Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-05-10
2004-10-26
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S270000, C604S910000, C600S120000, C606S108000
Reexamination Certificate
active
06808519
ABSTRACT:
TECHNICAL FIELD
This invention relates to medical devices, more particularly to feeding tubes for delivery of nutritional products to the intestinal tract.
BACKGROUND OF THE INVENTION
Patients for which normal ingestion of food becomes difficult or impossible, may require placement of a feeding tube to assist in providing their nutritional needs. For some individuals, such as comatose patients, stroke victims, or those with a compromised gastrointestinal tract, this may require placement of a tube that is introduced percutaneously into the stomach for delivery of nutritional products directly into the stomach or jejunum. The procedure, known as a Percutaneous Endoscopic Gastrostomy (PEG), involves introduction of a gastroscope into the stomach, while the desired site where the stoma is to be created is indicated from above by depressing the abdomen. A sheathed needle punctures the abdominal wall and enters the stomach, creating a stoma. The needle is removed and a looped insertion wire is introduced through the sheath where it is grasped by a snare deployed from the working channel of the gastroscope. Once it is captured, the insertion wire is pulled into the channel of the gastroscope. The gastroscope is then withdrawn from the patient via the oral cavity, pulling the wire with it. In the standard Ponsky method (or “pull” method), the distal loop of a percutaneous gastrostomy feeding tube is coupled to the insertion wire loop exiting the patient's mouth. With the insertion wire now tethered to the gastrostomy feeding tube, the endoscopist then retracts the insertion wire exiting the stoma, thereby pulling the gastrostomy feeding tube into the patient's mouth and on toward the stomach. The tapered dilator portion aids in allowing the gastrostomy feeding tube to pass through the stoma. Once the tube has been properly positioned with the end cap snug against the internal wall of the stomach, the dilator portion of the gastrostomy feeding tube is cut away. Finally, the internal position of the gastrostomy feeding tube is checked by reintroducing the gastroscope.
In the variation of the PEG procedure known as the “push” method, the gastrostomy feeding tube is not tethered to the suture and pulled back through the gastrointestinal tract, but rather it is advanced or pushed down the esophagus by the physician and into positioned in the stomach, using a wire that has been placed in the same manner as the suture in the “pull” method. As with the “pull” method, the gastroscope is usually reintroduced to verify that the end cap is properly positioned against the stomach wall.
A disadvantage of most of the standard methods used to place a gastrostomy feeding tube is the need to reintroduce the gastroscope after placement to ensure that the end cap is in the correct position. This causes discomfort to the patient, yet eliminating this safeguard can result in the gastrostomy feeding tube not being properly positioned against the stomach wall. What is needed is a gastrostomy feeding tube and method for placement where the step of separately introducing the gastroscope is eliminated, while still having the benefit of using it for verification of gastrostomy feeding tube placement.
SUMMARY OF THE INVENTION
The foregoing problems are solved and a technical advance is achieved with illustrative gastrostomy (or PEG) feeding tube apparatus comprising a gastrostomy feeding tube and a coupling member, such as an elongate tract for allowing an endoscope, such as a gastroscope, to be coupled to, and introduced along with, the gastrostomy feeding tube. In one aspect of the invention, the elongate tract comprises an elongate thread member made of a polymer (synthetic) material, natural fiber, metal wire, etc., that is attached near the loop end of the gastrostomy feeding tube where it extends through the passageway and exits the second (end cap) end. The elongate tract is sufficiently long and sized in diameter such that it can be drawn through the working channel of a gastroscope using an engaging member, such as a standard polypectomy-type snare, which is then withdrawn out the proximal end of the gastroscope. This allows the gastroscope and gastrostomy feeding tube to be coupled together after the insertion wire has been drawn through the alimentary tract and exits the patient's mouth, allowing for safe and atraumatic introduction of the scope along with gastrostomy feeding tube as the latter is being placed within the patient. Otherwise, the gastroscope requires a separate introduction to confirm correct placement of the gastrostomy feeding tube, thus adding trauma and possible risk to the patient.
In another aspect of the invention, the coupling member comprises an attachment point, such as a hook, loop, or other structural element or apparatus for facilitating engagement with the engaging member of the gastroscope or an ancillary device or instrument to allow the gastroscope to be coupled with the gastrostomy feeding tube such that the gastroscope can be pulled down the throat and into the stomach along with the gastrostomy feeding tube. To engage the attachment point on the coupling member, the gastroscope itself can be modified to include an engagement mechanism, such as a loop, hook, etc., or the engaging member can comprise a separate snare, hooked stylet, etc. that can be introduced through the working channel of the scope to engage the attachment point, thereby allowing the distal end of the gastroscope to be drawn inside of the end cap and coupled thereto for introduction into the patient.
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Clark Tamisha H.
Fanelli Robert D.
Casler Brian L.
DeSanto Matthew
Wilson-Cook Medical Incorporated
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