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. A .Iadd.drug delivery .Iaddend.system .[.for trans-dermal delivery of a dose of a medicament,.]. comprising.Iadd.: .Iaddend. a delivery device.Iadd.; .Iaddend.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.]. .Iadd.comprises: .Iaddend. a reservoir for holding .[.the.]. .Iadd.a .Iaddend.medicament .[.to be delivered,.]. .Iadd.and; .Iaddend. .[.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.Iadd.: .Iaddend. .[.one or more rotors and/or one or more.]. .Iadd.a rotor or an .Iaddend.axial pump .[.elements for transforming rotational and/or axial force into the pumping force,.]. .Iadd.element; .Iaddend.and .[.at least one.]. .Iadd.a .Iaddend.safe-lock .[.mechanism.]. .Iadd.means .Iaddend.for preventing .[.mechanical action to cause.]. rotation of the .[.at least one or more rotors and/or.]. .Iadd.rotor or .Iaddend.movement of the .[.one or more.]. axial pump .[.elements.]. .Iadd.element, .Iaddend.thereby preventing .[.passage.]. .Iadd.delivery .Iaddend.of the medicament.[.from the reservoir to the trans-dermal injection element unless a dose is requested.].; .Iadd.and .Iaddend. .Iadd.wherein .Iaddend.the separate .[.hand-held.]. drive device .[.being.]. .Iadd.is .Iaddend.configured to be placed temporarily in proximity to the delivery device when a dose of medicament is required, the .[.hand-held.]. .Iadd.separate .Iaddend.drive device comprising.Iadd.: .Iaddend. an activation unit .[.for activating the control unit of the delivery device, the activation unit comprising at least one unlocking element to.]. .Iadd.configured to (i) .Iaddend.provide energy to the control unit of the delivery device for unlocking the .[.at least one.]. safe-lock .[.mechanism.]. .Iadd.means .Iaddend.and .[.a drive unit to.]. .Iadd.(ii) .Iaddend.provide energy for .[.any of the one or more rotors and/or one or more.]. .Iadd.the rotor or the .Iaddend.axial pump .[.elements.]. .Iadd.element .Iaddend.of the control unit only when the separate .[.hand-held.]. drive device is in proximity to the delivery device.[.,.]..Iadd.; .Iaddend.and .[.wherein the hand-held drive device comprises.]. a sensor capable of detecting the amount of energy being transferred .[.and/or.]. .Iadd.or .Iaddend.transformed into pumping force.
2. The system of claim 1, wherein the .[.at least one.]. .Iadd.activation unit comprises an .Iaddend.unlocking element and .[.the.]. .Iadd.a .Iaddend.drive unit, which cooperate .[.synergistically.]. to activate the control unit.[.in a specific manner as a key.]..
3. The system of claim 1.Iadd., .Iaddend.further comprising a magnetic key.
4. The system of claim 1, wherein the delivery device comprises a pump for pumping the medicament from the reservoir.[.to the trans-dermal injection element.]..
5. The system of claim 1, wherein.Iadd.: .Iaddend. the delivery device comprises a base rotor.[.for holding.]..Iadd.; and .Iaddend. the reservoir .Iadd.is disposed on the base rotor.Iaddend..
6. The system of claim 1, wherein the .[.one or more rotors.]. .Iadd.rotor .Iaddend.comprises .[.at least one.]. .Iadd.a .Iaddend.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.]. .Iadd.rotor .Iaddend.comprises .[.at least one.]. .Iadd.a .Iaddend.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.]. .Iadd.8.Iaddend., 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.]. .Iadd.a .Iaddend.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.]. .Iadd.the axial pump element comprises a first axial pump element that .Iaddend.moves in an alternate direction along an axis with respect to movement of .[.the one or more.]. .Iadd.a second .Iaddend.axial pump .[.elements.]. .Iadd.element.Iaddend..
13. The system of claim .[.12.]. .Iadd.1.Iaddend., wherein.Iadd.: the control unit comprises the axial pump element; and .Iaddend. the .[.one or more.]. axial pump .[.elements is.]. .Iadd.element comprises .Iaddend.a membrane.
14. The system of claim 1, wherein.Iadd.: the control unit comprises the axial pump element and the rotor; and .Iaddend. the .[.one or more.]. axial pump .[.elements are.]. .Iadd.element is .Iaddend.connected to the .[.one or more rotors.]. .Iadd.rotor, wherein the rotor comprises a rotor .Iaddend.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.Iadd.: .Iaddend. the reservoir for holding the medicament .[.to be delivered.]. is a syringe-type reservoir comprising a first end and .[.at least one.]. .Iadd.an .Iaddend.opening in .[.correspondence of.]. said first end for pumping medicament to .[.the.]. .Iadd.a .Iaddend.trans-dermal injection element .[.and/or.]. .Iadd.or .Iaddend.for introducing the medicament in the syringe-type reservoir, a second open end, and walls between .[.said.]. .Iadd.the .Iaddend.first end and .[.said.]. .Iadd.the .Iaddend.second end.Iadd.; the control unit comprises the axial pump element; and the axial pump element comprises a first axial pump element configured to fit .Iaddend.into .[.which the one or more axial pump elements comprises a first axial pump element which fits.]. .Iadd.the second open end of the syringe type reservoir .Iaddend.in a fluid-tight manner.
16. The system of claim 15, wherein the .[.control unit.]. .Iadd.axial pump element .Iaddend.comprises a second axial pump element aligned with the syringe-type reservoir in .[.correspondence of said.]. .Iadd.the .Iaddend.second open end.Iadd., .Iaddend.wherein the first axial pump element is adapted to move towards .[.said.]. .Iadd.the .Iaddend.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.]. .Iadd.in response to .Iaddend.the second axial pump element .[.has come into contact.]. .Iadd.contacting .Iaddend.or .[.has engaged.]. .Iadd.engaging .Iaddend.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.]. .Iadd.and is configured to pull .Iaddend.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.]. .Iadd.or of the axial pump element.Iaddend..
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,.]. .Iadd.the rotor .Iaddend.to rotate in a preferred direction .[., and/or.]. .Iadd.or .Iaddend.the .[.one or more.]. axial pump .[.elements.]. .Iadd.element .Iaddend.to move in a preferred direction.
21. The system of claim 1, wherein .[.any of the one or more rotors.]. .Iadd.the rotor .Iaddend.comprises .[.at least one.]. .Iadd.a .Iaddend.magnet or a ferromagnetic .[.element.]. .Iadd.material.Iaddend..
22. The system of claim 1, wherein the .[.at least one.]. safe-lock .[.mechanism.]. .Iadd.means .Iaddend.comprises a ferromagnetic .[.element or at least one.]. .Iadd.material or a .Iaddend.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.]. .Iadd.means.Iaddend..
23. The system of claim .[.1.]. .Iadd.2.Iaddend., wherein the .[.at least one.]. safe-lock .[.mechanism.]. .Iadd.means .Iaddend.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 device.[.which 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.]. .Iadd.2.Iaddend., wherein the drive unit provides rotational force .[.and/or.]. .Iadd.or .Iaddend.axial force to the .[.one or more rotors and/or one or more.]. .Iadd.rotor or the .Iaddend.axial pump .[.elements.]. .Iadd.element .Iaddend.when the .[.hand-held.]. drive device is placed in proximity to the delivery device.
26. The system of claim .[.1.]. .Iadd.2.Iaddend., 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.]. .Iadd.defines .Iaddend.a .[.complementary.]. cavity into which at least a .[.part.]. .Iadd.portion .Iaddend.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.]. .Iadd.a .Iaddend.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.]. .Iadd.device .Iaddend.comprises an RFID chip .[.for being.]. .Iadd.that is configured to be .Iaddend.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.]. .Iadd.in response to being .Iaddend.directly or indirectly .Iadd.contacted .Iaddend.by moving the .[.one or more.]. axial pump .[.elements.]. .Iadd.element.Iaddend..
32. The system of claim .[.1.]. .Iadd.2.Iaddend., wherein the delivery device comprises a capacitor or .Iadd.an .Iaddend.accumulator for receiving .[.and/or.]. .Iadd.or .Iaddend.accumulating energy from the drive unit when the drive unit is placed in proximity of the delivery device.
.Iadd.33. The system of claim 1, wherein the drive device is a hand-held drive device. .Iaddend.
.Iadd.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. .Iaddend.
.Iadd.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. .Iaddend.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) FIG. 1a shows a system comprising a delivery device and a separate drive device temporarily placed in proximity of the delivery device.
(2) FIG. 1b shows a variant of FIG. 1a wherein the delivery device comprises also a pump.
(3) FIG. 2 shows a pump rotor connected to the pump inside the delivery device.
(4) FIG. 3 shows part of a control unit comprising a primary rotor.
(5) FIG. 4 shows a variant of the embodiment of FIG. 3.
(6) FIG. 5 shows part of a control unit wherein a primary rotor is locked by a safe-lock mechanism.
(7) FIG. 6 shows the pump of FIG. 2 connected to an axial pump element locked by a safe-lock mechanism.
(8) FIG. 7 shows a secondary rotor and a primary rotor having different axis of rotation, the primary rotor being locked by a safe-lock mechanism.
(9) FIG. 8a is a perspective view of an embodiment comprising a spring located between a primary rotor and a secondary rotor.
(10) FIG. 8b is a bottom view of the embodiment of FIG. 7.
(11) FIG. 9 shows a pump rotor designed to engage with an axial pump element and to transform rotational force into axial force upon activation.
(12) FIG. 10 shows another example wherein the pump rotor needs to move in the axial direction before freedom to rotate is provided.
(13) FIG. 11 shows a coil integrated in the delivery device capable of providing induced electrical power for unlocking a safe-lock mechanism.
(14) FIG. 12 shows a reservoir comprising an array of blisters disposed on a base rotor.
(15) FIG. 13 shows the elements of an activation unit comprised in the drive device.
(16) FIG. 14 shows a different embodiment of an activation unit.
(17) FIG. 15 shows another embodiment of an activation unit.
(18) FIG. 16 shows some of the components of a delivery device more in detail in an exploded view.
(19) FIG. 17a shows the interaction between some of the elements of the delivery device of FIG. 16 through the housing partially removed for clarity.
(20) FIG. 17b shows the interaction between some of the elements of the delivery device of FIG. 16 through the housing partially removed for clarity.
(21) FIG. 18a shows the interaction between some of the elements of the delivery device of FIG. 16 in cross-sectional view.
(22) FIG. 18b shows the interaction between some of the elements of the delivery device of FIG. 16 in cross-sectional view.
(23) FIG. 19 shows a hand-held drive device wherein part of the housing has been removed to show some of the elements inside.
DETAILED DESCRIPTION OF THE INVENTION
(24) FIG. 1a shows a system 300 for trans-dermal delivery of doses of a medicament, comprising a delivery device 100 to be placed in dermal contact with a patient. The delivery device 100 comprises a reservoir 101 for holding a medicament to be delivered, a trans-dermal injection element 102 for delivering doses of the medicament to the patient, a control unit 120 for controlling the delivery of the medicament when activated. The system 300 further comprises a separate hand-held drive device 200 temporarily placed in proximity of the delivery device 100, the drive device 200 comprising an activation unit 220 for activating the control unit 120 of the delivery device 100. The drive device 200 in correspondence of the activation unit 220 is shaped as to form a complementary cavity 221 into which the delivery device 100 comprising the control unit 120 substantially fits. The drive device 200 further comprises all the elements needed for operation and control, e.g. a processor 230, other electronic components (not shown) such as a memory, a printed circuit board, wires, etc. . . . a battery 240, a port 250 for recharging and/or for connecting to other devices, e.g. a computer, e.g. for exchanging data, buttons or switches 260 located on the housing of the device, visual and/or Braille-like screens, e.g. an LCD 270, alert or warning lights (not shown).
(25) FIG. 1b is the same as FIG. 1a except that the delivery device 100 further comprises a pump 110 for pumping the medicament from the reservoir 101 to the trans-dermal injection element 102.
(26) FIG. 2 shows a pump rotor 111 connected to the pump 110 located in the delivery device 100 transforming rotational force into pumping force when rotating around an axis 112. The pump rotor 111 presents a saw-like or gear-like edge 113.
(27) FIGS. 3 to 11 depict preferred embodiments of the control unit 120.
(28) FIG. 3 shows a primary rotor 130 connected to the pump rotor 111 via a gear mechanism, adapted to transfer rotational force to the pump rotor 111. The pump rotor 111 fits with a certain tolerance into a cavity 131 at the bottom of the primary rotor 130. The primary rotor 130 and the pump rotor 111 thus have approximately the same axis of rotation 112, i.e. they are concentrically arranged. The primary rotor 130 comprises a pin 132 parallel to the axis of rotation 112, which fits into a cavity (not shown). The primary rotor 130 works as a stabilization element wherein it is allowed to incline its axis within a tolerance range without causing an inclination of the axis of the pump rotor 111. In this way the moment of tilt of the pump rotor is minimized, that is inclinations of the axis 112 during rotation are minimized. The pin 132 could be attached directly to the pump rotor 111. The primary rotor 130 comprises also a series of permanent magnets 133 arranged according to a specific magnetic configuration. Magnets 133 could have been disposed also on the primary rotor 111.
(29) FIG. 4 shows a variant of the embodiment of FIG. 3 wherein a compartment 134 carved in the housing of the delivery device 100 and designed to fit the footprint of the primary rotor 130 is part of the stabilization element. This could be used together with the pin 132.
(30) FIG. 5 shows part of a control unit 120 wherein a primary rotor 130 is locked by a safe-lock mechanism 140. The safe-lock mechanism 140 prevents the primary rotor 130 to rotate until unlocked. The safe-lock mechanism 140 thus eliminates the risk of external interferences, i.e. that medicament is pumped when not required. The safe-lock mechanism 140 has the form of L-shaped pivotable arms, designed as a clamp, which can assume either of two positions, a tight position (as shown in the figure) when it is in a locked status and an enlarged position when it is in an unlocked status (not shown). The safe-lock mechanism 140 is designed to fit at one extremity between the teeth of a saw-like edge 135 of the primary rotor 130 and is made of a rigid but flexible elastic material capable of being stretched and to return to its original position afterwards. The safe-lock mechanism 140 comprises permanent magnets 141. Also shown in FIG. 5 is a directional element 142, which allows the primary rotor 130 to rotate in one direction only when unlocked. The directional element 142 is an inclined flexible elastic tongue fitting between the teeth of the saw-like edge 135 of the primary rotor 130.
(31) FIG. 6 shows the pump 110 connected to an axial pump element 150 locked by a safe-lock mechanism 140. The axial pump element 150 is directly attached to the pump 110 and is adapted to transform axial force into pumping force. Disposed on the axial pump element is a magnet 133. The safe-lock mechanism 140 is similar to that shown in FIG. 5. In this case, it prevents the axial pump element 150 to move up and/or down until unlocked.
(32) FIG. 7 shows a secondary rotor 160 and a primary rotor 130 having different axis of rotation 115 and 112 respectively, while the primary rotor 130 and the pump rotor 111 have the same axis of rotation 112. The secondary rotor 160 has here the function to change the magnitude of the torque on the primary rotor 130 and hence on the pump rotor 111 by means of a gear mechanism 162. The secondary rotor 160 comprises a series of permanent magnets 133 and is capable of transferring rotational force to the primary rotor 130, which in turn is capable of transferring rotational force to the pump rotor 111. The primary rotor 130 is locked by a safe-lock mechanism 140, which acts as a brake on the primary rotor 130 until unlocked. The safe lock mechanism 140 may be unlocked analogously to FIGS. 5 and 6 magnetically or electronically, e.g. powered by an induced electric current.
(33) FIG. 8a is a perspective view of an embodiment comprising a mainspring 170 located between a primary rotor 130 and a secondary rotor 160. The secondary rotor 160 comprises a series of permanent magnets 133 arranged according to a specific magnetic configuration. The secondary rotor 160 is locked by a safe-lock mechanism 140 similar to that shown in FIG. 5. The safe-lock mechanism 140 fits at one extremity between the teeth of a saw-like frame 161 of the secondary rotor 160 and prevents the secondary rotor 160 to rotate until unlocked. A second safe-lock mechanism (not shown) may lock the primary rotor 130 while the secondary rotor 160 is unlocked and allowed to rotate. A directional element 142 allows the secondary rotor 160 to rotate in one direction only when unlocked. Rotation of the secondary rotor 160 in one direction has in this case the function to load the mainspring 170. Once the mainspring 170 is loaded the drive device 200 may be removed as rotational force is transferred now to the primary rotor 130 by the mainspring 170 while returning to its previous status. The mainspring 170 may be differently loaded according to the dose to be delivered.
(34) FIG. 8b is a bottom view of the embodiment of FIG. 8a wherein the secondary rotor 160 has been made transparent for clarity. The pump rotor 111, the primary rotor 130 and the secondary rotor 160 are concentrically arranged with the mainspring 170 located between the secondary rotor 160 and the primary rotor 130. The primary rotor 130 could have been in place of the secondary rotor 130 and the mainspring 170 could have been located between the primary rotor 130 and the pump rotor 111.
(35) FIG. 9 shows a pump rotor 111 designed to engage with an axial pump element 150 and to transform rotational force into axial force upon activation. The pump rotor 111 and the axial pump element 150 are not connected to each other, i.e. the pump rotor 111 may be allowed to rotate but eventual rotational force applied to the pump rotor 111 is not transferred to the axial pump element 150 and transformed into axial force, until the separate hand-held drive device 200 comprising the activation unit 220 is temporarily placed in proximity of the delivery device 100. Thus the separation of the pump rotor 111 and the axial pump element 150 has the same function of a safe-lock mechanism 140. Unlocking the safe-lock mechanism here means moving the pump rotor 111 in axial direction in order to engage with the axial pump element 150. In particular, a gear element 114 of the pump rotor 111 is engaged with a gear element 151 of the axial pump element 150. The pump rotor 111 comprises a series of permanent magnets 133, 136 arranged according to a specific magnetic configuration. The axial pump element 150 is here the plunger of a syringe-like reservoir (not shown), comprising the medicament to be delivered. A spring 138 allows the pump rotor 111 to disengage and return to its original locked status once the drive device 200 is no longer in proximity of the delivery device 100.
(36) Using a similar mechanism and with reference to FIG. 3 one can imagine a primary rotor 130, which needs to move in the axial direction in order to be engaged with the pump rotor 111.
(37) FIG. 10 shows another example wherein the pump rotor 111 needs to be pulled in the axial direction out of its locked position 137 before freedom to rotate is provided.
(38) FIG. 11 shows a coil 180 integrated in the delivery device 100. A specific magnetic field generated by the activation unit 220 when the drive device 200 is placed in proximity of the delivery device 100 induces a specific current, e.g. modulated, in the coil 180, which provides electrical power for unlocking the safe-lock mechanism 140 for a specific period of time.
(39) FIG. 12 shows a reservoir 101 comprising an array of blisters 103 disposed on a base rotor 104, each blister 103 containing a fraction of dose of medicament to be delivered and being connected by a microfluidic channel 105 to the trans-dermal injection element 102. The base rotor 104 is capable of rotating, at least partially when a new dose is required. The control unit comprises a safe-lock mechanism (not shown) preventing the base rotor 104 to rotate until unlocked and an axial pump element (not shown) transforming axial force into pumping force by pressing on the blisters 103 one at a time. Instead of a rotating base rotor 104 a rotating axial pump element (not shown) could be used as well. Instead of an array of blisters 103 a single larger pouch (not shown) could be used as well.
(40) FIG. 13 shows the elements of an activation unit 220 comprised in the drive device 200. The design of the activation unit 220 may vary in order to adapt to different control units 120. The activation unit 220 of FIG. 13 is for example suitable for a control unit as shown in FIGS. 5 to 8. In particular, the activation unit 220 comprises an unlocking element 221 for unlocking the at least one safe-lock mechanism 140 of the control unit 120 when the hand-held drive device 200 is placed in proximity of the delivery device 100. The unlocking element 221 comprises permanent magnets 223 symmetrically arranged. This symmetry may be convenient in order to avoid dependency on the angle with which the hand-held drive device 200 is placed in proximity of the delivery device 100. An electromagnet could have also been used. The magnetic field generated by the unlocking element 221, which may be specific, is the key for unlocking the safe-lock mechanism 140. The activation unit 220 further comprises a drive unit 222 providing rotational force and/or axial force to any one or more elements selected from the group of a base rotor 104, a pump rotor 111, a primary rotor 130, a secondary rotor 160, an axial pump element 150 when the hand-held drive device 200 is placed in proximity of the delivery device 100. The drive unit 222 comprises a drive rotor 230 connected to a motor 240 via a belt 252, the drive rotor 230 comprising a series of magnets 231. An electromagnet could have also been used.
(41) FIG. 14 shows a different embodiment of an activation unit 220 wherein the magnets 231 comprised in the drive rotor 230 are differently arranged. The drive rotor 230 comprises also another magnet 232 at the center, which acts as unlocking element 221 for a safe-lock mechanism like that described e.g. in relation to FIGS. 9 and 10.
(42) FIG. 15 shows still another embodiment of an activation unit comprising a magnet 232 at the center and acting as unlocking element 221 similarly to that shown in FIG. 14. As a drive unit 222 a series of electromagnets represented by coils 233 are used instead.
(43) FIG. 16 to FIG. 18b show the elements of a delivery device 100 according a preferred embodiment and are to be seen together. FIG. 16 is an exploded view showing most of the elements of the delivery device 100. FIG. 17a and FIG. 17b show the interaction between some of the elements of the delivery device 100 of FIG. 16, wherein in FIG. 17a shows the safe-lock mechanism in a locked status and FIG. 17b shows the safe-lock mechanism in an unlocked status. FIG. 18a and FIG. 18b show the interaction between some other elements of the delivery device 100 of FIG. 16 not visible in FIG. 17a and FIG. 17b. The embodiment shown in these figures is similar in principle to that shown in FIG. 9. The reservoir 155 is a syringe for containing the medicament to be delivered. A plunger-like axial pump element consisting of a first axial pump element 153 and a second axial pump element 150 transforms axial force into pumping force for pushing the medicament out of the syringe via opening 157 fluidically connected to trans-dermal injection element 102 (not shown). A second opening 156 may be used, e.g. to introduce the medicament into the syringe 155. The first axial pump element 153 comprises o-rings 154 for achieving a fluid-tight sealing with the inner walls of syringe 155. The first axial pump element 153 is disconnected from the second axial pump element 150 before introducing the medicament into then syringe. Particularly, the first axial pump element 153 is close to a first end of the syringe 155 in proximity of the openings 156, 157 and is pushed towards second axial pump element 150 by the medicament being introduced into the syringe 155, until engaging with the second axial pump element 150 by fitting head 169 of the second axial pump element 150 into cavity 171 of the first axial pump element 153. The syringe 155 is closed at the second open end with a cap 159 secured at the inner walls of the syringe 155 so that it is not allowed to rotate. The cap comprises a hole in the center and a tooth (not shown) protruding towards the center. The second axial pump element 150 may pass through the hole of the cap 159. The second axial pump element 150 comprises a gear element 151 and a groove 158, into which the tooth of the cap 159 fits. In this way the second axial pump element 150 may move axially into the syringe 155 through the hole of the cap 159 but may not rotate, due to the groove 158 being aligned with the tooth of the cap 159. The second axial pump element 150 fits into the body of pump rotor 111 and is connected via the gear element 151 with a first internal gear element 114 of the pump rotor 111. The pump rotor 111 is designed to transform rotational force into axial force by pushing upon rotation the second axial pump element 150 in axial direction, which in turn pushes the first axial pump element 153. A primary rotor 130 is connected via gear element 174 with a second external gear element 173 of the pump rotor 111. The primary rotor 130 is designed to transfer rotational force to pump rotor 111 upon activation. The pump rotor 111 may rotate and transform rotational force into axial force only if the primary rotor 130 is allowed to rotate. The primary rotor 150 is however locked by a safe-lock mechanism 140 and is not allowed to rotate until a separate hand-held drive device 200 is placed in proximity of the delivery device and only when a dose of medicament is required, the drive device 200 comprising an activation unit 220 for activating the control unit 120 of the delivery device 100, the activation unit 220 comprising an unlocking element 221 to provide energy for unlocking the safe-lock mechanism 140 and a drive unit 222 to provide energy for the primary rotor 130 to rotate.
(44) The safe-lock mechanism 140 comprises a locking element 165 comprising teeth 166. The locking element 165 is designed to be functionally coupled to primary rotor 130 so that primary rotor 130 may rotate only together with locking element 165. This is achieved by matching recesses 172 of the locking element 165 with protrusions 167 on the primary rotor 130. A spring 138 located between the locking element 165 and the primary rotor 130 pushes the locking element 165 against the inner walls of the housing 190 of the delivery device 100, wherein similar protruding teeth 168 prevent the locking element 165 and thus the primary rotor 130 to rotate. A spring 138 like that shown in FIG. 16 may be more suitable than a spring 138 like that shown in FIG. 17a and FIG. 17b. The spring type has been changed in FIG. 17a and FIG. 17b for illustration purpose only, wherein also the distance between the locking element 165 and the primary rotor 130 has been exaggerated for better clarity. During operation, the locking element 165 is normally not allowed to go over the upper level of protrusions 167 on the primary rotor 130. The primary rotor 130 comprises also two permanent magnets 133. Another magnet 136 is placed above the locking element 165.
(45) The safe-lock mechanism 140 comprises in this case the locking element 165 with teeth 166, the spring 138, the magnet 136 and teeth 168 of the housing 190. The control unit 120 comprises the primary rotor 130, the pump rotor 111, the second axial pump element 150, the first axial pump element 153, the cap 159, and the safe-lock mechanism 140.
(46) When a dose of medicament is required a separate hand-held drive device 200 comprising an activation unit 220 similar to that shown in FIG. 14 or FIG. 15 is placed in proximity of the delivery device 100 and a command is given to activate the control unit 120 to delivery specifically the dose of medicament needed. The drive device 200 comprises an activation unit 220 for activating the control unit 120 of the delivery device 100. The activation unit 220 comprises an unlocking element 221, the unlocking element 221 comprising a magnet 232 to interact specifically with magnet 136, so that the magnetic force overcomes the force provided by the spring 138 and the locking element is pushed downwards towards the primary rotor 130, thus freeing the locking element 165 from teeth 168 and unlocking the control unit 120. At the same time the drive unit 222 of the drive device 200, comprising magnets 231 with a specific magnetic configuration matching the polarity of the magnets 133 on the primary rotor 130 provides to the primary rotor 130 the exact amount of energy to rotate, which is transformed via pump rotor 111 into the exact axial force required to deliver the correct dose of medicament. As soon as the requested dose has been delivered, the drive unit 222 stops to provide energy to the primary rotor 130, which stops rotating. The hand-held device sends a feedback signal, e.g. visual, vibrational, acoustic, to inform the user that it is possible to remove the hand-held device 200 from the delivery device 100. The safe-lock mechanism 140 is then locked again, thus locking the control unit 120. The combined effect of the unlocking element 221 and the drive unit 222 on the combined elements of the control unit 120 makes the activation of the control unit 120 specific as a key.
(47) FIG. 19 shows a hand-held drive device 200 wherein part of the housing has been removed to show some of the elements inside. Particularly a Hall sensor 280 and an encoder 290 are shown. The Hall sensor is capable of detecting the fluctuation of the magnetic field induced by the magnets 133 when the primary rotor 130 rotates and thus enables the verification that the correct amount of energy has been transferred to the control unit 120 and transformed into pumping force and delivery of the correct dose of medicament. In this case, the drive device 200 comprises an activation unit similar to that of FIG. 14 and the encoder 290 is used to verify the rotational movement of the drive unit 222. The data from the hall sensor 280 and the encoder 290 may be compared for further verification.
(48) Of course numerous variations of the described embodiments are possible without departing from the scope of the invention.
