In-Situ Microneedle Formation Device with Temperature Control
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Solution Overview
Problem
Conventional microneedle arrays face limitations such as limited penetration, customization requirements, difficulties in achieving clinically relevant dimensions, poor conformation to skin, need for secondary bandages, inability to administer multiple therapeutics simultaneously with controlled spatiotemporal distribution, and limited shelf-life, which hinder their clinical application.
Innovation Solution
A handheld device for in-situ formation of microneedles in tissue, comprising a microneedle coupled to a chamber with a reservoir of biomaterial fluid, motors for precise control, and a temperature control assembly, allowing for adjustable microneedle size and density, and enabling the formation of microneedle arrays directly in the tissue without prior fabrication.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If prefabricated microneedle arrays are used, then microneedles can be manufactured with controlled dimensions, but they have limited penetration strength and limited shelf-life
Solution Approach 1:
The device performs preliminary actions by forming microneedles in-situ within the tissue rather than inserting prefabricated microneedles. The microneedle-forming composition is delivered through hollow needles and solidifies to create microneedles that are already positioned and adapted to the tissue, eliminating the need for strong prefabricated microneedles to penetrate intact tissue.
Solution Approach 2:
The hollow needles serve as intermediaries to deliver the microneedle-forming composition into the tissue. These hollow needles penetrate the tissue (which is easier than inserting solid microneedles into intact tissue) and then the delivered composition forms the actual microneedles in-situ, transferring the penetration function to the hollow needles while the final microneedles provide the therapeutic function.
2Manufacturing precision
If prefabricated microneedle arrays are used, then microneedles can be manufactured with controlled dimensions, but they have limited shelf-life
Solution Approach 1:
The device performs preliminary actions by forming microneedles in-situ within the tissue rather than inserting prefabricated microneedles. The microneedle-forming composition is delivered through hollow needles and solidifies to create microneedles that are already positioned and adapted to the tissue, eliminating the need for strong prefabricated microneedles to penetrate intact tissue.
Solution Approach 2:
The system changes the state of the microneedle material from liquid/composed state (in the reservoir) to solid microneedle structure (in-situ in tissue) through parameter changes such as temperature control, pH adjustment, or crosslinking. This allows the microneedles to be manufactured on-demand with precise dimensional control while avoiding shelf-life limitations of prefabricated arrays.
3Ease of operation
If conventional microneedle arrays are applied to skin, then they can deliver therapeutics, but they require secondary bandages to secure the array in place
Solution Approach 1:
The in-situ formed microneedles are self-securing within the tissue matrix. Once the composition is delivered and solidifies, the microneedles become integrated into the tissue structure, eliminating the need for external bandages or securing mechanisms. The microneedles serve themselves by becoming part of the tissue architecture.
4Productivity
If conventional microneedle arrays are used, then they can deliver therapeutics, but they have limited ability to administer multiple therapeutics simultaneously with controlled spatiotemporal distribution
Solution Approach 1:
The microneedle-forming composition can be segmented into multiple compositions delivered through the same or different hollow needles. Each composition can contain different therapeutics with controlled release properties, allowing simultaneous administration of multiple therapeutics with independent spatiotemporal distribution control within the same tissue site.
Solution Approach 2:
The hollow needle delivery system serves multiple functions: it penetrates tissue, delivers microneedle-forming composition, and can deliver multiple different therapeutic compositions. This universal delivery platform replaces the need for separate microneedle arrays for each therapeutic, enabling multi-therapeutic administration through a single device.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables precise and effective delivery of therapeutics, overcoming penetration strength limitations, eliminating the need for secondary bandages, and allowing for customizable, simultaneous administration of multiple therapeutics with controlled release, while maintaining tissue integrity and reducing material usage.
Implementation Method 1
a first motor coupled to the body and the reservoir, the first motor configured to activate the reservoir to expel the biomaterial fluid to the microneedle
Implementation Method 2
a temperature control assembly coupled to the reservoir, the temperature control assembly configured to set and maintain a temperature of the reservoir
Implementation Method 3
a second motor coupled to the body and the microneedle... the microneedle to penetrate the tissue
Implementation Method 4
inject the biomaterial fluid into the tissue to generate an in-situ microneedle in the tissue
Data Source
AI summary
A device and method for generating in-situ microneedles in a subject. The device includes a body, a microneedle coupled to the body, a reservoir coupled to the body, a first motor. The microneedle is positioned within a chamber at a distal end of the body. The reservoir includes a biomaterial fluid and is in fluid communication with the microneedle. The first motor is configured to activate the reservoir to expel the biomaterial fluid to the microneedle. The device also includes a temperature control assembly coupled to the reservoir and configured to set and maintain a temperature of the reservoir, a second motor coupled to the body and the microneedle, a microneedle size device coupled to the microneedle and configured to set a length of the microneedle extending from the chamber. Lastly, the device includes a user interface configured to receive input from a user to control the microneedle to penetrate the tissue to inject the biomaterial fluid into the tissue to generate an in-situ microneedle in the tissue.