁇ shape, a V shape or an ⁇ shape.
  • the stent of the device wherein the shape memory alloy wire has a wire diameter of 0.05 mm to 0.5 mm.
  • the stent of the device wherein the outer diameter of the coil spring is 1.0 mm to 4.5 mm.
  • the stent of the device wherein other components constituting the intrauterine device can be placed inside the stent, and other components constituting the intrauterine device can be attached or hanged outside the stent.
  • the shape memory alloy coil spring bracket has the shape retaining ability and can be built into the copper.
  • the shape memory alloy coil spring has much smaller supporting force than the stainless steel spring commonly used in the current intrauterine device, it cannot support the IUD alone in the uterus. It does not fall off inside, so it is necessary to add an inner bracket for supporting.
  • the invention adds an inner support for supporting the inside of the coil spring made of the shape memory alloy wire, and the inner bracket itself has a small weight, and the desired support force can be obtained by the shape design.
  • the stent of the present invention combines the conformal capability of the TiNi shape memory alloy stent with the advantage that the stainless steel stent can be built into the copper.
  • 1 is a schematic view showing the structure of a stent of the contraceptive device of the present invention.
  • 1 is the inner bracket
  • 2 is the outer bracket
  • 11 is the two ends of the inner bracket.
  • the present invention has been achieved by the following techniques:
  • the shape memory alloy is wound into a coil spring as the outer bracket 2, and inside the outer bracket 2 is a medically acceptable (implantable human body) wire inner frame 1 of the planar structure, two of the inner bracket 1 The end 11 extends outside the coil spring of the outer bracket 2.
  • the inner stent 1 can also be shaped with a shape memory alloy as in the outer stent 2, and can theoretically be any known shape memory alloy. But considering the practical application, because of the TiNi shape In addition to the shape memory effect, the memory alloy has good biocompatibility and can form a stable passivation film with the living body. Therefore, the TiNi shape memory alloy is preferred in the present invention.
  • the inner diameter of the inner stent 1 of the present invention preferably ranges from 0.1 mm to 0.6 mm, and the planar structure is formed into a shape suitable for the morphology of the uterine cavity, such as: uterine cavity, triangular shape, 7 shape, serpentine shape, T shape, Y shape , ⁇ shape, 0 shape, ⁇ shape, V shape, ⁇ shape, etc.
  • the wire diameter of the outer frame 2 is preferably in the range of 0.05 mm to 0.5 mm, and the outer diameter of the coil spring made of the outer frame 2 is preferably in the range of 1.0 mm to 4.5 mm.
  • a coil spring-shaped outer bracket 2 is formed by winding a shape memory alloy, and an inner bracket 1 of a near-y-shaped planar structure made of an implantable human body wire is provided inside the outer bracket 2.
  • the inside of the outer stent 2 can be placed with copper (having a killing effect on sperm or fertilized eggs) or other intrauterine device components or drugs, and the drug can be an anti-inflammatory drug (such as indomethacin) or a contraceptive (eg: progestogen alone) Or a progestogen/estrogen combination drug that slowly releases progesterone into the uterine cavity, causing the endometrium to shrink, which is not conducive to implantation of the fertilized egg).
  • an anti-inflammatory drug such as indomethacin
  • a contraceptive eg: progestogen alone
  • a progestogen/estrogen combination drug that slowly releases progesterone into the uterine cavity, causing the endometrium to shrink, which is not conducive to implantation of the fertilized egg.

Landscapes

  • Health & Medical Sciences (AREA)
  • Reproductive Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Prostheses (AREA)

Abstract

一种用于宫内节育器的支架，包括用医学上可接受的金属丝制成的平面结构的内支架（1），以及用形状记忆合金丝制成的螺旋簧外支架（2）。该支架兼具TiNi形状记忆合金支架的保形能力与不锈钢支架可将铜内置的优点。

Description

一种节育器的支架 技术领域
本发明涉及一种女性用宫内避孕用具，特别涉及一种用于宫内节育器 的支架。 背景技术
宫内节育器 （简称 "节育器"） 是放置在女性子宫腔内的避孕器具， 是一种可逆性的、 长效的避孕器具， 是目前我国育龄妇女广泛使用的避孕 方法。节育器对全身的干扰较少，基本作用于局部。取出后并不影响生育， 具有安全、 简便等优点。
目前使用的宫内节育器大部分为有支架的宫内节育器， 而宫内节育器 支架可以分为三种： 聚乙烯、 不锈钢以及形状记忆合金。 其中聚乙烯、 不 锈钢支架受外力时以塑性变形为主， 保形能力差， 产品使用后常因变形而 脱落， 导致意外妊娠；而形状记忆合金变形以弹性变形为主，保形能力强。
不锈钢支架虽保形能力差但其有一个额外的优势， 即将支架制成螺旋 簧状， 将铜内置于螺旋簧内， 以避免与子宫直接接触， 可以减小铜对子宫 的剌激。
形状记忆合金螺旋簧支架虽然具有保形能力， 并且可将铜内置在螺旋 簧内， 但与子宫腔相适宜尺寸的形状记忆合金螺旋簧与目前宫内节育器常 用的不锈钢簧相比支撑力小很多， 无法单独起到支撑节育器在子宫内不脱 落的作用。 为了增加形状记忆合金螺旋簧的支撑力， 可以采用增大丝径、 增大螺旋簧外径等方法，但增大丝径意味着节育器的更重，脱落风险增加。 增大螺旋簧外径意味着节育器整体尺寸加大， 增大了放置、 取出的难度， 且与子宫腔不适应性增加。 发明内容
本发明目的在于提供一种用于宫内节育器的支架， 兼具形状记忆合金 支架的保形能力与不锈钢支架将可将铜内置的优点。
为实现上述目的，本发明提供的节育器的支架，包括内支架和外支架， 其中： 内支架为医学上可以接受的金属丝制成的平面结构， 外支架为形状 记忆合金丝制成的螺旋簧。
所述节育器的支架， 其中， 内支架为 TiNi形状记忆合金。
所述节育器的支架， 其中， 形状记忆合金为 TiNi形状记忆合金。 所述节育器的支架， 其中， 内支架的丝径范围为 0.1mm-0.6mm。
所述节育器的支架， 其中， 平面结构为宫腔形、 三角形、 7形、 蛇形、 T形、 Y形、 γ形、 0形、 Η形、 V形或 Ω形。
所述节育器的支架， 其中， 形状记忆合金丝的丝径为 0.05mm-0.5mm。 所述节育器的支架， 其中， 螺旋簧的簧外径为 1.0mm-4.5mm。
所述节育器的支架， 其中， 支架内部可放置构成宫内节育器的其他组 件， 支架外部可附着或悬挂构成宫内节育器的其他组件。
形状记忆合金螺旋簧支架具有保形能力， 且可将铜内置， 但由于形状 记忆合金螺旋簧与目前宫内节育器常用的不锈钢簧相比支撑力小很多， 无 法单独起到支撑节育器在子宫内不脱落的作用， 因此需增加一个起支撑作 用的内支架。本发明在形状记忆合金丝制成的螺旋簧的内部增加一个起支 撑作用的内支架， 内支架本身重量较小， 通过形状设计可取得预期的支撑 力。 使得本发明的支架兼具 TiNi形状记忆合金支架的保形能力与不锈钢 支架可将铜内置的优点。 附图说明
图 1为本发明节育器的支架结构示意图。 图中： 1为内支架， 2为外 支架， 11为内支架的两端。 具体实施方式
本发明是通过下述技术得以实现的：
将形状记忆合金绕制成螺旋簧作为外支架 2， 在外支架 2的内部有一 个医学上可接受的 （可植入人体的） 金属丝制成的平面结构的内支架 1， 内支架 1的两端 11延伸出外支架 2的螺旋簧外部。
内支架 1也可以和外支架 2—样都采用形状记忆合金， 从理论上可以 是任何一种公知的形状记忆合金。 但从实际应用上考虑， 因为 TiNi 形状 记忆合金除了具有形状记忆效应外， 还具有良好的生物相容性， 可以与生 物体形成稳定的钝化膜， 所以本发明优选 TiNi形状记忆合金。
本发明的内支架 1的丝径优选范围为 0.1mm-0.6mm，制成的平面结构 为适合子宫腔形态的形状， 如： 宫腔形、 三角形、 7 形、 蛇形、 T 形、 Y 形、 γ 形、 0 形、 Η 形、 V 形、 Ω 形等。 外支架 2 的丝径优选范围为 0.05mm-0.5mm,外支架 2制成的螺旋簧的外径优选范围为 1.0mm-4.5mm。
下面结合附图做具体说明， 由于内支架的各种形状为公知技术， 本发 明以 Y形为例进行说明。 为便于理解， 图 1的左半部分绘出其剖视图， 右 半部为外视图。
实施例 1
将形状记忆合金绕制成的螺旋簧形状的外支架 2， 在外支架 2的内部 有一个可植入的人体的金属丝制成的近 Y形的平面结构的内支架 1。
外支架 2的内部可以放置铜（对精子或受精卵具有杀伤作用）或其他 宫内节育器组件或药物，其药物可以是消炎药（如吲哚美辛）或避孕药（如： 单纯孕激素，或者是孕激素 /雌激素复方药物，缓慢释放孕激素到子宫腔内， 使子宫内膜萎缩， 不利于受精卵着床）。

Claims

权 利 要 求
1、 一种节育器的支架， 包括内支架和外支架， 其特征在于： 内支架 为医学上可以接受的金属丝制成的平面结构， 外支架为形状记忆合金丝制 成的螺旋簧。
2、 根据权利要求 1所述节育器的支架， 其特征在于： 内支架为 TiNi 形状记忆合金。
3、 根据权利要求 1 所述节育器的支架， 其特征在于： 形状记忆合金 为 TiNi形状记忆合金。
4、 根据权利要求 1 所述节育器的支架， 其特征在于： 内支架的丝径 范围为 0.1mm-0.6mm。
5、 根据权利要求 1 所述节育器的支架， 其特征在于： 所述的平面结 构为宫腔形、 三角形、 7形、 蛇形、 T形、 Y形、 γ形、 0形、 Η形、 V形 或 Ω形。
6、 根据权利要求 1 所述节育器的支架， 其特征在于： 形状记忆合金 丝的丝径为 0.05mm-0.5mm。
7、 根据权利要求 1 所述节育器的支架， 其特征在于： 螺旋簧的簧外 径为 1.0mm-4.5mm。
8、 根据权利要求 1 所述节育器的支架， 其特征在于： 支架内部可放 置构成宫内节育器的其他组件， 支架外部可附着或悬挂构成宫内节育器的 其他组件。
PCT/CN2012/078429 2011-08-03 2012-07-10 一种节育器的支架 WO2013017007A1 (zh)

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CN201110225635.8 2011-08-03

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103127558B (zh) * 2013-03-06 2015-11-18 史凤阳 用于封闭形宫内节育器的钛合金
CN106137346A (zh) * 2016-07-28 2016-11-23 山东中医药大学附属医院 一种可降解宫腔防粘连装置

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CN1030180A (zh) * 1987-07-02 1989-01-11 上海钢铁研究所 宫内节育器及其制造方法和置入器
CN200970293Y (zh) * 2006-09-20 2007-11-07 赵斌 宫内节育器
CN101278872A (zh) * 2007-04-05 2008-10-08 辽宁爱母医疗科技有限公司 纳米记忆合金宫内节育器
CN101485601A (zh) * 2009-02-17 2009-07-22 山东省计划生育科学技术研究所 一种h型宫内节育器
CN201275175Y (zh) * 2008-07-10 2009-07-22 重庆市人口和计划生育科学技术研究院 记忆合金宫t形宫内节育器及配套的放置器
US20110094519A1 (en) * 2009-10-23 2011-04-28 Vidya Gopal Contraceptive devices and methods

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US4353363A (en) * 1978-11-23 1982-10-12 Angel Sopena Quesada Intrauterine spermicide
CN1030180A (zh) * 1987-07-02 1989-01-11 上海钢铁研究所 宫内节育器及其制造方法和置入器
CN200970293Y (zh) * 2006-09-20 2007-11-07 赵斌 宫内节育器
CN101278872A (zh) * 2007-04-05 2008-10-08 辽宁爱母医疗科技有限公司 纳米记忆合金宫内节育器
CN201275175Y (zh) * 2008-07-10 2009-07-22 重庆市人口和计划生育科学技术研究院 记忆合金宫t形宫内节育器及配套的放置器
CN101485601A (zh) * 2009-02-17 2009-07-22 山东省计划生育科学技术研究所 一种h型宫内节育器
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