Self expanding stent system with imaging
In exemplary examples, methods and systems for treating vascular disease by implanting a stent within the vasculature and using intravascular imaging to determine and ensure that the stent was property implanted and producing a desirable and effective results is disclosed herein. For example, a system may obtain optical shape sensing data and intravascular imaging data for a blood vessel. The system may process the optical shape sensing data and the intravascular imaging data to generate a three-dimensional model and image of the blood vessel immediately before and immediately after stent implantation into the blood vessel, and perform a precise comparison of the before and after images to ensure that the stent was properly implanted and will produce or is producing a desirable and effective result. The precise comparison may be based on a derived diameter associated with the location at which the stent is placed in the blood vessel based on the generated pre and post generated three-dimensional models.
1 . A stent delivery system comprising:
a shape sensing wire configured to produce shape sensing data representative of a region of interest in a vessel in a subject;
a stent delivery device disposed over the shape sensing wire, wherein the stent delivery device comprises a stent and an imaging element disposed distally of the stent, wherein the imaging element is configured to produce intravascular ultrasound imaging data representative of the region of interest for deploying the stent in the region of interest;
a fluoroscopy imaging device configured to produce fluoroscopic image data corresponding to the region of interest; and
a computing system comprising:
one or more processors; and
non-transitory memory storing instructions that, when executed by the one or more processors, cause the one or more processors to:
receive a plurality of first signals corresponding to the shape sensing data;
receive a plurality of second signals corresponding to the intravascular ultrasound imaging data;
co-register the first signals, the second signals, and the fluoroscopic image data with one another;
process the co-registered first signals, second signals and fluoroscopic image data to generate a pre-deployment three-dimensional model of the region of interest;
perform at least one geometric measurement of the region of interest using the pre-deployment three-dimensional model before deployment of the stent in the region of interest;
based on the at least one geometric measurement, determine a pre-deployment size characteristic of the region of interest;
receiving a stent-deployment signal indicative of the stent being deployed;
receive a plurality of third signals corresponding to the shape sensing data after receiving the stent-deployment signal;
receive a plurality of fourth signals corresponding to the intravascular ultrasound imaging data after receiving the stent-deployment signal;
co-register the third signals and the fourth signals;
process the co-registered third and fourth signals to generate a post-deployment three-dimensional model of the region of interest;
perform at least one geometric measurement of the region of interest using the post-deployment three-dimensional model after the deployment of the stent in the region of interest;
based on the at least one geometric measurement, determine a post-deployment size characteristic of the region of interest;
calculate a comparison of the pre-deployment size characteristic and the post-deployment size characteristic; and
provide, to a monitor, the comparison.
2 . The stent delivery system of claim 1 , wherein the stent delivery device comprises a sensor, wherein the sensor produces a stent deployment signal upon retraction of a sheath over the stent delivery device.
3 . The stent delivery system of claim 1 , wherein each of the pre-deployment size characteristic and the post-deployment size characteristic is a derived diameter of the region of interest.
4 . The stent delivery system of claim 3 , wherein the at least one geometric measurement of the region of interest comprises at least one of an area, a volume, or a perimeter of the region of interest.
5 . The stent delivery system of claim 4 , wherein the derived diameter is determined based on the area of the region of interest.
6 . The stent delivery system of claim 4 , wherein the derived diameter is determined based on the volume of the region of interest.
7 . The stent delivery system of claim 4 , wherein the derived diameter is determined based on the perimeter of the region of interest.
8 . The stent delivery system of claim 3 , wherein the derived diameter is determined based on at least two of an area, a volume, and a perimeter of the region of interest.
9 . The stent delivery system of claim 1 , wherein the stent delivery device comprises:
an outer sheath configured to cover the stent during introduction of the stent into the vessel; and
a shaft configured to slidably move within the outer sheath while carrying the stent, enabling deployment of the stent when the stent extends past a distal end of the outer sheath.
10 . The stent delivery system of claim 9 , wherein the stent delivery device further comprises:
a first sensor positioned on the outer sheath at a distal end of the outer sheath; and
a second sensor positioned on the shaft proximal to the stent,
wherein at least one of the first sensor or the second sensor produces a stent deployment signal when the first sensor and the second sensor overlap in response to relative movement between the outer sheath and the shaft to enable the deployment of the stent.
11 . The stent delivery system of claim 1 , wherein the region of interest includes an obstruction in the vessel that results in a restriction to blood flow through the vessel.
12 . The stent delivery system of claim 11 , wherein the obstruction comprises a stenosis.
13 . The stent delivery system of claim 11 , wherein the obstruction comprises a compression caused by pressure from an external artery that limits the blood flow through the vessel.
14 . A system comprising:
one or more processors; and
non-transitory memory storing instructions that, when executed by the one or more processors, cause the one or more processors to:
obtain a plurality of first signals corresponding to shape sensing data for a region of interest in a vessel of a subject;
obtain a plurality of second signals corresponding to intravascular ultrasound imaging data for the region of interest;
obtain fluoroscopic image data corresponding to fluoroscopic images of the region of interest acquired simultaneously with acquisition of the shape sensing data and/or the intravascular ultrasound imaging data;
co-register the first signals, the second signals, and the fluoroscopic image data with one another;
process the co-registered first and second signals to generate a pre-deployment three-dimensional composite image of the region of interest;
perform at least one geometric measurement of the region of interest using the pre-deployment three-dimensional composite image before deployment of the stent in the region of interest;
based on the at least one geometric measurement, determine an initial volume of blood capable of passing through the region of interest;
receiving a stent-deployment signal indicative of a stent being deployed in the region of interest;
receive a plurality of third signals corresponding to the shape sensing data after receiving the stent-deployment signal;
receive a plurality of fourth signals corresponding to the intravascular ultrasound imaging data after receiving the stent-deployment signal;
co-register the third signals and the fourth signals;
process the co-registered third and fourth signals to generate a post-deployment three-dimensional composite image of the region of interest;
perform at least one geometric measurement of the region of interest using the post-deployment three-dimensional composite image after the deployment of the stent in the region of interest;
based on the at least one geometric measurement, determine an updated volume of blood capable of passing through the region of interest;
calculate a comparison of the initial volume of blood and the updated volume of blood; and
provide a comparison signal indicative of the comparison.
15 . The system of claim 14 , wherein execution of the instructions by the one or more processors further cause the one or more processors to receive a stent deployment signal from a sensor upon retraction of a sheath over the stent for deployment of the stent.
16 . The system of claim 14 , wherein execution of the instructions by the one or more processors further cause the one or more processors to co-register fluoroscopic image data with the first signals and the second signals, and process the co-registered fluoroscopic image data, first signals and second signals to generate the pre-deployment three-dimensional composite image of the region of interest.
17 . A non-transitory computer readable medium storing instructions for execution by one or more processors incorporated into a system, wherein execution of the instructions by the one or more processors cause the one or more processors to:
obtain initial optical shape sensing data for a blood vessel;
obtain initial intravascular imaging data for the blood vessel;
obtain fluoroscopic image data corresponding to fluoroscopic images of the blood vessel acquired simultaneously with the initial optical shape sensing data and/or the initial intravascular imaging data;
co-register the initial optical shape sensing data, the initial intravascular imaging data, and the fluoroscopic image data with one another;
generate an initial three-dimensional model of the blood vessel from the co-registered initial optical shape sensing data, initial intravascular imaging data, and fluoroscopic image data;
perform at least one geometric measurement of the blood vessel using the initial three-dimensional model after deployment of the stent in the region of interest;
determine an initial derived diameter associated with a portion of the initial three-dimensional model based on the at least one geometric measurement;
obtain subsequent intravascular imaging data for the blood vessel;
co-registering the initial optical shape sensing data and the subsequent intravascular imaging data;
generate a subsequent three-dimensional model of the blood vessel from the co-registered initial optical shape sensing data and subsequent intravascular imaging data;
perform at least one geometric measurement of the blood vessel using the subsequent three-dimensional model after the deployment of the stent in the region of interest;
determine a subsequent derived diameter associated with a portion of the subsequent three-dimensional model based on the at least one geometric measurement; and
provide, to a monitor, a signal representative of a comparison of the initial derived diameter and the subsequent derived diameter.