Medical device for administering a solution

• US 10,112,008 B2
• Filed: 06/18/2007
• Issued: 10/30/2018
• Est. Priority Date: 07/06/2006
• Status: Active Grant

• Current Assignee: Debiotech S.A.
• Original Assignee: Debiotech S.A.
• Inventors: Neftel, Frederic
• Primary Examiner(s): Hayman, Imani
• Application Number:
  US12/300,740
• Publication Number:
  US 20090118695A1
• Time in Patent Office: 4,152 Days
• Field of Search: 604 65, 604 67, 604151, 604500, 6048901
• 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

A medical device for administering a solution, the device including a pump, a reservoir, and a communication structure for connecting the reservoir and the pump, and a line for connecting the medical device to the patient, wherein the medical device is adapted to use a mathematical model in order to determine at any moment a physical or chemical characteristics of the solution, which is contained in the reservoir, wherein the mathematical model takes account of a modification of the solution in the reservoir over the course of time as a function of an exposure to temperature, to humidity, or to pressure of the solution, or ageing or permeability of the reservoir; and the medical device is adapted to inform the patient about refilling the solution or changing the reservoir depending on the modification of the characteristics of the solution.

Claims

1. A medical device for administering a solution, said device comprising:

a pump that is not inside a patient,

a reservoir that is not inside the patient, and

a communication structure for connecting said reservoir and said pump, wherein said communication structure is not inside the patient, and

a line for connecting the medical device to the patient,

a sensor for measuring an exposure of the solution, which is contained in the reservoir, to temperature, to humidity, or to pressure of the solution, or ageing or permeability of the reservoir, over the course of time,

wherein the medical device uses a mathematical model in order to determine at any moment physical or chemical characteristics of the solution, which is contained in the reservoir, wherein the mathematical model takes account of a modification of the solution in the reservoir over the course of time as a function of an exposure to temperature, to humidity, or to pressure of the solution, or ageing or permeability of the reservoir; and

wherein the medical device informs the patient about refilling the solution or changing the reservoir depending on the modification of the characteristics of the solution.

2. The device as claimed in claim 1, wherein the mathematical model takes account of the exposure to temperature of the solution.

3. The device as claimed in claim 1, wherein the reservoir has walls and the mathematical model takes account of the permeability of the walls.

4. The device as claimed in claim 1, wherein the mathematical model takes account of the exposure to humidity of the solution.

5. The device as claimed in claim 1, wherein the mathematical model takes account of the exposure to pressure of the solution.

6. The device as claimed in claim 1, wherein the mathematical model takes account of the ageing or deterioration of the reservoir over the course of time.

7. The device as claimed in claim 1, wherein the mathematical model takes account of the exposure to temperature, to humidity, or to pressure of the reservoir over the course of time.

8. The device as claimed in claim 1, wherein the medical device is further adapted to vary the administration of the solution as a function of a variation in the concentration of the solution determined by the mathematical model.

9. The device as claimed in claim 1, comprising a temperature sensor for regularly measuring the temperature of the solution, said medical device being functionally connected to said temperature sensor for continuously measuring the temperature.

10. The device as claimed in claim 1, wherein said mathematical model takes account of the degradation of the solution as a function of time or temperature.

11. The device as claimed in claim 10, wherein the medical device is further adapted to vary the administration of the solution as a function of the concentration of non-degraded active substance contained in the reservoir.

12. The device as claimed in claim 1, wherein 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.

13. The device as claimed in claim 1, wherein the mathematical model is designed to determine the characteristics of the solution after each refilling of the reservoir.

14. The device as claimed in claim 1, wherein said sensor measures a conductivity or resistance of the solution, a pH or any other physical parameter of the solution.

15. The device as claimed in claim 1, wherein the medical device is adapted to warn the patient when the solution contained in the reservoir is estimated to no longer correspond to the treatment requirements.

16. The device as claimed in claim 15, wherein the warning is adapted to alert the patient to the fact that the reservoir has to be refilled.

17. The device as claimed in claim 1, wherein the medical device is adapted to warn the patient when the temperature of the solution contained in the reservoir has exceeded a defined threshold during a minimal duration.

18. The device as claimed in claim 1, wherein the medical device is adapted to warn the patient based on a function of the 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.

19. The device as claimed in claim 1, comprising the reservoir designed to contain insulin.

20. The device as claimed in claim 1, wherein the reservoir comprises at least one membrane not totally impermeable to water vapor or to certain components of the solution.

21. The device as claimed in claim 1, wherein the medical device is adapted for indicating the time remaining for possible use of the solution under the current or foreseeable conditions of use.

22. The device as claimed in claim 1, wherein the medical device is designed to inform the patient of the quality of the solution in a way allowing the patient to anticipate a change or refilling in advance.

23. The device as claimed in claim 1, wherein the mathematical model takes account whether the reservoir is vibrated or not.

24. A medical device for administering a solution, said device comprising:

a pump that is not inside a patient,

a reservoir that is not inside the patient,

a communication structure for connecting said reservoir and said pump, and wherein the communication structure is not inside the patient,

a line for connecting the medical device to the patient, and

a sensor for measuring an exposure of the solution, which is contained in the reservoir, to temperature over a course of time,

wherein the medical device uses a mathematical model in order to determine at any moment physical or chemical characteristics of the solution wherein the mathematical model takes account of the data of exposure of the solution to temperature, and

wherein the medical device informs the patient about refilling the solution or changing the reservoir depending on the modification of the characteristics of the solution.

25. The device as claimed in claim 24, wherein the medical device is adapted for estimating the development of certain physical or the chemical characteristics of the solution as a function of time.

26. The device as claimed in claim 24, wherein the medical device is adapted for preventing the administration of the solution when certain physical or chemical characteristics are estimated to have been modified beyond certain acceptable limits.

27. The device as claimed in claim 26, wherein the medical device is adapted for preventing the administration of the solution when the physical or the chemical characteristics no longer correspond to the pharmacopeia defined for said solution.

28. A medical device for administering a solution, said device comprising:

a pump that is not inside a patient,

a reservoir that is not inside the patient,

a communication structure for connecting said reservoir and said pump, and wherein the communication structure is not inside the patient,

a line for connecting the medical device to the patient, and

a sensor for measuring an exposure of the solution, which is contained in the reservoir, to temperature over a course of time,

wherein the medical device uses a mathematical model in order to predict a concentration of an active principle in the solution at a given moment wherein the mathematical model takes account of the data of exposure of the solution to temperature, and

wherein the medical device informs the patient as a function of the mathematical model that takes into account the temperature to which the solution has been exposed at each instant and also the duration of this exposure.

29. The device as claimed in claim 28, wherein the mathematical model takes account whether the reservoir is vibrated or not.

30. A medical device for administering a solution, the device comprising:

a pump that is not inside a patient;

a container that is not inside the patient;

a communication structure between the reservoir and the pump, the communication structure is not inside the patient; and

a line for connecting the medical device to the patient,

a sensor for measuring an exposure of the solution, which is contained in the reservoir, to temperature, to humidity, or to pressure of the solution, or ageing or permeability of the reservoir, over the course of time,

wherein the medical device uses a mathematical model to estimate at different moments physical or chemical characteristics of the solution, which is located in the reservoir, the mathematical model takes account of a modification of the solution in the reservoir over a course of time as a function of an exposure to temperature, to humidity, or to pressure of the solution, or ageing or permeability of the reservoir, and

wherein the medical device informs the patient about refilling the solution or changing the reservoir and to prevent the administration of the solution when certain physical or chemical characteristics are estimated to be modified beyond acceptable limits.