Dilator And Sheath Hub Coupling For Axial And Rotational Stability
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Solution Overview
Problem
Current devices for creating punctures or perforations in heart tissues, such as the Brockenbrough™ Needle and radiofrequency perforation apparatuses, rely on mechanical force or focused radiofrequency energy, which may not provide adequate control or stability during the perforation process.
Innovation Solution
A dilator system is introduced that includes a dilator shaft with a lumen for receiving a puncturing device, a dilator hub with a flange and opening to inhibit relative rotation with a sheath, and an axial lock feature to secure the dilator hub within the sheath hub, enhancing stability and control during tissue perforation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a stiff needle or thin probe is used for puncture, then the device can penetrate tissue, but control and stability during the procedure are insufficient
Solution Approach 1:
The patent employs a nested structure where the needle is contained within the dilator, which is in turn contained within the sheath. This nested arrangement allows the thin needle to maintain its penetration capability while the progressively larger outer components (dilator and sheath) provide increasing levels of support and stability, resolving the contradiction between penetration strength and procedural stability.
Solution Approach 2:
The device is divided into distinct functional segments: the needle for penetration, the dilator for stabilization and dilation, and the sheath for support and guidance. Each segment performs a specific function, allowing the system to achieve both penetration capability and procedural stability through coordinated action of its parts.
2Stability of the object's composition
If a dilator and sheath are used together, then stability and control are improved, but the device structure becomes more complex
Solution Approach 1:
The dilator and sheath are designed to serve multiple functions simultaneously. The sheath provides both structural support and guidance, while the dilator serves as both a stabilizing element and a dilation tool. This multi-functionality reduces the need for additional separate components, thereby limiting the increase in device complexity while maintaining improved stability and control.
3Stability of the object's composition
If the dilator hub and sheath hub are designed to inhibit relative rotation, then rotational control is improved, but the coupling mechanism requires additional features
Solution Approach 1:
The dilator hub and sheath hub incorporate asymmetric features such as keyed connections or asymmetric flanges that prevent relative rotation between the components. These asymmetric coupling features provide inherent rotational control through their geometry alone, eliminating the need for additional active locking mechanisms and thereby limiting the increase in coupling mechanism complexity.
Data Source
AI summary
A system for facilitating access to a patient's heart includes a sheath having a sheath body defining a lumen adapted to receive a dilator. The sheath body includes a proximal portion and a distal portion. A sheath hub is coupled to the proximal portion of the sheath. The sheath hub includes a passageway for receiving a portion of a dilator hub and a protrusion adjacent the passageway. The dilator has a dilator shaft defining a lumen to receive and support a puncturing device. The dilator shaft includes a proximal portion for manipulation by a user and a tapered distal portion for placement in or near the heart. A dilator hub is coupled to the proximal portion of the dilator shaft. The dilator hub includes a flange having an opening, the opening configured for receiving a portion of the sheath hub to inhibit relative rotation between the dilator and the sheath.