Adjustable Hydraulic Diameter Intra-Atrial Shunt
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Solution Overview
Problem
Current treatments for diastolic heart failure, such as pressure relief shunts, face challenges in adapting to the dynamic hemodynamic conditions of heart failure, leading to potential worsening of symptoms due to static sizing and the risks associated with long-term catheter dwell time, including pulmonary hypertrophy and adverse reactions.
Innovation Solution
Development of an implantable shunting device with adjustable hydraulic diameter, featuring anchors and a shunting section that can be manually or automatically altered to respond to changing hemodynamic conditions, allowing for gradual expansion or contraction to optimize blood flow and mitigate risks like pulmonary hypertrophy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a static pressure relief shunt is used to treat diastolic heart failure, then the device structure is simple and easy to implant, but the shunt cannot adapt to changing hemodynamic conditions leading to potential worsening of symptoms
Solution Approach 1:
The shunt device incorporates a dynamically adjustable structure that allows the opening size to be modified after implantation. The shunt includes an adjustable component that can change the effective opening area in response to hemodynamic conditions, transforming a static device into a dynamic one that adapts to patient needs over time
Solution Approach 2:
The invention changes the geometric parameter of the shunt opening to create different flow rates. By adjusting the opening size parameter, the device can optimize blood flow according to varying hemodynamic conditions, allowing the same device to function effectively under different physiological states
2Productivity
If a large shunt opening is created to provide sufficient blood flow, then therapeutic effect is improved, but the risk of pulmonary hypertrophy and adverse reactions increases
Solution Approach 1:
The shunt employs a dynamic opening mechanism that allows the effective aperture to be adjusted based on clinical response. This enables the device to provide high flow rates when needed for therapeutic effect while reducing the opening size when signs of pulmonary hypertrophy appear, thus balancing productivity with safety
Solution Approach 2:
The adjustable shunt design incorporates feedback mechanisms where clinical monitoring of pulmonary pressure and patient symptoms guides adjustments to the opening size. This feedback loop allows optimization of blood flow while preventing adverse effects by reducing the opening when harmful effects begin to manifest
3Productivity
If the shunt opening size is increased to treat worsening heart failure, then symptom relief is improved, but acute rebound stress may occur
Solution Approach 1:
The shunt adjustment process follows a periodic protocol with staged opening expansions rather than single large increases. This periodic action allows the cardiovascular system to adapt gradually to increased flow, preventing acute rebound stress while achieving sufficient symptom relief through cumulative adjustments over time
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 device effectively reduces left atrial and pulmonary venous pressure, providing a dynamic treatment that adjusts to the patient's changing conditions, reducing the risk of acute worsening and pulmonary hypertrophy while maintaining therapeutic blood flow.
Implementation Method 1
a shunt is sized too large the short term effect of the creation of a pressure relief shunt may include a sudden worsening of heart failure... if the pressure relief shunt is sized too small the patient may not experience any clinical improvement
Data Source
AI summary
Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. Devices may include an adjustable hydraulic diameter and/or a removable and/or replaceable shunt portion. Devices may include absorbable materials, the absorption of which directly or indirectly causes alterations of the fluid flow capacities the devices.