# US 9,039,395 B2 · System, method, and apparatus for utilizing a pumping cassette

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- Number: US 9,039,395 B2
- Document ID: US9039395B2
- Status: Granted
- Kind: B2
- Application number: 14/294,122
- Filed: 2014-06-02
- Published: 2014-09-25
- Granted: 2015-05-26
- Earliest claimed: 1999-07-20
- Assignees: DEKA Products Limited Partnership
- Applicants: DEKA Products Limited Partnership
- Inventors: Larry B. Gray; Robert J. Bryant, Jr.; Geoffrey P. Spencer
- Web page: https://patentgrep.com/patent/US9039395B2

## CPC

- F04B 49/12: by varying the length of stroke of the working members
- A61M 1/1649: {with pulsatile dialysis fluid flow}
- A61M 1/267: {used for pumping}
- A61M 1/36225: {with blood pumping means or components thereof}
- A61M 1/362264: {the filter being a blood filter}
- A61M 1/362265: {Details of valves}
- A61M 1/367: {Circuit parts not covered by the preceding subgroups of group A61M1/3621}
- A61M 5/14: Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M 5/14224: {Diaphragm type}
- A61M 5/172: electrical or electronic
- F04B 43/067: the fluid being actuated directly by a piston
- F04B 45/00: Pumps or pumping installations having flexible working members and specially adapted for elastic fluids
- F04B 45/02: having bellows
- F04B 49/065: {and making use of computers}
- F04B 53/10: Valves; Arrangement of valves
- F04B 53/16: Casings; Cylinders; Cylinder liners or heads; Fluid connections
- G01M 3/26: by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors
- G01M 3/32: for containers, e.g. radiators
- G05D 16/20: characterised by the use of electric means
- A61M 1/362227: {the interface providing means for actuating on functional elements of the cassette, e.g. plungers}
- A61M 1/362261: {at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil}
- A61M 1/362266: {Means for adding solutions or substances to the blood}
- A61M 5/14593: {the diaphragm being actuated by fluid pressure}
- A61M 39/228: {with a tubular diaphragm constrictable by radial fluid force}
- A61M 2205/12: with interchangeable cassettes forming partially or totally the fluid circuit
- A61M 2209/02: Equipment for testing the apparatus
- F04B: POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS (machines for liquids, or pumps, of rotary-piston or oscillating-piston type F04C; non-positive-displacement pumps F04D; pumping of fluid by direct contact of another fluid or by using inertia of fluid to be pumped F04F)
- 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)}
- G01M: TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
- G05D: SYSTEMS FOR CONTROLLING OR REGULATING NON-ELECTRIC VARIABLES

## Abstract

The present invention involves, in some embodiments, systems and methods involving fluid handling apparatus for pumping fluid to and from a patient, which may include a reusable component and a disposable pumping cartridge. The reusable component may comprise a control chamber and a pressure transducer configured to measure a gas pressure associated with the control chamber, as well as a processor. The processor may be configured to supply the control chamber with a gas at a predetermined pressure, monitor the gas pressure associated within the control chamber with the pressure transducer over a predetermined period of time, and determine if the change in gas pressure associated within the control chamber exceeds a maximum allowable predetermined limit.

## Claims

### Claim 1

A fluid handling system for pumping fluid to and from a patient configured to perform a dry cartridge integrity test, the system comprising:
a reusable component comprising:
a processor;
a control chamber; and
a pressure transducer configured to measure a gas pressure associated with the control chamber; and
a disposable pumping cartridge comprising:
a flexible membrane;
a rigid portion comprising a pump chamber, the flexible membrane overlying the pump chamber;
an inlet and an outline line; and
a valve configured to isolate the pump chamber of the disposable pumping cartridge,
wherein the disposable pumping cartridge is configured to mate with the reusable component, wherein the control chamber of the reusable component mates with the pump chamber of the disposable pumping cartridge, and
wherein the processor is configured to:
supply the control chamber with a gas at a predetermined pressure;
open the valve such that the pump chamber of the disposable pumping cartridge is not isolated from the surroundings;
with the valve open, monitor the gas pressure associated with the control chamber using the pressure transducer over a predetermined period of time; and
determine if the change in gas pressure associated with the control chamber exceeds a maximum allowable predetermined limit.

### Claim 2 (depends on 1)

The system of claim 1, wherein if the change in gas pressure associated with the control chamber exceeds the maximum allowable predetermined limit, the processor will indicate a fault condition.

### Claim 3 (depends on 2)

The system of claim 2, wherein the reusable component is configured to terminate operation of the pumping cartridge if the change in gas pressure associated within the control chamber exceeds the maximum allowable predetermined limit.

### Claim 4 (depends on 1)

The system of claim 1, wherein if the change in gas pressure associated with the control chamber fails to exceed the maximum allowable predetermined limit, the processor will commence operation of the system.

### Claim 5 (depends on 1)

The fluid handling system of claim 1, wherein the processor is configured to: supply the control chamber with a gas at a predetermined pressure before introducing liquid into the pumping cartridge.

### Claim 6

A fluid handling apparatus for pumping fluid to and from a patient comprising:
a control chamber configured to mate with a pump chamber of a pumping cartridge;
a pressure transducer configured to measure a gas pressure associated with the control chamber; and
a processor, the processor configured to:
supply the control chamber with a gas at a predetermined pressure before liquid enters the pumping cartridge;
monitor the gas pressure associated with the control chamber with using the pressure transducer over a predetermined period of time; and
determine if a change in gas pressure associated with the control chamber exceeds a maximum allowable predetermined limit.

### Claim 7 (depends on 6)

The apparatus of claim 6, wherein if the change in the gas pressure exceeds the maximum allowable predetermined limit, the processor will indicate a fault condition.

### Claim 8 (depends on 7)

The apparatus of claim 7, wherein the processor will also terminate operation of the pumping cartridge.

### Claim 9 (depends on 6)

The apparatus of claim 6, wherein the processor is configured to close at least one valve to the control chamber to isolate the control chamber.

### Claim 10 (depends on 6)

The apparatus of claim 6, wherein the processor is configured to open at least one inlet valve of the pumping cartridge, the at least one inlet valve being in fluid communication with the pump chamber.

### Claim 11 (depends on 6)

The apparatus of claim 6, wherein the pumping cartridge is disposable.

### Claim 12 (depends on 6)

The apparatus of claim 6, wherein the processor is configured to isolate the pump chamber of the pumping cartridge using at least one valve.

### Claim 13 (depends on 6)

The apparatus of claim 6, wherein the fluid handling apparatus is reusable.

### Claim 14

A method for using a reusable component of a fluid handling system for pumping fluid to and from a patient to test the integrity of a pumping cartridge having a pump chamber, the system comprising a reusable component comprising a control chamber configured to mate with the pump chamber of the pumping cartridge, the method comprising:
mating the pumping cartridge to the reusable component;
supplying the control chamber of the reusable component with a gas at a predetermined pressure before liquid enters the pumping cartridge;
monitoring the gas pressure associated with the control chamber using a pressure transducer configured to measure a gas pressure associated with the control chamber over a predetermined period of time; and
determining if a change in the gas pressure associated with the control chamber exceeds a maximum allowable predetermined limit.

### Claim 15 (depends on 14)

The method of claim 14, further comprising determining if the change in the gas pressure exceeds a maximum fault condition by determining if the change in gas pressure associated with the control chamber exceeds a maximum allowable predetermined limit.

### Claim 16 (depends on 15)

The method of claim 15, further comprising terminating operation of the pumping cartridge if it is determined that the gas pressure exceeds the maximum allowable predetermined limit.

### Claim 17 (depends on 14)

The method of claim 14, further comprising opening at least one valve, wherein the at least one valve in fluid communication with the pumping cartridge.

### Claim 18 (depends on 14)

The method of claim 14, wherein the pumping cartridge comprises a flexible membrane and a rigid portion forming the pump chamber, further comprising a step of opening the pump chamber to the surroundings.

### Claim 19 (depends on 18)

The method of claim 18, wherein opening the pump chamber to the surroundings comprises opening at least one valve in fluid communication with the pump chamber.
