US-12622752-B2 - Self expanding stent system with imaging

US12622752B2US 12622752 B2US12622752 B2US 12622752B2US-12622752-B2

Abstract

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.

Inventors

Michael Sean Owens

Assignees

KONINKLIJKE PHILIPS N.V.

Dates

Publication Date: 20260512
Application Date: 20210308

Claims (17)

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.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is the U.S. National Phase application under 35 U.S.C. § 371 of International Application No. PCT/EP2021/055698 filed Mar. 8, 2021, which claims the benefit of U.S. Provisional Patent Application No. 62/990,503 filed Mar. 17, 2020. These applications are hereby incorporated by reference herein. FIELD OF THE DISCLOSURE The systems and devices described herein generally relate to treating and imaging blood vessels. More particularly, the present disclosure is directed to implants and 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. BACKGROUND Intravascular ultrasound (IVUS) imaging is widely used in interventional cardiology and peripheral vascular intervention as a diagnostic tool for assessing a diseased vessel, such as an artery or vein, within the human body to determine the need for treatment, to guide the intervention, and/or to assess its effectiveness. An IVUS device, including one or more ultrasound transducers, is passed into the vessel and guided to the area to be imaged. The transducers emit ultrasonic energy in order to create an image of the vessel of interest. Ultrasonic waves are partially reflected by discontinuities arising from tissue structures (such as the various layers of the vessel wall), red blood cells, and other features of interest. Echoes from the reflected waves are received by the transducer and passed along to an IVUS imaging system. The imaging system processes the received ultrasound echoes to produce a cross-sectional image of the vessel where the device is placed. There are two types of IVUS catheters commonly in use today: rotational and solid-state. For a typical rotational IVUS catheter, a single ultrasound transducer element is located at the tip of a flexible driveshaft that spins inside a plastic sheath inserted into the vessel of interest. The transducer element is oriented such that the ultrasound beam propagates generally perpendicular to the axis of the device. The fluid-filled sheath protects the vessel tissue from the spinning transducer and driveshaft while permitting ultrasound signals to propagate from the transducer into the tissue and back. As the driveshaft rotates, the transducer is periodically excited with a high voltage pulse to emit a short burst of ultrasound. The same transducer then listens for the returning echoes reflected from various tissue structures. The IVUS imaging system assembles a two dimensional display of the vessel cross-section from a sequence of pulse/acquisition cycles occurring during a single revolution of the transducer. In contrast, solid-state IVUS catheters carry an ultrasound scanner assembly that includes an array of ultrasound transducers distributed around the circumference of the device connected to a set of transducer control circuits. The transducer control circuits select individual transducers or a combination of transducers for transmitting an ultrasound pulse and for receiving the echo signal. By stepping through a sequence of transmitter-receiver pairs, the solid-state IVUS system may synthesize the effect of a mechanically scanned transducer element but without moving parts. Since there is no rotating mechanical element, the transducer array may be placed in direct contact with the blood and vessel tissue with minimal risk of vessel trauma. Furthermore, because there is no rotating element, the interface is simplified. The solid-state scanner may be wired directly to the imaging system with a simple electrical cable and a standard detachable electrical connector. IVUS imaging may be utilized before, during, and/or after percutaneous coronary intervention (PCI) or peripheral vascular intervention. For example, IVUS imaging may be used for diagnosis and treatment planning to identify a diseased portion of a blood vessel and determine an appropriate diameter and length for a stent to be positioned within the diseased portion of the blood vessel. In other words, blood vessel and stent diameters and/or lengths may be obtained from intravascular image data (e.g., IVUS imaging and/or optical coherence tomography (OCT)). IVUS imaging is typically performed with a separate intravascular device prior to stent implantation. After performing the IVUS imaging, the intravascular device is removed from the vasculature, and a stent delivery device is then inserted to implant the stent. If a clinician wishes to view the stent after being implanted, the clinician must first remove the stent delivery device before re-inserting the IVUS intravascular device. And even upon re-insertion, it is difficult for the IVUS intravascular device to perform a precise comparison of the location of interest in the blood vessel before and after stent implantation because the clinician is unable to determin