Resorbable Vascular Closure Device for Puncture Sealing
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Solution Overview
Problem
Current methods for sealing puncture wounds in blood vessels after medical procedures, such as cardiac catheterization, are painful, require prolonged immobilization, and are prone to reopening, especially when using larger caliber catheters, which complicates cardiac catheterization procedures.
Innovation Solution
A hemostasis device comprising a rigid post with clamping members that sandwich the blood vessel wall for effective sealing, along with a deployment instrument to apply tension and deploy the device, using resorbable materials and hemostatic materials like collagen to enhance clotting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If digital pressure and conventional pressure dressings are applied to seal puncture wounds, then hemostasis can be achieved, but the procedure becomes painful and requires prolonged immobilization
Solution Approach 1:
The patent replaces the mechanical pressure dressing system with a self-expanding vascular closure device that uses elastic recovery to seal the puncture site. The device is inserted through the puncture and automatically expands to seal the vessel wall without requiring external pressure application or prolonged immobilization.
Solution Approach 2:
The closure device is designed to self-deploy and self-seal the puncture site through its elastic properties. Once inserted, the device automatically expands to its full size to seal the vessel without requiring continuous external pressure or prolonged immobilization, making the system self-sufficient.
2Adaptability or versatility
If larger caliber catheters are used for cardiac catheterization, then procedural effectiveness is improved, but sealing difficulties increase
Solution Approach 1:
The device changes the sealing mechanism from pressure-dependent to geometry-dependent. The self-expanding structure with controlled expansion ratios creates a reliable seal based on the device's geometric configuration rather than the size of the catheter used, allowing effective sealing with various catheter calibers.
Solution Approach 2:
The device incorporates hemostatic materials such as collagen in conjunction with the elastic structure. This composite approach combines the mechanical sealing capability of the elastic device with the hemostatic properties of collagen to achieve reliable sealing regardless of catheter size.
3Reliability
If prolonged pressure application is used to ensure wound closure, then sealing reliability is improved, but the procedure time and patient discomfort increase
Solution Approach 1:
The device is deployed and sealed before the patient is discharged, performing the sealing action in advance. The self-expanding mechanism ensures immediate and reliable closure at the time of deployment, eliminating the need for prolonged post-procedure bed rest and pressure application.
Solution Approach 2:
The patent replaces the time-dependent pressure application method with a mechanically self-sealing device that achieves reliable closure immediately upon deployment, significantly reducing the required bed rest period from hours to minutes.
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
Facilitates faster and more secure sealing of blood vessel punctures, reducing pain and immobilization time, and allows for the use of larger caliber catheters without increasing sealing difficulties, thereby improving the efficiency of cardiac catheterization procedures.
Implementation Method 1
The first and second clamping members are spaced relatively far apart along the length of the rigid post in an initial collapsed state, and are relatively close together in a deployed state, the wall of the blood vessel being sandwiched between the first and second clamping members in the deployed state
Implementation Method 2
using resorbable materials and hemostatic materials like collagen to enhance clotting
Data Source
AI summary
A hemostasis device for percutaneously sealing a puncture in the wall of a blood vessel includes a rigid post, and a foot, a seal and a retaining member mounted on the rigid post. The hemostasis device may be deployed in the puncture so that the foot is positioned within the blood vessel. Tension is applied to the rigid post to hold the foot against the inside surface of the blood vessel. The retaining member is then pushed along the length of the rigid post, advancing the seal to a deployed state against the outside surface of the blood vessel. The puncture in the blood vessel is sandwiched between the foot and the seal in the deployed state. The rigid post, foot, seal and retaining member may all be formed from a resorbable polymeric material.