Abstract:
An access port for a medical fluid container is provided and in one embodiment includes a shell and a perforator located within the shell, the perforator including an end configured to pierce a medical fluid container. The access port also includes a safety cap, the safety cap initially preventing the perforator from rotating relative to the plane of the container or piercing the container film. The safety cap is manually removable to enable the perforator to pierce the medical fluid container. The shell includes a pair of hinged moving arms and members hinged to the arms. The members push the perforator towards the medical fluid container when the arms are pushed downwardly.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part of U.S. patent application Ser. No. 11/139,244, filed May 27, 2005, titled “Access Port with Safety Tab and Fluid Container Employing Same,” which is a continuation-in-part of U.S. patent application Ser. No. 10/277,432, filed Oct. 22, 2002, titled “Formed, Filled, Sealed Solution Container, Port And Method For Establishing Flow Between The Container And An Administration Set.” Each of these applications is hereby incorporated by reference in its entirety. 
     
    
     BACKGROUND 
       [0002]    The present invention generally relates to a container, an access port and a method for establishing flow between the container and an administration set. The access port establishes flow of fluid from the container into an appropriate administration set. More specifically, a valve or base that seals to a container is provided. A perforator or plunger in the valve punctures the container and provides access to the solution in the container. A protective cap on the access port protects the access port and helps to maintain integrity and sterility of the connection. 
         [0003]    Containers for the administration of medical solutions are well known. Typically, the containers are made from flexible film that is folded and sealed together along peripheral side edges. Further, the containers typically have an inlet and an outlet. The containers further typically have a device for piercing the outlet and establishing a fluid communication between the device and the solution inside the container. The solution may then be exhausted from the device to an administration set and/or patient. 
         [0004]    Maintaining the sterility of the medical solution to be administered to the patient is extremely important. However, handling of the medical solution container may create risks of contamination. The risk of contamination may increase in emergency situations where quick manipulation of the various components may introduce bacteria or other pathogens into the container. For example, a user may inadvertently touch and/or contaminate a sterile end surface of an inlet or an outlet. The contamination may then be transferred to the contents of the container. 
         [0005]    Further, containers for the administration of medical solutions are typically flexible. Accordingly, making an aseptic connection to the flexible container for withdrawing the contents in an aseptic manner may be difficult. For example, U.S. Reissue Pat. No. RE 29,656 to Chittenden et al. discloses an additive transfer unit having a tubular member that seals to a solution container. The unit includes a needle that punctures a stopper of the solution container. Obtaining a liquid-tight and leak-proof connection through the flexible container using traditional medical connectors such as, for example, needles or piercing pins is difficult. 
         [0006]    Further, administration ports are securely bonded to the flexible container. However, the administration ports of known flexible solution containers are often the weakest part of the container. Accordingly, certain medical solutions, which are sensitive to oxygen and/or other penetrating gases, may be compromised. Further, preformed administration ports constitute potential sites of leakage and are potential points of contaminant ingress. 
         [0007]    Other means for establishing a fluid connection between the container and an administration set are also known. Generally, known access ports require a two-handed operated access port and do not produce audible or visible notification when the access port is fully engaged. Further, many of the known access ports do not substantially protect against touch and airborne contaminants. 
         [0008]    A need therefore exists for a formed, filled, sealed solution container with an access port and a method for establishing flow between the container and an administration set. Further, a medical solution container and access port with improved ease of access is needed. Further still, a solution container and a protected, covered access port with a liquid tight seal to avoid leaking, minimize touch and/or airborne contamination and minimize permeation of oxygen and other gases are needed. Additional features and advantages are described herein, and will be apparent from, the following Detailed Description and the figures. 
       SUMMARY 
       [0009]    Embodiments of the present invention provide solutions to these problems. A first embodiment provides an access port. The access port includes a shell adapted for connection to a fluid container, a perforator located within the shell and capable of axial movement therein, the perforator including a first end configured to pierce a medical fluid container and a second end configured to connect to a fluid carrying device. The access port also includes a removable safety cap configured to fit over the second end, the cap adapted to impede axial movement of the perforator while coupled to the second end. In some embodiments, the safety cap further comprises a ring protrusion configured to fit inside the shell to impede rotation of the shell relative to the plane of the medical fluid container, and wherein a fit of the safety cap over the second end is a friction fit between the ring protrusion and the perforator or between the ring protrusion and the shell. The access port may also include an O-ring seal around the perforator to prevent leakage of fluid after the perforator pierces the medical fluid container. 
         [0010]    Another embodiment provides an access port. The access port includes a perforator including a piercing end configured to pierce a medical fluid container and a connecting end adapted to connect to a fluid conduit, a shell positioned outside of the perforator, the shell including a body and a pair of arms connected hingedly to the body and extending angularly away from the body toward the piercing end of the perforator, the shell further including members each having a first end connected hingedly to one of the arms and a second end contacting the perforator, the members operable to push the perforator towards the medical fluid container when the arms are pushed towards the body of the shell. The access port also includes a cap, the cap configured to cover the connecting end of the perforator and to prevent the perforator from piercing the medical fluid container until the cap is removed. In some embodiments, the cap further comprises a ring protrusion fitting closely within the shell. 
         [0011]    Another embodiment provides a medical fluid container assembly. The medical fluid container assembly includes at least one flexible film forming a fluid tight container, an access port with a shell configured to be coupled to the container, a perforator located within the shell and capable of axial movement therein, the perforator including a first end configured to pierce a medical fluid container and a second end configured to connect to a fluid carrying device, and a removable safety cap configured to cover one end of the access port, the cap adapted to impede axial movement of the perforator while coupled to the second end. In some embodiments, the safety cap further comprises a ring protrusion configured to fit inside the access port to impede rotation of the shell relative to the plane of the medical fluid container, and wherein a fit of the safety cap over the access port is a friction fit between the ring protrusion and the perforator or between the ring protrusion and the shell. There are many embodiments of the invention, only a few of which are described in the figures and detailed description below. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0012]      FIG. 1  is a perspective view of one embodiment of a medical fluid container, valve and access port; 
           [0013]      FIG. 2  is another perspective view of the fluid container, valve and access port of  FIG. 1 ; 
           [0014]      FIG. 3  is a side elevation view of the access port of  FIGS. 1-2 ; 
           [0015]      FIG. 4  is a side sectioned view of the access port of  FIGS. 1-3  in a non-perforating position; and 
           [0016]      FIG. 5  is a side-sectioned view of the access port of  FIGS. 1-3  in a perforating position. 
       
    
    
     DETAILED DESCRIPTION 
       [0017]    Embodiments may provide for a single-handed operation and may provide audible and visible notification when a perforator has punctured a film in a fluid bag to allow solution flow from a container. Further, the embodiments may inhibit contamination by fully shrouding the fluid generation path to exclude touch and air-borne contamination and not allowing for the removal of the perforator or plunger from the fluid engagement position, after engagement is achieved. Still further, the embodiments may reduce the amount of force needed to penetrate the film of the container. 
         [0018]    Referring now to  FIG. 1 , one embodiment of an access port is illustrated via perforation assembly  10 , which is connected to a solution container  100 , such as a dialysate bag. Solution container  100  can be constructed by folding a film and sealing the film along the sides of the film. The folded film may then be filled with a medical solution and then sealed along the top to form a sealed, fluid-filled container. Container  100  may be constructed from a transparent material, for example, a multilayer ClearFlex™ material. In one embodiment, container  100  includes a medication port  120  that is adapted to receive a medication additive. As illustrated, medication port  120  in one implementation includes an injection site protected by a plastic cap. 
         [0019]    Container  100  also includes a flap  110  with a reinforced hanger  112 , which enables container  100  to be hung vertically if desired. Hanger  112  is placed at the top of container  100 , so that perforation assembly  10  extends downwardly enabling solution to be gravity fed and/or to aid a pump in pumping the solution. 
         [0020]    As illustrated, container  100  is a multi-compartment container including a first compartment  114  and a second compartment  116 . Compartment  114  holds a first fluid, such as a dextrose-and-electrolyte component of a peritoneal dialysis or parenteral nutrition solution. Compartment  116  holds a second fluid, such as a bicarbonate buffer component of a peritoneal dialysis solution or an amino acid component of a parenteral nutrition solution. When seal  118  is ruptured or broken, the first and second fluids mix to form the completed medical solution, for example a dialysate that is delivered to the patient&#39;s peritoneal cavity or a parenteral nutrition solution that may be administered intravenously. One suitable multi-compartment bag is described in U.S. Pat. No. 6,663,743, assigned to the assignee of the present application, the entire contents of which are incorporated herein by reference. 
         [0021]    Container  100  includes a valved output  30 , through which a medical solution is delivered to the patient. In one embodiment valve  30  has a liner constructed from an elastomeric material, such as, for example, the same material used for compartments  114  and  116 . Perforation assembly  10  connects, e.g., snap-fits, onto a port extending from valve  30 . An administration line, such as a tube, is connected to the opposite end of perforation assembly  10 , which in turn is connected to an object, such as a disposable cassette, patient, other bag, etc. 
         [0022]    Perforation assembly  10  includes a shell  12 . Shell  12  includes a bottom portion  14  that snap-fits over the port extending from valve  30  sealed to solution container  100 . As seen best in  FIGS. 2 to 5 , bottom portion  14  of shell  12  includes a plurality of separate flanged sections  14   a  to  14   d . The separate sections can flex to snap-fit over the port extending from valve  30  of container  100 . 
         [0023]    Shell  12  encloses a perforator  16 . Shell  12  and perforator  16  are made of any suitable medically compatible material, such as any plastic that may be sterilized via gamma radiation, ethylene oxide or steam. Specifically, suitable materials include polypropylene (PP), polycarbonate (PC), polystyrene (PS), polyoxymethylene (POM), acrylonitrile-butadiene-styrene (ABS), and many other medically acceptable plastics. 
         [0024]    As seen in  FIGS. 4 and 5 , perforator  16  includes a threaded end  32  that extends out the top of the shell  12 . Threaded end  32  is configured to connect fluidly to a luer or other type of connector, which in turn connects to a tube or hose of an administration set. The threads of threaded end  32  also couple to a female threaded cap  18  ( FIGS. 1-3 ), which protects threaded end  32  prior to use of perforation assembly  10 . 
         [0025]    At its opposite end, perforator  16  includes a beveled tip  34 . The angle of bevel may be any suitable angle, such as thirty to sixty degrees relative to a longitudinal axis of a stem  36  of perforator  16 . Beveled tip  34  in one embodiment includes ribs  38 , which extend longitudinally with tip  34  and provide, when engaged into slots designed inside the valve  30 , means to block the rotation of the perforator  16  when cap  18  or a luer connector of the administration set are screwed on and off. 
         [0026]    A series of flanges extend radially outwardly from stem  36  of perforator  16 . Beginning from the top, a circular flange  26  extends outwardly from a top portion of stem  36  of perforator  16 . For rigidity, a plurality of gussets  40  support flange  26 . Gussets  40  operate to stabilize flange  26  plunging the perforator  16 . 
         [0027]    A series of guiding flanges  42  are provided on stem  36  below flange  26 . Guiding flanges  42  are designed to ease the assembly procedure of both members  50  through the aperture  52  when the perforator  16  is inserted inside the shell  12 . Although not specifically illustrated, projections  44  extending inwardly from the inside wall of shell  12  are provided ( FIG. 5 ). These projections  44  are tapered or rounded along their upper periphery to enable a ramped engagement with drive flange  48  when perforator  16  is being moved towards a bag piercing position. Projections  44  are substantially perpendicular to the wall of shell  12  along their lower periphery to provide a locking engagement with drive flange  48  when perforator  16  has been moved or snapped to its bag piercing position. 
         [0028]    As seen in  FIGS. 1-5 , shell  12  includes a plurality of U-shaped cutout flaps  46 . Cutout flaps  46  can flex slightly relative to the remainder of shell  12 . Projections  44  are located on the inner surface of flaps  46 . As perforator  16  is moved relative to shell  12 , flaps  46  flex slightly outwardly to enable drive flange  48  to move past projections  44  and eventually snap-fit between and/or around projections  44 . The engagement between drive flange  48  and projections  44  precludes the removal of perforator  16  from container  100  after the container is pierced: This engagement may also provide tactile and/or audible feedback to the user indicating that container  100  is being pierced. 
         [0029]    As seen in  FIGS. 2 ,  4 , and  5 , a drive flange  48  is provided on stem  36  below guiding flanges  42 . Members  50  are coupled hingedly at first ends to arms  22  of shell  12 . Members  50  extend through apertures  52  defined by shell  12  and contact the top surface of drive flange  48  at their second ends. Arms  22  in turn are coupled hingedly to the top of the body of shell  12 . 
         [0030]      FIGS. 4 and 5  illustrate the piercing motion of perforation assembly  10 . Once integrated cap  18  is removed, manual pressure is applied to the outside of arms  22 . As illustrated by the arrows A of  FIG. 4 , the manual pressure causes arms  22  to rotate towards the body of shell  12 . The rotation of arms  22  causes each member  50  to rotate towards its respective arm  22 . The rotation of members  50  causes drive flange  48  and perforator  16  to move downwards (towards container  100 ). 
         [0031]    As seen in  FIGS. 4 and 5 , when perforator  16  is in the piercing position, arms  22  and members  50  are collapsed onto shell  12  and in substantial alignment with the body of shell  12 . Perforator  16  is moved fully downwards. Flange  48  is locked between/about projections  44 . Also, arms  22  define at their distal ends locking openings  54  that engage and snap-fit onto knobs  56  extending from shell  12 . The friction or snap-fit engagement of openings  54  and knobs  56 : (i) serves further to hold perforation assembly  10  in a locked position once piercing engagement and fluid connection is made with container  100 , (ii) provide tactile and/or audible feedback to the user indicating that container  100  is being pierced and (iii) preclude the removal of perforator  16  from container  100  after the container is pierced. 
         [0032]    A pair of sealing flanges  58  extends from stem  36 , near beveled tip  34  and ribs  38 . Sealing flanges  58  define a groove in which an appropriate sealing gasket sits (not represented). The gasket seal helps create a liquid-tight and bacteria-tight seal between the perforator  16  and the valve  30 . This seal also helps ensure sterile delivery of the contents of the container  100  through the perforation assembly  10 . 
         [0033]    As seen in  FIGS. 1-4 , perforator  16  is attached initially to a removable integrated safety cap  18 . When the cap is threaded onto perforator  16 , the cap restrains axial movement within shell  12  to puncture the film, even if inward force is applied to arms  22 . Lip  18   a  and downward extending ring protrusion  18   b  of cap  18  also preferably fit closely against shell  12 . 
         [0034]    The cap preferably also includes a plurality of exterior ribs or gripping flanges  18   c . Ribs  18   c  add stability to the cap. These features make it easier for a user to grasp and remove the cap. Cap  18  also preferably connects to the non-penetrating end of the penetrator with internal female threads  18   d , mating to threads  32  on the penetrator. In a preferred embodiment threads  32  and  18   d  may be the threads of female and male luer lock connectors. 
         [0035]    As can be better seen in  FIG. 4 , ring protrusion  18   b  fits between shell  12  and perforator  16 . The width of design of the ring protrusion may be selected to fit tightly against the shell, the perforator, or both. At least one of these fits is tight enough so that it causes friction or a slight interference when the cap is placed on the access port or when the cap is removed from the access port. In one embodiment, there is a tighter fit between the ring protrusion  18   a  of the cap and the upper portion of the perforator  16  than between the ring protrusion  18   a  and the upper portion of shell  12 . This helps to prevent movement of the perforator and helps to ensure the sterility of the connector at the upper end of the perforator. This friction or tight fit also prevents rotation of the shell around the perforator as long as the cap remains in place on the access port. The interference between the perforator and the cap ring is preferably higher than the interference between the cap ring and the shell. 
         [0036]    The operator connects a device such as an administration set with luer connector to the perforator  16  in a fluid-tight manner by removing cap  18  and connecting the device via threads  32  located at the top of the perforator  16 . With the perforation assembly  10  installed in the valve  30  and the safety cap  18  removed, arms  22  can be then pressed inwardly to cause perforator  16  to move and puncture the solution container  100 . Fluid flows from container  100 , through stem  36  of perforator  16 , through the administration set, and to a patient or other container. In one embodiment, different fluids within container  100  are premixed before the above fluid connection is made. 
         [0037]    It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.