Stent Pockets for Therapeutic Agent Carrying Capacity
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Solution Overview
Problem
Current medical devices, such as stents, have limited carrying capacity for therapeutic agents, particularly when delivering biopharmaceuticals like gene therapies and proteins, making it difficult to explore and test the upper therapeutic application windows.
Innovation Solution
A stent design featuring struts with pockets defined by multiple layers, where at least one pocket contains a therapeutic agent, allowing for increased carrying capacity and controlled release of the agent.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If a coated medical device is used for delivering therapeutic agents, then localized delivery is achieved, but the carrying capacity is limited
Solution Approach 1:
The stent surface is segmented into multiple discrete pockets formed by radial folds, allowing therapeutic agents to be contained in separate compartments. This segmentation increases the total carrying capacity by creating multiple storage sites while maintaining a relatively simple overall device structure.
Solution Approach 2:
The invention transitions from a two-dimensional surface coating to a three-dimensional pocket structure by creating radial folds that extend inward from the stent surface. This dimensional change provides additional volume for therapeutic agent storage, significantly increasing carrying capacity without substantially increasing the external device footprint.
2Quantity of substance
If the surface area of the medical device is increased, then the carrying capacity increases, but the device becomes more complex
Solution Approach 1:
The invention utilizes the radial dimension by creating folds that extend inward from the stent surface, creating pockets with significant volume relative to the surface area. This allows increased carrying capacity without proportionally increasing the external surface area of the device.
Solution Approach 2:
The pockets are nested within the stent structure itself, utilizing the existing stent material and geometry to form the storage compartments. This nesting approach increases carrying capacity by utilizing internal volume rather than requiring additional external material.
3Adaptability or versatility
If biopharmaceuticals are delivered using coated medical devices, then therapeutic delivery is achieved, but the upper therapeutic application windows are difficult to explore
Solution Approach 1:
The multiple pockets provide separate compartments for different biopharmaceuticals or different doses of the same agent, enabling exploration of upper therapeutic application windows by allowing combination therapy or dose escalation without increasing overall device complexity.
Solution Approach 2:
The three-dimensional pocket structure provides substantially increased volume for biopharmaceutical storage compared to traditional surface coating, enabling delivery of larger doses and broader therapeutic application windows for proteins and gene therapies.
Data Source
Figure 1A
Figure 1B~2A
Figure 2B~2C
AI summary
A medical device for delivering a therapeutic agent to a body lumen is described. The device may generally be a stent with an inner sidewall surface and an outer sidewall surface, with a plurality of struts having a plurality of openings therein. An inner and outer layer may be applied to the stent, forming pockets within at least a portion of the openings. The pockets may be filled with at least one therapeutic agent. The pockets may take a variety of shapes and sizes, and may be designed for release or rupture in variety of ways.