Cassette system for peritoneal dialysis machine

• US 7,935,074 B2
• Filed: 08/31/2006
• Issued: 05/03/2011
• Est. Priority Date: 02/28/2005
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Klatte, Stephan, Plahey, Kulwinder S., Hedmann, Frank L., Folden, Thomas I.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US11/515,359
• Publication Number:
  US 20070112297A1
• Time in Patent Office: 1,706 Days
• Field of Search: 604 28- 33, 604/131, 417/477.2, 5 28- 33, 513/1, 210/258, 210/646, 210/787
• US Class Current: 604/29
• CPC Class Codes: A61M 1/1522 the interface being evacuated interfaces to enhance contact
• 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 1/281 Instillation other than by gravity
• CPC Class Codes: A61M 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 2205/122 using evacuated interfaces to enhance contact
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches

Abstract

A portable peritoneal dialysis apparatus having a side-hinged, inclined door for enclosing a disposable cassette that seals tightly shut using air pressure which imposes a safety interlock, a cassette with its inlet/outlet tube exclusively along the lower edge so that the connected lines can hang straight, a circumferential channel defined in the cassette, and a pneumatic system for sealing the membranes of both the pump chamber diaphragms and the pressure sensor diaphragms in the cassette to the respective mating pistons and pressure sensors in the cycler. In addition a system for draining patient line fluid to an empty solution bag is disclosed.

Claims

1. An apparatus for pumping fluids between a peritoneal dialysis machine and a patient in order to perform peritoneal dialysis on the patient, comprising:

a disposable cassette for routing PD solution,

a cassette compartment defined by a deck and a door hinged from the side so as to close in parallel over the deck and enclose the cassette within the compartment,

wherein the deck has openings for valve actuators and piston heads, and when the apparatus is resting on a substantially horizontal surface during use, the deck lies in a plane inclined from the vertical by 10 to 35 degrees, and the apparatus comprises two substantially mushroom head shaped piston heads that travel back and forth through two of the openings in the deck when reciprocated.

2. The apparatus of claim 1 wherein when the apparatus is resting on a substantially horizontal surface during use, the deck lies in a plane inclined from the vertical by about 20 to 25 degrees.

3. The apparatus of claim 2 wherein when the apparatus is resting on a substantially horizontal surface during use, the deck lies in a plane inclined from the vertical by about 22 degrees.

4. The apparatus of claim 1, wherein the cassette has inlet/outlet connections along the bottom of the cassette, the compartment accommodating the connection of vertically hanging tubes to the inlet/outlet connections on the cassette.

5. The apparatus of claim 4, wherein all of the inlet/outlet connections are in a line along the bottom edge of the cassette so that when the cassette is disposed in the compartment and the tubes are connected to the inlet/outlet connections of the cassette, the tubes bend, between the cassette and a substantially horizontal surface on which the system is resting, at an angle substantially greater than 90 degrees.

6. The apparatus of claim 1 wherein the apparatus comprises a plurality of inflatable balloon valves positioned in a plurality of the openings in the deck.

7. The apparatus of claim 1, wherein the cassette comprises a rigid base defining a recessed region, and a flexible membrane attached to the base in a manner such that the flexible membrane, when pressed against the base, cooperates with a portion of the base defining the recessed region to form a pump chamber.

8. The apparatus of claim 7, wherein the pump chamber has an inlet port and an outlet port.

9. A system for pumping fluids between a peritoneal dialysis machine and a patient in order to perform peritoneal dialysis on the patient, the system comprising:

a PD solution cassette comprising

a rigid base defining a recessed region;

a flexible membrane attached to the base in a manner such that the flexible membrane, when pressed against the base, cooperates with a portion of the base defining the recessed region to form a pump chamber having an inlet port and an outlet port; and

tubing connectors positioned along only one edge of the cassette; and

a PD cycler comprising

a door hinged along one of its sides to the base so as to close over a cassette deck to form a cassette compartment configured to contain the PD solution cassette, wherein, when the system is resting on a substantially horizontal surface and the PD solution cassette is contained in the cassette compartment, the cassette deck lies in a plane inclined from the vertical by 10 to 35 degrees and the tubing connectors are positioned along a bottom edge of the cassette; and

a substantially mushroom head shaped piston head mounted for reciprocation in an opening defined in the cassette deck, the piston head being substantially aligned with the pump chamber of the PD solution cassette when the PD solution cassette is contained in the cassette compartment.

10. The system of claim 9 wherein when the system is resting on a substantially horizontal surface during use, the deck lies in a plane inclined from the vertical by about 20 to 25 degrees.

11. The system of claim 10 wherein when the system is resting on a substantially horizontal surface during use, the deck lies in a plane inclined from the vertical by about 22 degrees.

12. The system of claim 9 wherein the PD solution cassette further comprises tubes connected to the tubing connectors and extending from the one edge of the cassette.

13. The system of claim 12 wherein all of the tubing connectors are in a line along the bottom edge of the PD solution cassette so that when the PD solution cassette is contained in the cassette compartment and the system is supported by a substantially horizontal surface, the tubes bend, between the cassette and the substantially horizontal surface, at an angle substantially greater than 90 degrees.

14. The system of claim 12 further comprising a clamp mechanism that extends across all of the tubes extending from the one edge of the cassette, the clamp mechanism being configured to crimp all of the tubes.

15. The system of claim 9 wherein the cassette has a sensor region that mates with a sensor of the PD cycler.

16. A system for pumping fluids between a peritoneal dialysis machine and a patient in order to perform peritoneal dialysis on the patient, the system comprising:

a PD solution cassette comprising

a rigid base defining a recessed region and a plurality of channels;

at least one flexible membrane attached to the base in a manner such that the at least one flexible membrane, when pressed against the base, cooperates with a portion of the base defining the recessed region to form a pump chamber having an inlet port and an outlet port and cooperates with portions of the base defining the plurality of channels to form fluid pathways that are fluidly connected to the pump chamber via the inlet and outlet ports;

tubing connectors positioned along one edge of the cassette; and

tubes connected to the tubing connectors and extending from the one edge of the cassette; and

a PD cycler comprising

a base,

a door hinged along one of its sides to the base so as to close in parallel over a cassette deck to form a cassette compartment configured to contain the PD solution cassette, wherein, when the system is resting on a substantially horizontal surface and the PD solution cassette is contained in the cassette compartment, the cassette deck lies in a plane inclined from the vertical by 10 to 35 degrees and the tubes extend from a bottom edge of the cassette;

an inflatable pad carried by the door, the inflatable pad pressing the membrane of the PD solution cassette against the base of the cassette and forcing the cassette into sealing engagement with the cassette deck when the PD solution cassette is contained in the cassette compartment and the pad is inflated;

a door latch mechanism that is locked by the force of the inflatable pad when the door is closed and the pad is inflated thus serving as a safety interlock so that the door cannot be manually opened until the pad is deflated;

a substantially mushroom head shaped piston head mounted for reciprocation in a cylindrical chamber extending inward from the cassette deck, the piston head being substantially aligned with the pump chamber of the PD solution cassette when the PD solution cassette is contained in the cassette compartment;

a sensor that mates with a sensor region of the PD solution cassette when the PD solution cassette is contained in the cassette compartment; and

a clamp mechanism that extends across all of the tubes extending from the one edge of the cassette, the clamp mechanism being configured to crimp all of the tubes.