IP Library Granted Patent US 9,326,963
Granted Patent B2
US 9,326,963 · App. 12/498,773 · Granted May 3, 2016

Nutritive compositions and methods of using same

Inventor: Eileen Moore (Parma, OH)
Assignee: Pentec Health, Inc.
A61K31/20A61K31/195A61K31/7004A61K45/06
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Quick Facts
Patent No.
US 9,326,963
App. No.
12/498,773
Granted
May 3, 2016
Kind
B2
Abstract

The invention provides intradialytic parenteral nutrition (IDPN) solutions with low carbohydrate for the treatment of malnutrition in dialysis patients. The IDPN solutions of the invention are particularly advantageous for the treatment of malnutrition in patients who are diabetic or suffer from other glucose management related pathologies or patients who require strict fluid management.

Claims (43)

1. A method, comprising parenterally administering a sterile aqueous intradialytic parenteral nutrition (IDPN) solution to a patient in need thereof, the IDPN solution consisting essentially of between 0.05 and 0.07 g/mL of dextrose and between 0.12 and 0.18 g/mL of amino acids, wherein the solution is lipid-free and the dextrose and the amino acids are both dissolved in the same aqueous solution.

2. The method of claim 1 , wherein the amino acids include combinations of two or more of the standard 20 amino acids.

3. The method of claim 1 , wherein the solution consists essentially of between 0.055 and 0.065 g/mL of dextrose and between 0.12 and 0.18 g/mL of amino acids.

4. The method of claim 1 , wherein the solution consists essentially of between 0.05 and 0.07 g/mL of dextrose and between 0.15 and 0.17 g/mL of amino acids.

5. The method of claim 1 , wherein the solution consists essentially of between 0.055 and 0.065 g/mL of dextrose and between 0.15 and 0.17 g/mL of amino acids.

6. The method of claim 1 , wherein the solution is free of vitamin B1.

7. The method of claim 1 , wherein the solution is free of minerals.

8. The method of claim 4 , wherein the solution is free of vitamin B1.

9. The method of claim 1 , wherein the amino acids include all 20 of the standard amino acids.

10. The method of claim 1 , wherein the amino acids include 17 of the standard amino acids.

11. The method of claim 1 , wherein the solution has a volume between 100 mL and 2 L.

12. The method of claim 1 , wherein the solution has a volume between 350 mL and 635 L.

13. The method of claim 1 , wherein the solution is packaged in a sterile container.

14. The method of claim 1 , wherein the solution does not induce hyperglycemia in the patient.

15. The method of claim 1 , wherein the solution does not induce rhonchi edema in the patient.

16. The method of claim 1 , wherein the solution does not induce dyspnea in the patient.

17. The method of claim 1 , wherein the solution does not increase the respiratory rate of the patient.

18. The method of claim 1 , wherein the solution does not induce hypertension in the patient.

19. The method of claim 1 , wherein the solution does not induce anxiety in the patient.

20. The method of claim 1 , wherein the patient is a hemodialysis patient.

21. The method of claim 3 , wherein the patient is a hemodialysis patient.

22. The method of claim 4 , wherein the patient is a hemodialysis patient.

23. The method of claim 5 , wherein the patient is a hemodialysis patient.

24. The method of any one of claims 20 - 23 , wherein the hemodialysis patient is diabetic.

25. The method of claim 24 , further comprising administering insulin to the patient.

26. The method of claim 24 , further comprising monitoring glucose tolerance in the patient.

27. The method of any one of claims 20 - 23 , further comprising monitoring protein status in the patient.

28. The method of claim 27 , wherein the patient is diabetic.

29. A method, comprising parenterally administering a sterile aqueous intradialyic parenteral nutrition (IDPN) solution to a patient in need thereof, the IDPN solution comprising between 0.05 and 0.07 g/mL of dextrose and between 0.12 and 0.18 g/mL of amino acids, wherein the solution is lipid-free and the dextrose and the amino acids are dissolved in the same aqueous solution.

30. The method of claim 29 , wherein the solution comprises between 0.055 and 0.065 g/mL of dextrose and between 0.12 and 0.18 g/mL of amino acids.

31. The method of claim 29 , wherein the solution comprises between 0.05 and 0.07 g/mL of dextrose and between 0.15 and 0.17 g/mL of amino acids.

32. The method of claim 29 , wherein the solution comprises between 0.055 and 0.065 g/mL of dextrose and between 0.15 and 0.17 g/mL of amino acids.

33. The method of claim 29 , wherein the solution, when administered to a patient in need thereof, does not induce hyperglycemia in the patient.

34. The method of claim 29 , wherein the solution, when administered to a patient in need thereof, does not induce rhonchi edema in the patient.

35. The method of claim 29 , wherein the solution, when administered to a patient in need thereof, does not induce dyspnea in the patient.

36. The method of claim 29 , wherein the solution, when administered to a patient in need thereof, does not increase the respiratory rate of the patient.

37. The method of claim 29 , wherein the solution, when administered to a patient in need thereof, does not induce hypertension in the patient.

38. The method of claim 29 , wherein the solution, when administered to a patient in need thereof, does not induce anxiety in the patient.

39. The method of claim 29 , wherein the patient is a hemodialysis patient.

40. The method of claim 39 , wherein the hemodialysis patient is diabetic.

41. The method of claim 40 , further comprising administering insulin to the patient.

42. The method of claim 40 , further comprising monitoring glucose tolerance in the patient.

43. The method of any one of claims 39 - 41 , further comprising monitoring protein statue in the patient.

Assignments (16)
SECURITY INTEREST Recorded Mar 28, 2024
From: PENTEC HEALTH, INC.
To: CERBERUS BUSINESS FINANCE AGENCY, LLC
Reel/Frame 066930/0431 →
RELEASE OF SECURITY INTEREST Recorded Mar 28, 2024
From: TWIN BROOK CAPITAL PARTNERS, LLC, AS AGENT
To: PENTEC HEALTH, INC.
Reel/Frame 066941/0966 →
SECURITY INTEREST Recorded Oct 12, 2021
From: PENTEC HEALTH, INC.
To: TWIN BROOK CAPITAL PARTNERS, LLC, AS AGENT
Reel/Frame 057764/0908 →
RELEASE OF SECURITY INTEREST Recorded Oct 11, 2021
From: CRESTLINE DIRECT FINANCE L.P.
To: PENTEC HEALTH, INC.
Reel/Frame 057752/0952 →
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENTS Recorded Nov 16, 2020
From: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
To: PENTEC HEALTH, INC.
Reel/Frame 054437/0511 →
SECURITY INTEREST Recorded Nov 13, 2020
From: PENTEC HEALTH, INC.
To: CRESTLINE DIRECT FINANCE, L.P.
Reel/Frame 054357/0071 →
PATENT RELEASE (PREVIOUSLY RECORDED JUNE 4, 2012, REEL/FRAME 028316/0542) Recorded Jan 19, 2017
From: MADISON CAPITAL FUNDING LLC, AS AGENT
To: PENTEC HEALTH, INC.
Reel/Frame 041431/0114 →
PATENT RELEASE (PREVIOUSLY RECORDED MAY 23, 2013, REEL/FRAME 030487/0157) Recorded Jan 19, 2017
From: MADISON CAPITAL FUNDING LLC, AS AGENT
To: PENTEC HEALTH, INC.
Reel/Frame 041431/0120 →
NOTICE OF GRANT OF SECURITY INTEREST IN PATENTS Recorded Jan 18, 2017
From: PENTEC HEALTH, INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 041389/0572 →
RELEASE OF SECURITY INTEREST Recorded Jan 10, 2017
From: MADISON CAPITAL FUNDING LLC, AS AGENT
To: PENTEC HEALTH, INC.
Reel/Frame 040919/0001 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE PREVIOUSLY RECORDED ON REEL 023939 FRAME 0482.ASSIGNOR(S) HEREBY CONFIRMS THE CORRECT ASSIGNEE IS PENTEC HEALTH,INC. Recorded Jul 17, 2012
From: MOORE, EILEEN; LINDENFELD, STAN; RICKER, MICHELLE
To: PENTEC HEALTH, INC.
Reel/Frame 028620/0355 →
SECURITY AGREEMENT Recorded Jun 4, 2012
From: PENTEC HEALTH, INC.
To: MADISON CAPITAL FUNDING LLC, AS AGENT
Reel/Frame 028316/0542 →
RELEASE OF SECURITY INTEREST Recorded Jun 29, 2011
From: COMERICA BANK
To: PENTEC HEALTH, INC.
Reel/Frame 026520/0372 →
SECURITY AGREEMENT Recorded Jun 17, 2011
From: COMERICA BANK
To: PENTEC HEALTH, INC.
Reel/Frame 026460/0404 →
SECURITY AGREEMENT Recorded May 25, 2011
From: PENTEC HEALTH, INC.
To: MADISON CAPITAL FUNDING LLC, AS AGENT
Reel/Frame 026340/0321 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 16, 2010
From: MOORE, EILEEN; LINDENFELD, STAN; RICKER, MICHELLE
To: PENTEC HEALTH
Reel/Frame 023939/0482 →
Continuity (3)
Provisional Application 61078636 · Jul 7, 2008
Provisional Application 61080567 · Jul 14, 2008
Related Publication 20100136133A1 · Jun 3, 2010