Apparatus and system for diabetes management

• US 8,992,464 B2
• Filed: 11/11/2009
• Issued: 03/31/2015
• Est. Priority Date: 11/11/2008
• Status: Active Grant

• Current Assignee: Hygieia, Inc.
• Original Assignee: Hygieia, Inc.
• Inventors: Bashan, Eran, Hodish, Israel
• Primary Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US13/128,358
• Publication Number:
  US 20110275986A1
• Time in Patent Office: 1,966 Days
• Field of Search: 604/66, 604/110, 600/316, 600/347, 600/365
• US Class Current: 604/66
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/507 Head Mounted Displays [HMD]
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 5/1684 by detecting the amount of infusate remaining, e.g. signalling end of infusion
• 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: A61M 5/31571 Means preventing accidental administration for automatic syringes A61M5/20
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 40/63 for local operation

Abstract

An apparatus and system diabetes management. The apparatus comprises a body which houses: (i) at least a first memory for storing data inputs corresponding at least to one or more components in a patient'"'"'s present insulin dosage regimen and the patient'"'"'s blood-glucose-level measurements determined at a plurality of times; (ii) a processor operatively connected to the at least first memory, the processor programmed at least to determine from the data inputs corresponding to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times whether and by how much to vary at least one of the one or more components of the patient'"'"'s present insulin dosage regimen; (iii) a display screen operatively connected to the processor; (iv) a quantity of insulin; (v) a needle communicating with the quantity of insulin for delivering insulin to the patient; (vi) means for effecting delivery of a portion of the quantity of insulin to the patient via the needle; and (vii) metering means for controlling the portion of the quantity of insulin delivered to the patient via the needle.

Claims

1. An apparatus for diabetes management, the apparatus comprising:

a body housing;

at least a first memory for storing data inputs corresponding at least to one or more components in a patient'"'"'s present insulin dosage regimen and the patient'"'"'s blood-glucose-level measurements determined at a plurality of times;

a processor operatively connected to the at least first memory, the processor programmed at least to determine from the data inputs corresponding to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times within a predetermined time interval whether and by how much to vary at least one of the one or more components of the patient'"'"'s present insulin dosage regimen,

wherein the predetermined time interval is longer than a time period between any two consecutive blood-glucose-level measurements, and

wherein said determination occurs only after a passage of the predetermined time interval since the need to update the patient'"'"'s insulin dosage regimen was last assessed or if urgent variation to the patient'"'"'s present insulin dosage is necessary, and

a display screen operatively connected to the processor;

a quantity of insulin;

a needle communicating with the quantity of insulin for delivering insulin to the patient;

means for effecting delivery of a portion of the quantity of insulin to the patient via the needle; and

metering means for controlling the portion of the quantity of insulin delivered to the patient via the needle.

2. The apparatus of claim 1, wherein the quantity of insulin is contained in a cartridge that is selectively removable from the housing so as to be replaceable upon exhaustion of the quantity of insulin therein.

3. The apparatus of claim 1, further comprising means for preventing a patient from administering an injection when there is an insufficient quantity of insulin remaining in the apparatus.

4. The apparatus of claim 1, wherein said blood-glucose-level measurements are taken several times per day.

5. The apparatus of claim 1, wherein said predetermined time interval is several days.

6. The apparatus of claim 1, wherein the body further houses a test strip port for receiving a test strip, and the processor is operative to determine a patient'"'"'s current blood glucose level measurement from a sample of the patient'"'"'s blood provided on a test strip.

7. The apparatus of claim 6, wherein the display is further operative to display a patient'"'"'s current blood glucose level measurement.

8. The apparatus of claim 1, wherein the quantity of insulin cannot be replenished upon exhaustion thereof.

9. The apparatus of claim 8, further comprising means for communicating data from the memory to a remote device for remote storage.

10. The apparatus of claim 8, further comprising means for communicating data from the memory to a second, like apparatus for taking blood glucose measurements and optimizing a patient'"'"'s insulin dosage regimen over time.

11. An system for diabetes management, comprising:

(a) a device comprising;

(i) at least a first memory for storing data inputs corresponding at least to one or more components in a patient'"'"'s present insulin dosage regimen and the patient'"'"'s blood-glucose-level measurements determined at a plurality of times; and

(ii) a processor operatively connected to the at least first memory, the processor programmed at least to determine from the data inputs corresponding to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times within a predetermined time interval whether and by how much to vary at least one of the one or more components of the patient'"'"'s present insulin dosage regimen,

wherein the predetermined time interval is longer than a time period between any two consecutive blood-glucose-level measurements, and

wherein said determination occurs only after a passage of the predetermined time interval since the need to update the patient'"'"'s insulin dosage regimen was last assessed or if urgent variation to the patient'"'"'s present insulin dosage is necessary, and

(b) an apparatus, remote from the device, comprising a body housing;

(i) at least a first memory;

(ii) a processor operatively connected to the at least first memory;

(iii) a display screen operatively connected to the processor;

(iv) a quantity of insulin;

(v) a needle communicating with the quantity of insulin for delivering insulin to a patient;

(vi) means for effecting delivery of a portion of the quantity of insulin to the patient via the needle; and

(vii) metering means for controlling the portion of the quantity of insulin delivered to the patient via the needle; and

(c) means for communicating data between the device and the apparatus, the data including at least data corresponding to a current recommended insulin dose.

12. The system of claim 11, wherein the quantity of insulin is contained in a cartridge that is selectively removable from the housing so as to be replaceable upon exhaustion of the quantity of insulin therein.

13. The system of claim 11, wherein the quantity of insulin cannot be replenished upon exhaustion thereof.

14. The system of claim 11, further comprising means for preventing a patient from administering an injection when there is an insufficient quantity of insulin remaining in the apparatus.

15. The system of claim 11, wherein the body further houses a test strip port for receiving a test strip, and the processor of the apparatus is operative to determine the patient'"'"'s current blood glucose level measurement from a sample of the patient'"'"'s blood provided on a test strip, and wherein further the means for communicating between the device and the apparatus are further operative for communicating the patient'"'"'s blood glucose measurement between the apparatus and the device.

16. The system of claim 15, wherein the display is further operative to display a patient'"'"'s current blood glucose level measurement.

17. An apparatus for diabetes management, the apparatus comprising:

a body housing;

at least a first memory for storing data inputs corresponding at least to one or more components in a patient'"'"'s present insulin dosage regimen and the patient'"'"'s blood-glucose-level measurements determined at a plurality of times;

a processor operatively connected to the at least first memory, the processor programmed at least to determine from the data inputs corresponding to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times whether and by how much to vary at least one of the one or more components of the patient'"'"'s present insulin dosage regimen;

means for communicating data from the memory to a second, like apparatus for taking blood glucose measurements and optimizing a patient'"'"'s insulin dosage regimen over time;

a display screen operatively connected to the processor;

a quantity of insulin;

a needle communicating with the quantity of insulin for delivering insulin to the patient;

means for effecting delivery of a portion of the quantity of insulin to the patient via the needle; and

metering means for controlling the portion of the quantity of insulin delivered to the patient via the needle.

18. The apparatus of claim 17, wherein the quantity of insulin is contained in a cartridge that is selectively removable from the housing so as to be replaceable upon exhaustion of the quantity of insulin therein.

19. The apparatus of claim 17, further comprising means for preventing a patient from administering an injection when there is an insufficient quantity of insulin remaining in the apparatus.

20. The apparatus of claim 17, wherein the body further houses a test strip port for receiving a test strip, and the processor is operative to determine a patient'"'"'s current blood glucose level measurement from a sample of the patient'"'"'s blood provided on a test strip.

21. The apparatus of claim 20, wherein the display is further operative to display a patient'"'"'s current blood glucose level measurement.

22. The apparatus of claim 17, wherein the quantity of insulin cannot be replenished upon exhaustion thereof.

23. The apparatus of claim 22, further comprising means for communicating data from the memory to a remote device for remote storage.