Additively Manufactured Biopsy Forceps for Deep Site Access
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Solution Overview
Problem
Existing endoscopic biopsy forceps face challenges in accessing deep body locations due to size limitations and complex assembly processes, which increase procedural duration, cost, and risk.
Innovation Solution
A medical device with an end effector that transitions between open and closed configurations, manufactured via additive manufacturing, featuring a movable operating member and a hub with offset control surfaces, allowing for efficient movement and reduced component complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If standard forceps jaws are used for deep body access, then the device structure is simple, but the device cannot reach difficult locations and requires larger size
Solution Approach 1:
The end effector is nested within the delivery device catheter, allowing the forceps to be concealed during delivery and then deployed at the target location. This enables access to deep body locations through tortuous paths while maintaining a compact delivery profile that can navigate through small openings and difficult-to-reach areas.
2Ease of manufacture
If multiple discrete parts are used for forceps construction, then the device can be assembled, but the manufacturing process becomes costly and time-intensive
Solution Approach 1:
The forceps arms, jaw components, and control mechanisms are merged into a single monolithic structure manufactured via additive manufacturing. This eliminates the need for assembling multiple discrete parts, significantly reducing manufacturing complexity, assembly time, and costs while improving production efficiency.
Solution Approach 2:
The manufacturing method transitions from traditional subtractive or assembly-based approaches to additive manufacturing, fundamentally changing the production parameter from multiple assembly steps to a single printing process. This parameter change enables complex geometries to be created directly without assembly, improving productivity and reducing costs.
3Device complexity
If complex assembly processes are used, then the device can be constructed with multiple components, but the procedural duration increases
Solution Approach 1:
Multiple components that would traditionally require separate manufacturing and assembly steps are merged into a single monolithic structure. This eliminates assembly time entirely for the forceps construction, reducing procedural duration while maintaining the necessary structural complexity for functionality.
4Ease of manufacture
If multiple discrete parts are assembled, then the device can be constructed, but the risk of malfunction increases
Solution Approach 1:
The forceps structure is merged into a monolithic single-piece construction, eliminating interfaces between discrete parts where failures could occur. This reduces the risk of malfunction from component separation, wear at interfaces, or assembly errors while maintaining ease of manufacture through additive manufacturing.
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
The device enhances procedural efficiency and safety by enabling access to smaller, hard-to-reach sites with reduced assembly time and cost, while minimizing the risk of malfunction and improving maneuverability.
Implementation Method 1
The additive manufacturing process may include depositing successive layers of material on a build platform and selectively sintering portions of the layers to form the medical device
Implementation Method 2
The selective sintering may be performed with a laser source
Implementation Method 3
separating the one or more support structures from the medical device using a wire electrical discharge machining process
Data Source
AI summary
A medical device includes an operating member, a hub, and an end effector. The operating member includes an actuation portion. The hub includes a channel receiving the actuation portion of the operating member. The actuation portion of the operating member moves within the channel. The end effector is movable between a closed configuration and an open configuration. Distal extension of the operating member transitions the end effector to the open configuration, and proximal retraction of the operating member transitions the end effector to the closed configuration. The medical device is formed through an additive manufacturing process.