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

• US 9,585,810 B2
• Filed: 10/14/2010
• Issued: 03/07/2017
• Est. Priority Date: 10/14/2010
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Jensen, Lynn E., Ghatikar, Venugopal R., Lindley, DeLoy, Jensen, Melvin D.
• Primary Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US12/904,637
• Publication Number:
  US 20120095392A1
• Time in Patent Office: 2,336 Days
• Field of Search: 604/29, 604/82, 604/408, 604/410, 604/416
• US Class Current: 1/1
• 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 solutions, comprising

A) a first compartment that contains a first medical solution and that is fluidly couplable with an outlet of the container system that includes a frangible seal,

B) a second compartment that contains a second medical solution, the second compartment being fluidly couplable with the first compartment via a fluid pathway-defining structure (hereinafter, “

port”

),

C) a diffuser for facilitating mixing of the first and second medical solutions that is disposed within and movable relative to the port, wherein the diffuser comprises a body that floats within the port, moving therein depending on a direction of solution flow through the port, wherein the body has one or more apertures to effect dispersion of any of the first and second medical solutions flowing from one of the compartments into the other compartment,

wherein the one or more apertures of the diffuser each comprise one or more passages extending any of through the body of and along a surface of the diffuser,

wherein the one or more apertures of the diffuser each facilitate two-way communication between the first and second compartments.

2. The container system of claim 1, wherein the first medical solution comprises a peritoneal dialysis (“

PD”

) osmotic agent and wherein the second medical solution comprises a PD buffer agent.

3. The container system of claim 1, wherein the diffuser moves from one end of the port to another end of the port, and/or to from points there between, depending on a direction of solution flow through the structure.

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

5. The container system of claim 4, 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.

6. The container system of claim 1, wherein the one or more apertures effect said dispersion on expulsion of any of said first and second medical solutions into said other compartment.

7. The container system of claim 1, wherein one of more of said apertures are oriented along an axis parallel to a fluid flow path of the port.

8. A multiple chamber vessel for peritoneal dialysis (PD) solutions, comprising

A) a first compartment that contains a PD osmotic agent and that is fluidly couplable with an outlet of the container system that includes a frangible seal,

B) a second compartment that contains a PD buffer agent, the second compartment being fluidly couplable with the first compartment via a fluid pathway-defining structure (hereinafter, “

port”

),

C) a diffuser for facilitating mixing of the first and second medical solutions that is disposed within and movable relative to the port, wherein the diffuser comprises a body having one or more apertures that floats within the port, moving therein depending on a direction of solution flow through the port,

wherein the one or more apertures of the diffuser each comprise one or more passages extending any of through the body of and along a surface of the diffuser,

wherein the one or more apertures of the diffuser each facilitate two-way communication between the first and second compartments.

9. The multiple chamber vessel of claim 8 formed such that at least one of the compartments to be bent, twisted, squeezed, folded and/or otherwise manipulated at least partially independently of the other compartment.

10. The multiple chamber vessel of claim 8, wherein portions of the vessel in which the respective compartments are formed are at least partially separable from one another.

11. The multiple chamber vessel of claim 10, wherein portions of the vessel in which the respective compartments 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.

12. The multiple chamber vessel of claim 8, wherein the port includes a first frangible seal to prevent contact between the PD osmotic agent and the PD buffer agent.

13. The multiple chamber vessel of claim 12, wherein the first frangible seal is adapted to be broken by a patient or health care provider to permit the agents to mix.

14. The multiple chamber vessel of claim 12, comprising a second frangible seal that prevents fluid transfer between the second compartment and an outlet fluid pathway of the vessel.

15. The multiple chamber vessel of claim 14, comprising a protective structure that deters breaking of the second seal prior to breaking of the first seal.

16. The multiple chamber vessel of claim 15, 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.

17. A container system for medical solutions, comprising

A) a first compartment that contains a first medical solution and that is fluidly couplable with an outlet of the container system that includes a frangible seal,

B) a second compartment that contains a second medical solution, the second compartment being fluidly couplable with the first compartment via a fluid pathway-defining structure (hereinafter, “

port”

),

C) a diffuser for facilitating mixing of the first and second medical solutions that is disposed within and movable relative to the port, wherein the diffuser comprises a body having one or more apertures that floats within the port, moving therein depending on a direction of solution flow through the port,

wherein the one or more apertures each comprise passages extending any of through the body of and along a surface of the diffuser, and wherein the one or more apertures each facilitate two-way communication between the first and second compartments,

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

18. The container system of claim 17, wherein the one or more structural elements are disposed at an end of the port and on an inner diameter thereof.

19. The container system of claim 18, 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 fluid passage to/from that end.

20. The container system of claim 17, in which the port includes one or more tabs that flex to allow the diffuser to be inserted into the port.

21. A multiple chamber vessel for peritoneal dialysis (PD) solutions, comprising

A) a first compartment that contains a PD osmotic agent and that is fluidly couplable with an outlet of the container system that includes a frangible seal,

B) a second compartment that contains a PD buffer agent, the second compartment being fluidly couplable with the first compartment via a fluid pathway-defining structure (hereinafter, “

port”

),

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

C) 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 obstructing flow of PD agent into, through and/or out of the port after that respective seal is broken, and a diffuser for facilitating mixing the first and second medical solutions that is disposed within and movable relative to the port, wherein the diffuser comprises a body having one or more apertures that floats within the port, wherein the one or more apertures each comprise a passage extending any of through the body of and along a surface of the diffuser moving therein depending on a direction of solution flow through the port, and wherein the one or more apertures each facilitate two-way communication between the first and second compartments.

22. The multiple chamber vessel of claim 21, wherein the port includes one or more structural elements that prevent the diffuser from obstructing flow of PD agent into, through and/or out of the port.