Systems and methods for dextrose containing peritoneal dialysis (PD) solutions with neutral pH and reduced glucose degradation product

• US 7,935,070 B2
• Filed: 01/28/2005
• Issued: 05/03/2011
• Est. Priority Date: 01/28/2005
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Tuominen, Olli, Jensen, Lynn E., Lan, Jay M.
• Primary Examiner(s): Deak; Leslie R
• Assistant Examiner(s): Wiest; Philip R
• Application Number:
  US11/046,667
• Publication Number:
  US 20060172954A1
• Time in Patent Office: 2,286 Days
• Field of Search: 604/403, 604408-416, 604 8- 10, 604 15- 18, 604/27, 604/30, 604/43, 604/108, 604/175, 604/184, 604/185, 604/264, 604272-280, 206418-422, 206/221, 514/2, 514/23, 424715-717, 210/645, 623/4, 623/5, 623/8, 606/109, 606/166, 606/184, 606/185
• US Class Current: 604/5.04
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2027 having frangible parts
• 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: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/287 Dialysates therefor
• CPC Class Codes: A61M 39/221 Frangible or pierceable closures within tubing A61M39/14 takes precedence; frangible closures for containers A61J1/14
• 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

Abstract

The invention provides container systems, kits and methods for peritoneal dialysis (PD) solutions. Such a system, for example, includes a first compartment that contains a PD osmotic agent and a second compartment that contains a PD buffer agent. The compartments maintain their respective contents separately from one another for purposes of transport, storage and/or sterilization. However, the compartments are fluidly couplable, so that their respective contents can be combined with one another, e.g., following sterilization of the agents and prior to their introduction into the patient'"'"'s abdomen.

Claims

1. A container system for peritoneal dialysis (PD) solutions, comprising:

a first compartment containing a PD osmotic agent,

a second compartment containing a PD buffer agent,

wherein the first and second compartments are coupled, any of directly or indirectly, to support fluid transfer therebetween, and

wherein the PD buffer agent comprises lactate and has a concentration of about 3-fold to about 15-fold higher than Normal PD buffer agent,

such that a PD solution that results from a mixing of the PD osmotic agent and the PD buffer agent would have reduced glucose degradation products relative to PD solutions produced from any of a conventional two-bag and a dual chamber PD solution container system.

2. The container system of claim 1, further comprising

first and second frangible seals,

wherein the first seal frangibly prevents fluid transfer between the first and the second compartment, and the second seal frangibly prevents fluid transfer between the second compartment and an outlet port of the container system.

3. The container system of claim 2, wherein the second compartment is formed in a vessel that is configured in the shape of a miniature bulb.

4. The container system of claim 2, wherein the second compartment is formed in a vessel is adapted for manipulation by a patient, health care provider, or other, to facilitate breaking any of the first and second frangible seals.

5. The container system of claim 4, wherein the vessel in which the second compartment is formed comprises rubber, polyolefin, polypropylene, and/or other medical grade material suitable for squeezing or other manipulation by the patient, health care provider, or other, to facilitate breaking any of the first and second frangible seals.

6. The container system of claim 4, wherein the vessel in which the second compartment is formed is collapsible along an axis substantially aligned with a direction of fluid flow between the respective compartments of the first and second vessels.

7. The container system of claim 6, wherein the vessel in which the second compartment is formed has walls that are fan-folded along at least a portion of a length thereof.

8. The container system of claim 4, wherein the vessel in which the second compartment is formed is any of blow-molded, dipping-formed or formed as part of an extrusion process.

9. The container system of claim 4, wherein the vessel in which the second compartment is formed is any of blow-molded or dipping-formed in-line with an outlet of a solution bag that comprises the first compartment.

10. The container system of claim 1, wherein the PD buffer agent has a concentration of about 10-fold or higher than Normal PD buffer agent.

11. The container system of claim 1, wherein the PD buffer agent has a concentration of about 15-fold or higher than Normal PD buffer agent.

12. The container system of claim 1, wherein the PD buffer agent comprises at least one of acetate and pyruvate.

13. The container system of claim 1, wherein the PD buffer agent has a pH of about 9.0 to about 13.

14. The system of claim 13, wherein the PD buffer agent comprises at least one of bicarbonate and hydroxide.

15. The container system of claim 1, wherein the PD buffer agent has a pH of about 10.0 to about 12.0.

16. The container system of claim 1, wherein the PD osmotic agent has a pH range of about 1.0 to about 3.0.

17. A container system for peritoneal dialysis (PD) solutions, comprising:

a first compartment containing a PD osmotic agent,

a second compartment containing a PD buffer agent comprising lactate,

wherein the first and second compartments are coupled for fluid transfer therebetween,

wherein a ratio of a volumetric capacity of the first compartment to a volumetric capacity of the second compartment is in the range of about 20;

1 to about 200;

1,

such that a PD solution that results from mixing of the PD osmotic agent and the PD buffer agent would have reduced glucose degradation products relative to PD solutions produced from any of a conventional two-bag and a dual chamber PD solution container system.

18. The container system of claim 17, wherein the first compartment is formed in a vessel that comprises an infusion bag or infusion bottle.

19. The container system of claim 17, wherein the second compartment is formed in a vessel that is at least a partially collapsible vessel.

20. The container system of claim 19, wherein the vessel in which the second compartment is formed is collapsible along an axis substantially aligned with a direction of fluid flow between the respective compartments of the first and second vessels.

21. The container system of claim 17, wherein the ratio of the volumetric capacity of the first compartment to the volumetric capacity of the second compartment is in the range of about 90:

1 to about 120;

1.

22. The container system of claim 21, wherein the PD osmotic agent has a pH range of about 1.0 to about 3.0.

23. The container system of claim 22, wherein the PD osmotic agent is a sugar selected from the group consisting of glucose, dextrose, icodextrin, and fructose.

24. The container system of claim 22, wherein PD buffer agent has a pH of about 9.0 to about 12.0.

25. The container system of claim 24, wherein PD buffer agent has a concentration at about 10-fold higher than Normal PD buffer agent.

26. The container system of claim 25, wherein PD buffer agent comprises at least one of acetate and pyruvate.

27. The system of claim 24, wherein the PD buffer agent comprises at least one of bicarbonate and hydroxide.

28. The container system of claim 17, further comprising:

a first frangible seal that prevents fluid transfer between the first compartment and the second compartment, and

a second frangible seal that prevents fluid transfer from the second compartment and an outlet port of the container system.

29. A method for producing a peritoneal dialysis (PD) solution with reduced glucose degradation products (GDPs), comprising:

sterilizing a PD osmotic agent,

sterilizing a PD buffer agent, where the PD buffer agent comprises lactate and has a concentration of about 3-fold to about 15-fold higher than Normal PD buffer agent,

combining the sterilized PD osmotic agent with the sterilized PD buffer agent, thereby producing a PD solution with reduced GDPs relative to PD solutions produced from any of a conventional two-bag and a dual chamber PD solution container system.

30. The method of claim 29, wherein the PD osmotic agent has a pH range of about 1.0 to about 6.0.

31. The method of claim 30, wherein the PD osmotic agent is a sugar selected from the group consisting of glucose, dextrose, icodextrin, and fructose.

32. The method of claim 29, wherein PD buffer agent has a pH or about 8.0 to about 14.0.

33. The method of claim 32, wherein PD buffer agent comprises at least one of acetate and pyruvate.

34. The method of claim 33, wherein the PD solution following the combining step has a pH ranging from about 6.0 to about 8.0.

35. The method of claim 29, wherein a volumetric ratio of the PD osmotic agent that is combined with the PD buffer agent in the combining step is in the range of about 20:

1 to about 200;

1.

36. The method of claim 29, wherein the PD buffer agent has a pH in a range between about 9.0 and about 13.0.

37. The method of claim 36, wherein the PD buffer agent comprises at least one of bicarbonate and hydroxide.

38. A container system for peritoneal dialysis (PD) solutions, comprising:

a first compartment containing a PD osmotic agent,

a second compartment containing a PD buffer agent that comprises lactate,

wherein the first and second compartments are coupled for fluid transfer therebetween,

a volumetric capacity of the first compartment is in a range of about 1 liter to about 5 liters, and a volumetric capacity of the second compartment is in a range of about 5 milliliters to about 50 milliliters, and

such that a PD solution that results from a mixing of the PD osmotic agent and the PD buffer agent has reduced glucose degradation products relative to PD solutions produced from any of a conventional two-bag and a dual chamber PD solution.

39. A container system according to claim 38, wherein a volumetric capacity of the second compartment is in a range of about 7.5 to about 37.5 milliliters.