Abstract:
A break-way PEG tube uses a releasable connector between two tubing segments to facilitate release of a feeding portion of the PEG tube when pulled on to avoid accidental removal of a distal portion of the PEG tube from a patient&#39;s abdomen.

Description:
PRIORITY 
       [0001]    The present application claims the benefit of U.S. Provisional Application 61/259,865 filed on Nov. 10, 2009 which is herein incorporated by reference in its entirety. 
     
    
     THE FIELD OF THE INVENTION 
       [0002]    The present invention relates to a gastric feeding tube. More specifically, the present invention relates to a break-away PEG tube. 
       BACKGROUND 
       [0003]    There are a wide variety of situations in which a person has difficulty eating food or drinking water normally. A variety of medical conditions such as stroke, esophageal trauma, throat cancer and other disorders render it difficult for a person to properly swallow nourishment which they need. Additionally, people who are in comatose states, those suffering from advanced dementia or individuals who are simply unable to feed themselves need access to nutrition. However, these people are also at the greatest risk to aspirate food and/or liquids and suffer from aspiration pneumonia. 
         [0004]    In enteral feeding and the like, a feeding tube may be inserted temporarily into a patient&#39;s stomach or intestine to allow food to be delivered to the patient while bypassing the physiological area of concern. This is commonly referred to as enteral nutrition. For short term situations, a tube may be inserted through a nasal passage and down into the patient&#39;s stomach or intestine. While nasoenteric feeding is desirable for short term feeding, the presence of a tube extending out of the nose is generally not desirable for long term feeding situations. The tube can be annoying to the patient and limits patient mobility. 
         [0005]    For longer term feeding situations, it is common for a gastric feeding tube to be inserted through a small incision or stoma in the abdomen and extended into the stomach or intestine. The gastric feeding tube is often less irritating than a tube extending out of a nostril and provides a safe and effective method for delivering long-term enteral nutrition. The most common type of gastric feeding tube is the percutaneous endoscopic gastrostomy (PEG) tube. 
         [0006]    A PEG tube is generally placed in an endoscopic procedure. The procedure may involve sedating a patient and then advancing an endoscope through the patient&#39;s mouth and esophagus and into the stomach or intestine. There are a variety of devices for determining location of the distal end of the endoscope or associated tools, such as the use of lights, magnetic or electronic detectors, etc. 
         [0007]    Once the endoscope or associated tool is positioned in the stomach, a needle may be inserted through the abdomen and a lead line or suture attached to the needle is grasped by the endoscope or associated tool and the endoscope is withdrawn so that the lead line is drawn up through the esophagus and out the patient&#39;s mouth. 
         [0008]    The lead line is then tied to the end of the PEG tube and the lead line is pulled back through the stoma in the patient&#39;s abdomen. This causes the PEG tube to be drawn down through the esophagus into the stomach and so that a portion of the PEG tube extends out of the stoma. A balloon or other retaining device prevents the PEG tube from being pulled completely out of the stoma under normal conditions. Once the PEG tube is properly positioned, it can be attached to a container of enteral feeding solution. The enteral feeding solution can be fed to the patient under the flow of gravity or can be driven and more precisely controlled by use of an enteral feeding pump. 
         [0009]    Gastric feeding tubes may be suitable for long term use, and may last for up to six months. After prolonged usage, the stoma in the abdominal wall begins to scar or otherwise set in the tissues and the tube can be removed and replaced without the need to repeat the procedure through the esophagus. This can be done by inserting a PEG with an inflatable balloon through the stoma and then inflating the balloon to hold it in place. 
         [0010]    One problem with the use of PEG tubes, especially with patients suffering dementia or otherwise being less than coherent, is the tendency for such patients to pull out the PEG tube. For example, a person suffering dementia may pull a PEG tube out if it is irritating him or her, not realizing that he or she has just severed the ability to receive nutrition. This is not uncommon in nursing homes and other long-term care facilities. If the PEG has been placed relatively recently, the entire procedure must often be repeated to place a new PEG tube. In that initial placement of a PEG tube can cost thousands of dollars, substantial time and expense are incurred returning the patient to the hospital, repeating the procedure and then returning the patient to the nursing facility. Moreover, some patients repeatedly pull out their PEG tubes. Thus, the costs can be significant. 
         [0011]    Even when patients are cooperative, PEG tubes can be problematic. It is not uncommon for a person to accidentally cause the PEG tube to be pulled out by stepping on the feeding line or catching the PEG tube on something while being moved from one bed to another or from a bed to a wheel chair. 
         [0012]    Accordingly, there exists a need for a break-away PEG tube that solves one or more of the problems herein described or that may come to the attention of one skilled in the art after becoming familiar with this disclosure. 
       SUMMARY OF THE INVENTION 
       [0013]    It is an object of the present invention to provide an improved break-away PEG tube. 
         [0014]    According to one aspect of the invention, a break-away connection is provided for a PEG tube, such that a force on the PEG tube causes the connection to break rather than the tube being removed from the patient. Thus, a patient that may lack the understanding of the consequences of pulling on the PEG tube, or a person who inadvertently pulls on the PEG tube avoids damage to themselves, a procedure to replace the PEG tube and/or some risk of infection. 
         [0015]    According to another aspect of the invention, the amount of force required for separation of the connection may be adjusted at the time of the insertion of the break-away PEG connection. This may be accomplished by inserting the joint to a specific depth and/or selecting a specific PEG joint. Thus, medical staff can determine the durability of the connection needed based on the risk of improper removal of the PEG tube. 
         [0016]    These and other aspects of the present invention are realized in a break-away PEG tube as shown and described in the following figures and related description. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]    Various embodiments of the present invention are shown and described in reference to the numbered drawings wherein: 
           [0018]      FIG. 1  shows a side, partially cut away, view of a break-away PEG tube system disposed in the abdominal wall of a patient; 
           [0019]      FIG. 1A  shows a side view of a break away PEG tube system used in conjunction with a feeding tube; 
           [0020]      FIG. 2A  shows a side view of a break-away PEG connector; 
           [0021]      FIG. 2B  shows a perspective view of the break-away PEG connector of  FIG. 2A ; and 
           [0022]      FIG. 3  is a side elevational view of a plurality of designs and configurations of break-away PEG tube connectors. 
       
    
    
       [0023]    It will be appreciated that the drawings are illustrative and not limiting of the scope of the invention which is defined by the appended claims. The embodiments shown accomplish various aspects and objects of the invention. It is appreciated that it is not possible to clearly show each element and aspect of the invention in a single figure, and as such, multiple figures are presented to separately illustrate the various details of the invention in greater clarity. Similarly, not every embodiment need accomplish all advantages of the present invention. 
       DETAILED DESCRIPTION 
       [0024]    The invention and accompanying drawings will now be discussed in reference to the numerals provided therein so as to enable one skilled in the art to practice the present invention. The drawings and descriptions are exemplary of various aspects of the invention and are not intended to narrow the scope of the appended claims. 
         [0025]    Turning now to  FIG. 1 , a side, partially cut-away view an endoscopic gastronomy system or PEG tube system is shown. A PEG tube, generally indicated at  10 , is placed in the abdominal wall  20  of a patient so that a first, proximal portion  10 A is disposed outside of the patient and extends between a first proximal end  10 B and a second, distal end  10 C. A distal portion  10 D has a distal end  10 E is disposed in the stomach or intestine. (It will be appreciated that modifications of the PEG tube, such as a PEGJ, which is designed to extend down into the intestine are included herein and are generally encompassed by references to the PEG tube unless expressly excluded). 
         [0026]    Disposed at a first, proximal end  10 B of the first, proximal portion  10 A, the PEG tube  10  may include a cap  14  into which a connector for a feeding solution container and feed line are attached to provide nutrition. Such attachment mechanisms are well known in the art and are not discussed in detail herein. As shown in  FIG. 1A , the first, proximal portion  10 A could be replaced directly with a feed line  16  connected directly to an enteral feeding supply, the feeding line  16  may include a first, proximal end  16 A attached to the feeding supply and a second, distal end  16 B connected to the PEG tube  10 . 
         [0027]    The distal portion  10 D of the PEG tube  10  may include an internal (i.e. inside the patient) retaining device  24  for holding the distal end  10 E of the distal portion of the PEG tube inside the stomach, etc., while allowing a more proximal portion of the distal portion  10 D to extend through the abdominal wall  20  and past an exterior (i.e. outside the patient) retaining device  26  to terminate in a proximal end  10 F. The internal retaining device  24  may be an inflatable balloon, or other retention mechanism such as are known in the art or may later be developed. The external retaining device  26  covers the stoma or hole in the abdominal wall  20  through which the PEG tube extends to minimize or prevent the movement of the tube relative to the abdominal wall. Such devices as a bolster or other retainers known in the art can be used for the external retaining device. 
         [0028]    In accordance with one aspect of the present invention, distal portion  10 D of the PEG tube  10  may be cut or formed so that it extends between 1 inch and 5 inches (typically 1-3 inches) from the external retaining device  26  or patient&#39;s abdominal wall  20  when installed, and then has the distal portion terminate at a proximal end  10 F. A break away PEG connection  34  (shown in the cut-away portion of  FIG. 1 ) may be mounted in the first, proximal end  10 F of the distal portion  10 D and in the second, distal end  10 C of the proximal portion to connect the two together to form the PEG tube  10 . The break-away PEG connector  34  connects the two segments and has a bore extending from an open first end disposed in the distal end  10 C of the proximal portion  10 A, to an open second end in the proximal end  10 F of the distal portion  10 D to allow enteral nutrition to be delivered through the PEG tube  10 . 
         [0029]    The break-away PEG connector  34  couples the feeding tube or proximal portion  10 A of the PEG tube  10  to the distal portion  10 D of the PEG tube, allowing the flow of nutrition through the PEG tube and into the patient. The tube may also be used for withdrawing stomach fluids if needed for testing, etc. 
         [0030]    Occasionally, patients pull out conventional PEG tubes in discomfort or unintentionally as they attempt to move. However, the break-away PEG connection  34  is configured to disconnect the distal portion  10 D and the feeding tube or proximal portion  10 A at a lower force threshold than is normally required to pull the balloon  24  or other retaining device on the distal portion  10 D out of the patient. Thus, the connector  34  may form a sacrificial connection with at least one of the tubes  10 C,  10 D and thus is configured to prevent the removal of the endoscopic gastronomy system from the stomach aperture of the patient. 
         [0031]    The break-away PEG tube  10  may provide resistance from separation. This is typically done by projections  38 ,  42  (which may include annular or circumferential ribs, linear projections, etc.) on the connector  34  being inserted into the tubing of the PEG tube (i.e., inserting the projections  42  into the proximal end  10 F of the distal portion  10 D and the projections  38  into the distal end  10 C of the proximal portion  10 A) and resisting removal from the tubing. It will be appreciated that the size of the projections will depend on the inner diameter of the tubing which forms the PEG tube  10  and on its radial expansivity. However, the projections  38 ,  42  will typically be between 0.01 inches and 0.5 inches, with a more specific length being dependent on the tubing. 
         [0032]    If a force is applied to the PEG tube  10  exceeds a desired threshold, the break-away PEG connector  34  may allow the PEG tube distal portion  10 D and feeding tube or proximal portion  10 A to separate from one another. This releasable connection prevents a patient from tugging on the PEG connection with sufficient force to remove the PEG tube or damage the patient. This, in turn, reduces the need for surgery to replace the PEG tube, remediation of damage to the patient stomach, abdomen and other tissues, resulting in potential pain, cost and wasted time. 
         [0033]      FIGS. 2A and 2B  show a side view and a perspective view of a break-away PEG tube connector  34 , respectively. The PEG connector  34  may be formed from a variety of materials, typically including biocompatible plastics, vinyls, etc. The PEG tube connector  34  has a body  40  which may be formed from a single piece or may be composed of multiple pieces. A plurality of projections  38  and  42  disposed along portions of the connector body  40  extend outwardly to engage the tubing which forms the proximal and distal portions  10 A,  10 D of the PEG tube, to releasably engage and hold the tubing portions together under normal conditions. A central portion of the PEG tube connector  34  body may have a disc or flanges  46  formed thereupon, to form a stop. The stop  46  may prevent a connected tube from advancing farther than the stop. The PEG connector  34  may also include a central bore ( 50 ,  FIG. 2B ), allowing matter to pass from one end to the other. Typically, the central bore  50  is close in diameter to the diameter of the tubing  10 A and  10 D so that the connector provides minimal interference with flow of the enteral feeding solution passing therethrough. 
         [0034]    The PEG connector  34  may be configured to be biased to remain in one tube and not the other when the proximal and distal portions of the PEG tube become disengaged. For example, it may be desirable to have the PEG connector  34  remain with the patient. Thus, the distal or patient side  34 A of the PEG connector  34  may include multiple and/or larger protrusions, such as flanges, ridges, bumps, ribs, spiral, high friction engagement surfaces, or other extensions  42  from the connector body. The feeding or proximal side  34 B may include a single and/or smaller protrusion. The net effect of multiple and/or larger protrusions may be that the PEG connector has a higher resistance to being pulled from the distal portion  10 D of the PEG tube  10  than from the feeding side or proximal portion  10 A. Thus, a force would typically first overcome the feeding side resistance. This would result in the removal of the feeding tube or proximal portion  10 A of the PEG tube from the PEG connector  34 , but the patient tube or distal portion  10 D would remain connected on the PEG connector, with the distal portion  10 D of the PEG tube disposed in the abdomen. 
         [0035]    Turning now to  FIG. 3 , a plurality of designs and configurations of break-away PEG connectors  34  are shown. There is a break-away PEG tube configured to include a plurality of protrusions. The plurality of protrusions include sizes of members and/or spacing that are different in various embodiments and vary according to the particular requirements of the PEG tube. As illustrated in  FIG. 3 , the protrusions may be of a different shape, different number, have different spacing and/or may or may not be symmetrical about the long axis of the tube. Furthermore, the plurality of protrusions may include a spiral configuration, a graduated configuration, a levered configuration, and/or a textured configuration, and still perform its intended function. 
         [0036]    The various geometries may include a graduated square rib, a double rounded rib and angled disc, an alternating angled disc and rib, a series of ribs followed by an angled disc, an angled disc followed by a series of ribs, a graduated rounded rib, a series of rounded ribs, a series of angled discs, a spiral rib, a series of square ribs, a spiral channel, and a series of angled discs followed by a rounded rib. Other geometries may include knobs or fins. 
         [0037]    However, it should be recognized that  FIG. 3  does not provide an exhaustive list of embodiments. The ideas and components may be further mixed and/or matched to create more PEG connectors. Furthermore, while it has been discussed and/or shown that the PEG connector may be symmetrical, it may also be asymmetrical. In one embodiment, the protrusions extend between ½ and ⅞ around the circumference of the central body of the PEG connector. The protrusions serve to push a flat portion of the central body (without protrusions) to the side of the tube. 
         [0038]    Similarly, while many embodiments shown have one or three protrusions per side, there may be more or less protrusions per side. The embodiments shown are just examples given to demonstrate a possibility of multiple or single protrusions per side. Other numbers have been considered, but the current examples are shown for clarity. 
         [0039]    For example, although the illustrated break-away tube of  FIG. 2A  shows a side view of four equally spaced saw-tooth protrusions it is understood that the protrusions may be of a different shape, different number, have different spacing and may or may not be symmetrical about the long axis of the tube. 
         [0040]    Additionally, although the figures illustrate particular sizing and spacing, it is understood that sizes of members and/or spacing may be different in various embodiments and may vary according to the particular requirements filled by the PEG tube. 
         [0041]    It is also envisioned that the break-away tube connector  34  may include one or more features configured to alter a force requirement before break-away, such as, but not limited to, graduated protrusions, spiral protrusions, a levered protrusion, and/or a set of progressively shaped/textured/material protrusions such that insertion of the break-away tube is possible in a plurality of manners or degrees and that the plurality of manners or degrees results in varied break-away force thresholds or friction effects or break-away mechanics. Accordingly, a user may be enabled to insert and/or operate the break-away tube and connector in a manner that permits the user to select between a set or continuum of coupling configurations having disparate break-away points. Thereby the same device configuration may be utilized for a variety of patients having a variety of issues that may be addressed by the break-away PEG. 
         [0042]    For example, in one embodiment, the feeding tube side of the break-away PEG connector may include a set of ribs increasing in size from a smaller rib at the tip or proximal end to a larger rib near the center of the connector. Between or on each rib may be labeled with an estimated force if that rib is chosen. A health care provider may then select the force by placing the tube onto the break-away PEG connector  34 , ensuring the tube overlaps the rib with the desired force requirement. 
         [0043]    Finally, it is envisioned that the components of the device may be constructed of a variety of materials, including but not limited to plastics, rubber, ceramic, wood, metal, composites, and combinations thereof. 
         [0044]    There is thus disclosed an improved break-away PEG tube. It will be appreciated that numerous changes may be made to the present invention without departing from the scope of the claims.