Apical Cardiac Valve Delivery System with De-aired Environment
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Solution Overview
Problem
There is a need for improved systems and methods for delivering expandable prosthetic cardiac valves using minimally-invasive techniques, particularly for effective positioning and deployment at the cardiac valve annulus without causing air embolism and ensuring precise alignment with the sinuses of Valsalva.
Innovation Solution
A cardiac valve implantation system comprising an expandable cardiac valve prosthesis with radially expandable portions and valve leaflets, a deployment instrument with independently operable deployment elements, and a delivery device that creates a de-aired or fluid-filled environment to facilitate minimally-invasive implantation, allowing for precise positioning and deployment at the cardiac valve annulus.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a delivery device is used to deliver the deployment instrument to the implantation site, then minimally-invasive implantation is achieved, but air embolism risk increases
Solution Approach 1:
The delivery device is filled with an inert gas (such as nitrogen or carbon dioxide) or fluid to create a de-aired environment. This inert atmosphere prevents air embolism by eliminating atmospheric air from the delivery system while maintaining the minimally-invasive delivery capability through the delivery device.
Solution Approach 2:
A fluid or inert gas is introduced as an intermediary substance within the delivery device. This intermediary fills the delivery device lumen and prevents air embolism by serving as a barrier between the delivery instrument and the patient's cardiovascular system, while still allowing minimally-invasive delivery.
2Reliability
If expandable prosthetic valves are implanted using traditional surgical operations, then reliable valve placement is achieved, but surgical invasiveness increases
Solution Approach 1:
Traditional open surgical operations are replaced with a mechanical delivery system that uses a delivery device and deployment instrument. The expandable valve prosthesis is delivered through a minimally-invasive pathway (such as transapical or percutaneous access) using mechanical guidance and control mechanisms, achieving reliable placement without requiring traditional open surgery.
Solution Approach 2:
The implantation system is divided into separate functional components: a delivery device for minimally-invasive transport, a deployment instrument for precise positioning and expansion, and the expandable valve prosthesis itself. This segmentation allows each component to be optimized for its specific function while collectively achieving reliable valve placement through minimally-invasive means.
3Measurement precision
If precise positioning at the cardiac valve annulus is achieved, then alignment with sinuses of Valsalva is improved, but device complexity increases
Solution Approach 1:
The deployment instrument incorporates dynamic control mechanisms that allow real-time adjustment and positioning of the expandable valve prosthesis. The instrument can be advanced, retracted, rotated, and positioned with precision control, enabling accurate alignment with the sinuses of Valsalva while managing complexity through programmable or mechanically adjustable systems.
Solution Approach 2:
Positioning precision is achieved through feedback mechanisms that monitor the location and orientation of the deployment instrument and valve prosthesis during delivery. Imaging guidance systems or sensors provide real-time feedback to ensure accurate alignment with the cardiac valve annulus and sinuses of Valsalva, allowing for precise positioning despite the complexity of the deployment instrument.
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 enables safe, precise, and minimally-invasive implantation of expandable cardiac valves, reducing the risk of air embolism and ensuring correct alignment with the sinuses of Valsalva, thereby improving the efficiency and effectiveness of cardiac valve replacement procedures.
Implementation Method 1
The delivery device is adapted to provide a de-aired, fluid-filled, or gas-filled environment surrounding the prosthesis
Implementation Method 2
positioning the cardiac valve prosthesis in a deployment instrument including a carrier portion, substantially removing atmospheric air from the carrier portion
Data Source
AI summary
A system for implanting a heart valve prosthesis in a patient's heart includes a balloon expandable, tissue, stented heart valve, and an apical valve delivery device for delivering the stented heart valve to a target site in the patient's heart. The delivery device includes an inflation balloon module for expanding the stented heart valve prosthesis, markers on the delivery device to assist in location of the delivery device at an appropriate location, and a streamlined cap.