Nested Balloon Assembly for Calcium Disruption
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Solution Overview
Problem
Current methods for treating aortic valve stenosis and other vascular lesions, such as balloon valvuloplasty and aortic valve replacement, are inadequate in effectively disrupting calcium deposits on heart valves, leading to performance and safety concerns, and are invasive and costly.
Innovation Solution
A catheter system with a balloon assembly comprising an inner and outer balloon, where a plasma-induced bubble is generated between the balloons to impart pressure waves for fracturing calcium deposits, using an energy source and energy guide to deliver energy and create a plasma-induced bubble in the interstitial space between the balloons.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If standard balloon valvuloplasty is used to treat aortic valve stenosis, then the procedure is less invasive and lower cost, but it does not have enough strength to sufficiently disrupt calcium deposits between the leaflets or at the base of the leaflets
Solution Approach 1:
The patent employs a nested balloon configuration where an inner balloon is positioned within an outer balloon. This nested structure allows the delivery of higher expansion forces to disrupt calcium deposits while maintaining a manageable device profile for catheter delivery. The inner balloon provides the primary fracturing force, while the outer balloon offers structural support and containment.
Solution Approach 2:
The balloon assembly is segmented into multiple functional components: an inner balloon for direct calcium deposit disruption, an outer balloon for structural support and fluid containment, and an interstitial space between them for energy guide placement. This segmentation allows each component to perform its specific function optimally while working together to achieve the overall therapeutic effect.
2Reliability
If aortic valve replacement is performed to treat severe aortic valve stenosis, then valve functionality is restored, but the procedure is highly invasive and extremely expensive
Solution Approach 1:
The patent performs preliminary valvuloplasty action using the dual-balloon system with plasma-induced bubble energy delivery to disrupt calcium deposits before valve replacement. This preliminary disruption of calcifications improves the effectiveness of subsequent valve placement and reduces the invasiveness and complexity of the overall procedure by pre-conditioning the valve structure.
Solution Approach 2:
The patent substitutes traditional mechanical high-pressure balloon expansion with a plasma-induced bubble energy delivery system. This non-mechanical or reduced-mechanical approach uses energy delivery through the interstitial space to achieve calcium deposit disruption with potentially lower mechanical forces, reducing the invasiveness associated with extreme high-pressure inflation.
3Strength
If high pressure is applied during balloon valvuloplasty to break apart calcification, then calcium deposits are disrupted, but the procedure may not achieve sufficient effectiveness for heavily calcified valves
Solution Approach 1:
The patent introduces an interstitial space between the inner and outer balloons as an intermediary medium for energy delivery. This space accommodates an energy guide that delivers plasma-induced bubble energy to the calcium deposits. The intermediary energy delivery mechanism allows effective calcium disruption without requiring extreme mechanical pressures that could damage the valve structure or surrounding tissue.
Solution Approach 2:
The patent changes the physical parameter of energy delivery from purely mechanical pressure to plasma-induced bubble energy. This parameter change enables effective calcium deposit disruption through a different physical mechanism that may be more selective and less damaging to surrounding tissues, achieving the desired strength effect with reduced harmful factors.
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 system effectively breaks up calcium deposits on heart valves, improving valve functionality and reducing the need for invasive procedures, while being more efficient and cost-effective than existing methods.
Implementation Method 1
A portion of the energy guide that receives the energy from the energy source is positioned within the interstitial space between the balloons so that a plasma-induced bubble (also sometimes referred to herein as 'plasma') is formed in the balloon fluid within the interstitial space
Implementation Method 2
the plasma-induced bubble formation imparts pressure waves upon the outer balloon and/or directly onto the treatment site to induce fractures in the vascular lesions
Data Source
AI summary
A catheter system (100) used for treating a treatment site (106) within or adjacent to the heart valve (108) includes an energy source (124), an energy guide (122A), and a balloon assembly (104). The energy source (124) generates energy. The energy guide (122A) is configured to receive energy from the energy source (124). The balloon assembly (104) is positionable substantially adjacent to the treatment site (106). The balloon assembly (104) includes an outer balloon (104B) and an inner balloon (104A) that is positioned substantially within the outer balloon (104B). Each of the balloons (104A, 104B) has a balloon wall (130) that defines a balloon interior (146). Each of the balloons (104A, 104B) is configured to retain a balloon fluid (132) within the balloon interior (146). The balloon wall (130) of the inner balloon (104A) is positioned spaced apart from the balloon wall (130) of the outer balloon (104B) to define an interstitial space (146A) therebetween. A portion of the energy guide (122A) that receives the energy from the energy source (124) is positioned within the interstitial space (146A) between the balloons (104A, 104B) so that a plasma-induced bubble (134) is formed in the balloon fluid (132) within the interstitial space (146A).