Vascular Closure Device with Hand-Size Adaptive Trigger
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Solution Overview
Problem
Current methods for sealing vascular punctures during medical procedures are inefficient, requiring prolonged bed rest, are uncomfortable for patients, and pose risks of hematoma due to bleeding before hemostasis occurs, and existing devices often snag tissue or do not accommodate variations in physician hand sizes.
Innovation Solution
An apparatus that delivers a closure element through tissue into a blood vessel opening, featuring a locator assembly that expands to engage the vessel wall, a carrier assembly to deploy the closure element, and a triggering system that adjusts for different hand sizes, allowing for comfortable and stable operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If external pressure is applied to the puncture site until clotting and wound sealing occur, then hemostasis is achieved, but the patient must remain bedridden for a substantial period of time and the procedure becomes time-consuming
Solution Approach 1:
The closure element is divided into multiple segments or struts that can be independently deployed and positioned. This segmentation allows the device to be delivered in a compact state through the introducer sheath and then expanded at the puncture site, achieving hemostasis without requiring prolonged bed rest or extended procedural time
Solution Approach 2:
The closure element is pre-formed and pre-loaded within the delivery apparatus in a compressed or collapsed state. This preliminary preparation allows for rapid deployment at the puncture site, eliminating the need for time-consuming in-situ formation of the closure structure and enabling quick hemostasis achievement
2Reliability
If external pressure is applied to the puncture site, then hemostasis occurs, but the patient experiences discomfort and must remain immobilized
Solution Approach 1:
The closure element is designed to be self-expanding or self-anchoring upon deployment. Once delivered to the puncture site, the device automatically expands to engage the vessel wall and seal the puncture without requiring continuous external pressure or manual manipulation, providing hemostasis while allowing patient mobility and comfort
3Reliability
If a biodegradable plug is delivered through an introducer sheath, then the puncture site is occluded, but the anchor may increase the risk of over-advancement into the vessel
Solution Approach 1:
The closure element incorporates features that engage the vessel wall in a radial or circumferential dimension rather than relying solely on axial anchoring. This dimensional approach allows the device to secure the puncture site effectively while preventing over-advancement into the vessel lumen, as the radial engagement provides a mechanical stop
4Ease of operation
If a deployable loop is advanced into a vessel to engage the inner wall, then the sheath is held in location, but the device complexity increases
Solution Approach 1:
The closure element is integrated with the delivery apparatus such that the same structural features that enable closure also provide anchoring and positioning functions. This merging of functions eliminates the need for separate deployable loops or additional positioning mechanisms, reducing overall device complexity while maintaining ease of operation
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
Enhances hemostasis by uniformly expanding and deploying the closure element to seal the vessel wall, reducing patient discomfort and procedural time, while accommodating variations in physician hand sizes for improved usability.
Implementation Method 1
The apparatus can be activated to deploy the closure element. The apparatus can be configured to substantially uniformly expand the closure element beyond a natural cross-section of the closure element such that the closure element, when deployed, is configured to engage the blood vessel wall
Data Source
AI summary
A device for closing a tissue opening includes a proximal housing portion having a first portion, a second portion, a third portion, and a fourth portion. The first portion and the fourth portion extending transversely to a longitudinal axis of the proximal housing portion on opposite sides of the proximal housing portion. A distal portion extends from the proximal housing portion. At least the second portion and the third portion are configured to move toward the first portion.