• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    A live-pore sterilizable medical package according to this invention is made of a specific blend of polyolefin polymers and additives in which during the manufacturing process, the blend is extruded to form a fine heterophasic substrate film comprising a rigid hard phase of a network of very fine crystalline latex which contributes to the strengthening and hardening of the film substrate, and a soft elastic phase of dispersing amorphous domains which accurately form the crystalline network. Under pressure in the sterilization process, these amorphous regions will enlarge their interstitial volumes, allowing submicrometer pores to allow gas phase sterilant to permeate through the package to sterilize medical products internally, and these live pores will automatically close when the package is removed from cleanrooms in a normal atmosphere. Without any open dead pore structure, but having an equilibrium set of heterophasic structures and some hydrophilic additives, this new package can be subjected to all common sterilization methods, especially via ethylene oxide or steam, so that the film is ideally used for sterile medical packaging with an excellent microbial barrier which clearly ensures the sterility of the product and extends its shelf life, even in poor storage conditions.
    公开号:CH715178B1
    申请号:CH01466/19
    申请日:2017-07-13
    公开日:2022-01-14
    发明作者:Wichitamornloet Arthorn
    申请人:Enzpire Ind Co Ltd；
    IPC主号:
    专利说明:

    Field of the invention
    The present invention relates to the field of polymer science and technology with particular attention to the production of a sterilized plastic package for products to be sterilized, especially medical products.
    Background of the invention
    A medical package is a sterile package, commonly made of plastic, with a good barrier to microbes or other contaminants to maintain the sterility of medical devices internally after the sterilization process. Commonly, medical packs on the market are classified into 2 categories according to their pore structures as follows: (1) a non-porous medical pack: which is commonly made of commodified thermoplastic polymers such as, but not limited to, polyethylene, polypropylene in variety of grades in the form of homopolymers, copolymers, heterophasic polymers, and mixtures thereof, processed by an extruder such as, but not limited to, blown film extruder, T-molded film extruder, or extrusion with calender for forming a monolayer, or multilayer film-like substrate which is then further fabricated to be a medical package. With no structure contained in non-fibrous web with open dead pores, these types of medical packaging provide excellent barrier property in protecting medical devices internally.
    Unfortunately, their compact structures may worsen their ability to overcome some sterilization methods, especially ethylene oxide gas sterilization or steam sterilization methods, where the ability of sterilizing gases to permeate through the package is a factor. key, so a radiation sterilization is a common alternative for this type of medical packaging; and (2) a porous medical package: which is normally made up of randomly arranged nets that contain open dead pores. The pores allow sterilizing gases, such as ethylene oxide or steam, to permeate through its structure. This type of medical packaging can be subjected to a greater number of sterilization methods than the one mentioned above. However, the mesh has a wide pore size distribution and variety of shapes which can cause a greater number of risks of losing their sterility as some microbes, impurities, or contaminants can enter the package through its large pores, as well as tolerance. Therefore, strict hygienic storage is required to ensure and maintain its sterility and extend the shelf life of products. Medical packaging with fibrous webs can be further classified into 2 categories according to the types of fibrous materials as follows: (2a) medical packaging with a paper web made of natural fibers of wood pulp or vegetable fiber such as cotton fiber, whose chemical structures are mainly cellulose. Cellulose is sensitive to water therefore it absorbs water which will decrease its physical resistance, and is ruined by microbes which consequently lead to the loss of their barrier functionality and sterility; and (2b) medical packaging with a thermoplastic fiber web, especially a high density polyethylene web, which can eliminate the disadvantage of a natural short fiber kraft paper described above. However, some disadvantages are feared in connection with tying and opening the package.
    [0004] Below are some examples of common sterilization methods:Radiation sterilization: use gamma rays or the electromagnetic energy emanating from radioisotope cobalt-60 to penetrate the package and sterilize medical devices internally, such as syringe, needle, IV set;Heat Sterilization: High pressure, high temperature water vapor in a steam autoclave is the most common method of sterilizing medical instruments or devices that can withstand high heat conditions such as forceps or other stainless steel devices through exposure to steam at 121 - 134 degrees Celsius (° C) in a pressurized chamber; AndChemical Sterilization: Ethylene oxide gas is used more widely as a chemical sterilant that permeates through a porous package to sterilize medical devices internally. This process is suitable for heat or moisture sensitive items such as plastic or rubber electronic parts or devices with a low melting point.
    Clearly, the first package with compacted structure has an excellent barrier property to maintain its sterility, but it cannot be subjected to all methods of sterilization, especially through sterilizers where adequate porosity is an essential factor, therefore one gamma radiation is an alternative method which has some disadvantages such as much stricter safety controls in the sterilization facility, concerns about incidents with radioactive substances, which limits the use of this type of packaging, while the other packaging sterile medical plastic, comprising fibrous webs, such as natural cellulosic kraft paper or synthetic thermoplastic web, allows for sterilization by steam or ethylene oxide gas, which are much more versatile for working safely even in a general hospital. However, its versatility to be sterilized with all common sterilization methods comes at the expense of its worst barrier function. Given its large pore size distribution, oversized pores will increase a risk of microbial penetration and then cause it to lose its sterility. Therefore, a selected sterilization method must be compatible with the package structure used and vice versa.
    Therefore, this new live pore sterilizable medical package, particularly live pores, is invented to provide a smarter package with excellent barrier and reliable sterility, which can also be subjected to all kinds of sterilization methods. In this text, "live pores" are defined as pores which open and close automatically and selectively under certain environmental conditions.
    Detailed description of the invention
    The present invention relates to a live pore sterilizable medical package comprising a live pores set, wherein the package is preferably a plastic film package, but without open dead pores or containing a non-fibrous mesh made of materials semi-crystalline polyolefins. Currently, the most common thermoplastic materials used in plastic packaging are polyethylene, polypropylene, polybutylene, and especially isotactic polypropylene which is used as the main raw material. However, these plastic raw materials that can be processed jointly via any commercial film / sheet forming process - such as blown film extrusion, cast film extrusion, with or without further stretch for orientation - will not provide a sterile medical package that can be subjected to and withstand all common sterilization methods especially via steam sterilization and ethylene oxide sterilization methods as their compact structures would often obstruct permeability to sterilizing vapors or gases, so that pressure will damage or deform the package during sterilization procedure.
    To solve this problem, the live-pore sterilizable medical package according to this invention therefore comprises a unique polyolefin blend formulation with specific proposed additives. A blend of polyolefins such as, but not limited to, polyethylene, polypropylene, polybutylene, C2-C8 alpha olefin copolymer, preferably comprising at least 50 weight percent isotactic polypropylene homopolymer, more preferably high crystallinity isotactic polypropylene homopolymer, for high molecular weight with low melt index below 5; a functional additive comprising 100-2,500 ppm of nucleating agent such as, but not limited to, sorbitol derivatives, 1,3,5-benzenetrisamide derivatives, which can induce very fine crystalline latexes of isotactic polypropylene which hardens the package structure by increasing the tensile strength of the film substrate, especially in the transverse direction, while their elongation percentage remains high; and 0.1-2 percent by weight of hydrophilic filler selected from silica with an average size of 5 microns or less, polyethylene oxide with a molecular weight greater than 1,000 or blends thereof to provide amphiphilic pathways that improve gas permeability, especially velocity water vapor transmission rate (e.g. in one embodiment, the water vapor transmission rate of said modified negative pressure package, -45 kPa, is at least 10 g / m <2> / day), and other common additives as requested.
    In a preferred embodiment, the above compound mixtures are heated and plasticized to 180 - 250 ° C in an extruder, such as, but not limited to, a blown film extruder to form a substrate material film-like with a cooling rate in the range of 1 - 10 ° C / second, and undergo a common process, similar to other packaging, such as corona discharge treatment, molding, gap sealing and cutting, to become a sterilizable medical package with live pores according to this invention.
    With the specific formula and condition of the film-forming process, the resulting live-pore sterilizable medical package according to this invention has a unique structure that provides an excellent barrier to microbes or other impurities since its structure has excluded pores open dead. The tensile strength ratio of said package in the transverse direction per machine direction is greater than 0.7. The ratio of an elongation of said package in the machine direction to the transverse direction is greater than 1, and the elongation in the machine direction is greater than 200%.
    With its heterophasic structure, in one embodiment, comprising a rigid hard network of isotactic polypropylene crystalline latex, which gives the entire strength to the plastic package, while the other amorphous elastic, soft dispersing region everything around the interface of the crystalline network plays a major role in gas permeability. In addition, with the equilibrium of both regions, a hard, rigid crystalline network and a soft elastic amorphous interface provide this unique heterophasic structure with an extraordinary physical property and performance similar to having a set of living pores. The resulting live pore sterilizable medical package will provide a good barrier where it can be stored in normal atmosphere or open air, but under controlled pressure in the sterilized chamber, especially under negative pressure during the evacuation process, the interstitial volume between the crystal interface will enlarge, allowing the submicrometer pores that are accurately dispersing through the matrix to allow water vapor or sterilant gas to permeate through the package to sterilize any products that need to be sterilized, such as medical products. With no open, dead pores, this live pore sterilizable medical packaging according to this invention will extend the shelf life of the product and provide better performance in maintaining sterility even under harsh conditions such as in military service or field applications.
    While this invention has been described in the context of a certain embodiment and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically described embodiment to other alternative embodiments and / or uses of the invention and obvious modifications and equivalents thereof.
    权利要求:
    Claims (4)
    [1]
    1. Sterilizable medical package with live pores comprising:- at least 50 percent by weight of an isotactic polypropylene homopolymer;- 100-2,500 ppm of a nucleating agent; And- 0.1-2 percent by weight of a hydrophilic filler; wherein the above compositions are mixed and plasticized at a temperature in the range of 180-250 ° C and cooled with a cooling rate in the range of 1-10 ° C per second to form a medical film package.
    [2]
    2. Live pore sterilizable medical package according to claim 1 wherein the nucleating agent is selected from a group of sorbitol derivatives, or 1,3,5-benzenetrisamide derivatives, or combinations thereof.
    [3]
    3. A live pore sterilizable medical package according to claim 1 wherein the hydrophilic filler is selected from a silica, or polyethylene oxide or combinations thereof.
    [4]
    4. Sterilizable live pore medical package according to claim 1 wherein the package comprises unopened, non-fibrous dead pore plastic film package.
    类似技术:
    公开号 | 公开日 | 专利标题
    JPWO2014088065A1|2017-01-05|Moisture permeable film and method for producing the same
    KR100932707B1|2009-12-21|Strengthened agricultural laminated film and its manufacturing method
    EP3214216B1|2021-02-24|Use of a spunbond non-woven fabric as a drape or medical clothing, non-woven fabric laminate, medical clothing, and drape
    DE102009006470A1|2010-08-19|Peelable film for fibrous substrates, composite of the film and a substrate and use thereof
    JP5580963B2|2014-08-27|Propylene-based resin material for melt spinning type electrospinning and method for melt spinning ultrafine fibers
    CH715178B1|2022-01-14|Sterilizable medical pack with live pores.
    WO2017175878A1|2017-10-12|Stretched porous film, and production method therefor
    JP2005290366A|2005-10-20|Porous polypropylene film for filter and filter using the same, mask and filter unit
    KR20090043681A|2009-05-07|Reflection film for cultivating plant and manufacturing method thereof
    BR112020009558A2|2020-11-03|multi-component fibers with improved adhesion
    JP2005007756A|2005-01-13|Composite sheet
    JP6063721B2|2017-01-18|Method for producing microporous film
    JP2008169304A|2008-07-24|Resin composition, molded article and resin product
    JP2016089009A|2016-05-23|Moisture permeable film and moisture permeable film laminate
    JP4305129B2|2009-07-29|Bacteria bed bag filter and bacteria bed container or fungus bed bag using the same
    KR101448287B1|2014-10-22|Manufacturing method of sheet for medical having excellent permeability and antibacterial activity
    JP2004345327A|2004-12-09|Laminate
    KR20140027228A|2014-03-06|Multi-layer elastic films
    JP2012197349A|2012-10-18|Polypropylene resin porous sheet and method of producing the same
    JP2021167365A|2021-10-21|Stretchable film and method for producing the same
    JP2017105031A|2017-06-15|Moisture permeable laminate
    JP2019163356A|2019-09-26|Moisture-permeable film, package, and method for producing moisture-permeable film
    JPH0716939A|1995-01-20|Porous film or sheet
    JP2021154586A|2021-10-07|Porous film
    JP2019163357A|2019-09-26|Moisture-permeable film, package, and method for producing moisture-permeable film
    同族专利:
    公开号 | 公开日
    JP2020514190A|2020-05-21|
    JP6884431B2|2021-06-09|
    CN109476886A|2019-03-15|
    GB201900248D0|2019-02-27|
    RU2751465C2|2021-07-14|
    US20200123359A1|2020-04-23|
    RU2019134964A|2021-04-30|
    KR20190032550A|2019-03-27|
    KR102273939B1|2021-07-06|
    DE112017003609T5|2019-07-04|
    RU2019134964A3|2021-04-30|
    GB2569046A|2019-06-05|
    WO2019013715A8|2019-11-07|
    SG11201909307UA|2019-11-28|
    WO2019013715A1|2019-01-17|
    EP3652246A4|2020-11-25|
    EP3652246A1|2020-05-20|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US5176953A|1990-12-21|1993-01-05|Amoco Corporation|Oriented polymeric microporous films|
    JP4117730B2|2002-04-17|2008-07-16|住友化学株式会社|Sterilizable packaging material|
    US7195818B2|2002-05-01|2007-03-27|Exxonmobil Oil Corporation|Sealable multi-layer opaque film|
    JP2006263245A|2005-03-25|2006-10-05|Kao Corp|Sterilizing bag|
    WO2010147149A1|2009-06-19|2010-12-23|三菱樹脂株式会社|Porous polypropylene film|
    CN102286169B|2010-06-18|2015-04-15|中国石油化工股份有限公司|Polypropylene composition and preparation method thereof|
    GB201105455D0|2011-03-31|2011-05-18|British American Tobacco Co|Blends of a polylactic acid and a water soluble polymer|
    KR20140081807A|2011-10-14|2014-07-01|도레이 카부시키가이샤|Porous polypropylene film and electrical storage device|
    US10245025B2|2012-04-06|2019-04-02|Ethicon, Inc.|Packaged antimicrobial medical device having improved shelf life and method of preparing same|
    JP2014117486A|2012-12-18|2014-06-30|Dainippon Printing Co Ltd|Laminate for sterilization packaging bag, and sterilization packaging bag|
    CN104419066A|2013-09-09|2015-03-18|中国石油化工股份有限公司|Polypropylene composition for preparing polypropylene microporous membrane and preparation method of polypropylene composition|
    EP3078704A4|2013-12-03|2017-07-19|Toray Industries, Inc.|Porous film, water-resistant and moisture-transmitting material, and medical garment and protective garment using water-resistant and moisture-transmitting material|
    JP2015163687A|2014-01-28|2015-09-10|東レ株式会社|Polypropylene porous film and construction/civil engineering moisture-permeable waterproof sheet|
    ES2713165T3|2014-10-27|2019-05-20|Borealis Ag|Heterophasic polypropylene with improved balance of impact resistance / toughness, improved powder flow, lower emissions and lower shrinkage|
    CN106700224B|2015-07-23|2020-08-28|中国石化扬子石油化工有限公司|Polypropylene composition and preparation method thereof|
    WO2018062077A1|2016-09-30|2018-04-05|富士フイルム株式会社|Polymer compound|CN111439481A|2020-03-23|2020-07-24|深圳大学|Medical sterilization packaging material capable of achieving efficient sterilization|
    法律状态:
    2021-12-15| PL| Patent ceased|
    优先权:
    申请号 | 申请日 | 专利标题
    PCT/TH2017/000054|WO2019013715A1|2017-07-13|2017-07-13|Sterilizable medical packaging with living pores|
    [返回顶部]