Bioabsorbable Surgical Adjuncts with Activated Medicants

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Solution Overview

Problem

Surgical staplers often cause leaks and inflammation due to staple holes, and biologic materials used to mitigate these issues are difficult to maintain and manufacture effectively for surgical applications.

Innovation Solution

A staple cartridge assembly with a biocompatible, bioabsorbable adjunct material and medicants that can be activated externally, allowing for monitoring and controlled release of therapeutic agents to minimize leaks and inflammation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If staples are used to close openings in tissue, then tissue closure is achieved, but leaks and inflammation occur due to staple holes

Engineering Contradiction:
Improvetissue closure effectivenessVSAvoidleaks and inflammation
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

A biocompatible, bioabsorbable material is introduced as an intermediary substance between the staples and the tissue. This material fills the gaps and holes created by the staples, providing a sealing layer that prevents fluid leakage while allowing the staples to maintain their structural function for tissue closure.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent utilizes changes in the physical and chemical parameters of the biocompatible material in response to the local tissue environment. The material's properties change to facilitate healing and sealing functions, such as absorbing into tissue or degrading at controlled rates, thereby eliminating harmful leakage while maintaining closure effectiveness.

Inventive Principle:
Principle #35Parameter changes

2Object-generated harmful factors

If biologic materials are used to reduce leaks and inflammation, then tissue integrity is improved, but the materials are difficult to maintain and manufacture

Engineering Contradiction:
Improveleaks and inflammationVSAvoidmanufacturing difficulty
Core Design Contradiction:
Object-generated harmful factorsVSEase of manufacture

Solution Approach 1:

The patent combines biocompatible, bioabsorbable materials with conventional stapling components to create a composite system. This integration allows the biologic material to be incorporated into the staple cartridge assembly using existing manufacturing infrastructure, thereby reducing manufacturing complexity while maintaining the beneficial properties of biologic materials for reducing leaks and inflammation.

Inventive Principle:
Principle #40Composite materials

3Stability of the object's composition

If biologic materials are used to maintain tissue characteristics, then natural flexibility is preserved, but the materials lack structural support

Engineering Contradiction:
Improvetissue flexibilityVSAvoidstructural support
Core Design Contradiction:
Stability of the object's compositionVSStrength

Solution Approach 1:

The patent merges the biocompatible, bioabsorbable material with the mechanical staple structure. The biologic material provides the desired tissue compatibility and flexibility preservation, while the rigid staple framework supplies the necessary structural support. This combination allows both functions to coexist, with the biologic material filling gaps and maintaining flexibility while the staples provide strength and stability.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentUS12016565B2Surgical adjuncts with medicants affected by activators
Publication Date: 2024.06.25 CILAG GMBH INTERNATIONAL
  • US12016565B2 patent drawing
  • US12016565B2 patent drawing
  • US12016565B2 patent drawing

AI summary

Various exemplary surgical adjuncts with medicants affected by activator materials are provided. In general, an adjunct is provided with at least one medicant that is configured to be activated by an activator material. The adjunct can be delivered to a tissue of a patient, where the adjunct can be implanted. Various activator materials can be configured to activate the at least one medicant retained by the adjunct, the activation causing any one or more of a variety of actions. For example, the at least one medicant can be activated so as to yield at least one of a signal and/or an effect on the adjunct.