Portable drug delivery device including a detachable and replaceable administration or dosing element

Abstract

A device for transdermal drug delivery and administration of differing dosages at specific times of the day automatically pursuant to a pre-programmed dosage profile. The device includes a control and display unit, a two-part dispensing mechanism, a drug reservoir, an administration element, and a solvent removal element. The dispensing mechanism may be a peristaltic pump having an active portion with a motor, a roller, a mounting plate and a detachable passive portion with tubing and a housing. The motor and roller are mounted in the reusable portion of the delivery device with the control unit and a power source. The speed of the micromotor is controlled by the control unit, so that the turning speed of the roller is controlled which, in turn, controls the flow rate to the administration. The passive portion and drug reservoir are detachable along with the administration element for attaching a new dosing reservoir.

We claim: 
     
       1. An apparatus for transdermally delivering a drug formulation and stopping dosing or delivery in an automatic, controllable manner, comprising:
 (a) an active assembly comprising a controller; 
 (b) a passive assembly adapted for mechanically coupling and decoupling with the active assembly, the passive assembly comprising:
 (i) a dispensing reservoir containing the drug formulation; and 
 (ii) a delivery element comprising an administration reservoir and a membrane in fluid communication with the administration reservoir, the membrane being permeable to an active substance in the drug formulation; 
 
 (c) a dispensing mechanism comprising:
 (i) an active portion in the active assembly providing a motive force to draw the drug formulation from the dispensing reservoir to the administration reservoir; and 
 (ii) a passive portion in the passive assembly proximate to the active portion and defining a feed chamber through which the drug formulation flows from the dispensing reservoir; and 
 
 (d) a stopping means for stopping dosing or slowing delivery by removing the drug or a solvent of the drug in the drug formulation from the administration reservoir, wherein the stopping means utilizes gas, air, fluid, or a combination thereof, which functions to flush the solvent, drug, or a combination thereof from the administration reservoir, and wherein the stopping means does not require removal of the apparatus from an application site during the flushing process. 
 
     
     
       2. The apparatus of  claim 1 , wherein the stopping means comprises a dispensing mechanism and a source of flushing air, gas, fluid or a combination thereof, the dispensing mechanism being selectively operable by the controller to pump the flushing air, gas, fluid or a combination thereof through the administration reservoir to a waste reservoir or evaporation element. 
     
     
       3. The apparatus of  claim 1 , wherein the stopping means comprises a micropump and a source of flushing air, gas, fluid or a combination thereof, the micropump being operable by the controller to pump the flushing air, gas, fluid or a combination thereof through the administration reservoir to a waste reservoir or evaporation element. 
     
     
       4. The apparatus of  claim 1 , the active assembly further comprising memory storing a dosing profile, wherein the controller operates the dispensing mechanism and the stopping means based on the dosing profile to initiate delivery of the drug formulation and to stop the delivery. 
     
     
       5. The apparatus of  claim 1 , wherein the stopping means utilizes gas, air, or a combination thereof, which functions to flush the solvent, drug, or a combination thereof from the administration reservoir. 
     
     
       6. A transdermal drug delivery device, comprising:
 (a) means for storing a first liquid and a second liquid each comprising a solvent and active substance mixture; 
 (b) a pump comprising an active portion including a motor and a passive portion including a pair of feed channels connected to the storing means and a pump housing for detachably receiving the active portion; 
 (c) an administration assembly comprising a reservoir connected to the feed channels for receiving the first and second liquids when pumped from the storing means by the pump and a membrane permeable to the active substances in fluid communication with the administration reservoir; and 
 (d) a stopping means for stopping dosing or slowing delivery by removing the active substance or the solvent from the administration reservoir, wherein the stopping means utilizes gas, air, fluid, or a combination thereof, which functions to flush the solvent, drug, or a combination thereof from the administration reservoir, and wherein the stopping means does not require removal of the apparatus from an application site during the flushing process. 
 
     
     
       7. The device of  claim 6 , wherein the first and second liquids are pumped concurrently to the administration reservoir. 
     
     
       8. The device of  claim 6 , wherein the first and second liquids are pumped separately to the administration reservoir and the device further comprises a switch for selectively blocking flow through one of the feed channels. 
     
     
       9. The device of  claim 6 , further comprising a controller operating automatically based on a dosing profile to control operations of the pump. 
     
     
       10. The device of  claim 6 , wherein the stopping means utilizes gas, air, or a combination thereof, which functions to flush the solvent, drug, or a combination thereof from the administration reservoir. 
     
     
       11. An apparatus comprising a disposable assembly for transdermally delivering an active substance to an application site, the disposable assembly being adapted for mechanically coupling and decoupling with a reusable assembly, the disposable assembly comprising:
 a drug reservoir containing the active substance dissolved in a solvent, the disposable assembly being adapted to receive a motive force from the reusable assembly when coupled to the reusable assembly to move the active substance and solvent out of the drug reservoir via a feed chamber or delivery tube;   an administration element adapted to deliver to a skin surface of a user the active substance delivered by the feed chamber or delivery tube; and   a solvent removal element comprising vents communicating with the administration element adapted to facilitate removal from the administration element of solvent delivered to the administration element by the feed chamber or delivery tube without removing the apparatus from the application site to stop or slow delivery of the active substance to the application site.   
     
     
       12. The apparatus of claim 11 wherein the solvent removal element further comprises a chamber communicating with the vents to receive solvent from the administration element. 
     
     
       13. The apparatus of claim 12 wherein the solvent removal element further comprises a solvent absorbing material disposed in the chamber. 
     
     
       14. The apparatus of claim 13 wherein the solvent absorbing material comprises a desiccant. 
     
     
       15. The apparatus of claim 11 wherein the administration element comprises a reservoir. 
     
     
       16. The apparatus of claim 11 wherein the administration element comprises a plurality of passageways. 
     
     
       17. The apparatus of claim 11 wherein the administration element comprises a permeable membrane. 
     
     
       18. The apparatus of claim 11 wherein the administration element comprises a sheet comprising porous plastic. 
     
     
       19. The apparatus of claim 11 wherein the motive force comprises fluid pressure from a pressurized reservoir. 
     
     
       20. An apparatus for transdermally delivering an active substance to an application site, the apparatus comprising:
 a reusable assembly comprising a controller, a power source and an actuator powered by the power source and controlled by the controller to provide a motive force; and   a disposable assembly adapted for mechanically coupling and decoupling with the reusable assembly, the disposable assembly comprising:
 a drug reservoir containing the active substance dissolved in a solvent, the disposable assembly being adapted to receive the motive force from the reusable assembly when coupled to the reusable assembly to move the active substance and solvent out of the drug reservoir via a feed chamber or delivery tube; 
 an administration element adapted to deliver to a skin surface of a user the active substance delivered by the feed chamber or delivery tube; and 
 a solvent removal element comprising vents communicating with the administration element adapted to facilitate removal from the administration element of solvent delivered to the administration element by the feed chamber or delivery tube without removing the apparatus from the application site to stop or slow delivery of the active substance to the application site. 
   
     
     
       21. The apparatus of claim 20 wherein the solvent removal element further comprises a chamber communicating with the vents to receive solvent from the administration element. 
     
     
       22. The apparatus of claim 21 wherein the solvent removal element further comprises a solvent absorbing material disposed in the chamber. 
     
     
       23. The apparatus of claim 22 wherein the solvent absorbing material comprises a desiccant. 
     
     
       24. The apparatus of claim 20 wherein the administration element comprises a reservoir. 
     
     
       25. The apparatus of claim 20 wherein the reusable assembly further comprises a pump providing the motive force. 
     
     
       26. The apparatus of claim 20 wherein the administration element comprises a plurality of passageways. 
     
     
       27. The apparatus of claim 20 wherein the administration element comprises a permeable membrane. 
     
     
       28. The apparatus of claim 20 wherein the administration element comprises a sheet comprising porous plastic. 
     
     
       29. The apparatus of claim 20 wherein the motive force comprises fluid pressure from a pressurized reservoir. 
     
     
       30. An apparatus comprising a disposable assembly for transdermally delivering an active substance to an application site, the disposable assembly being adapted for mechanically coupling and decoupling with a reusable assembly, the disposable assembly comprising:
 a drug reservoir containing the active substance dissolved in a solvent, the disposable assembly being adapted to receive a motive force from the reusable assembly when coupled to the reusable assembly to move the active substance and solvent out of the drug reservoir via a feed chamber or delivery tube;   an administration element adapted to deliver to a skin surface of a user the active substance delivered by the feed chamber or delivery tube; and   a stopping means for stopping dosing or slowing delivery of the active substance by removing the active substance or solvent from the administration element, wherein the stopping means utilizes gas, air, fluid, or a combination thereof, which functions to remove the solvent, active substance, or a combination thereof from the administration element, and wherein the stopping means does not require removal of the apparatus from an application site during the removing process.   
     
     
       31. The apparatus of claim 30 wherein the stopping means further comprises a chamber communicating with the vents to receive solvent from the administration element. 
     
     
       32. The apparatus of claim 31 wherein the stopping means further comprises a solvent absorbing material disposed in the chamber. 
     
     
       33. The apparatus of claim 32 wherein the solvent absorbing material comprises a desiccant. 
     
     
       34. The apparatus of claim 30 wherein the administration element comprises a reservoir. 
     
     
       35. The apparatus of claim 30 wherein the administration element comprises a plurality of passageways. 
     
     
       36. The apparatus of claim 30 wherein the administration element comprises a permeable membrane. 
     
     
       37. The apparatus of claim 30 wherein the administration element comprises a sheet comprising porous plastic. 
     
     
       38. The apparatus of claim 30 wherein the motive force comprises fluid pressure from a pressurized reservoir. 
     
     
       39. An apparatus for transdermally delivering an active substance to an application site, the apparatus comprising:
 a reusable assembly comprising a controller, a power source and an actuator powered by the power source and controlled by the controller to provide a motive force; and   a disposable assembly adapted for mechanically coupling and decoupling with the reusable assembly, the disposable assembly comprising:
 a drug reservoir containing the active substance dissolved in a solvent, the disposable assembly being adapted to receive the motive force from the reusable assembly when coupled to the reusable assembly to move the active substance and solvent out of the drug reservoir via a feed chamber or delivery tube; 
 an administration element adapted to deliver to a skin surface of a user the active substance delivered by the feed chamber or delivery tube; and 
 a stopping means for stopping dosing or slowing delivery of the active substance by removing the active substance or solvent from the administration element, wherein the stopping means utilizes gas, air, fluid, or a combination thereof, which functions to remove the solvent, active substance, or a combination thereof from the administration element, and wherein the stopping means does not require removal of the apparatus from an application site during the removing process. 
   
     
     
       40. The apparatus of claim 39 wherein the stopping means further comprises a chamber communicating with the vents to receive solvent from the administration element. 
     
     
       41. The apparatus of claim 40 wherein the stopping means further comprises a solvent absorbing material disposed in the chamber. 
     
     
       42. The apparatus of claim 41 wherein the solvent absorbing material comprises a desiccant. 
     
     
       43. The apparatus of claim 39 wherein the administration element comprises a reservoir. 
     
     
       44. The apparatus of claim 39 wherein the reusable assembly further comprises a pump providing the motive force. 
     
     
       45. The apparatus of claim 39 wherein the administration element comprises a plurality of passageways. 
     
     
       46. The apparatus of claim 39 wherein the administration element comprises a permeable membrane. 
     
     
       47. The apparatus of claim 39 wherein the administration element comprises a sheet comprising porous plastic. 
     
     
       48. The apparatus of claim 39 wherein the motive force comprises fluid pressure from a pressurized reservoir.