Systems and methods for delivery of peritoneal dialysis (PD) solutions
First Claim
1. A vessel for storing peritoneal dialysis (PD) solutions, comprising:
- a first compartment containing a first PD agent,a second compartment containing a second PD agent, 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, anda second seal preventing fluid transfer between the second compartment and an outlet fluid pathway of the vessel,the vessel adapted to inhibit breaking of the second seal prior to breaking of the first seal,the vessel being configured so that the first seal breaks before the second seal breaks, andwherein at least two distinct manipulations are required to break the first and second seals.
1 Assignment
0 Petitions
Reexamination
Accused Products
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.
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Citations
50 Claims
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1. A vessel for storing peritoneal dialysis (PD) solutions, comprising:
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a first compartment containing a first PD agent, a second compartment containing a second PD agent, 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 vessel, the vessel adapted to inhibit breaking of the second seal prior to breaking of the first seal, the vessel being configured so that the first seal breaks before the second seal breaks, and wherein at least two distinct manipulations are required to break the first and second seals. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A container system for storing a plurality of fluids, comprising:
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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, the vessel being configured to inhibit breaking of the second seal prior to breaking of the first seal so that the first seal breaks before the second seal breaks, 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, wherein the first seal is disposed within an interior fluid flow pathway of the port. - View Dependent Claims (10, 11, 12, 13)
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14. A container system for peritoneal dialysis (PD) solutions, comprising:
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a first compartment containing a first PD agent, 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 first seal preventing fluid transfer between the first compartment and the second compartment, and a second seal preventing fluid transfer out of the second compartment of the container system, the container system configured to inhibit breaking of the first seal and the second seal at the same time and so that the first seal breaks before the second seal breaks. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36)
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37. A container system for peritoneal dialysis (PD) solutions, comprising:
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A. a first vessel defining a first compartment that contains a first PD agent, B. a second vessel defining a second compartment that contains 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. the second frangible seal being disposed within the second compartment, and wherein breaking of the second seal is inhibited by pressure in the second compartment until after the first seal is broken, and F. the vessel being configured so that the first seal breaks before the second seal breaks.
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38. A method of dispensing a peritoneal dialysis (PD) solution from a PD container system, comprising:
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providing the PD container comprising; (i) a first compartment containing a first PD agent, (ii) a second compartment containing a second PD agent, the second compartment being in any of direct and indirect fluid coupling with the first compartment, (iii) a first seal preventing fluid transfer between the first compartment and the second compartment, (iv) a second seal preventing fluid transfer between the second compartment and an outlet fluid pathway of the container system, and (v) preventing the second seal from breaking before the first seal breaks and thereby inhibiting fluid transfer out of the PD container prior to mixing the first PD agent with the second PD agent.
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39. A method of dispensing peritoneal dialysis (PD) solution from a PD container system, comprising:
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breaking a first seal in a PD container system of the type comprising;
a first compartment that contains a first PD agent and a second compartment that contains a second PD agent, andsqueezing, twisting or otherwise manipulating the second compartment to break a second seal 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 the container system is configured to inhibit breaking of the second seal prior to breaking of the first seal so that the first seal breaks before the second seal breaks.
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40. A vessel for storing peritoneal dialysis (PD) solutions, comprising:
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a first compartment, a second compartment, a first seal preventing fluid transfer between the first compartment and the second compartment, and at least one of a port and catheter (collectively, “
port”
) that is coupled to the second compartment,a second seal preventing fluid transfer between the second compartment and the port, and protective structure that is initially disposed in surrounding relation to the port, the vessel being configured so that the first seal is broken in order to allow the user to more readily manipulate the port, the vessel being configured to inhibit breaking of the second seal prior to breaking of the first seal so that the first seal breaks before the second seal breaks. - View Dependent Claims (41, 42, 43, 44, 45, 46, 47)
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48. A flexible vessel for storing peritoneal dialysis (PD) solutions, comprising:
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a first compartment formed in the vessel, a second compartment formed in the vessel, a first seal preventing fluid transfer between the first compartment and the second compartment, protective structure that is initially disposed in surrounding relation to at least one of a port and catheter (collectively, “
port”
) forming at least part of an outlet fluid pathway of the vessel,a second seal that prevents fluid transfer from at least one of the first and second compartments and the outlet fluid pathway, the vessel being configured to inhibit breaking of the second seal prior to breaking of the first seal so that the first seal breaks before the second seal breaks. - View Dependent Claims (49, 50)
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Specification