Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-12-26
2004-11-09
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C128S912000, C024S546000, C024S563000, C024S570000
Reexamination Certificate
active
06814716
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to medical tubes of the type having a distal end implanted in a patient and a proximal end extending externally from the patient and relates more particularly to gastrostomy feeding tubes.
Certain patients are unable to take food transorally due to an inability to swallow. Such an inability to swallow may be due to a variety of reasons, such as esophageal cancer, neurological impairment and the like. Although the intravenous administration of food to such patients may be a viable short-term approach, it is not well-suited for the long-term. Accordingly, the most common approach to the long-term feeding of such patients involves gastrostomy, i.e., the creation of a feeding tract or stoma between the stomach and the upper abdominal wall. Feeding is then typically performed by administering food through a feeding tube that has been inserted into the feeding tract, with the distal end of the feeding tube extending into the stomach and being retained therein by an internal anchor or bolster and the proximal end of the feeding tube extending through the abdominal wall.
Although gastrostomies were first performed surgically, most gastrostomies are now performed using percutaneous endoscopy. In one type of percutaneous endoscopic gastrostomy (PEG) technique, the distal end of an endoscope is inserted into a patient's mouth and is passed through the esophagus into the stomach. After distension of the stomach by inflation, an incision site on the abdomen is identified and an incision is made. A needle, with an outer cannula, is inserted through the incision across the abdominal and gastric walls and into a snare loop extended from the distal end of the endoscope. While keeping the cannula in place, the needle is then removed and a flexible wire is passed through the cannula into the stomach. The endoscopic snare loop is then used to grasp the wire, the cannula is released, and the endoscope and wire are withdrawn through the esophagus and mouth of the patient. A silicone gastrostomy feeding tube, the distal end of which is attached to a silicone, dome-shaped internal bolster, is then secured to the wire and is pulled retrograde through the esophagus and into the stomach until the internal bolster engages the stomach wall and the feeding tube extends through the stomach and abdominal walls, with the proximal end of the feeding tube extending approximately one foot beyond the abdominal wall. (Over a period of several days following implantation of the feeding tube, a stable stoma tract forms around the feeding tube between the gastric and abdominal walls.)
With the internal bolster in place against the gastric wall, an external bolster is typically secured to the feeding tube to engage the abdomen so as to prevent longitudinal movement of the feeding tube within the stoma tract. Additionally, a “Y-port” adapter is typically attached to the proximal end of the feeding tube, the Y-port adapter being adapted to receive a pair of connector tips through which food and/or medications may be dispensed.
With the distal end of a gastrostomy feeding tube implanted into a patient, the proximal portion of the feeding tube extends out from the body of the patient. Typically, a considerable length of the feeding tube extends out from the body of the patient to facilitate the process of dispensing food and/or medications therethrough.
As can be appreciated, implanting a gastrostomy feeding tube in such a manner so that a substantial length of the feeding tube extends out from the patient introduces numerous drawbacks.
As a first drawback, implanting a gastrostomy feeding tube in such a manner so that a substantial length of the feeding tube extends out from the patient renders the feeding tube susceptible to the leakage of gastric fluids therethrough. Accordingly, a detachable locking clip is typically secured onto the feeding tube at a point between the external bolster and the Y-port adapter to prevent gastric fluids from escaping through the proximal end of the feeding tube when the feeding tube is not in use.
As a second drawback, implanting a gastrostomy feeding tube in such a manner so that a substantial length of the feeding tube extends out from the patient renders the feeding tube conspicuous in nature, inadvertently cumbersome and a hindrance for the patient to bend or otherwise move. Accordingly, it is well known in the art for a gastrostomy feeding tube to be manipulated into a compact configuration, such as through bending or winding of the tubing, when not used to dispense food and/or medications therethrough. Furthermore, while maintaining the tubing in its compact configuration, an adhesive, such as medical tape, is typically used to retain the tubing in its compact configuration and to temporarily secure the tubing against the body of the patient in a low profile.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a novel device for externally retaining a length of medical tubing, such as a gastrostomy feeding tube, in place against a patient, the length of medical tubing having a distal end implanted in the patient.
It is another object of the present invention to provide a device as described above that can additionally be used to store the proximal end of the medical tubing in a low profile when said medical tubing is not in use, i.e., between feedings, drainings, etc.
It is yet another object of the present invention to provide a device as described above that can be used to store the proximal end of the medical tubing, when said medical tubing is not in use, in such a way as to prevent the escape of bodily fluids therethrough.
It is still another object of the present invention to provide a device as described above that, when externally secured to a length of medical tubing implanted in a patient, minimally interferes with patient movement and causes minimal patient discomfort.
It is yet still another object of the present invention to provide a device as described above that permits the proximal end of the medical tubing to be easily removed from storage for feedings, for drainage and the like.
It is another object of the present invention to provide a device as described above that has a limited number of parts, that is inexpensive to manufacture and that is easy to use.
Accordingly, in furtherance of the above objects, as well as other objects to be described or to become apparent from the description that follows, there is provided herein a device for externally retaining a medical tube against a patient, said medical tube having a distal portion and a proximal portion, said distal portion being disposed within the patient and terminating in a distal end, said proximal portion extending externally from the patient and terminating in a proximal end, said device comprising a clip, said clip being constructed to define a bore and a tubing storage cavity, said bore being dimensioned to receive a length of the proximal portion of the medical tube therethrough, with the remainder of the proximal portion being held in a looped back configuration by said tubing storage cavity.
Said clip is preferably a generally rectangular unitary structure made of molded medical grade plastic and comprising (a) a first end wall, said first end wall having a top surface and a bottom surface, said bore extending from said top surface to said bottom surface; (b) a second end wall spaced apart from said first end wall; (c) a lower wall interconnecting said first end wall and said second end wall; and (d) an upper wall connected at a first end to said first end wall; (e) wherein said first end wall, said second end wall, said lower wall and said upper wall together define said tubing storage cavity.
In one embodiment, said upper wall further has a second end opposite to said first end, said second end being spaced apart from said second end wall so as to define a tubing inlet therebetween through which the medical tubing may be inserted into said tubing storage cavity.
In another embodiment, the device fur
Bouphavichith Laddvanh
Brenner Laurence D.
Chu Michael S. H.
Churchill William L.
Casler Brian L.
Han Mark K.
Kriegsman & Kriegsman
Sci-Med Life Systems, Inc.
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