Device and method for intravascular imaging and sensing
An intravascular sensor device can be used to guide treatment of a diseased blood vessel in the body of a patient. In some examples, the intravascular sensor device includes a pressure sensor and an ultrasound transducer. The intravascular sensor device is used to measure a pressure within the diseased blood vessel and acquire an ultrasound image of the diseased blood vessel. The pressure may be measured during hyperemic blood flow that is caused by a pharmacologic vasodilator drug. The measured pressure can be used to calculate a fractional flow reserve value. The ultrasound image can be used to determine a physical dimension of the blood vessel, such as cross-sectional area. The fractional flow reserve value and physical dimensions of the blood vessel can be used to optimize patient treatment.
1. A sensing catheter for insertion into a blood vessel, the sensing catheter comprising:
a first portion including:
a first lumen extending between an entry port and an exit port, the first lumen structured for receiving a guide wire having an outer diameter of 0.014 inches; and
a sensor assembly surrounding the first lumen, the sensor assembly including:
at least one ultrasound transducer array; and
a pressure sensor; and
a second portion extending from the first portion, the second portion including:
a second lumen for housing a flexible circuit assembly connected to the sensor assembly, wherein the second portion has an outer diameter less than an outer diameter of the first portion, and wherein the outer diameter of the second portion when combined with an unenclosed portion of the guide wire is less than a threshold determined by an artery lumen cross-sectional area and an estimated percentage of occlusion.
2. The sensing catheter of claim 1 , wherein the pressure sensor and the at least one ultrasound transducer array are fabricated on a same substrate.
3. The sensing catheter of claim 1 , wherein the sensor assembly includes a set of sensor subassemblies positioned around the first lumen, and the flexible circuit assembly further includes flexible circuit arms each connected to a sensor subassembly of the set of sensor subassemblies.
4. The sensing catheter of claim 1 , wherein the at least one ultrasound transducer array has a width between 0.012 inches and 0.024 inches, and a length between 0.020 inches and 0.8 inches.
5. The sensing catheter of claim 1 , wherein the sensor assembly includes a ring array of piezoelectric elements.
6. The sensing catheter of claim 1 , wherein the first lumen has an inner diameter of 0.0165 inches extending between the entry port and the exit port.
7. The sensing catheter of claim 1 , wherein the first portion is tapered.
8. The sensing catheter of claim 1 , wherein the first portion has a first wall thickness between 0.003 inches and 0.009 inches at the exit port and a second wall thickness between 0.001 inches and 0.003 inches at the entry port.
9. The sensing catheter of claim 1 , wherein the first portion has a length between 0.20 inches and 1.18 inches for tracking along the guide wire.
10. The sensing catheter of claim 1 , wherein the first lumen includes an inner liner that reduces friction between the first lumen and the guide wire.
11. The sensing catheter of claim 1 , wherein the first portion is made of an elastomer.
12. The sensing catheter of claim 1 , wherein the first portion includes a side port for fluid communication between a coronary artery and a portion of the sensor assembly.
13. The sensing catheter of claim 1 , wherein the second portion includes a jacket for sealing the flexible circuit assembly inside the second lumen.
14. The sensing catheter of claim 1 , wherein the second lumen has an inner diameter of 0.016 inches or less.
15. The sensing catheter of claim 1 , wherein the first lumen is discontinued along a length of the second portion.
16. The sensing catheter of claim 1 , wherein the second portion includes a hypotube.