Patent Publication Number: US-10328252-B2

Title: Antimicrobial IV access cap

Description:
RELATED APPLICATION 
     This application is a continuation of U.S. patent application Ser. No. 13/180,995, entitled ANTIMICROBIAL IV ACCESS CAP, filed on Jul. 12, 2011, which claims priority to U.S. Provisional Patent Application No. 61/364,447, entitled ANTIMICROBIAL I.V. ACCESS CAP, filed on Jul. 15, 2010, which are incorporated herein in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates generally to systems and method for preventing contamination of access ports. In particular, this disclosure discusses an antimicrobial access cap which is configured to receiving an access port of an intravascular device, an inner surface of the antimicrobial access cap having been treated with an antimicrobial agent. 
     In the fields of medicine and health care, a patient&#39;s skin may be punctured in a variety of manners and for a variety of reasons. In one example, a cannula or an intravenous (“IV”) catheter is forced through the patient&#39;s skin into an interior space, such as the patient&#39;s vasculature. In this example, the cannula or IV catheter can be used for infusing fluid (e.g., saline solution, medicaments, and/or total parenteral nutrition) into the patient, withdrawing fluids (e.g., blood) from the patient, and/or monitoring various parameters of the patient&#39;s vascular system. The cannula or IV catheter generally comprises a distal end which is positioned within the patient&#39;s vasculature, and a proximal end which is located external to the vasculature of the patient. As such, a physician may access the vasculature of the patient via the exposed, proximal end of the IV catheter. 
     While an IV catheter is convenient for providing prolonged access to the vasculature of the patient, the exposed portions of the catheter are susceptible to contamination by various strains of bacteria and viruses. Indeed, it is estimated that each year hundreds of thousands of patients in the United States alone develop some form of bloodstream infection that is caused by pathogens that were communicated to the patient through or because of an IV catheter or another IV access device, such as a hypodermic needle. Many of the bacterial pathogens that cause these catheter-related bloodstream infections are introduced into the vasculature of the patient through repeated attempts to access the patient&#39;s vasculature via the exposed portion of the IV catheter. Bacterial colonies which develop on the exposed portion of the IV catheter are transferred to the patient by way of a needle or syringe which is inserted into the proximal, exposed portion of the IV catheter. 
     Often, these catheter-related bloodstream infections cause patient illness and, in some cases, death. Furthermore, because some infections are caused by bacterial strains (e.g., Methicillin-resistant  Staphylococcus aureus  (“MRSA”) and Vancomycin-resistant  Enterococci  (“VRE”)) that are resistant to antibiotics, such infections can be hard to treat and may be becoming more prevalent. Additionally, because patients that have a bloodstream infection may require additional medical treatment, catheter-related bloodstream infections may also be associated with increased medical costs. 
     In an attempt to limit bloodstream infections (i.e., catheter-related infections) in hospital, outpatient, home care, and other health care settings, many have implemented sanitary techniques. For example, many health care providers have placed a strong emphasis on wearing gloves, cleaning hands, and cleaning the exposed portion of the IV catheter before inserting a needle or syringe. Some health care providers have devised a medical device cap which includes a cleaning solution, as taught in U.S. patent application Ser. No. 12/877,519, which is incorporated herein by reference, in its entirety. However, the demands of some medical emergency situations often preclude the use of currently available sanitary techniques. 
     Thus, while methods and systems currently exist to reduce bloodstream infections, challenges still exist. Accordingly, it would be an improvement in the art to augment or even replace current techniques with other techniques. 
     BRIEF SUMMARY OF THE INVENTION 
     The systems and methods of the present disclosure have been developed in response to problems and needs in the art that have not yet been fully resolved by currently available infusion systems and methods. Thus, these systems and methods are developed to provide for safer and more efficient rapid infusion procedures. 
     In some implementations of the present invention, a device is provided for preventing contamination of an access port, the device including an access cap having an inner surface defining a space for receiving a portion of the access port, the inner surface further including an antimicrobial agent. In some implementations, the access port is a portion of an intravenous or intravascular device, such as a y-port. In other implementations, the access port is a male or female luer of an intravascular device. Further still, in some aspects of the present invention the access port is at least one of a syringe, a catheter, a catheter hub, a needle, a piece of intravenous tubing, and/or an input or output valve of a medical device, such as centrifuge or a dialysis machine. 
     In some aspects of the invention, an access cap is provided which is configured to cover and thereby protect an exposed portion of the access port, thereby preventing contamination of the access port by bacteria or viruses. In some implementations, an access cap is provided which is connected to a portion of the access port. For example, in some implementations access cap is connected or attached to the access port via a tether. In other implementations, access cap is attached to the access port via a hinged tether. Further, in other implementations the access cap is slidably coupled to the intravascular device. Further still, in some implementations the access cap is pivotally coupled at least one of the access port and the intravascular device. 
     The antimicrobial agent is generally provided on a surface of the access cap such that when the access cap is placed onto the access port, the antimicrobial agent is in direct contact with an exposed portion of the access port. In some implementations, the antimicrobial agent is applied directly to the access cap. In other embodiments, the antimicrobial agent is applied to a material (such as a sponge, a foam, or a gel) which is applied to a surface of the access cap. Thus, when the access cap is placed adjacent to the access port, the antimicrobial agent maintains contact with an exposed or external portion of the access port. 
     In some implementation of the present invention, a method for preventing contamination of an access port is provided. Some aspects of the invention provide steps for providing a cap having an inner surface defining a space for receiving a portion of the access port, applying an antimicrobial agent to a portion of the inner surface, and attaching the cap to the access port. In some implementations, the access port is an intravenous or intravascular device. In other implementations, a further step is provided wherein the antimicrobial agent is retained by a material disposed within the inner surface of the cap. 
     Further still, in some implementations of the present invention an access port adapter, or an intravenous device adapter is provided having a body which includes a proximal end and a distal end, the proximal end having a first coupling surface for receiving a first or upstream intravascular device, and the distal end having a second coupling surface for receiving a second or downstream intravascular device. The access port adapter further includes a cap or access cap coupled to the body of the access port adapter, the cap having an inner surface defining a space for receiving a portion of the access port, and an antimicrobial agent disposed within the inner surface of the cap. 
     In some aspects of the present invention, the first and second coupling surfaces are threaded. In other aspects of the invention, a material is disposed within the inner surface of the cap which is capable of receiving and storing an antimicrobial agent. The material generally includes adsorptive or absorptive properties which allow the antimicrobial agent to be stored within the material. In some implementations, the material includes at least one of a sponge, a gel, a foam material, a woven material, a non-woven material, and a polymeric material. 
     The present invention further includes methods for manufacturing an antimicrobial IV access cap, wherein the method includes steps for coupling an access cap to a portion of an intravenous device, the intravenous device having an access port, and inserting an antimicrobial agent within an inner surface of the access cap, the inner surface of the access cap being configured to receive an exposed portion of the access port. The method for manufacturing the antimicrobial IV access cap further includes steps for hingedly coupling the access cap to a body portion of the intravenous device, as well as modifying the tethered connection between the access cap and the intravenous device with various other features, discussed in detail below. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
       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 which 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. 
         FIG. 1  is a perspective view of an access port in accordance with a representative embodiment of the present invention. 
         FIG. 2  is a cross-section side view of an access port in accordance with a representative embodiment of the present invention. 
         FIG. 3  is a perspective view of an intravenous device adapter and downstream intravenous device in accordance with a representative embodiment of the present invention. 
         FIG. 4  is a cross-section side view of an intravenous device adapter joined to a downstream intravenous device in accordance with a representative embodiment of the present invention. 
         FIG. 5  is a plane view of an intravenous device adapter and antimicrobial access cap in accordance with a representative embodiment of the present invention. 
         FIG. 6  is a plane view of an intravenous device adapter and antimicrobial access cap in accordance with a representative embodiment of the present invention. 
         FIGS. 7A, 7B, 7C, 7D, and 7E  are plane views of an intravenous device adapter and antimicrobial access cap in accordance with a representative embodiment of the present invention. 
         FIGS. 8A and 8B  are plane views of an intravenous device adapter and antimicrobial access cap in accordance with a representative embodiment of the present invention. 
         FIGS. 9A and 9B  are plane views of an intravenous device adapter and antimicrobial access cap in accordance with a representative embodiment of the present invention. 
         FIGS. 10A and 10B  are plane views of an intravenous device adapter and antimicrobial access cap in accordance with a representative embodiment of the present invention. 
         FIGS. 11A and 11B  are plane views of an intravenous device adapter and antimicrobial access cap in accordance with a representative embodiment of the present invention. 
         FIGS. 12A, 12B, 12C, and 12D  are views of an intravenous device and antimicrobial spring hinge cap in accordance with a representative embodiment of the present invention. 
         FIGS. 13A, 13B, 13C, and 13D  are views of an antimicrobial access cap in accordance with a representative embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Embodiments of the present invention will be best 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. 
     The systems and methods of the present invention are generally designed for use in combination with a vascular infusion system capable delivering an infusant to the vascular system of a patient. Referring now to  FIG. 1 , an antimicrobial IV access cap  10  is shown, in accordance with a representative embodiment of the present invention. In some embodiments, cap  10  prevents contamination of an access port  20 , such as a y-port of an intravenous tube  30 . In some embodiments, cap  10  further comprises a tether  12  by which cap  10  is coupled to a portion of access port  20 . In this way, cap  10  may be removed from covering access port  20  without being misplaced or lost. In some embodiments, cap  10 , tether  12  and access port  20  comprises the same material. In other embodiments, cap  10 , tether  12  and access port  20  comprise two or more materials. Further, in some embodiments access port  20  comprises at least one of an intravenous access port, a PRN adapter, a Posiflow access port, a Q-Syte access port, a Maxiplus access port, and a Clearlink access port. Access port  20  may further include any port or other structure which may be utilized to access the vasculature of a patient. 
     Referring now to  FIG. 2 , a cross-section of an access port  20  and IV access cap  10 , is shown. In some embodiments, access port  20  comprises a portion of an intravenous tube  22 . In other embodiments, access port  20  comprises a portion of a catheter tubing adapter  28 , wherein a first and second end  24  and  26  of the catheter tubing adapter is fitted with a section of intravenous tubing, thereby permitting flow between the sections of intravenous tubing, via adapter  28 . 
     Cap  10  generally comprises an inner surface  14  which defines a space for receiving a portion  16  of access port  20 . The inner surface  14  further defines a space for storing an antimicrobial agent  40 . In some embodiments, antimicrobial agent  40  comprises a material, solution, compound or coating which prevents colonization of undesirable bacteria and viruses. In some embodiments, antimicrobial agent  40  is selected from the group of chlorhexidine gluconate, chlorhexidine acetate, PCMX, Triclosan, silver sulfadiazine, and the like. In other embodiments, antimicrobial agent  40  comprises a topical antibiotic, such as Mupirocin, bacitracine, and the like. 
     In some embodiments, antimicrobial agent  40  is applied directly to the inner surface  14  of access cap  10 . In other embodiments, antimicrobial agent  40  is retained within the inner surface  14  of access cap  10  via a material, such as a sponge material, a gel material, a foam material, a woven material, a non-woven material, and/or a polymeric material. The antimicrobial agent  40  is applied to the inner surface  14  of cap  10  such that when cap  10  is placed over access port  20 , antimicrobial agent  40  contacts an opening surface  32  of access port  20 . In this way, antimicrobial agent  40  prevents colonization of bacterial and/or viruses within access port  20 . 
     Referring now to  FIG. 3 , in some embodiments access cap  10  comprises a portion of an intravenous device adapter  50 . Adapter  50  generally comprises a proximal end  52  having a first threaded surface  62  for receiving an upstream intravenous device (such as a male luer from a syringe, not shown), and a distal end  54  having a second threaded surface  64  for threadedly receiving a downstream intravenous device  60 , such as catheter  60 . Adapter  50  thereby permits the addition of an access cap  10  to a downstream intravenous device  60  which otherwise does not include an antimicrobial access cap  10 . 
     Distal end  54  is threadedly coupled to downstream intravenous device  60  via the second threaded surface  64  thereby preventing bacterial colonization between adapter  50  and downstream intravenous device  60 , as shown in  FIG. 4 . When not being used, proximal end  52  is insertedly position within inner surface  14  of access cap  10  such that antimicrobial agent  40  is in direct contact with proximal end  52 . When ready for use, access cap  10  is removed from proximal end  52  thereby permitting a threaded connection between threaded surface  62  and an upstream intravenous device (not show). 
     One having skill in the art will appreciate that the interaction between access cap  10  and intravenous device adapter  50  may be accomplished by any number of different techniques. For example, in some embodiments access cap  10  is tethered to the outer surface  56  of adapter  50 , as shown in  FIG. 4 . However, in some embodiments access cap  10  comprises a tether  70  having a loop  72 , defining a distal end of the tether  70 , wherein loop  72  is positioned around the second threaded surface  64  of distal end  54 , as shown in  FIG. 5 . 
     With reference to  FIG. 6 , in some embodiments access cap  10  further comprises a plurality of threads  18  formed on the inner surface  14  of cap  10  whereby cap  10  may be threadedly coupled to the first threaded surface  62  of proximal end  52 . Further, in some embodiments tether  70  further comprises a second loop  74  which defines a proximal end of the tether. The second loop  74  is secured in a groove  32  provided on an outer surface of access cap  10 , thereby permitting free rotation of access cap  10  when threadedly coupling access cap  10  proximal end  52  of adapter  50 . 
     In some embodiments, tether  80  comprises a loop  82  configured to ride within a channel  56  formed on an outer surface of adapter  50 , as shown in  FIGS. 7A-7E . Referring now to  FIG. 7A , in some embodiments access cap  10  is removed from proximal end  52  by first moving access cap  10  in an upward-backward direction  76 . Once access cap  10  has cleared proximal end  52 , access cap and tether  80  are moved in a downward direction  78 , thereby fully exposing proximal end  52 , as shown in  FIG. 7B . Proximal end  52  is recapped by reversing the movements by which access cap  10  was removed from proximal end  52 . 
     In some embodiments, tether  80  further comprises a lever  84  whereby the user by shift tether  80  in a proximal direction  86  with one hand, thereby advancing access cap  10  in a proximal direction which results in access cap  10  being removed from proximal end  52 , as shown in  FIGS. 7C and 7D . In some embodiments, access cap  10  is biased away from intravenous device adapter  50  due to outwardly biased tension provided in tether  80 . Thus, when access cap  10  is advanced beyond proximal end  52 , access cap  10  automatically springs away from proximal end  52  thereby providing unobstructed access to proximal end  52 . Access cap is reapplied to proximal end  52  by forcing access cap  10  towards adapter  50  until the cap opening is aligned with proximal end  52 . Access cap  10  is then slid in a distal direction onto the proximal end  52  thereby causing loop  82  of tether  80  to resume its initial position within channel  56  of adapter  50 . In some embodiments, access cap  10  is twisted by the user such that no portion of cap  10  overlaps adapter  50 , as shown in  FIG. 7E . Access cap  10  and tether  80  are then slid in a distal direction  88  to resume the initial position of loop  82  within channel  56  of adapter  50 . 
     In some embodiments, intravenous device adapter  50  further comprises a hinged antimicrobial cap  100 , as shown in  FIGS. 8A and 8B . Access cap  100  may comprise a different design than access cap  10 . For example, in some embodiments access cap  100  comprises a platform  102  having a surface  104  against which the antimicrobial agent  40  is applied. In some embodiments, platform  102  further comprises a lever  110  or handle whereby access cap  100  is manipulated by the user, with one hand, to remove access cap  100  and antimicrobial agent  40  from proximal end  52  of adapter  50 . 
     In some embodiments, access cap  100  is hingedly coupled to adapter  50  via a hinged tether  120 . Hinged tether  120  includes a hinged joint  122  which moves access cap  100  between a closed position (as shown in  FIG. 8A ) and an opened position (as shown in  FIG. 8B ). In some embodiments, hinged joint  122  biases access cap  100  against proximal end  52  when in the closed position. In other embodiments, hinged joint  122  biases access cap  100  away from proximal end  52  when in the opened position. Thus, the user may move access cap  100  between the opened and closed positions as desired to access the vasculature of a patient. 
     Referring now to  FIGS. 9A and 9B , in some embodiments tether  130  comprises a loop  132  defining a distal end of the tether, and a hinged joint  140  coupled to the platform  102  of hinged cap  100 , which defines the proximal end of tether  130 . Loop  132  is generally configured to ride in groove or channel  56  of adapter  50  between proximal and distal positions. When in a proximal position (as shown in  FIG. 9A ), access cap  100  is in a closed position such that antimicrobial agent  40  is in contact with proximal end  52  of adapter  50 . Tether  130  further comprises a lever  134  or handle by which the user may, with one hand, move tether  130  between the proximal and distal positions. When moved to a distal position (as shown in  FIG. 9B ), access cap  100  is moved to an opened position such that access cap  100  is cleared from proximal end  52 . In some embodiments, the access cap  100  is automatically moved from the closed position to the opened position as a result of the user sliding tether  130  in a distal direction. In other embodiments, the user first flips access cap  100  to an opened position and then slides tether  130  to the distal position. 
     In some embodiments, tether  150  comprises a loop  152  which defines a middle portion of tether  150 , as shown in  FIGS. 10A and 10B . Loop  152  is generally configured to sit within a groove or channel  56  of adapter  50  which maintains the position at which tether  150  is attached to adapter  50 . In some embodiments, the interaction between loop  152  and channel  56  provides a pivot point or fulcrum  154  for tether  150 . Thus, when the lever portion  160  of tether  150  is pushed inwardly towards the distal end  54  of adapter  50 , tether  150  pivots about fulcrum  154  thereby causing access cap  100  to be removed from proximal end  52  in an outward direction, as shown in  FIG. 10B . When lever portion  160  is released, access cap  100  is returned to its initial position which results in antimicrobial agent  40  contacting proximal end  52 , as shown in  FIG. 10A . 
     Referring now to  FIGS. 11A and 11B , in some embodiments tether  170  comprises a rigid lever having a proximal end coupled to access cap  100 , and a distal end pivotally coupled to intravenous device adapter  50 . Tether  170  further comprises a handle or pad  174  to facilitate a user in manipulating a rotated position of tether  170  relative to adapter  50 . 
     The pivoting connection  172  between tether  170  and adapter  50  enables tether  170  to be pivoted or rotated between a closed position (as shown in  FIG. 11A ) and an opened position (as shown in  FIG. 11B ). In some embodiments, pivoting connection  172  is spring-loaded, such that tether  170  is biased into the closed position. In some embodiments, adapter  50  further comprises a stop  180  which prevent over-forward rotation of tether  170  when in the closed position. 
     A user accesses proximal end  52  of adapter  50  by pushing pad  174  in rearward direction  182 , thereby causing access cap  100  to be displaced from proximal end  52 , as shown in  FIG. 11B . Pad  174  is configured such that a user may manipulate the position of access cap  100  with a single hand, thereby freeing the user&#39;s other hand to attach an intravenous device to the proximal end  52  of adapter  50 . Upon releasing pad  174 , access cap  100  automatically rotates in a forward direction  184  thereby returning access cap  100  to its initial position which results in antimicrobial agent  40  resuming contact with proximal end  52 , as shown in  FIG. 11A . 
     In some embodiments, a section of intravenous tubing  240  comprises a male luer connector  250 . The male luer connector  250  enables access to the intravenous tubing  240 . For example, in some embodiments an infusion device, such as a syringe (not shown), is attached to the intravenous tubing  240  via a threaded connection between the male luer connector  250  and the syringe. In some embodiments, an exposed surface of male luer connector  250  is protected with a spring hinge cap  260 , as shown in  FIGS. 12A-12D . For example, in some embodiments spring hinge cap  260  comprises a set of distal threads thereby enabling spring hinge cap  260  to be threadedly coupled to male luer connector  250 . In other embodiments, spring hinge cap  260  is press fit over the outer diameter of the male luer connector housing. Further, in some embodiments spring hinge cap  260  comprises a set of proximal threads  262  thereby enabling spring hinge cap  260  to be threadedly coupled to a syringe or other infusion device. 
     In other embodiments, spring hinge cap  260  is fitted over male luer connector  250  such that the proximal threaded surface of male luer connector  250  passes through a body portion of cap  260  and is positioned inside cap  260 . As such, male luer connector  250  may still be accessed by manipulating cap  260  to reveal the proximal threaded surface of male luer connector  250 . 
     In some embodiments, spring hinge cap  260  comprises a first tab  264  and a second tab  266 , each of which is hingedly coupled to a body portion of spring hinge cap  260 . In some embodiments, first and second tabs  264  and  266  are further pivotally coupled to a body portion of cap  260  thereby enabling an opened position, as shown in  FIGS. 12A and 12B , and closed position, as shown in  FIGS. 12C and 12D . Further, in some embodiments first and second tabs  264  and  266  are spring loaded, such that the tabs  264  and  266  are biased into the closed position, wherein the proximal ends of tabs  264  and  266  are in contact with one another. The tabs  264  and  266  are manually biased into the opened position by squeezing the distal ends of tabs  264  and  266  inwardly towards the body of spring hinge cap  260 . In some embodiments, spring hinge cap  260  opens when tabs  264  and  266  are squeezed, thereby exposing the female connection of the luer connector for system connection access. 
     In some embodiments, tabs  264  and  266  further comprise an inner surface  268  and  270 , respectively, which form a seal when in the closed position. In some embodiments, inner surfaces  268  and  270  are coated with an antimicrobial agent, in accordance with the teachings of the present invention. Thus, when in the closed position the exposed proximal surfaces of male luer connector  250 , or proximal threads  262  of cap  260 , are contained within the antimicrobial agent coating of tabs  264  and  266 , thereby preventing undesirable contamination thereof. 
     Referring now to  FIGS. 13A-13D , in some embodiments a cap  280  is provided having a lid  282  which is hingedly coupled to a body portion  290  of cap  280 . Body portion  290  generally comprises an internal space for receiving an access port or other intravenous device. In some embodiments, the internal space of body portion  290  comprises a set of threads for threadedly receiving an access port. In other embodiments, the internal space of body portion  290  is simply press fit over the outer diameter of a male luer connector housing. 
     Lid  282  comprises an inner surface  284  which forms a closed end of the internal space when lid  282  is in a closed position, as shown in  FIGS. 13A and 13B . In some embodiments, inner surface  284  further comprises an antimicrobial agent  40 , in accordance with the teachings of the present invention. 
     In some embodiments, lid  282  further comprises a lever  294 . Lever  294  comprises a first end  286  hingedly coupled to body portion  290 , and a second end rigidly coupled to lid  282 . Lever  294  further comprises a joint  300  whereby lid  284  and second end  288  pivot into an opened position when lever  294  pressed inwardly towards body portion  290 , as shown in  FIGS. 13C and 13D . In some embodiments, a channel  310  is provided in body portion  290  thereby enabling lever  294  and joint  300  to be pressed through body portion  290  and into the internal space of body portion  290 . Upon releasing lever  294 , lid  282  returns to its closed position, as shown in  FIGS. 13A and 13B . 
     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.