Abstract:
Patients continue to acquire infections from healthcare facilities such as hospitals at an alarming rate. These infections can be transmitted when drugs or other medical materials are delivered from a syringe system into an IV line through an IV port. Some current methods of preventing contamination include swabbing the syringe with alcohol or using disposable alcohol caps; however, these methods are often inefficient. A system is described using caps that cover the entry and exit points of the IV port and the syringe system, respectively. The caps can be temporarily displaced from the entry and exit points when a sufficient force is applied to an area far enough away from the entry and exit points so as to prevent contamination. Once the caps are displaced, the syringe system can interact with the IV port using a locking mechanism such as luer locks to ensure the stability of the connection.

Description:
The present invention is generally directed to a system comprising a sterile entry IV port and a sterile entry syringe delivery mechanism. The IV port and syringe delivery mechanism can each have a cover over their respective entry or exit point. These covers keep the components of the IV port and/or syringe delivery mechanism sterile. The IV port and/or syringe delivery mechanism covers can each include a mechanism, such as a push mechanism, placed adjacent to the entry or exit point. When sufficient force is applied to this mechanism, the cover is raised away from the entry or exit point, allowing an IV port and syringe delivery mechanism to be joined using, for example, a single or double luer lock system. By enabling the cover to be raised without touching the entry or exit points, embodiments of the present invention can prevent contamination of the IV port and syringe delivery mechanism. Further, the covers and/or the system comprising the covers can be reusable. 
     BACKGROUND 
     According to The Joint Commission, a hospital accrediting organization, patients continue to acquire healthcare-associated infections at an alarming rate. The Commission has therefore established a list of National Patient Safety Goals (“NPSG&#39;s”) to combat these infections. NPSG #7 for 2011-2012 specifically addressed sterile environments and the prevention of healthcare-associated infections:
         NPSG #7.01.01: Comply with either the current Centers for Disease Control and Prevention (CDC) hand hygiene guidelines or the current World Health Organization (WHO) hand hygiene guidelines.   NPSG #7.03.01: Implement evidence-based practices to prevent health care-associated infections due to multidrug-resistant organisms in acute care hospitals.   NPSG #7.04.01: Implement evidence-based practices to prevent central line-associated bloodstream infections.       

     Current clinical practice generally provides for the delivery of sterile solutions (e.g. drugs, fluids, and/or blood) via uncapped luer lock syringes into uncovered luer lock needleless IV ports. In order to ensure a sterile environment, practitioners currently either swab the needleless IV port with alcohol or use single-use alcohol impregnated caps that are placed on the needleless IV port for about three minutes before delivery. As evidenced by The Joint Commission&#39;s finding that patients continue to acquire healthcare-associated infections at an alarming rate, these measures are not always effective in ensuring a sterile environment. 
     Various systems have been designed to aid medical professionals in the intravenous delivery of sterile solutions. Such systems are described, for example, in U.S. Pat. No. 6,003,556 to Brugger et al.; U.S. Pat. No. 5,881,774 to Utterberg ; and U.S. Pat. No. 5,817,067 to Tsukada; as well as U.S. Pat. Pub. Nos. 2012/0238965 and 2100/0298783 to Chang, the figures and descriptions of all five of these patents and publications being incorporated herein in their entirety by reference. However, these systems are lacking in many regards. For instance, none of these systems ensures a sterile environment, and extra precautions such as those described above must therefore accompany their use. 
     SUMMARY 
     Systems and methods are described for a single or double-lock sterile entry intravenous port and syringe system. The system can include caps which can be hinged. These caps can cover the entry points of the IV port and/or syringe and can prevent the contamination of these areas. In some embodiments, when ready for use a portion of each cap can be removed from the port by pressing on a mechanism spaced sufficiently away to prevent contamination by finger contact with the port opening. In turn, pressing on the mechanism causes the cap cover to raise, allowing access to the entry point of the IV port and/or syringe delivery mechanism. The system can be reusable. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows a cut-away view of one embodiment of a sterile entry IV port adjacent one embodiment of a sterile entry syringe delivery mechanism. 
         FIG. 2  shows a cut-away view of the sterile entry IV port and sterile entry syringe delivery mechanism of  FIG. 1  with the respective cover caps removed from the respective entry and exit points. 
         FIG. 3  shows a cut-away view of the sterile entry IV port and sterile entry syringe delivery mechanism of  FIG. 1  in the locked (interconnected) position. 
         FIG. 4  shows a cut-away view of another embodiment of a sterile entry IV port and sterile entry syringe delivery mechanism. 
         FIG. 5  shows a cut-away view of the sterile entry IV port and the sterile entry syringe delivery mechanism of  FIG. 4  with the respective cover caps removed from the respective entry and exit points. 
         FIG. 6  shows a cut-away view of the sterile entry IV port and the sterile entry syringe delivery mechanism of  FIG. 4  in a first locked position. 
         FIG. 7  shows a cut-away view of the sterile entry IV port and the sterile entry syringe delivery mechanism of  FIG. 4  in a second locked position. 
         FIG. 8  is a perspective side view of the first embodiment as shown in  FIG. 1 . 
         FIG. 9  is a perspective side view of the first embodiment as shown in  FIG. 2 . 
         FIG. 10  is a perspective side view of the second embodiment as shown in  FIG. 4 . 
         FIG. 11  is a perspective side view of the second embodiment as shown in  FIG. 5 . 
     
    
    
     DETAILED DESCRIPTION 
     The present invention provides embodiments of a sterile entry IV port and a sterile entry syringe delivery mechanism that can joined together as part of a fluid delivery system. Embodiments of sterile entry IV ports and sterile entry syringe delivery mechanisms can include a cover over the entry or exit point of the IV port and the syringe delivery mechanism such that the entry/exit point and all of the components behind the entry/exit point remain sterile. This cover can be cantilevered. The movement of the covers can be caused by the application of force to a portion of the cover structure at a point spaced from the entry/exit point in order to avoid contamination of the entry/exit point. Thus, the necessity of swabbing or otherwise sterilizing the entry/exit point can be eliminated. In some embodiments the cover and movement system are reusable. 
     It is understood that when an element is referred to as being “on” another element, it can be directly on the other element or intervening elements may also be present. Furthermore, relative terms such as “inner”, “outer”, “upper”, “above”, “lower”, “beneath”, and “below”, and similar terms, may be used herein to describe a relationship of one element to another. Terms such as “higher”, “lower”, “wider”, “narrower”, and similar terms, may be used herein to describe relative relationships. It is understood that these terms are intended to encompass different locations and orientations in addition to the orientation depicted in the figures. 
     Although the terms first, second, etc., may be used herein to describe various elements, components, regions and/or sections, these elements, components, regions, and/or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, or section from another. Thus, unless expressly stated otherwise, a first element, component, region, or section discussed below could be termed a second element, component, region, or section without departing from the teachings of the present invention. 
     Embodiments of the invention are described herein with reference to illustrations that are schematic illustrations. As such, the actual thickness of elements can be different, and variations from the shapes of the illustrations as a result, for example, of manufacturing techniques and/or tolerances are expected. Thus, the elements illustrated in the figures are schematic in nature and their shapes are not intended to illustrate the precise shape of a region of a package and are not intended to limit the scope of the invention. 
       FIG. 1  shows a cut-away view and  FIG. 8  shows a side perspective view an embodiment of a sterile entry IV port  100  incorporating features of the invention (referred to below as the “ FIG. 1 ” embodiment and/or position). An IV tube  102  is attached to the IV port  100  to receive fluid flow and is accessed through an entry point  104 . A syringe  200  can be attached to the IV port  100  by placement through the IV port entry point  120 . As previously described, in many current IV port/syringe systems, practitioners must either swab an IV port with alcohol, or must use single-use alcohol impregnated caps placed on the port for several minutes before injection. These systems can be tedious and in some cases ineffective. In the embodiment of  FIG. 1 , the port entry point  120  is instead covered by an entry cover  114 . The entry cover  114 , when in its closed position as shown in  FIG. 1 , can keep the port entry point  120  sterile such that no alcohol swabbing or impregnated caps are necessary to sterilize the device. Although not necessary, the entry cover  114  can include sterilization components such as alcohol. The entry cover  114  can be reusable or can be designed for a single use. 
     In order to keep the port entry point  120  sterile, it is desirable to keep practitioner body parts, such as fingers, away from the surface of the entry point  120 . This can present a challenge when the practitioner must remove the prior available entry covers. The  FIGS. 1 and 8  embodiment of the sterile entry IV port  100  includes a push-surface mechanism  112  such that the practitioner need not come close to contacting the sterile entry IV port  100  near the entry point  120 . The entry cover  114  can be rotated about hinge  116  if a sufficient downward force is applied to push-surface  112 , located between the front hinge  116  and a rear hinge or retention point  118  space longitudinally from the front hinge  116  and the entry port  120 . A practitioner can apply this force without contacting the sterile entry liquid containing IV port  100  near the entry point  120 . 
       FIG. 1  also shows an embodiment of a sterile entry syringe mechanism  200 . The  FIG. 1  embodiment can be used in conjunction with the  FIG. 1  sterile entry IV port  100 , or could be used with other IV ports. The sterile entry syringe system  200  can include an entry cover  214  and an exit point  220 . As with the IV port, it is desirable to keep the exit point  220 , and the components behind the exit point  220 , sterile. The  FIG. 1  embodiment uses a push-surface  212  similar to that of the sterile entry IV port  100 . When a sufficient force is applied to push-surface  212 , the entry cover  214  can rotate about a hinge  216 . 
       FIG. 2  shows a cut-away view and  FIG. 9  shows a side perspective view of the sterile entry IV port  100  and the sterile entry syringe mechanism  200  with their respective covers  114 ,  214  in an open position (referred to below as the “ FIG. 2 ” embodiment and/or position). When a practitioner applies a sufficient downward force to the surfaces  112 ,  212 , the surfaces move to the open positions as shown in  FIG. 2 ; in some embodiments this is achieved by rotation about the hinges  116 ,  216  or retention points  118 ,  218 , respectively. The hinges can also rotate to the positions shown in  FIG. 2 . Finally, the covers can open to the positions shown in  FIG. 2 . While in the  FIG. 2  embodiment these positions are approximately 90° from the closed position, other embodiments can have entry covers  114 ,  214  that rotate past 90°. In some embodiments the cover cap assembly  211  can also slide back to an alternate location  211 ′ as represented by the dotted lines in  FIG. 2 . 
     The embodiments shown in  FIGS. 1 and 2  include the hinges  116 ,  216  and the retention points  118 ,  218  spaced longitudinally from the hinges  116 ,  216 . Other embodiments can also only include one hinge or 2 or more hinges. In some embodiments hinges can replace retention points. Some embodiments do not use hinges but other mechanical devices to provide a movement to the entry covers  114 ,  214 . In some embodiments, the entry covers  114 ,  214  are not rotated away from the entry point  120  and exit point  220  respectively, but instead slide away or are displaced in another manner. In some embodiments, a push-surface is not used; instead, a sliding mechanism can be used to cause the entry covers  114 ,  214  to be moved away from the entry point  120  and the exit point  220  respectively. 
     The embodiments of  FIGS. 1 and 2  also include locking mechanisms to ensure that the connection between the IV port  100  and the syringe system  200  is secure. A male luer lock fitting  108  and female luer lock fitting  110  can be used in conjunction with a female luer lock fitting  208  and male luer lock fitting  210 , respectively. While the  FIGS. 1 and 2  embodiments include luer lock components, many other locking mechanisms such as threaded connections can also be used. Further, any combination of male/female parts is possible so long as male parts lock with compatible female parts. Finally, while the embodiments of  FIGS. 1 and 2  show a double-lock system with a double-lock IV port and a double-lock syringe system, any locking system with at least one lock can be used, or a system with another securing mechanism can be used. The current application is not limited to any single securing mechanism, as such mechanisms are well known in the art. 
       FIG. 3  shows the sterile entry IV port  100  and the sterile entry syringe delivery mechanism  200  in their locked positions after delivery of the liquid in the syringe. First, the covers  114 ,  214  are displaced by pushing the surfaces  112 ,  212  and the IV port  100  is connected to the syringe system  200  by sliding the syringe mechanism  200  into the IV port  100 . This can be made possible by including a channel  122  in the IV port to accommodate the outer wall portion  222  of the syringe mechanism. Once the syringe mechanism  200  is slid into the IV port  100 , the combinations of the luer locks  108 / 208 ,  110 / 210  can be made simultaneously and the connection can be secured. Finally, the syringe plunger  206  is moved forward to the position shown in  FIG. 3 , causing the plunger lead  204  to move to the position shown in  FIG. 3  for delivery of the fluid. The medical fluid is thus delivered to the IV tube  102  through the IV entry point  104  by the syringe delivery portion  204 . 
       FIGS. 4-7 and 10-11  show variations of the embodiments shown in  FIGS. 1-3 and 8-9 ; elements present in the earlier embodiments are identified by the same number. Whereas in the embodiments shown by  FIGS. 1-3  the two sets of luer locks could be locked simultaneously, in the embodiments of  FIGS. 4-7  the luer locks can lock independently. 
       FIG. 4  shows a cut-away view and  FIG. 10  shows a perspective side view of the IV port  300  and the syringe mechanism  400  with the covers  114  and  214  in the closed position (referred to below as the “ FIG. 4 ” embodiment and/or position).  FIG. 5  shows a cut-away view and  FIG. 11  shows a perspective side view of the IV port  300  and the syringe mechanism  400  with the covers  114  and  214  in the open position (referred to below as the “ FIG. 4 ” embodiment and/or position). In the embodiments of  FIGS. 4-7 and 10-11 , the cover  214  can be part of a movable assembly  440 . This assembly can slide or otherwise move; in the embodiment shown, the movable assembly can move to the position shown at  440 ′. Once the movable assembly  440  has been moved, the syringe mechanism  400  can be inserted into the IV port  300  such that the lock combination  110 / 210  can be locked, as shown in  FIG. 6 . The movable assembly  440  can then be slid or otherwise moved forward such that the portion  422  of the movable assembly  440  fits into the channel  122  of the IV port  100  and such that the lock combination  108 / 208  is made, as shown in  FIG. 7 . Once the IV port  300  and syringe mechanism  400  are appropriately secured as shown in  FIG. 7 , fluid delivery can commence as described above with regard to the embodiments of  FIGS. 1-3 . 
     Although the present invention has been described in detail with reference to certain preferred configurations thereof, other versions or combinations of the disclosed embodiments are possible. Therefore, the spirit and scope of the invention should not be limited to the versions described above.