Aortic Valve Cusp Sizing and Patterning Instrument

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Solution Overview

Problem

Current methods for replacing aortic valves, such as prosthetic valve replacement, often result in pressure loss due to the thickness of the valve annulus, and existing solutions like mechanical and biovalves pose risks of rejection, bleeding issues, and high costs, while valve reconstruction methods face challenges in accurately measuring and shaping the valve cusp for reconstruction.

Innovation Solution

An instrument comprising a valve cusp sizer and template for measuring and patterning the size and shape of a valve cusp using an autologous biomembrane or artificial membrane, allowing for precise reconstruction of the aortic valve by stitching a prosthetic valve cusp conforming to the excised valve cusp, without reducing the valve annulus diameter.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If prosthetic valve replacement is performed, then valve function is restored, but pressure loss occurs due to valve annulus thickness

Engineering Contradiction:

Improvevalve functionVSAvoidpressure loss

Core Design Contradiction:

ReliabilityVSLoss of energy

Solution Approach 1:

The invention segments the valve replacement procedure into two parts: removing only the abnormal valve cusp while preserving the native valve annulus and healthy cusps, rather than replacing the entire valve. This segmentation allows restoration of valve function without the pressure loss associated with full prosthetic valve annulus installation

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The invention extracts and removes only the specific abnormal portion (valve cusp) that needs replacement, while leaving the healthy valve annulus and other cusps intact. This selective extraction avoids the harmful effect of pressure loss caused by the thickness of a complete prosthetic valve annulus

Inventive Principle:

Principle #2Taking out (Extraction)

2Reliability

If mechanical or biovalve replacement is performed, then valve function is restored, but risks of rejection, bleeding, and high costs occur

Engineering Contradiction:

Improvevalve functionVSAvoidrejection and bleeding risks

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention uses the patient's own tissue (autologous pericardium) to create the replacement valve cusp, allowing the body's own immune system to recognize and accept the implant without rejection. This self-service approach eliminates the need for immunosuppression and reduces bleeding risks associated with foreign material implants

Inventive Principle:

Principle #25Self-service

3Object-affected harmful factors

If valve reconstruction is performed, then avoidance of prosthetic risks is achieved, but accurate measurement and shaping of valve cusp is challenging

Engineering Contradiction:

Improveprosthetic risksVSAvoidvalve cusp shape accuracy

Core Design Contradiction:

Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The invention creates a physical template by copying the shape and size of the removed abnormal valve cusp. This template serves as a precise guide for cutting the autologous pericardium to match the exact dimensions needed, ensuring accurate reconstruction without requiring complex measurement procedures

Inventive Principle:

Principle #26Copying

Solution Approach 2:

The invention performs preliminary action by creating a physical template of the desired valve cusp shape before actually cutting the replacement tissue. This template preparation in advance ensures that the final reconstruction achieves the required precision without difficulty during the actual implantation procedure

Inventive Principle:

Principle #10Preliminary action

4Reliability

If full valve replacement is performed, then valve function is restored, but valve annulus diameter is reduced

Engineering Contradiction:

Improvevalve functionVSAvoidvalve annulus diameter

Core Design Contradiction:

ReliabilityVSLength of stationary object

Solution Approach 1:

The invention segments the replacement procedure to affect only the valve cusp level, preserving the native valve annulus structure. This segmentation prevents the reduction of valve annulus diameter that occurs when a complete prosthetic valve with its own annulus is implanted

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The invention merges the replacement cusp with the existing native valve annulus, creating a hybrid structure that maintains the original annulus diameter. This combining approach avoids the need to implant a separate prosthetic annulus that would reduce the effective valve opening diameter

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS9788940B2Instrument of patterning cusp for cardiac valve reconstruction and component thereof

Publication Date: 2017.10.17 JAPANESE ORG FOR MEDICAL DEVICE DEV INC

AI summary

In a case of repairing an aortic valve by forming a valve cusp with a biomembrane, the shape and the size of a valve cusp can be determined easily. An instrument including a valve cusp sizer for measuring the size of the valve cusp and a template for scribing lines for the shape of a valve cusp conforming to the measured size of the valve cusp, in which the valve cusp sizer has a plurality of differently-sized sizer blocks attached to each of the top ends of grip members respectively and each sizer block has an arcuate surface formed by cutting each of differently-sized circular cylinders at an angle conforming to the central angle for the commissure portions and, the template is formed with a scribing portion including a substantially semi-circular valve cusp base forming portion.