PUMPING SYSTEMS FOR CASSETTE-BASED DIALYSIS

• US 20140257176A1
• Filed: 05/21/2014
• Published: 09/11/2014
• Est. Priority Date: 07/19/2002
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Childers, Robert W., Lauman, Brian
• Granted Patent: US 9,795,729 B2
• Time in Patent Office: Days
• US Class Current: 604/28
• CPC Class Codes: A61M 1/1522 the interface being evacuated interfaces to enhance contact
• 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 1/1562 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• 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 1/284 Continuous flow peritoneal dialysis [CFPD]
• CPC Class Codes: A61M 2205/122 using evacuated interfaces to enhance contact

Abstract

A dialysis machine includes: a hardware unit including at least one pump actuator, at least one valve actuator and a cassette interface, the cassette interface including: (i) a plate that abuts the cassette; (ii) at least one pump aperture defined by the plate; (iii) at least one pump head moveable out of and retractable into the at least one pump aperture to operate a pumping portion of the cassette; (iv) at least one valve aperture defined by the plate; (v) at least one valve apparatus moveable out of and retractable into the at least one valve aperture to operate a valve portion of the cassette; (vi) at least one sensor aperture defined by the plate; and (vii) at least one sensor located in the least one sensor aperture, the at least one sensor operable with a sensor portion of the cassette.

Claims

1. A peritoneal dialysis method comprising:

enabling a disposable pumping cassette to be aligned so that (i) a soft side of the disposable pumping cassette faces towards a vacuum chamber and a rigid piston head of a peritoneal dialysis machine, the rigid piston head attached to a rigid piston shaft that is connected mechanically to a stepper motor via a coupler, and (ii) a dialysis fluid supply line, a patient line and a drain line extend from a hard part of the disposable cassette to the outside of the peritoneal dialysis machine and communicate with a respective dialysis fluid supply container, a patient and a drain;

positioning the rigid piston head relative to the vacuum chamber such that the rigid piston shaft translates back and forth within the vacuum chamber;

applying a vacuum from a negative pressure source communicating pneumatically through the vacuum chamber such that the soft side of the disposable pumping cassette is pulled into contact with a surface of the rigid piston head to at least partially mate the soft side of the disposable pumping cassette with the rigid piston head;

operating a stepper motor such that the rigid piston head and the soft side of the disposable pumping cassette extend at least partially into the hard part of the disposable pumping cassette so as to push (i) fresh dialysis fluid from the disposable pumping cassette, through the patient line or (ii) used dialysis fluid from the disposable cassette, through the drain line and to the drain; and

operating the stepper motor such that the rigid piston head retracts from the hard part of the disposable pumping cassette while the negative pressure source applies a vacuum through the vacuum chamber to the soft side of the disposable pumping cassette to hold the soft side in at least partial contact with the surface of the rigid piston head so as to draw (i) fresh dialysis fluid from the dialysis fluid supply container through the supply line and into the disposable pumping cassette through the supply line or (ii) used dialysis fluid from the patient through the patient line and into the disposable pumping cassette.

2. The peritoneal dialysis method of claim 1, which includes retracting the rigid piston head completely out of the hard part of the disposable pumping cassette and alternating the soft side of the disposable pumping cassette to move away from the hard side of the disposable pumping cassette.

3. The peritoneal dialysis method of claim 1, which includes extending the rigid piston head at least partially into the hard part of the disposable pumping cassette by a preset distance using the stepper motor.

4. The peritoneal dialysis method of claim 1, which includes enabling the disposable pumping cassette to be aligned with the peritoneal dialysis machine at a non-vertical angle.

5. The peritoneal dialysis method of claim 1, which includes conforming the shape and size of the rigid piston head to a shape and size of a pump chamber portion of the hard part of the disposable cassette.

6. The peritoneal dialysis method of claim 1, which includes positioning the rigid piston head relative to the vacuum chamber such that the rigid piston shaft moves back and forth sealingly within the vacuum chamber.

7. The peritoneal dialysis method of claim 1, which includes configuring the disposable cassette so that when accepted by the peritoneal dialysis machine multiple dialysis fluid supply lines extend from a same surface of the peritoneal dialysis machine.

8. A peritoneal dialysis method comprising:

enabling the mating of a disposable pumping cassette with a peritoneal dialysis machine having first and second rigid piston heads attached to first and second respective rigid piston shafts;

operating a stepper motor such that the first and second rigid piston shafts are moved within a vacuum chamber towards the disposable pumping cassette and the first and second respective rigid piston heads contact and move first and second respective portions of a flexible membrane of the disposable pumping cassette into a rigid portion of the disposable pumping cassette to push (i) fresh dialysate out of the disposable pumping cassette, through a patient line towards a patient or (ii) used dialysate out of the disposable pumping cassette, through a drain line towards a drain; and

using a negative pressure source communicating pneumatically through the vacuum chamber to apply (a) a first vacuum mating the first portion of the flexible membrane to a surface of the first rigid piston head and (b) a second vacuum mating the second portion of the flexible membrane to a surface of the second rigid piston head, causing the first and second portions of the flexible membrane to respectively follow the first and second rigid piston heads as either rigid piston head is moved away from the disposable pumping cassette to pull (i) fresh dialysate from a fresh dialysate supply line into the disposable pumping cassette or (ii) used dialysate from the patient line to fill a respective first or second pump chamber of the disposable pumping cassette.

9. The peritoneal dialysis method of claim 8, which in a first stroke includes moving the first rigid piston head towards the disposable pumping cassette to push fresh dialysate through the patient line or used dialysate through the drain line while moving the second rigid piston head away from the disposable pumping cassette to pull fresh dialysate from the dialysate supply line or used dialysate from the patient line, respectively.

10. The peritoneal dialysis method of claim 9, which in a second stroke includes moving the first rigid piston head away from the disposable pumping cassette to pull fresh dialysate from the dialysate supply line or used dialysate from the patient line, while moving the second rigid piston head towards the disposable pumping cassette to push fresh dialysate through the patient line or used dialysate through the drain line, respectively.

11. The peritoneal dialysis method of claim 8, which includes prompting a fluid connection of the patient line to an indwelling patient catheter after mating the disposable pumping cassette to the peritoneal dialysis machine.

12. The peritoneal dialysis method of claim 11, which includes moving the first and second rigid piston heads and applying the first and second vacuums to prime the disposable pumping cassette with fresh dialysate prior to prompting the fluid connection.

13. A peritoneal dialysis method comprising:

applying a vacuum to a pumping portion of a flexible membrane of a dialysis fluid carrying pumping cassette aligned with a vacuum chamber, the vacuum generated from a negative pressure source communicating pneumatically with the vacuum chamber;

turning a stepper motor shaft a controlled amount to move a rigid piston shaft and a rigid piston head attached to the rigid piston shaft such that the rigid piston head contacts and moves the pumping portion of the flexible membrane into the dialysis fluid carrying pumping cassette, thereby causing (i) fresh dialysis fluid to be pushed out of the dialysis fluid carrying pumping cassette, through a patient line connected to a patient connector or (ii) used dialysis fluid to be pumped out of the dialysis fluid carrying pumping cassette, through a drain line connected to a drain; and

turning the stepper motor shaft in an opposite direction a controlled amount to move the rigid piston shaft and the rigid piston head such that the rigid piston head retracts within the pumping portion of the flexible membrane of the dialysis fluid carrying pumping cassette, the vacuum generated from the negative pressure source causing the flexible membrane to follow a surface of the rigid piston head as the rigid piston head is retracted, so as to draw fresh dialysis fluid into the dialysis fluid carrying pumping cassette from a fill line connected to a dialysate source or used dialysis fluid into the dialysate fluid carrying pumping cassette from the patient line.

14. The peritoneal dialysis method of claim 13, which includes directly contacting the pumping portion of the flexible membrane with the piston head when moving the piston head into the pumping cassette.

15. The peritoneal dialysis method of claim 13, which includes retracting the rigid piston head completely away from a rigid portion of the dialysis fluid carrying pumping cassette.

16. The peritoneal dialysis method of claim 13, which includes connecting the drain line to a drain before moving the rigid piston head towards the dialysis fluid carrying pumping cassette.

17. The peritoneal dialysis method of claim 13, which includes communicating the negative pressure source with the vacuum chamber via a channel defined in at least one of the rigid piston shaft and the rigid piston head.

18. The peritoneal dialysis method of claim 17, which includes rotatably sealing the rigid piston shaft to an opening in the vacuum chamber.

19. The peritoneal dialysis method of claim 13, which includes connecting the patient line to a patient transfer set before moving the rigid piston head into the dialysis fluid carrying pumping cassette.

20. The peritoneal dialysis method of claim 13, which includes coupling the dialysis fluid carrying pumping cassette to the peritoneal dialysis machine at a non-vertical angle.