WO2016077376A1 - Surfaces antimicrobiennes acoustiquement transparentes - Google Patents

Surfaces antimicrobiennes acoustiquement transparentes Download PDF

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Publication number
WO2016077376A1
WO2016077376A1 PCT/US2015/060001 US2015060001W WO2016077376A1 WO 2016077376 A1 WO2016077376 A1 WO 2016077376A1 US 2015060001 W US2015060001 W US 2015060001W WO 2016077376 A1 WO2016077376 A1 WO 2016077376A1
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Prior art keywords
medical device
antimicrobial
acoustically transmissive
diaphragm
stethoscope
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PCT/US2015/060001
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English (en)
Inventor
Rajesh Mukherjee
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Nitto Denko Corp
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Nitto Denko Corp
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B7/00—Instruments for auscultation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00—Surgical drapes
    • A61B46/10—Surgical drapes specially adapted for instruments, e.g. microscopes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J23/00—Catalysts comprising metals or metal oxides or hydroxides, not provided for in group B01J21/00
    • B01J23/70—Catalysts comprising metals or metal oxides or hydroxides, not provided for in group B01J21/00 of the iron group metals or copper
    • B01J23/72—Copper
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J35/00—Catalysts, in general, characterised by their form or physical properties
    • B01J35/30—Catalysts, in general, characterised by their form or physical properties characterised by their physical properties
    • B01J35/39—Photocatalytic properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00889—Material properties antimicrobial, disinfectant

Definitions

  • Some embodiments are related to stethoscopes and to accessories for stethoscopes.
  • the present embodiments relate to a medical device useful for enhancing microbial protection while retaining desired acoustic sensitivity.
  • Some embodiments include a medical device element comprising: an acoustically transmissive element having a sound transmission with less than 5 decibels of transmission loss, wherein the acoustically transmissive element has a first side and a second side, and an antimicrobial element comprising a metal or a metal oxide, wherein the antimicrobial element is disposed on or within the first side of the acoustically transmissive element, such that the acoustic transmission of the medical device is within 0.5 decibels of the acoustically transmissive element free of the antimicrobial element, wherein the medical device is configured so that, with proper use, the first side of the acoustically transmissive element contacts a patient body surface.
  • Some embodiments include a self-sterilizing stethoscope comprising this medical device element.
  • FIG. 1 A is a schematic of a stethoscope diaphragm described herein.
  • FIGs. 1 B-F are schematics of embodiments of a stethoscope diaphragm described herein.
  • FIG. 2 is a schematic of a stethoscope
  • FIG. 2A is a cross-sectional view of an embodiment of a stethoscope described herein.
  • FIG. 2B is a cross-sectional view of an embodiment of a stethoscope described herein.
  • FIG. 3 is a transmitted amplitude-time waveform of a normal human heartbeat through a commercially available stethoscope.
  • FIG. 4 is a transmitted amplitude-time waveform of a normal human heartbeat through an embodiment of a stethoscope diaphragm described herein.
  • FIG. 5 is a transmitted amplitude-time waveform of a normal human heartbeat through another embodiment of a stethoscope diaphragm described herein.
  • FIG. 6 is a transmitted amplitude-time waveform of a normal human heartbeat through a comparative stethoscope diaphragm.
  • FIG. 7 is a graph of antimicrobial activity of an embodiment of a stethoscope diaphragm described herein.
  • this disclosure relates to a medical device element comprising an acoustically transmissive element, such as an acoustically transmissive element having a sound transmission with less than five decibels of transmission loss.
  • the acoustically transmissive element has a first side and a second side.
  • the first side of the acoustically transmissive element has an antimicrobial element, typically comprising a metal or metal oxide, that is disposed on or within the first side of the acoustically transmissive element.
  • the acoustically transmissive element is configured so that the acoustic transmission of the medical device is within 0.5 decibels of the same acoustically transmissive element free of the antimicrobial element.
  • the medical device is configured so that, with proper use, the first side of the acoustically transmissive element contacts a patient body surface.
  • An acoustically transmissive element includes an element of a medical device that can transmit sound from the first side to the second side of the acoustically transmissive element.
  • an acoustically transmissive element could be a diaphragm of a stethoscope.
  • the acoustically transmissive element can transmit sound without significant transmission loss, such as about 20 decibels or less, about 10 decibels or less, about 5 decibels or less, about 1 decibel or less, about 0.5 decibels or less, or any other amount within this range of transmission loss.
  • an acoustically transmissive element transmits at least 70%, at least 80%, at least 90%, at least 95%, and/or any other value bound by these ranges of the acoustic wave energy from one surface to the opposing surface. In some embodiments, an acoustically transmissive element loses less than about 1 dB, about 2 dB, about 4 dB, about 7 dB, less than about 10 dB, and/or any other value bound by these ranges of sound from one side to the other side.
  • the matrix may comprise epoxy and fiberglass.
  • An acoustically transmissive element may comprise, or be composed of, a suitable matrix material, such as the material commercially available as a LITTMAN® CARDIOLOGY IIITM diaphragm (3M, Minneapolis, MN, USA).
  • the antimicrobial element may be substantially acoustically transparent.
  • the acoustic transmission of the diaphragm may further comprise an antimicrobial element within at least about 0.25 decibels, 0.5 decibels, 0.75 decibels, 1 .0 decibels, 1 .5 decibels, 2.0 decibels, 2.5 decibels, 3.0 decibels, 3.5 decibels, 4.0 decibels, 4.5 decibels, 5.0 decibels, and/or any other value bound by these ranges of the acoustic transmission loss by the diaphragm substantially free of the antimicrobial element.
  • the first side of the acoustically transmissive element may contact a patient body surface.
  • the antimicrobial element may be photocatalytic.
  • the first side of the acoustically transmissive element may be self-sterilizing in the presence of light, such as ambient room light.
  • a self-sterilizing stethoscope could have a diaphragm where the contact side of the diaphragm is the first side of the acoustically transmissive element.
  • the antimicrobial element is typically a permanent, rather than temporary or disposable, part of the acoustically transmissive element. Thus, with proper use, the antimicrobial element retains adequate antimicrobial properties throughout the life of the medical device element, or is not routinely replaced independently of the medical device element.
  • the antimicrobial element may be acoustically integral with the acoustically transmissive element.
  • a diaphragm may comprise a composite material having a metal or metal oxide of an antimicrobial element and an acoustically transparent material.
  • a material that is acoustically integral may include a stethoscope diaphragm comprising an acoustically transparent substrate and an antimicrobial layer which is bound the diaphragm surface.
  • the permanence of an antimicrobial element may be evaluated by known adhesion test methods, for example, following the procedures described in ASTM- D3359.
  • the percent of the antimicrobial element removed may be less than about 35%, less than about 20%, less than about 15%, less than about 10%, less than about 5%, and/or any other value bound by these ranges removed using the procedures described in ASDM-D3359.
  • the antimicrobial element, or a solid coating containing the antimicrobial element may be characterized by an adhesion test value of at least 0B, at least 1 B, at least 2B, at least 3B, at least 4B, at least 5B, at least 6B, and/or any other value bound by these ranges using the procedures described in ASTM-D3359.
  • the adhesion of the antimicrobial element, or a solid coating containing the antimicrobial element may be evaluated by known hardness tests.
  • the layers are characterized by a hardness test of at least 2H, of at least 3H, of at least 4H, and/or any other value bound by these ranges. Hardness of the photocatalytic element/coating may be evaluated by known hardness determination methods, for example, following the procedures described in ASTM-3363.
  • the antimicrobial element may comprise a metal or metal oxide, and may be deposited directly on, and/or embedded or dispersed into, the first side of the acoustically transmissive element; or may be dispersed in a solid coating that is deposited on, and/or embedded into, the acoustically transmissive element.
  • the metal or metal oxide may include any metal or metal oxide that imparts or improves the antimicrobial properties of the antimicrobial element.
  • the antimicrobial element comprises copper, such as elemental copper or a copper oxide; a titanium oxide, such as anatase Ti0 2 or rutile Ti0 2 ; or a combination thereof.
  • the metal or metal oxide may comprise a combination of anatase Ti0 2 or rutile Ti0 2 , such as about 60-90% anatase Ti0 2 and about 10-40% rutile Ti0 2 , about 80-90% anatase Ti0 2 and about 10-20% rutile Ti0 2 , or about 80-85% anatase Ti0 2 and about 15-20% rutile Ti0 2 based upon the total weight of Ti0 2 .
  • anatase Ti0 2 or rutile Ti0 2 such as about 60-90% anatase Ti0 2 and about 10-40% rutile Ti0 2 , about 80-90% anatase Ti0 2 and about 10-20% rutile Ti0 2 , or about 80-85% anatase Ti0 2 and about 15-20% rutile Ti0 2 based upon the total weight of Ti0 2 .
  • the anatase phase may be about 2.5% to about 97.5%, about 5% to about 95%, about 10% to about 90%; and/or any other value bound by these ranges and the rutile phase may be about 97.5% to about 2.5%, about 95% to about 5%, about 10% to about 90%, and/or any other value bound by these ranges.
  • a non-limiting example of a suitable material includes, but is not limited to, a Ti0 2 mixture sold under the brand name AEROSIL® P25 (about 83% anatase Ti0 2 + about 17% rutile Ti0 2 ) sold by Evonik (Parissipany, NJ, USA)).
  • Some antimicrobial elements comprising Ti0 2 , such as a combination of anatase Ti0 2 and rutile Ti0 2 identified in the paragraph above, may also comprise copper or a copper oxide, such as Cu x O, such as about 0.1 -10%, about 0.5-5%, about 0.8-1 .2%, about 1 % copper oxide, and/or any other value bound by these ranges based upon the total weight of copper oxide and titanium oxide.
  • copper or a copper oxide such as Cu x O, such as about 0.1 -10%, about 0.5-5%, about 0.8-1 .2%, about 1 % copper oxide, and/or any other value bound by these ranges based upon the total weight of copper oxide and titanium oxide.
  • metal or metal oxide may be, but is not limited to, loaded and/or unloaded, doped and/or undoped forms of titanium dioxide (Ti0 2 ), tungsten oxide (WO 3 ), strontium titanate (SrTiOs), Sn:Ti(C,N,0) 2 , cerium dioxide (Ce0 2 ), tin oxide (Sn0 2 ), copper(l) oxide (Cu 2 0), copper(ll) oxide (CuO), and/or combinations thereof.
  • the metal or metal oxide may be a plural phase composite.
  • the metal or metal oxide may be anatase, rutile, wurtzite, spinel, perovskite, pyrocholore, garnet, zircon, and/or tialite phase material or mixtures thereof.
  • each of these options is given its ordinary meaning as understood by one having ordinary skill in the semiconductor art. Comparison of an x-ray diffraction pattern of a given standard and the produced sample is one of a number of methods that may be used to determine whether the sample comprises a particular phase.
  • Exemplary standards include those XRD spectra provided by the National Institute of Standards and Technology (NIST) (Gaitherburg, MD, USA) and/or the International Centre for Diffraction Data (ICDD, formerly the Joint Committee on Powder Diffraction Standards [JCPDS]) (Newtown Square, PA, USA).
  • an antimicrobial element may comprise silver, silver compounds, e.g., silver dihydrogen citrate (SDC), copper, copper alloys, copper compounds, triclosan, halogen releasing compounds, selenium-containing compounds, and/or mixtures thereof.
  • the antimicrobial element may be substantially free from arsenic, silver, tin, heavy metals, polychlorinated phenols and/or any combinations thereof.
  • suitable metal oxides may be photo catalysts that may include composite multivalence metal loaded oxides.
  • multivalence metal loaded oxides comprise a p-type compound/composition/element in electrochemical communication with an n-type compound/composition/element.
  • Suitable multivalence metal loaded oxides, p-type and n-type compositions are described in U.S. Patent Application No. 13/840,859, filed March 15, 2013; and U.S. Provisional Patent Application No. 61/835,399, filed June 14, 2013, which are each hereby incorporated by reference in their entireties.
  • Photocatalytic compositions contemplated include those described in U.S. Provisional Application No.
  • the antimicrobial element may be part of a solid coating, such as a binder, that is disposed on the first side, or the patient contact side, of the acoustically transmissive element.
  • a solid coating such as a binder
  • the metal or the metal oxide may be dispersed within the solid coating.
  • the solid coating, such as a binder could be an organic material such as a polymer resin.
  • the binder material can be a silicone resin.
  • the silicone resin may be a silicone alkyd resin, a silicone epoxy resin, a silicone acrylic resin, a silicone polyester resin, and/or mixtures thereof.
  • the silicone resin may be a silicone polyester resin.
  • the suitable silicone polyester resins may be commercially available products, e.g., KR5230 and/or KR5235 (Shin-Etsu Chemical Co., Ltd, Tokyo, JP).
  • the binder to metal, metal oxide, or photocatalytic material may be provided in a ratio of about 0.5 to about 2.0 parts binder (weight%) to about 1 part (weight%) photocatalytic material.
  • the binder material may be a polymeric compound.
  • the above described layers may be polymerically- bound, e.g., by using a polymer adhesive; using a polymer and monomer mixture, then cured; etc.
  • the bound layers may be bound by thermally heating the materials to fluidize them and subsequently cooling and binding them together.
  • Embodiments of the medical device may reduce the transference of microbial pathogens between/from patients and/or healthcare workers.
  • the medical device may be an externally contacting device, such as, but not limited to, stethoscope diaphragms, echocardiogram devices, acoustic probes based on the Doppler effect, ultrasound wands, transducers and probes, etc.
  • an externally contacting device such as, but not limited to, stethoscope diaphragms, echocardiogram devices, acoustic probes based on the Doppler effect, ultrasound wands, transducers and probes, etc.
  • a medical device element 10 having an acoustically transmissive element 8 having a first side or contact surface 6 and a second side or surface 4.
  • the contact element and/or acoustically transmissive element may comprise a substrate.
  • the contact and/or acoustically transmissive element may comprise a matrix.
  • the contact surface of the contact element and/or acoustically transmissive element may contact an interior body surface.
  • the contact surface of the contact element and/or acoustically transmissive element may contact an external body surface or part.
  • a medical device element 10 comprising a acoustically transmissive element 8 is shown in combination with an antimicrobial element 12, wherein the medical element has a first or patient contact surface 6 and a second surface 4.
  • the medical device element 10 may be a circular annulus or ring that fits over the bell, retaining the acoustically transmissive material between the bell and the mammalian or patient's surface.
  • a medical device element 10 is shown with a separate acoustically transmissive element 8, with a first substrate surface 120 and a second substrate surface 122, and an antimicrobial element 12.
  • Antimicrobial element 12 has a first antimicrobial element surface 126 and a second antimicrobial element surface 128.
  • the acoustically transmissive element 8 and antimicrobial element 12 are conjoined to form the medical device element 10. In one embodiment, a discernible boundary between the two elements is perceived. In another embodiment, the patient contact surface 6 coincides with the first antimicrobial element surface 126.
  • acoustically transmissive element 8 and antimicrobial element 12 are conjoined to form the medical device element 10.
  • an indiscernible boundary as indicated by the dotted lines, may be between the two elements.
  • the acoustically transmissive element 8 can be substantially a matrix substrate material
  • the antimicrobial element 12 can be substantially the antimicrobial substrate material.
  • a gradient of material transitions may from portions consisting essentially or at least 50% of the medical device matrix material to portions consisting essentially or at least 50% of the antimicrobial element material.
  • a gradient of material transitions may from portions comprising more of the medical device matrix material to portions comprising more of the antimicrobial element material.
  • the device matrix material may comprise a portion adjacent to and/or forming a portion of the patient interface surface.
  • the antimicrobial element material may be disposed within the portion adjacent to and/or a portion of the patient interface surface.
  • the antimicrobial material may be disposed within the matrix material.
  • the antimicrobial material may be diffused into the medical element matrix material.
  • the matrix material may include any suitable binder described above, or other materials.
  • acoustically transmissive element 8 and antimicrobial element 12 are conjoined by an adhesive layer 14.
  • the adhesive layer can be substantially entirely over the surface interface between the acoustically transmissive element 8 and the antimicrobial element 12.
  • the adhesive layer 14 may be over a portion of the surface interface between the acoustically transmissive element 8 and the antimicrobial element 12.
  • the portion of the surface interface sans the adhesive layer 14 maintains acoustical communication with the antimicrobial element 12.
  • the antimicrobial element 12, sans the adhesive layer 14, is in physical contact with the acoustically transmissive element 8.
  • acoustically transmissive element 8 and antimicrobial element 12 are conjoined to form a medical device element 10.
  • the medical device element 10 can comprise a composite element, wherein the material of a acoustically transmissive element 8 and antimicrobial element 12 are blended, dispersed or alloyed to form the medical device element 10.
  • the medical device element 10 comprises a composite element, wherein the antimicrobial elements 12 are separate plural islands of material disposed in the surface of the acoustically transmissive element 8.
  • the photocatalysts need not be a complete film or layer over the matrix or substrate.
  • the photocatalysts could include a plurality of nanoparticles, microparticles, nanostructures, or microstructures that are dispersed on, but do not necessarily entirely cover, the surface upon which the photocatalysts are deposited.
  • an external contacting surface may have a surface comprising a plurality of irregularly arranged protrusions, particles, or aggregates thereof.
  • an external contacting surface may have a surface comprising a plurality of regularly arranged protrusions, particles, or aggregates thereof.
  • the protrusions or particles may be nanoprotrusions, including nanoprotrusions having one or more dimensions in the nanometer to micron range.
  • nanoprotrusions or nanoparticles may have: an average x dimension of about 400 nm, about 500 nm, about 1000 nm, about 1500 nm, about 2000 nm, about 2500 nm, about 3000 nm, or any value in a range bounded by, or between, any of these lengths; an average y dimension of about 50 nm, about 100 nm, about 300 nm, about 500 nm, about 700 nm, about 1000 nm, about 1200 nm, about 1500 nm, about 1800 nm, about 2000 nm, or any value in a range bounded by, or between, any of these lengths; and/or an average z dimension of about 10 nm, about 30 nm, about 50 nm, about 70 nm, about 90 nm, about 100 nm,
  • At least one particle in the film, or average of the particles in the film may have an x dimension, a y dimension, or a z dimension of: about 0.01 ⁇ , about 0.02 ⁇ , about 0.05 ⁇ , about 0.1 ⁇ , about 0.5 ⁇ , about 1 ⁇ , about 2 ⁇ , about 5 ⁇ , about 10 ⁇ , about 20 ⁇ , about 50 ⁇ , about 100 ⁇ , about 150 ⁇ , about 200 ⁇ , about 500 ⁇ , about 1000 ⁇ , or any length in a range bounded by, or between, any of these values.
  • the medical device element 10 is shown in relation to a stethoscope head 22.
  • the medical device element 10 may be a modified stethoscope diaphragm, which may be used with any stethoscope provided it is structurally figured to closely fit the diameter of the diaphragm.
  • the stethoscope can comprise head 22.
  • the head 22 may comprise a diaphragm portion 24, a bell portion 26 and a tubular outlet member 28 containing an air column.
  • a flexible hose 30 connects the outlet 28 to a hinge which in turn is attached to the binaural earpiece members, not shown.
  • the diaphragm portion 24 is formed of a flat cup 34 on which is mounted a semi-rigid medical device element 10, which can include a diaphragm portion or substrate, held in place by an annulus or circular ring 36.
  • the contact element can be disposed on the side of the bell 26, opposite the acoustically transmissive element, and placed in contact with the patient/skin 42.
  • the circular ring may comprise a matrix or substrate.
  • the matrix or substrate may comprise a first material.
  • the matrix or substrate can comprise acoustically transmissive material.
  • a suitable antimicrobial element is described and/or can be made according to U.S. Provisional Patent Application No. 61 /899,423, filed November 4, 2013, which is incorporated by reference in its entirety.
  • the substrate may form a patient interface surface.
  • a patient interface surface refers to a surface of a device that may be in direct or indirect contact with the skin of a patient during ordinary operation of that device.
  • the acoustically transmissive substrate and/or matrix material may be acoustically transmissive.
  • the contact element may be an annulus or circular ring.
  • the annulus may comprise a matrix/substrate and an antimicrobial element layer contacting the substrate.
  • the antibacterial element may comprise photocatalytic material/particles, the material disposed or embedded within the annulus or ring.
  • the antimicrobial element may be formed as a layer on the surface of the substrate.
  • the antimicrobial element may comprise a contact element matrix and an inorganic photocatalytic material.
  • the contact element may be an annular portion of the stethoscope bell or head.
  • the acoustically transmissive element may be a diaphragm, such as a diaphragm of a stethoscope.
  • the diaphragm may comprise an acoustically transparent matrix/substrate and an antimicrobial element layer contacting the substrate.
  • the antimicrobial element may be formed as a layer on the surface of the substrate.
  • the antimicrobial element may comprise an acoustically transparent matrix and an inorganic photocatalytic material.
  • the antimicrobial element may be formed as a layer by vapor deposition like either chemical vapor deposition (CVD) or physical vapor deposition (PVD); laminating, pressing, rolling, soaking, melting, gluing, sol-gel deposition, spin coating; dip coating; bar coating; slot coating; brush coating; sputtering; thermal spraying including flame spray, plasma spray (DC or RF); high velocity oxy-fuel spray (HVOF) atomic layer deposition (ALD); cold spraying or aerosol deposition.
  • CVD chemical vapor deposition
  • PVD physical vapor deposition
  • laminating, pressing, rolling, soaking, melting, gluing, sol-gel deposition, spin coating dip coating; bar coating; slot coating; brush coating; sputtering
  • thermal spraying including flame spray, plasma spray (DC or RF); high velocity oxy-fuel spray (HVOF) atomic layer deposition (ALD); cold spraying or aerosol deposition.
  • the antimicrobial element may be partially embedded into a surface of the acoustically transmissive element by direct loading. Some acoustically transmissive elements are formed by creating a mixture of a polymer and a solvent. Then the antimicrobial element is directly loaded into the mixture, creating a slurry. The resulting slurry is formed into the substrate so that the antimicrobial element is integral with the acoustically transmissive element. In some embodiments, the antimicrobial element may be an integral part of the surface of the resulting acoustically transmissive element. In some embodiments, the antimicrobial element may substantially cover the acoustically transmissive element. In some embodiment, the antimicrobial element may contact or cover at least about 75%, at least about 85%, at least about 95%, about 100%, and/or any other value bound by these ranges of the acoustically transmissive element surface.
  • the antimicrobial element is partially embedded into the surface of the acoustically transmissive element by particle transfer.
  • a suitable method for achieving this can be as described in U.S. Provisional Patent Application No. 61 /898,980, filed November 1 , 2013, and Japanese Patent Application No. JP2014-1 13003, filed May 30, 2014, which are incorporated by reference in their entirety.
  • the antimicrobial element is partially embedded in the surface of the acoustically transmissive element by chemical etching. A suitable method for achieving this can be as described in U.S. Provisional Patent Application No. 61/946,61 1 , filed February 28, 2014, U.S. Provisional Application No.
  • the antimicrobial element may comprise a photocatalytic material and a polymer film.
  • the polymer film may be a PET film with an adhesive backing so that the acoustically transmissive element may be affixed to medical equipment.
  • the medical element may further comprise a visual indicator to show the user the remaining efficacy of the antimicrobial antimicrobial element, so the user will know when to replace the device. For example a color change or fading of text or symbols could indicate that the antimicrobial element is no longer effective.
  • Example 1 A Manufacturing the photocatalytic element (Ex-1 )
  • a copper metal target was provided as a copper source material and placed on the target platform (cathode side) within the vacuum chamber of a CRESSINGTONTM 108 auto sputtering apparatus.
  • a 5 cm circle of a stethoscope diaphragm (LITTMAN ® CARDIOVASCULAR IIITM diaphragm, 3M, Minneapolis, MN, USA) was placed on the anode side.
  • the sputtering apparatus was provided with the following parameters: driving current about 0.1 mA and a pressure of 1 torr.
  • Argon gas was introduced into the vacuum chamber for deposition of about 20 s.
  • the substrate temperature was at room temperature.
  • EXAMPLE (1AB) Photocatalytic (Cu x O/plural phase Ti0 2 ) coating on diaphragm
  • LITTMAN ® stethoscope diaphragm Commercial available LITTMAN ® stethoscope diaphragm (LITTMAN ® CARDIOLOGY I IITM, 3M, Minneapolis, MN, USA) was used as substrate for photocatalytic coating. The diaphragm was cleaned with a sequence of soap and water; acetone; and methanol; and then dried.
  • a binder solution containing 10 wt% silicone modified polyester resin was made by mixing a modified silicon polyether resin (sold under the brand designation, "KR-5230", by SHINETSU ® Silicones, Tokyo,JP) with PGMEA (Propylene Glycol Monomethyl Ether Acetate, reagent >99.5%, Sigma-Aldrich, St. Louis, MO, USA). The mixing was conducted with planetary centrifugal mixer (THINKY ® AR-310, Thinky USA, Inc., Madison Hills, CA, USA) at about 2000 rpm for 2 min for mixing and then at about 2200 rpm for about 1 min for defoaming.
  • the photocatalytic powder (Cu x O loaded P25) was made according to that described in U.S. Provisional Patent Application No. 61/899,423, filed November 4, 2013; U.S. Patent Application No. 13/840,859, filed March 15, 2013; and U.S. Provisional Patent Application No. 61 /835,399, filed June 14, 2013; and U.S. Patent Application No. 13/741 ,191 , filed January 14, 2013 (United States Patent Publication No. 2013/0192976, published August 1 , 2013).
  • the photocatalytic powder comprises copper loaded plural phase titanium oxide to increase the light absorption in the visible light range.
  • the nominal copper content in photocatalytic material was 1 wt%.
  • 1 g of photocatalytic powder was dispersed in 10 g of binder solution (10% binder in 90% solvent) by keeping the glass vial containing the mixture in a sonication bath for about 1 h.
  • the obtained suspension was passed through an in-line filter with stainless steel screen with opening of 30 ⁇ .
  • the coating of the substrate (Ex-2) was performed on the prepared stethoscope diaphragm substrate by spin coating with spin coater (SCS 6800 series, Specialty Coating System, Indianapolis, IN, USA) at about 1200 rpm for about 20 s.
  • SCS 6800 series Specialty Coating System, Indianapolis, IN, USA
  • An additional example (Ex-3) was prepared in a manner similar to Ex-2, except that the photocatalytic coating was formed on a prepared PET substrate instead of directly on a stethoscope diaphragm by tape casting with use of doctor blade and tape caster (AFA-II, MTI Corporation, Richmond, CA, USA) by the method described in U.S. Patent No. 8,283,843, filed January 28, 201 1 , issued October 9, 2012.
  • the gap of doctor blade was kept in the range of 3 mm to 20 mm (1 mm equals to 1/1000 in or 25.4 ⁇ ).
  • PET substrate with photocatalytic coating was dried at ambient atmosphere at 1 10 °C for about 1 h.
  • the coated PET sheet was cut to the same diameter as the stethoscope diaphragm.
  • Nitto brand double-sided adhesive tape AS-1902P12TM; Nitto Denko, Osaka, JP was applied to the surface of the PET sample opposite the coating and the PET coated sheet was attached to the stethoscope diaphragm.
  • Adhesion of Photocatalytic coating was evaluated by following the procedures described in ASTM-D3359.
  • Coating hardness was evaluated by following the procedures described in ASTM-3363. The results of the coating hardness are described in Table 1 below.
  • One of the ear pieces of the stethoscope was fitted with an electret microphone (RadioShack 33-3013) for capturing the transmitted sound.
  • the output of the electret microphone was captured via a Windows 7 ® PC running Adobe AUDITION ® CS6 software.
  • the other stethoscope earpiece wave was stuffed with polyurethane foam to dampen external noise but letting the sound waves from the diaphragm escape without creating back pressure.
  • Diaphragms described in Examples 1 above, with and without modifications, were tested thus and waveforms were analyzed using Adobe AUDITION ® CS6 and in MATLAB ® .
  • the transmission through the diaphragm of a pink noise file generated using Adobe AUDITION ® CS 6 was used for detailed studies.
  • FIG. 3 shows the sound wave depicted by an uncoated/bare diaphragm.
  • FIG. 4 shows the sound wave depicted by the coated diaphragm (Ex-1 ) made as described in Example 1AA (sputtering) above.
  • FIG. 5 shows the sound wave depicted by the coated PET/diaphragm (Ex-3) made as described in Example 1AC (tape cast Cu x O)/P25 diaphragm) above.
  • FIG. 6 shows the sound wave depicted by a comparative silver-infused hard plastic diaphragm cover (STETHOCAPTM, weekly use diaphragm cover, model number 2PTFTA, Palm Coasat, FL, , USA).
  • FIG. 3 shows the sound wave depicted by an uncoated/bare diaphragm.
  • FIG. 4 shows the sound wave depicted by the coated diaphragm (Ex-1 ) made as described in Example 1AA (sputtering) above.
  • FIG. 5 shows the sound wave depict
  • Example 1 AA sputtering
  • Example 1 AC tape case coating
  • Example 4 Antibacterial performance was evaluated by following the procedures. [0070] The respective diaphragms were placed in a glass dish with a water soaked filter paper for maintaining moisture, and glass spacers were inserted between the substrate and the filter paper to separate them.
  • E. coli (ATCC 8739) was streaked onto a 10 cm diameter petri dish containing about 20 mL of LB (lysogeny broth/luria broth) agar, and incubated at about 37 °C overnight.
  • LB lysogeny broth/luria broth
  • a single colony was picked to inoculate about 3 mL nutrient broth, and the inoculated culture was incubated at about 37 °C for about 16 h to create an overnight culture ( ⁇ 10 9 cells/mL).
  • a fresh log-phase culture of the overnight culture was obtained by diluting the overnight culture x100, inoculating another 5 cm petri dish with LB agar, and incubating at about 37 °C for about 2.5 h.
  • the fresh culture was diluted 50x with 0.85% saline, which will give a cell suspension of about 2x10 6 cells/mL.
  • 50 ⁇ of the cell suspension was pipetted onto each deposited glass substrate.
  • a sterilized (in 70% and then 100% EtOH) plastic film (20 mm x 40 mm) was placed over the suspension to spread it evenly under the film.
  • the specimen was kept in the dark (CuxCVDark) or then irradiated under blue LED light (455 nm, 10 mW/cm 2 ) (CuCVIight).
  • the specimen was placed in 10 mL of 0.85% saline and vortexed to wash off the bacteria.
  • the wash off suspension was retained, then serially diluted using 0.85% saline, and then plated on LB agar and incubated at about 37 °C overnight to determine the number of viable cells in terms of CFU/specimen.
  • FIG. 7 shows the antibacterial (E. coli) performance of photocatalytic coated PET attached to a diaphragm made as described in Example 1AC (Ex-3) and a diaphragm made as described in Example 1 (sputtering).
  • EXAMPLE 5 (P-CAT (Cu x O/Ti0 2 ) coating on PET substrate)
  • PET polyethylene terephthalate film
  • Eplastics Inc. San Diego, CA, USA
  • the substrate was cut into 8.5 cm X 1 1 .5 cm sheets.
  • the cut PET substrate was cleaned with acetone and then dried.
  • a binder solution containing 10 wt% UV curable hard coat was made by mixing about 1 g UV-curable acrylate binder (sold under the brand designation, UNIDIC17806TM, by DIC corporation, Chuo, JP), about 24 mg of a photoinitiator (sold under the brand designation IRGACURE 907TM, BASF, Ludwigshafen, DE) and about 10 g cyclopentanone (reagent >99.5%, Sigma-Aldrich, St. Louis, MO, USA).
  • the mixing was conducted with planetary centrifugal mixer (THINKY ® AR-310, Thinky USA, Inc., Madison Hills, CA, USA) at about 2000 rpm for 2 min for mixing and then at about 2200 rpm for about 1 min for defoaming.
  • planetary centrifugal mixer TINKY ® AR-310, Thinky USA, Inc., Madison Hills, CA, USA
  • the photocatalytic powder comprises copper oxide loaded titanium oxide (P25 [83% anatase Ti0 2 and 17% rutile Ti0 2 ] sold by Evonik, Parissipany, NJ, US).
  • the nominal copper content in the copper oxide loaded titanium oxide was 1 wt%.
  • 0.2 g of photocatalytic powder was dispersed in the binder solution (about 1 g, 10% solution) by keeping the glass vial containing the mixture in a sonication bath for about half hour followed by probe sonication for about 20-30 min. The obtained suspension was passed through a filter with opening of 5 ⁇ .
  • the cleaned PET substrate was subject to corona discharge treatment to increase the hydrophilicity of substrate surface for good wettability of coating suspension.
  • a corona treatment apparatus (TEWC-4AX, KASUGA DENKI Inc., Kanagawa, JP) was used at discharge power of 100 W and scan speed of 0.5 m/s for two scans.
  • the coating of the substrate was performed on the prepared PET substrate by tape casting with use of doctor blade and tape caster (AFA-II, MTI Corporation, Richmond, CA, USA) by the method described in U.S. Patent No. 8,283,843, filed January 28, 201 1 , issued October 9, 2012.
  • the gap of doctor blade was kept in the range of 3 mm to 20 mm (1 mm equals to 1/1000 in or 25.4 ⁇ ).
  • PET substrate with photocatalytic coating was dried at ambient atmosphere and then preheated at 90 to 100 °C for about 2 min, then UV cured under DYMAX ® UVCS light curing conveyor system (Dymax Corp., Torrington, CT, USA) powered by two 400 W EC power supplies (Dymax Corp., Torrington, CT, USA).
  • the UV light energy was monitored by the ZETA 701 1 -A Dosimeter-Radiometer with the energy intensity about 225 mW/cm 2 . Additional examples (Test 2, 3, 4, 5, 6, 7, and 8) were prepared in a manner similar to Test 1 , as indicated in Table 2 below.
  • Substrate (1 in x 2 in glass slide) was prepared by sequential application of 70% IPA (Isopropyl Alcohol) and 100% ethanol (EtOH) and then dried in air.
  • IPA Isopropyl Alcohol
  • EtOH 100% ethanol
  • Cu x O/P25 powder was dispersed in 100% EtOH at 2 mg/mL concentration and then 100 ⁇ _ of the suspension was applied to the substrate, and then dried. The application process was repeated 5 times to attain 1 mg of Cu x O/P25 on the substrate.
  • the substrate was then dried at room temperature.
  • the coated substrates were placed in a glass dish with a water soaked filter paper for maintaining moisture, and glass spacers were inserted between the substrate and the filter paper to separate them.
  • Ex-1 B and Ex-1 C were prepared in the same manner as Ex-1 A.
  • CE-1 a, -1 b, and -1 c were prepared in the same manner as Ex- 1 A, except that P25 powder was used instead of Cu x O/P25 powder.
  • S. aureus (ATCC 6538) was streaked onto a 10 cm diameter petri dish containing about 25 mL of LB agar, and was incubated at about 37 °C overnight. For each experiment, a single colony was picked to inoculate about 3 mL nutrient broth, and the inoculated culture was incubated at about 37 °C for about 16 h to create an overnight culture ( ⁇ 10 9 cells/mL). A fresh log-phase culture was obtained by diluting the overnight culture 100x, and then incubated at about 37 °C for about 2.5 h. The fresh culture was diluted 50x, which gave a cell suspension of about 2 x 10 6 cells/mL.
  • the wash off suspension was serially diluted using 0.85% saline, and plated on LB agar and incubated at about 37 °C overnight to determine the number of viable cells in terms of CFU/Specimen. Counting was performed by visual inspection and the result multiplied by the dilution factor to arrive at the determined number. The results are shown in the table below, wherein the Cu x O/P25 sample showed at least 1 log reduction, whereas the Comparative Example 1 lacking Cu x O showed only a 0.1 to about 0.4 log reduction.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Materials Engineering (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Molecular Biology (AREA)
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Abstract

L'invention concerne des éléments médicaux permettant de réduire la contamination microbienne entre les patients, comprenant un élément de contact et/ou une matrice de transmission acoustique et un élément antimicrobien.
PCT/US2015/060001 2014-11-10 2015-11-10 Surfaces antimicrobiennes acoustiquement transparentes Ceased WO2016077376A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024256435A1 (fr) * 2023-06-12 2024-12-19 Lapsi Health B.V. Écouteur pectoral pour stéthoscope, procédé et utilisation

Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5466898A (en) 1992-03-20 1995-11-14 Gilbert; Edwin E. Stethoscope isolation system
US6520281B1 (en) 2000-08-18 2003-02-18 Doctors Research Group Elastomeric anti-microbial stethoscope diaphragm
US6575917B2 (en) 2001-03-14 2003-06-10 St. Joseph Solutions Llc Protective-sleeve cartridge and stethoscope incorporating same
EP1600105A2 (fr) 2004-05-29 2005-11-30 Arno Barthelmes Stéthoscope double
KR20060055894A (ko) 2004-11-19 2006-05-24 양원동 나노실버와 향이 함유된 청진기
US20070193822A1 (en) 2006-02-03 2007-08-23 Barry Statner Stethoscope protective device
US20080166384A1 (en) 2007-01-05 2008-07-10 Darren Jones Stethoscope head cover and associated method
US8283843B2 (en) 2010-02-04 2012-10-09 Nitto Denko Corporation Light emissive ceramic laminate and method of making same
US20130180932A1 (en) 2012-01-12 2013-07-18 Nitto Denko Corporation Transparent Photocatalyst Coating
US20130192976A1 (en) 2012-01-18 2013-08-01 Nitto Denko Corporation Titania photocatalytic compounds and methods of making the same
JP2014113003A (ja) 2012-12-05 2014-06-19 Toyota Motor Corp 車両
WO2015073582A1 (fr) * 2013-11-12 2015-05-21 Nitto Denko Corporation Surfaces antimicrobiennes à transparence acoustique

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5466898A (en) 1992-03-20 1995-11-14 Gilbert; Edwin E. Stethoscope isolation system
US6520281B1 (en) 2000-08-18 2003-02-18 Doctors Research Group Elastomeric anti-microbial stethoscope diaphragm
US6575917B2 (en) 2001-03-14 2003-06-10 St. Joseph Solutions Llc Protective-sleeve cartridge and stethoscope incorporating same
EP1600105A2 (fr) 2004-05-29 2005-11-30 Arno Barthelmes Stéthoscope double
KR20060055894A (ko) 2004-11-19 2006-05-24 양원동 나노실버와 향이 함유된 청진기
US20070193822A1 (en) 2006-02-03 2007-08-23 Barry Statner Stethoscope protective device
US20080166384A1 (en) 2007-01-05 2008-07-10 Darren Jones Stethoscope head cover and associated method
US8283843B2 (en) 2010-02-04 2012-10-09 Nitto Denko Corporation Light emissive ceramic laminate and method of making same
US20130180932A1 (en) 2012-01-12 2013-07-18 Nitto Denko Corporation Transparent Photocatalyst Coating
US20130192976A1 (en) 2012-01-18 2013-08-01 Nitto Denko Corporation Titania photocatalytic compounds and methods of making the same
JP2014113003A (ja) 2012-12-05 2014-06-19 Toyota Motor Corp 車両
WO2015073582A1 (fr) * 2013-11-12 2015-05-21 Nitto Denko Corporation Surfaces antimicrobiennes à transparence acoustique

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024256435A1 (fr) * 2023-06-12 2024-12-19 Lapsi Health B.V. Écouteur pectoral pour stéthoscope, procédé et utilisation

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