Dose capturing cartridge module for drug delivery device

Patent metadata

Field	Value
Publication number	US-10201664-B2
Application number	US-201414767506-A
Country	US
Kind code	B2
Filing date	Feb 19, 2014
Priority date	Feb 19, 2013
Publication date	Feb 12, 2019
Grant date	Feb 12, 2019

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.

First claim

The invention claimed is:

1. An electronic logging unit configured to be located within an outer cavity of a cartridge configured to hold a drug, 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 electronic logging unit comprising:
a longitudinal axis,
a first distal portion adapted to engage the axially displaceable piston of the cartridge and move axially with the piston during dose expelling,
a second proximal portion adapted to engage a rotating element having a rotational axis corresponding to the longitudinal axis,
the first distal portion and the second proximal portion comprising a sensor structure, wherein the sensor structure is configured to detect relative rotation between the axially displaceable piston and the rotating element, 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 distal portion of the sensor structure comprises:
electronic circuitry, and
a first rotary sensor part,

wherein the second proximal portion of the sensor structure comprises:
a second rotary sensor part.

3. An electronic logging unit as in claim 2 , wherein:
(i) the first rotary sensor part comprises a pattern of a plurality of individual electrically conducting sensor areas connected to the electronic circuitry, and
(ii) 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 electronic logging unit has an effective diameter of less than 30 mm.

6. An electronic logging unit as in claim 1 in combination with 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, an outer cavity being formed between the piston and the proximal opening,
wherein the electronic 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:
the 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 piston 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 force on the electronic logging unit, the force being transferred to the piston by the electronic logging unit.

10. An electronic logging unit as in claim 1 ,
wherein a first proximal portion of the sensor structure comprises:
electronic circuitry, and
a first rotary sensor part,

wherein the second proximal portion of the sensor structure comprises:
a second rotary sensor part.

11. An electronic logging unit as in claim 10 , wherein:
(i) the first rotary sensor part comprises a pattern of a plurality of individual electrically conducting sensor areas connected to the electronic circuitry, and
(ii) 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.

12. An electronic logging unit in combination with the drug delivery device as in claim 9 , wherein: the force is used to activate a contact to thereby turn on the electronic logging unit.

13. A method for providing a drug delivery device adapted to create a log for expelled amounts of a drug, comprising:
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 axially displaceable 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 the received drug-filled cartridge,
an axially displaceable piston rod adapted to move the axially displaceable piston of the received drug-filled cartridge in a distal direction to thereby expel drug from the drug-filled cartridge, the axially displaceable piston rod rotating relative to the drug-filled cartridge during axial movement,

providing an electronic logging unit adapted to be arranged initially at least partly in the drug-filled cartridge outer cavity and being configured to be moved fully into the drug-filled cartridge outer cavity, the electronic logging unit comprising:
a longitudinal axis,
a first distal portion adapted to engage the axially displaceable piston of the cartridge,
a second proximal portion adapted to engage the piston rod having a rotational axis corresponding to the longitudinal axis,
the first distal portion and the second proximal portion comprising a sensor structure, wherein the sensor structure is configured to detect relative rotation between the axially displaceable piston rod and the axially displaceable piston of the drug-filled cartridge during expelling of a dose of drug, and
storage structure adapted to store data representing expelled dose amounts,

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

Assignees

• Novo Nordisk As

Inventors

• Madsen John Oestergaard
• Windum Jesper Peter

Classifications

• A61M5/315 Primary

  Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod {or piston}; Appliances on the rod for facilitating dosing {; Dosing mechanisms} · CPC title

• A61M5/31565

  Administration mechanisms, i.e. constructional features, modes of administering a dose (dosing mechanisms for setting a dose A61M5/31533) · CPC title

• A61M5/31568 Primary

  Means keeping track of the total dose administered, e.g. since the cartridge was inserted · CPC title

• A61M2205/52

  with memories providing a history of measured variating parameters of apparatus or patient · CPC title