Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2001-02-26
2003-02-25
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S400000, C514S893000, C426S416000, C426S443000, C426S800000
Reexamination Certificate
active
06524610
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a nutritional composition. More particularly, the present invention relates to a nutritional composition made from conventional foods for mixing on site in a blender and treating patients with hepatic disorders.
2. Description of the Prior Art
The liver, and its proper functioning, is of utmost importance to the survival of a patient. Because it is responsible for the metabolism of nearly all nutrients, and is the primary site for the inactivation of numerous toxins, the liver is one of the most important organs of the body. For example, the liver accounts for approximately 20% of the body's basal metabolism.
The liver extracts a majority of the amino acids, carbohydrates, lipids, vitamins, and minerals from portal circulation. These nutrients, extracted by the liver, are used as substrates or cofactors in all metabolic processes carried out in the liver. Synthesis of plasma proteins and bile secretion are additionally important processes carried out by the liver.
Due to a variety of insults and pathogens, the liver can become diseased. Liver disease is a broad classification encompassing a number of acute and chronic diseases.
These diseases include hepatitis (viral and non-viral), cirrhosis (alcoholic and non-alcoholic), and liver failure. Liver failure is perhaps the most severe disease and may be accompanied by a complex set of conditions including hepatic encephalopathy, hemorrhage, coagulapathy, ascites, jaundice, and hepatorenal syndrome.
Although many medical treatments have been devised for treating liver disease, due to the paradoxical relationship between hepatic function and metabolism, medical treatment of the liver disease is complex and difficult. Most, if not all, liver diseases require or benefit from nutritional management. Those diseases which are believed to benefit most from nutritional management, include alcoholic and non-alcoholic cirrhosis, obstructive jaundice, and in some situations, acute liver failure. The goals of such nutritional therapies vary depending on disease and patient. The goals can be either restorative or supportive.
Liver disease can affect both hepatic cellular function and structure. In chronic conditions, such as alcoholic cirrhosis, exposure to a toxicant promotes inflammation of the periportal areas of the liver. As a result, fibrosis develops and when sufficiently advanced, canaliculi become blocked. As a result of inadequate regional perfusion, hepatocyte degeneration occurs.
In an attempt to restore adequate circulation, portal hypertension develops. Porto systemic shunting of the blood results in chronic hypertension. Many of the serious complications of liver disease are due to this event.
Porto systemic shunting allows many substances, for example, amino acids, fatty acids, ammonia, and others, to bypass the liver. These substances then flood the neurological system. Porto systemic shunting results in many clinical features including variceal changes and encephalopathy.
Many specific metabolic derangements are associated with liver disease. This is especially true of liver disease of a chronic nature. Such derangements include increased plasma glycogen, hyperinsulinemia, increased plasma epinephrine and cortisol, decreased liver and muscle carbohydrate stores, accelerated gluconeogenesis, hypoglycemia, hyperammonemia, increased plasma aromatic amino acid, increased plasma methionine, glutamine, asparagine, and histidine, and decreased plasma branched chain amino acids.
A number of hypotheses, mostly metabolism based, have been advanced to concerning the pathogenesis of hepatic encephalopathy. For example, excess nitrogen (ammonium) production and accumulation of false neural transmitters have been advanced as possible causes.
Numerous innovations for nutritional compositions have been provided in the prior art that will be described. Even though these innovations may be suitable for the specific individual purposes to which they address, however, they differ from the present invention in that they do not teach a nutritional composition made from conventional foods for mixing onsite in a blender and treating patients with hepatic disorders.
FOR EXAMPLE, U.S. Pat. No. 4,497,800 to Larson et al. teaches a nutritionally complete ready-to-use liquid diet for providing total patient nourishment. This diet contains a source of protein equivalent comprised of free amino acids and small peptides; a carbohydrate source comprised of maltodextrin with a dextrose equivalent between 7 and 24 and a smaller amount of modified corn starch; a lipid component; nutritionally significant amounts of all essential vitamins and minerals; and stabilizers; all in an acidic aqueous emulsion which can be sterilized.
ANOTHER EXAMPLE, U.S. Pat. No. 4,753,926 to Lucas et al. teaches infant foods suitable for use in the feeding of low birth weight infants, more especially preterm infants, are disclosed. The foods contain a relatively high level of vitamin B.sub.2 and may be prepared so as to have an opacity greater than that of human breast milk leading to less susceptibility of the vitamin B.sub.2 to breakdown by UV-light when used for the feeding of low birth weight infants who are receiving photo therapy. Preferred infant foods according to the invention also have high contents of vitamin B.sub.6, vitamin C, vitamin D, vitamin E, folic acid, copper and zinc while containing no added iron. Another aspect of the invention is the inclusion of taurine and carnitine. One unexpected property of the infant foods according to the invention with high vitamin content is that their use has it been found to reduce the incidence of hyperbilirubinaemia in low birth weight infants.
STILL ANOTHER EXAMPLE, U.S. Pat. No. 5,413,803 to Chung teaches a nutritious milk composition containing a specific ratio of raw soybean milk to raw cows' milk which is an effective milk product for the regulation of micro nutrients, e.g., methionine and calcium contents and for the production of a synergistic effect between saturated and unsaturated fatty acids.
YET ANOTHER EXAMPLE, U.S. Pat. No. 5,728,678 to Trimbo et al. teaches a composition as well as method for providing nutrition to renal patients. Pursuant to the present invention, the enteral composition includes an effective amount of a protein source including whey protein and free amino acids that provide essential as well as nonessential amino acids. The composition is calorically dense and has a moderate osmolality.
It is apparent that numerous innovations for nutritional compositions have been provided in the prior art that are adapted to be used. Furthermore, even though these innovations may be suitable for the specific individual purposes to which they address, however, they would not be suitable for the purposes of the present invention as heretofore described.
SUMMARY OF THE INVENTION
ACCORDINGLY, AN OBJECT of the present invention is to provide a nutritional composition made from conventional foods for mixing onsite in a blender and treating patients with hepatic disorders that avoids the disadvantages of the prior art.
ANOTHER OBJECT of the present invention is to provide a nutritional composition made from conventional foods for mixing onsite in a blender and treating patients with hepatic disorders that is simple and inexpensive to manufacture.
STILL ANOTHER OBJECT of the present invention is to provide a nutritional composition foods for mixing onsite in a blender and treating patients with hepatic disorders that is simple to use.
BRIEFLY STATED, YET ANOTHER OBJECT of the present invention is to provide a nutritional composition made from conventional food for mixing on-site in a blender and treating patients with hepatic disorders. The composition includes a vitamin A enriched conventional food, a vitamin D enriched conventional food, a vitamin E enriched conventional food, a vitamin K enriched conventional food, a vitamin C enriched conventional food, a thiamine enriched conventional food, a riboflavin enriched conve
Evans Charesse
Page Thurman K.
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