Batch filtration system for preparation of sterile fluid for renal replacement therapy
First Claim
1. A tubing set for a renal replacement therapy system requiring a sterile medicament, the tubing set comprising:
- a sterile filter connectable to a fluid source to filter fluid passing therethrough and thereby yield an infusible grade sterile fluid, said filter being of a configuration to prevent pathogens from flowing across a membrane thereof;
a batch container having an interior volume and a first port; and
a fluid line connected to the first port of the batch container, which is arranged such that the batch container interior volume can receive the infusible grade sterile fluid from the sterile filter by way of said fluid line,wherein the tubing set is adapted for one-time use at a location and a time at which a patient is to be infused with said sterile medicament, andthe fluid line includes at least one connection therein, a downstream connector of said connection being detachable therefrom and in fluid communication with the batch container first port such that said infusible grade sterile fluid can be conveyed from the batch container interior volume through said first port to a fluid circuit of the renal replacement therapy system for use at a rate that is independent of a rate permitted by said sterile filter when the detachable connector is connected to the renal replacement therapy system.
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0 Petitions
Accused Products
Abstract
A method and device for blood treatments that use fluids such as dialysate and replacement fluid for renal replacement therapy. In an embodiment, fluid is passed either by pump or passively by gravity feed, through a microporous sterilization filter from a fluid source to a replacement fluid container. The latter forms a batch that may be used during treatment. The advantage of forming the batch before treatment is that the rate of filtering needn'"'"'t match the rate of consumption during treatment. As a result, the sterilization filter can have a small capacity. In another embodiment, a filter is placed immediately prior to the point at which the sterile fluid is consumed by the treatment process. The latter may be used in combination with the former embodiment as a last-chance guarantee of sterility and/or that the fluid is free of air bubbles. It may also be used as the primary means of sterile-filtration.
98 Citations
16 Claims
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1. A tubing set for a renal replacement therapy system requiring a sterile medicament, the tubing set comprising:
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a sterile filter connectable to a fluid source to filter fluid passing therethrough and thereby yield an infusible grade sterile fluid, said filter being of a configuration to prevent pathogens from flowing across a membrane thereof; a batch container having an interior volume and a first port; and a fluid line connected to the first port of the batch container, which is arranged such that the batch container interior volume can receive the infusible grade sterile fluid from the sterile filter by way of said fluid line, wherein the tubing set is adapted for one-time use at a location and a time at which a patient is to be infused with said sterile medicament, and the fluid line includes at least one connection therein, a downstream connector of said connection being detachable therefrom and in fluid communication with the batch container first port such that said infusible grade sterile fluid can be conveyed from the batch container interior volume through said first port to a fluid circuit of the renal replacement therapy system for use at a rate that is independent of a rate permitted by said sterile filter when the detachable connector is connected to the renal replacement therapy system. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A tubing set for a renal replacement therapy requiring an sterile medicament, the tubing set comprising:
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a sterile filter connectable to a fluid source to filter fluid passing therethrough and thereby yield an infusible grade sterile fluid, said filter being of a configuration to prevent pathogens from flowing across a membrane thereof and to block air bubbles; and a batch container having an interior volume and a first port; and a fluid line connected to the first port of the batch container, which is arranged such that the batch container interior volume can receive the infusible grade sterile fluid from the sterile filter by way of said fluid line, wherein the tubing set is adapted for one-time use at a location and a time at which a patient is to be infused with said sterile medicament, the fluid line includes at least one connection therein, a downstream connector of said connection being detachable therefrom and in fluid communication with the batch container first port such that said infusible grade sterile fluid can be conveyed from the batch container interior volume through said first port to a fluid circuit of the renal replacement therapy system when the detachable connector is connected to the renal replacement therapy system, and said batch container is fitted with at least one additional connection to permit recirculation of fluid through said fluid circuit to remove gas from said fluid circuit by permitting air to settle in said batch container. - View Dependent Claims (13, 14, 15, 16)
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Specification