Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-06-20
2004-01-06
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S910000, C604S270000, C128S898000
Reexamination Certificate
active
06673058
ABSTRACT:
BACKGROUND OF THE INVENTION
A PEG procedure, or Percutaneous Endoscopic Gastrostomy, involves placing a tube percutaneously through the abdomen and into the stomach of a patient to provide a feeding port for a patient who cannot swallow. A similar procedure is known as Percutaneous Endoscopic Jejunostomy or PEJ where the system is placed into the jejunum. This device may be used for a host of reasons including administering food or drugs, allowing drainage of the body or providing a surgical access port. The PEG tube resides in place for a few months at a time and allows the practitioner to access the stomach from outside the body. The tube is usually replaced over time, typically every three months.
Initial placement of PEG devices will vary depending upon the device design, condition of the patient and the medical professional's preferred technique. Most designs rely on anchoring one end of the PEG system inside the body and one end outside the body. More specifically, a bolster is incorporated at the distal end of the PEG tube, which is internal to patient. This bolster may be a balloon or a flexible disk positioned annularly around the outside edge of the tube. The bolster is designed to be delivered in a constricted state and once in position within the body, deployed in an expanded state. The bolster may dictate how the PEG is placed. For example, a rigid disk could not go into the body through a small hole, so the PEG may be introduced into the patient's mouth through the esophagus, into the stomach, and out through the abdomen. If the bolster is collapsed or collapsible, then the PEG may be placed percutaneously in a pushing manner.
Once a PEG device is positioned within a patient, it remains in place until such a time as the practitioner decides that it should be replaced or that the treatment has ended. Replacement is typically effected by removing the initial PEG tube, by tugging it out of the fistula or wound track, and pushing in a new PEG system. There are often no other tools involved. Advancement of the replacement PEG to the correct position may be hindered as a result of many factors such as the tortuous fistula path, a shrunken fistula, and the column strength of the PEG tube. As a result, the PEG tube may not advance very easily and a smaller PEG tube may have to be used. Smaller diameter PEGs tend to clog more frequently and eventually need replacement. This size reduction cycle can continue as PEGs are removed and replaced over months until the procedure is not practical.
Current PEG replacement systems are not optimized for placement within the body of a patient. The medical field is in need of a PEG replacement tube that can be placed quickly and accurately into the initial PEG fistula with minimal pain and trauma to the patient. The preferred device would maintain the initial stoma size and be placed accurately.
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Casler Brian L.
DeSanto Matthew F
Sci-Med Life Systems, Inc.
Shaw William J.
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