Endovascular Phrenic Nerve Pacing for ICU Ventilator Weaning
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Solution Overview
Problem
Current methods for mechanical ventilation in ICU patients lead to rapid diaphragmatic dysfunction, muscle atrophy, and prolonged ventilator dependence, with existing phrenic nerve stimulation and diaphragmatic pacing systems being invasive, costly, and unsuitable for temporary use in critically ill patients.
Innovation Solution
A minimally invasive transvascular diaphragm pacing system using disposable endovascular electrodes for percutaneous placement under local anesthesia, synchronizing electrical stimulation with ventilator breaths to prevent or reverse diaphragm disuse atrophy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional phrenic nerve stimulation or diaphragmatic pacing systems are used, then diaphragm function can be maintained or improved, but the procedures are invasive, time-consuming, and require surgical implantation with incisions
Solution Approach 1:
The patent uses the vasculature (veins) as an intermediary pathway to deliver electrodes to the diaphragm. Instead of direct surgical access to the diaphragm or phrenic nerve, the system navigates through existing blood vessels to reach the target area, thereby avoiding incisions and reducing invasiveness while maintaining the ability to stimulate the diaphragm effectively
Solution Approach 2:
The patent replaces the mechanical surgical implantation process with a less invasive endovascular approach. The electrodes are delivered through catheters navigated through the vasculature, substituting the mechanical cutting and suturing of traditional surgery with a minimally invasive navigation and placement system
2Reliability
If conventional diaphragmatic pacing with four electrodes is used, then diaphragm stimulation is achieved, but the procedure is time-consuming and requires laparoscopic implantation with incisions
Solution Approach 1:
The patent segments the diaphragm stimulation function across multiple electrode configurations that can be selectively deployed. Instead of requiring all four electrodes to be implanted simultaneously through laparoscopy, the system can deploy electrodes sequentially or in different configurations through the endovascular route, reducing the overall implantation time and procedural complexity
3Reliability
If conventional nerve cuff implantation around phrenic nerve is used, then phrenic nerve stimulation is achieved, but direct placement may damage the phrenic nerves and requires incisions
Solution Approach 1:
The patent uses the vasculature as an intermediary to reach the diaphragm and phrenic nerve area without directly manipulating or placing cuffs around the delicate phrenic nerves. This indirect approach through blood vessels eliminates the risk of nerve damage associated with direct nerve cuff placement while still enabling effective stimulation
Solution Approach 2:
The patent employs disposable electrodes that are delivered through the vasculature and can be removed after use. These single-use electrodes eliminate the need for permanent implantation and associated surgical procedures, reducing both the risk of nerve damage and the complexity of the implantation process
4Reliability
If prolonged mechanical ventilation is used, then ventilatory support is provided, but diaphragm disuse atrophy occurs rapidly leading to ventilator dependence
Solution Approach 1:
The patent applies diaphragm pacing early in the ventilatory support course, before significant atrophy occurs. By initiating diaphragm stimulation preemptively during the first few days of mechanical ventilation, the system prevents the onset of disuse atrophy rather than treating it after it has developed, thereby reducing the duration of ventilator dependence
Solution Approach 2:
The patent provides continuous or frequent diaphragm stimulation throughout the period of mechanical ventilation. This ongoing activation ensures the diaphragm remains toned and functional despite the presence of the ventilator, maintaining muscle health and enabling earlier weaning from ventilatory support
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 rapid, short-term diaphragm pacing that prevents or reverses diaphragmatic atrophy, allowing earlier weaning from mechanical ventilation and reducing healthcare costs and complications associated with prolonged ventilation.
Implementation Method 1
delivering a stimulation signal with a transvascular electrode in electrical communication with the phrenic nerve
Data Source
AI summary
Transvascular diaphragm pacing systems (TDPS) and methods are disclosed for providing respiratory therapy to a patient. The TDPS can provide rapid insertion and deployment of endovascular pacing electrodes in critically ill patients who require intubation and invasive PPMV in order to support the physiological requirements of the human ventilatory system. The systems and methods make best use of the contractile properties of the diaphragm muscle and prevent muscle disuse and muscle atrophy. This can be carried out by engaging the phrenic nerves using patterned functional electrical stimulation applied to endovascular electrodes that are temporarily and reversibly inserted in central veins of the patient, such as the left subclavian vein and the superior vena cava. The TDPS can be designed to seamlessly interface with any commercially available positive-pressure ventilatory assistance/support equipment such as is commonly in use in hospital intensive care units (ICU) for treating critically ill patients with breathing insufficiencies, pain, trauma, sepsis or neurological diseases or deficits.