Hexagonal Coupling Self-Alignment for Heart Pump Delivery
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Solution Overview
Problem
Current mechanical circulatory support systems face performance deficiencies such as inadequate blood flow, requirement for motor purging, high hemolysis, and inadequate hemodynamic parameter sensing, particularly in managing cardiogenic shock and high-risk coronary interventions.
Innovation Solution
A minimally invasive miniaturized percutaneous mechanical circulatory support system with a tubular housing, motor, and impeller, featuring a guidewire lumen with a curved contour, an insertion tool, and an introducer sheath with a hexagonal coupling for self-alignment and haptic feedback, which allows for transcatheter delivery and active unloading of the left ventricle without purging, and includes sensors for real-time hemodynamic parameter measurement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a miniaturized percutaneous mechanical circulatory support system is used, then ease of operation and minimally invasive delivery are improved, but device complexity increases due to integration requirements
Solution Approach 1:
The pump device is nested within the insertion tool, which is in turn nested within the introducer sheath. The pump includes a tubular housing with an impeller and motor that fits within the insertion tool's tubular body, allowing the entire assembly to be delivered percutaneously through a single access point while maintaining miniaturization.
Solution Approach 2:
The insertion tool serves multiple functions: it acts as a delivery catheter for the pump, provides structural support during implantation, and includes a coupling mechanism for connection to the introducer sheath. The hexagonal coupling provides both mechanical connection and self-alignment capabilities in a single integrated feature.
2Loss of time
If the pump operates without purging, then loss of time and operational efficiency are improved, but reliability may worsen due to potential motor contamination
Solution Approach 1:
The motor is extracted from direct contact with the blood flow path and enclosed within a sealed motor housing. This allows the pump to operate without purging while preventing blood from contaminating the motor, as the motor housing acts as a barrier separating the motor from the biological environment.
Solution Approach 2:
A sealed motor housing serves as an intermediary barrier between the motor and the blood flow. This housing allows magnetic coupling to transmit rotational force to the impeller while preventing direct contact between blood and motor components, eliminating the need for purging while maintaining reliability.
3Measurement precision
If real-time hemodynamic parameter sensing is implemented, then measurement precision is improved, but device complexity increases due to additional sensors
Solution Approach 1:
The sensing capabilities are merged into the pump device itself, with sensors integrated into the tubular housing and catheter shaft. This allows real-time hemodynamic parameter measurement without requiring separate sensing devices, as the pump structure incorporates the sensing functionality directly.
4Ease of operation
If the coupling provides self-alignment and haptic feedback, then ease of operation is improved, but manufacturing precision requirements increase
Solution Approach 1:
The coupling includes hexagonal portions with asymmetric geometry that provide self-alignment through geometric constraints. The hexagonal shape with specific facet orientations enables automatic orientation during connection while providing tactile feedback through the interaction of complementary hexagonal surfaces, reducing the need for high-precision alignment procedures.
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 system provides effective blood flow support up to 4.0 liters per minute for 6 hours without purging, reduces hemolysis, and enables real-time monitoring of critical parameters, enhancing treatment efficacy for cardiogenic shock and high-risk coronary interventions.
Implementation Method 1
The coupling may include hexagonal portions for self-alignment and haptic feedback
Implementation Method 2
The pump may include a tubular housing, a motor, an impeller configured to be rotated by the motor
Implementation Method 3
includes sensors for real-time hemodynamic parameter measurement
Data Source
AI summary
A minimally invasive miniaturized percutaneous mechanical circulatory support system for transcatheter delivery of a pump to the heart that actively unloads the left ventricle by pumping blood from the left ventricle into the ascending aorta and systemic circulation. The pump may include a tubular housing, a motor, an impeller configured to be rotated by the motor, and a distal tip of the pump. The tip may include a guidewire lumen with a curved and/or extended contour. The system may have an insertion tool having a tubular body and configured to axially movably receive the circulatory support device, and an introducer sheath configured to axially movably receive the insertion tool. A coupling allows for connection and disconnection of the insertion tool and introducer sheath. The coupling may include hexagonal portions for self-alignment and haptic feedback.