Drug delivery device and method for a drug delivery device

• US 9,492,620 B2
• Filed: 11/10/2011
• Issued: 11/15/2016
• Est. Priority Date: 11/12/2010
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Schabbach, Michael, Graham, Jay
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Snyder, Melissa A
• Application Number:
  US13/883,391
• Publication Number:
  US 20130226134A1
• Time in Patent Office: 1,832 Days
• US Class Current: 1/1
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61M 2005/2485 Ampoule holder connected to rest of syringe
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3389 Continuous level detection A61M2205/3393 takes precedence
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 5/1684 by detecting the amount of infusate remaining, e.g. signalling end of infusion
• CPC Class Codes: A61M 5/2066 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/3146 Priming, e.g. purging, reducing backlash or clearance
• 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 5/31541 Means preventing setting of a dose beyond the amount remaining in the cartridge
• CPC Class Codes: A61M 5/31596 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

A drug delivery device is provided comprising a container, a first product and a second product. The device is configured to mix the first product and the second product with each other within the container for forming a drug mixture. The device is further configured for dispensing the drug mixture. The device comprises a mixing member. The device is switchable from a first state, in which the first product and the second product are separated, into a second state, in which the first product and the second product are mixed. The mixing member is configured to exert a force onto the container in order to move the container to mix the first product and the second product with each other. Furthermore, a method for maintaining a predetermined property of a drug mixture to be dispensed from a drug delivery device is provided.

Claims

1. A drug delivery device comprising:

a container,

a first product and a second product, the device being configured to mix the first product and the second product with each other within the container for forming a drug mixture, the device being further configured for dispensing the drug mixture, and

a mixing member,

wherein the device is switchable from a first state, in which the first product and the second product are separated, into a second state, in which the first product and the second product are mixed, and wherein the mixing member is configured to exert a force onto the container in order to move the container to mix the first product and the second product with each other,

wherein the device comprises a measuring unit comprising at least one sensor, the measuring unit being configured to determine a value of a parameter of the drug mixture when the device is in the second state, wherein the sensor detects the opacity, cloudiness, or light scattering, reflection or transmission of the drug mixture as the parameter that exists after mixing the first product and the second product with each other that is indicative for a mixing property of the drug mixture.

2. The drug delivery device of claim 1, wherein the container comprises at least two retaining sections, wherein, in the first state, a first retaining section holds the first product and a second retaining section holds the second product, and wherein the first retaining section and the second retaining section, in the first state, are separated from one another by means of a separating member which is adapted and arranged to prevent fluid communication between the first retaining section and the second retaining section, the separating member being moveable with respect to the container when switching the device from the first state into the second state.

3. The drug delivery device according to claim 2, wherein the container comprises a bypass adapted and arranged to enable fluid communication between the first retaining section and the second retaining section, wherein the bypass is opened when the separating member is moved with respect to the container when the device is switched from the first state into the second state.

4. The drug delivery device according to claim 3, wherein a bung is moveably retained within the container, and wherein, in the first state, one end of the first retaining section is formed by the bung and the other end is formed by the separating member, and wherein, for switching the device from the first state into the second state, the device is configured to transfer a movement of the bung to the separating member to open the bypass, wherein, when the bypass is opened, the bung is configured to force the first product out of the first retaining section, the bung being displaceable with respect to the separating member until the bung abuts the separating member.

5. The drug delivery device according to claim 1, wherein the container comprises an inner surface, the inner surface comprising a profile being rotationally asymmetrical.

6. The drug delivery device according to claim 1, wherein the device comprises a housing, and wherein the measuring unit is configured to determine a position of the separating member with respect to the housing.

7. The drug delivery device according to claim 1, wherein the device comprises a control unit, the control unit being configured to:

store a predetermined range of values of a parameter of the drug mixture,

compare the determined value of the parameter of the drug mixture with the stored range of values,

control the state of the device dependent on the result of the comparison of the determined value with the predetermined range of values.

8. The drug delivery device according to claim 7, wherein the at least one sensor comprises a plurality of sensors disposed at different positions along the container, the sensors comprising optical sensors.

9. The drug delivery device according to claim 7, wherein, when the device is in the second state, the control unit is configured to determine whether the drug mixture fulfills a requirement for being dispensed from the device, wherein, when the value of the parameter determined by the measuring unit lies within the predetermined range, the control unit is configured to cause the device to be in a ready-to-dispense mode, and wherein, when the value is out of the predetermined range, the control unit is configured to cause the device to be switched into a hold mode.

10. The drug delivery device according to claim 9, wherein, when the value is out of the predetermined range, the control unit is configured to cause the mixing member to exert force onto the container such that the container holding the drug mixture is moved with respect to the housing for mixing the drug mixture until the value is again in the predetermined range before the device is switched from the hold mode into the ready-to-dispense mode.

11. The drug delivery device according to claim 9, wherein the device comprises a user interface adapted and arranged to indicate to a user whether the device is in the ready-to-dispense mode or in the hold mode, wherein the user interface is controlled by the control unit.

12. The drug delivery device according to claim 1, wherein the device comprises a timer, the timer being configured to at least one of or both of:

cause the mixing member to move the container for mixing the drug mixture after a predetermined period of time when the device is in the second state,

cause the mixing member to move the container for mixing the drug mixture for a predetermined period of time when the device is in the second state.

13. The drug delivery device according to claim 2, wherein, when the device is in the second state, the measuring unit is configured to determine whether the device has to be primed or not and, wherein, when the device has to be primed, a volume of the second retaining section is greater than the volume of the drug mixture.

14. The drug delivery device according to claim 1, wherein the first product is a fluid product and the second product is a fluid product or a solid product, and wherein the drug mixture comprises an emulsion, a solution or a suspension.

15. A method for maintaining a predetermined property of a drug mixture to be dispensed from a drug delivery device, the drug delivery device comprising a measuring unit comprising at least one sensor, wherein the measuring unit is configured to determine a value of a parameter of the drug mixture, the method comprising the following steps:

providing a container for the drug delivery device, the container being configured to hold the drug mixture,

sensing the parameter with the at least one sensor, where the parameter detected is the opacity, cloudiness, or light scattering, reflection or transmission of the drug mixture that exists after first mixing a first product and a second product to form the drug mixture,

based on collected information from the at least one sensor, determining a value of a parameter of the drug mixture, wherein the parameter is indicative for a mixing property of the drug mixture,

determining whether said value lies within a predetermined range of values, and

exerting force onto the container to move the container and the drug mixture if the value is out of the predetermined range of values.