ELECTRONICALLY ASSISTED DRUG DELIVERY DEVICE

• US 20110270214A1
• Filed: 11/05/2009
• Published: 11/03/2011
• Est. Priority Date: 11/06/2008
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Rolsted, Niels Pryds, Beyerholm, Erik, Ludvigsen, Henrik Groth, Holme, Jens, Linnebjerg, Steven, Jørgensen, Bjarke Dupont, Petersen, Jan Lindhardt, Hansen, Michael Ejstrup, Elahi, Ramin Nateghi
• Granted Patent: US 9,186,465 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61M 2005/2407 from the rear
• CPC Class Codes: A61M 2005/2488 via rotation, e.g. threads or bayonet
• CPC Class Codes: A61M 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2005/3126 Specific display means related to dosing
• CPC Class Codes: A61M 2005/3152 including gearings to multiply or attenuate the piston displacing force
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/31535 Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
• CPC Class Codes: A61M 5/31543 piston rod reset means, i.e. means for causing or facilitating retraction of piston rod to its starting position during cartridge change
• CPC Class Codes: A61M 5/31551 including axial movement of dose setting member
• CPC Class Codes: A61M 5/31558 using scaling up or down transmissions, e.g. gearbox
• CPC Class Codes: A61M 5/3157 Means providing feedback signals when administration is completed A61M5/20 takes precedence
• CPC Class Codes: A61M 5/31575 using scaling up or down transmissions, e.g. gearbox
• CPC Class Codes: A61M 5/3158 performed by axially moving actuator operated by user, e.g. an injection button

Abstract

The present invention relates to electronically assisted drug delivery devices (100). The drug delivery device may include a Gray code type detector for sensing dosage data, wherein the detector comprises a code track consisting of a sequence of alternating markings and a plurality of detectors that are mutually spaced in a direction extending along the code track. The drug delivery device may also include a dosage selector (260) which is moved in a proximal direction upon dose setting and in a distal direction upon dose injection, where the dosage selector is latched in the end of dose position by a latching element, the latching element actuating an end of dose switch for signalling the end of dose state. The drug delivery device may also incorporate power-management arrangements which effectively minimizes power consumption for the incorporated electronic circuitry.

Claims

1. A drug delivery device for setting and injecting set doses of a drug from a drug-filled reservoir, comprising:

a Gray code type detector for detecting relative movements between a first element and a second element, said elements moving relatively during dose setting and/or during injection wherein the Gray code type detector comprises a code track disposed on the first element, the code track comprising a sequence of markings alternating between different states, and wherein the code track is associated with a plurality of detectors disposed on the second element, each detector being adapted to sense the different states of the markings,

wherein the plurality of detectors are mutually offset in a direction extending along the code track to provide a reading sequence of a Gray code scheme when the plurality of detectors are moved relatively to the code track along the sequence of the coded markings.

2. A drug delivery device as in claim 1, wherein the Gray code type detector comprises alternating first and second areas of respective first and second states, each of the first areas having an extension along the code track of extension X₁ and each of the second areas having an extension along the code track of extension X₂.

3. A drug delivery device as in claim 1, wherein the code track is arranged as a circumferential band on a cylindrical surface, either on an interior cylindrical surface or an external cylindrical surface, said band comprising a single or a multitude of repeated Gray code sequences.

4. A drug delivery device as in any of claim 1, wherein the Gray code type detector includes at least one additional area which is sensed by one or more additional detectors, said additional detector(s) being arranged for sensing movement of the Gray code track in directions transverse to the direction along the Gray code sequence.

5. A drug delivery device as in any of claim 1, wherein the sequence of markings of the Gray code track includes areas of electrical conducting and electrical non-conducting material and wherein the detectors are contact switches arranged to electronically sense the presence or absence of an electrical conducting material at said markings.

6. A drug delivery device for setting and injecting set doses of a drug from a drug drug-filled reservoir, comprising:

a dosage selector which is raised in a proximal direction to set a dose and pushed in a distal position to expel the set dose from the drug delivery device,

a latch mechanism for latching the dosage selector in the most distal position at the end of dose position, said latch mechanism including one or more latch elements which at least partly moves in a radial direction when said dosage selector is in the end of dose position, the latching of the dosage selector being released upon user manipulation by pulling the dosage selector in the proximal direction,

wherein said one or more latch element(s) actuates one or more of said end of dose switch(es) to signal the end of dose position of the dosage selector.

7. A drug delivery device as in claim 6, wherein at least one of said one or more latch elements are biased towards its latched position.

8. A drug delivery device as in claim 6, wherein the one or more latch elements is/are ball(s) and at least one of said one or more balls being incorporated in a respective ball lock mechanism configuration.

9. A drug delivery device as in claim 6, wherein at least two end of dose switches are positioned so as to oppose each other and wherein a first one of said at least two dose switch(es) is activated by a movement of its corresponding latch element in a first direction and wherein a second of said at least two end of dose switches is activated by a movement by its corresponding latch element in a direction different from said first direction, and wherein said switches forms a redundant set of switches for signalling the end of dose position of the dosage selector.

10. A drug delivery device, comprising:

a switch circuit comprising a controller for monitoring a condition of at least one component of the drug delivery device, the controller having a plurality of input terminals and output terminals,

a plurality of switches being operated upon a change in condition of said at least one component, each respective switch at a first end connected to a ground voltage level terminal of the controller and at a second end connected to a respective input terminal of the controller,

a plurality of pull-up resistors, each pull-up resistor being connected in series with a respective one of said plurality of switches by connecting a first end of the resistor to the respective input terminal and the second end of the resistor to a respective output terminal of the controller,

wherein the voltage level of each respective output terminal is controllable from a first voltage level, where a closing of the respective switch is detectable by the respective input terminal, to a second voltage level upon the closing of said switch to operate the respective pull-up resistor at a substantially zero-current state, and further to said first voltage level in response to at least one other of said plurality of switches being closed.

11. A drug delivery device as in claim 10, wherein said plurality of switches comprises a first switch and a second switch where the polarity of the first switch is opposite to the polarity of said second switch.

12. A drug delivery device as in claim 11, wherein said plurality of switches comprises first and second switches where the first switch closes upon a component of the device moves from a first position to a second position and where the second switch closes upon said component moves from the second position to a third position.

13. A drug delivery device as in claim 10, wherein said drug delivery device comprises a dose setting mechanism operable to select a dose of medicine to be delivered from a held reservoir, the drug delivery device further comprising a position encoder for monitoring dose related information by detecting the position of a member which moves during dose setting and/or dose expelling, said position encoder including one or more electrically conductive coded track(s), each track including conductive and non-conductive areas, said position encoder further comprising an encoding switch circuitry including a plurality of said switches adapted to read said one or more conductive coded tracks as the switches and the electrically conductive coded track(s) move relatively to each other.

14. A drug delivery device as in claim 13, wherein the one or more electrically conductive coded track(s) forms a single gray code sequence or a multitude of repeated gray code sequences forming a total sequence code length n and wherein the plurality of switches of said encoding switch circuitry reading said conductive coded track(s) are selected as three, such as four, such as five, such as six and such as seven switches.

15. A drug delivery device as in claim 14, wherein the gray code is so configured that at least one switch of said encoding switch circuitry is closed upon at least every second state change in either direction from a present position, said present position being selected from any of each possible n positions.

16. A drug delivery device as in claim 13, wherein the position encoder includes a single electrically conductive coded track having consecutive conductive and non-conductive areas and where the switches of said encoding switch circuitry is distributed along the single track so as to obtain said single or multitude of repeated gray code sequences.

17. A drug delivery device as in claim 13, wherein the position encoder includes a plurality of electrically conductive coded tracks forming a matrix including a plurality of columns and rows and where a single or a plurality of switches of said encoding switch circuitry is aligned with a different row of said matrix.

18. A drug delivery device, comprising:

first user-operatable means for setting a dose of drug to be expelled,

second user-operatable means for expelling a set dose from a drug reservoir,

electronic circuitry for storing and communicating data, the electronic circuitry having a hibernating state and a first operating state,

contact means for energizing the electronic circuitry from the hibernating to the operating state,

wherein user manipulation of the first or second user-operatable means actuates the contact means to thereby energize the electronic circuitry from the hibernating to the first operating state.

19. A drug delivery device as in claim 18,

wherein the electronic circuitry comprises communication means for wirelessly transmitting and/or receiving data, the communication means having a sleep state in the hibernating state and an energized state in the first operating state.

20. A drug delivery device as in claim 19, wherein the state for the communication means is changed from the energized to the sleep state when a first pre-set condition is met.

21. A drug delivery device as in claim 20, wherein the first pre-set condition belongs to the group of conditions consisting of:

the communication means have unsuccessfully tried to establish wireless communication with a corresponding device for a predefined amount of time,

the communication means have unsuccessfully tried to transmit an amount of data to a corresponding device for a predefined amount of time,

the communication means have successfully transmitted an amount of data to a corresponding device,

the first or second user-operatable means are actuated to set a dose respectively to expel a set dose, and

the first or second user-operatable means are arranged in a parked position.

22. A drug delivery device as in claim 18, wherein

the first user-operatable means is in the form of a rotatable member, and

the second user-operatable means is in the form of an axially displaceable member.

23. A drug delivery device as in claim 22, comprising a combined user-operatable member (1260) being both rotationally and axially displaceable to provide the first respectively second user-operatable means.

24. A drug delivery device as in claim 22, wherein at least one of the user-operatable means has a parked and a neutral position, the contact means being actuated when the user-operatable means is moved between its parked and neutral position.

25. A drug delivery device as in claim 18,

wherein the electronic circuitry has a second operating state,

wherein the first operating state has a first level of power consumption and the second operating state has a second lower level of power consumption,

wherein the operating state changes from the first to the second level when a first pre-set condition is met, and

wherein the operating state changes from the second level to the hibernating state when a second pre-set condition is met.

26. A drug delivery device as in claim 25, wherein the electronic circuitry comprises:

communication means for wirelessly transmitting and/or receiving data, the communication means having a sleep state in the hibernating state, an energized state in the first operating state, and a sleep state in the second operating state, and

detection means for detecting and storing data representing an amount/time log for drug expelled from the drug delivery device, the detection means having a sleep state in the hibernating state, and an energized state in the first and second operating states.

27. A drug delivery device as in claim 25, wherein

(a) the first pre-set condition belongs to the group of conditions consisting of:

the communication means have unsuccessfully tried to establish wireless communication with a corresponding device for a predefined amount of time,

the communication means have unsuccessfully tried to transmit an amount of data to a corresponding device for a predefined amount of time,

the communication means have successfully transmitted an amount of data to a corresponding device,

the first or second user-operatable means are actuated to set a dose respectively expel a set dose, and

the first or second user-operatable means are arranged in a parked position, and

(b) the second pre-set condition belongs to the group of conditions consisting of;

the second user-operatable means have been actuated to expel a set dose,

the second user-operatable means have been actuated to expel a set dose and a predefined amount of time has lapsed, the amount of time allowing the electronic circuitry to display the amount of drug expelled,

the second user-operatable means are arranged in a parked position,

the second user-operatable means are arranged in a parked position and a predefined amount of time has lapsed, the amount of time allowing the electronic circuitry to display the amount of drug expelled,

a predefined amount of time has lapsed.

28. A drug delivery device as in claim 25, wherein

the first user-operatable means is in the form of a rotatable member, and

the second user-operatable means is in the form of an axially displaceable member.

29. A drug delivery device as in claim 28, comprising a combined user-operatable member being both rotationally and axially displaceable to provide the first respectively second user-operatable means.

30. A drug delivery device as in claim 28, wherein at least one of the user-operatable means has a parked and a neutral position, the contact means being actuated when the user-operatable means is moved between its parked and neutral position.

31. A drug delivery device as in claim 18, comprising mechanical dose setting and expelling means operatable by the first respectively second user-operatable means.

32. A drug delivery device as in claim 18, comprising a drug-filled reservoir or being adapted to receive a drug-filled reservoir.

33. A method of operating a drug delivery device comprising:

providing a drug delivery device having a dose setting member and a wireless transmitter,

energizing the wireless transmitter by moving the wireless transmitter to a first position, and

de-energizing the wireless transmitter by moving the wireless transmitter to a second position.