Granted Patent B2

US 12,290,663 · App. 18/112,265 · Granted May 6, 2025

Inventors: Paul Erik Fabricius (Holstebro, DK); Jan Olesen (Holstebro, DK); Steen Jensen (Dragør, DK); Henrik Egesborg (Hellerup, DK); Per Mølgaard Pedersen (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 (62)

1. An auto injector for preparing or administering a medicament from a cartridge having a first cartridge end and a second cartridge end and having a cartridge outlet at the first cartridge end, the cartridge comprising a cartridge compartment with 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, the auto injector comprising:

a housing;

a cartridge receiver with a cartridge receiver opening, the cartridge receiver being configured to receive the cartridge by insertion of the second end of the cartridge through the cartridge receiver opening;

a code sensor configured to detect reception of the cartridge in the cartridge receiver and provide a cartridge detection signal indicative of the cartridge being received in the cartridge receiver, read a cartridge code feature and provide a code signal indicative of the cartridge code feature;

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 a first stopper;

an orientation sensor configured to provide an orientation signal indicative of the orientation of the cartridge when received in the cartridge receiver; and

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

the processing unit being configured to:

receive a first input signal;

receive the cartridge detection signal;

receive the code signal;

receive the orientation signal;

control the drive module to move the plunger rod to a mix plunger rod position following reception of the cartridge detection signal and the first input signal; and

control the drive module to move the plunger rod to a prime plunger rod position following completion of movement of the plunger rod to the mix plunger rod position, wherein movement of the plunger rod to the mix plunger rod position and/or the prime plunger rod position and/or an injection plunger rod position is based on the code signal.

2. 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 after completion of movement of the plunger rod to the prime plunger rod position.

3. The auto injector according to claim 1 , wherein the orientation sensor comprises an accelerometer.

4. The auto injector according to claim 1 , wherein the processing unit is configured to determine an unauthorized cartridge based on the code signal.

5. The auto injector according to claim 1 , wherein movement of the plunger rod to the prime plunger rod position has a prime plunger rod speed, and wherein the prime plunger rod speed is based on the code signal.

6. The auto injector according to claim 1 , wherein movement of the plunger rod to the mix plunger rod position has a mix plunger rod speed, and wherein the mix plunger rod speed is based on the code signal.

7. The auto injector according to claim 1 , wherein movement of the plunger rod to the injection plunger rod position has an injection plunger rod speed, and wherein the injection plunger rod speed is based on the code signal.

8. The auto injector according to claim 1 , comprising a resistance sensor configured to provide a resistance signal indicative of resistance against movement of the plunger rod, the processing unit being coupled to the resistance sensor and being configured to receive the resistance signal.

9. The auto injector according to claim 8 , wherein the processing unit is configured to determine an unauthorized cartridge based on the resistance signal.

10. The auto injector according to claim 8 , wherein the processing unit is configured to determine a cartridge parameter based on the resistance signal.

11. The auto injector according to claim 8 , wherein control of the drive module to move the plunger rod to the mix plunger rod position is based on the resistance signal.

12. The auto injector according to claim 8 , wherein the processing unit is configured to control the drive module to move the plunger rod to the mix plunger rod position only if the resistance signal indicates resistance against movement of the plunger rod above a low resistance threshold.

13. The auto injector according to claim 1 , comprising a first input device configured to provide the first input signal, the first input signal being indicative of a first user interaction with the first input device, the processing unit being coupled to the first input device.

14. The auto injector according to claim 1 , comprising a contact member movable between an extended contact member position and a retracted contact member position, the contact member being biased towards the extended contact member position, and the contact member being configured to be moved towards the retracted contact member position when pressed against the injection site, the contact member also being configured to provide a contact member signal indicative of position of the contact member, and wherein the processing unit is coupled to the contact member and is configured to receive the contact member signal.

15. The auto injector according to claim 14 ,

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 after completion of movement of the plunger rod to the prime plunger rod position,

wherein the trigger event comprises the contact member signal being indicative of the contact member being in a first contact member position.

16. The auto injector according to claim 14 , wherein the contact member is configured to be in a second contact member position if a needle cover is present on the cartridge, and the processing unit is configured to control the drive module to move the plunger rod to the mix plunger rod position based on the contact member signal.

17. The auto injector according to claim 1 , wherein control of the drive module to move the plunger rod to the prime plunger rod position is based on the orientation signal.

18. The auto injector according to claim 17 , wherein the processing unit is configured to control the drive module to move the plunger rod to the prime plunger rod position only if the orientation signal indicates that a tilt angle between vertical and a longitudinal axis extending along the cartridge is within 45 degrees of vertical and the cartridge outlet is in a vertical position above the cartridge compartment.

19. The auto injector according to claim 1 , wherein the processing unit is configured to control the drive module to move the plunger rod to a pre-mix plunger rod position following reception of the cartridge detection signal and the first input signal, wherein movement of the plunger rod to the pre-mix plunger rod position has a pre-mix plunger rod speed, and movement of the plunger rod to the mix plunger rod position has a mix plunger rod speed, wherein the pre-mix plunger rod speed is faster than the mix plunger rod speed.

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

21. The auto injector according to claim 20 , wherein the reconstitution time is based on the code signal.

22. The auto injector according to claim 1 , wherein the processing unit is configured to control the drive module to move the plunger rod towards the retracted plunger rod position following completion of the movement of the plunger rod to the injection plunger rod position.

23. The auto injector according to claim 1 , wherein the processing unit is configured to control the drive module to move the plunger rod towards the retracted position only after a dwell time has elapsed since completion of the movement of the plunger rod to the injection plunger rod position.

24. The auto injector according to claim 1 , wherein the processing unit is configured to provide a user output via a user interface after a dwell time has elapsed since completion of the movement of the plunger rod to the injection plunger rod position.

25. The auto injector according to claim 1 , wherein control of the drive module to move the plunger rod to the mix plunger rod position is based on the orientation signal.

26. The auto injector according to claim 25 , wherein the processing unit is configured to control the drive module to move the plunger rod to the mix plunger rod position only if the orientation signal indicates that a tilt angle between vertical and a longitudinal axis extending along the cartridge is within 45 degrees of vertical and the cartridge outlet is in a vertical position above the cartridge compartment.

27. The auto injector according to claim 1 , wherein movement of the plunger rod to the mix plunger rod position locks the cartridge in the cartridge receiver.

28. The auto injector according to claim 1 , wherein movement of the plunger rod to the retracted plunger rod position unlocks the cartridge in the cartridge receiver.

29. The auto injector according to claim 1 , wherein the medicament is a human growth hormone.

30. A cartridge for an auto injector comprising a first cartridge end and a second cartridge end and having a cartridge outlet at the first cartridge end, the cartridge comprising a cartridge compartment with 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, the cartridge being configured to be received by a cartridge receiver of an auto injector according to claim 1 by insertion of the second cartridge end of the cartridge through the cartridge receiver opening of the auto injector.

31. A system comprising an auto injector according to claim 1 , and a cartridge, the cartridge comprising a first cartridge end and a second cartridge end and having a cartridge outlet at the first cartridge end, the cartridge comprising a cartridge compartment with 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, the cartridge being configured to be received by the cartridge receiver of the auto injector.

32. A method for operating an auto injector comprising a plunger rod and a cartridge receiver configured to receive a cartridge, the cartridge having a first cartridge end and a second cartridge end and having a cartridge outlet at the first cartridge end, the cartridge comprising a cartridge compartment with 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, the method comprising:

receiving a first input signal;

detecting reception of the cartridge in the cartridge receiver;

reading the cartridge code feature;

determining orientation of the cartridge;

moving the plunger rod to a mix plunger rod position following detection of the cartridge being received in the cartridge receiver and reception of the first input signal; and

moving the plunger rod to a prime plunger rod position following completion of movement of the plunger rod to the mix plunger rod position, wherein movement of the plunger rod to the mix plunger rod position and/or the prime plunger rod position is based on the code signal.

33. The method according to claim 32 , further comprising:

receiving a trigger event; and

moving the plunger rod to an injection plunger rod position following reception of the trigger event after completion of movement of the plunger rod to the prime plunger rod position.

34. The method according to claim 32 , wherein moving the plunger rod to the mix plunger rod position is based on the orientation of the cartridge.

35. The method according to claim 32 , wherein moving the plunger rod to the prime plunger rod position is based on the orientation of the cartridge.

Assignments (3)

Priority Claims (2)

Continuity (2)

References Cited (229)