Peritoneal dialysis systems and related devices and methods

• US 9,579,443 B2
• Filed: 01/10/2013
• Issued: 02/28/2017
• Est. Priority Date: 01/10/2013
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Plahey, Kulwinder S., Farrell, Sean
• Primary Examiner(s): Hayman, Imani
• Assistant Examiner(s): SHAH, NILAY J
• Application Number:
  US13/738,144
• Publication Number:
  US 20140194809A1
• Time in Patent Office: 1,510 Days
• US Class Current: 1/1
• CPC Class Codes: 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
• CPC Class Codes: A61M 1/1524 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/154 with sensing means or components thereof
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: 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
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/282 Operational modes
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/127 with provisions for heating or cooling
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient

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

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 has a size and a weight that are less than a size and a weight of the base peritoneal dialysis system, and 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

at least one valve seat,

a fluid exchange device that is sized to be handheld, the fluid exchange device including

a compartment configured to receive the second disposable unit,

at least one valve member arranged to cooperate with the at least one valve seat of the second disposable unit when the second disposable unit is disposed in the compartment, 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 the peritoneal cavity of the 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.

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

3. 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.

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

5. 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.

6. 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.

7. 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 a duration of fluid flow through the peritoneal dialysis fluid exchange system, and

use the calculated fluid flow rates and the 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.

8. The system of claim 7, wherein the processor is further configured to store at least one of the calculated fluid flow rates, the calculated duration, the volume of fluid transferred to the patient and the volume of fluid drained from the patient.

9. The system of claim 7, 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.

10. 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.

11. The system of claim 10, 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.

12. The system of claim 11 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.

13. The system of claim 11 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.

14. The system of claim 13 wherein the second disposable unit comprises a bypass passageway that selectively permits fluid flow to be diverted past the pump chamber.

15. The peritoneal dialysis system of claim 13 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.

16. The peritoneal dialysis system of claim 15 wherein the fluid exchange device comprises a bypass valve at a location corresponding to the bypass valve seat.

17. The peritoneal dialysis system of claim 10 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 inner diameters of portions of the fluid passageway on either side of the orifice plate.

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

19. The system of claim 1, wherein the weight of the peritoneal dialysis fluid exchange system is less than 1 lb.