Transapical Puncture Catheter with Balloon Anchoring
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Solution Overview
Problem
Current methods for mitral valve replacement, particularly in transcatheter procedures, face challenges due to the complexity of the native mitral valve and the need for large anchors, which result in increased trauma to the patient and higher morbidity, as they require significant intercostal punctures for secure anchoring.
Innovation Solution
A delivery catheter system comprising a guide catheter with an inflatable balloon, an anchor catheter, and a needle is used to create a transapical puncture and deploy a collapsible and expandable anchor within the heart, allowing for secure anchoring of a prosthetic valve without the need for an intercostal puncture, utilizing a steerable guide catheter and positioning catheters to align and deploy the anchor effectively.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If large anchors are used to secure the prosthetic valve, then anchoring security is improved, but patient trauma and morbidity increase due to significant intercostal punctures
Solution Approach 1:
The patent transitions from intercostal access (lateral dimension) to transapical access (apical dimension), changing the anatomical approach to deliver anchors that secure the prosthetic valve without requiring large intercostal punctures. The needle and guide catheter are advanced through the apex of the heart, allowing anchor deployment from a different spatial dimension that avoids the harmful intercostal route.
Solution Approach 2:
The patent extracts the intercostal puncture step from the procedure entirely, eliminating the source of patient trauma and morbidity. By using transapical access, the large intercostal punctures required for traditional anchor delivery are removed from the procedural pathway, while anchor security is maintained through alternative delivery methods.
2Reliability
If traditional open heart surgery is performed for valve replacement, then valve replacement is achieved, but morbidity and cost increase due to extra-corporeal circulation
Solution Approach 1:
The patent replaces the mechanical extra-corporeal circulation system with a fully catheter-based transcatheter approach. The needle, guide catheter, and anchor delivery system are advanced percutaneously through vascular access, eliminating the need for surgical opening of the thorax and connection to heart-lung machine, thereby reducing morbidity while maintaining valve replacement efficacy.
Solution Approach 2:
The patent employs a nested catheter system where the needle is positioned within the guide catheter, which itself is advanced through vascular access. This nested configuration allows multiple functions (puncture, guidance, anchor delivery) to be integrated in a compact, minimally invasive system that avoids open surgery and extra-corporeal circulation.
3Measurement precision
If the needle is positioned radially inward of the guide catheter, then transapical puncture precision is improved, but device complexity increases
Solution Approach 1:
The patent merges the needle and guide catheter into an integrated assembly where the needle is positioned radially inward within the guide catheter. This combined structure allows the needle to be precisely guided along the catheter's longitudinal axis during transapical puncture, improving precision while the overall complexity is managed through the unified design rather than separate components.
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 reduces patient trauma and morbidity by enabling secure anchoring of prosthetic heart valves with reduced invasiveness, minimizing the need for large punctures and allowing for a fully transcatheter procedure, thereby improving patient outcomes and reducing recovery time.
Implementation Method 1
a balloon formed along a length of the guide catheter, the balloon being inflatable via a lumen in fluid communication with the balloon
Implementation Method 2
The spring element positioned between the balloon and a distal end of the guide catheter, the spring element biasing the guide catheter toward a straight condition
Data Source
AI summary
A delivery catheter system includes a guide catheter, an anchor catheter, a collapsible and expandable anchor, a balloon formed from a portion of the positioning catheter, and a needle. The anchor may be for anchoring a prosthetic heart valve in a native heart valve. The anchor may be configured to be received within the anchor catheter. The balloon may be inflated or deflated and provide mechanical support to enable the needle to pierce a ventricle wall. A metallic guide wire can simultaneously be inserted through the aorta to outline the heart when viewed through fluoroscopic imaging.