Hemostatic Device Sleeve Reduces Catheter Deployment Friction
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Solution Overview
Problem
Current medical device deployment systems require high forces to deploy endoluminal prostheses due to significant frictional resistance, which can lead to operator fatigue and inaccurate placement.
Innovation Solution
A delivery system with a sheath and catheter configuration that includes a housing with a first seal and a movable sleeve with a second seal, allowing the sleeve to change positions to reduce frictional resistance, thereby decreasing the force needed to move the sheath relative to the catheter, potentially by 10%, 25%, or 50%.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a seal is used to create a sealing engagement between the hemostatic device and the catheter, then sealing effectiveness is improved, but frictional resistance increases requiring higher deployment force
Solution Approach 1:
The sealing interface is divided into two separate seals: a first seal between the hemostatic device housing and the delivery catheter, and a second seal between the movable sleeve and the delivery catheter. This segmentation allows each seal to be optimized independently, with the second seal configured to provide sealing while minimizing frictional resistance during sheath withdrawal.
Solution Approach 2:
The movable sleeve acts as an intermediary component between the hemostatic device housing and the delivery catheter. By introducing this intermediate element with its own sealing interface, the system reduces direct friction between the housing and catheter, thereby lowering the force required for deployment while maintaining sealing integrity.
2Reliability
If a high sealing force is applied by the first seal on the catheter, then sealing reliability is improved, but the frictional resistance between the hemostatic device and catheter increases
Solution Approach 1:
The sealing function is segmented between two separate seals with different force characteristics. The first seal provides high sealing force for reliability, while the second seal provides low-friction sealing for ease of operation. This segmentation allows the system to achieve both sealing reliability and operational ease simultaneously.
Solution Approach 2:
Different sealing characteristics are applied at different locations: the first seal at the hemostatic device housing provides high sealing force, while the second seal at the movable sleeve provides low-friction sealing. This local differentiation of sealing quality optimizes both sealing reliability and ease of sheath withdrawal.
3Reliability
If the sleeve is positioned outside the housing, then the first seal exerts high sealing force on the catheter, but high frictional resistance requires more deployment force
Solution Approach 1:
The movable sleeve is designed to change position dynamically during the procedure. It can be positioned outside the housing when high sealing force is needed, and moved inside the housing when low frictional resistance is needed for sheath withdrawal. This dynamic repositioning allows the system to adapt to different operational requirements.
Solution Approach 2:
The system changes the physical parameters of the sealing interface by moving the sleeve between two positions. When the sleeve is inside the housing, it alters the sealing configuration to reduce frictional resistance, thereby changing the force parameter from high (when outside) to low (when inside), facilitating easier sheath withdrawal.
4Force
If the sleeve is moved inside the housing, then frictional resistance is reduced, but the system complexity increases
Solution Approach 1:
The movable sleeve performs multiple functions: it provides a second sealing interface, reduces frictional resistance when positioned inside the housing, and can be integrated with existing delivery system components. This multi-functionality justifies the added complexity by delivering multiple benefits from a single component.
Solution Approach 2:
The movable sleeve is designed to nest within the hemostatic device housing when in the reduced-friction position. This nesting arrangement minimizes the overall device footprint and integrates the additional complexity into the existing structure, reducing the impact on device complexity while maintaining the friction-reduction benefit.
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
The system reduces the force required to deploy medical devices within a body lumen, enhancing operator comfort and accuracy by minimizing the frictional resistance between the sheath and catheter.
Implementation Method 1
the first seal exerts a first sealing force on the catheter that effects a first frictional resistance between the hemostatic device and the catheter
Implementation Method 2
the second seal of the sleeve exerts a second sealing force on the catheter that effects a second frictional resistance between the hemostatic device and the catheter
Data Source
Figure 1
Figure 2
Figure 3(a)~6(b)
AI summary
A delivery system for a medical device may include a sheath (12), a catheter (24) slideably disposed within the sheath, and a hemostatic device comprising a housing disposed around and sealingly engaged with the sheath by a first seal (28). A sleeve (120) is slideably coupled to the catheter and comprises a second seal (132) sealingly engaging the catheter. The sleeve is movable between a first position, in which the sleeve is disposed outside of the housing and the first seal is sealingly engaged with an outer surface of the catheter, and a second position in which at least a portion of the sleeve is disposed within the housing between an inner surface of the housing and the outer surface of the catheter, wherein, in the second position, the first seal is sealingly engaged with an outer surface of the sleeve and the second seal is sealingly engaged with the outer surface of the catheter.