# US 10,117,986 B2 · Peritoneal dialysis machine

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- Number: US 10,117,986 B2
- Document ID: US10117986B2
- Status: Granted
- Kind: B2
- Application number: 14/553,104
- Filed: 2014-11-25
- Published: 2015-03-26
- Granted: 2018-11-06
- Earliest claimed: 2003-10-28
- Assignees: Baxter International Inc.; Baxter Healthcare S.A.
- Applicants: Baxter International Inc.; Baxter Healthcare S.A.
- Inventors: Robert W. Childers
- Web page: https://patentgrep.com/patent/US10117986B2

## CPC

- A61M 1/284: {Continuous flow peritoneal dialysis [CFPD]}
- A61M 1/1522: {the interface being evacuated interfaces to enhance contact}
- A61M 1/1524: {the interface providing means for actuating on functional elements of the cassette, e.g. plungers}
- A61M 1/154: {with sensing means or components thereof}
- A61M 1/155: {with treatment-fluid pumping means or components thereof}
- A61M 1/1561: {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 1/1565: {Details of valves}
- A61M 1/159: {specially adapted for peritoneal dialysis}
- A61M 1/28: Peritoneal dialysis {; Other peritoneal treatment, e.g. oxygenation}
- A61M 1/281: {Instillation other than by gravity}
- A61M 1/288: {Priming (priming in extracorporeal blood circuits A61M1/3643)}
- A61M 1/3621: {Extra-corporeal blood circuits (single-needle circuits A61M1/30)}
- A61M 1/3639: {Blood pressure control, pressure transducers specially adapted therefor}
- A61M 1/3641: {Pressure isolators}
- A61M 1/3643: {Priming, rinsing before or after use}
- A61M 1/3644: {Mode of operation}
- A61M 1/3652: {using gas, e.g. air}
- G01L 7/00: Measuring the steady or quasi-steady pressure of a fluid or a fluent solid material by mechanical or fluid pressure-sensitive elements ({G01L11/004 takes precedence;} transmitting or indicating the displacement of mechanical pressure-sensitive elements by electric {, e.g., photoelectric} or magnetic means G01L9/00; measuring differences of two or more pressure values G01L13/00; measuring two or more pressure values simultaneously G01L15/00)
- G01M 3/04: by detecting the presence of fluid at the leakage point
- A61B 5/02042: {Determining blood loss or bleeding, e.g. during a surgical procedure}
- A61M 2205/122: using evacuated interfaces to enhance contact
- A61M 2205/128: with incorporated valves
- A61M 2205/70: with testing or calibration facilities
- 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)}
- G01L: MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE (weighing G01G)
- G01M: TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A method for operating a dialysis cassette including a flexible membrane that covers a pump chamber includes allowing a source of fluid to fluidly communicate with the pump chamber of the dialysis cassette, filling the pump chamber with the fluid from the source, mechanically extending the flexible membrane into the pump chamber with a piston head to expel the fluid from the pump chamber through a flow path, and directly sensing a pressure of the fluid flowing through the flow path at a location of the dialysis cassette adjacent to the pump chamber and using the sensed pressure to perform a test prior to delivering fluid to a patient.

## Claims

### Claim 1

A method for operating a dialysis cassette including a flexible membrane that covers a pump chamber, the method comprising:
allowing a source of fluid to fluidly communicate with the pump chamber of the dialysis cassette;
filling the pump chamber with the fluid from the source;
mechanically extending the flexible membrane into the pump chamber with a piston head to expel the fluid from the pump chamber through a flow path; and
directly sensing a pressure of the fluid flowing through the flow path at a location of the dialysis cassette adjacent to the pump chamber and using the sensed pressure to perform a test prior to delivering fluid to a patient.

### Claim 2 (depends on 1)

The dialysis cassette operating method of claim 1, wherein the test includes determining that a line occlusion has occurred based on the sensed pressure.

### Claim 3 (depends on 1)

The dialysis cassette operating method of claim 1, which includes pulling a vacuum on the flexible membrane, opening the membrane within the pump chamber to fill the pump chamber with the fluid.

### Claim 4 (depends on 1)

The dialysis cassette operating method of claim 1, wherein directly sensing the pressure includes directly sensing the pressure of the fluid flowing through the flow path at a location of the dialysis cassette between the pump chamber and a valve actuation position of the flow path.

### Claim 5 (depends on 1)

The dialysis cassette operating method of claim 1, wherein directly sensing the pressure includes contacting the flexible membrane with a pressure sensor.

### Claim 6

A method for operating a dialysis cassette including a flexible membrane that covers a pump chamber, the method comprising:
allowing a source of fluid to fluidly communicate with the pump chamber of the dialysis cassette;
filling the pump chamber with the fluid from the source;
pushing the flexible membrane into the pump chamber to expel the fluid from the pump chamber through a flow path;
directly sensing a pressure of the fluid flowing through the flow path at a location of the dialysis cassette adjacent to the pump chamber; and
determining that a line occlusion has occurred based on the sensed pressure.

### Claim 7 (depends on 6)

The dialysis cassette operating method of claim 6, which includes determining that the line occlusion has occurred if the sensed pressure increases when pushing the flexible membrane into the pump chamber.

### Claim 8 (depends on 6)

The dialysis cassette operating method of claim 6, which includes determining that the line occlusion has occurred if the sensed pressure fails to meet an expected pressure drop when pushing the flexible membrane into the pump chamber.

### Claim 9 (depends on 6)

The dialysis cassette operating method of claim 6, which includes determining that the line occlusion has occurred during a priming sequence.

### Claim 10 (depends on 6)

The dialysis cassette operating method of claim 6, which includes pulling a vacuum on the flexible membrane, opening the membrane within the pump chamber to fill the pump chamber with the fluid.

### Claim 11 (depends on 6)

The dialysis cassette operating method of claim 6, wherein directly sensing the pressure includes contacting the flexible membrane with a pressure sensor.

### Claim 12

A dialysis machine comprising:
a housing;
a mechanically actuated piston head extending from a pump actuator housed by the housing, the mechanically actuated piston head positioned to extend towards and away from a fluid pumping cassette, the fluid pumping cassette coupled operably to the housing such that a flexible membrane of the fluid pumping cassette faces the piston head so that the piston head can push the flexible membrane into a pump chamber of the fluid pumping cassette to expel a fluid from the pump chamber;
a pressure sensor located adjacent to the mechanically actuated piston head so as to sense a pressure of the fluid moved by the mechanically actuated piston head within the fluid pumping cassette; and
a controller programmed to use the sensed pressure to perform a test prior to delivering fluid to a patient.

### Claim 13 (depends on 12)

The dialysis machine of claim 12, wherein the test determines whether a line occlusion has occurred.

### Claim 14 (depends on 12)

The dialysis machine of claim 12, which includes a vacuum chamber configured to pull a vacuum on the flexible membrane to open the membrane within the pump chamber to fill the pump chamber with the fluid.

### Claim 15 (depends on 12)

The dialysis machine of claim 12, wherein the pressure sensor directly senses the pressure of the fluid flowing through a flow path at a location of the fluid pumping cassette between the pump chamber and a flow path valve.

### Claim 16 (depends on 12)

The dialysis machine of claim 12, wherein the pressure sensor contacts the flexible membrane.

### Claim 17

A dialysis machine comprising:
a housing;
a mechanically actuated piston head extending from a pump actuator housed by the housing, the mechanically actuated piston head positioned to extend towards and away from a fluid pumping cassette, the fluid pumping cassette coupled operably to the housing such that a flexible membrane of the fluid pumping cassette faces the piston head so that the piston head can push the flexible membrane into a pump chamber of the fluid pumping cassette to expel a fluid from the pump chamber;
a pressure sensor located adjacent to the mechanically actuated piston head so as to sense a pressure of the fluid moved by the mechanically actuated piston head within the fluid pumping cassette; and
a controller programmed to use the sensed pressure to determine whether a line occlusion has occurred.

### Claim 18 (depends on 17)

The dialysis machine of claim 17, wherein the line occlusion is determined by the controller if the sensed pressure increases when extending the flexible membrane into the pump chamber.

### Claim 19 (depends on 17)

The dialysis machine of claim 17, wherein the line occlusion is determined by the controller if the sensed pressure fails to meet an expected pressure drop when extending the flexible membrane into the pump chamber.

### Claim 20 (depends on 17)

The dialysis machine of claim 17, wherein the line occlusion is determined by the controller during a priming sequence.

### Claim 21 (depends on 17)

The dialysis machine of claim 17, which includes a vacuum chamber configured to pull a vacuum on the flexible membrane to open the membrane within the pump chamber to fill the pump chamber with the fluid.

### Claim 22 (depends on 17)

The dialysis machine of claim 17, wherein the pressure sensor contacts the flexible membrane.