Segmented Lithotripsy Balloon for Varying Vessel Diameters
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Solution Overview
Problem
Vascular lesions within and adjacent to vessels in the body are difficult to treat effectively, posing a risk for major adverse events such as myocardial infarction, embolism, and stroke, and existing interventions may not always be ideal or require subsequent treatment.
Innovation Solution
A catheter system with an inflatable balloon configured to be movable between inflated and deflated states, featuring distinct balloon regions with varying diameters and an energy carrier, such as an optical fiber, to deliver energy pulses that induce plasma formation and pressure waves to fracture vascular lesions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional interventions (drug therapy, balloon angioplasty, atherectomy, stent placement) are used to treat severe vascular lesions, then treatment can be performed, but treatment efficacy is insufficient and subsequent treatments are required
Solution Approach 1:
The patent replaces conventional mechanical interventions (balloon angioplasty, atherectomy) with acoustic energy delivery through a catheter system. The system uses acoustic waves to fragment calcified lesions, substituting mechanical force with acoustic energy to achieve more effective lesion treatment and reduce the need for subsequent procedures.
Solution Approach 2:
The patent changes the physical parameters of energy delivery by using acoustic waves with specific frequency and intensity ranges to fragment calcified tissue. The system delivers acoustic energy at parameters optimized for calcification fragmentation, transforming the treatment approach from mechanical to acoustic parameter-based intervention.
2Adaptability or versatility
If the balloon diameter is uniform throughout, then manufacturing is simpler, but the balloon cannot effectively adapt to vessels with varying diameters or deliver energy to different lesion locations
Solution Approach 1:
The balloon is divided into multiple segments with different diameters along its length. Each segment can be independently inflated to match the local vessel diameter, allowing the balloon to adapt to varying vessel geometries and effectively treat lesions at different locations along the vessel.
Solution Approach 2:
Different portions of the balloon are designed with different diameters and acoustic energy delivery characteristics tailored to local requirements. The balloon incorporates varying wall thicknesses, acoustic transducer placements, and inflation pressures at different segments to optimize treatment efficacy for specific lesion types and locations.
3Reliability
If acoustic energy is delivered to fragment calcified lesions, then treatment efficacy is improved, but the system complexity increases due to energy carrier and delivery mechanisms
Solution Approach 1:
The patent introduces an acoustic transducer as an intermediary device that converts electrical energy to acoustic waves for lesion fragmentation. The transducer acts as a mediator between the power source and the calcified lesion, enabling effective energy transfer while containing the complexity within a standardized component that can be integrated into the catheter system.
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 treats vascular lesions by imparting mechanical energy to induce fractures, reducing the risk of adverse events and improving treatment efficacy.
Implementation Method 1
energy pulses that induce plasma formation and pressure waves to fracture vascular lesions
Implementation Method 2
energy pulses that induce plasma formation and pressure waves to fracture vascular lesions
Implementation Method 3
The energy source is a laser
Data Source
AI summary
A catheter system (100) for treating a treatment site (106) within or adjacent to a vessel wall (108) or heart valve includes a balloon (104) having a balloon length (204L). The balloon (104) is configured to be movable between an inflated state (135) and a deflated state. The balloon (104) includes (i) a balloon proximal region (250), (ii) a balloon distal region (254), and (iii) a balloon transition region (252). The balloon proximal region (250) has a balloon proximal end (204P) and a substantially constant balloon proximal region diameter (256) while the balloon (104) is in the inflated state (135). The balloon distal region (254) has a balloon distal end (104D), and a substantially constant balloon distal region diameter (262) while the balloon (104) is in the inflated state (135). The balloon distal region diameter (262) is different than the balloon proximal region diameter (256). The balloon transition region (252) has a balloon transition region diameter (260) that varies. The balloon transition region (252) is positioned between the balloon proximal region (250) and the balloon distal region (254).