Surgery – Endoscope – With guide means for body insertion
Reexamination Certificate
1999-10-15
2001-11-27
Leubecker, John P. (Department: 3739)
Surgery
Endoscope
With guide means for body insertion
C600S156000, C600S115000, C604S264000, C604S500000
Reexamination Certificate
active
06322495
ABSTRACT:
TECHNICAL FIELD
This invention relates to a feeding tube and, more particularly, to an improved feeding tube which allows visualization inside a gastrointestinal tract during the feeding tube placement or replacement.
BACKGROUND INFORMATION
Patients who are unable to take oral feedings can receive nutrients through a feeding tube by placing a distal end of the feeding tube in a patient's gastrointestinal tract and delivering nutrients to a proximal end of the feeding tube. Various procedural options exist for placing a feeding tube inside a patient.
One feeding tube placement method involves passing a nasoenteric feeding tube through a patient's mouth into his or her alimentary tract. This method, however, may not be suitable for certain patients, such as those with an obstruction in the alimentary tract at or beyond the pylorus, those with severe gastroesophageal reflux, those who require long-term enteral feeding in a non-hospital environment, and those who can support their caloric requirements with a self-administered enteral diet. Nasoenteric feeding tubes may also cause complications from either tube placement or enteral feeding. Complications resulting from a nasoenteric feeding tube placement include cribriform plate injuries, nasotracheal placement, alar cartilage erosion and tube occlusion which requires reinsertion of the tube. Complications resulting from enteral feeding include aspiration pneumonia, diarrhea, dehydration, and hyperglycemia.
Alternatively, a feeding tube may be placed surgically. In general, surgery involves providing an access to the stomach, inserting the feeding tube into the stomach, and securing the inserted feeding tube to the abdominal wall. Although surgical gastrostomy or jejunostomy allows accurate placement of the feeding tube, a surgical procedure is invasive, costly, and may be inappropriate for certain patients. In addition, surgery can cause complications such as bleeding, infection, pneumonia, myocardial injuries, and even death.
Still another way to place a feeding tube in a patient is to place it percutaneously or laparoscopically. Percutaneous and laparoscopic methods, however, are not widely utilized due to fear of blindly puncturing the abdomen. Percutaneous endoscopic gastrostomy overcomes this problem, but requires endoscopy which is uncomfortable for a patient. Several percutaneous endoscopic gastrostomy techniques exist including the pull technique, the push technique, and the introducer technique.
According to the pull technique, an endoscope is inserted into a patient's mouth and passed through the esophagus into the stomach. The patient's stomach is insufflated, and an opening to the stomach is made by inserting a needle into the stomach. An introducer catheter is introduced into the stomach through the opening. A guide wire is introduced into the stomach through the introducer, and an endoscopic snare tightens around the guide wire. The endoscope, the snare, and the guide wire are pulled out of the patient's mouth. A feeding tube is attached to an end of the guide wire extending from the mouth, and the guide wire extending from the stomach is pulled. This motion pulls the feeding tube through the esophagus and the stomach and positions the feeding tube such that the end of the feeding tube with the retention device remains inside the stomach, while the rest of the feeding tube remains outside the stomach.
The push technique is similar to the pull technique, except that the feeding tube is pushed through the abdominal wall over the guide wire, rather than being attached and pulled into the stomach. The guide wire is placed inside the patient in the same manner as in the pull method.
The introducer technique differs from the push and pull techniques in that the feeding tube is inserted through the abdominal wall and not through the mouth. After an endoscope is advanced into the stomach, a T-fastener is placed to move the stomach close to the abdominal wall. A needle is inserted through the abdominal wall into the stomach to create an opening. A guide wire is advanced through the opening, and an introducer with a peel-away sheath is passed over the guide wire. The introducer is then removed, and a gastrostomy tube is inserted into the stomach through the peel-away sheath. The feeding tube is a catheter with a Foley balloon at its distal end. The balloon is inflated to retain the feeding tube inside the stomach. The sheath is then peeled away, leaving behind the feeding tube.
Since proper feeding tube placement in a jejunum is more difficult than placing the feeding tube in a stomach, a jejunostomy tube is typically placed through a gastrostomy tube already positioned in a patient. A jejunostomy tube is typically longer and has a smaller cross section than a gastrostomy tube. Existing jejunostomy method, however, requires the use of an endoscope to provide visualization while feeding the tube through a duodenum into a jejunum. A guide wire is inserted through the gastrostomy tube and the jejunostomy tube is advanced over the guide wire into a jejunum under endoscopic guidance.
With existing feeding tube placement methods, feeding tube placement in a patient can be an unpleasant experience. However many patients must also go through feeding tube replacement. Approximately 70% of all patients receiving gastrostomy or jejunostomy feeding need long term feeding, which requires replacement of the feeding tube on a regular basis. During gastrostomy tube replacement, it is critical that the replacement tube is properly placed within the gastric cavity, and not into peritoneal space. Existing replacement method involves removing the tube in place and simply inserting the replacement tube into the gastric cavity through an existing opening. Physicians must endoscope the patient during this replacement procedure or send the patient to radiology to confirm proper tube replacement. Therefore, accurate feeding tube replacement can be invasive and burdensome to the patient. A feeding tube that is capable of accurate placement and replacement with minimal invasiveness to the patient would be useful.
SUMMARY OF THE INVENTION
The invention relates to an optical feeding tube. The optical feeding tube permits visualization of a passageway ahead of a distal end of the feeding tube, while the feeding tube is being placed in a patient, thereby eliminating the need for endoscopy. The optical feeding tube performs ideally as replacement feeding tubes. The optical feeding tube, however, may also be used for initial feeding tube placement when used according to the introducer method.
In general, in one aspect, the invention features an optical feeding tube which includes an elongated sheath having a first lumen for delivering nutrients to a gastro-intestinal tract and a second lumen. An imaging device is disposed in the second lumen. The imaging device provides visualization of an area adjacent a distal end of the elongated sheath.
Embodiments of this aspect of the invention include the following features. In some embodiments, the imaging device comprises an optical fiber extending from a proximal end to a distal end of the elongated sheath. In other embodiments, the optical feeding tube further includes a retention device disposed at a distal end of the elongated sheath. The retention device prevents movement of the feeding tube after placement. One example of the retention device is a balloon. In this embodiment, the elongated sheath includes a third lumen for transporting a fluid to and from the balloon. Another example of the retention device is a bolster.
In general, in another aspect, the invention features a method for placing a feeding tube inside a gastro-intestinal tract. According to the method, a distal end of the feeding tube is inserted into an opening which extends through an abdominal wall into a stomach cavity. The feeding tube includes an elongated sheath having a first lumen for delivering nutrients and a second lumen. An imaging device is disposed in the second lumen. The feeding tube is passed through t
Phalen Michael P.
Snow Todd H.
Leubecker John P.
Sci-Med Life Systems, Inc.
Testa Hurwitz & Thibeault LLP
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