Swallowable Capsule with Expandable Balloon for Intestinal Wall Delivery
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Solution Overview
Problem
Existing drug delivery methods, such as oral administration, are limited due to poor absorption, degradation, and toleration issues in the gastrointestinal tract, while alternative methods like intravenous and implantable pumps have drawbacks like pain, infection risk, and semi-permanent implantation.
Innovation Solution
A swallowable drug delivery device comprising a capsule with a deployable aligner and a delivery mechanism, which includes a degradable capsule wall, an expandable balloon for alignment and drug delivery, and tissue penetrating members to deliver therapeutic agents directly into the intestinal wall.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If oral administration is used, then ease of operation is improved, but absorption and toleration are worsened
Solution Approach 1:
The capsule is divided into functional segments: an outer coating layer that protects against stomach acid, a deployable aligner mechanism, and a delivery mechanism with tissue-penetrating members. This segmentation allows the device to survive gastric conditions while enabling reliable intestinal wall penetration and drug delivery.
Solution Approach 2:
The patent introduces an intermediary delivery system that bridges the gap between oral administration and direct tissue delivery. The capsule serves as an intermediary vehicle that protects the drug through the stomach and delivers it directly to the intestinal wall, bypassing the limitations of conventional oral absorption.
2Ease of operation
If conventional oral delivery is used, then ease of operation is improved, but drug degradation is worsened
Solution Approach 1:
The outer coating is applied in advance to protect the drug from gastric acid degradation before the capsule enters the stomach. This preliminary protective action ensures the drug remains stable during gastric transit and is only released when it reaches the intended delivery site in the intestinal wall.
Solution Approach 2:
The invention extracts the drug from the vulnerable gastrointestinal lumen environment and delivers it directly into the intestinal wall tissue, removing it from the degrading gastric acid environment and placing it directly into the absorptive tissue where it can exert its therapeutic effect.
3Reliability
If intravenous delivery is used, then absorption reliability is improved, but ease of operation is worsened
Solution Approach 1:
The capsule is a self-contained delivery system that automatically navigates through the GI tract, deploys its aligner mechanism, penetrates the intestinal wall, and releases the drug without requiring external intervention. This self-service capability eliminates the need for needles, sterile technique, and medical professional intervention required by intravenous delivery.
4Manufacturing precision
If targeted intestinal wall delivery is used, then drug delivery precision is improved, but device complexity is worsened
Solution Approach 1:
The patent merges multiple functions into a single integrated capsule device: the outer coating provides gastric protection, the deployable aligner provides positioning, and the tissue-penetrating members provide delivery. This consolidation of functions into one swallowable unit achieves precise targeted delivery without requiring multiple separate devices or complex implantation procedures.
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 device enables targeted and efficient delivery of therapeutic agents, including proteins and peptides, that are poorly absorbed orally, while avoiding the drawbacks of conventional drug delivery methods by providing rapid and controlled release of drugs into the bloodstream.
Implementation Method 1
an expandable balloon for alignment and drug delivery
Implementation Method 2
The capsule wall is degradable by contact with liquids in the GI tract
Implementation Method 3
an outer coating or layer which only degrades in the higher pH's found in the small intestine
Data Source
AI summary
Embodiments provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade within the wall to release the drug to produce a therapeutic effect. The preparation can be coupled to a delivery mechanism having one or more balloons or other expandable devices which are expandable responsive to a condition in the small intestine or other GI lumen to advance the preparation out of the capsule into the intestinal wall. Embodiments are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.