Device and a system for delivery of biological material

• US 8,540,678 B2
• Filed: 06/05/2009
• Issued: 09/24/2013
• 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:
  US12/996,368
• Publication Number:
  US 20110196308A1
• Time in Patent Office: 1,572 Days
• Field of Search: 604/173, 604/22, 604/272, 606/186
• US Class Current: 604/173
• 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 application 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 microneedles.

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, the device comprises a micro-needle strip comprising one or more biodegradable micro-needles, a housing (7), a roll(1), a main piston (2), an auxiliary piston (4) and a cutter (8), and a mechanism to select the number of biodegradable micro-needles to be delivered;

the device is characterized in that it comprises a mechanism to cut, position and discharge on to the skin, a selected portion of biodegradable micro-needle corresponding to a selected dose of the therapeutic active ingredient to be delivered;

said mechanism comprises the cutter (8) and auxiliary piston (4) directly attached to the main piston (2).

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, or a claw mechanism made of a sharp edged metal.

4. The device as claimed in claim 1, wherein main piston (2), auxiliary piston (4), and the roll (1) are made of metal, plastic, polymeric material and or combination thereof.

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

6. The device as claimed in claim 1 wherein the therapeutically active ingredient is selected from the group consisting of one or more of peptides, proteins, carbohydrates, nucleic acid molecules, lipids and other pharmaceutically active ingredients or combinations thereof.

7. The device of claim 1, wherein the auxiliary piston (4) is attached to the main piston (2) circumferentially at an angle.

8. The device of claim 7, wherein the auxiliary piston (4) is attached to the main piston (2) at its end.

9. The device of claim 7, wherein the angle is from 30°

to 180°

.

10. The device of claim 1, wherein the cutter (8) is integrally attached to the main piston (2) circumferentially.

11. The device of claim 1, wherein the main piston (2) is of circular, rectangular or square shape.

12. The device of claim 1, wherein the auxiliary piston (4) is of circular, rectangular or square shape.