Vessel Sealing Device with Twisting Frame for Aperture Closure
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Solution Overview
Problem
Minimally invasive surgical procedures for the heart face challenges with vessel opening, access, and closure, leading to increased risks and complications, such as infection and adverse effects from heart-lung machine use, due to difficulties in effectively managing vessel apertures.
Innovation Solution
The development of implantable devices and delivery apparatuses that include an annular puncture frame, tubular sealing member, and twisting frame to securely open and close vessel apertures, allowing access to the vessel lumen during procedures and ensuring sealing post-procedure, utilizing a sealing device with a self-extending mechanism and suture loop for secure closure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If open-heart surgical procedures are conducted under general anesthesia with heart-lung bypass machine, then the heart can be accessed for surgical procedures, but the patient is exposed to high invasiveness and potential risks such as infection, stroke, and renal failure
Solution Approach 1:
The sealing device is divided into multiple functional components: an annular frame for aperture closure, a tubular sealing member for sealing the puncture site, and a twisting frame for actuation. This segmentation allows each component to perform its specific function efficiently while minimizing overall procedural risk
Solution Approach 2:
The sealing device is deployed and the aperture is closed before the actual surgical procedure begins. This preliminary closure protects the patient from potential complications during the procedure, and the aperture can be reopened if needed using the same device
2Object-affected harmful factors
If minimally invasive surgical approaches are used to access the heart through small incisions, then the invasiveness is reduced, but difficulties in vessel opening, access, and closure negatively impact the procedure utility
Solution Approach 1:
The sealing device is self-contained and self-actuating. The twisting frame rotates the tubular sealing member to close the aperture automatically without requiring additional surgical instruments or procedures. The device serves itself to both open and close the vessel access site
Solution Approach 2:
The sealing device performs multiple functions: it creates the aperture, maintains it open during the procedure, and closes it afterward. This multi-functionality eliminates the need for separate devices for vessel opening and closure, simplifying the minimally invasive approach
3Reliability
If additional procedures are performed to seal the aperture in the vessel sidewall following the endoluminal procedure, then the aperture can be sealed, but the procedural complexity and time are increased
Solution Approach 1:
The aperture creation and sealing functions are merged into a single device and a single procedural sequence. The annular frame and tubular sealing member work together as an integrated system that can both open and close the aperture, reducing the number of procedural steps while maintaining reliable sealing
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 solution enables safe and efficient access to the vessel lumen during minimally invasive procedures, reducing the need for additional sealing steps and minimizing complications by providing a reliable and secure closure mechanism, thus enhancing the safety and efficacy of heart surgeries.
Implementation Method 1
The tubular sealing member comprises an open state that allows access to a lumen of the vessel via the aperture, and can be twisted to a sealed state by angular rotation of the twisting frame to close the aperture in the vessel sidewall
Implementation Method 2
The distal fingers can be moved to a constrained state pointing in a substantially axial direction for insertion through the aperture in the vessel sidewall and can self-extend to the non-constrained state, thereby pinching the vessel sidewall between the proximal and distal fingers
Data Source
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AI summary
Embodiments of the present disclosure are directed to implantable sealing devices, delivery apparatuses, and methods of their use, for closing surgical openings or defects in a sidewall of a vessel in a subject. In several embodiments, the disclosed implantable sealing devices, delivery apparatuses, and methods can be used to close a surgical opening in a sidewall of the heart.