# US 12,005,169 B2 · Modular assembly for a portable hemodialysis system

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- Number: US 12,005,169 B2
- Document ID: US12005169B2
- Status: Granted
- Kind: B2
- Application number: 17/718,533
- Filed: 2022-04-12
- Published: 2022-08-04
- Granted: 2024-06-11
- Earliest claimed: 2007-02-27
- Assignees: DEKA Products Limited Partnership
- Applicants: DEKA Products Limited Partnership
- Inventors: Dean Kamen; Jason A. Demers; Michael J. Wilt; Kevin L. Grant; Shannon Prescott; David E. Collins
- Web page: https://patentgrep.com/patent/US12005169B2

## CPC

- A61M 1/1656: {Apparatus for preparing dialysates}
- A61M 1/16: with membranes
- A61M 1/1601: {Control or regulation}
- A61M 1/1633: {with more than one dialyser unit}
- A61M 1/1639: {linked by membranes}
- A61M 1/1668: {Details of containers}
- A61M 1/1682: {both machine and membrane module, i.e. also the module blood side}
- A61M 1/1686: {by heat}
- A61M 1/34: Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M 1/3403: {Regulation parameters}
- A61M 1/3406: {Physical characteristics of the filtrate, e.g. urea}
- A61M 1/36: Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation {; Extra-corporeal blood circuits}
- A61M 1/3607: {Regulation parameters}
- A61M 1/3609: {Physical characteristics of the blood, e.g. haematocrit, urea}
- A61M 1/3623: {Means for actively controlling temperature of blood}
- A61M 1/842: {rotating (continuously rotating surgical cutting instruments A61B17/32002)}
- A61M 1/85: {with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants (for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208)}
- A61M 60/37: Haemodialysis, haemofiltration or diafiltration
- A61M 60/40: Details relating to driving
- A61M 60/427: the force acting on the blood contacting member being hydraulic or pneumatic
- B01D 61/30: Accessories; Auxiliary operation
- B01D 61/32: Controlling or regulating
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 40/63: for local operation
- A61M 1/1696: {with dialysate regeneration}
- A61M 1/36225: {with blood pumping means or components thereof}
- A61M 1/3627: {Degassing devices; Buffer reservoirs; Drip chambers; Blood filters}
- A61M 39/1011: {Locking means for securing connection; Additional tamper safeties (A61M39/16 takes precedence)}
- A61M 39/105: {Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes (multi-channel connectors in general F16L37/56)}
- A61M 60/113: in other functional devices, e.g. dialysers or heart-lung machines
- A61M 60/43: using vacuum at the blood pump, e.g. to accelerate filling
- A61M 2205/12: with interchangeable cassettes forming partially or totally the fluid circuit
- A61M 2205/15: Detection of leaks
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3368: Temperature
- A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/58: Means for facilitating use, e.g. by people with impaired vision
- A61M 2209/08: Supports for equipment
- 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)}
- B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A modular assembly for a portable hemodialysis system may include a dialysis unit, e.g., that contains suitable components for performing hemodialysis, such as a dialyzer, one or more pumps to circulate blood through the dialyzer, a source of dialysate, and one or more pumps to circulate the dialysate through the dialyzer, and a power unit having a housing that contains suitable components for providing operating power to the pumps of the dialysis unit. The power unit may be selectively connected to the dialysis unit and provide power (e.g., pneumatic power in the form of pressure and/or to vacuum) to the dialysis unit for the pumps when connected to the dialysis unit, but may be incapable of providing power to the dialysis unit when disconnected from the dialysis unit. The dialysis unit and the power unit are sized and weighted to each be carried by hand by a human.

## Claims

### Claim 1

An apparatus to perform dialysis comprising:
a dialyzer with a blood inlet, a fresh dialysate inlet and a used dialysate outlet;
a balance pod with a used dialysate port connected to a used dialysate chamber, a fresh dialysate port connected to a fresh dialysate chamber and to the fresh dialysate inlet on the dialyzer, and a diaphragm separating the used dialysate chamber from the fresh dialysate chamber;
a blood pump actuated by a blood pneumatic pressure and configured to deliver blood to the blood inlet on the dialyzer;
a first dialysate pump actuated by a dialysate delivery pneumatic pressure and configured to deliver used dialysate to the used dialysate port of the balance pod;
a second dialysate pump actuated by a dialysate fill pneumatic pressure and configured to draw used dialysate from the used dialysate outlet on the dialyzer; and
a pneumatic control system configured to measure and control the blood pneumatic pressure, the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure, and configured to provide the blood pneumatic pressure, the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure to the blood pump, the first dialysate pump and the second dialysate pump, respectively, wherein the blood pneumatic pressure and dialysate delivery pneumatic pressure are controlled to be greater than atmospheric and the dialysate fill pneumatic pressure is controlled to be not less than atmospheric,
wherein the pneumatic control system controls the dialysate delivery pneumatic pressure or dialysate fill pneumatic pressure based on the blood pneumatic pressure.

### Claim 2 (depends on 1)

The apparatus of claim 1, wherein the pneumatic control system is configured to control the dialysate delivery pneumatic pressure to be a pressure higher than the blood pneumatic pressure.

### Claim 3 (depends on 1)

The apparatus of claim 1, wherein the pneumatic control system is configured to control the dialysate fill pneumatic pressure to be a pressure less than the blood pneumatic pressure.

### Claim 4 (depends on 1)

The apparatus of claim 1, wherein the pneumatic control system is configured to control the blood pneumatic pressure, the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure such that a pressure across the dialyzer is a difference between the blood pneumatic pressure and an average of the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure and wherein the pressure across the dialyzer is approximately balanced to produce no net flow across the dialyzer.

### Claim 5 (depends on 1)

The apparatus of claim 1, further comprising a heater fluidly connected to supply fresh dialysate to the fresh dialysate port on the balance pod.

### Claim 6 (depends on 1)

The apparatus of claim 1, wherein the pneumatic control system controls the dialysate delivery pneumatic pressure to match the blood pneumatic pressure.

### Claim 7 (depends on 1)

The apparatus of claim 1, wherein the pneumatic control system controls the dialysate delivery pneumatic pressure to synchronize the first dialysate pump with the blood pump.

### Claim 8 (depends on 1)

The apparatus of claim 1, wherein the pneumatic control system controls the dialysate fill pneumatic pressure to synchronize the second dialysate pump with the blood pump.

### Claim 9 (depends on 1)

The apparatus of claim 1, wherein the balance pod, first dialysate pump and second dialysate pump are part of a disposable dialysate cassette assembly.

### Claim 10 (depends on 1)

The apparatus of claim 1, wherein the blood pump is part of a disposable blood cassette assembly.

### Claim 11

An apparatus to perform dialysis comprising:
a dialyzer with a blood inlet, a fresh dialysate inlet and a used dialysate outlet;
a balance pod with a used dialysate port connected to a used dialysate chamber, a fresh dialysate port fluidly connected to a fresh dialysate chamber, the fresh dialysate port connected via a first pneumatically actuated valve to the fresh dialysate inlet on the dialyzer, and a diaphragm separating the used dialysate chamber from the fresh dialysate chamber;
a blood pump actuated by a blood pneumatic pressure and configured to deliver blood to the blood inlet on the dialyzer;
a first dialysate pump actuated by a dialysate delivery pneumatic pressure, fluidly connected to the used dialysate port via a pneumatically actuated second valve and configured to deliver used dialysate to the used dialysate chamber of the balance pod;
a second dialysate pump actuated by a dialysate fill pneumatic pressure, fluidly connected via a pneumatically actuated third valve to the used dialysate outlet and configured to draw used dialysate from the dialyzer;
a dialysate supply;
a heater;
a third dialysate pump actuated by a variable outside dialysate pneumatic pressure, the third dialysate pump configured to draw fresh dialysate from the dialysate supply and deliver the fresh dialysate through the heater to the fresh dialysate chamber in the balance pod; and
a pneumatic control system configured to measure and control the blood pneumatic pressure, the dialysate delivery pneumatic pressure, the dialysate fill pneumatic pressure and the variable outside dialysate pneumatic pressure, and configured to provide the blood pneumatic pressure, the dialysate delivery pneumatic pressure, the dialysate fill pneumatic pressure and the variable outside dialysate pneumatic pressure to the blood pump, the first dialysate pump, the second dialysate pump and the third dialysate pump, respectively, the pneumatic control system configured to provide a valve actuation pneumatic pressure to actuate one more of the first, second and third pneumatically actuated valves, wherein the pneumatic control system is configured to control the dialysate delivery pneumatic pressure, the dialysate fill pneumatic pressure and the valve actuation pneumatic pressure to be greater than atmospheric in order to avoid outgassing in the fresh or used dialysate, and wherein the pneumatic control system is configured to control the variable outside dialysate pressure to vary from a negative to positive gauge pressure.

### Claim 12 (depends on 11)

The apparatus of claim 11, wherein the heater is fluidly connected to the fresh dialysate port on the balance pod.

### Claim 13 (depends on 11)

The apparatus of claim 11, wherein the first and third pneumatically actuated valves are ganged together and actuated by a single pressure control.

### Claim 14 (depends on 11)

The apparatus of claim 11, wherein the pneumatic control system is configured to close the first, second and third pneumatically actuated valves when the blood pump is not delivering blood to the dialyzer.

### Claim 15 (depends on 11)

The apparatus of claim 11, wherein the first dialysate pump and second dialysate pump are frozen when the blood pump is not delivering blood to the dialyzer.

### Claim 16

An apparatus to perform dialysis comprising:
a dialyzer with a blood inlet, a fresh dialysate inlet and a used dialysate outlet;
a disposable cassette assembly comprising:
a balance pod with a used dialysate port connected to a used dialysate chamber, a fresh dialysate port connected to a fresh dialysate chamber and to the fresh dialysate inlet on the dialyzer, and a diaphragm separating the used dialysate chamber from the fresh dialysate chamber;
a blood pump actuated by a blood pneumatic pressure and configured to deliver blood to the blood inlet on the dialyzer;
a first dialysate pump actuated by a dialysate delivery pneumatic pressure and configured to deliver used dialysate to the used dialysate port of the balance pod;
a second dialysate pump actuated by a dialysate fill pneumatic pressure and configured to draw used dialysate from the used dialysate outlet on the dialyzer; and
a pneumatic control system configured to measure and control the blood pneumatic pressure, the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure, and configured to provide the blood pneumatic pressure, the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure to the blood pump, the first dialysate pump and the second dialysate pump, respectively, wherein the pneumatic control system is configured to control the dialysate delivery pneumatic pressure to be greater than the blood pneumatic pressure and to control the dialysate fill pneumatic pressure to be less than the blood pneumatic pressure, and wherein the pneumatic control system is configured to control the dialysate delivery pneumatic pressure to synchronize the first dialysate pump with the blood pump.

### Claim 17 (depends on 16)

The apparatus of claim 16, wherein the pneumatic control system is configured to control the blood pneumatic pressure, the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure such that a pressure across the dialyzer is a difference in pressure between the blood pneumatic pressure and an average of the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure, and wherein the pressure across the dialyzer is approximately balanced to produce no net flow across the dialyzer.

### Claim 18 (depends on 16)

The apparatus of claim 16, wherein the pneumatic control system controls the dialysate fill pneumatic pressure to synchronize the second dialysate pump with the blood pump.

### Claim 19

An apparatus to perform dialysis comprising:
a dialyzer with a blood inlet, a fresh dialysate inlet and a used dialysate outlet;
a balance pod with a used dialysate port connected to a used dialysate chamber, a fresh dialysate port connected to a fresh dialysate chamber and to the fresh dialysate inlet on the dialyzer, and a diaphragm separating the used dialysate chamber from the fresh dialysate chamber;
a blood pump actuated by a blood pneumatic pressure and configured to deliver blood to the blood inlet on the dialyzer;
a first dialysate pump actuated by a dialysate delivery pneumatic pressure and configured to deliver used dialysate to the used dialysate port of the balance pod;
a second dialysate pump actuated by a dialysate fill pneumatic pressure and configured to draw used dialysate from the used dialysate outlet on the dialyzer; and
a pneumatic control system configured to measure and control the blood pneumatic pressure, the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure, and configured to provide the blood pneumatic pressure, the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure to the blood pump, the first dialysate pump and the second dialysate pump, respectively, wherein the blood pneumatic pressure and dialysate delivery pneumatic pressure are controlled to be greater than atmospheric and the dialysate fill pneumatic pressure is controlled to be not less than atmospheric, wherein the pneumatic control system controls the dialysate delivery pneumatic pressure to match the blood pneumatic pressure.

### Claim 20 (depends on 19)

The apparatus of claim 19, wherein the pneumatic control system is configured to control the blood pneumatic pressure, the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure such that a pressure across the dialyzer is a difference in pressure between the blood pneumatic pressure and an average of the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure and wherein the pressure across the dialyzer is approximately balanced to produce no net flow across the dialyzer.

### Claim 21 (depends on 19)

The apparatus of claim 19, further comprising a heater fluidly connected to supply fresh dialysate to the fresh dialysate port on the balance pod.

### Claim 22 (depends on 19)

The apparatus of claim 19, wherein the pneumatic control system controls the dialysate delivery pneumatic pressure to synchronize the first dialysate pump with the blood pump.

### Claim 23 (depends on 19)

The apparatus of claim 19, wherein the pneumatic control system controls the dialysate fill pneumatic pressure to synchronize the second dialysate pump with the blood pump.

### Claim 24 (depends on 19)

The apparatus of claim 19, wherein the balance pod, first dialysate pump and second dialysate pump are part of a disposable dialysate cassette assembly.

### Claim 25 (depends on 19)

The apparatus of claim 19, wherein the blood pump is part of a disposable blood cassette assembly.

### Claim 26

An apparatus to perform dialysis comprising:
a dialyzer with a blood inlet, a fresh dialysate inlet and a used dialysate outlet;
a balance pod with a used dialysate port connected to a used dialysate chamber, a fresh dialysate port connected to a fresh dialysate chamber and to the fresh dialysate inlet on the dialyzer, and a diaphragm separating the used dialysate chamber from the fresh dialysate chamber;
a blood pump actuated by a blood pneumatic pressure and configured to deliver blood to the blood inlet on the dialyzer;
a first dialysate pump actuated by a dialysate delivery pneumatic pressure and configured to deliver used dialysate to the used dialysate port of the balance pod;
a second dialysate pump actuated by a dialysate fill pneumatic pressure and configured to draw used dialysate from the used dialysate outlet on the dialyzer; and
a pneumatic control system configured to measure and control the blood pneumatic pressure, the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure, and configured to provide the blood pneumatic pressure, the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure to the blood pump, the first dialysate pump and the second dialysate pump, respectively, wherein the blood pneumatic pressure and dialysate delivery pneumatic pressure are controlled to be greater than atmospheric and the dialysate fill pneumatic pressure is controlled to be not less than atmospheric, wherein the pneumatic control system controls the dialysate delivery pneumatic pressure to synchronize the first dialysate pump with the blood pump.

### Claim 27 (depends on 26)

The apparatus of claim 26, wherein the pneumatic control system is configured to control the dialysate delivery pneumatic pressure to be a pressure higher than the blood pneumatic pressure.

### Claim 28 (depends on 26)

The apparatus of claim 26, wherein the pneumatic control system is configured to control the dialysate fill pneumatic pressure to be a pressure less than the blood pneumatic pressure.

### Claim 29 (depends on 26)

The apparatus of claim 26, wherein the pneumatic control system is configured to control the blood pneumatic pressure, the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure such that a pressure across the dialyzer is a difference in pressure between the blood pneumatic pressure and an average of the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure and wherein the pressure across the dialyzer is approximately balanced to produce no net flow across the dialyzer.

### Claim 30

An apparatus to perform dialysis comprising:
a dialyzer with a blood inlet, a fresh dialysate inlet and a used dialysate outlet;
a balance pod with a used dialysate port connected to a used dialysate chamber, a fresh dialysate port fluidly connected to a fresh dialysate chamber, the fresh dialysate port connected via a first pneumatically actuated valve to the fresh dialysate inlet on the dialyzer, and a diaphragm separating the used dialysate chamber from the fresh dialysate chamber;
a blood pump actuated by a blood pneumatic pressure and configured to deliver blood to the blood inlet on the dialyzer;
a first dialysate pump actuated by a dialysate delivery pneumatic pressure, fluidly connected to the used dialysate port via a pneumatically actuated second valve and configured to deliver used dialysate to the used dialysate chamber of the balance pod;
a second dialysate pump actuated by a dialysate fill pneumatic pressure, fluidly connected via a pneumatically actuated third valve to the used dialysate outlet and configured to draw used dialysate from the dialyzer; and
a pneumatic control system configured to measure and control the blood pneumatic pressure, the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure, and configured to provide the blood pneumatic pressure, the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure to the blood pump, the first dialysate pump and the second dialysate pump, respectively, the pneumatic control system configured to provide a valve actuation pneumatic pressure to actuate one more of the first, second and third pneumatically actuated valves, wherein the pneumatic control system is configured to control the dialysate delivery pneumatic pressure, the dialysate fill pneumatic pressure and the valve actuation pneumatic pressure to be greater than atmospheric in order to avoid outgassing in the fresh or used dialysate, wherein the first and third pneumatically actuated valves are ganged together and actuated by a single pressure control.

### Claim 31 (depends on 30)

The apparatus of claim 30, further comprising a heater fluidly connected to the fresh dialysate port on the balance pod.

### Claim 32 (depends on 30)

The apparatus of claim 30, wherein the first dialysate pump and second dialysate pump are frozen when the blood pump is not delivering blood to the dialyzer.

### Claim 33

An apparatus to perform dialysis comprising:
a dialyzer with a blood inlet, a fresh dialysate inlet and a used dialysate outlet;
a balance pod with a used dialysate port connected to a used dialysate chamber, a fresh dialysate port fluidly connected to a fresh dialysate chamber, the fresh dialysate port connected via a first pneumatically actuated valve to the fresh dialysate inlet on the dialyzer, and a diaphragm separating the used dialysate chamber from the fresh dialysate chamber;
a blood pump actuated by a blood pneumatic pressure and configured to deliver blood to the blood inlet on the dialyzer;
a first dialysate pump actuated by a dialysate delivery pneumatic pressure, fluidly connected to the used dialysate port via a pneumatically actuated second valve and configured to deliver used dialysate to the used dialysate chamber of the balance pod;
a second dialysate pump actuated by a dialysate fill pneumatic pressure, fluidly connected via a pneumatically actuated third valve to the used dialysate outlet and configured to draw used dialysate from the dialyzer; and
a pneumatic control system configured to measure and control the blood pneumatic pressure, the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure, and configured to provide the blood pneumatic pressure, the dialysate delivery pneumatic pressure and the dialysate fill pneumatic pressure to the blood pump, the first dialysate pump and the second dialysate pump, respectively, the pneumatic control system configured to provide a valve actuation pneumatic pressure to actuate one more of the first, second and third pneumatically actuated valves, wherein the pneumatic control system is configured to control the dialysate delivery pneumatic pressure, the dialysate fill pneumatic pressure and the valve actuation pneumatic pressure to be greater than atmospheric in order to avoid outgassing in the fresh or used dialysate, wherein the pneumatic control system closes the first, second and third pneumatically actuated valves when the blood pump is not delivering blood to the dialyzer.

### Claim 34 (depends on 33)

The apparatus of claim 33, further comprising a heater fluidly connected to the fresh dialysate port on the balance pod.

### Claim 35 (depends on 33)

The apparatus of claim 33, wherein the first dialysate pump and second dialysate pump are frozen when the blood pump is not delivering blood to the dialyzer.