Swallowable Capsule with Biodegradable Shell for Cell Delivery
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Solution Overview
Problem
Current methods for delivering viable cells, such as proteins and stem cells, face challenges including poor oral toleration, gastric irritation, breakdown in the stomach, and inefficient absorption, while conventional delivery methods like intravenous and implantable pumps have drawbacks like pain, infection risk, and require sterile techniques.
Innovation Solution
Development of swallowable devices with biodegradable shells and viability-sustaining gels that protect cells as they pass through the gastrointestinal tract, allowing for targeted delivery of living cells, like pancreatic beta cells, to the intestinal tissue, using pH-sensitive coatings and expandable balloons for penetration and deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If viable cells are delivered orally, then the delivery route is non-invasive and convenient, but the cells suffer from gastric irritation, breakdown in the stomach, and poor absorption
Solution Approach 1:
The delivery system is segmented into multiple functional components: an outer capsule for oral administration, an inner shell for tissue penetration, and a cell-containing composition. This segmentation allows each component to perform its specific function - the capsule protects cells during GI transit, the shell penetrates tissue, and the composition delivers viable cells to the target site
Solution Approach 2:
The shell is pre-configured with a tissue-penetrating tip and the cell composition is pre-prepared in a viable state within the shell before administration. The pH-sensitive coating is pre-applied to the shell to ensure it remains intact during stomach passage and only degrades at the target pH level in intestinal tissue, preserving cell viability until delivery
2Reliability
If conventional delivery methods like intravenous injection are used, then cells can be delivered directly to bloodstream, but the method causes pain, infection risk, and requires sterile technique
Solution Approach 1:
The swallowable capsule and biodegradable shell act as intermediaries that enable cell delivery without direct needle injection. The oral capsule serves as a non-invasive vehicle to transport the cell-containing shell through the GI tract, eliminating the need for sterile IV techniques and needle-related complications while still achieving effective cell delivery to target tissue
3Duration of action of moving object
If implantable delivery pumps are used, then cells can be delivered continuously, but the device requires semi-permanent implantation and maintains limitations of IV delivery
Solution Approach 1:
The invention uses a disposable, single-use swallowable capsule containing a biodegradable shell instead of a permanent implantable pump. The shell is designed to degrade after delivering its cell payload, eliminating the need for complex implantable devices while providing sufficient delivery duration for therapeutic effect. This approach reduces device complexity and eliminates long-term implantation requirements
4Productivity
If the shell degrades quickly in tissue, then cells are released rapidly for immediate therapeutic effect, but the shell may not survive long enough to reach the target tissue
Solution Approach 1:
The shell's degradation behavior is controlled by changing the pH parameter - it remains stable at lower pH (stomach) and degrades at higher pH (intestinal tissue). This parameter-based control allows the shell to survive transit through the GI tract and then rapidly degrade upon reaching the target tissue, achieving both prolonged survival time during transport and rapid cell release at the destination
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 the effective and safe delivery of viable cells to the intestinal tissue, maintaining cell viability and facilitating the release of therapeutically beneficial agents, such as insulin, with controlled degradation and acoustical monitoring of shell bioerosion for optimal delivery timing.
Implementation Method 1
The shell may have a pH-sensitive coating configured to resist degradation in the stomach and degrade in the intestine
Implementation Method 2
The device may include an expandable balloon configured to penetrate the tissue upon expansion
Implementation Method 3
The shell may be biodegradable and configured to degrade in the tissue after delivery
Data Source
AI summary
Embodiments provide swallowable devices, preparations and methods for delivering viable cells (VC) into the GI tract including GI wall tissue or other tissue site. Particular embodiments provide a swallowable device such as a capsule for delivering VC into an intestinal wall or other site. The VC can be contained within a tissue-penetrating shell disposed in the capsule that protects the VC as they pass through the GI tract until they are inserted into GI tract tissue or other location. The shell desirably has shape, size and material consistency to be contained in a swallowable capsule, delivered from the capsule into solid tissue by the application of force on the shell and biodegrade within the solid tissue to release the VC into the tissue. Within the shell or other structure the VC can be maintained in a viability-sustaining gel that preserves the viability of the VC for selected time periods.