Method of manufacturing an intracutaneous microneedle array

A method of preparing a mold for manufacturing a microneedle array, comprising:

• providing a photoresist material, in contact with a temporary substrate;
• placing a mask layer upon said photoresist material, said mask layer having a predetermined pattern, at least a portion of said mask layer comprising a material that prevents high energy radiation from passing therethrough;
• exposing said combination photoresist material/mask layer to high energy radiation;
• removing said mask layer, and chemically developing exposed portions of said photo-resist material, thereby removing portions of the photoresist material and leaving behind a pattern of said photoresist material that represents a three-dimensional structure emulating a plurality of microneedles that are to be later formed;
• electroplating said patterned photoresist material with a metallic substance;
• and
• detaching said metallic substance from said patterned photoresist material, said metallic substance thereby forming a microneedle array mold;
• wherein said patterned photoresist material is chemically coated before the step of electroplating to aid in later detachment of the metallic substance from the patterned photoresist material.

A method of preparing a mold for manufacturing a microneedle array, comprising:

• providing a photoresist material, in contact with a temporary substrate;
• placing a mask layer upon said photoresist material, said mask layer having a predetermined pattern, at least a portion of said mask layer comprising a material that prevents high energy radiation from passing therethrough;
• exposing said combination photoresist material/mask layer to high energy radiation;
• removing said mask layer, and chemically developing exposed portions of said photo-resist material, thereby removing portions of the photoresist material and leaving behind a pattern of said photoresist material that represents a three-dimensional structure emulating a plurality of microneedles that are to be later formed;
• electroplating said patterned photoresist material with a metallic substance;
• and
• detaching said metallic substance from said patterned photoresist material, said metallic substance thereby forming a microneedle array mold;
• wherein said method of preparing a mold for manufacturing a microneedle array further comprises a microembossing procedure, comprising:
• placing a plastic material upon a temperature-controlled surface and, by use of said temperature-controlled surface, heating said plastic material to substantially its elastic working temperature, said plastic material having a first substantially planar surface touching said temperature-controlled surface and a second substantially planar surface on its opposite side;
• pressing said microneedle array mold against the second substantially planar surface of said plastic material, thereby forming a three-dimensional pattern comprising a microneedle array in said plastic material;
• by use of said temperature-controlled surface, cooling said patterned plastic material below its deformable temperature;
• and
• de-molding, by removing said microneedle array mold from contact with said patterned plastic material, thereby leaving behind a plastic microneedle array.

A method of manufacturing a microneedle array, comprising:

• providing a microneedle array mold;
• providing a temperature-controlled mold chamber;
• providing a heated plastic material into said temperature-controlled mold chamber having its temperature raised substantially to its elastic working temperature, while causing said microneedle array mold to be held in an appropriate position until a microneedle array three-dimensional pattern is formed in said plastic material;
• by use of said temperature-controlled mold chamber, cooling said patterned plastic material below its deformable temperature;
• and
• de-molding, by removing said microneedle array mold from contact with said patterned plastic material, thereby leaving behind a plastic microneedle array.

A method of manufacturing a microneedle array, comprising:

• providing a laminate material comprising two layers of biocompatible plastic;
• providing a first mold having a plurality of projections that face against a surface of said laminate material;
• placing said laminate material upon a first temperature-controlled surface and, by use of said first temperature-controlled surface, heating said laminate material to substantially its elastic working temperature;
• pressing said first mold against one surface of said laminate material such that said plurality of projections extend completely through a first of the two layers of biocompatible plastic, thereby forming a plurality of through-holes in said first layer;
• by use of said first temperature-controlled surface, cooling said laminate material below its deformable temperature;
• detaching said two layers of biocompatible plastic, and retaining said first layer;
• placing said first layer of biocompatible plastic upon a second temperature-controlled surface and, by use of said second temperature-controlled surface, heating said first layer of biocompatible plastic to substantially its elastic working temperature;
• providing a second mold having a microneedle array pattern, and pressing said second mold against one surface of said first layer of biocompatible plastic, thereby forming a three-dimensional pattern comprising a microneedle array in said first layer of biocompatible plastic;
• by use of said second temperature-controlled surface, cooling said patterned biocompatible plastic below its deformable temperature;
• and
• de-molding, by removing said second mold from contact with said patterned biocompatible plastic, thereby leaving behind a plastic microneedle array that exhibits through-holes in its base element.