Deflectable Pulmonary Access Tool for Controlled Airway Wall Piercing
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Solution Overview
Problem
Existing bronchoscopy procedures face challenges in accessing tissue located outside the airway walls due to the complexity and uncontrolled nature of piercing through bronchial walls, often requiring multiple devices and personnel, which can lead to damage of additional tissues.
Innovation Solution
A catheter navigation system with a rail system and spring-loaded actuator for the access tool, allowing controlled advancement and manipulation of the piercing and dilating members, and incorporating sensors for precise tracking and positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If sufficient force is applied to pierce the airway wall, then the piercing element can successfully penetrate the tough airway wall, but the piercing element becomes uncontrolled and can damage additional tissues beyond the airway wall
Solution Approach 1:
The piercing element is designed with a deflectable portion that allows it to dynamically adapt during penetration. The deflectable section enables the piercing element to bend and follow the natural curvature of tissue planes, maintaining controlled penetration through the airway wall while preventing uncontrolled deviation that could damage surrounding tissues. This dynamic flexibility resolves the contradiction by allowing sufficient piercing force to be applied while maintaining directional control.
Solution Approach 2:
The dilating catheter serves as an intermediary between the piercing element and the target tissue beyond the airway wall. After the piercing element creates the initial puncture, the dilating catheter is advanced over it to gradually expand the opening and create a controlled access pathway. This intermediary device prevents direct uncontrolled advancement of the piercing element into surrounding tissues, thereby reducing tissue damage while maintaining access capability.
2Adaptability or versatility
If multiple devices (bronchoscope, catheter, piercing element, dilating catheter) are used to access tissue outside airway walls, then comprehensive diagnostic and therapy capabilities are achieved, but the device complexity and handling difficulty increase significantly
Solution Approach 1:
The piercing element and dilating catheter are designed as a integrated access system where the dilating catheter can be advanced over the piercing element in a coordinated manner. The system combines multiple functions (piercing, dilating, and providing access for diagnostic/therapy tools) into a unified approach that reduces the number of separate manipulation steps and devices needed, while maintaining comprehensive diagnostic and therapy capabilities.
Solution Approach 2:
The access system employs a nested configuration where the piercing element is initially advanced, then the dilating catheter is nested over it, and finally the extended working channel catheter is advanced over the dilating catheter. This nested arrangement allows multiple devices to be contained within one another, simplifying the overall handling by reducing the number of external manipulations required while maintaining all necessary diagnostic and therapy functions.
3Ease of operation
If the piercing element is advanced to pierce the airway wall, then access to tissue beyond the airway wall is achieved, but control over the piercing element is lost and additional tissues may be damaged
Solution Approach 1:
The deflectable portion of the piercing element provides dynamic control during advancement. As the piercing element penetrates the airway wall, the deflectable section allows it to naturally follow tissue planes and bend away from critical structures, maintaining operator control while ensuring safe passage through the wall. This dynamic behavior enhances both ease of operation and tissue safety simultaneously.
Solution Approach 2:
The dilating catheter acts as an intermediary that takes over control after the piercing element creates the initial puncture. By advancing the dilating catheter over the piercing element, the operator transitions from direct piercing control to controlled dilation, thereby maintaining reliability and tissue safety while achieving access to target tissue beyond the airway wall.
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 and accurate access to target tissues outside the airway walls, reducing the need for multiple personnel and minimizing tissue damage during bronchoscopy procedures.
Implementation Method 1
a spring-loaded actuator, the spring-loaded actuator operably connecting the piercing member and the dilating member such that upon unlocking of the slidable and lockable anchor connected to the piercing member, the handle of the piercing member is urged in the direction of the handle of the dilating member
Data Source
AI summary
An access tool for piercing an airway wall including a dilating member (308) having a minimally traumatic tip formed on a distal end, a piercing member (302) having a piercing tip on a distal and a handle (304) formed on a proximal end, and a spring-loaded actuator (406) connecting the piercing member and the dilating member such that upon actuation the piercing member is urged in the direction of the dilating member.


