DRUG DELIVERY SYSTEM WITH WIRELESS MONITOR

• US 20110004188A1
• Filed: 02/04/2009
• Published: 01/06/2011
• Est. Priority Date: 02/04/2008
• Status: Abandoned Application

• Current Assignee: Nilimedix Ltd.
• Original Assignee: Nilimedix Ltd.
• Inventors: Shekalim, Avraham
• Application Number:
  US12/865,863
• Publication Number:
  US 20110004188A1
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• 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 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A portable drug delivery system (10) includes a remote unit (14) which serves as a wireless monitor for a drug delivery device (12). Programming of the drug delivery device (12) can be achieved by use of the remote unit (14), but requires tactile intervention by the user with the drug delivery device, thereby avoiding inadvertent or unauthorized changes to the drug delivery settings via the wireless unit. Also disclosed are configurations for receiving and retaining a drug cartridge (42) within a disposable unit (40) of the drug delivery device, and a kit providing user-selectable form factor for the infusion set used with the drug delivery device, allowing the user to select either an integrated infusion set (112) or an external infusion (106) set for each session of use.

Claims

1. A drug delivery system for delivering a drug to the body of a user, the system comprising:

(a) a drug delivery device including;

(i) a housing;

(ii) a reservoir containing a quantity of the drug, said reservoir being located at least partially within said housing;

(iii) an infusion arrangement for delivering the drug into the body of the user;

(iv) a flow controller for controlling a flow of the drug from the reservoir to the infusion arrangement; and

(v) a first communication device associated with said flow controller and including at least a transmitter, said first communication device transmitting wirelessly information indicative of a current state of operation of said flow controller; and

(b) a remote unit including;

(i) a display;

(ii) a plurality of user input controls;

(iii) a remote unit controller associated with said display and said user input controls; and

(iv) a second communication device associated with said remote unit controller and including at least a receiver, said second communication device receiving said wirelessly transmitted information and supplying said information to said remote unit controller for display on said display,

wherein said remote unit is configured to receive user input via said user input controls to define a required change in operation of said flow controller, and wherein said drug delivery device is configured to require tactile intervention by the user prior to said required change in operation being implemented.

2. The drug delivery system of claim 1, wherein said first communication device includes a receiver and said second communication device includes a transmitter, and wherein data indicative of said required change in operation is transmitted wirelessly from said remote unit to said drug delivery device, said drug delivery device further comprising a manually operable user input, said tactile intervention requiring actuation of said manually operable user input to confirm said required change in operation.

3. The drug delivery system of claim 2, wherein said manually operable user input is implemented as a readily accessible button configured to be operable by pressure of a finger applied through a garment.

4. The drug delivery system of claim 1, further comprising a tethered connection selectively deployable to provide a tethered link between said remote unit and said drug delivery device, wherein said tactile intervention requiring deployment of said tethered connection.

5. The drug delivery system of claim 4, wherein said tethered connection is a wired communication link along which is transmitted data indicative of said required change in operation.

6. The drug delivery system of claim 1, further comprising a data storage device, wherein each of said drug delivery device and said remote unit comprises a connector for removable attachment of said data storage device, and wherein said tactile intervention requires transfer of said data storage device from said remote unit to said drug delivery device.

7. A method for operating a drug delivery system for delivering a drug to the body of a user, the method comprising the steps of:

(a) providing a drug delivery device including a reservoir containing a quantity of the drug and a flow controller for controlling a flow of the drug from the reservoir to the body of the user;

(b) providing a remote unit including a display and a plurality of user input controls;

(c) deploying the drug delivery device to deliver the drug to the body of the user in a first defined manner;

(d) during operation of the drug delivery device, transmitting wirelessly from the drug delivery device to the remote unit information indicative of a current state of operation of the drug delivery device for display on the display;

(e) inputting to the remote unit via the user input controls a required change in operation of the drug delivery device;

(f) transferring to the drug delivery device data indicative of the required change in operation; and

(g) changing the operation of the drug delivery device in accordance with said data,

wherein at least one of said transferring and said changing requires tactile intervention by the user with the drug delivery device.

8. The method of claim 7, wherein said tactile intervention comprises manual operation of an input device located on the drug delivery device.

9. The method of claim 8, wherein said user input on the drug delivery device is implemented as a readily accessible button configured to be operable by pressure of a finger applied through a garment.

10. The method of claim 7, wherein said tactile intervention comprises deployment of a tethered connection between the remote unit and the drug delivery device.

11. The method of claim 10, wherein said tethered connection is a wired communication link along which is transmitted data indicative of the required change in operation.

12. The method of claim 7, wherein said tactile intervention comprises transfer of a data storage device from the remote unit to the drug delivery device.

13. A drug delivery device for delivering a drug to the body of a user, the device comprising a disposable unit for receiving a cartridge containing a drug to be delivered, said disposable unit comprising:

(a) a channel for receiving the cartridge containing the drug to be delivered, said channel having an opening and a direction of extension;

(b) a loading spring deployed within said channel for applying a loading force on the cartridge when inserted within said channel, said loading force acting along said direction of extension towards said opening; and

(c) a retention configuration deployed near said opening, said retention configuration including a plurality of rearwardly directed resilient teeth configured;

(i) to retain said loading spring in a pre-compressed state within said channel prior to insertion of the cartridge,

(ii) to flex outwards to allow insertion of the cartridge between said teeth, and

(iii) to assume a retaining position engaging a recessed portion of the cartridge when the cartridge is fully inserted.

14. The drug delivery device of claim 13, wherein said plurality of rearward directed resilient teeth are formed as part of a collar deployed within said opening.

15. The drug delivery device of claim 13, further comprising a user-tillable cartridge sized and shaped for insertion into said channel.

16. The drug delivery device of claim 15, wherein said cartridge has an open base and a displaceable piston, and wherein said loading spring is configured to apply a load on said displaceable piston so as to pressurize the contents of said cartridge.

17. A modular drug delivery system kit for delivering a drug to the body of a user, the kit comprising:

(a) a drug delivery device comprising a disposable unit having an outlet arrangement with at least one outlet for release of a drug for infusion into the body of the user;

(b) a first infusion set including a canula in fluid connection with a length of flexible tube for delivery of the drug into the body of the user at a location spaced from said drug delivery device, said first infusion set being configured for fluid connection to said outlet arrangement; and

(c) a second infusion set including a canula deployable in fixed relation to a body contact element, said body contact element being configured to cooperate with said drug delivery device to define a fixed spatial alignment between said body contact element and said drug delivery device, and to define a fluid flow path from said outlet arrangement to said canula,

wherein one of said first infusion set and said second infusion set is attached to said drug delivery device to provide a user selected form factor for the drug delivery system.

18. The modular drug delivery system kit of claim 17, wherein said outlet arrangement includes a first outlet for attachment of said first infusion set and a second outlet for attachment of said second infusion set.

19. The modular drug delivery system kit of claim 17, wherein said at least one outlet is formed with a septum needle recessed within a socket, and with an elastomer seal deployed within said socket so as to seal the end of said septum needle prior to attachment of said first or second infusion set.