Steerable Sheath Robotic Handle Mode Switching

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Solution Overview

Problem

Current steerable medical instruments lack the flexibility to seamlessly transition between robotic and manual modes without withdrawing the distal end from the patient, which can lead to malfunctions and reduced mechanical independence, compromising patient safety and procedural efficiency.

Innovation Solution

A robotic catheter cradle system that allows a steerable sheath to be operated in both robotic and manual modes independently, enabling the operator to switch between modes without disengaging from the patient, with a receiving module for the steerable sheath handle and a steering drive module for robotic control, and an axial drive module for translation, ensuring mechanical independence and flexibility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a steerable sheath is introduced into a robotic catheter cradle for robotic control, then automated steering and positioning precision are improved, but the ability to rapidly switch to manual mode without withdrawing the distal end is compromised

Engineering Contradiction:
Improvepositioning precisionVSAvoidmode switching flexibility
Core Design Contradiction:
Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The system allows dynamic switching between robotic and manual modes while the distal end remains in the patient. The handle can be disengaged from the robotic cradle's receiving module at any time, enabling the operator to transition from automated control to direct manual control without withdrawing the catheter, thus resolving the contradiction between positioning precision and mode switching flexibility

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system separates the control functions into distinct modules: the robotic cradle provides automated steering control when engaged, while the handle allows direct manual control when disengaged. This segmentation enables selective engagement of robotic or manual control modes without requiring catheter withdrawal, addressing both positioning precision and adaptability requirements

Inventive Principle:
Principle #1Segmentation

2Productivity

If the steerable sheath is mechanically coupled to the robotic cradle for automated operation, then operational efficiency is improved, but mechanical independence and patient safety are worsened due to potential cradle malfunctions

Engineering Contradiction:
Improveoperational efficiencyVSAvoidpatient safety
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The handle serves as an intermediary between the operator and the catheter. When disengaged from the robotic cradle, the handle provides a direct mechanical connection that allows manual control independent of the robotic system. This intermediary mechanism ensures that if the robotic cradle malfunctions, the operator can immediately take manual control without withdrawing the catheter, thus maintaining patient safety while preserving operational efficiency during normal robotic operation

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system provides a pre-established manual control pathway through the handle that can be activated immediately if robotic control fails. This prior cushioning mechanism ensures that the operator always has a backup control method available, reducing the risk associated with robotic cradle malfunctions while maintaining high operational efficiency during normal automated operation

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Adaptability or versatility

If the distal end is withdrawn from the patient to switch to manual mode, then mechanical independence is improved, but procedural time and patient risk are worsened

Engineering Contradiction:
Improvemechanical independenceVSAvoidprocedural time
Core Design Contradiction:
Adaptability or versatilityVSLoss of time

Solution Approach 1:

The system enables dynamic mode switching where the handle can be disengaged from the robotic cradle while the distal end remains in the patient. This dynamic capability provides mechanical independence for manual operation without requiring catheter withdrawal, thus eliminating the time loss and reduced patient safety associated with repeated insertions and withdrawals

Inventive Principle:
Principle #15Dynamics

Data Source

PatentUS20240138946A1Steerable sheath with robotic handle stand
Publication Date: 2024.05.02 NEXTERN INNOVATION LLC
  • US20240138946A1 patent drawing
  • US20240138946A1 patent drawing
  • US20240138946A1 patent drawing

AI summary

Apparatus and associated methods relate to a robotic catheter cradle having a receiving module configured to releasably receive a steerable sheath after a distal end of the steerable sheath has been manually introduced into a patient independent of the receiving module. In an illustrative example, a steering drive module may be operably coupled to the robotic catheter cradle to robotically operate at least one interface of the handle to selectively actuate at least one guidewire of the steerable sheath such that a distal end of the steerable sheath is controllably deflected. An axial drive module may, for example, be operably coupled to the robotic catheter cradle to robotically translate the steerable sheath. Various embodiments may advantageously enable a human operator to remove the steerable sheath into a manual mode that permits operation mechanically independent of the robotic catheter cradle without withdrawing the distal end from the patient.