Patent Abstract:
A method of feeding a patient through the patient&#39;s gastrostomy feeding tube. The method includes the steps of connecting a connector of a filled feeding bag directly to a port of the feeding tube; manipulating the feeding bag such that the fluid within the filled feeding bag is driven through the connector and into the feeding tube; and disconnecting the feeding bag connector from the port of the feeding tube after the fluid has been expelled from the feeding bag.

Full Description:
FIELD OF THE INVENTION 
       [0001]    This invention relates to gastrostomy fluid delivery. More particularly, the invention relates to a system and method for delivery of fluids through a gastrostomy feeding tube. 
       BACKGROUND OF THE INVENTION 
       [0002]    Percutaneous endoscopic gastrostomy (PEG) is an endoscopic medical procedure in which a tube (PEG tube) is passed into a patient&#39;s stomach through the abdominal wall, most commonly to provide a means of feeding when oral intake is not adequate. This provides enteral nutrition (making use of the natural digestion process of the gastrointestinal tract) despite bypassing the mouth. In addition to the PEG procedure, a gastrostomy feeding tube may be placed using an open surgical gastrostomy insertion procedure. While the description herein refers to a PEG feeding tube, it is recognized that the present invention may be utilized with feeding tubes regardless of the procedure utilized to position the tube with respect to a patient. 
         [0003]    Referring to  FIG. 1 , the PEG tube  10  typically extends from a site  12  on the patient&#39;s abdomen  14 . The opposite end of the tube  10  includes a connection fitting  16  or the like with one or more ports  17 ,  19  for connection of a supply apparatus. A clamp  18  may be positioned along the tube  10  to seal the tube  10 . Once the PEG tube is installed, the patient may be fed, provided medicine or the like through one of the ports  17 ,  19 . Currently the process of PEG feeding is very tedious, prone to fluid spills, slow and awkward to administer, and prone to introduce infection. 
         [0004]    The most prevalent method of providing nutrition fluid to a patient requiring PEG feeding is illustrated in  FIG. 1 . The feeding fluid typically comes in 8 ounce cans  30  and the fluid from these cans must be poured into a syringe  22  for bolus feeding. In many cases, because of the high viscosity of the fluid, it must be forced out of syringe  22  using a plunger  24 . The person doing the feeding must open the can/package  30  of food and pour it into the (2 ounce) syringe  22  and then plunge the food into the tube  10 . For an 8 ounce feeding, this process is commonly repeated a total of four times. After each of these partial feedings, the syringe  22  must be removed from the respective port  17 / 19  for refilling of the syringe  22 . The plunger  24  cannot simply be removed from the syringe  22  since such action would draw the fluid back into the syringe  22 . The required steps are to close clamp  18 , remove syringe  22  from the port  17 / 19 , pull plunger  24  out of syringe  22 , cap the syringe stem, fill the syringe  22  from the can  30 , reinsert the plunger  24 , invert syringe  22  and remove cap, reconnect the syringe  22  to the port  17 / 19 , open the clamp  18  and push down the plunger  24 . Since the can  30  and the syringe  22  are each held in a hand during the process, the administrator typically must set down plunger  24  to fill the syringe  22 . After the first round of partial feeding, the plunger  24  will have fluid thereon which will drip onto the surface on which the plunger  24  is set. It should be obvious the risk of a spill, misstep, complication and contamination is likely during this involved repetitive process. Additionally, the time to complete a feeding is extended because of this involved repetitive process. 
         [0005]    The complications with the plunger may avoided by instead allowing the food to be delivered by gravity. Such a method has its own drawbacks. For example, since the food is not pushed by a plunger, the feeding can take much longer. During this extended time, the administrator is often forced to hold the syringe  22  in an elevated position. 
         [0006]    As an alternative to bolus feeding, feeding may be provided through a mechanical pump  40  illustrated in  FIG. 2 . A feeding fluid fillable bag  42  is supported by a pole or the like and a feeding line  44  extending therefrom is passed through the pump  40  and then connected to one of the ports  17 ,  19  of the PEG tube  10 . While addressing some of the problems with bolus feeding, pump feeding raises additional problems. First, pump systems are rather cumbersome with its size on a pole with a large footprint base, a power supply wire and a snagable tube to the patient. Furthermore, the bag-tube set on the pump  40  must be changed on a daily basis for sanitary reasons and the pump  40  often must be frequently reset. The pump  40  is typically configured to deliver the fluid in a slow, continuous manner. In principle, pumps need only be used when the administration of fluid flow needs to be very slow and controlled. The need for pump administration most commonly occurs when a patient&#39;s digestive system is being reintroduced to nutrition. Cumbersome portable backpack pumps (not shown) are prescribed to mobile people most commonly simply because it is the easiest way to get liquid food into them. 
         [0007]    In another method, most commonly used in nursing homes, the nutritional fluid comes in large collapsible bags 1 liter or more and is configured to hang on a pole. A flexible supply tube is molded into the bottom of the bag at one end and has a PEG tube fitting on the other. The fluid flow rate is controlled by pinching the supply tube with a roller clamp. The down side of this method is the bag is relatively large, and as a result, it must be hung above the patient to have the fluid flow. Squeezing this bag requires a lot of force due to its large surface area thus making it impractical for manually expelling the fluid for fast and convenient feeding. Also, because of the large-size, the flow rate must be carefully monitored to prevent over feeding of the patient. Furthermore, the large size is cumbersome and inconvenient for many PEG feeding applications. 
         [0008]    In nearly all cases, due to the complications involved in PEG feeding, most commonly in home environments, the caregiver or patient becomes frustrated. As a result, the outcome is often very unsatisfactory. 
       SUMMARY OF THE INVENTION 
       [0009]    Compared to the prior art delivery methods, the present invention provides a single dose feeding delivery container that attaches directly to a PEG tube fitting and the rate of fluid delivery can be easily controlled by driving or otherwise delivering fluid from the feeding bag. It has been demonstrated that the fluid can be delivered in as little as one minute. As a result, it should be obvious that a method that only involves opening a fluid container, connecting it to port, opening a clamp, delivering the fluid, closing clamp and disconnecting the feeding bag is a far easier, faster and safer method of delivering fluid to a person. In some embodiments wherein the PEG tube fitting includes a check valve, the steps of opening and closing the clamp may be removed. 
         [0010]    In at least one embodiment, the present invention provides a method of feeding the patient through the patient&#39;s gastrostomy feeding tube. The method includes releasing a seal preventing a fluid within the filled feeding bag from exiting; connecting the filled feeding bag directly to a port of the feeding tube; opening a clamp on the feeding tube, driving the fluid within the filled feeding bag such that it is discharged through the connector and into the feeding tube; closing the clamp and disconnecting the feeding bag connector from the port of the feeding tube. 
         [0011]    In at least one embodiment of the invention, the feeding bag is a pre-filled, sealed bag. 
         [0012]    In at least one embodiment of the invention, the feeding bag is refillable and re-sealable. 
         [0013]    In at least one embodiment of the invention, the feeding bag connector is integrally formed with the feeding bag. 
         [0014]    In at least one embodiment of the invention, the filled feeding bag has an empty overall approximate internal width of 2¾ inches. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]    The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings: 
           [0016]      FIG. 1  is a perspective view illustrating a syringe bolus feeding procedure. 
           [0017]      FIG. 2  is a perspective view illustrating a pump feeding procedure. 
           [0018]      FIG. 3  is a plan view of an exemplary filled feeding bag in accordance with an embodiment of the invention. 
           [0019]      FIGS. 4 and 5  are partial perspective views of another exemplary filled feeding bag in accordance with an embodiment of the invention in sealed and unsealed conditions, respectively. 
           [0020]      FIG. 6  is a cross-sectional view of another exemplary filled feeding bag in accordance with an embodiment of the invention. 
           [0021]      FIGS. 7A and 7B  are exploded and assembled perspective views, respectively, of an alternative connection fitting including a seal puncture spear and a check valve. 
           [0022]      FIG. 8  is a perspective view of yet another exemplary filled feeding bag in accordance with an embodiment of the invention wherein the bag includes a bag filling port. 
           [0023]      FIG. 9  is a flow diagram illustrating an exemplary method of feeding a patient through the patient&#39;s gastrostomy feeding tube. 
           [0024]      FIG. 10  is a perspective view illustrating the filled feeding bag of  FIG. 1  prior to connection to a PEG feeding tube. 
           [0025]      FIG. 11  is a perspective view similar to  FIG. 10  illustrating the filled feeding bag of  FIG. 1  connected to the PEG feeding tube. 
           [0026]      FIGS. 12 and 13  are perspective views similar to  FIG. 10  illustrating progression of an exemplary method of expelling of fluid from the filled feeding bag of  FIG. 1  into the PEG feeding tube. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0027]    In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The following describes preferred embodiments of the present invention. However, it should be understood, based on this disclosure, that the invention is not limited by the preferred embodiments described herein. 
         [0028]    Referring to  FIG. 3 , an exemplary filled feeding bag  50  in accordance with an embodiment of the invention will be described. The filled feeding bag  50  includes a tubular body  52  extending from a closed end  51  to a connection end  53  with an internal chamber  59  defined therebetween. The internal chamber  59  preferably has a volume equal to or slightly larger than the amount of fluid  60  intended to be delivered. For example, the internal chamber  59  may have a volume of 8 fluid ounces to correspond to the volume of a typical feeding can  30 . The tubular body  52  is preferably manufactured from a flexible material such that the tubular body  52  may be compressed to expel fluid from within the chamber  59 . To assist with expelling of the fluid, the tubular body  52  preferably has a narrow configuration, i.e. a length L larger than the width W. An exemplary tubular body  52  may be approximately 7½ inches long by 2¾ inches wide. In a preferred embodiment, the tubular body has a length L to width W ratio of at least 2 to 1, and more preferably a ratio of at least 2.75 to 1, however, it is recognized that the width W may be maintained while the length L is adjusted to accommodate different volumes of fluid. With this configuration, when the tubular body  52  is squeezed, rolled or otherwise compressed, the fluid  60  is driven toward the connection end  53 . 
         [0029]    To further facilitate driving of the fluid from the chamber  59 , the illustrated tubular body  52  tapers to a neck  54  which in turn is connected to a connector  56 . The connector  56  is configured to connect with a port of a PEG feeding tube  10 . Pursuant to recent regulations, the connector  56  preferably has the form of a luer connector, however, it may have other configurations. In the current embodiment, a cap  58  is positioned over the luer connector  56  until the feeding bag  50  is ready for use. The cap  58  maintains the sterility of the connector  56  and also maintains the fluid  60  or other fluid remains sealingly within the chamber  59  until the cap  58  is removed. 
         [0030]    Additionally, the seal may take other configurations other than a cap. Referring to  FIGS. 4 and 5 , another exemplary filled feeding bag  50 ′ is illustrated. The feeding bag  50 ′ is substantially the same as the previous embodiment except that the bag  50 ′ includes an elongated neck  54 ′ with a clamp  57  positioned thereon to seal the bag  50 ′. The clamp  57  is opened and removed from the neck  54 ′ when it is desired to unseal the bag  50 ′. A tube  55  may extend from the elongated neck  54 ′ to the connector  56 ′. 
         [0031]    Referring to  FIG. 6 , another exemplary filled feeding bag  50 ″ is illustrated. The feeding bag  50 ″ is substantially the same as the first embodiment, except that the bag  50 ″ includes a sealing membrane  59  extending across the neck  54 . The membrane  59  may be configured to be punctured as the connector  56  is connected to the connection fitting  16 ′ of the PEG tube  10 . In such an embodiment, the connection fitting  16 ′ includes a luer connector  20  with a spike  24  extending therefrom. When the connection fitting  16 ′ is fully connected to the connector  56 , the spike  24  punctures the membrane  59 . A lumen  25  extends through the connection fitting  16 ′ such that fluid within the bag  50 ″ will flow to the PEG tube  10 , connected at the opposite end  21  of the connection fitting  16 ′, once the spike  24  punctures the membrane  59 . 
         [0032]    While puncturing of the membrane seal  59  is illustrated, the membrane  59  may be configured such that sufficient pressure within the bag  50 , for example, by squeezing the tubular body  52 , may cause the membrane  59  to break. As another alternative, the membrane  59  may be manufactured from a frangible material such that squeezing or bending of the neck  54  will cause the membrane  59  to break. Such examples are provided for illustrative purposes only and various mechanisms and methods may be utilized to break the membrane seal  59 . Additionally, sealing of the filled feeding bag  50 ,  50 ′,  50 ″ is not limited to the illustrated cap  58 , clamp  57  or membrane  59  and it is understood that other mechanisms and methods may be utilized. 
         [0033]    Referring to  FIGS. 7A and 7B , an alternative connection fitting  16 ″ will be described. The alternative connection fitting  16 ″ includes an optional check valve  26  positioned along the lumen  25  to prevent backflow from the PEG tube  10 . While not illustrated, it is noted that a control port may be positioned between the check valve  26  and the PEG tube  10  to facilitate controlled back flow if desired. Additionally, a barb  22  is provided on end  21  to facilitate a more positive connection to the PEG tube  10 . The barb  22  is configured such that a pulling force away from the fitting  16 ″ causes the barb  22  to bite into and retain the PEG tube  10 . At times it may be desirable to change the fitting  16 ″, or remove the fitting  16 ″ for additional cleaning, without disconnecting the PEG tube  10  from the patient. In the illustrated embodiment, a tapered ring  27  is positioned between the check valve  26  and the PEG tube  10  to assist with disconnection of the PEG tube  10 . Pushing of the tapered ring  27  away from the fitting  16 ″ will push the PEG tube  10  over the barb  22  without the barb  22  biting into the tube. The PEG tube  10  can then be connected over the barb  22  of a cleaned or new fitting  16 ″. 
         [0034]    In the embodiments illustrated in  FIGS. 3-6 , the chambers  59  are prefilled with a desired amount of fluid  60  and the closed end  51  is factory sealed. Such bags  50 ,  50 ′,  50 ″ are intended to be disposable.  FIG. 8  illustrates another exemplary filled feeding bag  50 ′″ which is configured to be reusable. The feeding bag  50 ′″ is substantially the same as the previous embodiments except that the closed end  51 ′″ includes an opening  65  configured to be closed by a resealable closure mechanism  67 , for example, a threaded cap. The invention is not limited to such a closure and may take other forms, for example, a plastic zipper or a folded over section retained with a clamp or the like. With such a configuration, a user may fill the internal chamber  59 ′″ with a desired amount of fluid  60  and then seal the closure mechanism  67  and the filled bag  50 ′″ is ready for use in a manner similar to the prefilled bags  50 ,  50 ′,  50 ″. 
         [0035]    Having described exemplary filled feeding bags  50 ,  50 ′,  50 ″,  50 ′″, an exemplary method  100  of feeding a patient utilizing one of the bags  50 ,  50 ′,  50 ″,  50 ′″ will be described with reference to  FIGS. 9-13 . For the bag  50 , in a first step  102 , the seal is released from the bag  50  by removing the cap  58 . Thereafter, in step  104 , the connector  56  of the filled bag  50  is connected within one of the ports  17  of the feeding tube connection fitting  16 , as illustrated in  FIGS. 10 and 11 . In the other embodiments, these steps may be reversed or combined. For example, for the bag  50 ′ illustrated in  FIGS. 4 and 5 , the connector  56  may be connected first and then the seal released by removing the clamp  57 . For the bag  50 ″ illustrated in  FIGS. 6 and 7 , the steps may be combined as the spike  24  will puncture the membrane  59  to release the seal as the connector  56  is connected. With the connector  56  connected and the seal released, the fluid  60  may flow from the internal chamber  59  into the feeding tube  10  and into the patient. 
         [0036]    The bag  50  may either be raised up, manually squeezed, pressed, rolled as illustrated in  FIGS. 12 and 13 , or otherwise manipulated to drive the fluid from the bag  50  to flow into the patient. This process can take as little as 1 minute by squeezing the bag, or as long as the patient wants by raising the bag for slow gravity feed. The illustrated method includes the step  106  of driving the fluid from the feeding bag  50  and through the feeding tube. The driving of the fluid may result from a user force or gravity. In step  108 , once the fluid  60  has been expelled from the chamber  59 , the connector  56  is disconnected from the connection fitting  16 . If the bag  50  is disposable, it can thereafter be disposed of, however, if it is a reusable bag  50 ′″, the bag  50 ′″ may be cleaned and refilled for future use. 
         [0037]    The benefits of a pre-filled collapsible bag are many. The nutritional fluid is never poured, thus eliminating spillage and contact with foreign materials that can cause contamination. This reduces the potential for bacteria which may cause GI distress. The system and method also prevent leakage through disconnection or spillage from pouring fluid from a can into a syringe. The system and method also saves time in feeding, since fluid can be squeezed through the tube  10 . Additionally, the bags are very portable and when empty are small and easily disposed of. 
         [0038]    With refillable collapsible feeding bags, users have the option to interchange with traditional fluids, introduce medication, use tap, distilled or bottled water. The bags can have wide mouth openings that can be easily sealed and closed. The caregiver or patient can administer the fluid as quickly as a minute if desired. 
         [0039]    These and other advantages of the present invention will be apparent to those skilled in the art from the foregoing specification. Accordingly, it will be recognized by those skilled in the art that changes or modifications may be made to the above-described embodiments without departing from the broad inventive concepts of the invention. It should therefore be understood that this invention is not limited to the particular embodiments described herein, but is intended to include all changes and modifications that are within the scope and spirit of the invention as defined in the claims.

Technology Classification (CPC): 0