Vascular Locator Anchor Hinge Mechanism
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Solution Overview
Problem
Conventional vascular closure devices are bulky, complex to use, and difficult to remove, requiring significant hospital staff time and causing patient discomfort due to the need for manual pressure to prevent bleeding after procedures.
Innovation Solution
A vascular locator device with a handle and a locator anchor that expands laterally using a hinge mechanism, allowing for precise placement and easy deployment of a vascular closure implant to seal the puncture site, simplifying the process and reducing manual effort.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional locator devices are used to determine puncture site location, then the vessel can be located, but the device becomes bulky and takes up excessive space in the vascular closure instrument
Solution Approach 1:
The locator device is nested within the introducer sheath, with the locator member housed inside the sheath when not in use. The locator member can be deployed from the sheath to extend beyond its distal end for vessel location determination, then retracted back into the sheath. This nesting arrangement allows the locator functionality to be integrated without increasing the overall device volume.
2Measurement precision
If conventional vascular closure and locator devices are used, then the vessel can be located, but the devices are complicated to use and difficult to remove after the vessel is located
Solution Approach 1:
The locator function and closure function are merged into a single integrated device. The locator member is positioned within the introducer sheath, and the closure element is delivered through the same sheath. This integration allows both functions to be performed with a single device that is simpler to operate and remove compared to separate locator and closure devices.
3Reliability
If manual pressure is applied to the skin above the access puncture to prevent bleeding, then blood loss is inhibited, but patient discomfort increases and hospital staff time is significantly required
Solution Approach 1:
The closure element is designed to self-expand and self-seal the puncture site upon deployment. Once delivered through the introducer sheath to the puncture site, the closure element autonomously performs the sealing function without requiring continuous manual pressure or extended staff monitoring, thereby reducing both patient discomfort and staff time requirements.
4Ease of operation
If an implant is deposited at the puncture site to obstruct blood flow, then staff time and patient comfort are improved, but the device becomes more complex to properly place
Solution Approach 1:
The introducer sheath serves multiple functions: it acts as the delivery conduit for the locator member, houses the closure element during delivery, and provides the structural framework for the entire closure system. This multi-functionality reduces the number of separate components needed, simplifying the overall device complexity while maintaining the benefits of implant-based closure.
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 enables efficient and comfortable closure of vascular puncture sites by simplifying the deployment of vascular closure implants, reducing patient discomfort and hospital staff time, while allowing for easy removal without dislodging the anchor.
Implementation Method 1
a locator anchor comprising a first hinge and a second hinge, the locator anchor positionable within the housing and displaceable from the housing distally outside a distal end of the insertion sheath
Implementation Method 2
an elongated member coupled to the locator anchor, the elongated member being movable in a proximal direction relative to the housing to fold the locator anchor at the first hinge and at the second hinge
Data Source
Figure 1
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AI summary
A vascular closure device (20) having a proximal end and a distal end is described. The vascular closure device may include an insertion sheath (28), a handle, and a locator anchor (38) positionable distally outside a distal end of the insertion sheath when the handle is in a first position. The handle may be movable from the first position to a second position located proximally relative to the first position, the locator anchor being configured to expand laterally when the handle is moved from the first position to the second position. Additionally, the handle may be movable from the second position to a third position located proximally relative to the second position to deploy a vascular closure implant in a puncture tract. A vascular closure method is also disclosed.