# US 10,441,697 B2 · Modular assembly for a portable hemodialysis system

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- Number: US 10,441,697 B2
- Document ID: US10441697B2
- Status: Granted
- Kind: B2
- Application number: 14/059,806
- Filed: 2013-10-22
- Published: 2014-04-17
- Granted: 2019-10-15
- 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/US10441697B2

## 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 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

A modular assembly system for a portable hemodialysis unit, comprising:
a dialysis unit including a dialysis unit housing that contains components for performing hemodialysis, including a dialyzer mount with fluidic connections for a dialyzer, a blood pump mounting section with pneumatic connections for operation of one or more pneumatically driven blood pumps to circulate blood through a dialyzer when mounted in the dialysis unit housing, one or more pneumatically driven dialysate pumps to circulate a dialysate through the dialyzer, a dialysate heater, and one or more electronic controllers for controlling the one or more blood and dialysate pumps; and
a pneumatic power unit within a pneumatic power unit housing configured to provide pneumatic power to the dialysis unit via mating pneumatic ports between the pneumatic power unit housing and the dialysis unit housing; wherein
the pneumatic power unit housing is reversibly connectable to the dialysis unit housing via a mechanical and pneumatic connection to the dialysis unit.

### Claim 2 (depends on 1)

The system of claim 1, wherein the pneumatic power unit housing is reversibly connectable to the dialysis unit housing via a manually operable connection handle, allowing for the interchangeable mechanical and pneumatic connection of a second pneumatic power unit housing with the dialysis unit housing.

### Claim 3 (depends on 1)

The system of claim 1, wherein pneumatic power unit includes one or more electrically operated pumps to provide positive or negative pneumatic pressure, and wherein the pneumatic power unit is connectable to the dialysis unit via an electrical power connection.

### Claim 4 (depends on 3)

The system of claim 3, wherein the dialysis unit is configured to supply electrical power to the pneumatic power unit via the electrical power connection, upon connection of the pneumatic power unit housing to the dialysis unit housing.

### Claim 5 (depends on 4)

The system of claim 4, wherein the pneumatic power unit housing is reversibly connectable to the dialysis unit housing via a manually operable connection handle, allowing for the interchangeable mechanical, pneumatic and electrical power connection of a second pneumatic power unit housing with the dialysis unit housing.

### Claim 6 (depends on 3)

The system of claim 3, wherein the dialysis unit is configured to provide electronic control to the pneumatic power unit via an electronic communications connection upon connection of the pneumatic power unit housing to the dialysis unit housing.

### Claim 7 (depends on 6)

The system of claim 6, wherein the pneumatic power unit housing is reversibly connectable to the dialysis unit housing via a manually operable connection handle, allowing for the interchangeable mechanical, pneumatic, electrical power and electronic communications connection of a second pneumatic power unit housing with the dialysis unit housing.

### Claim 8 (depends on 3)

The system of claim 3, wherein the pneumatic power unit and the dialysis unit are configured to be electrically powered through a single residential electrical outlet.

### Claim 9 (depends on 3)

The system of claim 3, wherein the pneumatic power unit includes one or more pneumatic reservoirs within the pneumatic power unit housing for storing positive or negative pneumatic pressure generated by the one or more pumps.

### Claim 10 (depends on 9)

The system of claim 9, wherein the one or more pneumatic reservoirs comprise a positive pneumatic pressure reservoir and a negative pneumatic pressure reservoir, and wherein the pneumatic ports include a positive pressure pneumatic port and a negative pressure pneumatic port.

### Claim 11 (depends on 10)

The system of claim 10, wherein the one or more pneumatic reservoirs comprise a first positive pressure reservoir and a second positive pressure reservoir, wherein the pneumatic power unit is configured to charge the second positive pressure reservoir with a second range of pressures different from the first range of pressures, and wherein the pneumatic ports include positive pressure pneumatic ports for each of the first and second positive pressure reservoirs.

### Claim 12

A modular assembly system for a portable hemodialysis unit, comprising:
a dialysis unit including a dialysis unit housing that contains components for performing hemodialysis, including a dialyzer mount with fluidic connections for a dialyzer, a blood pump mounting section with pneumatic connections for operation of one or more pneumatically driven blood pumps for circulating blood through a dialyzer when mounted in the dialysis unit housing, one or more pneumatically driven dialysate pumps for circulating dialysate through the dialyzer, a dialysate heater, and one or more electronic controllers for controlling the one or more blood and dialysate pumps; and
a pneumatic power unit within a pneumatic power unit housing configured to provide pneumatic power to the dialysis unit via mating pneumatic ports between the pneumatic power unit housing and the dialysis unit housing;
wherein the pneumatic power unit includes one or more electrically operated pumps to provide positive or negative pneumatic pressure, and wherein the pneumatic power unit housing is reversibly connectable via a mechanical, pneumatic and electrical power connection to the dialysis unit housing.

### Claim 13 (depends on 12)

The system of claim 12, wherein the pneumatic power unit housing is reversibly connectable to the dialysis unit housing by a manually operable connection handle, allowing for the interchangeable mechanical, pneumatic and electrical power connection of a second pneumatic power unit housing with the dialysis unit housing.

### Claim 14 (depends on 12)

The system of claim 12, wherein the dialysis unit is configured to supply electrical power to the pneumatic power unit via the electrical power connection, upon connection of the pneumatic power unit housing to the dialysis unit housing.

### Claim 15 (depends on 14)

The system of claim 14, wherein the pneumatic power unit housing is reversibly connectable to the dialysis unit housing via a manually operable connection handle, allowing for the interchangeable mechanical, pneumatic and electrical power connection of a second pneumatic power unit housing with the dialysis unit housing.

### Claim 16 (depends on 12)

The system of claim 12, wherein the dialysis unit is configured to provide electronic control to the pneumatic power unit via an electronic communications connection, upon connection of the pneumatic power unit housing to the dialysis unit housing.

### Claim 17 (depends on 16)

The system of claim 16, wherein the pneumatic power unit housing is reversibly connectable to the dialysis unit housing via a manually operable connection handle, allowing for the interchangeable mechanical, pneumatic, electrical power and electronic communications connection of a second pneumatic power unit housing with the dialysis unit housing.

### Claim 18

A modular assembly system for a portable hemodialysis unit, comprising:
dialysis unit including a dialysis unit housing that contains components for performing hemodialysis, including a dialyzer mount with fluidic connections for a dialyzer, a blood pump mounting section with pneumatic connections for operation of one or more pneumatically driven blood pumps for circulating blood through a dialyzer when mounted in the dialysis unit housing, one or more pneumatically driven dialysate pumps for circulating dialysate through the dialyzer, a dialysate heater, and one or more electronic controllers for controlling the one or more blood and dialysate pumps; and
a pneumatic power unit within a pneumatic power unit housing configured to provide pneumatic power to the dialysis unit via mating pneumatic ports between the pneumatic power unit housing and the dialysis unit housing;
wherein the pneumatic power unit includes one or more electrically operated pumps to provide positive or negative pneumatic pressure, wherein the dialysis unit comprises an electronic controller configured to provide electronic control to the pumps of the pneumatic power unit, and wherein the pneumatic power unit housing is reversibly connectable via a mechanical, pneumatic, electrical power and electronic communications connection to the dialysis unit housing.

### Claim 19 (depends on 18)

The system of claim 18, wherein the pneumatic power unit housing is reversibly connectable to the dialysis unit housing via a manually operable connection handle, allowing for the interchangeable mechanical, pneumatic, electrical power and electronic communications connection of a second pneumatic power unit housing with the dialysis unit housing.

### Claim 20 (depends on 18)

The system of claim 18, wherein the dialysis unit is configured to supply electrical power to the pneumatic power unit via the electrical power connection, upon connection of the pneumatic power unit housing to the dialysis unit housing.
