Patent Publication Number: US-2005124935-A1

Title: Venting adapter for feeding device

Description:
BACKGROUND  
      Numerous situations exist in which a body cavity needs to be catheterized to achieve a desired medical goal. One relatively common situation is to provide nutritional solutions or medicines directly into the stomach or intestines. A stoma is formed in the stomach or intestinal wall and a catheter is placed through the stoma. Feeding solutions can be injected through the catheter to provide nutrients directly to the stomach or intestines (known as enteral feeding). A variety of different catheters intended for enteral feeding have been developed over the years, including some having a “low profile” relative to the patient during use and those having the more traditional or non-low profile configuration.  
      As indicated above, there are a variety of instances in which it may be necessary to use a catheter, one of which is the not uncommon reaction following major surgery in which a patient&#39;s stomach function is impaired for a period of time. In spite of the need to supply or supplement the body with a certain level of nutrients and the like following surgery as well as in other instances of impaired or limited gastric functionality, an unfed gut can become a source of bacteria that gets into the bloodstream. These types of problems may be resolved by the introduction of nutrients through an enteral feeding device tube properly inserted through the patient&#39;s abdominal wall, gastric wall, pylorus, duodenum, and/or into the jejunum beyond the Ligament of Treitz.  
      A problem universal to low profile and non-low profile devices is difficulty in decompressing or venting gases from a patient thereby enabling the release of enteric gases and resulting pressure. Just as with a patient who consumes or takes in food or medication orally without the need for enteral feeding via a catheter, a patient receiving nutrition or medication through an enteral catheter may generate gases within his enteral region either as part of the digestive process or as a result of a reaction to the medication. While some level of gas and pressure is natural in either case, a higher level of gas and pressure may develop.  
      Another condition where enteral catheterization and feeding may be needed is if the patient cannot swallow. The inability to swallow or otherwise satisfactorily control one&#39;s neck muscles could inhibit one&#39;s ability to relieve some of the pressure and gases which build up in the enteral region. Specifically, one may not be able to vent or expel gases naturally (e.g., belching).  
      Alternatively, due to a patient&#39;s condition, the patient may not be able to take a medication to reduce the gases and relieve the pressure. Furthermore, the addition of nutritional fluids or medications through a catheter that does not provide venting will result in a pressure increase inasmuch as more fluids are now present in the same area than immediately before the addition. While some of these fluids may be absorbed into the body over a period of time, the resulting pressure may be uncomfortable until some of the fluids are absorbed into the body.  
      In the past, an extension set was intermittently attached to the enteral feeding device to allow venting of the gases and pressures discussed above. However, that method of venting has several drawbacks. First, an extension set used to provide liquid nutritional supplement and/or medication to the enteral feeding device does not prevent liquids from passing or escaping therethrough. Although it may be possible to reduce liquid escape or back flow with the prior technique, additional effort is required to make sure that the end of the extension set is maintained at a sufficient height and that the user activity is minimized or restricted during the venting process. Second, as liquids can escape through prior catheters and extension sets and because activity of the user may need to be limited to maintain the elevation of the extension set above the enteral feeding device during the venting process, the prior techniques for venting are performed on an intermittent basis. Regardless of a patient&#39;s ability to perform the venting on their own, intermittent venting can create difficulties. For example, if not done on a regular basis it can result in discomfort to the user. However, if done on a regular basis, it may inconvenience a patient to minimize or restrict their activities and/or to need to assume certain positions several times a day to enable or facilitate venting. Furthermore, if the patient is not able to perform the necessary venting on their own, the assistance of a clinician to perform the venting may be required multiple times a day.  
      Accordingly, while a number of improvements have been made to conventional enteral tubes, there remains the need and the desire for a way to vent enteral feeding devices not only on a continuous basis, but such that liquids do not escape during the venting procedure, as well as the need for a venting mechanism and procedure which do not restrict the activity or position of a user while the venting is being performed. The present invention meets these needs.  
     SUMMARY OF THE INVENTION  
      In response to the difficulties and problems discussed above an adapter configured for use with a feeding tube has been developed. More specifically, one aspect of this invention is directed to a venting adapter having two openings in fluid communication with one another, and an insert comprising at least in part a porous material. One of the openings of the adapter is capable of insertion into the feeding tube. The second opening of the adapter may be configured to receive the insert; the insert being positioned within the second opening. The adapter may be configured so as to allow gases but not liquids to pass therethrough. The adapter may also incorporate a mechanism adapted to removably secure the adapter to a feeding tube.  
      Another embodiment of the present invention is directed to an adapter adapted for use with an enteral feeding device feeding tube. The adapter may generally include a first opening and a second opening in fluid communication, a male end and an insert being at least in part a porous material. The first opening is located in the male end and is adapted for insertion into a port of the feeding tube. The second opening is configured to receive the insert which may be positioned between the first opening and the second opening. The insert is configured so as to allow gases but not liquids to pass therethrough.  
      The present invention is also directed to an apparatus which enables enteral feeding as well as the ability to vent an enteral cavity. One embodiment may include an enteral feeding device and an adapter configured for connection to the feeding device so as to allow gases but not liquids to vent therethrough. More specifically, an embodiment may include an adapter having a first opening and a second opening in fluid communication, a male end, and an insert including comprising at least in part a porous material. The first opening may be located in the male end of the adapter and should be adapted for insertion into a port of a feeding device. The second opening may be configured to receive the insert which is positioned near second opening. The adapter may be configured so as to allow gases but not liquids to vent therethrough.  
      Yet another aspect of the present invention is directed to a venting adapter configured for use with a feeding tube. The adapter may generally include two openings in fluid communication with one another, and an insert comprising at least in part a porous material. One of the openings being capable of insertion into the feeding tube and the second opening configured to receive the insert which is positioned about the second opening. The adapter being configured so as to allow gases but not liquids to pass therethrough when the insert is positioned about the second opening.  
      Another aspect of the present invention is directed to a venting adapter configured for use with a feeding tube. The adapter including two openings in fluid communication with one another, and an insert comprising at least in part a porous material. One of the openings is capable of insertion into the feeding tube. The insert of the adapter being positioned between the first opening and the second opening and wherein the adapter is configured to allow gases but not liquids to pass therethrough when the insert is positioned between the first opening and the second opening.  
      The invention will be more fully understood and further features and advantages will become apparent when reference is made to the following detailed description of exemplary embodiments of the invention and the accompanying drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
      The above and other objects, features and advantages of the invention will become apparent from consideration of the subsequent detailed description presented in connection with the accompanying drawings in which:  
       FIG. 1  shows a perspective view of an adapter in accordance with the present invention;  
       FIG. 2  is a cross-sectional view of one embodiment of the present invention, the adapter having a porous insert positioned therein;  
       FIG. 3  is a cross-sectional view of one embodiment of the present invention, the adapter having a removable insert positioned therein;  
       FIG. 4  is a cross-sectional view of an exemplary low profile catheter suitable for receiving an adapter of the present invention; and  
       FIG. 5  is an illustration of an adapter in accordance with the present invention attached to an exemplary low profile catheter. 
    
    
     DETAILED DESCRIPTION OF THE PRESENT INVENTION  
      Reference will now be made to the drawings in which the various elements of the present invention will be given numeral designations and in which the invention will be discussed so as to enable one skilled in the art to make and use the invention.  
      The present invention relates generally to enteral tubes or catheters, and more particularly to a product that may be used therewith which enables the venting or decompression of gases through an enteral tube.  
      It will be appreciated that throughout the disclosure reference is made to enteral feeding catheters for purposes of ease of reading and understanding the disclosure, however, the present invention is not intended to be limited to enteral feeding devices, enteral feeding tubes or the like.  
      Referring now to  FIGS. 1 and 2 , there is shown a perspective view and a sectional view, respectively, of an adapter  10  made in accordance with the teachings of the present invention. The adapter  10  is generally configured for use with an enteral feeding catheter, such as those discussed below. The adapter  10  is shown having two openings  12 ,  14  ( FIGS. 1-3  and  FIGS. 2, 3  and  5 , respectively) in fluid communication with one another, and an insert  16  ( FIGS. 2 and 3 ) comprising at least in part a porous material. Desirably, one of the openings  12  is capable of insertion into a catheter or feeding tube  100  ( FIGS. 4 and 5 ), and may be found in a male end  18  ( FIGS. 1 and 2 ) of the adapter  10 . It will be appreciated that the insert  16  ( FIGS. 2 and 3 ) may be positioned within the adapter  10  in a variety of manners (some permanently and some less than permanent) including, for example, overmolding of the adapter about the insert, friction fit, the insertion of an insert and/or a rim about a portion of the insert into a groove in the adapter (e.g., groove and boss relationship), or the like to retain or assist in retaining the insert  16  ( FIGS. 2 and 3 ) in the adapter  10 . The adapter  10  may desirably allow for removal of the insert  16  so as to provide for cleaning and/or replacement. In those embodiments in which the insert  16  ( FIGS. 2 and 3 ) is removable, the second opening  14  ( FIG. 5 ) is desirably configured to receive the insert  16  ( FIGS. 2 and 3 ). In use the insert  16  may be positioned between the first opening  12  ( FIGS. 1, 2  and  3 ) and the second opening  14  ( FIGS. 3 and 5 ), wherein the adapter  10  ( FIGS. 1, 2 ,  3  and  5 ) is configured so as to allow gases but not liquids to pass therethrough. It will be appreciated that an alternative adapter (not shown) may have the insert positioned over or about the second opening yet still be able to achieve the same function. It will be appreciated that all such combinations or variations are contemplated by the present invention.  
      As noted above, the first opening  12  ( FIGS. 1, 2  and  3 ) may be positioned in a male end or portion  18  ( FIGS. 1, 2  and  3 ) of the adapter  10 . The male end or portion  18  ( FIGS. 1, 2  and  3 ) of the adapter  10  is desirably such that it is adapted or configured to open a valve (e.g., a duckbill valve) or the like in a port (e.g., the gastric port  102  ( FIG. 4 )) or lumen (not shown) of the catheter  100  ( FIGS. 4 and 5 ) upon insertion thereinto.  
      Although the adapter may be releasably secured or connected to a catheter by friction alone, the adapter  10  may also include a mechanism adapted to releasably secure the adapter  10  to a catheter  100 . Suitable mechanisms adapted to releasably secure the adapter  10  to a catheter include but are not limited to a bayonet lock, boss and detent, lock and key mechanism, snap fit, screw threads, grooves and the like. Other suitable mechanisms which are known in the art are also contemplated. It will be appreciated that in some embodiments, only part of a suitable mechanism may be present in or on the adapter  10  while another portion is present in or on the catheter  100 . That is, for example, where a lock and key mechanism is used, the adapter  10  may contain the key or protrusion portion thereof, while the catheter  100  contains the lock or recess portion thereof. Of course, it will be appreciated that another embodiment of the present invention may be such that the lock or recess portion of the mechanism is contained in the adapter while the key or protrusion is present on the catheter. Again, any suitable combination and configuration thereof is contemplated by the present invention and intended to be claimed herein.  
      The adapter  10  of  FIGS. 1, 2  and  3  is shown as having an optional protrusion or key  22  which may be received in a port  102 ,  104  ( FIG. 4  and  FIGS. 4 and 5 , respectively) of the catheter  100  ( FIGS. 4 and 5 ) and rotated such that the adapter  10  is positioned as desired (e.g. considering the position of second opening  14  ( FIGS. 2 and 5 ) and the profile of the adapter  10  relative to the catheter  100  and patient (not shown)). It will be appreciated that a desired in use positioning of the adapter  10  relative to a catheter  100  ( FIGS. 4 and 5 ) may be such as that shown in  FIG. 5  in which the adapter  10  is not removable until the protrusion  22  ( FIGS. 1-3 ) is aligned with the lock or recess portion  103  ( FIG. 4 ) of the port  102  ( FIG. 4 ). The port  102  may include a portion of a SECUR-LOK* lock and key mechanism (available from Ballard Medical Products, a subsidiary of the assignee) which is capable of receiving an adapter  10  with such a protrusion  22  ( FIGS. 1-3 ). To facilitate attachment or detachment of the adapter  10  and catheter  100  ( FIGS. 4 and 5 ) the adapter and/or catheter may have a lock orientation indicator  24  such as that shown in  FIGS. 1 and 5 . Although in most instances, the adapter  10  will generally be connected to the gastric port  102  or lumen of the catheter  100 , if, for example, the catheter has another nutritional or medicinal port such as the jejunal port  104  shown in  FIGS. 4 and 5 , adapter  10  of the present invention could also be used therewith, although a different sized or shaped adapter may be more desirable depending on the location of the other port  104 .  
      While it is desired that the adapter  10  ( FIGS. 1-3  and  5 ) be removably inserted or secured to a catheter  100  ( FIGS. 4 and 5 ), it is contemplated that because the insert  16  ( FIGS. 2 and 3 ) is removable in one or more embodiments, the adapter  10  ( FIGS. 1-3  and  5 ) could be more permanently affixed yet still allow the nutritional fluids, medications, or the like to be passed therethrough into the catheter  100  ( FIGS. 4 and 5 ) while the insert  16  ( FIGS. 2 and 3 ) is removed and then upon completion of the provision of nutritional fluids, medications, or the like the insert  16  could be repositioned in or about the second opening  14  ( FIGS. 2-3  and  5 ) as discussed above. It will be appreciated that depending on the construction of the adapter  10  and/or the insert  16  the useful life of each may vary. Accordingly, there may be a need to replace either the adapter  10  or the insert  16  before the useful life of the other component has expired. Because the adapter  10  and/or insert  16  may be exposed to less than sterile conditions (e.g., enteral liquids and gases, even though the liquids should not pass through the insert), the adapter  10  and/or insert  16  may need to be replaced on a periodic basis (e.g., weekly, bi-weekly, etc.) depending on the amount and/or conditions of use.  
      Turning now to the make up of the insert, exemplarily shown as  16  in  FIGS. 2 and 3 . The inserts contemplated by the present invention are desirably such that will allow gases but not liquids to pass therethrough. Stated alternately, the inserts of the present invention desirably are vapor permeable and liquid impermeable. The insert  16  may comprise any suitable material or combination thereof. Exemplary suitable materials for the insert include but are not limited to reticulated polymer foams, expanded polymers (such as Porex® expanded polymers available from Porex Corporation, having offices in Fairburn, Ga.), expanded PTFE (such as Gore-Tex® expanded PTFE available from W.L. Gore &amp; Associates, Inc., having offices in Newark, Del.), and porous metals (or powdered metals). As will be appreciated the rate at which the gases are allowed to pass through the insert  16  is not critical so long as it is sufficient to achieve the desired venting. It will also be appreciated that venting rate may be affected or controlled in part by the composition of the insert. Nevertheless, in most embodiments of an adapter of the present invention intended for use with adult catheters, it is generally desirable for the insert to be able to allow at least 3-5 liters of gas to pass therethrough per hour. For use with a pediatric catheter, it may be desirable for the insert in an appropriately sized adapter to be able to allow at least 1-2 liters of gas to pass therethrough per hour. Further, it will be appreciated that the filter or insert media may be hydrophobic or hydrophilic, although it is desired that the insert or insert media be generally hydrophobic. Where the insert is or contains a hydrophobic filter media or where the insert media is at least in part hydrophobically treated, the media may have larger pore sizes and therefore a higher flow rate therethrough (as compared to a hydrophilic or hydrophilically treated media) as the insert will be less likely to absorb liquids, become saturated and allow liquid to pass therethrough.  
      The present invention contemplates and is intended to include numerous other optional aspects which may be included or added to the adapters and/or catheters of the present invention. Exemplary optional aspects include, for example, a hole or well  20  ( FIGS. 1-3  and  5 ) in the adapter  10  ( FIGS. 1-3  and  5 ) which is configured to receive a plug, such as that which may be included with some catheters. The well  20  ( FIGS. 1-3  and  5 ) enables a plug such as that shown at  120  in  FIGS. 4 and 5  to be inserted therein and thus not be loose while the adapter  10  is attached to the catheter  100 . The ability to retain the plug  120  in well  20  significantly reduces the chances that the lanyard  122  ( FIGS. 4 and 5 ) associated with plug  120  will get caught in or tangled up with something (e.g. tubing or clothing) and thereby cause or result in the dislodgement of the catheter and/or the creation of discomfort to the patient if sufficient force is translated to the catheter. It is of note that in at least one embodiment of the present invention that the ability to vent may be temporarily suspended by the insertion of plug  120  or the like into opening  14  of the adapter. Venting can resume upon removal of the plug  120  or the like from the opening  14 .  
      It will be appreciated that the adapter may be of any suitable shape and size, although the adapter will desirably have a low profile if used with a catheter having a low profile. The openings  12 ,  14  ( FIGS. 1-3  and  FIGS. 2, 3  and  5 , respectively) may be located on any side of the adapter  10  ( FIGS. 1-3  and  5 ) which when connected with or to a catheter  100  ( FIGS. 4 and 5 ) will allow venting. Recognizing that the adapter may be attached and then removed (e.g., during provision of nutritional or medicinal fluids) numerous times, the second opening  14  ( FIGS. 2-3 , and  5 ) is desirably located at the end of the adapter  10  which is opposite the male end  18  ( FIGS. 1 and 2 ) of the adapter  10 . Such a location of the second opening  14  may help avoid accidental occlusion of the opening.  
      Referring now to  FIGS. 4 and 5 , there is shown a sectional view and a partial side view, respectively, of a catheter  100  made in accordance with the teachings of the present invention. The catheter  100  generally includes a head  114 , a shaft  116 , and a retention mechanism or expandable member, shown as balloon  118  in  FIG. 4 . The catheter may be of a “low profile” as shown in  FIGS. 4 and 5  such that the head  114  may rest on or near the skin of a patient (not shown) when the catheter  100  is properly positioned within the patient, or the catheter may take a more traditional or non-low profile configuration (such as that discussed in U.S. Pat. No. 4,701,163 to Parks) wherein the head of the catheter generally extends away from the skin of the patient when the catheter is properly positioned in the patient and wherein the head is frequently larger as concealment or the potential therefore may not be of significant concern.  
      In all prior traditional or low profile catheters extension sets (not shown) were necessary to achieve the desired or necessary venting. With a significant length of tubing associated therewith, the extension set adds considerable bulk to the catheter, making concealment of the catheter and its components more difficult and troublesome. This is especially true with the use of a low profile catheter as the portion of the catheter which extends above the patient&#39;s skin is generally minimal and does not include much tubing external to the patient so as to conceal the presence of the catheter as well as to reduce the likelihood that the device will get caught on or in something and potentially dislodge the catheter from the patient. The present invention provides a solution which overcomes problems and difficulties associated with the prior catheters.  
      As suggested above, the adapter of the present invention is intended to work with a variety of enteral feeding devices. Exemplary enteral feeding devices include but are not limited to gastrostomy devices, jejunostomy devices, transgastric-jejunal devices and the like any of which may be low profile or non-low profile. A more detailed description and discussion of specific embodiments of suitable catheters may be found in U.S. Pat. No. 5,997,503 to Willis et al. and U.S. Pat. No. 5,997,546 to Foster et al., and commonly assigned copending U.S. patent application Ser. No. 10/159,514 (Attorney Docket No. 17,508A), filed May 31, 2002.  
      It should be appreciated that each example and drawing is provided by way of explaining the invention, and not as a limitation of the invention. For example, features illustrated or described with respect to one aspect may be used with another aspect to yield still a further aspect of the invention. These and other modifications and variations are within the scope and spirit of the invention.  
      It should further be appreciated that each aspect of the present invention may not possess each and every component described or contemplated hereby and/or may not possess each and every advantage described or contemplated herein but all such aspects are nevertheless contemplated to be within the scope of the disclosure and the attached claims.  
      Each of the patents, applications, and/or references mentioned, referred to, or discussed herein is herein incorporated by reference in its entirety.  
      While various patents and other reference materials have been incorporated herein by reference, to the extent there is any inconsistency between incorporated material and that of the written specification, the written specification shall control. In addition, while the invention has been described in detail with respect to specific aspects thereof, those skilled in the art, upon obtaining an understanding of the invention, may readily conceive of alterations to, variations of, and equivalents to the described aspects. It is intended that the present invention include such modifications and variations as come within the scope of the appended claims and their equivalents.