WO2000024438A9 - Composition indicatrice d"activite microbienne et couche de revetement - Google Patents

Composition indicatrice d"activite microbienne et couche de revetement

Info

Publication number
WO2000024438A9
WO2000024438A9 PCT/US1999/025089 US9925089W WO0024438A9 WO 2000024438 A9 WO2000024438 A9 WO 2000024438A9 US 9925089 W US9925089 W US 9925089W WO 0024438 A9 WO0024438 A9 WO 0024438A9
Authority
WO
WIPO (PCT)
Prior art keywords
medical device
microbial
composition
microbial indicator
indicator
Prior art date
Application number
PCT/US1999/025089
Other languages
English (en)
Other versions
WO2000024438A1 (fr
Inventor
Rabih O Darouiche
Steven J Ferry
Original Assignee
Baylor College Medicine
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 Baylor College Medicine filed Critical Baylor College Medicine
Priority to AU23436/00A priority Critical patent/AU2343600A/en
Publication of WO2000024438A1 publication Critical patent/WO2000024438A1/fr
Publication of WO2000024438A9 publication Critical patent/WO2000024438A9/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions

Definitions

  • the present invention relates to a composition for coating medical devices that indicate
  • the medical device when, and if, the medical device is contaminated with microorganisms, and in particularly to a
  • microbial activity indicator composition for coating medical devices which indicate the presence
  • microbial activity is present on the medical device. Accordingly, even if the medical device turns
  • the medical device As much as 85% of the time, the medical device
  • coated medical device which: enables inspection of the medical device to determine whether
  • microbial activity is present on the surface of the medical device without requiring removal of the medical device, thereby realizing cost savings to hospitals, and thus, patients; and allows monitoring of the medical device to determine the level of microbial activity present on the
  • coated medical device which: enables inspection of the medical device to determine whether
  • microbial activity is present on the surface of the medical device without requiring removal of
  • the medical device thereby realizing cost savings to hospitals, and thus, patients; and allows
  • composition may further comprise a base
  • composition Another feature of the composition is that the at least one microbial indicator agent
  • composition may include at least one tetrazolium salt.
  • An additional feature of the composition is that the at least one tetrazolium salt.
  • At least one microbial indicator agent may include at least one fluorescent indicator.
  • the at least one microbial indicator agent may include at least
  • thermochromic indicator one thermochromic indicator.
  • the foregoing advantages have also been achieved through the present method for coating a medical device, having at least one surface, for indicating the presence of bacterial activity on the at least one surface of the medical device
  • a further feature of the method for coating a medical device is that the microbial
  • composition may be formed by mixing 2,3,5-Triphenyltetrazolium chloride (TTC)
  • microbial indicator composition may be applied to the medical device by contacting the
  • a layer of the microbial indicator composition on the at least one surface of the medical device is a layer of the microbial indicator composition on the at least one surface of the medical device.
  • Another feature of the method for coating a medical device is that the microbial indicator
  • composition may be applied to the medical device by integrating the microbial indicator
  • a further feature of the coated medical device is that the microbial indicator composition
  • coating may include at least one microbial indicator agent.
  • the microbial indicator composition coating may further include a base
  • Another feature of the coated medical device is that the at least one microbial indicator
  • a further feature of the coated medical device may include at least one tetrazolium salt.
  • the at least one microbial indicator agent may include at least one fluorescent indicator.
  • An additional feature of the coated medical device is that the at least one microbial indicator
  • agent may include at least one thermochromic indicator. Another feature of the coated medical
  • the base material may be selected from the group consisting of rubbers,
  • thermoplastics and elastomers.
  • composition may further comprise a base
  • composition is that the at least one microbial indicator
  • agent may include at least one tetrazolium salt other than triphenyltetrazolium chloride.
  • the at least one microbial indicator agent may include at least
  • composition is that the at least one microbial compound,
  • indicator agent may include at least one thermochromic indicator.
  • composition is that the base material may be selected from the group consisting of rubbers,
  • thermoplastics and elastomers.
  • a further feature of the method for coating a medical device is that the microbial indicator
  • composition may be applied to the medical device by contacting the microbial indicator
  • composition with the medical device for a period of time sufficient to form a layer of the
  • the medical device may be applied to the medical device by integrating the microbial indicator composition with the
  • a further feature of the coated medical device is that the microbial indicator composition
  • coating may include at least one microbial indicator agent.
  • the microbial indicator composition coating may further include a base
  • Another feature of the coated medical device is that the at least one microbial indicator
  • the agent may include at least one tetrazolium salt other than triphenyltetrazolium salt.
  • the at least one microbial indicator agent may include
  • At least one microbial indicator agent may include at least one thermochromic indicator.
  • the base material may be selected from the group
  • composition may further comprise a base
  • composition is that the at least one microbial indicator
  • agent may include at least one tetrazolium salt. Another feature of the composition is that the
  • At least one microbial indicator agent may include at least one fluorescent indicator.
  • the at least one microbial indicator agent may include at least
  • thermochromic indicator one thermochromic indicator.
  • the resin may be selected from the group consisting of rubbers, thermoplastics, and elastomers.
  • a further feature of the method for coating a medical device is that the microbial indicator
  • composition may be applied to the medical device by contacting the microbial indicator
  • composition with the medical device for a period of time sufficient to form a layer of the
  • the medical device may be applied to the medical device by integrating the microbial indicator composition with
  • a further feature of the coated medical device is that the microbial indicator composition
  • coating may include at least one microbial indicator agent.
  • the microbial indicator composition coating may include a base material.
  • the microbial indicator agent may include
  • a further feature of the coated medical device is that the microbial
  • indicator agent may include at least one fluorescent indicator.
  • the microbial indicator agent may include at least one thermochromic
  • the base material may be selected
  • the microbial indicator composition coating for medical devices, method of coating is selected from the group consisting of rubbers, thermoplastics, and elastomers.
  • FIG. 1 is a specific embodiment of a catheter insertion seal having a microbial indicator composition inco ⁇ orated into an adhesive layer located on the catheter insertion seal.
  • the present invention is directed to a microbial indicator composition, or
  • microbial indicator composition coating or coating, which is applied to medical devices and which indicates the presence of microbial activity.
  • the microbial indicator composition may
  • the microbial indicator composition coating includes a microbial indicator agent which, in its activated state, indicates the presence of microbial activity on the surface of
  • the medical device Specifically, the microbial indicator composition coating for medical devices
  • Staphylococcus may be formulated to indicate the presence of gram-positive bacteria, such as Staphylococcus
  • epidermidis gram-negative bacteria, such as Pseudomonas aeruginosa, fungi, such as Candida
  • the microbial indicator composition coating may include a microbial indicator agent alone, preferably, the microbial indicator composition coating includes
  • the microbial indicator composition may also be a base material and a microbial indicator agent.
  • the microbial indicator composition may also be a base material and a microbial indicator agent.
  • Medical devices are herein defined as disposable or permanent catheters, (e.g., central venous catheters, dialysis catheters, long-term tunneled central venous catheters, short-term
  • central venous catheters peripherally inserted central catheters, peripheral venous catheters,
  • pulmonary artery Swan-Ganz catheters urinary catheters, and peritoneal catheters
  • long-term urinary devices tissue bonding urinary devices, vascular grafts, vascular catheter ports, wound
  • drain tubes ventricular catheters, hydrocephalus shunts, heart valves, heart assist devices (e.g., left ventricular assist devices), pacemaker capsules, incontinence devices, small or temporary joint replacements, urinary dilator, cannulas, elastomers, hydrogels, dental instruments, tubings, such as intravenous tubes, breathing tubes, dental water lines, dental drain tubes, and feeding
  • indicator strips e.g., paper indicator strips or plastic indicator strips
  • adhesives e.g., hydrogel adhesives, hot-melt adhesives, or solvent-based adhesives
  • bandages e.g., hydrogel adhesives, hot-melt adhesives, or solvent-based adhesives
  • orthopedic implants and any other medical device which may be inserted or implanted into a
  • the insertion or implantation site and which include at least one surface which is susceptible to
  • Medical devices also include any other surface which may be desired or necessary to indicate the presence of microbial activity, such as the surfaces of equipment in operating rooms, emergency rooms, hospital rooms, and bathrooms.
  • any other surface which may be desired or necessary to indicate the presence of microbial activity such as the surfaces of equipment in operating rooms, emergency rooms, hospital rooms, and bathrooms.
  • the microbial indicator composition is integrated into an adhesive, such as tape, thereby providing an adhesive which may indicate microbial activity on the surface of the adhesive.
  • Implantable medical devices include orthopedic implants which may be inspected for microbial activity indicating contamination or infection using endoscopy. Insertable medical
  • devices include catheters and shunts which can be inspected without invasive techniques such as
  • the medical devices may be formed of any suitable metallic materials or non-
  • metallic materials known to persons skilled in the art. Examples of metallic materials include,
  • non-metallic materials include, but are not limited to, thermoplastic or polymeric materials such as rubber, plastic,
  • polyesters polyethylene, polyurethane, silicone, Gortex (polytetrafluoroethylene), Dacron
  • the medical devices include
  • the microbial indicator composition is applied to the entire medical device.
  • the microbial indicator composition may include any number of microbial indicator
  • the microbial indicator composition is biocompatible with
  • Biocompatible is herein defined as compatible with living tissues, such that the medical device is not rejected or does not cause harm to the living tissue.
  • the microbial indicator agent may be any microbial indicator agent
  • Microbial activity is herein defined as any biological function of gram-positive bacteria, gram-negative bacteria, fungi or viruses
  • Microbial activity includes bacterial activity, fungal activity, and
  • Bacterial activity is herein defined as any biological function of gram-positive bacteria or gram-negative bacteria living or proliferating on the surface of the medical device.
  • positive and gram-negative bacteria include, but are not limited to, all spherical, rod-shaped, and
  • Some examples include Staphylococcus epidermidis, Staphylococcus aureus,
  • Fungal activity is herein defined as any biological function of fungi living or
  • Candida albicans proliferating on the surface of the medical device.
  • a fungus is Candida albicans.
  • Suitable microbial indicators agents include chemical indicators, florescent indicators, and thermochromic indicators.
  • Suitable chemical indicators include tetrazolium salts such as tetrazolium blue, tetrazolium violet, neotetrazolium chloride, tetrazolium red (i.e., 2,3,5-
  • Triphenyltetrazolium chloride TTC
  • nitroblue tetrazolium tetranitroblue tetrazolium
  • thiocarbamio nitroblue tetrazolium The concentration of the chemical indicator in the microbial
  • indicator composition may be in the range from about 0.1% to 25% based upon the total weight
  • microbial indicator composition Preferably, chemical indicator is present in the microbial
  • the tetrazolium salts function as color indicators of microbial activity.
  • the tetrazolium salts change color in the presence of microbial activity.
  • TTC has an off-white color which turns red in the presence of microbial oxidative
  • One benefit of utilizing the tetrazolium salts is that the color change of the tetrazolium salts can
  • the utilization of the tetrazolium salts provides in situ examination of
  • the medical device determines whether microbial infection has occurred. Accordingly,
  • preferred chemical indicators provide colormetric indication of microbial activity in the same
  • powder TTC is combined with silicone to form the microbial indicator composition.
  • concentration of TTC in the microbial indicator is the concentration of TTC in the microbial indicator
  • composition may be in the range of 0.1% to 25% TTC.
  • TTC is present in the microbial indicator composition at a concentration of about 1% to 15%. While it is contemplated that other chemical indicators such as tetrazolium salts, as well as fluorescent and thermochromic
  • TTC do not detect the presence of fungal activity of at least one fungus, Candida albicans. Accordingly, the absence of activation of the TTC, and thus the absence of a change in color in the microbial indicator composition, maybe helpful in
  • the microbial indicator agents are fluorescent indicators.
  • fluorescent indicators examples include fluorescein, fluoresceine, fluoresamine, fluoresceine sodium salt, and lumazine.
  • concentration of fluorescent indicator in the microbial indicator composition may be in the range from about 0.1% to 25% based upon the total weight of the microbial indicator composition.
  • fluorescent indicator is present
  • the microbial indicator composition in the microbial indicator composition at a concentration of about 1% to about 15%.
  • the utilization of fluorescent indicators provides a system of identifying potentially pathogenic microbes by a chemical reaction utilizing color changes in the ultraviolet light range.
  • microbial indicator agents are activated, i.e., become fluorescent at a specific wave length in the
  • the activation of the microbial indicator agent may be detected by means of a portable ultraviolet light source so that microbial activity on the surface of the medical device can be detected visually. Therefore, the utilization of the fluorescent indicators provides
  • fluorescent indicators may be used to detect bacterial activity, fungal activity, and/or viral activity.
  • the microbial indicator agents are thermochromic
  • thermochromic indicators examples include thermochromic liquid crystals
  • thermochromic indicator in the microbial indicator
  • composition may be in the range from about 0.1% to 25% based upon the total weight of the
  • thermochromic indicator is present in the microbial
  • Microbial colonization, or contamination, results in a localized
  • the microbial activity increases the temperature of the tissue surrounding the medical device and,
  • the surface temperature of the medical device itself is contemplated. Therefore, by detecting
  • thermochromic indicators indicate the presence of microbial activity.
  • thermochromic indicators may be used to detect bacterial activity, fungal
  • Thermochromic liquid crystals are similar to liquid crystal displays used in lap top
  • thermochromic liquid crystals change color depending on the thermochromic liquid crystals
  • Thermochromic liquid crystals can be formulated to change temperatures from -25 °F to 250 °F
  • thermochromic liquid crystals are usually black below their formulated temperature range and progress to brown, red, yellow, green, blue, and violet at the peak temperature range. Once exceeded, the thermochromic liquid crystal will revert to black once again. Given the small
  • thermochromic liquid crystals would not run through the entire chromic
  • thermochromic liquid crystals can be formulated such that, as the basal
  • thermochromic liquid crystal's change in color would not revert back to its original, threshold color, i.e., the color at the body's normal basal temperature, 98.6°F.
  • thermochromic liquid crystals may be formulated to have a threshold color of black at 98.6°F, a brown color at 99.6°F, a red color at 100.6°F, a yellow
  • thermochromic liquid utilizing thermochromic liquid
  • crystals as the microbial indicator agent could be developed as a "positive/negative" indicator when the localized area or basal body temperature rises above a threshold temperature.
  • thermochromic liquid crystal indicator to indicate "positive" contamination.
  • Leucodyes are a class of thermochromic materials which change from a color at a cold
  • leucodyes may be applied to medical devices in a manner similar to the
  • thermochromic liquid crystal materials and detect changes in temperature. These materials may be selected from thermochromic liquid crystal materials and detect changes in temperature. These materials may be selected from thermochromic liquid crystal materials and detect changes in temperature. These materials may be selected from thermochromic liquid crystal materials and detect changes in temperature. These materials may be selected from thermochromic liquid crystal materials and detect changes in temperature. These materials may be selected from thermochromic liquid crystal materials and detect changes in temperature. These materials may be selected from thermochromic liquid crystal materials and detect changes in temperature. These materials may be used.
  • the leucodye indicator would be designed to be reversible, i.e., as the temperature returns to its threshold temperature, the leucodyes change from clear to their threshold color. Therefore, as the microbial contamination is treated and abolished from the surface of the medical device, the leucodye indicator would be designed to be reversible, i.e., as the temperature returns to its threshold temperature, the leucodyes change from clear to their threshold color. Therefore, as the microbial contamination is treated and abolished from the surface of the medical device, the leucodye indicator would be designed to be reversible, i.e., as the temperature returns to its threshold temperature, the leucodyes change from clear to their threshold color. Therefore, as the microbial contamination is treated and abolished from the surface of the medical device, the leucodye indicator would be designed to be reversible, i.e., as the temperature returns to its threshold temperature, the leucodyes change from clear to their threshold color. Therefore, as the
  • the same medical device could be left in place to indicate subsequent contamination.
  • the leucodye indicator may be designed to be irreversible. Therefore, once the leucodye indicator changes from color to clear, the device would be required
  • base material is defined herein as any of a group of materials which
  • the base material also facilitates the adhesion of the microbial indicator composition to at least one surface of the medical device and prevents the microbial
  • suitable base materials include polyvinyl, polyethylene, polyurethane, polypropylene, silicone (e.g., silicone elastomers and silicone adhesives), polycarboxylic acids, (e.g., polyacrylic acid, polymethacrylic acid, polymaleic acid, poly-(maleic), polyvinyl, polyethylene, polyurethane, polypropylene, silicone (e.g., silicone elastomers and silicone adhesives), polycarboxylic acids, (e.g., polyacrylic acid, polymethacrylic acid, polymaleic acid, poly-(maleic
  • polycarboxylic acid anhydrides e.g., polymaleic anhydride, polymethacrylic anhydride or
  • polyacrylic acid anhydride polyamines
  • polyamine ions e.g., polyethylene imine
  • polystyrene or poly-(vinylpyridine)
  • polyammonium ions e.g., poly-(2-methacryloxyethyl trialkyl
  • polysulfonates e.g. poly-(vinyl sulfonate)
  • latex and derivatives thereof, elastomers and Dacron sealed with gelatin, collagen or albumin, cyanoacrylates, methacrylates, papers with porous barrier films, adhesives, e.g., hot melt
  • adhesives solvent based adhesives, and adhesive hydrogels, fabrics, and crosslinked and non- crosslinked hydrogels, and any other polymeric materials which facilitate dispersion of the
  • Linear copolymers Linear copolymers, cross-linked copolymers, graft polymers, and block
  • polymers containing monomers as constituents of the above exemplified polymers may also be used.
  • polyvinyl is defined herein as any of a group of polymerized vinyl compounds
  • PV-coA-coA Polyvinyl butyryl-co-vinyl alcohol-co-vinylacetate
  • PV-coA-coA Polyvinyl butyryl-co-vinyl alcohol-co-vinylacetate
  • nylon is defined herein as any of a group of synthetic long-chain polymeric
  • polycaprolactam polylauryl-lactam and polyhexamethylene sebacamide.
  • indicator agent is added to indicate the presence of microbial activity on the at least one surface.
  • the amount will vary for each of the microbial indicator agents and upon known factors such as pharmaceutical characteristics; the type of medical device; age, sex, health and weight of the
  • the invention is directed to a method for coating a medical device.
  • the method for coating a medical device includes the steps of providing a medical device, providing, or forming, a microbial indicator composition as described in greater detail above, and applying the microbial indicator composition to at least one surface of the medical
  • the method of coating a medical device includes the steps of forming a microbial indicator composition of an effective concentration for activating the
  • the microbial indicator composition is formed by combining a microbial indicator agent and a base material. At least one surface of the medical device is then contacted
  • composition covers at least one surface of the medical device.
  • Contacting includes, but is not
  • the step of forming a microbial indicator composition may also include any one or all of the steps of adding an
  • organic solvent is herein defined as solvents that can be used to dissolve
  • microbial indicator agents including alcohols, e.g., methanol and ethanol, ketones, e.g., acetone
  • ethers e.g., tetrahydrofuran
  • aldehydes e.g.,. formaldehyde, acetonitrile, acetic acid, methylene chloride, chloroform, carbonates, water, and alkyl hydrocarbons, e.g.,
  • penetrating agent is herein defined as an organic compound that can be used
  • Suitable penetrating agents include esters, e.g., ethyl acetate, propyl acetate, butyl acetate, amyl acetate, and combination thereof, ketones, e.g., acetone and methylethylketone, methylene chloride, chloroform, and xylene.
  • alkalinizing agent is herein defined as organic and inorganic bases including
  • high ionic strength salts is herein defined as salts exhibiting high ionic
  • high ionic strength salts may also be used in the step of forming the microbial indicator composition.
  • the microbial indicator composition is preferably formed by combining a microbial
  • the composition may be contacted with the heated microbial indicator composition for a period of time sufficient for the microbial indicator
  • composition to adhere to at least one surface of the medical device.
  • composition is applied to a surface of the medical device, it is allowed to dry.
  • the medical device is preferably placed in contact with the heated microbial indicator
  • composition by dipping the medical device in the microbial indicator composition for a period
  • the medical device is placed in contact with the heated microbial indicator composition by dipping the medical device
  • the medical device is then removed from the heated microbial indicator composition and the microbial indicator composition is allowed to dry.
  • the medical device may be placed in an
  • the medical device is placed in an heated environment having
  • the medical device is placed in an oven at a temperature ranging from about 120°F to about
  • one layer, or coat, of the microbial indicator composition is believed to provide the desired microbial indicator composition coating, multiple layers are preferred.
  • the multiple layers are preferred. The multiple
  • layers of the microbial indicator composition are preferably applied to the at least one surface of
  • the medical device by repeating the steps discussed above.
  • the medical device is
  • composition to dry on at least one surface of the medical device prior to contacting the medical device with the microbial indicator composition for each subsequent layer.
  • medical device preferably includes three coats, or layers, of the microbial indicator composition
  • the medical device by dissolving a microbial indicator in an organic solvent, combining a
  • penetrating agent to the microbial indicator and organic solvent, and combining an alkalinizing agent to the microbial indicator, organic solvent, and penetrating agent to improve the reactivity
  • the microbial indicator composition is then heated to a temperature ranging from about 30 °C to about 70 °C to enhance the adherence of the microbial indicator composition to at least one surface of the medical device.
  • composition is applied to at least one surface of the medical device, preferably by contacting the
  • the medical device is removed from the microbial indicator composition and
  • the medical device may then be rinsed with a liquid, such as water.
  • a catheter was coated with a microbial indicator composition wherein the microbial
  • the indicator agent was TTC.
  • the microbial indicator composition was formed by combining 10.35
  • TTC powder one-half (2.5) grams was pre-solubilized in 10 ml of acetone to form a TTC
  • TTC microbial indicator composition then mixed with 2.5 grams of the TTC solution to form a TTC microbial indicator composition
  • TTC 0.86 gram silicone to gram of TTC (i.e., 7% TTC).
  • the microbial indicator composition in the microbial indicator composition may be adjusted as desired or necessary without undue
  • composition may be formed by combining 0.53 g TTC powder in the 10 ml acetone and then
  • TTC microbial indicator composition was then covered and the TTC microbial indicator solution was mixed for
  • the TTC microbial indicator composition was then applied to the catheter by contacting
  • the microbial indicator composition was formed by dissolving 450
  • the method of coating the medical devices with a microbial indicator composition includes the steps of forming the microbial indicator composition and
  • the microbial indicator composition may be combined with the material forming the medical device, e.g., silicone, polyurethane,
  • the microbial indicator composition may be
  • coated medical device having a microbial indicator An example of a coated medical device having a microbial indicator
  • embodiment is the catheter insertion seal having an adhesive layer described below in greater detail.
  • the invention is directed to coated medical devices. Broadly, the invention is directed to coated medical devices. Broadly, the
  • coated medical devices include a microbial indicator composition applied to at least one surface of the medical device. Suitable medical devices and microbial indicator compositions are described above in greater detail. The microbial indicator composition may be applied to at least
  • the microbial indicator is any suitable manner.
  • the microbial indicator is any suitable manner.
  • composition may be applied to the medical devices following any of the methods described
  • a septum, or adhesive layer is made of a breathable material
  • the adhesive layer may also include a layer of gauze to facilitate a lower incidence
  • coated medical devices
  • the invention is directed to a
  • catheter insertion seal 10 which includes the microbial indicator composition 15.
  • the catheter insertion seal 10 includes a first end 11, a second end 12, and an
  • aperture 13 connecting first end 11 in second end 12. Aperture 13 runs through the catheter
  • Second end 12 includes an adhesive layer 14 which facilitates securing the catheter
  • insertion seal 10 to the external surface of a human being or animal, i.e., the skin.
  • a human being or animal i.e., the skin.
  • adhesive layer 14 may be an integral part of the catheter insertion seal 10.
  • a catheter (not shown) may then be placed through the catheter insertion seal 10 by passing the catheter through the
  • Aperture 13 may be connected to first end 11 and second end 12 at an angle (not shown) less than 90 degrees, to facilitate insertion of the catheter through the aperture 13 and into
  • the catheter may then be secured to the catheter insertion seal 10
  • tabs may include tabs (not shown) or flanges (not shown) which are reciprocal to tabs or flanges on
  • catheter may also secure the catheter to the catheter insertion seal 10.
  • the adhesive layer 14 may be formed out of any material known to persons skilled in the
  • the adhesive layer 14 includes at least one side having a "sticky" adhesive for
  • adhesive layer 14 may be formed out of any of the materials identified above
  • the microbial indicator composition 15 may be inco ⁇ orated into the adhesive layer 14
  • the microbial indicator composition may be inco ⁇ orated into the adhesive layer 14 as discussed above in greater detail. Accordingly, the adhesive layer 14 facilitates securing the catheter insertion seal 10, and thus the
  • catheter and provides a defense from contamination or infection at the insertion or implantation site by keeping microbes away from the insertion or implantation site.
  • microbial indicator compositions may be formed at concentrations sufficient for indicating lower levels of microbial activity depending on the cause
  • composition as described in greater detail above (the "coated tubings"), and were initially
  • Candida albicans as well as on agar plates that had been freshly inoculated with bacterial
  • the TTC coated tubings were compared with six uncoated silicone tubings (the
  • Staphylococcus epidermidis were red after 24 hours.
  • the TTC coated tubings placed in bacterial suspension and agar plate of Pseudomonas aeruginosa were moderately red after 24 hours.
  • the TTC coated tubings placed in bacterial suspension and agar plate of Candida albicans were not
  • TTC microbial indicator composition applied to silicone tubing indicated the presence of bacterial activity caused by Staphylococcus epidermidis and
  • suspensions having higher concentrations of bacteria compared to lower concentrations of bacteria having higher concentrations of bacteria compared to lower concentrations of bacteria.
  • composition or 15% TTC microbial indicator composition, as described above in greater detail,
  • tubings were monitored every hour to determine the amount of time required for the coated and uncoated tubings to turn red. The results are in Table II. One of each of the coated and uncoated tubings were then placed in a sonication device and another of each of the coated and uncoated
  • tubings were placed on a roll plate to determine the concentration of Staphylococcus epidermidis
  • concentration of Staphylococcus epidermidis was determined by sonication and roll-plate analysis in the same manner as the coated tubings. The number of colonies forming units
  • Staphylococcus epidermidis Staphylococcus epidermidis
  • TTC coating hours (cfu/ml) (cfu/ml) (hours) (cfu/ml) (cfu/ml)
  • the microbial indicator composition may be combined with antimicrobial agents or antimicrobial compositions to provide medical devices having microbial indicating capabilities and antimicrobial capabilities.

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

La présente invention concerne une composition indicatrice d"activité microbienne destinée à revêtir des dispositifs médicaux et capable d"indiquer la présence d"une activité microbienne sur ces dispositifs médicaux. Cette composition indicatrice d"activité microbienne qui inclut un agent indicateur microbien, peut également comporter un matériau de base. L"invention concerne également, non seulement des dispositifs médicaux revêtus d"une telle composition indicatrice d"activité microbienne, mais également un procédé se rapportant à l"application d"une couche de cette composition indicatrice d"activité microbienne sur des dispositifs médicaux.
PCT/US1999/025089 1998-10-27 1999-10-26 Composition indicatrice d"activite microbienne et couche de revetement WO2000024438A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU23436/00A AU2343600A (en) 1998-10-27 1999-10-26 Microbial activity indicator composition and coating

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US17950998A 1998-10-27 1998-10-27
US09/179,509 1998-10-27

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WO2000024438A1 WO2000024438A1 (fr) 2000-05-04
WO2000024438A9 true WO2000024438A9 (fr) 2002-08-22

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US7785299B2 (en) * 2006-05-08 2010-08-31 Becton, Dickinson And Company Vascular access device time sensitive status indication
EP2200562B1 (fr) * 2007-10-26 2014-04-23 3M Innovative Properties Company Composition dentaire pour detecter la presence de bacteries, kit and utilisation comprenant cette composition
EP2052712A1 (fr) * 2007-10-26 2009-04-29 3M Innovative Properties Company Composition dentaire
WO2012120517A1 (fr) * 2011-03-07 2012-09-13 Mekorot Water Company, Ltd. Procédés et dispositifs permettant de traiter le bioencrassement
US8883177B2 (en) 2011-06-28 2014-11-11 Nian Wu Pharmaceutical compositions for parenteral administration
US9228996B2 (en) 2013-05-31 2016-01-05 Empire Technology Development Llc Method and device for detecting device colonization
US20140356900A1 (en) * 2013-05-31 2014-12-04 Empire Technology Development Llc Detection of luminal urinary catheter colonization
US9535043B2 (en) 2013-05-31 2017-01-03 Empire Technology Development Llc Color change indicator of biofilm formation
US9963732B2 (en) 2015-12-30 2018-05-08 Palo Alto Research Center Incorporated Thermochromic sensing devices, systems, and methods
US10598554B2 (en) 2015-12-30 2020-03-24 Palo Alto Research Center Incorporated Thermochromic sensing for nanocalorimetry
US20170191020A1 (en) * 2015-12-30 2017-07-06 Palo Alto Research Center Incorporated Thermochromic sensing devices, systems, and methods
EP3100748B1 (fr) 2016-04-14 2018-06-13 Sefar AG Pansement
ES2754400T3 (es) 2016-09-08 2020-04-17 Sefar Ag Recubrimiento indicador y procedimiento para indicar una contaminación en una herida
CN108998500A (zh) * 2018-07-12 2018-12-14 浙江省产品质量安全检测研究院 一种材料抗菌性能快速检测方法
CN110463832A (zh) * 2019-08-13 2019-11-19 广州悦蜂生物防治科技有限公司 一种天敌昆虫人工液态营养饲料品质的专用指示剂

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AU2343600A (en) 2000-05-15

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