Self-Righting GI Needle for Targeted Biologic Tissue Delivery
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Solution Overview
Problem
Existing pharmaceutical drug formulations face challenges in delivering biologic drugs like insulin through the GI tract due to degradation by enzymes and require refrigeration, while oral administration results in random diffusion and inefficient delivery.
Innovation Solution
Self-righting articles with differential density portions and self-actuating mechanisms enable targeted delivery by anchoring and releasing active pharmaceutical agents directly into tissue, utilizing self-righting behavior and mechanical or electrical components for precise administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If liquid formulation is used for injection, then delivery of biologic drugs is achieved, but API stability deteriorates requiring refrigeration and increased bulk
Solution Approach 1:
The patent changes the physical state parameter of the API from liquid to solid formulation. The solid needle comprises compressed API material that can be directly implanted into tissue, eliminating the need for liquid formulation and associated refrigeration requirements while maintaining API stability.
Solution Approach 2:
The patent extracts the liquid formulation step from the delivery system. Instead of delivering API as a liquid that requires refrigeration and dilution, the solid needle delivers compressed API directly to the target tissue, removing the unstable liquid phase entirely.
2Ease of operation
If oral administration is used, then ease of administration is improved, but delivery precision deteriorates due to random diffusion
Solution Approach 1:
The self-righting article uses its own structural properties (asymmetric density distribution) to automatically orient itself toward the tissue wall upon ingestion, eliminating the need for external guidance systems while achieving precise tissue targeting through passive gravitational and buoyant forces.
Solution Approach 2:
The patent employs asymmetric density distribution within the article structure, with denser portions positioned to create a preferred orientation axis. This asymmetry causes the article to rotate and self-align perpendicular to the GI tract wall, transforming random diffusion into directed tissue penetration.
3Reliability
If mucoadhesives and texturing are used to ensure juxtaposition with GI mucosa, then delivery effectiveness is improved, but device complexity increases
Solution Approach 1:
The patent replaces chemical mucoadhesive mechanisms with a physical self-righting mechanism based on density-driven orientation. The asymmetric density distribution creates gravitational and buoyant forces that automatically align the needle perpendicular to the tissue wall, eliminating the need for chemical adhesives or complex mechanical anchoring structures.
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
Achieves targeted delivery of biologic drugs with higher bioavailability and stability, reducing the need for refrigeration and external force, and allows for localized administration in the GI tract.
Implementation Method 1
the self-righting article comprises a first portion, a second portion adjacent the first portion having a different average density than the first portion
Implementation Method 2
a spring at least partially encapsulated within the outer shell, a support material associated with the spring such that the support material maintains at least a portion of the spring under at least 5% compressive strain
Implementation Method 3
the support material maintains at least a portion of the spring under at least 5% compressive strain under ambient conditions
Implementation Method 4
at least one anchoring mechanism associated with the self-righting article... configured to anchor at a location internal to a subject
Data Source
AI summary
Self-actuating articles including, for example, self-actuating needles and/or self-actuating biopsy punches, are generally provided. Advantageously, the self-actuating articles described herein may be useful as a general platform for delivery of a wide variety of pharmaceutical drugs that are typically delivered via injection directly into tissue due to degradation in the GI tract. The self-actuating articles described herein may also be used to deliver sensors and/or take biopsies without the need for an endoscopy. In some embodiments, the article comprises a spring (e.g., a coil spring, a beam, a material having particular mechanical recovery characteristics). Those of ordinary skill in the art would understand that the term spring is not intended to be limited to coil springs, but generally encompass any reversibly compressive material and/or component which, after releasing an applied compressive force on the material/component, the material/component substantially returns to an uncompressed length of the material/component (e.g., the within 95% of the length of the material/component prior to compression).