Hemodialysis systems and methods
First Claim
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1. A hemodialysis system, comprising:
- a cassette system, comprising a directing fluid circuit, a mixing fluid circuit and a balancing fluid circuit,wherein the directing fluid circuit is able to direct water from a water supply to the mixing fluid circuit and direct dialysate from the mixing fluid circuit to a balancing fluid circuit, the mixing fluid circuit is able to mix water from the directing fluid circuit with dialysate precursor from a dialysate precursor supply to produce a dialysate, andthe balancing fluid circuit is able to control the amount of dialysate passing through a dialyzer.
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Abstract
The present invention generally relates to hemodialysis and similar dialysis systems, including a variety of systems and methods that would make hemodialysis more efficient, easier, and/or more affordable. One aspect of the invention is generally directed to new fluid circuits for fluid flow. In one set of embodiments, a hemodialysis system may include a blood flow path and a dialysate flow path, where the dialysate flow path includes one or more of a balancing circuit, a mixing circuit, and/or a directing circuit. Preparation of dialysate by the preparation circuit, in some instances, may be decoupled from patient dialysis. In some cases, the circuits are defined, at least partially, within one or more cassettes, optionally interconnected with conduits, pumps, or the like. In one embodiment, the fluid circuit and/or the various fluid flow paths may be at least partially isolated, spatially and/or thermally, from electrical components of the hemodialysis system. In some cases, a gas supply may be provided in fluid communication with the dialysate flow path and/or the dialyzer that, when activated, is able to urge dialysate to pass through the dialyzer and urge blood in the blood flow path back to the patient. Such a system may be useful, for example, in certain emergency situations (e.g., a power failure) where it is desirable to return as much blood to the patient as possible. The hemodialysis system may also include, in another aspect of the invention, one or more fluid handling devices, such as pumps, valves, mixers, or the like, which can be actuated using a control fluid, such as air. In some cases, the control fluid may be delivered to the fluid handling devices using an external pump or other device, which may be detachable in certain instances. In one embodiment, one or more of the fluid handling devices may be generally rigid (e.g., having a spheroid shape), optionally with a diaphragm contained within the device, dividing it into first and second compartments.
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Citations
118 Claims
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1. A hemodialysis system, comprising:
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a cassette system, comprising a directing fluid circuit, a mixing fluid circuit and a balancing fluid circuit, wherein the directing fluid circuit is able to direct water from a water supply to the mixing fluid circuit and direct dialysate from the mixing fluid circuit to a balancing fluid circuit, the mixing fluid circuit is able to mix water from the directing fluid circuit with dialysate precursor from a dialysate precursor supply to produce a dialysate, and the balancing fluid circuit is able to control the amount of dialysate passing through a dialyzer. - View Dependent Claims (10, 11, 17, 18, 19, 20, 21, 23, 25, 27, 29, 31, 33, 35, 37, 40, 42, 44, 45, 46, 48, 49, 51, 53, 55, 57, 59, 61, 62, 63, 65, 67, 69, 71, 75, 77, 81, 83, 87, 89, 93, 95, 99, 104, 106, 108, 111, 113, 115, 117, 118)
a pump diaphragm mounted within the pumping volume; and an actuation port for connecting the pod pump to a pneumatic actuation system so that the diaphragm can be actuated to urge fluid into and out of the pumping volume, wherein the pump diaphragm separates the fluid from a gas in fluid communication with the pneumatic actuation system.
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69. The hemodialysis system of claim 65, wherein the at least one pod pump comprises:
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a rigid curved wall defining a pumping volume and having an inlet and an outlet; a pump diaphragm mounted within the pumping volume; and an actuation port for connecting the pod pump to a pneumatic actuation system so that the diaphragm can be actuated to urge fluid into and out of the pumping volume, wherein the pump diaphragm separates the fluid from a gas in fluid communication with the pneumatic actuation system.
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71. The hemodialysis system of claim 1, wherein the directing fluid circuit comprises at least one pod pump, wherein the at least one pod pump is actuated by a control fluid, and wherein the control fluid is controlled by a controller.
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75. The hemodialysis system of claim 57, wherein the common control fluid is controlled by a controller.
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77. The hemodialysis system of claim 71, wherein the controller is positioned in a first section, and the pump is positioned in a second section.
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81. The hemodialysis system of claim 75, wherein the controller is positioned in a first section, and the pump is positioned in a second section.
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83. The hemodialysis system of claim 77, wherein the first section is at least partially thermally isolated from the second section.
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87. The hemodialysis system of claim 81, wherein the first section is at least partially thermally isolated from the second section.
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89. The hemodialysis system of claim 77, wherein the first section is spatially isolated from the second section.
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93. The hemodialysis system of claim 81, wherein the first section is spatially isolated from the second section.
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95. The hemodialysis system of claim 71, wherein the control fluid is delivered using one or more tubes.
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99. The hemodialysis system of claim 71, wherein the controller is able to pressurize the control fluid.
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104. The hemodialysis system of claim 65, wherein the rigid curved wall defines a substantially spherical volume.
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106. The hemodialysis system of claim 67, wherein the rigid curved wall defines a substantially spherical volume.
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108. The hemodialysis system of claim 69, wherein the rigid curved wall defines a substantially spherical volume.
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111. The hemodialysis system as in claim 1, wherein the balancing fluid circuit, mixing fluid circuit and directing fluid circuit are combined in a cassette assembly.
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113. The hemodialysis system as in claim 1, wherein the cassette system defining the dialysate flow path comprises at least two distinct cassettes.
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115. The hemodialysis system as in claim 113, wherein the balancing fluid circuit is defined by a first cassette, the mixing fluid circuit is defined by a second cassette and the directing fluid circuit is defined by a third cassette.
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117. The hemodialysis system of claim 1, wherein the mixing fluid circuit is able to mix water from the directing fluid circuit with dialysate precursor from a plurality of dialysate precursor supplies to produce dialysate.
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118. The hemodialysis system of claim 1, wherein the balancing fluid circuit is configured to be able to substantially equalize an amount of dialysate flowing into a dialyzer with an amount of dialysate flowing out of the dialyzer.
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2. A hemodialysis system, comprising:
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a blood flow path through which blood is drawn from a patient and passed through a dialyzer; and a dialysate flow path through which dialysate flows from a dialysate supply through the dialyzer, the dialysate flow path comprising; a balancing fluid circuit which controls the amount of dialysate passing through the dialyzer, the balancing fluid circuit comprising at least two pumps, a mixing fluid circuit which forms dialysate from dialysate precursor and water, and a directing fluid circuit which passes water from a water supply to the mixing fluid circuit and passes dialysate from the mixing fluid circuit to the balancing fluid circuit, wherein the blood flow path is defined by a blood flow cassette. - View Dependent Claims (3, 4, 5, 6, 7, 38, 102)
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8. A hemodialysis system, comprising:
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a blood flow path through which blood is drawn from a patient and passed through a dialyzer; and a dialysate flow path through which dialysate flows from a dialysate supply through the dialyzer, the dialysate flow path comprising; a balancing fluid circuit which controls the amount of dialysate passing through the dialyzer, the balancing fluid circuit comprising at least two pumps, a mixing fluid circuit which forms dialysate from dialysate precursor and water, and a directing fluid circuit which passes water from a water supply to the mixing fluid circuit and passes dialysate from the mixing fluid circuit to the balancing fluid circuit, wherein the balancing fluid circuit comprises at least one pod pump. - View Dependent Claims (47, 64, 68, 103, 107)
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9. A hemodialysis system, comprising:
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a blood flow path through which blood is drawn from a patient and passed through a dialyzer; and a dialysate flow path through which dialysate flows from a dialysate supply through the dialyzer, the dialysate flow path comprising; a balancing fluid circuit which controls the amount of dialysate passing through the dialyzer, the balancing fluid circuit comprising at least two pumps, a mixing fluid circuit which forms dialysate from dialysate precursor and water, and a directing fluid circuit which passes water from a water supply to the mixing fluid circuit and passes dialysate from the mixing fluid circuit to the balancing fluid circuit, wherein the balancing fluid circuit comprises two pod pumps and two balancing chambers.
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12. A hemodialysis system, comprising:
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a blood flow path through which blood is drawn from a patient and passed through a dialyzer; and a dialysate flow path through which dialysate flows from a dialysate supply through the dialyzer, the dialysate flow path comprising; a balancing fluid circuit which controls the amount of dialysate passing through the dialyzer, the balancing fluid circuit comprising at least two pumps, a mixing fluid circuit which forms dialysate from dialysate precursor and water, and a directing fluid circuit which passes water from a water supply to the mixing fluid circuit and passes dialysate from the mixing fluid circuit to the balancing fluid circuit, wherein the balancing fluid circuit comprises at least two valves controlled by a common control fluid. - View Dependent Claims (13, 14, 15, 16, 72, 73, 78, 79, 84, 85, 90, 91, 96, 97, 100, 101)
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22. A hemodialysis system, comprising:
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a blood flow path through which blood is drawn from a patient and passed through a dialyzer; and a dialysate flow path through which dialysate flows from a dialysate supply through the dialyzer, the dialysate flow path comprising; a balancing fluid circuit which controls the amount of dialysate passing through the dialyzer, the balancing fluid circuit comprising at least two pumps, a mixing fluid circuit which forms dialysate from dialysate precursor and water, and a directing fluid circuit which passes water from a water supply to the mixing fluid circuit and passes dialysate from the mixing fluid circuit to the balancing fluid circuit, wherein the balancing fluid circuit comprises a sensor element, and wherein the sensor comprises a thermal well, the thermal well comprising a hollow housing of a thermally conductive material, said housing having an outer surface and an inner surface, said inner surface of a predetermined shape so as to form a mating relationship with a sensing probe, whereby said mating thermally couples the inner surface with a sensing probe.
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24. A hemodialysis system, comprising:
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a blood flow path through which blood is drawn from a patient and passed through a dialyzer; and a dialysate flow path through which dialysate flows from a dialysate supply through the dialyzer, the dialysate flow path comprising; a balancing fluid circuit which controls the amount of dialysate passing through the dialyzer, the balancing fluid circuit comprising at least two pumps, a mixing fluid circuit which forms dialysate from dialysate precursor and water, and a directing fluid circuit which passes water from a water supply to the mixing fluid circuit and passes dialysate from the mixing fluid circuit to the balancing fluid circuit, wherein the mixing fluid circuit comprises a sensor element, and wherein the sensor comprises a thermal well, the thermal well comprising a hollow housing of a thermally conductive material, said housing having an outer surface and an inner surface, said inner surface of a predetermined shape so as to form a mating relationship with a sensing probe, whereby said mating thermally couples the inner surface with a sensing probe.
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26. A hemodialysis system, comprising:
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a blood flow path through which blood is drawn from a patient and passed through a dialyzer; and a dialysate flow path through which dialysate flows from a dialysate supply through the dialyzer, the dialysate flow path comprising; a balancing fluid circuit which controls the amount of dialysate passing through the dialyzer, the balancing fluid circuit comprising at least two pumps, a mixing fluid circuit which forms dialysate from dialysate precursor and water, and a directing fluid circuit which passes water from a water supply to the mixing fluid circuit and passes dialysate from the mixing fluid circuit to the balancing fluid circuit, wherein the balancing fluid circuit is fluidically connectable to a positive pressure source.
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28. A hemodialysis system, comprising:
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a blood flow path through which blood is drawn from a patient and passed through a dialyzer; and a dialysate flow path through which dialysate flows from a dialysate supply through the dialyzer, the dialysate flow path comprising; a balancing fluid circuit which controls the amount of dialysate passing through the dialyzer, the balancing fluid circuit comprising at least two pumps, a mixing fluid circuit which forms dialysate from dialysate precursor and water, and a directing fluid circuit which passes water from a water supply to the mixing fluid circuit and passes dialysate from the mixing fluid circuit to the balancing fluid circuit, wherein the mixing fluid circuit is fluidically connectable to a positive pressure source.
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30. A hemodialysis system, comprising:
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a blood flow path through which blood is drawn from a patient and passed through a dialyzer; and a dialysate flow path through which dialysate flows from a dialysate supply through the dialyzer, the dialysate flow path comprising; a balancing fluid circuit which controls the amount of dialysate passing through the dialyzer, the balancing fluid circuit comprising at least two pumps, a mixing fluid circuit which forms dialysate from dialysate precursor and water, and a directing fluid circuit which passes water from a water supply to the mixing fluid circuit and passes dialysate from the mixing fluid circuit to the balancing fluid circuit, wherein the directing fluid circuit is fluidically connectable to a positive pressure source.
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32. A hemodialysis system, comprising:
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a blood flow path through which blood is drawn from a patient and passed through a dialyzer; and a dialysate flow path through which dialysate flows from a dialysate supply through the dialyzer, the dialysate flow path comprising; a balancing fluid circuit which controls the amount of dialysate passing through the dialyzer, the balancing fluid circuit comprising at least two pumps, a mixing fluid circuit which forms dialysate from dialysate precursor and water, and a directing fluid circuit which passes water from a water supply to the mixing fluid circuit and passes dialysate from the mixing fluid circuit to the balancing fluid circuit, wherein the balancing fluid circuit is fluidically connectable to a low-pressure source. - View Dependent Claims (39)
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34. A hemodialysis system, comprising:
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a blood flow path through which blood is drawn from a patient and passed through a dialyzer; and a dialysate flow path through which dialysate flows from a dialysate supply through the dialyzer, the dialysate flow path comprising; a balancing fluid circuit which controls the amount of dialysate passing through the dialyzer, the balancing fluid circuit comprising at least two pumps, a mixing fluid circuit which forms dialysate from dialysate precursor and water, and a directing fluid circuit which passes water from a water supply to the mixing fluid circuit and passes dialysate from the mixing fluid circuit to the balancing fluid circuit, wherein the mixing fluid circuit is fluidically connectable to a low-pressure source. - View Dependent Claims (41)
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36. A hemodialysis system, comprising:
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a blood flow path through which blood is drawn from a patient and passed through a dialyzer; and a dialysate flow path through which dialysate flows from a dialysate supply through the dialyzer, the dialysate flow path comprising; a balancing fluid circuit which controls the amount of dialysate passing through the dialyzer, the balancing fluid circuit comprising at least two pumps, a mixing fluid circuit which forms dialysate from dialysate precursor and water, and a directing fluid circuit which passes water from a water supply to the mixing fluid circuit and passes dialysate from the mixing fluid circuit to the balancing fluid circuit, wherein the directing fluid circuit is fluidically connectable to a low-pressure source. - View Dependent Claims (43)
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50. A hemodialysis system, comprising:
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a blood flow path through which blood is drawn from a patient and passed through a dialyzer; and a dialysate flow path through which dialysate flows from a dialysate supply through the dialyzer, the dialysate flow path comprising; a balancing fluid circuit which controls the amount of dialysate passing through the dialyzer, the balancing fluid circuit comprising at least two pumps, a mixing fluid circuit which forms dialysate from dialysate precursor and water, and a directing fluid circuit which passes water from a water supply to the mixing fluid circuit and passes dialysate from the mixing fluid circuit to the balancing fluid circuit, wherein the directing fluid circuit comprises at least one pod pump. - View Dependent Claims (52, 58, 60, 66, 105)
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54. A hemodialysis system, comprising:
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a blood flow path through which blood is drawn from a patient and passed through a dialyzer; and a dialysate flow path through which dialysate flows from a dialysate supply through the dialyzer, the dialysate flow path comprising; a balancing fluid circuit which controls the amount of dialysate passing through the dialyzer, the balancing fluid circuit comprising at least two pumps, a mixing fluid circuit which forms dialysate from dialysate precursor and water, and a directing fluid circuit which passes water from a water supply to the mixing fluid circuit and passes dialysate from the mixing fluid circuit to the balancing fluid circuit, wherein the directing fluid circuit comprises at least two pod pumps. - View Dependent Claims (56, 74, 80, 86, 92)
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70. A hemodialysis system, comprising:
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a blood flow path through which blood is drawn from a patient and passed through a dialyzer; and a dialysate flow path through which dialysate flows from a dialysate supply through the dialyzer, the dialysate flow path comprising; a balancing fluid circuit which controls the amount of dialysate passing through the dialyzer, the balancing fluid circuit comprising at least two pumps, a mixing fluid circuit which forms dialysate from dialysate precursor and water, and a directing fluid circuit which passes water from a water supply to the mixing fluid circuit and passes dialysate from the mixing fluid circuit to the balancing fluid circuit, wherein the directing fluid circuit comprises at least one pod pump, wherein the at least one pod pump is actuated by a control fluid, and wherein the control fluid is controlled by a controller. - View Dependent Claims (76, 82, 88, 94, 98)
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109. A hemodialysis system, comprising:
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a blood flow path through which blood is drawn from a patient and passed through a dialyzer; and a dialysate flow path through which dialysate flows from a dialysate supply through the dialyzer, the dialysate flow path comprising; a balancing fluid circuit which controls the amount of dialysate passing through the dialyzer, the balancing fluid circuit comprising at least two pumps, a mixing fluid circuit which forms dialysate from dialysate precursor and water, and a directing fluid circuit which passes water from a water supply to the mixing fluid circuit and passes dialysate from the mixing fluid circuit to the balancing fluid circuit, wherein at least one of the blood flow path and the dialysate flow path is defined by a cassette system comprising at least one cassette. - View Dependent Claims (110, 112, 114, 116)
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Specification
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Current AssigneeDeka Products Limited Partnership
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Original AssigneeDeka Products Limited Partnership
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InventorsWilt, Michael J., Demers, Jason A., Grant, Kevin L., Tracey, Brian, Dale, James D.
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Primary Examiner(s)Kim, John
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Application NumberUS12/072,908Publication NumberTime in Patent Office1,637 DaysField of Search210/85, 210/87, 210/90, 210/97, 210/103, 210/134, 210/143, 210/252, 210/257.1, 210/257.2, 210/258, 210/321.6, 604/4.01, 604/6.11, 417/375US Class Current210/258CPC Class CodesA61M 1/154 with sensing means or compo...A61M 1/155 with treatment-fluid pumpin...A61M 1/1561 at least one cassette surfa...A61M 1/15625 the reservoirs acting as ba...A61M 1/1565 Details of valvesA61M 1/16 with membranesA61M 1/1601 Control or regulationA61M 1/1621 Constructional aspects ther...A61M 1/1654 Dialysates thereforA61M 1/1694 with recirculating dialysin...A61M 1/267 used for pumpingA61M 1/3401 Cassettes thereforA61M 1/341 by measuring the filtrate r...A61M 1/3413 DiafiltrationA61M 1/3424 Substitution fluid pathA61M 1/3609 Physical characteristics of...A61M 1/3621 Extra-corporeal blood circu...A61M 1/36224 with sensing means or compo...A61M 1/36225 with blood pumping means or...A61M 1/362261 at least one cassette surfa...View All
