Systems and methods for applying an antimicrobial coating to a medical device.

(54) Title: SYSTEMS AND METHODS TO APPLY AN ANTIMICROBIAL COATING TO A MEDICAL DEVICE.

(54) Title: SYSTEMS AND METHODS FOR APPLYING AN ANTIMICROBIAL COATING TO A MEDICAL DEVICE.

(57) Summary

Methods for applying an antimicrobial coating to a medical device are disclosed. Generally, the methods comprise providing a medical device, administering an antimicrobial layer on the device, flushing excess coating from the device, and curing the layer on the device. In one aspect, the coating includes a UV (ultra violet light) curable antimicrobial composition. In this regard, the medical device can be coated and the coating can be cured with UV light in seconds. In another aspect, the coating includes an antimicrobial solution containing a polymer or copolymer acrylate. In this regard, the medical device can be coated and the coating can be heat cured in minutes. Both the UV curable composition and the antimicrobial solution can also include rheology modifiers, as needed. Additionally, the compositions include one or more antimicrobial agents, which can be selected from a wide range of agents.

(57) Abstract

Methods for applying an antimicrobial coating to a medical device is disclosed. Generally, the methods comprise providing a medical device, dispensing an antimicrobial coating onto the device, flushing excess coating from the device, and curing the coating onto the device. In one aspect, the coating includes a UV-curable, antimicrobial composition. In this aspect, the medical device can be coated and the coating can be cured with UV light in a manner of seconds. In another aspect, the coating includes an antimicrobial solution that contains an acrylate-type polymer or copolymer. In this aspect, the medical device can be coated and the coating can be heat-cured in a manner of minutes. Both the UV curable composition and the antimicrobial solution can also inelude rheological modifiers, as necessary. Additionally, the compositions inelude one or more antimicrobial agents, which may be selected from a wide array of agents.

PATENT TITLE No. 349482

Holders): BECTON, DICKINSON AND COMPANY

Address: 1 Becton Drive Mail Code 110, Franklin Lakes, New Jersey, 07417-1880, USA

Name: SYSTEMS AND METHODS FOR APPLYING AN ANTIMICROBIAL COATING TO A MEDICAL DEVICE.

Classification: CIP: B05D3 / 02; B05D3 / 06

CPC: A61L29 / 085; A61L29 / 16; B05D3 / 067; B05D3 / 0254; C09D4 / 06; C09D5 / 14;

C09D5 / 1668; C10M169 / 04; A61L2300 / 206: A61L2300 / 208; A61L2300 / 404;

C08F220 / 18; C08F222 / 1006; C10M2201 / 105; C10M2205 / 14; C10M2215 / 04;

C10M2215 / 06; C10M2229 / 0515; C10N2220 / 082; C10N2230 / 16;

C10N2240 / 66

Inventor (s): DAVID TIEN-TUNG OU-YANG; AZHAR KHAN; KEN CLUFF

REQUEST

<td>Number:</td><td colspan="2">International Presentation Date:</td>

<td>MX / a / 2011/005738</td><td colspan="2">November 30, 2009</td>

<td></td><td>PRIORITY</td><td></td>

<td>Country:</td><td>Date:</td><td>Number:</td>

<td>US</td><td>December 1, 2008</td><td> 61/118,988</td>

<td>US</td><td>June 23, 2009</td><td> 12/490.235</td>

Validity: Twenty years

Expiration Date: November 30, 2029

Issue Date: July 28, 2017 ......

The reference patent is granted based on articles 1 ° 2 ° section V, 6? Section III, and 59 of the Industrial Property Law.

In accordance with article 23 of the Industrial Property Law, this patent has a validity of twenty years, non-extendable, counted from the filing date of the international application and will be subject to the payment of the fee to keep the rights in force.

Whoever signs this title does so based on the provisions of articles 6^or Sections III and 7 'bs 2 of the Industrial Property Law (Official Gazette of the Federation (DOF) 06/27/1991, amended on 08/02/1994, 10/25/1996, 12/26/1997, 17 / 05/1999, 26/01/2004, 16/06/2005 25/01/2006, 06/05 / 2009,06 / 01/2010, 18/06/2010, 28/06/2010. 27/01 / 2012 and 04/09/2012); items 1^or, 3rd fraction V part a), 4^or and 12^or Sections I and III of the Regulations of the Mexican Institute of Industrial Property (DOF 12/14/1999, amended on 07/01/2002, 07/15/2004, 07/28/2004 and 09/07/2007) articles 1^or, 3^or, 4^or, 5^or fraction V subsection a), 16 fractions I and III and 30 of the Organic Statute of the Mexican Institute of Industrial Property (DOF 12/27/1999, amended on 10/10/2002, 07/29/2004, 08/04/2004 and 09/13/2007); 1 ", 3? and 5 'subsection a) of the Agreement that delegates powers to the Deputy General Directors, Coordinator, Divisional Directors, Heads of Regional Offices, Divisional Deputy Directors, Departmental Coordinators and other subordinates of the Mexican Institute of Industrial Property. (DOF 12/15/1999, amended on 02/04/2000, 07/29/2004, 08/04/2004 and 09/13/2007).

This document is signed with an advanced electronic signature (FIEL), based on articles 7 BIS 2 of the Industrial Property Law; 3 of its Regulations, and 1 section III, 2 section V, 26 BIS and 26 TER of the Agreement establishing the guidelines for the use of the Payment and Electronic Services Portal (PASE) of the Mexican Institute of Industrial Property, in the procedures indicated.

THE DIVISIONAL DIRECTOR OF PATENTS

NAHANNY CANAL REYES

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SYSTEMS AND METHODS TO APPLY A COATING e-ANTIMICBODIA14O ~ ^ ~ '

TO A MEDICAL DEVICE

BACKGROUND OF THE INVENTION

The present invention relates to antimicrobial compositions and methods for using those compositions in various medical applications. One of the greatest challenges of modern medical treatment is controlling infection and the spread of microbial organisms.

One area where this challenge is constantly presented is in infusion therapy of various kinds. Infusion therapy is one of the most common health care procedures. Hospitalized patients, those who receive care at home, as well as others who receive fluids, pharmaceuticals, and blood products through a vascular access device inserted into the vascular system. Infusion therapy can be used to treat an infection, provide anesthesia or analgesia, provide nutritional support, treat the growth of cancerous tumors, maintain blood pressure and heart rate, or 20 many other clinically important uses.

Infusion therapy is facilitated by a vascular access device. The vascular access device can access the central or peripheral vasculature of the patient. The vascular access device can be permanent for a short time (days), a moderate term (weeks), or a long term (months to years). The vascular access device can be used for continuous infusion therapy or for intermittent therapy.

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A common vascular access device is a plastic catheter that is inserted into the patient's vein. The length of the catheter can vary from a few centimeters for peripheral access, to many centimeters for central access, and can include devices such as peripherally inserted central catheters (PICCs). The catheter can be inserted transcutaneously or it can be surgically implanted under the skin of the patient. The catheter, or any other vascular access device attached thereto, can have a single or multiple lumen for the infusion of many simultaneous fluids.

The vascular access device commonly includes an adapter (eg, the Luer adapter) to which other medical devices can be attached. For example, a delivery set can be attached to a vascular access device at one end while an intravenous (IV) bag is attached to the other. The administration set is a fluid conduit for continuous infusion of fluids and pharmaceuticals. Commonly, an intravenous access device is a vascular access device that can be attached to another vascular access device, closes the vascular access device, and allows intermittent infusion or injection of fluids and pharmaceuticals. An IV access device can include a housing and a septum to shut down the system. The septum can be opened with a blunt cannula or a male Luer from a medical device.

When the septum of the vascular access device fails to operate properly or has inadequate design features, certain complications can occur. Complications associated with infusion therapy can cause significant morbidity and even mortality. A major complication is the catheter related to blood flow infection (CRBSI). A calculation of

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250,000 - 4,000,000 central venous catheter (CVC) cases associated with BSIs occur annually in US hospitals.

Current vascular access devices avoid complications, such as the resulting infection in the CRBSIs, by providing a septum that functions properly during fixation and / or passage of the vascular access device by other medical devices. The properly functioning septum will act, in part, as infection barriers between the internal and external environments of the vascular access device during fixation and / or access of other medical devices. By functioning properly as barriers to infection, the septum minimizes CRBSI's and other complications.

In some cases, a vascular access device can serve as a nest of infection, leading to a BSI spread. This can be caused by not regularly washing the appliance, a non-sterile insertion technique, or by pathogens entering the fluid flow path through either end of the pathway subsequent to catheter insertion. When a vascular access device is contaminated, pathogens adhere to the vascular access device, colonize, and form a biofilm. Many biofilms are resistant to a variety of biocidal agents and provide a replenishment source for pathogens to enter the patient's bloodstream and cause a BSI (Blood Stream Infection) Blood Stream Infection.

During the past decades, there has been a common practice to use a thermoplastic polyurethane solution as the carrier for an antimicrobial coating. The solvent is generally tetrahydrofuran (THF), dimethylformamide (DMF), or a mixture of both. Since THF can oxidize quickly and tends

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when using THF as a solvent. Strong solvents, such as THF and DMF, are also highly toxic and dangerous to the environment. Additionally, harsh solvents tend to attack most polymeric materials (i.e. polyurethane, silicone, polyisoprene, polybutyl rubber polycarbonate, polyvinyl chloride, PET, and acrylics) that are used to produce medical devices (for example , vascular access devices). Therefore, medical devices made with these materials can become distorted and / or form micro-cracks on their surface. Another problem with coatings involves strong solvents which are those coatings that generally require a relatively long period of time (eg, around 24 hours) for the solvent to completely evaporate with heat. Yet another issue with coatings comprising a hard solvent is that solvents are difficult to apply evenly to the surface of a medical device.

Consequently, conventional technologies using aggressive solvents have persistent problems with processing and performance.

Another conventional method for supplying medical devices with antimicrobial characteristics involves the use of silver salts and elemental silver. Silver salts and elemental silver are well known antimicrobial agents, both in the medical surgical industry, and in the industry in general. They are generally incorporated into polymeric bulk material or coating on the surface of medical devices by plasma, heat evaporation, electroplating, or by conventional solvent coating technologies. These technologies, however, are often very tedious, expensive, time consuming and dangerous to the environment.

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Additionally, the performance of silver-coated medical devices is mediocre at best. For example, it may take up to 8 hours before silver ion, ionized silver salts, or a silver element can reach some efficacy as antimicrobial agents. As a result, significant microbial activity can occur before the silver coating takes effect. Also, the compound of silver or an element of silver has an unpleasant color, from dark amber to black.

Consequently, there is a need in the art to improve the layers to provide the antimicrobial capacity of medical devices of different types, and in particular devices related to infusion therapy. There is also a need to improve the methods of applying such antimicrobial coatings to medical devices.

BACKGROUND OF THE INVENTION

The present invention has been developed in response to problems and needs in the art that have not yet been fully solved by systems and methods for applying antimicrobial layers to medical devices. Therefore, the described methods, systems and compositions were developed to reduce complications (e.g. Crisis occurrence, damage medical devices caused by hard solvents, environmental damage caused by hard solvents, etc.) by providing methods and systems to protect medical devices with an enhanced antimicrobial coating.

Generally, the present invention includes a coating of a medical device with an antimicrobial coating. The methods described can be

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DE LA M0WEDAO used to coat a medical device made of a variety of maOfa'le some preferred implementations, however, the methods of use used to coat medical devices that comprise one or more polymeric substrates, which include, but are not limited to polycarbonate, polyurethane, polyvinyl chloride, acrylic, and a combination thereof.

The described methods can be performed with one or a wider variety of coatings. However, the preferred coating is selected from a curable, antimicrobial ultraviolet (IIV) light and an antimicrobial solution.

When the coating comprises the L) V curable antimicrobial composition, the UV curable composition can comprise any suitable ingredient. In some implementations, the UV-curable composition comprises a UV-curing material comprising one or more polyester or urethane-type oligomers, with at least one acrylate-type functional group, acrylate-type monomers, and photoinitiators. Furthermore, in some applications, the UV curable composition further comprises one or more rheology modifiers and antimicrobial agents.

When the coating comprises the antimicrobial solution, the solution can comprise any suitable ingredient. In fact, in some implementations, the solution comprises one or more solvents, coating resins, rheology modifiers, and antimicrobial agents.

Methods generally described include providing a medical device, which prepares an antimicrobial coating on the surface of the device, washing excess coating from the device, and cures the coating on the device. Of course, the methods can be modified in any suitable way. In a

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INDUSTRIAL example of a modification, the methods include concealing a part of the device to prevent the coating from depositing on the part of the medical device that is covered by the masking.

In the described methods, the coating can be prepared on a surface of the device in any suitable way. In one example, a machine injects a calculated amount of coating into the device.

After the antimicrobial coating has been applied to the medical devices, the excess coating, if any, can be removed from the device in any suitable manner. For example, excess coating can be removed by excess coating from the device with an inert gas, spinning the medical device in a centrifuge, cleaning the device with a material, through gravity, etc. In some implementations currently, however, nitrogen gas that is used to blow excess coating off medical devices is preferred.

With the excess coating removed from the medical device, the coating can be cured in any suitable manner. For example, the UV curable composition can be rapidly cured through exposure to UV light. For example, after the UV curable composition is applied to the medical device, the composition can be cured in seconds or minutes, depending on the formulation and curing conditions. In another example, the antimicrobial solution can be cured relatively quickly by being exposed to heat (eg, infrared heat). In fact, under certain circumstances, the solution can be heat cured at about 100 ° Celsius (C) in about 5 minutes or less.

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While the methods of the present invention have proven to be particularly useful in the area of ​​coating IV access devices, those skilled in the art will appreciate that the methods described can be used for a variety of different applications in a variety of different areas. manufacturing that includes a coating of an object with an antimicrobial layer.

These and other features and advantages of the present invention will be adjusted or will become more apparent from the description that follows and the appended claims. The characteristics and advantages can be realized and obtained by means of the instruments and combinations, particularly those indicated in the appended claims. Furthermore, the features and advantages of the invention may be learned by practice of the invention or will be obvious from the description, as will be established hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that the above, and other characteristics and advantages of the invention are listed in the manner in which they are obtained and easily understood, a more specific description of the invention will be briefly described by reference to the specific embodiments thereof, which are illustrated in the accompanying drawings. With the understanding that these drawings represent only typical embodiments of the invention and are not, therefore, considered to be limiting of this scope, the invention will be described and explained in further specificity and detail through the use of the accompanying drawings in the that:

Figure 1 illustrates a block diagram of a representative embodiment of a method for coating a medical device with an antimicrobial layer;

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Figure 2 illustrates a block diagram of a representative embodiment of the method for coating a medical device with an antimicrobial coating;

Figure 3 illustrates a perspective view of a representative embodiment of an IV access device;

Figure 4A illustrates a perspective view of a representative embodiment of a system for applying an antimicrobial coating to a medical device; Y

Figure 4B illustrates a perspective view of a representative platform for retaining a medical device during operation of the system shown in Figure 4A.

DETAILED DESCRIPTION OF THE INVENTION

The disclosed invention relates to methods and compositions for coating one or more surfaces of a medical device with an antimicrobial coating. Once the coating is cured in the medical device, an antimicrobial agent in the coating can spread into the coating when the coating is softened by IV fluids or other fluids. Consequently, microbes that may be in contact with the coated surface of the medical device can be killed and the medical device can remain hygienic for an extended period of time.

Figure 1 illustrates a representative embodiment of the coated methods described. Specifically, Figure 1 shows that method 10 for coating a

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DtunovuoAD medical device with an antimicrobial coating generalrriWil ^ '&amp; mprentfc · To provide a medical device 12, by preparing an iMimicrebial coating on the device 14, the excess coating is washed from the device 16, and the coating of the device is cured. In order to provide a better understanding of the described coating method, the following disclosure provides a more detailed disclosure of medical devices and antimicrobial coatings that can be used with the coating method, the different steps of the method, and the systems for carry out the method.

With regard to the types of medical devices that can be used with the coating methods, the methods can be used with any of the appropriate medical devices, including, but not limited to, an IV access device, medical tubing, a catheter assembly, and any other viable medical grade instrument that has contact with fluids flowing into or out of a patient.

The medical device can comprise any material that is suitable for use with the described methods. In some typical embodiments, however, the medical device comprises one or more polymeric substrates. For example, the medical device can comprise one or more polycarbonates, polyurethanes, polyvinyl chloride, silicones, PET plastics, styrene butadiene rubber, acrylics, and a combination thereof.

The antimicrobial layer can comprise any suitable antimicrobial composition that is suitable for use in medical devices. However, in preferred embodiments, the antimicrobial coating is selected from a UV-curable antimicrobial composition and a solution

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OF THE antimicrobial pjOHYTH. To provide a better understanding of the curable compost and antimicrobial solution, each will be discussed later in CUI IIIláü Cizallé. '¹

In some preferred embodiments, the antimicrobial coating comprises a UV-curable antimicrobial composition. In such embodiments, the UV curable composition can comprise any suitable ingredient. In one aspect of the invention, the UV curable coating comprises materials (referred to herein as the "UV curable material") that are capable of forming a UV curable polymer composition. While the UV curable material can comprise any suitable ingredient, in some preferred embodiments, the UV curable material comprises one or more oligomers, monomers, and photoinitiators. In addition to the UV curable material, the UV curable composition further comprises an effective antimicrobial agent. The various ingredients that are added together to form the UV curable composition are described below. In the following discussion, the UV curable material will comprise 100 parts by weight. Additionally, the ingredients added to the UV curable material to form the UV curable composition will be defined in parts by weight added to 100 parts by weight of the UV curable material.

The UV curable material may comprise an oligomer which is compatible with the other components of the UV curable composition and which is used within the scope of the present invention. However, the oligomer is generally selected from one or more acrylated aliphatic urethanes, acrylated aromatic urethanes, acrylated polyesters, unsaturated polyesters, acrylated polyesters, acrylated acrylics, and the like, or a combination thereof. In fact, in some embodiments, the UV curable coating comprises a polyester or urethane type acrylate, such as 7104, 7101, 7124-K, 7105-5K from Electronic

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DiUMWIEDAC iNwmiAi-Materials Inc. (EMI) (EM Breckenridge, Co.), 1168-M, 1-20781 from Dymax Corporation (Torrington, CT.), Or UV 630 from Permabond Engineering Adhesives ”(Somerset, NJ). Where the oligomer comprises an acrylatazo functional group, the functional group is preferably selected from a mono-functional, di-functional, tri-functional, penta-functional, and hexa-functional acrylate.

The oligomer can account for any suitable portion of the UV curable material. Typically, however, the oligomer will comprise from about 10% to 90% UV curable material. In some preferred embodiments, the oligomer comprises about 20% to 80% UV curable material. However in certain other embodiments, the oligomer comprises about 30% to 60% UV curable material.

While the monomer in the UV-curable material can be selected from any monomer that is compatible with other components of the UV-curable composition and that is usable within the scope of the invention, the monomer is preferably selected from 2 ethylexy, isooctyl acrylates acrylate, isobornyl acrylate, 1,6 hexanediol diacrylate, diethylene glycol diacrylate, triethylene glycol diacrylate, pentaerythritol tetra acrylate, pentaerythritol tri acrylate, methyl hexyl acetophenone dimethoxy phenyl acrylate, 1,6 hexanidiol methacrylate, and the like, or combinations of these compounds.

In typical embodiments, the monomer comprises about 5% to 90% of the UV curable material. In other embodiments, however, the monomer comprises from about 10% to 75% of the UV curable material. In still other embodiments, the monomer comprises about 20% to 60% of the UV curable material.

The photoinitiator can comprise any photoinitiator that is compatible with other components of the UV curable composition (ie, UV curable material) and that is usable within the scope of the invention. Generally, the photoinitiator is selected from either a single molecule cleavage type photoinitiator, such as one or more benzoin ethers, acetophenones, benzoyl oximes, and the acyl phosphine oxides, or a type of hydrogen abstraction of the photoinitiator, such as as Michler's ketone, thioxanthone, anthroguionone, benzophenone, methylamine diethanol, and 2N-butoxyethyl-4- (dimethylamino) benzoate.

The photoinitiator typically comprises about 0.5% to 10% of the UV curable material. In still other embodiments, the photoinitiator comprises from 2% to about 7% UV curable material.

The antimicrobial agent can comprise any antimicrobial agent that is compatible with other components of the UV curable composition and that is usable within the scope of the invention. Additionally, in some embodiments, the antimicrobial agent comprises an agent that dissolves in the UV curable composition or can be uniformly distributed herein. Consequently, in such embodiments, sufficient antimicrobial agent can migrate within the UV curable composition to contact the location of microbial activity. In any event, it is preferred that the antimicrobial agent does not react chemically with other components of the UV curable composition. Some examples of antimicrobial agents are suitable for use with the

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The antimicrobial agent is generally present in the UV curable composition in the amount of from about 0.5 to about 50 parts, by weight, compared to 100 parts by weight of the UV curable material. In other embodiments, the antimicrobial agent is present in the UV curable composition in the amount of 0.5 to about 30 parts, by weight, compared to 100 parts of UV curable material. In later embodiments of the curable composition, the antimicrobial agent is present in the amount of about 0.5 to 20 parts, by weight compared to 100 parts of UV curable material.

In addition to the aforementioned materials, the UV curable composition can comprise any other suitable component. In fact, in certain embodiments, the UV curable composition also includes a rheological modifier to improve the flow characteristics of the composition and to help the components to be evenly distributed throughout the composition. In such embodiments, the rheological modifier is preferably selected from organic clay, castor wax, polyamide wax, polyurethane, and fumed silica. Additionally, in such embodiments, the rheological modifier comprises about 0.1 to 30 parts, by weight, added to 100 parts, by weight, of the UV-curable material (i.e. the UV-curable material is 100 weight units, while the modifier rheological comprises 0.1 to 30 parts of additional weight that is added to the 100 parts of the UV curable material). In other embodiments, the rheological modifier comprises 0.1 to about 20 parts by weight compared to 100 parts by weight of the UV curable material.

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In certain later embodiments, the rheological modifier comprises 0.2 to 10 parts by weight compared to 100 parts by weight of the UV curable material.

The UV curable composition can also have any other suitable characteristics. For example, in some embodiments, the UV curable composition has a viscosity that is less than about 10,000 centipoise (cps). In other embodiments, the viscosity of the UV curable composition is below 5,000 cps. In some current preferred embodiments, the curable composition has a viscosity that is between about 20 and 1,000 cps.

While the UV curable composition has been specifically described above, a more detailed description of the UV curable composition is found in US Patent Application No. 12 / 397,760, filed March 4, 2009, and entitled "Antimicrobial Compositions." , the entire disclosure of which is hereby incorporated by reference.

Where the antimicrobial coating comprises an antimicrobial solution, the solution can comprise any suitable ingredient. In some embodiments, the antibacterial solution comprises an acrylate polymer or copolymer, a solvent, and an antimicrobial agent. To provide a better understanding of the antimicrobial solution, each of the aforementioned ingredients is described in more detail below.

The acrylate polymer or copolymer can comprise any acrylate polymer and / or copolymer that is compatible with other components of the antimicrobial solution and that is usable within the scope of the invention. In some embodiments, the acrylate-type polymer, copolymer, or polymer resin is insoluble.

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in water while it is soluble in one or more of the solvents that will be discussed hereinafter. For example, the acrylate polymer or copolymer is generally selected from one or more alkyl acrylates, alkyl methacrylates, alkyl methacrylates, hydroxyalkyl (meth) acrylates, and methoxycinnamate acrylates. In this example, the acrylate can be alkyl acrylate, hydroxyalkyl (meth) acrylate, or alkyl methacrylate. Additionally, in this example, the alkyl group may have a carbon number from 0 to 22, where 0 means hydrogen, 1 means a methyl group, 2 means an ethyl group, 3 means a propyl group, etc.) , but preferably a number from 0 to 6 and more preferably from 0 to 3.

The solvent in the antimicrobial solution can comprise any solvent that is compatible with the other components of the antimicrobial solution and that allows the solution to function as intended. For example, the solvent may comprise one or more variety of solvents that are capable of dissolving the aforementioned acrylate polymer or copolymer. Some examples of suitable solvents include one or more low molecular weight alcohols, low molecular alkanes, simple ketones, and a combination thereof. Some examples of suitable low molecular weight alcohols include alcohols having 1 to 6 carbons (eg, methanol, ethanol, propanol, isopropanol, and butanol). Since methanol evaporates relatively quickly, however, methanol cannot be preferred in all embodiments. Instead, in some current preferred embodiments, the solvent comprises ethanol or isopropanol. Some suitable examples of suitable low molecular weight alkanes comprise alkanes having 5 to 7 carbons (eg, pentane, hexane, heptane, and isomers thereof). In fact, in some preferred embodiments the solvent comprises hexane and / or heptane. Additionally, an example of a suitable simple ketone is acetone. It should be noted, however, that in some modalities that comprise

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While the solvent can comprise any suitable amount of an antimicrobial solution, in some embodiments, the solvent comprises less than about 67% of the dry weight of the antimicrobial solution. For example, where the polymer represents about 60% ± 10% of the antimicrobial solution, the solvent may represent less than about 40% ± 10% of the solution. In one embodiment, however, the solvent comprises less than about 50% of the dry weight of the composition. In still other embodiments the solvent comprises less than about 40% of the dry weight of the composition.

The antimicrobial agent in the antimicrobial solution can comprise any antimicrobial agent that is compatible with the other components of the solution and that allows the solution to function as directed. In fact, the antimicrobial agent for the antimicrobial solution is generally selected from one or more aldehydes, anilides, biguanides, silver, silver compounds, bispheonols, and quaternary ammonium compounds. In certain cases, the antimicrobial agent is preferably selected from cetylpyridinium chloride, cetrimide, benzalkonium chloride, alexidine, chlorhexidine diacetate, and o-phthalaldehyde.

While the antimicrobial agent can comprise any suitable amount of the antimicrobial solution, in some embodiments, the antimicrobial agent comprises less than 50% of the dry weight of the solution. In other embodiments, the antimicrobial comprises less than about 30% of the dry weight of the antimicrobial solution. In still other modes, the agent

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INDUSTRIAL antimicrobial comprises approximately 0.5% and approximately 20% of the dry weight of the antimicrobial solution.

In addition to the aforementioned ingredients, the antimicrobial solution can comprise any other suitable ingredients. In fact, in some embodiments, the antimicrobial solution comprises a rheological modifier that is generally selected from organic clay, castor wax, polyamide wax, polyurethane, and fumed silica. In such embodiments, the rheological modifier is generally present in an amount of about 0.2% to 30% of the dry weight of the antimicrobial solution. That is, the weight of the composition after the solvent has evaporated. In certain other embodiments, the rheological modifier is present in the amount of about 0.2% to 20% of the dry weight of the antimicrobial solution. In certain other embodiments, the rheological modifier is present in an amount of approximately 0.2% to 10% of the dry weight of the antimicrobial solution.

While the antimicrobial solution has been specifically described above, a more detailed description of the antimicrobial solution is found in US Patent Application No. 12 / 476,997, filed June 2, 2009, and is titled "Antimicrobial Coated Compositions." , the entire disclosure of which is incorporated herein by reference.

The described methods can be carried out or modified in a suitable way. By way of example, Figure 2 illustrates a current preferred embodiment of the disclosed method for coating a medical device. Specifically, Figure 2 shows an example in which method 11 starts at 12 providing a medical device.

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Next, at 13, Figure 2 method 10 is shown which optionally includes masking one or more desired portions of the medical device to prevent the antimicrobial coating from contacting the masked portion (s). By way of illustration, Figure 3 shows blue where the medical device comprises a portion of an IV access device 100 (for example, the DE BECTON DICKINSON'S Q-SYTE® IV access device) has a Luer component 102, the component Luer 102 can be inserted into a medical grade tube 104 such that the outer surface of the Luer 102 is prevented from being coated with the antimicrobial coating.

Returning back to Figure 2, Table 14 shows that Method 10 continues to prepare the antimicrobial coating (eg, UV curable composition or antimicrobial solution) on the medical device. Any suitable amount of the antimicrobial coating can be prepared on the desired surface (s) of the medical device. For example, where the medical device comprises the IV medical device of Figure 3, between about 0.01 and about 0.05 grams of antimicrobial coating that can be prepared in the internal lumen of the device 106. In another example, where the medical device comprises the device IV port of Figure 3, between 0.02 and approximately 0.04 grams of antimicrobial coating is prepared in the internal lumen of the device.

After the antimicrobial coating has been prepared on the medical device, from Table 16 of Figure 2 showing that any excess coating on the device is washed or otherwise removed from the medical device. In this way, the antimicrobial coating can be caused to have a uniform thickness across the coated surface. Excess coating

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INDUSTRIAL can be removed in any suitable way, including by blowing an inert gas across the coated surface of the medical device, spinning the medical device in a centrifuge, allowing excess material to drain from the device due to gravity, etc. . However, in some preferred embodiments, a pressurized inert gas, such as nitrogen, helium, or argon, is blown across the coated surface. By way of example, where the medical device comprises the IV access device 100 of Figure 3, an inert gas, such as nitrogen, with an air pressure of between about 5 and 15 pounds per square inch (psi) (per example, 10 psi ± 5 psi) is preferably blown past the coated surface.

In order to reduce the amount of antimicrobial coating that is wasted during the described method, table 17 of Figure 2 shows that excess antimicrobial coating that is washed from the medical device is optionally collected and recycled. In other words, the excess antimicrobial coating can be collected and used to coat another medical device.

With the excess antimicrobial coating removed from the medical device, Figures 20 and 22 show that the left coating of the device is cured. While the antimicrobial coating can be cured in any suitable manner, Table 20 shows that in some embodiments where the antimicrobial coating comprises the UV-curable composition, the UV-curable composition is cured upon exposure to UV light. In such embodiments, the UV curable composition can be exposed to any suitable wavelength of UV light. In one example, the UV curable composition is exposed to UV light with a wavelength of between about 320 to 500 nm. In another example, the UV-curable composition is cross-linked when exposed to light with a wavelength between about 350 and 45 ° C.

Additionally, the UV curable composition can be exposed to UV light for any amount of time that the UV curable composition allows to dry and cure for the medical device. In fact, in one example, the UV curable composition is cured after less than 1 minute of exposure to UV light. In another example, the UV-curable coating is cured after less than about 30 seconds of exposure to UV light. In yet another example, the UV curable coating is cured after less than about 10 seconds of exposure to UV light. In a final example, the UV curable coating is cured after less than about 4 seconds of exposure to UV light.

Referring now to Table 22, Figure 2 shows that in some embodiments where the antimicrobial coating comprises the antimicrobial solution, the solution is cured through exposure to heat from a heat source (e.g. an infrared heater, a convection heater, a conventional heater, etc.). In such embodiments, the antimicrobial solution coats the device that can be cured at any suitable temperature. In one example, the solution is cured at a temperature of less than about 120 ° C. In another example, the antimicrobial solution is cured at a temperature of less than about 100 ° C. In yet another example, the antimicrobial solution is cured at a temperature of less than about 60 ° C.

While the antimicrobial solution can be cured in any amount of time, under certain conditions, the solution is cured after less than 10

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minutes of exposure to a temperature of less than aprOTinadamai'ila G0ⁿ G. Similarly, under certain conditions, the antimicrobial solution is cured after less than about 5 minutes of exposure to a temperature of less than about 100 ° C.

Once the antimicrobial coating is cured, box 24 in Figure 2 shows that any masking material is optionally removed from the medical device. At that point, the medical device can be used and the antimicrobial coating can be effective almost immediately after exposure to the fluid (eg, intravenous fluid).

The described methods can be carried out by any suitable system and / or apparatus that are capable of carrying out one or more of the characteristics illustrated in Figure 2. In fact, in some embodiments, at least a portion of the The methods described are carried out using the coating system of the medical device. While such a system may comprise any suitable or characteristic component, Figure 4A illustrates a representative embodiment wherein the medical device coating system 200 comprises a device holder 202, a topsheet 204 with heads prepared with liners 206, and heads prepared with coatings. gas 208, jacketed valves 210, gas valves 212, a gas reservoir 214, excess funnels 216, and a pressurized liner reservoir 218.

While the medical device coating system can be used in any way, in order to provide a better understanding of the system, a typical example of this use is provided herein. Specifically, Figure 4B shows that one or more medical devices, such as the

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INDUSTRIAL intravenous access 100, can be positioned in the holder of the medical device 202 such that an opening 108 to the internal lumen 106 of the device 100 is oriented towards a head 206 prepared with coating (shown in Figure 4A).

In order to ensure that the medical device remains in a proper orientation throughout the coating process, the base may secure the medical device in a desired orientation, in any suitable manner. By way of illustration, Figure 4B shows an embodiment where IV access device 100 is secured to bracket 202 when an edge 110 on the access device is traversed into a slot 220 of bracket 202.

With the medical devices secured to the holder 202, Figure 4A shows that the holder 202 is positioned below the topsheet 204. At this point, the topsheet 204 can be moved relative to the holder 202 such that it engages the head ready to liner 206 is placed over the opening of each device (not shown in Figure 4A).

Once the prepared heads are aligned with the surface of the medical device to be coated, the coated valves 210 are opened to allow a predetermined amount (eg, between about 0.01 and 0.05 g) of antimicrobial coating to be squirted from from the pressurized coated reservoir 218, through the ready coating heads 206, and into the medical device. While this preparation process can take any amount of time, in some cases, the preparation process took a little more than 4 seconds or less (for example, approximately 2 seconds ± 1 second).

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IMPI MEXICAN INSTITUTE

THE MOHEDAL.

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After the liner has been prepared, the luminum 2U4 is moved in the direction of arrow 222 so that the gas dispensing head 208 is disposed on the coated surface of each medical device. Once the gas dispensing heads are properly aligned, the topsheet 204 moves in the direction of arrow 224 such that the gas dispensing heads 208 form a seal against the opening of the medical device (shown in Figure 4A). . Once the seal is formed, gas valves 212 are opened to allow a controlled amount of inert gas, at a controlled pressure, to wash off any excess coating from the medical device. This excess coating is then collected in excess funnels 216, which direct the excess coating back to pressurized coating reservoir 218 for future use.

With the removal of excess coating from medical devices, the holder 202 can be removed from under the topsheet 204 and placed in a curing chamber (not shown), such as a UV light chamber or a hot chamber. - depending on the composition of the antimicrobial coating.

Following the curing process, the medical devices are removed from the holder and a new batch of uncoated medical devices can be placed on the holder so that the process can be repeated.

The described system can be modified in any suitable way. In one example, while Figure 4A shows an embodiment where the system 200 is configured to coat 4 medical devices simultaneously, the system can be modified to simultaneously coat any suitable number of

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VDUmML medical devices. For example, the system can be modified to coat 1, 2, 3, 5, 6, 7, 8 or more medical devices, simultaneously. In another example, instead of comprising a coating dispenser head and a separate gas dispensing head, the antimicrobial coating and the inert gas can be dispensed to a medical device through a single head such that the time rate between the dispenser and wash portions of the method. In still another embodiment, the base, the gas dispensing head, or some other component in proximity to the medical devices may comprise a UV light source. In such embodiments, the system can cure medical devices without requiring the base to be removed from the location below the topsheet.

As discussed above, the disclosed methods, apparatus, and compositions have several beneficial characteristics. In one example, the disclosed methods allow a medical device to be coated with an antimicrobial coating (eg, the UV curable composition) in a relatively short period of time. For example, instead of taking several hours (for example 24) to cure a hard solvent (for example THF or DMF) in a medical device, the UV-curable coating and antimicrobial solution can be cured in a medical device in some seconds or minutes, respectively. In fact, in some embodiments where the antimicrobial coating comprises the UV curable composition, the composition can be prepared, washed and cured in 30 seconds. In some preferred embodiments, the UV curable composition can be prepared, washed, and cured within 10 seconds. Similarly, in some embodiments where the antimicrobial coating comprises the antimicrobial solution, the solution is prepared, washed, and cured within 10 minutes. However, in some current preferred embodiments, the antimicrobial solution is prepared, washed, and cured in less than about 5 minutes.

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In another example of beneficial characteristics of the disclosed methods, the methods may allow the antimicrobial coating to be applied to the medical device with a substantially uniform coating thickness. In yet another example, since the described methods allow for excess antimicrobial coating to be recycled, the described methods may use less antibacterial coating, total, than certain conventional coating techniques.

In still another example, the disclosed antimicrobial and UV curable solutions provide several advantages over certain known antimicrobial coatings. For example, UV-curable and antimicrobial solutions can be less toxic, less expensive, more environmentally friendly, cause less warping or cracking of a medical device, are more aesthetic, and require less expensive equipment than multiple competitive antimicrobial layers (e.g. THF and DMF).

The present invention may be incorporated in other specific forms without departing from its structures, methods, or other essential features as broadly described herein and claimed hereinafter. The described embodiments and the examples are considered in all respects only as illustrative, and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than the foregoing description. All changes that come within the meaning and range of equivalence of the claims will be adopted within the scope.

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