CN106377011A - 一种糖尿病足的专用鞋垫 - Google Patents

一种糖尿病足的专用鞋垫 Download PDF

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CN106377011A
CN106377011A CN201611048106.4A CN201611048106A CN106377011A CN 106377011 A CN106377011 A CN 106377011A CN 201611048106 A CN201611048106 A CN 201611048106A CN 106377011 A CN106377011 A CN 106377011A
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shoe pad
diabetic foot
foot
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赵应征
鲁翠涛
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Wenzhou Medical University
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    • D01D5/28—Formation of filaments, threads, or the like while mixing different spinning solutions or melts during the spinning operation; Spinnerette packs therefor
    • D01D5/30—Conjugate filaments; Spinnerette packs therefor
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
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    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01F—CHEMICAL FEATURES IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS; APPARATUS SPECIALLY ADAPTED FOR THE MANUFACTURE OF CARBON FILAMENTS
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    • D—TEXTILES; PAPER
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Abstract

本发明提供了一种适用于糖尿病足的专用鞋垫及其制备方法，所述的专用鞋垫呈足部工学结构，由A和B两层紧密贴合组成，A层朝向鞋底，是由含有铜离子的碳气凝胶组成；B层朝向足底，是由丝素蛋白、壳聚糖、活性因子、银离子组成混纺丝面料组成。本发明的糖尿病足专用鞋垫吸湿性强、耐磨耐腐、保温耐潮、抗菌除臭、降血糖，有利于糖尿病足的修复。

Description

一种糖尿病足的专用鞋垫
技术领域
本发明涉及一种医疗保健的专用鞋垫，具体涉及一种保护糖尿病患者足部护理的专用鞋垫。
背景技术
糖尿病是由于胰岛素分泌不足导致血糖过高代谢障碍。病人早期症状不明显，继之有烦渴、多尿、易饿多食、疲乏消瘦、皮肤瘙痒等。临床显示，发生糖尿病七年以后，就会发生“糖尿病足”的危险。
糖尿病足分为湿性坏疽、干性坏疽和混合性坏疽。(1)湿性坏疽是糖尿足病中较为常见的足部坏死现象。由于糖尿病患者的血管硬化、斑块已形成，支端神经损伤，血管容易闭塞，同时微循环受到破坏，坏死组织的代谢物无法排出，长久堆积后，形成病变组织严重腐败菌感染，形成局部组织肿胀，有些足部发展成呈暗绿色或污黑色。由于腐败菌分解蛋白质，产生吲哚、粪臭素等，糖尿病足患者身上很容易发出恶臭味。(2)干性坏疽是凝固性坏死加上坏死组织的水分蒸发变干的结果，大多见于四肢末端，例如动脉粥样硬化、血栓闭塞性脉管炎和冻伤等疾患时。此时动脉受阻而静脉仍通畅，故坏死组织的水分少，再加上在空气中蒸发，故病变部位干固皱缩，呈黑褐色，与周围健康组织之间有明显的分界线。同时，由于坏死组织比较干燥，故既可防止细菌的入侵，也可阻抑坏死组织的自溶分解。因而干性坏疽的腐败菌感染一般较轻。(3)混合性坏疽兼具湿性坏疽和干性坏疽的特点。
目前，我国糖尿病足的发病已出现“中青年化”，最年轻的患者只有38岁。由于“足”离心脏最远，因此糖尿病足的闭塞现象最严重，从而引发水肿、发黑、腐烂、坏死，形成坏疽。目前，各大医院对糖尿病足患者一般采取截肢、搭桥或干细胞移植手术，由于“糖尿病足”患者大多数年岁已高，手术创伤面大，伤口很难愈合，很容易感染和复发，而且患者截肢后，两年内死亡率为51％，内对侧肢体截肢率大于50％，因此，“糖足”病的传统治疗风险非常高，许多患者得了此病后，很容易丧失生活的信心。
糖尿病足患者因末梢神经损害，足部的感觉迟钝，因此要格外注意保护足部，宜穿宽大柔软的袜子，应保持足部干燥洁净，适当使用润滑油或护肤软膏，切忌室内外赤脚行走。足部承受负荷量不宜过大，不宜过度劳动、行走及站立过久等。
因此，糖尿病患者需要专用鞋垫，以保证其足部的病变不继续恶化。理想的糖尿病足患者专用鞋垫应具备如下条件：(1)材料生物相容性好，柔软轻便，无毒无刺激。(2)有较好的吸汗保温作用，保持足部的柔软干燥的环境。(3)有利于缓解糖尿病足病变，有利于提高微小血管活性，提高微循环血流量。(4)耐潮吸汗，抗菌防腐。
目前尚未见到同时满足以上所有条件的糖尿病足患者专用鞋垫的报道。
发明内容
为了克服现有技术的缺陷，本发明的目的在于提供一种保护糖尿病患者足部的专用鞋垫。本发明人发现，银离子、活性因子对于糖尿病足具有良好的医疗护理作用，但是稳定性差，需要适宜的载体；碳气凝胶具有良好的导电性、力学弹性等性能，且轻便耐磨，但柔顺感和生物相容性差；丝素蛋白丝具有良好的生物相容性和柔顺感，保暖吸湿，但是缺乏强度和韧性。因此本发明人将银离子、活性因子、碳气凝胶和丝素蛋白联合应用，制备糖尿病足的专用鞋垫，发挥了各项材料优势互补的特点，制备对于糖尿病足具有良好的保护作用专用鞋垫。
本发明的专用鞋垫呈足部工学结构，由A和B两层紧密贴合组成，A层朝向鞋底，是由含有铜离子的碳气凝胶组成；B层朝向足底，是由丝素蛋白、壳聚糖、活性因子、银离子组成的混纺丝面料组成。
上述的碳气凝胶是由有机气凝胶经固相碳化反应生成的具有交联状结构的多孔碳素气凝胶。
上述的活性因子是指促进糖尿病足修复的一种或几种活性因子或药物。
上述的壳聚糖是指壳聚糖及其衍生物，包括N-三甲基壳聚糖、N-马来酰化壳聚糖、羧甲基壳聚糖、N，O-羧甲基壳聚糖、羟丙基壳聚糖的一种或几种。
上述的专用鞋垫可以进一步加入药物、色素和柔顺剂。
一种上述的糖尿病足的专用鞋垫的制备方法，其特征在于：
a.将活性因子加入丝素蛋白溶液中，配成含活性因子的丝素蛋白溶液A；
b.将银离子加入壳聚糖或其衍生物制成溶液B；
c.将溶液A和B采用高压静电法混纺制成混纺丝，织成混纺丝面料C；
d.将水溶性糖类化合物和水溶性高分子溶于水，加入有机酸或碱，在200～300℃反应，加入铜离子溶液，脱水得到含铜离子的碳气凝胶D。
e.将混纺丝面料C和含铜离子的碳气凝胶D复合，模压制成具有足部工学结构的糖尿病足的专用鞋垫。
上述糖尿病足的专用鞋垫吸湿性强、耐磨耐腐、保温耐潮、抗菌除臭、降血糖，有利于糖尿病足的修复。
本发明的糖尿病足患者专用鞋垫具备以下优点：(1)材料生物相容性好，柔软，无毒无刺激。(2)良好的吸汗保温作用，保持足部的柔软干燥的环境。(3)耐磨耐腐、绝热保温、吸湿性好。(4)有利于缓解糖尿病足病变，有利于提高微小血管活性，提高微循环血流量。(5)无刺激，抗菌除臭。
具体实施方式
下文将详细描述本发明具体实施例。应当注意的是，下述实施例中描述的技术特征或者技术特征的组合不应当被认为是孤立的，它们可以被相互组合从而达到更好的技术效果。
实施例1一种适合于糖尿病患者的专用鞋垫制备
按照表1的专用鞋垫的组成制备各实验组和对照组，制备适合于糖尿病患者的专用鞋垫，各实验组和对照组采用以下方法制备：
a.将活性因子加入丝素蛋白溶液中，配成含活性因子的丝素蛋白溶液A；
b.将银离子加入壳聚糖或其衍生物制成溶液B；
c.将溶液A和B采用高压静电法混纺制成混纺丝，织成混纺丝面料C；
d.将水溶性糖类化合物和水溶性高分子溶于水，加入有机酸或碱，在200～300℃反应，加入铜离子溶液，脱水得到含铜离子的碳气凝胶D。
e.将混纺丝面料C和含铜离子的碳气凝胶D复合，模压制成具有足部工学结构的糖尿病足的专用鞋垫。
表1糖尿病足专用鞋垫的组成
注：“/”代表此项为空；“■”代表此项应用标题对应的材料。
实施例2专用鞋垫的使用效果和满意度评价
(1)使用效果评价
将60名糖尿病患者随机分成12个小组，每组5名，右脚试用实施例1中各实验组和对照组制得的专用鞋垫4周，左脚应用普通鞋垫，通过左脚和右脚的对比，观察足部病变情况，给出使用效果评价。使用效果评分从1到10共分10个等级，数值越高表示专用鞋垫对糖尿病足的保护效果。
(2)满意度评价
将60名糖尿病患者随机分成12个小组，每组5名，试穿实施例1中各实验组和对照组制得的专用鞋垫4周，从刺激性、轻便性、舒适度、保型性、耐磨性、吸汗性、保温性、抗菌除臭能力等方面综合打分，给出满意度指标。满意度评分从1到10共分10个等级，数值越高表示测试者对于糖尿病足专用鞋垫的应用满意度越高。
实验结果：以上各组的专用鞋垫使用效果和满意度结果见表2。
从表2数据可见，各个实验组在使用效果和满意度指标上表现优异，验证了实验组专用鞋垫对糖尿病足的具有良好的保护效果。各个对照组在使用效果和满意度指标上明显劣于实验组，表明对照组的专用鞋垫对糖尿病足的保护效果差，尤其是对照组1和2，选用硅橡胶代替碳气凝胶制备A层，或选用涤纶材料代替丝素蛋白，与壳聚糖混纺制备B层，结果都表明对糖尿病足的保护效果不佳，证明了本发明各项主要组分的重要性和不可替代性。
表2糖尿病足专用鞋垫的使用效果和满意度评价
上述详细说明是针对发明的可行实施例的具体说明，该实施例并非用以限制本发明的专利范围，凡未脱离本发明的等效实施或变更，均应当包含于本发明的专利范围内。
另外，本领域技术人员还可在本发明权利要求公开的范围和精神内做其它形式和细节上的各种修改、添加和替换。当然，这些依据本发明精神所做的各种修改、添加和替换等变化，都应包含在本发明所要求保护的范围之内。

Claims (7)

1.一种糖尿病足的专用鞋垫，其特征在于：所述的专用鞋垫呈足部工学结构，由A和B两层紧密贴合组成，A层朝向鞋底，是由含有铜离子的碳气凝胶组成；B层朝向足底，是由丝素蛋白、壳聚糖、活性因子、银离子组成的混纺丝面料组成。
2.根据权利要求1所述的糖尿病足的专用鞋垫，其特征在于：所述的碳气凝胶是由有机气凝胶经固相碳化反应生成的具有交联状结构的多孔碳素气凝胶。
3.根据权利要求1所述的糖尿病足的专用鞋垫，其特征在于：所述的活性因子是指促进糖尿病足修复的一种或几种活性因子或药物。
4.根据权利要求1所述的糖尿病足的专用鞋垫，其特征在于：所述的壳聚糖是指壳聚糖及其衍生物，包括N-三甲基壳聚糖、N-马来酰化壳聚糖、羧甲基壳聚糖、N，O-羧甲基壳聚糖、羟丙基壳聚糖的一种或几种。
5.一种根据权利要求1所述的糖尿病足的专用鞋垫，其特征在于：专用鞋垫可以进一步加入药物、色素和柔顺剂。
6.一种根据权利要求1所述的糖尿病足的专用鞋垫的制备方法，其特征在于：
a.将活性因子加入丝素蛋白溶液中，配成含活性因子的丝素蛋白溶液A；
b.将银离子加入壳聚糖或其衍生物制成溶液B；
c.将溶液A和B采用高压静电法混纺制成混纺丝，织成混纺丝面料C；
d.将水溶性糖类化合物和水溶性高分子溶于水，加入有机酸或碱，在200～300℃反应，加入铜离子溶液，脱水得到含铜离子的碳气凝胶D。
e.将混纺丝面料C和含铜离子的碳气凝胶D复合，模压制成具有足部工学结构的糖尿病足的专用鞋垫。
7.一种根据权利要求1～6所述的糖尿病足的专用鞋垫，其特征在于：该糖尿病足的专用鞋垫吸湿性强、耐磨耐腐、保温耐潮、抗菌除臭、降血糖，有利于糖尿病足的修复。
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