WO2013003988A1 - 一种脊柱手术定位装置的制造方法 - Google Patents

一种脊柱手术定位装置的制造方法 Download PDF

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WO2013003988A1
WO2013003988A1 PCT/CN2011/001615 CN2011001615W WO2013003988A1 WO 2013003988 A1 WO2013003988 A1 WO 2013003988A1 CN 2011001615 W CN2011001615 W CN 2011001615W WO 2013003988 A1 WO2013003988 A1 WO 2013003988A1
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compound
parts
mixture
weight
ruthenium
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PCT/CN2011/001615
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French (fr)
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邵卫星
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Shao Weixing
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    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L27/446—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • 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
    • A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L31/125—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L31/128—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
    • 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
    • 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
    • A61L31/18—Materials at least partially X-ray or laser opaque
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/12—Arrangements for detecting or locating foreign bodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/48—Diagnostic techniques
    • A61B6/481—Diagnostic techniques involving the use of contrast agents
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/44—Radioisotopes, radionuclides
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs

Definitions

  • the present invention relates to a method of manufacturing a surgical medical device, and more particularly to a method of manufacturing a spinal surgery positioning device.
  • the well-known technology is a Chinese patent entitled "A Spinal Surgical Positioning Device” authorized by the Patent Office of the State Intellectual Property Office of China, and the patent number is 200910197534.
  • the spine surgery positioning device structure but does not disclose its manufacturing method.
  • the mesh spine surgery positioning device is mostly formed by stamping a stainless steel plate. Since the surgical positioning device is used once, the cost is made by using stainless steel as a material. Too high, increased the cost of surgery, and increased the economic burden of patients, which is a deficiency of the prior art.
  • the object of the present invention is to provide a technical solution for manufacturing a spinal surgery positioning device according to the deficiencies of the prior art, which uses a polymer material of a polymer material or a mixture of a rubber and an X-ray absorbing material as a material. Made by injection molding, casting or pressing, which reduces costs, reduces surgical costs, and reduces the financial burden on patients.
  • the solution is achieved by the following technical measures: the solution is characterized in that a mixture of 3-7 parts by weight of a polymer material and 4-7 parts by weight of an X-ray absorbing material is used as a material, and the material is injection molded and poured. Or the pressing means is injected into the cavity of the same shape as the surgical positioning device, and is molded into a product after the shaping; the polymer material is a mixture of one or more of plastic or rubber; the X-ray absorption
  • the material is an iron compound, a bismuth compound, a secret compound or a tungsten compound.
  • a specific feature of the present embodiment is that the iron compound is iron oxide.
  • the antimony compound is barium carbonate, barium sulfate or barium titanate.
  • the bismuth compounds are cerium oxide, cerium hypocarbonate, cerium oxychloride.
  • the tungsten compound is calcium tungstate or tungsten oxide.
  • Preferred among the hydrazine compounds is barium sulfate.
  • Preferred among the ruthenium compounds is ruthenium oxychloride.
  • the rubber also includes a thermoplastic elastomer.
  • the beneficial effects of the present solution can be known from the description of the above scheme, since the mixture is made of a mixture of 3-7 parts by weight of the polymer material and 4-7 parts by weight of the X-ray absorbing material.
  • Injection molding, pouring or pressing means injecting into a mold cavity having the same shape as the surgical positioning device, and demoulding and demoulding into a product;
  • the polymer material is a mixture of one or more of plastic or rubber;
  • the X-ray absorbing material is an iron compound, a cerium compound, a cerium compound or a tungsten compound.
  • This method is made by using a mixture of plastic or rubber and X-ray absorbing materials using relatively inexpensive polymer materials, and is formed by conventional injection molding, casting or pressing methods, which can satisfy the positioning of X-ray surgery.
  • the requirements reduce costs, reduce the cost of surgery, and reduce the financial burden on patients. It can be seen that the present invention has outstanding substantive features and significant steps compared with the prior art, and the beneficial effects of the implementation thereof are also obvious.
  • the first embodiment 7 parts by weight of the polymer material polyethylene is mixed with 3 parts by weight of the X-ray absorbing material bismuth oxychloride, and then the mixture is injected into the cavity through the injection molding machine and the shape of the surgical positioning device is the same. In the mold, the finished product is taken out after solidification molding.
  • the second specific embodiment 4 parts by weight of the polymer material polyethylene is mixed with 6 parts by weight of the X-ray absorbing material barium sulfate, and then the mixture is injected into the mold cavity and the mold of the same shape as the surgical positioning device through the injection molding machine. In the middle, after solidification molding, the finished product is taken out.
  • the third embodiment is as follows: 2 parts by weight of polyethylene of polymer material and 1 part by weight of ethylene-vinegar
  • the acid-vinyl copolymer (EVA) is further mixed with 7 parts by weight of the X-ray absorbing material barium sulfate, and then the mixture is injected into the mold having the same shape and shape as the surgical positioning device through the injection molding machine, and the finished product is taken out after solidification molding.
  • the fourth embodiment is as follows: 6 parts by weight of the polymer material, nylon is mixed with 4 parts by weight of the X-ray absorbing material, bismuth oxychloride, and then the mixture is poured into the cavity through the casting machine and has the same shape as the surgical positioning device. In the mold, the finished product is taken out after solidification molding.
  • the fifth embodiment is as follows: 5 parts by weight of the liquid silicone rubber of the polymer material is mixed with 5 parts by weight of the X-ray absorbing material barium sulfate, and then the mixture is poured into the cavity through the casting machine to have the same shape as the surgical positioning device. In the mold, the finished product is taken out after solidification molding.
  • the seventh embodiment is as follows: 5 parts by weight of a polymer material urea-formaldehyde resin is mixed with 5 parts by weight of the X-ray absorbing material barium sulfate, and then the mixture is filled into a mold having the same shape as the surgical positioning device. After heat curing, the finished product is taken out.
  • the eighth embodiment is as follows: taking 4.5 parts by weight of a polymer material styrene-butadiene-styrene block copolymer (SBS), and mixing with 5. 5 parts by weight of the X-ray absorbing material barium sulfate, and then mixing material injection molding machine by the same mold cavity with the surgical positioning means in the shape of a mold, the molding removed after curing the finished 0
  • SBS polymer material styrene-butadiene-styrene block copolymer

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Materials Engineering (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Engineering & Computer Science (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Composite Materials (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Materials For Medical Uses (AREA)
  • Injection Moulding Of Plastics Or The Like (AREA)

Abstract

一种脊柱手术定位装置的制造方法，所述脊柱手术定位装置采用3—7重量份的高分子材料与4一7重量份X光吸收材料的混合料为材料，将所述的材料经注塑、浇注或压制手段注入到与手术定位装置形状相同的模具腔中成型，定型后脱模成制品。所述高分子材料是塑料或橡胶中的一种或几种的混合，所述X光吸收材料是铁化合物、钡化合物、铋化合物或钨化合物。所述方法制得的脊柱手术定位装置在满足X光下手术的定位要求的前提下，降低了成本，减少了手术费用。

Description

一种脊柱手术定位装置的制造方法 技术领域：
本发明涉及的是一种手术医疗器械的制造方法， 尤其是一种脊柱手术定位 装置的制造方法。
背景技术：
在现有技术中， 公知的技术是中国国家知识产权局专利局授权公开的专利 号为 200910197534. 7号， 名称为 "一种脊柱手术定位装置"的中国专利， 该专 利公开了一种网状的脊柱手术定位装置结构， 但没有公开其制造方法， 目前， 网状的脊柱手术定位装置多采用不锈钢板经模具冲压成型， 由于手术定位装置 是一次性使用， 因此采用不锈钢为材料来制作其成本太高， 提高了手术费用， 增加了患者的经济负担， 这是现有技术所存在的不足之处。
发明内容：
本发明的目的就是针对现有技术所存在的不足， 而提供一种脊柱手术定位 装置的制造方法技术方案，该方案采用高分子材料的塑料或橡胶和 X光吸收材 料的混合料为材料， 利用注塑、 浇注或压制方法来制成， 降低了成本， 减少了 手术费用， 也减轻了患者的经济负担。
本方案是通过如下技术措施来实现的:本方案的特点是采用高分子材料 3-7 重量份与 X光吸收材料 4-7重量份的混合料为材料， 将所述的材料经注塑、 浇 注或压制手段注入到与手术定位装置形状相同的模具腔中成型， 定型后脱模成 制品； 所述的高分子材料是塑料或橡胶中的一种或几种的混合； 所述的 X光吸 收材料是铁化合物、钡化合物、祕化合物或钨化合物。本方案具体的特点还有， 所述的铁化合物是氧化铁。 所述的钡化合物是碳酸钡、 硫酸钡或钛酸钡。 所述 的铋化合物是氧化铋、 次碳酸铋、 氯氧化铋。 所述的钨化合物是钨酸钙、 氧化 钨。所述的钡化合物中优选的是硫酸钡。所述的铋化合物中优选的是氯氧化铋。 所述的橡胶中还包括有热塑性弹性体。
本方案的有益效果可根据对上述方案的叙述得知， 由于在该方案中采用高 分子材料 3-7重量份与 X光吸收材料 4-7重量份的混合料为材料， 将所述的材料 经注塑、 浇注或压制手段注入到与手术定位装置形状相同的模具腔中成型， 定 型后脱模成制品； 所述的高分子材料是塑料或橡胶中的一种或几种的混合； 所 述的 X光吸收材料是铁化合物、 钡化合物、 铋化合物或钨化合物。 这一方法， 由于采用采用较为廉价的高分子材料的塑料或橡胶和 X光吸收材料的混合料为 材料， 利用常规的注塑、 浇注或压制方法来制成， 既能满足 X光下手术的定位 要求， 又降低了成本， 减少了手术费用， 也减轻了患者的经济负担。 由此可见， 本发明与现有技术相比， 具有突出的实质性特点和显著的迸步， 其实施的有益 效果也是显而易见的。
具体实施方式：
为能清楚说明本方案的技术特点， 下面通过几个具体实施方式， 对本方案 进行阐述。
第一个具体实施方式： 取高分子材料聚乙烯 7重量份， 与 3重量份的 X光 吸收材料氯氧化铋混合均匀， 然后将混合料通过注塑机注射到模腔与手术定位 装置形状相同的模具中， 固化成型后取出成品。
第二个具体实施方式： 取高分子材料聚乙烯 4重量份， 与 6重量份的 X光 吸收材料硫酸钡混合均匀， 然后将混合料通过注塑机注射到模腔与手术定位装 置形状相同的模具中， 固化成型后取出成品。
第三个具体实施方式： 取高分子材料聚乙烯 2重量份和 1重量份的乙烯-醋 酸乙烯共聚物（EVA), 再加 7重量份的 X光吸收材料硫酸钡混合均匀， 然后将混 合料通过注塑机注射到模腔与手术定位装置形状相同的模具中， 固化成型后取 出成品。
第四个具体实施方式： 取高分子材料浇注尼龙 6重量份， 与 4重量份的 X 光吸收材料氯氧化铋混合均勾， 然后将混合料通过浇注机浇注到模腔与手术定 位装置形状相同的模具中， 固化成型后取出成品。
第五个具体实施方式： 取高分子材料液体硅橡胶 5重量份， 与 5重量份的 X光吸收材料硫酸钡混合均匀， 然后将混合料通过浇注机浇注到模腔与手术定 位装置形状相同的模具中， 固化成型后取出成品。
第六个具体实施方式： 取高分子材料蜜胺树脂 7重量份， 与 3重量份的 X 光吸收材料氯氧化铋混合均匀， 然后将混合料装填到模腔与手术定位装置形状 相同的压模中， 加热固化成型后取出成品。
第七个具体实施方式： 取高分子材料脲醛树脂 5重量份， 与 5重量份的 X 光吸收材料硫酸钡混合均勾， 然后将混合料装填到模腔与手术定位装置形状相 同的压模中， 加热固化成型后取出成品。
第八个具体实施方式： 取高分子材料苯乙烯一丁二烯一苯乙烯嵌段共聚物 (SBS) 4.5重量份， 与 5. 5重量份的 X光吸收材料硫酸钡混合均匀， 然后将混 合料通过注塑机注射到模腔与手术定位装置形状相同的模具中， 固化成型后取 出成品 0
本发明并不仅限于上述具体实施方式， 本领域普通技术人员在本发明的实 质范围内做出的变化、 改型、 添加或替换， 也应属于本发明的保护范围。

Claims

权利要求
1. 一种脊柱手术定位装置的制造方法， 其特征是： 采用高分子材料 3-7重 量份与 X光吸收材料 4-7重量份的混合料为材料， 将所述的材料经注塑、 浇注 或压制手段注入到与手术定位装置形状相同的模具腔中成型， 定型后脱模成制 品； 所述的高分子材料是塑料或橡胶中的一种或几种的混合； 所述的 X光吸收 材料是铁化合物、 钡化合物、 铋化合物或钨化合物。
2. 根据权利要求 1所述的方法， 其特征是： 所述的铁化合物是氧化铁。
3. 根据权利要求 1所述的方法， 其特征是： 所述的钡化合物是碳酸钡、 硫 酸钡或钛酸钡。
4. 根据权利要求 1所述的方法， 其特征是： 所述的铋化合物是氧化铋、 次 碳酸铋、 氯氧化铋。
5. 根据权利要求 1所述的方法， 其特征是： 所述的钨化合物是钨酸钙、 氧 化钨。
6. 根据权利要求 3所述的方法， 其特征是： 所述的钡化合物中优选的是硫 酸钡。
7. 根据权利要求 4所述的方法， 其特征是： 所述的铋化合物中优选的是氯 氧化铋。
8. 根据权利要求 1所述的方法， 其特征是： 所述的橡胶中还包括有热塑性 弹性体。
替换页
PCT/CN2011/001615 2011-07-05 2011-09-23 一种脊柱手术定位装置的制造方法 WO2013003988A1 (zh)

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