Apparatus and method for manufacturing microneedles

• US 7,708,544 B2
• Filed: 07/21/2004
• Issued: 05/04/2010
• Est. Priority Date: 07/21/2003
• Status: Active Grant

• Current Assignee: 10x Technology LLC
• Original Assignee: 10x Technology LLC
• Inventors: Pricone, Robert M.
• Primary Examiner(s): Gupta; Yogendra
• Assistant Examiner(s): Luk; Emmanuel S
• Application Number:
  US10/565,356
• Publication Number:
  US 20080099963A1
• Time in Patent Office: 2,113 Days
• Field of Search: 425/387.1, 425/405.1, 425/503, 425/504, 425/812, 425/817.R, 425/817.C, 264/570, 264/154, 264/155, 264/156
• US Class Current: 425/387.1
• CPC Class Codes: B29C 2043/3647 Membranes, diaphragms
• CPC Class Codes: B29C 33/3814 Porous moulds adapted for vacuum forming B29C51/365
• CPC Class Codes: B29C 33/50 elastic or flexible for isostatic pressing B29C43/3642
• CPC Class Codes: B29C 43/021 characterised by the shape of the surface
• CPC Class Codes: B29C 43/12 using bags surrounding the moulding material or using membranes contacting the moulding material
• CPC Class Codes: B29L 2031/7544 Injection needles, syringes
• CPC Class Codes: B29L 2031/756 Microarticles, nanoarticles

Abstract

The apparatus comprises a mold assembly including at least one bore therethrough having a cavity therein defining the shape of the finished microneedle shape to be formed therein. The bore has an inlet opening and an exit opening. The apparatus also comprises means for locating the polymer to be formed at one end of the cavity and means for introducing fluid into the inlet opening of said bore and into the cavity. The apparatus also comprises exhaust means communicating with the exit opening of the bore, so that introducing the fluid through the polymer causes the polymer to assume the shape of the cavity and the fluid forms a hollow channel to define a needle-like structure in the polymer as the fluid is exhausted through the cavity and the bore.

Claims

1. Apparatus for forming an array of microneedle structures in a polymer material, said apparatus comprising a mold assembly including at least one bore therethrough having a cavity therein defining the shape of the finished microneedle shape to be formed therein, said bore having an inlet opening and an exit opening;

means for locating the polymer to be formed at one end of said cavity;

means for introducing fluid into said inlet opening of said bore and into said cavity; and

exhaust means for communicating with said exit opening of said bore, whereby introducing said fluid through said polymer causes said polymer to assume the shape of said cavity and said fluid forms a hollow channel to define a needle-like structure in said polymer as said fluid is exhausted through said cavity and said bore, and wherein said mold assembly includes upper and lower manifolds separated by a fluid-tight gasket disposed therebetween, and said mold forming cavity is in said upper manifold.

2. The apparatus set forth in claim 1, and further including a gas permeable membrane disposed between said gasket and said cavity with said polymer to be disposed above said gas permeable membrane.

3. The apparatus of claim 1, wherein said lower manifold has a gas inlet communicating with an internal cavity that feeds to said at least one bore.

4. The apparatus of claim 1, wherein the polymer is a UV-curable polymer and said upper manifold is formed with a transparent or translucent section to allow such polymer to be exposed to UV light while still in said mold cavity for curing said formed polymer.

5. The apparatus of claim 1, wherein said gas permeable membrane is formed of a polyester fabric.

6. The apparatus of claim 1, wherein said gasket is in the form of a rigid strip of material having openings therein aligned with said bore and said cavity.

7. The apparatus of claim 1, wherein said gasket is comprised of a silicone rubber.

8. The apparatus of claim 1, wherein said structure defining said microneedle-shaped cavity further comprises a mold form disposed between said upper and lower manifolds and above said gas permeable member.

9. An apparatus for forming an array of microneedle structures in a polymer material, said apparatus comprising a mold assembly having an upper manifold and lower manifold, each of said manifolds being adapted to be positioned in airtight relation relative to one another, the upper manifold having at least one cavity formed therein;

at least one bore in said lower cavity feeding through to a bore in said cavity and through said upper manifold;

an inlet port feeding said bore in said lower manifold;

an exit port for exhausting said upper cavity via said bore in said upper manifold;

a gas impervious gasket disposed between said upper and lower manifolds;

a gas permeable membrane adapted to be positioned between said upper and lower manifolds.

10. The apparatus of claim 9, wherein said upper manifold includes a plurality of mold forming cavities therein, each of said mold forming cavities being configured to provide a microneedle-like structure therein, with the height of said needle being approximately 160 microns and having a base diameter of approximately 50 microns and the spacing of at least two of said microneedle assemblies being disposed approximately 300 microns from one another center-to-center.

11. The apparatus of claim 9, wherein the through hole or channel formed by said microneedle cavity is of a tapered configuration.

12. The apparatus of claim 11, wherein said gas permeable membrane is formed of a polyester fabric.

13. The apparatus of claim 11, wherein said gasket is in the form of a rigid strip of material having openings therein aligned with said bore and said cavity.

14. The apparatus of claim 11, wherein said gasket is comprised of a silicone rubber.

15. The apparatus of claim 11, wherein said structure defining said microneedle-shaped cavity further comprises a mold form disposed between said upper and lower manifolds and above said gas permeable member.