Target site selection, entry and update with automatic remote image annotation

Abstract

To provide a target site selection, entry and update with automatic remote image annotation.SOLUTION: Fluoroscopic imaging of a patient's heart is performed by positioning a patient in a sterile field and imaging the heart using an x-ray fluoroscopy system within the sterile field to produce a two-dimensional image. The two-dimensional image is simultaneously displayed on an operative display within or adjacent the sterile field and on a display of a remote image processor outside the operative field. The two-dimensional image of the remote display is manually marked or annotated to show anatomical or treatment information which is simultaneously shown on the operative display. Alternatively, a patient's heart is imaged using a catheter to produce a real time image. The image is presented on a screen and sent to an image processor. Treatment parameters are input to the image processor, and the image processor calculates locations of a plurality of target treatment sites which are displayed on the screen.SELECTED DRAWING: None

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to Provisional Application No. 61 / 750,226, filed January 8, 2013 (Attorney Docket No. 29181-703.101); Provisional Application No. 61 / 750,233, filed January 8, 2013 (Attorney Docket No. 29181-704.101); and Provisional Application No. 61 / 750,237, filed January 8, 2013 (Attorney Docket No. 29181-705.101), the entire contents of which are incorporated herein by reference.

[0002] (background) 1. Field of the Invention The present invention relates generally to imaging modalities, and more particularly to methods and systems for performing fluoroscopy of anatomical structures, remotely annotating images, and presenting additional images or other information useful during surgical procedures. [Background technology]

[0003] Imaging modalities such as MRI, CT, and echocardiography are used in cardiovascular diagnostic applications and may be fused with x-ray fluoroscopy using custom software to register and overlay MRI, CT, or echocardiography-derived two-dimensional (2D) and three-dimensional (3D) images of the heart, displaying endocardium, epicardium, infarct, and other regions of interest and / or data on live x-ray fluoroscopy images.

[0004] Cardiovascular disease is the leading cause of death in developed countries and the leading cause of death in the United States. More than 7.9 million American adults suffer from myocardial infarction (MI), with 1.1 million first or recurrent MI cases occurring annually. MI is characterized by blood flow restriction, resulting in oxygen deprivation and eventual massive loss of myocardium, which cannot spontaneously regenerate and ultimately leads to heart failure. Current treatments for restoring cardiac function after myocardial injury have been limited to strict drug regimens and, as a last resort, heart transplantation. However, demand far exceeds the supply of healthy donor hearts, forcing the cardiovascular industry to explore novel and promising therapeutic strategies, including regenerative medicine, gene therapy, and cell therapy. Recent clinical trials have tested different types of stem cells, genes, and growth factors using several delivery routes, including intramyocardial injection, intracoronary infusion, intravenous infusion, and retrograde delivery, including both epicardial and transendocardial injection. However, intramyocardial transendocardial injection, while less invasive, has also been shown to improve acute occlusion compared to other delivery routes. This improved occlusion with transendocardial delivery has been shown to lead to greater therapeutic potential for tissue regeneration and functional recovery, slowing and ultimately reversing adverse remodeling after myocardial infarction. In patients with recent MI, the infarct zone can be very vulnerable, and intramyocardial injection in the infarct zone or infarct border 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 biologic agents are important for patient safety.

[0005] In traditional cardiovascular catheterization procedures, X-ray fluoroscopy is typically used to assist interventional cardiologists in guiding catheters, such as balloon catheters, into blocked arteries within the heart during angioplasty, or with a small grasping device at the end during cardiac biopsy. It also assists in guiding percutaneous injection catheters into and within 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 identified and tracked during the procedure. However, using only X-ray fluoroscopy for more complex procedures, such as transendocardial injection, has several disadvantages that can significantly affect catheter navigation and image interpretation. (1) X-ray imaging is a projection imaging modality, and typically two orthogonal views, i.e., right anterior oblique (RAO) and left anterior oblique (LAO), are required to obtain an accurate sense of the catheter's location and orientation within the heart in three-dimensional (3D) space. (2) Because two views are required, if the catheterization facility is equipped with a single-plane X-ray fluoroscopy system, the X-ray C-arm must be constantly rotated between these two views throughout the procedure to obtain the required projections and thus enable proper guidance of the transendocardial catheter to the selected intramyocardial target injection site. This is, of course, easier if the catheterization facility is equipped with a biplane X-ray fluoroscopy system. (3) X-ray imaging provides excellent device visualization but offers little 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 anatomical and topographical view of the patient's heart. This can be particularly important for interventional cardiologists, who rely on therapy options that attempt to precisely target healthy tissue, infarcted tissue, infarct border zone tissue, or a combination thereof, for intramyocardial injection of biologic agents.For these reasons, image fusion systems that combine X-ray fluoroscopy with anatomical and functional 3D models constructed from magnetic resonance (MR) or computed tomography (CT) images, thereby providing real-time information and visualization of the catheter, are of particular interest for these applications.

[0006] Magnetic resonance imaging (MRI) is the most accurate diagnostic imaging modality, providing high-quality 3D anatomical and functional roadmaps of a patient's heart. Therefore, it is most commonly used in conjunction with X-ray fluoroscopy in these fusion imaging systems. Cardiac MRI sections, from which cardiac images can be reconstructed, are obtained with excellent tissue contrast. These cardiac images allow for accurate and efficient differentiation between healthy tissue, infarcted tissue, and infarct border zone tissue. However, while most catheters and other cardiac devices are safe for use with and visualization using X-ray fluoroscopy, they are not fully MRI-compatible. Most of these devices contain ferromagnetic materials, which introduce imaging artifacts and pose a safety hazard due to patient exposure to strong magnetic fields during MRI. Furthermore, even with the most advanced techniques and equipment available, MRI image acquisition can still take 15 to 60 minutes, depending on the type of image acquired and the MRI sequence activated. Therefore, it makes sense that MRI scans can be performed prior to interventional procedures. Cardiac images reconstructed from these scanned sections can then be used in parallel with x-ray fluoroscopy to accurately and safely guide the interventional cardiologist to target regions of healthy, infarcted, and / or infarct border zone tissue for either injection of biologic agents or sampling of cardiac tissue during transendocardial procedures.

[0007] 2. Description of Background Technology Methods and systems for fusing preoperative images with information about real-time fluoroscopic images are described in U.S. Patent No. 6,466,813, U.S. Patent Publication Nos. 2008 / 0043901, 2011 / 0087088, and 2011 / 0087110, and Tomkowiak et al. (2011) Catheterization and Cardiovascular Interventions 78:468-478. See also U.S. Patent No. 7,848,553 and U.S. Patent Publication No. 2013 / 0102890. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Patent No. 6,466,813 [Patent Document 2] US Patent Application Publication No. 2008 / 0043901 [Patent Document 3] US Patent Application Publication No. 2011 / 0087088 [Patent Document 4] US Patent Application Publication No. 2011 / 0087110 [Patent Document 5] U.S. Patent No. 7,848,553 [Patent Document 6] US Patent Application Publication No. 2013 / 0102890 Summary of the Invention [Means for solving the problem]

[0009] The present invention aims to facilitate the selection and targeting of injection sites for intramyocardial biologic or other injectable agents using a transendocardial injection catheter equipped with a piercing element at the distal end of the catheter in patients suffering from cardiovascular diseases, including, but not limited to, chronic heart failure, including chronic myocardial ischemia, acute myocardial infarction, ischemic and non-ischemic heart failure, and dilated cardiomyopathy. Biologic agent delivery includes cell therapy, gene therapy, protein and peptide therapy, and small molecule pharmaceuticals. Injectable agent delivery includes, but is not limited to, synthetic polymers, natural biopolymers, and microparticles in the 15-150 μm range. The present invention can also be used to select and target sampling sites for cardiac biopsy procedures to test for immune rejection in patients undergoing or who have undergone heart transplants, patients showing symptoms of cardiomyopathy, cardiac amyloidosis, and myocarditis, or patients whose cardiac cells are to be harvested for other therapeutic or diagnostic purposes.

[0010] Fluoroscopy of a patient's heart is performed by positioning the patient in a sterile field and using an x-ray fluoroscopy system within the sterile field to image the heart and generate two-dimensional images. The two-dimensional images are simultaneously displayed on an operating room display within or adjacent to the sterile field and on a remote image processor display outside the operating field. The two-dimensional images on the remote display are manually marked or annotated to indicate anatomical or therapeutic information, which is simultaneously shown on the operating room display.

[0011] Manually marking the image may include manipulating a graphical user interface on the remote image processor, the graphical user interface including a touch screen, a mouse, a roller ball, or a joystick. Manually marking the two-dimensional image may include marking any one or more of an outline of the heart or portion thereof, a target treatment area, areas to avoid treatment, and the like.

[0012] In a second aspect of the present invention, a patient's heart is imaged using a catheter to generate real-time images. The images are presented on a screen and transmitted to an image processor. Treatment parameters are input to the image processor, which calculates the locations of multiple target treatment sites, which are displayed on the screen. The catheter is advanced to position treatment elements on the catheter proximate the target treatment site locations, and the actual locations of the treatment elements may differ from the calculated locations. After treatment at the actual treatment locations, the image processor calculates the difference between the calculated and actual treatment site locations. All remaining target treatment locations may be recalculated by the image processor.

[0013] The imaging may include producing a two-dimensional image using X-ray fluoroscopy or producing two orthogonal two-dimensional images. The imaging may further include superimposing an outline of the heart on the two-dimensional image, where the superimposing may include providing a static three-dimensional image of the heart, and an image processor registering the three-dimensional image to the two-dimensional image and calculating an outline, which is projected onto the two-dimensional image. Alternatively, the superimposing may include manually typing in an outline, which is projected onto the two-dimensional image. The method of the present invention may further include repeating the advancing, determining, treating, and recalculating steps for successive treatment sites.

[0014] In a third aspect, the present invention facilitates the selection and targeting of injection sites for intramyocardial biologic or other injectable agents using a transendocardial injection catheter with a piercing element at the distal end of the catheter in patients suffering from cardiovascular disease, including, but not limited to, chronic heart failure, including chronic myocardial ischemia, acute myocardial infarction, ischemic and non-ischemic heart failure, and dilated cardiomyopathy. Biologic agent delivery includes cell therapy, gene therapy, protein and peptide therapy, and small molecule pharmaceuticals. Injectable agent delivery includes, but is not limited to, synthetic polymers, natural biopolymers, and microparticles in the 15-150 μm range. The present invention can also be used to select and target sampling sites for cardiac biopsy procedures to test for immune rejection in patients undergoing or who have undergone heart transplants, patients showing symptoms of cardiomyopathy, cardiac amyloidosis, and myocarditis, or patients whose cardiac cells are to be harvested for other therapeutic or diagnostic purposes.

[0015] The patient's heart is imaged using the catheter, generating a real-time image that is displayed on a screen. The image is also sent to an image processor, where treatment parameters are input. The image processor then calculates safe and / or unsafe regions for performing treatment or diagnosis within the heart based on the input treatment conditions. The image processor overlays information on the image on the screen to identify the safe and / or unsafe regions. The overlaid information may comprise at least one of color coding, creating a border, inserting written information, and inserting an icon.

[0016] The present invention has other advantages and features that will become more readily apparent from the following detailed description and appended claims when considered in conjunction with the accompanying drawings. The present invention provides, for example, the following. (Item 1) 1. A method for fluoroscopy of a patient's heart, comprising: positioning the patient in a sterile field having an X-ray fluoroscopy system; imaging the heart using the x-ray fluoroscopy system to generate a two-dimensional image; simultaneously displaying the two-dimensional image on an operating room display within or adjacent to the sterile field and on a display of a remote image processor outside the operating field; manually marking the two-dimensional image on the remote display to indicate anatomical or procedural information that is simultaneously shown on the operating room display; A method comprising: (Item 2) Item 10. The method of item 1, wherein the step of manually marking the image includes the step of manipulating a graphical user interface on the remote image processor. (Item 3) Item 3. The method of item 2, wherein the graphical user interface comprises a touch screen, a mouse, a roller ball, or a joystick. (Item 4) Item 10. The method of item 1, wherein manually marking the two-dimensional image includes marking any one or more of an outline of the heart or a portion thereof, a target treatment area, and an area where treatment should be avoided. (Item 5) 5. The method of claim 4, wherein the region comprises a myocardial infarct site, a hypokinetic region, an akinetic region, a papillary muscle, a mitral valve, an apical region of the heart, a bundle of His, or a thin region of the heart. (Item 6) 1. A method for treating a patient's heart using a catheter, comprising: imaging the heart to generate a real-time image; displaying the image on a screen; sending the image to an image processor; inputting treatment parameters into the image processor, the image processor calculating locations of multiple target treatment sites to be displayed on the screen; advancing the catheter to position a treatment element on the catheter proximate to a location of a target treatment site, wherein the actual location of the treatment element may differ from the calculated location of the target treatment site; treating tissue at the actual treatment location with the treatment element; using the image processor to determine the difference between the actual treatment site location and the calculated location of the target treatment site; and recalculating, with said image processor, the locations of all remaining target treatment sites that have not yet been treated. (Item 7) 7. The method of claim 6, wherein imaging includes generating a two-dimensional image using X-ray fluoroscopy. (Item 8) Item 9. The method of item 7, wherein imaging includes generating two orthogonal two-dimensional images. 7. The method of claim 6, wherein imaging further comprises superimposing an outline of the heart on the two-dimensional image. (Item 10) 10. The method of claim 9, wherein the superimposing includes providing a static three-dimensional image of the heart, and the image processor registers the three-dimensional image to the two-dimensional image and calculates the outline to be projected onto the two-dimensional image. (Item 11) 11. The method of claim 10, wherein the static three-dimensional image of the heart comprises an MRI, CT, or echocardiography-derived image of the heart. (Item 12) 7. The method of claim 6, wherein the superimposing step includes manually typing in the outline to be projected onto the two-dimensional image. (Item 13) 7. The method of claim 6, further comprising repeating the advancing, determining, treating, and recalculating steps for successive treatment sites. (Item 14) 1. A method of imaging to facilitate treatment of a patient's heart using a catheter, comprising: imaging the heart to produce a real-time image; displaying the image on a screen; sending the image to an image processor; inputting treatment parameters into the image processor, wherein the image processor calculates safe and / or unsafe regions based on the input treatment conditions for performing treatment or diagnosis within the heart, and the image processor overlays information on the image on the screen to identify the safe and / or unsafe regions. (Item 15) Item 15. The method of item 14, wherein the superimposed information includes at least one of color coding, creating a border, inserting written information, or inserting an icon. [Brief explanation of the drawings]

[0017] [Figure 1] 1-5 illustrate specific embodiments described below. [Figure 2-1] 1-5 illustrate specific embodiments described below. [Figure 2-2] 1-5 illustrate specific embodiments described below. [Figure 2-3] 1-5 illustrate specific embodiments described below. [Figure 2-4] 1-5 illustrate specific embodiments described below. [Figure 3] 1-5 illustrate specific embodiments described below. [Figure 4] 1-5 illustrate specific embodiments described below. [Figure 5] 1-5 illustrate specific embodiments described below. DETAILED DESCRIPTION OF THE INVENTION

[0018] (Detailed explanation) In this invention, we combine 3D model reconstructions of the heart derived from magnetic resonance imaging performed prior to the interventional procedure with live X-ray fluoroscopic images during the catheter placement procedure to facilitate intramyocardial catheter navigation, thus improving the safety and accuracy of transcatheter injection of biological and chemical therapeutic agents within the diseased heart. Cardiac MRI slices detailing the endocardial and epicardial surfaces of the heart as well as the infarcted area within the heart are acquired during the MRI scan. We use software such as Segment (Medviso), The Visualization Toolkit (Kitware, Inc.), and QMass® MR Ent A commercially available platform-independent contouring package, such as Enterprise Solution (Medis Medical Imaging System, Inc.) or other freeware, is used to define the endocardial and epicardial walls and infarcts slice by slice, thus generating a 3D model of the patient's heart prior to the interventional procedure. Note that any other imaging modality (e.g., CT, echocardiography) capable of defining the anatomical and functional details of the heart from which a 3D model can be reconstructed can alternatively be used instead of MRI. The only criterion is the output format from the contouring package, which must be compatible with the X-ray fluoroscopy system. Prior to the procedure, a 3D space within the field of view of the fluoroscopy system is virtually created in the fusion imaging system. During the interventional procedure, ventriculograms are taken of the patient's left ventricle in two orthogonal views. The 3D model created from the MRI scan is then virtually placed in the 3D space and registered to match the ventriculogram of the X-ray fluoroscopy system. The 3D model is then transported onto a live X-ray fluoroscopy screen in either 2D or 3D. The fusion imaging system's software can then be used to define and display essential parameters and limits central to patient safety according to study protocols. For example, in the case of transendocardial injection of a biologic agent into a patient's heart, important information such as myocardial infarct location and size, the distinction between infarct zones (if more than one), left ventricular wall thickness, hypokinetic and akinetic regions, target injection zones and "non-injection" zones (including, but not limited to, the papillary muscles, mitral valve, apex, areas adjacent to the basal septal wall where the His bundle is located, and thin areas of the myocardial wall) are necessary data points for patient safety. These data points can be obtained from MRI sections or CT slices using a software interface and then translated into a 2D or 3D model of the heart to create an anatomical and functional roadmap of the heart prior to the interventional procedure.Based on the inclusion and exclusion criteria for intramyocardial injection in each study, specific regions will be traced and demarcated using different colors and / or patterns, thus clearly displaying to the interventional cardiologist the selected target regions and "non-injection" zones.

[0019] Here, we disclose specific embodiments for a fusion imaging system with x-ray fluoroscopy, cardiac catheterization, and transendocardial injection catheterization, and methods of use for registering and transposing multi-modality images to guide intramyocardial targeted procedures such as transendocardial delivery and cardiac biopsy.

[0020] (2D recording of left ventricular contour and target area on the screen)

[0021] Example 1

[0022] As previously mentioned, one of the major disadvantages of using only x-ray fluoroscopy in cardiac interventional procedures is that x-ray fluoroscopy is a projection imaging modality that typically requires projections in two orthogonal views, i.e., the RAO view and the LAO view, to determine the location and orientation of a percutaneous catheter within the left ventricle. During a typical transendocardial injection procedure in a catheter placement facility equipped with a single-plane x-ray fluoroscopy system, the two fluoroscopic views are overlaid and fixed on a single monitor of the x-ray system. At the start of the procedure, a ventriculography is performed, during which contrast material is injected into the left ventricle and the left ventricle is mapped. During the map, the left ventricular contour of the heart in diastole and systole is traced on one fluoroscopic view in one orthogonal view. The fluoroscopic view is then flipped out, the C-arm of the fluoroscopy system is rotated, and the contour of the heart in diastole and systole is traced on the second fluoroscopic view. The transendocardial injection is then performed, and each time an injection is made, the injection site is also marked in both orthogonal views on the two fluoroscopic views. This requires constant switching between orthogonal views and between fluoroscopic views. Depending on the number of injections, this back-and-forth switching of the fluoroscopic view and the C-arm of the fluoroscopy system in each view may be performed multiple times during a single procedure, which can be cumbersome and extend the length of the procedure. Furthermore, the person changing the overlay should stand near the sterile zone and take care not to accidentally disrupt sterility. That person also typically stands near the C-arm of the x-ray fluoroscopy system and may therefore be unintentionally exposed to a significant dose of x-rays.

[0023] In one embodiment of the present invention, as shown in FIG. 1, we eliminate the use of fluoroscopic images. Using a ventriculogram, the left ventricular contour of the patient's heart in diastole and systole is digitally outlined using a touchscreen, mouse, tablet, or other graphical input device and displayed as both orthogonal views in 2D space on a separate computer or workstation monitor, located either in the catheter placement facility's control room or a designated area, away from the fluoroscopy system and outside the sterile zone. The computer or workstation has an internal modem or network connection device that communicates with the single-plane fluoroscopy system computer via an intranet communications link system. The communications link to the network may be of any acceptable type, including telephone lines, fiber optics, cable modem links, and wireless data transfer systems, among others. Thus, what is input and displayed on the separate computer or workstation monitor is output on the single-plane fluoroscopy system monitor, and vice versa. For transendocardial injection of biologic agents into a patient's heart, information such as the location of myocardial infarction, areas of dyskinesis and akinesis, and "no-injection" zones, as previously described, is important to identify. This information may be displayed on a monitor within the catheter placement facility and will help guide the interventional cardiologist during the procedure. This occurs after mapping the left ventricle in two orthogonal views and prior to the start of the transendocardial injection procedure. Based on the specific requirements of the procedure and therapy, the operator marks these critical zones on the remote computer and clearly demarcates areas on the ventriculogram in both orthogonal views where injection should and should not occur. These boundaries are achieved by color coding, the use of solid and dashed lines, and / or the use of different shapes and patterns. As previously described, the two orthogonal views are useful for verifying the location and orientation of the percutaneous catheter within the left ventricle and for verifying and marking the injection site. A function or key is used to toggle between the annotated LV contour maps in the two orthogonal views on the remote computer and displayed on the monitor of the fluoroscopy system.Toggling between two LV contour maps allows the operator to remotely mark the target injection site in each view without having to switch between fluoroscopic views fixed on the monitor of the single-plane X-ray fluoroscopy system in the catheter placement facility. Marking of the injection site is performed by digitally marking the location of the catheter tip during the transendocardial injection process. If it is isocenter and the table is not moved, a single marker should be valid in both views. The mark may be color-coded, have variable shapes or sizes, and / or have any number of associated fields for recording additional information. Site coloring or numbering can then be displayed with adjustable levels of fluoroscopy or hidden on the display. They may also be grouped so that certain characteristics can be changed for groups instead of individually. Some parameters associated with the marked site may also be displayed on the screen in a separate window. In the latter case, the operator can select parameters they want to appear adjacent to the marked injection site by checking or unchecking checkboxes associated with such parameters, as needed. Examples of these parameters include the injection site number, total number of injections, volume of therapeutic agent injected (0.1 ml to 1.0 ml per injection for intramyocardial injections), dose of therapeutic agent delivered (concentration, total number of cells from 1 x 10 to 200 x 10, total amount of plasmid / gene or peptide or protein, total number of particles), timestamp, screen coordinates, ventricular wall thickness or electrophysiological activity at that injection site, the compartment injected based on a 17-compartment bull's-eye map, its distance from the infarct location, and its distance from other injection sites.

[0024] If a biplane x-ray fluoroscopy system is available within the catheter placement facility, the same capabilities of the software will be available. However, there is no need to toggle from RAO view to LAO view, as both views are typically projected onto two separate screens onboard the biplane x-ray system. In this case, the two projected fluoroscopic images are input independently into the computer and then output, along with associated annotations as described above, to either one of two independent displays or two windows on a single display.

[0025] The software interface will also allow the 2D left ventricular image projection in any view, the injection site marked, and parameters to be toggled on and off.

[0026] Example 2 Preselected Target Sites

[0027] In this example, as shown in Figure 2, we describe a second method for selecting target points within a patient's heart for injecting therapeutic agents in a transendocardial intervention or for sampling tissue in a biopsy procedure. In this method, the same procedure as in Example 1 is followed, but target sites are preselected either manually or using various algorithms. These algorithms may be implemented by a computer and may result in: (1) a uniformly and equally distributed grid projection on the endocardial surface; (2) a uniform grid excluding the infarct zone and spaced 0-20 mm from the infarct zone; (3) a uniform grid within the infarct zone; (4) a distally located uniform grid equally distributed within the distal third of the ventricular or apical region of the left ventricle; or (5) a uniformly distributed circular pattern or other functional geometric distribution, which may be preferred. Target sites ranging from 1 to 20 are therefore preselected based on a set of parameters required for the specific procedure. In addition to those described in Example 1, these parameters can further include distance from the infarct zone, wall thickness of at least 5 millimeters, distance between injection sites (5 millimeters or more), equally spaced injection sites, injection sites randomly spaced from the infarct zone, and randomly spaced injection sites at a defined distance from the infarct zone that may exclude previous sites of therapy delivery for transendocardial injections and previous sampling sites for cardiac biopsies. Prior to the day of the procedure, diagnostic cardiac MRI scans, CT scans, and echocardiography may be used to determine the required pre-specified information, including, but not limited to, wall thickness and infarct tissue location. On the day of the procedure, prior to the start of the procedure, ventriculography is performed in both orthogonal views, and the contour of the left ventricle is mapped as described in Example 1. An algorithm selected from the foregoing list is then executed by the computer, and target sites are pre-selected using the pre-defined parameters and then displayed. As in Example 1, the display of preselected target points may be done using markers of different shapes, patterns, and / or colors that can be grouped or ungrouped and toggled on and off.The tip of the puncture element at the distal end of the transendocardial catheter or guided biopsy catheter is then moved to one of the preselected target points. Once the injection or sampling is performed, the actual injection site is then marked, at which point the preselected target point may be hidden or replaced. The marker for the actual injection or sampling may be a different shape, pattern, and / or color than the target marker. The new marker may be saved and shaded or hidden before moving to the next preselected target point. If the actual target site differs from the preselected target site, an algorithm can be applied to readjust the remainder of the preselected target sites based on the parameters applied to the preselection. The algorithm can be restarted after each injection / sampling to adjust the preselected site accordingly. Additionally, if the interventional cardiologist is not satisfied with the pre-selected target site, the interventional cardiologist can indicate the location he or she desires to be the first site, which can be registered by clicking on the new site location in both the RAO and LAO views, and the algorithm can then be restarted to change the locations of the remaining pre-selected target sites to the redefined first site.

[0028] The actual target site within the patient's left ventricle where the injection will occur is registered and stored. These target points can be displayed with a set of parameters, including patient identification number, injection number, timestamp, identity of the therapy being injected, volume injected at the injection site, concentration injected, total dose injected, screen coordinates, wall thickness and / or electrophysiological activity at the injection site, distance from the infarct site to the injection site, distance from the nearest injection site, and the quality or characteristics of contrast delivery either from the base of the puncture element or through the distal puncture element. When sampling is performed, such as in a right ventricular cardiac biopsy, the set of parameters can include a previous record of where the sample was taken from the patient's heart, including data related to sample characteristics such as its rejection grade score. This can facilitate future sampling strategies and algorithm preselection, as discussed in Example 2. Additional parameters include patient identification number, sample number, timestamp, set of coordinates where the tissue is sampled, wall from which the sample is taken, section of a standard 17-section cardiac model bull's-eye plot from which the sample is taken, wall thickness at the sampling site, distance from the sampling site to the infarct location, and distance from the nearest sampling site if more than one sample is taken. Using a sampling device or biopsy forceps, including the ability to deliver contrast through either a distal element within the tissue or a contrast port at the base of the biopsy element, the quality or characteristics of the contrast delivered through the catheter, either from the base of the puncturing element or through the puncturing element, can also be recorded. Similarly, using a sampling device capable of recording bipolar signals, electrophysiological activity at the sample site can also be recorded.

[0029] (Recording of target area on screen - 3D)

[0030] Example 3

[0031] Here, as shown in Figure 3, we describe a method for selecting target points within a patient's left ventricle and injecting therapeutic agents in transendocardial interventions or sampling tissue in biopsy procedures. In this method, we combine a 3D cardiac model reconstructed prior to the interventional procedure from cardiac slices obtained using imaging modalities capable of 3D visualization of cardiovascular structures (magnetic resonance imaging, computed tomography, echocardiography) with live X-ray fluoroscopy images during the catheter placement procedure. After acquisition of the patient's ventriculogram, the 3D cardiac model reconstruction is registered onto the orthogonal ventriculogram and projected onto the live X-ray fluoroscopy image. This creates an X-ray projection image combined with an overlay of the registered MR, CT, or echocardiography image.

[0032] Registration is achieved by first aligning at least two anatomical fiducial markers on the 3D reconstructed model with corresponding points on the ventriculogram in two orthogonal views. This and all subsequent steps in target point selection are performed on a separate computer or workstation in a control room or designated area of ​​the catheter placement facility that communicates directly with the fluoroscopy system, away from the fluoroscopy system and sterile zone, so that the resulting output can be displayed on the fluoroscopy system monitor or on a separate monitor visible to the physician. The target injection or sampling area is selected based on the procedure's inclusion and exclusion criteria. For example, in the case of transendocardial injection, wall thickness of 5 mm or less, infarct location, infarct size, distance from the infarct to the injection site, and the basal section of the left ventricular septum can be identified and marked along the 3D surface of the left ventricle on the remote computer and output on the fluoroscopy monitor. Similarly, in the case of tissue sampling for a biopsy procedure, wall thickness, infarct location, infarct size, and previous biopsy sampling site can all be marked. These areas may be indicated by color coding, the use of solid and dashed lines, and / or the use of different shapes and patterns. These boundaries allow the interventional cardiologist to visualize the location where therapy should be injected or tissue sampled. During the procedure, the tip of the puncture element at the distal end of the transendocardial injection catheter or guided biopsy catheter is moved to the target point. Using visual recognition, the target point is fixed in 2D space using a target marker on the monitor. The target marker is superimposed on the tip of the puncture element in two orthogonal RAO ​​and LAO views, and when in target identification mode, the target marker can be forced to advance in 3D space along the endocardium so that it is in the same 3D space as the tip of the puncture element. Registration of the fixed target point and target marker is performed using markers that can be of different shapes and can be color-coded. Once the injection or sampling is performed, registration of the actual injection point is performed by replacing the target point marker with a marker of a different shape and / or color.The new marker is saved and can be hidden or shaded before moving to the next target point.

[0033] If a biplane x-ray fluoroscopy system is available at the catheter placement facility, as in Example 1, there is no need to toggle from RAO view to LAO view, as both views are typically projected onto two separate screens mounted on the biplane x-ray system.

[0034] Example 4

[0035] In another embodiment, as shown in FIG. 4, we describe a method for fitting a 2D cardiac model onto a left ventriculogram in both RAO and LAO views, followed by a live X-ray fluoroscopy image. The same steps are followed and the same software capabilities are used as in Example 2. However, instead of fitting a 3D model of the left ventricle contour, data obtained from cardiac MRI, CT, or echocardiography sections is used to reconstruct a 2D model of the left ventricle in the same plane as the fluoroscopy projection prior to the procedure, and the same regions of interest and parameters described above are marked on the 2D model. These markings are primarily achieved through color coding, the use of solid and dashed lines, and / or the use of different shapes and patterns, which can be toggled on and off. Otherwise, target site selection and registration are performed in the same manner as described in Examples 1 and 2.

[0036] As in Examples 1 and 2, if a biplane x-ray fluoroscopy system is available at the catheter placement facility, the need to toggle from RAO view to LAO view is not necessary, thereby eliminating, since both views are typically projected onto two separate screens mounted on the biplane x-ray system.

[0037] Example 5

[0038] In this example, as shown in FIG. 5, we describe a second method for using multimodal fusion imaging to select target points within a patient's left ventricle for injecting therapeutic agents in a transendocardial intervention or for sampling tissue in a biopsy procedure. This method follows the same procedure as in Example 3, except that target sites are preselected using a computer algorithm. The computer algorithm is programmed to select between 1 and 20 target sites based on a set of parameters required for the specific procedure. In addition to those previously described in Example 3, these parameters can include distance from the infarct zone, distance between injection sites (5 mm or greater), equally spaced injection sites, randomly spaced injection sites from the infarct zone, randomly spaced injection sites at a defined distance from the infarct zone, or predefined electrophysiological activity. Prior to the start of the procedure, target sites are preselected using the algorithm in conjunction with predefined parameters, which are displayed by the software. As in Example 3, the display of preselected target points is performed using markers of different shapes, patterns, and / or colors that can be toggled on and off. The tip of a puncture element at the distal end of the transendocardial catheter or guided biopsy catheter is then moved to one of the preselected target points. Once the injection or sampling is performed, the actual target point is then registered by replacing the marker marking of the preselected target point with a new marker of a different shape, pattern, and / or color. The new marker is saved and can be shaded or hidden before moving to the next preselected target point. If the actual target site differs from the preselected target site, an algorithm can be applied to readjust the remaining preselected target sites based on the parameters applied to the preselection. The algorithm can be restarted after each injection / sampling to adjust the preselected site accordingly.Furthermore, if the interventional cardiologist is not satisfied with the pre-selected target sites, the interventional cardiologist can indicate any desired target location, which can be registered by clicking on the new site location in both the RAO and LAO views, and the algorithm can then be restarted to change the remaining locations of the pre-selected target sites relative to the first one.

[0039] In these examples, target points within the patient's left ventricle where injections are made are registered and stored. These target points can be displayed with a set of parameters, including a patient identification number, an injection number, a timestamp, an identification of the therapy injection, the volume injected at the injection site, the concentration injected, the total dose injected, screen coordinates, wall thickness at the injection site, electrophysiological activity, the distance from the infarct site to the injection site, and the distance from the nearest injection site. If sampling is performed, the set of parameters can include the patient identification number, the sample number, the timestamp, the set of coordinates where the tissue is sampled, the wall where the sample is taken, the section of a standard 17-section cardiac model bull's-eye plot where the sample is taken, the wall thickness at the sampling site, the electrophysiological activity, the distance of the sampling site from the infarct site, and, if more than one sample is taken, the distance from the nearest sampling site.

[0040] While the foregoing is a complete description of the preferred embodiment of the present invention, various alternatives, modifications, and equivalents may be used. Accordingly, the foregoing description should not be taken as limiting the scope of the invention, which is defined by the appended claims.

Claims

[Claim 1] Target site selection, entry and update using automatic remote image annotation.

Images