Display for electrode proximity

Abstract

A display system configured to communicate tissue proximity data from a plurality of electrodes includes a display. The display outputs a circular graphical representation. The circular graphical representation includes a plurality of color regions forming a first circle. Each color region conveys a classification value for the respective electrode that is indicative of tissue proximity for the respective electrode. The plurality of pattern regions form a second circle. Each graphical region conveys a relative value of a respective electrode that is indicative of tissue proximity of the respective electrode.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 412,760, filed on October 3, 2022, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] The present invention generally relates to catheters, and methods and systems for electrical impedance based detection of tissue proximity of electrodes. Background Art

[0004] Catheters can be used for a variety of operations within the human body. In many such applications, whether collecting data from surrounding tissue or administering therapy, it is important to determine whether portions of the catheter (particularly electrodes that collect data and / or administer therapy) are in contact with or close to adjacent tissue. A variety of methods can be used to make this determination, including, for example, monitoring electrocardiogram signals (e.g., the voltage measured between electrodes) and / or the impedance of the electrodes. For example, impedance is generally understood to increase in response to contact with tissue. However, many other factors can also cause impedance changes, including the location of the electrodes in the body (i.e., different chambers of the heart exposed to different blood flows may exhibit different impedance values) and movement of surrounding tissue due to heartbeats, etc. These factors make it difficult to rely on impedance measurements. Therefore, it would be beneficial to develop a method for reliably detecting proximity based on impedance measurements.

[0005] Furthermore, efficient data communication in clinical workflow is important to improve treatment outcomes, reduce errors, and shorten procedure times. Therefore, it would be beneficial to develop a method to display electrode contact and / or electrode proximity in an efficient manner. Summary of the invention

[0006] Embodiments of the present disclosure describe a display system configured to convey tissue proximity data from multiple electrodes, the display system comprising a display configured to output a circular graphical representation comprising a plurality of color regions forming a first circle, each color region configured to convey a classification value of a corresponding electrode, the classification value indicating the tissue proximity of the corresponding electrode, and a plurality of graphic regions forming a second circle, each graphic region configured to convey a relative value of the corresponding electrode, the relative value indicating the tissue proximity of the corresponding electrode.

[0007] Embodiments of the present disclosure describe a user interface system for a catheter device, the user interface system comprising a display, the display comprising a circular proximity display area, the circular proximity display area comprising a plurality of circular sectors, each circular sector corresponding to one or more electrodes disposed on the catheter device, and one or more control features configured to manipulate the catheter device and / or the electrodes disposed on the catheter device, wherein the one or more control features are configured to select one or more system states.

[0008] An embodiment of the present disclosure describes a display method, comprising receiving tissue proximity data from a plurality of electrodes, converting the received data into a circular arrangement, the circular arrangement comprising a plurality of circular sectors, each circular sector corresponding to one or more electrodes, and displaying the circular arrangement on a user interface, wherein each circular sector comprises a classification value display and a relative value display.

[0009] The details of one or more examples are set forth in the description below. Other features, objects, and advantages will be apparent from the description and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] This written disclosure describes non-limiting and non-exhaustive illustrative embodiments. In the drawings, which are not necessarily drawn to scale, like numerals describe substantially similar components in the several views. Like numerals with different letter suffixes represent different instances of substantially similar components. Figure 1 The various embodiments discussed in this document are generally presented by way of example and not limitation.

[0011] Referring to the illustrative embodiment shown in the drawings, in which:

[0012] Figure 1 is a side view of a medical device according to one or more embodiments of the present disclosure.

[0013] Figure 2 is an exploded side view of a medical device according to one or more embodiments of the present disclosure.

[0014] Figure 3 is an isometric view of a medical device according to one or more embodiments of the present disclosure.

[0015] Figure 4 is an isometric view of a medical device according to one or more embodiments of the present disclosure.

[0016] Figure 5 is an exemplary embodiment of a display in an organization proximity mode according to one or more embodiments of the present disclosure.

[0017] Figure 6is an exemplary embodiment of a display in a baseline collection mode according to one or more embodiments of the present disclosure.

[0018] Figure 7 is an exemplary embodiment of a two-dimensional (2-D) drawing display according to one or more embodiments of the present disclosure.

[0019] Figure 8 is a flow chart of a system status progression according to one or more embodiments of the present disclosure.

[0020] Fig. 9 is an exemplary embodiment of disabling a display in a system state according to one or more embodiments of the present disclosure.

[0021] Fig. 10A is an exemplary embodiment of a display in an electrode selection system state according to one or more embodiments of the present disclosure.

[0022] Fig. 10B is an exemplary embodiment of a display in an electrode selection system state according to one or more embodiments of the present disclosure.

[0023] Fig. 10C is an exemplary embodiment of a display in an electrode selection system state according to one or more embodiments of the present disclosure.

[0024] Fig. 10D is an exemplary embodiment of a display in an electrode selection system state according to one or more embodiments of the present disclosure.

[0025] Fig.11A is an exemplary embodiment of a display in a baseline collection system state according to one or more embodiments of the present disclosure.

[0026] Fig. 11B is an exemplary embodiment of a display in a baseline collection system state according to one or more embodiments of the present disclosure.

[0027] Fig. 11C is an exemplary embodiment of a display in a baseline collection system state according to one or more embodiments of the present disclosure.

[0028] Fig. 12A is an exemplary embodiment of a display of an organization proximity system state according to one or more embodiments of the present disclosure.

[0029] Fig. 12B is an exemplary embodiment of a display of an organization proximity system state according to one or more embodiments of the present disclosure.

[0030] Fig. 12Cis an exemplary embodiment of a display of an organization proximity system state according to one or more embodiments of the present disclosure.

[0031] Fig.13A is an exemplary embodiment of a display of a therapy delivery system status according to one or more embodiments of the present disclosure.

[0032] Fig. 13B is an exemplary embodiment of a display of a therapy delivery system status according to one or more embodiments of the present disclosure.

[0033] Fig.14 is a flowchart of a display method according to one or more embodiments of the present disclosure. DETAILED DESCRIPTION

[0034] According to some embodiments, the claimed invention utilizes a circular graphical representation on a display to reflect the shape of the catheter. The use of representative shapes (compared to linear graphical representations) supports the translation and interpretation of information displayed on the display (which is a representation of reality) to more easily infer what is actually happening but not visible using the catheter. Likewise, the display behavior in tissue proximity mode produces visual effects that support visualization of catheter manipulation.

[0035] According to some embodiments, the claimed invention presents tissue proximity information at various fidelity levels. For example, color segments can be used to display classification values, i.e., optimal proximity, suboptimal proximity, and electrodes in error state and deselected treatment electrodes. In addition to reinforcing the classification value, the inner graphical area can also identify the position of the value within the classification / range (i.e., relative value). This approach facilitates information processing at different levels.

[0036] In some embodiments, the claimed invention utilizes direct manipulation to select activated treatment electrodes. Direct manipulation is an interaction mode in which a user acts on a displayed object of interest using physical, step-by-step, reversible actions, the effects of which are immediately displayed on the screen. Instead of using a separate controller to control the selection of electrodes, an operator can directly select electrodes by interacting with a graphical representation displayed on a display device. And according to some embodiments of the present disclosure, the claimed invention integrates system status with gatekeeping functions. For example, the display appearance can change to direct the operator's attention to a recommended action or a feasible next step.

[0037] Figure 1-4An exemplary medical device 100 is shown, such as a diagnostic and / or therapeutic catheter, sheath, or other similar type of device. The medical device 100 includes a distal end and a proximal end (not shown) that includes a handle (not shown) operated by a technician and a connection point (not shown) that connects the medical device to an electronic control unit (ECU) 118 and a display 120. The distal end of the medical device may include a plurality of electrodes 105 or electrode pairs 105a and 105b.

[0038] like Figure 1-2 As shown, the medical device 100 may include a plurality of splines 110 extending from the medical device 100, wherein each spline 110 includes one or more electrodes 105, or as shown in FIG. Figure 2 As shown, it includes electrode pairs 105a-105b. Figure 1 and 2 In the illustrated embodiment, each spline 110 includes a plurality of electrodes 105, wherein Figure 2 The voltage and / or current 108 measured between electrodes 105a-105b is shown. In other embodiments, such as Figure 3 and 4 In the illustrated embodiment, each spline 310 and 410 may include a single electrode region 305 and 405a-405h, respectively. Each electrode region 305 and 405a-405h may include one or more electrodes. In some embodiments, the medical device may include eight splines (e.g., see Figure 3-4 In other embodiments, any number of splines 110, 310, 410 may be used.

[0039] like Figure 3 As shown, the medical device 100 includes a distal end 320 and a centerline 330 defining a central axis 335, and has a plurality of splines 310, each of the plurality of splines 310 having an electrode region 305 disposed radially outward from the central axis 335. In some embodiments, the electrode region 305 is disposed on a portion of the spline 310 that is farthest from the central axis 335. In other words, the electrode region 305 can be disposed on a radially outermost portion of the spline 310 relative to the central axis 335. In some embodiments, the electrode region 305 and / or the plurality of splines 310 can deliver ablation therapy to a target tissue.

[0040] like Figure 4As shown, the medical device 100 may include a plurality of electrode regions 405a-405h, each corresponding to a spline 410 disposed on the medical device 100. In some embodiments, each electrode region 405a-405h may include an electrode pair, wherein a voltage, impedance, current, or other electrical signal is measured across the electrode pair. In other embodiments, each electrode region 405a-405h may include a single electrode. In some embodiments, a voltage, impedance, current, or other electrical signal may be measured across the corresponding electrode regions 405a-405h. For example, a voltage, impedance, current, or other electrical signal may be measured across electrode region 405a and electrode region 405b. In some embodiments, the electrode regions 405a-405h and / or the plurality of splines 410 may deliver ablation therapy to the target tissue. Figure 1-4 A circular distribution of electrodes / splines disposed circumferentially about a central axis is shown. In some embodiments, the medical device 100 may include different electrode / spline arrangements, including, for example, a grid or array of electrodes on a single plane, one or more electrode rings, electrodes disposed along a single elongated member, and / or other electrode / spline configurations.

[0041] At once Figure 1-4 For the embodiment shown, the proximity of multiple electrodes 105 (or electrodes 305, 405) located at the distal end of the medical device 100 can be determined based on bipolar electrode complex impedance (BECI) measurement. Generally, BECI measurement is generated by driving an excitation signal between two electrodes forming a bipolar pair. The voltage generated at each electrode is measured and used to derive a complex impedance signal. The ECU 118 uses the measured BECI measurement value to determine the contact and / or proximity state of each electrode relative to the adjacent tissue 112.

[0042] Determining the contact state of the electrode 105 can include a tissue proximity mode, in which the real-time impedance measurement of each of the plurality of electrodes 105 is converted into a tissue proximity score associated with the electrode's proximity to the cardiac tissue using a baseline measurement. Typically, the tissue proximity score is a ratio of the real-time impedance measurement to the baseline value. The tissue proximity score can be compared to a fixed, device-specific (or procedure-specific) threshold value for assigning a tissue proximity category (i.e., optimal / contact, suboptimal / not in contact) to each electrode.

[0043] In some embodiments, accurate baseline measurements may be required to calculate reliable tissue proximity measurements, and thus determining the contact status of the electrodes 105 may include a baseline collection mode. The baseline collection mode may help a user identify when an acceptable baseline measurement has been collected for each electrode 105. The baseline collection mode may include a series of conditions, where the satisfaction of each condition increases the reliability of the baseline value.

[0044] Figure 5-14 Devices, systems, and methods for displaying impedance-based measurements, such as those described above, and for manipulating a medical device by displaying a user interface are shown. Figure 5-14 In the illustrated embodiment, the display 500 outputs a circular graphical representation of electrode proximity data to the user in real time. The display 500 reflects the user's high-level needs, thereby producing a simplified display that conveys meaningful information in an efficient and accurate manner.

[0045] During cardiac surgery, raw BECI data can be difficult to analyze in real time. For example, Figure 7 An exemplary embodiment of a two-dimensional (2-D) graph 600 of a raw BECI baseline measurement 610 is shown. Figure 1-4 Each electrode and / or electrode pair on the medical device 100 shown transmits data back to the ECU 118, which is displayed on a 2-D graph 600, resulting in many different plot lines. The 2-D graph 600 of the baseline measurement is inefficient because the user must interpret in real time what each graph line represents, which electrode is selected, the scale and / or measurement unit of the x-axis and y-axis, etc. Therefore, a display system is needed that minimizes unnecessary information and presents meaningful measurement data to improve efficiency and facilitate clinical workflow.

[0046] like Figure 5 As shown, the display 500 includes a circular display area 505 and a plurality of circular sectors 510a-510h. Figure 5 In the illustrated embodiment, each of the eight circular sectors 510a-510h (collectively referred to as circular sectors 510) corresponds to an electrode and / or spline (e.g., Figure 4 In some embodiments, each circular sector 510 may correspond to an electrode, electrode pair, or spline on a catheter device. The catheter device 100 may include any number of splines 110, 310, 410, and thus, the number of circular sectors 510 may vary depending on the number of splines 110, 310, 410 included in the connected catheter device 100.

[0047] Figure 5 Display 500 showing tissue proximity system status (see also Figures 12A-12C). For simplicity, only circular sectors 510a and 510b are fully labeled. Each circular sector 510a-510h includes an electrode label 516a-516h, in which case the electrode labels 516a-516h (collectively referred to as electrode labels 516) are numbered "1" to "8". Each circular sector 510a-510h may also include a color region 518a-518h (collectively referred to as color region 518), and the color region 518a-518h indicates the classification value of each electrode and / or electrode pair. For example, a first color (e.g., blue) can be used to indicate optimal contact / proximity between a particular electrode and adjacent tissue, a second color (e.g., white) can be used to indicate suboptimal contact / proximity, and a third color (e.g., yellow) can be used to indicate an error state. In other embodiments, additional colors can be used to indicate additional proximity / contact states or operating states of the electrode. As Figure 5-6 As shown, display 500 may include a color table area 520 to convey the classification value represented by each corresponding color.

[0048] Displaying categorical values ​​(represented by colors) is beneficial because it allows information to be communicated efficiently without overwhelming the user. A particular numerical baseline value or numerical proximity value may not be relevant to the user, and instead the user only needs to know whether a certain threshold is met. In this case, displaying a number or numerical representation (e.g., a bar graph or 2-D graph) is not the most efficient form of communication because the user is forced to compare the numerical value / numerical representation to a threshold and determine whether the threshold is met. Instead, the display 500 communicates whether the electrode corresponding to each circular sector 510a-510h meets the threshold requirement without requiring any further action by the user.

[0049] In some embodiments, color regions 518a-518h and color table region 520 may change from one system state to another. Figure 5 The display 500 in the tissue proximity system state is shown, wherein the color region 518 is limited to the outermost ring of each circular sector 510, and the color table region 520 displays the first color, the second color, and the third color. Figure 6 The display 500 is shown in a baseline collection system state, wherein the color region 518 extends radially inward to the second annular segment 522 and the third annular segment 524, Figure 6 The color table area shows the secondary, tertiary, quaternary, and quinary colors. Using different color schemes for different system states can minimize user errors, for example, green immediately communicates to the user that the system is in a baseline collection state rather than an organization proximity state.

[0050] like Figure 5As shown, each circular sector 510a-510h may include a graphical segment 530 extending radially inward from the color region 518a-518h, and the graphical segment 530 is configured to convey the relative value of the electrode measurement. The graphical segment 530 may include an inner boundary line 532, a threshold line 534, a current value bar 536, and an outer boundary line 538. The threshold line 534 may be based on the baseline collection system state (see Figure 6 and Figures 11A-11C ), and / or generated based on fixed thresholds programmed into the system. For example, threshold line 534 can be generated by collecting baseline data in a baseline collection state and setting a fixed threshold / ratio above the baseline (e.g., 20% above the baseline). The fixed threshold above the baseline can vary, but is typically between 1% and 100% above the baseline value. In other embodiments, the fixed threshold above the baseline can be more than 100% above the baseline. Threshold line 534 can represent a boundary threshold between an optimal proximity value and a suboptimal proximity value. Figure 5 In the illustrated embodiment, the threshold line 534 is consistent between the circular sectors 510a-510h. The current value bar 536 can represent the real-time tissue proximity value of the corresponding electrode or electrode pair, wherein the optimal tissue proximity value will be represented by the current value bar 536 set radially outward from the threshold line 534 (e.g., see circular sectors 510a-510c) and the suboptimal tissue proximity value will be represented by the current value bar 536 set radially inward from the threshold line 534 (e.g., see circular sector 510d). In other words, as the tissue proximity value increases (indicating that the electrode is very close to the tissue), the current value bar 536 is pushed radially outward to reflect the tissue proximity value relative to the threshold line 534. Figure 5 In the illustrated embodiment, when the current value bar 536 is disposed radially outward from the threshold line 534 (e.g., see circular sectors 510a-510c), the corresponding color region may display a first color indicative of optimal electrode proximity. The relative value display is beneficial because the user can see how close or far each electrode measurement is from the optimal tissue proximity value.

[0051] The display 500 can output a circular display area 505 having a circular shape to provide a user with a visual representation of a circular catheter with electrodes distributed around the circumference of the circular catheter. The use of a circular shape representation (rather than a linear display) supports the conversion and interpretation of information displayed on the display to help the user infer what is actually happening on the catheter device. In some embodiments, multiple color areas 518a-518h are combined together to form a first circular shape, and multiple graphic areas 530a-530h are combined together to form a second circular shape. The circular display area 505, the first circular shape, the second circular shape, and the center circular display 560 form multiple concentric circles to effectively communicate tissue proximity data.

[0052] In some embodiments, each circular sector 510a-510h includes an equal outer arc length L and an equal center angle θ. For example, the display 500 shows eight circular sectors 510a-510h corresponding to eight electrodes or electrode pairs (e.g., corresponding to electrodes 405a-405h), each of which has an outer arc length c / 8 (L=c / 8), where "c" is the circumference of the circular display area 505, and each of which has a center angle of 45° (θ=360° / 8). In other embodiments, a different number of circular sectors may be used to correspond to a different number of electrodes and / or splines.

[0053] The display 500 includes a display user interface 502, which may include one or more control features, such as a baseline mode control 550, a select all electrodes control 552, selectable individual electrode controls 554a-554h, a proximity mode control (not shown), and a therapy mode control (not shown). The one or more control features may be selected via the display user interface 502, and the one or more control features may control a therapy device (e.g., Figure 1-4 The device 100 in the embodiment of the present invention may include a function of the device 100) and / or may control the electrode measurement function. For example, one or more control features may include a selectable electrode feature, in which individual electrodes and / or electrode pairs may be selected for impedance-based measurements and / or the therapeutic delivery capability of the electrodes may be activated or deactivated. In some embodiments, electrodes may be deselected. Deselecting electrodes may be helpful in helping to direct the user's attention to electrodes associated with therapeutic delivery. In some embodiments, the selection or deselection of electrodes will only affect whether data is displayed to the user, that is, electrode measurements will continue regardless of the selection or deselection state. Deselecting an electrode may selectively disable therapeutic delivery of the electrode. In some embodiments, the display 500 may integrate one or more system states into the display user interface 502.

[0054] One or more control features may be configured to allow direct manipulation of the catheter device. The term "direct manipulation" is an interaction mode in which a user acts on a displayed object of interest using physical, gradual, reversible actions, the effects of which are immediately displayed on the screen. An operator can directly select electrodes by manipulating the display device, rather than using a separate controller to control the selection of electrodes. In some embodiments, a user can interact with the display user interface 502 via a touch screen, mouse / keyboard, and / or other buttons / controls known in the art.

[0055] Figure 6 shows the baseline collection pattern (see Figures 11A-11C) is an exemplary embodiment of a display 500 under FIG. The display 500 includes circular sectors 510a-510h and color regions 518a-518h. Figure 6 The embodiment in also includes circular sectors 510a-501h having a first annular segment 522 (see first annular segments 522a-522c, 522h corresponding to circular sectors 510a-510c, 510h) and a second annular segment 524 (see second annular segments 524a, 524b corresponding to circular sectors 510a, 510b), wherein the first annular segment 522 indicates marginal baseline collection from the corresponding electrode and the second annular segment 524 indicates acceptable baseline collection from the corresponding electrode. When the corresponding electrode collects marginal baseline measurements, the first annular segment 522 can have a fourth color (e.g., light green) and when the corresponding electrode collects acceptable baseline measurements, the second annular segment 524 can have a fifth color (e.g., dark green). The first annular segment 522 and the second annular segment 524 of the circular sectors 510a - 510h (eg, circular sectors 510d - 510f ) corresponding to electrodes that did not collect marginal or acceptable baseline measurements may remain empty.

[0056] like Figure 8 , a flow chart 700 showing an exemplary progression of system states is shown. Display 500 with user interface 502 displayed may progress to a disabled state 702, an electrode selection state 704, a baseline collection state 706, a tissue proximity state 708, and / or a therapy delivery state 710. Figure 9-13B An exemplary display 500 is shown for each of a plurality of system states 702, 704, 706, 708, and 710. In some embodiments, the progression of system states 702, 704, 706, 708, and 710 is not linear. For example, a user can toggle back and forth between tissue proximity state 708 and baseline collection state 706.

[0057] The disabled state 702 indicates that a catheter connection has not been established. Fig. 9 An exemplary embodiment of the display 500 is shown in a disabled state 702. Fig. 9 502 are disabled. In some embodiments, a dark grey color is used to indicate the disabled state 702. In the disabled state 702, the user cannot access one or more control features, and the display 500 does not display any data. Once the catheter connection is established, the display 500 and the display user interface 502 can enter the electrode selection state 704.

[0058] Figures 10A-10D An exemplary embodiment of the electrode selection state 704 is shown. Fig. 10AAs shown, color regions 518 corresponding to electrode labels 516a-516h may be assigned a first color (eg, dark gray) indicating that the corresponding electrodes are in an inactive state. Fig. 10B As shown, the color area 518 corresponding to the electrode label 516a-516e can be assigned a second color (e.g., white), indicating that the corresponding electrode is in an activated state. The color area 518 may include an outline area 540 to indicate that the corresponding electrode is optional. The electrode can be selected by displaying the user interface 502. Selecting an electrode can enable the electrode to deliver treatment and / or display electrode proximity data on the display 500. Deselecting an electrode can disable the treatment delivery of the electrode and / or disable the display of electrode proximity data on the display 500. Selecting and / or deselecting electrodes may be beneficial because in some cases, some electrodes on the medical device 100 may accidentally contact or approach the esophagus, nerves, and / or other non-target tissues. Therefore, delivering ablation therapy to all electrodes may cause accidental damage to non-target tissues. In some embodiments, electrodes can be selected and / or deselected to deliver different degrees of treatment on each electrode. For example, a first electrode can be selected and a first treatment can be delivered, and then, a second electrode can be selected and a second treatment can be delivered.

[0059] Fig. 10C An exemplary embodiment of a circular sector 510e displaying an error is shown. In other words, the electrode and / or spline corresponding to the circular sector 510e may be damaged, disconnected, or otherwise malfunctioning, and thus, the user is notified of the error before collecting electrophysiological data. Fig. 10D An exemplary embodiment is shown in which all electrodes are selected and operational. A user may select the baseline mode control 550 in the display user interface 502 to begin a baseline collection state 706 .

[0060] Figures 11A-11C An exemplary embodiment of a baseline collection state 706 is shown. Fig.11A As shown, each circular sector 510a-510h corresponding to an electrode or electrode pair (eg, electrodes 405a-405h) initially does not have any color. As the baseline collection mode progresses and marginal baseline data (see Fig. 11B Circular sectors 510c and 510h) and / or acceptable baseline data (see Fig. 11B The corresponding colors in the first annular segment 522 and / or the second annular segment 524 display the classification colors. Once all eight electrodes or electrode pairs have collected acceptable baseline measurements, the center circular display 560 may communicate the completion of the baseline collection state 706 with a first symbol 562 (see, e.g., Fig. 11C ).

[0061] Figures 12A-12C An exemplary embodiment of a tissue proximity state 708 is shown. In the tissue proximity state 708, the electrodes corresponding to each circular sector 510a-510h are selectable, as shown by the outline area 540. The tissue proximity state 708 displays real-time proximity data on the display 500, where each circular sector 510a-510h includes a color area 518a-518h and a graphic segment 530. Fig. 12A Electrodes corresponding to circular sectors 510a-510e are displayed as "activated", with circular sector 510e displaying an error value. In some embodiments (such as Fig. 12A ), color region 518 may convey an "inactive and error" output, where electrode label 516 is assigned a corresponding color (e.g., orange) and color region 518 is assigned a corresponding color (e.g., dark gray) (see, e.g. Fig. 12A Circular sector 510f). Fig. 12B An example of a tissue proximity state 708 is shown in which the circular segment 510e no longer displays an erroneous value (eg, Fig. 12A as shown).

[0062] Fig. 12C It is shown that the electrodes corresponding to circular sectors 510a-510c and 510f-510h are activated and optimal, while circular sectors 510d and 510e are activated and suboptimal, and the current value bar 536 of each electrode is close to the threshold line 534. In other words, Fig. 12C Six of the eight electrodes are shown to be in optimal proximity, with the remaining two electrodes close to optimal proximity. In this case, the user can choose whether to continue catheter manipulation to achieve the eight out of eight optimal values, or whether to continue with treatment delivery (see Figures 13A-13B ).

[0063] Figures 13A-13B An exemplary embodiment of a therapy delivery state 710 is shown. Fig.13A As shown, the treatment delivery status 710 may include a countdown 564 displayed in the center circular display 560. The countdown 564 may display a decreasing time until the treatment is delivered via the catheter device. During the countdown, the display 500 may continue to display real-time electrode proximity data to the user. The treatment delivery status 710 includes delivering a medical treatment via the catheter device. In some embodiments, the medical treatment may include ablation, balloon angioplasty, vascular stenting, and / or drug delivery. In some embodiments, ablation treatment may be delivered directly via the activated electrode. During the medical treatment, a second symbol 566 may be displayed in the center circular display 560, such as Fig. 13B Display 500 may continue to display real-time electrode proximity data to the user.

[0064] In some embodiments, the display user interface 502 may have a gatekeeping function for the catheter device. For example, in the tissue proximity state 708, the display user interface 502 may require that at least six of the eight electrodes or electrode pairs have an "optimal" proximity value before starting the therapy delivery state 710. In such an example, the therapy delivery controls (not shown) will not be displayed and / or cannot be manipulated until the minimum threshold is met.

[0065] In some embodiments, the display user interface 502 may perform a gatekeeping function for each of the system states 702, 704, 706, 708, and 710. In other words, each system state must satisfy certain conditions in order to unlock the functionality of the display user interface 502. For example, in the electrode selection state 704, the display user interface 502 may not allow the user to directly enter the tissue proximity state 708. Instead, the display user interface 502 may require the user to enter the baseline collection state 706 before entering the tissue proximity state 708.

[0066] The gatekeeping function of the display user interface 502 is beneficial because it can guide the user step by step through the standardized process. The gatekeeping function can help ensure that no steps are skipped and / or ensure that each step is completed to at least a minimum satisfaction level. Each step and each minimum satisfaction level can be programmed into the ECU 118.

[0067] Fig.14 A display method 800 is shown, which includes a display 500, a display user interface 502, and a plurality of circular sectors 510. The display method 800 includes the following steps: Step 802, receiving tissue proximity data, including receiving tissue proximity data from a plurality of electrodes or electrode pairs disposed on a medical device. In some embodiments, the tissue proximity data may include BECI measurements. Step 804, converting the data, including converting the received data from a numerical value to a circular arrangement of categorical values ​​for each of the plurality of electrodes. In some embodiments, step 804 also includes analyzing the BECI measurements, such as a ratio of measured impedance to a baseline measurement. Step 806, displaying the circular arrangement on a user interface, including displaying the circular arrangement on a user interface.

[0068] The following is a non-exclusive description of possible embodiments of the invention.

[0069] According to one aspect, a display system is configured to communicate tissue proximity data from a plurality of electrodes, comprising a display. The display outputs a circular graphical representation. The circular graphical representation comprises a plurality of color regions forming a first circle. Each color region communicates a classification value of a corresponding electrode, indicating tissue proximity of the corresponding electrode. The plurality of graphical regions form a second circle. Each graphical region communicates a relative value of a corresponding electrode, indicating tissue proximity of the corresponding electrode.

[0070] The display system of the preceding paragraphs may optionally additionally and / or alternatively include one or more of the following features, configurations and / or additional components.

[0071] For example, the display system may optionally be configured such that the display outputs a graphical user interface. The graphical user interface enables direct manipulation of the plurality of electrodes.

[0072] The display system may optionally be configured to enable a graphical user interface to directly manipulate the therapeutic device.

[0073] The display system may optionally be configured such that the graphical user interface performs one or more gatekeeping functions.

[0074] The display system may optionally be configured such that the categorical value indicates whether a threshold level of electrode contact is met.The relative value indicates the electrode contact value, and in some embodiments, the relative value may include a graphical comparison between the electrode contact value and a threshold line.

[0075] The display system may optionally be configured such that the circular graphical representation represents a circular electrode distribution on the medical device.

[0076] According to one aspect, a user interface system for a catheter device includes a display. The display includes a circular proximity display area having a plurality of circular sectors. Each of the plurality of circular sectors corresponds to one or more electrodes disposed on the catheter device. The user interface system includes one or more control features configured to manipulate the catheter device and / or one or more electrodes disposed on the catheter device. The one or more control features are configured to select one or more system states.

[0077] The user interface system of the preceding paragraphs may optionally additionally and / or alternatively include one or more of the following features, configurations, and / or additional components.

[0078] For example, the user interface system may optionally be configured such that the one or more system states include a tissue proximity state. The tissue proximity state displays a categorical value of an electrode measurement in each of a plurality of circular sectors.

[0079] The user interface system may optionally be configured such that the tissue proximity status displays relative values ​​of electrode measurements in each of a plurality of circular sectors.

[0080] The user interface system may optionally be configured such that the color segments convey categorical values ​​of the electrode measurements and the graphical segments display relative values ​​of the electrode measurements.

[0081] The user interface system can optionally be configured such that the one or more system states include a baseline collection state. The baseline collection state displays a plurality of radial segments within each circular sector. Each radial segment conveys a categorical value of a baseline measurement.

[0082] The user interface system may optionally be configured such that the one or more system states include a therapy delivery state.The therapy delivery state initiates ablation therapy via the catheter device.

[0083] The user interface system may optionally be configured such that one or more control features are configured as a gatekeeping function for the catheter device.

[0084] The user interface system may optionally be configured such that one or more control features are configured to select one or more electrodes. Selecting an electrode may selectively enable the electrode for therapy delivery and / or electrode measurement. Deselecting an electrode may selectively disable the electrode for therapy delivery and electrode measurement.

[0085] According to one aspect, a display method includes receiving tissue proximity data from a plurality of electrodes. The received data is converted into a circular arrangement. The circular arrangement includes a plurality of circular sectors. Each circular sector corresponds to one or more electrodes. The circular arrangement is displayed on a user interface. Each circular sector includes a categorical value display and a relative value display.

[0086] The display method of the preceding paragraph may optionally additionally and / or alternatively include one or more of the following features, configurations and / or additional components.

[0087] For example, the display method can be optionally configured so that the classification value display includes output values. The output values ​​include optimal proximity, suboptimal proximity, and error status. Each output value corresponds to a corresponding color output.

[0088] The display method may optionally be configured such that the relative value display includes a threshold line and a current proximity line.

[0089] The display method may optionally be configured such that the plurality of electrodes are arranged on a plurality of splines extending circumferentially around a central axis of the medical device.

[0090] The display method may optionally be configured such that the number of splines included on the medical device corresponds to the number of circular sectors of the circular arrangement.

[0091] The display method may optionally be configured to convert the received data into a circular arrangement, including comparing the measured bipolar electrode complex impedance (BECI) measurements to the baseline BECI measurements.

[0092] Although the present invention has been described with reference to exemplary embodiments, it will be appreciated by those skilled in the art that various changes may be made and equivalents may be substituted for its elements without departing from the scope of the present invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the present invention without departing from its basic scope. Therefore, the present invention is not limited to the specific embodiments disclosed, but the present invention will include all embodiments within the scope of the appended claims.

Claims

1. A display system configured to communicate tissue proximity data from a plurality of electrodes, the display system comprising: A display configured to output a circular graphical representation, the circular graphical representation comprising: a plurality of color regions forming a first circle, each of the plurality of color regions conveying a classification value for a corresponding electrode, the classification value indicating tissue proximity of the corresponding electrode; and A second circular plurality of graphic areas are formed, each of the plurality of graphic areas conveying a relative value of the corresponding electrode, the relative value indicating the tissue proximity of the corresponding electrode.

2. The display system of claim 1, wherein the display outputs a graphical user interface, wherein the graphical user interface is capable of directly manipulating the plurality of electrodes.

3. A display system according to claim 2, wherein the graphical user interface is capable of directly manipulating the treatment device.

4. The display system of claim 3, wherein the graphical user interface performs one or more gatekeeping functions. 5 . The display system of claim 1 , wherein the classification value indicates whether a threshold level of electrode contact is met, and wherein the relative value indicates an electrode contact value.

6. The display system of claim 1, wherein the circular graphical representation represents a circular electrode distribution on a medical device.

7. A user interface system for a catheter device, the user interface system comprising: a display comprising a circular proximity display area including a plurality of circular sectors, each of the plurality of circular sectors corresponding to one or more electrodes disposed on the catheter device; as well as one or more control features configured to manipulate the catheter device and / or the one or more electrodes disposed on the catheter device, Wherein the one or more control features are configured to select one or more system states.

8. The user interface system of claim 7, wherein the one or more system states include a tissue proximity state, wherein the tissue proximity state displays a categorical value of an electrode measurement in each of the plurality of circular sectors.

9. The user interface system of claim 8, wherein the tissue proximity status displays relative values ​​of electrode measurements in each of the plurality of circular sectors.

10. The user interface system of claim 9, wherein a color segment conveys the categorical value of the electrode measurement and a graphical segment displays the relative value of the electrode measurement.

11. The user interface system of claim 7, wherein the one or more system states include a baseline collection state, wherein the baseline collection state displays a plurality of radial segments within each circular sector, each radial segment conveying a categorical value of a baseline measurement.

12. The user interface system of claim 7, wherein the one or more system states include a therapy delivery state, wherein the therapy delivery state initiates ablation therapy via the catheter device.

13. The user interface system of claim 7, wherein the one or more control features are configured to provide a gatekeeping function to the catheter device.

14. A user interface system according to claim 7, wherein the one or more control features are configured to select the one or more electrodes, wherein selection of an electrode selectively enables the electrode for therapy delivery and / or electrode measurement, and wherein deselection of the electrode selectively disables the electrode for therapy delivery and electrode measurement.

15. A display method, comprising: receiving tissue proximity data from a plurality of electrodes; converting the received data into a circular arrangement, the circular arrangement comprising a plurality of circular sectors, each circular sector corresponding to one or more electrodes; as well as displaying the circular arrangement on a user interface, Each circular sector includes a categorical value display and a relative value display.

16. The method of claim 15, wherein the categorical value display includes output values, the output values ​​including optimal proximity, suboptimal proximity, and error status, each of the output values ​​corresponding to a respective color output. The method of claim 16 , wherein the relative value display includes a threshold line and a current proximity line.

18. The method of claim 15, wherein the plurality of electrodes are arranged on a plurality of splines extending circumferentially around a central axis of the medical device.

19. The method of claim 18, wherein the number of splines included on the medical device corresponds to the number of circular sectors of the circular arrangement.

20. The method of claim 15, wherein converting the received data into the circular arrangement comprises comparing measured bipolar electrode complex impedance (BECI) measurements to baseline BECI measurements.

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