Self-orienting Screw Probe for Coronary Sinus Implantation

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Solution Overview

Problem

The challenge lies in safely and precisely implanting cardiac stimulation probes in the left heart cavity, particularly due to the risks of bubble passage into the cerebral vascular network, delicate venous network access, and maintaining stable electrode contact amidst variations in posture and movement, while avoiding phrenic stimulation.

Innovation Solution

A screw probe combined with a double-curvature guide catheter allows for self-orientation and stabilization, enabling precise positioning of the anchoring screw within the coronary sinus, reducing operator dependency and ensuring secure fixation without dissection risks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If a preformed probe is used for implantation in the coronary venous network, then the probe can be self-orienting towards the epicardium, but the probe is difficult to advance and may return to its initial shape causing postoperative micro-displacements

Engineering Contradiction:
Improveprobe positioning precisionVSAvoidprobe advancement ease
Core Design Contradiction:
Manufacturing precisionVSEase of operation

Solution Approach 1:

The probe is divided into two independent parts: a flexible shaft for navigation through the coronary venous network and a separate preformed curved head for epicardial positioning. This segmentation allows the shaft to be easily advanced while the head maintains its self-orienting function without being constrained by the shaft's flexibility.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The probe transitions from a static preformed structure to a dynamic system where the flexible shaft can adapt its configuration during advancement while the curved head maintains its orientation. The mandrel can be advanced or removed as needed, allowing the probe to dynamically adjust its properties during the procedure.

Inventive Principle:
Principle #15Dynamics

2Reliability

If multiple electrodes are arranged along the probe body to increase chances of acceptable electrical contact, then the electrical efficiency can be improved, but the device complexity increases with multiplication of components and electrical connections

Engineering Contradiction:
Improveelectrical contact reliabilityVSAvoidprobe structure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The electrode assembly is extracted from the probe shaft and placed exclusively on the curved head. This concentration of electrodes in a specific location simplifies the overall structure by removing the need for multiple electrodes distributed along the shaft, while maintaining reliable electrical contact through the focused electrode configuration on the head.

Inventive Principle:
Principle #2Taking out (Extraction)

3Stability of the object's composition

If an anchoring screw is used to fix the probe in the coronary sinus, then the probe stability can be improved, but the risk of dissection and operator dependency increases

Engineering Contradiction:
Improveprobe stabilityVSAvoiddissection risk
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

A mandrel is introduced as an intermediary tool during the procedure. The mandrel is advanced through the coronary sinus to the target location, providing a stable platform for screw anchoring. This intermediary device facilitates the anchoring process while distributing the mechanical stress and reducing the risk of direct dissection of the coronary sinus walls.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Adaptability or versatility

If the probe is pushed through the coronary sinus opening via endocavitary route, then access to left heart cavities is achieved, but the operational risks including bubble passage to cerebral vascular network increase

Engineering Contradiction:
Improveaccess to left heart cavitiesVSAvoidbubble passage risk
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The curved head of the probe is pre-formed to orient the electrode towards the epicardium before insertion. This preliminary orientation ensures that when the probe reaches the target location, the electrode is already positioned correctly for effective stimulation, reducing the need for post-implantation adjustments that could increase bubble passage risk.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP2275170B1Assembly suitable for implantation in the coronary sinus, including a stimulation probe with anchoring screw
Publication Date: 2012.08.29 SORIN CRM
  • EP2275170B1 patent drawingFigure 1~3
  • EP2275170B1 patent drawingFigure 4~5

AI summary

The assembly has a simulation screw probe (10) with a helical anchoring screw (14) axially extending a head of the probe. A detachable catheter (26) implants the probe and includes a single preformed tube having two surfaces (38, 40) with two curves in absence of solicitation. The curves auto-orient a distal end of the tube in a target vein with the head in a retracted position and maintain an axis of the screw in a direction of an epicardium during combined displacement and screwing movement of the head to a deployed position.