• 专利附录
  • 专利说明
  • 权利要求
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    • 专利摘要:

    公开号:BR112012000469B1
    申请号:R112012000469-7
    申请日:2010-07-08
    公开日:2018-07-31
    发明作者:Karl Burkholz Jonathan；Quang Hoang Minh
    申请人:Becton, Dickinson And Company；
    IPC主号:
    专利说明:

    (54) Title: ANTIMICROBIAL CATHETER DEVICE (51) Int.CI .: A61L 29/08; A61L 29/16 (30) Unionist Priority: 07/07/2010 US 12 / 831.880, 07/09/2009 US 61 / 224.168 (73) Holder (s): BECTON, DICKINSON AND COMPANY (72) Inventor (s): JONATHAN KARL BURKHOLZ; MINH QUANG HOANG (85) National Phase Start Date: 01/09/2012
    1/11 “ANTIMICROBIAL CATHETER DEVICE”
    Background of the Invention
    The present invention relates to a coating for dermally invasive devices. In particular, the present invention relates to processes and systems whereby an antimicrobial coating is applied to the outer surface of a catheter device to prevent infection.
    Catheters are commonly used for a variety of infusion therapies. For example, catheters are commonly used for infusing fluids, such as normal saline, various medications, and total parenteral nutrition in a patient, withdrawing blood from a patient, as well as monitoring various parameters of the patient's vascular system.
    Catheters are commonly inserted into a patient's vasculature as part of an intravenous catheter assembly. The catheter assembly generally includes a catheter hub, which supports the catheter, the catheter hub being coupled to a needle hub that supports a needle that is inserted. The needle that is inserted is extended and positioned inside the catheter so that a beveled portion of the needle is exposed beyond the tip of the catheter. The beveled portion of the needle is used to pierce the patient's skin to provide an opening through which the needle is inserted into the patient's vasculature. Following insertion and placement of the catheter, the inserted needle is removed from the catheter, whereby providing intravenous access for the patient.
    Catheter-related bloodstream infections are caused by colonization of microorganisms in patients with intravascular catheters and I.V.
    These infections are a major cause of illness and medical cost overruns, when approximately 250,000 catheter-related bloodstream infections occur in intensive care units in the United States each year. In addition to monetary costs, these infections are associated with anywhere from 20,000 to 100,000 deaths each year.
    Despite guidelines to help reduce healthcare-associated infections (HAIs), catheter-related bloodstream infections continue to plague our healthcare system. The 10 most common pathogens (totaling 84% of any HAIs) were negative staphylococci (15%) - coagulase, Staphylococcus aureus (15%), Enterococcus species 12%), Candida species (11%), Escherichia coli (10%), Pseudomonas aeruginosa (8%), Klebsiella pneumoniae (6%), Enterobacter species (5%), Acinetobacter bau35 mannii (3%), and Klebsiella oxytoca (2%). The average proportion collected of pathogenic isolates resistant to antimicrobial agents varied significantly across types of HAI for some combinations of antimicrobial - pathogen. As much as 16% of all HAIs were awarded 870180030688, of 4/16/2018, p. 7/21
    2/11 ram associated with the following resistant pathogens - multidrug: methicillin resistant S. aureus (8% HAIs), vancomycin resistant Enterococcus faecium (4%), carbapenem resistant P. aeruginosa (2%), K. pneumoniae cephalosporin-resistant (1%), extended spectrum cephalosporin-resistant E. coli (0.5%), and A. baumannii resistant to car5 banpenem, K. pneumoniae, K. oxytoca, and E. coli (0.5% ) antimicrobial resistant pathogens.
    Impregnating catheters with various antimicrobial agents is an approach that has been implemented to prevent these infections. These catheters, however, yielded less than satisfactory results. In addition, some microbes have developed resistance to the various antimicrobial agents in the system.
    Likewise, there is a need in the art for dermally invasive devices having improved antimicrobial capabilities. Such a process and systems are shown here.
    Brief Summary of the Invention
    In order to overcome the limitations discussed above, the present invention relates to an antimicrobial coating matrix applied to a catheter device so that with full insertion of the catheter device in a patient, the antimicrobial coating is interposed between the catheter and the layers the patient's skin.
    In some implementations, an antimicrobial formulation is provided as an insoluble coating material that is applied to a transdermal region, surface or portion of a catheter device. The coating material is applied in order to avoid exposure of the coating to the patient's vasculature. Thus, the patient's bloodstream is preserved from being exposed to any toxicity associated with the antimicrobial formulation.
    In some implementations, an antimicrobial formulation is provided as a gel coating. With catheter insertion, the insertion site acts as a drying roller to remove excess gel coating from the catheter device. The excess coating material remains external to the insertion site. In some implementations, trace amounts of antimicrobial agent remain associated with the transdermal portion of the catheter device so that the antimicrobial agent is transferred at the insertion site. In other implementations, trace amounts of antimicrobial agent remain associated with the entire outer surface of the catheter, so that an amount of the antimicrobial agent is exposed to the patient's bloodstream.
    In some implementations, an antimicrobial formulation is provided as a moldable coating material. With catheter insertion, the insertion site acts as a drying roller to remove excess moldable lining material from the catheter device. The excess coating material remains external to the
    Petition 870180030688, of 4/16/2018, p. 8/21
    3/11 insertion where it is manually molded around the catheter and catheter insertion site to form a physical barrier. In some implementations, the catheter's intravascular surface is further modified to include an antithrombogenic coating or lubricant as may be desired to increase the likelihood of blood clots.
    Brief Description of the Various Views of the Drawings
    In order that the manner in which the characteristics and advantages recited above and others of the invention are obtained are easily understood, a more particular description of the invention briefly described above will be provided by reference to its specific embodiments which are illustrated in the attached drawings. These drawings show only typical embodiments of the invention and are therefore not to be considered as limiting the scope of the invention.
    Figure 1 is a perspective view of a catheter device coated with an antimicrobial coating according to a representative embodiment of the present invention.
    Figure 2 is a perspective view of a catheter device coated with an antimicrobial coating according to a representative embodiment of the present invention.
    Figure 3 is a side perspective view of a catheter device coated with an antimicrobial coating and inserted into a patient according to a representative embodiment of the present invention.
    Figure 4A is a perspective view of a catheter device coated with an antimicrobial gel coating according to a representative embodiment of the present invention.
    Figure 4B is a perspective view of a catheter device coated with an antimicrobial gel coating during insertion of the catheter into a patient according to a representative embodiment of the present invention.
    Figure 5 is a side perspective view of a catheter device coated with an antimicrobial gel coating and inserted into a patient according to a representative embodiment of the present invention.
    Figure 6 is a perspective view of a catheter device coated with a moldable antimicrobial coating in accordance with a representative embodiment of the present invention.
    Figure 7 is a side perspective view of a catheter device coated with a moldable antimicrobial coating and inserted into a patient according to a representative embodiment of the present invention.
    Figure 8 is a side perspective view of a catheter device coated with an antimicrobial gel and an anti-thrombogenic lubricant according to an accomplishmentPetition 870180030688, of 04/16/2018, pg. 9/21
    4/11 representative representation of the present invention.
    Figure 9 is a side perspective view of a catheter device coated with an antimicrobial gel coating corresponding to transdermal and intravascular surfaces of the catheter device according to a representative embodiment of the present invention.
    Figure 10 is a perspective view of a catheter device coated with an antimicrobial gel coating during insertion of the catheter into a patient according to a representative embodiment of the present invention.
    Figure 11 is a top view of an insertion site and an inserted catheter device 10 still protected with an antimicrobial dressing and skin preparation treatment according to a representative embodiment of the present invention.
    Figure 12 is a side perspective view of a catheter device coated with an antimicrobial gel coating inserted into a patient, the catheter device further including an antimicrobial dressing and skin preparation treatment according to a representative embodiment of the invention.
    Detailed Description of the Invention
    The presently preferred embodiment of the present invention will be better understood by reference to the drawings, where similar reference numbers indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generically described and illustrated in the present figures, can be arranged and designed in a variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of presently preferred embodiments of the invention.
    Referring now to Figure 1, a catheter device mounting system 10 is shown. In general, a catheter device system 10 according to the present invention provides access to a patient's vasculature 22. In some embodiments, the catheter device system 10 comprises a catheter hub 30 that supports a catheter tube 40. The catheter tube 40 extends out of catheter hub 30 and is in fluid communication with it.
    In some embodiments, the catheter device system 10 further comprises a needle hub 50 that supports a needle that is inserted 60. Needle that is introduced 60 is threadedly positioned through catheter hub 30 and catheter tube 40 so that a beveled tip 62 of needle 60 extends beyond catheter tip 42.
    Beveled tip 62 provides a cut surface for skin penetration of patient 20 and provides access to the vasculature of patient 22. Once catheter 40 is fully inserted into vasculature 22, a needle that is inserted 60 and a needle hub 50 are removed,
    Petition 870180030688, of 4/16/2018, p. 10/21
    5/11 providing intravenous access to patient 20 via catheter 40 and catheter adapter 30.
    The inserted catheter 40 is characterized as having a transdermal region or surface 42 and an intravascular region or surface 44. Transdermal surface 44 refers to that portion of catheter 40 that passes through the patient's dermal layer or layers 24
    20 when catheter 40 is fully inserted into vasculature 22 of patient 20. In some embodiments, transdermal surface 44 refers to any portion of catheter 40 that is positioned internally within patient 20, not yet inserted into vasculature 22.
    Also, in some embodiments transdermal surface 44 refers to any portion of catheter 40 that is not inserted into vasculature 22 of patient 20. Intravascular surface 46 refers to that portion of catheter 40 that resides within vasculature 22 following complete insertion of catheter 40. Thus, the lengths of the respective surfaces 44 and 46 can vary depending on the type of catheter device system 10 and the anticipated use.
    For example, where a catheter is used to access a patient's peripheral vasculature, transdermal surface 44 can vary from approximately 1 mm to approximately 6 mm in length. However, where a catheter is used to access a patient's non-peripheral vasculature, transdermal surface 44 can vary from approximately 6 mm to approximately 700 mm. For example, such a catheter can include a central vascular catheter system.
    In some embodiments, an antimicrobial coating 70 is applied to transdermal surface 44 prior to insertion of catheter 40. Coating 70 and applied to catheter 40 so that after placement of catheter 40 within patient 20, coating 70 extends from the point of entrance of skin 20 to the entrance of vein 22 and is close to the beds25 of dermals 24 of skin 20. Thus, the lining 70 provides a protective barrier between the external environment 12 and vasculature 22, thus preventing or minimizing the possibility of bacterial infection via insertion site 14.
    In some embodiments, the coating 70 comprises a thin, insoluble or soluble polymer matrix 72 arranged over a transdermal portion 44, as shown in Figure 30. As previously discussed, the matrix location 72 is such that after placement of the device 10, transdermal portion 44 extends from entry point 14 to entry of vein 22, as shown in Figure 3.
    In some embodiments, the coating 70 comprises a viscous gel and lubricant matrix 74 disposed on a transdermal surface 44, as shown in Figure
    4A.With insertion of catheter 40 in patient 20, the insertion site 14 acts as a drying roller to remove excess matrix 74 from the transdermal surface 44, as shown in Figure 4B. Excess matrix 74 remains external for patient 2 °, so it will be provided Petition 870180030688, of 04/16/2018, pg. 11/21
    6/11 of a matrix 76 meeting 74 near and surrounding the insertion site 14, as shown in Figure 5.
    The meeting 76 provides a physical barrier of antimicrobial coating material 70, thus preventing the introduction of unwanted microorganisms at the insertion site 14. In some embodiments, amounts in matrix traces 74 remain associated with transdermal surface 44 through dermal layers 24. Thus, matrix 74 provides both external and internal protection against the insertion site 14. In some embodiments, the insertion site dryer roller function 14 removes matrix 74 to provide a coating gradient 70 on transdermal surface 44. In others embodiments a combination of the insertion site dryer roller function 14 and the matrix solubility 74 provides a coating gradient 70 on transdermal surface 44.
    In some embodiments, the coating 70 comprises a putty-like, conformable matrix 78 disposed on a transdermal surface 44, as shown in Figure 6. With catheter insertion 40 in patient 20, the insertion site 14 acts as a drying roller for remove excess matrix 78 from transdermal surface 44. Excess matrix 78 remains external to patient 20 as a moldable mass 80, as shown in Figure 7. Moldable mass 80 is then able to be manually shaped to cover the insertion site 14 and any area close to it, as may be desired. In some embodiments, trace amounts of matrix 78 remain associated with transdermal surface 44 through dermal layers 24. Thus, matrix 78 provides both external and internal protection from the insertion site 14.
    Referring now to Figure 8, in some embodiments the coating 70 still comprises a biocompatible coloring substance 90 which provides a color indication of continued antimicrobial activity. For example, in some embodiments coloring substance 90 provides a first color in the absence of microbial activity, and provides a second color in the presence of microbial activity. In general, the dye substance 90 is positioned over catheter 40 in order to be close to the insertion site 14. Thus, any microbial activity close to the insertion site 14 will be indicated by dye 90.
    In some embodiments, catheter 40 still comprises an anti-thrombogenic lubricant 92 corresponding to an intravascular surface 46. Anti-thrombogenic lubricant 92 decreases the likelihood of blood clotting for intravascular portion 46 of catheter 40. Likewise, in some embodiments, antithrombogenic lubricant 92 it is at least partially soluble to aid the mobility and effectiveness of anti-thrombogenic properties. By restricting the placement of coating 70 and lubricant 92 to those portions of the catheter that will be in contact with the targeted tissues, that is, dermal layers 24 and vasculature 22, respectively, toxicity from coating 70 is minimized while limiting clot potential. .
    Petition 870180030688, of 4/16/2018, p. 12/21
    7/11
    Referring to Figure 9, in some embodiments the coating 70 is disposed on both transdermal 44 and intravascular 46 surfaces of catheter 110. With insertion of catheter 110, the insertion site 14 acts as a drying roller to remove excess coating 70, as discussed above and shown in Figure 10. In some embodiments, residual amounts of coating 70 remain associated with intravascular surface 46 and transdermal surface 44 of catheter 110, thereby providing antimicrobial protection over the entire length of catheter 110. In some embodiments, coating 70 it is at least partially soluble to aid mobility and effectiveness of the coating. For example, where liner 70 is at least partially soluble, liner 70 is easily mobilized when brought into contact with a patient's body fluid 20. In some embodiments, liner 70 is arranged over the entire length of catheter 110 on a gradient decreasing or increasing from catheter hub 30 to catheter tip 42. In some embodiments, coating 70 comprises a mixture of an antimicrobial agent, an anti-thrombogenic lubricant, and a biocompatible coloring substance.
    In some embodiments, catheter 40 and insertion site 14 are further combined with an antimicrobial insertion site preparation 100 and an antimicrobial dressing 102, as shown in Figures 11 and 12. For example, in some embodiments, a potential insertion site Patient 14 is first prepared with an anti-microbial preparation 100, such as an iodine smear. Catheter 40 and needle and being inserted 60 are then inserted into the insertion site 14. In some embodiments, the liner 70 forms a puddle 76 surrounding the insertion site 14, as discussed above. Following insertion, the needle that is inserted 60 is removed and antimicrobial dressing 102 is provided as an external barrier for catheter 40 and catheter adapter 30. Thus, in some embodiments additional antimicrobial protection is provided to further protect insertion site 14 from microbial activity. .
    In general, the present invention relates to a new antimicrobial formulation that contains antimicrobial agents used to disinfect a catheter and a patient's catheter insertion site. As discussed earlier, the antimicrobial formulation can be provided in various consistencies and forms to allow for various coating processes as desired. The coating of the antimicrobial agent (s) on the surface of medical devices prevents the growth of unwanted microorganisms, as well as reduces colonization of microorganisms on medical devices during normal application, that is, it prevents contamination due to contact with the patient's skin flora, or due to exposure to microorganisms before patient contact. In addition, due to a reduction in the colonization of microorganisms, the medical device can be left on the patient for extended lengths of time without causing infection.
    Petition 870180030688, of 4/16/2018, p. 13/21
    11/11
    In some embodiments, a coating is provided comprising a mixture of antimicrobial agents that are selected to provide long-lasting antimicrobial efficacy after multiple applications. For example, in some embodiments, antimicrobial agents are selected and formulated in a polymer matrix having very low solubility in water.
    Thus, antimicrobial formulations support multiple procedures, such as blood draws, drug infusion, TPN procedures, as well as washes with saline and heparin.
    In some embodiments, antimicrobial coating 70 comprises a matrix 10 of one or more antimicrobial agents. Non-limiting examples of coating 70 are shown in Table 1.
    Table 1
    Formula 1 2 3 4 5 6 7 8 9 10 11 Ethyl alcohol 70.00 70.0 70.00 70.00 70.00 24.0 24.0 Isopropyl alcohollyric 70.00 70.00 70.00 70.00 THF 70 70 Gluconatechloroexifdin 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 5.00 5.00 Chlorine xylenol 0.10 0.10 Triclosan 0.10 0.10 0.10 Hexetidine 0.10 0.10 PCMX 0.10 0.10 Cationic polymersingle 1.0 0.10 Chitosan 1.0 1.0 Polyurethane 1.0 Polyvinyl alcohollyric 1.0 Water 24.90 25.90 24.90 25.90 25.90 25.90 25.90 24.90 25.90
    Suitable alcohol components generally include a lower alcohol having between one and six carbons (C1-Ce). In some embodiments, coating 70 comprises an alcohol component selected from the group consisting of ethyl alcohol, isopropanol, propanol, and butanol. In other embodiments, the coating 70 comprises two or more lower alcohol components, for example, a mixture of isopropyl alcohol and ethyl alcohol in a ratio of about 1:10 to about 1: 1. Furthermore, in some embodiments, the coating 70 comprises a mixture of more than two alcohol components.
    In some embodiments, the coating 70 comprises an alcohol component in
    Petition 870180030688, of 4/16/2018, p. 14/21
    9/11 an amount approximately equal to 40% (weight / volume) of coating 70. In other embodiments, coating 70 comprises an alcohol component in an amount of approximately 20% (weight / volume) to approximately 95% (weight / volume) .
    In some embodiments, coating 70 further comprises one or more fugitive solvents, such as tetrahydrofuran (THF), methyl ethyl ketone (MEK) and hexane solvents. In some embodiments, coating 70 comprises a fugitive solvent in an amount approximately equal to n70% (weight / volume) of coating 70. In other embodiments, coating 70 comprises two or more fugitive solvents.
    Antimicrobial coating 70 generally comprises a biocidal or biocidal antimicrobial agent effective against various forms and strains of bacteria that can cause infection within a patient 20. The terms "biocidal agent" or "biocidal", as used herein, refer to an agent that destroys , inhibits and / or prevents the spread, growth, colonization and multiplication of unwanted organisms. The term “organism” includes, but is not limited to, microorganisms, bacteria, undulating bacteria, spirochetes, spores, organisms forming spores, gram-negative organisms, gram-positive organisms, yeasts, fungi, molds, viruses, aerobic organisms, anaerobic organisms and mycobacteria. Specific examples of such organisms include the fungi Aspergillus niger, Aspergillus flavus, Rhizopus nigricans, Cladosprorium herbarium, Epidermophyton floccosum, Trichophyton mentagrophytes, Histoplasma capsulatum, and the like; bacteria such as Pseudoma20 nas aeruginosa, Escherichia coli, Proteus vulgaris, Staphylococcus aureus, Staphylococcus epidermis, Streptococcus faecalis, Klebsiella, Enterobacter aerogenes, Proteus mirabilis, and other gram-positive bacteria and similar gram-positive bacteria; and yeasts such as Saccharomyces cerevisiae, Candida albicans, and the like. In addition, spores of microorganisms, viruses and the like are organisms within the scope of the present invention.
    Biocidal agents suitable for use in the present invention include, but are not limited to, biocides such as phenol, quaternary ammonium, and guanidine-containing biocides. For example, in some embodiments the coating 70 comprises a biocidal agent selected from taurolidine, for chlorine meta xylenol, silver sulfadiazine, silver oxide, and silver nitrate. In other embodiments, coating 70 comprises a biocidal agent selected from a pyridinium biocide, benzalkonium chloride, cetrimide, benethonium chloride, cetyl pyridinium chloride, dekalinium acetate, dequalinium chloride, and xylenol chlorine.
    Also, in some embodiments, coating 70 comprises a biocidal agent selected on the basis of chlorhexidine, chlorhexidine gluconate, chlorhexidine acetate, chlorhexidine hydrochloride, chlorhexidine dihydrochloride, dibromo propamidine, halogenated diphenyl alkanyl chloride, salicyl anilide, tetra carbanilide trichloride and mixtures thereof. Also, in some embodiments, coating 70 comprises a selected biocidal agent
    Petition 870180030688, of 4/16/2018, p. 15/21
    10/11 chlorhexidine dihydrochloride, chlorhexidine gluconate, chlorhexidine acetate, chlorhexidine diacetate, triclosan, chlorine xylenol, dequalinium chloride, benzethonium chloride, benzalkonium chloride, and their combinations.
    In some embodiments, coating 70 comprises one or more bio-acidic agents in an amount of approximately 0.01% (weight / volume) to approximately 10.0% (weight / volume) of coating 70. In other embodiments, coating 70 comprises one or more biocidal agents in an amount of approximately 0.01% (weight / volume) to approximately 5.0% (weight / volume) of coating 70.
    In some embodiments, the longevity of the antimicrobial coating has been increased by adding a cationic polymer to the formulation. The cationic polymer combined with the antimicrobial agent, thereby forming a bond with the surface of the medical device. Thus, when the antimicrobial coating was applied to the surface of the medical device, a solvent in the coating was evaporated whereby leaving the antimicrobial agent and cationic polymer attached to the medical device. Non-limiting examples of cationic polymers include cellulosic polymer, chitosan, polyvinyl alcohol, polyvinyl pyrrolidone, polyvinyl acetate, polyurethane, and water soluble cellulose. In some embodiments, a cationic polymer was selected that was soluble in alcohol, but insoluble in water. In other embodiments, a cationic polymer was selected that was soluble in water.
    In some embodiments, the antimicrobial coating 70 is prepared by simply mixing the various ingredients at room temperature. Typically, organic solvents or alcohols, and water components are mixed first, followed by the addition of the other ingredients, in any order. Formulations 1-11, from Table 1, were prepared with ingredients as shown in Table 2
    Table 2
    Ingredient Provider Ethanol (grade 190) Grain Processing Inc. Isopropyl alcohol (IPA) (> 99% alcohol) JT Baker Phillipsburg, New Jersey Chlorhexidine gluconate (20%) Xttrium LaboratoriesChicago, Illinois Triclosan Ciba Specialty Chemicals Chlorhexidine diacetate Uhe and Fragehem Chlorine xylenol Clarien North Carolina Ethyl cellulose The Dow Chemical CompanyMidland, Michigan Solvent hexanes or MEK or THF Sigma Aldrich, Fisher Scientific USP Water Becton Dickinson Cationic cellulosic polymer Amerchol Corporation, a subsidiary
    Petition 870180030688, of 4/16/2018, p. 16/21
    11/11
    DOW Chemical Company
    The present invention can be carried out in other specific forms without evading its structures, processes, or other essential characteristics as widely described and claimed hereinafter. For example, the present invention can be applied to any dermally invasive devices, such as needles, scalpels, trocars, endoscopes, stoma apparatus, and the like. The described achievements are to be considered in all respects only as illustrative, and not restrictive. The scope of the invention is therefore indicated by the stated claims, rather than by the previous description. All changes that fall within the meaning and equivalence range of the claims are to be covered within its scope.
    Petition 870180030688, of 4/16/2018, p. 17/21
    1/3
    权利要求:
    Claims (12)
    [1]
    1. Antimicrobial catheter device, FEATURED by understanding:
    a catheter having a pointed end, a base end, and an extended portion 5 extending between them, the catheter still having an outer surface including a transdermal surface and an intravascular surface; and an antimicrobial agent in the form of a mass-like matrix, which can be manipulated in an adjustable way applied to the transdermal surface of the external surface of the catheter, so that following insertion of the catheter in a patient, the antimicrobial agent is interposably positioned between the transdermal surface and the patient's skin surface, where a first portion of the antimicrobial agent remains applied to the transdermal surface and in contact with the patient's dermal layers and a second portion of the antimicrobial agent is removed from the transdermal surface and deposited externally and surrounding an insertion site in the which the catheter is inserted, thus forming a mass
    15 manually moldable of the antimicrobial agent close to the insertion site.
    [2]
    2. Device, according to claim 1, CHARACTERIZED by the fact that the antimicrobial agent comprises:
    a polymer component; a fugitive solvent component;
    An alcohol component; and a biocidal agent.
    [3]
    3. Device according to claim 2, CHARACTERIZED by the fact that the polymer component comprises a cationic polymer component.
    [4]
    4. Device, according to claim 2, CHARACTERIZED by the fact that
    25 that the polymer component is insoluble in water.
    [5]
    5. Device according to claim 4, CHARACTERIZED by the fact that the polymer component is at least one of cellulosic polymer, chitosan, polyvinyl alcohol, polyvinyl pyrrolidone, polyvinyl acetate, polyurethane.
    [6]
    6. Device, according to claim 2, CHARACTERIZED by the fact that the polymer component is soluble in water.
    [7]
    7. Device according to claim 2, CHARACTERIZED by the fact that the biocidal agent is present in an amount of approximately 0.01% (weight / volume) to approximately 10.0% (weight / volume).
    [8]
    8. Device according to claim 2, CHARACTERIZED by the fact that the biocidal agent is present in an amount of approximately 0.01% (weight / volume) to approximately 5.0% (weight / volume).
    [9]
    9. Device, according to claim 2, CHARACTERIZED by the fact that
    Petition 870180030688, of 4/16/2018, p. 18/21
    2/3 that the polymer component is present in an amount of approximately 0.001% (weight / volume) to approximately 5.0% (weight / volume).
    [10]
    10. Device according to claim 2, CHARACTERIZED by the fact that the biocidal agent is at least one of chlorhexidine dihydrochloride, chlorhexidine gluconate, chlorhexidine acetate, chlorhexidine diacetate, trichloosane, xylenol chloride, qualinium chloride, benzethonium chloride, benzalkonium chloride.
    [11]
    11. Device according to claim 2, CHARACTERIZED by the fact that the alcohol component comprises a lower alcohol having between one and six carbon atoms.
    10. Device, according to claim 2, CHARACTERIZED by the fact that the alcohol component is present within an antimicrobial agent in an amount approximately equal to 20% (weight / volume).
    13. Device according to claim 2, CHARACTERIZED by the fact that the alcohol component comprises a mixture of isopropyl alcohol and ethanol and is
    15 present within the antimicrobial agent in an amount of approximately 40% (weight / volume) to approximately 95% (weight / volume).
    14. Device according to claim 2, CHARACTERIZED by the fact that the fugitive solvent comprises an organic solvent that is present within an antimicrobial agent in an amount of approximately 20% (weight / volume) to approximately 95% (weight / volume).
    15. Device according to claim 2, CHARACTERIZED by the fact that the polymer component comprises a cationic polymer.
    16. Device according to claim 1, CHARACTERIZED by the fact that the antimicrobial agent comprises:
    25 ethanol;
    isopropyl alcohol; chlorhexidine gluconate; triclosan;
    chlorhexidine diacetate;
    Chloroxylenol;
    ethyl cellulose;
    tetrahydrofuran, methyl ethyl ketone or hexane: water; and cationic cellulosic polymer.
    17. Device according to claim 16, CHARACTERIZED by the fact that ethanol is present in the antimicrobial agent in an amount of 70% (weight / volume).
    Petition 870180030688, of 4/16/2018, p. 19/21
    3/3
    18. Device, according to claim 16, CHARACTERIZED by the fact that chlorhexidine gluconate is present in the antimicrobial agent in an amount of 4% (weight / volume).
    19. Device, according to claim 16, CHARACTERIZED by the fact that chloroxylenol is present in the antimicrobial agent in an amount of 0.1% (weight / volume).
    20. Device according to claim 16, CHARACTERIZED by the fact that the antimicrobial agent comprises a biocompatible bacterial indicator dye.
    Petition 870180030688, of 4/16/2018, p. 20/21
    1/12
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    12/12
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    法律状态:
    2018-02-14| B06T| Formal requirements before examination [chapter 6.20 patent gazette]|
    2018-04-10| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2018-06-26| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2018-07-31| B16A| Patent or certificate of addition of invention granted|
    优先权:
    申请号 | 申请日 | 专利标题
    US22416809P| true| 2009-07-09|2009-07-09|
    US61/224.168|2009-07-09|
    US12/831,880|US8821455B2|2009-07-09|2010-07-07|Antimicrobial coating for dermally invasive devices|
    US12/831.880|2010-07-07|
    PCT/US2010/041358|WO2011005951A2|2009-07-09|2010-07-08|Antimicrobial coating for dermally invasive devices|
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