Haemostatic Agent Injection for Surgical Site Marker Stability

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Solution Overview

Problem

Surgical site markers used in breast biopsies tend to migrate within or out of the biopsy site due to breast compression and subsequent release, making it difficult for surgeons or radiologists to accurately locate the lesion or biopsied area for follow-up treatments.

Innovation Solution

A method using a haemostatic agent, such as Arista™, is injected into the biopsy site to cause clotting and secure the site marker in place, preventing migration by utilizing a deployment device that delivers the agent in powder, slurry, or other forms to accelerate clotting and lock the marker within the tissue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a site marker is deployed into the biopsy site, then the location can be identified for follow-up treatment, but the marker migrates within or out of the site due to breast compression and release

Engineering Contradiction:
Improvelocation identification precisionVSAvoidmarker position stability
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

A haemostatic agent is introduced as an intermediary substance between the site marker and the breast tissue. This agent facilitates bonding between the marker and tissue, preventing marker migration while maintaining location identification precision for follow-up treatment.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The physical or chemical state of the haemostatic agent is changed upon contact with breast tissue or blood, enabling it to transition from a deliverable form (powder, slurry, or liquid) to a bonded state that secures the marker in place, thereby preventing migration.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If the breast is released from compression after biopsy, then normal function is restored, but the site marker migrates within the site or out through the needle tract

Engineering Contradiction:
Improvebreast function restorationVSAvoidmarker position stability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The haemostatic agent is deployed into the biopsy site before the breast compression is released. This preliminary action creates a bonding mechanism in advance that prevents marker migration when compression is released, allowing normal breast function to be restored without compromising marker stability.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If a haemostatic agent is injected to secure the marker, then marker migration is prevented, but additional material and procedure steps are required

Engineering Contradiction:
Improvemarker position stabilityVSAvoiddeployment procedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The haemostatic agent serves multiple functions: it acts as a securing mechanism to prevent marker migration, and can be delivered through the existing biopsy device or a simple deployment device. This multi-functionality reduces overall procedure complexity by combining marker deployment and securing into a unified approach.

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

The solution effectively keeps the site marker bonded in place, ensuring precise location identification during follow-up treatments by preventing migration, even after breast compression is released.

Implementation Method 1

A method using a haemostatic agent, such as Arista™, is injected into the biopsy site to cause clotting and secure the site marker in place

Methodology Applied
Scientific EffectClotting: Coagulation

Data Source

PatentUS10159540B2Securement for a surgical site marker and deployment device for same
Publication Date: 2018.12.25 SUROS SURGICAL SYSTEMS INC
  • US10159540B2 patent drawing
  • US10159540B2 patent drawing
  • US10159540B2 patent drawing

AI summary

A method of securing a biopsy marker within a biopsy site includes depositing a marker element within a biopsy site and fixing the marker element within the biopsy site by injecting a securing agent within the biopsy site. Delivery devices for delivering the securing agent to the biopsy site are also disclosed.