Systems and methods for delivery of peritoneal dialysis (PD) solutions with integrated inter chamber diffuser

• US 10,842,714 B2
• Filed: 08/31/2016
• Issued: 11/24/2020
• Est. Priority Date: 10/14/2010
• 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., Ghatikar, Venugopal R., Lindley, Deloy, Jensen, Melvin D.
• Primary Examiner(s): Medway, Scott J
• Application Number:
  US15/252,815
• Publication Number:
  US 20170043079A1
• Time in Patent Office: 1,546 Days
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/2003 Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
• CPC Class Codes: A61J 1/2013 having two piercing ends
• 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: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61M 1/287 Dialysates therefor

Abstract

The invention provides, in some aspects, a container system for medical solutions such as peritoneal dialysis (PD) solutions. The invention particularly features a system which includes a first compartment that contains a first medical solution, e.g., a PD osmotic agent, and a second compartment that contains a second medical solution, e.g., 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. To that end, a container system can include a diffuser that is disposed in a fluid pathway between the first and second compartments, e.g., to facilitate homogeneous mixing of the first and second PD agents. That diffuser is disposed within and moves relative to a structure, such as a port that defines the fluid pathway between those compartment. Thus, for example, the diffuser can comprise a body that “floats” within that pathway-defining structure and that moves from one end to the other (and/or to from points there between), depending on a direction of solution flow through the structure.

Claims

1. A container system for medical agents, comprising:

a first compartment that contains a first medical agent,

a second compartment that contains a second medical agent, the second compartment being fluidly couplable with the first compartment via a fluid pathway-defining port that is disposed internally to one or more of the first and second compartments, and

a diffuser that is disposed within and movable relative to the port,

wherein the diffuser is movable toward one end of the port to permit movement of at least one of said medical agents through the port and into the first compartment and to facilitate mixing therein,

wherein the diffuser is movable toward another end of the port to permit movement of at least one of said medical agents through the port and into the second compartment to facilitate mixing therein.

2. The container system of claim 1, comprising structural elements that prevent the diffuser from blocking movement of medical agents through the port.

3. The container system of claim 1, wherein the first medical agent comprises a peritoneal dialysis (PD) osmotic agent and wherein the second medical agent comprises a PD buffer agent.

4. The container system of claim 3, wherein the PD buffer agent is selected from the group consisting of lactate, acetate, and pyruvate.

5. The container system of claim 3, wherein the PD osmotic agent is a sugar selected from the group consisting of glucose, dextrose, icodextrin, and fructose.

6. The container system of claim 1, wherein the diffuser moves from one end of the port to another end of the port, depending on the direction of movement of any of said medical agents therethrough.

7. The container system of claim 1, wherein the diffuser is enclosed at least substantially entirely within the port.

8. The container system of claim 7, wherein the diffuser is enclosed within the port such that at extremes of its motion within the port, the diffuser does not protrude substantially beyond an end of the port.

9. The contain system of claim 1, wherein the diffuser comprises one or more apertures to effect dispersion of any of the first and second medical agents moving from one of the compartments into the other compartment.

10. The container system of claim 9, wherein the one or more apertures effect said dispersion on expulsion of any of said first and second medical agents from one of the compartments into the other compartment.

11. The container system of claim 10, wherein one or more of the apertures comprise passages extending any of through the body of and along a surface of the diffuser.

12. The container system of claim 11, wherein one of more of said apertures are oriented along an axis parallel to a path through the port.

13. The container system of claim 9, wherein the one or more apertures effecting angular dispersion of any of the first and second medical agents.

14. The container system of claim 13, wherein the angular dispersion is in the range of 40°

-140°

.

15. The container system of claim 13, wherein the angular dispersion is in the range of 60°

-120°

.

16. The container system of claim 13, wherein the angular dispersion is about 50°

.

17. A multiple chamber vessel for peritoneal dialysis (PD) agents, comprising

a first compartment that contains a PD osmotic agent,

a second compartment that contains a PD buffer agent, the second compartment being fluidly couplable with the first compartment via an elongate fluid pathway-defining port that is disposed internally to one or more of the first and second compartments, and

a diffuser that is disposed within and movable relative to the port,

wherein the diffuser is movable toward one end of the port to permit movement of at least one of said PD agents through the port and into the first compartment and to facilitate mixing therein,

wherein the diffuser is movable toward another end of the port to permit movement of at least one of said PD agents through the port and into the second compartment to facilitate mixing therein, and

the port including a first frangible seal to prevent contact between the PD osmotic agent and the PD buffer agent.

18. The multiple chamber vessel of claim 17 formed such that at least one of the compartments is adapted to be bent, twisted, squeezed, folded and/or otherwise manipulated at least partially independently of the other compartment.

19. The multiple chamber vessel of claim 17, wherein portions of the vessel in which the respective compartments are formed are at least partially separable from one another.

20. The multiple chamber vessel of claim 19, wherein portions of the vessel in which the respective compartments are disposed are formed so that one portion can be folded and its respective compartment squeezed without substantially folding the other portion and squeezing its respective compartment.

21. The multiple chamber vessel of claim 17, comprising structural elements to prevent the first frangible seal from blocking movement of medical agent through the port if the first frangible seal becomes fully detached from the port.

22. The multiple chamber vessel of claim 17, wherein the first frangible seal is adapted to be broken by a patient or health care provider to permit any of liquids, gasses and solids comprising the agents to mix.

23. The multiple chamber vessel of claim 21, comprising a second frangible seal that prevents fluid transfer between the second compartment and an outlet fluid pathway of the vessel.

24. The multiple chamber vessel of claim 23, comprising a protective structure that deters breaking of the second seal prior to breaking of the first seal.

25. The multiple chamber vessel of claim 24, wherein the protective structure includes an opening arranged to slide over at least a portion of the vessel forming the second compartment only if that vessel is at least partially folded.

26. A container system for medical agents, comprising

a first compartment that contains a first medical agent,

a second compartment that contains a second medical agent, the second compartment being fluidly couplable with the first compartment via a fluid pathway-defining port that is disposed internally to one or more of the first and second compartments,

a diffuser that comprises one or more apertures and that is disposed within and movable relative to the port,

wherein the diffuser is movable to one end of the port to permit movement of at least one of said medical agents through the port and into the first compartment and to facilitate mixing therein,

wherein the diffuser is movable to another end of the port to permit movement of at least one of said medical agents through the port and into the second compartment to facilitate mixing therein, and

wherein the port includes one or more structural elements that prevent the diffuser from obstructing movement of the medical agents into, through and/or out of the port.

27. The container system of claim 26, wherein the one or more structural elements are disposed at an end of the port and on an inner diameter thereof.

28. The container system of claim 27, wherein the one or more structural elements are any of sized and shaped to prevent the diffuser from advancing toward an end of the structure closer than an offset that ensures adequate clearance for passage of any of said medical agents to/from that end of the structure.

29. The container system of claim 26, in which the port includes one or more tabs that flex to allow the diffuser to be inserted into the port.

30. A multiple chamber vessel for peritoneal dialysis (PD) agents, comprising

a first compartment that contains a PD osmotic agent,

a second compartment that contains a PD buffer agent, the second compartment being fluidly couplable with the first compartment via a fluid pathway-defining port,

a diffuser that is disposed within and movable relative to the port, wherein the diffuser is movable toward one end of the port to permit movement of at least one of said PD agents through the port and into the first compartment and to facilitate mixing therein, wherein the diffuser is movable toward another end of the port to permit movement of at least one of said PD agents through the port and into the second compartment to facilitate mixing therein,

wherein the port includes a first frangible seal to prevent contact between the PD osmotic agent and the PD buffer agent,

a second frangible seal that prevents fluid transfer between the second compartment and an outlet fluid pathway of the vessel,

wherein the port includes one or more structural elements that prevent at least one of the first and second seals from obstructing movement of any of said PD agents into, through and/or out of the port after that respective seal is broken.

31. The multiple chamber vessel of claim 30, wherein the port includes one or more structural elements that prevent the diffuser from obstructing movement of any of said PD agents into, through and/or out of the port.