SYSTEM AND METHOD FOR MODIFYING A FLUID FOR ORAL ADMINISTRATION

• US 20080089993A1
• Filed: 02/16/2007
• Published: 04/17/2008
• Est. Priority Date: 08/23/2004
• Status: Abandoned Application

• Current Assignee: Remote Clinical Solutions, Inc.
• Original Assignee: Remote Clinical Solutions, Inc.
• Inventors: Eaton, Rebecca, Hwang, Charles
• Application Number:
  US11/676,228
• Publication Number:
  US 20080089993A1
• Time in Patent Office: Days
• US Class Current: 426/590
• CPC Class Codes: A61J 1/03 for pills or tablets containers for pills or tablets with special dispensing means therefor B65D83/04
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2031 having openings brought into alignment
• CPC Class Codes: A61J 1/2034 having separation clips
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61J 7/0076 Medicament distribution means with pill counting devices A61J7/02; with time indication A61J7/04; containers or packages with special means for dispensing contents B65D83/00
• CPC Class Codes: A61J 9/00 Feeding-bottles in general

Abstract

Methods and systems are provided for modifying a fluid for oral administration. Typical systems include a reservoir which contains or may be filled with water or other aqueous components. The systems also include a container or retention pocket which is integral with or mountable on or in the reservoir. The container holds a soluble beneficial agent, typically an electrolyte, a nutrient or a medicament. The container is adapted to selectively combine a measured amount of the beneficial agent with the aqueous component based upon patient need.

Claims

1. A method for providing a hydration fluid to a patient, said method comprising:

determining a level of hydration of the patient; and

preparing a hydration fluid by combining an amount of a soluble hydration agent with an aqueous component, wherein the amount and/or type of hydration agent is selected based on the patient'"'"'s determined level of hydration.

2. A method as in claim 1, wherein determining the level of hydration comprises measuring sodium concentration or osmolality of a bodily fluid and/or biomarkers for sodium concentration or osmolality of a bodily fluid.

3. A method as in claim 2, wherein the bodily fluid comprises saliva, oral fluids, sweat, tears, breath, urine, transudates, exudates, or blood.

4. A method as in claim 2, wherein determining the level of hydration further comprises utilizing at least one known patient average.

5. A method as in claim 4, wherein the at least one known patient average comprises total body water as a percentage of total body weight, fluid electrolyte concentration, a rate or amount of fluid loss, a rate or amount of electrolyte loss, and any combination of these.

6. A method as in claim 2, wherein determining the level of hydration further comprises utilizing additional patient data.

7. A method as in claim 6, wherein said additional patient data comprises rate or amount of fluid loss, rate or amount of electrolyte loss, fluid electrolyte concentration, fluid osmolality, prior or expected future fluid consumption, prior or expected future electrolyte consumption, weight, weight gain or less, body mass index, sex, age, race, height, behavioral data, diet, fitness level, physical exertion level, physical appearance, cognitive capability, environmental data such as temperature, humidity, and altitude, the level of other disease markers, medication and medical procedure history, the presence, absence or severity of one or more particular medical conditions, and any combination of these.

8. A method as in claim 2, wherein determining the level of hydration further comprises utilizing patient biometric data and/or previously-determined patient biometric data and/or trends in patient biometric data.

9. A method as in claim 1, wherein the amount and/or type of hydration agent is further selected based on a patient preference.

10. A method as in claim 1, wherein preparing the hydration agent comprises releasing the amount of soluble rehydration agent from a container which is integral with, or mounted or mountable on or in, a reservoir which holds the aqueous component.

11. A method as in claim 1, wherein the reservoir comprises a cup, bottle, bladder, tube, box, can, sack, thermos, canister, soft gu-like pouch, nursing bottle, covered children'"'"'s cup, rehydration container, drinking-straw-type tube, or an on-demand drinking apparatus.

12. A method as in claim 1, wherein the reservoir is comprised of a hard material, a soft material, plastic, glass, aluminum, stainless steel, rubber or a combination thereof.

13. A method as in claim 1, wherein the reservoir includes a drinking spout through which the patient may drink.

14. A method as in claim 13, wherein the container is removably attached to, formed integrally with, or detached from the reservoir or drinking spout.

15. A method as in claim 1, wherein the at least one hydration agent is present in the container as one or multiple doses and wherein the one or multiple doses can be individually released into the aqueous component.

16. A method as in claim 1, wherein preparing the hydration fluid comprises mechanically releasing a calibrated amount of the hydration agent into the aqueous component held in a reservoir.

17. A method as in claim 16, wherein mechanically releasing a calibrated amount of agent is accomplished by advancing a pusher plate or bar, turning a dial, or depressing a blister mechanism.

18. A method as in claim 1, wherein preparing the hydration fluid comprises pouring or dropping a measured amount of the hydration agent into the aqueous component held in a reservoir.

19. A method as in claim 1, wherein the hydration agent comprises a powder or granulated solid, a dissolvable tablet, a plurality of encapsulated pellets, a liquid or gel.

20. A method as in claim 1, wherein the hydration agent is disposed in a pouch or osmotic device or is formulated in a controlled-release dosage form.

21. A method as in claim 1, wherein the hydration agent is selected from the group consisting of electrolytes, rehydration solutions, carbohydrates, nutrients, ergogenic supplements, medicaments, probiotics, and diagnostic agents.

22. A method as in claim 21, wherein the hydration agent comprises an electrolyte selected from the group consisting of sodium, potassium, calcium, magnesium, salts of chloride, bicarbonate, phosphate, and sulfate.

23. A method as in claim 21, wherein the hydration agent comprises a carbohydrate selected from the group consisting of sucrose, glucose, fructose, glucose polymers, and maltodextrins.

24. A method as in claim 21, wherein the hydration agent comprises a nutrient selected from the group consisting of glutamine, hydrolysates, vitamins, minerals, proteins, amino acids, polyamines, arginine, oligosaccharides, short chain fatty acids, enzymes, soluble fibers, fermentable fiber, phytochemicals, pyruvamide, pyruvyl-amino acids, amides of pyruvyl-amino acids, pyruvates, esters, salts, structured lipids, fats, d-chiroinositol, lactoferrin, marine oils, acidulents, ascorbic acid, and anti-oxidants.

25. A method as in claim 21, wherein the hydration agent comprises an ergogenic supplement selected from the group consisting of creatine, carbohydrates, caffeine, carnitine, bicarbonate, glycerol, antioxidant vitamins, colostrums, glutamine, amino acids, inosine, coenzyme QlO, herbs, beta-Hydroxy-beta-MethylButyrate, chromium, choline, GHB, vanadyl sulphate, and hydroxymethylbutyrate.

26. A method as in claim 21, wherein the hydration agent comprises a medicament selected from the group consisting of medications for diabetic conditions, chemotherapy agents, gastrointestinal drugs, antacids, antibiotics, probiotic medications, prokinetic medications, bioactive peptides, antihistamine drugs, anti-infective agents, antivirals, urinary tract anti-infectives, antineoplastic agents, autonomic drugs, adrenergic agents, skeletal muscle relaxants, blood formation drugs, coagulation drugs, cardiovascular drugs, central nervous system agents, diagnostic agents, electrolytic balance agents, caloric balance agents, water balance agents, enzymes, antitussive agents, expectorant agents, mucolytic agents, gold compounds, hormones, synthetic substitutes, smooth muscle relaxants, H.sub.2 blockers, Tagamet.RTM, and consistency-altering agents.

27. A method as in claim 21, wherein the hydration agent comprises a probiotic selected from the group consisting of Lactobacillus reuteri, Lactobacillus acidophilus, Lactobacillus animalis, Lactobacillus salivarius, or a live or dead microbial food supplement which affects the host'"'"'s microbial balance in the gastrointestinal tract.

28. A method as in claim 1, wherein preparing the hydration fluid further comprises combining a flavoring agent in the aqueous component.

29. A drinking system comprising:

a reservoir containing an aqueous component; and

means integral with or attached or attachable to the reservoir combining a measured amount of soluble beneficial agent with the aqueous component.

30. A drinking system as in claim 29, wherein the combining means comprises a container integral with or mounted or mountable on or in the reservoir, said container holding at least one soluble beneficial agent.

31. A drinking system as in claim 29, further comprising a first receiving system for receiving a patient'"'"'s measured biometric data, said receiving system calibrated as a function of at least one biometric data type;

and a processor which calculates a quantity of the agent that is to be released to the reservoir utilizing the received measured biometric data.

32. A drinking system as in claim 31, wherein the combining means releases the quantity of agent calculated by the processor.

33. A drinking system as in claim 32, further comprising additional receiving systems for receiving additional patient data and/or patient preferences, wherein the processor calculates the quantity of the at least one beneficial agent that is to be released to the reservoir utilizing the biometric data together with the additional patient data and/or patient preferences.

34. A drinking system as in claim 33, wherein said receiving systems receive manually input patient biometric data, patient preference data, and additional patient data.

35. A drinking system as in claim 34, wherein said additional patient data comprises rate or amount of fluid loss, rate or amount of electrolyte loss, fluid electrolyte concentration, fluid osmolality, prior or expected future fluid consumption, prior or expected future electrolyte consumption, weight, weight gain or loss, body mass index, sex, age, race, height, behavioral data, diet, fitness level, physical exertion level, physical appearance, cognitive capability, environmental data such as temperature, humidity, and altitude, the level of other disease markers, medication and medical procedure history, the presence, absence or severity of one or more particular medical conditions, and any combination of these.

36. A drinking system as in claim 33, wherein the processor calculates the quantity utilizing known patient averages and/or previously-recorded patient biometric data or trends in previously-recorded patient biometric data.

37. A drinking system as in claim 36, wherein the known patient average comprises total body water as a percentage of total body weight, fluid electrolyte concentration, a rate or amount of fluid loss or a rate or amount of electrolyte loss.