WO2015018349A1 - 一种复合结构的止血贴片及其制备方法 - Google Patents

一种复合结构的止血贴片及其制备方法 Download PDF

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Publication number
WO2015018349A1
WO2015018349A1 PCT/CN2014/083847 CN2014083847W WO2015018349A1 WO 2015018349 A1 WO2015018349 A1 WO 2015018349A1 CN 2014083847 W CN2014083847 W CN 2014083847W WO 2015018349 A1 WO2015018349 A1 WO 2015018349A1
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layer
woven fabric
calcium alginate
fabric layer
composite structure
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PCT/CN2014/083847
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English (en)
French (fr)
Inventor
奚敏敏
季杰
唐燕
朱鑫建
潘科
杜广武
罗七一
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上海微创医疗器械(集团)有限公司
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Publication of WO2015018349A1 publication Critical patent/WO2015018349A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/28Polysaccharides or their derivatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/44Medicaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/04Materials for stopping bleeding

Definitions

  • the present invention relates to medical devices, and in particular to a hemostatic patch of a composite structure and a method of preparing the same. Background technique
  • calcium alginate gradually transforms into sodium alginate dissolved in water, forming a thin layer of hydrogel on the surface of the wound, which can maintain the moisturization of nerve endings, slow down the pain of patients, and also create wounds.
  • the healing creates a good microcirculation environment that causes the wound to heal as early as possible.
  • the calcium alginate nonwoven fabric can absorb up to 10-20 times its own weight.
  • the calcium alginate nonwoven fabric has a certain hemostatic function, it has no antibacterial ability, and has high cost, low strength, high brittleness, and resistance to acid and alkali, which affects its effect. Summary of the invention
  • the present invention provides a composite structure of a hemostatic patch which can achieve hemostasis, analgesic, anti-inflammatory, maintain a moist environment, and promote wound healing, and can reduce the cost of treatment and improve the practicality.
  • the hemostatic patch of the composite structure of the present invention comprises a composite nonwoven layer, and a metal ion or metal nanoparticle layer on the surface of the composite nonwoven layer.
  • the composite nonwoven layer comprises a mixed nonwoven layer of hydrophobic fibers and hydrophilic fibers, And a calcium alginate nonwoven fabric layer, wherein the mixed nonwoven fabric layer and the calcium alginate nonwoven fabric layer are compounded by processing adhesion.
  • the material of the mixed non-woven fabric layer is polyester-viscose, velvet or polyester-cotton.
  • the metal ion is a zinc ion, a copper ion, or a silver ion.
  • the metal nanoparticles are from a nanosilver.
  • the invention also provides a preparation method of the hemostatic patch of the composite structure, comprising the following steps: (1) mixing 1-2 layers of hydrophobic fibers such as polyester/gum sticky/polyester cotton and hydrophilic fibers with a non-woven fabric layer, A layer of calcium alginate nonwoven fabric is laminated and then laminated to form a composite nonwoven fabric layer by processing; (2) on the surface of the above composite nonwoven fabric layer (ie, calcium alginate A layer of metal ion or nano silver paste sprayed onto the woven layer.
  • the above step (1) is a nonwoven fabric obtained by mixing a hydrophobic fiber and a hydrophilic fiber by carding into a web and then needle-punching.
  • the spraying technique refines the liquid to the sub-micron level and then directly coats the surface of the calcium alginate nonwoven layer. Since the coating is a liquid that is micronized to sub-micron or even nano-scale, a sub-micron-scale, nano-scale film thickness and a high-precision film can be formed; the bismuth liquid is directly coated in a dispersed state.
  • the calcium alginate fiber of the present invention has a strong hemostatic effect, and a water-soluble metal compound serves as a metal ion source.
  • the metal ions and nano silver particles of the present invention have adsorption to microorganisms, and after the microorganisms are adsorbed by metal ions and nano silver particles, the respiration function loses its effect, and the cell walls and cell membranes of the microorganisms are When damaged, microorganisms will die quickly, so their bactericidal ability is particularly strong.
  • Hydrophobic fibers such as polyester, the basic constituent material is polyethylene terephthalate, which does not contain a hydrophilic group, is durable and has good elasticity.
  • Hydrophilic fibers such as viscose
  • the function of the hemostatic patch prevents the invasion of external bacteria and the overflow of the inner boundary wound exudate endangers other wounds.
  • the hemostatic patch of the invention is used for hemostasis of minimally invasive interventional surgery, and the combination of the calcium alginate non-woven fabric and other non-woven fabrics has high strength, and the different fiber components of other non-woven fabrics play a role in hydrophobicity and water absorption.
  • the composite calcium alginate hemostatic patch has a hemostatic function, an antibacterial function, a moisturizing function, a liquid absorbing function, etc. due to spraying metal ions and nano silver particles on the calcium alginate non-woven layer.
  • the use of calcium alginate non-woven fabric and polyester/glue/polyester/cotton non-woven fabric composite can greatly improve the fastness of the hemostatic patch, making it an excellent medical hemostatic patch.
  • Fig. 1 shows a hemostatic patch of the present invention, wherein a 1-aluminum alginate nonwoven layer; a 2-polyester-free layer; a 3-silver compound.
  • FIG. 2 is a hemostatic patch of the present invention, wherein a 1-aluminum alginate nonwoven layer; a 2-polyester-free layer; a 3-nano-silver.
  • Figure 3 is a hemostatic patch of the present invention, wherein a 1-aluminum alginate nonwoven layer; a 2-pink-free layer; a 3-silver compound
  • Figure 4 is a hemostatic patch of the present invention, wherein 1-aluminum alginate nonwoven fabric layer; 2-polyester cotton nonwoven fabric layer; 3-silver compound
  • the hemostatic patch of the present invention comprises 1-2 layers of polyester-bonded nonwoven fabric (2) and layer A calcium alginate nonwoven fabric (1), which is reinforced by a needle-punching method.
  • the needle acupuncture method uses a micro-needle machine.
  • the main structure includes a needle plate, a trawl plate, and a dial plate.
  • the needle needle density is determined according to the diameter of the needle handle of the needle.
  • the density of the needle is according to the length and fineness of the reinforcing fiber. Reinforce the fastness to determine.
  • a silver compound solution (3) is sprayed on the surface of the calcium alginate nonwoven layer to adsorb silver ions on the calcium alginate fiber.
  • Example 2
  • the non-woven layer of the hemostatic patch of the present invention is compounded with j3 ⁇ 4 polyester, viscose mixed non-woven fabric and calcium alginate non-woven fabric, and the coating is coated with nano silver. .
  • Example 3
  • the hemostatic patch nonwoven fabric layer of the present invention is compounded with a nylon, a viscose-fiber hybrid nonwoven fabric and a calcium alginate nonwoven fabric, and the coating is a silver compound.
  • Example 4 Similar to the method of Example 1, as shown in Fig. 3, the hemostatic patch nonwoven fabric layer of the present invention is compounded with a nylon, a viscose-fiber hybrid nonwoven fabric and a calcium alginate nonwoven fabric, and the coating is a silver compound.
  • the hemostatic patch nonwoven fabric layer of the present invention is a composite of a polyester, cotton mixed nonwoven fabric and a calcium alginate nonwoven fabric, and the coating is a silver compound.

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  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Materials Engineering (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

一种复合结构的止血贴片及其制备方法。所述止血贴片包括疏水性纤维和亲水性纤维的混合无纺布层,海藻酸钙无纺布层(1),以及涂布在复合无纺布层表面上的金属离子或金属纳米颗粒层。该止血贴片具有止血、镇痛、消炎、保持创口潮湿的环境、促使创口愈合等作用。

Description

-种复合结构的止血贴片及其制备方法 技术领域
本发明涉及医疗器械, 具体涉及复合结构的止血贴片及其制备方 法。 背景技术
在曰常的微创手术创口止血护理工作中, 通常采用浸有药液的脱 脂纱布敷贴在创口上或者嵌入^口中, 起到止血、 镇痛、 消炎、 保持 创口湿润的环境、 促进创口愈合等作用。 近些年来, 己有很多专利文 献和非专利文献公开或报道了釆用海藻酸钙止血敷料。 海藻酸钙止血敷料的优点在于, 海藻酸钙无纺布中的纤维与创口 渗出液及血液中的销离子进行交换, 释放出钙离子, 钙离子能加速毛 细血管末端中血块的形成。 随着吸收钠离子量的增多, 海藻酸钙逐渐 转换成溶于水的海藻酸钠, 在创口表面形成水凝胶薄层, —可以维持神 经末梢的湿润, 减缓患者的疼痛, 并且也为创面的愈合创造了一个良 好的微循环环境, 促使创口尽早愈合。 海藻酸钙无纺布的吸液量可达 自身重量的 10- 20倍。 然而, 海藻酸钙无纺布虽有一定的止血功能, 却 无抗菌能力, 且其成本高、 强度低、 脆性大、 不耐酸碱, 影响它的使 周效果。 发明内容
本发 提供了一种复合结构的止血贴片, 它可以达到止血、 镇痛、 消炎、 保持创口潮湿的环境、 促使创口愈合等作用, 而 ϋ可以降低治 疗成本, 提高实用性。 本发明的复合结构的止血贴片, 包括复合无纺布层, 以及位于复 合无纺布层表面上的金属离子或金属纳米颗粒层。 在一实施方案中, 所述复合无纺布层包括疏水性纤维和亲水性纤维的混合无纺布层, 以 及海藻酸钙无纺布层, 所述混合无纺布层与海藻酸钙无纺布层通过加 工粘连复合在一起。 在另一实施方案中, 所述混合无纺布层的材料为 涤粘、 锦粘或涤棉。 在另一实施方案中, 所述金属离子为锌离子、 铜 离子或银离子。 在另一实施方案中, 所述金属纳米颗粒来自纳米银浆。 本发明还提供复合结构的止血贴片的制备方法, 包括下列步骤: ( 1 )将 1-2层的涤粘 /锦粘 /涤棉等疏水性纤维和亲水性纤维混合无纺布 层、 1层海藻酸钙无纺布层叠放在一起, 然后通过加工, 使其粘连复合 在一起, 制成复合无纺布层; (2) 在上述复合无纺布层的表面 (即海 藻酸钙无紡布层) 上喷涂金属离子或纳米银浆的液体。 在一实施方案 中, 上述步骤 (1 ) 是将疏水性纤维和亲水性纤维混合在一起通过梳理 成网, 再通过针刺法制成的无纺布。 喷涂技术让液体细化为次微米级, 然后直接涂在海藻酸钙无纺布层表面上。 由于涂布的是微细化至次微 米级甚至纳米级的液体, 所以可以形成次微米级、 纳米级膜厚以及高 精度形成薄膜; ϋ液体是以分散后的状态直接涂布。 本发明的海藻酸钙纤维具有很强的止血效果, 水溶性金属化合物 作为金属离子源。 不受任何理论的限制, 本发明的金属离子、 纳米银 颗粒对微生物具有吸附作^, 微生物被金属离子、 纳米银颗粒吸附后, 起呼吸作用的酶就失去功效, 且微生物的细胞壁、 细胞膜都会受到破 坏, 微生物就会迅速死亡, 所以其杀菌能力特别强。 疏水性纤维例如 涤纶, 基本组成物质是聚对苯二甲酸乙二酯, 不含有亲水性基团, 结 实耐用, 弹性好。 而亲水性纤维例如粘胶, 含有亲水性基团, 例如羟 基, 结晶度较低, 具有良好的吸湿性, 能及时将伤口的渗出液吸收, 祛除细菌生长的潜在场所。 止血贴片的使 能防止外界细菌的入侵和 内界伤口渗出液的外溢面危及其它伤口。 本发明止血贴片用于微创介入手术穿刺伤口止血, 采周海藻酸钙 无纺布和其他无纺布的复合, 强度高, 且其他无纺布中不同纤维成分 各发挥疏水和吸水的作 ¾, 能及时将伤口的渗出液吸收, 祛除细菌生 长的潜在场所, 同时能防止外界细菌的入侵和内界伤口渗出液的外溢 而危及其它伤口。 同时, 这种复合海藻酸钙止血贴片由于在海藻酸钙无纺布层上喷 涂階有金属离子、 纳米银颗粒, 使它兼具有止血功能、 抗菌功能、 保 湿功能、 吸液功能等, 又由于采用海藻酸钙无纺布和涤粘 /锦粘/涤棉无 纺布复合, 能大大提高止血贴片的使用牢度, 使其成为一种极为优良 的医用止血贴片。 附图说明
为了更清楚地描述本发明的技术方案, 下面将结合附图作筒要介 绍。 显 易见, 这些附图仅是本申请记载的一些具体实施方式。 本发 明包括但不限于这些附图。 图 1 为本发明的止血贴片, 其中 1-海藻酸钙无纺布层; 2-涤粘无 层; 3-银化合物。
图 2为本发明的止血贴片, 其中 1-海藻酸钙无纺布层; 2-涤粘无 ¾层; 3-纳米银。
图 3为本发明的止血贴片, 其中 1-海藻酸钙无纺布层; 2-锦粘无 层; 3-银化合物
图 4为本发明的止血贴片, 其中 1-海藻酸钙无纺布层; 2-涤棉无 纺布层; 3-银化合物 具体实施方式
为了进一步理解本发明, 下面将结合实施例对本发明的优选方案 进行描述。 这些描述只是举例说 本发明止血贴片的特征和优点, 而 非限制本发明的保护范圍。
实施例 1
根据图 1, 本发明的止血贴片包括 1-2层涤粘无纺布 (2 ) 和〗层 海藻酸钙无纺布 (1 ) , 通过针刺加固法将 2- 3层无纺布加固在一起。 针刺加固法是采用微型针刺机, 其主要结构包括针板、 拖网板、 拨网 板, 针板布针密度根据刺针的针柄直径来确定, 针刺密度根据加固纤 维长度、 细度以及加固牢度来确定。 然后在海藻酸钙无纺布层表面上 喷涂银化合物溶液 (3 ) , 使银离子吸附在海藻酸钙纤维上。 实施例 2
与实施例 1 的方法类似, 如图 2所示, 本发明的止血贴片中无纺 布层采 j¾涤纶、 粘胶混合无纺布和海藻酸钙无纺布复合, 涂层采周纳 米银。 实施例 3
与实施例 1 的方法类似, 如图 3所示, 本发明的止血贴片无紡布 层采 锦纶、 粘胶纤维混合无纺布和海藻酸钙无纺布复合, 涂层采用 银化合物。 实施例 4
与实施例 1 的方法类似, 如图 4所示, 本发明的止血贴片无纺布 层采用涤纶、 棉 维混合无纺布和海藻酸钙无纺布复合, 涂层采用银 化合物。 以上实施例的说明只是周于帮助理解本发明的核心思想。 应当指 出, 对于本领域的普通技术人员面言, 在不脱离本发明原理的前提下, 还可以对本发明的止血贴片及其制备方法进行若干改进和修饰, 但这 些改进和修饰也落入本发明权利要求请求保护的范围内。

Claims

权 利 要 求 书
1。 一种复合结构的止血贴片, 包括海藻酸钙无纺布层, 以及涂布 于所述海藻酸钙无纺布层上的金属离子或金属纳米颗粒。
2. 根据权利要求〗所述的复合结构的止血贴片, 还包括混合无纺 布层, 所述混合无纺布层包括疏水性纤维和亲水性纤维, 所述混合无 纺布层与所述海藻酸^无纺布层通过加工粘连复合在一起。
3. 根据权利要求 2所述的复合结构的止血贴片, 其中所述混合无 纺布层的材料为涤粘、 锦粘或涤棉。
4. 根据权利要求 1 -3任一项所述的复合结构的止血贴片, 其中所 述金属离子为锌离子、 铜离子或银离子。
5. 根据权利要求 1 -3任一项所述的复合结构的止血贴片, 其中所 述金属纳米颗粒来自纳米银浆。
6. 一种制备权利要求 1-5任一项所述的复合结构的止血贴片的方 法' 包括下列步骤:
( 1 ) 提供海藻酸钙无纺布层; 以及
( 2 )在所述海藻酸钙无纺布层的表面上涂布金属离子或金属纳米 颗粒
7. 根据权利要求 6 所述的制备方法, 还包括在步骤 (2 ) 之前或 之后, 将所述海藻酸钙无纺布层与混合无纺布层叠放在一起, 并使所 述海藻酸钙无纺布层未经涂布的表面与所述混合无纺布层的表面接触 并粘接。
8. 根据权利要求 7所述的制备方法, 其中所述混合无纺布层是由 疏水性纤维和亲水性纤维混合在一起通过梳理成网, 再通过针剌法制 成。
9. 根据权利要求 6所述的制备方法, 其中所述涂布是通过喷涂技 术使得液体微细化为次微米级或纳米级, 然后直接涂布在所述海藻酸 钙无纺布层的表面上。
PCT/CN2014/083847 2013-08-07 2014-08-07 一种复合结构的止血贴片及其制备方法 WO2015018349A1 (zh)

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CN105536030B (zh) * 2016-01-08 2018-09-18 山东明德生物医学工程有限公司 一种止血促修复敷料芯片及其制备方法
CN105727346B (zh) * 2016-02-04 2019-08-27 中国科学院化学研究所 一种止血织物及其制备方法与应用
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