Pericardial Transection Device for Reducing Heart Failure 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 transection device is developed, comprising extension members with incision assemblies that can be steered and controlled to introduce incisions in the pericardium, thereby reducing pericardial restraint.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If pericardial restraint is maintained to provide structural support, then pericardial integrity is preserved, but cardiac filling space is restricted causing exertional dyspnea in HFpEF patients

Engineering Contradiction:

Improvecardiac filling capacityVSAvoidpericardial structural integrity

Core Design Contradiction:

Ease of operationVSStrength

Solution Approach 1:

The pericardium is segmented through controlled incisions that divide the continuous fibrous constraint into separate sections. This segmentation reduces the overall restraining force while preserving localized structural support, allowing the heart to expand more freely during filling without complete loss of pericardial integrity

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The incision device creates localized modifications in specific regions of the pericardium rather than uniform changes throughout. By targeting specific areas with incisions, the treatment reduces restraint in critical filling zones while maintaining structural support in other regions, achieving differentiated mechanical properties across the pericardial surface

Inventive Principle:

Principle #3Local quality

2Ease of operation

If pericardial incisions are created to reduce restraint, then cardiac filling space is improved, but risk of uncontrolled tissue damage increases

Engineering Contradiction:

Improvepericardial complianceVSAvoidtissue damage risk

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The incision device incorporates dynamic control mechanisms that allow real-time adjustment of cutting depth, direction, and extent during the procedure. This dynamic capability enables the operator to respond to tissue feedback and anatomical variations, creating incisions that achieve the desired compliance improvement while avoiding excessive depth that could damage underlying cardiac structures

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The device incorporates feedback mechanisms that provide information about tissue characteristics and incision progress during the procedure. This feedback allows for real-time adjustments to cutting parameters, ensuring that incisions remain within safe boundaries and prevent uncontrolled tissue damage while achieving adequate pericardial compliance

Inventive Principle:

Principle #23Feedback

3Productivity

If traditional surgical approaches are used to address pericardial restraint, then pericardial release can be achieved, but procedural complexity and recovery time increase

Engineering Contradiction:

Improvetreatment efficacyVSAvoidsurgical procedure complexity

Core Design Contradiction:

ProductivityVSDevice complexity

Solution Approach 1:

The device replaces traditional open surgical mechanical procedures with a minimally invasive percutaneous approach. Instead of requiring large incisions, sternotomy, and manual dissection, the system uses a catheter-based delivery mechanism with controlled energy delivery or mechanical cutting through the pericardium, significantly reducing procedural complexity and patient trauma while maintaining treatment efficacy

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The incision device is nested within a delivery catheter system that provides a minimally invasive access pathway. The cutting or energy-delivering components are contained within the catheter until deployment, allowing the complex functional elements to be delivered through a simple vascular or percutaneous route, thereby reducing the overall procedural complexity compared to open surgery

Inventive Principle:

Principle #7Nested doll (Nesting)

Data Source

PatentUS20250072925A1Pericardial transection devices with plurality of incision members and methods of reducing pericardial restraint

Publication Date: 2025.03.06 EDWARDS LIFESCIENCES CORP

AI summary

Several exemplary transection devices are disclosed, comprising an elongated member having a distal end and a proximal end along a longitudinal axis, the proximal end coupled to an end of a catheter, a plurality of extensions operably coupled to the distal end of the elongated member, a sheath having a distal end encircling the elongated member in a longitudinally slidable relation, where in a first sliding position, the elongated member and the plurality of extensions are encircled by the sheath; and a second sliding position, the plurality of extensions projects from the distal end of the sheath. Such devices are useful for deployment in the pericardial cavity and making incisions through the pericardial membrane or parietal layer of the pericardium. These examples share the characteristic that they are deployed intravascularly through the RA, RAA, IVC, SVC, CS, or via a subxiphoid approach.