Implantable microneedle and manufacturing method therefor
Inventors
Yang, Seung Yun • YIM, Sang-Gu • HWANG, Young Jun
Assignees
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Publication Number
US-11938308-B2
Publication Date
2024-03-26
Expiration Date
Abstract
The present invention provides an implantable microneedle and a manufacturing method therefor. An implantable microneedle according to the present invention comprises a coating layer for covering at least one part of the surface of a tip part of the microneedle. When exposed to moisture, the coating layer can be separated from the tip part of the microneedle and thus be implanted.
Core Innovation
The disclosed invention provides an implantable microneedle having a tip with a swellable-polymer based coating layer covering at least a portion of the tip surface. The coating layer is removable from the microneedle in a body environment. A sacrificial layer is disposed between the tip surface and the swellable-polymer based coating layer, and the sacrificial layer dissolves in moisture before the swellable-polymer based coating layer dissolves.
In the manufacturing approach, a sacrificial layer solution is coated on the tip before forming the coating layer. A swellable polymer solution is then dripped on the sacrificial layer to form the coating layer thereon. The sacrificial layer has been dissolved in water before the swellable polymer based coating layer is dissolved in water, thereby enabling separation behavior associated with insertion and removal.
The swellable polymer based coating layer is configured for mechanical engagement with tissue by swelling in moisture, including bodily fluid or blood, to mechanically engage tissue. During insertion and removal, the coating layer separates and can be implanted while the microneedle is removed. The coating and sacrificial layers together support selective drug carriage in the tip coating for quantitative delivery, with sustained release related to crosslinking.
Claims Coverage
The document contains two independent claims that share a core concept: a microneedle tip that carries a swellable-polymer based coating layer with an intervening sacrificial layer that dissolves earlier in moisture to allow the coating layer to separate and become implanted. The independent claims cover a manufacturing method with sequential sacrificial-layer and coating-layer dripping and dissolution timing, and an implantable microneedle structure with a moisture-ordered dissolution and removable coating layer in a body environment.
Sequential sacrificial-layer coating and swellable-polymer deposition
Before forming the coating layer, coating a sacrificial layer solution on a surface of the tip of the microneedle to form a sacrificial layer thereon; wherein forming the coating layer includes dripping the swellable polymer solution on the sacrificial layer to form the coating layer thereon.
Moisture-ordered dissolution to enable removable coating
The sacrificial layer has been dissolved in water before the swellable polymer based coating layer has been dissolved in water.
Removable swellable-polymer based coating in body environment
A tip; and a swellable polymer based coating layer covering at least a portion of a surface of the tip, wherein the coating layer is removable from the microneedle in a body environment.
Sacrificial layer disposed between tip and swellable coating
A sacrificial layer disposed between the surface of the tip of the microneedle and the swellable polymer based coating layer, wherein the sacrificial layer covers at least a portion of the tip surface of the microneedle, wherein the sacrificial layer has been dissolved in moisture before the swellable polymer based coating layer has been dissolved in moisture, and wherein the coating layer covers at least a portion of the sacrificial layer.
Across the independent claims, the inventive concept centers on a swellable-polymer based coating layer on a microneedle tip that is removable in a body environment, made possible by a sacrificial layer that dissolves in moisture before the swellable-polymer coating dissolves. The manufacturing claim further grounds the concept by requiring sequential coating of the sacrificial layer followed by dripping the swellable polymer solution onto the sacrificial layer, with the sacrificial layer dissolved in water before the swellable coating layer is dissolved.
Stated Advantages
Selective drug carriage in the tip coating for quantitative delivery.
Reduced drug waste.
Sustained release via crosslinking.
Prevention of tissue damage/secondary infection by filling the insertion hole.
Documented Applications
An implantable microneedle where the coating layer can separate and be implanted in the body during insertion and removal, including use as a drug delivery means for quantitative delivery with sustained release.
Filling an insertion hole in the body to prevent tissue damage/secondary infection by the retained coating layer.
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