Visualization of distal end effector on bi-planar view or tri-planar view using intracardiac echography

Abstract

A medical system includes a utility probe and an ultrasound probe, and a processor. The probes are configured for operation within an organ. A utility probe includes a distal end effector and a first sensor configured to output a first signal indicative of a first position of the distal end effector. The ultrasound probe includes an ultrasound transducer array configured to image a volume including a portion of a distal end effector within the organ and a second sensor configured to output a second signal indicative of a second position of the ultrasound transducer array. The processor is configured to: select slices of the imaging volume using the imaging volume and the first and second positions, the slices including at least components of the distal end effector in spatial relationship with the organ; generating a bi-planar view and / or a tri-planar view of the component of the distal end effector from the selected slice; and presenting the bi-planar view and / or the tri-planar view to a user.

Description

Technical Field

[0001] The present disclosure relates generally to visualization of invasive medical devices, and particularly to real-time visualization of cardiac probes using ultrasound (US) probes. Background Art

[0002] Medical visualization using invasive US probes has been proposed previously in the patent literature. For example, U.S. Patent 7,604,601 describes a medical imaging system for imaging a patient's body, the system comprising a catheter having a magnetic position sensor and an ultrasound imaging sensor. A processor determines position information of a portion of the catheter based on an electrical signal sent by the position sensor. The processor displays a catheter icon on a display in the same orientation as the orientation of the portion of the catheter in the patient's body based on the position information derived from the magnetic position sensor. The processor also generates an ultrasound image of a target based on a signal sent by the ultrasound sensor, and depicts the generated ultrasound image in real time on a display in the same orientation as the orientation of the portion of the catheter in the patient's body based on the position information derived from the magnetic position sensor.

[0003] The present disclosure will be more fully understood through the following detailed description of examples of the present disclosure in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Figure 1 is a schematic illustration of a probe-based ultrasound (US) imaging and electrophysiological (EP) mapping and ablation system according to one example of the present disclosure;

[0005] Figure 2 According to the example of the present disclosure Figure 1 US biplane view of the distal end effector arm (or spline) of the EP mapping catheter, which is Figure 1 The two US slices selected from the volume acquired by the US probe are exported; and

[0006] Figure 3 is a schematic diagram showing a method of selecting and processing an image according to an example of the present disclosure. Figure 1 Flow chart of a method for acquiring US slices using a US probe to visualize a distal end effector in a bi-plane or tri-plane US view. DETAILED DESCRIPTION

[0007] Overview

[0008] During a probe-based clinical procedure in a lumen of a patient's organ, different distal end effectors of a utility probe (eg, a catheter and / or other invasive probe) may be inserted into the organ.

[0009] One example of an invasive procedure is the diagnosis and treatment of arrhythmias in a cardiac chamber. In this example, an EP mapping catheter having multiple electrodes on a distal end effector is inserted to acquire data points that are used by a processor to generate an electroanatomical model (e.g., an EP map) of the cardiac chamber of interest. Another example of such an invasive procedure is a heart valve replacement or a left atrial appendage occlusion device.

[0010] One example of a distal end effector is an expandable multi-stripe assembly, such as a basket assembly. Another example is an expandable multi-arm assembly, such as Figure 1 and Figure 2 As shown in Yet another example is a delivery system for a prosthetic valve.

[0011] Practical probes such as EP mapping catheters or therapeutic catheters such as electroablation catheters can be visualized during clinical procedures using an ultrasound (US) probe that is also inserted into the heart.

[0012] The utility probe may also be visualized using other imaging probes, such as by a transesophageal ultrasound (TEE) probe, which may have a sensor or use another method (eg, using anatomical landmarks) for position / image registration with the utility probe.

[0013] One way to visualize a practical probe (e.g., a catheter) is to display an icon of the distal end effector of the catheter showing its position and orientation relative to the anatomical model of the organ. The known size and mechanical structure of the distal end effector and the monitored position of the distal end of the shaft within the cavity can be used to create this icon.

[0014] The inventors have discovered that it may be desirable to indicate a selected portion of a distal end effector on a bi-plane view and / or tri-plane view generated by a "four-dimensional" (4D) US probe (a probe that acquires a series of 3D US images over time). Specifically, providing a bi-plane view and / or tri-plane view may enhance a physician's ability to visualize and guide a distal end effector within a cavity.

[0015] Bi-plane and tri-plane views are a way to visualize two imaging planes (bi-plane, typically but not necessarily orthogonal (can be user-defined)) or three imaging planes (tri-plane, typically with 60° increments between planes). Bi-plane and tri-plane views provide high-resolution images that can be used by the physician to monitor proper positioning and manipulation of the distal end effector.

[0016] Examples of the present disclosure described herein provide a technique for visualizing a distal end effector in a bi-plane view and / or a tri-plane view based on image processing of volume data acquired by a 4D US probe. Typically, the technique includes selecting two or three US slices of the imaging volume, as described below.

[0017] In some examples, a medical system is provided that includes a utility probe, such as a diagnostic catheter, for insertion into a cavity of an organ. The utility probe includes (i) a distal end effector mounted at a distal end of the utility probe, and (ii) a first magnetic or electric sensor configured to output an initial signal indicating a first position of the distal end effector within the organ. The system also includes an ultrasound probe for insertion into an organ of the body, the ultrasound probe including (i) a two-dimensional array of ultrasound transducers (grid design) configured to image a volume of the organ, the volume including at least a portion of the distal end effector, and (ii) a second sensor configured to output a second signal indicating a second position of the ultrasound transducer array within the organ. The processor of the system is configured to: (i) select one or more slices of an imaging volume (using the imaging volume, a first position, and a second position), the one or more slices including at least a component of the distal end effector having a spatial relationship with organ tissue, and (ii) generate at least one of a bi-plane view and a tri-plane view of the component of the distal end effector from the selected one or more slices, and (iii) present at least one of the bi-plane view and the tri-plane view to a user.

[0018] The processor is configured to use the position information to select the one or more slices using an image processing algorithm, such as by applying a threshold process to voxel values ​​within a subset of voxels of the imaging volume and identifying and calculating an embedding plane that includes the identified voxels. The resulting slice is the result of the intersection of the plane with the imaging volume at a given thickness. The registration of the position data of the US probe position with the position data of the distal end effector position makes the selection process faster and more efficient.

[0019] The processor is also configured to use the same or a different image processing algorithm to generate at least one of a bi-plane view and a tri-plane view from the selected one or more slices.

[0020] In one example, the physician can indicate which arms or splines of the distal end effector are to be displayed, and the system can display icons of the specific arms or splines of interest on a slice view (bi-plane view or tri-plane view). This can provide the physician with real-time visualization of distal end effector elements (e.g., catheter electrodes) in contact with tissue during navigation and confirmation of electrode-tissue contact with less effort and with less or no use of X-ray fluoroscopy. When treating arrhythmias, indication of electrode-tissue contact is critical for successful energy delivery.

[0021] System Description

[0022] Figure 1 is a schematic illustration of a probe-based ultrasound (US) imaging and electrophysiological (EP) mapping and ablation system 10 according to one example of the present disclosure.

[0023] The system 10 includes a plurality of probes (eg, catheters) that are inserted percutaneously by a physician 24 through the patient's vascular system into chambers or vascular structures of interest in the heart 12 .

[0024] The physician may initially or at any time during the procedure insert a 4D US probe 60 including a 2D ultrasound array 65 and an integrated position sensor 63 into the heart 12. Thereafter, a position-tracked EP mapping and ablation catheter 14 is inserted into the heart 12 via the delivery sheath 23 in the desired location.

[0025] As seen in inset 25, the 2D ultrasound array 65 generates a 3D fan-shaped ultrasound beam 85 that occupies a limited solid angle, such a beam being referred to herein as a "wedge 85". Using a wedge 85 beam, the 2D ultrasound array can image a relatively large volume of an organ, such as an entire cardiac chamber or a regional sector of interest (such as a valve or LAA) (e.g., the entire left atrium 45). Figure 1 In FIG. 4 , the US probe 60 images the left atrium 45 while the multi-arm effector 40 is placed therein.

[0026] As further seen in inset 25, the multi-arm catheter 14 includes one or more sensing electrodes 26, which are optionally distributed on multiple arms 16 at the expandable distal end effector 40 and are configured to sense intracardiac electrogram (IEGM) signals. The catheter 14 additionally includes a proximal position sensor (at the Figure 2 A position sensor 29 is shown in Figure 2 to track the position of the distal end of the shaft 22. Optionally and preferably, the position sensor is a magnetic-based position sensor including a magnetic coil for sensing three-dimensional (3D) position.

[0027] The catheter 14 itself or another catheter to be inserted may be used to perform the ablation.

[0028] As seen in inset 25, physician 24 brings a multi-arm assembly 40 (hereinafter also referred to as "expandable distal tip assembly 40" or "distal end effector 40") mounted on shaft 22 of catheter 14 into contact with wall 47 of left atrium 45 for sensing a target site in heart 12. For ablation, physician 24 may use the same catheter 14, or similarly, bring the distal tip of an ablation catheter to the target site. The image produced by the real-time 2D ultrasound array thus includes components of sensing electrodes 26 in contact with tissue.

[0029] The integrated position sensor 63 of the US probe 21 is pre-registered with the array 65 of the US probe. Due to the integrated position sensor, the spatial coordinates of each voxel in the imaged heart chamber are known. Specifically, the sensor 63 is configured to output a first signal indicating the position and orientation of the ultrasound transducer array 65 within the heart 12.

[0030] During navigation of the distal end 22 in the heart 12, the console 24 receives position and orientation signals from the position sensors 63 and 29 in response to the magnetic field from the external field generator 32. The magnetic field generator 32 is placed at a known position on the positioning pad 25 outside the patient 23. These position and orientation signals indicate the position and orientation of the ultrasound array 65 in the coordinate system of the position tracking system. Using the signals from the sensor 29, the real-time position and orientation of the distal end of the catheter 14 of the shaft 22 is also calculated.

[0031] Details of magnetic-based position sensing technology are described in U.S. Patents 5,5391,199, 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.

[0032] The system 10 includes one or more electrode patches 38 positioned in contact with the skin of the patient 23 to establish a position reference for impedance-based tracking of the positioning pad 25 and the electrodes 26. For impedance-based tracking, current is directed toward the electrodes 26 and sensed at the electrode skin patches 38 so that the position of each electrode can be triangulated via the electrode patches 38. Details of impedance-based position tracking techniques are described in U.S. Patents 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182.

[0033] Recorder 11 displays electrograms 21 captured using surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured using electrodes 26 of catheter 14. Recorder 11 may include pacing capabilities for pacing the cardiac rhythm and / or may be electrically connected to a separate pacemaker.

[0034] The system 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes at the distal tip of a catheter configured for ablation. The energy generated by the ablation energy generator 50 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that may be used to achieve irreversible electroporation (IRE)), or a combination thereof.

[0035] The patient interface unit (PIU) 30 is configured to establish electrical communication between catheters, electrophysiology equipment, a power source, and a workstation 55 for controlling the operation of the system 10. The electrophysiology equipment of the system 10 may include, for example, a plurality of catheters, a positioning pad 25, 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 enabling real-time calculations of catheter positions and for performing ECG calculations.

[0036] The workstation 55 includes a memory 57, a processor unit 56 having memory or storage loaded with appropriate operating software, and user interface capabilities. The workstation 55 can provide multiple functions, optionally including: (i) three-dimensional (3D) modeling of the endocardial anatomy and rendering the model or anatomical map 20 for display on the display device 27; (ii) displaying the activation sequence (or other data) compiled from the recorded electrograms 21 on the display device 27 as representative visual markers or images superimposed on the rendered anatomical map 20; (iii) displaying the real-time position and orientation of multiple catheters within the cardiac chamber; and (iv) displaying areas of interest (such as where ablation energy has been applied) on the display device 27. A commercial product embodying elements of the system 10, the commercial product being capable of being displayed in a CARTO TM The 3 system was purchased from Biosense Webster, Inc., 31A Technology Drive, Irvine, CA 92618.

[0037] Visualization of the distal end effector on bi-planar / tri-planar US views

[0038] Figure 2 According to the example of the present disclosure Figure 1 A US bi-planar view 204 of the arms 236 and 246 of the distal end effector 40 of the EP mapping catheter 14 is shown from the perspective of Figure 1Two selected US slices 213 and 214 are exported from the volume 85 acquired by the 4D US probe 60. The image colors are inverted for clarity.

[0039] In some examples, the physician may indicate which spline(s) / arms to display (i.e., indicating arms 216 and 226), and the system may display icons of the specific splines / arms of interest (rather than the arms themselves) on the bi-plane view 204 or tri-plane view.

[0040] like Figure 2 As seen in FIG. 1 , biplane 204 images 206 and 208 are derived (ie, image processed) from slices 213 and 214, respectively. To find and select slices 213 and 214, the processor calculates the plane in which the target arm (ie, indicated arms 216 and 226) is embedded by the distal end effector 40.

[0041] Slices 213 and 214 are then calculated as the intersection of the corresponding planes with the image volume 85. In implementation, any selected slice is taken at a given thickness (eg, 2 mm).

[0042] The position information enables the processor to search for arms 216 and 226 in an efficient manner, e.g., in a sub-volume of imaging volume 85. To do this, the processor applies image processing software to the sub-volume, which, for example, uses a threshold value of voxel values ​​to identify electrodes 26 in contact with tissue of wall 47. Using this information, the processor can then calculate the desired plane.

[0043] exist Figure 2 In the embodiment, the magnetic position sensor 29 mounted on the distal end of the shaft 22 and / or the sensing electrode 26 mounted on the arm of the distal end actuator 40 are used to obtain the position information about the actuator 40. The magnetic position sensor 63 is used to obtain the position information about the US probe 60, such as Figure 1 Visible in.

[0044] Method for estimating the shape of a basket catheter pressed against tissue

[0045] Figure 3 is a schematic diagram showing a method of selecting and processing an image according to an example of the present disclosure. Figure 1 Flow chart of a method for visualizing the distal end effector 40 in a bi-plane or tri-plane US view (e.g., bi-plane view 204 images 206 and 208) using US slices (e.g., slices 213 and 214) acquired by a 4D US probe 60. Although the method described is for a specific cardiac scenario involving US imaging of diagnostic and / or therapeutic cardiac catheters, the principles of the method are applicable to generating bi-plane or tri-plane views of other invasive devices carried by practical probes.

[0046] According to the example presented, the algorithm executes a process that begins with the physician 24 inserting an intracardiac echography (ICE) 4DUS probe 60 into a chamber of the heart 12 at a US probe insertion step 302 .

[0047] Next, at a mapping and / or ablation catheter insertion step 304 , the physician inserts a distal end effector (eg, effector 40 ) into the heart 12 .

[0048] At a tracking step 306 , the processor 56 tracks the position and orientation of the US probe 60 and distal end effector 40 using position sensors on the US probe and on the mapping and / or ablation catheter, such as magnetic sensors 29 and 63 , and / or electrodes 26 .

[0049] In parallel, at a US acquisition step 308 , the processor 56 receives from the 4DUS probe 60 an acquired volume wedge 85 that includes at least a component of the distal end effector 40 in spatial relationship with the cardiac tissue.

[0050] At a slice selection step 310, the processor selects a US slice for further image processing (based on tracking and by running an image processing application), wherein the slice includes information about the spatial relationship between one or more arms (or splines) of the distal end effector relative to the cardiac tissue.

[0051] At an image processing step 312 , processor 56 performs image processing on the selected slice to generate a bi-planar view (eg, view 204 ) or a tri-planar view of one or more arms (or splines) of the distal end effector relative to the heart tissue.

[0052] Finally, at a display step 314, processor 56 displays the two-plane view or the three-plane view to the user (eg, on display 27).

[0053] Figure 3 The flow charts shown are chosen purely for conceptual clarity. Embodiments of the present invention may be applied mutatis mutandis to another distal end effector, such as a basket catheter or another invasive device (eg, a catheter delivering a prosthetic valve).

[0054] Example

[0055] Example 1

[0056] A medical system (10) includes a utility probe (14), an ultrasound probe (60), and a processor (56). The utility probe is configured for insertion into a cavity of an organ, the utility probe comprising (a) a distal end effector (40) mounted at a distal end of the utility probe (14), and (b) a first sensor (29) configured to output a first signal indicating a first position of the distal end effector (14) within the cavity. The ultrasound probe (60) is configured for insertion into an organ of the body, the ultrasound probe comprising (A) an ultrasound transducer array (65) configured to image a volume (85) of the organ, the volume including at least a portion of the distal end effector (40), and (B) a second sensor (63) configured to output a second signal indicating a second position of the ultrasound transducer array (65) within the cavity. The processor (56) is configured to use an imaging volume (85), the first position, and the second position to (i) select one or more slices (213, 214) of the imaging volume (85), the one or more slices comprising at least a component of the distal end effector (40) having a spatial relationship with the organ, (ii) generate at least one of a bi-plane view (204) and a tri-plane view of the component of the distal end effector from the selected one or more slices, and (iii) present at least one of the bi-plane view (204) and the tri-plane view to a user.

[0057] Example 2

[0058] A system (10) according to Example 1, wherein the component of the distal end effector (40) includes one of an expandable spline and an expandable arm (16).

[0059] Example 3

[0060]

[00136] The system (10) of Example 1, wherein the component of the distal end effector comprises a prosthetic valve.

[0061] Example 4

[0062] A system (10) according to any one of embodiments 1 to 3, wherein the ultrasound probe (60) is an intracardiac echography (ICE) 4D ultrasound (US) catheter.

[0063] Example 5

[0064] A system (10) according to any one of embodiments 1 to 4, wherein the first sensor and the second sensor (29, 63) are magnetic position sensors, which are configured to generate the first signal and the second signal in response to a magnetic field applied by a position tracking system.

[0065] Example 6

[0066] A system according to any one of embodiments 1 to 4, wherein the first sensor is an electrode (26) of the distal end effector as part of an electrical position tracking system, the electrode being configured to generate the first signal.

[0067] Example 7

[0068] The system (10) of any one of embodiments 1 to 6, wherein the processor is configured to select one or more slices (213, 214) using an image processing algorithm.

[0069] Example 8

[0070] A system (10) according to any one of embodiments 1 to 7, wherein the processor is configured to generate at least one of a bi-plane view (204) and a tri-plane view from the selected one or more slices (213, 214) using an image processing algorithm.

[0071] Example 9

[0072] A system (10) according to any one of Examples 1 to 8, wherein the chamber of the organ is a chamber of the heart (12).

[0073] Example 10

[0074] A medical method includes inserting a utility probe (14) into a cavity of an organ, the utility probe including (a) a distal end effector (40) mounted at a distal end of the utility probe (14), and a first sensor (29), the first sensor configured to output a first signal indicating a first position of the distal end effector (40) within the cavity. An ultrasound probe (60) is inserted into the organ of the body, the ultrasound probe (60) including an ultrasound transducer array (65) configured to image a volume (85) of the organ, the volume including at least a portion of the distal end effector (40), and a second sensor (63), the second sensor configured to output a second signal indicating a second position of the ultrasound transducer array (65) within the cavity. Using the imaging volume, the first position, and the second position, one or more slices (213, 214) of the imaging volume (85) are selected, the one or more slices including at least a portion of the distal end effector (40) having a spatial relationship with the organ. At least one of a bi-plane view 204 and a tri-plane view of the components of the distal end effector (40) is generated from the selected one or more slices (213, 214). The at least one of the bi-plane view (204) and the tri-plane view is presented to a user.

[0075] Although the embodiments described herein are primarily directed to cardiac diagnostic applications, the methods and systems described herein may also be used in other medical applications.

[0076] It should be understood that the above embodiments are cited by way of example, and the present disclosure is not limited to what is specifically shown and described above. On the contrary, the scope of the present disclosure includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereof, which will occur to those skilled in the art upon reading the above description, and which are not disclosed in the prior art.

Claims

1. A medical system comprising: A practical probe, the practical probe being used to be inserted into a cavity of an organ, the practical probe comprising: a distal end effector mounted at a distal end of the utility probe; and a first sensor configured to output a first signal indicative of a first position of the distal end effector within the lumen; An ultrasound probe, the ultrasound probe being used to be inserted into an organ of a body, the ultrasound probe comprising: an ultrasound transducer array configured to image a volume of the organ, the volume including at least a portion of the distal end effector; and a second sensor configured to output a second signal indicative of a second position of the ultrasound transducer array within the cavity; and A processor configured to: selecting, using an imaging volume, the first position, and the second position, one or more slices of the imaging volume, the one or more slices including at least a component of the distal end effector in spatial relationship with the organ; generating at least one of a bi-planar view and a tri-planar view of the component of the distal end effector from the selected one or more slices; and The at least one of the two-plane view and the three-plane view is presented to a user.

2. The system according to claim 1, wherein: The component of the distal end effector includes one of an expandable spline and an expandable arm.

3. The system according to claim 1, wherein: The component of the distal end effector includes a prosthetic valve.

4. The system according to claim 1, wherein: The ultrasound probe is an intracardiac echography (ICE) 4D ultrasound (US) catheter.

5. The system according to 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.

6. The system according to claim 1, wherein: The first sensor is an electrode of the distal end effector as part of an electrical position tracking system, the electrode being configured to generate the first signal.

7. The system according to claim 1, wherein: The processor is configured to select one or more slices using an image processing algorithm.

8. The system according to claim 1, wherein: The processor is configured to generate at least one of a bi-plane view and a tri-plane view from the selected one or more slices using an image processing algorithm.

9. The system according to claim 1, wherein: The chamber of the organ is a chamber of the heart.

10. A medical method comprising: A utility probe is inserted into a cavity of an organ, the utility probe comprising: a distal end effector mounted at a distal end of the utility probe; and a first sensor configured to output a first signal indicative of a first position of the distal end effector within the lumen; An ultrasound probe is inserted into an organ of the body, the ultrasound probe comprising: an ultrasound transducer array configured to image a volume of the organ, the volume including at least a portion of the distal end effector; and a second sensor configured to output a second signal indicative of a second position of the ultrasound transducer array within the cavity; selecting, using an imaging volume, the first position, and the second position, one or more slices of the imaging volume, the one or more slices including at least a component of the distal end effector in spatial relationship with the organ; generating at least one of a bi-planar view and a tri-planar view of the component of the distal end effector from the selected one or more slices; and The at least one of the two-plane view and the three-plane view is presented to a user.

11. The method according to claim 10, wherein: The component of the distal end effector includes one of an expandable spline and an expandable arm.

12. The method according to claim 10, wherein: The component of the distal end effector includes a prosthetic valve.

13. The method according to claim 10, wherein: The ultrasound probe is an intracardiac echography (ICE) 4D ultrasound (US) catheter.

14. The method according to 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.

15. The method according to claim 10, wherein: The first sensor is an electrode of the distal end effector as part of an electrical position tracking system, the electrode being configured to generate the first signal.

16. The method according to claim 10, wherein: Selecting one or more slices includes using an image processing algorithm.

17. The method according to claim 10, wherein: Generating at least one of a bi-plane view and a tri-plane view from the selected one or more slices includes using an image processing algorithm.

18. The method according to claim 10, wherein: The chamber of the organ is a chamber of the heart.

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