Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-05-12
2001-12-25
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S270000, C604S275000, C604S910000
Reexamination Certificate
active
06332877
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to catheters and medical devices comprising ostomy tubes for the insertion into a mammalian body, preferably humans. In particular, the invention relates to feeding tubes and their placement and securement to a patient.
BACKGROUND OF THE INVENTION
The use of enteral feeding tubes which supply nutritional requirements of a patient directly to the stomach or other location in the digestive tract is often required when the patient for one reason or another cannot swallow, is unable to chew his or her food, or is unable to ingest enough food to meet the body's caloric requirements. Burn victims, the chronically ill, those inflicted with Alzheimer's disease and cancer patients are prime examples of these types of individuals. Enteral feeding usually employs a nasogastric tube to transport the liquid nutritional products through the nasal cavity and pharayrx and into the stomach.
Gastrostomy tubes may either be placed through the surgical creation of an ostomy while the patient is under general anesthesia or by means of percutaneous endoscopic gastrostomy (PEG) which involves the creation of an opening or stoma in the stomach through the abdominal wall. The endoscope is passed down the throat until its terminus contacts the interior of the stomach. A needle with a stylet is inserted into the stomach wall until it passes therethrough. The stylet of the needle is retracted and a guidewire inserted through the cannula of the needle. The guidewire is grasped and pulled back through the esophagus and out of the mouth with the endoscope. The gastrostomy tube is attached to the guidewire at the mouth while the opposite end of the guidewire protrudes from the cannula needle. Pulling the guidewire at the cannula directs the gastrostomy tube down the esophagus and into the stomach and eventually into the tract created by the cannula needle.
U.S. Pat. No. 4,516,970 to Kaufman et al. discloses a catheter or feeding tube in which the front end portion that enters the patient's body is comprised of a weighted bolus tip. The weighted tip may either be open-ended in which the tip comprises a central lumen which is confluent with the lumen of the feeding tube or may be of solid construction in which the feeding tube adjacent thereto is perforated for delivery of the nutritional/medicinal fluids to the patient. The tip is intended to facilitate insertion of the feeding tube into the stoma of a patient.
U.S. Pat. No. 4,944,732 to Russo discloses a gastrostomy feeding port comprising a definable, conical tip portion with at least one opening therein for the discharge of nutritional or medicinal liquids, a tube portion that is confluent with the opening in the tip and extends rearwardly therefrom and a fitting with a removable flange and valve at the rear end of the tube portion. In use, the tip is inserted into the stomach through a surgically incised stoma in the skin of the patient. The flange and fitting portion secure the tube to the skin of the patient at the stoma. The tip portion is designed so that upon pressing it against the stoma, the tip is deformed to an elongated configuration so that it can be more easily passed through the stoma. Lubricants and associated anesthetics can be applied to the surface of the tip for even easier insertion.
U.S. Pat. No. 5,413,565 to Michels et al. teaches and claims a gastrostomy feeding port comprising an elastic, conically-shaped tip adaptable to fit a variety of different stoma lengths. The conical tip is attached to a middle tube portion and a retaining flange. The tip has an opening which is confluent with the central lumen of the feeding tube and through which nutritional and/or medicinal fluids are fed to the patient. The tip portion is collapsible, a feature which facilitates entry of the feeding tube into the stomach through the ostomy and its subsequent removal thereof. The tip is also provided with anchoring means to secure the tube to the inside of the stomach. The flange portion, is positioned some distance down the tube from the tip and secures the tip externally to the skin of the patient.
U.S. Pat. No. 5,454,790 to Dubrul discloses a catheter and method for its use in the percutaneous placement of feeding and drainage tubes comprising an elastic access tube in an internal stylet. The stylet has a sharpened distal tip which extends beyond the distal end of the access tube. The tip may be inserted through previously incised ostomy or may directly penetrate the skin and stoma of the patient. The access tube is then guided over the tip and the internal tube until it also penetrates the stomach. The gastrostomy feeding tube is then guided thereover.
Finally, U.S. Pat. No. 5,522,801 to Wang teaches and claims an integrated silicone balloon catheter comprising a shaft which defines a drainage lumen with a longitudinal groove on the outside, a conical tip attached to one end of the shaft and a sheath bonded to and disposed around the shaft. The sheath is inflatable and the tip is used to guide the catheter primarily through naturally occurring lumens in the body such as the urethra, anus, esophagus and the like.
All of the devices disclosed in the prior art are relatively complex structures which are manufactured as an integral part of the gastrostomy feeding tube or catheter itself. Not all facilitate easy and direct insertion of the catheter or ostomy tube itself, for example the blunt end tips, and moreover, none of these devices allow for the very simple removal thereof since the bulbous head or tip must somehow be withdrawn either endoscopically up and out through the gastrointestinal tract or it must be pulled back out through the ostomy, thereby possible resulting in further abrasion and discomfort to the patient. In addition, insertion of the tapered tips of the prior art exposes the gut wall opposite to the insertion point to damage if the tip is inadvertently forced or pressed against it.
It is an object of the present invention to provide a one-piece tapered and/or rounded tip for use in the insertion of catheters and ostomy tubes such as gastrostomy feeding tubes for the delivery of nutritional and medicinal fluids to patients. It is a further object of the present invention to provide a conically-shaped tip that is detachably inserted into the end of the gastrostomy feeding tube for simple placement, guidance and insertion of the tube through a pre-incised ostomy in the skin and fascia of a patient.
It is a further object of the present invention to provide a conical tip that is simple to manufacture in a large number of sizes and designs so as to be readily attached to a wide variety of feeding tubes at the time of placement. Finally, it is an object of the invention to provide a conical, flexible tip that can be detachably inserted into the distal end of a catheter or gastrostomy feeding tube so that once the tube is properly placed in the stomach or small intestine, the tip can be readily detached from the tube into the body of the patient where it is readily dissolved and/or discharged therefrom.
REFERENCES:
patent: 2603217 (1952-07-01), McShirley
patent: 3640281 (1972-02-01), Robertson
patent: 4143651 (1979-03-01), Patel
patent: 4361152 (1982-11-01), Patel
patent: 4393873 (1983-07-01), Nawash et al.
patent: 4516970 (1985-05-01), Kaufman et al.
patent: 4698056 (1987-10-01), Ciannella
patent: 4936835 (1990-06-01), Haaga
patent: 4944732 (1990-07-01), Russo
patent: 5049138 (1991-09-01), Chevalier
patent: 5407437 (1995-04-01), Heimreid
patent: 5413565 (1995-05-01), Michels et al.
patent: 5454790 (1995-10-01), Dubrul
patent: 5474542 (1995-12-01), Gandi et al.
patent: 5522801 (1996-06-01), Wang
patent: 5722933 (1998-03-01), Yabe et al.
patent: 5860916 (1999-01-01), Pylant
patent: 6077275 (2000-06-01), Bryars
patent: 0 437 248 (1991-07-01), None
patent: 2 103 936 (1983-03-01), None
patent: 91/07200 (1991-05-01), None
patent: 94/25093 (1994-11-01), None
Hayes Michael J.
Lee Michael U.
Novartis AG
Pfeiffer Hesna J.
Seidel Richard K.
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