Microseeding device for gene delivery by microneedle injection

• US 7,422,574 B2
• Filed: 02/25/2003
• Issued: 09/09/2008
• Est. Priority Date: 05/19/1995
• Status: Expired due to Fees

• Current Assignee: Applied Tissue Technologies LLC
• Original Assignee: Applied Tissue Technologies LLC
• Inventors: Allison, W. Robert, Baker, Christian, Eriksson, Elof, Guiney, Patrick, Labombard, Denis, Johnson, Tom, Downing, Anthony, Porait, David, Navickas, John
• Primary Examiner(s): Mendez; Manuel A
• Application Number:
  US10/374,853
• Publication Number:
  US 20040058882A1
• Time in Patent Office: 2,023 Days
• Field of Search: 604/20, 604/21, 604/22, 604/66, 604/67, 604/289, 604/181, 604 65- 71, 604/131, 604/132, 604/134, 604/136, 604/151, 604/156, 604/183, 604/186, 604/191, 604/239, 604/246, 604/247, 604/257, 604/272, 604/273, 604/232, 604/290
• US Class Current: 604/264
• CPC Class Codes: A61K 48/00 Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
• CPC Class Codes: A61K 48/0083 characterised by an aspect of the administration regime
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons

Abstract

An apparatus is provided to enable the direct gene transfer of genetic material into a target cell site (“microseeding”), as a means of obtaining long term expression of native or non-native polypeptides in a host. The apparatus includes a matrix of microneedles that oscillate at a predetermined frequency and receive the genetic material from a delivery system that is integrated with the apparatus.

Claims

1. A microseeding assembly for delivering genetic material from a dispenser to a target site, the assembly comprising:

a housing;

a matrix of microneedles disposed on a translatable shaft at one end of the housing;

an integrated dispenser support assembly connected to the housing for supporting a genetic material dispenser, wherein the support assembly includes an actuator for initiating the delivery of genetic material from the dispenser to the microneedles; and

a drive assembly connected to the housing and communicating with the actuator and the microneedles to initiate delivery of genetic material to the microneedles and to oscillate the microneedles at a predetermined frequency.

2. The microseeding assembly as recited in claim 1, wherein the drive assembly comprises a first motor having an output shaft in mechanical communication with the microneedles.

3. The microseeding assembly as recited in claim 2, wherein the drive assembly further comprises a drive body disposed between the output shaft and the microneedles to convert rotational motion of the output shaft to linear oscillating motion of the microneedles.

4. The microseeding assembly as recited in claim 2, wherein the drive assembly further comprises a second motor having an output shaft in mechanical communication with the actuator.

5. The microseeding assembly as recited in claim 4, wherein the second motor is connected to a threaded output shaft, and wherein the actuator is connected to a follower receiving the threads of the output shaft and is translated in response to rotation of the output shaft.

6. The microseeding assembly as recited in claim 1, wherein the genetic material dispenser comprises a syringe.

7. The microseeding assembly as recited in claim 6, wherein the syringe comprises an output that delivers genetic material to the microneedles.

8. The microseeding assembly as recited in claim 2, wherein the microneedles are removably connected to the output shaft.

9. The microseeding assembly as recited in claim 8, further comprising a yoke connected to the output shaft.

10. The microseeding assembly as recited in claim 9, further comprising a microneedle assembly having a base and microneedles extending outwardly from the base, wherein the base is removably connectable to the yoke.

11. The microseeding assembly as recited in claim 4, further comprising a control module in electrical communication with the housing to control the first and second motors.

12. The microseeding assembly as recited in claim 11, wherein the control module controls activation of the first and second motors.

13. The microseeding assembly as recited in claim 11, wherein the control module controls a frequency of oscillation of the first motor.

14. The microseeding assembly as recited in claim 11, wherein the control module controls the rate of delivery of genetic material.

15. The microseeding assembly as recited in claim 1, wherein the microneedles are formed from photoetched flat sheet metal.

16. The microseeding assembly as recited in claim 1, wherein the microneedles are solid.

17. The microseeding assembly as recited in claim 16, wherein the microneedles are arranged into a multi-row matrix.