Transapical Annuloplasty Ring Delivery via Guiding Sheath
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Solution Overview
Problem
Current methods for repairing heart valves, such as open heart surgery, are invasive and pose significant risks to patients, including infection and long recovery times, especially for those with heart valve defects like regurgitation.
Innovation Solution
The development of percutaneous transcatheter delivery and fixation systems for annuloplasty rings using a trans-apical approach, which allows for minimally invasive delivery and anchoring of annuloplasty rings to the heart valve annulus via a guiding sheath and balloon assembly, enabling the rings to be expanded and securely anchored without open surgery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open heart surgery is used to implant annuloplasty rings, then the valve repair reliability is improved, but the patient recovery time and surgical risk increase significantly
Solution Approach 1:
The patent uses a guiding sheath as an intermediary device to deliver the annuloplasty ring through a minimally invasive transapical approach. The sheath provides a protected pathway through the heart apex, allowing the ring to be delivered without requiring open thoracic surgery while maintaining precise positioning capability and surgical control.
Solution Approach 2:
The annuloplasty ring is delivered in a compressed state within the guiding sheath, similar to a nested doll structure. The ring is collapsed into a compact configuration that fits inside the sheath lumen, then expanded at the target site to achieve its functional annular shape for valve repair.
2Reliability
If open heart surgery is used to implant annuloplasty rings, then the valve repair reliability is improved, but the risk of infection and surgical complications increases
Solution Approach 1:
The guiding sheath acts as a sterile barrier and intermediary pathway that minimizes exposure to external contaminants. By delivering the ring through a percutaneous transapical route rather than open thoracotomy, the procedure reduces the surgical wound surface area and duration of cardiopulmonary bypass, thereby lowering infection risk while maintaining repair reliability.
Solution Approach 2:
The patent extracts the need for open heart surgery entirely from the procedure. By removing the requirement for sternotomy and cardiopulmonary bypass, the method eliminates the major sources of surgical infection and complications associated with traditional open heart surgery while preserving the therapeutic effect of annuloplasty ring implantation.
3Ease of operation
If the annuloplasty ring is delivered in a compressed geometry through a catheter, then the ease of delivery is improved, but the device complexity increases
Solution Approach 1:
The annuloplasty ring is designed with nested segments that can be compressed into a compact configuration within the guiding sheath. The ring consists of multiple articulated sections that fold or collapse into one another, allowing the large annular structure to be delivered through a relatively small catheter while maintaining the ability to expand to full size at the implantation site.
Solution Approach 2:
The annuloplasty ring is divided into multiple segments or articulated sections that can move relative to one another. This segmentation allows the ring to be compressed for delivery while maintaining structural integrity and the ability to expand to its functional annular configuration once deployed at the valve annulus.
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 method provides a less invasive alternative for repairing heart valves, reducing recovery time and minimizing risks associated with traditional open heart surgery, while effectively restoring valve function by securely anchoring the annuloplasty rings.
Implementation Method 1
The lower balloon of the balloon assembly may be inflated, at least partially, to expand the annuloplasty ring from the delivery geometry to an operable geometry
Implementation Method 2
The anchors may be configured to be pressed into and engage tissue of the annulus of the target valve
Data Source
Figure 1A
Figure 1B
Figure 1C~1D
AI summary
Apparatus, systems, and methods are provided for repairing heart valves through percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves via a trans-apical approach to accessing the heart. A guiding sheath may be introduced into a ventricle of the heart through an access site at an apex of the heart. A distal end of the guiding sheath can be positioned retrograde through the target valve. An annuloplasty ring arranged in a compressed delivery geometry is advanced through the guiding sheath and into a distal portion of the guiding sheath positioned within the atrium of the heart. The distal end of the guiding sheath is retracted, thereby exposing the annuloplasty ring. The annuloplasty ring may be expanded from the delivery geometry to an operable geometry. Anchors on the annuloplasty ring may be deployed to press into and engage tissue of the annulus of the target valve.