Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-08-17
2001-05-15
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S174000, C604S513000, C604S164040, C128SDIG008, C606S108000
Reexamination Certificate
active
06231549
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a medical device for use with enteral feeding systems, and more particularly to a support arrangement for use with a low profile gastrostomy tube inserted inside a patient. More specifically, the present invention relates to an adjustable shim device for accommodating the gradual growth of a patient during convalescence.
2. Prior Art
Enteral feeding systems are frequently used for long term tube fed patients who require some type of gastrostomy device to provide nutrition to a patient unable to take nutrition orally. These enteral systems typically comprise an administration tubing set attached to a source of nutrition at one end and some kind of enteral feeding tube at the other end for providing nutrition directly to a patient's stomach or small intestine. A standard gastrostomy tube properly inserted inside a viscera of a patient usually extends outwardly a distance from the patient's outer abdominal wall which the patient may find inconvenient or uncomfortable due to the high profile of the gastrostomy tube relative to the patient. Further, the outwardly extending gastrostomy tube may present an unsightly appearance to some patients. Accordingly, a low profile gastrostomy tube was developed to provide a less intrusive alternative to the standard gastrostomy tube arrangement.
The low profile gastrostomy tube is normally inserted into and through a stoma formed in the patient's abdominal wall utilizing an internal retention member disposed inside a patient's viscera to anchor the free end of the gastrostomy tube therein, while an external retention member is seated on the patient's outer abdominal wall with a tubular member attached between the respective retention members. The tubular member provides a fluid pathway between the administration tubing set connected to a source of nutrition and the internal retention member of the low profile gastrostomy tube disposed inside the patient. The internal retention member attaches to a distal or free end of the low profile gastrostomy tube to hold and affix a hollow organ of choice, e.g. the stomach, against the posterior abdominal wall of a patient. The hollow organ is affixed by capturing the organ wall and the abdominal wall between the external retention member seated on the outer abdominal wall of a patient and the internal retention member anchored inside the patient's viscera.
A typical internal retention member is disclosed in U.S. Pat. No. 5,248,302 to Patrick et al. entitled “Percutaneous Obturatable Internal Anchoring Device” which describes a deformable obturatable internal retention member designed to pass through a stoma formed in a wall of the abdomen and stomach or other viscera of a patient in order to secure the low profile gastrostomy tube within the organ of choice and is herein incorporated by reference in its entirety. The method of using this type of obturatable internal retention member consists of inserting an obturator rod through the tubular member of the low profile gastrostomy tube until the rod abuts or engages the distal end of the internal retention member. The internal retention member comprises a plurality of flexible retaining arms attached to the hollow tubular member that mechanically elongate and thereby slenderize the silicone or polyurethane retaining arms to a size about that of the diameter or the tubular member when the obturator rod is pushed axially toward the patient. Such slenderization of the retaining arms allows safe insertion or removal of the tubular member and internal retention member into or from an established, matured stoma of a patient. Such obturatable internal retention members are one of many current means used to insert, anchor and secure the low profile gastrostomy tube in a matured stoma of a patient.
After the internal retention member has been inserted inside the stomach, the obturator rod is withdrawn through the tubular member which allows the flexible retaining arms of the internal retention member to assume their preset enlarged shape, thereby retaining the internal retention member inside the stomach so that it cannot be withdrawn back through the stoma. Once the internal retention member assumes its preset enlarged shape the feeding tube with a connection member at one end is attached to the external retention member of the low profile gastrostomy tube in order to establish fluid flow communication between the source of nutrition and the patient's stomach. In this way, nutrition is provided directly to the patient's stomach through the low profile gastrostomy tube. Unfortunately, the current low profile gastrostomy tube arrangement may often require an extra space between the patient's outer skin and the external retention member in order to later accommodate the patient's growth as he or she adds weight during convalescence, thereby gradually filling up the extra space. Further, the external retention member is required to be seated on the patient's stomach for long periods of time while the patient is being fed through the low profile gastrostomy tube. This long term, continuous contact between the legs of the external retention member and the patient's outer abdominal wall can cause pressure necrosis of the patient's skin.
Therefore, there appears to be a need in the art for a shim device that is adjustable and can accommodate the gradual growth of a patient as he or she adds weight without changing shim devices. Further, there is a need in the art for a shim device that supports the weight of an external retention member of a low profile gastrostomy tube in order to more evenly distribute the weight of the external retention member over a wider area of the patient's outer abdominal wall, while also taking up any extra space between the external retention member and the patient's skin.
OBJECTS AND SUMMARY OF THE INVENTION
In brief summary, the present invention overcomes and substantially alleviates the deficiencies in the prior art by providing an adjustable shim device for accommodating the gradual growth of a patient during convalescence. The shim device of the present invention comprises a shim body having a top side and a bottom side with a plurality of pads extending perpendicularly from each side of the shim body. The plurality of pads are adapted to support and evenly distribute the weight of an external retention member of a low profile gastrostomy tube over an area of a patient's outer skin layer. The plurality of pads formed on one side of the shim body are of a greater height than the pads formed on the opposing side, so that pads on one side will support the external retention member at a greater distance from the patient's body than the pads located on the opposing side. This differential in pad height between the two opposing sides of the shim body provides for an adjustable shim device of the present invention with two alternative heights for supporting the external retention member depending on which side of the shim body is placed on the patient's outer skin layer.
The shim body of the present invention further includes a center portion which defines an axial opening and four outer portions that extend outwardly from the inner portion which, in conjunction with the pads, provide the means for supporting and evenly distributing the weight of the external retention member on the patient. Two small pads are provided along the outer edge of each outer portion for evenly distributing the weight of the external retention member along the outer portions of the shim body, while four large pads are positioned around the inner portion for evenly distributing that same weight around the inner portion of the shim device. In the preferred arrangement, one large pad is juxtapositioned between each respective outer portion along the inner portion. A pair of apertures are formed between any two inner pads for providing air circulation between the space formed between the pads when
Meier Kevin C.
Noecker Angela M.
Greensfelder Hemker & Gale, P.C.
Maynard Jennifer
Seidel Richard K.
Sherwood Services AG
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