Integrated intra-dermal delivery, diagnostic and communication system

• US 10,384,005 B2
• Filed: 03/31/2015
• Issued: 08/20/2019
• Est. Priority Date: 12/17/2007
• Status: Active Grant

• Current Assignee: New World Pharmaceuticals, LLC
• Original Assignee: New World Pharmaceuticals, LLC
• Inventors: Sexton, Frederick A., Suni, Ian Ivar, Cetinkaya, Cetin, Schuckers, Stephanie, Sazonov, Eduard
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Wilson, Larry R.
• Application Number:
  US14/674,847
• Publication Number:
  US 20150273148A1
• Time in Patent Office: 1,603 Days
• 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 microcontroller(s) 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:

a plurality of drug delivery devices that are arranged in an array, the plurality of drug delivery devices for intra-dermally delivering at least one drug below a stratum corneum, the at least one drug being stored in at least one storage cell within each of the plurality of drug delivery devices, each drug delivery device of the plurality of drug delivery devices having a lancet and an actuator causing selective movement of a respective drug delivery device to deliver the at least one drug contained in the at least one storage cell of the respective drug delivery device below the stratum corneum;

a programmable controller in communication with the plurality of drug delivery devices for controlling the actuation of the actuators of the plurality of drug delivery devices; and

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

wherein the programmable controller is programmed based on patient information to deliver the at least one drug at a prescribed time or based on a signal received from the biofeedback device;

wherein the actuator of each drug delivery device of the plurality of drug delivery devices comprises a first actuating element and a second actuating element, and wherein each at least one storage cell includes the first actuating element associated therewith; and

the lancet of each drug delivery device of the plurality of drug delivery devices has a delivery conduit defined by an entrance and an exit defined at a sharp distal end of the lancet, each lancet having the 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 at least one storage cell so as to cause the one respective drug stored in the at least one storage cell to flow into the entrance, through the lancet to the exit for releasing the one respective drug below the stratum corneum.

2. The system of claim 1, wherein the first and second actuating elements comprise one of first and second magnetic members and first and second piezoelectric elements.

3. The system of claim 1, wherein the biofeedback device is in wireless communication with the programmable controller.

4. The system of claim 1, wherein the at least one storage cell includes a flexible stable membrane that holds the one respective drug and the first actuating element is a magnetic membrane disposed along one surface of the flexible stable membrane.

5. The system of claim 1, wherein the lancet of each drug delivery device of the plurality of drug delivery devices has a base portion on which the second actuating element is disposed and is located opposite the sharp distal end such that the entrance is located between the base portion and the sharp distal end.

6. The system of claim 5, wherein each drug delivery device of the plurality of drug delivery devices 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 respective drug delivery device is in an active mode due to energizing the actuator, and upon the actuator being de-energized the biasing member is configured to release its stored energy and cause the lancet to retract from the at least one storage cell.

7. The system of claim 1, wherein the programmable controller is configured to sequentially signal the actuator of each of the plurality of drug delivery devices to cause sequential actuation of a prescribed number of the plurality of drug delivery devices.

8. The system of claim 1, wherein the plurality of drug delivery devices includes a first set of drug delivery devices containing a first drug and a second set of drug delivery devices containing a second drug to permit timed separate delivery of the first drug and the second drug.

9. The system of claim 1, wherein the at least one storage cell includes a flexible stable membrane that holds the one respective drug and the first actuating element is a magnetic membrane disposed along one surface of the flexible stable membrane and the second actuating element comprises a magnetic contact comprising one or more magnetic pads.

10. The system of claim 9, wherein the lancet of each drug delivery device of the plurality of drug delivery devices has a length that is approximately equal to a thickness of the stratum corneum.

11. The system of claim 9, wherein at least one of the first actuating element and the second actuating element comprises an electro-magnet and the other of the first actuating element and the second actuating element comprises at least one of a permanent magnet and a permanent magnetic layer.

12. The system of claim 9, wherein the magnetic membrane has a variable thickness with a peripheral outer edge having a greater thickness than a center portion of the magnetic membrane.

13. The system of claim 9, wherein the first actuating element and the second actuating element and the programmable controller are configured such that the first actuating element and the second actuating element can be energized multiple times in succession to create a pumping action.

14. The system of claim 1, wherein the entrance is open along a side of the lancet of each drug delivery device of the plurality of drug delivery devices and is formed perpendicular to a main longitudinal portion of the delivery conduit defined with the exit being formed at one end of the main longitudinal portion.

15. The system of claim 1, wherein in an extended position of the lancet of each drug delivery device of the plurality of drug delivery devices after either of the first or second actuating element is energized, the entrance is disposed within the at least one storage cell to permit entry of the at least one drug into the lancet of each drug delivery device of the plurality of drug delivery devices and flow to the exit, the entrance being oriented along an axis that is perpendicular to an axis that passes through the exit.

16. The system of claim 1, wherein the plurality of drug delivery devices comprises micro sized drug delivery devices.

17. The system of claim 1, wherein the plurality of drug delivery devices comprises nano sized drug delivery devices.