Device, system and method for facilitating syringe based drug delivery and management thereof

• US 9,808,577 B2
• Filed: 05/10/2012
• Issued: 11/07/2017
• Est. Priority Date: 05/10/2011
• Status: Active Grant

• Current Assignee: InsuLine Medical Ltd.
• Original Assignee: InsuLine Medical Ltd.
• Inventors: Nagar, Ron, Bitton, Gabriel, Amir, Elisha, Fadlun, Moshe
• Primary Examiner(s): Flick, Jason
• Application Number:
  US14/116,768
• Publication Number:
  US 20140207099A1
• Time in Patent Office: 2,007 Days
• Field of Search: 6048901
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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 5/50 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile retractable needles or needle protectors with means for preventing re-use A61M5/321

Abstract

The present invention relates to a device, system and a method for optimizing syringe based drug delivery profile with a treatment element and in particular, to such a device, system and method in which optimization is based on a plurality of data that directly and/or indirectly affect the optimization of the drug delivery profile. The device facilitating syringe based drug delivery, by optimizing drug delivery of the injected drug, records user'"'"'s activity, and data relative to drug injections, comprising a disposable unit configured for a single use period and a rechargeable reusable unit having electronics comprising a sensor module.

Claims

1. A device for facilitating drug delivery with a syringe based device, wherein the device optimizes the delivery of an injected drug, records activity and data relative to said drug injections while the drug is administered, the device comprising:

a disposable unit configured for a single use period characterized in that said disposable unit is rendered non-functional after said single use period, the disposable unit comprising a lower surface having a biocompatible adhesive with removable laminate for coupling said disposable unit over an area of skin defining an injection area; and

a reusable unit having electronics comprising;

control module, memory module, power supply module, communication module, contactless communication module, treatment element module and sensor module,

the disposable unit having at least one connector for coupling with said reusable unit and an activating member configured to activate said reusable unit,

wherein said power supply module comprises a rechargeable energy source that may be replenished with a base station unit for charging said power supply,

wherein the disposable unit comprises two surfaces and a member connecting an end of one of the surfaces to an end of the other of the surfaces.

2. The device of claim 1 wherein said single use period is any of:

a) days of use, b) from about one day or up to three days, c) number of injection administered in the injection area, and d) at least 4 injections.

3. The device of claim 1 wherein said disposable unit is configured for use as a drug delivery port having a single use cannula over said injection area and a single use period of about three days.

4. The device of claim 1 wherein said reusable unit and disposable unit are moved relative to one another to assume a plurality of configurations including an open configuration and a closed configuration.

5. The device of claim 1 wherein said base station unit is adapted for receiving and securely associating with said reusable unit;

said base station comprising a power supply module provided for recharging or powering said reusable unit and a communication module provided for communicating and data exchange with said reusable unit; and

wherein said base station unit charges said reusable unit via electrical contacts or by induction.

6. The device of claim 1 wherein said reusable unit communication module provides for communicating and interfacing with at least one or more auxiliary devices selected from the group consisting of:

a mobile communication device, a meal detection device, a blood glucose monitor, a physical activity detector, a syringe, a syringe based device, a drug delivery pen, a caloric intake calculator, a food analysis device, a basal only pump, a bolus only pump, a blood pressure and a pulse monitor, and any combination thereof.

7. The device of claim 1 wherein said communication module may be selected from the group consisting of:

contactless communication, near field communication, wireless communication, cellular communication, RFID based communication, Bluetooth, WiFi, ZigBee, optical communication, and piezoelectric/acoustic communication.

8. The device of claim 1 wherein said contactless communication module is adapted for interfacing with a syringe based drug delivery device fit with at least one or more corresponding contactless electronic identification circuitry for identifying and communicating data associated with the syringe based delivery device data and drug contents.

9. The device of claim 8 wherein data communicated from said syringe based drug delivery device is selected from the group consisting of:

drug delivery device identification, injection date and time stamp, drug identification, drug lot number, drug manufacturing details, delivered dose, type of drug, environmental exposure associated with the drug, type of delivery device used, time stamp of delivery, injection time length, location of injection, and any combination thereof.

10. The device of claim 9 wherein data communicated from said at least one syringe based drug delivery device is utilized to optimize said drug delivery about said injection area.

11. The device of claim 1 wherein said sensor module comprises a meal detection sensor for detecting a user'"'"'s meal state, and a physical activity sensor for detecting a user'"'"'s physical activity and positioning or posture.

12. The device of claim 11 wherein said sensor module further comprises at least one or more sensors selected from the group consisting of an impedance sensor for identifying drug delivery status, physiological sensor for identifying the user'"'"'s physiological parameters, and a treatment element for applying a treatment to a user before, after or during a syringe based drug administration.

13. The device of claim 12 wherein said treatment optimizes a drug delivery profile and improves the pharmacodynamic and pharmacokinetic drug profile.

14. A system for facilitating and managing drug delivery data from a plurality of syringe based drug delivery devices, the system including:

the drug delivery optimizing device of claim 1 and at least one contactless electronic identification circuitry adapted for coupling or otherwise attaching to a syringe based drug delivery device for communicating injection data and administering drug data to said drug delivery optimizing device.

15. The system of claim 14 wherein said drug delivery optimizing device is interfaced and in communication with a mobile communication device or a HUB.

16. The system of claim 15 further comprising at least one auxiliary device selected from the group consisting of:

a meal detection device, a blood glucose monitor, a physical activity detector, a syringe, a syringe based device, a drug delivery pen, a caloric intake calculator, a food analysis device, a basal only pump, a bolus only pump and a blood pressure monitor.

17. The system of claim 16 wherein the reusable unit of said drug delivery optimizing device provides for interfacing with said auxiliary devices, for integrating and storing data provided from individual said auxiliary devices.

18. The system of claim 17 wherein communication with said auxiliary devices is facilitated with said HUB or said mobile communication device.

19. A method for optimizing drug delivery with a syringe based drug delivery device with the system of claim 15, the method comprising:

associating said drug delivery optimizing device of claim 1 with said HUB;

associating a plurality of auxiliary devices with said HUB;

communicating data from said plurality of auxiliary devices and said syringe based drug delivery device to said HUB;

determining an optimization drug delivery protocol based on said communicated data that is abstracted relative to at least one goal for maintaining balanced blood glucose level; and

communicating the optimized drug delivery protocol to said drug delivery optimizing device.

20. A method for optimizing drug delivery with the drug delivery optimizing device of claim 11, the method comprising:

coupling said drug delivery optimizing device with a user for continuously recording user'"'"'s daily activity with said physical activity sensor and a meal event with said meal detection sensor;

continuously communicating with at least one or more auxiliary devices for obtaining supplementary user data and storing said data;

during drug administration establishing contactless communication between said syringe based drug delivery device and said drug delivery optimizing device, both for bolus or basal drug delivery injections, to obtain syringe data including syringe identification, syringe parameters and data associated with the syringe contents, wherein data exchange is provided by said contactless communication module and wherein said communicated data is stored in said memory module of said drug delivery optimizing device, along with a date and time stamp; and

communicating all supplementary obtained data to said drug delivery optimizing device for controlling a treatment element provided to optimize drug delivery.

21. The method of claim 20 wherein said drug delivery optimizing device detects a mealtime event with said physical activity sensor and said meal detection sensor;

and further comprises;

initiating a timer from detection of said meal time event and await a bolus injection;

providing a reminder as necessary;

detecting a pending injection through contactless communication with syringe based drug delivery device; and

initiating a drug delivery treatment protocol based on available data.