Occlusion Device Preventing Glue Clogging in Vascular Surgery
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Solution Overview
Problem
Current methods for closing percutaneous vascular entry sites after procedures are inefficient, particularly for patients with coagulation issues or vascular prostheses, as they often lead to bleeding complications and require skilled operators, and quick-setting haemostatic liquids are difficult to apply effectively due to premature hardening and clogging issues.
Innovation Solution
A device with a duct and coupling mechanism that prevents blood and biological materials from contacting the surgical glue, allowing for the undiluted release of quick-setting haemostatic liquids, such as cyanoacrylate, at the entry site to form a strong and flexible closure without echographic control, using a sliding coupling with a short tube to maintain the glue in close proximity to the introducer sheath and prevent backflow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If quick-setting haemostatic liquids are used to close vascular entry sites, then the closure strength and speed are improved, but the ducts are easily blocked by premature hardening
Solution Approach 1:
A barrier liquid (saline solution or water) is introduced as an intermediary substance that fills the duct first and prevents direct contact between the quick-setting haemostatic liquid and blood. The barrier liquid is expelled before the haemostatic liquid, ensuring the duct remains unclogged while enabling rapid closure at the target site.
Solution Approach 2:
The barrier liquid is pre-loaded into the duct before the haemostatic liquid. This preliminary action creates a protective layer that prevents premature hardening in the duct, allowing the haemostatic liquid to be injected quickly without clogging the delivery system.
2Reliability
If compression force is applied to close entry sites, then natural haemostasis is facilitated, but the treatment time is prolonged and patient mobility is restricted
Solution Approach 1:
The invention changes the fundamental parameter of haemostasis from mechanical compression over time to immediate chemical bonding. The cyanoacrylate-based surgical glue provides instant adhesion and sealing upon contact with blood, eliminating the need for prolonged compression and enabling patient mobility immediately after procedure.
Solution Approach 2:
The mechanical compression system is replaced with a chemical bonding system. Instead of using external force to maintain closure, the invention uses the chemical properties of cyanoacrylate glue to create permanent adhesion between tissue edges, substituting mechanical pressure with chemical bonding.
3Reliability
If entry sites on vascular prostheses are closed by natural repair processes, then healing occurs, but the entry sites cannot heal and require surgical treatment
Solution Approach 1:
The natural biological healing process is replaced with an immediate chemical sealing mechanism. The surgical glue provides instant closure by bonding to the prosthesis surface and sealing the entry site, eliminating the need for complex surgical interventions while achieving reliable closure on non-healing synthetic materials.
4Productivity
If mechanical closing devices are used, then closure speed is improved, but the requirement for skilled operators and assistant operators increases
Solution Approach 1:
The system is designed to be self-regulating through the sequential expulsion mechanism. The barrier liquid automatically prevents duct clogging, and the haemostatic liquid self-adheres upon contact with blood, reducing the need for complex manual manipulation and minimizing the skill level and number of operators required.
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 effectively prevents premature hardening of the surgical glue, allowing for efficient closure of vascular entry sites, reducing bleeding risks and complications, and can be used by a single operator without the need for echographic control, even in obese patients or those with vascular prostheses.
Implementation Method 1
quick-setting haemostatic liquids, such as cyanoacrylate... to form a strong and flexible closure
Data Source
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AI summary
An occlusion device (40) for vascular surgery, said device suitable for clogging treatments of vascular entry sites and for endovascular interventions such as embolizations of blood vessels, treatment of arteriovenous malformations or small aneurysms, arterial dissections and the like, by releasing in an operation region a quick setting surgical glue or haemostatic fluid, through an outlet mouth of a duct (21). The device comprises a means for preventing the surgical glue from contacting within the duct a patient's biological fluids, in particular blood, which would close duct 21. In the case of clogging treatments of vascular entry sites, a backflow preventing means may be provided, said backflow preventing means preferably provided by a coupling means between duct 21 and introducer sheath 3 by which outlet mouth 18 is kept at contact to keep in a one-way fluid tight contact against said outer surface 8 of introducer sheath 3 until an injection pressure P2 is applied to the surgical glue, which causes the release of the surgical glue. In particular, the surgical glue flows through the narrow space 16 defined by a short tube 13 arranged about the surface 8 of introducer sheath 3 and by surface 8, and exploits a zone of the tissues modified by introducer sheath 3 to reach arterial entry site. In another exemplary embodiment, liquid contact preventing means to avoid the contact in the duct between the surgical glue and the biological medium are provided by a barrier liquid that is retained within the duct while the path made through the duct for achieving an operation region, which can be a vascular entry site or an endovascular intervention site.