# US 2014/0194809 A1 · Peritoneal dialysis systems and related devices and methods

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- Number: US 2014/0194809 A1
- Document ID: US20140194809A1
- Status: Published application
- Kind: A1
- Application number: 13/738,144
- Filed: 2013-01-10
- Published: 2014-07-10
- Earliest claimed: 2013-01-10
- Assignees: Fresenius Medical Care Holdings, Inc.
- Applicants: Fresenius Medical Care Holdings, Inc.
- Inventors: Kulwinder S. Plahey; Sean Farrell
- Web page: https://patentgrep.com/patent/US20140194809A1

## CPC

- A61M 1/282: {Operational modes}
- 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 1/14: Dialysis systems; Artificial kidneys; Blood oxygenators (semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00){; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis}
- A61M 1/16: with membranes
- A61M 2205/12: with interchangeable cassettes forming partially or totally the fluid circuit
- A61M 2205/127: with provisions for heating or cooling
- A61M 2205/128: with incorporated valves
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3561: local, e.g. within room or hospital
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/3576: with non implanted data transmission devices, e.g. using external transmitter or receiver
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- 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

A peritoneal dialysis system includes a base peritoneal dialysis system and a peritoneal dialysis fluid exchange system that operates independently of the base system. The base system includes a first cassette including a first patient line configured to be connected to a patient, and a PD cycler. The PD cycler receives the first cassette, and includes a pump that cooperates with the first cassette to deliver dialysate to and drain dialysate from a peritoneal cavity of the patient via the first patient line. The peritoneal dialysis fluid exchange system includes a second cassette including a second patient line configured to be connected to the patient and a fluid exchange device that receives the second cassette. The fluid exchange device includes a data exchange interface operable to transfer patient treatment data from the peritoneal dialysis fluid exchange system to the base peritoneal dialysis system.

## Claims

### Claim 1

A peritoneal dialysis system comprising a base peritoneal dialysis system and a peritoneal dialysis fluid exchange system that operates independently of the base peritoneal dialysis system, wherein
the base peritoneal dialysis system includes
a first disposable unit including a first patient line configured to be connected to a patient, and
a peritoneal dialysis device including
a compartment configured to receive the first disposable unit, and
at least one pump arranged so that when the first disposable unit is disposed within the compartment, the pump cooperates with the first disposable unit to deliver dialysate to and drain dialysate from a peritoneal cavity of the patient via the first patient line of the first disposable unit,
the peritoneal dialysis fluid exchange system includes
a second disposable unit including a second patient line configured to be connected to the patient such that fluid can be delivered to and drained from the peritoneal cavity of the patient via the second patient line, and
a fluid exchange device including
a compartment configured to receive the second disposable unit, and
a data exchange interface operable to transfer patient treatment data from the peritoneal dialysis fluid exchange system to the base peritoneal dialysis system, and
the base peritoneal dialysis system is configured to
automatically deliver dialysate to and automatically drain dialysate from a peritoneal cavity of a patient based on a patient treatment plan, and
modify the patient treatment plan based on the patient treatment data transferred from the peritoneal dialysis fluid exchange system.

### Claim 2

(canceled)

### Claim 3 (depends on 1)

The system of claim 1, wherein the data exchange interface is a transmitter, and the base peritoneal dialysis system further comprises a receiver.

### Claim 4 (depends on 1)

The system of claim 1, wherein the data exchange interface is an input/output port configured to permit connection to a data communication line extending from the base peritoneal dialysis system.

### Claim 5 (depends on 1)

The system of claim 1, wherein the peritoneal dialysis fluid exchange system comprises a fluid flow meter.

### Claim 6 (depends on 1)

The system of claim 1, wherein the fluid exchange device further comprises a sensor disposed adjacent to the second disposable unit when the second disposable unit is disposed in the compartment of the fluid exchange device, the sensor being operable to obtain the patient treatment data.

### Claim 7 (depends on 1)

The system of claim 1, wherein the patient treatment data includes a volume of fluid transferred to the patient and a volume of fluid drained from the patient.

### Claim 8 (depends on 1)

The system of claim 1, wherein the peritoneal dialysis fluid exchange system includes a processor configured to
calculate fluid flow rates through the peritoneal dialysis fluid exchange system,
calculate the duration of fluid flow through the peritoneal dialysis fluid exchange system, and
use the calculated fluid flow rates and calculated duration to determine at least one of a volume of fluid infused to the patient and a volume of fluid drained from the patient.

### Claim 9 (depends on 8)

The system of claim 8, wherein the processor is further configured to store at least one of the calculated fluid flow rates, calculated duration, volume of fluid transferred to the patient and a volume of fluid drained from the patient.

### Claim 10 (depends on 8)

The system of claim 8, wherein the second disposable unit comprises
a base, and
a flexible membrane attached to the base in such a way that the base and the flexible membrane cooperate to form a fluid passageway that can be placed in communication with the second patient line,
wherein
the fluid passageway includes a first pressure sensor seat, a second pressure sensor seat, and a localized region of reduced fluid passageway diameter disposed between the first pressure sensor seat and the second pressure sensor seat.

### Claim 11 (depends on 1)

The system of claim 1, wherein the second disposable unit comprises
a base, and
a flexible membrane attached to the base in such a way that the base and the flexible membrane cooperate to form a fluid passageway that can be placed in communication with the second patient line, the second patient line having a patient line portion connected to an infusion line portion and a drain line portion,
wherein
the patient line portion includes a first pressure sensor seat, a second pressure sensor seat, and a localized region of reduced fluid passageway diameter disposed between the first pressure sensor seat and the second pressure sensor seat.

### Claim 12 (depends on 11)

The system of claim 11, wherein
the fluid exchange device includes a first pressure sensor and a second pressure sensor,
the fluid exchange device is configured to receive the second disposable unit within the fluid exchange device compartment in a manner such that the first pressure sensor is disposed at a location corresponding to the first pressure sensor seat, and the second pressure sensor is disposed at a location corresponding to the second pressure sensor seat, and
the fluid exchange device further includes
a controller that is configured to
receive fluid pressure data detected by the first pressure sensor and the second pressure sensor, and calculate fluid flow data based on the received fluid pressure data, and
transmit the fluid flow data to the data exchange interface.

### Claim 13 (depends on 12)

The system of claim 12 wherein
the infusion line portion includes an infusion line portion valve seat,
the drain line portion includes a drain line portion valve seat,
the second disposable unit includes a pump chamber disposed between the first pressure sensor seat and a region in which the infusion line portion and the drain line portion connect to the patient line portion, and
the fluid exchange device is configured to receive the second disposable unit within the fluid exchange device compartment in a manner such that
an infusion line valve is disposed at a location corresponding to the infusion line portion valve seat,
a drain line valve is disposed at a location corresponding to the drain line portion valve seat, and
a fluid pump is disposed at a location corresponding to the pump chamber, the fluid pump configured to cooperate with the pump chamber to pump fluid within the fluid passageway.

### Claim 14 (depends on 12)

The system of claim 12 wherein
the infusion line portion includes an infusion line portion valve seat,
the drain line portion includes a drain line portion valve seat,
the second disposable unit includes a pump chamber disposed between the first pressure sensor seat and a region in which the infusion line portion and the drain line portion connect to the patient line portion, and a pump rotor disposed within the pump chamber, and
the fluid exchange device is configured to receive the second disposable unit within the fluid exchange device compartment in a manner such that
an infusion line valve is disposed at a location corresponding to the infusion line portion valve seat,
a drain line valve is disposed at a location corresponding to the drain line portion valve seat, and
an induction coil is disposed at a location corresponding to the pump chamber, the induction coil configured to drive the pump rotor to pump fluid within the fluid passageway.

### Claim 15 (depends on 14)

The system of claim 14 wherein the second disposable unit comprises a bypass passageway that selectively permits fluid flow to be diverted past the pump chamber.

### Claim 16 (depends on 14)

The peritoneal dialysis system of claim 14 wherein the second disposable unit comprises a bypass passageway including
a first end that communicates with the patient line portion at a location between the pump chamber and the region in which the infusion line portion and the drain line portion connect to the patient line portion,
a second end that communicates with the patient line portion at a location between the pump chamber and the first pressure sensor seat, and
a bypass valve seat.

### Claim 17 (depends on 16)

The peritoneal dialysis system of claim 16 wherein the fluid exchange device comprises a bypass valve at a location corresponding to the bypass valve seat.

### Claim 18 (depends on 11)

The peritoneal dialysis system of claim 11 wherein the localized region of reduced fluid passageway diameter includes an orifice plate disposed in the fluid passageway, the orifice plate including an opening having a smaller diameter than the inner diameter of portions of the fluid passageway on either side of the orifice plate.

### Claim 19 (depends on 1)

The system of claim 1, wherein the transferred patient treatment data is synchronized with patient treatment data of the base peritoneal dialysis system.

### Claim 20 (depends on 1)

The system of claim 1, wherein the peritoneal dialysis fluid exchange system has a size and a weight that are less than the size and the weight of the base peritoneal dialysis system.

### Claim 21 (depends on 20)

The system of claim 20, wherein the peritoneal dialysis fluid exchange system has a weight that is less than 1 lb.

### Claim 22

A peritoneal dialysis device comprising
a compartment configured to receive a disposable unit that includes a patient line configured to be connected to a patient,
at least one pump arranged so that when the disposable unit is disposed within the compartment, the pump cooperates with the disposable unit to deliver dialysate to and drain dialysate from a peritoneal cavity of the patient via the patient line of the disposable unit in accordance with a patient treatment plan,
a data transfer interface configured to receive patient treatment data from an independent peritoneal dialysis system, the patient data having been obtained during peritoneal dialysis performed by the independent peritoneal dialysis system, and
a controller that automatically modifies the patient treatment plan based on the received patient treatment data.

### Claim 23

A method of providing dialysis treatment comprising
obtaining patient treatment data during peritoneal dialysis performed by a first peritoneal dialysis system,
transferring the obtained patient treatment data from the first peritoneal dialysis system to a second peritoneal dialysis system, and
determining a modified patient treatment plan using the second peritoneal dialysis system based on the obtained patient treatment data transferred from the first peritoneal dialysis system, the modified patient treatment plan to be carried out by the second peritoneal dialysis system.

### Claim 24 (depends on 23)

The method of claim 23, further comprising
performing peritoneal dialysis using the second peritoneal dialysis system based on the modified patient treatment plan.

### Claim 25 (depends on 23)

The method of claim 23, wherein obtaining the patient treatment data includes measuring fluid flow rates through the first peritoneal dialysis system and measuring fluid flow durations through the first peritoneal dialysis system.

### Claim 26 (depends on 23)

The method of claim 23, wherein obtaining the patient treatment data includes measuring fluid flow rates through the first peritoneal dialysis system and measuring fluid flow durations through the first peritoneal dialysis system, and using the measured fluid flow rates and measured fluid flow durations to determine at least one of a volume of fluid infused to the patient and a volume of fluid drained from the patient.

### Claim 27 (depends on 26)

The method of claim 26 wherein determining the modified patient treatment plan includes adjusting at least one of an infusing volume and a draining volume in a dialysis treatment based on the volume of fluid infused to the patient and a volume of fluid drained from the patient using the first peritoneal dialysis system.

### Claim 28 (depends on 23)

The method of claim 23 wherein transferring the obtained patient treatment data is achieved via a wireless connection between the first peritoneal dialysis system and the second peritoneal dialysis system.

### Claim 29 (depends on 23)

The method of claim 23 wherein transferring the obtained patient treatment data is achieved via a wired connection between the first peritoneal dialysis system and the second peritoneal dialysis system.

### Claim 30

A peritoneal dialysis cassette including
a base, and
a flexible membrane attached to the base in such a way that the base and the flexible membrane cooperate to form a fluid passageway, the fluid passageway having a patient line portion connected to an infusion line portion and a drain line portion,
wherein the fluid passageway includes a first pressure sensor seat, a second pressure sensor seat, and a localized region of reduced fluid passageway diameter disposed between the first pressure sensor seat and the second pressure sensor seat.

### Claim 31 (depends on 30)

The peritoneal dialysis cassette of claim 30 comprising a pump chamber disposed along the fluid passageway between the first pressure sensor seat and a region in which the infusion line portion and the drain line portion connect to the patient line portion.

### Claim 32 (depends on 31)

The peritoneal dialysis cassette of claim 31 comprising an induction pump at least partially disposed within the pump chamber.

### Claim 33 (depends on 31)

The peritoneal dialysis cassette of claim 31 comprising a bypass passageway that selectively permits fluid flow to be diverted past the pump chamber.

### Claim 34 (depends on 31)

The peritoneal dialysis cassette of claim 31 comprising a bypass passageway including
a first end that communicates with the patient line portion at a location between the pump chamber and the region in which the infusion line portion and the drain line portion connect to the patient line portion,
a second end that communicates with the patient line portion at a location between the pump chamber and the first pressure sensor seat, and
a bypass valve seat.

### Claim 35 (depends on 30)

The peritoneal dialysis cassette of claim 30 wherein the localized region includes an orifice plate disposed in the fluid passageway, the orifice plate including an opening having a smaller diameter than the inner diameter of portions of the fluid passageway on either side of the orifice plate.

### Claim 36

A peritoneal dialysis system comprising
a peritoneal dialysis cassette including
a base, and
a flexible membrane attached to the base in such a way that the base and the flexible membrane cooperate to form a fluid passageway, the fluid passageway having a patient line portion connected to an infusion line portion and a drain line portion,
wherein the fluid passageway includes a first pressure sensor seat, a second pressure sensor seat, and a localized region of reduced fluid passageway diameter disposed between the first pressure sensor seat and the second pressure sensor seat.

### Claim 37 (depends on 36)

The peritoneal dialysis system of claim 36, wherein
the system further comprises a fluid exchange device that includes a first pressure sensor and a second pressure sensor,
the fluid exchange device is configured to support the cassette in a manner such that the first fluid pressure sensor is disposed at a location corresponding to the first pressure sensor seat, and the second fluid pressure sensor is disposed at a location corresponding to the second pressure sensor seat, and
the fluid exchange device further includes
a controller that is configured to receive fluid pressure data detected by the first fluid pressure sensor and the second fluid pressure sensor, and calculate fluid flow data based on the received fluid pressure data, and
a data exchange interface that is configured to transmit fluid flow data to a location remote from the peritoneal dialysis device.

### Claim 38 (depends on 37)

The peritoneal dialysis system of claim 37 wherein
the infusion line portion includes an infusion line portion valve seat,
the drain line portion includes a drain line portion valve seat,
the peritoneal dialysis cassette includes a pump chamber disposed between the first pressure sensor seat and a region in which the infusion line portion and the drain line portion connect to the patient line portion, and
the fluid exchange device includes
an infusion line valve at a location corresponding to the infusion line portion valve seat,
a drain line valve at a location corresponding to the drain line portion valve seat, and
a fluid pump at a location corresponding to the pump chamber, the fluid pump configured to cooperate with the pump chamber to pump fluid through the fluid passageway.

### Claim 39 (depends on 37)

The peritoneal dialysis system of claim 37 wherein
the infusion line portion includes an infusion line portion valve seat,
the drain line portion includes a drain line portion valve seat,
the peritoneal dialysis cassette further includes
a pump chamber disposed between the first pressure sensor seat and a region in which the infusion line portion and the drain line portion connect to the patient line portion, and
a pump rotor disposed within the pump chamber, and
the fluid exchange device includes
an infusion line valve at a location corresponding to the infusion line portion valve seat,
a drain line valve at a location corresponding to the drain line portion valve seat, and
an induction coil at a location corresponding to the pump chamber, the induction coil configured to drive the pump rotor to pump fluid through the fluid passageway.

### Claim 40 (depends on 39)

The peritoneal dialysis system of claim 39 wherein the peritoneal dialysis cassette further comprises a bypass passageway that selectively permits fluid flow to be diverted past the pump chamber.

### Claim 41 (depends on 39)

The peritoneal dialysis system of claim 39 wherein the peritoneal dialysis cassette further comprises a bypass passageway including
a first end that communicates with the patient line portion at a location between the pump chamber and the region in which the infusion line portion and the drain line portion connect to the patient line portion,
a second end that communicates with the patient line portion at a location between the pump chamber and the first pressure sensor seat, and
a bypass valve seat.

### Claim 42 (depends on 41)

The peritoneal dialysis system of claim 41 wherein the fluid exchange device includes a bypass valve at a location corresponding to the bypass valve seat.

### Claim 43 (depends on 36)

The peritoneal dialysis system of claim 36 wherein the localized region of reduced fluid passageway diameter includes an orifice plate disposed in the fluid passageway, the orifice plate including an opening having a smaller diameter than the inner diameter of portions of the fluid passageway on either side of the orifice plate.
