MEDICAL ASSEMBLY WITH MONITORING DEVICE

• US 20110295215A1
• Filed: 10/01/2009
• Published: 12/01/2011
• Est. Priority Date: 10/01/2008
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Madsen, John Østergaard, Nielsen, Ole Christian
• Granted Patent: US 9,089,650 B2
• Time in Patent Office: Days
• US Class Current: 604/257
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• 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 2205/3569 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 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8212 with means or measures taken for minimising energy consumption
• CPC Class Codes: A61M 2205/8243 by induction
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/178 Syringes
• 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 5/31525 Dosing burettes, pipettes B01L3/02
• CPC Class Codes: A61M 5/31533 Dosing mechanisms, i.e. setting a dose administrating mechanisms A61M5/31565
• 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 5/31548 : Mechanically operated dose setting member
• CPC Class Codes: A61M 5/3202 : Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/5086 : for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection

Abstract

An assembly comprises a drug delivery device and a monitoring device adapted to detect an action taking place in the drug delivery device. The drug delivery device comprises a main portion having a drug expelling mechanism for expelling drug from a reservoir through an outlet, a housing in which at least a portion of the expelling mechanism is arranged, and coupling means for a cover. The cover is adapted to cover the outlet when mounted on the main portion. The monitoring device comprises a housing portion, means for detecting an action taking place in the drug delivery device, and coupling means adapted to engage the coupling means on the main portion. By this arrangement the monitoring device can be placed in a pre-determined position relative to the main portion when the coupling means engage each other, this allowing efficient transmission of information between the monitoring device and the main portion.

Claims

1. An assembly comprising:

(a) a drug delivery device (1) comprising;

a reservoir (5) for a drug,

an outlet (6) for the drug,

a drug expelling mechanism for expelling drug from the reservoir and out through the outlet,

a housing (3) in which at least a portion of the drug expelling mechanism is arranged, and

first coupling means (14) for a cap,

(b) a cap (20) adapted to cover the outlet, comprising;

second coupling means for engaging the first coupling means, and

(c) a monitoring device (30) comprising;

a housing portion (31),

means for detecting and/or registering an action performed in the drug delivery device, and

third coupling means (32) adapted to engage the first coupling means on the drug delivery device,

whereby the monitoring device can be arranged in a pre-determined mounted position relative to the drug delivery device when the first and third coupling means engage each other, this allowing information to be transferred between the drug delivery device and the monitoring device, and

whereby the monitoring device does not cover the outlet when arranged in the mounted position, thus allowing an amount of drug to be expelled from the reservoir while the monitoring device is coupled to the drug delivery device.

2. An assembly as in claim 1, wherein the monitoring device comprises fourth coupling means adapted to engage the second coupling means, this allowing the cap to be attached to the drug delivery device via the monitoring device.

3. An assembly as in claim 1, wherein the monitoring device comprises fourth coupling means adapted to engage fifth coupling means arranged on a second cap (40), this allowing the second cap to be attached to the drug delivery device via the monitoring device.

4. An assembly as in claim 1, wherein the monitoring device comprises means (36, 37, 38, 39) for biasing a portion of the monitoring device against a housing portion of the drug delivery device to thereby enhance transfer of information between the two devices.

5. An assembly as in claim 1, wherein the monitoring device comprises a mounting portion (50, 750, 950) and a monitoring portion (60, 760, 960), the mounting portion comprising the third coupling means (52), wherein the mounting portion and the monitoring portion comprise releasable coupling means (54, 55, 64, 65) for coupling the two portions.

6. An assembly as in claim 5, wherein the mounting portion comprises non-releasable coupling means (58) for engaging the drug delivery device.

7. An assembly as in claim 1, wherein the monitoring device comprises a further coupling means (33) adapted to engage a further specific coupling structure (10) on the drug delivery device.

8. An assembly as in claim 1, wherein the drug expelling mechanism comprises mechanical means and the detection means is adapted to detect audible, optical, vibration or electromagnetic signals generated by the drug expelling mechanism.

9. An assembly as in claim 8, wherein the drug expelling mechanism is adapted to set and expel the set dose, the detection means being adapted to detect the size of a dose being set and/or the size of a dose being expelled.

10. An assembly as in claim 1, wherein the monitoring device comprises means for transferring data to an external device, e.g. by wireless means.

11. An assembly as in claim 1, wherein the reservoir is prefilled with a fluid drug.

12. An assembly as in claim 1, wherein information is transferred through a housing portion of the drug delivery device by non-galvanic means.

13. An assembly as in claim 1, wherein the monitoring device can be arranged in a non-rotational mounted position relative to the drug delivery device.

14. An assembly as in claim 1, wherein the reservoir comprises a transparent area allowing a user to inspect at least a portion of the reservoir, and wherein the cap in its mounted position is adapted to cover the transparent area to thereby protect a drug contained in the reservoir from ambient light.

15. An assembly comprising:

(a) a drug delivery device (1) comprising;

a holder (4) for a drug reservoir (5) having an outlet, the holder having an inspection area (19) allowing a portion of the drug reservoir to be inspected by a user,

a drug expelling mechanism for, in a situation of use when a drug reservoir is mounted, expelling drug from the reservoir and through the outlet,

a housing (3) in which at least a portion of the expelling mechanism is arranged, and,

first coupling means (14) for a cap,

(b) a cap (20) adapted to cover the inspection area, the cap comprising second coupling means for engaging the first coupling means, and

(c) a monitoring device (30) comprising;

a housing portion (31),

means for detecting and/or registering an action performed in the drug delivery device, and

third coupling means (32) adapted to engage the first coupling means on the drug delivery device,

whereby the monitoring device can be arranged in a pre-determined mounted position relative to the drug delivery device when the first and third coupling means engage each other, this allowing information to be transferred between the drug delivery device and the monitoring device, and

whereby the monitoring device, in the situation of use, does not cover the outlet when arranged in the mounted position, this allowing an amount of drug to be expelled from the reservoir while the monitoring device is coupled to the main portion.