Dialysis device and method of dialysis

Abstract

A dialysis device is provided comprising a disposable housing having a dialysate flow path along which dialysate received from a patient is subjected to contaminant removal when in operation, wherein said disposable housing comprises a storage chamber in fluid communication with the dialysate flow path for storing the dialysate therein; a controller for controlling the operation of said disposable housing; an interface means capable of operably coupling the controller and the disposable housing to enable the contaminant removal from the dialysate, and a fluid displacement means configured to move the dialysate along the dialysate flow path, wherein said fluid displacement means comprises a deformable diaphragm integrally formed with at least one wall of said storage chamber, wherein the flow path is fluidly sealed from the controller and interface means. A method of dialysis, a dialysis system and kits are also provided.

1 .- 61 . (canceled) 
     
     
         62 . A dialysis device comprising:
 a disposable housing having a dialysate flow path along which dialysate received from a patient is subjected to contaminant removal when in operation, wherein said disposable housing comprises a storage chamber in fluid communication with the dialysate flow path for storing the dialysate therein;   a controller for controlling the operation of said disposable housing;   an interface means capable of operably coupling the controller and the disposable housing to enable the contaminant removal from the dialysate, and   a fluid displacement means configured to move the dialysate along the dialysate flow path, wherein said fluid displacement means comprises a deformable diaphragm integrally formed with at least one wall of said storage chamber,   wherein the flow path is fluidly sealed from the controller and interface means.   
     
     
         63 . The dialysis device as claimed in  claim 62 , wherein said disposable housing comprises a sorbent zone in fluid communication with the dialysate flow path for removing contaminants in the dialysate. 
     
     
         64 . The dialysis device as claimed in  claim 62 , wherein said disposable housing further comprises valve means disposed along the dialysate flow path configured to control the direction of movement of the dialysate relative to the sorbent zone and storage chamber. 
     
     
         65 . The dialysis device as claimed in  claim 64 , wherein said valve means is operative by the flow direction of dialysate along said flow path. 
     
     
         66 . The dialysis device as claimed in  claim 64 , the controller further comprising actuation means for actuating said fluid displacement means and said valve means when said controller is connected to the disposable housing by said interface means. 
     
     
         67 . The dialysis device as claimed in  claim 62 , wherein said deformable diaphragm is in fluid contact on one side with the dialysate flow path and, on another opposite side, in contact with a pressure chamber that is capable of receiving fluid therein. 
     
     
         68 . The dialysis device as claimed in  claim 67 , wherein the deformable diaphragm is disposed and fluidly sealed from the pressure chamber and a rigid member. 
     
     
         69 . The dialysis device as claimed in  claim 67 , wherein the actuation means comprises a pump capable of fluid communication with the pressure chamber when said interface means operably couples said disposable housing to said controller. 
     
     
         70 . The dialysis device as claimed in  claim 69 , wherein said interface means comprises a conduit connector that fluidly couples the pump of the controller to the pressure chamber of the disposable housing. 
     
     
         71 . The dialysis device as claimed in  claim 70 , wherein the conduit connector comprises a first mating part disposed on the controller and a second mating part adapted disposed on the disposable housing, and wherein the first and second mating parts are configured to lockingly engage with each other. 
     
     
         72 . The dialysis device as claimed in  claim 70 , wherein the disposable housing comprises an additive dispensing means for dispensing a desired additive into the dialysate. 
     
     
         73 . The dialysis device as claimed in  claim 72 , wherein the additive dispensing means is activated by fluid pressure changes that occur in the conduit connector that is in fluid communication with the pump. 
     
     
         74 . The dialysis device as claimed in  claim 72 , wherein the additive dispensing means is discrete from the disposable housing. 
     
     
         75 . The dialysis device as claimed in  claim 74 , wherein the additive dispensing means comprises an interface means. 
     
     
         76 . The dialysis device as claimed in  claim 75 , wherein the interface means comprises a connector that fluidly couples the additive dispensing means to the flow path disposed in the disposable housing. 
     
     
         77 . The dialysis device as claimed in  claim 76 , wherein the connector comprises a first mating part disposed on the additive dispensing means and a second mating part disposed on the disposable housing, and wherein the first and second mating parts are configured to lockingly engage with each other. 
     
     
         78 . The dialysis device as claimed in  claim 77 , wherein the first mating part disposed on the additive dispensing means and/or second mating part disposed on the disposable housing are sealed to maintain the sterility of the additive solution in the additive dispensing means. 
     
     
         79 . The dialysis device as claimed in  claim 78 , wherein the first mating part disposed on the additive dispensing means and/or second mating part disposed on the disposable housing are sealed by means of a plug or frangible seal. 
     
     
         80 . The dialysis device as claimed in  claim 79 , wherein the first mating part disposed on the additive dispensing means mates with the second mating part disposed on the disposable housing by breaking or puncturing or dislodging the plug or seal of the mating part. 
     
     
         81 . The dialysis device as claimed in  claim 70 , wherein said disposable housing further comprises a gas vent in fluid communication with the flow path for venting gas from said dialysate. 
     
     
         82 . The dialysis device as claimed in  claim 81 , wherein the gas vent is activated by fluid pressure changes that occur in the conduit connector that is in fluid communication with the pump. 
     
     
         83 . The dialysis device as claimed in  claim 82 , wherein the gas vent is coupled to a hydrophilic bacteria filter in the dialysate flow path. 
     
     
         84 . The dialysis device as claimed in  claim 62 , wherein said storage chamber is upstream of said sorbent zone. 
     
     
         85 . The dialysis device as claimed in  claim 69 , wherein said controller comprises a computer configured to act on instructions for operation of the pump. 
     
     
         86 . The dialysis device as claimed in  claim 70 , wherein the interface means comprises a pressure sensor configured to determine the pressure of said dialysate when in the disposable housing. 
     
     
         87 . The dialysis device as claimed in  claim 86 , wherein the pressure sensor is disposed in the controller and is in fluid communication with the conduit connector. 
     
     
         88 . The dialysis device as claimed in  claim 62 , comprising an ammonia sensor configured to detect ammonia present in said dialysate. 
     
     
         89 . The dialysis device as claimed in  claim 88 , wherein the ammonia sensor is disposed in the disposable housing. 
     
     
         90 . The dialysis device as claimed in  claim 89 , wherein the ammonia sensor is configured to detect ammonia or ammonium ions. 
     
     
         91 . The dialysis device as claimed in  claim 89 , wherein the ammonia sensor comprises a material which changes color in the presence of ammonia. 
     
     
         92 . The dialysis device as claimed in  claim 89 , wherein the ammonia sensor comprises an ammonia-sensitive membrane. 
     
     
         93 . The dialysis device as claimed in  claim 88 , wherein the ammonia sensor is disposed in the controller. 
     
     
         94 . The dialysis device as claimed in  claim 93 , wherein the ammonia sensor is configured to detect ammonia or ammonium ions. 
     
     
         95 . The dialysis device as claimed in  claim 93 , wherein the ammonia sensor comprises a material which changes color in the presence of ammonia. 
     
     
         96 . The dialysis device as claimed in  claim 93 , wherein the ammonia sensor comprises an ammonia-sensitive membrane. 
     
     
         97 . The dialysis device as claimed in  claim 89 , wherein the ammonia sensor comprises an ammonia-selective potentiometric or amperometric electrode. 
     
     
         98 . The dialysis device as claimed in  claim 93 , wherein the ammonia sensor is configured to detect ammonia in gas extracted from a dialysate flow by a degasser. 
     
     
         99 . The dialysis device as claimed in  claim 98 , wherein the degasser is disposed in the disposable housing. 
     
     
         100 . The dialysis device as claimed in  claim 62 , wherein the device is powered by a battery. 
     
     
         101 . The dialysis device as claimed in  claim 100 , wherein the battery is a rechargeable battery. 
     
     
         102 . The dialysis device as claimed in  claim 101 , wherein the rechargeable battery is a lithium polymer battery. 
     
     
         103 . The dialysis device as claimed in  claim 62 , wherein the flow path comprises a fibrin trap located upstream of the sorbent zone. 
     
     
         104 . A kit comprising the dialysis device of  claim 62 , together with instructions for use.