Adjustable Sphincterotome Wire for Cutting-Angle Control
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Solution Overview
Problem
Conventional medical devices for cutting tissue, such as sphincterotomes, have limited ability to adjust the cutting angle and deflection, leading to increased procedural risks, duration, and cognitive load on operators.
Innovation Solution
A medical device with a shaft and a wire lumen, featuring adjustable cutting wire configurations through strategically aligned openings at the shaft's distal end, allowing for precise angle adjustments and deflection control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional sphincterotomes are used with fixed cutting instruments, then device structure is simple, but cutting angle adjustment ability is limited and maneuverability is difficult
Solution Approach 1:
The cutting wire is designed to be movable relative to the shaft through a wire lumen, allowing dynamic adjustment of the cutting angle. The wire can be advanced, retreated, and angled relative to the shaft axis, transforming a fixed cutting instrument into a dynamically adjustable one that adapts to different cutting requirements.
Solution Approach 2:
The device is segmented into functionally independent components: the shaft provides structural support and positioning, while the separate cutting wire provides the cutting function. This segmentation allows the cutting wire to be independently controlled and angled relative to the shaft, enabling multiple cutting angles without increasing overall device complexity.
2Reliability
If conventional sphincterotomes with limited deflection ability are used, then device structure is simple, but procedural safety is reduced due to increased risk of injury
Solution Approach 1:
The cutting wire incorporates dynamic deflection control through its interaction with the shaft and wire lumen. The wire can be angled and positioned dynamically relative to the shaft axis, allowing the operator to control the cutting direction and avoid unintended tissue damage, thereby improving procedural safety.
Solution Approach 2:
The device enables feedback control of the cutting wire position and angle relative to the shaft. The operator can adjust the wire position based on visual feedback from the endoscope, allowing real-time correction of cutting trajectory to prevent injury to surrounding tissues.
3Productivity
If conventional devices with fixed cutting instruments are used, then manufacturing is simple, but procedure time is increased
Solution Approach 1:
The movable cutting wire design allows rapid adjustment of cutting angles during the procedure without requiring multiple devices or complex repositioning maneuvers. This dynamic capability reduces the time needed to achieve the correct cutting angle and complete the procedure efficiently.
Solution Approach 2:
The cutting wire can be pre-positioned and pre-angled relative to the shaft before the actual cutting operation. This preliminary positioning allows the operator to quickly achieve the correct cutting configuration, reducing overall procedure time.
4Ease of operation
If conventional sphincterotomes are used, then device structure is simple, but cognitive load on operator is increased due to difficulty in obtaining desired cutting position
Solution Approach 1:
The cutting wire can be dynamically adjusted and angled relative to the shaft through controlled movement within the wire lumen. This dynamic adjustment mechanism reduces the cognitive load on the operator by providing intuitive control over the cutting angle and position, eliminating the need for complex mental calculations and multiple trial positions.
Data Source
AI summary
A medical device may comprise: a handle including an actuator; a shaft extending from the handle, wherein the shaft includes a wire lumen extending longitudinally through the shaft; and a wire positioned within the wire lumen and extending from the handle to a distal end of the shaft. A distal portion of the wire extends (i) out of a rear-side opening of the shaft and (ii) into a tip-side opening of the shaft such that an exposed portion of the wire is outside of the shaft between the rear-side opening and the tip-side opening; and a distal end of the wire is coupled to the shaft.