Allergen-Coated Microneedles for Food Allergy Desensitization
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Solution Overview
Problem
Current treatments for peanut allergy, such as oral immunotherapy and subcutaneous injections, face challenges with high adverse events and lack of sustained unresponsiveness, while transdermal patches have low immune modulating effects due to skin impermeability to large molecules.
Innovation Solution
A method using microneedle arrays coated with allergens, which are inserted into the skin to deliver allergens and optionally adjuvants, allowing them to dissociate and induce a protective immune response, achieving desensitization and potentially sustained unresponsiveness.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If transdermal patches are used to deliver peanut proteins, then the treatment is non-invasive and easy to administer, but the skin's impermeability to large molecules prevents effective delivery of the allergen
Solution Approach 1:
The microneedle array divides the delivery function into multiple individual needles, each capable of penetrating the skin barrier independently. This segmentation allows the system to overcome the skin's impermeability while maintaining ease of application as a single patch unit.
Solution Approach 2:
The invention transitions from surface-level transdermal delivery to subsurface delivery by using microneedles that penetrate through the epidermis. This dimensional change from 2D surface contact to 3D tissue penetration enables effective allergen delivery while keeping the application process simple.
2Reliability
If oral immunotherapy with rapidly escalating peanut doses is used, then desensitization can be achieved, but high adverse reaction rates occur during the rush dose escalation phase
Solution Approach 1:
The microneedle delivery system performs preliminary action by directly introducing the allergen into the cutis layer, bypassing the need for rapid oral dose escalation. This preliminary penetration allows controlled immune system exposure without triggering severe gastrointestinal or systemic reactions.
Solution Approach 2:
The microneedles act as an intermediary delivery mechanism between the allergen and the immune system. This intermediary approach replaces direct oral ingestion with controlled transdermal delivery, reducing adverse reactions while maintaining desensitization effectiveness.
3Quantity of substance
If subcutaneous injections are used for immunotherapy, then the allergen can be delivered effectively, but the procedure is invasive and requires medical personnel administration
Solution Approach 1:
The invention extracts the invasive injection needle from the administration process by using microneedles that are too small to require syringes or medical personnel. The allergen delivery function is separated from the complex injection apparatus, enabling patient self-administration.
Solution Approach 2:
The microneedle patch enables self-service administration by eliminating the need for medical personnel. Patients can apply the patch themselves, making the treatment accessible outside clinical settings while maintaining effective allergen delivery.
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
The method achieves significant desensitization and reduced adverse events by targeting dendritic cells in the skin, increasing allergen-specific IgG antibodies and decreasing IgE antibodies, mast cells, and promoting sustained unresponsiveness to peanut allergens.
Implementation Method 1
inserting one or more solid microneedles each having a base, shaft and tip into the subject's cutis
Implementation Method 2
The allergen is allowed to dissociate from the microneedles while inserted in the subject's cutis
Implementation Method 3
delivering an effective amount of an allergen associated with the food allergy into the subject's cutis
Data Source
AI summary
Methods and devices are provided for treating a food allergy in a subject in need thereof. The method entails delivering an effective amount of an allergen associated with the food allergy into the subject's cutis skin layer. Delivering the allergen is carried out by inserting one or more allergen-coated solid microneedles into the subject's skin. The one or more solid microneedles each has a base, shaft and tip, and when inserted in the subject, do not extend beyond the cutis. The allergen is allowed to dissociate from the one or more microneedles while inserted in the subject's cutis. Once the allergen disassociates, the one or more microneedles is removed from the subject's skin.