Stepper motor driven peritoneal dialysis machine

• US 9,511,180 B2
• Filed: 08/09/2013
• Issued: 12/06/2016
• Est. Priority Date: 05/24/2002
• Status: Expired due to Term

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: (Krensky) Britton, Andrea, Busby, Donald, Callahan, Eric, Childers, Robert, Hopping, Peter, Khorashahi, Seyed, Reese, William, Sharo, Randall, Toczko, Debra, Yue, Li
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US13/963,553
• Publication Number:
  US 20130324915A1
• Time in Patent Office: 1,215 Days
• US Class Current: 1/1
• 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 1/153 the cassette being adapted for heating or cooling the treating fluid, e.g. the dialysate or the treating gas
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/156 Constructional details of the cassette, e.g. specific details on material or shape
• 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 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/267 used for pumping
• 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 2205/127 with provisions for heating or cooling
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback

Abstract

A peritoneal dialysis system includes: an enclosure including an actuation surface and a door; a stepper motor housed by the enclosure; a pump head and a solid pump piston structurally linking the pump head to the stepper motor; and a disposable unit accepted by the enclosure, the disposable unit including a flexible membrane attached to a rigid piece, the actuation surface of the enclosure and the disposable unit so configured and arranged that when the stepper motor turns and consequently translates the solid pump piston and the pump head towards the door, the pump head physically contacts and stretches the membrane from a relaxed position to a stretched position, and when the stepper motor turns and consequently translates the solid pump piston and the pump head away from the door, the membrane follows the pump head and transitions from the stretched position to the relaxed position.

Claims

1. A peritoneal dialysis system comprising:

an enclosure including an actuation surface and a door;

a stepper motor housed by the enclosure;

a pump head and a solid pump piston structurally linking the pump head to the stepper motor;

a vacuum source; and

a disposable unit accepted by the enclosure, the disposable unit including a flexible membrane attached to a rigid piece, the vacuum source configured to apply a negative pressure to the flexible membrane to pull the flexible membrane towards the pump head, the actuation surface of the enclosure and the disposable unit so configured and arranged that when the stepper motor turns and consequently translates the solid pump piston and the pump head towards the door, the pump head physically contacts and stretches the flexible membrane from a relaxed position to a stretched position, and when the stepper motor turns and consequently translates the solid pump piston and the pump head away from the door, the flexible membrane follows the pump head and transitions from the stretched position to the relaxed position.

2. The peritoneal dialysis system of claim 1, wherein the stepper motor moves the solid pump piston and pump head from a home position in which the flexible membrane is in the relaxed position to an end-of-stroke position in which the flexible membrane is in the stretched position.

3. The peritoneal dialysis system of claim 2, wherein at least one of the home position or the end-of stroke position can be maintained via encoder feedback, sensor feedback or pump accuracy.

4. The peritoneal dialysis system of claim 1, wherein the negative pressure is applied between the pump head and the flexible membrane to help maintain contact between the flexible membrane and the pump head.

5. The peritoneal dialysis device of claim 4, wherein the negative pressure is applied through the actuation surface so as to reach between the pump head and the flexible membrane.

6. The peritoneal dialysis system of claim 1, wherein the vacuum source is in fluid communication with an area between the pump head and the flexible membrane.

7. The peritoneal dialysis system of claim 6, which includes a pneumatic line located between the vacuum source and the area between the pump head and the flexible membrane.

8. The peritoneal dialysis system of claim 1, wherein the flexible membrane is a first flexible membrane, and wherein the disposable unit includes a second flexible membrane attached to the rigid piece, the first and second flexible membranes forming a fluid pumping chamber.

9. The peritoneal dialysis system of claim 1, wherein the door is connected hingedly to the enclosure.

10. The peritoneal dialysis system of claim 1, wherein the door includes an opening to accept the pump head while stretching the flexible membrane.

11. The peritoneal dialysis system of claim 1, which includes at least one valve actuator, wherein the disposable unit includes at least one valve seat, and wherein the actuation surface of the enclosure includes at least one opening to allow the at least one valve actuator to mechanically communicate with the at least one valve seat.

12. The peritoneal dialysis system of claim 1, wherein the pump head when fully retracted by the stepper motor and pump piston forms a small gap between the pump head and the flexible membrane, the small gap smaller than a distance traveled by the pump head when stretching the flexible membrane towards the door of the enclosure.

13. The peritoneal dialysis system of claim 12, wherein a membrane contacting surface of the pump head is rounded or sloped, causing the gap to be smallest at the center of the pump head.

14. The peritoneal dialysis system of claim 1, wherein the pump head is pulled against the actuation surface when fully retracted.

15. A peritoneal dialysis system comprising:

an enclosure including an actuation surface and door;

a stepper motor housed by the enclosure;

a pump head and a solid pump piston structurally linking the pump head to the stepper motor; and

a disposable unit including a flexible membrane attached to a rigid piece, wherein the enclosure accepts the disposable unit so that (i) the flexible membrane in an unstressed state lies between the door and the actuation surface with the pump head lying between the flexible membrane and the actuation surface, and (ii) the pump head in a fully retracted position forms a gap between the pump head and the flexible membrane, wherein the gap is smaller than a distance traveled by the pump head and the flexible membrane when the stepper motor and the solid pump piston cause the pump head to move towards the door.

16. The peritoneal dialysis system of claim 15, wherein a thickness of the pump head is non-uniform and wherein the gap resides between the flexible membrane and a thickest portion of the pump head.

17. The peritoneal dialysis system of claim 15, wherein the pump head stretches the flexible membrane as the stepper motor and the solid pump piston move the pump head and the flexible membrane towards the door, and wherein the flexible membrane unstretches as the stepper motor and the solid pump piston pull the pump head away from the door.

18. The peritoneal dialysis system of claim 15, wherein the gap enables a negative pressure to be applied between the pump head and the flexible membrane.

19. A peritoneal dialysis method comprising:

applying a negative pressure from a vacuum source to a flexible membrane to pull the flexible membrane towards a pump head;

mechanically pushing a solid pump piston and the pump head;

causing the flexible membrane to stretch via the pushing of the solid pump piston and the pump head;

closing a chamber volume by stretching the flexible membrane;

expelling peritoneal dialysis fluid by closing the chamber volume;

mechanically pulling the solid pump piston and the pump head;

causing the flexible membrane to unstretch by the pulling of the solid pump piston and the pump head;

opening the chamber volume by unstretching the flexible membrane; and

drawing peritoneal dialysis fluid by opening the chamber volume.

20. The peritoneal dialysis method of claim 19, wherein the expelling and the drawing of peritoneal dialysis fluid include expelling peritoneal dialysis fluid from the chamber volume and pulling peritoneal dialysis fluid into the chamber volume, respectively.

21. The peritoneal dialysis method of claim 19, wherein the peritoneal dialysis fluid is fresh or spent peritoneal dialysis fluid.