Integrated Cardiac Dilator Locking Mechanism for Needle Protrusion Control
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Solution Overview
Problem
Current integrated needle-based perforation and dilation devices for the heart are cumbersome and lack precise control over the protrusion length of the puncture needle, leading to potential accidental punctures, increased procedure complexity, and risks such as tamponade during transseptal access.
Innovation Solution
A perforation device integrated with a dilator that includes an indicator mechanism to provide feedback on protrusion length and a locking mechanism to maintain the desired position, allowing for precise control and preventing unintended needle retraction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the puncture needle protrudes fully from the dilator, then mechanical puncture efficacy is improved, but the risk of accidental puncture to unintended tissue sites increases
Solution Approach 1:
The puncture needle is designed with dynamic protrusion capability, allowing it to extend from and retract into the dilator as needed. This dynamic configuration enables the operator to adjust the protrusion length according to the specific procedure requirements, providing full protrusion for mechanical puncture when needed while allowing retraction to minimize accidental puncture risk
Solution Approach 2:
The system allows changing the protrusion parameter of the puncture needle relative to the dilator. By controlling the extent of protrusion, the operator can optimize for mechanical puncture efficacy when full protrusion is needed, or reduce protrusion to minimize harmful effects such as accidental punctures
2Reliability
If the puncture needle protrusion is restricted, then current density increases and current leakage into blood pool is reduced, but mechanical puncture capability is compromised
Solution Approach 1:
The puncture needle's protrusion is made dynamic rather than fixed, allowing the operator to adjust the protrusion length based on the mode of puncture being performed. For RF puncture, the needle can be positioned with restricted protrusion to increase current density, while for mechanical puncture, full protrusion can be achieved
Solution Approach 2:
The system enables parameter changes in needle protrusion length to optimize for different puncture modes. The operator can control the protrusion parameter to achieve the desired balance between current density for RF puncture and mechanical puncture capability
3Measurement precision
If the operator applies continuous pressure to maintain needle protrusion, then puncture needle position is controlled, but operator fatigue increases and procedural complexity increases
Solution Approach 1:
The system incorporates a locking mechanism that allows the needle to maintain its protrusion position without continuous operator pressure. The lockable advancement point enables the needle to self-maintain its position once advanced, reducing operator fatigue and simplifying the procedure
Solution Approach 2:
The system provides visual feedback through markings on the dilator that indicate the protrusion length of the needle. This feedback mechanism allows the operator to precisely control and verify the needle position without requiring continuous pressure application
4Force
If the puncture needle is advanced against tissue, then puncture force is applied, but the likelihood of accidental mechanical puncture to unintended tissue sites increases
Solution Approach 1:
The needle's protrusion is dynamically controllable, allowing the operator to advance the needle only to the required extent before locking it in place. This prevents excessive protrusion that could lead to accidental punctures while maintaining sufficient protrusion for effective puncture force application when needed
5Productivity
If the operator must simultaneously maintain device position, maintain alignment, apply pressure, and activate electrocautery, then all procedural tasks are performed, but hands crossing occurs and procedure complexity increases
Solution Approach 1:
The locking mechanism allows the needle position to be set and locked without requiring continuous operator intervention. This reduces the number of simultaneous tasks the operator must perform, eliminating the need for hand crossing and simplifying the overall procedure
Data Source
AI summary
An access system for perforating a tissue within a heart is disclosed. The system includes a perforation device having a perforation device body including a proximal portion and a distal portion terminating in a distal tip. The system further includes a dilator comprising an elongated body, a proximal end and a distal end portion terminating in a distal tip, a handle connected to the proximal end of the elongated body and a dilator lumen extending through the handle and the elongated body and dimensioned to slidingly receive the perforation device. The system also includes an indicator mechanism positioned on the dilator indicating a protrusion length of the perforation device. Furthermore, the system includes a locking mechanism located on the dilator having an unlocked position and a locked position. The locking mechanism is configured to impede longitudinal movement of the perforation device within the dilator lumen.