Introducer Sheath Deformable Septum Single Access Point
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Solution Overview
Problem
Current medical procedures involving multiple instruments require multiple puncture points, leading to increased patient discomfort, complications, and prolonged procedure times, especially when instruments are used sequentially through a single access point.
Innovation Solution
An introducer sheath with a plurality of lumens and a deformable elastomeric septum that selectively isolates and communicates them, allowing multiple medical instruments to be inserted through a single access point by transitioning a guidewire between lumens, enabling simultaneous or sequential use without the need for multiple punctures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If multiple puncture points are created to insert multiple medical instruments simultaneously, then multiple instruments can be inserted at once, but patient discomfort and complications increase
Solution Approach 1:
The patent combines multiple instrument passage functions into a single introducer sheath with multiple lumens. This allows multiple medical instruments to be inserted through one puncture point rather than requiring separate puncture points for each instrument, thereby maintaining productivity while reducing patient discomfort and complications associated with multiple punctures.
Solution Approach 2:
The introducer sheath is segmented into multiple lumens that can be independently used for different instruments. The septum is also segmented to allow selective communication between lumens, enabling flexible instrument passage while maintaining the benefit of a single access point.
2Ease of operation
If one instrument is removed completely before inserting another instrument through a single puncture point, then instrument passage is simplified, but patient discomfort and procedure time increase
Solution Approach 1:
The patent implements a nested structure where multiple instruments can be simultaneously contained within the introducer sheath's multiple lumens. Instruments can be inserted, manipulated, and removed independently within their respective lumens without requiring complete removal of other instruments, thus reducing procedure time while maintaining ease of operation.
Solution Approach 2:
The septum acts as an intermediary structure that can be selectively deflected to allow guidewire transfer between lumens. This enables smooth transition of instruments between lumens without requiring complete removal, maintaining both ease of operation and reduced procedure time.
3Object-affected harmful factors
If multiple instruments are used simultaneously through a single puncture point, then patient trauma is reduced, but device complexity increases
Solution Approach 1:
The introducer sheath is divided into multiple lumens with a septum that can be selectively deflected. This segmentation allows independent use of each lumen for different instruments while maintaining a relatively simple overall structure that minimizes patient trauma.
Solution Approach 2:
The septum is designed to be dynamically deflectable from a biased condition to allow communication between lumens when needed. This dynamic feature enables flexible instrument passage while maintaining a simple closed structure during normal operation, balancing functionality with structural simplicity.
4Stability of the object's composition
If a rigid septum is used to separate lumens, then lumen isolation is maintained, but guidewire transition between lumens becomes difficult
Solution Approach 1:
The septum is designed with dynamic properties, being deflectable from a biased condition to allow guidewire passage between lumens when needed. This maintains stable lumen isolation during normal use while enabling easy guidewire transition when required, resolving the contradiction between isolation stability and transition ease.
Solution Approach 2:
The septum's physical state is changed from a rigid isolated condition to a deflectable open condition by applying force to overcome its bias. This parameter change allows guidewire to transition between lumens while maintaining the ability to return to the isolated state, balancing both lumen isolation and guidewire transition ease.
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
This solution reduces patient trauma and procedure time by allowing multiple instruments to be used through a single access point, minimizing friction and facilitating smooth outer contour alignment, thus enhancing procedural efficiency and comfort.
Implementation Method 1
The septum is at least partially formed from a deformable and elastomeric material. The septum has a biased condition in which the plurality of sheath lumens are at least partially isolated from one another. The septum is selectively deflectable from the biased condition to at least partially place at least one of the plurality of sheath lumens in fluid communication with at least one other of the plurality of sheath lumens.
Data Source
AI summary
An introducer sheath is provided for inserting at least one medical instrument directly toward a target patient tissue site. A plurality of lumens extend longitudinally between sheath proximal and distal ends of the introducer sheath. A septum extends between the sheath proximal and distal ends and selectively laterally separates each of the sheath lumens from one another. The septum is at least partially formed from a deformable and elastomeric material. The septum has a biased condition in which the plurality of sheath lumens are at least partially isolated from one another. The septum is selectively deflectable from the biased condition to at least partially place at least one of the plurality of sheath lumens in fluid communication with at least one other of the plurality of sheath lumens.