Sheath Assembly Dilator Length Control for Transseptal Puncture
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Solution Overview
Problem
Existing sheath assemblies for transseptal puncture procedures face challenges in controlling the pressure applied to the septum, leading to either insufficient tenting or excessive risk of the sheath/dilator springing forward into the left atrium.
Innovation Solution
A kit comprising an elongated dilator assembly, an elongated sheath assembly, a dilator-receiver device, and a dilator-receiver mover, which allows for selective extension or retraction of the dilator assembly within the sheath assembly, enabling precise control over the length and pressure applied to the septum.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the sheath assembly applies sufficient force to tent the septum, then the puncture accuracy is improved, but the risk of the sheath/dilator springing forward into the left atrium increases
Solution Approach 1:
The dilator assembly is designed with movable segments that can be dynamically extended or retracted relative to the sheath assembly. This dynamic configuration allows the operator to adjust the protrusion length of the dilator tip, thereby controlling the force applied to the septum in real-time to achieve accurate tenting without excessive force that could cause springing forward
Solution Approach 2:
The system enables changing the physical parameter of the dilator assembly's length by extending or retracting the dilator relative to the sheath. This parameter adjustment allows optimization of the force distribution and contact pressure on the septum, achieving the precise balance between sufficient tenting force and preventing harmful forward springing
2Measurement precision
If the sheath assembly applies excessive force to tent the septum, then the puncture accuracy is improved, but tissue damage or complications increase
Solution Approach 1:
The dilator assembly's dynamic extension and retraction capability allows for precise control of the force applied to the septum. By adjusting the protrusion length, the operator can apply exactly the right amount of force needed for accurate tenting without exceeding the threshold that would cause tissue damage
Solution Approach 2:
Changing the effective length parameter of the dilator assembly through extension/retraction mechanisms enables optimization of the mechanical properties during the procedure, allowing sufficient force for accurate puncture while staying within safe limits to prevent tissue damage
3Device complexity
If the dilator assembly length is fixed, then the device complexity is reduced, but the ability to control pressure applied to the septum is insufficient
Solution Approach 1:
The system transitions from a fixed-length dilator to a dynamic configuration where the dilator can be extended or retracted relative to the sheath. This dynamic feature, while adding some complexity, provides significant operational benefit by enabling precise pressure control during the puncture procedure
Solution Approach 2:
The dilator assembly is nested within the sheath assembly, with the dilator capable of moving in and out of the sheath. This nested configuration allows for controlled extension and retraction, providing pressure adjustment capability while maintaining a relatively compact integrated structure
Data Source
Figure 1A~2A
Figure 2B
Figure 3A~3B
AI summary
An apparatus is for an elongated sheath assembly configured to receive, at least in part, an elongated dilator assembly. The apparatus includes a dilator-receiver device configured to be installed to the elongated sheath assembly. A dilator-receiver mover is configured to be mounted, at least in part, to the elongated sheath assembly. The dilator-receiver mover is configured to be operatively connected to the dilator-receiver device. The dilator-receiver mover is also configured to selectively move the dilator-receiver device along a predetermined distance.