Medical assembly with monitoring device

• US 9,089,650 B2
• Filed: 10/01/2009
• Issued: 07/28/2015
• Est. Priority Date: 10/01/2008
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Nielsen, Ole Christian, Madsen, John stergaard
• Primary Examiner(s): Bosworth, Kami A
• Assistant Examiner(s): HAYMAN, IMANI N
• Application Number:
  US13/121,010
• Publication Number:
  US 20110295215A1
• Time in Patent Office: 2,126 Days
• Field of Search: 604/19, 604 65- 67, 604/125, 604/173, 604/181, 604/187, 604207-211, 604/246, 604/264, 604/272, 604/506
• US Class Current: 1/1
• 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 including a drug delivery device and a monitoring device adapted to detect an action taking place in the drug delivery device. The drug delivery device including a main portion having a drug expelling mechanism for expelling drug from the reservoir through an outlet, a housing in which at least a portion of the expelling mechanism is arranged, and a member able to attach a cover to the drug delivery device. The cover is adapted to cover the outlet when mounted. The monitoring device includes a housing portion, a member for detecting an action taking place in the drug delivery device, and at least one member adapted to engage a member present on the main portion. By this arrangement the monitoring device can be placed in a pre-determined position relative to the main portion, allowing efficient transmission of information between the monitoring device and the main portion.

Claims

1. An assembly comprising:

a drug delivery device (1) comprising;

a reservoir (5) for a drug,

an outlet (6) for the drug,

a drug expelling mechanism for expelling the 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

a first coupling structure (14) for a cap, the cap (20) adapted to cover the outlet, comprising;

a second coupling structure for engaging the first coupling structure, and a monitoring device (30) comprising;

a housing portion (31),

a structure for detecting or registering an action performed in the drug delivery device, and

a third coupling structure (32 or 52) adapted to engage the first coupling structure on the drug delivery device,

whereby the monitoring device is arranged in a pre-determined mounted position relative to the drug delivery device when the first and third coupling structure engage each other, thus 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. The assembly as in claim 1, wherein the monitoring device comprises a fourth coupling structure adapted to engage the second coupling structure, this allowing the cap to be attached to the drug delivery device via the monitoring device.

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

4. The assembly as in claim 1, wherein the monitoring device comprises a structure (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. The 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 structure (32 or 52), wherein the monitoring portion can be releasable from the mounting portion.

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

7. The assembly as in claim 1, wherein the monitoring device comprises a further coupling structure (33 or 53) adapted to engage a further specific coupling structure (10) on the drug delivery device.

8. The assembly as in claim 1, wherein the drug expelling mechanism comprises a mechanical structure and the structure for detecting is adapted to detect audible, optical, vibration or electromagnetic signals generated by the drug expelling mechanism.

9. The assembly as in claim 8, wherein the drug expelling mechanism is adapted to set and expel the set dose, the structure for detecting is adapted to detect the size of a dose being set or the size of a dose being expelled.

10. The assembly as in claim 8, wherein the drug expelling mechanism is adapted to set and expel the set dose, the structure for detecting is adapted to detect the size of a dose being set and the size of a dose being expelled.

11. The assembly as in claim 1, wherein the monitoring device comprises a structure for transferring data to an external device.

12. The assembly as in claim 11, wherein said means is a wireless structure.

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

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

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

16. The 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 the drug contained in the reservoir from ambient light.

17. An assembly comprising:

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 the 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,

a first coupling structure (14) for a cap,

the cap (20) adapted to cover the inspection area, the cap comprising a second coupling structure for engaging the first coupling structure, and a monitoring device (30) comprising;

a housing portion (31),

a structure for detecting or registering an action performed in the drug delivery device, and

a third coupling structure (32 or 52) adapted to engage the first coupling structure on the drug delivery device,

whereby the monitoring device is arranged in a pre-determined mounted position relative to the drug delivery device when the first and third coupling structure engage each other, thus 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, thus allowing an amount of drug to be expelled from the reservoir while the monitoring device is coupled to the main portion.

18. An assembly comprising:

a drug delivery device (1) comprising;

a reservoir (5) for a drug,

an outlet (6) for the drug,

a drug expelling mechanism for expelling the 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

a first coupling structure (14) for a cap,

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

a second coupling structure for engaging the first coupling structure, and a monitoring device (30) comprising;

a housing portion (31),

a structure for detecting and registering an action performed in the drug delivery device, and

a third coupling structure (32 or 52) adapted to engage the first coupling structure on the drug delivery device,

whereby the monitoring device is arranged in a pre-determined mounted position relative to the drug delivery device when the first and third coupling structure engage each other, thus 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.

19. The assembly as in claim 18, wherein the drug expelling mechanism comprises a mechanical structure and the structure for detecting is adapted to detect audible, optical, vibration or electromagnetic signals generated by the drug expelling mechanism.

20. The assembly as in claim 19, wherein the drug expelling mechanism is adapted to set and expel the set dose, the structure for detecting is adapted to detect the size of a dose being set and the size of a dose being expelled.

21. An assembly comprising:

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 the 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,

a first coupling structure (14) for a cap, the cap (20) adapted to cover the inspection area, the cap comprising a second coupling structure for engaging the first coupling structure, and a monitoring device (30) comprising;

a housing portion (31),

a structure for detecting and registering an action performed in the drug delivery device, and

a third coupling structure (32 or 52) adapted to engage the first coupling structure on the drug delivery device,

whereby the monitoring device is arranged in a pre-determined mounted position relative to the drug delivery device when the first and third coupling structure engage each other, thus 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, thus allowing an amount of drug to be expelled from the reservoir while the monitoring device is coupled to the main portion.