Tissue Thickness Compensator Capsule Segmentation

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Solution Overview

Problem

Current surgical stapling instruments face challenges in consistently forming staples across varying tissue thicknesses and types, leading to inconsistent compressive pressure and potential malformation of staples, which can affect the efficacy of tissue closure and hemostasis.

Innovation Solution

The introduction of a tissue thickness compensator, which is a compressible mat integrated with the staple cartridge, adjusts to different tissue thicknesses by altering its compressive pressure, ensuring consistent staple formation and pressure application regardless of tissue thickness or type, and compensates for malformed staples by applying additional pressure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If a surgical stapling instrument uses a standard staple cartridge without compensation mechanism, then the device structure remains simple, but the staple formation consistency deteriorates when tissue thickness varies

Engineering Contradiction:
Improvestaple formation consistencyVSAvoiddevice structure
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The tissue thickness compensator is divided into multiple capsules containing different materials (hydrophilic polymer, hydrophobic polymer, gas, liquid, or vacuum). Each capsule segment can independently compress or expand based on tissue thickness, allowing the system to maintain simple overall structure while achieving consistent staple formation across varying tissue conditions.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The compensator changes its physical parameters (compression level, expansion state) in response to tissue thickness variations. By adjusting the state of the capsule contents (liquid expansion, gas pressure, vacuum collapse), the system maintains appropriate compressive force on the tissue regardless of thickness, ensuring consistent staple formation without complex mechanical adjustments.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If the compressive pressure is increased to compensate for malformed staples, then the staple formation reliability improves, but the tissue damage risk increases

Engineering Contradiction:
Improvestaple formation reliabilityVSAvoidtissue damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The compensator applies compressive force locally and uniformly across the tissue surface where staples will be formed. By distributing the pressure through multiple capsules rather than concentrating force at single points, the system ensures reliable staple formation while preventing localized tissue damage that would occur with excessive point pressure.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The compensator pre-adjusts the compressive force based on tissue thickness before staple formation occurs. By having the capsules already in their appropriate compression state, the system prevents both insufficient compression (leading to malformed staples) and excessive compression (leading to tissue damage), achieving reliable staple formation with safe pressure levels.

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

3Adaptability or versatility

If the tissue thickness compensator uses multiple capsules with different materials, then the adaptability to different tissue conditions improves, but the manufacturing complexity increases

Engineering Contradiction:
Improveadaptability to tissue conditionsVSAvoidmanufacturing complexity
Core Design Contradiction:
Adaptability or versatilityVSEase of manufacture

Solution Approach 1:

The compensator design uses multiple capsules that can be configured with different materials (hydrophilic polymer, hydrophobic polymer, gas, liquid, vacuum) to handle various tissue conditions. The same basic capsule structure and placement methodology can accommodate different material choices, allowing the system to adapt to different tissue types while maintaining a standardized manufacturing process for the capsule assembly itself.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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

This solution ensures consistent staple formation and compressive pressure across varying tissue thicknesses and types, enhancing tissue closure and hemostasis by adapting to different tissue conditions and maintaining effective staple formation even with malformed staples.

Implementation Method 1

the first capsule comprises a hydrophilic polymer material and the second capsule comprises a hydrophobic polymer material

Methodology Applied
Scientific EffectOsmosis: Osmosis

Data Source

PatentEP3275378B1Tissue thickness compensator comprising a plurality of capsules
Publication Date: 2019.07.17 ETHICON INC
  • EP3275378B1 patent drawingFigure 1
  • EP3275378B1 patent drawingFigure 1A
  • EP3275378B1 patent drawingFigure 1B~1E

AI summary

A tissue thickness compensator can comprise a plurality of layers. Various embodiments are disclosed herein for manufacturing a tissue thickness compensator. In certain embodiments, a tissue thickness compensator can comprise at least one medicament tube, capsule, and/or packet contained therein