Self-Adjusting Compression Staple for Controlled Tissue Force

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Solution Overview

Problem

Conventional surgical staples lack the ability to automatically control the compression force applied to tissue, leading to potential tissue damage due to inconsistent force delivery, especially when dealing with varying tissue hardness, composition, and flexibility, making it difficult to maintain optimal tissue compression without causing necrosis.

Innovation Solution

The development of a self-adjusting, pre-tensioned compression staple with an internal compression device that regulates and maintains a constant compressive force within a desired range, independent of staple firing, using a sinusoidal or double-sinusoidal compression resistor to ensure optimal tissue compression.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional staples are used to fasten tissue, then the stapling operation can be performed, but the compression force applied to the tissue cannot be controlled, leading to potential tissue damage

Engineering Contradiction:
Improvetissue compression controlVSAvoidtissue damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by incorporating a compression device with a spring element that can be adjusted to different compression forces. The spring constant and pre-compression distance are modified to deliver optimal compression force to the tissue, transforming the staple from a simple fastening device to one with controllable compression parameters.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The compression device is integrated into the staple itself, allowing the staple to self-regulate compression force through the spring mechanism. The spring automatically adjusts to maintain optimal compression as tissue expands or contracts, without requiring external control systems.

Inventive Principle:
Principle #25Self-service

2Reliability

If the staple compression force is increased to ensure secure fastening, then the fastening reliability improves, but tissue necrosis may occur

Engineering Contradiction:
Improvefastening securityVSAvoidtissue necrosis
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent employs dynamics by using a spring-based compression device that can dynamically adjust to tissue movement and expansion. The spring allows for controlled compression force that adapts as the tissue heals and changes volume, maintaining secure fastening without excessive force that would cause necrosis.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The spring element acts as a cushioning mechanism that absorbs excess compression force. By pre-loading the spring with a controlled amount of energy, the system delivers consistent optimal compression force and prevents sudden excessive forces that could damage tissue.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Manufacturing precision

If the staple design is modified to include adjustable compression, then the tissue compression precision improves, but the device complexity increases

Engineering Contradiction:
Improvecompression force precisionVSAvoidstaple structure
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The compression device is nested within the staple structure, with the spring element housed inside the staple body. This nesting allows the complex compression mechanism to be integrated into the existing staple form factor without significantly increasing overall size or complexity.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The patent merges the fastening and compression functions into a single integrated staple device. The spring mechanism is combined with the staple legs and bridge, allowing both fastening and controlled compression to be achieved through one device rather than separate components.

Inventive Principle:
Principle #5Merging (Combining)

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 solution ensures that the compression force remains within the optimal tissue compression range, preventing tissue damage by maintaining a consistent compressive force during tissue expansion and contraction, thereby enhancing the safety and effectiveness of surgical stapling procedures.

Implementation Method 1

a compression device (163) capable of regulating compressive force imposed on the material stapled therein independent of a magnitude of staple firing

Methodology Applied
Scientific EffectSpring: Spring

Implementation Method 2

The solution ensures that the compression force remains within the optimal tissue compression range, preventing tissue damage by maintaining a consistent compressive force during tissue expansion and contraction

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP3385549B1Adjustable compression staple
Publication Date: 2021.09.29 ETHICON ENDO SURGERY INC
  • EP3385549B1 patent drawingFigure 1
  • EP3385549B1 patent drawingFigure 2
  • EP3385549B1 patent drawingFigure 3

AI summary

A compression-self-adjusting staple (20) includes a substantially U-shaped staple body and a compression device (23). The staple body has a bridge (21) and two legs (26) extending from the bridge at an angle thereto. Each of the legs has a base end integral with the bridge and a deformable distal end defining a stapling point shaped to pierce material to be stapled. The compression device is at least partly disposed between the legs and has a bias portion (25) with a compression surface movably disposed between the legs and a compression resistor connected to the bridge and to the compression surface and formed to resist movement of the compression surface towards the bridge with a force.