Pulmonary Artery Implant With External Pressure Feedback
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Solution Overview
Problem
Current treatments for pulmonary hypertension, such as pharmaceuticals, are expensive and insufficiently effective, and existing implantable systems lack efficient monitoring capabilities.
Innovation Solution
An implantable component with a compliant member in the pulmonary artery, coupled to a subcutaneous reservoir via a conduit, is monitored externally using a clinical controller, sensors, and mobile application to adjust and display parameters, ensuring proper functioning and compliance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pharmaceuticals are used to treat pulmonary hypertension, then treatment is provided, but the treatment is extremely expensive and not sufficiently effective
Solution Approach 1:
The treatment system is divided into separate components: an implantable component with a compliant member (stent or balloon) that can be deployed in the pulmonary artery, and an external controller for monitoring and adjustment. This segmentation allows for targeted mechanical intervention rather than systemic pharmaceutical treatment, improving effectiveness while enabling cost control through device reuse and adjustment capabilities.
Solution Approach 2:
The compliant member's physical parameters (expansion ratio, stiffness, position) can be adjusted after implantation through the external controller based on measured pressure parameters. This dynamic parameter adjustment allows optimization of treatment effectiveness without requiring expensive trial-and-error pharmaceutical regimens, and the device can be reused across multiple treatment adjustments.
2Reliability
If implantable systems are used to treat pulmonary hypertension, then treatment effectiveness is improved, but the ability to monitor operation after implantation is insufficient
Solution Approach 1:
The system incorporates sensors that continuously measure pressure parameters within the pulmonary artery and transmit this information to an external controller. This feedback loop enables real-time monitoring of treatment effectiveness, allowing clinicians to assess whether the compliant member is achieving the desired pressure reduction and to make informed adjustments to device parameters or treatment strategy.
Solution Approach 2:
An external controller acts as an intermediary between the implantable component and the clinician. This intermediary receives sensor data from the implantable device, processes the information, and provides a user interface for monitoring and control. This intermediary layer solves the monitoring problem by bridging the gap between the implanted sensor and the clinician's decision-making process.
3Stress or pressure
If a compliant member is implanted in the pulmonary artery to reduce peak pressure, then peak pressure is reduced, but the system complexity increases
Solution Approach 1:
The compliant member is designed to perform multiple functions: it provides mechanical support to reduce peak pressure, incorporates sensors for pressure measurement, and can be adjusted through the external controller. This multi-functionality reduces overall system complexity by integrating what would otherwise be separate components (support structure, sensor, actuator) into a single universal element.
Solution Approach 2:
The system merges the compliant member (stent or balloon), sensors, and control mechanisms into an integrated implantable unit. This consolidation reduces the number of separate implantable components, simplifies the implantation procedure, and reduces the complexity of having multiple independent systems interacting within the body.
Data Source
AI summary
A system for treating heart disease, such as pulmonary hypertension or right heart failure, including an implantable component and external components for monitoring the implantable component is provided. The implantable component may include a compliant member, e.g., balloon, coupled to a reservoir via a conduit. Preferably, the compliant member is adapted to be implanted in a pulmonary artery and the reservoir is adapted to be implanted subcutaneously. The external components may include a clinical controller component, monitoring software configured to run a clinician's computer, a patient monitoring device, and a mobile application configured to run on a patient's mobile device.