Abstract:
A gastrostomy tube retainer comprising a patient base, a venting tube extension cover connected to the patient base, and a torso wrap connected to the patient base. The patient base and venting tube extension cover protectively surround the retention button and venting tube extension of surgically implanted gastrostomy tube and are secured to the gastrostomy tube recipient by the torso wrap. In operation, the gastrostomy tube retainer tends to inhibit the nonprescribed removal of the gastrostomy tube by the tube recipient.

Description:
FIELD OF INVENTION 
     The present invention relates to gastrostomy tubes and, more particularly, to a gastrostomy tube retention device tat inhibits non-prescribed removal of the gastrostomy tube by the patient. 
     BACKGROUND OF THE INVENTION 
     A gastrostomy tube, commonly referred to as a “g-tube”, is a tubular device that is placed in the stomach of a patient to provide the patient with essential nutrients for survival. A typical post-surgery g-tube includes a primary tube, a balloon device, a retention button, and a venting tube extension. The primary tube is placed within the stomach through a passageway cut through the abdominal and stomach walls. The balloon device inflates about the periphery of the primary tube in the stomach to anchor the primary tube in position within the stomach. The retention button is positioned about the primary tube on the exterior of the abdominal wall and, along with the balloon, sandwiches the abdominal wall to maintain the position of the primary tube in the stomach. The venting tube extension extends from the retention button outside of the body. The primary tube and venting tube extension typically include feeding, suction and inflation lumens. 
     It typically takes about two months for the passageway cut through the abdominal and stomach walls to form a track. During this time, and especially during the first two weeks while the wound is still fresh, it is essential that the tube not be pulled out, otherwise it could result in another surgical procedure to replace the device within hours of being pulled out. There are, however, millions of people that have g-tubes for many different reasons, most of whom are babies, toddlers, severely handicapped individuals, or elderly. Thus, a large percentage of the g-tube recipients, whether children or adults suffering from limited brain function, lack the capacity to understand not to pull on or pull out the g-tube. Unfortunately, there is no suitable means available to prevent these patients from pulling on the g-tube, whether accidentally or intentionally, which could make the area sore and/or potentially pull the g-tube out. Hospital personnel tend to respond by “rigging” available items, such as towels or blankets, together and then loosely packing these items around the g-tube. However, most patients easily remove this “rigging” in their attempts to pull the g-tube out. As a result, someone must keep watch over the g-tube patient to prevent the g-tube from being pulled out. This is especially difficult for even the most attentive caregiver. 
     In addition to the retention problem, there is no suitable means available to comfortably orient the g-tube in an upright and fully vented position. Hospital personnel tend to attempt a “rigging” using tape and gauze that will hold the newly placed g-tube in an upright and fully vented position. However, such a “rigging” inhibits movement of the patient more than a few inches. 
     Thus, it would be advantageous to provide a device that tends to prevent the patient from pulling on the g-tube and inhibit the non-prescribed removal of the g-tube. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to a g-tube retainer device that tends to inhibit non-prescribed removal of a g-tube by the g-tube recipient. In a first embodiment, the g-tube retainer of the present invention includes a patient base integrally formed with an elongate venting tube extension cover. The patient base, which includes batting material, foam padding, or the like, covers a retention button of the g-tube positioned on the exterior of a patient&#39;s abdominal wall. The patient base is held in position against the patient by a torso wrap. The torso wrap is preferably adjustable with fasteners or may comprise an expandable band. The venting tube extension cover, which also includes batting material, foam padding, or the like, surrounds a substantial portion of the venting tube extension of the patients g-tube. A passageway in the venting tube extension cover is preferably lined with a material, such as plastic and the like, that tends to slide over the g-tube venting tube extension as the g-tube recipient grabs the venting tube extension cover and attempts to pull on the g-tube venting tube extension. 
     In a second embodiment, the g-tube retainer of the present invention includes a patient base and an elongate venting tube extension cover. The patient base and venting tube extension cover are preferably formed as separate parts that are connectable to one another with fasteners on corresponding ends to provide for more flexibility of care by the caregiver and less disturbance of the g-tube recipient during care giving. The fasteners may include Velcro®, snaps, buttons, hooks and loops, and the like. The patient base and extension tube cover preferably include batting material, foam padding, or the like. In an operative mode, the patient base and extension tube cover are generally tubular or cylindrical in shape and surround the g-tube retention button and venting tube extension. The patient base and extension tube cover may include fasteners, such as Velcro®, snaps, buttons, hooks and loops, that may be disengaged in a inoperative mode to enable the patient base and extension tube cover to unroll to allow for cleaning or provide other functions. Like the first embodiment, the patent base is held in position on the patient with an adjustable torso wrap and the venting tube extension cover includes a passageway that is lined with a material, such as plastic and the like, that tends to slide along the g-tube venting tube extension as the g-tube recipient grabs the venting tube extension cover and attempts to pull on the g-tube venting tube extension. 
     In an inoperative mode, the patient base may remain held in position and laid flat on the patient. A pouch, which is attachable to the patient base while in an inoperative mode, may be utilized to neatly hold the venting tube extension in a rolled up configuration. 
     In another aspect, the g-tube retainer of the present invention may include a mounting loop and band to conveniently and flexibly position the g-tube and retainer in a number of desired positions for such functions as regular feeding or upright fully vented feeding. 
     Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a side view of a gastrostomy tube or g-tube in the stomach of a patient. 
     FIG. 2 is a side view of a g-tube retainer device of the present invention shown mounted over the g-tube shown in FIG.  1 . 
     FIG. 3 is an isometric view of a first embodiment of the g-tube retainer device of the present invention. 
     FIG. 4 is a cross-sectional view of the g-tube retainer device taken along line  4 — 4  in FIG.  3 . 
     FIG. 5 is an isometric view of a patient base and torso wrap of an alternative embodiment of the g-tube retainer device of the present invention. 
     FIG. 6 is an isometric view of a venting tube extension cover of the g-tube retainer of the present invention. 
     FIGS. 7 a  and  7   b  are top and bottom views, respectively, of the patient base of FIG. 5 shown in an inoperative state. 
     FIG. 8 is a top view of the venting tube extension cover of FIG. 8 shown in an inoperative mode. 
     FIG. 9 is a top view of a torso wrap of the present invention. 
     FIG. 10 is a top view of a mounting band of the present invention. 
     FIG. 11 is a front view of a patient base extension pouch. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring to FIG. 1, a typical gastrostomy tube or “g-tube”  10  is shown implanted in a patient P. The g-tube  10  includes a tube  16  anchored in position in the patient&#39;s stomach S with a balloon  15 . The g-tube  10  is further held in position via a retention button  12  positioned exterior to the patients abdominal wall A opposing the balloon  15 . The retention button  12  comprises a base  13 , typically disc-shaped, positioned against the patient&#39;s abdominal wall A and a tube neck  14  extending outwardly therefrom. A g-tube venting tube extension  11  extends from the tube neck  14 . 
     Turning to FIGS. 2-4, a first embodiment of a g-tube retention device  20  of the present invention is shown. The g-tube retainer  20  comprises a patient base  22 , an elongate venting tube extension cover  24  and a transition section  23  interposing and connecting the patient base  22  and venting tube extension cover  24 . The patient base  22 , transition section  23  and extension cover  24  are integrally formed as a single unit. The patient base  22  is generally cylindrical in shape with an outer covering  25  preferably formed from a cotton cloth or fleece or some other non-irritating fabric or material. Batting  27  or some other padding is sandwiched between an inner covering  21  and the outer covering  25 . The inner covering  21 , which is formed from the same material as the outer covering  25 , is fastened to the outer covering  25 . 
     The venting tube extension cover  24  is generally cylindrical shaped elongate member with an outer covering  25  preferably formed from a cotton cloth or fleece or some other non-irritating fabric or material. As shown in the figures, the outer covering  25  for the patient base  22  and venting tube extension cover  24  is a single unit that forms the transition section  23  between the patient base  22  and extension cover  24 . Like the patent base  22 , batting  27  or some other padding is placed around the interior of the venting tube extension cover  24 . The passageway  31  through the venting tube extension cover  24  is preferably lined with plastic sheeting or tubing  29  or other material that is slidable relative to the g-tube venting tube extension  11 . 
     A torso wrap  30  is attached to the patient base  22  to secure the g-tube retainer  20  in place on the patient P. The torso wrap  30  may comprise an elastic band or be adjustable with a plurality of fasteners  32  attached to the ends of the wrap  30 . The fasteners  32  may comprise Velero®, snaps, buttons, hooks and loops, and the like. 
     In operation, the patient base  22  and venting tube extension cover  24  are slid over the g-tube venting tube extension  11  with venting tube extension  11  passing through the plastic  29  lined passageway  31  of the venting tube extension cover  24 . The patient base  22  is slid over the retention button  12  of the g-tube  10  and brought into contact with the exterior of the abdominal wall A. With the patient base  22  positioned against the exterior of the abdominal wall A and surrounding the retention button  12 , the torso wrap  30  is extended around the g-tube recipient&#39;s P torso and adjusted to snugly fit around the recipient&#39;s P torso. A loop  26  attached to the proximal end of the venting tube extension cover  24  and a mounting band  28  may be used to orient the g-tube  10  and retainer  20  in a variety of desired positions to perform different functions such as regular feedings and fully vented feedings. 
     When installed, the g-tube retainer  20  tends to prevent the g-tube recipient from pulling on and pulling out his g-tube. Further, the padding  27  in the retainer  20  tends to inhibit the g-tube recipient from securely gripping the g-tube  10  and the g-tube venting tube extension  11 . Even if the venting tube extension cover  24  is securely gripped by the g-tube recipient, the plastic sheeting or tubing  29  within the passageway  31  of the venting tube extension cover  24  tends to cause the venting tube extension cover  24  to slide relative to the venting tube extension  11 , and thus prevent the g-tube  10  from being pulled out of the recipient&#39;s stomach. 
     Turning to FIGS. 5-10, an alternate embodiment of a g-tube retainer  120  of the present invention is shown. The g-tube retainer  120  comprises a patient base  122  and an elongate venting tube extension cover  124  that is separate from and connectable to the patient base  122 . The patient base  122  includes a patient or distal end  123  and a venting or proximal end  129 . The venting end  123  preferably includes a first half of a fastener or fasteners  140  such as Velcro®, snaps, buttons, hooks and loops, and the like. The venting tube extension cover  124  includes a matching or second half of a fastener or fasteners  142  mounted on the interior of a base or distal end connector flap  141 . When the patient base  122  and venting tube extension cover  124  are connected by fastening fasteners  140  and  142 , the g-tube retainer  120  looks similar to the g-tube retainer  20  shown in FIGS. 2 and 3. 
     As shown in FIGS. 5,  7   a  and  7   b,  the patient base  122  may be rolled up (FIG. 5) and positioned about the retention button  12  of a g-tube  10  or unrolled (FIGS. 7 a  and  7   b ) to be cleaned or stored against the patients body in an inoperative state. When unrolled, the patient base  122  is generally rectangular in shape. The patient base  125  includes a first or outer covering  125  and a second or inner covering  121 , both preferably formed of a heavy cotton cloth or fleece or some other material or fabric that is non-irritating. The second covering  121  is attached to the first covering  125  in a manner that creates a pocket there between in which padding  127 , such as batting material, foam padding, and the like, may be inserted. First and second connector flaps  134  and  136  on opposing sides of the patient base  122  include mating fasteners, such as Velcro®, snaps, button, hooks and loops, and the like, to enable the patient base  122  to be easily rolled up in a generally cylindrical shape in an operative state and unrolled in an inoperative state. 
     The patient base  122  further comprises a torso wrap  130  to secure the patient base  122  in position on the patient. The torso wrap  130  connects at a first end to the patient end  123  of the patient base  122 . Matching or mating fasteners  132   a  and  132   b  are attached to the torso wrap  130  at a second end. As shown in FIG. 9, the torso wrap  130  may be easily adjusted using the mating fasteners  132   a  and  132   b.    
     Referring to FIGS. 6 and 8, the elongate venting tube extension cover  124  may be rolled up in an operative state (FIG. 6) or unrolled (FIG. 8) in an inoperative state to be easily cleaned or detached from the patient base  122 . When unrolled, the venting tube extension cover  124  is generally rectangular in shape. The cover  124  includes an outer cover  125  preferably formed from a heavy cotton cloth or fleece or some other non-irritating material or fabric. Padding  127 , such as batting material, foam, and the liked, is attached to the interior of the outer cover  125 . Sheeting  144 , preferably plastic or some other material that would be slidable relative to the venting tube extension  11  of the g-tube  10 , is mounted over the padding  127 . The venting tube extension cover  124  further comprises first and second connector flaps  146  and  147  at opposing sides of the cover  124 . The flaps  146  and  147  include mating fasteners that enable the flaps  146  and  147  to be connected and hold the cover  124  in a rolled up operative state. When rolled up, the cover  124  is generally cylindrically shaped elongate member with a passageway  145 , substantially lined with a sheeting material  144 , extending therethrough. In an inoperative state the cover  124  may be unrolled and disconnected from the patient base  122  for cleaning. 
     The cover  124  further comprises a mounting loop  126  connected to its outermost or proximal end. The loop  126  may be used in conjunction with a mounting band  150  to secure the g-tube  10  and g-tube retainer  120  in a variety of desired positions for regular feed mode or upright fully-vented feeding mode. As shown in FIG. 10, the mounting band includes a plurality of mating fasteners such as opposing halves  152 ,  153 ,  154  and  155  of Velcro®, which enable the band  150  to be easily draped over any convenient structure and then adjusted to an appropriate length. 
     The cover  124  may also comprise an elastic loop  143  attached to the outermost end of the cover  124  that may be used to connect a feeding bag to the g-tube retainer  120 . 
     In operation, the patient base  122  is positioned in an unrolled state against the patient&#39;s abdominal wall A adjacent the retention button  12  of the g-tube  10  and then rolled up to surround the button  12 . The fasteners on the connector flaps  134  and  136  are fastened to secure the patient base  122  in a rolled up state. The torso wrap  130  is then extended around the patient&#39;s torso, adjusted and fastened to secure the patient base  22  in position on the patient&#39;s torso. Next, the venting tube extension cover  124  is positioned such that the connector flap  141  and fastener  142  overlap a portion of the fastener  140  on the venting end  129  of the patient base  120 . Once positioned, the cover  124  is rolled up such that it surrounds the venting tube extension  11  and the connector flap  141  completely surrounds the fastener  140 . The fasteners on the connector flaps  146  and  147  are fastened to secure the cover in a rolled up state and the fasteners  140  and  142  are fastened to secure the cover  124  to the patient base  122 . 
     When installed and fully connected, the g-tube retainer  120  tends to prevent the g-tube recipient from pulling on, causing discomfort, and pulling out the g-tube. Further, the padding  127  in the cover  124  tends to inhibit the g-tube recipient from securely gripping the g-tube  10  and the g-tube venting tube extension  11 . Even if the venting tube extension cover  124  is securely gripped by the g-tube recipient, the plastic sheeting  144  within the passageway  145  of the venting tube extension cover  124  tends to cause the venting tube extension cover  124  to slide relative to the venting tube extension  11 , and thus prevent the g-tube  10  from being pulled out of the recipient&#39;s stomach. 
     In an inoperative state, the cover  124  may be removed by unfastening the fasteners on the connector flaps  146  and  147  and unfastening the fasteners  140  and  141  connecting the cover  124  to the base  122 . However, the patient base  122  need not be removed from the patient, but rather it may be left in a rolled position against that patient&#39;s body for added comfort, or unrolled by unfastening the fasteners on the connector flaps  134  and  136  and then laid flat against the patient&#39;s body for future use. A base extension pouch  160  may be connected to the patient base  122  to conveniently store the venting tube extension  11  in a rolled up manner. This allows for the tube  11  to be placed in a side lying position for inoperative use of the g-tube  10  or for unvented feeding weeks later as the patient is further into recovery process. The pouch  160  comprises a base connector  162  having connector flap  163  with a fastener that is attachable to the fastener  140  on the venting end  129  of the patient base  122 . The pouch  160  further includes opposing semi-circular panels  161  and detachable panel connectors  164  attached at the bottom edge of the panels  161 . 
     While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular form disclosed, but to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the appended claims.