Tubular Surgical Construct with Biologic Adjunct for Staple Line Sealing

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Solution Overview

Problem

Surgical staplers often cause leaks and inflammation due to staple holes, and biologic materials used to address these issues are difficult to maintain and manufacture effectively, lacking natural tissue characteristics and structural support.

Innovation Solution

A tubular surgical construct with a biocompatible adjunct material and medicants that provides structural support while allowing fluid flow, featuring a radially collapsible design and heterogeneous fiber lattice sections to promote tissue remodeling, and can be integrated with surgical staplers to secure the construct within tissue lumens.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If biologic materials are used to seal staple holes and reduce inflammation, then tissue healing is improved, but the materials are difficult to maintain at desired location and lack structural support

Engineering Contradiction:
Improvetissue healingVSAvoidmaterial positioning
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent combines biologic materials with a synthetic tubular construct to create a composite structure. The tubular construct provides structural support and positioning stability, while the biologic material layer provides sealing and healing benefits. This composite approach allows the biologic material to be delivered and maintained at the desired location without compromising its healing effectiveness.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The biologic material is configured as a thin film or coating on the tubular construct. This thin film configuration allows the biologic material to conform to the tissue surface while being supported by the underlying tubular structure, solving the positioning and structural support problems while maintaining the healing benefits.

Inventive Principle:
Principle #30Flexible shells and thin films

2Reliability

If biologic materials are used to address staple hole leaks, then sealing effectiveness is improved, but manufacturing to desired shape and thickness is difficult

Engineering Contradiction:
Improvesealing effectivenessVSAvoidshape and thickness control
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The biologic material is manufactured as a thin film with controlled thickness that can be conformally applied to the tubular construct. This thin film approach enables precise control over thickness and shape while maintaining the sealing effectiveness needed to address staple hole leaks.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The synthetic tubular construct serves as a manufacturable substrate that can be produced with precise geometry, to which the biologic material is then applied. This separates the manufacturing challenges (handled by the synthetic tubular construct) from the sealing requirements (handled by the biologic material layer).

Inventive Principle:
Principle #40Composite materials

3Productivity

If surgical staplers are used to close tissue openings, then tissue closure is achieved, but leaks occur through staple holes and tissue inflammation occurs

Engineering Contradiction:
Improvetissue closureVSAvoidleaks and inflammation
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The biologic material acts as an intermediary substance applied to the tissue at the staple line. It fills and seals the holes created by staples while also providing anti-inflammatory effects, thereby eliminating leaks and reducing tissue inflammation without compromising the tissue closure achieved by the stapler.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP3135223B1Tubular surgical constructs including adjunct material
Publication Date: 2022.05.18 ETHICON INC
  • EP3135223B1 patent drawingFigure 1
  • EP3135223B1 patent drawingFigure 2~3
  • EP3135223B1 patent drawingFigure 4~5

AI summary

Tubular surgical constructs including adjunct material are provided. In general, a tubular construct can be configured to be applied to tissue of a patient. The tubular construct can be configured to be implantable and to be implanted within a tissue lumen. The tubular construct can be configured to radially expand and radially constrict. The tubular construct can have an adjunct material disposed thereon. The adjunct can have one or more medicants releasably retained therein. Each of the one or more medicants can be effective to provide a desired effect on tissue in a predetermined manner.