Balloon Drug Delivery Coating with Polymer Encapsulation
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Solution Overview
Problem
There is a need for medical device technology that can rapidly, efficiently, and safely transfer a drug delivery formulation from a percutaneous medical device coating to a specific site in the body, with existing solutions not adequately addressing the requirements of reproducibility and safety.
Innovation Solution
A medical device is developed where at least 50% of the pharmaceutical agent's surface area is encapsulated in a polymer layer, with specific thickness and crystallinity, using spray-drying or tumbling processes, and deposited on a balloon using the eSTAT coating process, ensuring controlled release of the agent upon inflation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a coating is applied to a percutaneous medical device, then the drug delivery formulation can be transferred to the body, but the transfer efficiency and reproducibility are insufficient
Solution Approach 1:
The pharmaceutical agent is pre-encapsulated in a polymer layer with specific thickness (5-15 microns) and crystallinity (25-95%) before device application. This preliminary structuring ensures controlled release kinetics and reproducible transfer characteristics when the device is deployed in the body.
Solution Approach 2:
The invention optimizes specific parameters including polymer layer thickness (5-15 microns), pharmaceutical agent crystallinity (25-95%), and particle size (1-10 microns) to achieve both high transfer efficiency and reproducible release profiles. These parameter controls enable predictable drug delivery performance.
2Quantity of substance
If the polymer layer is made thicker to encapsulate more drug, then the drug loading increases, but the release control becomes more difficult
Solution Approach 1:
The invention maintains polymer layer thickness within 5-15 microns and controls pharmaceutical agent crystallinity between 25-95% to optimize both drug loading capacity and release profile precision. These parameter ranges enable sufficient drug encapsulation while maintaining controllable release kinetics.
Solution Approach 2:
The polymer-pharmaceutical agent composite structure with specific crystallinity ranges creates a material system that balances high drug loading with controlled release. The composite formulation enables both increased drug capacity and maintained release precision.
3Stability of the object's composition
If the pharmaceutical agent is highly crystalline for stability, then the storage stability improves, but the release rate may be reduced
Solution Approach 1:
The invention optimizes pharmaceutical agent crystallinity within 25-95% to balance storage stability and release rate. This parameter optimization ensures that the drug maintains sufficient crystalline structure for stability while preserving adequate release kinetics for effective therapy.
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 solution enables controlled and efficient release of the pharmaceutical agent, ensuring at least 3% of the drug is released upon balloon inflation, with sustained release profiles up to 72 hours, enhancing the delivery efficacy and safety of the drug formulation.
Implementation Method 1
at least 50% of the surface area of the pharmaceutical agent is encapsulated in the polymer layer
Implementation Method 2
deposited on a balloon using the eSTAT coating process
Implementation Method 3
ensuring controlled release of the agent upon inflation
Data Source
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AI summary
A medical device that releases a pharmaceutical agent to a target site is disclosed. The medical device includes a balloon, and a coating on at least a portion of the balloon. Each particle of the particles of the pharmaceutical agent is at least partially encapsulated in a polymer layer. The method includes the steps of providing a device including a balloon, and a coating on at least a portion of the balloon, the coating including particles of a pharmaceutical agent, and each particle of the pharmaceutical agent is at least partially encapsulated in a polymer layer; positioning the device to allow the balloon to reach the target site; and inflating the balloon of the device.