System for performing peritoneal dialysis

• US 8,585,634 B2
• Filed: 08/02/2004
• Issued: 11/19/2013
• Est. Priority Date: 07/31/2003
• Status: Active Grant

• Current Assignee: Debiotech S.A.
• Original Assignee: Debiotech S.A.
• Inventors: Neftel, Frdric, Junod, Florent, Vecten, Didier
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): WILSON, LARRY ROSS
• Application Number:
  US10/565,810
• Publication Number:
  US 20080058711A1
• Time in Patent Office: 3,396 Days
• Field of Search: 604/29, 604/131, 604/890.1, 604/151, 604/153, 417/477.2, 417/477.3, 251/89, 251/93, 251/287, 251/355, 251/335.1, 251/335.2, 251/358, 137/561.A, 137/561.R, 137/270, 137/597
• US Class Current: 604/29
• 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 1/154 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 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/281 Instillation other than by gravity
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media
• CPC Class Codes: F04B 43/1253 by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing
• CPC Class Codes: Y10T 137/87249 Multiple inlet with multiple outlet

Abstract

The invention concerns a system and a method of use of said system for performing fluid administration on a patient, the system comprising a liquid pump, a liquid distribution system, a liquid supply means, and patient conduit. The liquid distribution system comprises two distinct hub chambers. The first hub chamber includes at least one liquid supply port with a dedicated valve means, one patient port with dedicated valve means, and one pump inlet. The second hub chamber includes at least one patient port or warmer port with dedicated valve means and one pump outlet. The system further comprises control means arranged to close the patient port of the first hub chamber when the liquid supply port is open, and vice versa.

Claims

1. A system for performing fluid administration on a patient comprising:

a partial peristaltic pump (1),

a liquid distribution system (2) that is a cartridge and that is separate from said pump and that is connected to said pump (1) in such a way that liquid can flow from the liquid distribution system (2) to the pump (1) and vice versa,

liquid supply means (3) for supplying liquid to a patient (4) via said liquid distribution system (2) and said pump (1),

a patient conduit (5) adapted for connecting said liquid distribution system (2) to a patient (4),

wherein said liquid distribution system (2) comprises two distinct hub chambers (7,8) which are separated by a space, the first hub chamber (7) including at least one liquid supply port with dedicated valve means (9), one patient port with dedicated valve means (10) and one pump inlet (26), the second hub chamber (8) including at least one patient port (18) or warmer port (16) with dedicated valve means and one pump outlet (27), said system further comprising control means arranged to close said patient port (10) of the first hub chamber (7) when said liquid supply port (9) is open and vice versa and

wherein all ports of the liquid distribution system that communicate with the pump are unidirectional such that liquid only flows in one direction.

2. System according to claim 1 wherein said second hub chamber (8) furthermore includes at least one drain port with dedicated valve means (11), said control means being also arranged to close said patient port (18) of the second hub chamber (8) when said drain port (11) is open and vice versa.

3. A system according to claim 1 wherein said liquid distribution system (2) only includes two hub chambers (7,8).

4. A system according to claim 1 furthermore comprising a warmer system (28), a cavity (17) including a warmer port (19) and a patient port (16), said patient port (18) of the second hub chamber (8) being connected to said warmer port (19) via said warmer system (28).

5. A system according to claim 4 wherein said warmer system (28) is a warmer in-line.

6. A system according to claim 5 wherein said warmer in-line comprises a warming plate contained therein, such warming plate being covered by a warming pouch.

7. A system according to claim 6 wherein said warming pouch is composed of a liquid channel which forces the liquid to be maintained within such warmer for a certain duration at a given flow rate.

8. A system according to claim 1 wherein said first hub chamber (7) includes several liquid supply ports with respective valve means (9).

9. A system according to claim 8 wherein said liquid supply ports (9) are connected to respective liquid supply means each having a different kind of liquid.

10. A system according to claim 1 wherein said peristaltic pump is unidirectional.

11. A system according to claim 1 wherein said pump (1) is composed of a tubing and rolling surface on which the tubing is compressed once the pump and liquid distribution system are inserted into a pumping device containing rollers.

12. A system according to claim 11 where said rollers (22) are of a conical shape in such a way as to be self inserted in the pump race, i.e. without any other mechanism.

13. A system according to claim 11 where said rollers are of a spherical shape.

14. A system according to claim 11 wherein said pump (1) comprises a flexible or partially flexible channel, a membrane covering said channel along an oblique plane, in order to allow a peristaltic movement induced by rollers or similar elements.

15. A system according to claim 14 comprising individual actuators or a cam adapted to induce a peristaltic movement.

16. A system according to claim 15 wherein said individual actuators are adapted to be actuated by fingers which are clipped to said membrane.

17. A system according to claim 1 wherein said pump (1) comprises a flexible or partially flexible channel and a series of movable finger elements successively situated above said channel, each finger element being movable along a direction which is substantially perpendicular to said channel, all finger elements being adapted to induce a peristaltic movement along said channel.

18. A system according to claim 17 wherein each finger element comprises a convex basis adapted to conform with the channel inner surface and a shaft adapted to be linked to an actuator.

19. A system according to claim 1 wherein said pump (1) and said liquid distribution system (2) are fixed together to form a single assembly.

20. A system according to claim 19 wherein said pump (1) is fixed to said liquid distribution system (2) by vibration attenuation means in order to minimize the vibration on the liquid distribution system (2) when the pump is operating.

21. A system according to claim 1 wherein all hub chambers, including said ports and ports, are made within one single part.

22. A system according to claim 21 wherein said single part is an injected part of plastic material.

23. A system according to claim 1 wherein each hub chamber (7,8) is closed with an upper wall made of a flexible membrane (13), said membrane including valve elements (39) situated above each of said port or port with valve means, said valve elements (39) being designed to close said port or port when the membrane (13) moves downwardly.

24. A system according to claim 23 wherein said membrane extends in such a way that it also covers said pump (1).

25. A system according to claim 23 wherein said membrane contains protruding elements designed for a liquid tight connection between said hub chambers.

26. A system according to claim 23 wherein each of said valve elements (39) is designed to be clipped to an actuator (34) arranged above said membrane (13).

27. A system according to claim 26 wherein each of said valve elements comprises a cavity designed to receive and hold the plunger of an actuator, said cavity having an height which substantially corresponds to at least the valve displacement.

28. A system according to claim 23 wherein said membrane (13) is press-fitted along its external border to the liquid distribution system, the membrane (13) being furthermore held by a frame (14).

29. A system according to claim 23 wherein said membrane (13) contains a portion (15) which is forming part of a pressure sensor.

30. A system according to claim 29 wherein the active area of said pressure sensor is designed to be more flexible than the remaining area.

31. A system according to claim 29 wherein said pressure sensor has the shape of a disc of which the periphery is gripped, said disc furthermore comprising an annular ply.

32. A system according to claim 29 wherein said pressure sensor is situated on the patient line, independently from said hub chambers.

33. A system according to claim 29 furthermore comprising a second pressure sensor, said second pressure sensor being in connection with the first hub chamber.

34. A pressure sensor for a system for performing fluid administration on a patient as defined in claim 29.

35. A system according to claim 23 comprising a molded frame adapted to cover the space between said hub chambers, each space above said hub chambers being covered by a flexible membrane.

36. A system according to claim 35 wherein said molded frame is fixed to said liquid distribution system by ultrasound, laser welding, gluing or thermal bonding.

37. A system according to claim 35 wherein said molded frame is at least partially made of silicone or polyurethane.

38. A system according to claim 35 wherein said frame, membrane and liquid distribution system are obtained by overmolding technique.

39. A system according to claim 23 using a double layer membrane adapted to prevents spallation or particle release into the fluid during use.

40. A system according to claim 23 furthermore comprising a rigid plate (67) which covers and holds the membrane (13), said rigid plate (67) comprising holes (70) adapted to let moving elements passing through.

41. A system according to claim 40 wherein said rigid plate (67) includes pins (68) situated on the membrane side, said pins (68) being adapted to be fixed on the liquid distribution system (2).

42. A system according to claim 1 wherein each hub chamber (7,8) is closed with an upper wall made of a flexible membrane (13), said membrane including clipping means adapted to clip elements.

43. A system according to claim 42 wherein said membrane is molded.

44. A system according to claim 43 wherein said membrane is made out of any of the following materials:

silicone or polyurethane.

45. A system according to claim 44 wherein said membrane includes liquid tight joints.

46. A system according to claim 1 wherein said liquid distribution system includes liquid tight joints arranged in such a manner that they allow a liquid tight connection between said liquid distribution system and a membrane situated on it.

47. A system according to claim 1 wherein said liquid distribution system includes an air sensor situated on the patient conduit side.

48. A system according to claim 1 comprising a cartridge loading mechanism which allows a tight connection between the membrane and the valves and the liquid distribution system.

49. A system according to claim 1 comprising flow blocking means adapted to block the flow towards or from the liquid distribution system when this latter one is released out of the system.

50. A system according to claim 49 wherein said blocking means is a mechanical clamp situated on the patient line.

51. A system according to claim 49 wherein said blocking means is a lip valve situated on the patient line, the system furthermore comprises a movable pin adapted to open said lip valve when the liquid distribution system is released out of the system.

52. A system according to claim 1 furthermore comprising a window for detecting correct positioning of the tube.

53. A liquid distribution system (2) for a system performing fluid administration on a patient as defined in claim 1.

54. Method of use of the system as defined in claim 1 wherein said patient port (10) is closed when said liquid supply port (9) is open and vice versa.

55. Method according to claim 54 wherein the pressure is always maintained positive with respect to the drain.

56. Method according to claim 54 wherein said liquid is always pumped in the same direction.

57. Method according to claim 54 consisting of sensing the liquid pressure entering and exiting the liquid distribution system and, if necessary, correct the pump flow rate in accordance with the pressure difference.

58. Method according to claim 54 consisting in regulating the pump flow rate according to a known predetermined alteration of the flow rate by aging of the tubing.

59. Method according to claim 54 wherein the drain phase is a function of the drain speed, said drain phase being ended when the speed is reaching a certain value based on the patient peritoneal cavity pressure measurement.

60. Method according to claim 54 wherein the peritoneal volume filled during a cycle is a function of the intra-peritoneal pressure.

61. Method according to claim 60 wherein the peritoneal cavity is partially emptied as soon as the pressure has reached a predefined threshold.

62. Method according to claim 54 consisting in the use of a low Natrium concentration liquid for the last exchange cycle to improve ultra-filtration.

63. Use of a system as defined in claim 1 for peritoneal dialysis comprising:

selecting a liquid,

supplying the liquid to a patient via use of the system for peritoneal dialysis.

64. A disposable cassette for use in performing fluid administration on a patient comprising:

a partial peristaltic pump (1),

a liquid distribution system (2) in a substantially rectangular-shaped member that is separate from said pump and that is abutted to a side of said pump (1) in such a way that liquid can flow from the liquid distribution system (2) to the pump (1) and vice versa,

liquid supply means (3) for supplying liquid to a patient (4) via said liquid distribution system (2) and said pump (1),

a patient conduit (5) adapted for connecting said liquid distribution system (2) to a patient (4),

wherein said liquid distribution system (2) comprises a first hub chamber and a distinct second hub chamber (7,8) which are separated by a space,

the first hub chamber (7) including at least one liquid supply port with dedicated valve means (9), one patient port with dedicated valve means (10) and one pump inlet (26),

the second hub chamber (8) including at least one patient port (18) or warmer port (16) with dedicated valve means and one pump outlet (27),

said system further comprising control means arranged to close said patient port (10) of the first hub chamber (7) when said liquid supply port (9) is open and vice versa, and

wherein all ports of the liquid distribution system that communicate with the pump are unidirectional ports.