Systems and methods for delivery of peritoneal dialysis (PD) solutions

• US 7,985,212 B2
• Filed: 07/27/2007
• Issued: 07/26/2011
• 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: Clark, Spencer, Jensen, Lynn E.
• Primary Examiner(s): Deak; Leslie R.
• Assistant Examiner(s): Wiest; Philip R
• Application Number:
  US11/829,611
• Publication Number:
  US 20080027374A1
• Time in Patent Office: 1,460 Days
• Field of Search: 604 82- 92, 604/248, 604403-416, 604/218, 604/236, 604/246, 604/27, 604/32, 604/190, 210646-655
• US Class Current: 604/416
• 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. The invention provides, in other aspects, such systems, kits and methods that provide protective structure which inhibits breaking of a seal prior between the second compartment and an outlet of the system, prior to breaking of a seal between the first and second compartments.

Claims

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

A. a first compartment containing a first PD agent,

B. a second compartment containing a second PD agent, the second compartment being in any of direct and indirect fluid coupling with the first compartment, a vessel in which the second compartment is formed expelling second PD agent upon application of force,

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

D. a second frangible seal that prevents fluid transfer between the second compartment and an outlet fluid pathway of the container system,

E. a protective member slideably disposed on the container system to move from a first position, wherein it inhibits breaking of the second frangible seal, to a second position, wherein it does not inhibit breaking of the second frangible seal, wherein the protective member has a slot or other opening sized to slide over at least a portion of the vessel in which the second compartment is formed and wherein presence of a quantity of second PD agent in the second compartment inhibits the slot or other opening from sliding over at least the portion of the vessel forming the second compartment.

2. The container system of claim 1, wherein the slot or other opening is arranged to slide over at least the portion of the vessel in which the second compartment is formed only after a quantity of second PD agent originally contained in that compartment has been expelled therefrom.

3. The container system of claim 2, wherein the slot or other opening is arranged to slide over at least the portion of the vessel in which the second compartment is formed only after at least 10%-30% of a quantity of second PD agent originally contained in that compartment has been expelled therefrom.

4. The container system of claim 2, wherein the slot or other opening is arranged to slide over at least the portion of the vessel in which the second compartment is formed only after at least 30%-50% of a quantity of second PD agent originally contained in that compartment has been expelled therefrom.

5. The container system of claim 2, wherein, the slot or other opening is arranged to slide over at least the portion of the vessel in which the second compartment is formed only after at least 75% of a quantity of second PD agent originally contained in that compartment has been expelled therefrom.

6. The container system of claim 2, wherein the slot or other opening is arranged to slide over at least the portion of the vessel in which the second compartment is formed only after substantially all of the second PD agent originally contained in that compartment has been expelled therefrom.

7. The system of claim 1, wherein the first compartment is formed in a vessel that comprises an infusion bag or infusion bottle.

8. The system of claim 1, wherein the vessel in which the second compartment is formed is adapted for manipulation by a patient, health care provider, or other, to facilitate folding thereof.

9. The system of claim 1, wherein any of the first and second frangible seals is adapted for manipulation by a patient, health care provider, or other, to facilitate breaking thereof.

10. The container system of claim 1, wherein the first PD agent is a PD osmotic agent and the second PD agent is a PD buffer agent.

11. The container system of claim 1, wherein two or more of the first seal, the protective member, and second seal bear visual indicia of an order in which they are to be manipulated by a patient, health care provider or other.

12. The system of claim 11, wherein the visual indicia is coloring.

13. The system of claim 12, wherein the first seal, protective member and second seal are colored differently from one another.

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

A. a first compartment containing a first PD agent,

B. a second compartment containing a second PD agent, the second compartment being in any of direct and indirect fluid coupling with the first compartment, a vessel in which the second compartment is formed folding upon application of force and expelling second PD agent in connection therewith,

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

D. a second seal that prevents fluid transfer between the second compartment and an outlet fluid pathway of the container system,

E. a protective member slideably disposed on the container system to move from a first position, wherein it inhibits breaking of the second seal, to a second position, wherein it does not inhibit breaking of the second seal,

F. the protective member including a slot or other opening is configured to slide over at least a portion of the vessel in which the second compartment is formed only if two or more sides thereof are aligned with the slot and that vessel is at least partially folded,

G. the first and second seals being adapted for breakage via manipulation by a patient, health care provider, or other.

15. The container system of claim 14, wherein the slot or other opening is arranged to slide over at least a portion of the vessel in which the second compartment is formed only if that vessel is at least partially folded, in a manner of butterfly wings.

16. The container system of claim 15, wherein presence of a quantity of second PD agent in the second compartment inhibits the slot or other opening from sliding over at least the portion of the vessel in which the second compartment is formed.

17. The container system of claim 16, wherein the slot or other opening is arranged to slide over at least the portion of the vessel in which the second compartment is formed only after a quantity of second PD agent originally contained in that compartment has been expelled therefrom.

18. The system of claim 14, wherein the protective member has an inner passageway sized to slide over at least a portion of the vessel in which the second compartment is formed.

19. The system of claim 18, wherein, prior to breaking of the first seal, movement of the cover from the first position to the second position is restrained by the vessel in which the second compartment is formed.

20. The system of claim 19, wherein the vessel in which the second compartment is formed has a first outer diameter prior to breaking of the first seal and a lesser outer diameter after breaking of the first seal.

21. The system of claim 20, wherein the protective member has an internal diameter that is (i) smaller than the first outer diameter and (ii) sized to slide over the vessel in which the second compartment is formed when it has the lesser outer diameter.

22. The container system of claim 14, wherein the first PD agent is a PD osmotic agent and the second PD agent is a PD buffer agent.

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

A. a first compartment containing a first PD agent,

B. a second compartment containing a second PD agent, the second compartment being in any of direct and indirect fluid coupling with the first compartment,

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

D. a second frangible seal that prevents fluid transfer between the second compartment and an outlet fluid pathway of the container system,

E. a protective member slideably disposed on the container system to move from a first position, wherein it inhibits breaking of the second frangible seal, to a second position, where it does not inhibit breaking of the second frangible seal, and wherein it covers at least a portion of a vessel in which the second compartment is formed.

24. The container system of claim 23, wherein the protective member causes at least a portion of the second PD agent to be expelled when the protective member is slid over the vessel in which the second compartment is formed.

25. The container system of claim 23, wherein a presence of a quantity of second PD agent in the second compartment inhibits the protective member from sliding over at least the portion of the vessel in which the second compartment is formed.

26. The container system of claim 23, wherein the protective member is configured to slide over at least the portion of the vessel in which the second compartment is formed only after a quantity of second PD agent originally contained in that compartment has been expelled therefrom.

27. The container system of claim 26, wherein the protective member is configured to slide over at least the portion of the vessel in which the second compartment is formed only after at least 10%-30% of a quantity of second PD agent originally contained in that compartment has been expelled therefrom.

28. The container system of claim 26, wherein the protective member is configured to slide over at least the portion of the vessel in which the second compartment is formed only after at least 30%-50% of a quantity of second PD agent originally contained in that compartment has been expelled therefrom.

29. The container system of claim 26, wherein protective member is configured to slide over at least the portion of the vessel in which the second compartment is formed only after at least 75% of a quantity of second PD agent originally contained in that compartment has been expelled therefrom.

30. The container system of claim 26, wherein the protective member is configured to slide over at least the portion of the vessel in which the second compartment is formed only after substantially all of the second PD agent originally contained in that compartment has been expelled therefrom.

31. The system of claim 23, wherein the first compartment is formed in a vessel that comprises an infusion bag or infusion bottle.

32. The system of claim 23, wherein the vessel in which the second compartment is formed is adapted for manipulation by a patient, health care provider, or other, to facilitate folding thereof.

33. The system of claim 23, wherein any of the first and second frangible seals is adapted for manipulation by a patient, health care provider, or other, to facilitate breaking thereof.

34. The container system of claim 23, wherein the first PD agent is a PD osmotic agent and the second PD agent is a PD buffer agent.

35. The container system of claim 23, wherein two or more of the first seal, the protective member, and second seal bear visual indicia of an order in which they are to be manipulated by a patient, health care provider or other.

36. The system of claim 35, wherein the visual indicia is coloring.

37. The system of claim 36, wherein the first seal, protective member and second seal are colored differently from one another.