Granted Patent B2

US 12,514,983 · App. 18/514,784 · Granted Jan 6, 2026

Inventors: Steen Jensen (Dragør, DK); Henrik Egesborg (Hellerup, DK); Bjørn Knud Andersen (Struer, DK); Martin Nørgaard Larsen (Viborg, DK); Johnny Elkjær (Struer, DK)

Assignee: Ascendis Pharma A/S

A61M5/2448A61M5/20A61M5/3146A61M5/44A61M2205/50A61M2205/581A61M2205/583A61M2205/6063

Abstract

Claims (44)

1 . An auto injector for administering a medicament, the auto injector comprising:

a housing;

a cartridge receiver configured to receive a cartridge assembly comprising a cartridge and a cartridge code feature, the cartridge comprising a first stopper and a cartridge compartment containing the medicament, the cartridge compartment having a first cartridge subcompartment containing a first medicament component of the medicament and a second cartridge subcompartment containing a second medicament component of the medicament, wherein the cartridge code feature is indicative of an amount of movement energy needed for optimal mixing of the first medicament component and the second medicament component;

a code sensor configured to read the cartridge code feature;

an orientation sensor configured to detect an orientation of the cartridge or an orientation of the auto injector or both;

a drive module coupled to move a plunger rod between a retracted plunger rod position and an extended plunger rod position, the plunger rod being configured to move the first stopper;

a processing unit coupled to the drive module, the orientation sensor and the code sensor, wherein the processing unit is configured to:

control the drive module to move the plunger rod from a first plunger rod position to a mix plunger rod position with a mix plunger rod speed, wherein the mix plunger rod position is selected to position the first stopper in a position wherein the first medicament component is mixed with the second medicament component;

receive an orientation signal;

receive from the code sensor a code signal indicative of the cartridge code feature;

determine a first movement parameter, wherein the first movement parameter is indicative of a frequency of movement of the auto injector; wherein the first movement parameter is based on a cumulative measure of the orientation signal over time; and

control the drive module to move the plunger rod from the mixed plunger rod position to a second plunger rod position when receiving an onset signal, wherein the onset signal is indicative that the first medicament component and the second medicament component has been reconstituted.

2 . The auto injector according to claim 1 , wherein the first movement parameter is based on a cumulative measure of the orientation signal since completion of movement of the plunger rod to the mix plunger rod position.

3 . The auto injector according to claim 1 , wherein the first movement parameter is indicative of the auto injector being shaken.

4 . The auto injector according to claim 1 , wherein the first movement parameter is indicative of a number of inversions of the auto injector or completed inversions of the auto injector or both.

5 . The auto injector according to claim 1 , wherein the second plunger rod position is selected to position the first stopper in a position wherein air in the cartridge compartment is reduced to an amount appropriate for injection.

6 . The auto injector according to claim 1 , wherein the first plunger rod position is a pre-mix plunger rod position, wherein the pre-mix plunger rod position is selected to position the first stopper in a position wherein fluid communication between the first cartridge subcompartment and the second cartridge subcompartment is not yet established.

7 . The auto injector according to claim 1 , wherein the processing unit is further configured to control the drive module to move the plunger rod to the second plunger rod position only after a reconstitution time has elapsed since completion of movement of the plunger rod to the mix plunger rod position.

8 . The auto injector according to claim 1 , wherein the cartridge code feature comprises one or more of a colour, a sequence of colours, a bar code, an RFID tag, an NFC tag, an identification number, or a QR code.

9 . The auto injector according to claim 1 , wherein the processing unit is further configured to control the drive module to move the plunger rod to the second plunger rod position only after a reconstitution time has elapsed since completion of movement of the plunger rod to the mix plunger rod position, and wherein the processing unit is further configured to determine the reconstitution time based on the code signal.

10 . The auto injector according to claim 1 , wherein the cartridge receiver is configured to receive a cartridge assembly comprising the cartridge and a cartridge code feature, and the auto injector comprises a cartridge sensor configured to detect reception of the cartridge in the cartridge receiver and wherein the processing unit is coupled to the cartridge sensor and is further configured to receive from the cartridge sensor a cartridge sensor signal indicative of whether the cartridge is received in the cartridge receiver.

11 . The auto injector according to claim 10 , wherein the cartridge receiver is configured to receive a cartridge assembly comprising the cartridge and a cartridge code feature, and wherein the auto injector comprises a code sensor configured to read the cartridge code feature, and wherein the processing unit is coupled to the code sensor and is further configured to receive from the code sensor a code signal indicative of the cartridge code feature, and further wherein the code sensor and the cartridge sensor are the same sensor.

12 . The auto injector according to claim 1 , wherein the processing unit is further configured to provide feedback when a predefined amount of energy has been applied to the auto injector or the cartridge or both.

13 . The auto injector according to claim 1 , wherein the drive module is an electro-mechanical motor and wherein the drive module is connected to a battery for receiving electrical power.

14 . The auto injector according to claim 1 , wherein the drive module comprises an arrangement of springs configured to actuate the plunger rod.

15 . The auto injector according to claim 1 , wherein the drive module comprises a pressurized gas configured to actuate the plunger rod.

16 . The auto injector according to claim 1 , wherein the processing unit is further configured to receive a trigger event and control the drive module to move the plunger rod to an injection plunger rod position following reception of the trigger event.

17 . A system comprising the auto injector for administering the medicament according to claim 1 and a cartridge, wherein the cartridge comprising a first stopper and a cartridge compartment containing the medicament, the cartridge compartment having a first cartridge subcompartment containing a first medicament component of the medicament and a second cartridge subcompartment containing a second medicament component of the medicament.

18 . The system according to claim 17 , wherein the first medicament component comprises a fluid composition and the second medicament component comprises a powder composition.

19 . A method for controlling an auto injector according to claim 1 , the method comprising:

moving a plunger rod from a first plunger rod position to a mix plunger rod position with a mix plunger rod speed, wherein the mix plunger rod position is selected to position the first stopper in a position wherein the first medicament component is mixed with the second medicament component;

receiving an orientation signal;

determining a first movement parameter, wherein the first movement parameter is indicative of a frequency of movement of the auto injector, wherein the first movement parameter is based on a cumulative measure of the orientation signal over time; and

moving the plunger rod from the mixed plunger rod position to a second plunger rod position when receiving an onset signal, wherein the onset signal is indicative that the first medicament component and the second medicament component has been reconstituted.

20 . An auto injector for administering a medicament, the auto injector comprising:

a housing;

a cartridge receiver configured to receive a cartridge comprising a first stopper and a cartridge compartment containing the medicament, the cartridge compartment having a first cartridge subcompartment containing a first medicament component of the medicament and a second cartridge subcompartment containing a second medicament component of the medicament;

an orientation sensor configured to detect an orientation of the cartridge or an orientation of the auto injector or both;

a drive module coupled to move a plunger rod between a retracted plunger rod position and an extended plunger rod position, the plunger rod being configured to move the first stopper;

a processing unit coupled to the drive module and the orientation sensor, wherein the processing unit is configured to:

control the drive module to move the plunger rod from a first plunger rod position to a mix plunger rod position with a mix plunger rod speed, wherein the mix plunger rod position is selected to position the first stopper in a position wherein the first medicament component is mixed with the second medicament component;

receive an orientation signal;

determine a first movement parameter; wherein the first movement parameter is based on a cumulative measure of the orientation signal over time, and wherein the first movement parameter is indicative of a number of inversions of the auto injector, completed inversions of the auto injector, the auto injector being shaken, or a combination thereof; and

control the drive module to move the plunger rod from the mixed plunger rod position to a second plunger rod position when receiving an onset signal, wherein the onset signal is indicative that the first medicament component and the second medicament component has been reconstituted.

Assignments (1)

Priority Claims (2)

Continuity (2)

References Cited (215)