Cardiac Sealing Element for Minimally Invasive Blood Pump Mounting

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Solution Overview

Problem

During the implantation of heart assist systems, the challenge is to prevent blood loss when inserting an inlet cannula or blood pump into the heart without a heart-lung machine, as the heart continues to beat, and makeshift sealing measures are inadequate, leading to blood leakage during the time between forming the opening and inserting the cannula.

Innovation Solution

A connecting element with a sealing mechanism that includes a suture ring made of soft sealing material and a connector ring, which can be securely attached to the heart, providing a reliable seal using a valve-like design that can be opened axially and locked with detent elements, and optionally enhanced with spring elements for easy handling and minimally invasive surgical techniques.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If makeshift sealing measures (thumb pressure) are used during cannula insertion, then the heart can be sealed during the procedure, but blood loss cannot be perfectly prevented and increases with time

Engineering Contradiction:
Improvesealing reliabilityVSAvoidblood loss
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The sealing element is pre-positioned on the connecting element before the heart opening is formed. This preliminary positioning ensures that when the opening is created, the sealing element is already in place to immediately seal the opening, eliminating the time gap where makeshift sealing measures would be needed and preventing blood loss during the critical insertion period.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The sealing element acts as an intermediary component between the connecting element and the heart opening. It provides a reliable seal by being pressed against the heart wall when the connecting element is inserted, replacing inadequate makeshift sealing measures with a dedicated sealing mechanism that prevents blood loss effectively.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Loss of substance

If a valve-like sealing element is used to seal the heart opening, then blood loss is reliably reduced, but the device complexity increases

Engineering Contradiction:
Improveblood lossVSAvoidsealing mechanism complexity
Core Design Contradiction:
Loss of substanceVSDevice complexity

Solution Approach 1:

The sealing element is divided into multiple independent sealing segments or lobes that can flexibly open and close. This segmentation allows the sealing element to effectively seal the opening while maintaining flexibility for insertion, reducing the need for complex mechanical actuation mechanisms and simplifying the overall device structure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The sealing element is designed with dynamic properties, allowing it to flexibly open during insertion and automatically close when the connecting element is properly positioned. This dynamic behavior eliminates the need for complex locking mechanisms or active control systems, reducing device complexity while maintaining effective sealing.

Inventive Principle:
Principle #15Dynamics

3Reliability

If the sealing element is made of soft sealing material, then the sealing effect between the suture ring and pump connector is improved, but the mechanical strength and resistance to deformation decreases

Engineering Contradiction:
Improvesealing effectVSAvoidmechanical strength
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The sealing element is constructed as a composite structure combining soft sealing material (such as silicone or elastomer) for the sealing surface with a stronger structural material (such as medical-grade plastic or metal) for the framework. This composite design maintains the softness needed for effective sealing while providing the mechanical strength and deformation resistance required for withstanding heart pressure and maintaining structural integrity.

Inventive Principle:
Principle #40Composite materials

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 effectively reduces blood loss by ensuring a reliable seal between the cannula or blood pump and the heart, allowing for efficient and minimally invasive implantation, even under the pressure of a beating heart, and maintains a blood-free surgical site.

Implementation Method 1

The sealing element can be opened via axial insertion of a cylindrical object, for example, but which otherwise tightly closes an opening in the cardiac wall formed under the connecting element

Methodology Applied
Scientific EffectPressure: Pressure Increase

Implementation Method 2

spring elements for easy handling and minimally invasive surgical techniques

Methodology Applied
Scientific EffectSpring: Spring

Implementation Method 3

The connector ring and/or the sealing element can comprise at least one detent element, by way of which the sealing element can be locked with the connector ring

Methodology Applied
Scientific EffectMechanical Fastener: Mechanical Fastener

Data Source

PatentUS9486565B2Connecting element for mounting a blood pump or a cannula on a heart
Publication Date: 2016.11.08 BERLIN HEART GMBH
  • US9486565B2 patent drawing
  • US9486565B2 patent drawing
  • US9486565B2 patent drawing

AI summary

A connecting element for connecting a blood pump or a cannula to a heart, the connecting element including a sealing element, which is designed to at least temporarily close an opening formed in the cardiac wall and to be opened via insertion of a preferably cylindrical object in the direction of an axis of the opening.