Solid micro-perforators and methods of use

• US 8,062,573 B2
• Filed: 09/15/2003
• Issued: 11/22/2011
• Est. Priority Date: 09/16/2002
• Status: Active Grant

• Current Assignee: TheraJect, Inc.
• Original Assignee: TheraJect, Inc.
• Inventors: Kwon, Sung-Yun
• Primary Examiner(s): Johnson; Christina
• Assistant Examiner(s): HAUTH, GALEN H
• Application Number:
  US10/528,059
• Publication Number:
  US 20050251088A1
• Time in Patent Office: 2,990 Days
• Field of Search: 264/319, 424/427, 424/428
• US Class Current: 264/319
• 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 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

Porous microperforators (210A), preferably in an array of multiple perforators are employed for delivery of a drug, where the micro-perforators may dissolve in situ. Suitable micro-perforators may include multiple layers of dissolvable materials to effect sequential drug delivery. In further aspects, contemplated micro-perforators may employ a diagnostic device in which a detector layer or detector is operationally coupled to the micro-perforators.

Claims

1. A method of manufacture of a micro-perforator, comprising:

providing a solidifiable material, and forming the solidifiable material, optionally in admixture with a diagnostic or therapeutic agent into a desired micro-perforator shape;

wherein the step of forming the solidifiable material includes a step of solidifying the solidifiable material such that the solidified material in the desired micro-perforator shape has a plurality of pores that optionally comprise the diagnostic or therapeutic agent; and

optically contacting the solidified material in the desired micro-perforator shape with the diagnostic or therapeutic agent such that the diagnostic or therapeutic agent is at least partially enclosed in the plurality of pores,

wherein the solidifiable material shrinks during the step of solidifying the solidifiable material, and

wherein shrinking of the solidifiable material is controlled by one of formulation of the solidifiable material and drying the solidifiable material to reduce an apex angle of the micro-perforator.

2. The method of claim 1 wherein the solidifiable material comprises a sol/gel material.

3. The method of claim 2 wherein the sol/gel material further comprises the diagnostic or therapeutic agent.

4. The method of claim 3 wherein the step of forming comprises a step of filing the sol/gel material into a mold to which a force is applied to improve settling of the sol/gel material into the mold, and wherein the step of forming is performed at ambient temperature.

5. The method of claim 2 wherein porosity of the solidified sol/gel material is controlled via adjustment of the pH in the unsolidified sol/gel material.

6. The method of claim 1 wherein the solidifiable material comprises a sinterable material.

7. The method of claim 6 wherein the sinterable material further comprises the diagnostic or therapeutic agent.

8. The method of claim 6 wherein porosity of the solidified sinterable material is controlled via at least one of pressure, particle size and temperature during the step forming the solidifiable material.

9. The method of claim 1 wherein the solidifiable material comprises a gelling agent or a viscous material, and wherein the step of forming the solidifiable material includes a step of removing air bubbles from the gelling agent or viscous material using positive or negative pressure.

10. The method of claim 1 wherein the solidified material in the desired micro-perforator shape that optionally comprises the diagnostic or therapeutic agent dissolves in a skin of a person over a predetermined period when applied to the skin.

11. The method of claim 10 wherein dissolution of the micro-perforator is completed in less than one day.

12. The method of claim 1 further comprising a step in which the solidified material is the desired micro-perforator shape is contacted with a second solidifiable material, and in which the second solidifiable material is formed into a desired micro-perforator shape to provide a laminated micro-perforator.