Endoscopic Biopsy Device With Pivoting End Effectors for Tortuous Paths
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Solution Overview
Problem
Conventional biopsy devices face challenges in accessing tortuous paths due to the size of their distal assembly, leading to unsatisfactory tissue acquisition and increased trauma, requiring multiple samples and longer procedure times.
Innovation Solution
A medical device with opposing first and second end effectors that pivot about a common axis, allowing for independent movement and a wide range of configurations, including a closed configuration for navigation through tortuous paths and an open configuration for tissue grasping and cutting, facilitated by a wire actuated through a catheter lumen.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional biopsy devices are used with a standard distal assembly size, then the device structure is simple and easy to manufacture, but the device cannot access tortuous paths and causes excessive tissue trauma
Solution Approach 1:
The distal assembly is divided into separate articulation joints that allow independent movement of end effectors relative to the catheter axis. This segmentation enables the device to navigate tortuous paths by bending at multiple joints while keeping the overall profile small enough to pass through narrow body passages.
Solution Approach 2:
The device incorporates articulation mechanisms that allow dynamic adjustment of the end effector orientation and position. The end effectors can pivot and rotate independently to adapt to the specific geometry of the target site, enabling access to hard-to-reach areas without forcing the device through tissue.
2Object-affected harmful factors
If the distal assembly size is reduced to access tortuous paths, then the device can navigate narrow passages, but the tissue acquisition capability becomes insufficient
Solution Approach 1:
The end effectors are designed with articulation capabilities that allow them to open to a sufficient gape for tissue grasping and cutting after navigating through the catheter. The dynamic opening mechanism ensures that despite the small profile during navigation, the end effectors can achieve adequate size for effective tissue acquisition at the target site.
Solution Approach 2:
The end effectors are configured to nest within the catheter lumen during insertion and navigation, presenting a minimal profile. Once positioned at the target site, the end effectors deploy outward from the nested configuration to achieve the necessary opening for tissue manipulation, effectively transitioning from a compact storage state to a functional working state.
3Quantity of substance
If multiple tissue samples are acquired to ensure sufficient quality, then the sample quality for analysis is improved, but the procedure time increases and costs increase
Solution Approach 1:
The device incorporates a cutting mechanism that works in conjunction with the grasping end effector to obtain adequate tissue samples in a single acquisition. This mechanical cutting capability replaces the need for multiple blind sampling attempts, ensuring sufficient tissue quality is achieved in one controlled action.
4Adaptability or versatility
If conventional biopsy devices are used, then the device structure is simple, but the device cannot independently pivot end effectors to contact tissue at different locations
Solution Approach 1:
The articulation system is divided into separate joints and linkages that control the movement of each end effector independently. This segmented mechanical structure allows the first and second end effectors to pivot and rotate relative to each other and to the catheter axis, providing independent positioning capability while maintaining a manageable overall device 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
Enhances the ability to access hard-to-reach areas with minimal tissue trauma and reduces the number of samples needed, improving procedure efficiency and safety.
Implementation Method 1
A medical device with opposing first and second end effectors that pivot about a common axis, allowing for independent movement and a wide range of configurations, including a closed configuration for navigation through tortuous paths and an open configuration for tissue grasping and cutting, facilitated by a wire actuated through a catheter lumen.
Data Source
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Figure 3A~4
Figure 5A~6
AI summary
A medical device includes opposing first and second end effectors coupled together to move from an open configuration to a closed configuration, a first link with a distal end pivotally connected to a proximal end of the first end effector, the first link including a first slot at a proximal end of the first link, a second link with a distal end pivotally connected to a proximal end of the second end effector, and a first actuator pin slidable within the first slot.