The present disclosure relates generally to an implant within a human heart including multiple sensors for monitoring physiological data.
An implant system for restoring and improving physiological intracardiac flow, preserving the atrioventricular pressure gradient, and ventricular geometric restoration in a human heart is provided including an implant for positioning at least partially in the atrium, partially within the atrio-ventricular valve, and partially in the ventricle of the human heart and defining a contact surface for directing the intracardiac flow; a base plate secured to the apex of the heart; a tether assembly connecting the implant to the base plate; and a sensor or sensors positioned on at least one of the implant components, the base plate, and the tether or shaft assembly for monitoring cardiac and intracardiac physiological data.
In some embodiments, the sensors are configured to gather, transmit, store, and/or report intracardiac data the implant experiences.
In some embodiments, the sensors are configured to measure cardiac rhythm, blood chemistry levels, and blood oxygen levels. In some embodiments, the sensors are configured to warn of cardiac danger such as pressures, exertion, fatigue, and imminent failure. In some embodiments, the sensors are configured to monitor white cell count, atrial pressures, ventricular pressures, cardiac energy, cardiac forces, transducted forces, flow dynamics and variations, vortical flows and vortical formations, flow vectors, and fluid dynamics.
In some embodiments, the sensors provide feedback to adjust the device. In some embodiments, the implant provides a feedback loop to adjust the resistance of the piston force, energy production, and/or resistance in the dual force configuration.
In some embodiments, the implant and/or control unit has an electronic transmitter to provide feedback outside of the body. The implant can be connected wirelessly to a monitoring platform, and/or to the internet. The implant can be remotely monitored. The implant can report its own status. The control unit, remotely, can control the inflation level of the implant.
The objects, features and advantages of the devices, systems, and methods described herein will be apparent from the following description of particular embodiments thereof, as illustrated in the accompanying drawings. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the devices, systems, and methods described herein.
One of the features of healthy heart function is proper physiological intracardiac flow. During ventricular systolic contraction, considerable forces are exerted on the closed atrio-ventricular valve by the atrioventricular pressure gradient. The atrioventricular pressure gradient is defined as the pressure difference (or a pressure differential) that produces or generates an energy and a force within the chambers of the heart that occurs naturally. As the pressure increases in the atrium and the pressure reduces in the ventricle, called the diastolic phase or diastole, blood flows from the higher pressure atrium into the lower pressure ventricle causing the valve leaflets to open and thus allowing the blood to pass through the valve orifice. During the systolic phase or systole, the pressure in the atrium is exceeded by the pressure in the ventricle thereby generating a pressure differential creating an energy and force which, in turn, pushes up and against the valve leaflets causing them to close and seal off the ventricle from the atrial chamber. The atrioventricular pressure gradient is the driving energy and force required to close the valve. These atrioventricular pressure gradient forces are transferred or transducted via the chordae tendinae and papillary muscles into the ventricular wall. There is a resulting valvulo-ventricular wall interaction, which provides and enables the healthy ventricle to maintain structural integrity to maintain healthy elliptical geometry and provides functional support for blood ejection. During ventricular diastole, the ventricular pressure rapidly decreases. The valve opens and blood rushes from the atrium into the ventricle through the valve orifice. The valve leaflets function as a vector or steering mechanism, directing ventricular flow at an angle or vector to create vortical initial spin as illustrated in
In accordance with the disclosed subject matter, a flow vectoring ‘member’ is implanted in the atrio-ventricular space extending into the ventricle VT of the heart H. It is connected to a tether or shaft anchored at the apex A, and extends through the valve orifice into the atrium AT. When the ventricle VT contracts in systole, the ‘member’ harnesses the valvular and sub valvular energy and force of the atrioventricular pressure gradient by allowing the pressure differential to act on the exposed area of the ‘member’, as the valve leaflets VL and subvalvular apparatus SV grab and pull on the ‘member’, which then transfers or transducts that energy to the therapeutic apical base plate in contact with apex A, via the tethering conduit shaft, in the form of stretching and or torsion utilizing a fluid reservoir. When the ventricle VT relaxes in diastole, releasing the ‘member’, the structure of the flow vectoring ‘member’ intercepts atrial blood and re-vectors it, enabling a changed or altered angle of flow or vector, enabling or assisting the initiation of vortex (i.e., spin) as blood flows off the leaflets and drains into the ventricle VT. By implanting the flow vectoring ‘member’, the normal intracardiac blood flow pattern that is disrupted by pathology or defect and unhealthy ventricular geometry can be restored and geometric distortion repaired via transduction delivered by the therapeutic apical base plate thus restoring the valvulo-ventricular relationship and it's critical ventricular and septal wall interaction by contact.
As illustrated in
In some embodiments, sensors 50 are provided on one or more locations. For example, sensors 50 are provided on the implant ‘member’ 110, which can be an implant ‘member’ within another implant member and/or a multi chamber fluid filled configuration. The multi lumen transducting fixed shaft 200 may contain sensors 50. As further illustrated in
As illustrated in
The ‘member’ 110 is illustrated in greater detail in
With reference to
With reference to
In one embodiment, fluid is introduced or removed with respect to chamber 602 to increase or decrease the girth or width of implant 110. Increasing or decreasing the implant girth alters the vector and adjusts the clinically adjudicated and prescribed amount of force transducted, by increasing or decreasing the exposed area of the implant, to the ventricle VT. The sensors 50, located along 150, on, in, or along 300, and in 200 (as illustrated in
In one embodiment, fluid is introduced or removed with respect to chamber 604 to increase or decrease fluid into axial adjusting balloon 206, thereby adjusting the longitudinal axial position of shaft 204 and thus the longitudinal position of implant 110 with respect to the ventricle VT, atrium AT, valvular leaflets VL and the line of coaptation 150 as reverse (positive) re-modeling occurs. The sensors 50, located along 126 and on or near 150, provide real-time data with respect to proper axial positioning to maximize the capture and delivery of native energy and forces to the septal wall, the ventricle, and the ventricular free walls and allows the system to provide feedback to adjust axially by increasing/decreasing the amount of fluid inside balloon 206, thereby adjusting the longitudinal position of implant 110.
In one embodiment, fluid is introduced or removed with respect to chamber 606 to create crescent shaped articulation in the wings 114 of implant 110, either anterior (
In one embodiment, chambers 610, or sealed vertical compartments, house a power source, transmitting source, and/or a data storage source for sensoring nodes 50 implanted within the implant system 100 itself. As such, the implant system 100 serves as a housing platform for the sensoring nodes 50. One or more lumens of the connecting multi-lumen connecting tube 400 connect the power source in chambers 610 with the sensoring nodes 50. Sensoring nodes 50 are devices, e.g., transducers, or other components which identify, detect, and electronically report glucose, blood chemistry, any diagnostic values, pressure, pressure changes, velocities, and velocity changes, etc., and may be embedded in the components of the system and/or its platform for any diagnostic detection, the detection, restoration, and management of vortex, vorticial flow, and assist in providing transduction therapy, e.g., as it applies to the ventricle VT and ventricular walls VW.
The fixed apical base plate 300, with round oval cutouts 306 to allow fibrous tissue in-growth for long term security, pulls the apex A upward in systole and releases the apex A in diastole and, in conjunction with the elongated 308 therapeutic extensions of the apical base 300 plate extending up the sides of the ventricle VT, impart by contact, specific shape, and fixation this transducted energy, with the ability to be monitored by sensoring technology 50 may be adjusted to individual pathology and/or patient specific requirements, intra and/or post operatively, via the control unit 600, delivering into said ventricle VT reduced or amplified energy and force based on specific clinical need, inducing a physiologic response by replacing the lost valvulo-ventricular interaction required to maintain healthy geometric shape of the septal, ventricle, ventricular structures, and the ventricular wall VW.
It will be appreciated that the methods and systems described above are set forth by way of example and not of limitation. Numerous variations, additions, omissions, and other modifications will be apparent to one of ordinary skill in the art. Thus, while particular embodiments have been shown and described, it will be apparent to those skilled in the art that various changes and modifications in form and details may be made therein without departing from the spirit and scope of this disclosure and are intended to form a part of the disclosure as defined by the following claims, which are to be interpreted in the broadest sense allowable by law.
This application claims the benefit under 35 USC § 119(e) of U.S. Provisional Application Ser. No. 62/513,003 filed May 31, 2017, which is hereby incorporated by reference in its entirety.
Number | Date | Country | |
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62513003 | May 2017 | US |