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

• US 8,328,784 B2
• Filed: 04/14/2009
• Issued: 12/11/2012
• 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: Jensen, Lynn E., Clark, Spencer, Tuominen, Olli, Lan, Jay M.
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US12/423,627
• Publication Number:
  US 20090264854A1
• Time in Patent Office: 1,337 Days
• Field of Search: 604 27- 30, 604/32, 604/190, 604/218, 604/236, 604246-248, 604/284, 604403-416
• 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 vessel comprising:

a first compartment containing a first agent of a solution,

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

at least one of the first and second compartments being adapted to be manipulated at least partially independently of the other of said first and second compartments,

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

a second seal preventing fluid transfer between the second compartment and an outlet fluid pathway of the system,

a protective member coupled to the vessel configured to inhibit breaking of the second seal prior to breaking of the first seal.

2. The vessel of claim 1 adapted to insure expulsion of at least a portion of the second agent from the second compartment to the first compartment prior to breakage of the second seal.

3. The vessel of claim 2, wherein the first chamber and second chamber of the vessel are formed by any one of cutting, welding, stamping, and gluing a sheet or web of material.

4. The vessel of claim 3, wherein one or more regions of the vessel that define the first chamber and second chamber, respectively, are separably affixed to one another by any of perforations and tacks.

5. The vessel of claim 4, wherein any of said perforations and tacks are adapted to be breakable by manipulation by a patient, health care provider, or other.

6. The vessel of claim 2, further comprising a diffuser adapted to facilitate mixing of the first agent and the second agent upon expulsion of the second agent from the second compartment.

7. The vessel of claim 1, wherein the protective member is slidably disposed on the system and adapted to move from a first position, wherein the protective member inhibits breaking of the second seal, to a second position, wherein the protective member does not inhibit breaking of the second seal.

8. The vessel of claim 7, wherein, prior to breaking of the first seal, movement of the protective member from the first position to the second position is restrained by the second compartment.

9. The vessel of claim 8, wherein presence of a quantity of fluid in the second compartment inhibits the protective member from sliding to the second position.

10. A container system for storing a plurality of fluids, comprising:

a vessel having a first chamber and a second chamber, the second chamber being in any of direct and indirect fluid coupling with the first chamber;

a first seal preventing fluid transfer between the first chamber and the second chamber;

a second seal preventing fluid transfer between the second chamber and an outlet fluid pathway of the container system;

a protective member configured to inhibit breaking of the second seal prior to breaking of the first seal; and

a port fluidly coupling the first chamber and the second chamber, the port comprising the first seal and a diffuser, the diffuser adapted to facilitate mixing of fluids upon expulsion of fluid from the second chamber to the first chamber.

11. The container system of claim 10, wherein the protective member has a slot or other opening sized to slide over at least a portion of the container forming the second chamber.

12. The container system of claim 11, wherein the slot or other opening is arranged to slide over at least the portion of the container forming the second chamber only after a quantity of fluid originally present in the second chamber has been expelled therefrom.

13. The container system of claim 11, wherein the slot or other opening is arranged to slide over at least the portion of the container forming the second chamber only if the second chamber is at least partially folded.