Granted Patent B2

US 12,296,148 · App. 17/741,314 · Granted May 13, 2025

Inventors: Per Mølgaard Pedersen (Struer, DK); Steen Jensen (Dragør, DK); Henrik Egesborg (Hellerup, DK); Bjørn Knud Andersen (Struer, DK)

Assignee: Ascendis Pharma A/S

A61M5/2066A61M5/20A61M5/24A61M5/31511A61M5/31573A61M5/31576A61M5/326A61M2005/2411A61M2005/31588A61M2005/3267A61M2205/332A61M2205/3368A61M2205/50A61M2205/502A61M2205/6063A61M2205/82A61M2205/8206

Abstract

Claims (50)

1. 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;

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 temperature sensor configured to provide a temperature signal indicative of the temperature of one or more of the auto injector, the cartridge, and the medicament in the cartridge;

an orientation sensor configured to provide an orientation signal indicative of the orientation of the cartridge;

a processing unit coupled to the temperature sensor, the drive module and the orientation sensor;

wherein the processing unit is configured to:

receive the temperature signal;

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;

determine a first movement parameter based on the orientation signal, wherein the first movement parameter is indicative of a number of inversions of the auto injector; and

control the drive module to move the plunger rod from the mix plunger rod position to a second plunger rod position after a reconstitution time has elapsed since completion of movement of the plunger rod to the mix plunger rod position, wherein the reconstitution time is based on a predefined number of inversions, which have been completed; the predefined number of inversions being based on the temperature signal.

2. The auto injector according to claim 1 , wherein the predefined number of inversions are between 1 and 10.

3. The auto injector according to claim 1 , wherein the predefined number of inversions are between 3 and 7.

4. The auto injector according to claim 1 , wherein the predefined number of inversions is 5.

5. The auto injector according to claim 1 , wherein the reconstitution time is based on the temperature signal.

6. The auto injector according to claim 1 , wherein the first plunger rod position or the mix plunger rod position is based on the temperature signal.

7. The auto injector according to claim 1 , wherein the mix plunger rod speed is based on the temperature signal.

8. 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 comprising a code sensor configured to read the cartridge code feature, and wherein the processing unit is coupled to the code sensor and further configured to receive from the code sensor a code signal indicative of the cartridge code feature, and wherein the movement from the first plunger rod position to the mix plunger rod position is based on the code signal.

9. The auto injector according to claim 8 , wherein the reconstitution time is based on the code signal.

10. The auto injector according to claim 8 , wherein the first plunger rod position or the mix plunger rod position is based on the code signal.

11. The auto injector according to claim 8 , wherein the mix plunger rod speed is based on the code signal.

12. The auto injector according to claim 1 , wherein the processing unit is coupled to the orientation sensor and further configured to receive the orientation signal, and wherein the movement from the first plunger rod position to the mix plunger rod position is based on the orientation signal.

13. The auto injector according to claim 12 , wherein the mix plunger rod speed is based on the orientation signal.

14. The auto injector according to claim 1 , wherein the processing unit is further configured to determine a first movement parameter based on cumulative movement of the auto injector.

15. The auto injector according to claim 14 , wherein the reconstitution time is based on the first movement parameter.

16. The auto injector according to claim 14 , wherein the mix plunger rod speed is based on the first movement parameter.

17. The auto injector according to claim 14 , wherein the first movement parameter is indicative of number of inversions of the auto injector.

18. The auto injector according to claim 14 , wherein the first movement parameter is indicative of a frequency of movement of the auto injector.

19. The auto injector according to claim 1 , wherein the temperature sensor comprises an infrared sensor.

20. The auto injector according to claim 1 , further comprising a temperature control unit configured to alter the temperature of the cartridge when received in the cartridge receiver.

21. The auto injector according to claim 20 , wherein the temperature control unit is configured to raise the temperature of the cartridge.

22. The auto injector according to claim 21 , wherein the temperature control unit comprises a resistive heating element.

23. The auto injector according to claim 21 , wherein the temperature control unit comprises a dielectric heating element.

24. The auto injector according to claim 20 , wherein the temperature control unit is configured to lower the temperature of the cartridge.

25. The auto injector according to claim 20 , wherein the temperature control unit comprises a thermoelectric element, such as a Peltier element.

26. The auto injector according to claim 20 , wherein the temperature control unit comprises a contact element configured to be in contact with the cartridge when received in the cartridge receiver.

27. The auto injector according to claim 20 , wherein the temperature control unit comprises a coil element configured to surround an entire perimeter of the cartridge when received in the cartridge receiver.

28. The auto injector according to claim 1 , wherein the first plunger rod position is a pre-mix plunger rod position, and 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.

29. The auto injector according to claim 1 , wherein the second plunger rod position is a prime plunger rod position, and the prime 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.

30. The auto injector according to claim 1 , wherein the processing unit is configured to control the drive module to move the plunger rod to an injection plunger rod position, and the injection plunger rod position is selected to position the first stopper in a position wherein medicament in the cartridge compartment is minimized.

31. The auto injector according to claim 30 , wherein the processing unit is further configured to:

receive a trigger event; and

control the drive module to move the plunger rod to the injection plunger rod position following reception of the trigger event.

32. A method for operating an auto injector comprising 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, a plunger rod configured to move the first stopper, and a temperature sensor, the method comprising:

receiving the temperature signal from the temperature sensor indicative of the temperature of the medicament when the cartridge is received in the cartridge receiver;

moving 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;

determining a first movement parameter based on the orientation signal, wherein the first movement parameter is indicative of a number of inversions of the auto injector;

moving the plunger rod from the mix plunger rod position to a second plunger rod position after a reconstitution time has elapsed since completion of movement of the plunger rod to the mix plunger rod position, wherein the reconstitution time is based on a predefined number of inversions have been completed; the predefined number of inversions are based on the temperature signal indicative of the temperature of the medicament.

33. The method according to claim 32 , wherein the second plunger rod position is a prime plunger rod position, the prime plunger rod position being selected to position the first stopper in a position wherein air in the cartridge compartment is reduced to an amount appropriate for injection.

Assignments (3)

Priority Claims (2)

Continuity (2)

References Cited (222)