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

• US 20060271020A1
• Filed: 05/24/2006
• Published: 11/30/2006
• Est. Priority Date: 05/24/2005
• Status: Active Grant

• Current Assignee: Morningside Venture Investments Ltd. (Morningside Group Ltd.)
• Original Assignee: Chrono Therapeutics Inc.
• Inventors: DiPierro, Guy, Huang, Joseph Zhili
• Granted Patent: US 8,372,040 B2
• Time in Patent Office: Days
• US Class Current: 604/890.100
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 35/00 Devices for applying media, e.g. remedies, on the human body devices for handling toiletry or cosmetic substances A45D; absorbent pads, e.g. swabs, A61F13/15
• CPC Class Codes: A61M 35/10 Wearable devices, e.g. garments, glasses or masks
• CPC Class Codes: A61M 5/14232 Roller pumps
• 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 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/445 the media being heated in the reservoir, e.g. warming bloodbags
• CPC Class Codes: F04B 23/02 having reservoirs
• CPC Class Codes: F04B 43/1253 by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing

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.

Claims

1. An apparatus for delivering a liquid, comprising:

an active assembly comprising a controller and a power source;

a passive assembly adapted for mechanically coupling and decoupling with the active assembly, the passive assembly comprising a dispensing reservoir containing the liquid; and

a dispensing mechanism comprising an active portion in the active assembly providing a motive force to draw the liquid from the dispensing reservoir and a passive portion in the passive assembly proximate the active portion and defining a feed chamber through which the liquid flows from the dispensing reservoir.

2. The apparatus of claim 1, wherein the passive portion and the active portion of the dispensing mechanism are mechanically coupled and wherein the active portion applies the motive force to the feed chamber without contacting the liquid.

3. The apparatus of claim 2, wherein dispensing mechanism comprises a peristaltic pump.

4. The apparatus of claim 3, wherein the active portion comprises a motor powered by the power source and operated by the controller to control a speed of the motor and time of operation, a roller with shoes, a shaft contacting the roller driven by the motor, and a mounting plate supporting the motor and wherein the passive portion comprises a housing with a guide slot for receiving the mounting plate to position one or more of the shoes in contact with an outer surface of the feed chamber.

5. The apparatus of claim 4, wherein the guide slot comprises a curved surface and the feed chamber comprises a tube fabricated from flexible material positioned between the curved surface and the shoes when the active and passive portions of the dispensing mechanism are mechanically coupled.

6. The apparatus of claim 4, wherein the shoes comprise at least three bearings that are rotatably mounted equidistally about the periphery of the roller.

7. The apparatus of claim 1, wherein the liquid comprises an active substance and a solvent and wherein the passive assembly further comprises a delivery element with a reservoir fluidically coupled to the feed chamber and a membrane in fluid communication with the administration reservoir, the membrane being permeable to the active substance.

8. The apparatus of claim 7, wherein the delivery element further comprises an evaporation channel defining a flow path for evaporated portions of the solvent to flow away from the administration reservoir and a heat element including the evaporation channel that operates selectively to increase a temperature of the liquid in the reservoir.

9. The apparatus of claim 7, wherein the delivery element further comprises an evaporation channel defining a flow path for evaporated portions of the solvent to flow substantially uniformly away from the administration reservoir and a gas distribution channel connected to the administration reservoir and wherein the active assembly further comprises a source of gas for selectively flowing through the gas distribution channel, the administration reservoir, and the evaporation channel.

10. The apparatus of claim 1, wherein the controller operates the dispensing mechanism to deliver quantities of the liquid from the dispensing reservoir based on dosing regimen that defines the quantities and timing of operation of the dispensing mechanism based on time of day and an active substance in the liquid.

11. A transdermal drug delivery device, comprising:

a drug reservoir for containing a liquid comprising a solvent and active substance mixture;

a peristaltic pump comprising an active portion including a motor, a roller driven by the motor, and two or more shoes attached to the roller and a passive portion including a tube with a first end connected to the drug reservoir and a pump housing for detachably receiving the active portion such that the shoes compress the tube when the roller is driven by the motor; and

an administration assembly comprising an administration reservoir connected to a second end of the tube for receiving the liquid from peristaltic pump and a membrane permeable to the active substance in fluid communication with the administration reservoir.

12. The device of claim 11, further comprising an absorbent sheet disposed in the administration reservoir distributing the received liquid substantially uniformly to a surface of the membrane adjacent the administration reservoir.

13. The device of claim 11, wherein the drug reservoir, the passive portion of the peristaltic pump, and the administration assembly are provided in a unitary housing.

14. The device of claim 13, further comprising a reusable housing containing the active portion of the peristaltic pump, a microprocessor controlling operation of the motor, and a battery providing power to the motor.

15. The device of claim 14, wherein the administration assembly further comprises a heat element adjacent the administration reservoir and a temperature sensor sensing a temperature in the administration assembly, the heat element configured to define a plurality of flow paths away from the administration reservoir and the microprocessor operating the heat element to increase the sensed temperature to an operating temperature 3 to 10 degrees Celsius above a dermal temperature.

16. The device of claim 11, wherein the administration assembly further comprises a chamber in communication with the administration reservoir, the chamber comprising a material that absorbs evaporated portions of the solvent.

17. A peristaltic micropump, comprising:

an active portion comprising an electric motor, a shaft driven by the motor, a roller plate connected to the shaft, and a plurality of shoes rotatably mounted to the roller plate; and

a passive portion comprising compressible tubing and a housing for supporting the electric motor, the housing having a recessed surface adapted for receiving the roller plate and a compression surface, wherein a length of the compressible tubing is positioned in contact with the compression surface and in contact with at least one of the shoes.

18. The micropump of claim 17, wherein the active and passive portions are configured for selective mechanical coupling and decoupling.

19. The micropump of claim 17, wherein the compressible tubing comprises a hollow module defining an internal flow chamber, the module having a first external surface for mating with the compression surface and a second external surface adjacent the internal flow chamber that is curved and contacts the shoes when the motor drives the roller plate.

20. The micropump of claim 19, wherein the compressible tubing is detachable from the housing and further comprises a pair of tube fittings in fluid communication with the internal flow chamber, whereby the compressible tubing can be replaced and connected to inlet and outlet tubing.

21. An apparatus for delivering a drug formulation and stopping dosing or delivery in a controllable manner, comprising:

an active assembly comprising a controller;

a passive assembly adapted for mechanically coupling and decoupling with the active assembly, the passive assembly comprising a dispensing reservoir containing the drug formulation and a delivery element with 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;

a dispensing mechanism comprising 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 a passive portion in the passive assembly proximate the active portion and defining a feed chamber through which the drug formulation flows from the dispensing reservoir; and

means for flushing the administration reservoir to remove the drug formulation, whereby dosing can be stopped.

22. The apparatus of claim 21, wherein the flushing means comprises the dispensing mechanism and a source of flushing fluid, the dispensing mechanism being selectively operable by the controller to pump the flushing fluid through the administration reservoir to a waster reservoir or evaporation element.

23. The apparatus of claim 21, wherein the flushing means comprises a micropump and a source of flushing fluid, the micropump being operable by the controller to pump the flushing fluid through the administration reservoir to a waste reservoir or evaporation element.

24. The apparatus of claim 21, the active assembly further comprising memory storing a dosing profile, wherein the controller operates the dispensing mechanism and the flushing means based on the dosing profile to initiate delivery of the drug formulation and to stop the delivery.

25. The apparatus of claim 21, further comprising a heating element proximate to the administration reservoir that is operable by the controller to increase the temperature of the drug formulation in the administration reservoir.

26. A transdermal drug delivery device, comprising:

means for storing a first liquid and a second liquid each comprising a solvent and active substance mixture;

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; and

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.

27. The device of claim 26, wherein the first and second liquids are pumped concurrently to the administration reservoir.

28. The device of claim 26, 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.

29. A transdermal drug delivery device, comprising:

means for storing a liquid comprising a solvent and an active substance;

a dispensing mechanism comprising a feed channel connected to the drug reservoir;

an administration assembly comprising an administration reservoir connected to the feed channel for receiving the liquid from the storing means when pumped by the pump and a membrane permeable to the active substances in fluid communication with the administration reservoir, wherein the administration assembly further comprises a heating element operable to apply heat to the administration reservoir and the membrane; and

a controller operating automatically based on a dosing profile to control operations of the dispensing mechanism and the heating element, whereby permeation is enhanced by selective operation of the heating element.

30. The device of claim 29, wherein the administration assembly further comprises a temperature sensor transmitting a signal to the controller and wherein the controller performs the control operations for the heating element based on the signal from the temperature sensor to maintain a temperature of a portion of the administration assembly within a preset temperature range.