Tissue Fastener with Protective Sheath for Controlled Compression
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Solution Overview
Problem
Current surgical fasteners for tightening the lower esophageal sphincter face issues with tissue thickness variability, leading to inadequate compression or excessive tissue necrosis, and expose needles during procedures, increasing the risk of collateral damage.
Innovation Solution
A tissue fastener system with a male and female member, where a protective member encloses the tissue-piercing tip until deployment, using a biasing element to ensure proper penetration and maintain constant compression, preventing collateral damage and necrosis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical fasteners are used to tighten the lower esophageal sphincter, then the LES is secured and reflux is prevented, but tissue necrosis occurs due to excessive compression
Solution Approach 1:
The fastener system transitions from a static compression state during insertion to a dynamic controlled compression state after deployment. The needles are initially enclosed in a protective sheath that prevents tissue penetration during insertion, then the sheath is retracted to allow needle penetration and tissue fastening. This dynamic transition enables controlled compression that prevents both excessive compression (necrosis) and insufficient compression (fastening failure).
Solution Approach 2:
The protective sheath pre-encloses the needles before tissue contact, preventing accidental penetration during insertion. The sheath is positioned and secured before the actual fastening action occurs, allowing for safe positioning and alignment. This preliminary protective action eliminates the risk of collateral damage during the insertion phase while maintaining the ability to perform effective fastening when needed.
2Ease of operation
If needles are exposed during the procedure, then tissue penetration and fastening is achieved, but collateral tissue damage risk increases
Solution Approach 1:
The protective sheath acts as an intermediary between the needles and the tissue during insertion. It allows the needles to be safely transported to the target location without直接接触 (direct contact) with the tissue. The sheath is then retracted or removed to allow the needles to penetrate the tissue at the precise intended location. This intermediary mechanism eliminates collateral damage during insertion while preserving the penetration capability when required.
Solution Approach 2:
The protective sheath provides preliminary protection to the needles during insertion, preventing accidental tissue contact before the fastening action is intentionally initiated. This allows for safe navigation through body cavities and precise positioning at the target site without causing unintended tissue damage.
3Manufacturing precision
If fasteners are designed for specific tissue thickness ranges, then adequate compression is achieved for that range, but effectiveness is lost when tissue thickness varies
Solution Approach 1:
The fastener system employs dynamic elements including spring-loaded needles that can adjust their penetration depth and compression force based on the actual tissue thickness encountered. The springs provide progressive resistance that automatically adapts to varying tissue densities and thicknesses, maintaining effective compression across a wide range of anatomical variations without requiring precise pre-setting for specific thickness ranges.
Solution Approach 2:
The fastener design incorporates variable parameters such as spring constant, needle length, and compression distance that can be adjusted or selected based on the specific application. This allows the same basic fastener mechanism to effectively handle different tissue thicknesses by changing these parameters, providing versatility across various anatomical conditions while maintaining precise compression control.
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 system effectively fastens tissue while minimizing collateral damage and preventing tissue necrosis across varying thicknesses, ensuring secure serosa-to-serosa healing.
Implementation Method 1
A biasing element can be, for example, a U-shaped spring that is mated to and extends between the base plate and the protective member, or a coil spring that is disposed around the post(s) and extends between the base plate and protective member
Data Source
AI summary
Methods and devices for fastening tissue are provided. In one exemplary embodiment, a tissue fastener is provided and includes a male fastening member having a base plate with at least one post extending therefrom and having a tissue-piercing tip. A protective member is coupled to the male fastening member and is movable between an open position in which the tissue-piercing tip is enclosed within the protective member such that the tissue-piercing tip is prevented from penetrating tissue, and a compressed position in which the tissue-piercing tip is exposed to penetrate tissue. A female fastening member is configured to mate to the male fastening member and to engage tissue therebetween.