Transapical VAD Implantation Without Cardiopulmonary Bypass
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Solution Overview
Problem
Current ventricular assist device (VAD) implantation procedures often require cardioplegia and cardiopulmonary bypass, which prolong surgery time and pose significant risks, and there is a need for a more efficient method to implant a VAD within the heart without these complications.
Innovation Solution
A transapical VAD system that includes an axial flow pump and a pedestal, along with a catheter featuring a balloon for sealing and a pressure transducer for measurement, allowing for implantation within the heart without cardiopulmonary bypass or cardioplegia, using a method that involves accessing the heart apex, attaching a mounting ring, coring the apex, and advancing the VAD through a cored opening while de-airing and securing it.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If cardioplegia and cardiopulmonary bypass are used for VAD implantation, then the implantation can be performed with established surgical methods, but the surgery time is prolonged and significant risks are posed
Solution Approach 1:
The patent extracts and eliminates the need for cardioplegia and cardiopulmonary bypass from the VAD implantation procedure. The transapical approach allows the pump to be implanted directly through the apex of the heart into the left ventricle without requiring these complex supportive measures, thereby significantly reducing surgery time while maintaining implantation reliability
Solution Approach 2:
The patent changes the surgical approach parameter from traditional lateral or anterior approaches requiring cardiopulmonary bypass to a transapical approach. This parameter change enables direct access to the left ventricle through the apex, allowing implantation without cardioplegia or bypass, thus reducing surgery time and risks
2Reliability
If cardioplegia and cardiopulmonary bypass are used for VAD implantation, then the implantation can be performed with established surgical methods, but significant risks are posed
Solution Approach 1:
The patent removes the harmful elements of cardioplegia and cardiopulmonary bypass from the surgical procedure. By using a transapical approach with direct puncture of the apex, the method eliminates exposure to these high-risk interventions while maintaining reliable VAD implantation through direct visual and tactile control
Solution Approach 2:
The patent introduces a guidewire and catheter system as intermediaries to facilitate safe transapical access. These intermediaries allow precise navigation and positioning through the apex and into the left ventricle without requiring cardioplegia or bypass, thereby reducing surgical risks while ensuring reliable implantation
3Ease of operation
If a traditional VAD with outflow graft is used, then the pump can be connected to the aorta, but the installation requires cardioplegia and cardiopulmonary bypass
Solution Approach 1:
The patent extracts and eliminates the outflow graft component from the VAD system. By positioning the pump directly in the left ventricle with the outlet facing the aortic valve, blood flows directly from the ventricle through the valve into the aorta, removing the need for complex graft surgery and simplifying the overall implantation procedure
Solution Approach 2:
The patent inverts the traditional configuration by placing the pump inside the heart rather than outside. This inversion allows the outlet to directly face the aortic valve, eliminating the need for external grafts and complex routing, thereby simplifying both device configuration and implantation procedure
4Device complexity
If a pump is inserted through a cored opening in the apex, then the need for outflow graft is avoided, but air or fluid trapped in the pump must be removed
Solution Approach 1:
The patent makes the catheter multi-functional by equipping it with both a balloon for sealing the cored opening and a lumen for de-airing the pump. This universal catheter performs multiple critical functions during implantation, simplifying the overall procedure while effectively addressing air removal without requiring separate specialized devices
Solution Approach 2:
The patent maintains continuous control over the pump interior throughout implantation by keeping the catheter in place. The catheter serves continuously both to seal the opening with its balloon and to remove air through its lumen, ensuring uninterrupted de-airing action throughout the critical implantation phases
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
This approach significantly reduces implantation time and blood loss, with average implant times of 5 minutes and less than 50 mL of blood loss, and ensures accurate placement of the VAD without the need for cardiopulmonary bypass or cardioplegia, as demonstrated in the example of transapical ventricular assist device implantation in healthy bovine.
Implementation Method 1
The catheter desirably includes at least two lumens one of which operates a balloon
Implementation Method 2
The catheter can also include a transducer, such as a pressure transducer, capable of measuring pressure of a fluid beyond or distal to the balloon
Implementation Method 3
the other of which communicates with a distal end of the catheter and is capable of removing air or other fluid disposed beyond or distal to the balloon
Data Source
AI summary
A method of implanting a blood pump in a heart of a mammalian subject includes maintaining a temporary plug in an inlet opening of a pump having a pump body and an outlet cannula projecting from the pump body, advancing the pump into a ventricle of the heart through a hole in a wall of the heart so that the inlet of the pump is disposed within the ventricle and the outlet cannula extends through a valve of the heart into an artery, and then withdrawing the temporary plug from the inlet of the pump.