Understanding the status of the balloon catheter

Abstract

To provide a system for use with a balloon disposed at a distal end of an intra-body probe.SOLUTION: A system for use with a balloon disposed at a distal end of an intra-body probe includes an output device, configured to produce an output indicating whether the balloon is elongated, and a processor. The processor is configured to calculate, based on respective locations of multiple elements disposed on a surface of the balloon, multiple values, over a time interval, of a parameter indicative of a radius of the balloon. The processor is further configured to modify a state of the output based on at least one of the values. Other embodiments are also described.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] This invention relates to the field of medical procedures such as cardiac ablation. [Background technology]

[0002] U.S. Patent Application Publication No. 2020 / 0155224 describes an inflatable balloon, the disclosure of which is incorporated herein by reference. The balloon comprises an inflatable membrane, one or more electrodes, and one or more conductive coils configured as magnetic sensors, coupled to the distal end of an axis for insertion into a patient's organ. The electrodes are provided across the entire outer surface of the membrane, and each of the conductive coils is provided in close proximity to each electrode of the membrane. [Overview of the project] [Means for solving the problem]

[0003] Some embodiments of the present invention provide a system for use with a balloon provided at the distal end of an intravascular probe. The system includes an output device configured to produce an output indicating whether the balloon is elongated, and a processor. The processor is configured to calculate a plurality of values ​​for a parameter indicating the radius of the balloon over a time interval, based on the location of each of a plurality of elements provided on the surface of the balloon. The processor is further configured to modify the state of the output based on at least one of the values.

[0004] In some embodiments, the elements include respective electrodes, and the processor is further configured to calculate the location based on the current passing through the electrodes or the respective voltage at the electrodes.

[0005] In some embodiments, the elements include a coil, and the processor is further configured to calculate the location based on the current induced in the coil by the magnetic field.

[0006] In some embodiments, the processor The numerical value is calculated based on the difference between the value at the end of the time interval and the value at the beginning of the time interval. When the numerical value exceeds a predetermined threshold, the output state is modified. It is configured to modify the output state by doing so.

[0007] In some embodiments, the duration of the time interval is 2 to 6 seconds.

[0008] In some embodiments, The value is a radius-related value, and the parameter is a radius-related parameter. The processor is further configured to compute multiple interval-related values ​​of an interval-related parameter that indicates the interval between an element and a portion of a probe proximal to the element over a time interval. The processor is also configured to modify the output state based on at least one of the interval-related values.

[0009] In some embodiments, the processor Based on the interval-related parameters, calculate the first change in the interval-related parameters over the first part of the time interval and the second change in the interval-related parameters over the second part of the time interval. The output state is modified in response to the first and second changes. It is configured to modify the output state based on at least one of the interval-related parameters.

[0010] In some embodiments, the processor is The first change and the second change each have opposite signs, The system is configured to modify the output state when the degree of the first change and the second change, respectively, exceeds a predetermined interval-related threshold.

[0011] In some embodiments, the processor is further configured to cause the output to indicate that the balloon is elongated before the end of the time interval, and the processor is configured to modify the state of the output by performing an action selected from a group of actions consisting of modifying the output to indicate that the balloon is no longer elongated, and terminating the output.

[0012] In some embodiments, the processor is Before the end of the time interval, prevent the balloon from inflating. It is further configured to stop the balloon from inflating based on at least one of the values.

[0013] In some embodiments, the processor is further configured to cause the output to indicate that the balloon is not elongated before the end of the time interval, and the processor is configured to modify the state of the output by performing an action selected from a group of actions consisting of modifying the output to indicate that the balloon is elongated and terminating the output.

[0014] Some embodiments of the present invention further provide a method for use with a balloon provided at the distal end of an intravascular probe. This method includes calculating a plurality of values ​​for a parameter indicating the radius of the balloon over a time interval, based on the location of each of a plurality of elements provided on the surface of the balloon. The method further includes modifying an output state indicating whether the balloon is elongated or not, based on at least one of the values.

[0015] Some embodiments of the present invention further provide a computer software product including a tangible non-transitory computer-readable medium storing program instructions. When read by a processor, these instructions cause the processor to calculate a plurality of values of a parameter indicating the radius of a balloon over a time interval based on the respective locations of a plurality of elements provided on the surface of a balloon provided at the distal end of an intravascular probe. The instructions further cause the processor to change an output state indicating whether the balloon is elongated based on at least one of the values.

[0016] The present invention will be more fully understood from the following detailed description of the invention, taken in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0017] [Figure 1] Schematic diagram of a system for ablating tissue of a target heart and / or sensing an electrogram signal passing through the tissue according to some embodiments of the present invention. [Figure 2A] Schematic diagram of a visual output generated in response to various respective states of a balloon according to some embodiments of the present invention. [Figure 2B] Schematic diagram of a visual output generated in response to various respective states of a balloon according to some embodiments of the present invention. [Figure 3A] Flowchart of an algorithm for promoting inflation of a balloon according to some embodiments of the present invention. [Figure 3B] Flowchart of an algorithm for promoting the balloon to stretch again according to some embodiments of the present invention.

Detailed Description of the Invention

[0018] Overview Certain types of intracellular medical probes are equipped with a balloon at their distal end. The surface of the balloon is fitted with multiple electrodes, which can be used to sense and / or ablate. Alternatively, or furthermore, the surface of the balloon may be fitted with an electrographic sensor.

[0019] When the balloon deploys, it is pumped out of the sheath, deflated, and then inflated. According to the instructions for use, the balloon is deflated and becomes elongated, then retracted into the sheath.

[0020] One challenge with using such balloons is that users may forget to deflate them before inflating them. Similarly, users may forget to extend the balloon before attempting to return it to its sheath. In each of these cases, the balloon may be damaged.

[0021] To address these challenges, embodiments of the present disclosure provide a processor configured to track the location of electrodes and / or electrographic sensors on a balloon. Based on the tracked location, the processor determines whether the balloon is elongated or deflated (i.e., not elongated). Upon determining the balloon's state, the processor may output any appropriate reminders or warnings to prompt the user to change the balloon's state as needed. Alternatively, or further, the processor may prevent the pump from inflating the balloon if it is elongated.

[0022] For example, following the balloon's exit from the sheath, the processor may display a reminder to deflate the balloon before inflation and / or stop the pump. Following the balloon's deflation, the processor may stop displaying the reminder and / or make the pump available again.

[0023] Similarly, if the user attempts to retract the balloon into its sheath before it is extended, the processor can output a reminder to extend the balloon. Following this extension, the processor can stop displaying the reminder.

[0024] In some embodiments, the processor identifies stretch and deflation events based on changes in the radius of the balloon that can be pulled away from the locations of electrodes and / or sensors on the balloon. For example, one indicator of deflation is an increase in radius over a predetermined threshold over a predetermined duration interval. Similarly, one indicator of stretch is a decrease in radius over a predetermined duration interval that exceeds a predetermined threshold.

[0025] Alternatively, or even moreover, the processor can detect elongation and contraction events based on changes in the spacing between electrodes and / or sensors, and on the more proximal portion of the probe. For example, one indicator of contraction is that a widening of the spacing over a predetermined duration interval is immediately followed by a narrowing of the spacing over another predetermined duration interval, and the degree of widening and narrowing exceeds a predetermined threshold. Similarly, one indicator of elongation is that a narrowing of the spacing over a predetermined duration interval is immediately followed by a widening of the spacing over another predetermined duration interval, and the degree of narrowing and widening exceeds a threshold.

[0026] System Overview First, refer to Figure 1, a schematic diagram of a system 20 for ablating the tissue of a heart 26 of a subject 28 and / or sensing electrographic signals passing through that tissue, according to some embodiments of the present invention.

[0027] The system 20 includes an internal probe 22. As shown in the insertion portion 25 of Figure 1, the probe 22 includes a balloon 40 provided at the distal end of the probe 22. In some embodiments, a plurality of electrodes 51 that can be used to sense intracardiac signals and / or ablate cardiac tissue are provided on the surface of the balloon 40. Alternatively or further, a plurality of coils 50 used for electromagnetic sensing may be provided on the surface of the balloon 40, for example, as described in U.S. Patent Application Publication No. 2020 / 0155224, the disclosure of which is incorporated herein by reference.

[0028] The system 20 further comprises a sheath 23. The physician 30 inserts the sheath 23 into the body of the subject 28, for example, through the superior or inferior vena cava of the subject. Subsequently, the physician 30 guides the sheath into the ventricle 26. Next, the physician advances the probe 22 through the sheath until the balloon exits the sheath.

[0029] The probe 22 is connected in close proximity to a pump 31, which may be located, for example, within a console 44. Upon receiving the balloon out of its sheath, the physician 30 can inflate the balloon with the pump 31 by pumping any suitable fluid, such as saline solution, into the balloon. Subsequently, the balloon can be used to ablate ventricular tissue. For example, the tissue may be ablated by an electric current passed between the electrode pair 51, or between electrode 51 and another electrode coupled to the chest of the subject. Such an electric current may be generated, for example, by an electric current generator (GEN) 45. Alternatively or further, the balloon can be used to sense signals from the tissue.

[0030] The system 20 further comprises a processor (PROC) 41, which may be provided, for example, on a console 44. The processor 41 is configured to control a pump 31 to inflate a balloon and, in some embodiments, to control a current generator 45 to ablate the target tissue. In some embodiments, the processor controls the pump and / or current generator in response to control signals generated by a physician operating buttons, switches, and / or any other control mechanisms on a control handle 32.

[0031] In some embodiments, the system 20 further comprises a plurality of magnetic field generating coils 42. When another current generator 43 passes current through the coils 42, a magnetic field is generated in the coils. This magnetic field induces signals in other electromagnetic sensors provided on the coil 50 and / or probe 22. These signals are carried through the probe to an appropriate circuit mechanism in the console 44 (for example, an analog-to-digital conversion circuit mechanism). For example, as described in U.S. Patents 5,391,199, 5,443,489 and 6,788,967 by Ben-Haim, as well as U.S. Patent 6,690,963 by Ben-Haim et al., U.S. Patent 5,558,091 by Acker et al., and U.S. Patent 6,177,792 by Govari, each disclosure of which is incorporated herein by reference, the processor 41 receives signals from the circuit mechanism and calculates the location of each electromagnetic sensor based on those signals. As will be explained below with reference to the following diagrams, based on this location, the processor can determine whether the balloon is elongated or deflated.

[0032] Alternatively, or furthermore, the system 20 may include a plurality of reference electrodes 49 that are coupled to the chest and / or back of the subject and can be connected to the console 44 via wires extending through the cable 39. Using the reference electrodes 49, the processor can calculate the location of one or more electrodes on the probe 22, such as electrode 51 and / or ring electrode 48 (Figure 2A), based on the applicable current passing through the electrodes or the applicable voltage at the electrodes. The processor can also determine for each electrode whether the electrode is inside or outside the sheath 23.

[0033] For example, the processor can pass current through each electrode and measure the resulting voltage between the electrode and a reference electrode. Alternatively, the processor can apply a voltage between each electrode and a reference electrode and measure the resulting current passing between that electrode and the reference electrode. Subsequently, the processor can calculate the location of the electrode based on the measured voltage or measured current (in such embodiments, a location map calibrated using an electromagnetic sensor can be utilized, for example, as described in U.S. Patent No. 7,536,218 by Govari et al. and U.S. Patent No. 8,456,182 by Bar-Tal et al., the disclosure of which is incorporated herein by reference). In such embodiments, a voltage rise or current decrease in response to a given current applied to an electrode may indicate an impedance increase between the electrode and the reference electrode, and therefore indicate that the electrode is in the sheath 23. Conversely, a voltage drop or current increase may indicate that the electrode is out of the sheath 23.

[0034] Alternatively, for example, the processor can pass a current between reference electrodes and measure the resulting voltage or current at the probe electrode. Subsequently, the processor can calculate the location of the probe electrode based on the measured voltage or measured current, for example, as described in U.S. Patent No. 5,983,126 by Wittkampf and U.S. Patent No. 5,944,022 by Nardella, whose respective disclosures are incorporated herein by reference. In such embodiments, a decrease in current through the electrode may indicate an increase in impedance between the electrode and the reference electrode, and therefore indicate that the electrode is in the sheath 23. Conversely, an increase in current may indicate that the electrode is out of the sheath.

[0035] The system 20 further comprises at least one output device configured to emit an output indicating whether the balloon is elongated or not. For example, as will be further described below with reference to Figures 2A and 2B, the display 24 may display a visual output 33 indicating whether the balloon 40 is elongated or not. Alternatively or further, for example, a speaker may output an audible indication depending on whether the balloon is elongated or not.

[0036] Typically, the processor 41 can be embodied as a single processor or as a collaboratively networked or clustered set of processors. The functionality of the processor 41 can be implemented in hardware only, for example, using one or more constant-function integrated circuits or general-purpose integrated circuits, application-specific integrated circuits (ASICs), and / or field-programmable gate arrays (FPGAs). Alternatively, this functionality may be implemented in at least some software. For example, the processor 41 can be embodied as a programmable processor, for example, a central processing unit (CPU) and / or a graphics processing unit (GPU). Program code and / or data, such as software programs, can be loaded for execution and processing by the CPU and / or GPU. The program code and / or data can be downloaded to the processor in electronic form, for example, over a network. Alternatively, or further, the program code and / or data can be provided and / or stored in a non-temporary tangible medium such as magnetic memory, optical memory, or electronic memory. Such program code and / or data, when provided to a processor, produce a machine or dedicated computer configured to perform the tasks described herein.

[0037] Herein, we refer to Figures 2A and 2B, which are schematic diagrams of the visual outputs 33 emitted in response to different states of the balloon 40 according to some embodiments of the present disclosure.

[0038] Figures 2A and 2B show a control handle 32 equipped with a knob 46. The knob 46 is connected to the distal tip 52 of the balloon 40 via a longitudinal element that passes through the probe 22. Thus, when the knob 46 is extended as shown in Figure 2A, the distal tip 52 is also extended, thereby elongating the balloon. Conversely, when the knob 46 is retracted as shown in Figure 2B, the distal tip 52 also retracts, causing the balloon to deflate. Instead of the knob 46, the control handle 32 may be equipped with any other suitable mechanism for extending and deflating the balloon 40.

[0039] While the balloon is inside the sheath 23, and again when the balloon leaves the sheath, the balloon becomes elongated. Thus, as shown in Figure 2A, when the balloon leaves (and possibly before), the processor 41 (Figure 1) can indicate to the user by output 33 that the balloon is elongated. For example, the output may clearly indicate that the balloon is elongated. Alternatively, or further, the output may clearly indicate that the balloon should not be inflated, thereby implicitly indicating that the balloon is elongated. Alternatively, or further, an audible warning, such as a series of beeps or extended beeps, may implicitly indicate that the balloon is elongated.

[0040] Following (and sometimes before) the balloon's emergence, the processor iteratively calculates a value for a radius-related parameter indicating the balloon's radius r, based on the location of each of several elements, such as electrodes 51 and / or coils 50 (Figure 1), provided on the balloon's surface. In some embodiments, the radius-related parameter may be the balloon's radius, diameter, or circumference at the location of the electrodes or coils along the longitudinal axis of the probe. (Typically, the location of each element calculated by the processor is the location of the element's center.) Such a parameter may be calculated, for example, by aligning a circle to the location of the elements. In other embodiments, the radius-related parameter may be the average spacing between electrode pairs 51 (e.g., opposing electrode pairs), the average spacing between coil pairs 50 (e.g., opposing coil pairs), or another parameter derived from one of the aforementioned average spacings.

[0041] Therefore, the processor continuously calculates the values ​​of radius-related parameters (hereinafter referred to as "radius-related values") as the balloon deflates. Following the balloon's deflating, the processor modifies the state of output 33 based on at least one of the radius-related values ​​calculated during the preceding time interval, for example, by modifying the output to indicate that the balloon is no longer elongated, or simply by ending the output.

[0042] For example, the processor may modify the output state upon receiving a latest radius-related value that exceeds a predetermined threshold. (For example, in an embodiment where the radius-related parameter is the radius of the balloon at the electrode position along the longitudinal axis of the probe, the processor may modify the output state upon receiving a latest radius-related value that exceeds a predetermined threshold.) Alternatively, or further, the processor may modify the output state upon receiving another numerical value, based on the difference between the radius-related value at the end of the time interval and the radius-related value at the beginning of the time interval, that exceeds another predetermined threshold. This numerical value may be, for example, the difference itself, or the difference divided by the duration of the time interval. For example, the processor may modify the output state upon receiving a difference that exceeds a threshold.

[0043] In some embodiments, instead of calculating radius-related values, or in addition to them, the processor iteratively calculates values ​​for spacing-related parameters that indicate the distance d between an element and a portion of a probe, such as a ring electrode 48, that is proximal to the element, based on the location of each element. Typically, spacing-related parameters include the average distance between an electrode 51 and a portion of the probe that is more proximal to it, or the average distance between a coil 50 and a portion of the probe that is more proximal to it.

[0044] In such embodiments, the processor can modify the output state based on at least one of the "interval-related values" calculated during the preceding time interval, instead of or in addition to at least one of the radius-related values. For example, based on the interval-related values, the processor can calculate a first change in the interval-related parameter over a first part of the time interval, and a second change in the interval-related parameter over a second part of the time interval. Subsequently, the processor can modify the output state in response to the first and second changes. For example, as will be further explained below with reference to Figure 3A, the processor can modify the output state in response to (i) the first and second changes having opposite signs, and (ii) the respective extents of the first and second changes exceeding a predetermined threshold.

[0045] Instead of displaying output 33 indicating that the balloon is elongated, or in addition to that, the processor may prevent the balloon from inflating once it has emerged from the sheath (and possibly before). For example, the processor may stop the pump 31 (Figure 1), or simply refrain from operating the pump even if a command to operate the pump has been received from the physician 30 (Figure 1). Subsequently, upon receiving confirmation that the balloon is deflated based on at least one of the radius-related values ​​and / or spacing-related values, the processor may stop preventing the balloon from inflating.

[0046] At any time after the balloon has deflated or before it has re-expanded, the processor may generate an output 33 indicating that the balloon is deflated, as shown in Figure 2B. For example, the processor may generate an output indicating that the balloon is deflated upon receiving confirmation that the balloon is deflated, confirmation that the air is leaking out of the balloon or is leaking out, or confirmation (for example, based on an increase in impedance) upon receiving confirmation that the more proximal portion of a probe, such as a ring electrode 48, is inside the sheath before the balloon re-expands, as shown in Figure 2B.

[0047] Output 33 can clearly indicate that the balloon is deflated. Alternatively, or further, the output may clearly indicate that the balloon should not be inserted into the sheath, thereby implicitly indicating that the balloon is deflated. Alternatively, or further, an audible warning, such as a series of beeps or extended beeps, may implicitly indicate that the balloon is deflated.

[0048] Furthermore, following the balloon's contraction, the processor continues to iteratively calculate the values ​​of the radius-related parameters and / or the interval-related parameters. Thus, the processor continues to calculate the radius-related values ​​and / or the interval-related values ​​as the balloon expands again. Following the balloon's re-expansion, the processor modifies the state of output 33, for example, by modifying the output to indicate that the balloon is elongated, or simply by ending the output, based on at least one of the radius-related values ​​and / or the interval-related values ​​calculated during the preceding time interval.

[0049] For example, the processor may modify the output state in response to the latest radius-related value exceeding a predetermined threshold. (For example, in an embodiment where the radius-related parameter is the radius of the balloon at the electrode position along the longitudinal axis of the probe, the processor may modify the output state in response to the latest radius-related value falling below a predetermined threshold.) Alternatively, or further, the processor may modify the output state in response to another numerical value, based on the difference between the radius-related value at the end of a time interval and the radius-related value at the beginning of the time interval, exceeding another predetermined threshold. For example, the processor may modify the output state in response to a negative difference (which may be divided by the duration of the time interval) exceeding a predetermined positive threshold.

[0050] Alternatively, or further, the processor may modify the output state in interval-related parameters in response to a first change over a first part of the time interval and a second change over a second part of the time interval. For example, as will be further explained below with reference to Figure 3B, the processor may modify the output state in response to (i) the first and second changes having opposite signs, and (ii) the degree to which the first and second changes exceed a predetermined threshold.

[0051] In some embodiments, a user can override the computer implementation logic that modifies the state of output 33 using any suitable input interface (such as a touchscreen belonging to display 24 (Figure 1)). Thus, for example, upon receiving an input indicating that the balloon is in a particular state, the processor can terminate an output indicating that the balloon is in another state.

[0052] Exemplary algorithms Here, we refer to Figure 3A, a flowchart of an algorithm 54 that facilitates the inflation of balloon 40 (Figure 1) according to some embodiments of the present invention. Algorithm 54 is executed by processor 41 before and during the deployment of balloon 40.

[0053] At the start of algorithm 54, the processor repeatedly checks in verification step 58 whether the balloon has exited the sheath. For example, the processor can check whether the impedance between electrode 51 and reference electrode 49 (Figure 1) has decreased, and whether the impedance between ring electrode 48 (Figure 2A) and reference electrode 49 has decreased. Alternatively, the processor may only need to check for a decrease in impedance between ring electrode 48 and reference electrode 49.

[0054] Upon confirming that the balloon is exiting the sheath, the processor outputs an indicator in output step 60 that the balloon is elongated, for example, as described above with reference to Figure 2A.

[0055] In other embodiments, the output step 60 may be performed even before the balloon has completely exited the sheath. For example, the processor may perform the output step 60 upon confirmation that the electrodes and / or sensors on the balloon have exited the sheath, or when the probe has been inserted into the sheath. (In such embodiments, the confirmation step 58 may not necessarily be performed.)

[0056] Following the output step 60, the processor repeatedly performs a calculation step 62 in which the processor calculates the values ​​of radius-related parameters and spacing-related parameters. (As explained above with reference to the previous figures, this calculation is based on the respective locations of several elements such as electrodes 51 and / or coils 50 provided on the surface of the balloon). Each calculated parameter value is stored in a buffer.

[0057] Following each of the calculation steps 62, the processor verifies in another verification step 64 whether the buffer is sufficiently filled. Specifically, the processor checks whether the values ​​in the buffer span a predetermined duration T, where T can be, for example, 2 to 6 seconds. If the buffer is not sufficiently filled, the processor returns to the calculation step 62.

[0058] Once the buffer is sufficiently filled, the processor calculates the change in radius-related parameters over a time interval in the change computing step 66. For example, the processor may calculate r[N]-r[N-kT], where r[N] is the most recently calculated value of the radius, k is the number calculated per second (i.e., the number of times per second that the calculation step 62 is performed), and T is the duration of the time interval in seconds. (If kT is not an integer, kT may be rounded to the nearest integer.)

[0059] Following the calculation of the change, the processor, in another verification step 68, determines if the change exceeds a predetermined threshold t r Check if it exceeds (in embodiments where the radius-related parameter is the balloon radius, t r(For example, this can be 1 to 5 mm). If it does not exceed this, the processor returns to calculation step 62. If it does exceed this, in another change computing step 70, the processor calculates the respective changes of the interval-related parameters over the two parts of the preceding time interval, the respective durations of which may be equal or unequal. For example, the processor can calculate the changes of intervals over two halves of the preceding time interval, i.e., d[N-kT / 2]-d[N-kT] and d[N]-d[N-kT / 2], where d[N] is the value of the most recently calculated interval. Subsequently, in another verification step 72, the processor verifies whether the changes meet a predetermined criterion to indicate balloon deflation.

[0060] For example, the inventors observed that while the balloons are deflated, the gap widens, thereby returning to (almost) its initial value. Therefore, the processor has (i) d[N-kT / 2]-d[N-kT]>t d (ii) d[N]-d[N-kT / 2]<-t d We can also check whether this is the case, and here, t d This is a predefined threshold. (t d (For example, this can be 0.5 to 3 mm). In other words, the processor determines whether d[N-kT / 2]-d[N-kT] is positive or d[N]-d[N-kT / 2] is negative, and whether both |d[N-kT / 2]-d[N-kT]| and |d[N]-d[N-kT / 2]| are t d You can also check if it is larger than that.

[0061] Upon verifying whether the change meets the criteria, the processor modifies the output state in output modification step 74, as described above with reference to Figure 2A, for example. In some cases, the processor may also stop inhibiting balloon inflation. For example, the processor may make the pump usable again. On the other hand, if the change does not meet the criteria, the processor returns to calculation step 62.

[0062] In other embodiments, the repetition of calculation step 62 may begin even before the balloon exits the sheath. Alternatively, or even moreover, the change computing step 70 and verification step 72 may be performed before the change computing step 66. Specifically, the change computing step 66 may be performed in response to verification step 72, which verifies whether the changes in interval-related parameters meet the criteria.

[0063] Herein, we refer to Figure 3B, a flowchart of an algorithm 76 that facilitates the re-expansion of the balloon 40 (Figure 1) according to some embodiments of the present invention. The algorithm 76 can be executed by the processor 41 at any time following the deflation of the balloon.

[0064] Algorithm 76 begins with a verification step 78, where the processor checks whether an indicator of balloon deflation is output at that time. If yes, the processor proceeds to the calculation step 62. Otherwise, in another verification step 80, the processor checks whether the ring electrode 48 (Figure 2A) has entered the sheath. If yes, in the output step 82, the processor outputs an indicator that the balloon is deflation, for example, as described above with reference to Figure 2B. Subsequently, or if the ring electrode has not yet entered the sheath, the processor proceeds to the calculation step 62.

[0065] Following each of the calculation steps 62, the processor performs a verification step 64 as described above with reference to Figure 3A. If the buffer is not sufficiently filled, the processor returns to the verification step 78. If it is filled, the processor performs the change computing step 66 as described above with reference to Figure 3A. Subsequently, in another verification step 68', the processor checks whether the change is below a negative threshold. For example, the processor checks if r[N]-r[N-kT] is -t rIt is possible to check whether it is below. If it is not below, the processor returns to the confirmation step 78. If it is below, the processor proceeds to the change computing step 70.

[0066] Following the performance of the change computing step 70, the processor checks in another confirmation step 72’ whether the change meets a predefined criterion so as to indicate the inflation of the balloon. For example, the inventors have noticed that while the balloon is elongated, the spacing-related meter drops and thereby (almost) returns to its initial value. Thus, the processor may check whether (i) d[N-kT / 2]-d[N-kT] < -t d , (ii) d[N]-d[N-kT / 2] > t d is true. In other words, the processor checks whether d[N-kT / 2]-d[N-kT] is negative, whether d[N]-d[N-kT / 2] is positive, and whether both |d[N-kT / 2]-d[N]-kT| and |d[N]-d[N-kT / 2]| are greater than t d .

[0067] (Note in the above example that in algorithm 76, it is assumed to use the same predefined time interval duration T as used in algorithm 54 (Figure 3A), and algorithm 76 may use different time interval durations).

[0068] If the change meets the predefined criterion, the processor changes the output state in the output renewal step 74 as described above while referring to, for example, Figure 2B. If not met, the processor returns to the confirmation step 78.

[0069] Those skilled in the art will see that the present invention is not limited to what has been specifically shown and described herein. Rather, the scope of embodiments of the present invention extends to both combinations and partial combinations of the various features described herein, as well as to variations and modifications not found in the prior art, which would be apparent to those skilled in the art upon reading the foregoing description. Documents incorporated by reference in this patent application shall be considered integral parts of this application, except that, to the extent that any term is defined in those incorporated documents in a manner that contradicts the definitions made herein, either explicitly or implicitly, as herein, only the definitions herein shall be considered.

[0070] [Implementation Method] (1) A system used in conjunction with a balloon provided at the distal end of an internal probe, An output device configured to produce an output indicating whether the balloon is elongated or not, It is a processor, Based on the location of each of the multiple elements provided on the surface of the balloon, multiple values ​​of a parameter indicating the radius of the balloon are calculated over time intervals. A system comprising a processor configured to modify the state of the output based on at least one of the aforementioned values. (2) The system according to Embodiment 1, wherein the element includes each electrode, and the processor is further configured to calculate the location based on the current passing through each electrode or the voltage at each electrode. (3) The system according to Embodiment 1, wherein the elements include each coil, and the processor is further configured to calculate the location based on each current induced in the coil by a magnetic field. (4) The processor A numerical value is calculated based on the difference between the value at the end of the aforementioned time interval and the value at the beginning of the aforementioned time interval. Upon the aforementioned numerical value exceeding a predetermined threshold, the state of the output is modified. The system according to Embodiment 1, configured to modify the state of the output by doing so. (5) The system according to Embodiment 4, wherein the duration of the time interval is 2 to 6 seconds.

[0071] (6) The value is a radius-related value, and the parameter is a radius-related parameter, The processor is further configured to calculate, based on the location, a plurality of interval-related values ​​of interval-related parameters that indicate the interval between the element and a portion of the probe proximal to the element over the time interval, The system according to Embodiment 1, wherein the processor is configured to modify the state of the output based on at least one of the interval-related values. (7) The processor Based on the interval-related values, a first change in the interval-related parameter over a first portion of the time interval and a second change in the interval-related parameter over a second portion of the time interval are calculated. The state of the output is modified in response to the first change and the second change. The system according to embodiment 6, configured to modify the state of the output based on at least one of the interval-related values. (8) The processor The first change and the second change each have opposite signs, The degree of each of the first and second changes exceeds a predetermined interval-related threshold, The system according to embodiment 7, configured to modify the state of the output in response to the above. (9) The system according to Embodiment 1, wherein the processor is further configured to cause the output to indicate that the balloon is elongated before the end of the time interval, and the processor is configured to modify the state of the output by performing an action selected from a group of actions consisting of modifying the output to indicate that the balloon is no longer elongated, and terminating the output. (10) The processor Before the end of the aforementioned time interval, the inflation of the balloon is prevented, Based on at least one of the above values, the balloon is stopped from inflating. The system according to embodiment 9, further configured as follows.

[0072] (11) The system according to Embodiment 1, wherein the processor is further configured to cause the output to indicate that the balloon is not elongated before the end of the time interval, and the processor is configured to modify the state of the output by performing an action selected from a group of actions consisting of modifying the output to indicate that the balloon is elongated and terminating the output. (12) A method of use in conjunction with a balloon provided at the distal end of an internal probe, Based on the location of each of the multiple elements provided on the surface of the balloon, multiple values ​​of a parameter indicating the radius of the balloon are calculated over time intervals. A method comprising modifying an output state indicating whether the balloon is elongated or not, based on at least one of the aforementioned values. (13) The method of Embodiment 12, wherein the element includes each electrode, and the method further comprises calculating the location based on the current passing through each electrode or the voltage at each electrode. (14) The method of Embodiment 12, wherein the element includes a coil, and the method further comprises calculating the location based on the current induced in the coil by a magnetic field. (15) Changing the state of the output is The numerical value is calculated based on the difference between the value at the end of the aforementioned time interval and the value at the beginning of the aforementioned time interval. The method according to Embodiment 12, comprising modifying the state of the output in response to the numerical value exceeding a predetermined threshold.

[0073] (16) The method according to embodiment 15, wherein the duration of the time interval is 2 to 6 seconds. (17) The value is a radius-related value, and the parameter is a radius-related parameter, The method further includes calculating a plurality of interval-related values ​​of an interval-related parameter that, based on the location, indicates the interval between the element and a portion of the probe located proximal to the element over the time interval, The method according to Embodiment 12, wherein modifying the state of the output includes modifying the state of the output based on at least one of the interval-related values. (18) Modifying the state of the output based on at least one of the interval-related values, Based on the interval-related values, calculate a first change in the interval-related parameter over a first portion of the time interval, and a second change in the interval-related parameter over a second portion of the time interval. The method according to Embodiment 17, comprising modifying the state of the output in response to the first change and the second change. (19) In response to the first change and the second change, the state of the output is modified. The first change and the second change each have opposite signs, The degree of the first change and the second change respectively exceeds a predefined interval-related threshold, The method according to Embodiment 18, which includes modifying the state of the output in response to the above. (20) The method of Embodiment 12, further comprising causing the output to indicate that the balloon is elongated before the end of the time interval, and modifying the state of the output is an action selected from a group of actions consisting of modifying the output to indicate that the balloon is no longer elongated, and terminating the output.

[0074] (21) Before the end of the time interval, the balloon will not inflate, The method according to Embodiment 20, further comprising stopping the inflation of the balloon based on at least one of the aforementioned values. (22) The method of Embodiment 12, further comprising causing the output to indicate that the balloon is not elongated before the end of the time interval, and modifying the state of the output comprising performing an action selected from a group of actions consisting of modifying the output to indicate that the balloon is elongated and terminating the output. (23) A computer software product comprising a tangible, non-temporary computer-readable medium in which program instructions are stored, wherein when the instructions are read by a processor, the processor Based on the location of each of the multiple elements provided on the surface of the balloon located at the distal end of the internal probe, multiple values ​​of a parameter indicating the radius of the balloon are calculated over time intervals. A computer software product that modifies the output state indicating whether the balloon is elongated or not, based on at least one of the aforementioned values.

Claims

1. A system used in conjunction with a balloon located at the distal end of an internal probe, An output device configured to produce an output indicating whether the balloon is elongated or not, It is a processor, Based on the location of each of the multiple elements provided on the surface of the balloon, multiple values ​​of a parameter indicating the radius of the balloon are calculated over time intervals. A processor configured to modify the state of the output based on at least one of the aforementioned plurality of values, The aforementioned multiple values ​​are radius-related values, and the aforementioned parameter is a radius-related parameter, The processor is further configured to calculate a plurality of interval-related values ​​of interval-related parameters that indicate the interval between the element and a portion of the internal probe proximal to the element over the time interval, based on the location. The processor is configured to modify the state of the output based on at least one of the plurality of interval-related values, The aforementioned processor, Based on the aforementioned multiple interval-related values, a first change in the interval-related parameter over a first portion of the time interval and a second change in the interval-related parameter over a second portion of the time interval are calculated. The state of the output is modified in response to the first change and the second change. The system is configured to modify the state of the output based on at least one of the multiple interval-related values, The aforementioned processor, The first change and the second change each have opposite signs, The degree of each of the first and second changes exceeds a predetermined interval-related threshold, A system configured to modify the state of the output in response to the above.

2. The system according to claim 1, wherein the element includes each electrode, and the processor is further configured to calculate the location based on the current passing through each electrode or the voltage at each electrode.

3. The system according to claim 1, wherein the elements include each coil, and the processor is further configured to calculate the location based on each current induced in the coil by a magnetic field.

4. The aforementioned processor, A numerical value is calculated based on the difference between the value at the end of the aforementioned time interval and the value at the beginning of the aforementioned time interval. Upon the aforementioned numerical value exceeding a predetermined threshold, the state of the output is modified. The system according to claim 1, configured to modify the state of the output by doing so.

5. The system according to claim 4, wherein the duration of the aforementioned time interval is 2 to 6 seconds.

6. A system for use in conjunction with a balloon provided at the distal end of an internal probe, An output device configured to produce an output indicating whether the balloon is elongated or not, It is a processor, Based on the location of each of the multiple elements provided on the surface of the balloon, multiple values ​​of a parameter indicating the radius of the balloon are calculated over time intervals. A processor configured to modify the state of the output based on at least one of the aforementioned plurality of values, The processor is further configured to cause the output to indicate that the balloon is elongated before the end of the time interval, and the processor is configured to modify the state of the output by performing an action selected from a group of actions consisting of modifying the output to indicate that the balloon is no longer elongated, and terminating the output. The aforementioned processor, Before the end of the aforementioned time interval, the inflation of the balloon is prevented, Based on at least one of the aforementioned multiple values, the balloon is prevented from inflating. The system described is further configured as follows.

7. The system according to claim 1, wherein the processor is further configured to cause the output to indicate that the balloon is not elongated before the end of the time interval, and the processor is configured to modify the state of the output by performing an action selected from a group of actions consisting of modifying the output to indicate that the balloon is elongated and terminating the output.

8. A method of use in conjunction with a balloon provided at the distal end of an internal probe, Based on the location of each of the multiple elements provided on the surface of the balloon, multiple values ​​of a parameter indicating the radius of the balloon are calculated over time intervals. This includes modifying the output state indicating whether the balloon is elongated or not based on at least one of the aforementioned multiple values, The aforementioned multiple values ​​are radius-related values, and the aforementioned parameters are radius-related parameters. The method further includes calculating a plurality of interval-related values ​​of an interval-related parameter that indicates the interval between the element and a portion of the internal probe located proximal to the element over the time interval, based on the location. Modifying the state of the output includes modifying the state of the output based on at least one of the plurality of interval-related values, The state of the output is modified based on at least one of the aforementioned interval-related values. Based on the aforementioned multiple interval-related values, calculate a first change in the interval-related parameter over a first portion of the time interval, and a second change in the interval-related parameter over a second portion of the time interval. This includes modifying the state of the output in response to the first change and the second change, In response to the first and second changes, the state of the output is modified. The first change and the second change each have opposite signs, The degree of the first change and the second change respectively exceeds a predetermined interval-related threshold, A method comprising modifying the state of the output in response to the above.

9. The method of claim 8, wherein the element includes each electrode, and the method further comprises calculating the location based on the current passing through each electrode or the voltage at each electrode.

10. The method of claim 8, wherein the element includes each coil, and the method further comprises calculating the location based on the current induced in each coil by a magnetic field.

11. To change the state of the output, The numerical value is calculated based on the difference between the value at the end of the aforementioned time interval and the value at the beginning of the aforementioned time interval. The method according to claim 8, comprising modifying the state of the output in response to the numerical value exceeding a predetermined threshold.

12. The method according to claim 11, wherein the duration of the time interval is 2 to 6 seconds.

13. A method for use in conjunction with a balloon provided at the distal end of an internal probe, Based on the location of each of the multiple elements provided on the surface of the balloon, multiple values ​​of a parameter indicating the radius of the balloon are calculated over time intervals. Based on at least one of the aforementioned multiple values, the output state indicating whether the balloon is elongated or not is modified, The output is made to indicate that the balloon is elongated before the end of the aforementioned time interval, Modifying the state of the output includes performing an action selected from a group of actions consisting of modifying the output to indicate that the balloon is no longer elongated, and ending the output. The method described above is The balloon's inflation is prevented before the end of the aforementioned time interval, A method further comprising stopping the inflation of the balloon based on at least one of the aforementioned multiple values.

14. The method of claim 8, further comprising causing the output to indicate that the balloon is not elongated before the end of the time interval, and modifying the state of the output comprising performing an action selected from a group of actions consisting of modifying the output to indicate that the balloon is elongated and terminating the output.

15. A computer software product comprising a tangible, non-temporary computer-readable medium in which program instructions are stored, wherein when the program instructions are read by a processor, the processor... Based on the location of each of the multiple elements provided on the surface of the balloon located at the distal end of the internal probe, multiple values ​​of a parameter indicating the radius of the balloon are calculated over time intervals. Based on at least one of the aforementioned multiple values, the output state indicating whether the balloon is elongated or not is modified. The aforementioned multiple values ​​are radius-related values, and the aforementioned parameters are radius-related parameters. When the program instruction is read by the processor, the processor is further instructed to calculate a plurality of interval-related values ​​of interval-related parameters that indicate the interval between the element and a portion of the internal probe proximal to the element over the time interval, based on the location. Causing the processor to modify the state of the output includes causing the processor to modify the state of the output based on at least one of the plurality of interval-related values, The processor is to modify the state of the output based on at least one of the plurality of interval-related values. The processor is instructed to calculate, based on the plurality of interval-related values, a first change in the interval-related parameter over a first portion of the time interval, and a second change in the interval-related parameter over a second portion of the time interval. This includes causing the processor to modify the state of the output in response to the first change and the second change, The processor is to modify the state of the output in response to the first change and the second change. The first change and the second change each have opposite signs, The degree of the first change and the second change respectively exceeds a predetermined interval-related threshold, A computer software product that, in response to this, causes the processor to modify the state of the output.

16. A computer software product comprising a tangible, non-temporary computer-readable medium storing program instructions, wherein when the program instructions are read by a processor, the processor... Based on the location of each of the multiple elements provided on the surface of the balloon located at the distal end of the internal probe, multiple values ​​of a parameter indicating the radius of the balloon are calculated over time intervals. Based on at least one of the aforementioned multiple values, the output state indicating whether the balloon is elongated or not is modified. Before the end of the aforementioned time interval, the output is made to indicate that the balloon is elongated. Causing the processor to modify the state of the output includes causing the processor to perform an action selected from a group of actions consisting of modifying the output to indicate that the balloon is no longer elongated, and terminating the output. When the aforementioned program instruction is read by the processor, the processor further: Before the end of the aforementioned time interval, the inflation of the balloon is prevented, A computer software product that prevents the balloon from inflating based on at least one of the aforementioned multiple values.

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