Adjustable Access Sheath Length Customization
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Solution Overview
Problem
Current access systems for medical procedures, such as catheterization, face challenges in accommodating the anatomical variability among patients, requiring multiple sheath lengths that can be cumbersome to manufacture and store.
Innovation Solution
An adjustable access sheath system that can be customized to a suitable length based on patient-specific factors like sex, weight, and anatomy, featuring a tubular member with indicators for length adjustment and a tapered dilator for tissue expansion, allowing for on-demand length modification.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple fixed-length access sheaths are manufactured to accommodate different patients, then all patients can receive appropriate care, but manufacturing complexity and inventory requirements increase
Solution Approach 1:
The access sheath incorporates an adjustable length mechanism that allows it to be modified from a single long sheath to various shorter lengths as needed. This dynamic adjustment capability eliminates the need to manufacture and store multiple fixed-length sheaths, while still providing appropriate length selection for different patient anatomies.
Solution Approach 2:
A single universal access sheath design serves multiple functions by being able to accommodate different patient requirements through length adjustment. This multi-functional approach replaces the need for multiple specialized sheaths of different fixed lengths, simplifying both manufacturing and inventory management.
2Device complexity
If a single long access sheath is used for all patients, then manufacturing and inventory are simplified, but proper fit for individual patients cannot be achieved
Solution Approach 1:
The access sheath includes an adjustable length mechanism that enables customization during the procedure. The sheath can be trimmed or adjusted to the appropriate length for each patient based on their specific anatomy, ensuring proper fit while starting from a single standardized manufacturing design.
Solution Approach 2:
The system enables the user to customize the sheath length directly at the point of use based on patient requirements. This self-service approach to length customization eliminates the need for pre-manufacturing multiple sizes, allowing the single sheath design to adapt to individual patient needs.
3Ease of operation
If multiple access sheath lengths are stored for different procedures, then optimal access can be achieved, but storage space and logistical complexity increase
Solution Approach 1:
A single access sheath design performs multiple length-related functions through adjustment capabilities. This universal design replaces the need to maintain inventory of multiple different-length sheaths, reducing storage requirements while ensuring optimal length can be achieved for each procedure.
Solution Approach 2:
The adjustable length mechanism allows the same sheath to be optimized for different procedural needs by modifying its length. This dynamic capability eliminates the static inventory requirement of storing multiple fixed-length sheaths, as one adjustable sheath can serve all length requirements.
4Ease of manufacture
If fixed-length access sheaths are used, then manufacturing is straightforward, but real-time adjustment for optimal patient fit is not possible
Solution Approach 1:
The access sheath incorporates an adjustable length feature that maintains relatively simple manufacturing processes while enabling post-manufacturing customization. The design allows for straightforward production of a standardized sheath that can then be adjusted to the appropriate length for each patient during the procedure.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables precise and flexible access channel creation tailored to individual patients, reducing the need for multiple sheath lengths and enhancing procedural efficiency by allowing real-time adjustment for optimal tool insertion and manipulation.
Implementation Method 1
an adjustable dilator locatable inside the adjustable access sheath, the adjustable dilator including a tapered portion near distal end thereof
Data Source
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Figure 4A~4B
Figure 5
AI summary
Embodiments disclosed herein generally relate to an access sheath and access systems. In some embodiments, the access sheath may be non-adjustable access sheath or an adjustable access sheath. For example, a length of the adjustable access sheath may be modified or customized (e.g., before insertion thereof in a patient) to a suitable length for a particular patient. In some embodiments, the access sheath and/or dilator may have a substantially fixed or predetermined length.