Percutaneous Ventricular Vent Loop for Temporary Heart Unloading
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Solution Overview
Problem
Existing ventricular assist devices are limited in their ability to effectively support both left and right ventricles, often require surgical placement, and can cause complications such as bleeding, infections, and hemolysis, while lacking a cost-effective alternative to mechanical circulatory support.
Innovation Solution
A percutaneous catheter-based transvalvar ventricular venting system with a single lumen left ventricular vent catheter and integrated piezoelectric microelectromechanical system check valves, along with a blood pump, to reduce heart workload by bypassing blood flow through the aortic and pulmonary valves, allowing for both left and right ventricular assistance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a patient undergoes surgical creation of a ventricular apex window, then ventricular decompression is achieved, but the patient faces lifelong risk of endocarditis and requires lifelong antibiotic therapy
Solution Approach 1:
A catheter-based device is introduced as an intermediary tool to perform ventricular decompression without requiring surgical creation of a permanent opening. The device allows temporary access and decompression while avoiding the lifelong endocarditis risk associated with permanent surgical windows
Solution Approach 2:
The patent replaces the mechanical surgical approach (knife-based apex window creation) with a catheter-based mechanical system that can achieve decompression through less invasive means, substituting open surgery with percutaneous intervention
2Productivity
If a patient receives a ventricular assist device (VAD), then cardiac output is supported, but the patient requires lifelong dependency on the device and associated complications
Solution Approach 1:
The catheter device enables periodic or temporary decompression sessions rather than continuous lifelong device dependency. The balloon can be inflated and deflated in cycles to manage ventricular pressure as needed, allowing the patient to function normally between treatments
Solution Approach 2:
The catheter device is designed for temporary use and can be removed after achieving the therapeutic goal. Unlike permanent VADs, this system allows recovery and removal of the device once ventricular function has been restored or stabilized
3Reliability
If a patient undergoes heart transplantation, then end-stage heart failure is treated, but organ availability is limited and the process is complex
Solution Approach 1:
The catheter-based decompression system provides a self-contained therapeutic approach that does not require donor organs or complex transplantation infrastructure. The device can be deployed using standard catheterization lab resources, making the treatment self-sufficient and independently implementable
4Ease of operation
If a catheter device is used for ventricular decompression, then the procedure is less invasive, but the device must navigate through the venous system to reach the ventricle
Solution Approach 1:
The catheter system employs a nested structure where the balloon catheter is contained within a delivery sheath. The balloon can be advanced through the venous system in a collapsed state within the sheath, then deployed at the target site, simplifying navigation while maintaining access capability
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 system provides effective mechanical circulatory support, reducing heart workload, enabling patient mobility, and minimizing complications like bleeding and hemolysis, while allowing for high-risk interventions like coronary interventions.
Implementation Method 1
a balloon, catheter and syringe assembly useful for performing ventricular decompression and assisting in the acute setting... expansion of the balloon within the ventricle
Data Source
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AI summary
Disclosed is a ventricular decompression and assisting apparatus (100). The apparatus (100) includes a pigtail and a catheter that is introduced percutaneously into a femoral/radial/brachial vein or artery and is advanced into the ventricle where blood is drawn and mechanically pumped back with an external blood pump (40) and pumped back downstream into the aorta (2) or venous system or the pulmonary artery using another suitable catheter from a second access into the femoral/radial/brachial artery or any vein and with tip thereof positioned at a desired location thus forming a ventricular vent loop. The desired cardiac circulation is maintained with smart pumping, monitoring and control while relieving the load on the heart muscle to rebuild strength thereof. The apparatus (100) provides user friendly simplified approach to ventricular venting and unloading as a means for mechanical circulatory support of the left heart, right heart or both circulations even simultaneously.