DRIVE CONTROL MECHANISMS AND AUTOMATIC INJECTORS FOR INJECTABLE CARTRIDGES

• US 20140012229A1
• Filed: 07/03/2013
• Published: 01/09/2014
• Est. Priority Date: 07/05/2012
• Status: Active Grant

• Current Assignee: UNL Holdings, LLC
• Original Assignee: Unitract Syringe Pty Limited (Unilife Corp.)
• Inventors: Bokelman, Kevin, Wohlhieter, George M., McGee, Thomas F., Marlin, Arthur G., Hurowitz, Stefanie A., Jansen, David R., Ni Chathail, Ellen
• Granted Patent: US 8,920,374 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/2414 from the side
• CPC Class Codes: A61M 2005/31588 electrically driven
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• 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 5/31513 Piston constructions to improve sealing or sliding
• CPC Class Codes: A61M 5/31515 Connection of piston with piston rod
• CPC Class Codes: A61M 5/31581 performed by rotationally moving or pivoting actuator operated by user, e.g. an injection lever or handle
• 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

Abstract

An automatic injector includes a housing having a guide, a drive control mechanism, a transmission assembly, a motor, and an energy source. The housing may further include a cartridge cover. A drive control mechanism includes a drive screw, a cartridge carrier, a plunger carrier, and one or more control transfer instruments, such as a puck or cylinder. The drive screw interfaces and connects with the plunger carrier. The automatic injector is configured to accept a variety of syringes as cartridges for drug delivery. The cartridges may be ejected from the injector and safely disposed after use, making the injector a reusable automatic injector. The reusable automatic injector may further include one or more sensors, such as a cartridge sensor and a patient sensor. The novel incorporation of the drive control mechanisms into the automatic injectors of the present invention enables a single motor and transmission assembly to drive the function of multiple components, which may include the steps of: preparation and alignment of a cartridge for injection, removal of a safety cap or needle shield, needle injection, drug dose delivery, and syringe and/or needle retraction. Methods of manufacture and methods of use are also disclosed.

Claims

1. An automatic injector adapted to receive a cartridge including a barrel, a needle, and a plunger assembly including a plunger seal, the cartridge defining a longitudinal axis, the injector comprising:

a housing,

a cartridge carrier adapted to receive at least a portion of the cartridge, the cartridge carrier being disposed for movement relative to the housing in a direction parallel to the longitudinal axis of the cartridge,

a plunger carrier disposed for movement relative to the cartridge carrier, the plunger carrier being disposed to confront and impart movement at least a portion of the plunger assembly,

at least one transfer instruments disposed to selectively couple the cartridge carrier to the plunger carrier for movement therewith, and

an elongated drive device coupled to the plunger carrier, the elongated drive device being disposed to provide movement of the plunger carrier in a direction parallel to the longitudinal axis of the cartridge.

2. The automatic injector of claim 1 further including a motor, and a transmission assembly coupling the motor to the elongated drive device.

3. The automatic injector of claim 2 wherein at least one of the plunger carrier and the cartridge carrier includes an opening that selectively receives the at least one transfer instrument to removably couple the cartridge carrier to the plunger carrier.

4. The automatic injector of claim 3 wherein the at least one transfer instrument is disposed within the openings in both the plunger carrier and the cartridge carrier to couple the plunger carrier and the cartridge carrier together.

5. The automatic injector of claim 1 wherein the transfer instrument is disposed for movement between a first position wherein the transfer instrument engages only one of the either the cartridge carrier or the plunger carrier, and a second position wherein the transfer instrument engages both of the cartridge carrier and the plunger carrier to couple the cartridge carrier and the plunger carrier together for contemporaneous movement.

6. The automatic injector of claim 1 wherein the cartridge carrier includes at least one opening, and the plunger carrier includes at least one opening, the cartridge carrier not be being coupled to the plunger carrier when the at least one transfer instrument is disposed in a first position within only one of the cartridge carrier opening and the plunger carrier opening, and the cartridge carrier being coupled to the plunger carrier for movement therewith when the at least one transfer instrument is disposed in a second position within both the cartridge carrier opening and the plunger carrier opening.

7. The automatic injector of claim 6 wherein the cartridge carrier includes an at least one channel, and the plunger carrier includes at least one recess, the housing further including at least one recess the cartridge carrier not be being coupled to the plunger carrier when the at least one transfer instrument is disposed in a first position within the housing recess and the cartridge carrier channel, and the cartridge carrier being coupled to the plunger carrier for movement therewith when the at least one transfer instrument is disposed in a second position within the cartridge carrier channel and the plunger carrier recess.

8. The automatic injector of claim 7 wherein at least one of the recesses has ramped edges and the transfer instrument includes an outer surface that is at least partially rounded, the at least partially rounded outer surface riding along at least a portion of the ramped edges as the transfer instrument moves between the first and second positions.

9. The automatic injector of claim 6 further including a retainer disposed to selectively retain the at least one transfer instrument within at least one of the openings in either the cartridge carrier or the plunger carrier.

10. The automatic injector of claim 2 wherein the elongated drive device includes a rack coupled to plunger carrier, and the transmission assembly includes a pinion gear disposed to engage and impart motion to the rack.

11. The automatic injector of claim 1 wherein the elongated drive device includes a threaded drive screw mounted for rotation by the motor, and the plunger carrier includes a treaded surface disposed to engage the drive screw.

12. The automatic injector of claim 11 further comprising a gear train including at least one gear disposed to transmit rotary motion from the motor to the drive screw.

13. The automatic injector of claim 1 wherein the motor includes an axle, the axle being disposed parallel to the longitudinal axis.

14. The automatic injector of claim 1 further including an energy source coupled to the motor.

15. The automatic injector of claim 1 adapted to receive a cartridge further including a plunger head and a plunger rod coupled to the plunger seal, and the plunger carrier is adapted to contact a plunger head.

16. The automatic injector of claim 1 wherein the plunger carrier includes an elongated rod adapted to contact the plunger seal.

17. The automatic injector of claim 1 wherein the cartridge carrier includes a cartridge connection feature adapted to engage at least a portion of the barrel whereby the cartridge carrier is adapted to impart motion to the barrel.

18. The automatic injector of claim 1 further including a user interface whereby a user may initiate operation of the automatic injector.

19. The automatic injector of claim 1 further including a cartridge cover disposed to selectively cover the cartridge and housing.

20. The automatic injector of claim 1 further including a cartridge ejector.

21. The automatic injector of claim 1 including at least one sensor.

22. The automatic injector of claim 21 wherein the at least one sensor includes a patient sensor.

23. The automatic injector of claim 21 further including a needle stripper.

24. A method of operating an automatic injector to inject a fluid from a cartridge, the method comprising

disposing the cartridge in the automatic injector with at least a portion of a barrel disposed within a cartridge carrier, and a plunger assembly disposed for confrontation with a plunger carrier, a needle end of the cartridge defining a distal end of the automatic injector and the opposite end of the cartridge defining a proximal end of the automatic injector,

coupling the cartridge carrier to the plunger carrier,

utilizing a single drive mechanism to move the plunger carrier and the cartridge carrier to advance the cartridge in an axial direction toward the distal end,

decoupling the cartridge carrier from the plunger carrier,

utilizing the drive mechanism to move the plunger carrier in the axial direction toward the distal end to dispense the fluid, and

retracting the plunger carrier in an axial direction toward the proximal end.

25. The method of claim 24 further including actuating the automatic injector.

26. The method of claim 24 further including covering the cartridge with a cartridge cover.

27. The method of claim 24 further including removably coupling the cartridge carrier to the plunger carrier and utilizing the drive mechanism to move the cartridge carrier and the plunger carrier in the axial the axial direction toward the proximal end following dispensing of the fluid.

28. The method of claim 24 further including utilizing the single drive mechanism to move the removably coupled cartridge carrier and plunger carrier in the axial direction toward the proximal end to disengage a needle shield from the cartridge prior to moving the plunger carrier and cartridge carrier in the axial direction toward the distal end.

29. The method of claim 24 wherein the steps of utilizing a single drive mechanism to move the plunger carrier and to move the plunger carrier and the cartridge carrier include imparting movement to an elongated drive device coupled to the plunger carrier.

30. The method of claim 29 including operating a motor to impart movement to the elongated drive device.

31. The method of claim 24 wherein the coupling step includes moving at least one transfer instrument from a first position wherein the transfer instrument engages only one of the either the cartridge carrier or the plunger carrier, to a second position wherein the transfer instrument engages both of the cartridge carrier and the plunger carrier to couple the cartridge carrier and the plunger carrier together for contemporaneous movement.

32. The method of claim 31 wherein the decoupling step includes moving the at least one transfer instrument from the second position to the first position.

33. The method of claim 24 wherein the coupling step includes moving at least one transfer instrument from a first position wherein the transfer instrument engages an opening in only one of the either the cartridge carrier or the plunger carrier, to a second position wherein the transfer instrument engages openings in both of the cartridge carrier and the plunger carrier to couple the cartridge carrier and the plunger carrier together for contemporaneous movement, and the decoupling step includes moving the at least one transfer instrument from the second position to the first position.

34. The method of claim 24 wherein the coupling step includes moving at least one transfer instrument from a first position wherein the transfer instrument engages an opening in the cartridge carrier and an opening in a housing to a second position wherein the transfer instrument engages the opening in the cartridge carrier and an opening in the plunger carrier to couple the cartridge carrier to the plunger carrier for movement therewith.

35. The method of claim 24 wherein the steps of utilizing a single drive mechanism include imparting movement to a threaded drive screw and drivingly engaging at least portion of the threads of the threaded drive screw with threads of the plunger assembly.

36. The method of claim 24 further including actuating an ejector to eject the cartridge following retraction.

37. The method of claim 30 wherein the step of operating the motor includes coupling an output of the motor to the elongated drive device with at least one gear.

38. The method of claim 24 further including operating a user interface.

39. A method of operating an automatic injector, the method comprising

disposing a first cartridge in a housing of the automatic injector,

actuating the automatic injector to dispense fluid from the first cartridge,

removing the first cartridge from the housing,

disposing a second cartridge in the housing, and

actuating the automatic injector to dispense fluid from the second cartridge.