SYSTEMS, METHODS AND COMPOSITIONS FOR IMPROVED TREATMENT OF ACIDOSIS

• US 20150196708A1
• Filed: 08/19/2013
• Published: 07/16/2015
• Est. Priority Date: 08/17/2012
• Status: Abandoned Application

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California), U.S. Government Represented By The Department Of Veterans Affairs
• Inventors: Mason, Thomas G., Kraut, Jeffrey A.
• Application Number:
  US14/420,861
• Publication Number:
  US 20150196708A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 9/19 lyophilised , i.e. freeze-dried, solutions or dispersions lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00
• CPC Class Codes: A61M 2230/202 partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
• CPC Class Codes: A61M 2230/208 pH-value
• CPC Class Codes: A61M 5/1409 in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems needle sets A61M5/162
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A system for treating an acidotic patient includes an intravenous-fluid supply system, an automated fluid mixer and dispenser connected to the intravenous-fluid supply system to receive at least one supply fluid therefrom, an electronic control system configured to communicate with the automated fluid mixer and dispenser, and an intravenous line fluidly connected to the automated fluid mixer and dispenser. The intravenous line includes an intravenous connecter configured for injecting intravenous fluid dispensed from the automated fluid mixer and dispenser intravenously into the acidotic patient. The electronic control system is configured to control at least one of a total volume or a flow rate of the intravenous fluid to be injected into the acidotic patient'"'"'s blood based on at least a measured pH of the acidotic patient'"'"'s blood and based on a composition of the at least one supply fluid. An intravenous solution for treating acidosis includes sodium bicarbonate and at least one of disodium carbonate, sodium hydroxide, and tris(hydroxymethyl)aminomethane dissolved in an aqueous solution. The intravenous solution has a pH of at least 10 and a total concentration of osmolites within a near isotonic range.

Claims

1. A system for treating an acidotic patient, comprising:

an intravenous-fluid supply system;

an automated fluid mixer and dispenser connected to said intravenous-fluid supply system to receive at least one supply fluid therefrom;

an electronic control system configured to communicate with said automated fluid mixer and dispenser; and

an intravenous line fluidly connected to said automated fluid mixer and dispenser, said intravenous line comprising an intravenous connecter configured for injecting intravenous fluid dispensed from said automated fluid mixer and dispenser intravenously into said acidotic patient,

wherein said electronic control system is configured to control at least one of a total volume or a flow rate of said intravenous fluid to be injected into said acidotic patient'"'"'s blood based on at least a measured pH of said acidotic patient'"'"'s blood and based on a composition of said at least one supply fluid.

2. A system for treating an acidotic patient according to claim 1, wherein said electronic control system is further configured to control at least one of said total volume or said flow rate of said intravenous fluid to be injected into said acidotic patient'"'"'s blood based on at least one of a predicted pH effect, a predicted pCO2 effect, and a predicted bicarbonate anion concentration effect of said intravenous fluid to be injected.

3. A system for treating an acidotic patient according to claim 2, wherein said electronic control system is further configured to control at least one of said total volume or said flow rate of said intravenous fluid to be injected into said acidotic patient'"'"'s blood further based on a predicted effect of said intravenous fluid to be injected on an isotonic condition of said acidotic patient'"'"'s blood.

4. A system for treating an acidotic patient according to claim 1, wherein said at least one supply fluid from said intravenous-fluid supply system comprises at least a first supply fluid and a second supply fluid, and

wherein said electronic control system is further configured to provide control signals to said automated fluid mixer and dispenser to mix said first and second supply fluids in a proportion based on at least said measured pH of said acidotic patient'"'"'s blood.

5. A system for treating an acidotic patient according to claim 2, wherein said at least one supply fluid from said intravenous-fluid supply system comprises at least a first supply fluid and a second supply fluid, and

wherein said electronic control system is further configured to provide control signals to said automated fluid mixer and dispenser to mix said first and second supply fluids in a proportion based on predicted pH and pCO2 effects of said intravenous fluid to be injected.

6. A system for treating an acidotic patient according to claim 5, wherein said electronic control system is further configured to provide control signals to said automated fluid mixer and dispenser to mix said first and second supply fluids in a proportion and a concentration based on a predicted effect of said intravenous fluid to be injected on an isotonic condition of said acidotic patient'"'"'s blood.

7. A system for treating an acidotic patient according to claim 4, wherein said first supply fluid has a higher pH in a base range than a pH of said second solution.

8. A system for treating an acidotic patient according to claim 7, wherein said second supply fluid is an aqueous solution comprising dissolved sodium bicarbonate, and said first solution is an aqueous solution comprising at least one of dissolved disodium carbonate, sodium hydroxide, or tris(hydroxymethyl)aminomethane.

9. A system for treating an acidotic patient according to claim 1, further comprising a blood sensor system configured to communicate with said electronic control system,

wherein said blood sensor system is configured to measure at least one property of said patient'"'"'s blood in real time and provide sensor signals to said electronic control system, and

wherein said electronic control system provides control signals to said automated fluid mixer and dispenser such that at least one of mixing or dispensing by said automated fluid mixer and dispenser is based at least partially on real-time information from said blood sensor system.

10. A system for treating an acidotic patient according to claim 9, wherein said blood sensor system comprises a pH sensor for real-time blood pH measurements and feedback control of said automated fluid mixer and dispenser by said electronic control system.

11. A system for treating an acidotic patient according to claim 1, further comprising a second intravenous line fluidly connected to said automated fluid mixer and dispenser, said second intravenous line comprising a second intravenous connecter configured for injecting second intravenous fluid dispensed from said automated fluid mixer and dispenser intravenously into a second position in said acidotic patient.

12. A system for treating an acidotic patient according to claim 11, wherein said first mentioned intravenous fluid dispensed from said automated fluid mixer and dispenser is substantially a same composition as said second intravenous fluid dispensed from said automated fluid mixer and dispenser.

13. A system for treating an acidotic patient according to claim 11, wherein said first mentioned intravenous fluid dispensed from said automated fluid mixer and dispenser has a different composition from said second intravenous fluid dispensed from said automated fluid mixer and dispenser, and

wherein said first-mentioned and said second intravenous fluids act together in said acidotic patient'"'"'s body to adjust at least said pH condition of at least said portion of said acidotic patient'"'"'s body while maintaining at least a near isotonic condition of said acidotic patient'"'"'s blood.

14. A system for treating an acidotic patient according to claim 13, wherein said intravenous-fluid supply system comprises a plurality of precursor solutions that when mixed by said automated fluid mixer and dispenser provides an intravenous solution to be dispensed,

wherein said intravenous solution comprises sodium bicarbonate and at least one of disodium carbonate, sodium hydroxide, and tris(hydroxymethyl)aminomethane dissolved in an aqueous solution, and

wherein said intravenous solution has a pH of at least 10 and a total concentration of osmolites within a near isotonic range.

15. A system for treating an acidotic patient according to claim 14, wherein said aqueous solution comprises disodium carbonate and sodium bicarbonate in a molar ratio of at least 2:

1.

16. A system for treating an acidotic patient according to claim 15, wherein said intravenous solution consists essentially of said disodium carbonate and sodium bicarbonate dissolved in said aqueous solution.

17. An intravenous solution for treating acidosis, comprising:

sodium bicarbonate; and

at least one of disodium carbonate, sodium hydroxide, and tris(hydroxymethyl)aminomethane dissolved in an aqueous solution,

wherein said intravenous solution has a pH of at least 10 and a total concentration of osmolites within a near isotonic range.

18. An intravenous solution according to claim 17, wherein said aqueous solution comprises disodium carbonate and sodium bicarbonate in a molar ratio of at least 2:

1.

19. An intravenous solution according to claim 18, wherein said intravenous solution consists essentially of said disodium carbonate and sodium bicarbonate dissolved in said aqueous solution.

20. A method of treating acidosis, comprising:

providing an intravenous solution for treating acidosis; and

administering said intravenous solution intravenously to an acidotic patient,

wherein said intravenous solution has a pH of at least 10 and a total concentration of osmolites within a near isotonic range.

21. A method of treating acidosis according to claim 20, wherein said intravenous solution comprises sodium bicarbonate and at least one of disodium carbonate, sodium hydroxide, and tris(hydroxymethyl)aminomethane dissolved in an aqueous solution.

22. A method of treating acidosis according to claim 21, wherein said aqueous solution comprises disodium carbonate and sodium bicarbonate in a molar ratio of at least 2:

1.

24. A method of treating acidosis according to claim 20, further comprising selecting said intravenous solution to have a composition based on at least one of a measured pH value, a measured pCO2 value, and a measured bicarbonate anion concentration of said acidotic patient.

25. A method of treating acidosis according to claim 20, further comprising:

measuring a pH of said acidotic patient; and

at least one of selecting or mixing said intravenous solution to have a composition based on said measuring said pH value of said acidotic patient.

26. A method of treating acidosis according to claim 20, further comprising repeating said measuring and at least one of selecting or mixing a plurality of times to provide a real-time adjusted method of treating acidosis.

23. A method of treating acidosis according to claim 23, wherein said intravenous solution consists essentially of said disodium carbonate and sodium bicarbonate dissolved in said aqueous solution.

27. An intravenous dispersion for treating acidosis, comprising:

a liquid; and

a plurality of particles dispersed in said liquid,

wherein each particle of said plurality of particles has a maximum outer dimension of less than about 2 micrometers such that said particles can pass unhindered through capillary blood vessels of an acidotic patient being treated,

wherein each of said plurality of particles comprises at least one of a shell and a matrix material that dissolves at a predetermined rate within said acidotic patient'"'"'s blood stream, and

wherein each of said plurality of particles comprises a pH-influencing material that mixes in said acidotic patient'"'"'s blood stream at a controlled rate while said at least one of said shell and said matrix material dissolves.

28. An intravenous dispersion for treating acidosis according to 27, wherein a rate of dissolution of said pH-influencing material is controlled by at least one of a composition of said at least one of said shell and said matrix material, a structure of said at least one of said shell and said matrix material, a relative volume fraction of said pH-influencing material and said at least one of said shell and said matrix material, and an average size of said plurality of particles.