Image-Guided Steerable Introducer for Coaxial Valve Alignment
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Solution Overview
Problem
Existing steerable introducers face challenges in achieving precise coaxial and coplanar alignment of interventional tools with anatomical structures due to limitations in actuation precision and translational motion, particularly in minimally invasive procedures like aortic valve replacement, where heart motion complicates alignment.
Innovation Solution
A steerable introducer system with image guidance and motion couplers, including linear actuators and rotary actuators, facilitates precise alignment by controlling translation, pivoting, and rotation of an end-effector within the anatomical object, guided by surgical image data.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If deflection tendons are used to actuate pitch and yaw motion of the introducer sheath, then the ability to achieve coaxial and coplanar alignment is improved, but the precision of actuation deteriorates due to transmission length and anatomical limitations
Solution Approach 1:
The patent replaces the mechanical deflection tendon system with a magnetic field-based actuation system. Magnets embedded in the introducer sheath are controlled by an external magnetic field generator, eliminating the need for long transmission tendons and enabling precise control at the distal end without mechanical transmission losses.
Solution Approach 2:
The patent introduces a magnetic field as an intermediary between the control system and the introducer sheath. This magnetic intermediary allows for wireless, precise actuation of the sheath's orientation and position, overcoming the limitations of direct mechanical coupling through tendons.
2Device complexity
If a straight line introducer sheath is used, then the结构简单性 is maintained, but the ability to achieve proper alignment deteriorates due to non-collinear anatomical structures
Solution Approach 1:
The patent transforms the static straight introducer sheath into a dynamic system with embedded magnets that can be actively controlled to change orientation and position. This allows the simple straight sheath structure to adapt dynamically to complex anatomical pathways and achieve proper alignment without mechanical complexity.
3Ease of operation
If deflection tendons are used to provide pitch and yaw motion, then the ability to orient the introducer sheath is improved, but the translational motion capability deteriorates
Solution Approach 1:
The patent makes the magnetic actuation system universal by using the same magnetic field mechanism for both rotational control (pitch and yaw) and translational control. The external magnetic field generator can independently control multiple degrees of freedom, providing both orientation and position adjustment through a single integrated system.
Data Source
Figure 1A~1B
Figure 1C~1D
Figure 1E
AI summary
A steerable introduction system for deploying an interventional tool (e.g., a replacement valve) within an anatomical object (e.g. a heart). The steerable introduction system employs a steerable introducer (20) including an end-effector for positioning the interventional tool within the anatomical object (e.g., the end-effector passively guides or actively steers the interventional tool within the anatomical object). The steerable introduction system further employs an image guidance workstation (120) controlling an actuation of a translation, a pivoting and/or a rotation of the end- effector within the anatomical object responsive to surgical image data illustrative of a position of the end-effector within the anatomical object (e.g., ultrasound or X-ray image data illustrative of a surgical positon of the end-effector within a heart). The motion actuation by the image guidance workstation (120) of the end-effector facilitates a coaxial alignment and/or a coplanar alignment of the interventional tool and a structure of the anatomical object (e.g., a diseased aortic valve of a heart).