Catheter Handle Segmented Housing for Stent Deployment
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Solution Overview
Problem
Current medical technologies lack a minimally invasive and predictable method for trans-arterial implantation of a self-expandable heart valve stent with a heart valve prosthesis, often requiring a heart-lung machine and being sensitive to the surgeon's skill, with risks of incorrect positioning and high costs.
Innovation Solution
A catheter system with a handle that ensures a predefined sequence of steps for releasing a self-expandable heart valve stent, using force transmission means to manipulate the catheter tip and housing portions, allowing controlled and predictable implantation without a heart-lung machine.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a self-expanding stent system is moved trans-arterially to an insufficient heart valve using existing insertion systems, then the heart valve prosthesis can be implanted with minimal invasiveness, but the implantation procedure becomes relatively complicated, difficult and expensive, and incorrect positioning cannot be corrected without more extensive operative intervention
Solution Approach 1:
The catheter tip is divided into multiple housing portions (first housing portion, second housing portion, third housing portion) that can be independently manipulated. Each housing portion controls the release of different stent components (positioning hoops, retaining hoops, valve prosthesis) in a predetermined sequence, allowing complex implantation steps to be broken down into manageable, sequential actions that reduce procedural complexity while maintaining minimal invasiveness
Solution Approach 2:
The handle is equipped with operating means that prescribe a pre-set sequence of steps for releasing the stent components. The positioning hoops are released first to secure anchorage, followed by the retaining hoops to release the valve prosthesis. This preliminary sequencing of actions ensures correct positioning before final deployment, preventing the need for corrective interventions
2Manufacturing precision
If the stent is released by external manipulation when the implantation location is reached, then self-expansion leads to secure anchorage and precise positioning, but the position cannot be corrected once the stent has expanded and the stent cannot be removed in a simple way
Solution Approach 1:
The system transitions from a static, all-or-nothing release mechanism to a dynamic, staged release process. The housing portions can be manipulated independently to release stent components in sequence: first the positioning hoops for anchorage, then the retaining hoops for prosthesis release. This dynamic control allows positioning to be optimized at each stage before final expansion, maintaining precision while enabling correction if needed
Solution Approach 2:
The positioning hoops are released and expanded before the retaining hoops. This preliminary action secures the stent anchorage and positioning first, allowing verification of correct placement before the final release of the valve prosthesis. If positioning is incorrect, the sequential design allows for intervention before complete expansion
3Ease of operation
If a heart valve prosthesis is implanted with minimal invasiveness using existing systems, then the procedure is less invasive, but incorrect positioning can frequently only be avoided when the heart surgeon or radiologist is especially experienced
Solution Approach 1:
The sequential release mechanism provides inherent feedback control. The first housing portion releases positioning hoops that expand and engage with the aortic wall, providing mechanical feedback on anchorage. The second housing portion then releases retaining hoops that provide feedback on prosthesis positioning. This staged feedback allows verification at each step, ensuring accurate positioning without requiring exceptional operator skill while maintaining minimal invasiveness
Solution Approach 2:
By segmenting the release process into distinct housing portions that control different stent components, the system separates positioning functions from deployment functions. This segmentation allows independent optimization and verification of positioning before final prosthesis release, improving reliability while maintaining the minimal invasiveness of the trans-arterial approach
4Reliability
If traditional surgical methods are used for heart valve replacement, then the implantation can be performed with established techniques, but the operation requires a heart-lung machine and causes significant physical and mental stress on the patient
Solution Approach 1:
The patent replaces the complex mechanical support system of a heart-lung machine with a self-expanding stent mechanism. The stent's elastic memory provides the mechanical force for expansion and anchorage, eliminating the need for external life support equipment. This substitution maintains implantation reliability through the self-expanding mechanism while dramatically reducing patient stress and operational complexity by avoiding cardiopulmonary bypass
Data Source
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Figure 3a~3b
AI summary
This invention is directed to a handle (70) for manipulating a catheter tip (10) of a catheter insertion system (100), with which a self-expandable heart valve stent (150) can be inserted into the body of a patient. The invention further concerns a catheter system (30) of a catheter insertion system (100) as well as a catheter insertion system (100) itself. The proposed catheter insertion system (100) is designed to enable the implantation of a heart valve prosthesis (160) attached to a heart valve stent (150) in the optimum implantation location in a sequence of events defined before the intervention. For this purpose, the catheter insertion system (100) comprises the handle (70) for manipulating the catheter tip (10) of the catheter insertion system (100), wherein the handle (70) comprises means (71, 81) that prescribe a pre-set sequence of steps such that each subsequent step is inhibited until the preceding step has been completed.