Abstract:
The present invention provides an enteral feeding set comprising tubing adapted for fluid flow therethrough and further adapted to be engaged by a pump unit, a valve mechanism in direct communication with said tubing, said valve mechanism being adapted to be engaged by said pump unit, and a feeding set indicator for permitting identification of the functional configuration of said administration feeding set by said pump unit, characterized in that said tubing comprises at least two inlet tubes on an upstream side of said valve mechanism and a single outlet tube on a downstream side thereof and wherein said inlet tubes each include a connector for connecting said tube to a supply of fluid at a connection end thereof, each of said connectors being of like form but visually distinguishable for indicating to a user which supply of fluid each connector should be attached thereto.

Description:
[0001]     The present invention relates to an enteral feeding set and in particular an enteral feeding set for connection to an automatic pump system wherein a fluid to be supplied to a patient is automatically selectable from one of two fluid sources.  
         [0002]     This Application claims priority to a pending U.S. patent application having Ser. No. 11/254,250 filed on 20 Oct. 2005. This Application is a Continuation in Part.  
         [0003]     Feeding sets with more than one connection to a fluid source are known. For example, Tyco Healthcare has marketed an enteral feeding set (product code no. 717324) for connection to a pump having two tubes from two connectors leading to a single Y-connection. Each of the tubes may be individually clamped shut.  
         [0004]     An enteral feeding set incorporating two fluid sources is shown in WO 2005/115501, the contents of which are incorporated by reference herein in their entirety. This document teaches the use of a flow control apparatus which controls the operation of a valve for selecting one of the fluid sources for fluid supply to a patient.  
         [0005]     Another arrangement incorporating two fluid sources is described in WO 98/046293.  
         [0006]     A wide variety of connectors for connecting enteral feeding sets to fluid sources are known. Examples include a sliding seal adapter described in WO 2004/017852 and a connector including a spike for piercing a foil seal described in EP 1 063 956.  
         [0007]     It is an object of the invention to provide an enteral feeding set for connection to two different fluid sources in a manner such that a correct correction of a fluid source can be more reliably made.  
       SUMMARY OF THE INVENTION  
       [0008]     The present invention provides in a first aspect an enteral feeding set comprising tubing adapted for fluid flow therethrough and further adapted to be engaged by a pump unit, a valve mechanism in direct communication with said tubing, said valve mechanism being adapted to be engaged by said pump unit, and a feeding set indicator for permitting identification of the functional configuration of said administration feeding set by said pump unit, characterized in that said tubing comprises at least two inlet tubes on an upstream side of said valve mechanism and a single outlet tube on a downstream side thereof and wherein said inlet tubes each include a connector for connecting said tube to a supply of fluid at a connection end thereof, each of said connectors being of like form but visually distinguishable for indicating to a user which supply of fluid each connector should be attached thereto.  
         [0009]     In a second aspect, there is provided an enteral feeding set comprising tubing adapted for fluid flow therethrough and further adapted to be engaged by a pump unit, a valve mechanism in direct communication with said tubing, said valve mechanism being adapted to be engaged by said pump unit, and a feeding set indicator for permitting identification of the functional configuration of said administration feeding set by said pump unit, characterized in that said tubing comprises at least two inlet tubes on an upstream side of said valve mechanism and a single outlet tube on a downstream side thereof and wherein a first inlet tube includes a connector at a connection end thereof for connecting said first inlet tube to a substantially rigid fluid container and a second inlet tube is connected to a pliable fluid container.  
         [0010]     The connectors of the enteral feeding sets of the invention may incorporate a projection for puncturing a seal on a fluid source in the form of a knife edge which punctures the seal and then, as the connector is being attached to the fluid source by means of a threaded coupling cuts the seal open to provide an opening in the seal which will not become blocked. Preferably, an air vent incorporating a microbial filter is also included. Sliding seal connectors may also be used.  
         [0011]     In order to avoid an operator connecting fluid sources to the wrong tubing, the connectors may be colour coded such as to match a corresponding colour marking on a fluid container.  
         [0012]     In a still further aspect of the invention, there is provided an enteral feeding set comprising a flush connector adapted to be coupled to a flush container holding a flush fluid therein, the flush connector comprising a first connector body, and a first liquid passage defined in the first connector body, the first liquid passage being in fluid communication with the flush container when the flush connector is coupled to the flush container, the first connector body further comprising a first spike extending outward for piercing a puncturable seal within the flush container, and a first air passage defined in the first connector body, the first air passage being coupled in fluid communication with the flush container for introducing air into the flush container; flush tubing coupled in fluid communication to the first liquid passage for receiving a flow of the flush fluid from the flush container; a feed connector adapted to be coupled to a feed container holding an enteral feed fluid therein, the feed connector comprising a second connector body, and a second liquid passage defined in the second connector body, the second liquid passage being in fluid communication with the feed container when the feed connector is coupled to the feed container, the second connector body further comprising a second spike extending outward for piercing a puncturable seal within the feed container, and a second air passage defined in the second connector body, the second air passage being coupled in fluid communication with the feed container for introducing air into the feed container; feed tubing coupled in fluid communication to the second liquid passage for receiving a flow of the enteral feed fluid from the feed container; and a valve having first and second inlets coupled in fluid communication with the feed and flush tubing, respectively, and a valve outlet, the valve being selectively operable to allow and block flow through the valve outlet.  
         [0013]     In another aspect, there is provided an enteral feed set comprising a generally flexible flush bag adapted to hold a flush fluid therein; the flush tubing coupled in fluid communication with the flexible flush bag for receiving a flow of the flush fluid therefrom; a feed connector adapted to be coupled to a feed container holding an enteral feed fluid therein, the feed connector comprising a connector body, and a liquid passage defined in the connector body, the liquid passage being in fluid communication with the feed container when the feed connector is coupled to the feed container, the connector body further comprising a spike extending outward for piercing a puncturable seal within the feed container, and an air passage defined in the connector body, the air passage being coupled in fluid communication with the feed container for introducing air into the feed container; feed tubing coupled in fluid communication to the liquid passage of the feed connector for receiving a flow of the enteral feed fluid from the feed container; and a valve having first and second inlets coupled in fluid communication with the feed and flush tubing, respectively, and a valve outlet, the valve being selectively operable to allow and block flow through the valve outlet.  
         [0014]     A further aspect of the invention is an enteral feed set comprising a flush adapter configured to be coupled in fluid communication to a flush container holding a flush fluid therein, the flush adapter comprising a first adapter body, a first spike member, a first spring, a first collar member, and a first sliding shaft seal, the first adapter body having a first annular flange, the first spike member being coupled with the first adapter body and including a first tube adapter, the first spring being disposed within the first adapter body for applying a spring force against the first spike member, the first collar member including a first annular groove configured to securely engage the first annular flange, the first sliding shaft seal being disposed at least partially within the first adapter body and being configured to slidingly engage in fluid tight engagement with the first spike member; flush tubing coupled in fluid communication to the first tube adapter for receiving a flow of the flush fluid from the flush container; a feed adapter configured to be coupled in fluid communication to a feed container holding an enteral feed fluid therein, the feed adapter comprising a second adapter body, a second spike member, a second spring, a second collar member, and a second sliding shaft seal, the second adapter body having a second annular flange, the second spike member being coupled with the second adapter body and including a second tube adapter, the second spring being disposed within the second adapter body for applying a spring force against the second spike member, the second collar member including a second annular groove configured to securely engage the second annular flange, the second sliding shaft seal being disposed at least partially within the second adapter body and being configured to slidingly engage in fluid tight engagement with the second spike member; feed tubing coupled in fluid communication to the second tube adapter for receiving a flow of the enteral feed fluid from the feed container; and a valve having first and second inlets coupled in fluid communication with the feed and flush tubing, respectively, and a valve outlet, the valve being selectively operable to allow and block flow through the valve outlet.  
     
    
     BRIEF INTRODUCTION TO THE DRAWINGS  
       [0015]     Preferred embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings in which:  
         [0016]      FIG. 1  is a schematic illustration of an enteral feed set for connection to two fluid sources;  
         [0017]      FIG. 2  is a perspective of a connector for connecting an enteral container of liquid nutrients to an enteral feeding tube;  
         [0018]      FIG. 3  is a vertical section of the connector;  
         [0019]      FIG. 4  is a vertical section of the connector snapped into to a small outlet container and attached to an enteral feeding tube;  
         [0020]      FIG. 5  is a vertical section of the connector threaded onto a large outlet container and attached to an enteral feeding tube;  
         [0021]      FIG. 6  is fragmentary exploded perspective of the large outlet container, the connector and the enteral feeding tube;  
         [0022]      FIG. 7  is a bottom plan view of the connector;  
         [0023]      FIG. 8  is a front elevation of the connector with a portion of a body of the connector broken away to reveal a spike of the connector;  
         [0024]      FIG. 9  is a side elevation of the connector with a portion of the body of the connector broken away to reveal the spike;  
         [0025]      FIG. 10  is a side elevation of the connector with an air filter exploded from the connector and a mount for the filter partially broken to illustrated internal  
         [0026]      FIG. 11  is a schematic illustration of a second enteral feeding set  
         [0027]      FIG. 12  shows a sliding seal connector; and  
         [0028]      FIG. 13  is a schematic illustration of a third enteral feeding set. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0029]      FIG. 1  shows an enteral feeding set  2  having two tubes  4 ,  6  for connection to respective fluid sources  8 ,  9  by means of respective connectors  10 .  
         [0030]     Referring now to  FIGS. 2-3 , the connector  10  is shown in more detail. The connector includes a body, generally indicated at  12 , having an interior surface  14  ( FIG. 3 ) that defines a cavity  16  for receiving an outlet of the container, as explained in more detail below ( FIGS. 4-6 ). The body  12  has a cylindrical lower portion  18  and a smaller cylindrical upper portion  20  projecting upward from a top surface  22  of the lower portion.  
         [0031]     Referring to  FIGS. 4-6 , the cavity  16  is configured for receiving different types of containers. As shown in  FIG. 4 , the cavity  16  at the upper portion  20  is sized and shaped for snap-fit reception of a relatively small outlet  24  of a container  26 . The interior surface  14  at the upper portion  20  is elastically deformable to allow a rigid snap-fit member  27  (e.g., a projecting rim extending around the outlet  24 ) to snap-fit into the upper portion.  
         [0032]     As shown in  FIG. 5 , the cavity  16  at the lower portion  18  is sized and shaped to threadably receive a relatively larger outlet  28  of a container  30 . The interior surface  14  at the lower portion  18  of the connector  10  includes internally projecting threads  32  for attaching to external threads  33  extending around the outlet  28  of the container  30 . The depth D ( FIG. 3 ) of the cavity  16  at the lower portion  18  is between about 1.40 cm and 1.80 cm. This depth D allows the connector  10  to attach to containers  30  having necks of different sizes and accommodates a more secure connection with the different containers. Further, the internal threads  32  of the lower portion  18  have a thickness T 1  of between about 0.12 cm and about 0.11 cm. Ridges  34  ( FIG. 2 ) disposed around an exterior surface of the body  12  at the lower portion  18  provide a user with adequate grip when threading the connector  10  on the container  30 . The connector  10  may be configured to attach to an outlet of a container in other ways without departing from the scope of this invention. Moreover, the connector  10  may be configured to attach only to one type of container, such as a threaded container or a snap-fit container, or the connector may be configured to attach to more than two types of containers.  
         [0033]     Referring to  FIGS. 3-5 , a liquid passage  38  extends through the upper portion  20  of the body  12  and is in fluid communication with the cavity  16 . An opening  40  of the liquid passage  38  is substantially flush with an upper surface section  42  of the interior surface  14  of the body  12  (i.e., the liquid passage does not extend into the cavity  16 ), although it is contemplated that the liquid passage may extend into the cavity. In the illustrated embodiment, the upper surface section  42  is substantially flat. The liquid passage  38  also extends through a conduit  44  projecting outward from the exterior surface of the body  12  at the upper portion  20 . The conduit  44  has externally projecting threads  46  for attaching to an internally threaded adapter  52  of an enteral feeding tube  54  ( FIGS. 4-6 ). The external threads  46  of the conduit  44  have a thickness T 2  of between about 0.11 cm and about 0.06 cm. Other ways of connecting the enteral feeding tube  54  to the connector  10 , including the use of an interference fitting, is within the scope of this invention.  
         [0034]     As shown in  FIGS. 4-6 , when assembled, the connector  10  is secured to the outlet  24 ,  28  of the respective container  26 ,  30  by either threading (as shown in  FIGS. 5 and 6 ) or fitting the connector on the container ( FIG. 4 ). The threaded adapter  52  is threaded on the conduit  44  of the connector  10 . Thus, when assembled, the connector  10  fluidly connects the enteral feeding tube  54  to the attached container  26 ,  30 .  
         [0035]     Referring to  FIGS. 3-8 , a generally elongate spike, generally indicated at  58 , formed integrally with the body  12  projects from the upper surface section  42  of the body into the cavity  16 . The spike  58  is spaced a distance Si ( FIG. 3 ) from a central axis A B  of the body  12  and a distance S 2  ( FIG. 3 ) from a longitudinal axis A O  of the opening  40  of the liquid passage  38 . The spike  58  is configured to puncture a puncturable seal  60  (e.g., foil seal) ( FIGS. 4-6 ) covering the outlet  24 ,  28  of the container  26 ,  30  to allow the liquid nutrients to exit the container. As shown best in  FIG. 7 , the spike  58  has a pair of opposite narrow sides  63 A,  63 B and a pair of opposite broad sides  63 C,  63 D extending between its length L S  ( FIG. 8 ).  
         [0036]     Referring to  FIGS. 7 and 8 , a bottom surface  62  of the spike  58  (i.e., at the free end of the spike) is generally flat. As shown in  FIG. 8 , the bottom surface  62  is bevelled from the narrow side  63 A (broadly, a first narrow side) to the opposite narrow side  63 B (broadly, a second narrow side), such that the bottom surface lies in a plane intersecting the central axis A B  of the body  12  at an angle θ 1 . This bevelled configuration of the bottom surface  62  forms a sharp tip  64  for puncturing the seal  60  of the threaded container  30 . As shown in  FIG. 8 , the bottom surface  62  is also bevelled from the broad side  63 C (broadly, a first broad side) to the opposite broad side  63 D (broadly, a second broad side), such that the bottom surface lies in a plane intersecting the central axis of the body A B  at an angle θ 2 .  
         [0037]     Referring to  FIG. 8 , the narrow side  63 B is bevelled from the broad side  63 D to the opposite broad side  63 C, defining a knife edge  66  along the length L S  of the spike to the tip  64 . After the seal  60  is punctured by the tip  64 , the knife edge  66  cuts the seal  60  as the connector  10  is rotated (e.g., threaded) on the outlet  24 ,  28  of the container  26 ,  30 . The spike  58  makes a relatively large (i.e., larger than the width of the spike  58 ), generally circular opening  70  through the seal, as illustrated in  FIGS. 4 and 5 .  
         [0038]     Referring to  FIGS. 7-9 , the broad side  63 D of the spike  58  is generally arcuate and joins the bevelled narrow side  63 B at folding edge  68 . The narrow side  63 B tapers toward the bottom surface  62  such that the folding edge  68  falls off or angles toward the tip  64 . As the connector  10  is rotated on the container  26 ,  30 , the knife edge  66  cuts the seal  60  and forms a foil edge margin  69  ( FIGS. 3 and 4 ) defining the opening  70 . Referring to  FIGS. 4 and 5 , as the connector  10  continues to rotate, the folding edge  68  of the spike  58  folds the foil edge margin  68  of the seal  60  away from the opening  70  in the seal  60  and away from the opening  40  of the liquid passage  38  so that the foil edge margin will not obstruct the openings.  
         [0039]     Referring to  FIGS. 3-5 , an air passage  72  extends from the cavity  16  through the spike  58  and the upper portion  20  of the body  12 . A vacuum within the container  26 ,  30 , created when the liquid exits the container, draws air into the container through the air passage  72 , thereby allowing the liquid to flow continuously and freely out of the container through the liquid passage  38  of the connector  10 . The air passage  72  opens at the bottom surface  62  of the spike  58  to communicate with the cavity  16 , although the passage may open at other locations along the length L S  of the spike.  
         [0040]     Referring to  FIGS. 3-5  and  9 , the air passage  72  is fluidly connected to a filter mount, generally indicated at  74 , projecting outward from the exterior surface of the body  12  at the upper portion  20 . The filter mount  74  includes a large cylindrical opening  76  ( FIG. 3 ) having a longitudinal axis Aco extending generally transverse to the central axis A B  of the body  12 . A tubular duct  78  disposed within the large opening  76  extends generally coaxially therein. As shown in  FIG. 3 , the duct  78  has a first open end  80  in fluid communication with the air passage  72  and a second open end  82  terminating within the large opening  76 . The large opening  76  and an exterior surface of the duct  78  define an annular socket  84  ( FIG. 3 ) making an interference fit with a tubular end  86  of a filter  88  ( FIG. 10 ) such that the filter is in fluid communication with the duct and the air passage  72  when fitted in the socket. As shown in  FIGS. 2, 4  and  5 , when the air filter  88  is received in the filter mount  74 , a filter medium  90  of the filter extends outside the mount.  
         [0041]     The entire connector  10 , excluding the air filter  88 , may be formed as a homogeneous and integral unit, such as by molding (e.g., injection molding) or by forming, including boring, from stock material. Alternatively, the connector  10  may be constructed of one or more separate components fastened together in a suitable manner. Suitable materials for making the connector  10  include polypropylene (e.g., polypropylene  535 ), polyethylene and other suitable polymers. Other material may be used, and different material may be used for the separate components of the connector  10 .  
         [0042]     Referring again to  FIG. 1 , the connectors  10  are connected to first ends of respective tubes  4  and  6 . These tubes are connected at their opposite ends to a valve unit  100  which also connects to a single tube  102  at a first end thereof. The tube  102  is attached to an automated peristaltic pump (not shown) which as well as controlling the pumping of fluid through the feeding set  2  operates the valve unit  100 . A magnetic feed set identifier  104  is attached to a second end of the tube  102  and a further tube  106  leads therefrom for connection to a patient-indwelling gastrostomy device (not shown). Details of a suitable automated pump arrangement are described in WO 2005/115501, the contents of which are incorporated herein by reference.  
         [0043]     Fluid sources are attachable to the connectors  10 . In the preferred embodiment, fluid sources  8  and  9  may be connected, in which fluid source  8  contains a feeding solution and fluid source  9  contains a flushing solution.  
         [0044]     In view of the automated operation of the pump, it is important that an operator correctly connects the fluid sources to the feed set in order that the automatic pump controls the valve appropriately. In order to ensure correct matching of a particular connector  10  to a particular fluid source, in the preferred embodiment, the connectors are colour coded such that a colour of the plastic molding of the body  12  of the connector corresponds to a colour of the fluid source container, whereby the container may, for example, be appropriately coloured by colouring a screw fitting molding to which the connector  10  is attached or by a coloured foil around the fluid container. Rather than colouring the connector  10 , a coloured flag could be attached to the appropriate tube  4  and  6  for matching with an appropriate coloured container.  
         [0045]     Another solution for providing an improved enteral feeding set is an arrangement as shown in  FIG. 11 . In the arrangement of  FIG. 11 , rather than the connectors  10  of the  FIG. 1  arrangement, the enteral feeding set  202  shown in  FIG. 11  includes two sliding seal connectors  210 . The sliding seal connectors  210  are fabricated in accordance with the arrangement shown in WO 2004/017852. An expanded view of one of the connectors  210  is shown in  FIG. 12 . As in the case of the feeding set  2 , the feeding set  202  provides means for correctly matching up a respective connector  210  to a respective fluid source. The preferred means in the case of the arrangement shown in  FIG. 11  is to colour code one of the components forming the connector, for example a body portion  220 . Of course, a coloured flag arrangement could also be used, as with the arrangement of  FIG. 1 .  
         [0046]     A still further solution for providing an improved enteral feeding set is an arrangement as shown in  FIG. 13 . In this arrangement, the enteral feeding set  302  incorporates a single connector  10  in accordance with the connector shown in  FIGS. 2-10  attached to one tube  306 . Second tube  308  terminates in a permanent connection to a refillable fluid bag  310 . By providing two different fluid sources, one a rigid container containing a feeding solution and a refillable bag for receiving a flushing solution, the arrangement of  FIG. 13  provides an enhanced degree of security that the correct fluid solution will be provided to the correct connection tube.  
         [0047]     When introducing elements of the present invention or the preferred embodiments(s) thereof, the articles “a”, “an”, “the” and “said” are intended to mean that there are one or more of the elements. The terms “comprising”, “including” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements.  
         [0048]     In view of the above, it will be seen that the several objects of the invention are achieved and other advantageous results attained.  
         [0049]     As various changes could be made in the above constructions, products, and methods without departing from the scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.