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JP-7855633-B2 - Entry and update using target site selection and automated remote image annotation.

JP7855633B2JP 7855633 B2JP7855633 B2JP 7855633B2JP-7855633-B2

Inventors

  • シェリル ウォン ポ フー
  • デイビッド サンダーソン
  • ピーター アルトマン

Assignees

  • バイオカーディア，インコーポレイテッド

Dates

Publication Date
20260508
Application Date
20240510
Priority Date
20130108

Claims (11)

  1. An imaging system for transendocardial delivery to a patient's heart and/or biopsy of the heart, wherein the imaging system is Image processing means configured to receive two orthogonal two-dimensional images, wherein the two orthogonal two-dimensional images are fluorescence fluoroscopy images of the patient's heart, and the image processing means is further configured to generate a combined three-dimensional model reconstruction of the heart by transposing a preoperative three-dimensional model obtained by computed tomography or magnetic resonance imaging of the patient's heart onto the two orthogonal two-dimensional images, wherein transposition includes aligning the preoperative three-dimensional model with the two orthogonal two-dimensional images by aligning the preoperative three-dimensional model with one or more anatomical features represented in the preoperative three-dimensional model and the two orthogonal two-dimensional images, and projecting the aligned preoperative three-dimensional model as a visual overlay onto the two orthogonal two-dimensional images on a display in or adjacent to the sterile field, wherein the combined three-dimensional model reconstruction includes the preoperative three-dimensional model aligned with and superimposed on the two orthogonal two-dimensional images, and the image processing means is configured to To guide the tip of the transendocardial catheter, the position of the tip of the transendocardial catheter is displayed relative to one or more anatomical structures represented on the combined three-dimensional model reconstruction, An image processing system further configured to record one or more locations of transendocardial delivery and/or biopsy of cardiac tissue on the two orthogonal two-dimensional images, wherein the one or more locations are aligned and stored on the two orthogonal two-dimensional images, and the recorded one or more locations are configured to remain visible on the combined three-dimensional model as the transendocardial catheter is advanced to perform subsequent transendocardial delivery and/or biopsy at additional locations.
  2. A system for transendocardial injection and/or biopsy of a patient's heart, wherein the system is The transendocardial catheter is configured to inject a therapeutic agent and/or biopsy cardiac tissue into one or more target sites of the heart, The transendocardial catheter is configured to be guided to one or more target sites using guidance means, The guidance means comprises an image processing means configured to receive two orthogonal two-dimensional images, the two orthogonal two-dimensional images being fluorescence fluoroscopy images of the patient's heart, and the image processing means is further configured to generate a combined three-dimensional model reconstruction of the heart by transposing a preoperative three-dimensional model obtained by computed tomography or magnetic resonance imaging of the patient's heart onto the two orthogonal two-dimensional images, the transposition including aligning the preoperative three-dimensional model with the two orthogonal two-dimensional images by aligning the preoperative three-dimensional model with the anatomical features represented in the preoperative three-dimensional model and the two orthogonal two-dimensional images, and projecting the aligned preoperative three-dimensional model as a visual overlay onto the two orthogonal two-dimensional images on a display in or adjacent to the sterile field, the combined three-dimensional model reconstruction including the preoperative three-dimensional model aligned with and superimposed on the two orthogonal two-dimensional images. The aforementioned image processing means is To guide the tip of the transendocardial catheter, the position of the tip of the transendocardial catheter relative to one or more anatomical structures represented on the combined three-dimensional model reconstruction is displayed, A system further configured to record one or more locations of transendocardial delivery and/or biopsy of cardiac tissue on the two orthogonal two-dimensional images, wherein the one or more locations are aligned and stored on the two orthogonal two-dimensional images, and the recorded one or more locations remain visible on the combined three-dimensional model as the transendocardial catheter is advanced to perform subsequent transendocardial delivery and/or biopsy at additional locations .
  3. The image processing system according to claim 1 or the system according to claim 2, wherein the image processing means for generating a combined three-dimensional model reconstruction of the heart by transposing a preoperative three-dimensional model onto two orthogonal two-dimensional images comprises means for aligning at least two anatomical features of the combined three-dimensional model reconstruction of the heart with corresponding points on the two orthogonal two-dimensional images.
  4. The image processing means is further configured to mark and display one or more target regions for transendocardial delivery and/or biopsy on the combined three-dimensional model reconstruction of the heart using corresponding points on the two orthogonal two-dimensional images, wherein the target regions are selected based on procedure selection and exclusion criteria including one or more of the following: wall thickness, myocardial infarction location, myocardial infarction size, distance from myocardial infarction, immobile region, akinetic region, distance between one or more target sites, one or more equally spaced target sites, one or more target sites randomly spaced from myocardial infarction, one or more target sites randomly spaced at a defined distance from myocardial infarction, distance from myocardial infarction to one or more target sites and the bottom segment of the left ventricular septum, site of therapeutic delivery for transendocardial injection, sampling site for cardiac biopsy, or predefined electrophysiological activity, as described in claim 1 or claim 2.
  5. The image processing system or system according to claim 4, wherein the one or more target regions are selected using a computer algorithm based on parameters including one or more of the following: wall thickness, location of myocardial infarction, size of myocardial infarction, distance from myocardial infarction, immobile region, akinetic region, distance between one or more target sites, one or more equally spaced target sites, one or more target sites randomly spaced from myocardial infarction, one or more target sites randomly spaced at a defined distance from myocardial infarction, distance from myocardial infarction to one or more target sites and the bottom segment of the left ventricular septum, site of therapeutic delivery for transendocardial injection, sampling site for cardiac biopsy, or predefined electrophysiological activity.
  6. An imaging system for transendocardial delivery to a patient's heart and/or biopsy of the heart, wherein the imaging system is Image processing means configured to receive two orthogonal two-dimensional images, wherein the two orthogonal two-dimensional images are fluorescence fluoroscopy images of the patient's heart, and the image processing means is further configured to generate a combined three-dimensional model reconstruction of the heart by transposing a preoperative three-dimensional model onto the two orthogonal two-dimensional images, wherein transposition includes aligning the preoperative three-dimensional model with the two orthogonal two-dimensional images by aligning the biological structure, and projecting the aligned preoperative three-dimensional model as a visual overlay onto the two orthogonal two-dimensional images on a display within or adjacent to the sterile field, wherein the combined three-dimensional model reconstruction includes the preoperative three-dimensional model aligned with and superimposed on the two orthogonal two-dimensional images, and the image processing means superimposes information indicating to the operator one or more target sites or regions to be avoided onto the combined three-dimensional model reconstruction of the patient's heart. The aforementioned image processing means is To guide the tip of the transendocardial catheter, the position of the tip of the transendocardial catheter relative to one or more target sites or regions represented on the combined three-dimensional model reconstruction is displayed, An image processing system further configured to record one or more locations of transendocardial delivery and/or biopsy of cardiac tissue on the two orthogonal two-dimensional images, wherein the one or more locations are aligned and stored on the two orthogonal two-dimensional images, and the recorded one or more locations are configured to remain visible on the combined three-dimensional model as the transendocardial catheter is advanced to perform subsequent transendocardial delivery and/or biopsy at additional locations.
  7. The image processing system according to claim 6, for generating a combined three-dimensional model reconstruction of the heart by transposing a preoperative three-dimensional model onto two orthogonal two- dimensional images , comprising means for aligning at least two anatomical reference markers on the combined three-dimensional model reconstruction of the heart with corresponding points on the two orthogonal two-dimensional images.
  8. The image processing means is further configured to mark and display one or more target regions for transendocardial delivery and/or biopsy on the combined three-dimensional model reconstruction of the heart using corresponding points on the two orthogonal two-dimensional images, wherein the target regions are selected based on procedure selection and exclusion criteria including one or more of the following: wall thickness, myocardial infarction location, myocardial infarction size, distance from myocardial infarction, immobile region, akinetic region, distance between one or more target sites, one or more equally spaced target sites, one or more target sites randomly spaced from myocardial infarction, one or more target sites randomly spaced at a defined distance from myocardial infarction, distance from myocardial infarction to one or more target sites and the bottom segment of the left ventricular septum, site of therapeutic delivery for transendocardial injection, sampling site for cardiac biopsy, or predefined electrophysiological activity.
  9. The image processing system according to claim 8, wherein the one or more target regions are selected using a computer algorithm based on parameters including one or more of the following: wall thickness, location of myocardial infarction, size of myocardial infarction, distance from myocardial infarction, immobility region, akinesia region, distance between one or more target sites, one or more equally spaced target sites, one or more target sites randomly spaced from myocardial infarction, one or more target sites randomly spaced at a defined distance from myocardial infarction, distance from myocardial infarction to one or more target sites and the bottom segment of the left ventricular septum, site of therapeutic delivery for transendocardial injection, sampling site for cardiac biopsy, or predefined electrophysiological activity.
  10. The image processing system according to claim 6, wherein the image processing means for superimposing information onto the combined three-dimensional model reconstruction of the heart is configured to generate one or more marks or annotations on the combined three-dimensional model reconstruction or the two orthogonal two-dimensional images .
  11. The image processing system according to claim 10, wherein the one or more marks or annotations include one or more of anatomical information, treatment information, markers, color coding, outlines, borders, written information, or icons.

Description

(Cross-reference to related applications) This application claims priority under Provisional Application No. 61/750,226 (Agent Case No. 29181-703.101), filed on 8 January 2013; Provisional Application No. 61/750,233 (Agent Case No. 29181-704.101), filed on 8 January 2013; and Provisional Application No. 61/750,237 (Agent Case No. 29181-705.101), filed on 8 January 2013, the contents of which in whole are incorporated herein by reference. (background) 1. Field of the Invention The present invention relates in general to imaging modalities (medical imaging methods), and more specifically to methods and systems for performing fluorescence fluoroscopy of biological structures, remotely annotating images, and displaying additional images or other information useful during surgical procedures. Imaging modalities such as MRI, CT, and echocardiography are used for cardiovascular diagnostics and may be fused with fluoroscopy using custom software to register and overlay 2D and 3D images derived from cardiac MRI, CT, or echocardiography, displaying endocardium, epicardium, infarcts, and other areas of interest and/or data on live fluoroscopy images. Cardiovascular disease is a leading cause of death in developed countries and the number one cause of death in the United States. More than 7.9 million American adults have suffered a myocardial infarction (MI), with 1.1 million new or recurrent MI cases annually. MI is characterized by limited blood flow, leading to oxygen deprivation and ultimately massive myocardial loss, which cannot regenerate spontaneously and ultimately leads to heart failure. Existing treatments to restore cardiac function after myocardial injury have so far been limited to strict drug regimens and heart transplantation as a last resort. However, demand far exceeds the supply of healthy donor hearts, leaving the cardiovascular industry to explore novel and promising treatment strategies, including regenerative medicine, gene therapy, and cell therapy. Recent clinical trials are testing different types of stem cells, genes, and growth factors using several delivery routes, including intramyocardial injection, intracoronary infusion, intravenous infusion, and retrograde delivery, as well as both epicardial and transendocardial injections. However, intracardiac transendocardial injection, while minimally invasive, has been shown to improve acute stasis compared to other delivery routes. This improved stasis with transendocardial delivery leads to significant therapeutic potential for tissue regeneration and functional recovery, slowing and ultimately restoring adverse remodeling after myocardial infarction. In recent MI patients, the infarct zone can be extremely fragile, and intracardiac injection in the infarct zone or borderline zone can increase the risk of perforation and pericardial effusion, which can lead to cardiac tamponade, a life-threatening event. In these cases, precise site targeting and injection of biological agents are crucial for patient safety. In conventional cardiovascular catheterization procedures, fluoroscopy is typically used to assist interventional cardiologists in guiding catheters, such as balloon catheters, into occluded arteries within the heart during angioplasty, or guiding catheters using small end-grasping devices during cardiac biopsies, or guiding percutaneous injection catheters into the myocardium for transendocardial injection of biological agents such as cells, genes, peptides, and proteins (e.g., growth factors and chemoattractants). Consequently, catheters employed in cardiovascular catheterization procedures are designed to be X-ray visible so that they can be clearly observed and tracked during the procedure. However, using fluoroscopy alone for more complex procedures such as transendocardial injections has several disadvantages, which can significantly impact catheter guidance and image interpretation. (1) X-ray imaging is a projection imaging modality, and typically requires two orthogonal views, namely right anterior oblique (RAO) and left anterior oblique (LAO), to obtain a precise sense of the location and orientation of the catheter within the heart in three-dimensional (3D) space. (2) Because two views are required, if the catheterization facility is equipped with a single-planar X-ray fluoroscopy system, the X-ray C-arm must be rotated at a constant rate between these two views throughout the procedure to obtain the required projection and thus enable proper guidance of the transendocardial catheter to the selected intramyocardial target injection site. This is naturally easier if the catheterization facility is equipped with a two-directional X-ray fluoroscopy system. (3) While X-ray imaging provides excellent device visualization, it does not offer much insight into cardiac tissue visualization. X-ray fluoroscopy does not distinguish between healthy tissue and infarcted tissue or tissue within the infarct border zone, nor does it provide a 3D a