WO2021082186A1 - 一种医用导电凝胶及其制备方法 - Google Patents

一种医用导电凝胶及其制备方法 Download PDF

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WO2021082186A1
WO2021082186A1 PCT/CN2019/123725 CN2019123725W WO2021082186A1 WO 2021082186 A1 WO2021082186 A1 WO 2021082186A1 CN 2019123725 W CN2019123725 W CN 2019123725W WO 2021082186 A1 WO2021082186 A1 WO 2021082186A1
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conductive gel
water
medical
stir
medical conductive
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章祥
高林明
范哲权
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索思（苏州）医疗科技有限公司
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    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J3/00—Processes of treating or compounding macromolecular substances
    • C08J3/02—Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques
    • C08J3/03—Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques in aqueous media
    • C08J3/075—Macromolecular gels
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/043—Proteins; Polypeptides; Degradation products thereof
    • A61L31/045—Gelatin
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/145—Hydrogels or hydrocolloids
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2389/00—Characterised by the use of proteins; Derivatives thereof
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    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
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    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K5/00—Use of organic ingredients
    • C08K5/04—Oxygen-containing compounds
    • C08K5/05—Alcohols; Metal alcoholates
    • C08K5/053—Polyhydroxylic alcohols

Definitions

  • This application belongs to the technical field of medical conductive materials, for example, it relates to a medical conductive gel and a preparation method thereof.
  • medical conductive adhesive As an intermediate between the human body and medical electrodes, medical conductive adhesive has important application value in the field of medical equipment such as electrocardiogram and electroencephalogram. Among them, the conductivity of the conductive adhesive directly affects the test results. In addition, the medical conductive adhesive must have good biocompatibility, that is, no cytotoxicity, no irritation to human skin, and sensitization.
  • Conductive glue is divided into liquid conductive glue and solid conductive glue.
  • the liquid medium has a strong penetrating power and moisturizing effect on the skin. As the monitoring progresses, the penetration of the liquid medium is improved, the conductivity is improved, the impedance is reduced, and the measurement result is more accurate and stable.
  • the liquid conductive adhesive has a narrow application range and requires complex structural design support, and is volatile and has a short storage time, which is not conducive to industrialization.
  • the solid conductive glue is convenient for industrial die-cutting, but its conductivity is poor and the contact resistance is high. Electrodes prepared by using this type of conductive hydrogel are noisy and cannot be used for the collection of weak signals.
  • the purpose of this application is to provide a medical conductive gel with good biocompatibility, low contact impedance, and low noise, which can be used for weak signal acquisition and a preparation method thereof, and the conductive gel is easy to industrialize, and after contact with human skin It can be changed from solid to liquid, with good wettability, and the measurement result is more accurate and stable.
  • a medical conductive gel comprising the following mass percentage components: salt electrolyte 2%-10%, water-retaining agent 5%-35%, gel forming agent 10-20%, water 50-80% .
  • the salt electrolyte is NaCl or KCl or a mixture of the two
  • the water-retaining agent is glycerin or sodium polyacrylate
  • the gel forming agent is pectin, gelatin, carrageenan , Agar, gellan gum, one or more than two
  • the water is deionized water.
  • this application also provides a method for preparing medical conductive gel, which includes the following steps:
  • step (3) The solution synthesized in step (2) is injection molded and cooled at room temperature for 6-24 hours to form, then the preparation of the conductive gel is completed.
  • the medical conductive gel of the present application disperses the water-retaining agent, salt electrolyte and gel-forming agent in water, plus the synergistic effect of water, water-retaining agent, and gel-forming agent to form intermolecular hydrogen bonds, and is easy to dissolve
  • the salt electrolyte is doped to play the role of ion conduction; and the medical conductive gel of the present application can be converted from solid gel to liquid after contact with human skin, which has strong penetrating power and moisturizing effect on the skin, and is extremely infiltrating. It reduces the contact resistance and the change of the contact capacitance, thereby improving its sensitivity to signal collection, and the measurement result is more accurate and stable.
  • the medical conductive gel of the present application has a simple preparation process, simple production equipment, low production cost, easy industrialization, simple and easy-to-obtain raw materials, and is safe and environmentally friendly.
  • the medical conductive gel of the present application has both low contact impedance and low noise, and can be used for the collection of electrophysiological signals of the human body such as electrocardiogram, fetal electrocardiogram, brain electricity, and myoelectricity.
  • the medical conductive gel of this embodiment specifically includes potassium chloride, glycerin, gelatin and deionized water.
  • the medical conductive gel of this embodiment specifically includes potassium chloride, glycerin, gelatin and deionized water.
  • the medical conductive gel of this embodiment specifically includes potassium chloride, glycerin, gelatin and deionized water.
  • the medical conductive gel of this embodiment specifically includes potassium chloride, glycerin, gelatin and deionized water.
  • the medical conductive gel of this embodiment specifically includes potassium chloride, glycerin, gelatin and deionized water.
  • Conductive gels have three relatively important performance indicators: AC impedance, noise, and wettability.
  • the medical conductive gels prepared in the above examples 1 to 5 are subjected to the relevant performance tests in Table 1 below, and the current conductive pastes on the market Test with conductive hydrogel, use the electrodes on our company’s wearable fetal ECG sensor as the test electrode, and use the recorder host of our company’s wearable fetal ECG monitor as the signal acquisition device. The test results are shown in the table. Shown in 1.

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  • Animal Behavior & Ethology (AREA)
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  • Veterinary Medicine (AREA)
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  • Heart & Thoracic Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
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  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

本申请属于医用导电材料技术领域，公开了一种医用导电凝胶及其制备方法。该医用导电凝胶包括如下质量百分比的组份：盐类电解质2％～10％，保水剂5％～35％，成胶剂10～20％，水50～80％。本申请医用导电凝胶通过在水中分散保水剂、盐类电解质和成胶剂，通过水、保水剂和盐类电解质与成胶剂的协同作用，使得本申请的医用导电凝胶具有优异的生物相容性和浸润性，较低的接触阻抗和噪声，能够用于医用电极领域。

Description

一种医用导电凝胶及其制备方法 技术领域
本申请属于医用导电材料技术领域，例如涉及一种医用导电凝胶及其制备方法。
背景技术
医用导电胶作为一种人体与医用电极的中间媒介，在心电图、脑电图等医疗器械领域具有重要的应用价值。其中导电胶的导电性能直接影响着检测结果，此外，医用导电胶必须具有良好的生物相容性，即无细胞毒性、对人体皮肤无刺激、致敏等特点。
导电胶分为液态导电胶与固态导电胶。液态介质对于皮肤有较强的穿透力和湿润效果，随着监测的进行，其液态介质渗透提高，导电性能提高，阻抗降低，测量的结果更准确、稳定。但是液态导电胶应用范围较窄且需要复杂的结构设计支持，而且易挥发使用寿命、存储时间较短，不利于产业化。而固态导电胶便于产业化模切成型，但其导电性差、接触阻抗高，使用此类导电水凝胶制备的电极噪声大，不能用于微弱信号的采集。
发明内容
以下是对本文详细描述的主题的概述。本概述并非是为了限制权利要求的保护范围。
本申请的目的在于提供一种生物相容性好、接触阻抗低、噪声小能用于微弱信号采集的医用导电凝胶及其制备方法，且该导电凝胶易于产业化，与人体皮肤接触后可由固态转为液态，浸润性佳，测量的结果更准确、稳定。
针对上述的技术目的，本申请将采取如下的技术方案：
一种医用导电凝胶，该医用导电凝胶包括如下质量百分比的组份：盐类电解质2％～10％，保水剂5％～35％，成胶剂10～20％，水50～80％。
作为本申请的进一步改进，所述的盐类电解质为NaCl或KCl或其两者的混合物，所述的保水剂为甘油或聚丙烯酸钠，所述的成胶剂为果胶、明胶、卡拉胶、琼脂、结冷胶中的一种或两种以上，所述的水为去离子水。
另外，本申请还提供了一种医用导电凝胶的制备方法，包括以下步骤：
(1)将上述的水加入到反应釜内并升温至50～70℃，升温完成后对其进行 150～300转/min搅拌；将上述的盐类电解质加入反应釜内，期间应搅拌不停、保持恒温；再搅拌5～15分钟；
(2)将上述的成胶剂与保水剂混合起来，搅拌成混合溶液；然后将混合溶液缓慢加入到反应釜内，边添加边低速搅拌，搅拌速度为10～50转/min；添加完成后进行150～300转/min搅拌，持续时间为1～3小时；
(3)将步骤(2)所合成的溶液注模，室温冷却6‐24h成型，则完成导电凝胶的制备。
与相关技术相比，本申请医用导电凝胶通过在水中分散保水剂、盐类电解质和成胶剂，加上水、保水剂、成胶剂的协同作用，形成分子间氢键，易容性盐类电解质掺杂其中起到离子导电的作用；且本申请的医用导电凝胶与人体皮肤接触后可由固态凝胶转为液态，对于皮肤有较强的穿透力和湿润效果，浸润性极佳，进而降低了接触阻抗，减少了接触电容的变化，进而提高了其对信号收集的灵敏度，测量的结果更准确、稳定。
本申请医用导电凝胶制备工艺简单，生产设备简单，生产成本低，易于产业化，原材料简单易得，安全环保。
另外，本申请的医用导电凝胶兼具低接触阻抗、低噪声，可用于心电、胎儿心电、脑电、肌电等人体电生理信号的采集。
在阅读并理解了详细描述后，可以明白其他方面。
具体实施方式
实施例1
本实施例提供了一种医用导电凝胶及其制备方法。本实施例医用导电凝胶具体包括氯化钾、甘油、明胶和去离子水。
本实施例医用导电凝胶制备方法如下：
(1)将100份水加入到反应釜内并升温至50～70℃；升温完成后对其进行150转/min搅拌，将4份氯化钾加入反应釜内(搅拌不停、保持恒温)，搅拌15分钟；
(2)将14份明胶和20份甘油混合起来，搅拌成混合溶液，然后将其缓慢加入到反应釜内，边添加边低速搅拌，搅拌速度30转/min，添加完成后进行200转/min搅拌，时间2小时；
(3)将所合成的溶液注模，室温冷却10h成型成导电凝胶，完成。
实施例2
本实施例提供了一种医用导电凝胶及其制备方法。本实施例医用导电凝胶具体包括氯化钾、甘油、明胶和去离子水。
本实施例医用导电凝胶制备方法如下：
(1)将100份水加入到反应釜内并升温至50～70℃；升温完成后对其进行150转/min搅拌，将5份氯化钾加入反应釜内(搅拌不停、保持恒温)，搅拌15分钟；
(2)将14份明胶和20份甘油混合起来，搅拌成混合溶液，然后将其缓慢加入到反应釜内，边添加边低速搅拌，搅拌速度30转/min，添加完成后进行200转/min搅拌，时间2小时；
(3)将所合成的溶液注模，室温冷却10h成型成导电凝胶，完成。
实施例3
本实施例提供了一种医用导电凝胶及其制备方法。本实施例医用导电凝胶具体包括氯化钾、甘油、明胶和去离子水。
本实施例医用导电凝胶制备方法如下：
(1)将100份水加入到反应釜内并升温至50～70℃；升温完成后对其进行150转/min搅拌，将6份氯化钾加入反应釜内(搅拌不停、保持恒温)，搅拌15分钟；
(2)将14份明胶和20份甘油混合起来，搅拌成混合溶液，然后将其缓慢加入到反应釜内，边添加边低速搅拌，搅拌速度30转/min，添加完成后进行200转/min搅拌，时间2小时；
(3)将所合成的溶液注模，室温冷却10h成型成导电凝胶，完成。
实施例4
本实施例提供了一种医用导电凝胶及其制备方法。本实施例医用导电凝胶具体包括氯化钾、甘油、明胶和去离子水。
本实施例医用导电凝胶制备方法如下：
(1)将100份水加入到反应釜内并升温至50～70℃；升温完成后对其进行150转/min搅拌，将5份氯化钾加入反应釜内(搅拌不停、保持恒温)，搅拌15分钟；
(2)将20份明胶和20份甘油混合起来，搅拌成混合溶液，然后将其缓慢加入到反应釜内，边添加边低速搅拌，搅拌速度30转/min，添加完成后进行200转/min搅拌，时间2小时；
(3)将所合成的溶液注模，室温冷却10h成型成导电凝胶，完成。
实施例5
本实施例提供了一种医用导电凝胶及其制备方法。本实施例医用导电凝胶具体包括氯化钾、甘油、明胶和去离子水。
本实施例医用导电凝胶制备方法如下：
(1)将100份水加入到反应釜内并升温至50～70℃；升温完成后对其进行150转/min搅拌，将5份氯化钾加入反应釜内(搅拌不停、保持恒温)，搅拌15分钟；
(2)将30份明胶和20份甘油混合起来，搅拌成混合溶液，然后将其缓慢加入到反应釜内，边添加边低速搅拌，搅拌速度30转/min，添加完成后进行200转/min搅拌，时间2小时；
(3)将所合成的溶液注模，室温冷却10h成型成导电凝胶，完成。
相关性能测试：
导电凝胶有三个相对重要的性能指标：交流阻抗、噪声、浸润性，将上述实施例1～5制备的医用导电凝胶进行如下表1中的相关性能测试，并对目前市场上的导电膏和导电水凝胶进行测试，使用本公司的穿戴式胎儿心电传感器上的电极作为测试电极，使用本公司的穿戴式胎儿心电监测仪配套的记录仪主机作为信号采集设备，测试结果如表1中所示。
表1
Figure PCTCN2019123725-appb-000001
虽然本申请已以较佳实施例公开如上，但实施例并不是用来限定本申请的。在不脱离本申请之精神和范围内，所做的任何等效变化或润饰，同样属于本申请之保护范围。因此本申请的保护范围应当以本申请的权利要求所界定的内容为标准。

Claims (7)

  1. 一种医用导电凝胶，其中，所述医用导电凝胶包括如下质量百分比的组份：盐类电解质2％～10％，保水剂5％～35％，成胶剂10～20％，水50～80％。
  2. 根据权利要求1所述的医用导电凝胶，其中，所述的盐类电解质为NaCl或KCl或其两者的混合物。
  3. 根据权利要求1所述的医用导电凝胶，其中，所述的保水剂为甘油或聚丙烯酸钠。
  4. 根据权利要求1所述的医用导电凝胶，其中，所述的成胶剂为果胶、明胶、卡拉胶、琼脂、结冷胶中的一种或两种以上。
  5. 根据权利要求1所述的医用导电凝胶，其中，所述的水为去离子水。
  6. 一种根据权利要求1‐5中任一项所述的医用导电凝胶的制备方法，其中，所述制备方法包括如下步骤：
    (1)将水加入到反应釜内并升温至50～70℃，升温完成后对其进行150～300转/min搅拌；将盐类电解质加入反应釜内，期间应搅拌不停、保持恒温；再搅拌5～15分钟；
    (2)将成胶剂与保水剂混合起来，搅拌成混合溶液；然后将混合溶液缓慢加入到反应釜内，边添加边低速搅拌，搅拌速度为10～50转/min；添加完成后进行150～300转/min搅拌，持续时间为1～3小时；
    (3)将步骤(2)所合成的溶液注模，室温冷却6‐24h成型，则完成导电凝胶的制备。
  7. 根据权利要求1‐5中任一项所述的医用导电凝胶在心电、胎儿心电、脑电、肌电电极等医用电极领域中的应用。
PCT/CN2019/123725 2019-10-29 2019-12-06 一种医用导电凝胶及其制备方法 WO2021082186A1 (zh)

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