Steerable Heart Valve Delivery Catheter for Precise Transapical Placement
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Solution Overview
Problem
Conventional heart valve replacement surgeries are highly invasive and carry significant risks, including bleeding, infection, stroke, and mortality, while minimally-invasive procedures face challenges in accurate placement of prosthetic valves without open-heart surgery or cardiopulmonary bypass.
Innovation Solution
A heart valve delivery system with a steerable catheter and introducer sheath, featuring varying stiffness sections and radiopaque markers, allows for precise positioning of a prosthetic heart valve through a transapical approach without opening the chest cavity, using a balloon to expand the valve in situ.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional open-heart surgery is performed for heart valve replacement, then accurate placement and reliable implantation of the prosthetic valve is achieved, but patient trauma, recovery time, and surgical risks are significantly increased
Solution Approach 1:
The delivery system is divided into multiple components including an introducer sheath, delivery catheter, balloon, and prosthetic valve assembly. This segmentation allows the system to navigate through the patient's vasculature to reach the heart valve position without requiring open chest surgery, thereby reducing patient trauma while maintaining implantation reliability
Solution Approach 2:
The prosthetic valve is nested within a delivery catheter, which is in turn nested within an introducer sheath. The balloon is nested within the delivery catheter. This nested configuration enables minimally invasive delivery through blood vessels while ensuring precise positioning and reliable implantation of the valve at the target site
2Object-affected harmful factors
If percutaneous valve delivery is used to reduce invasiveness, then patient trauma and recovery time are reduced, but accurate placement of the prosthetic valve becomes difficult
Solution Approach 1:
The delivery system incorporates radiopaque markers on the balloon and delivery catheter that provide visual feedback during fluoroscopic guidance. This allows the operator to accurately track the position of the prosthetic valve during delivery and make real-time adjustments to achieve precise placement relative to the native valve and coronary ostia
Solution Approach 2:
Radiopaque markers and contrast elements are integrated into the delivery system components, enabling visualization under fluoroscopic imaging. These visual indicators change appearance under X-ray imaging, allowing precise determination of device position and orientation during the minimally invasive procedure
3Device complexity
If self-expanding stents are used as anchors for percutaneous valve delivery, then device complexity is reduced, but control over final valve position is lost due to premature expansion
Solution Approach 1:
The prosthetic valve is pre-assembled on the balloon in a compressed state within the delivery catheter before the procedure. The balloon remains deflated during navigation to maintain valve compression, allowing precise positioning to be achieved first, and only then is the balloon inflated to expand and anchor the valve at the predetermined location
Solution Approach 2:
The delivery system transitions from a static compressed configuration during navigation to a dynamic expanded state at implantation. The balloon can be inflated or deflated as needed to control valve expansion timing, providing operational flexibility and precise positioning control that static self-expanding stents cannot achieve
4Measurement precision
If balloon expansion is used to implant the prosthetic valve, then accurate positioning is maintained, but the risk of emboli and other complications increases
Solution Approach 1:
The delivery system includes features designed to prevent complications before they occur. The valve and delivery system are designed to minimize disruption to native valve tissue and surrounding structures during delivery and expansion. The controlled balloon expansion process reduces the risk of dislodging calcifications or creating emboli compared to more aggressive deployment methods
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 accurate implantation of prosthetic heart valves with reduced trauma and recovery time, avoiding open-heart surgery and cardiopulmonary bypass, thus minimizing complications and improving patient outcomes.
Implementation Method 1
using a balloon to expand the valve in situ
Data Source
AI summary
A delivery system and method for delivering a prosthetic heart valve to the aortic valve. The system includes a delivery catheter having a steering mechanism thereon for delivering a balloon-expandable prosthetic heart valve to the aortic valve through an introducer passing into the left ventricle through its apex. The introducer may have a more floppy distal section than a proximal section to reduce trauma to the heart wall while preserving good operating field stability. The delivery catheter includes a deflecting segment just proximal to a distal balloon to facilitate positioning of the prosthetic heart valve in the proper orientation. A trigger in a catheter handle may be coupled to a deflection wire that actuates the deflecting segment, while a slider in the handle controls retraction of a valve pusher. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.