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

• US 7,837,666 B2
• Filed: 01/26/2006
• Issued: 11/23/2010
• 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:
  US11/340,403
• Publication Number:
  US 20060186045A1
• Time in Patent Office: 1,762 Days
• Field of Search: 604 82- 92, 604/248, 604403-416, 604/218, 604/236, 604/246, 604/27, 604/32, 604/190
• 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 method of dispensing a peritoneal dialysis solution from a peritoneal dialysis (PD) container system, comprising the steps of:

A. breaking a first seal in a PD container system of the type comprising a first compartment containing a first PD agent and a second compartment containing a second PD agent,

B. sliding a protective member from a first position, wherein it inhibits breaking of a second seal, to a second position, and

C. breaking the second seal to allow fluid to exit the container system via an outlet, wherein a presence of a quantity of fluid in the second compartment prior to breaking of the first seal inhibits sliding of the protective member.

2. The method of claim 1, further comprising:

preventing fluid transfer between the first compartment and the second compartment before breaking the first seal,

preventing fluid transfer between the second compartment and the outlet before breaking the second seal, and

inhibiting breakage of the second seal with the protective member prior to breaking of the first seal.

3. The method of claim 2, wherein the first and second seals are frangible.

4. The method of claim 2, wherein the protective member is a cover that is slidably disposed on the PD container system, and wherein the cover at the second position does not inhibit breaking of the second seal.

5. The method of claim 4, further comprising:

disposing the cover in the first position in surrounding relation to at least one of

i. the second seal, and

ii. one or more other structures of the container system in vicinity of the second seal that a patient, health care provider, or other manipulates in order to break that second seal.

6. The method of claim 4, wherein sliding the protective member comprises sliding an inner passageway of the cover over at least a portion of a vessel forming the second compartment.

7. The method of claim 4, further comprising:

restraining movement of the cover from the first position to the second position with the vessel forming the second compartment prior to breaking of the first seal.

8. The method of claim 7, wherein breaking the first seal includes decreasing an outer diameter of the second compartment.

9. The method of claim 8, wherein the cover has an internal diameter that is (i) smaller than an original outer diameter of the second compartment and (ii) sized to slide over the vessel forming the second compartment after decreasing the outer diameter of the second compartment.

10. The method of claim 9, wherein the second vessel is configured in the shape of a miniature bulb.

11. The method of claim 10, wherein the second vessel is adapted for manipulation by a patient, health care provider, or other, to facilitate breaking any of the first and second frangible seals.

12. The method of claim 10, wherein the second vessel comprises rubber, polyolefin, polypropylene, and/or other medical grade material suitable for squeezing, twisting or other manipulation by the patient, health care provider, or other, to facilitate breaking any of the first and second frangible seals.

13. The method of claim 9, wherein the first vessel comprises an infusion bag or infusion bottle.

14. The method of claim 2, further comprising:

defining the first compartment by at least a portion of a first vessel and defining the second compartment by at least a portion of a second vessel.

15. The method of claim 1, wherein the protective member is a cover and wherein the sliding step includes sliding the cover over a portion of a vessel forming the second compartment.

16. The method of claim 1, wherein the breaking steps comprise breaking frangible seals.

17. The method of claim 1, comprising compressing a vessel forming the second compartment, after breaking the first seal, in order to reduce an outer diameter of that vessel.

18. The method of claim 1, wherein the protective member includes a slot or other opening arranged to slide over at least a portion of the second compartment if a side thereof is aligned with the slot.

19. The method of claim 1, wherein the first PD agent is a PD osmotic agent and the second PD agent is a PD buffer agent.

20. A method of dispensing a peritoneal dialysis solution from a peritoneal dialysis (PD) container system, comprising the steps of:

A. breaking a first seal in a PD container system of the type comprising a first vessel defining a first compartment that contains a PD osmotic agent and a second vessel defining a second compartment that contains a PD buffer agent,

B. squeezing, twisting or otherwise manipulating the second vessel in order to break a frangible seal disposed within the second compartment that prevents fluid transfer between the second compartment and an outlet fluid pathway of the container system to allow fluid to exit the container system via the outlet, wherein a presence of a quantity of fluid in the second compartment prior to breaking of the first seal inhibits breaking the frangible seal.

21. The method of claim 20, further comprising:

preventing fluid transfer between the first compartment and the second compartment with the first seal, the first seal comprising a first frangible seal,

preventing fluid transfer between the second compartment and an outlet fluid pathway of the container system with the frangible seal, the frangible seal comprising a second frangible seal disposed within the second compartment.

22. The method of claim 21, wherein the second vessel is configured in the shape of a miniature bulb.

23. The method of claim 22, wherein second vessel is adapted for manipulation by a patient, health care provider, or other, to facilitate breaking at least the second frangible seal.

24. The method of claim 21, wherein the first vessel comprises an infusion bag or infusion bottle.

25. The method of claim 21, further comprising:

inhibiting any of squeezing, twisting or other manipulation of the second vessel for purposes of breaking of the second seal with a presence of a quantity of buffer agent in the second compartment prior to breaking of the first frangible seal.

26. The method of claim 21, wherein the PD container system further comprises a piercing member disposed within the second compartment, wherein compressing the second compartment results in breaking of the second seal by the piercing member.

27. The method of claim 26, further comprising:

inhibiting compression of the second compartment with a presence of a quantity of buffer agent in the second compartment prior to breaking of the first seal.

28. The method of claim 26, wherein the second vessel is configured in the shape of a miniature bulb.

29. The method of claim 26, wherein the first vessel comprises an infusion bag or infusion bottle.

30. The method of claim 26, wherein manipulating the second vessel includes collapsing the second vessel along an axis substantially aligned with a direction of fluid flow between the first and second compartments.

31. The method of claim 30, wherein the second vessel has walls that are fan-folded along at least a portion of a length thereof.

32. A method of dispensing a peritoneal dialysis solution from a peritoneal dialysis (PD) container system, comprising the steps of:

A. breaking a first seal in a PD container system of the type comprising a first vessel defining a first compartment that contains a first PD first and a second vessel defining a second compartment that contains a second PD agent, and

B. inhibiting breakage of a second seal that prevents fluid transfer between the second compartment and an outlet fluid pathway of the container system with a presence of a quantity of the second PD agent in the second compartment prior to breaking of the first seal.