Elastically Deformable Insertion Aperture for Minimally Invasive Cardiac Device Implantation
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Solution Overview
Problem
Current methods for implanting cardiac assist devices, such as sternotomy, are invasive, painful, and result in long recovery times and high infection risks for patients with congestive heart failure, while minimally invasive approaches are slow and stressful for patients.
Innovation Solution
A minimally invasive apparatus and method using an elastically deformable insertion aperture member with a flange for deployment through a linear incision in the pericardial sac, allowing for the implantation of a cardiac assist device via a left thoracotomy or subxiphoid incision, reducing surgical time and infection risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sternotomy is used for implantation of cardiac compression device, then access to heart is achieved, but procedure is painful with long recovery time and high infection risk
Solution Approach 1:
The pericardium is incised to create a pericardial opening, separating the access path from the sternum. This allows the device to be implanted through the pericardial sac without dividing the sternum, thus avoiding sternotomy-related complications while maintaining access to the heart.
Solution Approach 2:
The pericardial sac serves as an intermediary pathway to reach the heart. Instead of directly accessing the heart through sternotomy, the invention uses the pericardial opening as a mediator route, allowing device implantation with minimal invasion and reduced infection risk.
2Object-affected harmful factors
If minimally invasive approach is used for device implantation, then infection risk is reduced, but implantation procedure becomes slow and difficult
Solution Approach 1:
The pericardial opening is created and the pericardial sac is accessed before device implantation. This preliminary preparation establishes a stable working pathway that facilitates subsequent rapid device deployment, reducing overall procedure time despite the minimally invasive approach.
Solution Approach 2:
The device is deployed in an expanded configuration after being introduced through the pericardial opening. This dynamic deployment allows the device to be inserted through a small opening and then expanded to its functional size, maintaining both minimally invasive access and effective device function.
3Reliability
If conventional direct cardiac compression device is implanted via sternotomy, then device function is achieved, but surgical time is lengthy with high complication risk
Solution Approach 1:
The implantation procedure is segmented into distinct steps: creating pericardial opening, accessing pericardial sac, deploying device. This segmentation allows for systematic and efficient execution of the procedure, reducing overall surgical time while ensuring proper device function.
Solution Approach 2:
The pericardial sac acts as an intermediary workspace that provides direct access to the heart without requiring sternotomy. This intermediary pathway significantly reduces surgical time and complication risks while maintaining the ability to implant functional cardiac compression devices.
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
Facilitates accelerated implantation and reduced recovery time, minimizing hospital stays and infection risks for patients, enabling restored cardiac function in as little as three weeks with improved quality of life.
Implementation Method 1
an elastically deformable insertion aperture member with a flange for deployment through a linear incision in the pericardial sac
Data Source
AI summary
A method and related apparatus for the minimally invasive implantation about a heart of at least a deployable device such as a heart assist device or cardiac compression device. The method comprises the steps of performing a left thoracotomy or subxiphoid incision; obtaining access to the pericardial sac; making a generally linear incision in the pericardial sac; positioning an assembly having an insertion aperture member with an upper ring and a lower ring or flange and insertion tube having therein a deployable device. The apparatus of the present invention includes an insertion aperture member having an upper ring and a lower ring or flange; and an insertion tube having therein a deployable device adapted to be deployed from the insertion tube inside the pericardial sac via a generally linear incision.