Biodegradable Statin Patch for Localized Cardiac Delivery
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Solution Overview
Problem
Current treatments for atrial fibrillation, particularly postoperative atrial fibrillation, are inadequate due to inconsistent systemic statin delivery leading to variable drug levels and increased risks of liver and muscle toxicities, while existing interventions have variable efficacy and associated risks.
Innovation Solution
A biodegradable polymeric matrix patch containing an HMG CoA reductase inhibitor, such as cerivastatin, is sutured to cardiac tissue for controlled and sustained release directly at the site of atrial fibrillation, providing consistent drug levels and minimizing systemic toxicity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If statins are administered systemically (orally), then vascular inflammation is reduced and NO bioavailability is improved, but drug levels become variable and liver/muscle toxicities increase
Solution Approach 1:
The patent applies local quality by transitioning from systemic statin administration to localized delivery at the atrial tissue site. The biodegradable polymeric matrix patch delivers statins directly to the target tissue, creating a localized high concentration of the drug where it is needed most, while minimizing systemic exposure and associated toxicities.
Solution Approach 2:
The biodegradable polymeric matrix acts as an intermediary carrier that enables controlled and sustained release of statins. This intermediary system provides consistent drug levels over time through its matrix structure, eliminating the variability associated with oral administration and first-pass metabolism.
2Reliability
If high dose statins are administered to ensure adequate concentration at target site, then AF prevention efficacy is improved, but liver and muscle toxicities increase
Solution Approach 1:
The patch delivers high concentrations of statins locally to the atrial tissue without requiring high systemic doses. This localized high-dose delivery achieves effective AF prevention at the target site while avoiding the systemic toxicity associated with high-dose oral statin therapy.
Solution Approach 2:
The invention segments the drug delivery system into a localized patch formulation that can be surgically implanted at the atrial site. This segmentation allows independent control of local drug concentration and duration, achieving high local efficacy without proportionally increasing systemic toxicity.
3Ease of operation
If oral statin administration is used, then ease of administration is maintained, but variability in patient response to liver metabolism reduces treatment reliability
Solution Approach 1:
The biodegradable polymeric matrix serves as an intermediary delivery system that bypasses the variable first-pass liver metabolism associated with oral administration. The matrix controls drug release kinetics directly at the target site, ensuring consistent drug levels regardless of individual patient metabolic variability.
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 local delivery of statins via a biodegradable patch achieves optimal vascular and cardiac benefits with reduced incidence of atrial fibrillation and minimized adverse effects, ensuring consistent drug levels and prolonged therapeutic action.
Implementation Method 1
controlled and sustained release directly at the site of atrial fibrillation
Implementation Method 2
biodegradable polymeric matrix
Data Source
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AI summary
A polymeric matrix for delivery of an HMG CoA reductase inhibitor such as a statin to tissue such as cardiac tissue in need thereof for the treatment or prevention of a disease or defect such as atrial fibrillation has been developed. In the preferred embodiment, a statin is delivered by means of a patch sutured to cardiac tissue at the time of cardiothoracic surgery. In the most preferred embodiment, the patch is a biodegradable material providing controlled or sustained release over a prolonged period of time, such as a week. Suitable materials include extracellular matrix, or other biodegradable hydrogels or polymeric materials providing sustained or controlled release of statin at the site of application.