Re-use of a hemodialysis cartridge

Abstract

The present invention provides a hemodialysis machine comprising a removably mountable cartridge having at least one inlet and at least one outlet, the cartridge defining a fluid pathway between said at least one inlet and said at least one outlet, a sanitisation device having an inlet and an outlet, a conduit connected between an outlet of the cartridge and the inlet of the sanitisation device and, a conduit connected between the outlet of the sanitisation device and an inlet of the cartridge.

The invention claimed is: 
     
       1. A method of cleaning a dialysate mixing and flow balance cartridge for re-use in the a hemodialysis machine, comprising:
 a) providing the cartridge, the cartridge having a first mixing pump chamber, a second mixing pump chamber connected to the first mixing pump chamber, a first flow balance pump chamber connected to the second mixing pump chamber, a second flow balance pump chamber, at least one inlet a plurality of inlets and at least one outlet a plurality of outlets; 
 b) connecting a sanitisation device chemical cleaning receptacle between the at least one inlet plurality of inlets and the at least one outlet plurality of outlets of the cartridge, wherein the sanitisation device comprising a chemical cleaning receptacle that is external to the cartridge; 
 c) flowing a liquid through the cartridge and the sanitisation device chemical cleaning receptacle in a first direction by actuation of at least one of the pump chambers on the cartridge; 
 d) flowing the liquid through the cartridge and the sanitisation device chemical cleaning receptacle in a second direction by actuation of at least one of the pump chambers on the cartridge; and 
 e) flowing the liquid out of the cartridge through the at least one outlet; and 
 wherein the at least one inlet of the cartridge comprises a plurality of inlets, each one of a spent dialysate solution inlet, a water inlet, a bicarbonate inlet and an acid inlet being a respective one of the plurality of inlets; and 
 the at least one outlet comprises a plurality of outlets, each one of a drain port, a clean dialysate solution outlet, and a water outlet being a respective one of the plurality of outlets at least one of the plurality of outlets. 
 
     
     
       2. The method of cleaning the cartridge for re-use in the hemodialysis machine according to  claim 1 , further comprising:
 f) connecting the spent dialysate solution inlet to the clean dialysate solution outlet;   g) connecting the water outlet to the bicarbonate inlet;   h) disconnecting the drain port;   i) connecting the water inlet to a purified water supply;   j) after performing the steps f through i, flushing purified water through the cartridge and out of the drain port and the acid inlet;   k) then connecting the drain port to the acid inlet;   I) then performing the step b connecting step by connecting the sanitisation device between the spent dialysate solution inlet and the clean dialysate solution outlet;   m) after performing the step I and while performing the step c, measuring conductivity of the liquid in the cartridge when flowing in the first direction to confirm that the liquid in the cartridge is not purified water;   n) after performing the steps m and d, disconnecting the sanitisation device, re-connecting the spent dialysate solution inlet to the clean dialysate solution outlet, and disconnecting the drain port from the acid inlet;   o) then performing the step e flowing step by flushing purified water through the cartridge and out of the drain port and the acid inlet;   p) then measuring the conductivity of the liquid in the cartridge to confirm that the liquid in the cartridge is purified water;   q) then disconnecting all of the cartridge inlets and outlets; and   r) then connecting the cartridge to the hemodialysis machine.   
     
     
       3. The method of cleaning the cartridge for re-use in the hemodialysis machine according to  claim 1 , further comprising:
 f) performing the step b connecting step by connecting the spent dialysate solution inlet, the clean dialysate solution outlet, the bicarbonate inlet, the acid inlet and the water outlet to the sanitisation device;   g) connecting the water inlet to a purified water supply;   h) connecting the drain port to a drain;   i) after performing the steps f through h, flushing purified water through the cartridge and out of the drain port;   j) then performing the step c by flowing a chemical from the sanitization device;   k) after or while performing step j, measuring conductivity of the liquid in the cartridge to confirm that the liquid in the cartridge is not purified water;   I) after performing the step k, performing the step e flowing step by flushing purified water through the cartridge and out of the drain port;   m) then measuring the conductivity of the liquid in the cartridge to confirm that the liquid in the cartridge is purified water;   n) then disconnecting all of the cartridge inlets and outlets; and   o) then connecting the cartridge to the hemodialysis machine.   
     
     
       4. The method of cleaning the cartridge for re-use in the hemodialysis machine according to  claim 1 , wherein the spent dialysate solution inlet, the clean dialysate solution outlet, the bicarbonate inlet, the acid inlet and the water outlet are connected to the sanitisation device via a common manifold, the manifold having a single fluid path to the sanitisation device. 
     
     
       5. The method of cleaning the cartridge for re-use in the hemodialysis machine according to  claim 1 , wherein the spent dialysate solution inlet, the clean dialysate solution outlet, the bicarbonate inlet, the acid inlet and the water outlet each have a respective fluid path to the sanitisation device. 
     
     
       6. The method of claim 1, wherein the plurality of inlets comprises at least one of a spent dialysate solution inlet, a water inlet, a bicarbonate inlet, and an acid inlet, and wherein the plurality of outlets comprises at least one of a drain port, a clean dialysate solution outlet, and a water outlet. 
     
     
       7. The method of claim 1, wherein the plurality of inlets comprises at least two of a spent dialysate solution inlet, a water inlet, a bicarbonate inlet, and an acid inlet. 
     
     
       8. The method of claim 1, wherein the plurality of inlets comprises at least three of a spent dialysate solution inlet, a water inlet, a bicarbonate inlet, and an acid inlet. 
     
     
       9. The method of claim 1, wherein the plurality of inlets comprises a spent dialysate solution inlet, a water inlet, a bicarbonate inlet, and an acid inlet. 
     
     
       10. The method of claim 1, wherein the plurality of outlets comprises at least two of a drain port, a clean dialysate solution outlet, and a water outlet. 
     
     
       11. The method of claim 1, wherein the plurality of outlets comprises at least three of a drain port, a clean dialysate solution outlet, and a water outlet. 
     
     
       12. The method of claim 1, wherein the plurality of outlets comprises a drain port, a clean dialysate solution outlet, and a water outlet. 
     
     
       13. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 6, further comprising:
 f) connecting the spent dialysate solution inlet to the clean dialysate solution outlet;   g) connecting the water outlet to the bicarbonate inlet;   h) disconnecting the drain port;   i) connecting the water inlet to a purified water supply;   j) after performing the steps f through i, flushing purified water through the cartridge and out of the drain port and the acid inlet;   k) then connecting the drain port to the acid inlet;   l) then performing the step b connecting step by connecting the chemical cleaning receptacle between the spent dialysate solution inlet and the clean dialysate solution outlet;   m) after performing the step l and while performing the step c, measuring conductivity of the liquid in the cartridge when flowing in the first direction to confirm that the liquid in the cartridge is not purified water;   n) after performing the steps m and d, disconnecting the chemical cleaning receptacle, re-connecting the spent dialysate solution inlet to the clean dialysate solution outlet, and disconnecting the drain port from the acid inlet;   o) then performing the step e flowing step by flushing purified water through the cartridge and out of the drain port and the acid inlet;   p) then measuring the conductivity of the liquid in the cartridge to confirm that the liquid in the cartridge is purified water;   q) then disconnecting the plurality of inlets and the plurality of outlets from the cartridge; and   r) then connecting the cartridge to the hemodialysis machine.   
     
     
       14. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 6, further comprising:
 f) performing the step b connecting step by connecting the spent dialysate solution inlet, the clean dialysate solution outlet, the bicarbonate inlet, the acid inlet and the water outlet to the chemical cleaning receptacle;   g) connecting the water inlet to a purified water supply;   h) connecting the drain port to a drain;   i) after performing the steps f through h, flushing purified water through the cartridge and out of the drain port;   j) then performing the step c by flowing a chemical from the chemical cleaning receptacle;   k) after or while performing step j, measuring conductivity of the liquid in the cartridge to confirm that the liquid in the cartridge is not purified water;   l) after performing the step k, performing the step e flowing step by flushing purified water through the cartridge and out of the drain port;   m) then measuring the conductivity of the liquid in the cartridge to confirm that the liquid in the cartridge is purified water;   n) then disconnecting the plurality of inlets and the plurality of outlets from the cartridge; and   o) then connecting the cartridge to the hemodialysis machine.   
     
     
       15. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 6, wherein the spent dialysate solution inlet, the clean dialysate solution outlet, the bicarbonate inlet, the acid inlet and the water outlet are connected to the chemical cleaning receptacle via a common manifold, the manifold having a single fluid path to the chemical cleaning receptacle. 
     
     
       16. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 1, wherein the plurality of inlets and the plurality of outlets are connected to the chemical cleaning receptacle via a common manifold. 
     
     
       17. The method of 16, wherein the manifold includes a single fluid path to the chemical cleaning receptacle. 
     
     
       18. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 6, wherein the spent dialysate solution inlet, the clean dialysate solution outlet, the bicarbonate inlet, the acid inlet and the water outlet each have a respective fluid path to the chemical cleaning receptacle. 
     
     
       19. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 1, wherein each of the plurality of inlets and each of the plurality of outlets have a respective fluid path to the chemical cleaning receptacle. 
     
     
       20. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 6, further comprising:
 f) connecting the spent dialysate solution inlet to the clean dialysate solution outlet.   
     
     
       21. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 20, further comprising:
 g) connecting the water outlet to the bicarbonate inlet.   
     
     
       22. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 21, further comprising:
 h) disconnecting the drain port.   
     
     
       23. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 22, further comprising:
 i) connecting the water inlet to a purified water supply.   
     
     
       24. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 23, further comprising:
 j) after performing the steps f through i, flushing purified water through the cartridge and out of the drain port and the acid inlet.   
     
     
       25. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 24, further comprising:
 k) then connecting the drain port to the acid inlet.   
     
     
       26. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 25, further comprising:
 l) then performing the step b connecting step by connecting the chemical cleaning receptacle between the spent dialysate solution inlet and the clean dialysate solution outlet.   
     
     
       27. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 26, further comprising:
 m) after performing the step l and while performing the step c, measuring conductivity of the liquid in the cartridge when flowing in the first direction to confirm that the liquid in the cartridge is not purified water.   
     
     
       28. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 27, further comprising:
 n) after performing the steps m and d, disconnecting the chemical cleaning receptacle, re-connecting the spent dialysate solution inlet to the clean dialysate solution outlet, and disconnecting the drain port from the acid inlet.   
     
     
       29. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 28, further comprising:
 o) then performing the step e flowing step by flushing purified water through the cartridge and out of the drain port and the acid inlet.   
     
     
       30. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 29, further comprising:
 p) then measuring the conductivity of the liquid in the cartridge to confirm that the liquid in the cartridge is purified water.   
     
     
       31. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 30, further comprising:
 q) then disconnecting all of the cartridge inlets and outlets.   
     
     
       32. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 6, further comprising:
 f) performing the step b connecting step by connecting the spent dialysate solution inlet, the clean dialysate solution outlet, the bicarbonate inlet, the acid inlet and the water outlet to the chemical cleaning receptacle.   
     
     
       33. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 32, further comprising:
 g) connecting the water inlet to a purified water supply.   
     
     
       34. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 33, further comprising:
 h) connecting the drain port to a drain.   
     
     
       35. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 34, further comprising:
 i) after performing the steps f through h, flushing purified water through the cartridge and out of the drain port.   
     
     
       36. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 35, further comprising:
 j) then performing the step c by flowing a chemical from the chemical cleaning receptacle.   
     
     
       37. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 36, further comprising:
 k) after or while performing step j, measuring conductivity of the liquid in the cartridge to confirm that the liquid in the cartridge is not purified water.   
     
     
       38. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 37, further comprising:
 l) after performing the step k, performing the step e flowing step by flushing purified water through the cartridge and out of the drain port.   
     
     
       39. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 38, further comprising:
 m) then measuring the conductivity of the liquid in the cartridge to confirm that the liquid in the cartridge is purified water.   
     
     
       40. The method of cleaning the cartridge for re-use in the hemodialysis machine according to claim 39, further comprising:
 n) then disconnecting all of the cartridge inlets and outlets.