Dose Capturing Cartridge Module for Drug Delivery Device

• US 20160008552A1
• Filed: 02/19/2014
• Published: 01/14/2016
• Est. Priority Date: 02/19/2013
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Madsen, John Oestergaard, Windum, Jesper Peter
• Granted Patent: US 10,201,664 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 5/315 Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
• CPC Class Codes: A61M 5/31565 Administration mechanisms, i.e. constructional features, modes of administering a dose dosing mechanisms for setting a dose A61M5/31533
• CPC Class Codes: A61M 5/31568 Means keeping track of the total dose administered, e.g. since the cartridge was inserted

Abstract

An electronic logging unit adapted to be housed in a drug-filled cartridge having an axially displaceable piston and an outer cavity formed between the piston and the cartridge proximal opening, the logging unit comprising a general axis, a first distal portion adapted to engage the cartridge piston, and a second proximal portion adapted to engage a rotating element having a rotational axis corresponding to the general axis. The unit is provided with sensor means adapted to detect the amount of relative rotation between the first and second portions, and storage means adapted to store data representing detected amounts of relative rotation.

Claims

1. An electronic logging unit adapted to be housed in a drug-filled cartridge outer cavity, the cartridge comprising a tubular main portion with a proximal opening, a distal outlet portion, and an axially displaceable piston arranged in the tubular main portion at a distance from the proximal opening, the outer cavity being formed between the piston and the proximal opening, the logging unit comprising:

a general axis,

a first distal portion adapted to engage the cartridge piston,

a second proximal portion adapted to engage a rotating element having a rotational axis corresponding to the general axis,

sensor structure adapted to detect the amount of relative rotation between the first and second portions, and

storage structure adapted to store data representing detected amounts of relative rotation.

2. An electronic logging unit as in claim 1,

wherein the first portion comprises:

electronic circuitry, and

a first rotary sensor part,

wherein the second portion comprises;

a second rotary sensor part.

3. An electronic logging unit as in claim 2, wherein:

the first rotary sensor part comprises a pattern of a plurality of individual electrically conducting sensor areas connected to the electronic circuitry, and

the second rotary sensor part comprises at least one contact structure adapted to engage and connect different sensor areas as the first and second part of the rotary sensor rotate relative to each, the connections being indicative of a rotational position between the first and second portions.

4. An electronic logging unit as in claim 1, wherein the electronic logging unit further comprises transmitter structure adapted to transmit stored data to an external receiver.

5. An electronic logging unit as in claim 1, wherein the logging unit has an effective diameter of less than 30 mm.

6. An electronic logging unit as in claim 1 in combination with a cartridge comprising a tubular main portion with a proximal opening, a distal outlet portion, and an axially displaceable piston arranged in the tubular main portion at a distance from the proximal opening, an outer cavity being formed between the piston and the proximal opening,

wherein the logging unit is housed in the cartridge outer cavity.

7. An electronic logging unit as in claim 1 in combination with a drug delivery device comprising:

a drug-filled cartridge comprising;

a generally tubular main portion with a proximal opening,

a distal outlet portion, and

an axially displaceable piston arranged in the tubular main portion at a distance from the proximal opening, an outer cavity being formed between the piston and the proximal opening,

drug expelling structure comprising an axially displaceable piston rod adapted to move the piston of a cartridge in a distal direction to thereby expel drug from the cartridge, the piston rod rotating relative to the cartridge during axial movement,

wherein the electronic logging unit initially is arranged at least partly in the cartridge outer cavity and being configured to be moved fully there into, the sensor structure being adapted to detect the amount of relative rotation between the piston rod and the cartridge during expelling of a dose of drug, the amount of relative rotation corresponding to the dose amount of drug expelled, the storage structure adapted to store data representing expelled dose amounts.

8. An electronic logging unit in combination with a drug delivery device as in claim 7,

wherein engagement of the first portion and the cartridge prevents rotational movement there between during expelling of a dose of drug, and engagement of the second portion and the piston rod prevents rotational movement there between during expelling of a dose of drug, and

wherein the first and second portion are adapted to be moved axially corresponding to axial movement of the piston and piston rod.

9. An electronic logging unit in combination with a drug delivery device as in claim 7, wherein the piston rod during expelling of a dose exerts a distally directed force on the logging unit, the force being transferred to the piston by the logging unit.

10. A method for providing a drug delivery device adapted to create a log for expelled amounts of a drug, comprising the steps of:

providing a drug-filled cartridge comprising;

a generally tubular main portion with a proximal opening,

a distal outlet portion, and

an axially displaceable piston arranged in the tubular main portion at a distance from the proximal opening, an outer cavity being formed between the piston and the proximal opening,

providing a drug delivery device adapted to receive the drug-filled cartridge, comprising drug expelling structure comprising;

dose setting structure allowing a user to set a dose of drug to be expelled from a received drug-filled cartridge,

an axially displaceable piston rod adapted to move the piston of a received drug-filled cartridge in a distal direction to thereby expel drug from the cartridge, the piston rod rotating relative to the cartridge during axial movement,

providing an electronic logging unit adapted to be arranged initially at least partly in the cartridge outer cavity and being configured to be moved fully there into, the logging unit comprising;

sensor structure adapted to detect the amount of relative rotation between the piston rod and the cartridge during expelling of a dose of drug, the amount of relative rotation corresponding to the dose amount of drug expelled, and

storage structure adapted to store data representing expelled dose amounts,

arranging the drug-filled cartridge and the logging unit in the drug delivery device, the logging unit being arranged at least partly in the cartridge outer cavity.

11. A method as in claim 10, wherein the provided logging unit comprises:

a first portion adapted to engage the piston, the engagement preventing rotational movement between the first portion and the piston during expelling of a dose of drug, and

a second portion adapted to engage the piston rod, the engagement preventing rotational movement between the second portion and the piston rod during expelling of a dose of drug,

wherein the first and second portions are adapted to be moved axially corresponding to the axial movement of the piston and piston rod.