Contractible Adjunct Materials for Surgical End Effectors

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Solution Overview

Problem

Surgical staplers often cause leaks and inflammation due to the trauma of stapling, and the materials used lack the natural flexibility of the tissue they are implanted in, leading to issues like staple holes growing under tension and tissue movement.

Innovation Solution

An end effector for surgical instruments featuring a cartridge with staple cavities and an anvil, equipped with adjunct materials and contractible attachment features, such as shrinkable polymers, that are releasably retained on the jaws to minimize leaks and inflammation by maintaining tissue flexibility and reinforcing the treatment site.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional stapling is used to close tissue openings, then the stapling process is simple and effective, but leaks occur due to staple holes and tissue trauma causes inflammation

Engineering Contradiction:
Improvesealing effectivenessVSAvoidtissue trauma and inflammation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A biocompatible adjunct material is introduced as an intermediary between the stapler and tissue. This material is applied to the tissue surface before stapling and serves as a protective layer that prevents direct contact between the stapler's mechanical action and the tissue, thereby reducing trauma and inflammation while maintaining sealing effectiveness

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The adjunct material is designed with specific physical and chemical parameters including porosity, degradation rate, and mechanical properties that match or exceed tissue characteristics. These parameters are optimized to provide both immediate protection during stapling and long-term healing support, reducing harmful effects while maintaining reliability

Inventive Principle:
Principle #35Parameter changes

2Strength

If staples are used to close tissue openings, then the closure is achieved through mechanical fastening, but the staples lack the natural flexibility of tissue causing holes to grow under tension

Engineering Contradiction:
Improveclosure strengthVSAvoidtissue flexibility and hole stability
Core Design Contradiction:
StrengthVSStability of the object's composition

Solution Approach 1:

The adjunct material's physical parameters including elasticity modulus, porosity, and degradation characteristics are specifically designed to match natural tissue properties. This allows the material to flex and deform with tissue movement, preventing hole expansion under tension while maintaining sufficient closure strength through the combined effect of the material and staples

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The solution creates a composite structure combining the adjunct material with traditional staples. The adjunct material provides flexibility and tissue-like behavior, while the staples provide mechanical anchoring. Together they form a composite closure system that achieves both strength and flexibility, preventing hole growth while maintaining closure integrity

Inventive Principle:
Principle #40Composite materials

3Ease of operation

If conventional stapling materials are used, then the procedure is straightforward, but the materials do not maintain natural tissue characteristics leading to inflammation and leaks

Engineering Contradiction:
Improvestapling procedure simplicityVSAvoidtissue compatibility and healing
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The biocompatible adjunct material serves as a protective intermediary layer between the stapler and tissue. This material is applied before stapling and maintains natural tissue characteristics during the procedure, preventing inflammation and leaks while allowing the stapling operation to remain simple and straightforward

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The material's parameters including biocompatibility, porosity, and mechanical properties are optimized to match natural tissue. This ensures that the material integrates well with tissue, maintaining natural characteristics during healing while allowing conventional stapling procedures to remain simple and effective

Inventive Principle:
Principle #35Parameter changes

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 effectively reduces leaks and inflammation by maintaining tissue flexibility and reinforcing the treatment site, allowing for secure stapling while minimizing tissue trauma and hole growth under tension.

Implementation Method 1

a contractible attachment feature configured to be transitioned from an original, non-contracted configuration to a contracted configuration under application of heat

Methodology Applied
Scientific EffectThermal contraction: Thermal Contraction

Data Source

PatentEP3363382B1Methods and systems for mating constrictable adjunct materials with end effectors
Publication Date: 2021.09.01 ETHICON INC
  • EP3363382B1 patent drawingFigure 1
  • EP3363382B1 patent drawingFigure 2
  • EP3363382B1 patent drawingFigure 3

AI summary

Systems and methods for releasably coupling an adjunct material to an end effector for a surgical instrument are provided. The adjunct can be configured to be releasably retained on a jaw, such as a cartridge or anvil, using a contractible attachment feature configured to be transitioned from an original, non-contracted configuration to a contracted configuration under application of heat. The attachment feature, such as one or more strands of a shrinkable polymer, can be engaged with the adjunct, and contraction of the attachment feature is effective to couple the adjunct with retaining members formed on the jaw. Another type of an adjunct has at least one portion configured to be reversibly stretched using application of a force such that, when the force is removed, the portion transitions from a stretched configuration to a contracted configuration and thereby causes the adjunct to be engaged with retaining members formed on the jaw.