Adjustable Balloon Catheter for Variable-Length Lesion Treatment
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Solution Overview
Problem
Existing balloon catheters with fixed positions and multiple lesions or geographic misalignment issues require multiple interventions, limiting treatment effectiveness and failing to provide controlled delivery of therapeutic agents and angioplasty.
Innovation Solution
A balloon catheter with adjustable and telescoping shafts supporting multiple inflatable balloons, allowing for customizable treatment length and pressure control, enabling precise delivery of therapeutic agents and angioplasty.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a drug-coated balloon is used to treat multiple lesions or misaligned treatment areas, then treatment coverage is improved, but multiple separate interventions are required
Solution Approach 1:
The catheter is divided into multiple independent inflatable balloons (first, second, and third balloons) that can be selectively inflated at different positions along the vessel. Each balloon can be independently controlled to treat specific lesion locations, allowing one intervention to cover multiple treatment areas that would otherwise require separate procedures
Solution Approach 2:
The catheter incorporates adjustable and telescoping shafts that allow dynamic repositioning of the balloons along the vessel length. The inner and outer shafts can be telescoped relative to each other, enabling the operator to adjust the spacing and positioning of the balloons to match the specific locations of multiple lesions, thereby eliminating geographic misalignment issues
2Measurement precision
If fixed position balloons are used to isolate a treatment area, then the treatment location is defined, but the ability to customize the treatment area is eliminated
Solution Approach 1:
The catheter shafts are designed with telescoping capability, allowing the operator to dynamically adjust the distance between the first, second, and third balloons. This enables customization of the treatment chamber size and position to precisely match the lesion boundaries, while still maintaining defined isolation of the treatment area
Solution Approach 2:
The system allows change in the spatial parameters (position and spacing) of the balloons along the vessel axis. By adjusting the telescoping shafts, the treatment chamber can be sized and positioned to accommodate different lesion lengths and locations, providing both precision and adaptability
3Productivity
If multiple balloons are arranged in series on a single catheter, then multiple treatment areas can be addressed in one intervention, but the balloons are fixed in position eliminating customization
Solution Approach 1:
The telescoping shaft design allows the balloons to be dynamically repositioned along the vessel while maintaining their series arrangement. The inner shaft can be telescoped relative to the outer shaft, enabling adjustment of balloon spacing and position to match different lesion configurations, thus combining multiple treatments per intervention with full position customization capability
4Device complexity
If a fixed balloon arrangement is used, then the device structure is simplified, but no means are provided for pressurizing the chamber to aid in delivery of the treatment agent or performing angioplasty
Solution Approach 1:
The catheter is segmented into multiple independently controllable balloons with separate inflation ports. This allows selective pressurization of individual balloons or combinations of balloons to create the desired chamber pressure for treatment agent delivery or angioplasty, while maintaining a relatively simple overall structure
Solution Approach 2:
The system enables change in pressure parameters within the treatment chamber by selectively inflating and pressurizing the balloons. The operator can control the pressure level and distribution across different balloons to optimize treatment agent delivery and perform angioplasty, adding functional capability without significantly increasing structural complexity
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
Enables controlled delivery of therapeutic agents to variable length treatment sites with improved treatment effectiveness by adjusting balloon positions and pressure, reducing the need for multiple interventions.
Implementation Method 1
a first inflatable balloon supported by the shaft, a second inflatable balloon supported by the shaft, a longitudinal position of the second inflatable balloon being adjustable relative to the first inflatable balloon, and a third inflatable balloon supported by the shaft between the first inflatable balloon and the second inflatable balloon
Implementation Method 2
The shaft comprises an outer shaft supporting the first inflatable balloon and an inner shaft supporting the second inflatable balloon. The inner shaft may comprise a first port proximal of the third inflatable balloon and a second port distal of the third inflatable balloon
Implementation Method 3
The outer shaft may comprise a retainer for retaining a position of the outer shaft relative to the inner shaft
Implementation Method 4
A proximal end of the shaft may comprise an infusion port for communicating with at least one opening in the shaft between the first inflatable balloon and the third inflatable balloon
Data Source
AI summary
An apparatus for performing angioplasty on a lesion (L) and applying a therapeutic agent (A) thereto. The apparatus includes a catheter (10) having a first inflatable balloon (12a), such as a non-compliant balloon, adapted to compress the lesion when inflated. At least one port (18,18a) is provided to deliver the therapeutic agent to adjacent the lesion. Second (12b) and third (12c) inflatable balloons, which may be compliant balloons located distally and proximally of the first inflatable balloon for compressing the lesion, may be inflated to form a sealed chamber (C) including the compressed lesion and the therapeutic agent once delivered via the at least one port. The relative positions of the second and third inflatable balloons may be adjustable to accommodate different lengths of lesions.