MEDICAL DEVICE FOR ADMINISTERING A SOLUTION

• US 20090118695A1
• Filed: 06/18/2007
• Published: 05/07/2009
• Est. Priority Date: 07/06/2006
• Status: Active Grant

• Current Assignee: Debiotech S.A.
• Original Assignee: Debiotech S.A.
• Inventors: Neftel, Frederic
• Granted Patent: US 10,112,008 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 5/1684 by detecting the amount of infusate remaining, e.g. signalling end of infusion

Abstract

Medical device for administering a solution, said device comprising pumping means, a reservoir, means of communication between said reservoir and said pumping means, and a line for connecting the medical device to a patient, characterized in that it comprises means for determining the physical/chemical characteristics of the solution as a function of time by means of a mathematical model that takes account of the permeability of the reservoir walls as a function of time and the temperature of the solution.

Claims

1-19. -19. (canceled)

20. A medical device for administering a solution, said device comprising pumping means, a reservoir, means of communication between said reservoir and said pumping means, and a line for connecting the medical device to a patient, characterized in that it comprises means for determining the physical/ chemical characteristics of the solution as a function of time by means of a mathematical model that takes account of a modification in the solution over the course of time as a function of one or more of said characteristics.

21. The device as claimed in claim 20, in which the mathematical model takes account of the exposure to temperature.

22. The device as claimed in claim 20, in which the mathematical model takes account of the permeability of the reservoir walls.

23. The device as claimed in claim 20, in which the mathematical model takes account of the exposure to humidity.

24. The device as claimed in claim 20, in which the mathematical model takes account of the exposure to pressure.

25. The device as claimed in claim 20, in which the mathematical model takes account of the ageing and/or deterioration of the reservoir over the course of time.

26. The device as claimed in claim 20, in which the mathematical model takes account of the exposure to any other condition of use.

27. The device as claimed in claim 20, characterized in that it comprises means for varying the administration of the solution as a function of a variation in the concentration of the solution determined by means of the mathematical model.

28. The device as claimed in claim 20, comprising means for regularly measuring the temperature of the solution, said means for varying the administration of the solution being functionally connected to said means for continuously measuring the temperature.

29. The device as claimed in claim 20, in which said mathematical model takes account of the degradation of the solution as a function of time and/or temperature.

30. The device as claimed in claim 29, characterized in that it comprises means for varying the administration of the solution as a function of the concentration of non-degraded active substance contained in the reservoir.

31. The device as claimed in claim 20, in which the mathematical model is designed to determine the variation in the new concentration of the solution after each refilling of the reservoir as a function of the residual volume of the solution and the refilling volume of the new solution.

32. The device as claimed in claim 20, in which the mathematical model is designed to determine the characteristics of the solution after each refilling of the reservoir.

33. The device as claimed in claim 20, comprising sensors for measuring certain characteristics of the solution, said sensors supplying information used by the mathematical model.

34. The device as claimed in claim 33, in which said sensor is a sensor that measures the conductivity and/or resistance of the solution, the pH or any other physical parameter of the solution.

35. The device as claimed in claim 20, comprising a first alarm designed to go off when the solution contained in the reservoir is estimated to no longer correspond to the treatment requirements.

36. The device as claimed in claim 35, in which the purpose of the alarm is to alert the user to the fact that the reservoir has to be refilled.

37. The device as claimed in claim 20, comprising a second alarm designed to go off when the temperature of the solution contained in the reservoir has exceeded a defined threshold during a minimal duration.

38. The device as claimed in claim 20, comprising a third alarm designed to go off as a function of a mathematical model that takes account of the temperature to which the solution is exposed at each instant and also of the duration of this exposure.

39. The device as claimed in claim 20, comprising a reservoir designed to contain insulin.

40. The device as claimed in claim 20, in which the reservoir comprises at least one membrane not totally impermeable to water vapor and/or to certain components of the solution.

41. The device as claimed in claim 20, in which the reservoir and the pumping means are provided by a syringe whose walls are not totally impermeable to water vapor and/or to certain compounds of the solution.

42. The device as claimed in claim 20, comprising means for indicating the time remaining for possible use of the solution under the current and/or foreseeable conditions of use.

43. The device as claimed in claim 20, in which the medical injection device is designed to inform the user of the quality of the solution in a way allowing said user to anticipate a change and/or refilling in advance.

44. A medical device for administering a solution, said device comprising pumping means, a reservoir, means of communication between said reservoir and said pumping means, and a line for connecting the medical device to a patient, characterized in that it comprises means for measuring the exposure of the solution to temperature over the course of time.

45. The device as claimed in claim 44, additionally comprising means for estimating the development of certain physical/chemical characteristics of the solution as a function of time.

46. The device as claimed in claim 44, additionally comprising means for preventing the administration of the solution when certain physical/chemical characteristics are estimated to have been modified beyond certain acceptable limits.

47. The device as claimed in claim 46, in which said means for preventing the administration of the solution can be activated when the physical/chemical characteristics no longer correspond to the pharmacopeia defined for said solution.

48. A method by which the administration of a solution, intended to be administered to a patient, is prevented when the physical/chemical characteristics are estimated to have been modified beyond certain limits that are deemed acceptable, said method comprising the use of a mathematical model.

49. The method as claimed in claim 48, in which said mathematical model estimates the state of degradation of the active substance contained in the solution.

50. The method as claimed in claim 48, in which the mathematical model comprises at least a limit temperature and a maximum time of exposure to this limit temperature.