System and methods for medicament infusion

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.

The invention claimed is: 
     
       1. A drug delivery system for trans-dermal delivery of a dose of a medicament, comprising: 
 a delivery device; and 
 a separate hand-held drive device, wherein 
 the delivery device is configured to be placed in dermal contact with a patient, the delivery device comprising comprises: 
 a reservoir for holding the a medicament to be delivered, and;  
 a trans-dermal injection element for delivering the dose of the medicament to the patient, 
 a control unit for controlling the transformation of external energy transferred from the hand-held drive device to the delivery device into a pumping force and for allowing a specific dose of the medicament to be pumped when the dose is requested, the control unit comprising: 
 one or more rotors and/or one or morea rotor or an axial pump elements for transforming rotational and/or axial force into the pumping force,element; and 
 at least onea safe-lock mechanismmeans for preventing mechanical action to cause rotation of the at least one or more rotors and/or rotor or movement of the one or more axial pump elements element, thereby preventing passage delivery of the medicamentfrom the reservoir to the trans-dermal injection element unless a dose is requested; and  
 
 
 wherein the separate hand-held drive device being is configured to be placed temporarily in proximity to the delivery device when a dose of medicament is required, the hand-held separate 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 configured to (i) provide energy to the control unit of the delivery device for unlocking the at least one safe-lock mechanism means and a drive unit to (ii) provide energy for any of the one or more rotors and/or one or more the rotor or the axial pump elements element of the control unit only when the separate hand-held drive device is in proximity to the delivery device,; and wherein the hand-held drive device comprises a sensor capable of detecting the amount of energy being transferred and/or or transformed into pumping force. 
 
 
     
     
       2. The system of  claim 1 , wherein the at least one activation unit comprises an unlocking element and the a drive unit, which cooperate synergistically to activate the control unitin a specific manner as a key. 
     
     
       3. The system of  claim 1 , further comprising a magnetic key. 
     
     
       4. The system of  claim 1 , wherein the delivery device comprises a pump for pumping the medicament from the reservoirto the trans-dermal injection element. 
     
     
       5. The system of  claim 1 , wherein: 
 the delivery device comprises a base rotorfor holding; and  
 the reservoir is disposed on the base rotor. 
 
     
     
       6. The system of  claim 1 , wherein the one or more rotors rotor comprises at least one a primary rotor to transfer rotational force to a pump rotor. 
     
     
       7. The system of  claim 6 , wherein the at least one primary rotor and the pump rotor have the same axis of rotation. 
     
     
       8. The system of  claim 6 , wherein the one or more rotors rotor comprises at least one a secondary rotor to transfer rotational force to the at least one primary rotor. 
     
     
       9. The system of  claim 8 , wherein the at least one secondary rotor and the at least one primary rotor have the same axis of rotation. 
     
     
       10. The system of claim  6  8, wherein the control unit comprises a spring located between the pump rotor and the at least one primary rotor or between the at least one primary rotor and the at least one secondary rotor wherein the spring is loaded when the a drive unit is placed in proximity of the delivery device and is configured to transfer rotational force to the pump rotor while the drive device is being removed. 
     
     
       11. The system of  claim 10 , wherein the spring is a mainspring. 
     
     
       12. The system of  claim 1 , wherein the one or more axial pump elements the axial pump element comprises a first axial pump element that moves in an alternate direction along an axis with respect to movement of the one or more a second axial pump elements element. 
     
     
       13. The system of claim  12  1, wherein:
 the control unit comprises the axial pump element; and  
 the one or more axial pump elements is element comprises a membrane. 
 
     
     
       14. The system of  claim 1 , wherein:
 the control unit comprises the axial pump element and the rotor; and  
 the one or more axial pump elements are element is connected to the one or more rotors rotor, wherein the rotor comprises a rotor selected from the group consisting of: a base rotor, a pump rotor, a primary rotor, and a secondary rotor, so that rotational force is transformed into axial force or vice versa. 
 
     
     
       15. The system of  claim 1 , wherein: 
 the reservoir for holding the medicament to be delivered is a syringe-type reservoir comprising a first end and at least one an opening in correspondence of said first end for pumping medicament to the a trans-dermal injection element and/or or for introducing the medicament in the syringe-type reservoir, a second open end, and walls between said the first end and said the second end; 
 the control unit comprises the axial pump element; and 
 the axial pump element comprises a first axial pump element configured to fit into which the one or more axial pump elements comprises a first axial pump element which fits the second open end of the syringe type reservoir in a fluid-tight manner. 
 
     
     
       16. The system of  claim 15 , wherein the control unit axial pump element comprises a second axial pump element aligned with the syringe-type reservoir in correspondence of said the second open end, wherein the first axial pump element is adapted to move towards said the second axial pump element when the medicament is being introduced into the syringe-type reservoir. 
     
     
       17. The system of  claim 16 , wherein the second axial pump element transfers axial force to the first axial pump element after in response to the second axial pump element has come into contact contacting or has engaged engaging with the first axial pump element. 
     
     
       18. The system of  claim 16 , wherein the second axial pump element is attached to the first axial pump element for pulling and is configured to pull the first axial pump element towards the first end of the syringe-type reservoir when a dose of medicament is to be delivered. 
     
     
       19. The system of  claim 1 , wherein the control unit comprises a stabilization element for minimizing the moment of tilt of any of the one or more rotors the rotor which are selected from the group consisting of: a base rotor, a pump rotor, a primary rotor, and a secondary rotor, or of the one or more axial pump elements or of the axial pump element. 
     
     
       20. The system of  claim 1 , wherein the control unit comprises at least one directional element, allowing any of the one or more rotors selected from the group consisting of: a base rotor, a pump rotor, a primary rotor, and a secondary rotor, the rotor to rotate in a preferred direction , and/or or the one or more axial pump elements element to move in a preferred direction. 
     
     
       21. The system of  claim 1 , wherein any of the one or more rotors the rotor comprises at least one a magnet or a ferromagnetic element material. 
     
     
       22. The system of  claim 1 , wherein the at least one safe-lock mechanism means comprises a ferromagnetic element or at least one material or a magnet or a combination of different magnets configured so that only a specific corresponding magnetic field can be used to unlock the at least one safe-lock mechanism means. 
     
     
       23. The system of claim  1  2, wherein the at least one safe-lock mechanism means comprises a coil and the at least one 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 devicewhich provides electrical power for unlocking the at least one safe-lock mechanism for a specific period of time. 
     
     
       24. The system of  claim 1 , wherein the at least one unlocking element comprises at least one magnet. 
     
     
       25. The system of claim  1  2, wherein the drive unit provides rotational force and/or or axial force to the one or more rotors and/or one or more rotor or the axial pump elements element when the hand-held drive device is placed in proximity to the delivery device. 
     
     
       26. The system of claim  1  2, wherein the drive unit comprises electromagnets or a drive rotor or a drive element connected to a motor, the drive rotor or the drive element comprising at least one magnet. 
     
     
       27. The system of  claim 1 , wherein the separate hand-held drive device is shaped as to form defines a complementary cavity into which at least a part portion of the delivery device comprising the control unit substantially fits. 
     
     
       28. The system of  claim 1 , wherein the sensor is a Hall sensor. 
     
     
       29. The system of  claim 1 , wherein the hand-held drive device comprises at least one element to inform the user that the a dose has been delivered and that the hand-held drive device can be removed, or that an atypical situation has been encountered, the at least one element being selected from the group consisting of: a warning light, audio, a vibration signal, an alarm, and any combination thereof. 
     
     
       30. The system of  claim 1 , wherein the delivery unit device comprises an RFID chip for being that is configured to be identified by the hand-held drive device. 
     
     
       31. The system of  claim 30 , wherein the RFID chip is adapted to send a feedback signal by being contacted in response to being directly or indirectly contacted by moving the one or more axial pump elements element. 
     
     
       32. The system of claim  1  2, wherein the delivery device comprises a capacitor or an accumulator for receiving and/or or accumulating energy from the drive unit when the drive unit is placed in proximity of the delivery device. 
     
     
       33. The system of claim 1, wherein the drive device is a hand-held drive device.  
     
     
       34. The system of claim 1, wherein the safe-lock means comprises at least one of a rod, a finger, one or more teeth, a spring, a ferromagnetic element, a magnet, a coil, a pivotable arm, or a clamp.  
     
     
       35. The system of claim 19, wherein the stabilization element comprises at least one of a rotor, a carved compartment, a chamber, a cavity, a groove, or a pin.