Anatomical Lumen Sizing Device with Nested Shape-Memory Indicators
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Solution Overview
Problem
Conventional sizing devices for lumens are tedious and time-consuming due to the need for multiple calibration steps and components, particularly when determining the appropriate size of medical devices like endobronchial valves for lung procedures.
Innovation Solution
A sizing device with an elongated member and an extendable assembly featuring shape-set memory bias elements that radially extend beyond the distal end of the member, allowing for accurate measurement without fluid pressurization or electronic controls, using an actuation mechanism to move elements between retracted and deployed positions for precise dimension assessment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional sizing devices are used, then measurement can be performed, but the process is tedious and time-consuming due to multiple calibration steps and components
Solution Approach 1:
The sizing device divides the measurement function into multiple discrete size indicators (first size indicator, second size indicator, third size indicator) that can be independently activated. Each indicator corresponds to a specific size measurement, allowing the operator to quickly determine the appropriate size without performing multiple calibration steps. The segmentation of the extendable assembly into multiple activatable sections enables this rapid, step-by-step sizing approach.
Solution Approach 2:
The size indicators are pre-configured on the device at known, predetermined positions. The first size indicator is positioned at a first known distance from the distal tip, the second at a second known distance, and so on. This preliminary positioning of measurement markers eliminates the need for calibration during the procedure, as the measurements are already established and ready for use.
2Measurement precision
If multiple calibration steps are required, then measurement accuracy can be achieved, but the procedure becomes time-consuming
Solution Approach 1:
The device incorporates multiple size indicators at pre-determined, known distances from the distal tip before the procedure begins. These indicators are manufactured at precise positions, eliminating the need for time-consuming calibration steps during the actual sizing procedure while maintaining measurement accuracy.
Solution Approach 2:
The sizing device is self-calibrating through its design. The extendable assembly, when activated, automatically presents the size indicators at their correct positions relative to the lumen. The device self-regulates the measurement process without requiring external calibration equipment or multiple adjustment steps, thereby maintaining precision while reducing time loss.
3Productivity
If an extendable assembly with multiple indicators is used, then sizing efficiency is improved, but the device structure becomes more complex
Solution Approach 1:
The extendable assembly is designed with nested sections that can be sequentially activated. The first section, second section, and third section are arranged in a nested configuration where each section can extend from or alongside the previous section. This nesting allows multiple size indicators to be contained within a compact structure that can be inserted into the lumen, presenting the indicators in sequence as needed without requiring a overly complex external structure.
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
This solution streamlines the measurement process by eliminating calibration steps and components, providing a fast, accurate, and safe method to determine lumen dimensions, enhancing the efficiency of medical device sizing for procedures like endobronchial valve placement.
Implementation Method 1
The extendable assembly can include wires having a shape-set memory bias. The shape-set memory bias can be configured to allow the wires to extend radially outward from a central axis of the elongated member.
Implementation Method 2
The shape-set memory bias can cause the wires to extend radially outward to define a plurality of successive testing dimensions.
Data Source
AI summary
A sizing device configured to measure a dimension of a lumen in a patient can include an elongated member, an extendable assembly, and an actuation mechanism. The elongated member can be insertable into the patient and define a lumen extending from a proximal end to a distal end. The extendable assembly can be insertable into the lumen. The extendable assembly can include elements that can have a shape-set memory bias. The shape-set memory bias can be configured to allow the elements to extend radially outward from a central axis of the elongated member. The actuation mechanism can be operably coupled to the extendable assembly and can be configured to move the elements between a retracted position and a plurality of deployed positions.