Rotatable Introducer Sheath Linkage Angled Access
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Solution Overview
Problem
Minimally invasive surgeries face challenges in accurately and efficiently imaging and accessing target tissues within a patient due to the limitations of existing medical devices, which often require larger profiles and complex guide mechanisms, leading to patient discomfort and procedural difficulties.
Innovation Solution
The use of rotatable sheaths and linkages that create a fluid seal, allowing for the passage of imaging devices and surgical instruments, enabling angled access and minimizing instrument profile size, while maintaining a sealed environment to reduce discomfort and procedural complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If larger profile introducers and complex guide mechanisms are used to access target tissues, then access reliability is improved, but patient discomfort increases
Solution Approach 1:
The device is divided into separate functional components: a introducer assembly for access and a scope assembly for imaging. This segmentation allows each component to be optimized independently - the introducer can be sized appropriately for reliable access while the scope provides the imaging function, avoiding the need for a single large-profile device that causes patient discomfort.
Solution Approach 2:
A guide wire serves as an intermediary element that enables the scope to navigate to the target tissue through the introducer. The guide wire provides a pathway that allows the thinner scope to reach the target site reliably without requiring the scope itself to have a large profile that would cause patient discomfort.
2Reliability
If larger profile introducers are used to access target tissues, then access reliability is improved, but procedural complexity increases
Solution Approach 1:
By separating the access function (introducer) from the imaging function (scope), the system allows simpler, more straightforward procedures. The introducer establishes reliable access with a simple insertion motion, and the scope follows through the established pathway, reducing the overall procedural complexity compared to using a single complex large-profile device.
Solution Approach 2:
The guide wire acts as a simple intermediary that simplifies the procedure by providing a pre-established pathway. Instead of maneuvering a complex large-profile device, the procedure becomes simpler: insert guide wire, then follow it with the scope through the introducer, reducing procedural complexity while maintaining access reliability.
3Object-affected harmful factors
If minimally invasive approaches are used to access target tissues, then patient discomfort is reduced, but imaging and access capability deteriorates
Solution Approach 1:
The segmentation of functions allows the scope assembly to be designed with optimized imaging and access capabilities independent of the introducer size. The scope can have the necessary imaging sensors, lights, and working channels while maintaining a thin profile that minimizes patient discomfort during insertion.
Solution Approach 2:
The guide wire serves as an intermediary that enables the scope to achieve full imaging and access capability through a minimally invasive pathway. The guide wire provides the mechanical support and directional guidance needed for the scope to perform complex imaging and surgical tasks despite its small profile, thus maintaining adaptability while reducing patient discomfort.
4Device complexity
If thinner profile devices are used for minimally invasive access, then device complexity is reduced, but access reliability deteriorates
Solution Approach 1:
The introducer assembly can be designed with simpler, more robust construction optimized for reliable access, while the scope assembly handles the delicate imaging functions. This segmentation allows the access component to have the structural simplicity and reliability of a straightforward insertion device, while the thinner scope provides imaging capability without compromising access reliability.
Solution Approach 2:
The guide wire serves as a simple, reliable intermediary that provides mechanical support and directional control. This simple component enables the thinner scope to maintain access reliability by following the stable pathway established by the guide wire, without requiring the scope itself to have complex structural features that would increase device complexity.
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 facilitates easier and more comfortable access to remote tissues by allowing flexible angulation and reduced instrument size, enhancing imaging capabilities and procedural efficiency while maintaining a sterile environment.
Implementation Method 1
The exit lumen is configured to align with the first lumen of the rotatable sheath and engage the first fluid seal to form a fluid seal between the rotatable sheath and the linkage when the rotatable sheath and the linkage are mated to one another
Data Source
AI summary
Various rotatable shafts and linkage mechanisms configured to allow imaging and access to tissue within a body are provided. In an exemplary embodiment, an introducer system has a rotatable sheath and a linkage that can rotatably engage each other. The rotatable sheath has a distal portion extending at a non-zero angle relative to a proximal portion thereof. The linkage has an exit lumen on its distal end and a plurality of entry lumens on its proximal end. The linkage merges the plurality of entry lumens into the exit lumen, and the exit lumen is aligned with the rotatable sheath upon engagement. Fluid and/or surgical instruments can thus be passed from the plurality of entry lumens of the linkage, through the exit lumen of the linkage, and into the rotatable sheath. The linkage and the rotatable sheath can both receive an imaging device therethrough.