Heart Valve Decalcification Device
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Solution Overview
Problem
Calcification deposits on heart valves lead to dysfunctional valve function, causing serious complications such as heart failure, blood clotting, and stroke, with current treatments requiring surgical replacement and lifelong blood thinners, and lacking effective methods for regeneration or repair.
Innovation Solution
Mechanical removal of calcium deposits using a bur or ultrasonic device, followed by biocompatible solvent cleaning and bioelectric stimulation to promote regeneration, optionally with nitinol ring placement and autologous cell-created leaflets, utilizing a handheld device or catheter system for decalcification and regeneration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical replacement is used to treat calcified heart valves, then valve function is restored, but patients require lifelong blood thinners and undergo major surgery
Solution Approach 1:
The patent extracts and removes only the calcified deposits from the heart valve while preserving the native valve structure, rather than replacing the entire valve. This is achieved through mechanical decalcification devices that selectively remove calcium deposits, allowing the valve to retain its original function without requiring replacement or lifelong anticoagulation therapy
Solution Approach 2:
The patent enables the heart valve to serve itself by regenerating and repairing its own tissue through bioelectric stimulation and biochemical treatments. The native valve tissue is stimulated to self-heal and regenerate, eliminating the need for external replacement devices and reducing long-term medication requirements
2Reliability
If mechanical decalcification is performed to remove calcium deposits, then valve function is improved, but debris must be removed and tissue regeneration required
Solution Approach 1:
The patent combines multiple functions into a single integrated procedure: mechanical decalcification to remove calcium deposits, simultaneous debris removal through suction, bioelectric stimulation for tissue regeneration, and biochemical treatment for healing. This multi-functional approach addresses all procedural needs in one treatment session, reducing overall complexity despite the comprehensive nature of the intervention
Solution Approach 2:
The patent introduces biochemical solvents and bioelectric stimulation as intermediary agents that facilitate the decalcification and regeneration process. These intermediaries help break down calcium deposits and stimulate tissue healing without requiring harsh mechanical force or complex multi-step procedures, simplifying the overall treatment approach
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
Restores heart valve function by removing calcification, promoting tissue healing and regeneration, potentially avoiding surgical replacement and lifelong medication, with minimally invasive procedures that reduce downtime and improve quality of life.
Implementation Method 1
The mechanical removal of the calcium deposits may be accomplished with a burr and/or an ultrasonic device
Implementation Method 2
calcium deposits on the heart valve may be further removed by directing a stream of biocompatible solvent onto the heart valve
Implementation Method 3
After cleaning, bioelectric stimulation may be provided to the heart valve
Data Source
AI summary
Methods of heart valve decalcification may include mechanically removing calcium deposits on a heart valve, and removing debris from the mechanical decalcification via suction. The mechanical removal of the calcium deposits may be accomplished with a burr and/or an ultrasonic device. In some embodiments, mechanical removal of the calcium deposits may be accomplished with a handheld mechanical decalcification device comprising a bur extending from a hand piece. A catheter system for removing plaque deposits from a heart valve may include at least one mechanical decalcification device configured for cleaning the edges of heart valve leaflets, and at least one active aspiration device. The at least one mechanical decalcification device may comprise a bur and/or an ultrasonic device. The system may additionally include a deployable net apparatus configured to encompass at least a portion of a heart valve.