Adjustable Hub Adapter With Locking for Diverse Sheath Hubs
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Solution Overview
Problem
Existing medical systems face challenges in accessing the left atrium of the heart through transseptal puncture due to the incompatibility of kitted dilators and guidewires with different sheaths and therapeutic devices, limiting their versatility and compatibility.
Innovation Solution
An adaptable dilator hub with a locking feature that can adjust its diameter to fit various sheath hubs, allowing for secure connection and compatibility with sheaths of varying sizes and shapes, ensuring stable positioning during medical procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a kitted dilator and guidewire are used with a specific sheath, then compatibility and secure connection are improved, but versatility with different sheath sizes and shapes deteriorates
Solution Approach 1:
The dilator hub incorporates a movable locking feature that can transition between a neutral position (defining a first diameter) and a second position (defining a second diameter), with an engaged position in between that defines an engaged diameter. This dynamic adjustment mechanism allows the locking feature to adapt its diameter to match different sheath inner diameters, enabling secure connection across multiple sheath sizes and configurations while maintaining connection stability.
Solution Approach 2:
The locking feature's diameter is made variable through mechanical adjustment, allowing it to change from a first diameter in the neutral position to a second diameter in the second position, with intermediate engaged diameters. This parameter change enables the dilator hub to accommodate sheaths with varying inner diameters, resolving the contradiction between maintaining secure connection and achieving versatility with different sheath specifications.
2Ease of manufacture
If a fixed-diameter dilator hub is used, then manufacturing simplicity is improved, but adaptability to different sheath sizes deteriorates
Solution Approach 1:
The dilator hub is segmented into a hub body and a movable locking feature that can independently adjust its diameter. This segmentation allows the locking feature to be manufactured with adjustment mechanisms (such as movable arms or expandable structures) while the main hub body remains relatively simple, balancing manufacturing ease with adaptability to different sheath sizes.
3Device complexity
If a single dilator hub design is used, then device complexity is reduced, but compatibility with varying sheath features deteriorates
Solution Approach 1:
The dilator hub is designed with a universal locking feature that can accommodate multiple sheath sizes and configurations through diameter adjustment. Instead of creating multiple specialized hub designs for different sheath types, this single universal hub design with adjustable locking feature provides compatibility across varying sheath features while maintaining manageable device complexity.
Data Source
AI summary
An adaptable dilator for use with a crossing device is provided herein. The dilator comprises a dilator hub housing defining a distal end and a proximal end. the dilator further comprises a dilator body extending distally from the dilator hub housing. The dilator further comprises a locking feature disposed adjacent the proximal side of the dilator hub housing. The locking feature being movable between a neutral position defining a first diameter and a second position defining a second diameter. The locking feature also defines an engaged position defining an engaged diameter, the engaged position between the neutral position and the second position and the engaged diameter between the first diameter and the second diameter. The engaged diameter is variable such that the engaged position is configured to engage an inner diameter of a therapy sheath hub.