Device and a system for delivery of biological material

• US 8,920,359 B2
• Filed: 03/15/2013
• Issued: 12/30/2014
• Est. Priority Date: 06/06/2008
• Status: Expired due to Fees

• Current Assignee: Wockhardt Limited
• Original Assignee: Wockhardt Limited
• Inventors: Kodgule, Mandar, Yallambalsi, Sachidananda
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US13/843,770
• Publication Number:
  US 20130226140A1
• Time in Patent Office: 655 Days
• Field of Search: 604/173, 604/22, 606/186
• US Class Current: 604/22
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001

Abstract

The present invention provides a device and a system for the delivery of biological material across the biological tissue. The device may be for the programmed delivery of biological material through a needle or a micro-needle or micro-needles or biodegradable micro-needles.

Claims

1. A device for delivery of a biodegradable micro-needle across a biological barrier, wherein the micro-needle comprises a therapeutically active ingredient and a biodegradable polymer, wherein the device comprises;

a. a micro-needle strip comprising a biodegradable micro-needle, and

b. a mechanism to cut a selected portion of biodegradable micro-needle corresponding to the selected dose of the biodegradable micro-needle to be delivered;

the mechanism further comprising a main piston and an auxiliary piston for positioning and applying the biodegradable micro-needles to the skin surface;

a roll for loading the micro-needle strip of biodegradable micro-needles;

a cutter for cutting the biodegradable micro-needles;

a flexible wall comprising an opening for discharge of micro-needles and housing holding all the components of the device;

wherein, the micro-needle strips comprising at least one biodegradable micro-needle.

2. The device as claimed in claim 1, wherein the geometrical shape of the biodegradable micro-needles is selected from the group consisting of cylindrical, conical, tapered, pyramidal, frustoconical and frustopyramidal.

3. The device as claimed in claim 1, wherein the cutting mechanism is a cutter, a razor, a known claw mechanism made of a sharp edged metal.

4. The device as claimed in claim 1, wherein main piston, auxiliary piston, and the roll is made of metal, plastic, polymeric material and combination thereof.

5. The device as claimed in claim 1, wherein biodegradable micro-needles has an outer diameter of from about 10 microns to 100 microns and length of at least 100 microns.

6. The device as claimed in claim 1, wherein the flexible wall is made of flexible polymeric material.

7. A method for delivering a biodegradable micro-needle comprising a biological material from a device wherein the method comprises (a) setting up the portion of the biodegradable micro-needle corresponding to the dose of the biodegradable micro-needle to be delivered, (b) rotating the main piston by half or one rotation in one direction to cut the portion of the biodegradable micro-needle corresponding to a set dose of biodegradable micro-needle, (c) rotating the main piston by half or one rotation for the next operation in the same direction to position the auxiliary piston for the next operation, (d) applying force on the main piston to position the biodegradable micro-needle on the flexible wall and to deliver the portion of the biodegradable micro-needle corresponding to a set dose of biodegradable micro-needle on to the skin surface and (e) a release mechanism to re-position the main piston to its original position.

8. The method as claimed in claim 7, wherein the portion of the biodegradable micro-needle corresponding to the selected dose includes the vertical movement of the micro-needle strip comprising of biodegradable micro-needles by a known mechanism.

9. The method as claimed in claim 7, wherein the application of force on the main piston either for positioning the biodegradable micro-needle or delivery on to the skin surface uses energy stored in a spring or any other known mechanism.

10. The method as claimed in claim 7 wherein the biological material is selected from the group comprising one or more peptides, proteins, carbohydrates, nucleic acid molecules, lipids and other pharmaceutically active ingredients or combinations thereof.