WO2013020435A1 - 吸水材料在医学上腔道扩张器的应用 - Google Patents

吸水材料在医学上腔道扩张器的应用 Download PDF

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Publication number
WO2013020435A1
WO2013020435A1 PCT/CN2012/078423 CN2012078423W WO2013020435A1 WO 2013020435 A1 WO2013020435 A1 WO 2013020435A1 CN 2012078423 W CN2012078423 W CN 2012078423W WO 2013020435 A1 WO2013020435 A1 WO 2013020435A1
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water
dilator
cavity channel
medical
expander
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PCT/CN2012/078423
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English (en)
French (fr)
Inventor
武小锋
史凤阳
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辽宁爱母医疗科技有限公司
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Priority to EP12821937.5A priority Critical patent/EP2742966A4/en
Publication of WO2013020435A1 publication Critical patent/WO2013020435A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
    • A61B5/4343—Pregnancy and labour monitoring, e.g. for labour onset detection
    • A61B5/435—Assessing cervix alteration or dilation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • 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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material

Definitions

  • the present invention relates to a medical dilator, and more particularly to the use of a water absorbing material on a natural cavity dilator. Background technique
  • the present invention is based on the following two aspects:
  • Water-absorbent resin is a functional polymer material with a large number of hydrophilic groups. It has high liquid absorption capacity, high liquid absorption rate and high liquid retention capacity in agriculture and horticulture (such as water retention agent and soil conditioner). ), industrial (such as as a moisture-proof agent, oil field displacing agent, dehydrating agent for organic solvents, thickeners, water-soluble paints, etc.), medical hygiene (such as used as sanitary napkins, baby diapers, napkins, medical ice packs, ointments, creams) Matrix medical materials such as agents, liniments, cataplasms, etc., and smart carriers prepared to control drug release, release time, and release space), buildings (for blockades in basements, tunnels, subway prefabricated joints; urban sewage treatment) And mud curing of dredging projects) are widely used in various fields:
  • the water-absorbent resin has a high water absorption function of absorbing water several hundred to several thousand times more than itself, and has excellent water retention performance. Once the water swells into a hydrogel, it is difficult to separate the water even if it is pressurized. Since the superabsorbent polymer is non-toxic, non-irritating to the human body, has no side reaction, and does not cause blood coagulation, it has been widely used in recent years, especially in the field of medicine.
  • a topical ointment with a large water content and a comfortable use; a medical bandage and a cotton ball capable of absorbing surgery and traumatic bleeding and secretion, and preventing purulence; and an anti-microbial resistance that can pass moisture and chemicals Infectious artificial skin, etc.
  • the human body has some natural channels, such as the vagina, uterus, mouth, nasal cavity, external auditory canal, lacrimal passage, etc., the operation of the natural cavity often requires a lumen dilator.
  • the cervix when performing uterine and fallopian tube surgery, most of them need to use surgical instruments to enter the uterus and fallopian tubes through the cervix.
  • the diameter of the cervix is small, and if the surgical instrument having an outer diameter of less than 5 mm enters, there is no need to expand the cervix.
  • most of the current surgical instruments have an outer diameter greater than 5 mm (eg, some IUD placement devices, abortion suction tubes, hysteroscopic instruments, etc.), and the use of these devices requires expansion of the cervix.
  • some operations that do not require instrument assistance eg, childbirth, induction of labor
  • the conventional cervical dilator in the hospital is mechanically forcibly expanded, made of metal material, and can be reused.
  • the plastic material of the cervical dilator used in products such as abortion suction tube is disposable, but it is also mechanically forcible. expansion.
  • ZL90210761.5 disclosed a gelatin cervical dilatation plug, suitable for childbirth, induction of labor, the use of progressive expansion of water to reduce the mechanical expansion of the traditional cervical dilator pain.
  • a seaweed cervical expansion rod sold on the market suitable for childbirth, abortion, hysteroscopic surgery, and progressive expansion of water absorption.
  • the above two materials absorb water at a slower rate, and the waiting time is longer than about hours to 24 hours.
  • the operation of the intrauterine device is relatively short, which is not suitable.
  • the medical cavity expander of the present invention is prepared from a water absorbing resin.
  • the channel dilator wherein the water absorbing resin of the channel dilator is in a dry or semi-dry state before use.
  • the lumen dilator wherein the lumen dilator pre-sucks a portion of the medical fluid prior to use.
  • the lumen dilator is sterilized prior to use, and the sterilization method is irradiation sterilization.
  • the channel dilator provided by the invention has a great improvement in water absorption capacity and water absorption speed, especially the water absorption speed, which can greatly reduce the waiting time of the patient, and can be applied to the expansion of all the above-mentioned cavity operations.
  • the channel expander of the present invention has a superslip effect on the water absorbing surface, and can smoothly enter the cavity without applying a lubricant.
  • Fig. 1 is a schematic view showing the dimensional change of a channel expander made of a water absorbing resin before and after water absorption. detailed description
  • the water-absorbent resin used in the present invention has a solid structure and is basically formed by crosslinking and polymerizing a matrix A and a crosslinking agent B.
  • the organic acid is a carboxylic acid, a sulfonic acid, a sulfinic acid or a sulfuric acid.
  • the derivative of the organic acid is an acid halide, an amide, an acid anhydride or an ester.
  • the organic acid is partially or completely neutralized by the base prior to polymerization.
  • the base is potassium hydroxide, sodium hydroxide or lithium hydroxide.
  • the polymerization method is heating polymerization, initiator polymerization or irradiation polymerization.
  • the tunnel dilator is sterilized by irradiation.
  • the cavity dilator pre-sucks a part of the medical liquid before use, which may be pure water (distilled water or sterile water for injection), may be a solution (physiological saline, glucose solution, etc.) or may be an auxiliary drug (anaesthetic) , anti-inflammatory painkillers, etc.).
  • a part of the medical liquid before use which may be pure water (distilled water or sterile water for injection), may be a solution (physiological saline, glucose solution, etc.) or may be an auxiliary drug (anaesthetic) , anti-inflammatory painkillers, etc.).
  • the water absorbing resin Since the water absorbing resin is originally made of an organic acid and a strong alkali as a raw material, it still exhibits a certain acidity or alkalinity after partial neutralization, but after it is used in a human body, the damage of the medical material to the human body is mainly reflected in the release of chemistry to the human body. substance.
  • the performance of the channel dilator of the present invention for absorbing liquid after contacting the human body far exceeds the performance of releasing substances to the human body. Therefore, the acidity or alkalinity of the lumen dilator itself does not cause damage to the human body.
  • the sample prepared in the first embodiment of the present invention passes the 24-hour cytotoxicity test, and the relative proliferation rate of the cells can reach 80% or more, and can reach the level of the first level, and the short-term contact medical device (contact time with the human body is less than 24 hours) The risk is acceptable.
  • the material used for lumen expansion needs to be sterilized before use. Irradiation sterilization can also promote the polymerization and cross-linking of the water-absorbing resin. Even if the polymerization process is not completely complete, it can be compensated by irradiation sterilization.
  • Conventional cavity dilators are made of metal or plastic. They have a certain resistance to enter the channel. They are often coated with lubricant to assist the entry. The water-absorbent resin absorbs water and has a super-slip effect. It can enter the cavity without applying lubricant. Road.
  • Example 1 Take the common Super Absorbent Polymer (SAP) as an example, inject into a container or mold at 40 ° C -80 ° C constant temperature water bath for 30 min -3h, or extrude through the extrusion equipment to obtain the natural cavity of the human body.
  • Compatible dilator After the prepared cavity dilator is dried, it shrinks to the original 50%-90% according to the ratio of the ratio, and the shrinkage ratio is 80%. If the diameter of the mold cavity is 5.5mm, the shrinkage is 4.4mm, and the water absorption is 5min. It can be restored to 5.5mm from left to right. It is more suitable for the operation of intrauterine device. It can be used for childbirth, artificial abortion and other operations after water absorption for about 2 hours. Compared with gelatin and seaweed products, the time is greatly shortened, which can reduce the waiting of patients. time.
  • the dimensional change of the channel expander of the present invention before and after water absorption is as shown in FIG.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Materials For Medical Uses (AREA)
  • Medicinal Preparation (AREA)

Abstract

一种医学上的腔道扩张器，由吸水树脂制备而成，该腔道扩张器在吸水能力和吸水速度上有较大改进，尤其是吸水速度，可大大减少患者的等待时间，适用于所有腔道手术时的扩张，此外，该腔道扩张器吸水后表面具有超滑效应，不用涂润滑剂便可顺利的进入腔道。

Description

吸水材料在医学上腔道扩张器的应用 技术领域
本发明涉及一种医学上的扩张器， 更具体地涉及吸水材料在自然腔体 扩张器上的应用。 背景技术
本发明是基于以下两个方面提出的：
一、 吸水性树脂是一种带有大量亲水基团的功能性高分子材料， 以其 高吸液能力、高吸液速度和高保液能力在农业与园艺（比如作为保水剂和 土壤改良剂）、 工业 （比如作为防潮剂、 油田驱油剂、 有机溶剂的脱水 剂、 增稠剂、 水溶性涂料等）、 医用卫生（比如用作卫生巾、 婴儿尿布、 餐巾、 医用冰袋、 软膏、 霜剂、 擦剂、 巴布剂等的基质医用材料， 以 及制作成控制药物释放量、释放时间、释放空间的智能载体）、建筑（用 于地下室、 隧道、 地铁预制缝的堵水； 城市污水处理和疏竣工程的泥 浆固化） 各领域得到广泛应用：
吸水性树脂具有吸收比自身重几百到几千倍水的高吸水功能， 并且保 水性能优良，一旦吸水膨胀成为水凝胶时，即使加压也很难把水分离出来。 由于高吸水聚合物具有无毒、 对人体无剌激性、 无副反应、 不引起血液凝 固等特点， 近年来， 尤其在医药领域被广泛应用。 例如， 用于含水量大、 使用舒适的外用软膏； 生产能吸收手术及外伤出血和分泌液， 并可防止化 脓的医用绷带及棉球； 制造能使水分和药剂通过而微生物不能透过的抗感 染性人造皮肤等。
二、 人体存在一些自然腔道， 如阴道、 子宫、 口腔、 鼻腔、 外耳道、 泪道等， 实施自然腔道的手术时常需腔道扩张器。
以子宫为例， 实施子宫、 输卵管手术时， 大部分需要使用手术器械， 将手术器械经子宫颈进入子宫、输卵管。在正常状态下子宫颈的孔径较小， 如果外径尺寸小于 5mm的手术器械进入时， 是不需要对子宫颈进行扩张 的。但目前大部分手术的器械外径都大于 5mm (如： 某些宫内节育器的放 置器、 流产吸引管、 宫腔镜器械等）， 使用这些器械时需要扩张子宫颈。 另外， 某些不需要器械辅助的手术 （如： 分娩、 引产）， 也需要扩张子宫 颈。 医院常规的子宫颈扩张器为机械性强行扩张， 采用金属材料制成， 可 以重复使用； 流产吸引管等产品配套使用的子宫颈扩张器的塑料材质虽然 是一次性使用， 但也是属于机械性强行扩张。
人们也在尝试其他扩张原理的的扩张器， 如 ZL90210761.5 公开了一 种明胶宫颈扩张栓， 适用于分娩、 引产， 采用吸水渐进扩张的方式减轻了 传统宫颈扩张器机械性强直扩张带来的痛苦。市场上销售的一种海藻宫颈 扩张棒， 适用于分娩、 人工流产、 宫腔镜手术， 也采用吸水渐进扩张。 但 上述两种材质吸水速度都比较慢， 约数小时至 24小时， 患者等待时间较 长。 另外放置宫内节育器的手术， 手术时间比较短， 其显得不适用。
基于上述背景， 至今未见有将吸水材料用在医学上扩张器的报道。 发明内容
本发明的目的在于将公知的吸水材料用在医学上的腔道扩张器。 为实现上述目的， 本发明的医学上的腔道扩张器， 由吸水树脂制备而 成。
所述的腔道扩张器， 其中， 腔道扩张器的吸水树脂使用前为干或半干 状态。
所述的腔道扩张器， 其中， 腔道扩张器使用前在体外预吸一部分医用 液体。
所述的腔道扩张器使用前进行灭菌， 其灭菌方法为辐照灭菌。
本发明提供的腔道扩张器， 在吸水能力和吸水速度上有较大改进， 尤 其是吸水速度， 可大大减少患者的等待时间， 可适用于上述所有的腔道手 术时的扩张。 并且本发明的的腔道扩张器吸水后表面具有超滑效应， 不用 涂润滑剂便可顺利的进入腔道。 附图说明
图 1是本发明利用吸水树脂制作的腔道扩张器吸水前后的尺寸变化示 意图。 具体实施方式
本发明采用的吸水性树脂为固态结构， 基本由基体 A和交联剂 B交 联聚合而成。
基体 A为含一个或多个 C=C、 C≡C、 N=N、 C=S、 N=S、 S=S、 C=N 或环状结构的不饱和有机酸或其衍生物。
交联剂 B是含两个或多个 C=C、 C≡C、 N=N、 C=S、 N=S、 S=S、 C=N 或环状结构的有机物。
有机酸为羧酸、 磺酸、 亚磺酸或硫羧酸。
有机酸的衍生物为酰卤、 酰胺、 酸酐或酯。
有机酸在聚合前被碱部分或完全中和。
碱为氢氧化钾、 氢氧化钠或氢氧化锂。
聚合方式为加热聚合、 加入引发剂聚合或辐照聚合。
腔道扩张器其灭菌方法为辐照灭菌。
腔道扩张器使用前在体外预吸一部分医用液体， 可以是纯水（蒸馏水 或无菌注射用水）、 可以是溶液 （生理盐水、 葡萄糖溶液等） 也可以是具 有辅助作用的药液 （麻醉药、 消炎止痛药等）。
由于吸水树脂本是使用有机酸和强碱作为原料， 部分中和后仍表现出 一定的酸性或碱性， 但将其用于人体后， 医用材料对人体的损害主要体现 在其向人体释放化学物质。而本发明的腔道扩张器接触人体后吸收液体的 性能远远超过向人体释放物质的性能， 因此， 腔道扩张器本身偏酸或偏碱 对人体不会产生损害。 本发明实施例 1制成的样品通过 24小时的细胞毒 性测试， 细胞相对增殖率可达到 80%以上， 即可达 1级的水平， 对于短暂 接触类医疗器械（与人体接触时间小于 24小时）来说风险是可以接受的。
用于腔道扩张的材料使用前需要灭菌， 采用辐照灭菌还可以促进吸水 树脂进一歩聚合与交联， 即使聚合的过程不是很完全也可以通过辐照灭菌 来弥补。
常规的腔道扩张器采用金属或塑料制成， 进入腔道有一定的阻力， 常 需涂润滑剂辅助进入， 而吸水树脂吸水后表面具有超滑效应， 不用涂润滑 剂便可顺利的进入腔道。
实施例 1 以常见的吸水树脂 (Super Absorbent Polymer, SAP)为例， 注入容器 或模具中 40°C-80°C恒温水浴 30min-3h后成型， 或经挤出设备挤出， 制得 与人体自然腔道相适应的扩张器。 制成的腔道扩张器经干燥后， 根据配比 不同直径收缩到原先的 50%-90%， 以收缩比例为 80%,若模具腔的直径为 5.5mm, 收缩后为 4.4mm， 吸水 5min左右可恢复 5.5mm， 比较适用于放 置宫内节育器的手术； 吸水 2h左右可大于 10mm， 可用于分娩、人工流产 等手术， 相比较于明胶、 海藻制品的时间大大缩短， 可减少患者的等待时 间。 本发明的腔道扩张器吸水前后的尺寸变化如图 1所示。

Claims

1、 一种医学上的腔道扩张器， 由吸水树脂制备而成。
2、 根据权利要求 1 所述的腔道扩张器， 其中， 腔道扩张器的吸水树 脂使用前为干或半干状态。
3、 根据权利要求 1 所述的腔道扩张器， 其中， 腔道扩张器使用前预 吸一部分医用液体。
4、 根据权利要求 1 所述的腔道扩张器， 其中， 腔道扩张器使用前进 行灭菌。
5、 根据权利要求 1或 4所述的腔道扩张器， 其中， 腔道扩张器使用 前采用辐照灭菌。
PCT/CN2012/078423 2011-08-10 2012-07-10 吸水材料在医学上腔道扩张器的应用 WO2013020435A1 (zh)

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EP12821937.5A EP2742966A4 (en) 2011-08-10 2012-07-10 APPLICATION OF WATER ABSORPTION MATERIAL IN A MEDICAL CAVITY CHANNEL DILATION DEVICE

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CN201110235444XA CN102921098A (zh) 2011-08-10 2011-08-10 吸水材料在医学上腔道扩张器的应用
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