MXPA06008729A - Simulation of invasive procedures - Google Patents

Abstract

A method for pre-planning and performing a cardiac procedure on a heart includes acquiring an image or map of the heart;displaying the image or map of the heart;marking at least one feature on the image or map;calculating dimensions of the at least one feature;identifying one or more points on or within the heart for treatment;determining paths to the one or more points on or within the heart for treatment;simulating insertion of a sheath into the heart;simulating insertion of a medical device through the sheath and within the heart;verifying that the one or more points on or within the heart can be accessed for treatment;and performing a medical procedure on or within the heart.

Description

SIMULATION OF INVASIVE PROCEDURES FIELD AND BACKGROUND OF THE INVENTION The present invention relates, in general, to the planning and implementation of medical procedures, and, in particular, to a new and useful method for planning, simulating and performing a medical procedure such as a cardiac treatment procedure, as well as a method A new and useful systematic method for treating atrial fibrillation under the guidance of ultrasound and a new and useful method for planning, simulating and performing a medical procedure to prevent the occurrence of macroreentrant circuits in the atrium of the heart. As is well known in the medical field, atrial fibrillation is a major disease state and is characterized as a common sustained cardiac arrhythmia, and is widely known to be a major cause of stroke. These conditions are perpetuated by reentrant wave trains, such as macroreentrant circuits, which propagate into the substrate of the abnormal atrial tissue with the conduction of heterogeneity and an altered refractory period. Several procedures have been developed to interrupt these trains of the macroreentrant circuits, including surgical atriotomy or catheter-mediated atriotomy. A common procedure to treat atrial fibrillation is through the use of radiofrequency (RF) ablation energy, using a ablation catheter. When using an RF ablation catheter, continuous linear lesions are formed by ablation, in order to segment the heart tissue of the atrium. By segmenting the cardiac tissue, electrical activity can not be transmitted from one segment to the other. Preferably, the segments become very small in order to be able to sustain the fibrillatory procedure. As a result, various catheter ablation techniques can be used to treat atrial fibrillation by cutting lines in the left atrium. The relevant anatomical features involved in this type of procedure are illustrated schematically in Figure 1B. Typically, for this purpose, the physician attempts to cut lines in the left atrium 10 around the orifices of the pulmonary veins (13, 14, 16 and 18), in order to isolate the foci of the arrhythmia. The doctor can also cut lines along the mitral isthmus that connects the right inferior pulmonary vein with the mitral valve 20 and / or the left atrial appendage ridge between the left superior pulmonary vein and the left atrial appendage 22. And as can be seen To a large extent, the ablation of structures in the left atrium can be a very complex and even delicate procedure, and it depends to a large extent on the skill of the operating physician. Part of the complexity of the procedure includes accessing the left atrium 10 in an efficient and safe manner. Thus, in order to properly reach or have access to the left atrium 10, the physician must pass a liner 40 through the vena cava in the right atrium, and then to through the interatrial septum 11 in the oval fossa 12 and in the left atrium 10. Next, the physician must pass an ablation catheter 50 through the lining 40 in the left atrium 10, and then place the catheter 50 in succession of locations that define the ablation lines. The procedure is schematically known in Figure 1B. Optimal deployment of liner 40 and catheter 50 for these purposes varies substantially from patient to patient, due to a high level of anatomical variability. Failure to place and operate medical devices or procedure tools correctly can result, at least, in the failure to completely isolate a focus from the arrhythmia, and can cause fatal complications. As a result, left atrial ablation has a suboptimal success rate.

BRIEF DESCRIPTION OF THE INVENTION The present invention is directed to several novel inventions that include methods for planning and implementing medical procedures. In particular, a novel method according to the present invention is directed to a novel and useful method for planning, simulating and performing a medical procedure, such as a cardiac treatment procedure. Another novel method according to the present invention is directed to a new and useful systematic method for treating atrial fibrillation under the guidance of ultrasound. In addition, another novel method according to the present invention is directed to a new and useful systematic method for planning, simulating and performing an atrial fibrillation procedure under the guidance of ultrasound. An additional novel method according to the present invention is directed to a new and useful method for planning, simulating and performing a medical procedure to prevent macroreentrant circuits from occurring in the atrium of the heart. According to an invention of the present invention, a method for pre-planning a cardiac procedure in the heart, comprises the steps of: acquiring an image or map of the heart; represent the image or map of the heart; mark at least one feature in the image or map; calculate the dimensions of at least one characteristic; identify one or more points in or inside the heart for treatment; determine the trajectories of one or more points in or within the heart for treatment; simulate the insertion of a lining in the heart; simulate the insertion of a medical device through the lining and into the heart; and verify that one or more points can be accessed in or within the heart for treatment.

According to another embodiment of the present invention, a method for developing a plan for a cardiac procedure comprises the steps of: acquiring an image or map of the heart; represent the image or map of the heart; mark at least one feature in the image or map; calculate the dimensions of at least one characteristic; identify one or more points in or inside the heart for treatment; determine the trajectories of one or more points in or within the heart for treatment; simulate the insertion of a lining in the heart; simulate the insertion of a medical device through the lining and into the heart; and verify that one or more points can be accessed in or within the heart for treatment. Another embodiment according to the present invention is a method for pre-planning and performing a cardiac procedure in a heart, comprising the steps of: acquiring an image or map of! heart; represent the image or map of the heart; mark at least one feature in the image or map; calculate the dimensions of at least one characteristic; identify one or more points in or inside the heart for treatment; determine the trajectories of one or more points in or within the heart for treatment; simulate the insertion of a lining in the heart; simulate the insertion of a medical device through the lining and into the heart; verify that one or more points can be accessed in or within the heart for treatment; and perform a medical procedure on or inside the heart. A further embodiment according to the present invention is a method for developing a plan and performing a cardiac procedure on a heart, comprising the steps of: acquiring an image or map of the heart; represent the image or map of the heart; mark at least one feature in the image or map; calculate the dimensions of at least one characteristic; identify one or more points in or inside the heart for treatment; determine the trajectories of one or more points in or within the heart for treatment; simulate the insertion of a lining in the heart; simulate the insertion of a medical device through the lining and into the heart; verify that one or more points can be accessed in or within the heart for treatment; and perform a medical procedure on or inside the heart. In addition, another embodiment of the present invention is a method for simulating a cardiac procedure in a heart, comprising the steps of: acquiring an image or map of the heart; represent the image or map of the heart; mark at least one feature in the image or map; calculate the dimensions of at least one characteristic; identify one or more points in or inside the heart for treatment; determine the trajectories of one or more points in or within the heart for treatment; simulate the insertion of a lining in the heart; simulate the insertion of a medical device through the lining and into the heart; and verify that one or more points can be accessed in or within the heart for treatment.

Also, another embodiment according to the present invention is a method for simulating and developing a plan for a cardiac procedure, comprising the steps of: acquiring an image or map of the heart; represent the image or map of the heart; mark at least one feature in the image or map; calculate the dimensions of at least one characteristic; identify one or more points in or inside the heart for treatment; determine the trajectories of one or more points in or within the heart for treatment; simulate the insertion of a lining in the heart; simulate the insertion of a medical device through the lining and into the heart; and verify that one or more points can be accessed in or within the heart for treatment. In addition, another embodiment of the present invention is directed to a method for simulating and performing a cardiac procedure in a heart, comprising the steps of: acquiring an image or map of the heart; represent the image or map of the heart; mark at least one feature in the image or map; calculate the dimensions of at least one characteristic; identify one or more points in or inside the heart for treatment; determine the trajectories of one or more points in or within the heart for treatment; simulate the insertion of a lining in the heart; simulate the insertion of a medical device through the lining and into the heart; verify that one or more points can be accessed in or within the heart for treatment; and perform a medical procedure on or inside the heart. In addition, another embodiment of the present invention is a method for simulating a cardiac procedure, developing a plan and performing a cardiac procedure on a heart, comprising the steps of: acquiring an image or map of the heart; represent the image or map of the heart; mark at least one feature in the image or map; calculate the dimensions of at least one characteristic; identify one or more points in or inside the heart for treatment; determine the trajectories of one or more points in or within the heart for treatment; simulate the insertion of a lining in the heart; simulate the insertion of a medical device through the lining and into the heart; verify that one or more points can be accessed in or within the heart for treatment; and perform a medical procedure on or inside the heart. Another invention according to the present invention is directed to a method for treating atrial fibrillation in a heart of a patient, comprising the steps of: placing an ultrasonic catheter in a first chamber of the heart; acquiring portions of a three-dimensional ultrasonic image of a second chamber of the heart and at least a portion of the surrounding structures of the second chamber, using the ultrasonic catheter placed in the first chamber; reconstruct a reconstruction of the three-dimensional ultrasonic image based on the portions of a three-dimensional ultrasonic image; represent the reconstruction of the three-dimensional ultrasonic image; identify a! minus a key reference mark in the reconstruction of the three-dimensional ultrasonic image; mark at least one key reference mark in the reconstruction of the three-dimensional ultrasonic image; penetrating the septum to access the second chamber of the heart while using at least one key reference mark marked for guidance; place a liner through the penetrated septum and into the second chamber of the heart; insert an ablation catheter through the lining and into the second chamber of the heart; and cutting a portion of the second chamber of the heart using the ablation catheter while under observation with the ultrasound catheter located in the first chamber of the heart. In addition, another embodiment of the invention is a method for simulating, developing a plan and treating atrial fibrillation in a heart of a patient, comprising the steps of: placing an ultrasonic catheter in a first chamber of the heart; acquiring portions of a three-dimensional ultrasonic image of a second chamber of the heart and at least a portion of the surrounding structures of the second chamber, using the ultrasonic catheter placed in the first chamber; reconstruct a reconstruction of the three-dimensional ultrasonic image based on the portions of a three-dimensional ultrasonic image; represent the reconstruction of the three-dimensional ultrasonic image; identify at least one key reference mark in the reconstruction of the three-dimensional ultrasonic image; mark at least one key reference mark in the reconstruction of the three-dimensional ultrasonic image; identify one or more points for the treatment of the reconstruction of the three-dimensional ultrasonic image; determining the trajectories of one or more points for the treatment using at least one key reference mark marked as a guide; simulate in the reconstruction of the three-dimensional ultrasonic image the insertion of a lining in the heart; simulate in the reconstruction of the three-dimensional ultrasonic image the insertion of a medical device through the lining and into the second chamber of the heart; verify that one or more points can be accessed for treatment in the second chamber of the heart for treatment; present a plan based on the simulation; use the plan, penetrating the septum of the heart to access the second chamber of the heart; place a liner through the penetrated septum and into the second chamber of the heart; insert an ablation catheter through the lining and into the second chamber of the heart; and cutting a portion of the second chamber of the heart using the ablation catheter while under observation with the ultrasound catheter located in the first chamber of the heart. In addition, the present invention is also directed to a method for preventing occurrence of macroreentrant circuits in a portion of a patient's heart, comprising the steps of: (a) acquiring an image or map of the heart portion; (b) represent the image or map of the heart portion; (c) mark at least one characteristic in the image or map; (d) calculating the dimensions of at least one characteristic; (e) identify one or more points in or within the heart for treatment as part of a treatment plan; (f) determining the trajectories of one or more points in or within the heart for treatment; (g) simulate the insertion of a lining in the heart; (h) simulate the insertion of a medical device through the lining and into the heart; (i) verify that one or more points can be accessed in or within the heart for treatment; (j) calculating a total surface area of the heart portion; (k) calculating an estimated untreated area in the heart portion based on the treatment plan; (I) assess whether there may be macroreentrant circuits in the estimated area not treated in the heart portion; (m) repeating steps (e) - (I) in the event that step (I) indicates that macroreentrant circuits may exist in the estimated untreated area in the heart portion; and (n) implement the treatment plan. Another embodiment of this invention according to the present invention is a method for treating atrial fibrillation in an atrium of a patient's heart, comprising the steps of: (a) acquiring an image or map of the atrium; (b) represent the image or map of the atrium; (c) mark at least one characteristic in the image or map; (d) calculating the dimensions of at least one characteristic; (e) identify one or more points in or within the atrium for treatment as part of a treatment plan; (f) determining the trajectories of one or more points in or within the atrium for treatment; (g) simulate the insertion of a lining in the atrium; (h) simulate the insertion of a medical device through the liner and into the atrium; (i) verify that access can be gained to one or more points in or within the atrium for treatment; (j) calculate a total surface area of the atrium; (k) calculate an estimated untreated area in the atrium based on the treatment plan; (I) assess whether there may be macroreentrant circuits in the estimated area not treated in the atrium; (m) repeating steps (e) - (I) in the event that step (I) indicates that macroreentrant circuits may exist in the estimated untreated area in the atrium; and (n) implement the treatment plan.

BRIEF DESCRIPTION OF THE DRAWINGS The novel features of the invention are set forth with particularity in the appended claims. The invention itself, however, so with respect to the organization as to the methods of operation, together with the objects and additional advantages thereof, can be understood with reference to the following description, taken in conjunction with the accompanying drawings, in the which: Figure 1 A is a flow diagram illustrating a method for simulating, planning and implementing a medical procedure according to an embodiment of the present invention; Figure 1 B is a schematic illustration of the method of Figure 1A in a representation for simulating, planning and implementing a cardiac procedure in the left atrium according to the present invention; Figure 2A is a flow diagram illustrating a method for performing a cardiac procedure using the ultrasound guidance, according to a second embodiment of the present invention; Figure 2B is a flow chart illustrating a method for simulating, planning and performing a cardiac procedure using the ultrasound guidance, according to a third embodiment of the present invention; Figure 2C is a schematic illustration of the methods of Figures 2A and 2B in a representation for simulating, planning and implementing a cardiac procedure, using the ultrasound guidance according to the present invention; Figure 3A is a flow diagram illustrating a method for simulating, planning and performing a cardiac procedure, in order to avoid macroreentrant circuits according to a fourth embodiment of the present invention; and Figure 3B is a schematic illustration of the method of Figure 3A in a representation for simulating, planning and implementing a cardiac procedure, while macroreentrant circuits in accordance with the present invention are avoided.

DESCRIPTION OF THE PREFERRED MODALITIES The present invention relates to several novel methods for planning and implementing medical procedures. In particular, a novel method according to the present invention is directed to a new and useful method for planning, simulating and performing a medical procedure, such as a cardiac treatment procedure. Another novel method according to the present invention is directed to a new and useful systematic method for treating atrial fibrillation under the guidance of ultrasound. Yet another novel method according to the present invention is directed to a new and useful systematic method for planning, simulating and performing an atrial fibrillation procedure under the guidance of ultrasound. An additional novel method according to the present invention is directed to a novel and useful method for planning, simulating and performing a medical procedure to prevent macroreentrant circuits from occurring in the atrium of the heart. Figures 1A and 1B illustrate a novel method, generally designated 100, according to the present invention, for planning, simulating and performing a medical procedure, such as a cardiac treatment procedure. The method 100 according to the present invention, comprises step 105 of obtaining, acquiring or using images and / or maps or images and / or pre-acquired maps of the left atrium 10 (Figure 1 B) in computer simulation of the ablation procedure. atrial left shown on the screen 8. The image or map may include, for example, a three-dimensional (3D) ultrasound image, an MRI image, a CT image or the like, or an electrical map or an electroanatomical map, such as that provided by the system. CARTO ™ mapping and navigation (manufactured and sold by Biosense Webster, Inc. of Diamond Bar, California), that is, a CARTO ™ map (which can be pre-registered with the image). The simulation and the method 100 according to the present invention can be used both for the purpose of planning the medical procedure and for guiding the doctor in carrying out the procedure. An exemplary scenario is described below.

Planning the ablation procedure As best illustrated in Figure 1A, in step 105, the physician acquires an image and / or map of the heart and marks key features 110 of the left atrium 10 (all shown in Figure 1 B), including the oval fossa (or foramen ovale) 12, the orifices of the four pulmonary veins (right superior pulmonary vein "RSPV" 13, right inferior pulmonary vein "RIPV" 14, superior left pulmonary vein "LSPV" 16, and left inferior pulmonary vein "LIPV" 18), the annulus of the mitral valve 20, and the orifice of the left atrial appendage 22. Alternatively, computer image recognition algorithms can identify some or all of these characteristics. In step 115, the dimensions of these characteristics or the key characteristics of the left atrium 10 are measured or calculated. A The dimension of these characteristics that is calculated is the diameter for each key characteristic. In this example, the diameters of the characteristics are calculated 115 and the next step 120 is to determine the desired trajectories for the treatment based on the calculated dimensions (in this example, diameters of the characteristics). Accordingly, for an RF ablation procedure and treatment with an ablation catheter 50, the diameters of the key features are calculated to be used to determine the trajectories of the ablation lines to be created by the ablation catheter 50. in the image / map and in the anatomical reference marks (key features) identified in steps 110 and 115, the trajectories for treatment 120 are determined and a computer simulates the procedure of inserting liner 40 (step 125) of the vein cava, through the right atrium and the ntetratrial septum 11 through the oval / foramen oval fossa 12, into the left atrium 10 as shown in Figure 1 B. This step 125 allows the angle of attack and depth of penetration of the lining 40 are determined in advance, in order to avoid injury to the patient during the actual penetration of the septum 11. The computer used for all the modalities of the pre This invention, which is described in this description, comprises signal processing circuits with programs and algorithms and is graphically represented in Figures 1 B, 2C and 3B as screen 8. Screen 8 is also used to describe images and / or maps , as well as the simulations and planning steps to include graphic representations of medical devices, such as liners 40, ablation catheters 50, ultrasound imaging catheters 55, etc. In step 130, the computer is used to simulate the insertion of selected ablation catheters 50 through liner 40. Typically, a range of different catheters 50 is available, wherein each catheter 50 is characterized by a certain radius of curvature as shown best in Figure 1B. As illustrated in Figure 1B, a catheter 50 of a certain curvature, after insertion through the liner 50, is shown in two different orientations on the screen 8, which are separated by approximately 180 ° of rotation. Next, the computer is used to simulate the operation of several different degrees of freedom in order to determine the ability of the catheter 50 to reach all the desired points that must be cut in the left atrium (one or more points selected for treatment, such as ablation). In addition, computer simulation is also used to determine the possible trajectories of the catheter 50 against the atrial wall of the left atrium 10, depending on the depth of insertion and the orientation angle of the catheter 50 in the left atrium 10, together with the properties Mechanical and mechanical effect of the atrial wall (with which the catheter 50 is in contact) in a particular trajectory of the catheter 50. In addition, the computer simulation is also used to determine the effect of the depth of the extension of the lining 40 in the left atrium 10 that can have in the path of the catheter. Steps 130 and 135 can be performed for different catheters 50 having different radii of curvature. At the physician's discretion, these steps are used to choose an optimal catheter 50 and to perform step 135, which is to verify that catheter 50 will be able to access all points in the left atrium that are not cut (one or more points in the left atrium to be treated). As best illustrated in Figure 1 B, the indicia 60, such as symbols, marks, annotations or check marks, are identified directly on the screen 8. In this example, the check marks are used as indicia 60 in the representations graphs of RSPV 13, LSPV 16 and LIPV 18 on screen 8, indicating that the selected catheter 50, will be able to trace and form ablation lines around these characteristics, while indications 60 in the form of a mark symbol of interrogation is shown in the graphic representation of RIPV 14 on screen 8, as a feature that may be inaccessible using the selected catheter 50. Based on the selected catheter 50 and on the characteristics and nsions of the cardiac anatomy, the physician and / or the computer (the doctor with or without the help of the computer and the program and simulation algorithm), designs and plans the 140 ablation for this patient This is done by marking one or more points to be treated, such as through the drawing of lines in the left atrium 10 that are going to be cut. The computer then calculates the execution parameters, such as the RF power, the type of electrode and the duration of the burn, which are required to achieve complete transmural ablation without damage of perforating the cardiac wall or causing collateral damage to extracardiac structures, such as the esophagus. These parameters can be based on the thickness of the tissue, as provided by the 3D image of the heart.

Execution of the procedure The computer is programmed to provide the physician with instructions in the course of the procedure, based on the ablation plan 140 and the execution parameters as previously determined (discussed above). The treatment plan (ablation) is then implemented 145. And in step 150, the computer verifies the execution of the procedure by tracking the position of catheter 50 (and liner 50 if desired), using suitable position sensors, such as electromagnetic position sensors used in the CARTO ™ navigation and mapping system (not shown). Accordingly, in step 150, the computer can instruct the doctor where and when to start and stop the cut, as well as where and at what angle to push the liner 40 through the septum 11. In step 150, the computer can also provide a guide to the doctor in step 145 (carrying out and implementing the ablation plan), guiding and preventing the doctor, that is, providing a warning to the doctor, of possible conditions and dangerous deviations of the ablation plan 140.

The method according to the present invention is shown in Figures 1A and 1B, it is particularly useful for acquiring an anatomical model (of the heart, particularly of the left atrium 10); simulate an invasive procedure based on the anatomical model and on the known properties of an instrument (or instruments), to be used in the procedure; and tracking the position of the instrument using a position sensor, in order to guide the current procedure based on the simulated procedure discussed above. This method according to the present invention is particularly advantageous in that it makes it possible to precisely pre-plan the complex procedures, in order to find an optimal choice of tools (medical devices or medical instruments) and maneuvers, that is, the use of the They are expected to provide a successful result, followed by verification, guidance and validation of the current procedure to ensure that the result complies with the simulation. In addition, the method described above can be used under robotic control; for example, in a closed cycle control manner, using controlled and robotically ordered instruments for catheter navigation and ablation. Although this method according to the present invention is particularly suitable for the treatment of atrial fibrillation by ablation of the left atrium 10, the principles of the invention can be applied for the treatment of ventricular tachycardia by cutting around a scar on the wall of the left ventricle, or for cell-based or gene-based therapies, through an injection catheter, as well as in other medical applications, such as invasive procedures in the fields of orthopedics, urology, neurology, thoracic, gastrointestinal , vascular, etc. The present invention is also directed to a novel systematic method for carrying out the ablation treatment of atrial fibrillation in the left atrium, as best illustrated in Figures 2A, 2B and 2C. This method, according to the present invention, is performed under the guidance of ultrasound using an ultrasound catheter 55 (Figure 2C), placed in the right atrium 30 of the patient's heart. The ultrasound catheter 55 may include a position sensor, such as an electromagnetic position sensor, as described in the U.S. patent application. do not. of series 11 / 114,847, filed on April 26, 2005, which is incorporated herein by reference. Thus, in this embodiment, the ultrasound catheter 55 with the position sensor is used in conjunction with a location system having a computer and signal processing circuits to determine the exact location of the position sensor and the catheter. , and navigate the catheter 55 in the patient's body. In this exemplary embodiment, the steps of procedure 90a are illustrated schematically in Figure 2A and are set forth below. First, in step 106, the physician places the ultrasound catheter 55 in a chamber of the patient's heart and obtains one or more images from an adjacent chamber using the ultrasound catheter 55. For example, the physician inserts the ultrasound catheter 55 into the right atrium 30 (Figure 2C) and directs the ultrasound beam 57 projected from catheter 55 to an adjacent chamber, eg, left atrium 10, and uses catheter 55 to acquire ultrasound images (two-dimensional "2D" ultrasound images) of the left atrium 10 and the surrounding structures. The position sensor (not shown) used in the ultrasound catheter 55 and its associated location system (not shown), allows the determination of the exact location (determination of position coordinates and orientation coordinates) of the position sensor and the catheter 55. For example, the position sensor allows a portion of the catheter 55 to be accurately tracked and navigated using three dimensions of the position coordinates (X, Y and Z coordinate axis directions), and at least two dimensions of the orientation coordinates (oscillation and step) to include up to three dimensions of the orientation coordinates (oscillation, pitch and rotation). Accordingly, since the location coordinates (position coordinates and orientation coordinates) for a portion of the catheter 55, are determined using a positioning system (not shown), operatively connected to the position sensor of the catheter 55, it is they obtain three-dimensional ultrasound portions using the 2D ultrasound images and their associated location coordinates for each pixel of each respective 2D ultrasound image.

Thus, the computer uses the location coordinates (position coordinates and orientation coordinates) for each pixel of each 2D ultrasound image and makes a portion of the resulting three-dimensional ultrasound image. Next, in step 108, the portions of the three-dimensional ultrasound image acquired by the catheter 55 and generated by the computer are also used by the computer (which has reconstruction algorithms and reconstruction program) to reconstruct a reconstruction of the 3D ultrasound image (3D model or 3D reconstructed image) of the left atrium 10. In addition, the model or reconstruction of the reconstructed 3D ultrasound image will include the aortic valve 26 and the ascending aorta 24, located behind the left atrium 10. In the next step 110, key features such as reference marks are identified in the 3D reconstructed image, either automatically or interactively, by the physician. These reference marks include the planes and contour of the oval fossa 12 and the aortic valve 26, as well as the aorta itself 24. Other key reference marks typically include the orifices of the four pulmonary veins (vein). upper right lung "RSPV" 13, right inferior pulmonary vein "RIPV" 14, left superior pulmonary vein "LSPV" 16 and left inferior pulmonary vein "LIPV" 18), annulus of mitral valve 20 and orifice of left atrial appendix 22 In preparing to insert the ablation catheter 50 of the right atrium 30 into the left atrium 10, in step 146 (Figure 2A), the physician pierces the septum 11 in the oval fossa 12 using a needle or liner 40 as shown in Figure 2C. The locations of the aortic valve 26 and the aorta 24 in the 3D ultrasound image are indicated to ensure that the physician does not accidentally pierce the aorta 24 with the needle. The system and the computer can be programmed to automatically guide the doctor to the correct direction and depth of needle insertion through the septum 11. The ultrasound catheter 55 can be used in Doppler mode to observe the creation of the hole in the septum 11 , detecting the flow of blood through the orifice of the left atrium 10 to the right atrium 30. In step 147, the ablation catheter 50 (and any other desired medical device if needed for the procedure), is inserted (through the lining 40) in the left atrium 10, in order to create the desired ablation pattern. In step 148, the ultrasound catheter 50 remains positioned only in the right atrium 30 and is used to form the image 57 of the tip area of the ablation catheter 50 (located in the left atrium 10), in order to observe and form the image of the ablation results in real time. The ultrasound catheter 55 and / or the ablation catheter 50 can be controlled automatically, for example, under robotic control, so that the fan or projection 57 of the 2D ultrasound tracks the location of the ablation catheter 50, according to the catheter of ablation 50 moves inside the left atrium 10. After the completion of the passage of the treatment, that is, the ablation step (under the guidance of the ultrasound) in step 148, the ultrasound catheter 55 captures additional ultrasound images of the left atrium 10 for the purpose of assessing the lesion and to ensure that the flow of blood through the pulmonary veins 13, 14, 16 and 18 has not been compromised in step 152. Thus, step 152 is used to assess the level of treatment provided and to verify the appropriate blood flow through the chambers of the blood. heart and key vessels, such as pulmonary veins 13, 14, 16 and 18. This method according to the present invention is particularly advantageous in that it improves the accuracy and safety of the ablation treatment for left atrial fibrillation, by of a novel combination of intracardiac ultrasound imaging, position detection, preplanting, simulation and guidance (discussed in more detail here below) ). Another embodiment of this method 90b according to the present invention, is illustrated in Figure 2B, and uses many of the steps set forth for the 90a method (Figure 2A), and likewise, the same reference numbers are used for the same steps of the method. However, an additional step, generally designated 112, is the step of preplanting and simulation, which are the same steps: calculating the dimensions of the features 115, determining the trajectories for the treatment 120, simulation of the lining insertion procedure 125 , simulation of the devices inserted through the liner 130, verify the access to all points to be treated 135, design the treatment plan 140, and verify the procedure and provide the guidelines 150 illustrated in Figure 1A and discussed in detail previously in the foregoing. In addition, these methods described above and illustrated in Figures 2A and 2B can also be used under robotic control, for example, in a closed-loop control manner using controlled and robotically ordered instruments for catheter navigation and ablation. Although the methods of the present invention illustrated in Figures 2A and 2B are particularly suitable for the treatment of atrial fibrillation by ablation of the left atrium, the principles of the invention can be applied in the ventricles and in other kinds of invasive procedures performed in other organs of the body, such as those briefly identified in the foregoing, by way of example. Another method according to the present invention is directed to the treatment of atrial fibrillation in the heart through a new and efficient method to prevent the occurrence of macroreentrant circuits in the atrial wall of the heart. As is well known, catheter-based treatments of left atrial fibrillation generally involve ablation of myocardial tissue in a pattern that is designed to surround, and therefore, isolate the orifices of the pulmonary veins. This treatment pattern is based on work (by the well-known electrophysiologist Dr. Haissaguerre and his colleagues), which show that atrial fibrillation is usually induced by the Stimulation of a site within the orifice to one or more of the pulmonary veins. Treatment of this kind, however, has a highly unacceptable rate of failure, when used as the sole treatment for atrial fibrillation, which is typically around a 30% failure rate. It is postulated that the reason for this high failure rate is that chronic atrial fibrillation does not require any kind of induction stimulus. Instead, as shown by the work of well-known electrophysiologists Dr. Wijffels and Dr. Allessie, once the atria begin to fibrillate, they undergo an electrical "remodeling" procedure, which causes the fibrillation to continue even in the absence of a specific induction site. Accordingly, the method according to the present invention is directed for the treatment is directed for the treatment of ablation to treat atrial fibrillation which is not directed solely to isolate the induction sites, such as the orifices of the pulmonary veins ( upper right pulmonary vein "RSPV" 13, right lower pulmonary vein "RIPV" 14, upper left pulmonary vein "LSPV" 16, and left inferior pulmonary vein "LIPV" 18, shown in Figure 3B), but also to prevent them from occurring the macroreentrant circuits 70 within the atrial wall itself in the left atrium 10. The physical size of these macroreentrant circuits 70 is determined by the duration of the refractory period at any given site in the atria. Normally, atrial refractory periods are long (duration average of the refractory period under normal conditions in a time interval of 120-150 msec), and consequently, macroreentrant circuits are consequently large (typically greater than 6-7 cm in diameter). In atrial fibrillation, however, the refractory period can be much shorter, i.e., in a time interval of 80-100 msec, so that the macroreentrant circuits 70 can be small enough to survive between the current ablation lines. 65, that is, macroreentrant circuits 70 as small as 1 cm in diameter. The circular trajectories marked 70 between the ablation lesions 65 shown in Figure 3B illustrate this situation. This problem becomes more difficult to manage the larger volume of the atria and the superficial area of the atrial endocardium. In response to this problem, the present invention offers a novel method 95 for preventing macroreentrant circuits 70 (Figure 3B) in the treatment of atrial fibrillation, as shown schematically in Figure 3A. According to the method 95 of the present invention, the first step 140 is to design a treatment plan, i.e. to design an ablation strategy (which includes both the isolation of the pulmonary veins and the ablation lines required for the appropriate isolation and blocking) on the surface of atrium 10, using a pre-acquired 3D image (such as CT, MR and / or ultrasound image). Again, the development of the treatment strategy (exposed in the step 140), may also include the general preplanting step and simulation 112 of Figure 1A, such as one or more individual steps, to include step 105 of acquiring an image and / or map of the surface or portion of the heart such as the atrium or portion of the atrium or other chamber or vessel; and representing the image and / or map of the surface or portion of the heart or atrium on the screen 8 (Figure 3B); step 110, marking at least one feature of the image and / or map (such as one or more key features to include the anatomical landmarks); Step 115, calculate the dimensions of one or more key features to include determining the diameter of of the key features, and identify one or more points in or within the heart for treatment, as part of a treatment plan; Step 120, determine the trajectories for the treatment; step 125, simulate the insertion of the liner 40; step 130, simulate the insertion of other medical devices, such as ablation catheters, through the liner and into the heart and atrium; step 135, verify that one or more points can be accessed in or within the heart for treatment; and step 140, design the treatment plan, wherein each of these steps can be used in any combination or sequence. The details of these steps have also been described here previously. As shown schematically in Figure 3A, after the treatment strategy has been developed and set forth in the treatment plan step 140, the total endocardial surface area of the atrium 10 is calculated in step 160. For the purposes of present invention, the step 160 is also directed to calculate any portion of the endocardial surface area and not only the entire surface area of the endocardial surface, but any surface or portion of surface area of interest. After calculating the endocardial surface of the atrium, the estimated area of each segment is calculated following the pattern of ablation planned in step 165. Representative examples of the segments are illustrated in Figure 3B and are the areas between the ablation lines. , ie, uncut areas between the ablation lines 65. Next, in step 170, there is access to each segment (uncut area or estimated area not treated as part of the designed treatment plan), to determine if it is whether or not it is possible for each segment to lodge or be likely to experience macroreentrant circuits 70. The step 170 is performed over a range of likely refractory periods, such as the refractory period intervals previously discussed in the foregoing (or adjusted by the user, if they know). If it is likely that one or more of the segments may still be large enough to accommodate the macroreentrant circuits, then the therapeutic plan is amended or modified (step 172), to reduce the areas of the segments, i.e., reduce the segment size planning additional ablation lines or blocking lines designated by the reference numbers 75 in Figure 3B. And step 170 is performed again in order to determine whether the reduced segment (segment with a smaller area or size now defined by the additional ablation lines 75), is capable of accommodating or experiencing macroreentrant circuits 70.

In the event that the size of the segment is sufficient in size or such that it is unable to accommodate or experience macroreentrant circuits 70, then the treatment plan is implemented and the therapy, such as the ablation treatment, is provided by the attending physician. step 175. Again, the execution of the therapeutic plan in step 175 can be performed manually (by the doctor) or under robotic control. After executing the treatment plan, the actual area of each segment is measured in step 180. In step 180, the measurement of the actual area of each segment created after the ablation lines 65 have been made (including the implementation of the planned ablation lines 75 for a small segment size), is usually performed at the end of the procedure. However, in step 185, if the measurement of the size of the actual segment or the area of the actual segment reveals that it is still possible for macroreentrant circuits to exist, then the therapeutic plan is amended or revised in step 172, in an effort to reduce the size of the segment, so that it is unable to experience macroreentrant circuits. And the amended plan will be implemented in step 175 with the remaining steps 180 and 185 performed again. In the case where the measurement of the size of the actual segment or the area of the actual segment in step 180 reveals that macroreentrant circuits are not possible (analysis performed in step 185), then the procedure is considered completed or completed (step 190, indicating that the procedure is complete).

As indicated above, additional ablation lines 75, are added to the original ablation pattern 65 (either in the planning stage in step 170 and 172 or after the first stage of execution in step 185 and 172), in order to cut segments that may still be large enough to maintain macroreentrant circuits. As is well known, the prior art and the current surgical and catheter-based treatments for atrial fibrillation use approximately the same pattern of injury for all patients, and consequently, these procedures in patients suffer from high rates of failure. The present invention solves this problem, providing a systematic way to adjust the treatment to the anatomical and electrophysiological characteristics of each specific patient, based on the quantitative measurements taken from images and / or maps of the heart in question. Thus, it is believed that this novel method, system and method will increase the success rate of the treatment for atrial fibrillation. To the extent that the above specification comprises preferred embodiments of the invention, it is understood that variations and modifications may be made thereto, in accordance with the inventive principles described, without departing from the scope of the invention. Although the preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided in a manner that example only. Numerous variations, changes and substitutions will now occur to those with experience in the art, without departing from the invention. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.

Claims (16)

NOVELTY OF THE INVENTION CLAIMS

1. - A method for pre-planning a cardiac procedure in a heart, comprising the steps of: acquiring an image or map of the heart; represent the image or map of the heart; mark at least one feature in the image or map; calculate the dimensions of at least one characteristic; identify one or more points in or inside the heart for treatment; determine the trajectories of one or more points in or within the heart for treatment; simulate the insertion of a lining in the heart; simulate the insertion of a medical device through the lining and into the heart; and verify that one or more points can be accessed in or within the heart for treatment.

2. A method to develop a plan for a cardiac procedure, comprising the steps of: acquiring an image or map of the heart; represent the image or map of the heart; mark at least one feature in the image or map; calculate the dimensions of at least one characteristic; identify one or more points in or inside the heart for treatment; determine the trajectories of one or more points in or within the heart for treatment; simulate the insertion of a lining in the heart; simulate the insertion of a medical device through the liner and into the heart; and verify that one or more points can be accessed in or within the heart for treatment.

3. A method for pre-planning and performing a cardiac procedure in a heart, comprising the steps of: acquiring an image or map of the heart; represent the image or map of the heart; mark at least one feature in the image or map; calculate the dimensions of at least one characteristic; identify one or more points in or inside the heart for treatment; determine the trajectories of one or more points in or within the heart for treatment; simulate the insertion of a lining in the heart; simulate the insertion of a medical device through the lining and into the heart; verify that one or more points can be accessed in or within the heart for treatment; and perform a medical procedure on or inside the heart.

4. The method according to claim 3, further characterized in that the medical procedure is verified and guided according to the plan.

5. The method according to claim 4, further characterized in that the medical procedure is verified and robotically guided according to the plan.

6. A method for developing a plan and performing a cardiac procedure in a heart, comprising the steps of: acquiring an image or map of the heart; represent the image or map of the heart; mark at least one feature in the image or map; calculate the dimensions of at least one characteristic; identify one or more points in or inside the heart for treatment; determine the trajectories of one or more points in or within the heart for treatment; simulate the insertion of a lining in the heart; simulate the insertion of a medical device through the lining and into the heart; verify that one or more points can be accessed in or within the heart for treatment; and perform a medical procedure on or inside the heart.

7. The method according to claim 6, further characterized in that the medical procedure is verified and guided according to the plan.

8. The method according to claim 7, further characterized in that the medical procedure is checked and robotically guided according to the plan.

9. A method for simulating a cardiac procedure in a heart, comprising the steps of: acquiring an image or map of the heart; represent the image or map of the heart; mark at least one feature in the image or map; calculate the dimensions of at least one characteristic; identify one or more points in or inside the heart for treatment; determine the trajectories of one or more points in or within the heart for treatment; simulate the insertion of a lining in the heart; simulate the insertion of a medical device through the lining and into the heart; and verify that one or more points can be accessed in or within the heart for treatment.

10. - A method for simulating and developing a plan for a cardiac procedure, comprising the steps of: acquiring an image or map of the heart; represent the image or map of the heart; mark at least one feature in the image or map; calculate the dimensions of at least one characteristic; identify one or more points in or inside the heart for treatment; determine the trajectories of one or more points in or within the heart for treatment; simulate the insertion of a lining in the heart; simulate the insertion of a medical device through the lining and into the heart; and verify that one or more points can be accessed in or within the heart for treatment.

11. A method for simulating and performing a cardiac procedure in a heart, comprising the steps of: acquiring an image or map of the heart; represent the image or map of the heart; mark at least one feature in the image or map; calculate the dimensions of at least one characteristic; identify one or more points in or inside the heart for treatment; determine the trajectories of one or more points in or within the heart for treatment; simulate the insertion of a lining in the heart; simulate the insertion of a medical device through the lining and into the heart; verify that one or more points can be accessed in or within the heart for treatment; and perform a medical procedure on or inside the heart.

12. - The method according to claim 11, further characterized in that the medical procedure is verified and guided according to the plan.

13. The method according to claim 12, further characterized in that the medical procedure is checked and robotically guided according to the plan.

14. A method for simulating a cardiac procedure, developing a plan and performing a cardiac procedure on a heart, comprising the steps of: acquiring an image or map of the heart; represent the image or map of the heart; mark at least one feature in the image or map; calculate the dimensions of at least one characteristic; identify one or more points in or inside the heart for treatment; determine the trajectories of one or more points in or within the heart for treatment; simulate the insertion of a lining in the heart; simulate the insertion of a medical device through the lining and into the heart; verify that one or more points can be accessed in or within the heart for treatment; and perform a medical procedure on or inside! heart.

15. The method according to claim 14, further characterized in that the medical procedure is verified and guided according to the plan.

16. - The method according to claim 15, further characterized in that the medical procedure is verified and robotically guided according to the plan.