Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-06-09
2001-02-20
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C424S465000
Reexamination Certificate
active
06190351
ABSTRACT:
FIELD OF THE INVENTION
This invention pertains to a delivery system for delivering an identifying agent to a nutritional support formulation. This invention relates also to a combination comprising the delivery system, a reservoir containing a nutritional support formulation and to a drip chamber. The invention pertains additionally to a process of adding an identifying agent to a nutritional support formulation, and to a method for administering a nutritional formulation to a patient.
BACKGROUND OF THE INVENTION
A clinical need exists for: (1) a nutritional system comprising a delivery identification means; (2) for a method for ascertaining if a patient on nutritional support is experiencing medical problems contemporaneously with the nutritional support; and (3) for a method to ensure that a patient is receiving the benefits of nutrition.
Nutritional support is the provision of nutrients to patients who cannot meet their nutritional requirements by eating standard diets. For patients on nutritional support, nutrients may be delivered to the gastrointestinal tract enterally, using oral nutritional supplements, nasogastric and nasoduodenal feeding tubes, and tube enterostomies. Current nutritional support techniques permit adequate nutrient delivery to virtually any patient.
Nutritional support is indicated for many patients, including patients with inadequate bowel syndromes, patients with a severe, prolonged hypercatabolic status, patients with extensive burns, multiple trauma and mechanical ventilation, patients requiring prolonged therapeutic bowel rest, patients with a treatable disease who have sustained a loss of over 25% body weight, patients with a functioning gastrointestinal tract (as a supplemental oral diet), and patients with other conditions, such as neurological disorders, recovering from surgery and clinical conditions, such as malabsorption disorders associated with Crohn's disease.
Nutritional support has enjoyed wide acceptance in medicine, and it is used daily in clinics, hospitals and nursing homes. While nutritional support is used to deliver many nutrients, problems are frequently associated with its use. For example, if an attending physician detects fluid in the lungs of a patient, the physician needs to know the nature and/or the content of the fluid, and consequently sucks fluid from the lungs to ascertain the origin of the fluid, in order to prescribe a mode of treatment. To effect a treatment, it is necessary to know if the fluid is stomach fluid that has been regurgitated up the esophagus and aspirated down the trachea into the lungs, fluid from an internal bleeding source, fluid that is infectious in origin, or fluid from a nutritional support system. Nutritional support and internal nutritional support are discussed in
Current Medical Diagnosis and Treatment
, Lange, pp. 1104-1108 (1996);
Textbook of Medicine
, Cecil, pp. 1168-1171 (1969);
The Meck Manual of Diagnosis and Therapy
, pp. 942-949 (1987); and
Principles of Internal Medicine
, pp. 466-472 (1994).
In light of the above presentation, it will be appreciated by those versed in the nutritional support art to which this invention pertains that a pressing need exists for means for ascertaining the presence of a nutritional support fluid administered to a patient to distinguish the nutritional support fluid from biological and infectious fluids. The pressing need exists, also, for a delivery system that delivers an identification to a nutritional support fluid that imparts a distinctive property to the nutritional support fluid.
OBJECTS OF THE INVENTION
Accordingly, in view of the above presentation, it is an immediate object of the invention to provide a nutritional support system for administering a nutritional formulation to a patient, indicated for better health.
Another object of the invention is to provide a nutritional support system comprising a delivery system that delivers an identifying agent to a nutritional support composition.
Another object of the invention is to provide a delivery system that delivers an identifying agent to a nutritional support formulation.
Another object of the invention is to provide a nutritional support system comprising a reservoir, a drip chamber, and a delivery system in the drip chamber for delivering a dye to a nutritional formulation that enters the drip chamber.
Another object of the invention is to provide a drip chamber for ascertaining the flow rate therethrough containing a delivery system that makes available a nontoxic dye to a nutritional fluid formulation that enters and leaves the drip chamber.
Another object of the invention is to provide a delivery system comprising a dye for adding to a nutritional formulation.
Another object of the invention is to provide a composition of matter for use in a delivery system and in a nutritional support formulation system.
Another object of the invention is to provide a method for adding means for identifying a nutritional support formulation by adding a pharmaceutically acceptable dye thereto.
Another object of the invention is to provide a method for adding a dye to a nutritional support formulation that comprises a reservoir of the nutritional formulation, a drip chamber, and a tube for feeding a person in need of nutritional support.
Another object of the invention is to provide a method for administering a nutrient to a patient by a nutritional support system.
Other objects, features and advantages of this invention will be more apparent to those versed in the nutritional support art from the following detailed specification and the accompanying claims.
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Ayer Atul D.
Barclay Brian L.
Pollock Brenda J.
Quan Ernest S.
Weyers Richard G.
ALZA Corporation
Dhuey John A.
Kennedy Sharon
Stone Steven F.
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