Dual-Loop Necrosectomy End Effector for Single-Session Debridement
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Solution Overview
Problem
Current endoscopic necrosectomy procedures for removing necrotic tissue are cumbersome, requiring multiple insertions, lack dedicated instruments, and face challenges in managing large amounts of tissue, deep retroperitoneal extension, and treating the distal left side of the pancreas, leading to increased duration, costs, and risks.
Innovation Solution
A medical device with a handle and end effector comprising movable sheaths and loops with shape-memory material, allowing for controlled expansion and contraction to grasp and remove necrotic tissue efficiently.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If multiple insertions/removals of endoscope and devices are performed to achieve complete debridement, then debridement completeness is improved, but procedure duration and patient risk increase
Solution Approach 1:
The end effector is divided into multiple independent loops (first loop with first and second arms, second loop with third and fourth arms) that can be controlled separately. Each loop can be extended or retracted independently through the intermediate sheath, allowing selective engagement with different portions of necrotic tissue in a single procedure, thereby achieving complete debridement without multiple insertions
Solution Approach 2:
The end effector employs dynamic control mechanisms where the first and second loops can be independently extended or retracted by moving the first and second movable bodies respectively. This dynamic capability allows the device to adapt to varying tissue loads and anatomical configurations during a single procedure, eliminating the need for repeated insertions
2Ease of operation
If conventional endoscopic devices are used for necrosectomy, then procedure simplicity is maintained, but ability to manage large amounts of tissue and access deep retroperitoneal regions is insufficient
Solution Approach 1:
The end effector segments the working area into multiple independent loops that can be controlled separately. The first loop and second loop can be independently extended or retracted, allowing selective engagement with different portions of necrotic tissue. This segmentation provides versatility in managing large amounts of tissue and accessing deep retroperitoneal regions while maintaining operational simplicity through dedicated control mechanisms
Solution Approach 2:
The end effector is designed as a multi-functional device that can handle various tasks including grasping, cutting, and removing necrotic tissue. The multiple loops with teeth structures provide universal capability to manage different types and amounts of tissue, including deep retroperitoneal extension and distal pancreas, while maintaining ease of operation through a unified control system
3Device complexity
If dedicated instruments are not available for specific anatomical regions, then device simplicity is maintained, but ability to treat distal left side of pancreas is limited
Solution Approach 1:
The end effector employs dynamic control mechanisms where the first and second loops can be independently extended or retracted by moving the first and second movable bodies respectively. This dynamic capability allows the device to adapt to varying tissue loads and anatomical configurations during a single procedure, eliminating the need for repeated insertions
Solution Approach 2:
The end effector introduces an additional dimension of control by enabling independent extension and retraction of multiple loops. This dimensional freedom allows the device to reach and treat difficult-to-access anatomical regions such as the distal left side of the pancreas and deep retroperitoneal spaces while maintaining overall device simplicity
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
Facilitates single-session complete debridement, reduces procedural duration and risks, and enhances tissue management, particularly in challenging anatomical regions like the distal pancreas.
Implementation Method 1
end effector comprising movable sheaths and loops with shape-memory material, allowing for controlled expansion and contraction
Data Source
AI summary
A medical device includes a handle including a stationary body, a first movable body, and a second movable body; a control member coupled to the second movable body; an intermediate sheath coupled to the first movable body; an external sheath coupled to the stationary body; and an end effector. The end effector includes a first loop and a second loop. The first loop includes a first arm and a second arm, and the first arm is coupled to the intermediate sheath. The second arm is coupled to the control member, and the second arm includes a first plurality of teeth. The second loop includes a third arm and a fourth arm. The third arm is coupled to the intermediate sheath, and the fourth arm is coupled to the control member. The fourth arm includes a second plurality of teeth.