Implantable Compliant Balloon Devices for Pulsatile Pressure Reduction
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Solution Overview
Problem
Current treatments for pulmonary hypertension and right heart failure, such as pharmaceuticals, do not directly address the excess stiffening of pulmonary arteries, leading to increased pulsatile pressure and right ventricular remodeling, which can result in heart failure and high mortality.
Innovation Solution
Implantable devices with a fluid reservoir, compliant member, and transvascular conduit that collapse during systole to reduce peak pressure and expand during diastole, using an anchor to secure the compliant member within a blood vessel, allowing for the transfer of fluid between the reservoir and the compliant member to mitigate pulsatile pressure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pharmaceuticals are used to treat pulmonary hypertension, then patient symptoms may be managed, but the excess stiffening of pulmonary arteries is not directly addressed, leading to increased pulsatile pressure and right ventricular remodeling
Solution Approach 1:
A compliant balloon is introduced as an intermediary device within the pulmonary artery to directly counteract the stiffening effects. The balloon acts as a mechanical mediator that absorbs pulsatile pressure changes through fluid displacement, thereby protecting the vessel wall from excessive stress and preventing further remodeling while pharmaceuticals continue to address other aspects of the disease.
2Object-affected harmful factors
If a compliant balloon with fluid is implanted in the pulmonary artery to restore compliance, then pulsatile pressure is reduced, but the device requires a complex reservoir and conduit system for fluid transfer
Solution Approach 1:
The device is segmented into three functional components: an implantable compliant balloon within the pulmonary artery, a separate subcutaneous reservoir, and a transvascular conduit connecting them. This segmentation allows the balloon to perform its pressure-regulating function independently while the reservoir and conduit system provides fluid refilling capability, distributing the system's complexity across separate modules with distinct functions.
3Adaptability or versatility
If the compliant member is made detachable from the anchor, then the device can be adjusted or replaced, but the stability and secure engagement within the blood vessel may be compromised
Solution Approach 1:
The connection between the compliant member and anchor is designed with dynamic characteristics, allowing the compliant member to be detachably engaged with the anchor. This enables the system to transition between a stable engaged state for normal operation and a detachable state for adjustment or replacement, providing both reliability during use and adaptability when needed through controlled engagement and disengagement mechanisms.
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 devices effectively reduce peak systolic pressure and increase diastolic pressure, improving heart efficiency and reducing the load on the right ventricle, thereby slowing disease progression and enhancing patient quality of life.
Implementation Method 1
PH causes the larger pulmonary arteries to dilate and stiffen. As the stiffening progresses, the pulmonary artery is less able to stretch to accommodate each incoming stroke volume.
Implementation Method 2
During right ventricular diastole, the drop in blood pressure within the pulmonary artery results in a pressure gradient between the fluid pressure in the reservoir and the deflated balloon in the pulmonary artery. This gradient causes the fluid to flow back through the conduit into the balloon from the reservoir.
Data Source
AI summary
An implantable device for reducing pulsatile pressure within a blood vessel is described herein, for example to treat pulmonary hypertension. The implantable device may include a fluid reservoir, a compliant member (e.g., a balloon), and a conduit coupled to the fluid reservoir and the compliant member. Advanced designs for anchoring the compliant member in the blood vessel are described. In addition, enhanced reservoir, conduit, and balloon designs, as well as methods for implanting/using the same, are provided.