Vascular Closure Force Management via Elastic Deformation
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Solution Overview
Problem
Current vascular closure devices face challenges in applying consistent and controlled pressure to seal vascular punctures, as excessive force can cause tissue damage, while insufficient force may fail to achieve hemostasis, due to the reliance on manual tensile force application by surgeons.
Innovation Solution
A vascular closure device featuring an elongate shaft with a vascular sealing structure and a carriage, coupled with elastically deformable structures such as springs or polymer materials, which transfer force to the shaft and include force indicators to visually, tactically, or audibly signal the applied force, ensuring appropriate pressure is applied without causing injury.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a surgeon applies tensile force to the catheter to pull the balloon against the lumen wall, then the puncture closure effectiveness is improved, but the risk of lumen wall damage and surrounding tissue injury increases
Solution Approach 1:
The device incorporates a force indicator that provides real-time feedback to the surgeon about the amount of force being applied to the catheter. This feedback mechanism allows the surgeon to monitor the force level and adjust it to remain within a safe range that ensures effective puncture closure without exceeding the threshold that would cause lumen wall damage or surrounding tissue injury.
Solution Approach 2:
The patent establishes specific force parameter ranges (e.g., 0-5 pounds of force) that optimize the balance between achieving effective puncture closure and preventing tissue damage. By defining and controlling the force parameter within this optimized range, the device resolves the contradiction between closure effectiveness and tissue safety.
2Object-affected harmful factors
If a surgeon applies insufficient tensile force to the catheter, then the risk of tissue damage is reduced, but the balloon may not apply adequate pressure to close the puncture
Solution Approach 1:
The force indicator provides real-time feedback to the surgeon, enabling them to verify that sufficient force is being applied to achieve effective puncture closure. The indicator shows when the force reaches the minimum threshold required for reliable closure, ensuring the surgeon applies adequate force without having to estimate or guess the appropriate level.
Solution Approach 2:
The patent replaces the surgeon's manual force estimation and application with an instrumented system that includes force sensors and indicators. This substitution transforms the subjective mechanical skill of force application into an objective, measurable, and controllable process, eliminating the uncertainty that previously existed between applying too little force and risking tissue damage.
3Ease of operation
If the device includes force management features such as elastically deformable structures and force indicators, then the control over applied pressure is improved, but the device complexity increases
Solution Approach 1:
The force indicator acts as an intermediary between the mechanical force application system and the surgeon. Rather than requiring the surgeon to directly sense or calculate the appropriate force, the indicator serves as a mediator that translates the complex mechanical state into simple, interpretable visual or tactile signals, thereby simplifying the surgeon's task despite the added device components.
Solution Approach 2:
The device incorporates self-regulating features such as elastically deformable structures that automatically respond to force application. These structures provide inherent mechanical feedback and can limit excessive force application through their elastic properties, allowing the device to partially regulate itself without requiring constant active control by the surgeon, thus improving ease of operation despite increased 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
The device effectively seals vascular punctures by providing controlled pressure, reducing the risk of hematoma or other complications by allowing surgeons to monitor and adjust the applied force, ensuring effective hemostasis without tissue damage.
Implementation Method 1
at least one elastically deformable structure configured to transfer at least a portion of a force applied to the carriage to the elongate shaft
Data Source
AI summary
A vascular closure device may comprise an elongate shaft, a vascular sealing structure, and a carriage. The vascular sealing structure may be located on the elongate shaft and configured to apply a pressure to an interior wall of a lumen. The carriage may be slidably coupled to the elongate shaft, and at least one elastically deformable structure may be configured to transfer at least a portion of a force applied to the carriage to the elongate shaft. A method of vascular closure may comprise positioning a vascular sealing structure located on the elongate shaft within a lumen, transferring at least a portion of a force applied to a carriage to the elongate shaft via at least one elastically deformable structure, and applying a pressure to an interior wall of the lumen with the vascular sealing structure to close a vascular opening.