Vascular Closure Device with Tissue Hooks
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Solution Overview
Problem
Current methods for closing vascular access sites after medical procedures are time-consuming, require patient immobilization, and can lead to complications such as hemorrhage and thrombosis due to manual pressure or suturing, which may not be feasible in all surgical settings.
Innovation Solution
A vascular closure device with hook-like extensions that engage the body vessel wall or adjacent tissue, allowing for rapid closure of the opening, either by capturing the vessel wall internally or using a plug member to seal the opening from inside, facilitated by an introducer system for delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual pressure or compressive weight is used to close the vascular access site, then the vessel can be closed, but the procedure takes half an hour or more and requires patient immobilization
Solution Approach 1:
The invention extracts the closure function from manual compression and suturing techniques by introducing a dedicated closure device that can be rapidly deployed. The device includes a closure member with tissue engagement structures that mechanically close the access site without requiring prolonged manual pressure application or complex suturing procedures
Solution Approach 2:
The closure device serves as an intermediary between the operator and the vascular access site. It includes an introducer system with a closure member that delivers tissue engagement structures to the access site, enabling rapid closure through a standardized mechanical process rather than manual techniques
2Reliability
If sutures are used to close the vascular access site, then the vessel can be closed, but the procedure requires skill and practice and may be difficult in limited access surgeries
Solution Approach 1:
The invention extracts the complex suturing process and replaces it with a pre-formed closure member that has tissue engagement structures already configured for effective closure. The closure member can be deployed through the introducer system without requiring the operator to perform intricate suturing maneuvers
Solution Approach 2:
The tissue engagement structures are pre-formed on the closure member before deployment. This preliminary configuration of hooks, bars, or other engagement features eliminates the need for complex intra-procedural suturing actions, making the closure process simpler and more accessible to operators with varying skill levels
3Reliability
If sutures are left intravascularly on the endothelial surface, then the vessel can be closed, but a nidus for thrombus or intravascular mural hyperplasia may occur
Solution Approach 1:
The invention extracts the suture material from the intravascular space by using a closure member with tissue engagement structures that secure the vessel wall from the outside or at the boundary of the access site. The closure member itself can be designed to minimize intravascular presence, reducing the nidus for thrombus formation
Solution Approach 2:
Instead of using traditional sutures that remain intravascularly, the invention employs a closure member with tissue engagement structures that replicate the closing function of sutures while minimizing harmful intravascular presence. The engagement structures can be designed to engage tissue at the access site boundary rather than requiring intravascular suturing
Data Source
AI summary
A device for closure of an opening formed through a wall of a body vessel of a patient is provided, as well as an introducer system for delivery of the closure device. Various embodiments include the closure device having hook members configured to engage the tissue interior of the body vessel wall, hook members configured to engage interstitial tissue adjacent to the body vessel, a plug member to contact sealably the opening from inside the body vessel, and combinations thereof. A retraction member is removably attached to the each of the embodiments to permit manipulation of the device. Remodelable material may be included with each of the embodiments to promote quicker healing. The introducer includes a sheath that is insertable through the opening and a pusher disposed within the lumen of the sheath and movable within the sheath lumen to deploy the device.