Devices and systems for determining fractional flow reserve
Devices and systems for determining fractional flow reserve. In at least one embodiment of a device for determining fractional flow reserve of a fluid within a luminal organ, the device comprises an elongated body sized and shaped to fit within a luminal organ, and at least two sensors positioned along the elongated body a predetermined distance from one another, wherein the device is operable to detect a first fluid with a first parameter having a first value using at least one of the at least two sensors when the device is positioned within the luminal organ, and wherein the device is further operable to detect a second fluid having a second parameter, wherein the second parameter of the second fluid has a second value different from the first value, upon introduction of the second fluid within the luminal organ at or near the at least two sensors, and wherein the device is further operable to determine fractional flow reserve when the device is positioned within the luminal organ at or near a stenosis, wherein the fractional flow reserve is based upon a flow velocity obtained by the device, a mean aortic pressure within the luminal organ, and at least one cross-sectional area at or near the stenosis.
1. A system for determining fractional flow reserve of a fluid within a luminal organ, the system comprising:
a) a device, comprising:
an elongated body sized and shaped to fit within a luminal organ; and
at least two sensors positioned along the elongated body a predetermined distance from one another, the at least two sensors configured to obtain data used by a data acquisition and processing system in communication with the device and configured to calculate at least one actual cross-sectional area within the luminal organ based on the data obtained by at least one of the at least two sensors and the predetermined distance therebetween;
wherein the device is configured to detect a first fluid with a first parameter having a first value using at least one of the at least two sensors when the device is positioned within the luminal organ, and wherein the device is further configured to detect a second fluid having a second parameter using at least one of the at least two sensors, wherein the second parameter of the second fluid has a second value different from the first value, upon introduction of the second fluid within the luminal organ at or near the at least two sensors; and
b) the data acquisition and processing system, which is further configured to determine fractional flow reserve when the device is positioned within the luminal organ at or near a stenosis, wherein the fractional flow reserve is calculated by the data acquisition and processing system using a) a flow velocity obtained using the at least two sensors of the device, b) a mean aortic pressure within the luminal organ, and c) the at least one cross-sectional area within the luminal organ at or near the stenosis, wherein the at least one actual cross-sectional area is calculated by the data acquisition and processing system using the data obtained by the at least two sensors in the presence of undiluted boluses of at least one of the first fluid and/or the second fluid and the mean aortic pressure is calculated using the flow velocity and the at least one cross-sectional area.
2. The system of claim 1 , wherein the second fluid detected by the at least two sensors allows for the data acquisition and processing system to calculate the flow velocity using time of detection of the second fluid by the at least two sensors and the distance between the at least two sensors.
3. The system of claim 1 , wherein the data acquisition and processing system is configured to determine the fractional flow reserve using the flow velocity obtained by the device, the mean aortic pressure within the luminal organ, a cross-sectional area of the luminal organ distal to the stenosis, and a cross-sectional area of the luminal organ proximal to the stenosis, and the mean aortic pressure is determined without the use of a pressure sensor.
4. The system of claim 1 , wherein the data acquisition and processing system is configured to determine the fractional flow reserve calculated using the flow velocity obtained by the device, the mean aortic pressure within the luminal organ, a cross-sectional area of the luminal organ distal to the stenosis, a cross-sectional area of the luminal organ proximal to the stenosis, and at least one cross-sectional area of the luminal organ at the stenosis.
5. The system of claim 1 , wherein the flow velocity allows for the data acquisition and processing system to calculate volumetric flow within the luminal organ, the volumetric flow calculated using the flow velocity and the at least one cross-sectional area.
6. The system of claim 1 , wherein the fractional flow reserve is further calculated using a blood viscosity.
7. The system of claim 1 , wherein the device has a configuration selected from the group consisting of a wire and a catheter.
8. A system for determining a flow reserve of a fluid within a luminal organ, the system comprising:
a) a device, comprising:
an elongated body sized and shaped to fit within a luminal organ;
at least one pair of excitation electrodes positioned along the elongated body; and
at least two pairs of detection electrodes positioned along the elongated body between the at least one pair of excitation electrodes, wherein the at least two pairs of detection electrodes are positioned a predetermined distance from each other and configured to obtain data for use by a data acquisition and processing system in communication with the device and to calculate at least one actual cross-sectional area within the luminal organ based on the data obtained by the detection electrodes and the predetermined distance therebetween;
wherein when the device is positioned within the luminal organ, the device is configured to detect a first conductance of a first fluid having a first conductivity within the luminal organ using the at least two pairs of detection electrodes, the device further configured to detect a second conductance of a second fluid having a second conductivity using the at least two pairs of detection electrodes upon introduction of the second fluid within the luminal organ at or near the at least two pairs of detection electrodes; and
b) the data acquisition and processing system, which is further configured to determine a fractional flow reserve when the device is positioned within the luminal organ at or near a stenosis, wherein the fractional flow reserve is calculated by the data acquisition and processing system using a first flow velocity of the first fluid obtained by the device and at least one cross-sectional area at or near the stenosis.
9. The system of claim 8 , wherein the second fluid detected by using the at least two pairs of detection electrodes allows for the data acquisition and processing system to calculate a second flow velocity using time of detection of the second fluid by the at least two pairs of detection electrodes and the predetermined distance between the at least two pairs of detection electrodes.
10. The system of claim 8 , wherein the flow velocity allows for the data acquisition and processing system to calculate volumetric flow within the luminal organ, the volumetric flow calculated using the flow velocity and the at least one cross-sectional area.
11. A system for determining fractional flow reserve of a fluid within a luminal organ, the system comprising:
a) a device for determining fractional flow reserve, the device comprising:
an elongated body sized and shaped to fit within a luminal organ, and
at least two sensors positioned along the elongated body a predetermined distance from one another, the at least two sensors configured to obtain data for use by a data acquisition and processing system in communication with the device, the data acquisition and processing system configured to calculate at least one actual cross-sectional area within the luminal organ,
wherein the device is configured to detect a first fluid with a first parameter having a first value using at least one of the at least two sensors when the device is positioned within the luminal organ, and wherein the device is further configured to detect a second fluid having a second parameter, wherein the second parameter of the second fluid has a second value different from the first value, upon introduction of the second fluid within the luminal organ at or near the at least two sensors; and
b) the data acquisition and processing system, wherein the data acquisition and processing system is configured to calculate a flow velocity of the second fluid calculated using timing of the detected second fluid by the at least two sensors and the distance between the at least two sensors and determine fractional flow reserve when the device is positioned within the luminal organ at or near a stenosis, the fractional flow reserve calculated by the data acquisition and processing system using a) the flow velocity, b) a mean aortic pressure within the luminal organ, and c) at least one cross-sectional area within the luminal organ at or near the stenosis, wherein the at least one actual cross-sectional area is calculated by the data acquisition and processing system using the data obtained by the at least two sensors in the presence of undiluted boluses of at least one of the first fluid and/or the second fluid and the mean aortic pressure is calculated using the flow velocity and the at least one cross-sectional area.
12. The system of claim 11 , wherein the data acquisition and processing system is configured to determine the fractional flow reserve using the flow velocity obtained by the device, the mean aortic pressure within the luminal organ, a cross-sectional area of the luminal organ distal to the stenosis, and a cross-sectional area of the luminal organ proximal to the stenosis, wherein the cross-sectional areas are calculated using the data obtained by the at least two sensors in the presence of undiluted boluses of at least one of the first fluid and/or the second fluid.
13. The system of claim 11 , wherein the data acquisition and processing system is configured to determine the fractional flow reserve using the flow velocity obtained by the device, the mean aortic pressure within the luminal organ, a cross-sectional area of the luminal organ distal to the stenosis, a cross-sectional area of the luminal organ proximal to the stenosis, and the at least one cross-sectional area of the luminal organ at or near the stenosis, wherein the cross-sectional areas are calculated using the data obtained by the at least two sensors in the presence of undiluted boluses of at least one of the first fluid and/or the second fluid and the mean aortic pressure is determined without the use of a pressure sensor.
14. The system of claim 11 , wherein the flow velocity allows for the data acquisition and processing system to calculate volumetric flow within the luminal organ, the volumetric flow calculated using the flow velocity and the at least one cross-sectional area.
15. A system for determining fractional flow reserve of a fluid within a luminal organ, the system comprising:
a device for determining fractional flow reserve, the device comprising:
an elongated body sized and shaped to fit within a luminal organ,
at least one pair of excitation electrodes positioned along the elongated body, and
at least two pairs of detection electrodes positioned along the elongated body between the at least one pair of excitation electrodes, wherein the at least two pairs of detection electrodes are positioned a predetermined distance from each other, at least one pair of the at least two pairs of detection electrodes configured to obtain data used by a data acquisition and processing system to calculate at least one actual cross-sectional area within the luminal organ based on the data obtained by the at least one pair of detection electrodes configured to obtain data and the predetermined distance between the detection electrodes,
wherein when the device is positioned within the luminal organ, the device is configured to detect a first conductance of a first fluid having a first conductivity within the luminal organ using the at least two pairs of detection electrodes, the device further configured to detect a second conductance of a second fluid having a second conductivity using the at least two pairs of detection electrodes upon introduction of the second fluid within the luminal organ at or near the at least two pairs of detection electrodes; and
the data acquisition and processing system in communication with the device, the data acquisition and processing system configured to calculate a flow velocity of the second fluid calculated using time of detection of the second fluid by the at least two pairs of detection electrodes and the predetermined distance between the at least two pairs of detection electrodes, the data acquisition and processing system further configured to determine fractional flow reserve when the device is positioned within the luminal organ at or near a stenosis; and
wherein the fractional flow reserve is calculated by the data acquisition and processing system using a) the flow velocity, b) a mean aortic pressure within the luminal organ, and c) at least one cross-sectional area within the luminal organ at or near the stenosis, wherein the at least one actual cross-sectional area is calculated by the data acquisition and processing system using the data obtained by at least one pair of the at least two pairs of detection electrodes in the presence of undiluted boluses of at least one of the first fluid and/or the second fluid and the mean aortic pressure is calculated using the flow velocity and the at least one cross-sectional area.
16. The system of claim 15 , wherein the data acquisition and processing system is configured to determine the fractional flow reserve using the flow velocity obtained by the device, the mean aortic pressure within the luminal organ, a cross-sectional area of the luminal organ distal to the stenosis, and a cross-sectional area of the luminal organ proximal to the stenosis, and the mean aortic pressure is determined without the use of a pressure sensor.
17. The system of claim 15 , wherein the data acquisition and processing system is configured to determine the fractional flow reserve using the flow velocity obtained by the device, the mean aortic pressure within the luminal organ, a cross-sectional area of the luminal organ distal to the stenosis, a cross-sectional area of the luminal organ proximal to the stenosis, and at least one cross-sectional area of the luminal organ at the stenosis.
18. The system of claim 15 , wherein the flow velocity allows for the data acquisition and processing system to calculate volumetric flow within the luminal organ, the volumetric flow calculated using the flow velocity and the at least one cross-sectional area.
19. The system of claim 8 , wherein the flow reserve the device is configured to determine is a fractional flow reserve, the fractional flow reserve further calculated using a mean aortic pressure within the luminal organ, the mean aortic pressure calculated by the data acquisition and processing system using the flow velocity and the at least one cross-sectional area and without the use of a pressure sensor.