Patent Publication Number: US-2022233837-A1

Title: An antimicrobial device for an insertion needle

Description:
TECHNICAL FIELD 
     The present disclosure relates to an antimicrobial device. In particular, the present disclosure relates to an antimicrobial device, a kit with an insertion device and an antimicrobial contact dressing, and a process of providing an antimicrobial agent around an insertion device. 
     BACKGROUND 
     Various tubes, pins, or other percutaneous devices pass through skin for a variety of functions, such as fluid delivery or medical device support. There are several types of percutaneous devices used to administer medication, such as, for example, a diabetic pump or a Huber needle, which might also include an implanted port. Some of these devices may be connected for an extended period of time causing irritation or discomfort on the skin and increasing the risks of infection at the injection site. 
     SUMMARY 
     The disclosed antimicrobial device has a contact dressing with both adhesive and antimicrobial agent on the contact dressing surface to securely attaches to an underlying substrate and the insertion needle punctures though the contact dressing. The contact adhesive and the antimicrobial agent remain adjacent to the inserted needle. 
     In one embodiment, the antimicrobial device comprises a contact dressing with a contact dressing first surface and contact dressing second surface, opposite the contact dressing first surface. The contact dressing first surface has an adhesive and an antimicrobial agent. The insertion needle is inserted through the contact dressing. The adhesive and antimicrobial agent are on the contact dressing first surface adjacent the inserted insertion needle. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         FIG. 1  is a side sectional view of one embodiment of an antimicrobial device; 
         FIG. 2  is a plan view of one embodiment of a first contact dressing surface; 
         FIG. 3  is a plan view of another embodiment of a first contact dressing surface; 
     
    
    
     While the above-identified drawings and figures set forth embodiments of the invention, other embodiments are also contemplated, as noted in the discussion. In all cases, this disclosure presents the invention by way of representation and not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art, which fall within the scope and spirit of this invention. The figures may not be drawn to scale. 
     DETAILED DESCRIPTION 
     A conventional device to providing antimicrobial protection to an insertion needle is a disk-shaped sponge loaded with an antimicrobial agent, commercially available as Biopatch™ protective disk available from Ethicon. To use the disk-shaped sponge, the tube or insertion needled is first threaded through the opening of the disk, and then the insertion needle is inserted into the substrate, typically skin. This requires two hands working together to thread the insertion needle through the disk. Also, the disk-shaped device is not transparent. Therefore, the disk-shaped device must be removed to view the area around the insertion needle for signs of infection. Another device that provides antimicrobial protection to an insertion needle is 3M Tegaderm CHG dressing, which includes a gel pad loaded with chlorhexidine gluconate. For this device, the needle is inserted and the gel pad is placed over the inserted needle. 
     The disclosed antimicrobial device  100  has an antimicrobial contact dressing  110  that securely attaches to an underlying substrate  140 . The antimicrobial contact dressing  110  has a surface with an adhesive  114  and an antimicrobial agent  115 . An insertion needle  134  can puncture though the antimicrobial contact dressing  110  for easy application and antimicrobial protection of the insertion needle  134 . The adhesive  114  and antimicrobial agent  115  are adjacent to the inserted needle  134 . The adhesive  114  maintains the contact dressing  110  securely in place to the underlying substrate  140  follow insertion of the insertion needle  134 , and the antimicrobial agent  115  also being adjacent to the insertion needle  134  maintains antimicrobial efficacy to the area around the insertion needle  115 . 
       FIG. 1  is a side sectional view of one embodiment of an antimicrobial device  100 . The antimicrobial device has a contact dressing  110  that secures to an underlying substrate  140 . The contact dressing  110  has a contact dressing first surface  112  with an adhesive  114  and antimicrobial agent  115 . The adhesive  114  on the contact dressing first surface  112  secures the contact dressing  110  to the underlying substrate  140 . Opposite from the contact dressing first surface  112 , is the contact dressing second surface  116 . Typically, the contact dressing  110  is a thin, flexible, conformable material with one or more layers, such as a film, paper, foil, woven, knitted, or nonwoven. 
     An access needle hub  130  includes a housing  132  and insertion needle  134 . In use, the housing  132  is adjacent to the contact dressing second surface  116 . The insertion needle  134  punctures through the contact dressing  110  and into the substrate  140 . Optionally, underlying the substrate  140  may be an access port  150  for receiving the insertion needle  134  and aligning with the housing  132 . The access needle hub  130  can be used to deliver fluid through the insertion needle  134  and into the substrate  140  and/or can be used to remove fluid from the underlying substrate  140 . The fluid flow through the access needle hub  130  could be a one-time delivery of fluid or could be continuously delivered. 
     To use the antimicrobial device  100 , the contact dressing first surface  112  is applied to a substrate  140 . After the contact dressing  110  is applied, the access needle hub  130  is placed over the contact dressing second surface  116 . The insertion needle  134  passes through the contact dressing  110 . 
     In one embodiment, the insertion needle  134  is protruding from the housing  130  and punctures though the contact dressing  110  as the access needle hub  130  comes into contact with the contact dressing second surface  110 . The insertion needle  134  can be linear or slightly curved at the end. A linear insertion needle  134 , often referred to as a non-coring needle, will tend to create a punch hole in the contact dressing  110 . When the insertion needle  134  curved at the end, the insertion needle  134  will slice through the contact dressing  110  and will tend to create a linear slit  118  in the contact dressing  110 . 
     In one embodiment, the insertion needle  134  is retracted within the housing  132  and as the access needle hub  130  comes into contact with the contact dressing second surface  116  the insertion needle  134  is actuated to release from within the housing  132 . To release the insertion needle  134  from the housing  132 , the insertion needle  134  can linearly projected out of the housing  132  and into the substrate  140 . The insertion needle  134  can be either linear or slightly curved at the end. Linearly projecting the linear insertion needle  134  from the housing  140  will tend to create a punch hole in the contact dressing  110 . Linearly projecting a slightly curved insertion needle  134  will tend to slice through the contact dressing  110  to create a slit  118 . Alternatively, to release the insertion needle  134  from the housing, the insertion needle  134  will rotationally project out of the housing  132 , pass through the contact dressing  110 , and enter into the substrate  140 . The rotational projection of the insertion needle  134  from the housing  132  will tend to create a linear slit  118  in the contact dressing  110 . 
     The antimicrobial device  100  with the contact dressing  110  and an overlying access needle hub  130  that punctures through the contact dressing  118  to form a slit  118  can be advantageous over insertion needles  134  that puncture straight linearly. When passing a linear insertion needle  134  linearly through a material, it is possible that a small amount of the material could become lodged into the insertion needle  134  and then exit in the substrate  140 . Non coring insertion needles  134  minimize this problem. Non coring insertion needles  134  will tend to create a slit  118  though the contact dressing  110 . 
     The adhesive  114  and antimicrobial agent  115  are included at least in the area surrounding the insertion needle  134  and with both the adhesive and the antimicrobial agent  115  in contact with the substrate  140 . The adhesive  114  and antimicrobial agent  115  may be applied to the contact dressing first surface  112  separately and adjacent to one another or the antimicrobial agent  115  is loaded into the adhesive  114 . 
     Because the adhesive  114  is present at least in the area surrounding the insertion needle  134 , the adhesive  114  secures the contact dressing  110  to the substrate  140 . Then during and after the insertion needle  134  punctures through the contact dressing  110 , the adhesive  114  maintains the contact dressing  110  in contact with the substrate  140 . Therefore, the contact dressing  110  does not become loose or able to be dislodges and inadvertently enter into the substrate  140 . Especially in embodiments of a non coring insertion needle  134  where a slit  118  is formed through the contact dressing  110 , the contact dressing  110  will tend to widen at the slit  118  and the underlying adhesive  114  on the contact dressing  110  will maintain secure connection of the contact dressing first surface  112  at the slit  118 . 
     Also, because the antimicrobial agent  115  is present at least in the area surrounding the insertion needle  134 , the antimicrobial agent  115  is present at the interface of the insertion needle  134  and substrate  140  to aid in minimizing contamination and reducing the risk of infection. 
     As shown in  FIG. 1 , an optional cover dressing  120  can be used to aid in securing the access needle hub  130 . The cover dressing  120  has a cover dressing first surface  122  and an opposite cover dressing second surface  126 . The cover dressing first surface  122  has a cover dressing adhesive  124  to allow the cover dressing to secure to the underlying access needle hub  130 , the contact dressing second surface  116 , and/or to the substrate  140 . 
       FIG. 2  is a plan view of one embodiment of a contact dressing first surface  112  showing the insertion needle  134 , which has formed a slit  118  though the contact dressing first surface  112 . In this embodiment, the adhesive  114  and antimicrobial agent  115  are located adjacent to the slit  118  and adjacent to the insertion needle  134 . In this embodiment, the adhesive  114  is distinct from the antimicrobial agent  115 . As shown in  FIG. 2 , each of the adhesive  114  and the antimicrobial agent  115  is applied in a pattern and separate from one another. As shown in this embodiment, the perimeter region comprises the adhesive  114 , and does not include the antimicrobial agent  115 . 
       FIG. 3  is a plan view of one embodiment of a contact dressing first surface  112  showing the insertion needle  134 , which has formed a slit  118  though the contact dressing first surface  112 . In this embodiment, the adhesive  114  and antimicrobial agent  115  are located adjacent to the slit  118  and adjacent to the insertion needle  134 . In this embodiment, the antimicrobial agent  115  is dispersed throughout the adhesive  114 . As shown in  FIG. 3 , the antimicrobial-containing adhesive  114  is uniformly applied over the contact dressing first surface  112 . In other embodiments, the antimicrobial-containing adhesive  114  may be applied discontinuously, such as in a pattern on the contact dressing first surface  112 . 
     Typically, to provide the antimicrobial device  100  may be provided to a health care provider in a kit with a access needle hub  130 . Optionally, a cover dressing and tape can be included in the kit. Optionally, skin antiseptic materials can be included in the kit to clean the skin prior to application of the contact dressing  110 . Optionally, gloves or masks can be provided in the kits for the health care provider to wear while applying the contact dressing and inserting the access needle hub. Typically, components in the kit are sterile or the entire kit is sterilized. 
     Contact Dressing/Cover Dressing 
     The contact dressing  110  and cover dressing  120  are typically thin film materials, coated with the adhesive. Typically, the thin film material provides resistance against incoming water and contaminants and has a high moisture vapor permeability to allow moisture vapor from the underlying skin to exit. One example of a suitable material is a high moisture vapor permeable film such as described in U.S. Pat. Nos. 3,645,835 and 4,595,001, the disclosures of which are herein incorporated by reference. Issued U.S. Pat. Nos. 3,645,835 and 4,595,001, the disclosures of which are hereby incorporated by reference, describe methods of making such films and methods for testing their permeability. Typically, the film/adhesive composite should transmit moisture vapor at a rate equal to or greater than human skin. Typically, the adhesive coated film transmits moisture vapor at a rate of at least 300 g/m 2 /24 hrs/37° C./100-10% RH, more preferably at least 700 g/m 2 /24 hrs/37° C./100-10% RH, and most preferably at least 2000 g/m 2 /24 hrs/37° C./100-10% RH using the inverted cup method as described in U.S. Pat. No. 4,595,001. 
     The material for the dressing is preferably conformable to anatomical surfaces. As such, when applied to an anatomical surface, it conforms to the surface even when the surface is moved and can stretch and retract. One embodiment of a film is elastomeric polyurethane, polyester, or polyether block amide films. These films combine the desirable properties of resiliency, high moisture vapor permeability, and transparency. Example of material for the thin film dressing is in 3M Tegaderm IV Dressings available from 3M Company. U.S. Patent application 62/783,368, filed Dec. 21, 2018 describes a medical article with backing that may be suitable as the contact dressing. 
     Additional materials can be included with the thin film to give the dressing strength, rigidity. For example, woven, knitted, nonwoven, or polymeric material can be included. US Patent Application Publication US 2016-0015570. Examples of multilayer constructions for a dressing is in 3M Tegaderm IV Advanced Dressings, available from 3M Company. 
     Typically, thin film dressing includes a frame. The frame is made of a substrate that is less resilient than the film and may be removable from the film. Examples of materials and frames include those in 3M Tegaderm IV Dressings and 3M Tegaderm IV Advanced Dressings, both available from 3M Company. 
     Antimicrobial Agent 
     The contact dressing first surface  112  contains an antimicrobial agent  115  to deliver antimicrobial activity to the skin in and around the injection site, reducing the likelihood of an infection. There are numerous biologically active materials, which include antimicrobial agents. The antimicrobial agent  115  can be applied directly to the contact dressing first surface  112  adjacent to the adhesive  114  or may be incorporated into the adhesive  114 . In some embodiments, the antimicrobial agent  115  may be applied in a pattern. Also, the antimicrobial agent  115  may be applied to the entire contact dressing first surface. 
     Examples of antimicrobial agents include parachlorometaxylenol; triclosan; chlorhexidine and its salts such as chlorhexidine gluconate, poly hexamethylene biguanide and its salts such as poly hexamethylene biguanidine chloride, iodine, idodophors; fatty acid monoesters; poly-n-vinyl pyrrolidone-iodophors; silver oxide, silver and its salts, peroxides (e.g. hydrogen peroxide), antibiotics (e.g. neomycin, bacitracin, and polymixin B). 
     The following active ingredients could also be used to suppress the regrowth or possibly treat an infection of microorganisms in the present invention: 2,2-thiobis(4-chlorophenol); 4,4-isopropylidenediphenol; 5-amino-6-chloro-o-cresol; acetaminosalol; alcloxa; aldioxa; aluminum acetate; aluminum benzoate; aluminum diacetate; aluminum formate; aluminum phenolsulfonate; ammonium iodide; ammonium phenolsulfonate; benzisothiazolinone; benzotriazole; benzoxiquine; benzylparaben; berberine chloride; boric acid; cetethyl morpholinium ethosulfate; cetethyldimonium bromide; cetrimonium tosylate; cetylpyridinium chloride; chloramine-t; chlorothymol; cloflucarban; cocotrimonium chloride; colloidal sulfur; copper usnate; dedm hydantoin; dedm hydantoin dilaurate; dequalinium acetate; dequalinium chloride; dibromopropamidine diisethionate; dichloro-m-xylenol; dichlorophene; dichlorophenyl imidazoldioxolan; diiodomethyltolylsulfone; dimethyl hydroxymethyl pyrazole; dimethylaminostyryl heptyl methyl thiazolium iodide; dodecylbenzyltrimonium chloride; domiphen bromide; ferulic acid; fluorosalan; glyoxal; hydroxymethyl dioxoazabicyclooctane; hydroxypropyl bistrimonium diiodide; ichthammol; isodecylparaben; isopropyl sorbate; lapyrium chloride; laurtrimonium trichlorophenoxide; lauryl isoquinolinium bromide; lauryl isoquinolinium saccharinate; laurylpyridinium chloride; m-cresol; mandelic acid; MDM hydantoin; MEAa-iodine; melaleuca alternifolia; methylbenzethonium chloride; mixed cresols; nonoxynol-12 iodine; nonoxynol-9 iodine; o-cresol; oxyquinoline benzoate; oxyquinoline sulfate; p-chlorophenol; p-cresol; PEG-15 dedm hydantoin; PEG-15 dedm hydantoin stearate; PEG-5 dedm hydantoin; PEG-5 dedm hydantoin oleate; phenol; phenoxyethylparaben; phenyl salicylate; polymethoxy bicyclic oxazolidine; potassium iodide; potassium lactate; potassium phenoxide; potassium troclosene; quaternium-14; quaternium-24; quaternium-8; ricinoleamidopropyltrimonium methosulfate; sodium iodide; sodium p-chloro-m-cresol; sodium phenolsulfonate; sodium phenoxide; sodium usnate; steapyrium chloride; strontium peroxide; tea-sorbate; tetrabutyl ammonium bromide; thiabendazole; triacetin; undecylenamide dea; undecylenamide mea; undecylenamidopropyltrimonium methosulfate; undecyleneth-6; undecylenoyl peg-5 paraben; usnic acid; zinc acetate; zinc borate; zinc phenolsulfonate; zinc sulfate; zinc undecylenate; and combinations of the foregoing. 
     The following actives could also be of use to also reduce regrowth of microorganisms on skin: 2-bromo-2-nitropropane-1,3-diol; 4-hydroxybenzoic acid; 5-bromo-5-nitro-1,3-dioxane; 7-ethylbicyclooxazolidine; ammonium benzoate; ammonium bisulfate; ammonium propionate; ammonium sulfite; behentrimonium chloride; benzalkonium bromide; benzalkonium chloride; benzalkonium saccharinate; benzethonium chloride; benzoic acid; benzyl alcohol; benzylhemiformal; bromochlorophene; butyl benzoate; butylparaben; calcium benzoate; calcium paraben; calcium propionate; calcium salicylate; calcium sorbate; calcium undecylenate; cetalkonium chloride; cetearalkonium bromide; cetrimonium bromide; cetrimonium chloride; chloroacetamide; chlorobutanol; chlorophene; chloroxylenol; chlorphenesin; climbazole; dehydroacetic acid; diazolidinyl urea; dibromohexamidine isethionate; dichlorobenzyl alcohol; dimethyl oxazolidine; DMDM hydantoin; ethyl benzoate; ethylparaben; formaldehyde; formic acid; glutaral; hexamidine; hexamidine diisethionate; hexamidine paraben; hexetidine; hydrogenated tallowtrimonium chloride; imidazolidinyl urea; iodopropynyl butylcarbamate; isobutyl benzoate; isobutylparaben; isopropyl benzoate; isopropyl cresols; isopropylparaben; lauralkonium bromide; lauralkonium chloride; laurtrimonium bromide; laurtrimonium chloride; magnesium benzoate; magnesium propionate; magnesium salicylate; MEA o-phenylphenate; MEA-benzoate; MEA-salicylate; MEA-undecylenate; methenamine; methyl benzoate; me thylchloroisothiazolinone; methyldibromo glutaronitrile; methylisothiazolinone; methylparaben; myristalkonium chloride; myristalkonium saccharinate; myrtrimonium bromide; o-cymen-5-ol; o-phenylphenol; olealkonium chloride; p-chloro-m-cresol; phenoxyethanol; phenoxyisopropanol; phenyl benzoate; phenyl mercuric acetate; phenyl mercuric benzoate; phenyl mercuric borate; phenyl mercuric bromide; phenyl mercuric chloride; phenylparaben; piroctone olamine; polyaminopropyl biguanide; potassium benzoate; potassium butylparaben; potassium ethylparaben; potassium metabisulfite; potassium methylparaben; potassium o-phenylphenate; potassium paraben; potassium propionate; potassium propylparaben; potassium salicylate; potassium sorbate; potassium sulfite; propionic acid; propyl benzoate; propylparaben; quaternium-15; salicylic acid; sodium benzoate; sodium bisulfate; sodium butylparaben; sodium dehydroacetate; sodium ethylparaben; sodium formate; sodium hydroxymethylglycinate; sodium iodate; sodium metabisulfite; sodium methylparaben; sodium o-phenylphenate; sodium paraben; sodium propionate; sodium propylparaben; sodium salicylate; sodium sorbate; sodium sulfite; sodium undecylenate; sorbic acid; soytrimonium chloride; stearalkonium chloride; steartrimonium chloride; tallowalkonium chloride; tallowtrimonium chloride; thimerosal; triclocarban; triclosan; undecylenic acid; zinc pyrithione; and combinations of the foregoing. 
     Adhesive 
     The adhesive used on the contact dressing and/or cover dressing is typically a pressure sensitive adhesive, such as an acrylate-based adhesive. The pressure sensitive adhesives described above typically transmit moisture vapor at a rate greater to or equal to that of human skin. 
     One example of a pressure sensitive acrylate adhesive that can be applied to skin is described in U.S. Pat. No. RE 24,906, the disclosure of which is hereby incorporated by reference. In one embodiment, a 97:3 iso-octyl acrylate:acrylamide copolymer adhesive can be used or a 70:15:15 isooctyl acrylate: ethyleneoxide acrylate:acrylic acid terpolymer, as described in U.S. Pat. No. 4,737,410 (Example 31), the disclosure of which is hereby incorporated by reference. Other useful adhesives are described in U.S. Pat. Nos. 3,389,827, 4,112,213, 4,310,509, and 4,323,557, the disclosures of which are hereby incorporated by reference. Silicone adhesive can also be used. Generally, silicone adhesives can provide suitable adhesion to skin while gently removing from skin. Suitable silicone adhesives are disclosed in PCT Publications WO2010/056541 and WO2010/056543, the disclosure of which are herein incorporate by reference. 
     US Patent Application Publications 2018/0280591 and 2015/0238444, the disclosure of which are herein incorporated by reference, disclose antimicrobial agents dispersed throughout an adhesive composition. For example, chlorohexidine gluconate can be included within the pressure-sensitive acrylate adhesive to provide continuous antimicrobial activity. 
     The adhesive  114  can be applied directly to the contact dressing first surface  112  adjacent to the antimicrobial agent  115  or the antimicrobial agent  115  may be incorporated into the adhesive  114 . In some embodiments, the adhesive may be applied in a pattern, as described in U.S. Pat. No. 4,595,001 which is hereby incorporated by reference. Also, it is understood that the entire surface may include adhesive or the adhesive may be at select portions. 
     Optionally a release liner maybe used to cover the adhesive. During use, the release liner is removed, exposing the adhesive. Release liners can be made of paper or films, such as kraft papers, polyethylene, polypropylene, polyester or composites of any of these materials. The release liners are typically coated with release agents such as fluorochemicals or silicones. 
     Although specific embodiments have been shown and described herein, it is understood that these embodiments are merely illustrative of the many possible specific arrangements that can be devised in application of the principles of the invention. Numerous and varied other arrangements can be devised in accordance with these principles by those of skill in the art without departing from the spirit and scope of the invention. The scope of the present invention should not be limited to the structures described in this application, but only by the structures described by the language of the claims and the equivalents of those structures.