Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-02-18
2001-11-27
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S105000, C604S164030
Reexamination Certificate
active
06322538
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to an apparatus for use in the placement of gastro-intestinal devices. More specifically, the present invention relates to a gastro-intestinal tube placement device which includes a tube deployment apparatus and a gastro-intestinal tube with a collapsible internal bolster.
BACKGROUND OF THE INVENTION
Medical practitioners utilize a variety of gastro-intestinal devices to access the gastro-intestinal tract. One type of gastro-intestinal device, the gastro-intestinal tube or gastrostomy tube, is widely used with patients who require catheterization for the purposes of, for example, delivering food or medication to the gastro-intestinal tract, draining the tract, or creating a surgical port.
Medical practitioners often use Percutaneous Endoscopic Gastrostomy (PEG) techniques, such as those described in U.S. Pat. Nos. 4,861,334; 4,900,306; and 5,080,650, to place tubes within the gastro-intestinal tract. These techniques typically involve either placing a gastro-intestinal tube in the patient's mouth and snaking it down the esophagus, into the stomach, and out the abdominal wall, or they involve inserting a tube into the stomach from outside of the abdominal wall by sliding the tube over a guidewire.
Gastro-intestinal tubes are often equipped with internal bolsters, or anchoring devices, at one end which help prevent the tube from being prematurely or inadvertently pulled through the stoma or other tract through which it has been placed. While serving that purpose, the size, shape and rigidity of these bolsters often frustrate attempts to place tubes equipped with such bolsters using PEG techniques.
When the tube is properly placed, the internal bolster lies inside the stomach wall, and the tube shaft extends out through the abdominal wall. Thus, when using PEG placement techniques which entail snaking the tube into place, the internal bolster is dragged along with the tube through the gastro-intestinal tract, often causing tissue trauma and potential contamination of the tract. Further, internal bolsters are often too large and rigid to allow placement by threading a bolster-equipped tube through a tract over a guidewire.
The internal bolsters also make tube removal difficult. Because the bolsters are often too large and rigid to allow easy removal by, for example, traction pull from outside the stomach, tubes with internal bolsters are often removed with an endoscopic snare.
SUMMARY OF THE INVENTION
The present invention provides a gastro-intestinal placement device which permits placement, through an existing stoma, of a gastro-intestinal tube with an internal bolster. The invention includes a gastro-intestinal tube with a collapsible internal bolster and a tube deployment device.
In the preferred embodiment, the deployment device has a containment element, such as an overtube, with an expandable distal tip and a slot through which the shaft of a gastro-intestinal tube can be threaded. The deployment device can be preloaded with the gastro-intestinal tube to form the placement device. The tube is loaded into the deployment device by collapsing or otherwise reducing the lateral extent of the tube's bolster, placing the bolster inside of the overtube at the overtube's distal end, and threading the shaft of the gastro-intestinal tube out through the slit in the overtube.
In that embodiment, the deployment device also has a displacing element, such as a pushtube, which is used to force the bolster out of the distal end of the overtube. In addition, the deployment device has a thumb-ring attached to the pushtube which facilitates moving the pushtube distally during tube placement. The deployment tube also has a spool at the proximal end of the overtube which provides physicians with a base on which to place their fingers and steady the deployment device during tube placement. The gastro-intestinal tube preferably has a collapsible bolster of umbrella-like design with retention ribs connected by cross-webbing. The bolster is preferably formed with memory of the umbrella-like shape.
REFERENCES:
patent: 4861334 (1989-08-01), Nawaz
patent: 4900306 (1990-02-01), Quinn et al.
patent: 5080650 (1992-01-01), Hirsch et al.
patent: 5112310 (1992-05-01), Grobe
patent: 5356391 (1994-10-01), Stewart
patent: 5376094 (1994-12-01), Kline
Elbert Linda D.
Nishtala Srinivas
Perkins D. H.
Kenyon & Kenyon
Maynard Jennifer
Sci-Med Life Systems, Inc.
Seidel Richard K.
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