Optimized transseptal puncture position

The processor-guided system optimizes transseptal puncture by using 4D ICE and magnetic sensors to ensure precise catheter alignment with the LAA entrance, addressing flexibility and maneuverability limitations and enhancing procedural safety and effectiveness.

JP2026501704APending Publication Date: 2026-01-16BIOSENSE WEBSTER (ISRAEL) LTD
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Patent Information

Application Number
JP2025539695
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-01-04
Filing Date
2023-12-07
Publication Date
2026-01-16

AI Technical Summary

Technical Problem

Existing methods for transseptal puncture in catheterization procedures face challenges in accurately selecting the puncture location, which affects the ease of accessing the left atrial appendage (LAA) and maintaining catheter stability, particularly due to limitations in sheath and catheter flexibility and maneuverability.

Method used

A processor-based system that utilizes 4D intracardiac echocardiography (ICE) and magnetic sensors to identify an optimal transseptal puncture location on the fossa ovalis, guiding the catheter to align with the LAA entrance and account for bending characteristics, ensuring a safe and stable access path.

Benefits of technology

Enhances the accuracy and safety of transseptal puncture by providing real-time guidance for optimal catheter positioning, reducing the risk of perforation and improving the ability to deploy medical devices like LAA occlusion devices.

✦ Generated by Eureka AI based on patent content.

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Abstract

The system includes a display and a processor. The display is configured to present a rendering of at least a portion of a septum and left atrium of a patient's heart. The processor is configured to (a) identify in the rendering (i) the septum and (ii) a target anatomical location for a probe to reach through the septum, (b) calculate a trajectory of the probe between the septum and the target anatomical location, including identifying an entry location for the probe to cross the septum to reach the target anatomical location, and (c) present the entry location for penetrating the septum to a user.
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Description

[Technical Field]

[0001] The present disclosure relates generally to treatment planning for medical probes, and more particularly to planning and / or guiding transseptal access for invasive medical devices. [Background technology]

[0002] Various methods for planning a catheter approach to the left atrium (LA) and performing catheterization-based treatments within the left atrium (LA), such as LA atrial appendage (LAA) occlusion or pulmonary vein (PV) electrophysiological isolation, have been proposed in the patent literature. For example, commonly assigned U.S. Patent Application Publication No. 2022 / 0133261 describes a method that includes using a processor to identify a patient's cardiac septum and LAA within an anatomical map of at least a portion of the heart. A plane of incidence, defined on the anatomical map, for a medical device delivered through a sheath that penetrates the septum engages the LAA. A normal to the plane of incidence is calculated. Multiple curves are calculated, each of which (i) has one end tangent to the normal, (ii) has a second end that contacts the septum, and (iii) conforms to the specific mechanical characteristics of the sheath. Multiple candidate locations on the septum are derived from the curves for transseptal puncture using the sheath. The multiple candidate locations are presented to a user.

[0003] The present disclosure will be more fully understood from the following detailed description of the embodiments thereof, taken in conjunction with the drawings in which: [Brief explanation of the drawings]

[0004] [Figure 1] FIG. 1 is a schematic, pictorial illustration of a catheterization system including a catheter carrying a device within the left atrium (LA) inserted into the LA using transseptal access, according to one embodiment of the present disclosure. [Figure 2] FIG. 1 is a schematic, depiction of a catheter in an optimized transseptal puncture position, according to one embodiment of the present disclosure. [Figure 3]3 is a flow chart that schematically illustrates a method for finding an optimized transseptal puncture location as described in FIG. 2, according to one embodiment of the present disclosure. [Figure 4] FIG. 10 is a schematic, pictorial illustration of a catheter in an optimized transseptal puncture position, according to another embodiment of the present disclosure. [Figure 5] 5 is a flow chart that schematically illustrates a method for finding an optimized transseptal puncture location as described in FIG. 4, according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0005] overview Catheterization is an established therapy for performing treatments within the left atrium (LA). To access the LA using a catheter, a physician typically first introduces the catheter into the right atrium (RA) via the body's vasculature and punctures the septum dividing the left and right atria with the catheter's sheath. The physician then passes the sheath through the puncture site into the LA and delivers a medical device (e.g., a catheter with attached electrodes) through the sheath to engage the LA tissue.

[0006] Physicians must further carefully consider the transseptal puncture location because it can affect their ability to control the catheter within the LA. Proper selection of the transseptal puncture location is important because it substantially impacts the achievement of several therapeutic milestones, such as the ease of advancing the sheath to a specific LA target location, achieving stable contact with the septal tissue, and maintaining the catheter position at the target LA location during the invasive procedure. Therefore, the combination of the above considerations, along with a patient's given medical profile, may limit a physician's options for successfully performing a catheterization process within the LA.

[0007] An invasive procedure requiring particularly careful consideration of the transseptal puncture location is occlusion of the left atrial appendage (LAA). Such a procedure is used to reduce the likelihood of blood clot formation in the atrial appendage, which can occur in certain patients with AF. The LAA is occluded with a catheter that deploys an LAA occlusion device. The occlusion procedure requires careful angular alignment of the catheter relative to the ostium of the LAA for a successful outcome. However, due to limitations in the flexibility and maneuverability of the sheath and catheter, successfully navigating the catheter from a suboptimal septal puncture location to the LAA is challenging.

[0008] The examples of the present disclosure described below provide techniques for optimizing the selection of a transseptal puncture location.

[0009] In the disclosed technique, it is assumed that the puncture will be performed at a location above the area of ​​the fossa ovalis. The fossa ovalis is a depression in the right atrium of the heart at the level of the atrial septum, the wall between the right and left atria. This assumption means that the location on the catheter shaft will coincide with the location of the fossa ovalis.

[0010] In one example, the disclosed technique assumes that the ease of access to a target location within the LA (e.g., the LAA) depends on where the transseptal puncture is made on the fossa ovalis. In the disclosed technique, a processor detects a location within the fossa ovalis that provides the most comfortable access to the LAA without requiring excessive bending of the catheter. This location can be determined based on imaging (4D intracardiac echocardiography (ICE) or CT scan) to identify the LAA location, as well as the known bending characteristics of the transseptal catheter.

[0011] The processor obtains three positions that are aligned with each other to enable reaching the correct position within the fossa ovalis: 1. the target position (e.g., the entrance to the LAA), 2. the candidate septum position on the fossa ovalis, and 3. the position of the device relative to the trajectory that the catheter should take based on the bending characteristics of the catheter (e.g., the achievable radius of curvature).

[0012] The processor can mark the device's location on a 4D ICE image or otherwise guide the physician to the detected location based on 3D position coordinates from a magnetic sensor on the catheter and the alignment between the imaging device and the sensor. The sheath, LAA landing site (e.g., location on the entrance plane), and transseptal puncture point (also called "access") can all be visualized with a 3D mapping system (e.g., CARTO®).

[0013] Another disclosed technique, which assumes accessing the RA via the inferior vena cava (LVC), utilizes a clinical strategy of aiming the catheter tip directly at the left superior pulmonary vein (LSPV) to ensure safe puncture. This technique overcomes the challenge of safely introducing a sheath and catheter into the LA without risking perforation by puncturing nearby vital organs, such as the aorta, LA posterior wall, and esophagus.

[0014] Using the direct-pointing approach, the catheter tip (e.g., a puncture device) is positioned and oriented within the RA so that the LSPV ostium is in direct line of sight of the puncture device (e.g., a needle) that is advanced toward the fossa ovalis. When the puncture location is deemed correct, the catheter is advanced to puncture the septum therein.

[0015] The disclosed technology provides the physician with real-time optimal catheter position and orientation for puncture by using an anatomical map, such as one generated using a US catheter (i.e., using 4D ICE), so that the processor can both identify the anatomical structures and automatically plan the safest access path. Accuracy can be improved by integrating catheter position and orientation information with US images using a magnetic position sensor on the catheter.

[0016] After performing the transseptal puncture, a further step may be to insert a 4D ICE probe into the LA to accurately map the clinical target (e.g., the LAA) for use with catheter guidance software. Such intra-LA mapping using a US catheter allows for highly accurate measurements of anatomical structures (e.g., the LAA), allowing the physician using the guidance software to select the most accurate treatment device (e.g., the optimal LAA occlusion device) in a beneficial manner for a particular clinical scenario.

[0017] Typically, the processor is programmed with software that contains specific algorithms that enable the processor to perform each of the processor-related steps and functions outlined above.

[0018] System Description 1 is a schematic, pictorial illustration of a catheterization system 10 including a catheter 14 carrying a device 40 within the left atrium (LA) 45, inserted into the left atrium (LA) using transseptal access 82, according to one embodiment of the present disclosure. By way of example, device 40 is a left atrial appendage (LAA) occlusion device. Also visible is an ultrasound probe 43 (e.g., an intracardiac ultrasound (US) catheter 43).

[0019] The distal end of shaft 22 of catheter 14 is inserted by physician 24 through sheath 28 and into left atrium 45 of heart 12, seen in insets 35 and 75 of patient 23 lying on a table. During insertion of shaft 22, LAA occlusion device 40 is maintained in a collapsed configuration by sheath 28. By housing LAA occlusion device 40 in a collapsed configuration, sheath 28 also helps minimize vascular trauma en route to the target location.

[0020] As seen in insets 35 and 75, to reach the LAA 85 within the LA 45, the physician 24 first navigates the sheath 28 to the inferior vena cava 244 access approach in the right atrium 47. The physician accesses the LA 45 using a punctured hole 82 (also called "transseptal access") in one of two ways described in Figures 2-3 and 4-5, where the septum 80 divides the atria.

[0021] Once within the LAA 85 , the physician advances the distal end of the shaft 22 through the sheath 28 to deploy the LAA occlusion device 40 coupled to the distal edge of the shaft within the LAA 85 .

[0022] As further seen in inset 75 , to successfully access the LAA 85 , the physician aligns the sheath 28 in a particular direction 66 within the LA 45 pointing toward the ostium 87 of the LAA 85 .

[0023] To guide the catheter 14 and image anatomical landmarks within the heart 12, the physician uses an ultrasound imaging catheter 43 (shown in inset 35) equipped with an ultrasound array 65 and a position sensor 67. The ultrasound array 65 may be 1D or 2D to generate 2D or 3D ultrasound images, respectively. The imaged target anatomical structures (e.g., the septum 80 and the LAA 85) are presented to the physician 24 by the processor on the display device 27, for example, as a volume rendering 20 (also referred to hereinafter as an "anatomical map"). References to a "volume rendering" or an "anatomical map" as used herein shall be understood to refer to a computational model stored in the memory of a computer processing system, whether actually displayed, i.e., "rendered," to a user via a user interface, or simply utilized by the processor for computational purposes, such as identifying target anatomical locations or trajectories between anatomical locations.

[0024] The integrated position sensor 67 is pre-aligned with the array 65 of the catheter 43. Specifically, the sensor 67 is configured to output a signal indicative of the position and orientation of the ultrasound transducer array 65 within the heart 12. The system's processor is configured to use the sensor's signal output to acquire one or more ultrasound images of corresponding anatomical structures oriented at various orientations relative to the ultrasound transducer array 65.

[0025] The magnetic-based position sensor 67 may be operated in conjunction with a location pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working volume. The real-time positions of the distal ends of catheters 43 and 14 may be tracked based on the magnetic fields generated by location pad 25 and sensed by magnetic-based position sensors 67 and 29, respectively. Details of magnetic-based position sensing technology are described in U.S. Patent Nos. 5,539,199; 5,443,489; 5,558,091; 6,172,499; 6,239,724; 6,332,089; 6,484,118; 6,618,612; 6,690,963; 6,788,967; and 6,892,091.

[0026] System 10 includes one or more electrode patches 38 positioned for skin contact with patient 23 to establish a position reference for location pads 25, as well as impedance-based tracking of electrodes 26. For impedance-based tracking, current is directed to electrodes 26 and sensed at electrode skin patches 38, thereby allowing the position of each electrode to be triangulated via electrode patches 38. Details of impedance-based position tracking techniques are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182.

[0027] Recorder 11 displays electrograms 21 captured by body surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured by electrodes 26 on catheter 14. Recorder 11 may include pacing capability for pacing the cardiac rhythm and / or may be electrically connected to a stand-alone pacer.

[0028] The system 10 may include an ablation energy generator 50 adapted to deliver ablation energy to one or more electrodes at the distal tip of a third catheter (not shown) configured for ablation. The third catheter may be used to ablate the ostium of a pulmonary vein (PV), such as the left superior PV (LSPV) 210, to eliminate arrhythmias (e.g., in an alternative procedure to the LAA 85 occlusion shown). The energy generated by the ablation energy generator 50 may include, but is not limited to, radiofrequency (RF) energy or pulsed-field ablation (PFA) energy, including monopolar or bipolar high-voltage DC pulses to effect irreversible electroporation (IRE), or a combination thereof.

[0029] The Patient Interface Unit (PIU) 30 is an interface configured to establish electrical communication between the catheters, electrophysiology equipment, a power source, and a workstation 55 that controls the operation of the system 10. The electrophysiology equipment of the system 10 may include, for example, multiple catheters, location pads 25, body surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, the PIU 30 additionally includes processing capabilities for performing real-time catheter position calculations and ECG calculations.

[0030] The workstation 55 includes a processor unit 56 having a memory 57, a memory or storage device having appropriate operating software loaded therein, and user interface functionality. The workstation 55 may optionally provide multiple functions, including (1) modeling the endocardial anatomy in three dimensions (3D) and rendering the model or anatomical map 20 for display on the display device 27, (2) displaying activation sequences (or other data) compiled from recorded intracardiac electrograms 21 as representative visual representations or images contained in the rendered anatomical map 20 on the display device 27, (3) displaying the real-time positions and orientations of multiple catheters within the cardiac chambers, and (4) displaying target sites, such as locations where ablation energy is being applied, on the display device 27. One commercially available product embodying elements of the system 10 is available as the CARTO™ 3 system, commercially available from Biosense Webster, Inc.

[0031] Optimal transseptal puncture location using a curved trajectory 2 is a schematic, pictorial illustration of catheter 150 at an optimized transseptal puncture location 240, according to one embodiment of the present disclosure. In this example, puncture location 240 is an optimal location found by a processor on the fossa ovalis region 208 of septum 80 by performing the steps described below and shown in FIG. 3. The goal of the puncture procedure is to allow a therapeutic catheter, such as catheter 14, the correct access point 240 to LAA 85.

[0032] FIG. 2 shows the completion of the puncture procedure after location 240 is found, after the physician has brought catheter 150 to the correct origin position 299A, and after the physician has punctured septum 80 at location 240 by advancing puncture guidewire 260 of catheter 150 through sheath 230.

[0033] As shown, the trajectory 246 of the catheter 150 is curved between the insertion location 299A of the guidewire 260 within the sheath 230 and its target location 299B within the LAA 85.

[0034] To find the optimal curve through location 240, the disclosed technique requires the processor to obtain three locations: 1. the target location 299B (e.g., the entrance to the LAA), 2. the septum location 240 on the trajectory the catheter should take based on the bending characteristics of the catheter (e.g., the achievable radius of curvature), and 3. the current location 299A of the device.

[0035] In practice, the physician advances the shaft 220 of the catheter 150, which has an insertion needle attached to its distal end.

[0036] In some examples, the processor acquires location 299B in real time using an anatomical map, such as that generated using the aforementioned US catheter 43 (i.e., using 4D ICE). It further acquires the current location of the distal end of sheath 230 from US imaging. Using known characteristics of the catheter (sheath and shaft), the processor can overlay a candidate trajectory that must terminate at location 299B. The processor executes an algorithm to calculate location 299A and the orientation of the sheath at location 299A, so that, based on its mechanical properties, the trajectory terminates at location 299B. The intersection of this trajectory with the fossa ovalis 208 region of the septum 80 is the optimal puncture location 240. The processor can tag locations 299A and 240 on the anatomical map, so that the physician can manipulate catheter 150 to achieve the proposed trajectory by manipulating the catheter and receiving real-time visual feedback from US imaging.

[0037] The example in Figure 2 is one of several possible examples. Alternatively, the system may perform the procedure using a position sensor-navigated sheath instead of, or in addition to, a sensor-based needle. In this case, the trajectory and position can be calculated based on the navigated sheath data. In another example, the catheter includes a force sensor on the needle, and the processor calculates the trajectory using the catheter's bending properties and force values.

[0038] Figure 3 is a flow chart that schematically illustrates a method for finding an optimized transseptal puncture location as described in Figure 2, according to one embodiment of the present disclosure. The algorithm according to the presented example executes a process that begins with the processor 56 uploading a rendering of at least a portion of the septum, including the adjacent RA volume, and the LA of the patient's heart, in a rendering upload step 302.

[0039] Next, the processor 56 is used to identify a target anatomical location (eg, the entrance 87 to the LAA 85 ) and a candidate puncture location 240 on the fossa ovalis region 208 of the septum 80 in an identification step 304 .

[0040] In a mechanical model uploading step, the processor uploads a mechanical model of the puncture probe (e.g., a catheter with a guidewire or a catheter with a needle-attached shaft, either of which is advanced using a catheter sheath) in a mechanical model uploading step 306. Examples of mechanical properties provided by the model include bending properties such as the minimum radius of curvature and maximum deflection angle of the transseptal catheter as a whole, or such mechanical properties achievable for each of its separate elements (e.g., the sheath and the guidewire or shaft). The model may account for multiple stages of catheter deployment, such as when the shaft or guidewire is within a sheath or partially extended.

[0041] In a trajectory calculation step 308, the processor 56 is used to calculate a trajectory within the LA between the candidate puncture location 240 and the target anatomical location. This trajectory is typically curved.

[0042] Next, the processor 56 is used to calculate the extension of the trajectory within the right atrium in a device location finding step 310, and the probe is aligned with the extension of the trajectory within the right atrium before entering the left atrium to identify the required location for the puncture device within the RA.

[0043] Finally, in a display step 312, the processor 56 displays the proposed trajectory (e.g., trajectory 246) on a rendering, which includes displaying the puncture location on the septum (e.g., location 240) and the location of the puncture device within the RA (e.g., location 299A).

[0044] The exemplary flowchart shown in FIG. 3 has been chosen purely for purposes of conceptual clarity. In some examples, the above process is performed in real time during a clinical procedure. In such cases, the processor can identify the current position of the puncture device within the RA (e.g., guidewire 260 while still within the distal end of sheath 220). The processor can mark the actual current position of the device on a 4D ICE image or otherwise guide the physician based on 3D position coordinates from magnetic sensors on the puncture catheter (e.g., on the shaft and / or sheath) and the alignment between the imaging device and the magnetic sensors.

[0045] Safe transseptal puncture using a linear trajectory 4 is a schematic, pictorial illustration of a catheter 450 at an optimized transseptal puncture location 482, according to another embodiment of the present disclosure. The puncture is performed at a location above the fossa ovalis region (shown as depression 408 in septum 80).

[0046] Because the puncture site is near the aorta, posterior cardiac wall, and esophagus, an incorrect approach could result in perforation. To mitigate risk, the disclosed technique guides the physician on how to position and orient the needle 470 within the RA 47 so that, when advanced (using the shaft 422) from the distal edge 433 of the sheath 430, it follows a selected linear trajectory 84 between the puncture location 482 and the left superior pulmonary vein (LSPV) 410.

[0047] In the disclosed technique, the physician must aim the puncture needle 470 at the ostium of the LSPV 410. To accomplish this, the processor 56 calculates the optimal position and orientation of the needle 470 for puncture. This process occurs in real time, and the physician or processor uses the aforementioned 4D ICE, such as the real-time US image sequence 400, for guidance.

[0048] Using real-time US images 400, the physician can identify the anatomical structures (or the processor can automatically identify the anatomical structures) and plan the safest access path (in the case of a processor, automatically plan the safest access path). As shown, during US image capture steps I, II, and III, the catheter is guided to the proper position and orientation within the RA 47. From the probe position and orientation, the physician can advance the needle in a straight-line trajectory through a puncture location 482 in the fossa ovalis (FO) 408 to the LSPV 410, as shown in step III. Continuous real-time feedback ensures that the physician is fully informed about the current probe position and orientation and how far they deviate from optimal.

[0049] ICE allows a physician or processor to navigate devices that lack position tracking sensing by identifying and segmenting them within the 4D volume acquired with ICE.

[0050] The accuracy of the position and orientation guidance can be improved by using a position tracking sensor. To this end, spatial information about the probe obtained using a magnetic position and orientation sensor such as sensor 29 can be integrated with the US image.

[0051] The inventors have found that the resulting puncture location 482 also provides useful access for a treatment catheter to a treatment location such as the LAA 85.

[0052] 5 is a flowchart that schematically illustrates a method for finding the optimized transseptal puncture location described in FIG. 4, according to one embodiment of the present disclosure. The algorithm according to the presented example executes a process that begins with an ICE display step 502, in which processor 56 displays a real-time rendering (e.g., 4D ICE) of the fossa ovalis region of the septum including the adjacent RA volume, the LA of the patient's heart including the ostium of the LSPV, and the distal tip of the puncture probe. One example of such a rendering is rendering 400.

[0053] Next, in an anatomical structure identification step 504, processor 56 is used to identify target anatomical locations on the rendering that are the LSPV and the fossa ovalis region of the septum.

[0054] In step 506, the processor identifies the optimal position and orientation of the needle of the puncture probe. One way to do this is to extend a straight line trajectory between the center of the LSPV ostium and the center of the fossa ovalis region. The center is defined to a given tolerance, so there is a tolerance across the line in space connecting the two anatomical landmarks. This tolerance is translated into a tolerance for the optimal position and orientation of the probe.

[0055] In one example, such tolerance is displayed (eg, superimposed on the US image) as a narrow acceptance cone into which the physician must bring the distal end of the probe.

[0056] Next, the physician or processor identifies the actual (ie, current) position and orientation of the puncture probe (eg, needle 470) in an actual position and orientation identification step 508.

[0057] In a next check step 510, the current position and orientation are compared (eg visually or by a processor) to the best fit up to a tolerance.

[0058] If the current position and orientation are optimal within tolerance, such as that shown in step III on rendering 400, the physician may perform a transseptal puncture by advancing needle 470 in a straight line trajectory toward the ostium of the LSPV in puncture step 512.

[0059] If the current position and orientation are not optimal within tolerance, for example, as shown in steps I or II on rendering 400, the physician or processor moves the distal end of the puncture probe to improve the position and orientation, as shown in steps I-III on rendering 400, and the process returns to step 508. [Example]

[0060] Example 1 The system (10) includes a display (27) and a processor (55). The display is configured to present a rendering (400) of at least a portion of a septum (80) and left atrium (45) of a patient's heart (12). The processor is configured to (a) identify, in the rendering, the septum and a target anatomical location (299B, 410) to be reached by a probe (14, 150, 450) through the septum, (b) calculate a probe trajectory (84, 246) between the septum and the target anatomical location, including identifying an entry location (82, 482) on the septum for the probe to cross the septum to reach the target anatomical location, and (c) present the entry location to a user for penetrating the septum therein.

[0061] Example 2 10. The system of claim 1, wherein the probe includes a flexible catheter, and the processor is configured to calculate the trajectory based on specific bending characteristics of the catheter.

[0062] Example 3 3. The system (10) of any of Examples 1 and 2, wherein the probe (14, 150, 450) comprises a transseptal needle (470) and the trajectory (84, 246) is a straight line (84).

[0063] Example 4 3. The system (10) of any of Examples 1 and 2, wherein the probe (14, 150, 450) comprises a transseptal guidewire (260).

[0064] Example 5 The system (10) of any one of Examples 1 to 3, wherein the processor (55) is further configured to calculate and display on the rendering (400) the extension of the trajectory within the right atrium to which the probe is aligned before entering the left atrium.

[0065] Example 6 A system (10) as described in any one of Examples 1 to 4, wherein the processor (55) is further configured to identify a target position and orientation of a puncture device (260, 470) coupled to the distal end of the probe along the trajectory.

[0066] Example 7 7. The system (10) of any one of Examples 1 to 6, wherein the rendering (400) is an ultrasound image (400) acquired using an invasive ultrasound probe (43).

[0067] Example 8 8. The system (10) of any one of Examples 1 to 7, wherein the processor (55) is configured to display the probe (14, 150, 450) on the ultrasound image (400).

[0068] Example 9 The system (10) of any one of Examples 1 to 8, wherein the processor (55) is further configured to identify the position and orientation of the distal end of the probe by using a sensor (29) attached to the distal end of the probe.

[0069] Example 10 10. The system (10) of any one of Examples 1 to 9, wherein the target anatomical location is the left atrial appendage (LAA) (85) of the heart and the probe (14) has an LAA occlusion device (40) attached thereto.

[0070] Example 11 10. The system (10) of any one of Examples 1 to 9, wherein the target anatomical location is the ostium (410) of the left superior pulmonary vein (LSPV).

[0071] Example 12 12. The system of any one of Examples 1 to 11, wherein the processor is further configured to align and display on the rendering (i) the current position of the probe, (ii) the entry position, and (iii) the target position in the target anatomical structure.

[0072] Example 13 The method includes (i) identifying, in a rendering (400), at least a portion of a septum (80) and a left atrium (45) of a patient's heart (12). The septum and a target anatomical location (299B, 410) are identified in the rendering to be reached by a probe (14, 150, 450) through the septum. A trajectory of the probe between the septum and the target anatomical location is calculated, including identifying an entry location (82, 482) on the septum for the probe to cross the septum and reach the target anatomical location. The entry location is presented to a user for penetration therein through the septum.

[0073] It will be understood that the embodiments described above are given by way of example, and that the present disclosure is not limited to what is particularly shown and described hereinabove. Rather, the scope of the present disclosure includes both combinations and subcombinations of the various features described above, as well as variations and modifications thereof that would occur to one skilled in the art upon reading the foregoing description and that are not disclosed in the prior art. Documents incorporated by reference into this patent application are to be considered an integral part of this application, provided that, to the extent that any term in these incorporated documents is defined in a manner that contradicts a definition expressly or implicitly made herein, only the definition herein shall be considered.

[0074] [Embodiment] (1) A system comprising: a display configured to present a rendering of at least a portion of the septum and left atrium of the patient's heart; 1. A processor, comprising: In said rendering, identifying (i) said septum and (ii) a target anatomical location reached by a probe through said septum; calculating a trajectory of the probe between the septum and the target anatomical location, the trajectory including identifying an entry position on the septum for the probe to cross the septum and reach the target anatomical location; and presenting the entry location to a user for penetrating the septum. (2) The system of embodiment 1, wherein the probe includes a flexible catheter and the processor is configured to calculate the trajectory based on specific bending characteristics of the catheter. (3) The system of embodiment 1, wherein the probe includes a transseptal needle and the trajectory is linear. (4) The system of embodiment 1, wherein the probe comprises a transseptal guidewire. (5) The system of embodiment 1, wherein the processor is further configured to calculate and display on the rendering the extension of the trajectory within the right atrium to which the probe is aligned before entering the left atrium.

[0075] (6) The system of embodiment 1, wherein the processor is further configured to identify a target position and orientation of a puncture device coupled to the distal end of the probe along the trajectory. (7) The system of embodiment 1, wherein the rendering is an ultrasound image acquired using an invasive ultrasound probe. (8) The system of embodiment 7, wherein the processor is configured to display the probe on the ultrasound image. (9) The system of embodiment 1, wherein the processor is further configured to identify the position and orientation of the distal end of the probe by using a sensor attached to the distal end of the probe. (10) The system of embodiment 1, wherein the target anatomical location is the left atrial appendage (LAA) of the heart and the probe is equipped with an LAA occlusion device.

[0076] (11) The system described in embodiment 1, wherein the target anatomical location is the ostium of the left superior pulmonary vein (LSPV). (12) The system of embodiment 1, wherein the processor is further configured to align (i) the current position of the probe, (ii) the entrance position, and (iii) the target position in the target anatomical structure with each other and display them on the rendering. (13) in rendering, identifying (i) a septum and (ii) a target anatomical location reached by a probe through said septum; calculating a trajectory of the probe between the septum and the target anatomical location, the trajectory including identifying an entry position on the septum for the probe to cross the septum and reach the target anatomical location; and presenting the entry location to a user for penetrating the septum. (14) The method of embodiment 13, wherein the probe includes a flexible catheter, and the processor is configured to calculate the trajectory based on specific bending characteristics of the catheter. (15) The method of embodiment 13, wherein the probe comprises a transseptal needle and the trajectory is linear.

[0077] (16) The method of embodiment 13, wherein the probe comprises a transseptal guidewire. (17) The method of embodiment 13, further comprising calculating and displaying on the rendering an extension of the trajectory within the right atrium to which the probe is aligned before entering the left atrium. (18) The method of claim 13, further comprising identifying a target location and orientation of a lancing device coupled to the distal end of the probe along the trajectory. (19) The method of embodiment 13, wherein the rendering is an ultrasound image acquired using an invasive ultrasound probe. (20) The method of embodiment 19, comprising displaying the probe on the ultrasound image.

[0078] (21) The method of embodiment 13, wherein identifying the position and orientation of the distal end of the probe includes using a sensor attached to the distal end of the probe. (22) The method of embodiment 13, wherein the target anatomical location is the left atrial appendage (LAA) of the heart and the probe is fitted with an LAA occlusion device. (23) The method of embodiment 13, wherein the target anatomical location is the ostium of the left superior pulmonary vein (LSPV). (24) The method of embodiment 13, comprising aligning (i) the current position of the probe, (ii) the entrance position, and (iii) the target position in the target anatomical structure with each other and displaying them on the rendering.

Claims

1. 1. A system comprising: a display configured to present a rendering of at least a portion of the septum and left atrium of the patient's heart; 1. A processor, comprising: In said rendering, identifying (i) the septum and (ii) a target anatomical location reached by a probe through the septum; calculating a trajectory of the probe between the septum and the target anatomical location, the trajectory including identifying an entry position on the septum for the probe to cross the septum and reach the target anatomical location; and presenting the entry location to a user for penetrating the septum.

2. The system of claim 1 , wherein the probe includes a flexible catheter, and the processor is configured to calculate the trajectory based on particular bending characteristics of the catheter.

3. The system of claim 1 , wherein the probe comprises a transseptal needle and the trajectory is linear.

4. The system of claim 1 , wherein the probe comprises a transseptal guidewire.

5. The system of claim 1 , wherein the processor is further configured to calculate and display on the rendering an extension of the trajectory in the right atrium to which the probe is aligned before entering the left atrium.

6. The system of claim 1 , wherein the processor is further configured to identify a target location and orientation of a lancing device coupled to a distal end of the probe along the trajectory.

7. The system of claim 1 , wherein the rendering is an ultrasound image acquired using an invasive ultrasound probe.

8. The system of claim 7 , wherein the processor is configured to display the probe on the ultrasound image.

9. The system of claim 1 , wherein the processor is further configured to identify a position and orientation of the distal end of the probe by using a sensor attached to the distal end of the probe.

10. The system of claim 1 , wherein the target anatomical location is a left atrial appendage (LAA) of the heart and the probe has an LAA occlusion device attached thereto.

11. The system of claim 1 , wherein the target anatomical location is the ostium of the left superior pulmonary vein (LSPV).

12. 2. The system of claim 1, wherein the processor is further configured to align and display on the rendering (i) the current position of the probe, (ii) the entry position, and (iii) a target position in the target anatomy.

13. In rendering, identifying (i) a septum and (ii) a target anatomical location reached by a probe through said septum; calculating a trajectory of the probe between the septum and the target anatomical location, the trajectory including identifying an entry position on the septum for the probe to cross the septum and reach the target anatomical location; and presenting the entry location to a user for penetrating the septum.

14. The method of claim 13 , wherein the probe includes a flexible catheter, and the processor is configured to calculate the trajectory based on particular bending characteristics of the catheter.

15. The method of claim 13 , wherein the probe comprises a transseptal needle and the trajectory is linear.

16. The method of claim 13 , wherein the probe comprises a transseptal guidewire.

17. 14. The method of claim 13, further comprising calculating and displaying on the rendering an extension of the trajectory in the right atrium to which the probe is aligned before entering the left atrium.

18. The method of claim 13 , including identifying a target location and orientation of a lancing device coupled to a distal end of the probe along the trajectory.

19. The method of claim 13 , wherein the rendering is an ultrasound image acquired using an invasive ultrasound probe.

20. 20. The method of claim 19, comprising displaying the probe on the ultrasound image.

21. The method of claim 13 , wherein identifying the position and orientation of the distal end of the probe includes using a sensor attached to the distal end of the probe.

22. 14. The method of claim 13, wherein the target anatomical location is the left atrial appendage (LAA) of the heart and the probe is fitted with an LAA occlusion device.

23. 14. The method of claim 13, wherein the target anatomical location is the ostium of the left superior pulmonary vein (LSPV).

24. 14. The method of claim 13, comprising registering and displaying on the rendering: (i) the current position of the probe, (ii) the entry position, and (iii) a target position in the target anatomy.