Transapical Heart Access Interface with Removable Hemostatic Valve

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Solution Overview

Problem

Existing transapical heart ports and hemostatic valves fail to provide a permanent separation of wet and dry zones within a patient's body, leading to blood leakage and limitations in attaching larger medical devices during cardiac procedures, and lack ease of access for component replacement or repair.

Innovation Solution

The development of a transapical access device with a removable hemostatic valve unit and a sealing unit that creates a separation of wet and dry zones, allowing for secure attachment of various medical devices and enabling easy replacement or repair of components, while preventing blood leakage and gas exchange.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a hemostatic valve is permanently attached to the heart port, then blood leakage is prevented, but the ability to replace or repair components is lost

Engineering Contradiction:
Improveblood leakage preventionVSAvoidcomponent replacement capability
Core Design Contradiction:
ReliabilityVSEase of repair

Solution Approach 1:

The device is divided into separate modular components: a heart port, a hemostatic valve, and a sealing unit. These components can be independently attached and detached, allowing the hemostatic valve to be removed and replaced without removing the entire heart port system, thus maintaining both hemostasis reliability and ease of repair.

Inventive Principle:
Principle #1Segmentation

2Ease of operation

If a transapical access device is used, then access to the heart chamber is achieved, but separation of wet and dry zones is not provided

Engineering Contradiction:
Improveheart chamber accessVSAvoidwet and dry zone separation
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The access device is segmented into a proximal portion (dry zone) and a distal portion (wet zone) separated by a sealing unit. This segmentation creates distinct functional zones that prevent blood contamination of external components while maintaining access to the heart chamber, resolving the contradiction between ease of operation and reliability of zone separation.

Inventive Principle:
Principle #1Segmentation

3Ease of operation

If a traditional heart port is used, then access to the heart is provided, but attachment of larger medical devices is limited

Engineering Contradiction:
Improveheart accessVSAvoiddevice attachment capability
Core Design Contradiction:
Ease of operationVSAdaptability or versatility

Solution Approach 1:

The heart port is designed with a universal connection interface that can accommodate multiple types of medical devices including hemostatic valves, sealing units, and larger cardiac assist devices. This multi-functional design allows the same access device to support various device sizes and types, resolving the contradiction between ease of operation and adaptability.

Inventive Principle:
Principle #6Universality (Multi-functionality)

4Ease of repair

If the hemostatic valve housing is made splittable, then ease of removal is improved, but structural integrity may be compromised

Engineering Contradiction:
Improvevalve removal easeVSAvoidhousing structural integrity
Core Design Contradiction:
Ease of repairVSStrength

Solution Approach 1:

The hemostatic valve housing is designed with a splittable structure that divides the housing into separable portions. This segmentation allows the valve to be easily removed from the heart port while the individual housing portions maintain sufficient structural integrity during assembly and removal operations, resolving the contradiction between ease of repair and structural strength.

Inventive Principle:
Principle #1Segmentation

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

The solution ensures a secure, leak-proof access to the heart chamber, facilitating the attachment of larger medical devices and enabling easy replacement or repair of components, thus enhancing the safety and efficiency of cardiac procedures.

Implementation Method 1

The bellows is arranged between an inner and an outer seal housing and establishes a biasing relationship with the seal

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentUS12383304B2Method of accessing a heart with a hemostatic device and an interface
Publication Date: 2025.08.12 SYNTACH AG
  • US12383304B2 patent drawing
  • US12383304B2 patent drawing
  • US12383304B2 patent drawing

AI summary

An access device for a heart chamber, a removable hemostatic valve unit, and a system including a cardiac assist unit are disclosed. In examples, the access device) includes an apical base plate and a sealing unit configured to provide a separation of a wet zone from a heart chamber and a dry zone with a gaseous environment outside of said heart chamber inside a patient body at the same time.