Bioabsorbable Metal Staple with Coating for Controlled Biocorrosion

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Solution Overview

Problem

Surgical staples made of bioabsorbable materials face challenges in maintaining structural integrity during the biocorrosion timeframe to ensure adequate tissue healing, while also being safe and compatible with electrosurgical instruments.

Innovation Solution

Development of bioabsorbable metal staples with specific coatings and designs that enhance their structural integrity and biocorrosion properties, including coatings that delay absorption and improve compatibility with surgical instruments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of moving object

If bioabsorbable materials are used for surgical staples, then the staples can ultimately dissolve and release the tissue after healing, but the staples lose structural integrity too quickly during the biocorrosion timeframe

Engineering Contradiction:
Improvebiocorrosion timeframeVSAvoidstructural integrity
Core Design Contradiction:
Duration of action of moving objectVSStrength

Solution Approach 1:

The staple is constructed as a composite structure with an inner core made of a first bioabsorbable material and an outer coating made of a second bioabsorbable material. This composite design allows the inner core to provide initial structural strength while the outer coating controls the degradation rate, enabling the staple to maintain structural integrity throughout the biocorrosion timeframe while ultimately dissolving to release the tissue.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent utilizes controlled parameter changes in the materials' degradation rates. The inner core material and outer coating material are selected with different degradation characteristics, allowing the staple to transition from a high-strength state during healing to a controlled dissolution state after healing, thereby resolving the contradiction between maintaining strength and enabling eventual dissolution.

Inventive Principle:
Principle #35Parameter changes

2Duration of action of moving object

If bioabsorbable materials are used for surgical staples, then the staples can dissolve and release the tissue, but the materials may have safety concerns such as toxicity

Engineering Contradiction:
Improvedissolution timeVSAvoidtoxicity
Core Design Contradiction:
Duration of action of moving objectVSObject-affected harmful factors

Solution Approach 1:

The outer coating acts as an intermediary layer between the inner core material and the surrounding tissue environment. This coating controls the interaction between the bioabsorbable materials and the body, regulating the dissolution process to prevent toxic effects while allowing beneficial tissue release after healing. The coating serves as a protective mediator that manages the interface between the implant and biological system.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Duration of action of moving object

If bioabsorbable materials are used for surgical staples, then the staples can dissolve after healing, but the materials may have incompatibility with electrosurgical instruments

Engineering Contradiction:
Improvedissolution timeVSAvoidcompatibility with electrosurgical instruments
Core Design Contradiction:
Duration of action of moving objectVSAdaptability or versatility

Solution Approach 1:

The patent selects bioabsorbable materials with specific physical and chemical parameters that are compatible with electrosurgical instruments. The outer coating material is chosen to have appropriate electrical properties and thermal stability that allow safe use with electrosurgical tools during the surgical procedure, while still maintaining its intended dissolution characteristics over time.

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 bioabsorbable metal staples effectively maintain tissue compression and support healing by ensuring structural integrity during the biocorrosion timeframe, while being safe and compatible with electrosurgical instruments.

Implementation Method 1

the staples must maintain their structural integrity for an amount of time, i.e., the biocorrosion timeframe, to allow for sufficient healing of the tissue

Methodology Applied
Scientific EffectBiocorrosion: Crevice Corrosion

Implementation Method 2

Development of bioabsorbable metal staples with specific coatings and designs that enhance their structural integrity and biocorrosion properties, including coatings that delay absorption and improve compatibility with surgical instruments

Methodology Applied
Scientific EffectCoating: Coatings

Data Source

PatentUS20220370064A1Method for delivering a staple in situ paired to the in situ environment
Publication Date: 2022.11.24 CILAG GMBH INTERNATIONAL
  • US20220370064A1 patent drawing
  • US20220370064A1 patent drawing
  • US20220370064A1 patent drawing

AI summary

A method of pairing bioabsorbable staples in a staple cartridge with the tissue being treated such that the staples are structurally sufficient during the healing window of the tissue but completely bioabsorb shortly thereafter.