Temporary Aortic Valve for Minimally Invasive Cardiac Repair
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Solution Overview
Problem
Current aortic valve replacement procedures require cardiopulmonary bypass, leading to significant morbidity and mortality, and there is a need for a minimally invasive approach that can perform valve replacement without causing stroke or cardiac failure, while also allowing for the placement of a prosthetic valve in the aorta.
Innovation Solution
The use of temporary valves and filters placed within the aorta to restrict retrograde blood flow, prevent emboli, and support the native valve during procedures, allowing for valve repair or replacement without cardiopulmonary bypass, using devices that can be inserted through peripheral vessels and expand within the aorta to facilitate procedures on a beating heart.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open heart surgery with cardiopulmonary bypass is used for aortic valve replacement, then effective treatment is achieved, but patient morbidity and mortality increase significantly
Solution Approach 1:
A temporary valve is introduced as an intermediary device to maintain aortic valve function during the replacement procedure. The temporary valve is positioned in the aorta to prevent retrograde blood flow and support the native valve while it is being manipulated, allowing the procedure to be performed without cardiopulmonary bypass
Solution Approach 2:
The temporary valve is deployed in advance before the native valve is manipulated or replaced. This preliminary placement ensures that aortic valve function is secured beforehand, preventing cardiac failure during the procedure and eliminating the need for cardiopulmonary bypass
2Ease of operation
If percutaneous balloon valvotomy is used to dilate the aortic valve, then minimally invasive approach is achieved, but restenosis occurs within one year
Solution Approach 1:
The temporary valve serves as a mediator that maintains proper aortic valve function during the procedure, allowing for more effective valve replacement or repair techniques that can achieve durable results while still using a minimally invasive percutaneous approach
3Ease of operation
If smaller chest wall incisions are used for aortic valve surgery, then invasiveness is reduced, but cardiopulmonary bypass is still required
Solution Approach 1:
The temporary valve acts as a life-support intermediary that takes over aortic valve function, allowing the surgeon to perform the valve replacement through smaller incisions without relying on cardiopulmonary bypass. The temporary valve ensures continuous aortic valve function throughout the procedure
Solution Approach 2:
The temporary valve provides self-service by automatically preventing retrograde blood flow and supporting aortic valve function through its one-way valve mechanism, eliminating the need for external cardiopulmonary bypass support during the procedure
4Reliability
If the native aortic valve is manipulated or removed, then valve replacement is achieved, but stroke or cardiac failure may occur
Solution Approach 1:
The temporary valve serves as a protective intermediary that maintains aortic valve function during native valve manipulation. By preventing retrograde blood flow and supporting forward flow, it protects against cardiac failure and reduces the risk of stroke from particulate material
Solution Approach 2:
The temporary valve provides beforehand cushioning by securing aortic valve function in advance before the native valve is manipulated. This protective measure cushions against potential complications such as acute valve incompetence, cardiac failure, and embolic events
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
Enables safe and effective aortic valve replacement without cardiopulmonary bypass, reducing patient morbidity and mortality, and allowing for quicker recovery by maintaining heart function during the procedure and filtering emboli, thus minimizing risks associated with valve manipulation.
Implementation Method 1
temporary valve means inserted into the aorta... which allows forward flow during systole and prevents retrograde flow during diastole
Implementation Method 2
temporary filter... to prevent emboli... filtering emboli, thus minimizing risks associated with valve manipulation
Data Source
AI summary
The present invention discloses devices and methods for performing intravascular procedures without cardiac bypass. The devices include various embodiments of temporary filter devices, temporary valves, and prosthetic valves.The temporary filter devices have one or more cannulae which provide access for surgical tools for effecting repair of the cardiac valves. A cannula may have filters of various configurations encircling the distal region of the cannula, which prevent embolitic material from entering the coronary arteries and aorta.The temporary valve devices may also have one or more cannulae which guide the insertion of the valve into the aorta. The valve devices expand in the aorta to occupy the entire flow path of the vessel. In one embodiment, the temporary valve is a disc of flexible, porous, material that acts to filter blood passing therethrough. A set of valve leaflets extend peripherally from the disc. These leaflets can alternately collapse to prevent blood flow through the valve and extend to permit flow.The prosthetic valves include valve fixation devices which secure the prosthetic valve to the wall of the vessel. In one embodiment, the prosthetic valves have at least one substantially rigid strut, at least two expandable fixation rings located about the circumference of the base of the apex of the valve, and one or more commissures and leaflets. The prosthetic valves are introduced into the vascular system a compressed state, advanced to the site of implantation, expanded and secured to the vessel wall.