Method for the assessment and validation of cleaning processes
    2.
    发明授权
    Method for the assessment and validation of cleaning processes 失效
    清洁过程评估和验证方法

    公开(公告)号:US5928948A

    公开(公告)日:1999-07-27

    申请号:US814804

    申请日:1997-03-10

    申请人: Paul S. Malchesky

    发明人: Paul S. Malchesky

    IPC分类号: A61L2/28 C12M1/00

    摘要: A porous material (10) is contaminated with soil (14). Optionally, the porous material is partially shielded by an impermeable layer. The contaminated porous material is packaged and shipped to a user site. The contaminated porous material is removed from the package and placed in an automated processor containing medical equipment (22). The medical equipment and porous material are subjected to a cleaning, disinfecting, or sterilizing cycle in the processor. The cleaning process is evaluated by examining the porous material with an infrared or other electronic reader (24) to determine the presence of remaining soil which has not be removed during the cleaning, disinfecting, or sterilizing cycle.

    摘要翻译: 多孔材料(10)被土壤污染(14)。 任选地,多孔材料被不渗透层部分屏蔽。 污染的多孔材料被包装并运送到用户现场。 污染的多孔材料从包装中移出并放置在包含医疗设备(22)的自动处理器中。 医疗设备和多孔材料在处理器中进行清洁,消毒或消毒循环。 通过使用红外线或其他电子阅读器(24)检查多孔材料来评估清洁过程,以确定在清洁,消毒或消毒循环期间未被除去的剩余土壤的存在。

    Apparatus and method for sterilizing medical devices
    3.
    发明授权
    Apparatus and method for sterilizing medical devices 失效
    医疗器械灭菌装置及方法

    公开(公告)号:US5858305A

    公开(公告)日:1999-01-12

    申请号:US882466

    申请日:1997-06-25

    申请人: Paul S. Malchesky

    发明人: Paul S. Malchesky

    摘要: A decontamination apparatus for medical devices includes a decontamination basin (14a, 14b) with a selectively opened and closed cover member (16a, 16b) to provide selective access to the basin (14a, 14b). A mixing chamber assembly (80) selectively dispenses detergent concentrate and decontaminant concentrate into a liquid to form a liquid cleaning solution or a liquid decontaminant solution, respectively. A source of decontaminated rinse liquid, such as a microbe removal filter (54), is in selective fluid communication with the basin (14a, 14b). A source of anti-microbial liquid is in selective fluid communication with the microbe removal filter (54) and rinse liquid flow paths (58) between the microbe removal filter and the basin for decontaminating the filter (54) and the rinse lines (58). Each channel of a medical device (E) being decontaminated is connected to a channel flush line (30) and a channel pump (32) for flushing the channels of the device (E). A pressure sensor (42) is in communication with each flush line (30) to sense a blockage in the channels of the medical device (E). The channel pumps (32) pump liquid or decontaminated air through the device channels. A leak test system is also provided for testing the integrity of an outer sheath of a medical device (E) such as an endoscope.

    摘要翻译: 用于医疗装置的净化设备包括具有选择性地打开和关闭的盖构件(16a,16b)的净化池(14a,14b),以提供对所述盆(14a,14b)的选择性通路。 混合室组件(80)分别选择性地将洗涤剂浓缩物和去污浓缩物分配到液体中以形成液体清洁溶液或液体去污剂溶液。 净化的漂洗液体源如微生物去除过滤器(54)与盆(14a,14b)选择性流体连通。 抗微生物液体源与微生物去除过滤器(54)选择性流体连通,并且漂洗微生物去除过滤器和盆之间的液体流动路径(58),以净化过滤器(54)和冲洗管线(58) 。 被净化的医疗装置(E)的每个通道连接到通道冲洗管线(30)和用于冲洗装置(E)的通道的通道泵(32)。 压力传感器(42)与每个冲洗线(30)连通,以感测医疗装置(E)的通道中的阻塞。 通道泵(32)通过设备通道泵送液体或去污空气。 还提供了用于测试诸如内窥镜的医疗装置(E)的外护套的完整性的泄漏测试系统。

    Porous clip for concurrent catheter sterilization and reshaping
    4.
    发明授权
    Porous clip for concurrent catheter sterilization and reshaping 失效
    多孔夹子用于并行导管消毒和重塑

    公开(公告)号:US5759490A

    公开(公告)日:1998-06-02

    申请号:US662663

    申请日:1996-06-14

    申请人: Paul S. Malchesky

    发明人: Paul S. Malchesky

    IPC分类号: A61L2/04 A61L2/26 A61L2/00

    CPC分类号: A61L2/04 A61L2/26

    摘要: A countertop decontamination unit (A) has a decontamination chamber (10) which contains items to be sterilized, disinfected, or otherwise microbially decontaminated. A catheter (60) has an initial curve shape (62A). However, the catheter (60) is straightened in use and returns to a shape (62B). During a decontamination cycle, one or more porous clips (64) are disposed into frictional contact with the catheter. The clip (64) holds the catheter in the initial or undersized shape (62A) during the decontamination process. In the decontamination process, the decontamination fluid is heated at least to a temperature that resets the shape memory of the catheter (e.g., 40.degree.-60.degree. C.). The clip (64) has a sufficient porosity that microbial decontamination fluid penetrates through the clip to wet portions of the item surface in frictional contact with the clip assuring total microbial decontamination of the catheter. Once the decontamination is complete and the catheter is cooled, it holds the reset initial shape (62A).

    摘要翻译: 台面净化单元(A)具有净化室(10),其包含待消毒,消毒或以其它方式微生物净化的物品。 导管(60)具有初始曲线形状(62A)。 然而,导管(60)在使用中被拉直并返回到形状(62B)。 在去污循环期间,将一个或多个多孔夹子(64)设置成与导管摩擦接触。 在净化过程中,夹子(64)将导管保持在初始形状或尺寸过小的形状(62A)。 在净化过程中,去污液至少加热到使导管形状记忆复位的温度(例如40°-60℃)。 夹子(64)具有足够的孔隙率,微生物净化流体通过夹子渗透到与夹子摩擦接触的物品表面的湿润部分,确保导管的总的微生物去污染。 一旦净化完成并且导管被冷却,它保持复位初始形状(62A)。

    Thermofiltration of plasma
    5.
    发明授权
    Thermofiltration of plasma 失效
    等离子体的热过滤

    公开(公告)号:US5080796A

    公开(公告)日:1992-01-14

    申请号:US478624

    申请日:1990-02-12

    摘要: A method for more selectively removing macromolecules from a plasma solution, whereby plasma containing the macromolecules to be removed is provided and heated to a temperature near or above normal body temperature but below the boiling point of the plasma solution. The heated plasma solution is filtered while at a temperature near or above normal body temperature but below its boiling point with a membrane filter to remove selectively macromolecules from the plasma solution. An apparatus for accomplishing the foregoing is also provided.

    摘要翻译: 一种用于从血浆溶液中更有选择地除去大分子的方法,由此提供含有要除去的大分子的等离子体并将其加热至接近或高于正常体温但低于等离子体溶液的沸点的温度。 加热的等离子体溶液在温度接近或高于正常体温但低于其沸点的同时用膜过滤器过滤以从血浆溶液中选择性地除去大分子。 还提供了一种用于实现前述的装置。

    Sub-critical fluid cleaning and antimicrobial decontamination system and process
    6.
    发明授权
    Sub-critical fluid cleaning and antimicrobial decontamination system and process 有权
    亚临界流体清洗和抗菌去污系统及工艺

    公开(公告)号:US06558622B1

    公开(公告)日:2003-05-06

    申请号:US09674787

    申请日:2000-11-03

    申请人: Paul S. Malchesky

    发明人: Paul S. Malchesky

    IPC分类号: A61L216

    摘要: A chamber (10) is supplied with a pressurized cleaning agent of carbon dioxide and cosolvents from a first source (12) and an antimicrobial fluid, such as ethylene oxide or hydrogen peroxide from a second source (16). Chamber conditions are maintained in the sub-critical range for the carbon dioxide. The cleaning agent and antimicrobial fluid are recirculated through a separator (32) and a condenser (38) to filter contaminants from the mixture before returning the carbon dioxide, and optionally the antimicrobial fluid and other additives, to the chamber. Medical instruments or other articles within the chamber are cleaned by the cleaning agent and sterilized by the antimicrobial fluid in a single cycle, rendering them ready for reuse in a short period of time. The instruments may be cleaned and stored in hermetically sealable containers (82). The cleaning agent is rapidly evaporated from surfaces of the articles at the end of the cycle by reducing the pressure in the chamber. optionally, a vacuum pump (60) assists in removing the antimicrobial fluid from the chamber.

    摘要翻译: 室(10)从第二源(12)和来自第二源(16)的抗氧化剂或过氧化氢的抗微生物流体中提供二氧化碳和助溶剂的加压清洁剂。 室内条件保持在二氧化碳的亚临界范围内。 清洁剂和抗微生物流体通过分离器(32)和冷凝器(38)再循环,以将来自混合物的污染物返回到室中,并且可选地将抗微生物流体和其它添加剂返回到室中。 腔室内的医疗器械或其他物品由清洁剂清洁并在单个循环中被抗微生物流体消毒,使得它们在短时间内准备好重新使用。 仪器可以被清洁并储存在可密封的密封容器(82)中。 在循环结束时,通过减小腔室中的压力,清洁剂从制品的表面快速蒸发。 可选地,真空泵(60)有助于从腔室去除抗微生物流体。

    Electrolytic synthesis of peracetic acid
    7.
    发明授权
    Electrolytic synthesis of peracetic acid 失效
    过乙酸的电解合成

    公开(公告)号:US06387238B1

    公开(公告)日:2002-05-14

    申请号:US09630934

    申请日:2000-08-02

    IPC分类号: C25B300

    摘要: An electrolysis unit (10, 210, 310) has an anode (16, 216,316) and a gas diffusion cathode (18, 218, 318). Air is fed to the cathode (18, 218) to generate peroxide species, such as hydrogen peroxide, peroxide ions, or peroxide radicals by electrolysis of oxygenated water. A peracetic acid precursor, such as acetyl salicylic acid, reacts with the peroxide to form peracetic acid. An ion selective barrier (20, 220) optionally separates the unit into two chambers, an anodic chamber (12, 212) and a cathodic chamber (14, 214). By selecting either a proton permeable membrane or an anion exchange membrane for the barrier, the peracetic acid may be formed in either an alkaline electrolyte in the cathodic chamber or in an acid electrolyte in the anode chamber, respectively.

    摘要翻译: 电解单元(10,210,310)具有阳极(16,216,316)和气体扩散阴极(18,218,318)。 通过电解含氧水将空气送入阴极(18,218)以产生过氧化物物质,例如过氧化氢,过氧化物离子或过氧化物自由基。 过乙酸前体如乙酰水杨酸与过氧化物反应形成过乙酸。 离子选择性屏障(20,220)可选地将该单元分离成两个室,阳极室(12,212)和阴极室(14,214)。 通过选择用于阻挡层的质子渗透膜或阴离子交换膜,过乙酸可以分别在阴极室中的碱性电解质中或在阳极室中的酸性电解质中形成。

    Sterilization apparatus utilizing catholyte and anolyte solutions
produced by electrolysis of water
    8.
    发明授权
    Sterilization apparatus utilizing catholyte and anolyte solutions produced by electrolysis of water 失效
    使用通过电解水生产的阴极电解液和阳极电解液的灭菌装置

    公开(公告)号:US5932171A

    公开(公告)日:1999-08-03

    申请号:US910385

    申请日:1997-08-13

    申请人: Paul S. Malchesky

    发明人: Paul S. Malchesky

    摘要: An apparatus (A) for sterilizing medical instruments and other articles includes a tray (12) with an article receiving area (14). An article to be microbially decontaminated is positioned in the receiving area (14) and a microbe blocking lid (10) is closed. A water electrolysis apparatus (30) receives water, splits the water into two separate streams that pass respectively through an anode chamber (34) and a cathode chamber (36), and exposes the streams to an electric field that results in the production of a catholyte solution for cleaning and an anolyte solution for sterilization. The anolyte and catholyte are selectively circulated through the article receiving area (14) by a pump (66) to clean and microbially decontaminate the external surfaces and internal passages of an article located therein. The anolyte or deactivated anolyte provides a sterile rinse solution. A reagent dispensing well (60) receives an ampule (80) or the like. The ampule (80) contains internal compartments which are selectively accessed or opened to dispense detergent concentrate and/or sterilant concentrate reagents into the circulating anolyte and catholyte solutions. A water treatment apparatus (28) dispenses either a salt or a cleaning agent into the water received from the source (24) to vary the electrolysis reaction or to form a cleaning solution to clean and flush the electrolysis apparatus (30), respectively.

    摘要翻译: 用于对医疗仪器和其他物品进行消毒的设备(A)包括具有物品接收区域(14)的托盘(12)。 将待微生物净化的物品定位在接收区域(14)中,并且关闭微生物阻挡盖(10)。 水电解装置(30)接收水,将水分解成分别通过阳极室(34)和阴极室(36)的两个分开的流,并将流体暴露于电场,导致产生 用于清洗的阴极电解液和用于灭菌的阳极电解液。 阳极电解液和阴极电解液通过泵(66)选择性地循环通过物品接收区域(14),以清洁和微生物净化位于其中的物品的外表面和内部通道。 阳极电解液或失活的阳极电解液提供无菌冲洗溶液。 试剂分配井(60)接收安瓿(80)等。 安瓿(80)包含内部隔室,其被选择性地接近或打开以将洗涤剂浓缩物和/或灭菌剂浓缩物试剂分配到循环阳极电解液和阴极电解液中。 水处理装置(28)将盐或清洁剂分配到从源(24)接收的水中以改变电解反应或形成清洁溶液以分别清洗和冲洗电解装置(30)。

    Method and apparatus for cleaning, decontaminating, and sterilizing
catheters
    9.
    发明授权
    Method and apparatus for cleaning, decontaminating, and sterilizing catheters 失效
    用于清洁,去污和消毒导管的方法和设备

    公开(公告)号:US5871692A

    公开(公告)日:1999-02-16

    申请号:US782647

    申请日:1997-01-14

    CPC分类号: A61L2/20 A61L2/14 A61L2/18

    摘要: A method for cleaning, decontaminating, and sterilizing catheters (10) using a combination of liquid and gaseous/plasma sterilization techniques to ensure the complete and efficient sterilization of a catheter (10). Angiographic dye and saline are removed from the interior (36) of the balloon (14) and its lumen (16). The outer surfaces of the catheter (10) and a guide wire lumen (18) of the catheter (10) are cleaned, decontaminated, and sterilized (42) with a liquid sterilant. The liquid sterilant fills a balloon (14) and a balloon lumen (16) of the catheter (10). The liquid sterilant is retained in the balloon (14) and the lumen (16) for a select amount of time. Thereafter, the liquid sterilant is drained from the balloon (14) and the balloon lumen (16). The filling, retaining, and draining steps are repeated until an interior (36) of the balloon (14) and the balloon lumen (16) are sterilized. Residual liquid sterilant is rinsed from the interior (36) of the balloon (14) and the balloon lumen (16). The catheter (10) is dried and then a plasma or gaseous sterilant is used to sterilize at least the outer surfaces and the guide wire lumen (18) of the catheter (10).

    摘要翻译: 一种使用液体和气体/等离子体灭菌技术的组合来清洁,净化和消毒导管(10)的方法,以确保导管(10)的完全和有效的灭菌。 从球囊(14)的内部(36)及其内腔(16)去除血管造影染料和盐水。 导管(10)的外表面和导管(10)的导丝管腔(18)用液体灭菌剂进行清洁,净化和灭菌(42)。 液体灭菌剂填充导管(10)的球囊(14)和球囊内腔(16)。 液体灭菌剂保留在球囊(14)和内腔(16)中一段时间​​。 此后,将液体灭菌剂从球囊(14)和球囊腔(16)排出。 重复填充,保持和排出步骤,直到球囊(14)的内部(36)和球囊腔(16)被消毒。 从气球(14)的内部(36)和球囊腔(16)冲洗剩余液体灭菌剂。 将导管(10)干燥,然后使用等离子体或气体灭菌剂至少对导管(10)的外表面和导丝管腔(18)进行灭菌。

    Scanning device for evaluating cleanliness and integrity of medical and
dental instruments
    10.
    发明授权
    Scanning device for evaluating cleanliness and integrity of medical and dental instruments 失效
    用于评估医疗和牙科仪器的清洁度和完整性的扫描装置

    公开(公告)号:US5747794A

    公开(公告)日:1998-05-05

    申请号:US732038

    申请日:1996-10-16

    申请人: Paul S. Malchesky

    发明人: Paul S. Malchesky

    IPC分类号: A61L2/28 G01N21/35 H01J5/16

    摘要: Medical and other instruments and devices (16, 44) may have a build-up of biological residue film, even after sterilizing. Dead cell membranes in this film can give off endotoxins. To check for the presence of biological residue film, light from a source (10, 40) travels along optical fibers (12, 42) and is focused by a lens (24) on a surface (26) to be examined. Reflected or transmitted light is conveyed by optical fibers (46) to an opto-electrical analyzing device (30, 48). In one embodiment, the opto-electrical device (30) senses the intensity of reflected light to provide an indication of reflectivity attributable to the biological film build-up. In another embodiment, a spectrophotometer (48) converts the returned light into an indication of the reflected spectrum which is analyzed (50) to determine the nature of the material which reflected the light, in particular the type of protein or other biological residue found on the examined surface.

    摘要翻译: 医疗和其他仪器和设备(16,44)即使在灭菌后也可能积聚生物残留物膜。 该膜中的死细胞膜可以释放内毒素。 为了检查生物残留物膜的存在,来自源(10,40)的光沿着光纤(12,42)行进,并被透镜(24)聚焦在待检查的表面(26)上。 反射或透射光被光纤(46)传送到光电分析装置(30,48)。 在一个实施例中,光电装置(30)感测反射光的强度,以提供归因于生物膜积聚的反射率的指示。 在另一个实施方案中,分光光度计(48)将返回的光转换成被分析的反射光谱的指示(50),以确定反射光的材料的性质,特别是在其上发现的蛋白质或其他生物残留物的类型 检查表面。