# Patent

## Title
Method and apparatus for registering 3D models of anatomical regions of a heart and a tracking system with projection images of an interventional fluoroscopic system

## Abstract

An imaging system for use in a medical intervention procedure is disclosed. A first image acquisition system is configured to produce a fluoroscopy image of an anatomical region. A second image acquisition system is configured to produce a 3D model of the anatomical region. An interventional tracking system, which includes a position indicator, is configured to maneuver within the anatomical region. A first anatomical reference system is common to both the first and the second image acquisition systems, and a second anatomical reference system is common to both the first image acquisition system and the interventional tracking system. A processing circuit configured to process executable instructions for registering the second image acquisition system with the first image acquisition system to define a first registration, registering the interventional tracking system with the first image acquisition system to define a second registration, and in response to the first and second registrations, registering the interventional tracking system with the second image acquisition system.

## Background
BACKGROUND
This invention relates generally to a medical imaging system, and more particularly to a method and apparatus for registering 3D models of anatomical regions with an interventional tracking system through projection images of the same anatomical regions obtained with a fluoroscopy system.
During a number of interventional procedures related to the improvement of electrical therapy in the heart, the physician has to manipulate catheters and/or leads inside the heart chambers. An example of the two most complex and common procedures include atrial fibrillation (AF) ablation, and bi-ventricular pacing.
Atrial fibrillation, an arrhythmia in which the atria (upper chambers of the heart) stop contracting as they fibrillate, is the most common of the heart rhythm problems. In United States alone it is estimated that there are over 2 million people who have atrial fibrillation. Present data suggest that it is the most common arrhythmia-related cause of hospital admissions. Patients with AF tend to have a high incidence of such complications as stroke and congestive heart failure. Premature atrial contractions may act as triggers and initiate paroxysms of AF. These premature atrial contractions have been shown to predominantly originate in the pulmonary veins from the left atrium. Since infrequent and non reproducible premature atrial contractions may limit the utility of ablating trigger sites, a variety of surgical and catheter techniques have been used to isolate the pulmonary veins from the left atrium.
One of the surgical techniques used to treat (ablate) AF involves applications of radiofrequency waves to create small scars on the heart's surface near the connection between the pulmonary veins and the left atrium. The small scars created by the radiofrequency waves tend to stop the erratic impulses of AF by directing the impulses to follow a normal electrical pathway through the heart. Typically, this type of surgical procedure is performed through a chest incision. Surgeons use specially designed instruments to deliver radiofrequency waves to the abnormal tissue, typically during the open heart surgery performed for other reasons, such as valve surgery or bypass surgery for example. Although this type of surgical technique is effective when the patient is undergoing open heart surgery for another reason, catheter-related treatment methods are more practical when the patient does not require the invasive open heart surgery for other reasons.
One of the catheter techniques involves fluoroscopic guided positioning of catheter in the left atrium after going through a blood vessel, and the application of radiofrequency energy at areas showing double potentials suggestive of sites capable of conducting between the left atrium and the pulmonary veins. It has also been shown that ablation at other sites such as between the mitral valve and left pulmonary veins, and between the pulmonary veins, as is done during the surgical intervention, may increase the success rate of AF ablation. The three-dimensional reconstruction of the left atrium using some currently available technologies, the inability of the physician to visualize the pulmonary vein ostia (opening of these veins into the left atrium) from inside, the varying size of the pulmonary veins and thus the pulmonary vein ostia, the difficulty in keeping the mapping and ablation catheters stable at the pulmonary vein ostial site due to the complex 3D geometry of these areas, all make current approaches to mapping and ablation using current fluoroscopically guided techniques somewhat cumbersome and lengthy. Because of these limitations, surgery has been preferred over radiofrequency catheter ablation, especially in patients with persistent atrial fibrillation, and it is estimated that less than 20 percent of patients with persistent AF undergoing radiofrequency ablation for AF, benefit from this approach.
A factor that may be associated with the above mentioned limitation is that the operator typically guides an interventional tool using mainly the fluoroscopy images. A typical task in such a procedure is the placement of a catheter at a specific location, such as one of the pulmonary veins for example. These anatomical structures are not well depicted by the x-ray system since they do not present contrast versus the surrounding anatomical structures.
The medical task would be much easier if these target anatomical structures were visible in the fluoroscopy image in the precise anatomic fashion separate from the surrounding anatomic structures.
Another important procedure, as mentioned above, involves bi-ventricular pacing in the treatment of heart failure. Despite considerable progress in the management of congestive heart failure (CHF), it remains a major health problem worldwide. It is estimated that there are 6-7 million people with CHF in the United States and Europe, and approximately 1 million patients are diagnosed with CHF every year.
Despite significant advances in the treatment of CHF using various pharmacological therapies, quality-of-life in patients with CHF is poor as they are frequently hospitalized, and heart failure is a common cause of death. In addition, there is significant cost attached to this problem.
Normal electrical activation in the heart involves activation of the upper chambers, called the atria, followed by simultaneous activation of both the right and the left lower chambers, called the ventricles, by the left and right bundle branches. As patients with advanced CHF may have conduction system disease, which may play a role in worsening cardiac function, pacing therapies have been introduced in an attempt to improve cardiac function. One frequently noted conduction abnormality is left bundle branch block (LBBB). In one study, (Xiao H B, et al. Differing effects of right ventricular pacing and LBBB on left ventricular function. Br Heart J 1993; 69:166-73) 29% of patients with CHF had LBBB. Left bundle branch block delays left ventricular ejection due to delayed left ventricular activation as the electrical impulse has to travel from the right to the left side leading to sequential rather than simultaneous activation, as mentioned before. In addition, different regions of the left ventricle (LV) may not contract in a coordinated fashion.
Cardiac resynchronization, also knows as Bi-Ventricular (Bi-V) pacing, has shown beneficial results in patients with CHF and LBBB. During Bi-V pacing, both the right and the left ventricle (RV, LV) of the heart are paced simultaneously to improve heart pumping efficiency. It has also been shown recently that even some patients with no conduction system abnormalities, such as LBBB, may also benefit from the Bi-V pacing. During Bi-V pacing, in addition to the standard right atrial and right ventricular lead used in currently available defibrillators or pacemakers, an additional lead is positioned into the coronary sinus. The additional lead is then advanced into one of the branches of the coronary sinus overlying the epicardial (outer) left ventricular surface. Once all of the leads are in place, the right and left ventricular leads are paced simultaneously, thus achieving synchronization with atrial contraction.
There are, however, several problems with this approach. First, this type of procedure is time-consuming. Second, placement of the LV lead is limited to sites available that provide reasonable pacing and sensing parameters. And third, cannulating the coronary sinus may be challenging as a result of an enlarged right atrium, rotation of the heart, or presence of Tebesian valve (a valve close to the opening of the coronary sinus). Coronary sinus stenosis (occlusion) has also been reported in patients with prior coronary artery bypass surgery, further complicating the problem.
In most instances, problems with the placement of the coronary sinus lead are identified at the time of the interventional procedure. In the event of the coronary sinus lead placement procedure being abandoned, the patient is brought back to the operating room and the LV lead is positioned epicardially. During this procedure, an incision is made on the lateral chest wall and the lead is placed on the outer side of the left ventricle.
Unfortunately, there are many problems with epicardial lead placement as well, some of which include but are not limited to:
Limited view of the posterolateral area of the left ventricle using the incision of the chest wall, also called minithoracotomy;
The limited number of placement sites providing reasonable pacing and sensing parameters;
Inability to identify the most appropriate location and placement of the lead at the most appropriate site;
Potential risk of damaging the coronary arteries and venous system; and
Difficulty in identifying the ideal pacing site as a result of one or more of the above limitations.
It has also been shown that LV pacing alone may be as effective as Bi-V pacing. However, due to the unstable nature of the coronary sinus lead, a pacing and sensing lead is usually placed in the right ventricle in currently used techniques.
Cardiac CT may be used to create a roadmap of coronary sinus and left ventricular anatomy such that appropriate sites may be identified for the placement of a LV pacing lead for Bi-V/LV pacing, either at the most appropriate branch of the coronary sinus, or on the left ventricular wall epicardially (from outside). CT or MR imaging may also identify areas devoid of blood vessels and nerves, as well as scar tissue. These modalities may also be used to determine the asymmetric contraction of the ventricles and identify different regions of the ventricles not contracting in a coordinated fashion. The presence of scarring from previous heart attacks may make this uncoordinated contraction even worse.
During an interventional procedure, the operator may guide an interventional tool using mainly the fluoroscopic images. However, strategically important anatomical structures, such as the left atrium and pulmonary veins in the case of AF interventional procedure planning and the coronary sinus and its branches in the case of bi ventricular pacing planning, for example, are not depicted by the x-ray system since they do not present contrast versus the surrounding anatomical makeup. Accordingly, the medical interventional task would be much easier if these target anatomical structure were visible in the fluoroscopic image.
In some cases, the operator may also use an interventional tracking system having a catheter-based tracking system equipped with navigational functionality, which is able to provide the location of the catheter in a given referential. However, navigational information provided by the probe is not displayed in the true 3D model.
While existing medical procedures may be suitable and appropriate for certain medical conditions, significant procedural limitations still exist. Accordingly, there remains a need in the art for an improved method and apparatus for registering 3D models of anatomical regions with projection images of the same, and for registering the 3D models with an interventional tracking system, to overcome these drawbacks.
BRIEF DESCRIPTION OF THE INVENTION
Embodiments of the invention include an imaging system for use in a medical intervention procedure. A first image acquisition system is configured to produce a fluoroscopy image of an anatomical region. A second image acquisition system is configured to produce a 3D model of the anatomical region. An interventional tracking system, which includes a position indicator, is configured to maneuver within the anatomical region. A first anatomical reference system is common to both the first and the second image acquisition systems, and a second anatomical reference system is common to both the first image acquisition system and the interventional tracking system. A processing circuit configured to process executable instructions for registering the second image acquisition system with the first image acquisition system to define a first registration, registering the interventional tracking system with the first image acquisition system to define a second registration, and in response to the first and second registrations, registering the interventional tracking system with the second image acquisition system.
Other embodiments of the invention include a method of registering a 3D model of an anatomical region of a patient with a catheter-based tracking system, the catheter-based tracking system comprising a catheter with a position indicator. The catheter with the position indicator is disposed within the anatomical region, and a fluoroscopy image of the anatomical region is generated. A 3D model of the anatomical region is also generated. Using a first common anatomical reference system and a discernible parameter associated with the catheter, the 3D model is registered with the fluoroscopy image, thereby defining a first registration. Using a second common anatomical reference system and signals from the position indicator representative of the location of the catheter in the fluoroscopy image, the catheter-based tracking system is registered with the fluoroscopy image, thereby defining a second registration. Using the first registration and the second registration, the 3D model is registered with the catheter-based tracking system.
Further embodiments of the invention include a computer program product for registering a 3D model of an anatomical region of a patient with a catheter-based tracking system, the catheter-based tracking system comprising a catheter with a position indicator. The product includes a storage medium, readable by a processing circuit, storing instructions for execution by the processing circuit for carrying out some or all portions of the aforementioned method.
Yet further embodiments of the invention include a computer program product for registering a 3D model of an anatomical region of a patient with projection images of the same from an interventional fluoroscopy system. The product includes a storage medium, readable by a processing circuit, storing instructions for execution by the processing circuit for carrying out some or all portions of the aforementioned method, and for monitoring the introduction of a catheter delivery apparatus into the anatomical region of interest, navigating the catheter delivery apparatus over the registered model to an anatomical site of interest, and using the catheter delivery apparatus to deliver therapy.



BRIEF DESCRIPTION OF THE DRAWINGS
Referring now to the figures, which are exemplary embodiments, and wherein like elements are numbered alike:
FIG. 1 depicts a generalized schematic of an imaging system for use in a medical intervention procedure;
FIG. 2 depicts an expanded view of a portion of the system of FIG. 1;
FIG. 3 depicts a generalized flowchart of a process for implementing an embodiment of the invention using the imaging system of FIG. 1;
FIGS. 4A, B and C, depict an exemplary registration of a 3D model with a fluoroscopy image in accordance with an embodiment of the invention;
FIGS. 5A, B, C, D, E and F, depict validation of the registration process performed in accordance with an embodiment of the invention;
FIG. 6 depicts a generalized flowchart of a registration process in accordance with an embodiment of the invention;
FIG. 7 depicts an exemplary catheter for use in accordance with an embodiment of the invention; and
FIG. 8 depicts an illustration of a probability region for use in accordance with an embodiment of the invention.



DETAILED DESCRIPTION
By using the 3D imaging capabilities of the CT and registering these images with projection images of the fluoroscopy system, pulmonary veins and other areas involved with initiating and sustaining AF may be more precisely and easily identified, thereby improving the success rate from a catheter procedure.
Embodiments of the invention disclosed herein also provide a system and method by which 3D models of anatomical structures, such as the coronary sinus and left ventricle for example, may be registered with projection images of the fluoroscopy system, thereby allowing the pacing leads to be navigated and placed at the most appropriate site.
By registering the tracking system in the referential of the interventional fluoroscopy system, the success rate of AF ablation using a catheter technique should be improved, and navigating the LV lead to the most appropriate site should assist in improving the effectiveness of Bi-V or LV pacing.
Embodiments of the invention use the referential of the projection images of the interventional fluoroscopy system to register the tracking system in the referential of the interventional system. This is accomplished after the 3D model of the anatomical region of interest has been registered with the interventional fluoroscopy system. Registration of the 3D anatomical region of interest obtained from an imaging an device, such as a CT scanner, is performed with the fluoroscopy system using a tool, such as a catheter or a lead for example, placed in an area of the anatomical region, such as the coronary sinus or the right ventricle for example, by a physician. A detailed description of embodiments of the invention is presented herein by way of exemplification and not limitation with reference to the several figures.
FIG. 1 depicts a generalized schematic of an imaging system 100 for use in a medical intervention procedure, such as, for example, an AF ablation procedure or a bi-ventricular procedure, for example. In an embodiment, the imaging system 100 includes: an imaging apparatus 110 for generating cardiac image data, such as, for example, image data of the left atrium and the coronary sinus, a data acquisition system 120 for acquiring the cardiac image data from imaging apparatus 110, an acquisition database 130 for storing the cardiac image data from data acquisition system 120, an image generation system 140 for generating a viewable image from the cardiac image data stored in acquisition database 130, an image database 150 for storing the viewable image from image generation system 140, an operator interface system 160 for managing the imaging apparatus 110 and the cardiac image data and viewable image in databases 130, 150, which may be combined into one database, and a processing system 180 for analyzing and displaying the viewable image in database 150 and being responsive to operator interface system 160. Processing software in processing system 180 includes instructions, and is therefore adapted, to analyze data and display images, thereby converting processing system 180 from a general processor into a specialized processor. Scanned data that is capable of being converted into a viewable image is referred to herein as image data.
System communication links 210, 212, 216, 218 and database communication links 220, 222 provide a means for signal communication amongst and between systems 110, 120, 140, 160, 180 and databases 130, 150. Communication links 210-222 may be hardwired or wireless. Operator interface system 160 may be a standalone input/output terminal or a computer including instructions in a variety of computer languages for use on a variety of computer platforms, such as but not limited to, for example, DOSTM-based computer systems, AppleTM-based computer systems, WindowsTM-based computer systems, HTML-based computer systems, specialized program language-based computer systems, or the like.
Operator interface system 160 includes a processor 170, such as, for example, a microprocessor (MP) or any other processing circuit suitable for the purposes disclosed herein, for managing the imaging apparatus 110, for managing the data acquisition and image generation systems 120, 140, for processing and managing the information in acquisition and image databases 130, 150, and for managing the processing at processing system 180. Operator interface system 160 also includes: a memory 200 that contains specific instructions relating to medical scanning procedures, user input means, such as, for example, a keyboard 162, and user output means, such as, for example, displays 164, 166. In an embodiment, interface system 160 and processing system 180 may be integrally arranged. Display 164 may be adapted for exam prescription, and display 166 may be adapted for visualization. Alternatively, displays 164 and 166 may be integrated into one display. Exam prescription includes such input parameters as: CT scan or region of scan control, fluoroscopy system control, data acquisition control, and the like. Operator interface system 160 may also be employed during an actual interventional procedure to display both fluoroscopy images and 3D CT images, as discussed below. During an actual medical interventional procedure, data port 205 accepts information from a medical probe, such as, for example, a catheter 260, thereby permitting data analysis in a real-time fashion during the actual interventional procedure.
Imaging apparatus 110 includes an electrocardiogram (EKG) monitor 112 that outputs R-peak events 114, which generally delineate the beginning of a heart cycle, through an interface board 116 into a scanner 118, such as a CT scanner for example, a fluoroscopy system 115, and a patient table 117. Scanner 118 and fluoroscopy system 115 are alternatively herein referred to as image acquisition systems. The interface board 116 enables synchronization between the scanner data and the EKG monitor data. Alternatively, the interface board 116 may be used to couple the EKG monitor 112 to the scanner 118. An example of an interface board 116 is a Gantry interface board. An exemplary scanner 118 is a cardiac computed tomography (CT) system with support for cardiac imaging, ECG gated reconstruction followed by segmentation reconstruction of 3D models (in diastolic phase) allows imaging of the heart free of motion. During sinus rhythm, segmentation reconstruction will be done at 75% of cardiac cycle (in diastole). Phase location is selected at around 45% of the cardiac cycle where the patient is in atria fibrillation. This phase is chosen as the R-R intervals are shorter. However, the illustrated scanner 118 is for exemplary purposes only; other imaging systems known in the art may also be used. Examples of other imaging systems include, but are not limited to, X-ray systems (including both conventional and digital or digitized imaging systems), magnetic resonance (MR) systems, positron emission tomography (PET) systems, ultrasound systems, nuclear medicine systems, and 3D fluoroscopy systems. Imaging apparatus 110 may have both a scanner 118 and a fluoroscopy system 115 for use as disclosed here, or imaging system 100 may have two imaging apparatuses 110, 110′, with imaging apparatus 110 having a CT scanner 118, and imaging apparatus 110′ having a fluoroscopy system 115. Fluoroscopy system 115 is also herein referred to as an interventional system or a first image acquisition system, and CT scanner 118 is also herein referred to as a 3D model system or a second image acquisition system.
FIG. 2 depicts an interventional system 115 where a patient 250 on table 117 has a catheter 260 placed within an anatomical region 255, such as the coronary sinus in the patient's heart for example. In an embodiment, catheter 260 is positioned at a known anatomical structure in the anatomical region (such as the coronary sinus at the heart) at a location defined by the intersection of a horizontal plane 265 and the line 270 joining the focal point 275 of the x-ray source 280 of the fluoroscopy system 115 to the projection of the catheter 260. Other anatomical regions may include a heart chamber, such as the right ventricle for pacing/defibrillation lead in bi-ventricular pacing, or a pulmonary vein for example, and other anatomical structures may include a mitral valve, a pulmonary vein ostia, a junction into an atria, or a junction into a ventricle, for example. However, embodiments of the invention are not intended to be limited to only those anatomical regions and structures disclosed herein. In an exemplary embodiment, the location of the horizontal plane 265 is defined by an elevation h above the anatomical reference system (table) 117 to the known anatomical structure (coronary sinus) at the anatomical region (heart) 255. In this manner, a known location of the catheter 260 in the fluoroscopy system 115 and the 3D model system 118 may be established.
Referring back to FIG. 1, imaging apparatus 110 also includes EKG gated acquisition or image reconstruction 135 capabilities to image the heart free of motion, typically in its diastolic phase. Interfacing with EKG monitor 112 allows real time acquisition of the cardiac electrical impulses and allows gated acquisition or retrospective reconstruction of the acquired data. As mentioned previously during sinus rhythm for example it could be 75% and during atria fibrillation at about 45% due to shorter R-R intervals. This allows elimination of the cardiac motion by imaging the heart in the same phase of the diastole. The acquired data may be stored on a database or used to generate the required image by using one or more protocols optimized for imaging. In an embodiment, the image data stream from image generation system 140 is communicated via link 212 to the operator interface system 160 for display and visualization, and communication link 216 to processing system 180. The image data used by software at operator interface system 160 for exam prescription and visualization may be stored in image database 150. The imaged data may be archived 167, put on a film 168, and/or sent over a network 169 to processing system 180 for analysis and review, including 3D post-processing. The 3D model image 184 and the fluoroscopy image 182 may be viewed singly or in combination on display 186. In the case of AF planning, post-processing software at processing system 180 allows detailed 3D and endocardial views of the left atrium and pulmonary veins. These images and others may be stored and viewed at the time of the interventional procedure.
Imaging apparatus 110 further includes circuitry for acquiring image data and for transforming the data into a useable form, which is then processed to create a reconstructed image of features of interest within the patient. The image data acquisition and processing circuitry is often referred to as a “scanner”, regardless of the type of imaging system, because some sort of physical or electronic scanning often occurs in the imaging process. The particular components of the system and related circuitry differ greatly between imaging systems due to the different physics and data processing requirements of the different system. However, it will be appreciated that the present invention can be applied regardless of the selection of a particular imaging system.
Data is output from imaging apparatus 110 into subsystem 230, which includes software to perform data acquisition in data acquisition system 120 and image generation in image generation system 140. Data control is either provided by operator interface system 160 or within subsystem 230 via communication link 212. Data that is output from the imaging apparatus 110, including R-peak events 114, is stored in the acquisition database 130. Data acquisition in system 120 is performed according to one or more acquisition protocols that are optimized for imaging the heart, and specifically for imaging the right atrium and/or coronary sinus.
In an exemplary embodiment, the 3D image data of the atrium is created using a protocol that is optimized for the left atrium, such as coronary artery imaging protocol or CardEP protocol for example. Exemplary parameters used in these protocols include 0.5 second Gantry periods with 0.375 helical pitch factors, 120 kilovolts, 250 milliamps and 0.625 or 1.25 mm (millimeter) slice thickness. These functions may be performed with commercially available off the shelf software tools, such as Advanced Vessel Analysis (AVP) or CardEP for example. After the above mentioned tools are applied to the image data, further processing may be applied, such as thresholding, floater filtering, and scalping, for example. These processes are used to clean up the images and may be automated. Automated processes may require queues from the operator as the operator is stepped through the process by the operating software. Following the image clean up process, the remaining cardiac chambers are eliminated and only the left atrium is visualized. A detailed 3D image of the left atrium and the pulmonary veins may then be created. The 3D and endocardial (view from inside) are visualized using volume rendering techniques using a variety of volume rendering commercially available software packages, such as VR and Cardiac Image Quality (CARDIQ) for example. Once the 3D images are created, the 3D model geometry then needs to be registered with that of the fluoroscopy system.
Registration is the process of aligning images. Intra-subject multi-modality registration is registration of two different modalities in the same patient. The number of parameters needed to describe a Transformation (Registration) is referred to herein as number of “Degrees of Freedom”. An assumption is made that the 3D model behaves as a rigid body, as the anatomy of the anatomical structure being registered has not changed significantly. In this case, 3 translations and 3 rotations, which give 6 degrees of freedom, will lead to a successful registration. Each device used for registration needs to be calibrated to approximate the size of the anatomical 3D model. This requires 3 extra degrees of freedom equating to “scaling” in each direction. If a set of corresponding anatomical landmarks (fiducials) x and y can be identified, then the registration can be affected by selecting a transformation that will align these areas. Each view in the device being used is being referred to as the co-ordinate system that will define a space in that view. Successful registration will involve the determination of a Transformation between the fiducials in one space (X) of one view, for example, with that of another space (Y), for example. Successful registration will involve determination of a Transformation T between fiducials in the “X” space with those in the “Y” space that minimizes the error T(x)−y, where T(x)=Ry+t, R is the Rotation, and t is the translation.
A Transformation matrix defines how to map points from one co-ordinate space into another co-ordinate space. By identifying the contents of the Transformation matrix, several standard operations, including rotation, translation and scaling, can be performed.
There may be significant difficulty in identifying and aligning anatomical landmarks in two co-ordinate spaces for successful registration. Instead of aligning anatomical structures, a unique feature of the present invention involves registration performed by aligning the anatomical structures with a tool placed by the physician in the anatomical structure. Although other tools such as a lead can be placed in a anatomical structure, such as the right ventricle in the case of bi-ventricular pacing for example, the embodiment disclosed herein uses a catheter placed in the coronary sinus.
Another embodiment of the invention involves registration of the fluoroscopic image with the 3D model of the anatomical structure. As depicted in FIGS. 4A, B and C, which are discussed in more detail below, the coronary sinus catheter positioned in the coronary sinus can be clearly seen on the fluoroscopic projection image. The fluoroscopy image can be also used as an interventional system to locate the mapping and ablation catheter and or/pacing lead as it is navigated to the appropriate site. A further embodiment of the invention involves using the motion of the coronary sinus catheter to determine the phase of the heart motion. Apart from assessing the continuous movement of the chamber, such as the left atrium, the motion of the catheter can also be used to perform registration of the same phase of diastole (75% of cardiac cycle for example) where the CT image is being reconstructed.
FIGS. 5A, B, C, D, E and F, have been used for validation of the registration process performed in accordance with an embodiment of the invention by the injection of contrast in one of the pulmonary veins. As illustrated, FIGS. 5A, B, C, D, E and F, depict injection of a contrast in the Right superior pulmonary vein (RSPV) through a sheath placed in the RSPV. The contrast is injected after the registration is completed to assess accuracy of registration. In FIG. 5A, there is no contrast, while FIG. 5B shows injection of the contrast followed by a gradual washout as shown in subsequent FIGS. 5C, D and E. In FIG. 5F, no more contrast is seen, suggesting that it has washed out completely. While not specifically delineated, it has been demonstrated that the contrast filled RSPV nicely superimposes on the RSPV shown on the registered CT image, suggesting an accurate registration.
The image formation model of the fluoroscopy system is a conic projection. The location of the center of the projection and the position of the imaging plane are in principle well described with respect to an anatomical reference system, such as the patient table 117 for example. This anatomical reference system 117 is coherent with that used to position the 3D model obtained from the CT system 118.
Assuming that an established protocol is followed by an operating technician during the positioning of the patient in the two acquisition systems, that is, the fluoroscopy system 115 and the CT system 118, the anatomical reference system 117 may then be considered common to both acquisitions systems, especially in terms of orientation, that is, rotation between the two reference systems may be considered negligible.
A coronary sinus catheter from the superior vena cava (SVC) is routinely placed during the AF interventional procedure. As previously mentioned, and to provide for the registration of the 3D model image 184 with the fluoroscopy image 182, a catheter 260 (depicted in-situ in FIG. 4) is employed during the operation of fluoroscopy system 115, which will now be described with reference to FIG. 3 in combination with FIGS. 1 and 2. As an important aside, however, it should be noted that the geometrical structure of the catheter 260 may not be sufficiently rich enough to allow a complete registration of the two modalities without employing embodiments of the invention disclosed herein. For example, and in the case of coronary imaging, a scaling factor computed only from the established relationship between the superior or inferior vena cava (SVC, IVC) and the coronary sinus (CS) in conjunction with the catheter 260 inside the CS, may not be precise enough for accurate registration.
In FIG. 4A, the 3D model of the left atrium obtained using CT imaging and segmentation in anteroposterior (AP) view is depicted. In FIG. 4B, a projection image of the heart obtained using fluoroscopy system is depicted, where multiple catheters including the coronary sinus catheter are positioned at different locations by the physician. As can be appreciated, there is little or no contrast differentiation between the different structures in the fluoroscopic image. In FIG. 4C, a registered image using the 3D model of the left atrium and the projection image using the fluoroscopy is depicted. Referring to FIGS. 4A, B and C collectively, which are all depicted in anteroposterior view, catheter 260 is located in the coronary sinus (CS Catheter), the left atrial appendage is designated LAA, the right superior pulmonary vein is designated RSPV, the left superior pulmonary vein is designated LSPV, and the mitral valve annulus is designated MV.
FIG. 3 depicts a flowchart of an exemplary method 300 for registering 3D model image 184 with fluoroscopy image 182, where fluoroscopy system 115 is used to generate 2D fluoroscopy images (such as x-ray projection images) 182, and CT system 118 is used to generate 3D model images 184. Prior to image acquisition, catheter 260 is placed at an anatomical structure (such as the coronary sinus) of an anatomical region (such as the heart) 255 of patient 250 using known techniques. During the acquisition of images 182, 184, a common anatomical reference system (such as the patient table) 117 is used, thereby establishing a referential link between the two imaging systems 115, 118. After image acquisition, processing circuit 170 processes 305 the image data 182, 184 in such a manner, to be discussed in more detail later, as to result in 3D model 184 being registered 310 with fluoroscopy image 182. In general, processing circuit 170 utilizes the common reference system 117 to link known geometric information between and pertaining to each image acquisition system 115, 118, and uses discernible parameters associated with catheter 260 that are available from both the first and second image acquisition systems 115, 118, in order to register the two images 182, 184.
During the processing phase 305, pre-processing 315, 320 on images 182, 184, respectively, takes place prior to the actual registration process 310. During pre-processing 315, the x-ray projection images 182 are analyzed 325, 330 to determine the likelihood of the apparent catheter image actually being the catheter 260, and to determine a magnification factor λ for the x-ray image 182 based on the known actual catheter size, measured prior to insertion into the patient 250, and the apparent catheter size, measured or known from the x-ray image 182.
Pre-processing 320 follows both paths 335, 340, where path 335 relates to the processing of the anatomical structures in the CT model used for registration, and path 340 relates to the processing of the clinical structure that is desired to be displayed following registration. In accordance with embodiments of the invention, at least one catheter is disposed in the superior vena cava SCV and/or coronary sinus CS. In either path 335, 340, pre-processing 320 performs a parallel projection operation 355 on the 3D model 184 with respect the geometry discernible from the fluoroscopy image 182, thereby properly orienting the 3D model 184 with respect to the fluoroscopy image 182. At block 360, image 184 is processed to establish the pathway of the catheter 260 in the vessel or vessels of interest, such as the SVC or coronary sinus. At block 365, the result of the processing done at 325 and 330 is used to register the images 182 with the pathway 360. As a result of this registration, a transformation is identified that links the images 184 and images 182.
At block 310, the registration process involves generating both a translation factor (x, y) for translating the 3D model 184 with respect to the fluoroscopy image 182, and a scaling factor λ for adjusting the scale of the 3D model 184 with respect to the fluoroscopy image 182. The translation factor is straightforward, and uses known techniques and processes, such as aligning the centers of common anatomical structures for example. In principle, the alignment method can also compensate for a rotation along an axis perpendicular to the projection plane. However, the scaling factor is not so straightforward and will now be described by way of alternative examples. In general, however, the scaling factor is dependent on known information from the common anatomical reference system 117 and discernable features of the catheter 260.
In a first embodiment, the apparent diameter of the catheter 260 in the fluoroscopy image 182 is determined and then compared with the known actual diameter of the catheter 260. From this information, the actual dimension of an anatomical structure in the anatomical region 255 in the fluoroscopy image 182 may be determined. The anatomical structure in the fluoroscopy image 182 is then matched with the same anatomical structure in the 3D model 184, where now the actual and apparent sizes of the same anatomical structure in the 3D model 184 may be compared. From this comparison, a scaling factor may be established between the first and second image acquisition systems 115, 118.
In a second embodiment, the catheter 260 is disposed at a known anatomical structure in the anatomical region 255 at a location defined by the intersection of a horizontal plane 265 and the line 270 joining the focal point 275 of the fluoroscopy system 115 to the projection of the catheter 260 in the fluoroscopy image 182. Here, the horizontal plane 265 is defined by an elevation h above the anatomical reference system 117 to the known anatomical structure in the fluoroscopy system 115, which establishes a known location of the catheter 260 in the fluoroscopy system 115 and the CT system 118 relative to the anatomical reference system 117. Knowing the location of the catheter 260 in the 3D model 184 and the actual and apparent dimensions for elevation h in the 3D model 184, the actual size of the same anatomical structure in the 3D model 184 as that in the fluoroscopy image 182 may be determined. By comparing the actual and apparent sizes of the anatomical structure in the 3D model 184, a scaling factor between the first and second image acquisition systems 115, 118 may be established.
In a third embodiment, the fluoroscopy system 115 is used to produce a first and a second set of fluoroscopy projection images, which are generated using at least two different x-ray projections separated by an angle sufficient to produce discernibly different projection images of the anatomical region 255. Here, as in other embodiments, the catheter 260 is disposed at a known anatomical structure in the anatomical region 255. By analyzing the two sets of projection images using a known triangulation approach, the location of the catheter 260 in the 3D model 184 with respect to the focal point 275 of the x-ray source 280 of the fluoroscopy system 115 may be determined, thereby defining a dimension b, which establishes a known location of the catheter 260 in the fluoroscopy system 115 and the CT system 118 relative to the focal point 275. Knowing the location of the catheter 260 in the 3D model 184 and the actual and apparent dimensions for dimension b in the 3D model 184, the actual size of the same anatomical structure in the 3D model 184 as that in the fluoroscopy image 182 may be determined. By comparing the actual and apparent sizes of the anatomical structure in the 3D model 184, a scaling factor between the first and second image acquisition systems 115, 118 may be established.
While exemplary embodiments disclosed herein reference the size of the catheter 260 for scaling purposes, it will be appreciated that other measurable features may also be used for scaling, such as the interelectrode distance at the catheter 260, for example. Accordingly, embodiments of the invention are not intended to be limited to only a reference to the size of catheter 260 for scaling purposes.
To avoid possible jitter of the registered image of the 3D model 184 due to cyclical movement of the heart, or other anatomical region 255 of interest, the processing circuit 170 may be responsive to additional executable instructions for registering the 3D model 184 with the fluoroscopy image 182 in synchronization with the cyclical movement of the anatomical region 255, that is, in synchronization with the cyclical movement of a heart beat.
With the registration of 3D model 184 with fluoroscopy image 182 having been established, reference will now be made to FIG. 6, which depicts a generalized flowchart of a registration method 400 for registering the 3D model 184 of anatomical region 255 of patient 250 with a catheter-based tracking system 405, best seen by referring to FIG. 7. In FIG. 6, the registration of 3D model 184 with fluoroscopy image 182 is referred to as a first registration R1, and the registration of catheter-based tracking system 405 with fluoroscopy image 182 is referred to as a second registration R2. Catheter-based tracking system 405 is generally referred to as an interventional tracking system since it may or may not include a catheter. For example, tracking system 405 may include a pacing and/or defibrillation lead. In an embodiment, catheter-based tracking system (tracking system) 405 includes catheter 260 having a position indicator 410 and an ablating electrode 415. Position indicator 410 may be a miniature coil, three miniature orthogonal coils, or any other position indicating device suitable for providing signals representative of its coordinates with respect to a defined second anatomical reference system 420 (with anatomical reference system (table) 117 being referred to as a first anatomical reference system). In an embodiment, second anatomical reference system 420 is a coordinate system common to both the tracking system 405 and the fluoroscopy image 182 of the fluoroscopy system 115. Signals from position indicator 410 are communicated to processing circuit 170 via catheter lead 262, communication link 218 or communication links 210 and 212. By using the (second) common anatomical reference system 420 and the signals from position indicator 410, processing circuit 170, being configured to execute appropriately coded instructions, is capable of registering the catheter-based tracking system 405 with the fluoroscopy image 182 and fluoroscopy system 115.
In addition to the previously discussed techniques for registering the 3D model 184 with the fluoroscopy image 182, processing circuit 170 is also configured to process executable instructions for recording the location of a first position of catheter 260 in fluoroscopy image 182, and in response to signals from position indicator 410, recording the respective coordinates of catheter 260 at the first position. By then registering the location information with the coordinate information, position indicator 410 may be registered with the fluoroscopy image 182. In general, proper registration of the catheter-based tracking system 405 with the fluoroscopy system 115 requires at least three data points associated with position indicator 410, with each image location and respective coordinate location being recorded. However, for enhanced accuracy, an embodiment of processing circuit 170 is configured to register a multitude of data points associated with position indicator 410.
Due to system variables, the position signals from position indicator 410 may not be capable of providing exact coordinates for the location of position indicator 410, providing instead only an approximation for the coordinates. While the approximation may be quite good, it nonetheless may still be only an approximation. In such an instance, an embodiment of processing circuit 170 may be configured to compute a probability function representative of the probability of catheter 260, or more specifically position indicator 410, being at the coordinates indicated by the signals from position indicator 410. An exemplary probability function is illustrated in FIG. 8 as a sphere 425, which defines a probability region that is representative of a region in the fluoroscopy image 182, and the registered 3D model 184, where the tip of catheter 260 is probably, more likely than not, located. While FIG. 8 depicts the x, y and z, positional distribution functions 430, 435 and 440, to be normal bell-shaped distribution functions, it will be appreciated that this is exemplary only, and that any distribution function may be substituted therefore. Here, processing circuit 170 may be programmed for computing a probability function representative of the probability of the pacing and/or defibrillation lead being at the coordinates indicated by the signals from the position indicator, and applying the probability function to the 3D model to define a probability region representative of a region in the 3D model where the lead is probably located.
While embodiments of the invention disclose a heart as an exemplary anatomical region, it will be appreciated that the invention is not so limited and that the scope of the invention includes other anatomical regions of interest within the patient. While embodiments of the invention disclose a coronary sinus as an exemplary anatomical structure within an anatomical region, it will be appreciated that the invention is not so limited and that the scope of the invention includes other anatomical structures within an anatomical region. While embodiments of the invention disclose a catheter placed within the patient, it will be appreciated that the invention is not so limited and that the scope of the invention includes other devices discernable via x-ray and CT, such as a pacing and/or defibrillation lead for example.
An embodiment of the invention may be embodied in the form of computer-implemented processes and apparatuses for practicing those processes. The present invention may also be embodied in the form of a computer program product having computer program code containing instructions embodied in tangible media, such as floppy diskettes, CD-ROMs, hard drives, USB (universal serial bus) drives, or any other computer readable storage medium, wherein, when the computer program code is loaded into and executed by a computer, the computer becomes an apparatus for practicing the invention. The present invention may also be embodied in the form of computer program code, for example, whether stored in a storage medium, loaded into and/or executed by a computer, or transmitted over some transmission medium, such as over electrical wiring or cabling, through fiber optics, or via electromagnetic radiation, wherein when the computer program code is loaded into and executed by a computer, the computer becomes an apparatus for practicing the invention. When implemented on a general-purpose microprocessor, the computer program code segments configure the microprocessor to create specific logic circuits. The technical effect of the executable instructions is to register a 3D model with a fluoroscopy image for at least the purpose of assisting in a medical intervention procedure.
As disclosed, some embodiments of the invention may include some of the following advantages: the availability of a CT-Fluoro registration technique that will allow pacing leads to be navigated and placed at the most appropriate site, thereby improving the effectiveness of bi-ventricular or left ventricle pacing; the availability of a CT-Fluoro registration technique that will show the location of the coronary sinus on the 3D model, thereby eliminating the need in bi-ventricular pacing to perform coronary sinus angiography prior to implantation of the coronary sinus lead; the ability to use the coronary sinus catheter in AF ablation for continuous registration; for a given orientation of the interventional system, the ability to automatically generate a projection of the 3D model that is geometrically close to the image provided by the interventional system; the ability to merge the information obtained from a 3D model generated using a scanner with the real-time live information provided by fluoroscopy imaging; the availability of a technique that will allow visualization of the true 3D geometry of the different pulmonary vein—left atrial junction and other strategic areas in the atria by using imaging capabilities of the CT, and more importantly registering these images with X-ray fluoroscopy, to help isolate the pulmonary veins and these areas which initiate and sustain AF more precisely and easily; and, the ability to accurately and continuously track the real-time movement of a catheter during an interventional procedure.
Furthermore, embodiments of the invention may be used to navigate a delivery system, such as a catheter or a sheath apparatus (depicted generally as catheter 260), for delivery of other forms of therapies, such as stent delivery, in coronary artery disease, delivery of cells, genes or other forms of therapies to the appropriate sites as needed. Here, processing circuit 170 may be programmed for generating a fluoroscopy image of the anatomical region from the fluoroscopy system, the anatomical region having disposed therein a catheter, generating a 3D model of the anatomical region from the second image acquisition system of a different modality, analyzing the fluoroscopy image and the 3D model with respect to a common anatomical reference system, monitoring the introduction of a catheter delivery apparatus into the anatomical region of interest, navigating the catheter delivery apparatus over the registered model to an anatomical site of interest, and using the catheter delivery apparatus to deliver therapy. While the invention has been described with reference to exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment disclosed as the best or only mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims. Moreover, the use of the terms first, second, etc. do not denote any order or importance, but rather the terms first, second, etc. are used to distinguish one element from another. Furthermore, the use of the terms a, an, etc. do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item.

## Claims

1. An imaging system for use in a medical intervention procedure, comprising:
a first image acquisition system configured to produce a fluoroscopy image of an anatomical region;
a second image acquisition system configured to produce a 3D model of the anatomical region;
an interventional tracking system configured to maneuver within the anatomical region, the interventional tracking system comprising a position indicator, the position indicator providing signals indicating coordinates of the position indicator in the anatomical region;
a first anatomical reference system common to both the first and the second image acquisition systems;
a second anatomical reference system common to both the first image acquisition system and the interventional tracking system, the coordinates of the position indicator being in the second anatomical reference system; and
a processing circuit configured to process executable instructions for:
registering the second image acquisition system with the first image acquisition system to define a first registration;
registering the interventional tracking system with the first image acquisition system utilizing the signals from the position indicator to define a second registration; and
in response to the first and second registrations, registering the interventional tracking system with the second image acquisition system using both the first and second registrations.

2. The imaging system of claim 1, wherein:
the interventional tracking system further comprises a catheter, the position indicator being coupled to the catheter;
the processing circuit is further configured to register the second image acquisition system with the first image acquisition system by registering the 3D model with the fluoroscopy image; and
the processing circuit is further configured to register the interventional tracking system with the first image acquisition system by registering the position indicator with the fluoroscopy image.

3. The imaging system of claim 2, wherein the processing circuit is further configured to process executable instructions for:
recording a location of a first position of the catheter in the fluoroscopy image;
in response to the signals from the position indicator, recording the coordinates of the position indicator on the catheter at the first position; and
registering the location with the coordinates thereby registering the position indicator with the fluoroscopy image.

4. The imaging system of claim 3, wherein the processing circuit is further configured to process executable instructions for:
recording at least three locations of at least first, second and third positions of the catheter in the fluoroscopy image;
in response to the signals from the position indicator, recording the coordinates of the position indicator on the catheter at the first, second and third, positions; and
registering the three locations with the coordinates at the first, second, and third positions thereby registering the position indicator with the fluoroscopy image.

5. The imaging system of claim 4, wherein the processing circuit is further configured to process executable instructions for:
computing a probability function representative of a probability of the catheter being at the coordinates of the first position indicated by the signals from the position indicator; and
applying the probability function to the 3D model to define a probability region representative of a region in the 3D model where the catheter is probably located.

6. The imaging system of claim 4, wherein the processing circuit is further configured to process executable instructions for:
computing a probability function representative of a probability of a pacing and/or defibrillation lead being at the coordinates of the first position indicated by the signals from the position indicator; and
applying the probability function to the 3D model to define a probability region representative of a region in the 3D model where the lead is probably located.

7. The imaging system of claim 4, wherein the processing circuit is further configured to process executable instructions for registering the 3D model with the fluoroscopy image in synchronization with cyclical movement of a heart.

8. The imaging system of claim 1, wherein:
the first image acquisition system comprises a 2D fluoroscopy system; and
the second image acquisition system comprises one of a CT system, a MR system, an Ultrasound system, a 3D fluoroscopy system, and a PET system.

9. A method of registering a 3D model of an anatomical region of a patient with a catheter-based tracking system, the catheter-based tracking system comprising a catheter with a position indicator, the method comprising:
generating a fluoroscopy image of the anatomical region, the catheter with the position indicator being disposed within the anatomical region;
generating a 3D model of the anatomical region;
using a first common anatomical reference system and a discernible parameter associated with the catheter, registering the 3D model with the fluoroscopy image, thereby defining a first registration;
generating signals indicating coordinates of the position indicator in the anatomical region utilizing the position indicator;
using a second common anatomical reference system and the signals from the position indicator representative of a location of the catheter in the fluoroscopy image, registering the catheter-based tracking system with the fluoroscopy image, thereby defining a second registration, the coordinates of the position indicator being in the second anatomical reference system;
using the first registration and the second registration, registering the 3D model with the catheter-based tracking system.

10. The method of claim 9, wherein the registering the 3D model comprises:
registering the 3D model with the fluoroscopy image in synchronization with cyclical movement of a heart.

11. The method of claim 9, wherein the 3D model is generated using a CT system, a MR system, an Ultrasound system, a 3D fluoroscopy system, or a PET system.

12. A computer program product for registering a 3D model of an anatomical region of a patient with a catheter-based tracking system, the catheter-based tracking system comprising a catheter with a position indicator, the product comprising:
a non-transitory storage medium, readable by a processing circuit, storing instructions for execution by the processing circuit for:
generating a fluoroscopy image of the anatomical region, the catheter with the position indicator being disposed within the anatomical region, the position indicator generating signals indicating coordinates of the position indicator in the anatomical region;
generating a 3D model of the anatomical region;
using a first common anatomical reference system and a discernible parameter associated with the catheter, registering the 3D model with the fluoroscopy image, thereby defining a first registration;
using a second common anatomical reference system and the signals from the position indicator representative of a location of the catheter in the fluoroscopy image, registering the catheter-based tracking system with the fluoroscopy image, thereby defining a second registration, the coordinates of the position indicator being in the second anatomical reference system; and
using the first registration and the second registration, registering the 3D model with the catheter-based tracking system;
wherein the first registration comprises generating a translation factor for translating the 3D model with respect to the fluoroscopy image, and generating a scaling factor for adjusting a scale of the 3D model with respect to the fluoroscopy image, the scaling factor being dependent on a discernable dimensional feature of the catheter.