Hemostatic Coating for Implantable Anchorage Devices

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Solution Overview

Problem

Current anchorage devices for implantable medical devices lack effective solutions for reducing surgical site infections and bleeding, with existing hemostatic agents being inadequate in preventing biofilm formation and antibiotic resistance.

Innovation Solution

A surgical system comprising a substrate with a coating that includes a polymer, glycerin, and a hemostatic agent, such as polyhydroxybutyrate, polyglycerol sebacate, or collagen, designed to prevent bacterial adhesion and promote hemostasis, while also providing antimicrobial properties to reduce infection and bleeding.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional anchorage devices are used to secure implantable medical devices, then the device can be anchored to surrounding tissue, but surgical site infections and bleeding complications occur

Engineering Contradiction:
Improveanchoring reliabilityVSAvoidsurgical site infections and bleeding
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent combines anchorage device functionality with hemostatic and antimicrobial properties into a single integrated device. The anchorage device incorporates hemostatic agents and antimicrobial coatings, merging multiple functions (anchoring, bleeding control, infection prevention) that were previously provided by separate products into one unified solution.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The anchorage device utilizes composite materials structure, combining biocompatible polymers (such as polyglycolic acid, polylactic acid, or silk fibroin) with hemostatic agents and antimicrobial substances. This composite approach allows the device to simultaneously provide mechanical anchoring strength while delivering hemostatic and antimicrobial effects.

Inventive Principle:
Principle #40Composite materials

2Object-affected harmful factors

If hemostatic agents are applied to control bleeding, then bleeding can be reduced, but they are inadequate in preventing biofilm formation and antibiotic resistance

Engineering Contradiction:
ImprovebleedingVSAvoidinfection prevention capability
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent merges hemostatic agents with antimicrobial agents into a single coating or integrated structure on the anchorage device. This combination ensures that both bleeding control and infection prevention (including biofilm prevention) are achieved simultaneously through one device rather than requiring separate applications.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The device employs composite material composition incorporating both hemostatic substances (such as thrombin, fibrin, or oxidized cellulose) and antimicrobial components (such as silver nanoparticles, chlorhexidine, or antibiotic-impregnated polymers) to provide dual functionality of bleeding control and comprehensive infection prevention.

Inventive Principle:
Principle #40Composite materials

3Object-affected harmful factors

If antibiotics are used to prevent surgical site infections, then infection risk can be reduced, but antibiotic resistance develops

Engineering Contradiction:
Improvesurgical site infectionsVSAvoidantibiotic effectiveness
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent introduces antimicrobial peptides, natural antimicrobial substances, or physical barriers (such as silver nanoparticles or chitosan coatings) as intermediary agents that provide infection prevention through non-antibiotic mechanisms. These intermediaries disrupt bacterial cell membranes or create physical barriers against biofilm formation, offering alternative pathways for infection control that do not contribute to antibiotic resistance.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 system effectively reduces bleeding and infection risks by promoting hemostasis and preventing bacterial adhesion, potentially minimizing the use of antibiotics and reducing antibiotic resistance.

Implementation Method 1

The coating includes a polymer, glycerin and a hemostatic agent... promote hemostasis

Methodology Applied
Scientific EffectCoagulation: Coagulation

Implementation Method 2

designed to prevent bacterial adhesion and promote hemostasis, while also providing antimicrobial properties

Methodology Applied
Scientific EffectAntimicrobial action:

Data Source

PatentUS12168085B2Surgical system and methods of use
Publication Date: 2024.12.17 MEDTRONIC INC
  • US12168085B2 patent drawing
  • US12168085B2 patent drawing
  • US12168085B2 patent drawing

AI summary

A surgical system including an implantable medical device having a size and shape. The surgical device having a substrate and a coating that covers at least a portion of the substrate. The coating includes a polymer, collagen, glycerin and a hemostatic agent. The polymer is selected from the group of polyhydroxybutyrate, polyglycerol sebacate and adducts of polyglycerol sebacate. The substrate including a first piece and a second piece that is joined with the first piece. The first piece and the second piece forming a pocket having a cavity and an opening that is in communication with the cavity. The device being pre-formed such that a size and shape of the cavity conforms to the size and shape of the implantable medical device.