Cutting Balloon Coating Transfer via Crystalline Drug Morphology
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Solution Overview
Problem
Current medical devices face challenges in rapidly, efficiently, and safely transferring drug delivery formulations from their surface to specific sites in the body, particularly with existing technologies not effectively addressing the need for controlled release and high transfer efficiency.
Innovation Solution
A medical device featuring a cutting balloon with a coating comprising a pharmaceutical agent in a crystalline form, which is adapted to be freed or transferred from the substrate upon stimulation, utilizing tacking elements like cutting wires and mechanical, chemical, or thermal stimulations to ensure controlled release and high transfer efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If a coating is applied to the substrate surface, then drug delivery capability is improved, but transfer efficiency to the target site deteriorates
Solution Approach 1:
The coating is segmented into multiple layers with different functions: an adhesive layer for substrate attachment, a drug-containing layer for therapeutic delivery, and a release layer for controlled transfer. This segmentation allows each layer to optimize its specific function, improving overall transfer efficiency while maintaining drug delivery capability.
Solution Approach 2:
The coating is pre-applied and stabilized on the substrate during device manufacturing, with the drug already positioned in the correct location and orientation. This preliminary action ensures that when the device is deployed, the transfer process only requires triggering the release mechanism, significantly improving transfer efficiency compared to applying drug coatings at the time of use.
2Stability of the object's composition
If the coating is firmly attached to the substrate, then manufacturing stability is improved, but release and transfer control deteriorates
Solution Approach 1:
The attachment between coating and substrate is made dynamic rather than static. The adhesive layer maintains strong attachment during manufacturing and delivery, but can be triggered to release under specific conditions (such as pH change, temperature, or mechanical stimulus). This dynamic property resolves the contradiction by providing both stability and controlled release capability.
Solution Approach 2:
An intermediary release layer is introduced between the drug-containing coating and the substrate. This intermediate layer provides the bonding strength needed for stable attachment during manufacturing, while also serving as the trigger point for controlled release. The intermediary layer can be designed to respond to specific stimuli, enabling precise control over when and how the coating transfers to the target site.
3Speed
If rapid drug transfer is achieved, then treatment effectiveness is improved, but control and safety deteriorate
Solution Approach 1:
The drug transfer process is designed as a periodic, triggered event rather than a continuous process. The coating remains stable on the substrate during delivery, then transfers rapidly in a single controlled event when triggered by a specific stimulus (such as pH change, temperature shift, or mechanical activation). This periodic action ensures both rapid transfer effectiveness and precise control over timing and location.
Solution Approach 2:
The release of the coating is controlled by changing a specific parameter (such as pH, temperature, or mechanical stress) at the target site. This parameter change triggers a conformational or chemical change in the release layer that causes rapid coating detachment and transfer. By using parameter changes rather than continuous force, the system achieves both rapid transfer and precise spatial-temporal control, maintaining safety and reliability.
Data Source
AI summary
Provided is a coated implantable medical device, comprising: a substrate; and a coating disposed on said substrate, wherein said coating comprises at least one polymer and at least one pharmaceutical agent in a therapeutically desirable morphology and/or at least one active biological agent and optionally, one or more pharmaceutical carrying agents; wherein substantially all of pharmaceutical agent and/or active biological agent remains within said coating and on said substrate until the implantable device is deployed at an intervention site inside the body of a subject and wherein upon deployment of said medical device in the body of said subject a portion of said pharmaceutical agent and/or active biological agent is delivered at said intervention site along with at least a portion of said polymer and/or a at least a portion of said pharmaceutical carrying agents.