Hemostatic Clip Core Member Frangible Link Deployment

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Solution Overview

Problem

Current two-piece hemostatic clip deployment requires a two-stage process, which is inefficient and may not allow for proper orientation and repeated opening/closing of the clip, limiting its effectiveness in endoscopic procedures for hemostasis.

Innovation Solution

A multifunctional core member with a frangible link that allows for single-stage deployment, enabling the clip to be properly oriented and repeatedly opened/closed, using a capsule and control wire mechanism to secure and deploy the clip in a single stage process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If a two-piece hemostatic clip uses a traditional two-stage deployment process, then the clip can be deployed, but the deployment is inefficient and does not allow for proper orientation and repeated opening/closing

Engineering Contradiction:
Improvedeployment efficiencyVSAvoidorientation and repeated opening/closing capability
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The core member is divided into first and second portions connected by a frangible link, allowing the distal portion to remain in the capsule while the proximal portion is retrieved. This segmentation enables single-stage deployment while maintaining the ability to open and close the clip multiple times for proper tissue engagement.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The frangible link provides a dynamic connection that can fracture under predetermined load, transitioning the clip from a closed deployed state to an open state for tissue engagement. This dynamic mechanism enables repeated opening/closing cycles while maintaining deployment efficiency.

Inventive Principle:
Principle #15Dynamics

2Device complexity

If the frangible link is designed to fracture under predetermined load, then the clip can be deployed in a single stage, but the link must be strong enough to maintain structural integrity during handling

Engineering Contradiction:
Improvedeployment stage reductionVSAvoidfrangible link structural integrity
Core Design Contradiction:
Device complexityVSStrength

Solution Approach 1:

The frangible link is designed with specific material properties and geometric parameters that allow it to fracture at a predetermined load threshold. The link's strength parameters are optimized to maintain structural integrity during handling and deployment, while fracturing at the required threshold to enable single-stage deployment.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If the core member includes protrusions for engaging cut-outs in the arm, then the clip achieves proper orientation, but the structure becomes more complex

Engineering Contradiction:
Improveclip orientationVSAvoidcore member structure
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

Protrusions are added locally to the core member at specific positions to engage with cut-outs in the arm, providing proper orientation functionality. This localized feature addition achieves the desired orientation capability without requiring complete redesign of the entire core member structure.

Inventive Principle:
Principle #3Local quality

Data Source

PatentUS9005219B2Multifunctional core for two-piece hemostasis clip
Publication Date: 2015.04.14 BOSTON SCIENTIFIC SCIMED INC
  • US9005219B2 patent drawing
  • US9005219B2 patent drawing
  • US9005219B2 patent drawing

AI summary

A device includes a clip including first and second arms distal ends of which are biased apart and a core member including first and second portions connected to one another via a frangible link. The first portion includes a first protrusion for engaging a cut-out in the first arm. The frangible link is fractured when subjected to a load of at least a predetermined level deploying the clip. The device also includes a capsule slidably housing the core member and a proximal portion of the clip.