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WO1996039479A1 - Procede de nettoyage de dispositifs medicaux implantables - Google Patents

Procede de nettoyage de dispositifs medicaux implantables Download PDF

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Publication number
WO1996039479A1
WO1996039479A1 PCT/US1996/008192 US9608192W WO9639479A1 WO 1996039479 A1 WO1996039479 A1 WO 1996039479A1 US 9608192 W US9608192 W US 9608192W WO 9639479 A1 WO9639479 A1 WO 9639479A1
Authority
WO
WIPO (PCT)
Prior art keywords
blend
parts
cleaning
present
alcohol
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US1996/008192
Other languages
English (en)
Inventor
Stephen M. Ramsey
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Intermedics Inc
Original Assignee
Intermedics Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Intermedics Inc filed Critical Intermedics Inc
Publication of WO1996039479A1 publication Critical patent/WO1996039479A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D7/00Compositions of detergents based essentially on non-surface-active compounds
    • C11D7/22Organic compounds
    • C11D7/26Organic compounds containing oxygen
    • C11D7/261Alcohols; Phenols
    • C11D7/262Alcohols; Phenols fatty or with at least 8 carbon atoms in the alkyl or alkenyl chain
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D7/00Compositions of detergents based essentially on non-surface-active compounds
    • C11D7/22Organic compounds
    • C11D7/26Organic compounds containing oxygen
    • C11D7/261Alcohols; Phenols
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D7/00Compositions of detergents based essentially on non-surface-active compounds
    • C11D7/50Solvents
    • C11D7/5004Organic solvents
    • C11D7/5022Organic solvents containing oxygen
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D2111/00Cleaning compositions characterised by the objects to be cleaned; Cleaning compositions characterised by non-standard cleaning or washing processes
    • C11D2111/10Objects to be cleaned
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D2111/00Cleaning compositions characterised by the objects to be cleaned; Cleaning compositions characterised by non-standard cleaning or washing processes
    • C11D2111/10Objects to be cleaned
    • C11D2111/14Hard surfaces
    • C11D2111/16Metals
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D2111/00Cleaning compositions characterised by the objects to be cleaned; Cleaning compositions characterised by non-standard cleaning or washing processes
    • C11D2111/10Objects to be cleaned
    • C11D2111/14Hard surfaces
    • C11D2111/18Glass; Plastics
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D7/00Compositions of detergents based essentially on non-surface-active compounds
    • C11D7/22Organic compounds
    • C11D7/24Hydrocarbons
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D7/00Compositions of detergents based essentially on non-surface-active compounds
    • C11D7/22Organic compounds
    • C11D7/26Organic compounds containing oxygen
    • C11D7/264Aldehydes; Ketones; Acetals or ketals
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D7/00Compositions of detergents based essentially on non-surface-active compounds
    • C11D7/22Organic compounds
    • C11D7/26Organic compounds containing oxygen
    • C11D7/266Esters or carbonates

Definitions

  • the present invention relates to an improved process for cleaning metal and plastic.
  • the present invention relates to a cleaning or degreasing process utilizing a blend of polar and non-polar organic molecules, and to the blend of polar and non-polar organic molecules itself, for cleaning and/or degreasing critical metal and plastic component parts of, for instance, implantable medical devices.
  • Background Art The cleaning and degreasing of the metal and plastic parts of implantable medical devices, and subassemblies comprised of such parts from which such devices are assembled, is an essential step in their manufacture.
  • plastics are used in making critical parts, and a variety of adhesives, including epoxies, silicone polymers and cements, elastomer-solvent cements, polysulf ⁇ de sealants, thermoplastic resins, and natural adhesives such as cellulosics and mineral-based adhesives, are used for assembling such parts to each other.
  • adhesives including epoxies, silicone polymers and cements, elastomer-solvent cements, polysulf ⁇ de sealants, thermoplastic resins, and natural adhesives such as cellulosics and mineral-based adhesives
  • some parts are coated or treated such that their surface properties are different than those of the underlying material.
  • the electrodes of an implantable medical device such as a pacemaker may be coated with an iridium oxide coating such as the IROX coating utilized on the electrode tip of pacemaker leads manufactured by Intermedics, Inc. (Angleton, TX).
  • Such parts include the parts of implantable and other medical devices, electrical circuitry, carburetor parts, fuel injectors and other parts of engines and vehicles, metal parts for painting, coating, or adhering, plastic parts which need to be cleaned prior to assembly, painting, or coating, control components, valves, semiconductor devices, and many other parts of types known in the art but too many in number and too diverse in type to list here, it being intended to exemplify the utility of the present invention with the preceding list. Disclosure of Invention
  • the improvement comprises the contacting the parts with a blend of an alcohol and a non-polar hydrocarbon selected from the group consisting of alkanes, alkenes, and alkynes.
  • the method of the present invention also contemplates increasing the temperature of either the parts or the blend and the use of ultrasonic energy during the cleaning process.
  • the present invention provides a composition comprising a blend of alcohol and non-polar hydrocarbon for use in cleaning or degreasing critical parts. Best Mode of Carrying Out the Invention
  • pacemaker leads are comprised of metal parts (stainless steel, titanium), coated metal parts (the aforementioned iridium oxide coating, for instance), polyurethane tubing, and silicone molded parts and tubing. These various parts are assembled to each other by adhesives such as epoxies, silicones, and polyurethanes such that the testing of the present invention on these parts and subassemblies provides broad-based verification of its efficacy. Further, it was during the testing of the present invention on such parts that a surprising result was discovered. Specifically, it was discovered that cleaning a subassembly including a glue joint in accordance with the method of the present invention resulted in an increase in the strength of the component plastic materials and the glue joints.
  • the process of the present invention comprises contacting the parts to be cleaned with a blend of an alcohol and a non-polar hydrocarbon.
  • the non-polar hydrocarbon is any straight, branched, or cyclical hydrocarbon, saturated or unsaturated, which is relatively non-polar.
  • relatively non-polar reference is being made to hydrocarbons and/or substituted hydrocarbons having a dipole moment ( ⁇ ) of less than about zero to about five Debye.
  • Preferred non ⁇ polar hydrocarbons are hydrocarbons which are liquids at room temperature, non-mutagenic and non- carcinogenic for safety, and which have relatively low vapor pressures so as to minimize loss to the atmosphere.
  • the non-polar hydrocarbons contemplated include those alkanes, alkenes, and alkynes comprised of carbon chains of between about four and about ten carbons in length.
  • the word "about” is used to describe the length, including branches, of the carbon chain because of the interaction of temperature with the non-polar hydrocarbon.
  • temperatures higher and lower than room temperature may also be used to advantage and shorter chain hydrocarbons which are gases at room temperature are liquids at lower temperatures.
  • hydrocarbons appropriate for use with the present invention in this fashion, particularly preferred hydrocarbons are alkanes and their straight chain and cyclic isomers having carbon chains of between five and eight carbons in length such as pentanes, cyclopentanes, pentenes, pentynes, and their isomers, hexanes, cyclohexanes, hexenes, hexynes, and their isomers, heptanes, heptenes, heptynes, and their isomers, octanes, octenes, octynes, and their isomers, toluene, benzene, xylene, and methyl-, ethyl-, propyl- and butyl- substituted derivatives of these alkanes, alkenes, and alkynes.
  • Suitable substituted non-polar hydrocarbons and their derivatives include, for instance, methyl-, ethyl-, propyl-, and butyl- ketone, methyl-, ethyl-, propyl-, methylchloro-, ethylchloro- and butyl- acetate, halide substituted derivatives of alkanes such as methyl-, ethyl-, and propylchloride, methylene chloride, chloroform, carbon tetrachloride, methyl-, ethyl-, propyl-, and butylchloroform, and alkanes, alkenes, and alkynes having aldehyde, ketone, ester, carboxylic acid, amide, and/or amine functional groups.
  • the alcohol contemplated for use in connection with the present invention is any alcohol which acts as a solvent for polar contaminants found on the critical parts to be cleaned and/or degreased which is also miscible with the non-polar hydrocarbon described above.
  • Alcohols comprised of a carbon chain of between one and about ten carbons are specifically contemplated for use in connection with the present invention and may be diols and even polyols.
  • Particularly preferred are alcohols comprised of a saturated or unsaturated carbon chain of one to six carbons in length, the hydoxyl group being located at any position on the carbon chain comprising the alcohol, for instance, propanol, butanol, and isopropyl and isobutyl alcohols.
  • the relative proportions of alcohol and non-polar hydrocarbon utilized depend in part on the specific components of the blend of the present invention. Another factor in selecting the specific components and their relative proportions is whether the blend of alcohol and non-polar hydrocarbon is itself to be cleaned for re-use. Such cleaning can be carried out in a number of ways known in the art, but if one commonly used process, e.g. distillation, is used to clean the blend, it may be advantageous to utilize a blend of alcohol and non-polar hydrocarbon which is azeotropic.
  • IPA isopropyl alcohol
  • heptane when utilized as alcohol and non-polar hydrocarbon, respectively in the composition of the present invention, they may be utilized in a 50.5/49.5 (percentages by weight) ratio so as to give an azeotropic blend. If it is desired to utilize isobutyl alcohol in the blend to maintain the azeotropic property of the blend, the different molecular weight of isobutyl alcohol changes the ratio accordingly.
  • Other factors to be considered in preparing the alcohol-non-polar hydrocarbon blend are the viscosities of the particular alcohol or non-polar hydrocarbon utilized, the nature of the contaminant(s) to be removed from the critical parts, and the composition of the critical parts .
  • the ratio of alcohol and non-polar hydrocarbon may vary continuously in any proportion in which the components are miscible with each other.
  • the proportions may vary from 1 :99 to 99: 1 alcohohnon- polar hydrocarbon such that many formulations other than an azeotropic blend may be utilized to advantage in connection with the present invention.
  • the blend may also utilize ratios beyond this range if, for instance, the blend is heated to make the components miscible.
  • one advantage of the cleaning process of the present invention is that it is effective in cleaning critical parts at room temperature, but the invention is not so limited.
  • the cleaning process may also be conducted at elevated temperature or even at a temperature lower than room temperature.
  • the process is conducted at a temperature which is increased to the boiling point of the blend of the present invention. In this latter instance it may also be advantageous to use an azeotropic blend of alcohol and non-polar hydrocarbon.
  • the process of the present invention may also include subjecting the critical parts to ultrasonic energy either during the contacting of the parts with the blend of the present invention or sequentially, i.e. , either before or after contacting the parts with the blend.
  • the use of ultrasonic energy may be combined with the use of increased temperature in the process of the present invention.
  • an azeotropic blend of isopropyl alcohol (IPA) and heptane was prepared by mixing 50.5% IPA and 49.5% heptane (percentages by weight).
  • a number of 316-type stainless steel washers were
  • contaminated washers were cleaned with FREON TMS in a Baron Blakeslee Model MSR-120LE degreaser, with a CFM Model Ultraflow cleaner, in the sump of the S & K Model IG-200 degreaser in boiling IPA and ultrasonically agitated, and with ultrasonic agitation in the blend of IPA and heptane at room temperature.
  • the effectiveness of each cleaning process was assessed by electron disperse X- ray (EDX) using the following method.
  • EDX is a semi-quantitative method in which carbon counts are compared to a standard, the ratio providing an indication of the relative effectiveness of the cleaning process.
  • Example 2 A Jeol JSM 35CF scanning electron microscope was used to zero in on the area to be analyzed and a Model TN5000 Tracor Northern, Inc. EDX analyzer used for analysis of that area. The results indicated that the IP A/heptane blend of the present invention was approximately as effective in removing carbon-containing contaminants from the surface of the washers as degreasing in FREON TMS and that those two cleaning processes might both have been somewhat more effective at removing such contaminants than the use of room temperature or boiling IPA.
  • Example 2 A Jeol JSM 35CF scanning electron microscope was used to zero in on the area to be analyzed and a Model TN5000 Tracor Northern, Inc. EDX analyzer used for analysis of that area. The results indicated that the IP A/heptane blend of the present invention was approximately as effective in removing carbon-containing contaminants from the surface of the washers as degreasing in FREON TMS and that those two cleaning processes might both have been somewhat more effective at removing such contaminants than the use of room temperature or boiling IPA.
  • Example 2 the IP A/heptane azeotropic blend of Example 1 was used to clean 30 subassemblies of parts for use in an implantable cardiac pacemaker.
  • the particular subassembly cleaned was comprised of the inner coil and bipolar pin of an Intermedics, Inc. (Angleton, TX) bipolar pacemaker lead, which are assembled with a commercially available epoxy and allowed to cure overnight. 30 additional such sub-assemblies were made for cleaning with FREON TMS vapor in a
  • the CpK or process capability index, is calculated by dividing the difference between the mean and the lower specification limit (1.5_lbs) by three times the standard deviation, it being desirable to exceed a CpK of 1.3 for efficient and reliable manufacturing process. Increase in both pull strength and CpK clearly indicates that, as noted above, the cleaning of the subassembly with the azeotropic IP A/heptane blend had a beneficial effect on performance.
  • Example 3 A third example tested the effect of the azeotropic IP A/heptane blend of Example 1 on silicone rubber. Thirty each silicone rubber coupons were soaked in FREON TMS, the azeotropic blend, or boiling azeotropic IP A/heptane blend, allowed to dry and tested as follows:
  • Boiling IPA/Heptane 79 1111 These data indicate that silicone rubber is not degraded by cleaning by the process of the present invention. Other similar tests indicate that the physical properties of the plastic (such as tensile strength) may actually be improved by contact with or cleaning in the blend of the present invention.
  • Example 4 In another test, it was determined that silicone rubber glue joints are not degraded by cleaning in accordance with the process of the present invention.
  • Example 5 Glue joints between polyurethane and stainless steel were tested by cleaning the tubing by the process of the present invention followed by adhering 80 A polyurethane tubing to stainless steel rods.

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Emergency Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Wood Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Detergent Compositions (AREA)

Abstract

Ce procédé amélioré permet de nettoyer des pièces et sous-ensembles d'importance critique composés notamment de métaux ou de plastiques, et d'améliorer les propriétés physiques de ces matériaux. Il consiste à mettre ces parties et/ou sous-ensembles en contact avec un mélange d'un alcool et d'un hydrocarbure non polaire et peut s'utiliser à température ambiante ou non. Ce mélange comprend un hydrocarbure non polaire tel que butane, pentane, hexane, heptane ou octane et un alcool tel que méthanol, propanol, isopropanol, butanol, isobutanol, pentanol ou hexanol, et, dans une variante nettement préférée, il s'agit d'un mélange azéotrope.
PCT/US1996/008192 1995-06-06 1996-05-31 Procede de nettoyage de dispositifs medicaux implantables Ceased WO1996039479A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US47074595A 1995-06-06 1995-06-06
US08/470,745 1995-06-06

Publications (1)

Publication Number Publication Date
WO1996039479A1 true WO1996039479A1 (fr) 1996-12-12

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ID=23868862

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1996/008192 Ceased WO1996039479A1 (fr) 1995-06-06 1996-05-31 Procede de nettoyage de dispositifs medicaux implantables

Country Status (1)

Country Link
WO (1) WO1996039479A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0326798A (ja) * 1989-06-23 1991-02-05 Takashi Nakamura プラスチック用洗浄剤
US5110367A (en) * 1990-04-12 1992-05-05 Mallinckrodt Specialty Chemicals Company Method for precision cleaning of medical devices
EP0529869A1 (fr) * 1991-08-30 1993-03-03 Imperial Chemical Industries Plc Composition de nettoyage
GB2265631A (en) * 1992-03-25 1993-10-06 Exxon Chemical Patents Inc Halocarbon-free solvent cleaning method
US5344494A (en) * 1993-01-21 1994-09-06 Smith & Nephew Richards, Inc. Method for cleaning porous and roughened surfaces on medical implants
JPH073291A (ja) * 1993-06-17 1995-01-06 Nippon Petrochem Co Ltd 洗浄材

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0326798A (ja) * 1989-06-23 1991-02-05 Takashi Nakamura プラスチック用洗浄剤
US5110367A (en) * 1990-04-12 1992-05-05 Mallinckrodt Specialty Chemicals Company Method for precision cleaning of medical devices
EP0529869A1 (fr) * 1991-08-30 1993-03-03 Imperial Chemical Industries Plc Composition de nettoyage
GB2265631A (en) * 1992-03-25 1993-10-06 Exxon Chemical Patents Inc Halocarbon-free solvent cleaning method
US5344494A (en) * 1993-01-21 1994-09-06 Smith & Nephew Richards, Inc. Method for cleaning porous and roughened surfaces on medical implants
JPH073291A (ja) * 1993-06-17 1995-01-06 Nippon Petrochem Co Ltd 洗浄材

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Section Ch Week 9111, Derwent World Patents Index; Class A60, AN 91-078521, XP002013666 *
DATABASE WPI Section Ch Week 9511, Derwent World Patents Index; Class A97, AN 95-078282, XP002013665 *

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