IP Library Granted Patent US 11,116,790
Granted Patent B2
US 11,116,790 · App. 16/927,901 · Granted Sep 14, 2021

Intradialytic use of sodium thiosulfate

Inventor: Craig Sherman (Scottsdale, AZ)
Assignee: Hope Medical Enterprises, Inc.
A61K33/04A61M1/1654A61M1/1656
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Quick Facts
Patent No.
US 11,116,790
App. No.
16/927,901
Granted
Sep 14, 2021
Kind
B2
Abstract

Provided herein are methods for maintaining physiological levels of thiosulfate in a subject undergoing hemodialysis. Also provided herein are methods of administering pharmaceutically acceptable sodium thiosulfate to a subject undergoing hemodialysis.

Claims (28)

1. A method for maintaining physiological levels of thiosulfate in a subject undergoing hemodialysis; preventing myocardial infarction in a subject undergoing dialysis; preventing sudden cardiac death in a subject undergoing dialysis; preventing stroke in a subject undergoing dialysis; preventing cardiovascular disease that is characterized by tissue ischemia in a subject undergoing dialysis; preventing high blood pressure in a subject undergoing dialysis; preventing pulmonary hypertension in a subject undergoing dialysis; preventing renal hypertension in a subject undergoing dialysis; or preventing atherosclerosis in a subject undergoing dialysis, comprising intradialytically contacting said subject's blood with a dialyzer membrane that is also in contact with a thiosulfate-spiked dialysate, wherein an aqueous solution comprising sodium thiosulfate is added to an unspiked dialysate as the unspiked dialysate flows from a dialysis machine to a dialyzer membrane, wherein said unspiked dialysate comprises a mixture of water, an acid concentrate solution, and a bicarbonate concentrate solution, and wherein said thiosulfate-spiked dialysate has a pH greater than about 7.0, wherein the concentration of thiosulfate in said thiosulfate-spiked dialysate is no more than about 10 micromolar, and further comprising administering to said subject one or more of copper, fluoride, iodine, iron, manganese, magnesium, nitrite, phosphorus, selenium, and zinc.

2. The method of claim 1 , wherein the physiological level of thiosulfate in said subject is no more than about 10 micromolar.

3. The method of claim 1 , wherein the physiological level of thiosulfate in said subject is between about 500 nanomolar and about 5 micromolar.

4. The method of claim 1 , wherein the physiological level of thiosulfate in said subject is about 3 micromolar.

5. The method of claim 1 , wherein the concentration of thiosulfate in said thiosulfate-spiked dialysate is between about 500 nanomolar and about 5 micromolar.

6. The method of claim 1 , wherein the concentration of thiosulfate in said thiosulfate-spiked dialysate is about 3 micromolar.

7. The method of claim 1 , wherein said aqueous solution comprising sodium thiosulfate comprises no more than about 300 mg/L of sodium thiosulfate.

8. The method of claim 1 , wherein said water comprises no more than about 200 mg/L of thiosulfate.

9. The method of claim 1 , wherein said aqueous solution comprising sodium thiosulfate is added to said unspiked dialysate through a valve that is attached to dialysate tubing at a location before said tubing connects to the dialyzer.

10. The method of claim 9 , wherein said unspiked dialysate flows through said dialysis tubing at a rate between about 500 mL/min and about 700 mL/min.

11. The method of claim 9 , wherein said unspiked dialysate flows through said dialysis tubing at a rate of about 600 mL/min.

12. The method of claim 9 , wherein said aqueous solution comprising sodium thiosulfate is added through said valve to said unspiked dialysate at a rate between about 100 mL/hr and about 550 mL/hr.

13. The method of claim 9 , wherein said aqueous solution comprising sodium thiosulfate is added through said valve to said unspiked dialysate at a rate of about 250 mL per hour.

14. The method of claim 1 , wherein the pH of said thiosulfate-spiked dialysate is between about 7.3 and about 7.5.

15. The method of claim 1 , wherein the pH of said thiosulfate-spiked dialysate is about 7.4.

16. The method of claim 1 , wherein said subject is a human with chronic renal failure.

17. The method of claim 1 , wherein said subject is a human with acute renal failure.

18. The method of claim 1 , wherein said subject undergoes dialysis from three to seven times per week.

19. The method of claim 1 , wherein copper is administered to said subject.

20. The method of claim 1 , wherein fluoride is administered to said subject.

21. The method of claim 1 , wherein iodine is administered to said subject.

22. The method of claim 1 , wherein iron is administered to said subject.

23. The method of claim 1 , wherein manganese is administered to said subject.

24. The method of claim 1 , wherein magnesium is administered to said subject.

25. The method of claim 1 , wherein nitrite is administered to said subject.

26. The method of claim 1 , wherein phosphorus is administered to said subject.

27. The method of claim 1 , wherein selenium is administered to said subject.

28. The method of claim 1 , wherein zinc is administered to said subject.

Continuity (3)
Continuation 15914661 · Mar 7, 2018
Provisional Application 62468871 · Mar 8, 2017
Related Publication 20200338120A1 · Oct 29, 2020
Cited By (2)
US 12,311,026 US 12,370,212