Peritoneal dialysis systems, devices, and methods

• US 10,603,424 B2
• Filed: 03/31/2017
• Issued: 03/31/2020
• Est. Priority Date: 03/23/2011
• Status: Active Grant

• Current Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Burbank, Jeffrey H., Brugger, James M., Treu, Dennis M., Wyeth, Mark T.
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US15/476,819
• Publication Number:
  US 20170203025A1
• Time in Patent Office: 1,096 Days
• 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 1/1562 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/1664 with temperature control
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/167 Flexible packaging for solid concentrates
• CPC Class Codes: A61M 1/1672 using membrane filters, e.g. for sterilising the dialysate
• CPC Class Codes: A61M 1/1674 using UV radiation sources for sterilising the dialysate
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/281 Instillation other than by gravity
• CPC Class Codes: A61M 1/282 Operational modes
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 1/287 Dialysates therefor
• CPC Class Codes: A61M 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/123 : with incorporated reservoirs
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: A61M 2205/14 : Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/33 : Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3351 : Controlling upstream pump pressure
• CPC Class Codes: A61M 2205/3355 : Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus

Abstract

A disposable fluid circuit used in a medical device that performs peritoneal dialysis includes a peritoneal dialysis tubing set that has a connection tube with a connector for a peritoneal catheter at a distal end and a connector configured to connect to a peritoneal cycler at a proximal end. The circuit also includes a pressure pod at the distal end, the pressure pod being of the type that has a flow chamber for carrying a liquid and an air chamber separated from the flow chamber by a diaphragm and an air port in fluid communication with the air chamber. The flow chamber is connected in-line with a lumen of the connection tube and a length of tubing runs from the air-port along the length of the connection tube with a connector at the proximal end configured to connect to a pressure transducer.

Claims

1. A disposable fluid circuit for performing peritoneal dialysis, comprising:

a first manifold with a first plurality of ports and configured to distribute fluid flow between the ports of the first plurality;

a second manifold with a second plurality of ports and configured to distribute fluid flow between the ports of the second plurality;

a pumping tube configured to mate to a pump and fluidly connecting the first manifold to the second manifold;

a peritoneal dialysis tubing set connected to the first plurality of ports and the second plurality of ports and including

a connection line with a first connector for a peritoneal catheter at a distal end of the connection line and a second connector configured to connect to a peritoneal cycler at a proximal end of the connection line;

a pressure pod at the distal end of the connection line, the pressure pod having a flow chamber for carrying a liquid and an air chamber separated from the flow chamber by a diaphragm and an air-port in fluid communication with the air chamber, wherein

the flow chamber of the pressure pod is connected in-line with a lumen of the connection line and

a length of tubing extends from the air-port along the connection line and has a third connector at a proximal end of the length of tubing configured to connect to a pressure transducer.

2. The disposable fluid circuit of claim 1, wherein

the fluid circuit is made entirely of polymer, and

the lumen of the connection line is sealed at both ends and sterile.

3. The disposable fluid circuit of claim 2, wherein

the distal end has a peritoneal catheter with a lumen interconnected to the distal end with the lumen of the peritoneal catheter and the connection line in flow communication.

4. The disposable fluid circuit of claim 1, further comprising:

a fluid container fluidly connected to at least one port of the first plurality of ports and to at least one port of the second plurality of ports.

5. The disposable fluid circuit of claim 4, further comprising:

a medicament container with at least one component of a medicament connected to at least one port of the first plurality of ports.

6. The disposable fluid circuit of claim 1, further comprising:

a first empty fluid container fluidly connected through at least the second manifold to the proximal end of the connection line and a second filled fluid container with at least one component of a medicament fluidly connected through at least the first manifold to the first empty fluid container by at least one fluid connection that is controlled by a valve.

7. The disposable fluid circuit of claim 1, wherein

the first manifold is physically immediately adjacent to the second manifold.

8. The disposable fluid circuit of claim 1, wherein

the first manifold is not in physical contact with the second manifold.

9. The disposable fluid circuit of claim 1, further comprising:

a backplane that provides support for the peritoneal dialysis tubing set.

10. The disposable fluid circuit of claim 1, further comprising:

two shell parts that at least partially enclose the peritoneal dialysis tubing set.

11. The disposable fluid circuit of claim 10, further comprising:

a plurality of windows in the two shell parts, the windows of the plurality exposing tubes of the peritoneal dialysis tubing set to a pinching mechanism.

12. The disposable fluid circuit of claim 10, wherein

the two shell parts form a housing around the peritoneal dialysis tubing set, and

all tubes of the peritoneal dialysis tubing set extend away from the housing from only a single side of the housing.