Pericardial Transection Device for HFpEF Restraint
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Solution Overview
Problem
Current therapeutic options for heart failure with preserved ejection fraction (HFpEF) do not effectively address pericardial restraint, which leads to increased left heart pressure and exertional dyspnea in patients.
Innovation Solution
A pericardial tissue transection device is provided, comprising an elongated body with a U-shaped notch and an incision member that extends from the body to the notch, designed to make incisions in the pericardial tissue to reduce pericardial restraint.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If pericardial restraint is maintained (normal physiologic process), then cardiac protection and containment are improved, but right heart filling space is reduced causing left heart overpressurization
Solution Approach 1:
The pericardium is divided into multiple segments through incisions made by the catheter device. The incision member creates controlled cuts in the pericardial tissue, segmenting the continuous restraining structure into separate sections that allow for expansion while maintaining localized containment.
Solution Approach 2:
The incision member extracts or removes portions of the pericardial tissue by making cuts that release the restraining force. By taking out the continuous pericardial constraint through incisions, the device allows the heart to expand without compromising the overall protective function.
2Stress or pressure
If pericardial restraint is reduced through incisions, then left heart pressure and breathing difficulties are improved, but structural integrity of pericardium is compromised
Solution Approach 1:
The incisions are made with specific local qualities - controlled depth, specific orientation, and localized positioning - that reduce restraining force only where needed while preserving structural integrity in other areas. The incision member creates localized changes in pericardial tissue properties without compromising overall strength.
3Adaptability or versatility
If a catheter device is introduced to make pericardial incisions, then pericardial transection capability is improved, but device complexity increases
Solution Approach 1:
The catheter device integrates multiple functions into a single instrument: navigation through blood vessels, positioning within the pericardial space, and making controlled incisions. The elongated body with its various components serves multiple purposes, reducing the need for separate devices while maintaining versatility.
Data Source
AI summary
Examples of transection devices are disclosed. One example includes an elongated body having a U-shaped notch, wherein the U-shaped notch includes a wall surface extending from a surface of the elongated body and an upper extension extending from the wall surface substantially parallel with the longitudinal axis of the elongated body. An incision member located in the U-shaped notch preferably extends from the elongated body toward the extension of the U-shaped notch at an angle. The incision member is well suited for cutting pericardial tissue as it passes through the U-shaped notch.