Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-03-21
2002-10-29
Walberg, Teresa (Department: 3742)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06471676
ABSTRACT:
FIELD OF THE INVENTION
The invention relates generally to catheters placed in patients in need of same, and more specifically, to feeding tubes surgically implanted in patients who for one reason or another, cannot receive their daily nutritional intake orally. More particularly, the invention relates to gastrostomy and jejunal feeding tubes and means for their attachment to the patient.
BACKGROUND OF THE INVENTION
There are many patients affected with disease, stroke or other physiological conditions that result in the inability to normally receive nutrition through the mouth which is then swallowed and broken down and absorbed by the digestive system. People suffering from stroke, Alzheimer's disease, cancer, inflammation or other infirmities often cannot properly chew or swallow their food or medication which must then be delivered to the patient in another fashion if starvation and malnutrition are to be avoided.
Gastroenterologic feeding tubes have been known for years and are inserted into the stomach by any one of a number of different methods. Generally, a catheter is placed in the body by way of the mouth and is either pulled or pushed downward into the stomach and either left there or is pushed further down into the jejunum of the small intestine. The feeding tubes may also enter the body either by way of the nasal passageway or by means of a gastrostomy in which they are surgically implanted through the abdomen.
The present invention relates to the enteral feeding of patients by these tubes and more particularly to a gastrostomy or jejunal feeding tube which is receivable through the wall of the stomach for feeding and medicating a patient and/or for draining fluids from the patient's stomach. The present invention also relates to a jejunostomy tube which similarly is receivable into the small intestine from outside the patient's abdomen.
The use of feeding tubes which extend directly into the stomachs of patients is often required when patients cannot swallow or when they have structures in their esophagi which prevent food from entering their stomachs. In a situation of this type, it is common to perform a gastrostomy on a patient wherein an opening is formed in the skin, facia and stomach wall and wherein a gastrostomy tube is inserted in the opening to allow food, fluid and/or medication to be passed directly into the stomach and also to allow bodily fluids to be drained therefrom.
Various types of gastrostomy devices have been inserted in patients by means of a percutaneous insertion, a surgical placement, a radiological placement or others. The procedures employed generally follow those known as the Sachs-Vine procedure, the Gauderer and Ponsky procedure, and others. Typical patents describing these procedures and publications of the technique are set forth in the U.S. Pat. Nos. 4,861,334 to Nawaz, U.S. Pat. No. 4,900,306 to Quinn et, al. and U.S. Pat No. 5,080,650 to Hirsch et. al. all of which are hereby incorporated by reference.
Enteral feeding tubes that enter the stomach through surgically incised openings through the skin, facia and peritoneum must be secured in some manner so that the tube does not move about within the patient or be displaced if pulled. Generally, enteral or gastrostomy feeding tubes are either surgically inserted through the skin of the abdomen or fed down to the stomach by way of the mouth and pharynx.
Catheters and enteral feeding tubes which enter the body are frequently held in place by both internal and external means. In some cases, the catheter/tube may have an internal retention means such that the end of the catheter is held in place within a body cavity such as the stomach or the bowel. This internal retainer portion may take the form of a disk, dome, multiple flanges or leaves or an inflatable balloon that is attached to the catheter tip. The external means of retention are often affixed (e.g., adhesives, sutures) to the patient's skin for security from inadvertent traction and removal. Nonetheless, catheters are often inadvertently dislodged by patients or care givers through excessive traction placed on connectors or tubing lines.
Particularly susceptible to inadvertent removal or displacement are those catheters that have no internal retention means and rely only on external attachments or fixation to maintain catheter position. For example, jejunostomy feeding tube which may be placed through the patient's abdomen and into the small bowel frequently consists of only a small bore tube with no expandable or bulbous “tip” present to hold it's position within the lumen of the bowel. Thus, only the external retention means at the patient's skin maintains the tube's position. In some cases, the tube itself, or a retainer or connector attached to the tube, are sutured to the patient's skin. Alternatively, adhesive tape or some other securement or adhesive method might be used. In either of these cases, traction placed on the external connected tubing will apply force directly to the catheter at the point where it enters the body and can result in extraction or displacement of the catheter if the sutures or adhesive releases. Providing a means for shock absorption (aka “strain relief”) between the connecting tube and the catheter could reduce the incidence of inadvertent catheter removal or displacement resulting from excessive traction on the tubing.
External retention means and devices also consist of various slidable or lockable components which may be attached to the catheter tube to prevent the tube from migrating inward to the patient. These devices may be sutured or adhered to the patient's skin to reduce the risk that external traction will dislodge the tube. Furthermore, some of these devices provide a single capture ring means for holding the tube in a right angle position from the point where it exits the patient's body. However, none of these external retention means satisfactorily addresses the issue of strain relief in that any traction force will still be transmitted directly to the tubing at the exit site point with the risk of resulting dislodgment.
U.S. Pat. No. 5,865,816 to Quinn, discloses a percutaneous endoscopic gastrostomy tube assembly comprising a distal end retention device which holds the tube in the stomach, secures the catheter and bends it at a right angle to the patient's skin. A bolus tip is comprised of a balloon which, once surgically implanted, is inflated thereby securing the catheter internally to the patient. An external bolster grips the tube at a selected distance from the balloon and forces it at a right angle so that a set connector lies immediately adjacent to the patient's abdomen when in place and is secure thereto.
U.S. Pat. No. 5,860,960 also to Quinn discloses another retention means for securing a gastrostomy tube to the wall of the stomach and the outer skin of the patient as well. The device consists of an elongated body comprised of silicone rubber that is split above a substantial portion of its body to form two legs joined together at one end. The legs are separable at the other end and the enteral feeding tube is inserted therebetween which is then gripped by the legs of the device. This is then turned at a 90° angle to position the feeding tube parallel to the surface of the outer skin affording the patient a more comfortable implantation.
U.S. Pat. No. 5,549,657 to Stem et. al. discloses a low profile adapter for gastrostomy feeding tubes. The adapter comprises an anti-reflux valve assembly having a stem which can be a one—way valve to prevent reflux of the gastric contents but still allows for the administration of dietary supplement to the patient. A clamp is placed around the feeding tube and the valve stem and is locked into place to secure the valve stem to the feeding tube at a location flush with the patients skin. A silicon cover is placed around the clamp to keep the area in a substantially sterile condition.
U.S. Pat. No. 5,374,254 to Buma teaches and claims specialized. catheters which contain
DeLegge Rebecca
Michels Lester David
Stauter Kathleen
Kung John W.
Novartis Nutrition AG
Robinson Daniel
Walberg Teresa
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