Integrated glucose monitor and insulin injection pen with automatic emergency notification

• US 9,358,334 B2
• Filed: 05/16/2012
• Issued: 06/07/2016
• Est. Priority Date: 08/18/2010
• Status: Expired due to Fees

• Current Assignee: Thuban Incorporated
• Original Assignee: Thuban Incorporated
• Inventors: Arefieg, Rana J.
• Primary Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US13/472,648
• Publication Number:
  US 20120238853A1
• Time in Patent Office: 1,483 Days
• Field of Search: 604 65- 67, 604131-155
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/1112 Global tracking of patients, e.g. by using GPS
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/741 using synthesised speech
• CPC Class Codes: A61B 5/747 in case of emergency, i.e. alerting emergency services
• CPC Class Codes: A61B 5/749 Voice-controlled interfaces
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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 5/31546 : Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
• CPC Class Codes: G16H 40/67 : for remote operation

Abstract

An insulin injection pen and blood glucose monitoring device is integrated into a single unit that fits in a user'"'"'s clothing pocket or handbag. The device includes a blood glucose monitoring system for detecting the user'"'"'s blood glucose level, an insulin injection mechanism, and a microprocessor that calculates an insulin dosage appropriate to the detected blood glucose level of a particular user and sets the insulin injection mechanism to administer the calculated insulin dosage. The device automatically informs a remote emergency service provider if the microprocessor determines that the detected blood glucose level presents a potential danger to the user. The microprocessor also calculates treatment regimens based on the detected blood glucose level and displays the treatment regimens on an LCD display. The device can include a GPS receiver that detects the location of the device, which is transmitted by the device to the remote emergency service.

Claims

1. A portable blood glucose monitoring device and insulin administering pen integrated into a single unit for testing and treating diabetes symptoms in a patient, the unit comprising:

a housing of a size suitable for transport in a handbag or clothing pocket;

a blood glucose monitoring system in said housing for receiving a biological sample from the patient, said blood glucose monitoring system being operable to detect the patient'"'"'s blood glucose level from the biological sample;

an insulin administration mechanism in said housing for administering an insulin dosage to the patient;

a microprocessor in said housing for determining a detected blood glucose level above a predetermined threshold indicating a hyperglycemic condition of potential danger to the patient and calculating an insulin dosage appropriate to the detected blood glucose level, wherein said insulin administration mechanism is operable to initiate an insulin dosage administration operation and thereafter provide a termination signal to said microprocessor indicating that an insulin dosage has been administered;

a display on said housing for displaying at least one of the detected blood glucose level and the calculated insulin dosage;

a timer in said housing operable to monitor the amount of time elapsed from initiation of the insulin dosage administration operation; and

a communication device in said housing and under the control of said microprocessor, wherein in the absence of receipt of said termination signal by said microprocessor after elapse of a predetermined time interval from the initiation of the insulin dosage administration operation, said microprocessor is operable to cause said communication device to automatically inform a remote emergency service provider of a hyperglycemic condition of potential danger to the patient as determined by said microprocessor.

2. A unit as in claim 1, further comprising:

a mode switch in said housing having a first state for actuating said blood glucose monitoring system to cause detection of the glucose level in the received biological sample and a second state for initiating an insulin dosage administration operation; and

at least one manual input device operable by a user in conjunction with information displayed on said display for providing a user interface permitting the user to set an insulin dosage that is changed from the calculated insulin dosage displayed on said display, wherein when said mode switch is in said second state said insulin administration mechanism is operable to administer the different insulin dosage when the calculated insulin dosage has been changed and to administer the calculated insulin dosage when it has not been changed.

3. A unit as in claim 2, wherein;

said mode switch is manually operable between its first and second states;

said insulin administration mechanism further includes an administration device through which the insulin can be introduced internally of the patient when said administration device is in place in contact with the patient; and

manually setting said mode switch to the second state automatically initiates the insulin dosage administration operation,

said unit further comprising;

a sensor for generating a sensing signal when said administration device is in place in contact with the patient for introducing insulin internally of the patient through said administration device; and

circuitry in said housing responsive to said sensing signal for automatically administering a dosage of insulin to the patient through said administration device when said sensor indicates that said administration device is in place in contact with the patient.

4. A unit as in claim 3, wherein said administration device includes a hypodermic needle for injecting the insulin dosage and said sensor generates said sensing signal when said needle has penetrated the skin of the patient.

5. A unit as in claim 3, wherein said mode switch has a neutral state and said microprocessor displays a prompt on said display instructing the user to take a biological sample and detect the patient'"'"'s blood glucose level therefrom when said mode switch is moved from its neutral state to its first state.

6. A unit as in claim 3, wherein receipt by said microprocessor of an actuating signal when said switch is in the second state changes said display to indicate a time interval during which the insulin dosage will be automatically administered.

7. A unit as in claim 6, wherein said administration device includes a hypodermic needle for injecting the insulin dosage and said sensor generates said sensing signal when said needle has penetrated the skin of the patient.

8. A unit as in claim 2, wherein said microprocessor further includes dose lock software that causes said display to display a prompt requiring the user to confirm the desire to change the amount of insulin to be administered before permitting said insulin administration mechanism to automatically administer the amount of insulin input by the user.

9. A unit as in claim 2, wherein:

said unit stores information regarding a particular patient'"'"'s treatment requirements and said microprocessor determines treatment regimens specific to the particular patient based on the detected blood glucose level and the stored information;

said treatment regimens include (i) ingestion of at least one blood glucose producing substance when the detected blood glucose level indicates that the patient is hypoglycemic, and (ii) administration of insulin when the detected blood glucose level indicates that the patient is hyperglycemic; and

said microprocessor causes said display to indicate at least one of (i) an amount of the at least one blood glucose producing substance to be consumed, (ii) the calculated insulin dosage, and (iii) the different insulin dosage.

10. A unit as in claim 1, wherein said communication device includes a cellular telephone and the remote emergency service provider is at least one of a public emergency service provider and an emergency service to which a user of the unit has subscribed.

11. A unit as in claim 10, wherein said communication device is at least one of (i) circuitry within said housing for establishing a wireless connection to a cellular telephone separate from said housing, and (ii) cellular telephone circuitry within said housing.

12. A unit as in claim 1, further comprising circuitry in said housing for detecting the location of the unit, wherein said communication device transmits information regarding the location to the remote emergency service provider.

13. A unit as in claim 12, wherein said circuitry for detecting the location of the unit comprises a GPS receiver.

14. A unit as in claim 1, wherein said unit stores information regarding a particular patient'"'"'s treatment requirements and said microprocessor is operable to determine treatment regimens specific to the particular patient based on the detected blood glucose level and the stored information and to display the treatment regimens on said display.

15. A unit as in claim 14, wherein said treatment regimens include

ingestion of at least one blood glucose producing substance in an amount calculated by said microprocessor based on the detected blood glucose level when the detected blood glucose level indicates that the patient is hypoglycemic;

and

administration of the calculated insulin dosage determined by said microprocessor based on the detected blood glucose level when the detected blood glucose level indicates that the patient is hyperglycemic.

16. A unit as in claim 1, further including a speaker in said housing connected to said microprocessor for providing voice messages to a user of the unit during operation thereof.

17. A unit as in claim 1, further including a storage device for storing the times of multiple administrations of medication doses and the corresponding medication dosages administered using the unit.

18. A unit as in claim 2, wherein at least one of said mode switch and said manual input device is controlled by touch.

19. A unit as in claim 17, wherein said communication device is operable to provide information in said storage device to a computer accessible to a healthcare provider of the patient.

20. A unit as in claim 1, wherein the biological sample is the blood of the patient.