Last-chance quality check and/or air/pathogen filter for infusion systems
First Claim
Patent Images
1. A method for performing hemofiltration, comprising the steps of:
- providing at least one container of fluid that is regulatory-cleared for infusion into patients;
connecting said at least one container to at least one filter effective to ensure a concentration of endotoxins in said fluid passing therethrough is below 0.03 EU/ml;
administering to a patient a blood treatment including a step of infusing said fluid into said patient after filtering said fluid by means of said at least one filter.
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Abstract
Blood treatment system and method for high rate hemofiltration ensures against pyrogenic patient reaction by providing various mechanisms for filtering replacement fluid to remove endotoxins and other safety features including detecting incorrect fluid administration.
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Citations
76 Claims
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1. A method for performing hemofiltration, comprising the steps of:
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providing at least one container of fluid that is regulatory-cleared for infusion into patients;
connecting said at least one container to at least one filter effective to ensure a concentration of endotoxins in said fluid passing therethrough is below 0.03 EU/ml;
administering to a patient a blood treatment including a step of infusing said fluid into said patient after filtering said fluid by means of said at least one filter. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A method for performing hemofiltration, comprising the steps of:
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providing at least one container of fluid that is regulatory-cleared for a defined rate of infusion into patients;
connecting said at least one container to at least one filter effective to reduce a concentration of endotoxins in said fluid to a rate below that of said fluid in said container;
administering to a patient a blood treatment including a step of infusing said fluid into said patient at said defined rate after filtering said fluid by means of said at least one filter. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16, 17)
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18. A method for performing hemofiltration, comprising the steps of:
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providing at least one container of fluid for infusion into patients;
connecting said at least one container to at least one filter effective to ensure a concentration of endotoxins in said fluid passing therethrough is below both 0.03 EU/ml and such as to deliver no more than 5 EU/hr per Kg of patient weight at a defined rate of infusion into a patient;
administering to a patient a blood treatment including a step of infusing said fluid into said patient. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26)
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27. A method for performing hemofiltration, comprising the steps of:
filtering a replacement fluid to ensure against a presence of endotoxins, in a filtered fluid resulting from said step of filtering, at a concentration no higher than 0.03 EU/ml;
drawing a waste fluid from a patient;
infusing said filtered fluid into said patient;
said step of filtering including filtering with a media having a pore size that is ineffective to block endotoxins, but made of a material that is effective to adsorb endotoxins. - View Dependent Claims (28, 29, 30, 31, 32, 33, 34, 35)
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36. A device for performing hemofiltration, comprising:
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at least one container of fluid for infusion into patients;
connected to said at least one container, at least one filter effective to ensure a concentration of endotoxins in said fluid passing therethrough is below both 0.03 EU/ml and such as to deliver no more than 5 EU/hr per Kg of patient weight at a defined rate of infusion into a patient;
a hemofiltration system including at least one pump for pumping blood from and back to said patient;
a fluid circuit for conveying said blood, said fluid circuit connecting an outlet of said filter with a return flow of blood, whereby replacement fluid having a low level of pyrogens in infused into said patient. - View Dependent Claims (37, 38, 39)
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40. A disposable fluid circuit for infusion, comprising:
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a line for receiving an infusible fluid;
a pumping portion for engagement with a peristaltic pump;
an inline filter downstream of said pumping portion and immediately prior to a connector to a patient access configured to filter an infusate prior to contact with a patient blood stream;
said inline filter having properties to one of degass and reduce a rate of endotoxins of said infusate. - View Dependent Claims (41, 42, 43, 44, 45, 46, 48)
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47. A disposable fluid circuit for infusion, comprising:
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a line for receiving an infusible fluid;
a pumping portion for engagement with a peristaltic pump;
an inline sensor effective to detect a property of an infusate prior to contact with a patient blood stream. - View Dependent Claims (49)
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50. A disposable fluid circuit for renal replacement therapy and connectable with a blood treatment machine, comprising:
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a blood line connectable to a blood filter having properties appropriate for treatment by hemofiltration or dialysis;
said blood line having arterial and venous portions connectable to a patient access;
a replacement fluid line connected to said venous portion of said blood line for diluting blood;
a connection for an inline component in said replacement fluid line located immediately upstream of a junction joining said replacement fluid line and said venous portion;
said inline component including at least one of an inline filter effective to block pyrogens and/or air and a fluid property sensor connectable to a controller or alarm. - View Dependent Claims (51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64)
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65. A device for batch preparation of replacement fluid retrofittable to a blood treatment machine, comprising:
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a disposable fluid circuit including a replacement fluid container with a first input line having a connector for an inline sterile filter and an inlet connectable to a source of replacement fluid to be filtered by said sterile filter;
a peristaltic pump actuator;
said first input line having a pumping portion engageable with said peristaltic pump actuator;
said replacement fluid container having a first outlet connectable to a replacement fluid connector of a blood treatment machine that consumes replacement fluid in performing renal replacement therapy. - View Dependent Claims (66, 67, 68, 69, 70, 71, 72)
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73. A tubing set for preparation of replacement fluid by sterile filtering, comprising:
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a sterile replacement fluid container with an inlet line connected to a filter and a connector for drawing replacement fluid from a source;
an outlet port for drawing filtered replacement fluid from said replacement fluid container;
at least one recirculation port to flow sterile replacement fluid in a recirculating flow through said replacement fluid container to purge air from said outlet line, said recirculation port and a connection between them provided by a blood treatment circuit. - View Dependent Claims (74, 75, 76)
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Specification