Transapical Heart Access Positioner with Suction Stabilization
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Solution Overview
Problem
Current heart repair procedures often require cardiopulmonary bypass and sternotomy, which can be risky for patients with comorbidities, limiting access to ventricle procedures and increasing trauma for patients.
Innovation Solution
A positioning device with a suction cup to stabilize the heart apex and hemostatic access valves for closed chest procedures, allowing access to the ventricle without sternotomy or bypass, and self-closing clips made from super-elastic materials to seal the entry point.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sternotomy bypass methods are used to access the ventricle, then reliable access and procedural control are achieved, but patient trauma and surgical risk are significantly increased
Solution Approach 1:
The procedure is segmented into two distinct access methods: a small subxiphoid incision for introducing the positioning device and catheter, followed by transapical puncture for precise ventricular access. This eliminates the need for a large sternotomy incision while maintaining procedural control through staged, minimally invasive approaches.
Solution Approach 2:
The invention changes the access parameters from large-bore sternotomy (requiring chest opening and bypass) to small-bore transapical puncture (through the heart apex). This parameter change reduces incision size, eliminates sternotomy trauma, and allows procedures to be performed without cardiopulmonary bypass.
2Reliability
If cardiopulmonary bypass is used to access the ventricle, then safe surgical conditions are created, but patient risk and procedural complexity are increased
Solution Approach 1:
The invention extracts and removes the cardiopulmonary bypass requirement from the transapical access procedure. By using small-bore catheters and controlled puncture techniques, the procedure can be performed on a beating heart without the need for bypass machinery, significantly simplifying the overall surgical approach.
Solution Approach 2:
The positioning device with suction cup is introduced through a small subxiphoid incision and positioned on the heart apex before the actual ventricular puncture. This preliminary positioning stabilizes the heart and establishes a secure base for subsequent catheter insertion, enabling safe transapical access without bypass.
3Manufacturing precision
If the heart apex is stabilized for access, then precise device placement is achieved, but heart movement and physiological function may be affected
Solution Approach 1:
The suction cup positioning device is designed to be dynamic rather than rigidly fixed. It maintains attachment to the heart apex through controlled suction that can be adjusted during the procedure, allowing the heart to beat and move physiologically while maintaining sufficient stabilization for accurate catheter placement. The device adapts to heart motion rather than restricting it completely.
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
Enables safer, less invasive access to the heart ventricle, reducing patient risk and trauma by allowing procedures without sternotomy or cardiopulmonary bypass, and providing effective closure of the entry point post-procedure.
Implementation Method 1
the cup can be a suction cup that attaches to the apex of the heart to allow positioning of the apex within a chest cavity
Implementation Method 2
clips are formed from a super-elastic shape memory alloy such as, for example, Nitinol
Implementation Method 3
A super-elastic metal is sometimes known as a shape memory alloy (also, smart metal, memory alloy or muscle wire) that remembers its shape and can be returned to that shape after being deformed
Data Source
AI summary
A positioning device for providing access to a ventricle of a heart. In one embodiment, the device includes a cup positionable over an apex of the heart and at least a first access valve in the cup for accessing an entry point to the ventricle of the heart.