Automated peritoneal dialysis system and process with in-line sterilization of dialysate
First Claim
1. An automated peritoneal dialysis system for performing continuous peritoneal dialysis of the type which includes repeated cycles of delivering sterile dialysate to a patient'"'"'s peritoneal cavity and removing spent dialysate from the patient'"'"'s cavity wherein said system comprises:
- a dialysate preparation component providing a generally continuous supply of proportioned osmotic dialysate ready on demand which is effective for dialysis;
a fluid circuit connected to said dialysate supply for delivering a flow of the dialysate to the patient and a flow of spent dialysate from the patient to a drain;
an inflow line segment in said fluid circuit for delivering said dialysate from said supply to the patient;
a dialysate sterilization component having an in-line sterilization filter assembly disposed in said inflow line segment for real-time sterilization of said dialysate in said flow line segment prior to delivery of the dialysate to the patient'"'"'s peritoneal cavity during the peritoneal dialysis;
an outflow line segment included in said fluid circuit for connection to the patient to drain spent dialysate from the peritoneal cavity;
a filter integrity test component operatively associated with said sterilization filter assembly for conducting a realtime, in-line integrity test on said filter assembly during peritoneal dialysis and prior to patient delivery to test for a filter failure which would allow contaminants into said dialysate;
a control system controlling the filling and draining of the patient'"'"'s peritoneal cavity to exchange a volume of dialysate until a desired fluid weight has been removed from the patient;
a system sterilization component associated with said fluid circuit for sterilizing said fluid circuit including said dialysate sterilization component after a filter failure; and
said control system controlling said filter test component and said system sterilization component aperative to test said sterilization filter assembly and sterilize the fluid circuit in the event of a filter failure.
1 Assignment
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Accused Products
Abstract
An automated peritoneal dialysis system for performing continuous peritoneal dialysis is disclosed which includes a fluid circuit for delivering unsterilized dialysate from an uninterrupted supply, and a dialysate sterilization component having at least one in-line sterilization filter assembly disposed in the inflow line segment for realtime sterilization of the unsterilized dialysate during flow prior to patient delivery. A filter test component is operatively associated with the sterilization filter assembly for conducting a realtime integrity test on the filter assembly to test for a filter failure which would allow contaminants into the dialysate prior to patient delivery. If the filter fails the test, the fluid is discarded. In this manner, sterilization of fluid in realtime during a peritoneal dialysis process provides a high rate of dialysate exchange during repeated dialysate fill and drain cycles.
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Citations
64 Claims
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1. An automated peritoneal dialysis system for performing continuous peritoneal dialysis of the type which includes repeated cycles of delivering sterile dialysate to a patient'"'"'s peritoneal cavity and removing spent dialysate from the patient'"'"'s cavity wherein said system comprises:
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a dialysate preparation component providing a generally continuous supply of proportioned osmotic dialysate ready on demand which is effective for dialysis;
a fluid circuit connected to said dialysate supply for delivering a flow of the dialysate to the patient and a flow of spent dialysate from the patient to a drain;
an inflow line segment in said fluid circuit for delivering said dialysate from said supply to the patient;
a dialysate sterilization component having an in-line sterilization filter assembly disposed in said inflow line segment for real-time sterilization of said dialysate in said flow line segment prior to delivery of the dialysate to the patient'"'"'s peritoneal cavity during the peritoneal dialysis;
an outflow line segment included in said fluid circuit for connection to the patient to drain spent dialysate from the peritoneal cavity;
a filter integrity test component operatively associated with said sterilization filter assembly for conducting a realtime, in-line integrity test on said filter assembly during peritoneal dialysis and prior to patient delivery to test for a filter failure which would allow contaminants into said dialysate;
a control system controlling the filling and draining of the patient'"'"'s peritoneal cavity to exchange a volume of dialysate until a desired fluid weight has been removed from the patient;
a system sterilization component associated with said fluid circuit for sterilizing said fluid circuit including said dialysate sterilization component after a filter failure; and
said control system controlling said filter test component and said system sterilization component aperative to test said sterilization filter assembly and sterilize the fluid circuit in the event of a filter failure. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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25. An automated peritoneal dialysis system for performing continuous peritoneal dialysis of the type which includes a fluid circuit for delivering sterile dialysate to the peritoneal cavity of a patient and removing spent dialysate from the patient;
- and a system controller for controlling the flow of dialysate during said fill and drain of dialysate wherein said system comprises;
a generally continuous supply of unsterilized dialysate for supplying large volumes of dialysate on demand;
an inflow line segment included in said fluid circuit for delivering dialysate from said supply to the patient;
an outflow line segment included in said fluid circuit for connection to the patient'"'"'s peritoneal cavity to drain spent dialysate from the peritoneal cavity;
an in-line sterilization filter assembly disposed in said inflow line segment for realtime sterilization of said unsterilized dialysate during flow of said dialysate in said inflow line segment and prior to patient delivery;
said sterilization filter assembly including an inlet port connected in said inflow line segment for receiving unsterilized dialysate, a sterilization filter medium through which said dialysate passes for producing sterilized dialysate, and an outlet port connected in said inflow line segment through which sterilized dialysate flows for delivery to the patient during the peritoneal dialysis;
a filter test component operatively associated with said sterilization filter assembly for conducting a realtime integrity test on said filter assembly to test for a filter failure condition which would allow contaminants into said dialysate prior to patient delivery, wherein said system controller is operative to control said filter test component to test said sterilization filter assembly after said dialysate has passed through said filter assembly and before said dialysate is delivered to the patient during the peritoneal dialysis; and
a test sensor in communication with said testing component for detecting said failure condition;
whereby large volumes of sterilized dialysate are available on demand in realtime during the peritoneal dialysis process to provide a high rate of dialysate exchange during repeated dialysate fill and drain cycles until a desired weight of fluid waste is removed from the patient. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32, 33, 34)
- and a system controller for controlling the flow of dialysate during said fill and drain of dialysate wherein said system comprises;
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35. An automated peritoneal dialysis system for performing continuous peritoneal dialysis of the type which includes a fluid circuit for delivering sterile dialysate to a patient'"'"'s peritoneal cavity and removing used dialysate from the patient;
- and a system controller for controlling said filling and draining to achieve an effective dialysis, wherein said system comprises;
a steady supply of a large volume dialysate effective for dialysis available on demand;
an inflow line segment included in said fluid circuit for connection to the patient to deliver dialysate from said supply;
an outflow line segment included in said fluid circuit for connection to the patient to drain spent dialysate from the peritoneal cavity;
a sterilization unit included in said inflow line segment which includes;
a primary in-line sterilization filter assembly disposed in said inflow line segment for real-time sterilization of said dialysate during flow of said dialysate in said inflow line segment prior to patient delivery;
a secondary in-line sterilization filter assembly disposed in said inflow line segment for real-time sterilization of said dialysate during flow of said dialysate in said inflow line segment prior to patient delivery;
said primary sterilization filter assembly unit including an inlet port connected in said inflow line segment for receiving said dialysate from said supply, a sterilization filter medium through which said dialysate passes for producing sterilized dialysate, and an outlet port connected in said inflow line segment through which sterilized dialysate flows;
a delivery vessel included in said inflow line connected to said outlet port of said primary sterilization filter assembly for accumulating said dialysate;
said secondary filter assembly having an inlet port connected to said delivery vessel for receiving said accumulated dialysate, a sterilization filter medium for sterilizing said dialysate, and an outlet port for delivering dialysate to the patient; and
a filter test component operatively associated with said primary and secondary sterilization filter assemblies for conducting a real-time integrity test on said filter assemblies to test for a filter failure condition which would allow contaminants into said dialysate while said dialysate is accumulated and prior to patient delivery;
whereby filling and draining of the peritoneal cavity with dialysate may be repeated by the system controller as needed using a realtime supply of sterilized dialysate ready on demand providing a high rate of dialysate exchange. - View Dependent Claims (36, 37, 38, 39, 40, 41)
- and a system controller for controlling said filling and draining to achieve an effective dialysis, wherein said system comprises;
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42. An automated peritoneal dialysis process for performing continuous peritoneal dialysis of the type which includes providing a supply of sterile dialysate to fill the patient'"'"'s peritoneal cavity and removing spent dialysate from the patient'"'"'s cavity, said process comprising the steps of:
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(a) providing a generally continuous supply of large volumes of unsterilized dialysate;
(b) passing said unsterilized dialysate from said supply through an in-line sterilization filter assembly to produce sterilized dialysate in realtime during the process prior to delivery to the patient'"'"'s peritoneal cavity;
(c) accumulating said sterilized dialysate in a delivery vessel prior to delivery to the patient;
(d) subjecting said in-line filter assembly to a realtime filter integrity test during the process to test for a filter failure that would allow contaminants into said dialysate prior to patient delivery;
(e) delivering said sterile dialysate from said delivery vessel to the patient'"'"'s peritoneal cavity after said filter integrity test is passed; and
(f) repeating steps (a) through (e) until a desired volume of dialysate is exchanged. - View Dependent Claims (43, 44, 45, 46, 47, 48, 49, 50, 51)
determining the amount of said sterile dialysate delivered into the peritoneal cavity of a patient;
generating a first signal determined from the amount of said sterile dialysate delivered to the peritoneal cavity of a patient;
draining spent dialysate from the patient'"'"'s peritoneal cavity determining the amount of spent dialysate drained from the peritoneal cavity of a patient;
generating a second signal determined from the amount of spent dialysate drained from the peritoneal cavity of a patient;
controlling the delivery of said sterile dialysate to the peritoneal cavity of a patient in response to said first and second signals until a desired volume of body fluid is removed from the peritoneal cavity of a patient.
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51. The process of claim 50, wherein said process further comprises the step of calculating the amount of the body fluid waste removed from the patient after totally draining said dialysate for proportioning an amount of osmotic substance in said dialysate for subsequent fill and drain cycles.
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52. In a continuous, cyclic peritoneal dialysis process, an in-line, realtime dialysis fluid sterilization process to produce a sterilized dialysate comprising:
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preparing an unsterilized osmotic dialysate effective for dialysis;
passing said dialysate through at least one in-line sterilization filter assembly connected in an inflow line to the patient in realtime during the process prior to delivery to the patient; and
testing said sterilization filter assembly in realtime during the process after said passing step for a filter failure condition prior to delivering said dialysate to the peritoneal cavity of the patient. - View Dependent Claims (53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64)
providing a source of sterile pressurized air for connection to said in-line sterilization filter assembly;
purging an upstream side of said filter assembly upstream of said peritoneal cavity with sterile pressurized air;
isolating said filter assembly upstream of said peritoneal cavity allowing the pressure to stabilize; and
monitoring the pressure decay for a given period of time.
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61. The process of claim 52 including providing first and second filter assemblies in parallel flow arrangement in said fluid circuit;
- and passing dialysate thru said first filter assembly and accumulating said dialysate in a first delivery vessel, subjecting said first filter assembly to an integrity test, and delivering said dialysate to said patient if the test is passed in a current fill cycle; and
passing dialysate thru said second filter assembly and accumulating said dialysate in a second delivery vessel, subjecting said first second assembly to an integrity test, and delivering said dialysate from said second delivery vessel to said patient if the test is passed during a next fill cycle.
- and passing dialysate thru said first filter assembly and accumulating said dialysate in a first delivery vessel, subjecting said first filter assembly to an integrity test, and delivering said dialysate to said patient if the test is passed in a current fill cycle; and
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62. The process of claim 52 comprising the steps of:
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carrying out said automated peritoneal dialysis process using an automatic peritoneal dialysis machine having a fluid circuit;
providing a sterilant solution to sterilize said peritoneal dialysis machine;
providing sterile water to sterilize said peritoneal dialysis machine;
flushing said continuous peritoneal dialysis machine with said sterilant solution; and
flushing said peritoneal dialysis machine with said sterile water.
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63. The process of claim 62 including pressurizing said sterilant solution to force opposing flow of said sterilant through said in-line sterilization filter assembly to dislodge accumulated residue on the filter medium.
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64. The process of claim 62 including pressurizing said sterile water to force opposing flow of said water through said in-line sterilization filter assembly to dislodge accumulated residue on the filter surface membrane.
Specification