# US 8,540,678 B2 · Device and a system for delivery of biological material

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- Number: US 8,540,678 B2
- Document ID: US8540678B2
- Status: Granted
- Kind: B2
- Application number: 12/996,368
- Filed: 2009-06-05
- Published: 2011-08-11
- Granted: 2013-09-24
- Earliest claimed: 2008-06-06
- Assignees: Wockhardt Limited
- Applicants: Mandar Kodgule; Sachidananda Yallambalsi
- Inventors: Mandar Kodgule; Sachidananda Yallambalsi
- Web page: https://patentgrep.com/patent/US8540678B2

## CPC

- A61M 37/0015: {by using microneedles}
- A61M 5/1452: {pressurised by means of pistons}
- 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)}
- A61M 5/2466: {by piercing without internal pressure increase (A61M5/2429 takes precedence)}
- 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; Devices for protection of needles
- A61M 2037/0023: {Drug applicators using microneedles}
- A61M 2037/003: {having a lumen}
- A61M 2037/0061: {Methods for using microneedles}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## 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

### Claim 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).

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 1)

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.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 1)

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

### Claim 8 (depends on 7)

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

### Claim 9 (depends on 7)

The device of claim 7, wherein the angle is from 30° to 180°.

### Claim 10 (depends on 1)

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

### Claim 11 (depends on 1)

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

### Claim 12 (depends on 1)

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