Systems and methods for treating pulmonary hypertension
Inventors
Vollmers, Karl • Scandurra, John
Assignees
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Publication Number
US-10682448-B2
Publication Date
2020-06-16
Expiration Date
Abstract
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.
Core Innovation
The disclosed invention relates to a system for treating pulmonary hypertension that includes an implantable component comprising a compliant member sized and shaped to be implanted in a pulmonary artery. The compliant member is configured to expand and contract responsive to pressure changes in the pulmonary artery, and an implantable sensor is associated with the implantable component to sense a parameter of the implantable component and generate a signal comprising information indicative of the sensed parameter.
A non-transitory computer readable medium is programmed with instructions that, when executed by a processor of a computer operatively coupled to the sensor, cause the computer to compare the information to a predetermined threshold and generate an alert if the comparison of the information to the predetermined threshold fails. The disclosed system is described as enabling monitoring and alerting based on sensed information exceeding predetermined thresholds.
The disclosed system further includes an implantable structure with a compliant member coupled to a reservoir via a conduit with fluidic communication. External components, including a clinical controller, a monitoring software system with a graphical user interface, and an external patient monitoring component with a mobile application, provide wireless/telemetry sensing and clinician review of pressure and hemodynamic parameters, with alarm detection, data logging, and calculation of pulmonary arterial compliance from monitored hemodynamics.
Claims Coverage
The partial claims content identifies three independent claim categories covering a treatment system, a non-transitory computer readable medium, and a method. Across these independent claims, the main inventive features are an implantable compliant member in a pulmonary artery, sensor-based sensing of a parameter, threshold comparison, and alert generation when the comparison fails.
Implantable compliant member responsive to pulmonary artery pressure changes
An implantable component comprising a compliant member sized and shaped to be implanted in a pulmonary artery, configured to expand and contract responsive to pressure changes in the pulmonary artery.
Sensor generating information indicative of a sensed implantable parameter
A sensor associated with the implantable component configured to sense a parameter of the implantable component and to generate a signal comprising information indicative of the sensed parameter.
Threshold comparison and alert generation if comparison fails
A non-transitory computer readable medium programmed with instructions that cause a computer to compare the information indicative of the sensed parameter to a predetermined threshold and to generate an alert if comparison of the information to the predetermined threshold fails.
Receiving sensed information, comparing to predetermined threshold, generating alert
Instructions that cause a computer to receive a signal comprising information indicative of a sensed parameter of the implantable component sensed by the sensor, compare the information to a predetermined threshold, and generate an alert if comparison of the information to the predetermined threshold fails.
Implanting compliant member, receiving sensed parameter information, and generating alert
A method comprising implanting an implantable component comprising a compliant member in a pulmonary artery configured to expand and contract responsive to pressure changes, receiving a signal comprising information indicative of a sensed parameter of the implantable component sensed by a sensor, comparing the information to a predetermined threshold, and generating an alert if comparison of the information to the predetermined threshold fails.
Across the independent claims, the core coverage is the same functional architecture: an implantable compliant member responsive to pulmonary artery pressure changes, a sensor that generates information indicative of a sensed parameter, and computer-executed comparison to a predetermined threshold with alert generation when the comparison fails.
Stated Advantages
Alert generation when sensed parameters exceed predetermined thresholds.
Monitoring and clinician review using external monitoring components and software, including display and alarm detection.
Calculation of pulmonary arterial compliance from monitored hemodynamics.
Documented examples show decreased peak systolic pressure and increased diastolic pressure with activation in calf and benchtop models.
Documented Applications
Treatment of pulmonary hypertension with an implantable compliant member in a pulmonary artery and external monitoring/alerting based on sensed parameters.
Pulmonary hypertension modeling and activation examples including an altitude-induced PH calf example and a benchtop model example.
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