System and Methods for Medicament Infusion

• US 20120245515A1
• Filed: 12/24/2009
• Published: 09/27/2012
• Est. Priority Date: 12/24/2008
• Status: Active Grant

• Current Assignee: Nuova OMPI srl Unipersonale
• Original Assignee: Medirio S.A.
• Inventors: Calasso, Irio Giuseppe, Calasso, Luca
• Granted Patent: US 10,188,788 B2
• Time in Patent Office: Days
• US Class Current: 604/67
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2205/8237 Charging means
• CPC Class Codes: A61M 2205/8287 operated by an external magnetic or electromagnetic field
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/168 Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body flow control in general G05D7/00
• 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 5/50 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile retractable needles or needle protectors with means for preventing re-use A61M5/321

Abstract

System for trans-dermal delivery of doses of a medicament, comprising a delivery device to be placed in dermal contact with a patient, the delivery device comprising a reservoir for holding a medicament to be delivered, a trans-dermal injection element for delivering doses of the medicament to the patient, a control unit for controlling the delivery of the medicament when activated, the system further comprising a separate hand-held drive device to be temporarily placed in proximity of the delivery device when a dose of medicament is required, the drive device comprising an activation unit for activating the control unit of the delivery device.

Claims

1. System for trans-dermal delivery of doses of a medicament, comprising

a) a delivery device to be placed in dermal contact with a patient, the delivery device comprising

a reservoir for holding a medicament to be delivered,

a trans-dermal injection element for delivering doses of the medicament to the patient,

a control unit to control the way an energy external to the delivery device is transformed into pumping force and to guarantee that the correct dose of medicament is pumped and only when a dose is requested, the control unit comprising

one or more rotors and/or one or more axial pump elements for transforming rotational and/or axial force into pumping force, and

at least one safe-lock mechanism preventing any one or more of the rotors to rotate and/or axial pump elements to move or otherwise preventing the passage of medicament from the reservoir to the trans-dermal injection device until a dose is to be delivered,

b) a separate hand-held drive device to be temporarily placed in proximity of the delivery device only when a dose of medicament is required, the drive device comprising an activation unit for activating the control unit of the delivery device, the activation unit comprising at least one unlocking element to provide energy for unlocking the at least one safe-lock mechanism and a drive unit to provide energy for any one or more of the rotors and/or axial pump elements of the control unit.

2. The system according to claim 1 wherein the unlocking element unlocks the safe-lock mechanism in a specific manner as a key.

3. The system according to claim 1 or 2 wherein the unlocking element and the drive unit cooperate synergistically to activate the control unit in a specific manner as a key.

4. The system according to claim 2 or 3 wherein the key is a magnetic key.

5. The system according to any of the preceding claims wherein the delivery device comprises a pump for pumping the medicament from the reservoir to the trans-dermal injection element.

6. The system according to any of the preceding claims wherein the delivery device comprises a base rotor for holding the reservoir.

7. The system according to any of the preceding claims wherein the control unit comprises at least one primary rotor transferring rotational force to the pump rotor.

8. The system according to claim 7 wherein the primary rotor and the pump rotor have the same axis of rotation.

9. The system according to claim 7 or 8 wherein the control unit comprises at least one secondary rotor transferring rotational force to the at least one primary rotor.

10. The system according to claim 9 wherein the secondary rotor and the primary rotor have the same axis of rotation.

11. The system according to any of the claims 7 to 10 wherein the control unit comprises a spring located between the pump rotor and the primary rotor or between the primary rotor and the secondary rotor wherein the spring can be loaded when the drive unit is placed in proximity of the delivery device and transfer rotational force to the pump rotor while the drive device is being removed.

12. The system according to claim 11 wherein the spring is a mainspring.

13. The system according to any of the preceding claims wherein the axial pump element moves in alternate direction along an axis.

14. The system according to claim 13 wherein the axial pump element is a membrane.

15. The system according to any of the preceding claims wherein one or more axial elements are connected to one or more of the rotors selected from the group of base rotor, pump rotor, primary rotor, secondary rotor, so that rotational force is transformed into axial force or vice versa.

16. The system according to any of the preceding claims wherein the reservoir for holding the medicament to be delivered is a syringe type reservoir comprising a first end and at least one opening in correspondence of said first end for pumping medicament to the trans-dermal injection element and/or for introducing the medicament in the syringe, a second open end, and walls between said first end and said second end into which a first axial pump element fits in a fluid tight manner.

17. The system according to claim 16 wherein the control unit comprises a second axial pump element aligned with said syringe in correspondence of said second open end wherein the first axial pump element is adapted to move towards said second axial pump element when the medicament is being introduced into the syringe.

18. The system according to claim 17 wherein the second axial pump element transfers axial force to the first axial pump element after the second axial pump element has come into contact or has engaged with the first axial pump element.

19. The system according to claim 17 wherein the second axial pump element is a wire attached to the first axial pump element for pulling the first axial pump element towards the first end of the syringe when a dose of medicament is to be delivered.

20. The system according to any of the preceding claims wherein the control unit comprises a stabilization element for minimizing the moment of tilt of any one or more of the rotors selected from the group of base rotor, pump rotor, primary rotor, secondary rotor, or of the axial pump element.

21. The system according to any of the preceding claims wherein the control unit comprises at least one directional element, allowing any one or more of the rotors selected from the group of base rotor, pump rotor, primary rotor, secondary rotor, to rotate in a preferred direction, and/or one or more axial pump elements to move in a preferred direction.

22. The system according to any of the preceding claims wherein any one or more of the elements selected from the group of base rotor, pump rotor, primary rotor, secondary rotor, axial pump element, comprises at least one magnet or a ferromagnetic element.

23. The system according to any of the preceding claims wherein the at least one safe-lock mechanism comprises a ferromagnetic element or at least one magnet or a combination of different magnets arranged to form a specific magnetic configuration, so that only a specific corresponding magnetic field can be used to unlock the safe-lock mechanism.

24. The system according to any of the preceding claims wherein the safe-lock mechanism comprises a coil and the unlocking element provides a specific magnetic field inducing a specific current in the coil when the drive device is placed in proximity of the delivery device which provides electrical power for unlocking the safe-lock mechanism for a specific period of time.

25. The system according to any of the preceding claims wherein the unlocking element comprises at least one magnet.

26. The system according to any of the preceding claims wherein the drive unit provides rotational force and/or axial force to any one or more elements selected from the group of a base rotor, a pump rotor, a primary rotor, a secondary rotor, an axial pump element when the hand-held drive device is placed in proximity of the delivery device.

27. The system according to any of the preceding claims wherein the drive unit comprises electromagnets or a drive rotor or a drive element connected to a motor, the drive rotor or element comprising at least one magnet.

28. The system according to any of the preceding claims wherein the separate hand-held drive device in correspondence of the activation unit is shaped as to form a complementary cavity into which at least a part of the delivery device comprising the control unit substantially fits.

29. The system according to any of the preceding claims wherein the hand held unit comprises a sensor, capable of detecting the amount of energy being transferred and/or transformed into pumping force and/or medicament delivery and/or that an atypical situation has been encountered.

30. The system according to claim 29 wherein the sensor is a hall sensor.

31. The system according to any of the preceding claims wherein the hand-held device comprises alert or warning lights and audio or vibration signals and alarms to inform the user that the dose has been delivered and the hand-held device can be removed, or that an atypical situation has been encountered.

32. The system according to any of the preceding claims wherein the delivery unit comprises an RFID chip for being identified by the hand-held drive device.

33. The system according to claim 32 wherein the RFID chip is adapted to send a feedback signal by being contacted directly or indirectly by a moving axial pump element.

34. The system according to any of the preceding claims wherein the delivery device comprises a capacitor or accumulator for receiving and/or accumulating energy from the drive unit when the drive unit is placed in proximity of the delivery device.

35. Safe-lock mechanism for preventing medicament being delivered from a delivery device wherein the safe-lock mechanism is adapted to lock one or more rotors and/or axial pump elements and to be unlocked specifically by an unlocking element comprised in a hand-held device to be temporarily placed in proximity of the delivery device, the safe-lock mechanism comprising a coil or at least one magnet or a combination of different magnets arranged to form a specific magnetic configuration and the unlocking element inducing a specific current in the coil or providing a specific magnetic field to be used to unlock the safe-lock mechanism.