Compound Barb Medical Device for Tissue Holding
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Solution Overview
Problem
Current methods for forming barbs on medical devices, such as sutures and staples, are often difficult and costly to implement, and there is a need for improved designs that can optimize tissue holding in various medical procedures, including wound closure and tissue repair, where the configuration of barbs may need to be adjusted based on the specific application.
Innovation Solution
A compound barb medical device with a crown interconnecting legs, featuring barbs with specific angles and orientations, formed using materials like titanium, stainless steel, or absorbable polymers, and a method involving vibrational energy to cut the barbs at precise angles and ratios, allowing for customizable barb configurations for different medical applications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If conventional methods are used to form barbs on sutures, then barbs can be created, but the process becomes difficult and costly to implement
Solution Approach 1:
The patent replaces complex mechanical barb-forming systems with a simplified die-based extrusion system. The die includes a relief feature that directly forms the barb projection during the extrusion process, eliminating the need for subsequent mechanical barb-forming operations. This substitution of the mechanical system reduces manufacturing complexity and cost while maintaining precise barb configuration through the die design.
Solution Approach 2:
The barb structure is pre-formed during the extrusion process itself, rather than being added as a separate step. The die relief feature creates the barb projection as the material is extruded, performing the barb-forming action preliminarily during manufacturing. This eliminates subsequent processing steps and reduces overall manufacturing complexity.
2Reliability
If barbs are configured for optimal wound closure, then tissue holding is improved, but the number of barbs must be increased, which complicates the device design
Solution Approach 1:
The barb projection is designed with an asymmetric cross-sectional geometry, being wider at the base and tapering toward the tip. This asymmetric configuration provides optimal tissue engagement and holding capability while maintaining a simple single-projection design per suture leg, avoiding the need for multiple complex barb arrangements.
Solution Approach 2:
The barb projection concentrates tissue-engaging features at specific locations on the suture legs rather than distributing complexity throughout the entire suture structure. Each barb is formed with specific geometric properties (width, length, angle) optimized for tissue holding, while the rest of the suture maintains a simple configuration.
3Adaptability or versatility
If bidirectional barbed suture is used to permit passing in both directions, then versatility is improved, but the barb configuration becomes more complex
Solution Approach 1:
The suture is divided into multiple segments or sections, each with barbs oriented in specific directions. One portion of the suture has barbs configured to engage tissue when pulled in a first direction, while another portion has barbs configured for engagement when pulled in a second direction. This segmentation allows bidirectional functionality while keeping each individual barb projection relatively simple in design.
Solution Approach 2:
The barb configuration allows the suture to dynamically adapt its engagement characteristics based on the direction of loading. When tension is applied in either direction, the barbs on the appropriately oriented portion of the suture engage the tissue, providing bidirectional versatility without requiring a fixed complex structure.
4Manufacturing precision
If surgical staples with complex deployment mechanisms are used, then proper staple deformation can be achieved, but the stapler structure becomes complex and difficult to operate
Solution Approach 1:
The patent extracts and eliminates the complex anvil-based deformation mechanism from the stapler system. Instead of requiring an anvil to crimp and deform the staples during deployment, the staples are pre-formed with their final configuration including the barb projections. This extraction of the deformation function from the deployment mechanism simplifies the stapler structure and improves ease of operation.
Solution Approach 2:
The staple deformation and barb formation are performed preliminarily during the staple manufacturing process, rather than during deployment. The staples are pre-shaped with the correct geometry and barb configurations before being loaded into the stapler. This preliminary action eliminates the need for complex real-time deformation mechanisms during surgical deployment.
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 compound barb design enhances tissue holding capabilities, reduces the complexity of staple deployment, and allows for bi-directional passage through tissue, improving the efficiency and effectiveness of medical procedures by providing adjustable barb configurations for various tissue types and repair needs.
Implementation Method 1
applying vibrational energy to a cutting element to form a compound barb on at least a portion of each leg
Data Source
AI summary
Barbed medical devices include a crown interconnecting a pair of legs and at least one barb extending from each of the legs. The at least one barb may define an inner surface with a first portion disposed at a first orientation relative to a longitudinal axis of the leg, a second portion disposed at a second orientation relative to the longitudinal axis, and optionally, a third portion disposed at a third orientation relative to the longitudinal axis of the leg.