Method and apparatus for a hemodiafiltration delivery module
First Claim
1. In a blood dialysis system including a dialysis machine and an extracorporeal circuit including a dialyzer, a diafiltration module that is an independent standalone unit relative to the dialysis machine and the extracorporeal circuit and is adapted to be detachably connected to at least one of the dialysis machine and the extracorporeal circuit, the diafiltration module comprising:
- a first conduit having a first end and an opposing second end, the first end for receiving a dialysate fluid from the dialysis machine and the second end for discharging the dialysate fluid to the dialyzer;
a second conduit in selective communication with the first conduit such that the second conduit selectively receives a diverted amount of the dialysate fluid from the first conduit, the second conduit communicating with at least one sterilizing filter for filtering the diverted amount of the dialysate fluid to produce a substitution fluid, wherein one end of the second conduit is configured to deliver the substitution fluid to the extracorporeal circuit;
a control unit responsive to a first detected characteristic of one of the dialysate fluid flowing within the first conduit and the diverted dialysate fluid flowing within the second conduit, the control unit being configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the first detected characteristic meets a prescribed criteria a pinch valve disposed within the second conduit for controlling the flow of the substitution fluid through the second conduit, the pinch valve being in communication with the control unit.
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Accused Products
Abstract
This invention provides a method and apparatus for a hemodiafiltration delivery module that is used in conjunction with a UF controlled dialysis machine to enable hemodiafiltration therapy to be performed. The advantage is that one can fully utilize a current functioning dialysis machine to perform a hemodiafiltration therapy as opposed to purchasing a completely new machine that offers this capability.
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Citations
41 Claims
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1. In a blood dialysis system including a dialysis machine and an extracorporeal circuit including a dialyzer, a diafiltration module that is an independent standalone unit relative to the dialysis machine and the extracorporeal circuit and is adapted to be detachably connected to at least one of the dialysis machine and the extracorporeal circuit, the diafiltration module comprising:
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a first conduit having a first end and an opposing second end, the first end for receiving a dialysate fluid from the dialysis machine and the second end for discharging the dialysate fluid to the dialyzer;
a second conduit in selective communication with the first conduit such that the second conduit selectively receives a diverted amount of the dialysate fluid from the first conduit, the second conduit communicating with at least one sterilizing filter for filtering the diverted amount of the dialysate fluid to produce a substitution fluid, wherein one end of the second conduit is configured to deliver the substitution fluid to the extracorporeal circuit;
a control unit responsive to a first detected characteristic of one of the dialysate fluid flowing within the first conduit and the diverted dialysate fluid flowing within the second conduit, the control unit being configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the first detected characteristic meets a prescribed criteria a pinch valve disposed within the second conduit for controlling the flow of the substitution fluid through the second conduit, the pinch valve being in communication with the control unit. - View Dependent Claims (2, 3, 4, 5, 6, 7, 41)
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8. In a blood dialysis system including a dialysis machine and an extracorporeal circuit including a dialyzer, a diafiltration module that is an independent standalone unit relative to the dialysis machine and the extracorporeal circuit and is adapted to be detachably connected to at least one of the dialysis machine and the extracorporeal circuit, the diafiltration module comprising:
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a first conduit having a first end and an opposing second end;
the first end for receiving a dialysate fluid from the dialysis machine and the second end for discharging the dialysate fluid to the dialyzer;
a second conduit in selective communication with the first conduit such that the second conduit selectively receives a diverted amount of the dialysate fluid from the first conduit, the second conduit communicating with at least one sterilizing filter for filtering the diverted amount of the dialysate fluid to produce a substitution fluid, wherein one end of the second conduit is configured to deliver the substitution fluid to the extracorporeal circuit;
a control unit responsive to a first detected characteristic of one of the dialysate fluid flowing within the first conduit and the diverted dialysate fluid flowing within the second conduit, the control unit being configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the first detected characteristic meets a prescribed criteria a substitution fluid pump disposed within the second conduit for diverting the amount of the dialysate fluid from the first conduit to the second conduit, the substitution fluid pump being in communication with the control unit; and
a flow switch disposed within the first conduit for detecting a flow rate within the first conduit, wherein the flow rate is the first detected characteristic, the flow switch being positionable between an ON position and an OFF position with the position of the flow switch being inputted to the control unit for controlling the operation of the substitution fluid pump. - View Dependent Claims (9)
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10. In a blood dialysis system including a dialysis machine and an extracorporeal circuit including a dialyzer, a diafiltration module that is an independent standalone unit relative to the dialysis machine and the extracorporeal circuit and is adapted to be detachably connected to at least one of the dialysis machine and the extracorporeal circuit, the diafiltration module comprising:
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a first conduit having a first end and an opposing second end, the first end for receiving a dialysate fluid from the dialysis machine and the second end for discharging the dialysate fluid to the dialyzer;
a second conduit in selective communication with the first conduit such that the second conduit selectively receives a diverted amount of the dialysate fluid from the first conduit, the second conduit communicating with at least one sterilizing filter for filtering the diverted amount of the dialysate fluid to produce a substitution fluid, wherein one end of the second conduit is configured to deliver the substitution fluid to the extracorporeal circuit;
a control unit responsive to a first detected characteristic of one of the dialysate fluid flowing within the first conduit and the diverted dialysate fluid flowing within the second conduit, the control unit being configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the first detected characteristic meets a prescribed criteria, wherein the control unit is responsive to a second detected characteristic of blood within the extracorporeal circuit, the second detected characteristic being a flow rate of the blood, wherein the control unit is configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the second detected characteristic meets a prescribed criteria; and
a substitution fluid pump disposed within the second conduit for diverting the amount of the dialysate fluid from the first conduit to the second conduit, the substitution fluid pump being in communication with the control unit;
wherein the dialysis machine includes a blood pump disposed within the extracorporeal circuit for transporting blood through the extracorporeal circuit; and
wherein the second detected characteristic of blood comprises pressure pulses in the extracorporeal circuit, the detection of pressure pulses being inputted to the control unit to signal whether the blood pump is operating below a predetermined threshold value, the pressure pulses being processed by the control unit as feedback control input for controlling operation of the substitution pump. - View Dependent Claims (11, 12, 13)
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14. In a blood dialysis system including a dialysis machine and an extracorporeal circuit including a dialyzer, a diafiltration module that is an independent standalone unit relative to the dialysis machine and the extracorporeal circuit and is adapted to be detachably connected to at least one of the dialysis machine and the extracorporeal circuit, the diafiltration module comprising:
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a first conduit having a first end and an opposing second end, the first end for receiving a dialysate fluid from the dialysis machine and the second end for discharging the dialysate fluid to the dialyzer;
a second conduit in selective communication with the first conduit such that the second conduit selectively receives a diverted amount of the dialysate fluid from the first conduit, the second conduit communicating with at least one sterilizing filter for filtering the diverted amount of the dialysate fluid to produce a substitution fluid, wherein one end of the second conduit is configured to deliver the substitution fluid to the extracorporeal circuit;
a control unit responsive to a first detected characteristic of one of the dialysate fluid flowing within the first conduit and the diverted dialysate fluid flowing within the second conduit the control unit being configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the first detected characteristic meets a prescribed criteria, wherein the control unit is responsive to a second detected characteristic of blood within the extracorporeal circuit, the second detected characteristic being a flow rate of the blood, wherein the control unit is configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the second detected characteristic meets a prescribed criteria, wherein the first detected characteristic is detected by a temperature decay measurement of at least one of the dialysate fluid in the first conduit and the diverted dialysate fluid in the second conduit.
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15. In a blood dialysis system including a dialysis machine and an extracorporeal circuit including a dialyzer, a diafiltration module that is an independent standalone unit relative to the dialysis machine and the extracorporeal circuit and is adapted to be detachably connected to at least one of the dialysis machine and the extracorporeal circuit, the diafiltration module comprising:
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a first conduit having a first end and an opposing second end, the first end for receiving a dialysate fluid from the dialysis machine and the second end for discharging the dialysate fluid to the dialyzer;
a second conduit in selective communication with the first conduit such that the second conduit selectively receives a diverted amount of the dialysate fluid from the first conduit, the second conduit communicating with at least one sterilizing filter for filtering the diverted amount of the dialysate fluid to produce a substitution fluid, wherein one end of the second conduit is configured to deliver the substitution fluid to the extracorporeal circuit;
a control unit responsive to a first detected characteristic of one of the dialysate fluid flowing within the first conduit and the diverted dialysate fluid flowing within the second conduit, the control unit being configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the first detected characteristic meets a prescribed criteria, wherein the control unit is responsive to a second detected characteristic of blood within the extracorporeal circuit, the second detected characteristic being a flow rate of the blood, wherein the control unit is configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the second detected characteristic meets a prescribed criteria, wherein the second detected characteristic is detected by a temperature decay measurement of the blood. - View Dependent Claims (20)
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16. In a blood dialysis system including a dialysis machine and an extracorporeal circuit including a dialyzer, a diafiltration module that is an independent standalone unit relative to the dialysis machine and the extracorporeal circuit and is adapted to be detachably connected to at least one of the dialysis machine and the extracorporeal circuit, the diafiltration module comprising:
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a first conduit having a first end and an opposing second end, the first end for receiving a dialysate fluid from the dialysis machine and the second end for discharging the dialysate fluid to the dialyzer;
a second conduit in selective communication with the first conduit such that the second conduit selectively receives a diverted amount of the dialysate fluid from the first conduit, the second conduit communicating with at least one sterilizing filter for filtering the diverted amount of the dialysate fluid to produce a substitution fluid, wherein one end of the second conduit is configured to deliver the substitution fluid to the extracorporeal circuit;
a control unit responsive to a first detected characteristic of one of the dialysate fluid flowing within the first conduit and the diverted dialysate fluid flowing within the second conduit, the control unit being configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the first detected characteristic meets a prescribed criteria, wherein the control unit is responsive to a second detected characteristic of blood within the extracorporeal circuit, the second detected characteristic being a flow rate of the blood, wherein the control unit is configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the second detected characteristic meets a prescribed criteria, wherein the first detected characteristic is calculated using a temperature decay measurement of one of the dialysate fluid and the diverted dialysate fluid and the second detected characteristic is calculated using a temperature decay measurement of the blood and the diafiltration module further includes;
a first temperature sensing device for detecting the temperature of one of the dialysate fluid in the first conduit and the diverted dialysate fluid in the second conduit, the first temperature sensing device in communication with the control unit and inputting the detected temperature to the control unit;
a second temperature sensing device for detecting the temperature of blood in the extracorporeal circuit, the second temperature sensing device in communication with the control unit and inputting the detected temperature to the control unit; and
wherein the control unit is configured to detect a decrease in flow rate of one of the dialysate fluid and the diverted dialysate fluid by monitoring the detected temperature inputted from the first temperature sensing device and a decrease in a blood flow rate within the extracorporeal circuit by monitoring the detected temperature inputted from the second temperature sensing device. - View Dependent Claims (17, 18, 19, 21)
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22. In a blood dialysis system including a dialysis machine and an extracorporeal circuit including a dialyzer, a diafiltration module that is an independent standalone unit relative to the dialysis machine and the extracorporeal circuit and is adapted to be detachably connected to at least one of the dialysis machine and the extracorporeal circuit, the diafiltration module comprising:
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a first conduit having a first end and an opposing second end, the first end for receiving a dialysate fluid from the dialysis machine and the second end for discharging the dialysate fluid to the dialyzer;
a second conduit in selective communication with the first conduit such that the second conduit selectively receives a diverted amount of the dialysate fluid from the first conduit, the second conduit communicating with at least one sterilizing filter for filtering the diverted amount of the dialysate fluid to produce a substitution fluid, wherein one end of the second conduit is configured to deliver the substitution fluid to the extracorporeal circuit;
a control unit responsive to a first detected characteristic of one of the dialysate fluid flowing within the first conduit and the diverted dialysate fluid flowing within the second conduit, the control unit being configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the first detected characteristic meets a prescribed criteria, wherein the control unit is responsive to a second detected characteristic of blood within the extracorporeal circuit, the second detected characteristic being a flow rate of the blood, wherein the control unit is configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the second detected characteristic meets a prescribed criteria, wherein the control unit is configured to prevent flow of the substitution fluid to the extracorporeal circuit when at least one of the first and second detected characteristics meets a prescribed criteria, wherein the second detected characteristic is detected by a rotational speed measurement of a blood pump that is part of the dialysis machine and is disposed within the extracorporeal circuit and wherein the prescribed criteria comprises a minimum rotational speed such that once the detected rotational speed measurement falls below the minimum rotational speed, the control unit prevents flow of the substitution fluid. - View Dependent Claims (23)
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24. In a blood dialysis system including a dialysis machine and an extracorporeal circuit including a dialyzer, a diafiltration module that is an independent standalone unit relative to the dialysis machine and the extracorporeal circuit and is adapted to be detachably connected to at least one of the dialysis machine and the extracorporeal circuit, the diafiltration module comprising:
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a first conduit having a first end and an opposing second end, the first end for receiving a dialysate fluid from the dialysis machine and the second end for discharging the dialysate fluid to the dialyzer;
a second conduit in selective communication with the first conduit such that the second conduit selectively receives a diverted amount of the dialysate fluid from the first conduit, the second conduit communicating with at least one sterilizing filter for filtering the diverted amount of the dialysate fluid to produce a substitution fluid, wherein one end of the second conduit is configured to deliver the substitution fluid to the extracorporeal circuit;
a control unit responsive to a first detected characteristic of one of the dialysate fluid flowing within the first conduit and the diverted dialysate fluid flowing within the second conduit, the control unit being configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the first detected characteristic meets a prescribed criteria, wherein the control unit is responsive to a second detected characteristic of blood within the extracorporeal circuit, the second detected characteristic being a flow rate of the blood, wherein the control unit is configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the second detected characteristic meets a prescribed criteria, wherein the control unit is configured to prevent flow of the substitution fluid to the extracorporeal circuit when at least one of the first and second detected characteristics meets a prescribed criteria, wherein the second detected characteristic is detected by monitoring a fluid level fluctuation of the blood within a drip chamber that is provided along the extracorporeal circuit and wherein the prescribed criteria is when the fluid level fluctuation is below an acceptable fluid level fluctuation value, thereby preventing the flow of substitution fluid to the extracorporeal circuit. - View Dependent Claims (25)
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26. In a blood dialysis system including a dialysis machine and an extracorporeal circuit including a dialyzer, a diafiltration module that is an independent standalone unit relative to the dialysis machine and the extracorporeal circuit and is adapted to be detachably connected to at least one of the dialysis machine and the extracorporeal circuit, the diafiltration module comprising:
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a first conduit having a first end and an opposing second end, the first end for receiving a dialysate fluid from the dialysis machine and the second end for discharging the dialysate fluid to the dialyzer;
a second conduit in selective communication with the first conduit such that the second conduit selectively receives a diverted amount of the dialysate fluid from the first conduit, the second conduit communicating with at least one sterilizing filter for filtering the diverted amount of the dialysate fluid to produce a substitution fluid, wherein one end of the second conduit is configured to deliver the substitution fluid to the extracorporeal circuit;
a control unit responsive to a first detected characteristic of one of the dialysate fluid flowing within the first conduit and the diverted dialysate fluid flowing within the second conduit, the control unit being configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the first detected characteristic meets a prescribed criteria, wherein the first detected characteristic is detected by inductively monitoring a current applied to an inlet valve that is disposed within a feed conduit that carries the dialysate fluid from the dialysis machine to one end of the first conduit. - View Dependent Claims (28)
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27. In a blood dialysis system including a dialysis machine and an extracorporeal circuit including a dialyzer, a diafiltration module that is an independent standalone unit relative to the dialysis machine and the extracorporeal circuit and is adapted to be detachably connected to at least one of the dialysis machine and the extracorporeal circuit, the diafiltration module comprising:
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a first conduit having a first end and an opposing second end, the first end for receiving a dialysate fluid from the dialysis machine and the second end for discharging the dialysate fluid to the dialyzer;
a second conduit in selective communication with the first conduit such that the second conduit selectively receives a diverted amount of the dialysate fluid from the first conduit, the second conduit communicating with at least one sterilizing filter for filtering the diverted amount of the dialysate fluid to produce a substitution fluid, wherein one end of the second conduit is configured to deliver the substitution fluid to the extracorporeal circuit;
a control unit responsive to a first detected characteristic of one of the dialysate fluid flowing within the first conduit and the diverted dialysate fluid flowing within the second conduit, the control unit being configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the first detected characteristic meets a prescribed criteria, wherein the control unit is responsive to a second detected characteristic of blood within the extracorporeal circuit, the second detected characteristic being a flow rate of the blood, wherein the control unit is configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the second detected characteristic meets a prescribed criteria, wherein the second detected characteristic is detected by inductively monitoring a current applied to a motor that drives a blood pump disposed within the extracorporeal circuit. - View Dependent Claims (29)
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30. In a blood dialysis system including a dialysis machine and an extracorporeal circuit including a dialyzer, a dialfiltration module that is an independent standalone unit relative to the dialysis machine and the extracorporeal circuit and is adapted to be detachably connected to at least one of the dialysis machine and the extracorporeal circuit, the diafiltration module comprising:
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a first conduit having a first end and an opposing second end, the first end for receiving a dialysate fluid from the dialysis machine and the second end for discharging the dialysate fluid to the dialyzer;
a second conduit in selective communication with the first conduit such that the second conduit selectively receives a diverted amount of the dialysate fluid from the first conduit, the second conduit communicating with at least one sterilizing filter for filtering the diverted amount of the dialysate fluid to produce a substitution fluid, wherein one end of the second conduit is configured to deliver the substitution fluid to the extracorporeal circuit;
a control unit responsive to a first detected characteristic of one of the dialysate fluid flowing within the first conduit and the diverted dialysate fluid flowing within the second conduit, the control unit being configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the first detected characteristic meets a prescribed criteria, wherein the control unit is responsive to a second detected characteristic of blood within the extracorporeal circuit, the second detected characteristic being a flow rate of the blood, wherein the control unit is configured to prevent flow of substitution fluid to the extracorporeal circuit by controlling flow of the diverted dialysate fluid within the second conduit in the control module when at least the second detected characteristic meets a prescribed criteria, wherein the second detected characteristic is detected by sensing vibrations generated by a blood pump that is disposed in the extracorporeal circuit. - View Dependent Claims (31)
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32. In a blood dialysis system including a dialysis machine that includes a source of dialysate fluid and an extracorporeal circuit, a method of preventing flow of substitution fluid to the extracorporeal circuit comprising the steps of:
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providing a diafiltration module including a first conduit having a first end and a second end for carrying dialysate fluid and a second conduit in selective communication with the first conduit such that the second conduit selectively receives a diverted amount of the dialysate fluid, the diafiltration module further including at least one sterilizing filter in fluid communication with the second conduit for filtering the diverted dialysate fluid to produce the substitution fluid;
fluidly connecting the first end of the first conduit to the dialysis machine so that the dialysate fluid flows from the source to the first conduit;
fluidly connecting the second conduit to the extracorporeal circuit such that the substitution fluid is delivered and introduced into the extracorporeal circuit;
providing a control unit;
detecting a first characteristic of the dialysate fluid flowing within the first conduit and detecting a second characteristic of the blood flowing within the extracorporeal circuit; and
inputting the detected first and second characteristics to the control unit, wherein the control unit is configured to prevent the flow and introduction of the substitution fluid into the extracorporeal circuit when at least the first characteristic meets a prescribed criteria wherein the first characteristic comprises a flow rate of the dialysate fluid and the second characteristic comprises a flow rate of the blood and the prescribed criteria comprises a situation where the dialysate flow rate falls below a predetermined flow rate. - View Dependent Claims (33, 34, 35, 36, 37, 38, 39, 40)
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Specification