INTEGRATED INTRA-DERMAL DELIVERY, DIAGNOSTIC AND COMMUNICATION SYSTEM

• US 20090187167A1
• Filed: 12/17/2008
• Published: 07/23/2009
• Est. Priority Date: 12/17/2007
• Status: Active Grant

• Current Assignee: New World Pharmaceuticals, LLC
• Original Assignee: New World Pharmaceuticals, LLC
• Inventors: Schuckers, Stephanie, Cetinkaya, Cetin, Sazonov, Eduard, Sexton, Frederick A., Suni, Ian Ivar
• Granted Patent: US 9,022,973 B2
• Time in Patent Office: Days
• US Class Current: 604/891.100
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0038 having a channel at the side surface
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

In one embodiment, an IDDC system utilizes an intelligent therapeutic agent delivery system comprised of one, but more likely an array of “cells” containing therapeutic agent(s) and/or diagnostic agents(s); an integrated bio-sensing system designed to sample and analyze biological materials using multiple sensors that include both hardware and software components. The software component involves biomedical signal processing to analyze complex liquid mixtures and a microcontrollers) acts as interface to the biosensors, to the therapeutic delivery elements, and to a communications system(s) for the purpose of controlling the amount of therapeutic agent to deliver and also to provide information in a useful form to interested parties on the progress of therapy and compliance thereto. The synergistic effect of combining the above describe elements is expected to dramatically improve patient compliance with prescribed therapy, quality and timeliness of care provided by physicians, and at the same time reduce the cost of providing effective healthcare to IDDC system users, thereby improving profitability for Managed Care organizations and pharmaceutical companies utilizing the system.

Claims

1. An intra-dermal delivery system comprising:

at least one micro/nano sized drug delivery device for intra-dermally delivering a drug below the stratum corneum, the drug being stored in a space within the device, the device having an actuator for causing selective movement of at least a portion of the device to deliver the drug below the stratum corneum;

a programmable controller in communication with the at least one device for controlling the actuation of the actuator; and

a biofeedback device that is in communication with the programmable controller and includes at least one biosensor that measures at least one bio-property of the patient,

wherein the controller is programmed based on a patient'"'"'s needs to delivery the drug at a prescribed time or based on a signal received from the biofeedback device.

2. The system of claim 1, wherein the at least one drug delivery device comprises:

at least one storage cell that has at least one substance stored therein for administration to a patient, each cell including a first actuating element associated therewith; and

a lancet that has a delivery conduit defined by an entrance and an exit defined at a sharp distal end of the lancet, the device having a second actuating element associated therewith;

wherein at least one of the first and second actuating elements is energized by a source of power to cause the first and second actuating elements to move together resulting in the lancet being driven toward and through the cell so as to cause the substance stored in the cell to flow into the entrance, through the lancet to the exit where it is discharged into the patient'"'"'s body below the stratum corneum.

3. The system of claim 2, wherein the first and second actuating elements comprise one of first and second magnetic members and first and second piezoelectric elements.

4. The system of claim 1, wherein the at least one drug delivery device comprises:

a first actuating element for placement along a target location of a patient'"'"'s skin;

an implant device having a base portion including a post and a second actuating element and an implant body for implantation in the patient, the implant body being removably coupled to the post and including barbs and containing a substance that is to be intra-dermally delivered to the patient; and

a means for energizing at least one of the first and second actuating elements to cause the implant device to be driven into the patient'"'"'s body, thereby implanting the implant body at a desired location and depth, the barbs preventing removal of the implant body when the base portion and post are retracted after the actuating element has been de-energized.

5. The system of claim 4, wherein the first and second actuating elements comprise one of first and second magnetic members and first and second piezoelectric elements.

6. The system of claim 1, wherein the at least one drug delivery device comprises:

an implant device having a substrate and a plurality of posts extending therefrom and a plurality of implant bodies being removably coupled to the posts and designed for implantation in the patient, each implant body including barbs and containing a substance that is to be intra-dermally delivered to the patient; and

a protective layer of gel material that can be penetrated by the implant bodies when a sufficient force is applied to the substrate in the direction of the gel layer.

7. The system of claim 1, wherein the at least one drug delivery device comprises:

a body having a hollow interior and a bottom edge that can be placed against the patient'"'"'s skin;

a reservoir located within the interior, the reservoir containing the drug;

a movable base that is disposed within the interior and defines at least a portion of the reservoir; and

at least one microneedle that is in selective communication with the reservoir and is coupled to the movable base such that movement of the base is translated into movement of the microneedle;

wherein the actuator is operatively coupled to movable base to cause controlled movement thereof, thereby causing the microneedle to be moved such that a drug delivery tip thereof is advanced beyond the bottom edge and into the skin below the stratum corneum.

8. The system of claim 7, wherein the actuator causes the movable base to oscillate resulting in the microneedles oscillating at a frequency between greater than 0 kHz to about 3 MHz, with amplitudes greater than 0 microns to about 250 microns.

9. The system of claim 7, wherein the microneedle includes at least one channel that is in selective communication with the drug reservoir to allow the drug to flow therethrough to an open distal tip.

10. The system of claim 9, wherein the at least one channel is in communication with a flow control member that controls flow of the drug through the channel.

11. The system of claim 8, wherein there are at least two channels formed in the microneedle, each channel having its own flow control member.

12. The system of claim 9, wherein one of the channels is a back pressure channel.

13. The system of claim 10, wherein the flow control member comprises a directional valve/pump.

14. The system of claim 7, wherein there are a plurality of microneedles each of which can be actuated and moved independently from the others.

15. The system of claim 7, wherein the actuator comprises first and second piezoelectric strips that are disposed such that the reservoir is located therebetween, the strips being operatively coupled to an energy source.

16. The system of claim 7, wherein the actuator is at least one actuator selected from the group consisting of a pressure actuator and a motion actuator.

17. The system of claim 7, wherein the biosensor is in selective communication with the reservoir via a channel that has a flow control device disposed therealong for restricting flow between the sensor and the reservoir.

18. The system of claim 7, wherein the sensor is integrated with the body of the at least one drug delivery device.

19. The system of claim 7, wherein the biofeedback device is in wireless communication with the programmable controller.

20. The system of claim 7, wherein at least one of the biofeedback device and the sensor measures the bio-property and sends a signal containing information regarding the measured bio-property to the programmable controller.

21. The system of claim 20, wherein the programmable controller is in communication with an external device that includes at least one of a display which can display the information regarding the measured bio-property and a memory in which the information can be stored.

22. The system of claim 21, wherein the external device is a handheld device and the communication comprises wireless communication between the handheld device and the controller.

23. The system of claim 7, wherein the actuator creates a back pressure in the microneedle causing a fluid to be drawn into the microneedle, into the reservoir and into contact with the sensor.

24. The system of claim 23, wherein the fluid is one of blood and interstitial fluid.

25. The system of claim 2, wherein the storage cell includes a flexible stable membrane that holds the substance and the first actuating element is a magnetic membrane disposed along one surface of the flexible membrane.

26. The system of claim 2, wherein the lancet has a base portion on which the second actuating element is disposed and is located opposite the sharp second end such that the entrance is located between the base portion and the second end.

27. The system of claim 26, wherein the delivery device includes a biasing member that is coupled to an underside of the base portion and in contact with the lancet above the entrance, the biasing member being configured to store energy when the delivery device is in an active mode due to energizing the actuating element and upon the actuating element being de-energized, the biasing member is configured to release its stored energy and cause the lancet to retract from the cell.

28. The system of claim 4, wherein the implant body is formed of a polymer matrix that has bioresorbable properties.

29. The system of claim 4, wherein the implant device includes a biasing member that is coupled to an underside of the base portion and in contact with the post, the biasing member being configured to store energy when the implant device is in an active mode due to energizing the actuating element and upon the actuating element being de-energized, the biasing member is configured to release its stored energy and cause the base portion and post to retract from the patient.

30. The system of claim 1, wherein the drug delivery device includes:

an implant device having a substrate and a plurality of posts extending therefrom and a plurality of implant bodies being removably coupled to the posts and designed for implantation in the patient, each implant body including barbs and containing a substance that is to be transdermally delivered to the patient; and

a protective layer of gel material that can be penetrated by the implant bodies when a sufficient force is applied to the substrate in the direction of the gel layer.

31. An intradermal system comprising:

at least one micro/nano sized device that is configured for intradermally delivering a drug below the stratum corneum and for withdrawing a body fluid for testing thereof;

the device having an actuator for causing selective movement of at least a portion of the device to deliver the drug below the stratum corneum or to withdraw the body fluid;

a programmable controller in communication with the at least one device for controlling the actuation of the actuator; and

a biofeedback device that is in communication with the programmable controller and includes at least one biosensor that measures at least one bio-property of the patient, wherein the biofeedback device is configured to send diagnostic information to the controller independently of drug delivery,

wherein the controller is programmed based on a patient'"'"'s needs to delivery the drug at a prescribed time or based on a signal received from the biofeedback device.

32. An intra-dermal delivery system comprising:

an array of combined micro/nano sized storage cells and delivery devices, each storage cell containing a drug;

a programmable controller that includes an energy source, each of the micro/nano sized storage cell/delivery device combinations being individually linked to the energy source, the controller being configured to be programmed depending upon the patient'"'"'s needs to sequentially fire a prescribed number of the delivery devices over a period of time to delivery the drug at set time intervals and over the period of time; and

a biofeedback device that is in communication with the programmable controller and includes at least one bio sensor that measures at lease one bio-property of the patient and sends a signal if the measured bio-property falls outside an acceptable range, thereby resulting in the biofeedback device instructing the programmable controller to actuate the energy source(s) associated with one or more of the combined micro/nano sized storage cells/delivery devices.

33. An intra-dermal delivery system comprising:

a cartridge including;

a flexible implant device having a substrate and a plurality of supports extending therefrom and a plurality of implant bodies being removably coupled to the supports and designed for implantation in the patient, each implant body including barbs and containing a substance that is to be intra-dermally delivered to the patient; and

a protective layer of gel material that can be penetrated by the implant bodies when a sufficient force is applied to the substrate in the direction of the gel layer; and

an applicator that has a compartment that receives the cartridge, the applicator having electronics, including a controller, formed on a permanent interface device thereof, the controller being configured to selectively actuate the cartridge for delivering a select number of implants to the patient and advance the implant device so that a fresh number of implant devices are ready for delivery.