Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-02-17
2002-10-01
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S175000, C604S535000, C604S910000
Reexamination Certificate
active
06458106
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to enteral feeding, and more particularly to a gastrojejunal feeding system. More specifically, the present invention relates to a jejunal adapter having a low profile configuration which permits venting of gas from the stomach while simultaneously providing fluid directly to the jejunum of a patient.
2. Prior Art
Enteral feeding is frequently used to assist patients who are ambulatory and/or in a combative state and require some sort of alternative feeding device to receive nutrition when unable to take nutrition orally. Typically, the patient is fed though a tube connected to a source of nutrition which is directed into a digestive organ of the patient through a feeding device. As used herein, the term feeding shall be interpreted to include nutritional feeding, medicating or hydrating.
Over the years a variety of feeding devices have been utilized. For instance, nasogastric or nasoenteric feeding devices have been used which direct a feeding tube into a patient's nose, through the nasal passage, down the esophagus and into either the stomach (nasogastric) or the small intestine (nasoenteric) of the patient. Both feeding devices operate satisfactorily to feed a patient by use of a relatively noninvasive procedure; however, each device also has several drawbacks. For instance, as the feeding tube is passed through the patient's nasal passage, it may become misdirected into the pulmonary tree which could result in discomfort or even harm to the patient, particularly if fluids are unintentionally administered through the feeding tube and into the pulmonary tree. Additionally, feeding tubes passed through the nasal passage may also result in local irritation, epistaxis, sinusitis, or various other complications to the patient.
In an attempt to advance the art of nasogastric and nasoenteric devices, lighter, smaller feeding tubes have been used to reduce irritation of the nasal passage. Although reducing discomfort, these type of feeding tubes were prone to kinking or clogging. Because of the above-noted deficiencies, nasal entry methods were typically used in short term applications for no longer than thirty days.
Since nasoenteric or nasogastric feeding devices were best suited for use in short term applications, a need existed for a device capable of long term deployment. A variety of surgical methods have been utilized such as a Stamms surgical gastrostomy in which the anterior gastric wall was lifted with a pair of guy sutures while the surgeon cut through the serosa and the muscular wall of the stomach to form a gastrostomy. A catheter was then introduced through the gastrostomy and into the stomach. Although a surgical gastrostomy was better suited for long-term applications, it was substantially more invasive to the patient and typically required use of a general anesthetic. Finally, as with any surgical procedure, the opportunity for infection or morbidity was increased.
In an attempt to provide a less invasive procedure for long-term access to the stomach, several percutaneous endoscopic gastrostomy methods have been suggested which access the stomach by a needle or cannula forced into the stomach. Generally, a percutaneous endoscopic gastrostomy (PEG) is performed in one of three methods: the pull technique, the push technique or the introducer technique.
In the pull technique, the gastrostomy tube was equipped with a wire loop through the proximal end of a catheter, while a cannula was slipped over the catheter so that a portion of the wire loop extended therefrom and a smooth transition from the wire loop to the cannula provided. A bolster or other similar stop member was attached at the distal end of the catheter and the gastrostomy tube was then deployed by an endoscopic procedure in which an endoscope was inserted down the patient's esophagus and into the stomach. Thereafter, the subcutaneous tissue was incised below the skin and a needle and cannula arrangement thrust through the incision adjacent the abdominal and gastric walls. Once the cannula penetrated the stomach wall, the needle was removed and the cannula was snared by a loop which extended from the endoscope. The physician then passed a length of suture through the cannula and into the patient's stomach. Once a sufficient length of the suture was directed into the patient's stomach, the snare was loosened from the cannula and retightened about the suture. The endoscope could then be removed which drew the snare and suture out through the patient's mouth. The gastrostomy tube was then tied to the suture extending from the patient's mouth and pulled back through the mouth, down the esophagus, into the stomach, and out through the gastrostomy until the bolster securely abutted the stomach wall. Finally, a retaining ring was fitted about the gastrostomy tube adjacent the patient's outer abdomen to secure the gastrostomy tube thereto.
Another method utilized to access the stomach was the push method. This method utilized an endoscope which was placed within the stomach through the patient's mouth. The skin and subcutaneous tissue could then be incised and a needle passed through the incision and pierced through the abdominal and stomach walls. Once the needle pierced through the stomach wall, a guide wire was passed through the needle and a snare deployed from the endoscope to capture the guide wire. As the endoscope was removed back through the mouth of the patient, the snare and guide wire were also pulled along and out the patient's mouth. As tension was maintained on the guide wire, a gastrostomy tube was pushed therealong until the proximal end of the gastrostomy tube extended outwardly from the gastrostomy. Once a portion of the gastrostomy tube extended from the gastrostomy, it was pulled the remainder of the distance outward until the bolster securely abutted the stomach wall. Finally, a retaining ring was fitted about the gastrostomy tube adjacent the patient's abdomen.
Another well known percutaneous endoscopic gastrostomy method was the introducer technique which involved thrusting a needle through the skin and into the stomach of a patient. Once the needle pierced through the stomach wall, a guide wire was threaded along the needle into the stomach and an incision was made about the guide wire. Next, the introducer set, which included an outer sheath and an inner dilator, was passed over the wire and into the stomach in order to dilate the incision. The physician then removed the inner dilator and wire leaving the outer sheath behind. A physician utilizing this method would then insert a catheter through the outer sheath and into the stomach. Thereafter, the outer sheath was frangibly peeled away and withdrawn from the patient leaving the catheter in place.
Although each of the above-described percutaneous endoscopic gastrostomy methods provided a relatively less invasive method than other surgical procedures, even these methods had drawbacks. Percutaneous endoscopic gastrostomy tubes extended a substantial distance outwardly from the patient might be deemed cosmetically undesirable by the patient. Moreover, even though these gastrostomy tubes could be deployed for a substantially greater period of time, they typically had to be removed and replaced after about six months.
In order to further advance the art, a variety of replacement gastrostomy tubes have been suggested. One such replacement gastrostomy tube is disclosed in U.S. Pat. No. 4,798,592 to Parks entitled “Gastrostomy Feeding Device” which describes a gastrostomy tube having an inflatable balloon and an adjustable ring. The gastrostomy tube was inserted through a matured stoma formed through the patient's stomach wall with the balloon in a deflated state. Once the distal end of the gastrostomy tube was properly positioned inside the patient's stomach, the balloon was inflated and the adjustable ring seated against the patient's outer abdomen so that the gastrostomy tube was secured in
Fournie Glenn G.
Meier Kevin C.
Ruddell Scott Alan
Von Dyck Peter M.
Casler Brian L.
Greensfelder Hemker & Gale, P.C.
Han Mark
Sherwood Services AG
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