Intraoperative aortic valve visualization test devices and systems and methods for using them
Devices and methods are provided for pressurization of an aortic valve of a heart before and/or after a valve surgery procedure to mimic the physiologic environment that the aortic valve experiences while allowing surgeons to visually inspect the aortic valve, so that if additional repair needs to be performed, it can be done immediately before aortotomy closure.
1 . A device for testing and/or visualizing a heart valve within a subject's body, comprising:
a transparent housing comprising one or more sidewalls extending between an open lower end sized for placement above a heart valve, and an upper end, the one or more sidewalls defining a peripheral outermost surface of the housing and surrounding an interior of the housing;
a transparent cover enclosing the upper end and the interior of the housing for viewing the heart valve;
a first port extending through the peripheral outermost surface of the housing and communicating with the interior for connection to a source of fluid to deliver fluid into the interior of the housing; and
one or more vacuum ports extending through the peripheral outermost surface of the housing and communicating with the interior to remove air from the interior of the housing,
wherein each of the one or more vacuum ports comprises a valve actuatable between an open position to allow air within the interior to be displaced by the fluid and a closed position to allow the fluid from the source of fluid to pressurize the interior and the heart valve.
2 . The device of claim 1 , wherein the one or more sidewalls comprise a cylindrical shape extending between the lower and upper ends of the housing.
3 . The device of claim 1 , wherein the one or more sidewalls comprise a funnel shape that tapers inwardly from the upper end to the lower end.
4 . The device of claim 1 , wherein the housing has a substantially uniform cross-section between the upper and lower ends.
5 . The device of claim 1 , wherein the housing comprises a substantially uniform cross-section upper region terminating at the upper end, and a tapered region transitioning between the upper region towards the lower end.
6 . The device of claim 5 , wherein the lower end has a cross-section smaller than the upper region.
7 . The device of claim 1 , wherein the cover is permanently attached to the upper end.
8 . The device of claim 1 , wherein the cover is removably attached to the upper end.
9 . The device of claim 1 , wherein the first port and each of the one or more vacuum ports comprise a nipple extending laterally from the one or more sidewalls.
10 . The device of claim 9 , wherein each nipple includes one of a Luer fitting, threaded connector, hub, ratcheted tubing connector for providing a fluid-tight connection.
11 . The device of claim 9 , further comprising a source of vacuum valve connected to each of the one or more vacuum ports.
12 . The device of claim 1 , further comprising a pressure sensor for providing pressure of fluid within the interior.
13 . The device of claim 1 , wherein the lower end comprises a lip extending radially around a perimeter of the lower end to facilitate removably securing the lower end to a region above the heart valve to provide a fluid-tight seal between the housing and the region.
14 . The device of claim 1 , wherein the valve comprises a handle movable between an open position to allow air to escape from the interior through the second port, and a closed position that closes the second port to allow the interior to be pressurized by the fluid delivered into the interior from the source.
15 . A system for testing and/or visualizing a heart valve within a subject's body, comprising:
a transparent housing comprising one or more sidewalls extending between an open lower end sized for placement above a heart valve, and an upper end, the one or more sidewalls defining a peripheral outermost surface of the device and surrounding an interior of the housing;
a transparent cover enclosing the upper end of the housing for viewing the heart valve;
a first port extending through the peripheral outermost surface of the housing and communicating with the interior;
a source of fluid connectable to the first port to deliver the fluid into the interior of the housing to test sealing of the valve; and
a second port extending through the peripheral outermost surface of the housing and communicating with the interior,
wherein the second port comprises a valve actuatable between an open position to remove air from the interior of the housing displaced by the fluid delivered into the interior and a closed position to allow the fluid from the source of fluid to pressurize the interior and the heart valve.
16 . The system of claim 15 , further comprising a pressure sensor for providing pressure of fluid within the interior.
17 . A method for testing a heart valve within a subject's body using the device of claim 1 , comprising:
placing the open lower end of the housing above the heart valve such that the heart valve is visible through the transparent cover;
delivering liquid into the interior of the housing via the first port such that air from the interior is displaced from the interior by the liquid through the one or more vacuum ports; and
closing the one or more vacuum ports and delivering additional liquid into the interior to apply pressure to the heart valve while visualizing the heart valve through the transparent cover to inspect competency of the heart valve.
18 . The method of claim 17 , further comprising discontinuing delivery of the liquid once a target pressure is achieved and maintaining the target pressure within the interior to allow the heart valve to be monitored during multiple cardiac cycles to ensure that leaflets of the heart valve coapt and function normally.