Method and system for detecting an occlusion in a tube

• US 20080021395A1
• Filed: 06/06/2007
• Published: 01/24/2008
• Est. Priority Date: 06/08/2006
• Status: Active Grant

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Medingo Ltd. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Iddan, Gavriel, Senesh, Gil
• Granted Patent: US 7,875,004 B2
• Time in Patent Office: Days
• US Class Current: 604/151
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

Systems and methods for detecting an occlusion in a fluid delivery device are disclosed. The system includes a fluid delivery tube, an occlusion detection sensor configured to be coupled to the fluid delivery tube and further configured to detect occlusion within the fluid delivery tube. The fluid delivery tube includes an occlusion detection portion. The occlusion detection sensor is further configured to detect alteration of a shape of the occlusion detection portion when at least one condition occurs within the fluid delivery tube.

Claims

1. A fluid delivery device for delivering therapeutic fluid to a patient comprising:

a fluid delivery tube;

an occlusion detection sensor configured to be coupled to said fluid delivery tube and further configured to detect occlusion within said fluid delivery tube;

said fluid delivery tube includes an occlusion detection portion; and

said occlusion detection sensor is further configured to detect alteration of a shape of said occlusion detection portion when at least one condition occurs within said fluid delivery tube.

2. The fluid delivery device according to claim 1, further comprises a reservoir coupled to said fluid delivery tube and configured to deliver therapeutic fluid to the patient via said fluid delivery tube.

3. The fluid delivery device according to claim 2, which comprises a dispensing unit configured to pump therapeutic fluid from said reservoir, wherein said dispensing unit includes

a peristaltic pump having a stator plate and rotary wheel with rollers, wherein said stator plate and said rollers are configured to squeeze said fluid delivery tube;

said peristaltic pump is configured to pump fluid from said reservoir via an inlet portion of said fluid delivery tube to an outlet portion of said fluid delivery tube upon squeezing said fluid delivery tube.

4. The fluid delivery device according to claim 1, wherein said at least one condition is a change in fluid pressure within said fluid delivery tube.

5. The fluid delivery device according to claim 4, wherein said occlusion detection portion is configured to expand when said fluid pressure increases within said fluid delivery tube.

6. The fluid delivery device according to claim 4, wherein said occlusion detection portion is a protrusion extending from said fluid delivery tube;

and

wherein said protrusion is configured to change its orientation with respect to said fluid delivery tube when said fluid pressure increases within said fluid delivery tube.

7. The fluid delivery device according to claim 4, wherein said occlusion detection sensor further comprises a light emitting source and a light collecting array;

wherein said light emitting source is configured to emit light and said light collecting array is configured to collect said light.

8. The fluid delivery device according to claim 7, wherein said light emitting source is configured to emit light toward said occlusion detection portion and said occlusion detection portion is configured to reflect said light towards said light collecting array at a reflection angle.

9. The fluid delivery device according to claim 8, wherein said occlusion detection sensor is configured to determine whether there is occlusion within said fluid delivery tube based on said angle of reflection.

10. The fluid delivery device according to claim 7, wherein said light emitting source is configured to emit light toward said occlusion detection portion and said occlusion detection portion is configured to block at least a portion of said light.

11. The fluid delivery device according to claim 10, wherein said light collecting array is configured to detect an amount of light blocked by said occlusion detection portion and based on said amount determine whether there is occlusion within said fluid delivery tube.

12. The fluid delivery device according to claim 7, wherein said light emitting source and said light collecting source are configured to be located on the same side of said occlusion detection portion.

13. The fluid delivery device according to claim 7, wherein said light emitting source and said light collecting source are configured to be located on opposite sides of said occlusion detection portion.

14. The fluid delivery device according to claim 4, wherein said occlusion detection sensor further comprises movable capacitance plates;

wherein said occlusion detection portion is configured to change a distance between said movable capacitance plates based on said change of said fluid pressure within said fluid delivery tube.

15. The fluid delivery device according to claim 14, wherein said occlusion detection sensor is configured to determine an occlusion within said fluid delivery tube based on said distance between said movable capacitance plates.

16. The fluid delivery device according to claim 1, wherein said occlusion detection sensor is configured to detect conditions selected from a group consisting of:

no occlusion, partial occlusion, and total occlusion.

17. The fluid delivery device according to claim 1, further comprising an alarm device configured to alert the patient when said occlusion detection sensor detects an occlusion within said fluid delivery tube.

18. The fluid delivery device according to claim 1, wherein said occlusion detection sensor is configured to detect normal delivery of therapeutic fluid to the patient based on a predetermined pressure value of the fluid associated with said normal delivery.

19. The fluid delivery device according to claim 18, wherein said normal delivery is a pulsating delivery.

20. The fluid delivery device according to claim 1, wherein said occlusion detection sensor is configured to detect leakage of therapeutic fluid from said fluid delivery tube based on a pressure of the fluid dropping below a threshold pressure value.

21. The fluid delivery device according to claim 1, wherein said occlusion detection sensor is configured to detect presence of air within said fluid delivery tube.

22. The fluid delivery device according to claim 1, further comprising a control valve, wherein said control valve is configured to control delivery of the therapeutic fluid in said fluid delivery tube for variation of pressure thereof.

23. The fluid delivery device according to claim 22, wherein said control valve is configured in such a manner that when it is closed, the pressure of the therapeutic fluid inside said fluid delivery tube increases, and when said control valve is open, the pressure of the therapeutic fluid inside said fluid delivery tube decreases.

24. The fluid delivery device according to claim 23, wherein during a normal operation of the fluid delivery device, said increase and said decrease of said pressure inside said fluid delivery tube are periodic.

25. The fluid delivery device according to claim 3, in which said dispensing unit comprises a reusable part configured to be operatively coupled to a disposable part.

26. The fluid delivery device according to claim 25, wherein said occlusion detection sensor is configured to be included in said reusable part and/or said disposable part;

wherein when said reusable part and said disposable part are operatively coupled together, said occlusion detection sensor is configured to become operative;

said reusable part is further configured to include said peristaltic pump and electronic components configured to collect data, process and perform data analysis;

said disposable part is further configured to include said reservoir and said fluid delivery tube.

27. A method of detecting an occlusion using a fluid delivery device for delivering therapeutic fluid to a patient, the fluid delivery device including a fluid delivery tube having an occlusion detection portion and an occlusion detection sensor configured to be coupled to the fluid delivery tube, the method comprising the steps of:

delivering therapeutic fluid through the fluid delivery tube;

detecting alternation of a shape of the occlusion detection portion of the fluid delivery tube based on at least one condition which occurs within the fluid delivery tube.

28. The method according to claim 27, further comprising sensing an occlusion within the fluid delivery tube based on the alteration of the shape of the occlusion detection portion.

29. The method according to claim 27, wherein the fluid delivery device further includes a reservoir coupled to the fluid delivery tube and configured to deliver therapeutic fluid to the patient via the fluid delivery tube.

30. The method according to claim 29, wherein the fluid delivery device is configured to pump therapeutic fluid from the reservoir, and comprises

a peristaltic pump having a stator plate and rotary wheel with rollers, wherein the stator plate and the rollers are configured to squeeze the fluid delivery tube;

the peristaltic pump is configured to pump fluid from the reservoir via an inlet portion of the fluid delivery tube to an outlet portion of the fluid delivery tube upon squeezing the fluid delivery tube.

31. The method according to claim 27, wherein the at least one condition is a change in fluid pressure within the fluid delivery tube.

32. The method according to claim 31, further comprising

detecting expansion of the occlusion detection portion when the fluid pressure increases within the fluid delivery tube.

33. The method according to claim 31, wherein the occlusion detection portion is a protrusion extending from said fluid delivery tube;

and

wherein the protrusion is configured to change its orientation with respect to the fluid delivery tube when the fluid pressure increases within the fluid delivery tube.

34. The method according to claim 31, wherein the occlusion detection sensor further includes a light emitting source and a light collecting array.

35. The method according to claim 34, further comprising

using the light emitting source to emit light toward the occlusion detection portion;

and

using the light collecting array to collect light reflected off of the occlusion detection portion;

wherein the light is reflected at a reflection angle.

36. The method according to claim 35, further comprising

determining whether there is occlusion within the fluid delivery tube based on the angle of reflection.

37. The method according to claim 34, further comprising

using the light emitting source to emit light toward the occlusion detection portion;

and

using the light collecting array to collect at least a portion of the light passing by or through the occlusion detection portion.

38. The method according to claim 37, further comprising

determining whether there is occlusion within the fluid delivery tube based on the amount of light collected by the light collecting array.

39. The method according to claim 34, wherein the light emitting source and the light collecting source are configured to be located on the same side of the occlusion detection portion.

40. The method according to claim 34, wherein the light emitting source and the light collecting source are configured to be located on opposite sides of the occlusion detection portion.

41. The method according to claim 31, wherein the occlusion detection sensor further includes movable capacitance plates.

42. The method according to claim 41, further comprising

detecting change in distance between the movable capacitance plates based on the change of the fluid pressure within the fluid delivery tube;

and

determining whether there is occlusion within the fluid delivery tube based on the distance between the movable capacitance plates.

43. The method according to claim 27, further comprising

using the occlusion detection sensor, detecting conditions within the fluid delivery tube, wherein the conditions are selected from a group consisting of:

no occlusion, partial occlusion, and total occlusion.

44. The method according to claim 27, further comprising

alerting the patient when occlusion is detected within the fluid delivery tube.

45. The method according to claim 27, further comprising

detecting normal delivery of therapeutic fluid to the patient based on a predetermined pressure value of the fluid during the normal delivery.

46. The method according to claim 45, wherein the normal delivery is a pulsating delivery.

47. The method according to claim 27, further comprising

detecting leakage of therapeutic fluid from the fluid delivery tube based on a pressure of the fluid when it drops below a threshold pressure value.

48. The method according to claim 27, further comprising

detecting presence of air within said fluid delivery tube.

49. The method according to claim 27, further comprising

using a control valve to control delivery of the therapeutic fluid in said fluid delivery tube for variation of the pressure thereof.

50. The method according to claim 49, wherein when the control valve is closed, the pressure of the therapeutic fluid inside the fluid delivery tube increases, and when the control valve is open, the pressure of the therapeutic fluid inside the fluid delivery tube decreases.

51. The method according to claim 50, wherein during a normal operation of the fluid delivery device, the increase and the decrease of the pressure inside the fluid delivery tube are periodic.

52. The method according to claim 30, wherein the fluid delivery device comprises a reusable part configured to be operatively coupled to a disposable part.

53. The method according to claim 52, wherein the occlusion detection sensor is locatable in the reusable part and/or the disposable part;

wherein when the reusable part and the disposable part are operatively coupled together, the occlusion detection sensor is configured to become operative;

the reusable part is further configured to include the peristaltic pump and electronic components configured to collect data, process and perform data analysis;

the disposable part is further configured to include the reservoir and the fluid delivery tube.