Pharmaceutical blend infusion thereof and Parkinson's disease monitoring system

• US 10,335,540 B2
• Filed: 04/17/2013
• Issued: 07/02/2019
• Est. Priority Date: 04/17/2012
• Status: Active Grant

• Current Assignee: Micrel Medical Devices S.A.
• Original Assignee: Micrel Medical Devices S.A.
• Inventors: Tsoukalis, Achilleas
• Primary Examiner(s): Stiles, Amber R
• Application Number:
  US13/864,927
• Publication Number:
  US 20130274654A1
• Time in Patent Office: 2,267 Days
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/58 Means for facilitating use, e.g. by people with impaired vision
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

The invention relates to a system for administering drug to a Parkinson'"'"'s disease patient comprising (a) a drug; (b) a storing bag for the drug; (c) a pump for administering the drug; (d) a pump controller for controlling the pump activity, the pump controller having access to a correlation of a first parameter t_x and a second parameter A_t, and to the current first parameter t_x, wherein the first parameter t_x is correlated with a certain activity of the patient and the second parameter A_t is correlated with a dosage of the drug and the pump controller controls the pump activity in dependence of the first parameter t_x and the correlation, and/or wherein the system comprises (e) a storing hag the drug suitable for pre-filling and long-term oxidations-free storage having a multi layer wall with the internal layer made of EVA or cyclic polyolefines and at least one further layer made of EVOH.

Claims

1. A system for administering a drug to a Parkinson'"'"'s disease patient comprising (a) a drug, (b) a storing bag for the drug, (c) a pump for administering the drug, and (d) a pump controller for controlling the pump activity,

the pump controller having access to a correlation of a first parameter t_x and a second parameter A_t, to a current first parameter t_x, and to a mobility calendar indicating start and finish times for particular values of the first parameter t_x,

wherein the first parameter t_x is correlated with an activity level of the patient and the second parameter A_t is correlated with a dosage of the drug and the pump controller controls a flow rate of the drug based on changes of the first parameter t_x scheduled in the mobility calendar of the first parameter t_x and the correlation of the first parameter t_x and the second parameter A_t;

and

wherein the controller further has access to a parameter “

b”

, wherein the controller controls the pump activity in case of a change of the first parameter by a multiplication of parameter b with the difference between an adjusted second parameter A_t+z that is correlated with an adjusted first parameter t+z after the change and the second parameter A_t that is correlated with the first parameter t_x before the change to amend the dosage z minutes prior to the change by adding the result of the multiplication b*(A_t+z−

A_t) to the dosage according to the second parameter A_t, wherein z is the time delay of the drug action being constant for each different drug and infusion path.

2. The system according to claim 1, wherein the storing bag for the drug comprises internal micro-striation texture.

3. The system according to claim 1, wherein the system comprises (f) at least one sensor for therapy feedback measurement and report and/or (g) recording and monitoring infusion, and/or (h) at least one sensor for remote therapy regiment adjustment.

4. The system according to claim 1, wherein the controller further has access to a parameter “

a”

for a master volume control, wherein the controller controls the pump activity by a multiplication of the parameter a with the second parameter A_t that is correlated with the first parameter t_x.

5. The system according to claim 1, wherein the controller further has access to a parameter “

a”

for a master volume control, wherein the controller controls the pump activity by a multiplication of the parameter a with the second parameter A_t that is correlated with the first parameter t_x;

wherein the system is arranged in a way that the first parameter t_x can be amended by the patient while parameters a, b and A_t can be amended by an attending physician and/or by a control system that is in contact with the system.

6. The system according to claim 1, wherein the system further comprises an interface for submitting data to a remote control system and/or a remote data storage unit and/or an attending physician and/or wherein the system further comprises an interface for receiving data from a remote control system and/or a remote data storage unit and/or the attending physician.

7. The system according to claim 1, wherein the system further comprises at least one sensor for measurement of the status of the patient.

8. The system according to claim 7, wherein the at least one sensor for measurement of the status of the patient are selected from the group consisting of a 3D accelerometer, a gyroscope, an electromyogram, and a bed foil with sensing of movement, heart rate and/or respiration during sleep capability.

9. The system according to claim 8, having a sensor for movement measurement which is done in vicinity of a proximity sensor that is activated when two wrists come close together or a button is pressed on a wrist band.

10. The system according to claim 7, wherein the at least one sensor for measurement of the status of the patient are selected from the group consisting of a 3D accelerometer, a gyroscope, and an electromyogram.

11. The system according to claim 1, wherein the system comprises a patient'"'"'s feedback function which comprises an input interface for a response of the patient to questions asked by the patient'"'"'s feedback function.

12. The system according to claim 1, comprising a sensor for detecting malfunction of the system.

13. The system according to claim 1, wherein the system is arranged in a way that in case of negative feedback by the patient, critical status of the patient and/or malfunction of the system the respective information is automatically submitted to a remote control system and/or a remote data storage unit and/or an attending physician.

14. The system according to claim 1, wherein the drug comprises Levodopa and/or Carbidopa and/or benserazide suspended in a viscous liquid having a viscosity of 300±

30 mPa-s measured at a moderate shear rate.

15. The system according to claim 1, wherein the drug is apomorphine.

16. The system according to claim 1, further comprising a catheter for delivering the drug to the digestive tract or the nasal cavity.

17. The system according to claim 1, wherein the storing bag for the drug is suitable for pre-filling and long-term oxidations-free storage has a multi layer wall with the internal layer made of ethylene vinyl acetate (EVA) or cyclic polyolefines and at least one further layer made of ethylene vinyl alcohol (EVOH).

18. The system according to claim 1, wherein, starting z minutes prior to the start time of a new activity, (i) when the activity level of the new activity is higher than the initial activity level, the flow rate of the drug is increased above a maintenance flow rate of the drug for the new activity, (ii) when the activity level of the new activity is lower than the initial activity level, the flow rate of the drug is decreased below a maintenance flow rate of the drug for the new activity, or (iii) both option (i) and option (ii), wherein z is the time delay of the drug action being constant for each different drug and infusion path.

19. The system according to claim 1, wherein the user is the patient or an assistant.

20. The system according to claim 1, wherein the drug comprises Levodopa and/or Carbidopa and/or benserazide in the form of microscopic particles.

21. The system according to claim 1, wherein the system is adapted to allow a user to schedule and/or update the particular values of the first parameter t_x in the mobility calendar.