Stress-Distributing Layer for Surgical Incise Drapes

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Solution Overview

Problem

Current surgical incise drapes fail to effectively protect skin from trauma caused by high compressive and stretching forces during tissue retraction, leading to tissue necrosis, bruising, and postoperative pain, and complicating wound closure.

Innovation Solution

A stress-distributing layer, at least 1 mm thick, is applied to the skin to distribute these forces, adhering to the skin and conforming to its shape, and is used in conjunction with a flexible polymeric film and pressure-sensitive adhesive to reduce trauma during surgical procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional adhesive-coated organic polymeric drapes are used to provide conformability and high adherence to skin, then the drape can maintain skin refraction without lifting, but the high compressive and stretching forces during tissue refraction cause tissue trauma, capillary blood flow disruption, and potential tissue necrosis

Engineering Contradiction:
Improveadherence to skinVSAvoidtissue trauma
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A stress-distributing layer is introduced as an intermediary between the retractor and the skin. This layer conforms to the skin surface while distributing the mechanical stresses of retraction over a broader area, preventing direct transmission of high compressive and stretching forces to the tissue, thereby reducing tissue trauma while maintaining adherence during skin refraction

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The stress-distributing layer changes the mechanical parameters of the system by altering stress distribution. Instead of concentrating force at a single point or narrow area, the layer redistributes the mechanical loads across a wider surface area, reducing peak stresses on the skin and underlying tissue during surgical refraction

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If high forces are applied during tissue refraction to maintain proper surgical exposure, then adequate surgical access is achieved, but capillary blood flow disruption occurs leading to tissue necrosis, significant bruising, and nerve damage

Engineering Contradiction:
Improvesurgical accessVSAvoidcapillary blood flow disruption
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The stress-distributing layer serves as a protective intermediary between the retractor and the tissue. It allows the surgeon to apply necessary forces for surgical exposure while the layer distributes these forces to prevent capillary damage, thereby maintaining surgical access without causing tissue necrosis or nerve injury

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The stress-distributing layer is applied to the skin before the surgical procedure begins, providing pre-established cushioning and protection. This beforehand cushioning ensures that when retraction forces are applied during surgery, the tissue is already protected against excessive stress, preventing capillary disruption and subsequent necrosis

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

3Duration of action of moving object

If prolonged retraction through the surgical procedure is performed to maintain surgical field exposure, then adequate surgical access is maintained, but skin stretching along the wound edge makes reapposition difficult

Engineering Contradiction:
Improveprolonged retractionVSAvoidskin stretching
Core Design Contradiction:
Duration of action of moving objectVSObject-affected harmful factors

Solution Approach 1:

The stress-distributing layer acts as a protective intermediary during prolonged retraction. It distributes the stretching forces across a broader area of the skin, preventing excessive localized tension that would cause permanent skin deformation and make reapposition difficult, thereby enabling prolonged surgical procedures without compromising wound closure

Inventive Principle:
Principle #24Intermediary (Mediator)

4Ease of operation

If a thin stress-distributing layer is used to minimize interference with surgery, then surgical access is maintained, but the layer may not provide sufficient stress distribution and could tear during retraction

Engineering Contradiction:
Improvesurgical accessVSAvoidstress distribution capability
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The stress-distributing layer is designed with specific physical parameters including minimum thickness (at least 1 mm), elasticity, and tensile strength. These parameters are optimized to ensure the layer is thick enough to provide effective stress distribution and tear resistance during retraction, while remaining thin enough to minimize interference with surgical access and instrumentation

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 reduces tissue trauma, promotes faster healing, improves cosmesis, decreases the risk of site infections, and minimizes postoperative pain by distributing retraction forces, preventing tissue stretching and necrosis.

Implementation Method 1

distributing the forces caused by refraction over a broad area

Methodology Applied
Scientific EffectStress distribution:

Implementation Method 2

adhering the stress-distributing layer to the patient such that it conforms to the shape of the tissue of the patient

Methodology Applied
Scientific EffectAdhesion: Adhesive

Data Source

PatentUS10092366B2Products for reducing tissue trauma using water-resistant stress-distributing materials
Publication Date: 2018.10.09 SOLVENTUM INTELLECTUAL PROPERTIES CO
  • US10092366B2 patent drawing
  • US10092366B2 patent drawing
  • US10092366B2 patent drawing

AI summary

Methods and products for protecting tissue of a patient during a surgical procedure that involve making an incision in the tissue and retracting the tissue to make a larger opening, wherein the methods and products use a water-resistant stress-distributing layer.