# US RE50,004 E1 · Dual haemodialysis and haemodiafiltration blood treatment device

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- Number: US RE50,004 E1
- Document ID: USRE50004E1
- Status: Granted
- Kind: E1
- Application number: 17/345,754
- Filed: 2021-06-11
- Granted: 2024-06-11
- Earliest claimed: 2013-08-14
- Assignees: Quanta Dialysis Technologies Limited
- Applicants: Quanta Dialysis Technologies Ltd.
- Inventors: Clive Henry Buckberry
- Web page: https://patentgrep.com/patent/USRE50004E1

## CPC

- A61M 1/168: {Sterilisation or cleaning before or after use}
- A61M 1/154: {with sensing means or components thereof}
- A61M 1/155: {with treatment-fluid pumping means or components thereof}
- A61M 1/156: {Constructional details of the cassette, e.g. specific details on material or shape}
- A61M 1/1562: {Details of incorporated reservoirs}
- A61M 1/15632: {the filter being a dialyser}
- A61M 1/1565: {Details of valves}
- A61M 1/16: with membranes
- A61M 1/1645: {with mechanically linked peristaltic dialysis fluid pumps one upstream, the other one downstream of the dialyser}
- A61M 1/34: Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M 1/3413: {Diafiltration}
- A61M 1/342: {Adding solutions to the blood, e.g. substitution solutions (for preventing coagulation A61M1/3672)}
- A61M 1/3635: {Constructional details}
- A61M 1/1566: {Means for adding solutions or substances to the treating fluid}
- A61M 2202/0413: Blood
- A61M 2205/128: with incorporated valves
- A61M 2205/33: Controlling, regulating or measuring
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The invention relates to a blood treatment device, in particular a device which can perform haemodialysis and haemodifiltration procedures. This is achieved using an interconnected pump and valve arrangement which can be controlled to direct fluid across a dialysis membrane or parallel to said membrane depending on the type of processing required. This allows dynamic variation between modes of operation and treatment.

## Claims

### Claim 1

A blood treatment device comprising:
a dialyzer;
a flow balance pump and valve arrangement, comprising:
a first pump operable to deliver a predetermined volume of cleaning solution from a cleaning solution source to the dialyzer or to remove the predetermined volume of cleaning solution from the dialyzer to a drain;
a second pump operable to deliver the predetermined volume of cleaning solution from the cleaning solution source to the dialyzer or to remove the predetermined volume of cleaning solution from the dialyzer to the drain;
a first dialyzer inlet valve arranged between the first pump and an inlet of the dialyzer;
a second dialyzer inlet valve arranged between the second pump and the inlet of the dialyzer;
a first dialyzer outlet valve arranged between an outlet of the dialyzer and the second pump;
a second dialyzer outlet valve arranged between the outlet of the dialyzer and the first pump;
a first cleaning solution source valve arranged between the cleaning solution source and the first pump;
a second cleaning solution source valve arranged between the cleaning solution source and the second pump;
a first drain valve arranged between the second pump and the drain;
a second drain valve arranged between the first pump and the drain; and
each of the valves and the pumps of the flow balance pump and valve arrangement being independently operable; and
a control system configured to operate the valves and pumps of the flow balance pump and valve arrangement in at least one first mode permitting hemodialysis and at least one second mode permitting hemodiafiltration;
wherein hemodialysis occurs because waste product from a patient's blood transfers to the cleaning solution via diffusion across a semi-permeable membrane in the dialyzer, but the cleaning solution substantially does not cross the membrane;
wherein hemodiafiltation occurs because the waste product from the patient's blood transfers to the cleaning solution when the cleaning solution is forced across the membrane into the patient's blood and then pulled back across the membrane; and
wherein the at least one second mode includes operating the first pump and the second pump in phase to generate a positive pressure in the dialyzer, or operating the first pump and the second pump out of phase to generate a positive pressure in the dialyzer.

### Claim 2 (depends on 1)

A device according to claim 1, wherein the control system is configured, in use, to alternate the operation of the valves and pumps between the at least one first mode and the at least one second mode.

### Claim 3 (depends on 1)

A device according to claim 1, wherein the control system is configured to alternate the pump responsible for delivering cleaning solution to the dialyzer and the pump responsible for removing spent cleaning solution from the dialyzer after a given number of pumping cycles.

### Claim 4 (depends on 3)

A device according to claim 3, wherein the number of pumping cycles is two or more pumping cycles.

### Claim 5 (depends on 1)

A device according to claim 1, wherein the pumps are positive displacement pumps.

### Claim 6 (depends on 5)

A device according to claim 5, wherein the pumps are membrane pumps.

### Claim 7 (depends on 1)

A device according to claim 1, wherein the flow balance pump and valve arrangement is formed on a disposable cartridge.

### Claim 8 (depends on 7)

A device according to claim 7, wherein the pumps and valves on the disposable cartridge are actuated by selective application of a negative or a positive air pressure thereto.

### Claim 9 (depends on 8)

A device according to claim 8, wherein the selective application of the negative or the positive air pressure is effected by a pneumatic pump.

### Claim 10 (depends on 9)

A device according to claim 9, wherein each pump or valve has an associated pneumatic pump on a machine which receives the cartridge.

### Claim 11 (depends on 10)

A device according to claim 10, wherein the control system controls the operation of the respective pneumatic pumps.

### Claim 12 (depends on 11)

A device according to claim 11, wherein the control system is a microprocessor which controls the pneumatic pumps electronically.

### Claim 13 (depends on 12)

A device according to claim 12, wherein the control is effected wirelessly.

### Claim 14 (depends on 1)

A method of operating the device according to claim 1,
wherein the valves and pumps of the flow balance pump and valve arrangement are operated by the control system in the at least one first mode permitting hemodialysis and the at least one second mode permitting hemodiafiltration.

### Claim 15 (depends on 14)

A method according to claim 14, wherein the valves and pumps are operated to alternate between the at least one first mode permitting hemodialysis and the at least one second mode permitting hemodiafiltration.

### Claim 16 (depends on 14)

A method according to claim 14, wherein the valves and pumps are operated in the at least one second mode permitting hemodiafiltration by operating the first and second pumps in phase to generate a positive pressure in the dialyzer.

### Claim 17 (depends on 14)

A method according to claim 14, wherein the at least one first mode comprises the steps of:
a) operating the first pump to draw the predetermined volume of cleaning solution from the cleaning solution source into the first pump and operating the second pump to expel the predetermined volume of spent cleaning solution from the second pump into the drain; and
b) operating the first pump to expel the predetermined volume of cleaning solution from the first pump into the dialyzer and operating the second pump to draw the predetermined volume of spent cleaning solution from the dialyzer into the second pump.

### Claim 18 (depends on 14)

A method according to claim 14, wherein the first mode comprises the steps of:
a) closing the first dialyzer inlet valve, closing the first dialyzer outlet valve, operating the first pump to draw the predetermined volume of cleaning solution from the cleaning solution source into the first pump and operating the second pump to expel the predetermined volume of cleaning solution from the second pump into the drain; and
b) opening the first dialyzer inlet valve, opening the first dialyzer outlet valve, operating the first pump to expel the predetermined volume of cleaning solution from the first pump into the dialyzer and operating the second pump to draw the predetermined volume of cleaning solution from the dialyzer into the second pump.

### Claim 19 (depends on 14)

A method according to claim 14, wherein the first mode comprises the steps of:
a) closing the first dialyzer inlet valve, closing the first dialyzer outlet valve, opening the first clean solution source valve, opening the first drain valve, operating the first pump to draw the predetermined volume of cleaning solution from the cleaning solution source into the first pump and operating the second pump to expel the predetermined volume of cleaning solution from the second pump into the drain; and
b) opening the first dialyzer inlet valve, opening the first dialyzer outlet valve, closing the first clean solution source valve, closing the first drain valve, operating the first pump to expel the predetermined volume of cleaning solution from the first pump into the dialyzer and operating the second pump to draw the predetermined volume of cleaning solution from the dialyzer into the second pump.

### Claim 20 (depends on 14)

A method according to claim 14, wherein the first mode comprises the steps of:
a) closing the first and second dialyzer inlet valves, closing the first and second dialyzer outlet valves, opening the first cleaning solution source valve, opening the first drain valve, closing the second cleaning solution source valve, closing the second drain valve, operating the first pump to draw the predetermined volume of cleaning solution from the cleaning solution source into the first pump and operating the second pump to expel the predetermined volume of cleaning solution from the second pump into the drain;
b) opening the first dialyzer inlet valve, opening the first dialyzer outlet valve, closing the first clean solution source valve, closing the first drain valve, operating the first pump to expel the predetermined volume of cleaning solution from the first pump into the dialyzer and operating the second pump to draw the predetermined volume of cleaning solution from the dialyzer into the second pump;
c) closing the first dialyzer inlet valve, closing the first dialyzer outlet valve, opening the first drain valve, and operating the second pump to expel the predetermined volume of cleaning solution from the second pump into the drain;
d) closing the first drain valve, opening the second cleaning solution source valve, and operating the second pump to draw the predetermined volume of cleaning solution from the clean solution source;
e) opening the second dialyzer inlet valve, opening the second dialyzer outlet valve, closing the second cleaning solution source valve, operating the second pump to expel the predetermined volume of cleaning solution from the second pump into the dialyzer and operating the first pump to draw the predetermined volume of cleaning solution from the dialyzer into the first pump; and
f) closing the second dialyzer outlet valve, opening the second drain valve, closing the second dialyzer inlet valve, opening the second cleaning solution source valve, operating the second pump to draw the predetermined volume of cleaning solution from the cleaning solution source and operating the first pump to expel the predetermined volume of cleaning solution from the first pump into the drain.

### Claim 21 (depends on 20)

A method according to claim 20, wherein the first mode further comprises repeating steps a) and b) one or more times before performing step c).

### Claim 22 (depends on 20)

A method according to claim 20, wherein the first mode further comprises repeating steps e) and 0 one or more times.

### Claim 23 (depends on 14)

A method according to claim 14, wherein the at least one second mode comprises the steps of:
a) operating the first pump to draw the cleaning solution from the cleaning solution source into the first pump and operating the second pump to draw the predetermined volume of cleaning solution from the dialyzer into the second pump; and
b) operating the first pump to expel the predetermined volume of cleaning solution from the first pump into the dialyzer and operating the second pump to expel the predetermined volume of cleaning solution from the second pump into the drain.

### Claim 24 (depends on 14)

A method according to claim 14, wherein the second mode comprises the steps of:
a) closing the first dialyzer inlet valve, opening the first dialyzer outlet valve, operating the first pump to draw the predetermined volume of cleaning solution from the cleaning solution source into the first pump and operating the second pump to draw the predetermined volume of cleaning solution from the dialyzer into the second pump; and
b) opening the first dialyzer inlet valve, closing the first dialyzer outlet valve, operating the first pump to expel the predetermined volume of cleaning solution from the first pump into the dialyzer and operating the second pump to expel the predetermined volume of cleaning solution from the second pump into the drain.

### Claim 25 (depends on 14)

A method according to claim 14, wherein the second mode comprises the steps of:
a) closing the first dialyzer inlet valve, opening the first dialyzer outlet valve, opening the first cleaning solution source valve, closing the first drain valve, operating the first pump to draw the predetermined volume of cleaning solution from the cleaning solution source into the first pump and operating the second pump to draw the predetermined volume of cleaning solution from the dialyzer into the second pump; and
b) opening the first dialyzer inlet valve, closing the first dialyzer outlet valve, closing the first cleaning solution source valve, opening the first drain valve, operating the first pump to expel the predetermined volume of cleaning solution from the first pump into the dialyzer and operating the second pump to expel the predetermined volume of cleaning solution from the second pump into the drain.

### Claim 26 (depends on 14)

A method according to claim 14, wherein the second mode comprises the steps of:
a) closing the first and second dialyzer inlet valves, opening the first dialyzer outlet valve, closing the second dialyzer outlet valve, opening the first cleaning solution source valve, closing the second cleaning solution source valve, closing the first and second drain valves, operating the first pump to draw the predetermined volume of cleaning solution from the cleaning solution source into the first pump and operating the second pump to draw the predetermined volume of cleaning solution from the dialyzer into the second pump;
b) opening the first dialyzer inlet valve, closing the first dialyzer outlet valve, closing the first cleaning solution source valve, opening the first drain valve, operating the first pump to expel the predetermined volume of cleaning solution from the first pump into the dialyzer and operating the second pump to expel the predetermined volume of cleaning solution from the second pump into the drain;
c) closing the first dialyzer inlet valve, opening the second dialyzer outlet valve, opening the second cleaning solution source valve, closing the first drain valve, operating the second pump to draw the predetermined volume of cleaning solution from the cleaning solution source into the second pump and operating the first pump to draw the predetermined volume of cleaning solution from the dialyzer into the first pump; and
d) opening the second dialyzer inlet valve, closing the first and second dialyzer outlet valves, closing the first cleaning solution source valve, opening the second drain valve, operating the first pump to expel the predetermined volume of cleaning solution from the first pump into the drain and operating the second pump to expel the predetermined volume of cleaning solution from the second pump into the dialyzer.

### Claim 27 (depends on 26)

A method according to claim 26, further comprising repeating steps a) and b) one or more times before performing step c).

### Claim 28 (depends on 26)

A method according to claim 26, further comprising a step after step d) of repeating steps c) and d) one or more times.

### Claim 29 (depends on 14)

A method according to claim 14, wherein the second mode comprises the steps of:
a) operating the first pump to draw the predetermined volume of cleaning solution from the cleaning solution source into the first pump and operating the second pump to expel the predetermined volume of cleaning solution from the second pump into the drain;
b) operating the first pump to expel the predetermined volume of cleaning solution from the first pump into the dialyzer; and
c) operating the operating the second pump to draw the predetermined volume of cleaning solution from the dialyzer into the second pump.

### Claim 30 (depends on 14)

A method according to claim 14, wherein the second mode comprises the steps of:
a) opening the first cleaning solution source valve, operating the first pump to draw the predetermined volume of cleaning solution from the cleaning solution source into the first pump and operating the second pump to expel the predetermined volume of cleaning solution from the second pump into the drain;
b) opening the first dialyzer inlet valve, operating the first pump to expel the predetermined volume of cleaning solution from the first pump into the dialyzer; and
c) closing the first dialyzer inlet valve, opening the first dialyzer outlet valve, operating the second pump to draw the predetermined volume of cleaning solution from the dialyzer into the second pump.

### Claim 31 (depends on 14)

A method according to claim 14, wherein the second mode comprises the steps of:
a) closing the first dialyzer outlet valve, opening the first cleaning solution source valve, opening the first drain valve, operating the first pump to draw the predetermined volume of cleaning solution from the cleaning solution source into the first pump and operating the second pump to expel the predetermined volume of cleaning solution from the second pump into the drain;
b) opening the first dialyzer inlet valve, closing the first cleaning solution source valve, and operating the first pump to expel the predetermined volume of cleaning solution from the first pump into the dialyzer; and
c) closing the first dialyzer inlet valve, opening the first dialyzer outlet valve, closing the first drain valve, and operating the second pump to draw the predetermined volume of cleaning solution from the dialyzer into the second pump.

### Claim 32 (depends on 14)

A method according to claim 14, wherein the second mode comprises the steps of:
a) closing the first dialyzer outlet valve, opening the first cleaning solution source valve, opening the first drain valve, operating the first pump to draw the predetermined volume of cleaning solution from the cleaning solution source into the first pump and operating the second pump to expel the predetermined volume of cleaning solution from the second pump into the drain;
b) opening the first dialyzer inlet valve, closing the first cleaning solution source valve, and operating the first pump to expel the predetermined volume of cleaning solution from the first pump into the dialyzer;
c) closing the first dialyzer inlet valve, opening the first dialyzer outlet valve, closing the first drain valve, and operating the second pump to draw the predetermined volume of cleaning solution from the dialyzer into the second pump;
d) opening the first drain valve, closing the first dialyzer outlet valve, and operating the second pump to expel the cleaning solution from the second pump into the drain;
e) closing the first drain valve, opening the second source valve, closing the second dialyzer inlet valve and operating the second pump to draw a predetermined volume cleaning solution from the cleaning solution source into the second pump;
f) closing the second source valve, opening the second dialyzer inlet valve and operating the second pump to expel the predetermined volume of cleaning solution from the second pump into the dialyzer;
g) closing the second dialyzer inlet, opening the second dialyzer outlet, closing the second drain valve and operating the first pump to draw the predetermined volume of cleaning solution into the first pump; and
h) opening the second drain valve, closing the second dialyzer outlet valve, opening the second source valve and operating the first pump to expel the predetermined volume of cleaning solution from the first pump into the drain and operating the second pump to draw the predetermined volume of cleaning solution from the cleaning solution source into the second pump.

### Claim 33 (depends on 32)

A method according to claim 32, further comprising repeating steps a) to c) one or more times before performing step d).

### Claim 34 (depends on 32)

A method according to claim 32, further comprising a step after step h) of repeating steps f) to h) one or more times.

### Claim 35 (depends on 14)

A method according to claim 14, wherein the second mode comprises the steps of:
a) operating both the first and second pumps to draw the predetermined volume of cleaning solution from the cleaning solution source into each of the first and second pumps;
b) operating both the first and second pumps to expel the predetermined volume of cleaning solution from each of the first and second pumps into the dialyzer and across the membrane of the dialyzer;
c) operating the first and second pumps to draw the predetermined volume of cleaning solution from the dialyzer into each of the first and second pumps; and
d) operating both the first and second pumps to expel the predetermined volume of cleaning solution from each of the first and second pumps into the drain.

### Claim 36 (depends on 14)

A method according to claim 14, wherein the second mode comprises:
a) opening the first and second cleaning solution source valves and the first and second dialyzer inlet valves, closing the first and second dialyzer outlet valves and the first and second drain valves and operating the first and second pumps to draw the predetermined volume of cleaning solution from the cleaning solution source into each of the first and second pumps;
b) closing the first and second source valves and the first and second dialyzer outlet valves, opening the first and second dialyzer inlet valves and operating both the first and second pumps to expel the predetermined volume of cleaning solution from each of the first and second pumps into the dialyzer;
c) opening the first and second dialyzer outlet valves, closing the first and second dialyzer inlet valves and operating both the first and second pumps to draw the predetermined volume of cleaning solution from the dialyzer into each of the first and second pumps; and
d) opening the first and second drain valves, closing the first and second dialyzer outlet valves and operating both the first and second pumps to expel the predetermined volume of cleaning solution from each of the first and second pumps into the drain.

### Claim 37 (depends on 14)

The method according to claim 14, wherein the valves and pumps are operated in the at least one second mode permitting hemodiafiltration by operating the first and second pumps out of phase to generate a positive pressure in the dialyzer.

### Claim 38

A blood treatment device comprising:
a dialyzer;
a first pump configured to deliver a cleaning solution to, and remove the cleaning solution from, the dialyzer;
a second pump configured to deliver the cleaning solution to, and remove the cleaning solution from, the dialyzer; and
a control system configured to operate one or more valves, the first pump, and the second pump in at least one first mode permitting hemodialysis and at least one second mode permitting hemodiafiltration, wherein the at least one second mode permitting hemodiafiltration includes transferring waste product from blood of a patient to the cleaning solution as the cleaning solution is forced across a semi-permeable membrane of the dialyzer and into the blood of the patient and then pulled back across the semi-permeable membrane, and the control system operates the first pump and the second pump out of phase with one another or in phase with one another such that a positive pressure is generated in the dialyzer in the at least one second mode permitting hemodiafiltration.

### Claim 39 (depends on 38)

The blood treatment device of claim 38, wherein the control system operates the one or more valves, the first pump, and the second pump to alternate between the at least one first mode permitting hemodialysis and the at least one second mode permitting hemodiafiltration.

### Claim 40 (depends on 38)

The blood treatment device of claim 38, further comprising the one or more valves.

### Claim 41 (depends on 38)

The blood treatment device of claim 38, wherein the one or more valves comprise at least one of a first dialyzer inlet valve, a second dialyzer inlet valve, a first dialyzer outlet valve, a second dialyzer outlet valve, a first cleaning solution source valve, a second cleaning solution source valve, a first drain valve, and a second drain valve.

### Claim 42 (depends on 38)

The blood treatment device of claim 38, wherein the one or more valves comprise at least two of a first dialyzer inlet valve, a second dialyzer inlet valve, a first dialyzer outlet valve, a second dialyzer outlet valve, a first cleaning solution source valve, a second cleaning solution source valve, a first drain valve, and a second drain valve.

### Claim 43 (depends on 38)

The blood treatment device of claim 38, wherein the one or more valves comprise a first dialyzer inlet valve, a second dialyzer inlet valve, a first dialyzer outlet valve, a second dialyzer outlet valve, a first cleaning solution source valve, a second cleaning solution source valve, a first drain valve, and a second drain valve.

### Claim 44 (depends on 38)

The blood treatment device of claim 38, wherein the first pump is operable to deliver and remove a predetermined volume of cleaning solution to and from the dialyzer.

### Claim 45 (depends on 38)

The blood treatment device of claim 38, wherein the second pump is operable to deliver and remove a predetermined volume of cleaning solution to and from the dialyzer.