Abstract:
A ported catheter adapter and septum actuator having various features to prevent displacement and dislodging of the septum actuator when accessing the patient&#39;s vasculature via the inserted infusion device. In particular, the systems and methods of the present invention provide an intravenous infusion device incorporating a septum actuator with a retention tab that interacts with a retention ring that is incorporated into the valve of a side port. This interaction retains the septum actuator within the lumen of the catheter adapter, thereby allowing for subsequent access to the patient&#39;s vasculature.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. Provisional Patent Application Ser. No. 61/929,686, filed Jan. 21, 2014, and entitled PORTED CATHETER ADAPTER WITH INTEGRATED SEPTUM ACTUATOR RETENTION, which is incorporated herein in its entirety. 
     
    
     BACKGROUND 
       [0002]    Intravenous infusion systems are commonly used to access the vasculature of a patient as part of an infusion therapy procedure. An intravenous infusion system generally includes a fluid reservoir of IV bag that is connected to the patient via an intravenous catheter. The catheter is commonly coupled to a catheter adapter having a Luer-lock connector, or other connector-type for coupling the catheter adapter to a syringe, a section of intravenous tubing, or some other external Luer device. Fluid from the IV bag flows into the patient via the catheter adapter and the intravenous catheter. 
         [0003]    In some instances, the catheter adapter further includes a blood control septum that is positioned within a fluid pathway running though the catheter adapter. The blood control septum is provided to allow selective flow of fluid through the fluid pathway. For example, the blood control septum may include a slit that may be bypassed when an external Luer device is coupled to the catheter adapter and directly engaging the septum. Upon removing the external Luer device, the slit is closed to prevent blood from leaking out of the catheter adapter. 
         [0004]    In some instances, the catheter adapter further includes a septum actuator that is contacted by the external or secondary infusion device, such as a Luer device, and advanced through the slit of the septum. The septum actuator is generally advanced through the septum to provide a temporary pathway through the septum. Upon removal of the secondary infusion device, the resilient nature of the septum backs the septum actuator out of the septum slit. 
         [0005]    In some instances, the septum actuator is accidently dislodged and displaced from the proximal opening of the catheter adapter, thereby preventing subsequent advancement through the septum. In this instance, the infusion device must be removed from the patient and replaced with a new device. Not only does this create an inconvenience for the care provider, this also results in increased risk of infection and trauma to the patient as a second catheterization is now required. 
         [0006]    Thus, while systems and methods currently exist to bypass a blood control septum as part of an infusion procedure, challenges still remain. Accordingly, it would be an improvement in the art to augment or replace current techniques with the system and methods discussed herein. 
       BRIEF SUMMARY OF THE INVENTION 
       [0007]    The present invention has been developed in response to problems and needs in the art that have not yet been fully resolved by currently available systems and methods. Thus, these systems and methods are developed to provide a ported catheter adapter and septum actuator having various features to prevent displacement and dislodging of the septum actuator when accessing the patient&#39;s vasculature via the inserted infusion device. Thus, the systems and methods of the present invention provide an intravenous infusion device incorporating a septum actuator with a retention tab that interacts with a retention ring that is incorporated into the valve of a side port. This interaction retains the septum actuator within the lumen of the catheter adapter, thereby allowing for subsequent access to the patient&#39;s vasculature. 
         [0008]    In some implementations, a ported catheter assembly is provided comprising a catheter adapter having a proximal end, a distal end and a lumen extending therebetween, the catheter adapter further comprising a side port forming a pathway through a sidewall of the catheter adapter and in communication with the lumen. The catheter assembly further comprises a blood control septum disposed within the lumen and dividing the lumen into a proximal chamber and a distal chamber. In some instances, the device further includes a septum actuator having an outer diameter and disposed within the proximal chamber and having a base, a tip and a body extending therebetween. The tip is positioned proximate to the blood control septum and the base is positioned proximate to the proximal end of the catheter adapter. The catheter assembly further comprises an actuator retention tab having an outer diameter and being positioned on an outer surface of the septum actuator body. 
         [0009]    The device further comprises a valve disposed within the lumen and forming a seal between the lumen and the pathway of the side port. In some instances, the valve includes a retention ring comprising an inner diameter that is greater than the outer diameter of the septum actuator and less than the outer diameter of the actuator retention tab, wherein the actuator retention tab is positioned on the outer surface of the septum actuator body between the blood control septum and the actuator retention ring. 
         [0010]    The valve of the side port generally comprises a flexible tube having an outer diameter that is approximately the same size as an inner diameter of the lumen, whereby the valve is retained within the lumen by an interference fit. The proximal end of the catheter adapter further comprises and opening through which a separate device may be inserted to contact the base of the septum actuator and advance the tip of the septum actuator through a slit of the blood control septum. In some instances, the base comprises an outer diameter that is greater than the inner diameter of the actuator retention ring. As such, the base is prevented from passing through the actuator retention ring. In other instances, the actuator retention ring further comprises a plurality of vents, each vent having a surface area that is selected to prevent or permit passage or air and/or fluid. 
         [0011]    In some implementations, the retention tab is spaced from the base of the septum actuator at a distance such that when the base contacts the retention ring the tip of the septum actuator is advanced through the slit of the septum, and the interface between the base and the actuator ring prevents the tip of the septum from further advancement through the slit. In other embodiments, the actuator retention ring is spaced from the base at a first distance, such that when the base contacts the retention ring, the tip of the septum actuator is advance through the septum slit and the interface between the base and the actuator retention ring prevents the tip of the septum actuator from further advancement through the slit. In some instances, the first distance is approximately equal to a second distance between a distal most surface of the tip of the septum actuator and a distal most surface of the blood control septum when the actuator retention tab is in contact with the actuator retention ring. 
         [0012]    In some implementations, an antimicrobial coating is applied to one or more surfaces of the infusion therapy device. In one instance, an antimicrobial coating is applied to the septum actuator retention tab, wherein the septum actuator retention tab is positioned within a fluid pathway through the lumen of the catheter adapter. The antimicrobial coating further includes an antimicrobial agent that is compatible for use in an infusion therapy device. Non-limiting examples of suitable antimicrobial agents include chlorhexidine diacetate, chlorhexidine gluconate, alexidine, silver sulfadiazine, silver acetate, silver citrate hydrate, cetrimide, cetyl pyridium chloride, benzalkonium chloride, o-phthalaldehyde, and silver element. In some instances, the antimicrobial coating comprises an eluting antimicrobial coating matrix whereby the eluting antimicrobial coating provides a zone of inhibition within a fluid within the lumen of the catheter adapter. 
         [0013]    Some implementations of the present invention further include an actuator retention tab device comprising an inner surface configured to receive an outer surface of a septum actuator and be fixedly attached thereto; an outer surface positioned opposite the inner surface and in communication with a fluid pathway of a lumen of the catheter adapter, the outer surface having an outer diameter that is greater than an inner diameter of an actuator retention ring of the catheter adapter, whereby the actuator retention tab is prevented from passing through the actuator retention ring. In some instances, the outer surface of the actuator retention tab is further coated with an antimicrobial coating. 
         [0014]    These and other features and advantages of the present invention may be incorporated into certain embodiments of the invention and will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter. The present invention does not require that all the advantageous features and all the advantages described herein be incorporated into every embodiment of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0015]    In order that the manner in which the above-recited and other features and advantages of the invention are obtained will be readily understood, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. These drawings depict only typical embodiments of the invention and are not therefore to be considered to limit the scope of the invention. 
           [0016]      FIG. 1  is a perspective view of a ported infusion therapy device in accordance with a representative embodiment of the present invention. 
           [0017]      FIG. 2  is a cross-section, side view of a ported catheter adapter having a retention ring, a septum actuator, and an actuator retention tab, and being shown prior to activation in accordance with a representative embodiment of the present invention. 
           [0018]      FIG. 3  is a cross-section, side view of a ported catheter adapter having a retention ring, a septum actuator, and an actuator retention tab, and being shown following activation in accordance with a representative embodiment of the present invention. 
           [0019]      FIG. 4A  is a cross-section rear view of a ported catheter adapter showing a cross-section of the retention ring in accordance with a representative embodiment of the present invention. 
           [0020]      FIG. 4B  is a cross-section rear view of a ported catheter adapter showing a cross-section of a vented retention ring in accordance with a representative embodiment of the present invention. 
           [0021]      FIG. 5  is a cross-section side view of a ported catheter adapter having a proximally positioned actuator retention ring and undergoing injection of a fluid via the catheter port in accordance with a representative embodiment of the present invention. 
           [0022]      FIG. 6  is a cross-section side view of a ported catheter having a distally positioned actuator retention ring in accordance with a representative embodiment of the present invention. 
           [0023]      FIG. 7  is a cross-section side view of a ported catheter having a distally positioned actuator retention ring and undergoing injection of a fluid via the catheter port in accordance with a representative embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0024]    The presently preferred embodiments of the present invention can be understood by reference to the drawings, wherein like reference numbers indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide 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. 
         [0025]    Moreover, the Figures may show simplified or partial views, and the dimensions of elements in the Figures may be exaggerated or otherwise not in proportion for clarity. In addition, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a terminal includes reference to one or more terminals. In addition, where reference is made to a list of elements (e.g., elements a, b, c), such reference is intended to include any one of the listed elements by itself, any combination of less than all of the listed elements, and/or a combination of all of the listed elements. 
         [0026]    The term “substantially” means that the recited characteristic, parameter, or value need not be achieved exactly, but that deviations or variations, including for example, tolerances, measurement error, measurement accuracy limitations and other factors known to those of skill in the art, may occur in amounts that do not preclude the effect the characteristic was intended to provide. 
         [0027]    As used herein, the term “proximal”, “top”, “up” or “upwardly” refers to a location on the device that is closest to the clinician using the device and farthest from the patient in connection with whom the device is used when the device is used in its normal operation. Conversely, the term “distal”, “bottom”, “down” or “downwardly” refers to a location on the device that is farthest from the clinician using the device and closest to the patient in connection with whom the device is used when the device is used in its normal operation. 
         [0028]    As used herein, the term “in” or “inwardly” refers to a location with respect to the device that, during normal use, is toward the inside of the device. Conversely, as used herein, the term “out” or “outwardly” refers to a location with respect to the device that, during normal use, is toward the outside of the device. 
         [0029]    Referring now to  FIG. 1 , a ported infusion therapy device  10  is shown. Device  10  generally comprises various features and elements to enable subcutaneous or intravenous infusion of a fluid or medicament into a patient. In some instances, device  10  further comprises feature to enable removal of a fluid from a patient, such as blood. 
         [0030]    Device  10  generally comprises a ported catheter adapter  20  having a proximal end  22 , a distal end  24  and a lumen  26  extending therebetween. In some instances, catheter adapter  20  further comprises a side port  30  forming a pathway through a sidewall of catheter adapter  20  and in communication with lumen  26 . A valve  40  (shown in  FIGS. 2-7 ) is placed within lumen  26  so as to provide a defeatable barrier between side port  30  and lumen  26 . Valve  40  generally comprises a resilient, flexible material that is easily deformed when fluid is introduced to port  30  via a syringe or other compatible device. For example, in some instances valve  40  comprises silicone, polyisoprene, or a similar polymer material. Upon deformation of valve  40 , fluid from the syringe is permitted to bypass the deformed valve and flow into lumen  26 . As the fluid pressure decreases, the resilient nature of the valve&#39;s material causes valve  40  to restore its original shape, thereby once again blocking the fluid pathway. 
         [0031]    Device  10  further comprises a catheter  12  that is coupled to distal end  24  and which is configured for insertion into a patient. In some instances, catheter  12  comprises a rigid plastic or metallic material having a sharpened distal end that can pierce the patient&#39;s skin and gain access to the vasculature or subcutaneous tissues of the patient. In other instance, catheter  12  comprises a flexible material having an inner diameter through which an introducer needle  16  is inserted. Introducer needle  16  comprises a rigid metallic material having a sharpened distal end that extends through catheter  12  and is exposed beyond the tip  14  of catheter  12 . The introducer needle is capable of piercing the skin to provide access to the vasculature or subcutaneous tissues of the patient. Once access is obtained, tip  14  of catheter  12  is inserted through the newly formed opening and into the desired location within the patient. Introducer needle  16  is then withdrawn from device  10 , and catheter  12  is left disposed within the patient. 
         [0032]    Proximal end  22  further comprises an opening  28  for receiving a secondary infusion therapy device  50 , such as a syringe or intravenous fluid line. In some instances, proximal end  22  comprises a set of threads configured to threadedly receive the secondary device  50  in a secure manner. Opening  28  may further comprise a tapered opening to receive secondary device  50  via an interference or friction fit. Proximal end  22  and opening  28  may alternatively comprises various surfaces and other features to enable coupling to a needle hub, a diagnostic device, and other suitable infusion therapy equipment. 
         [0033]    Referring now to  FIG. 2 , a cross-section side view of a ported catheter adapter  20  is shown. Catheter adapter  20  further comprises a blood control septum  60  that is disposed within lumen  26  towards distal end  24 , thereby dividing lumen  26  into proximal  70  and distal  80  fluid chambers. Septum  60  may comprise and shape or structure that is compatible with the teachings of the instant invention. In some instances, septum  60  comprises a cylindrical structure having a proximal opening  62  and a distal membrane  64  comprising a slit  66 . Slit  66  provides a fluid-tight seal, thereby preventing fluid from bypassing septum  60 . 
         [0034]    Septum  60  further comprises a flexible, resilient material that may be selectively deformed to open slit  66  to permit passage of fluids. For example, in some embodiments increased fluid pressure within proximal fluid chamber  70  will result in septum  60  being temporarily deformed, thereby permitting fluid within proximal chamber  70  to bypass septum  60  through slit  66  and flow into distal fluid chamber  80 . 
         [0035]    In some instances, valve  40  is positioned within lumen  26  at a positioned between opening  28  and blood control septum  60 . Valve  40  may be secured within lumen  26  by any compatible means. For example, in some embodiments valve  40  is secured within lumen  26  via an adhesive. In other embodiments, valve  40  is secured within lumen  26  via an interference fit. Further, in some instances valve  40  is inserted into an annular groove formed on the inner surface of lumen  26 . Valve  40  is placed within lumen  26  so as to overlap and form a seal between lumen  26  and the pathway of side port  30 . Valve  40  comprises a proximal opening  42 , a distal opening  44 , and a pathway  46  extending therebetween. In some instances, proximal opening  42  comprises a reduced diameter. 
         [0036]    In other embodiments, catheter adapter  20  further comprises a septum actuator  90  that is slidably disposed within proximal fluid chamber  70 . Septum actuator  90  comprises a base  92 , a tip  94 , and a body  96  extending therebetween. Septum actuator  90  further comprises a hollow interior through which a fluid may pass. In some instances, septum actuator  90  further comprises one or more fluid vents forming a fluid pathway through a sidewall of septum actuator  90  and in communication with lumen  26 , thereby providing diverse flow patterns for a fluid passing through lumen  26  and septum actuator  90 . 
         [0037]    Base  92  is generally positioned proximate to opening  28  of catheter adapter  20 , thereby being accessible to a secondary infusion therapy device  50 . Tip  94  is positioned proximate to septum  60 , and in some embodiments is inserted within proximal opening  62  and in direct proximity to membrane  64  and slit  66 . Tip  94  is advanced through slit  66  as base  92  is pushed in distal direction  100  by a secondary infusion therapy device  50  that is inserted through opening  28 , as shown in  FIG. 3 . Upon removal of secondary device  50 , the resilient nature of septum  60  causes membrane  64  to restore its original formation, thereby backing tip  94  out of slit  66 , and sliding septum actuator  90  in proximal direction  102 , thereby restoring the fluid-tight seal of slit  66 . 
         [0038]    With continued reference to  FIGS. 2 and 3 , septum actuator  90  further comprises an actuator retention tab  98 . In some instances, retention tab  98  comprises an annular protrusion on the outer surface of body  96 . In other embodiments, retention tab  98  comprises an annular ring that is fitted onto the outer surface of body  96 . Further still, in some embodiments retention tab  98  comprises one or more protrusions having an effective diameter smaller than pathway  46  and larger than proximal opening  42 . Thus, retention tab  98  may comprise various structural configurations. 
         [0039]    Retention tab  98  is located on body  96  so as to be positioned within pathway  46  of valve  40 . Retention tab  98  comprises an outer diameter that is greater than the outer diameter of body  96  and less than an inner diameter of pathway  46 , thereby permitting retention tab  98  to slide freely within pathway  46  of valve  40 . 
         [0040]    Further, the outer diameter of retention tab  98  is greater than a minimum diameter of proximal opening  42 . As such, proximal opening  42  comprises a retention ring  48  that prevents retention tab  98  from bypassing proximal opening  42  in proximal direction  102 . Thus, retention tab  98  and retention ring  48  prevent removal of septum actuator  90  through opening  28  of catheter adapter  20 . 
         [0041]    In some embodiments, retention tab  98  is positioned on septum actuator body  96  at a distance from base  92 , such that base  92  contacts a proximal surface of retention ring  48  when tip  94  is advanced through slit  66  to a desired depth. For example, in some instances it may be desirable to prevent over-insertion of tip  94  through slit  66 . Over-insertion may be understood to describe a penetration depth of tip  94  into slit  66  where septum  60  is incapable of backing tip  94  out of slit  66  when secondary infusion device  50  is removed from opening  28 . Over-insertion of tip  94  into slit  66  may thus prevent slit  66  from reforming a fluid-tight seal. Accordingly, in some embodiments, contact between base  92  and a proximal surface of retention ring  48  prevents additional advancement of tip  94  in distal direction  100 , thereby preventing over-insertion. 
         [0042]    Similarly, retention tab  98  is positioned on septum actuator body  96  at a distance from base  92 , such that tip  94  of septum actuator  90  is permitted to penetrate slit  66  of septum  60  to a minimum insertion depth. Minimum insertion depth may be understood to describe a penetration depth of tip  94  into slit  66  where the surface area of the opening provided in slit  66  is greater than or equal to the surface area of the opening of tip  94 . As such, the minimum insertion depth through slit  66  provides an opening or fluid pathway through septum  60  that does not impede or interfere with the flow of fluid passing through septum actuator  90 . Thus, the position of retention ring  98  relative to the positions of base  92  and tip  94  ensure proper insertion depth of tip  94  through slit  66  of septum  60 . 
         [0043]    Referring now to  FIGS. 4A and 4B , retention ring  48  of valve  40  generally comprises an inner diameter that is greater than the outer diameter of septum actuator  90 . As such, septum actuator  90  may freely slide proximally and distally though retention ring  48 . In some instances, retention ring  48  comprises a continuous annular surface that approximates the outer surface of septum actuator  90 . A small gap  47  is provided between septum actuator  90  and valve  40 , thereby permitting free unhindered movement of septum actuator  90  through retention ring  48 , as shown in  FIG. 4A . In some instances, gap  47  limits the rate at which fluid and/or air is able to bypass retention ring  48 . For example, in some instances gap  47  comprises a surface area sufficient to permit passage of air and fluid at a desire flow rate. In other embodiments, gap  47  comprises a surface area sufficient to permit passage of air, yet prevent passage of a fluid. Further, in at least one embodiment gap  47  comprises a surface area sufficient to prevent passage of air and fluid. Thus, gap  47  may be configured to control or prevent flashback of blood and other fluid through catheter adapter  20 . 
         [0044]    In other embodiments, retention ring  48  comprises a plurality of vents  49  arranged in an annular pattern around proximal opening  42 . Vents  49  may comprise any surface area as may be desired to affect the flow of fluid and/or air through catheter adapter  20 . For example, in some embodiments vents  49  each comprise a surface area sufficient to permit passage of fluid and air at a desired rate. In other embodiments, vents  49  comprise a surface area sufficient to permit passage of air at a desired rate, yet prevent passage of a fluid. Further still, in some embodiments vents  49  comprise a surface area that prevents passage of air and fluid. 
         [0045]    In some instances, plurality of vents  49  reduces the stiffness or rigidity of valve  40 . As such, valve  40  may more easily be deformed when fluid is injected into side port  30 . Thus, in some instances the number and size of vents  49  is selected to achieve a desired stiffness or rigidity for valve  40 . 
         [0046]    Referring now to  FIG. 5 , a cross-section side view of a ported catheter device  10  undergoing injection of a fluid  110  is shown. Valve  40  generally comprises a flexible polymer tube that may be readily deformed by a fluid  110  that is injected into side port  30  via a secondary infusion device  50 . In some instances, retention ring  48  and retention tab  98  are positioned between proximal opening  28  and side port  30 . As such, the distal end or opening  48  of valve  40  is deformed and partially collapses as fluid  110  is injected into side port  30 . Fluid  110  passes between the outer surface of valve  40  and the inner surface of lumen  26  in distal direction  100  toward blood control septum  60 . In some instances, fluid  110  passes between the outer surface of valve  40  and the inner surface of lumen  26  in a proximal direction towards retention ring  48 . 
         [0047]    In some instances, pressure buildup in proximal fluid chamber due to fluid  110  causes slit  66  of septum  60  to partially open, thereby permitting fluid  110  to bypass septum  60  and flow into distal fluid chamber  80 . In other instances, fluid  110  remains within proximal fluid chamber  70  until septum actuator  90  is advanced through slit  66  to provide a pathway through septum  60 . 
         [0048]    In other embodiments, retention ring  48  is positioned proximate to the middle of valve  40  and at a position that is between side port  30  and blood control valve  60 , as shown in  FIG. 6 . Retention tab  98  is positioned distally to retention ring  48  and at a position that is between retention ring  48  and blood control valve  60 . Proximal opening  42  remains positioned on the proximal end of valve  40  and at a position that is between side port  30  and proximal opening  28 . Thus, the distance between base  92  and proximal opening  42  prevents over-insertion, while ensuring a minimum insertion depth of tip  94  through slit  66 , as discussed above. 
         [0049]    The distal positions of retention ring  48  and retention tab  98  provide rigidity to the portion of valve  40  located between side port  30  and septum  60 . As such, the proximal end or opening  42  of valve  40  is deformed and partially collapses as fluid  110  is injected into side port  30 , as shown in  FIG. 7 . Fluid  110  passes between the outer surface of valve  40  and inner surface of lumen  26  in proximal direction  102  towards proximal opening  28 . Upon removal of secondary infusion device  50  from side port  30 , the resilient nature of valve  40  restores the fluid tight seal between valve  40  and side port  30 , thereby preventing fluid  110  from exiting catheter adapter  20  via side port  30 . For this configuration, fluid  110  is generally injected via side port  30  when a secondary infusion device  50  is coupled to proximal opening  28 . Thus, fluid  110  may flow through a vent  91  of septum actuator  90 , or through proximal opening  42  and into distal fluid chamber  80  via an opening provided through septum  60  by septum actuator  90 . 
         [0050]    Some embodiments of the present invention further comprise an antimicrobial agent that is applied to one or more surfaces of the infusion therapy device  10  as an antimicrobial coating. The antimicrobial agent may comprise any material or combination of materials that are compatible for use on an intravenous device. Non-limiting examples of suitable antimicrobial agents include chlorhexidine diacetate, chlorhexidine gluconate, alexidine, silver sulfadiazine, silver acetate, silver citrate hydrate, cetrimide, cetyl pyridium chloride, benzalkonium chloride, o-phthalaldehyde, and silver element. 
         [0051]    The antimicrobial agent is applied to one or more surfaces of the infusion therapy device  10  in a coating matrix that permits the antimicrobial agent to be eluted from the matrix when exposed to a fluid within the catheter adapter. Thus, the eluted antimicrobial agent provides a zone of inhibition around the coating surface or component of the infusion therapy device  10 . For example, in some instances the retaining tab  98  is coated with an antimicrobial coating matrix comprising an antimicrobial agent that is capable of eluting out of the coating matrix when the coating matrix is exposed to a fluid. Thus, the antimicrobial agent provides a zone of inhibition around the retention tab. Further, the antimicrobial agent provides antimicrobial properties to the fluid that bypasses the retention tab as it moves through the catheter adapter. Thus, the antimicrobial coating matrix may provide a zone of inhibition to the fluid and other surfaces of the infusion therapy device  10  that are downstream from the coated component. 
         [0052]    One having skill in the art will appreciate that the coating matrix and eluting antimicrobial agent may be applied to one or more surfaces of the infusion therapy device  10 . For example, in some embodiments one or more of the following components or surfaces of the infusion therapy device  10  is coated with a coating matrix comprising an eluting antimicrobial agent: lumen  26 , retention tab  98 , septum actuator  90 , blood control septum  60 , proximal fluid chamber  70 , distal fluid chamber  80 , valve  40 , and side port  30 . In other embodiments, a surface or component of infusion therapy device  10  that is positioned in a fluid pathway of the device is coated with an antimicrobial coating and agent, as described herein. 
         [0053]    Some embodiments of the present invention further comprise one or more methods for manufacturing a ported catheter assembly according to the teachings of the instant invention. For example, in at least one embodiment a method of manufacturing is provided comprising the following steps: 1) providing a catheter adapter having a proximal end, a distal end and a lumen extending therebetween; 2) placing a side port on a sidewall of the catheter adapter and forming a pathway through the sidewall of the catheter adapter and in communication with the lumen: 3) disposing a blood control septum within the lumen and dividing the lumen into a proximal chamber and a distal chamber; 4) disposing a septum actuator within the proximal chamber of the lumen, the septum actuator having a base, a tip and a body extending therebetween, the tip being positioned proximate to the blood control septum and the base being positioned proximate to the proximal end of the catheter adapter, the septum actuator further comprising an outer diameter; 5) positioning an actuator retention tab on an outer surface of the body, the actuator retention tab having an outer diameter; and 6) disposing a valve within the lumen and forming a seal between the lumen and the pathway of the side port, the valve having a retention ring comprising an inner diameter that is greater than the outer diameter of the septum actuator and less than the outer diameter of the actuator retention tab, wherein the actuator retention tab is positioned on the outer surface of the body between the blood control septum and the actuator retention ring. The method may further comprise a step for applying an antimicrobial coating to at least one of the lumen  26  of the catheter adapter  20 , the valve  40 , the septum actuator  90  and the retention clip  98  wherein the antimicrobial coating comprises an eluting antimicrobial coating whereby the eluting antimicrobial coating provides a zone of inhibition within a fluid within the lumen of the catheter adapter. In some instances, a further step is provided for providing a plurality of vents within the actuator retention ring. 
         [0054]    The ported catheter may alternatively be assembled by first inserting the valve into the lumen, and then inserting the actuator, wherein the retention tabs of the actuator snap past the retention ring of the valve. The valve material is resilient and therefore easily deforms to allow the actuator retention tabs to pass, thereafter resuming its original conformation. 
         [0055]    The present invention may be embodied in other specific forms without departing from its structures, methods, or other essential characteristics as broadly described herein and claimed hereinafter. The described embodiments are to be considered in all respects only as illustrative, and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.