Safety alerts based on 4D intracardiac echocardiographic (ICE) catheter tracking

The 4D ICE probe with integrated sensors tracks treatment devices and landmarks to provide real-time alerts, addressing the challenge of unseen sensitive tissues during invasive procedures, thereby improving procedural safety.

JP2025528997APending Publication Date: 2025-09-04BIOSENSE WEBSTER (ISRAEL) LTD
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Patent Information

Application Number
JP2024570334
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-09-01
Filing Date
2023-08-02
Publication Date
2025-09-04

AI Technical Summary

Technical Problem

Existing ultrasound imaging systems fail to accurately alert physicians about sensitive tissue regions that may not be visible in real-time images during invasive procedures, leading to potential tissue damage from treatment devices.

Method used

A 4D intracardiac echocardiographic (ICE) probe with integrated position sensors tracks both the treatment device and anatomical landmarks, providing real-time alerts when the treatment device approaches sensitive areas, even if those areas are not currently visible in the ultrasound image.

Benefits of technology

Ensures precise tracking and alerts physicians of potential tissue damage, enhancing procedural safety by preventing injuries to unseen sensitive tissues during cardiac interventions.

✦ Generated by Eureka AI based on patent content.

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Abstract

The medical system includes an ultrasound probe, a treatment probe, and a processor. The ultrasound probe and the treatment probe are each configured to be inserted into an organ to image a volume of the organ and introduce a treatment device therein. The probes each include a first sensor configured to output a first signal indicative of a first position of an ultrasound transducer array of the probe within the organ and a second sensor configured to output a second signal indicative of a second position of the treatment device within the organ. The processor is configured to receive tags added to ultrasound images acquired using the ultrasound probe and marking tissue regions of the organ, align the first position of the ultrasound transducer array and the second position of the treatment device with each other, use the alignment to track the relative position between the treatment device and the tagged tissue region, and (iv) issue an alert to a user when the treatment device is within a predefined proximity range of the tagged tissue region.
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Description

[Technical Field]

[0001] The present disclosure relates generally to treatment systems utilizing internal medical probes, and more particularly to using location-tracked medical ultrasound (US) probes to provide alerts of potential danger from the location-tracked treatment probes. [Background technology]

[0002] Various methods for guiding a catheter using a medical ultrasound probe have been proposed. For example, U.S. Patent No. 7,981,038 describes a method and system for generating images of an object, such as a human heart. The method may include acquiring an ultrasound image of the object using a catheter equipped with a position sensor. The method may also include capturing a plurality of 4D surface registration points within the acquired ultrasound image corresponding to points on the object. The method may also include spatially and temporally registering a high-resolution 4D model of the object with the plurality of 4D surface registration points. The method may also include displaying a high-resolution, real-time image of the object during the medical procedure based on the registration of the high-resolution 4D model to the 4D surface registration points. Examples of the present disclosure are particularly useful in left atrial ablation procedures. According to other embodiments, two or more catheters may be used. In such examples, a clinician may insert a second catheter containing an ablation device into the relevant region of the heart. Preferably, such an ablation catheter would also include a position sensor so that a position tracking system can track the position and orientation of the second catheter. That way, the clinician can use one catheter to acquire ultrasound images and the other catheter to perform the ablation.

[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 an ultrasound imaging-based system capable of alerting a user performing an ablation in real time when the ablation catheter is too close to a sensitive area, according to one embodiment of the present disclosure. [Figure 2] 2 is a schematic, pictorial illustration of an ultrasound image generated in real time by the system of FIG. 1 to visualize the cause of an alert, according to one embodiment of the present disclosure. [Figure 3] 10 is a flowchart that generally illustrates a method for alerting a physician administering a treatment in real time when a treatment probe is too close to a tagged tissue region, according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0005] overview When using a probe to perform invasive treatment of an internal organ, such as surgical cutting or ablation, there may be certain areas of the organ that the physician may want to avoid. As an example, when creating a transseptal puncture of the heart, it is important to avoid puncturing the aorta. When radiofrequency (RF) ablation of the ostia of a pulmonary vein, it is important to avoid creating lesions through the esophageal wall.

[0006] If ultrasound imaging, e.g., intracardiac ultrasound (ICE), is available, the physician may scan the area surrounding the target treatment site to search for sensitive tissue regions (hereinafter also referred to as "landmark locations") and memorize such specific landmarks to be avoided before selecting a location for performing treatment (e.g., puncture or ablation). During the invasive procedure, the system may display one or more selected ultrasound image slices captured by the ICE probe in real time to allow the physician to verify the safety of the invasive procedure.

[0007] However, sensitive tissue regions that should be avoided may not appear in the selected ultrasound image slices displayed to the physician during the procedure. The sensitive tissue regions may move during the procedure. Furthermore, increasing the number of displayed ultrasound image slices may be impractical and may not help the user understand the real-time updated 3D information.

[0008] The embodiments of the present disclosure described herein provide methods and systems for alerting a physician when a treatment device fitted onto a treatment probe is positioned in a specific area that the physician may wish to avoid. In some embodiments, the physician scans a volume with a 4D ICE ultrasound probe prior to ablation or puncture. The physician uses a graphical user interface (GUI) to tag (e.g., draw with one click) landmark locations on the image to be avoided. Once the landmarks are tagged, 4D ultrasound acquisition of the tagged tissue region in the image continues without necessarily showing an image of the tagged region to the physician. A software module uses real-time ultrasound data to track the landmark locations in real time.

[0009] To this end, the disclosed technique uses a 4D ICE probe that images a treatment device fitted onto the treatment probe in real time. Both the 4D ICE probe and the treatment probe are positionally tracked by a position tracking system using a position sensor (e.g., a magnetic sensor) fitted to the probe. The sensor outputs a first signal indicating a first position of an ultrasound transducer array inside the organ. The position sensor in the 4D ICE probe is pre-aligned with the 2D ultrasound array of the 4D ICE probe, so the positions of the imaged voxels of the anatomical structure are also known.

[0010] The 2D array of the 4D ICE probe generates a fan-shaped ultrasound beam with a wide field of view (FOV), thus enabling imaging of large anatomical structures of an organ, such as the entire cardiac chamber. The wide FOV of the ultrasound beam allows the US probe to acquire various sensitive tissue regions, even if those regions are not currently visible to the physician. In other words, the US probe can capture all relevant landmarks, including those not currently visible to the physician, while the invasive procedure is being performed.

[0011] As mentioned above, the location of the treatment device is also known, for example, based on a precise integrated position sensor (e.g., a magnetic sensor) fitted to the treatment probe, which outputs a second signal indicating a second position of the treatment device inside the organ. To correlate the positions of the two different probes, the processor of the position tracking system aligns the positions of the US probe and the treatment probe with each other. The processor also compares the tracked location of the landmark with the tracked location of the invasive treatment probe tip (e.g., of an electrode of an ablation catheter or of a surgical cutting / piercing tool such as a transseptal needle) in real time. In this way, the processor can correlate the location of the treatment device with the location of tagged landmark locations in real time with 1 mm accuracy. Based on such capabilities, the processor alerts the physician when the treatment probe tip is too close to a tagged tissue area.

[0012] Thus, in some examples, a medical system is provided that includes a 4D ultrasound probe, a treatment probe, and a processor configured to (i) receive tagging on an ultrasound image of one or more tissue regions of an organ acquired using the 4D ultrasound probe, (ii) align positions of integrated position sensors of the ultrasound imaging and treatment probes with respect to one or more tagged tissue regions, (iii) use the aligned positions to track the position of a treatment device mated to the treatment probe relative to the one or more tagged tissue regions, and (iv) alert a user in real time when the treatment device is within a predefined proximity range of the tagged tissue regions.

[0013] The user may set a threshold to define the proximity to a tagged tissue region (e.g., to a tagged landmark location) required before providing an alert to the user. The alert may be visual, audible, and / or tactile. This alert serves as a safety net for the physician. Even if the landmark location is not within the FOV of the real-time image slice being displayed on the screen, the system still identifies the proximity and provides an alert.

[0014] System Description 1 is a schematic, pictorial illustration of an ultrasound (US) imaging-based system 20 capable of alerting a user performing an ablation procedure in real time when the ablation catheter is too close to a sensitive tissue region, according to one embodiment of the present disclosure. System 20 uses a 4D ultrasound probe 21 having a US probe distal tip assembly 60 (shown in inset 25) with a 2D ultrasound array 65 and an integrated position sensor 67 to monitor in real time a location-tracked radiofrequency (RF) ablation catheter 40 having a catheter distal tip assembly 62 with a position sensor 47 and an ablation electrode 48.

[0015] The physician 30 advances the distal end assembly 60 of the US probe 21 through the inferior vena cava (IVC) 43 into the right atrium of the heart 26, from where the physician images the inter-atrial septum 50 (typically before performing a transseptal puncture). In the illustrated example, the ablation catheter 40 is inserted through the superior vena cava (SVC) 42 using a sheath 44.

[0016] As can be seen, the 2D ultrasound array 65 generates a 3D fan-shaped ultrasound beam 265 that occupies a defined solid angle (such a beam is referred to herein as a "wedge 265"). With the wide FOV covered by the wedge 265, the 2D ultrasound array can image a substantial volume of an organ, such as an entire cardiac chamber (e.g., the entire left atrium (LA) 45).

[0017] The distal tip assembly 60 is fitted at the distal end of the catheter shaft 22. The shaft 22 is inserted through a sheath 23 into the heart 26 of a patient 28 lying on an operating table 29. The proximal end of the shaft 22 is connected to a control console 24. To orient the ultrasound array in the required orientation, the physician can use, for example, a manipulator 32 near the proximal end of the US probe 21.

[0018] The integrated position sensor 67 of the US probe 21 is pre-aligned with the US probe's array 65. Due to the integrated location sensor, the spatial coordinates of all voxels within the imaged chamber are known. Specifically, the sensor 67 is configured to output a first signal indicative of the location and orientation of the ultrasound transducer array 65 within the heart 26.

[0019] Any imaged target anatomy (eg, left atrium 45 including pulmonary vein ostia 55) may be presented to physician 30 by processor 41 on monitor 27, for example, as volumetric rendering 33.

[0020] After puncturing the septum 50 (e.g., using the sheath 44), the US probe 21 images the entire LA 45 with the ablation catheter 40 positioned therein, e.g., near the ostium 55. The 2D ultrasound array-generated image therefore includes the ablation electrode 48.

[0021] Thus, distal end assembly 62 of RF ablation catheter 40 is further seen inserted through sheath 44 into LA 45 to perform ablation within LA 45 using electrodes 48 while being imaged in real time using 4D ICE probe 21. As shown, esophagus 99 passes closely through the posterior wall of LA 45, and sensitive esophageal 99 tissue may suffer thermal damage if exposed to ablation heat.

[0022] To alert the user that the location of the RF ablation electrode 48 is close to a sensitive tissue area (e.g., in the esophagus 99), the user or processor tags the sensitive area, such as the portion of the posterior wall that overlaps the esophagus 99. The physician uses a graphical user interface (GUI) 100 to tag or render (e.g., draw with one click) landmark locations to be avoided on the ultrasound image. To this end, the physician scans the volume with a 4D ICE ultrasound probe prior to ablation or puncture. The GUI 100 may include a touchscreen 27 as well as a keyboard and trackball.

[0023] For example, once tagged by a physician, ultrasound acquisition of the tagged tissue region continues without necessarily showing the physician the tagged region. A software module uses the real-time ultrasound data to track the location of the landmark in real time. Using the software, the processor further compares the tracked location of the landmark with the real-time location of the invasive probe tip (e.g., of an ablation catheter or transseptal needle) and warns the physician if the RF probe tip electrode 48 is too close to the tagged tissue region. The system alerts the physician if the ablation electrode 48 is too close to an unrelated tissue region that may be harmed by RF ablation.

[0024] The control console 24 includes a processor 41, typically a general-purpose computer, with suitable front-end and interface circuitry 38 for receiving signals from the catheter 21. The console 24 also includes a driver circuit 34 configured to drive the magnetic field generator 36. During navigation of the distal end 22 within the heart 26, the console 24 receives location and orientation signals from the position sensors 67 and 47 in response to magnetic fields from the external magnetic field generator 36. The magnetic field generator 36 is positioned at a known location external to the patient 28, for example, beneath the table 29 on which the patient lies. These location and orientation signals indicate the location and orientation of the ultrasound array 65 in the coordinate system of the position tracking system.

[0025] Location and orientation sensing methods using external magnetic fields have been implemented in a variety of medical applications, for example, in the CARTO™ system manufactured by Biosense Webster, and are described in detail in U.S. Pat. Nos. 6,618,612 and 6,332,089, WO 96 / 05768, and U.S. Patent Application Publication Nos. 2002 / 0065455, 2003 / 0120150, and 2004 / 0068178, the disclosures of which are all incorporated herein by reference.

[0026] The processor 41 is programmed with software to perform the functions described herein. The software may be downloaded into the computer's memory 35 in electronic form, for example, over a network, or alternatively or additionally may be provided and / or stored on a non-transitory tangible medium, such as magnetic, optical, or electronic memory. In particular, the processor 41 executes dedicated algorithms as disclosed herein, including FIG. 2, that enable the processor 41 to perform the disclosed steps, as further described below.

[0027] 1 is chosen solely for conceptual clarity. The disclosed techniques may be similarly applied using probe / catheter access other than through the IVC 43 / SVC 44, such as via another vein or via an artery. In the example described above, the alert is for danger to the esophagus 99, but any sensitive anatomical structures, such as the left atrium appendage (LAA) 57 and the bulging area near the septum 50, may be tagged to avoid injury.

[0028] Real-time monitoring of fixed-position therapeutic catheters using a fixed-position 4D ICE probe As described above, the processor executes a software module to track the location of landmarks in real time using 4D ultrasound data. In the process, the processor also compares the tracked location of the landmarks with the real-time location of an invasive probe tip (e.g., an electrode of an ablation catheter or a transseptal needle). The processor alerts the physician if the probe tip is too close to a tagged tissue region. This alert can be provided without displaying an associated image to the physician. Nevertheless, in some instances, it is beneficial for the physician to receive an associated view (e.g., a 2D or 3D reconstruction) that visualizes the cause of the alert.

[0029] 2 is a schematic, pictorial illustration of an ultrasound image 200 that the system 20 of FIG. 1 generates in real time to visualize the cause of an alert, according to one embodiment of the present disclosure. The image shown in FIG. 2 is an image of a slice, although in general the image can be a 3D rendering.

[0030] 2 is generated and presented by processor 41 after the processor has issued an alert (e.g., an audiovisual alert). Image 200 (e.g., ultrasound view 200) highlights ablation electrode 248 of catheter 240 in contact with tagged region 245 of the posterior wall of LA 45, thereby being too close to delineated esophageal region 299 (as determined using a distal sensor on probe 240, not shown in FIG. 2 but shown as sensor 47 in FIG. 1). As can be seen, the physician receives a view indicating why the system issued the alert, and the displayed view clearly shows the spatial relationship between the aforementioned elements in close proximity (i.e., the ablation electrode relative to the esophagus).

[0031] The user may instruct the processor to generate other views, i.e., 3D renderings, for example, from different viewing directions of the treatment device relative to the tagged tissue region.

[0032] A method for real-time monitoring of fixed-position therapeutic catheters using a fixed-position 4D ICE probe 3 is a flow chart that schematically illustrates a method for alerting a physician performing a treatment in real time when a treatment probe is too close to a tagged tissue region, according to one embodiment of the present disclosure. As an example, the system referred to is system 20 of FIG. 1, where the treatment probe is an ablation catheter 40. According to the example provided, the algorithm implements a process that begins with physician 30 imaging heart 26 at ICE step 302, as seen in FIG. 1. Processor 41 displays a 3D rendering of the imaged portion of the heart.

[0033] In a tagging step 304, processor 41 receives (eg, from physician 30) tags indicating landmark locations (one or more tissue regions, such as within the posterior wall of LA 45) that should be avoided during RF ablation.

[0034] Next, in a tracking step 306, the processor 41 uses 4D ICE and software to track the tags in real time while the physician positions the ablation catheter 40 with the electrodes 48 in the required locations for ablation. Tagging benefits from the wide FOV of the wedge 265; even tagged tissue regions that are not currently visible to the physician 30 are still acquired with the US probe 21, and the acquired data is processed to enable tracking.

[0035] In parallel, in a therapy device tracking step 308, processor 41 uses a magnetic tracking system to track position electrode 48 while the physician positions ablation catheter 40 to begin ablation. The tracking system includes a US probe tracking signal (from sensor 67) and a tracking signal from sensor 47 of the aligned catheter 40, allowing processor 41 to correlate the location of electrode 48 to the location of landmark locations within 1 mm accuracy in real time.

[0036] Finally, in an alerting step 310, processor 41 issues an alert (e.g., a flashing message accompanied by a beep) whenever the processor identifies that the electrode 48 location and one of the landmark locations are closer to each other than a predefined minimum distance. For example, the processor issues an alert when the electrode is in contact with the posterior wall of the LA 45 just anterior to the esophagus 99.

[0037] The exemplary flowchart shown in Figure 3 has been chosen purely for purposes of conceptual clarity, as additional steps may be performed, such as occasional x-ray imaging.

[0038] Although the embodiments described herein primarily address monitoring of cardiac treatment probes with cardiac ultrasound imaging probes, the techniques described herein can also be used in other organs, such as the digestive system. Is this correct? [Example]

[0039] Example 1 The medical system (20) includes an ultrasound probe (21), a treatment probe (40, 240), and a processor (41). The ultrasound probe is configured to be inserted into an organ of a body and includes an ultrasound transducer array (65) configured to image a volume of the organ and a first sensor (67) configured to output a first signal indicative of a first position of the ultrasound transducer array within the organ. The treatment probe is configured to be inserted into the organ and includes a treatment device (48, 248) fitted at a distal end of the treatment probe and a second sensor (47) configured to output a second signal indicative of a second position of the treatment device within the organ. The processor is configured to (i) receive tags that have been added by a user to one or more ultrasound images (200) acquired using the ultrasound probe and that mark one or more tissue regions (245) of an organ, (ii) align a first position of the ultrasound transducer array and a second position of the treatment device with respect to one another, (iii) use the aligned first and second positions to track the relative position between the treatment device and the one or more tagged tissue regions, and (iv) alert the user when the treatment device (248) is within a predefined proximity range of the tagged tissue region (245).

[0040] Example 2 10. The system (20) of example 1, wherein the first sensor and the second sensor are magnetic position sensors configured to generate a first signal and a second signal in response to a magnetic field applied by the position tracking system.

[0041] Example 3 3. The system of any one of the preceding examples, wherein the processor is configured to alert the user by issuing an audiovisual alert.

[0042] Example 4 4. The system of any one of Examples 1 to 3, wherein the processor (41) is configured to generate an ultrasound view (200) showing the treatment device relative to the tagged tissue region.

[0043] Example 5 The system of any one of Examples 1 to 4, wherein the processor (41) is configured to generate an ultrasound view (200) having a field of view (FOV) that does not include the tagged tissue region and to alert the user when the treatment device is within a predefined proximity range of the tagged tissue region, even if the tagged tissue region is not visible in the ultrasound view.

[0044] Example 6 The system of any one of Examples 1 to 5, wherein the treatment device comprises one of a surgical cutting tool, a transseptal access device, and an ablation electrode (48, 248).

[0045] Example 7 The system of any one of Examples 1 to 6, wherein the processor (41) is configured to receive tags by a user tagging the ultrasound image using a graphical user interface (GUI) (100).

[0046] Example 8 8. The system of any one of Examples 1 to 7, wherein the processor (41) is configured to receive tags by receiving a tagged anatomical map that is aligned with the ultrasound image and tagging the ultrasound image using the tagged anatomical map.

[0047] Example 9 The system of any one of Examples 1 to 8, wherein the organ is a heart (26).

[0048] Example 10 The method includes inserting an ultrasound probe into a bodily organ, the ultrasound probe including an ultrasound transducer array configured to image a volume of the organ and a first sensor configured to output a first signal indicating a first position of the ultrasound transducer array within the organ. A treatment probe is inserted into the organ, the treatment probe including a treatment device fitted at a distal end of the treatment probe and a second sensor configured to output a second signal indicating a second position of the treatment device within the organ. Tags added by a user to one or more ultrasound images acquired using the ultrasound probe and marking one or more tissue regions of the organ are received. The first position of the ultrasound transducer array and the second position of the treatment device are registered with each other. The registered first and second positions are used to track the relative position between the treatment device and one or more tagged tissue regions. An alert is issued to the user when the treatment device is within a predefined proximity range of the tagged tissue regions.

[0049] Therefore, it will be understood that the embodiments described above are cited by way of example, and that the present disclosure is not limited to what has been shown and described herein above. Rather, the scope of the present disclosure includes both combinations and subcombinations of the various features described herein above, as well as variations and modifications thereof not disclosed in the prior art that would occur to one skilled in the art upon reading the foregoing description. Documents incorporated by reference into this patent application should 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 should be considered.

[0050] [Embodiment] (1) A health care system: 1. An ultrasound probe for insertion into a body organ, comprising: an ultrasound transducer array configured to image a volume of the organ; a first sensor configured to output a first signal indicative of a first position of the ultrasound transducer array within the organ; and a treatment probe for insertion into said organ, a treatment device fitted at the distal end of the treatment probe; a second sensor configured to output a second signal indicative of a second position of the treatment device within the organ; and 1. A processor, comprising: receiving tags that have been added by a user to one or more ultrasound images acquired using the ultrasound probe and that mark one or more tissue regions of the organ; aligning the first position of the ultrasound transducer array and the second position of the treatment device with each other; using the registered first and second positions to track a relative position between the treatment device and the one or more tagged tissue regions; a processor configured to alert a user when the treatment device is within a predefined proximity range of a tagged tissue region. (2) The system of embodiment 1, wherein the first sensor and the second sensor are magnetic position sensors configured to generate the first signal and the second signal in response to a magnetic field applied by a position tracking system. (3) The system of embodiment 1, wherein the processor is configured to alert the user by issuing an audiovisual alert. (4) The system of embodiment 1, wherein the processor is configured to generate an ultrasound view showing the treatment device relative to the tagged tissue region. (5) The system of embodiment 1, wherein the processor is configured to generate an ultrasound view having a field of view (FOV) that does not include the tagged tissue region and to alert the user when the treatment device is within the predefined proximity range of the tagged tissue region, even if the tagged tissue region is not visible in the ultrasound view.

[0051] (6) The system of embodiment 1, wherein the treatment device comprises one of a surgical cutting tool, a transseptal access device, and an ablation electrode. (7) The system of embodiment 1, wherein the processor is configured to receive the tag by the user tagging the ultrasound image using a graphical user interface (GUI). (8) The system of embodiment 1, wherein the processor is configured to receive the tag by receiving a tagged anatomical map that is aligned with an ultrasound image and tagging the ultrasound image using the tagged anatomical map. (9) The system of embodiment 1, wherein the organ is a heart. (10) A method comprising: Inserting an ultrasound probe into a bodily organ, the ultrasound probe comprising: an ultrasound transducer array configured to image a volume of the organ; a first sensor configured to output a first signal indicative of a first position of the ultrasound transducer array within the organ; inserting a treatment probe into the organ, the treatment probe comprising: a treatment device fitted at the distal end of the treatment probe; a second sensor configured to output a second signal indicative of a second position of the treatment device within the organ; receiving tags that have been added by a user to one or more ultrasound images acquired using the ultrasound probe and that mark one or more tissue regions of the organ; Aligning the first position of the ultrasound transducer array and the second position of the treatment device with each other; tracking a relative position between the treatment device and the one or more tagged tissue regions using the registered first and second positions; alerting a user when the treatment device is within a predefined proximity range of a tagged tissue region.

[0052] (11) The method of embodiment 10, wherein the first sensor and the second sensor are magnetic position sensors configured to generate the first signal and the second signal in response to a magnetic field applied by a position tracking system. (12) The method of embodiment 10, wherein alerting the user includes issuing an audiovisual alert. (13) The method of embodiment 10, wherein generating an ultrasound view includes showing the treatment device relative to the tagged tissue region. (14) The method of embodiment 10, comprising generating an ultrasound view having a field of view (FOV) that does not include the tagged tissue region, and alerting the user when the treatment device is within the predefined proximity range of the tagged tissue region even if the tagged tissue region is not visible in the ultrasound view. (15) The method of embodiment 10, wherein the treatment device comprises one of a surgical cutting tool, a transseptal access device, and an ablation electrode.

[0053] (16) The method of embodiment 10, wherein receiving the tag includes the user tagging the ultrasound image using a graphical user interface (GUI). (17) The method of embodiment 10, wherein receiving the tag includes receiving a tagged anatomical map that is registered with an ultrasound image, and tagging the ultrasound image using the tagged anatomical map. (18) The method of embodiment 10, wherein the organ is the heart.

Claims

1. 1. A healthcare system comprising:

1. An ultrasound probe for insertion into a body organ, comprising: an ultrasound transducer array configured to image a volume of the organ; a first sensor configured to output a first signal indicative of a first position of the ultrasound transducer array within the organ; and a treatment probe for insertion into said organ, a treatment device fitted at the distal end of the treatment probe; a second sensor configured to output a second signal indicative of a second position of the treatment device within the organ; and 1. A processor, comprising: receiving tags that have been added by a user to one or more ultrasound images acquired using the ultrasound probe and that mark one or more tissue regions of the organ; aligning the first position of the ultrasound transducer array and the second position of the treatment device with each other; using the registered first and second positions to track a relative position between the treatment device and the one or more tagged tissue regions; a processor configured to alert a user when the treatment device is within a predefined proximity range of a tagged tissue region.

2. 2. The system of claim 1, wherein the first sensor and the second sensor are magnetic position sensors configured to generate the first signal and the second signal in response to a magnetic field applied by a position tracking system.

3. The system of claim 1 , wherein the processor is configured to alert the user by issuing an audiovisual alert.

4. The system of claim 1 , wherein the processor is configured to generate ultrasound views showing the treatment device relative to the tagged tissue region.

5. 2. The system of claim 1, wherein the processor is configured to generate ultrasound views having a field of view (FOV) that does not include tagged tissue regions and to alert the user when the treatment device is within the predefined proximity range of the tagged tissue regions even if the tagged tissue regions are not visible in the ultrasound views.

6. The system of claim 1 , wherein the treatment device comprises one of a surgical cutting tool, a transseptal access device, and an ablation electrode.

7. The system of claim 1 , wherein the processor is configured to receive the tag by the user tagging the ultrasound image using a graphical user interface (GUI).

8. 10. The system of claim 1, wherein the processor is configured to receive the tags by receiving a tagged anatomical map that is registered with an ultrasound image and tagging the ultrasound image using the tagged anatomical map.

9. The system of claim 1 , wherein the organ is a heart.

10. 1. A method comprising: Inserting an ultrasound probe into a bodily organ, the ultrasound probe comprising: an ultrasound transducer array configured to image a volume of the organ; a first sensor configured to output a first signal indicative of a first position of the ultrasound transducer array within the organ; inserting a treatment probe into the organ, the treatment probe comprising: a treatment device fitted at the distal end of the treatment probe; a second sensor configured to output a second signal indicative of a second position of the treatment device within the organ; receiving tags that have been added by a user to one or more ultrasound images acquired using the ultrasound probe and that mark one or more tissue regions of the organ; Aligning the first position of the ultrasound transducer array and the second position of the treatment device with each other; tracking a relative position between the treatment device and the one or more tagged tissue regions using the registered first and second positions; alerting a user when the treatment device is within a predefined proximity range of a tagged tissue region.

11. 11. The method of claim 10, wherein the first sensor and the second sensor are magnetic position sensors configured to generate the first signal and the second signal in response to a magnetic field applied by a position tracking system.

12. The method of claim 10 , wherein alerting the user includes issuing an audiovisual alert.

13. The method of claim 10 , wherein generating an ultrasound view includes showing the treatment device relative to the tagged tissue region.

14. 11. The method of claim 10, comprising generating an ultrasound view having a field of view (FOV) that does not include a tagged tissue region, and alerting the user when the therapy device is within the predefined proximity range of the tagged tissue region even if the tagged tissue region is not visible in the ultrasound view.

15. The method of claim 10 , wherein the treatment device comprises one of a surgical cutting tool, a transseptal access device, and an ablation electrode.

16. The method of claim 10 , wherein receiving the tag includes the user tagging the ultrasound image using a graphical user interface (GUI).

17. 11. The method of claim 10, wherein receiving the tags comprises receiving a tagged anatomical map that is registered with an ultrasound image, and tagging the ultrasound image using the tagged anatomical map.

18. The method of claim 10, wherein the organ is the heart.